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ARTICLES
Chief-editor:
Drs. A.C.H. van Peski [2009/0001] Region Profile: EU/EEA / 3
[2009/0002] Substances hazardous to water (WGK and
Editorial Board: GAM) / 11
Dr. M.M. Kops-Werkhoven
Drs. H.A.F. van Well European Union
Dr. J.A.S.J. Razenberg [2009/0003] REACH: ECHA New Publications
Dr. L.J.M. Rodenburg December-January 2008 / 12
Drs. G.A. Schouten [2009/0004] EU-GHS or CLP Regulation (EC)
Drs. J. Zawierko No. 1272/2008 published / 13
[2009/0005] Belgium: Dimethyl fumarate / 15
Advisory Board: [2009/0006] EU Toys Directive: German BfR
K. E. Armstrong (U.S.A.) comments / 15
Dr. R. Fielding (United Kingdom) [2009/0007] Germany: Limit Value List 2008
Drs. A. Gondová (BGIA-Report 6/2008) / 16
Dr. C. van Lint (Australia)
Dan Liu (U.S.A.) International
S. Park (S.-Korea) [2009/0008] GHS Country Update (January 2009) / 16
H. Sano (Japan) [2009/0009] USA: revision to definition of Volatile
S. Savary (Canada) Organic Compounds – exclusion of propy-
J. Simpson (Australia) lene carbonate and dimethyl carbonate / 17
Dr. U. Schumacher (China) [2009/0010] Canada (Ontario): Cosmetic Pesticides Ban
P.G. Tse (New Zealand) Act 2008 / 17
[2009/0011] Japan: Review of the Chemical Substances
Control Law / 17
PUBLICATIONS
PUBLICATIONS
No. 2 Internet
[2009/0039] DHL: Dangerous Goods Regulations
March2009 overview / 55
Volume 6
OFFICIAL PUBLICATIONS
Part of Stoffennieuws.nl
[2009/0040] The Netherlands (period January 2009) / 55
[2009/0041] Belgium (period January 2009) / 55
[2009/0042] United Kingdom (Period December
2008-January 2009) / 56
content
will allow for a more structured cooperation. Dealing with confidential business
Consortia do not necessarily limit their activi- information
ties to REACH. Both consortia and SIEFs will Confidential Business Information (CBI) is
closely need to take into account the EU com- defined as information that:
petition law requirements (see below). (a) is secret in the sense that it is not, as a body
or in the precise configuration and assem-
Data Sharing and Cost Sharing bly of its components, generally known
REACH requires SIEF participants to share among or readily accessible to persons
studies involving vertebrate animals. In addi- within the circles that normally deal with
tion, REACH allows participants to share oth- the kind of information in question;
er studies as well. While the latter is not man- (b) has commercial value because it is secret;
datory, it is advisable to share all relevant in- and
formation, including non-animal data such as (c) has been subject to reasonable steps under
results from (Q)SARs for cost saving reasons. the circumstances, by the person lawfully
At this stage, inclusion of information from in control of the information, to keep it
chemicals which are assumed to have compa- secret.
rable properties (so called ‘read across’), may REACH does contain a specific single article or
be considered. On the basis of the informa- section on protection of CBI. There are how-
tion provided by participants, data gaps can ever provisions in REACH aimed at protect-
be identified and additional information ing CBI. While the ‘public right to know’ pro-
needs per volume band can be agreed upon. visions of Regulation (EC) No. 1049/2001 are
It may be that the available data suffices for applicable to documents held by the ECHA,
lower band registrations, in which case com- article 118 also specifies that ‘disclosure of
panies who only register for these limited vol- certain information shall normally be deemed
umes are not required to share in the cost for to undermine the commercial interests of the
the additional studies. concerned person: this information includes
details of composition, specific use, functions
Cost sharing and application if substances, precise tonnage
The cost made by a SIEF may include man- and business relations’. Furthermore, regis-
agement cost, compensation of data holders trants can claim confidential treatment of
and cost of additional testing. Apart from certain information (article 10). Finally, un-
these costs, individual companies will have der article 11 and 19, registrants are allowed
to take care of their own management costs to opt out from joint submission because of
and registration fees payable to ECHA. Com- the risk of disclosing CBI (see point below).
pensation of costs made by data holders in A manufacturer, importer or where relevant
the past, may be depending on the number downstream user, who does not want to be
of tests available per end point, the quality identified, may want to appoint a so called
of the test and the number of registrants that third party representative (TPR) for discus-
will make use of the test. Cost sharing is not sions (for instance in SIEFs and consortia)
provided for extensively in REACH itself; the with other stakeholders. The actor appoint-
only requirement is that costs of sharing in- ing the TPR will retain full responsibility (and
formation are determined in a fair, transpar- liability) however for all obligations under
ent and non-discriminatory way. Again, avail- REACH. Finally, SIEF-participants may want
able guidances provide valuable information to enter into confidentiality agreements.
and advice about cost sharing.
Based on the information submitted by indu- wing legislations: The Pesticides Act 1974 (Act
stry, the Department of Environment (DOE) 149), The Poisons Act 1952 (Act 366), and The
will establish the Malaysian Chemicals Regis- Chemical Weapons Convention Act 2005 (Act
ter. The Malaysian Chemicals Register will 641).
contain information about the identity of sub- Only substances manufactured or imported in
stances that have been notified to DOE, their certain amounts by the individual manufac-
uses in Malaysia, their hazard classification turer/importer will require notification. For
and the accumulated amounts placed on the other exemptions to the notification require-
market in Malaysia. Information in the Che- ment, please refer to the ‘Guidance Document
micals Register will be available to the public for Industry’.
through the Internet. Accumulated amounts The notification requirement will be phased
manufactured or imported will only be publi- in over a number of years. The first phase will
cised for substances notified by three or more include substances that are defined as environ-
manufacturers or importers. A particular use mentally hazardous substances (EHS) under
of a substance will likewise only be publicised The Environmental Quality Act (1974).
if notified by three or more manufacturers or Output: Parallel to the notification and regi-
importers. stration scheme, the Department of Envi-
Scope: The notification scheme covers: ronment (DOE) is also introducing a scheme
– All substances not covered by other noti- for risk assessment of chemical substances of
fication/registration schemes in Malaysia concern in Malaysia. The chemicals of con-
and fulfilling the criteria for classification cern that will be considered in the risk assess-
as hazardous according to the Globally ment scheme will be prioritised based on their
Harmonised System of Classification and classification according to the Globally Har-
Labelling (GHS), or until GHS is fully monised System of Classification and Label-
implemented, the classification according ling (GHS) or until GHS is fully implemented,
to the current classification requirements classification according to the current classifi-
for chemicals in Malaysia. cation requirements for chemicals in Malay-
– Other substances that are considered sub- sia, and in addition the total annual tonnage
stances of concern due to properties not of substance manufactured or imported to
covered by the GHS classification scheme. Malaysia. Substances of concern due to effects
The notification requirement does not apply which are not covered by the GHS classifica-
to substances for which information is already tion criteria will be prioritised based on annu-
submitted to a Government agency in Malay- al tonnage and use in the country. Based on
sia by means of other legislations. This regards the outcome of the risk assessment, DOE and
substances notified/registered under the follo- other agencies in chemicals management will
decide upon the risk reduction strategy and substances. This list is published on: http://
the risk reduction actions to be implemented. www.e-ehs.doe.gov.my/homepage/ehs_list/.
Implementation Plan for EHS Notification
and Registration: The Notification and Regi- Guidelines for HS Notification &
stration of EHS by chemical industries in Registration
Malaysia will be implemented in phases. Ini- Chemical manufacturers and importers
tially the scheme will be on a voluntary basis, making the notification and registration of
where in 2009 all chemical industries, irrespec- EHS are encouraged to follow the steps given
tive of the tonnage imported or manufactu- below:
red, can register to participate in the scheme. A. Pre-notification
However, beginning Year 2010, the notification (1) Compile an inventory (list) of all indivi-
of EHS by manufacturers and importers will dual chemical substances manufactured and/
only be based on the total tonnage of EHS or imported by the company during the year
manufactured and imported. The phase-in of notification. The substances to be listed,
year for the notification based on tonnage is together with their identification number (e.g.
given in the Table below. CAS No or EC No), may be in pure form or as
part of mixtures or in finished products.
All substances that, under GHS classification, (2) Check whether each of the listed chemical
are assigned an aquatic toxicity classification substances is hazardous or not. There are two
of “chronic 1” (/) or are suspected or known ways to achieve this:
human carcinogens, reproductive toxicants Log into the Department of Environment’s
or mutagens (+) must also be notified during on-line EHS Notification and Registration
years 2010 and 2011. System. In the EHS Reference List box, type
EHS Register: The EHS Register is a listing of the identification number (CAS No or EC
all chemical substances, notified by manufac- No) of the substance and click on the Search
turers and importers in Malaysia, which are button. A result of the search function will be
hazardous to human health and the environ- displayed to the user. If the substance is on the
ment. Due to confidentiality requirements, EHS Reference List and already has an agreed
only substances which are notified by three or GHS hazard classification, as shown by the
more companies are presented in this output. displayed chemical name, classification code
The default list includes all substances which and other properties, a basic notification of
have been notified since the scheme was start- the substance is required from the company.
ed in 2007. The hazard classification catego- The basic notification is however not required
ry of Malaysia is based on the Occupational if the annual tonnage of the substance is below
Safety and Health (Chemicals Classification, the tonnage trigger point currently enforced
Labelling and Safety Data Sheet) Regulation by the Department of Environment Malaysia
(CLASS). (see Implementation). The information can
EHS Reference List: The EHS Reference List be notified by completing the form under the
adopted by the Department of Environment sub-menu “Basic Notification of EHS”. (Note:
Malaysia is based on the published European A chemical company needs to register with
Annex I to the Substance Directive (Directive the EHS system first before a notification is
67/548/EEC). Annex I is a comprehensive list permitted - See Step 4).
of dangerous substances classified with har- Next, type the identification number (CAS
monised classification and labelling; compris- No or EC No) of the substance in the CMR
ing of 2550 existing substances and 700 new Reference List and click on the Search button.
If the substance is on the CMR Reference List
and already has an agreed GHS hazard clas- be made available for inspection on request by
sification, as shown by the displayed chemical the Department of Environment Malaysia.
name, classification code and other properties, For some substances, it is recognized that the
a basic notification of the said substance is producer and/or importer may be unable to
also required from the company; irrespective carry out a GHS classification (e.g. because of
of the annual tonnage produced or imported insufficient data or uncertainty in the struc-
by the company. ture of the substance). In this case, the pro-
(3) If the substance is not on the EHS and ducer or importer should submit all of the
CMR Reference Lists or which do not have an available data, including tonnage, and submit
agreed GHS classification, as indicated by the them to the DOE with an explanation of why
message “Record Not Found”, the manufactu- it was not possible to assign a GHS classifica-
rer or importer will then be required to assess tion.
that substance against the GHS classification (5) Finalize the list of all hazardous substances
criteria. If the substance is assigned a GHS manufactured and/or imported by your com-
classification, the manufacturer or importer pany. The list shall have, at least, all the infor-
will then be required to supply the infor- mation required for basic notification of EHS,
mation that they have used to carry out the i.e. name of chemical, ID no, annual tonnage,
classification, the classification itself and the occurrence, source, uses, etc.
data on tonnage per annum (as defined in the Full details and guidance on the Notification
basic notification of EHS). The manufacturer and Registration Process are available in the
or importer can also refer to the Safety Data Guidance Document which can be downloa-
Sheet (SDS) of the given substance or mixtu- ded from this website.
re/product, where in Section 2 on “Composi- B. Notification
tion/Information on Ingredients”, a listing of (1) Register your company with the Depart-
the hazardous substances in the mixture/pro- ment of Environment Malaysia to partici-
ducts is documented. Note: There is a need to pate in the EHS Notification and Registration
differentiate between the SDS of a substance Scheme. This can be done by logging into the
and a SDS of a mixture or product. The EHS DOE website (http://www.doe.gov.my) and
Notification and Registration Scheme is for activating the menu on EHS Notification and
environmentally hazardous substances only. Registration. Select the option on Company
If in doubt about the properties given in the Registration in the resultant output to regis-
SDS, please contact the supplier or manufac- ter your company. A letter of approval, sent by
turer of the substance or mixture/product. If e-mail, will be communicated to you once the
through any of the above ways the substance registration is verified and approved by the
is determine to be hazardous, a detail notifi- Department.
cation of the substance is required from the (2) A two stage approach is recommended to
company. The information can be notified by chemical industries for the Notification and
completing the form under the sub-menu on Registration of EHS. Once access to your com-
“Detail Notification of EHS”. pany private domain or window is obtained,
(4) For those substances which are not assig- i.e. after entering the User ID and Password,
ned a GHS classification in Step 3, the manu- follow the procedures listed below:
facturer or importer shall however be required Activate the menu on Basic Notification of
to retain the data used to make their GHS EHS to undertake a basic notification for each
assessment for a minimum of 5 years, after hazardous substance which you have finalized
the assessment has been made. The data must in Step 5. On completion of data entry, check
for correctness of your data before submit-
Importer or manufacturer of individual substances Importer of substances as part of a mixture or finished product
• The substance is included in the EHS Reference List • The substance is included in the EHS Reference List
• The substance is not included in the EHS Reference List • The substance is not included in the EHS Reference List
but is classified as hazardous according to GHS criteria but is classified as hazardous according to GHS criteria
as outlined in CLASS regulation/guidance document as outlined in CLASS regulation/guidance document
• The substance is not exempted from notification • The substance is not exempted from notification
• The EHS is manufactured or imported annually in • The cumulated annual amount of the EHS in mixtures
amounts exceeding the defined tonnage trigger point and/or products where the concentration of the sub-
and covered by phase-in criteria (see Implementa- stance exceeds 1 % (0.1 % for carcinogenic substan-
tion) ces, substances toxic to reproduction, and category 1
and 2 mutagens) is above the defined tonnage trigger
point and covered by phase-in criteria (see Implemen-
tation)
ting the information to DOE, since informa- In this case, detail data previously notified can
tion once submitted will not be subject to any be accessed and edited to reflect the changes
changes. Repeat the basic notification for all
substances in your list. A display listing all Registration of Companies: Company regi-
substances entered into the system and noti- stration in the EHS Notification and Registra-
fied by your company is available for your tion Scheme of the Department of Environ-
viewing and printing, if required. Explana- ment Malaysia is aimed solely at manufacturers
tory texts to assist you in entering the data as and importers of chemical substances and
well as how to proceed with the notification importers of chemical substances as part of
process are given the system. a mixture or finished product. Registration
Once the basic notification has been comple- may be required for companies belonging to
ted, a detail notification can then be underta- the following categories:
ken. In this case, the substances which require 1) The company is a manufacturer of EHS
detail notification will be listed when the and these EHS are used by the company
menu Detail Notification of EHS is activa- or sourced by other companies (local
ted. Select a particular substance to begin the or overseas) down the supply chain, to
detail notification process. (Note: All six sets trade or formulate/manufacture chemical
of data, i.e. EHS Identification, Physical Che- mixtures or products. Chemical indus-
mical Properties, Physical Hazards, Hazards to tries involved only in the manufacture
Human Health, Hazards to Aquatic Environ- of chemical mixtures or products using
ment and Overall GHS Classification must be locally manufactured EHS or imported
completed before submitting the data to the EHS sourced from local suppliers as raw
Department of Environment Malaysia). materials are not subject to notification
If a substance had been previously notified in and registration of EHS.
detail (e.g. in the previous year), a detail noti- 2) The company is an importer of individual
fication of the said substance is not required EHS and/or chemical mixtures or finished
anymore. However a new detail notification products containing EHS as constituents.
of the substance should be made if new data Chemical companies involved only in the
are available to the company. formulation, distribution, retailing and
Nickel compounds
The classifications of the nickel compounds
listed in this Directive are based on the effects
originating from the Ni(2+) ion and on the
available data for nickel compounds. The
classifications were derived bij grouping nic-
kel compounds into categories on the basis of
water solubility (e.g. groups insoluble, slightly
soluble and soluble nickel compounds respec-
tively). Water solubility was used as an initial
criterion to define these categories, based on
the argument that nickel substances having
similar water solubility will indicate similar
bioavailability of the Ni(2+) ion and similar
systemic toxicity. This justifies a read across
within groups from the substances for which
the available adequate test data demonstrate a
specific systemic effect to those lacking such
test data. For some effects, read across bet-
ween groups is justified, as similar effects have
been observed across the range of water solu-
bility. For example, epidemiological studies
show that both soluble and insoluble nickel
compounds (at opposite ends of the range on 1 May 2004 or on 1 January 2007, by the
of solubility) have local carcinogenic effects manufacturer or importer at any time bet-
in the respiratory tract. There is, therefore, ween 18 September 1981 and 31 October
good reason to conclude that slightly soluble 1993 inclusive, and before the entry into force
compounds (at the middle of this range) have of this Regulation it was considered as having
similar carcinogenic properties. been notified in accordance with the first
As part of an evaluation of all the available indent of Article 8(1) of Directive 67/548/EEC
information for the nickel compounds, water in the version of Article 8(1) resulting from
solubility can be used as an approximation of the amendment effected by Directive 79/831/
systemic bioavailability of the Ni(2+) ion for EEC, but it does not meet the definition of a
many effects and substances. polymer as set out in this Regulation, provi-
Reference: http://eur-lex.europa.eu/LexUriServ/LexU- ded the manufacturer or importer has docu-
riServ.do?uri=OJ:L:2009:011:0006:0082:EN mentary evidence of this;’,
:PDF read: ‘(c) it was placed on the market in the
Community, or in the countries acceding
to the European Union on 1 January 1995,
Again corrigendum to REACH text on 1 May 2004 or on 1 January 2007, by the
manufacturer or importer before the entry
[2009/0031] into force of this Regulation and it was con-
sidered as having been notified in accordance
Corrigendum to Regulation (EC) No1907/2006 with the first indent of Article 8(1) of Direc-
concerning the Registration, Evaluation, tive 67/548/EEC in the version of Article 8(1)
Authorisation and Restriction of Chemicals resulting from the amendment effected bij
(REACH), establishing a European Chemi- Directive 79/831/EEC, but it does not meet
cals Agency, amending Directive 1999/45/ the definition of a polymer as set out in this
EC and repealing Council Regulation (EEC) Regulation, provided the manufacturer or
No. 793/93 and Commission Regulation importer has documentary evidence of this,
(EC) No 1488/94 as well as Council Direc- including proof that the substance was placed
tive 76/769/EEC and Commission Directi- on the market by any manufacturer or impor-
ves 91/155/EEC, 93/67/EEC, 93/105/EC and ter between 18 September 1981 and 31 Octo-
2000/21/EC (Official Journal of the European ber 1993 inclusive;’.
Union L 396 of 30 December 2006, p. 1; cor- Reference: http://eur-lex.europa.eu/LexUriServ/LexU-
rected by OJ L 136, 29.5.2007, p. 3) riServ.do?uri=OJ:L:2009:036:0084:0084:EN
The following reference is to the publica- :PDF
tion in OJ L 136, 29.5.2007, as amended by
Regulation (EC) No 1354/2007 (OJ L 304, International
22.11.2007, p. 1) and as corrected by the May
2008 corrigendum to Article 3(20)(c) (OJ L
141, 31.5.2008, p. 22). USA: New Children’s Product
This corrigendum cancels and replaces the Safety Laws on lead and phthalates
corrigendum published in OJ L 141, 31.5.2008,
p. 22, as follows: [2009/0032]
On page 21, Article 3(20)(c):
for: ‘(c) it was placed on the market in the On 10 February 2009, new requirements of the
Community, or in the countries acceding Consumer Product Safety Improvement Act
to the European Union on 1 January 1995, (CPSIA) take effect. Manufacturers, import-
ers and retailers are expected to comply with USA: Occupational Exposure to
the new Congressionally-mandated laws. Hexavalent Chromium
Under the new law, children’s products with
more than 600 ppm total lead cannot lawfully [2009/0033]
be sold in the United States on or after 10 Feb-
ruary 2009, even if they were manufactured This NIOSH criteria document is derived from
before that date. The total lead limit drops to reviews of information from human, animal,
300 ppm on 14 August 2009. and experimental studies of the toxicity of
Certain children’s products manufactured on hexavalent chromium (Cr(VI)) compounds
or after February 10, 2009 cannot be sold if and is intended to describe the potential health
they contain more than 0.1% of certain spe- effects of occupational exposure to this group
cific phthalates or if they fail to meet new of chemical compounds. Cr(VI) compounds
mandatory standards for toys [(a)…any chil- include a large group of chemicals with vary-
dren’s toy or child care article that contains ing chemical properties, uses, and workplace
concentrations of more than 0.1 percent of exposures. The major chromium-containing
di-(2-ethylhexyl) phthalate (DEHP), dibutyl materials in the marketplace are chromite ore,
phthalate (DBP), or benzyl butyl phthalate chromium chemicals, ferroalloys, and metal.
(BBP); (b) … until a final rule is promulgat- The United States is a major World producer
ed…. any children’s toy that can be placed in of chromium metal, chromium chemicals, and
a child’s mouth or child care article that con- stainless steel. Sodium dichromate is the most
tains concentrations of more than 0.1 percent common chromium chemical from which
of diisononyl phthalate (DINP), diisodecyl other Cr(VI) compounds may be produced.
phthalate (DIDP), or di-n-octyl phthalate Cr(VI) compounds commonly manufactured
(DnOP).] include sodium dichromate, sodium chroma-
While the U.S. Consumer Product Safety te, potassium dichromate, potassium chro-
Commission (CPSC) expects every company mate, ammonium dichromate, and Cr(VI)
to comply fully with the new laws resellers oxide. Other Cr(VI)-containing materials
should pay special attention to certain prod- commonly manufactured include various
uct categories. Among these are recalled chil- paint and primer pigments, graphic art sup-
dren’s products, particularly cribs and play plies, fungicides, corrosion inhibitors, and
yards; children’s products that may contain wood preservatives.
lead, such as children’s jewelry and painted NIOSH recommends that airborne exposure
wooden or metal toys; flimsily made toys that to all Cr(VI) compounds be limited to a con-
are easily breakable into small parts; toys that centration of 0.2 μg Cr(VI)/m3 for an 8-hr
lack the required age warnings; and dolls and TWA exposure, during a 40-hr workweek.
stuffed toys that have buttons, eyes, noses or Due to the residual risk of lung cancer at the
other small parts that are not securely fas- REL, NIOSH further recommends that all
tened and could present a choking hazard for reasonable efforts be made to reduce expo-
young children. sures to Cr(VI) compounds below the REL
Reference: http://www.cpsc.gov/cpscpub/prerel/ through the use of engineering controls and
prhtml09/09086.html work practices.
Legal text: http://www.cpsc.gov/cpsia.Pdf In addition to limiting airborne concentra-
tions of Cr(VI) compounds, NIOSH recom-
mends that dermal exposure to Cr(VI) be
prevented in the workplace to reduce the
risk of adverse dermal health effects inclu-
evaluate the risks the materials may pose to was not possible, so a conservative approach
health and the environment, the group said. – grouping polymers into low concern and
It is estimated that more than 800 consumer potential concern groups – was used in this
products containing nanomaterials are being initial analysis. Polymers that were considered
sold around the world. They include skin care to be PLCs showed generally low concern for
products, cosmetics, electronics, food addi- health or ecotoxicological effects, although
tives and medical therapies. Nanotechnology some effects of potential health concern were
is the science of manipulating particles smaller reported.
than 100 nanometres — more than 800 times Amongst the polymers that met the PLC cri-
smaller than the width of a human hair. teria, 87.8% showed low health concern and/
Reference: http://www.cbc.ca/health/ or low ecotoxicological concern. This value
story/2009/01/28/nanotech. represents the outcome of this initial analysis,
html#socialcomments given the level of confidence in the available
data. It is noteworthy that such a large propor-
tion of PLCs were clearly of low health con-
OECD: Polymers of Low Concern cern despite the use of conservative assumpti-
ons. It is likely that a higher level of confidence
[2009/0037] could be achieved with improved data quality
and analytical techniques.
In March 2007, the OECD Task Force on New One of the most striking findings related to
Chemicals Notification and Assessment orga- the number-average molecular weight (Mn)
nised an Expert Group Meeting on polymers, of a polymer; the lower the Mn, the higher the
held in Tokyo, Japan. At this meeting, the potential for health or ecotoxicological con-
Expert Group agreed to carry out a prelimi- cern. Similar results were obtained when the
nary analysis of data on polymers with a view contents of low molecular weight, oligomeric
to share experiences and provide evidence for species were investigated – the higher the con-
countries to reconsider their rule regarding tent, the more likely a polymer was to display
identification of Polymers of Low Concern concern. Trends were not clearly observed bet-
(PLCs). Data for 205 polymers were collated ween polymer class and any observed toxicity,
from Australia, Canada, Japan, Korea and US. but many classes were each represented by
Countries classified the polymers under two only a few polymers. No potential for health
categories (PLCs and non-PLCs) using the US concern was observed amongst the polyesters
EPA criteria. The analysis was aimed at iden- of the dataset.
tifying correlations between polymer charac- Reactive functional groups were more often
teristics and potential for health or ecotoxico- seen in potential health and ecotoxicologi-
logical concern. cal concern polymers than amongst the low
Definition: “Polymers of low concern are health concern polymers, but the level of data
those deemed to have insignificant environ- available was insufficient to confidently ana-
mental and human health impacts. Therefore, lyse any specific reactive functional groups. No
these polymers should have reduced regula- confident trends were observed between the
tory requirements.” functional group equivalent weight (FGEW)
Data of variable quality were collected. Sever- of a polymer and its potential for concern.
al health effects were reported for polymers, However, there was some suggestion that
and it was not possible to critically evaluate higher concern polymers had lower FGEWs
the quality of this data based on what was than low concern polymers.
available. Also, examination of specific effects
Law on the REACH Regulation EC/1907/2006 Order relating to the annual declaration of
adopted 25-Apr-2008 manufacturers, importers and users of PFOS
Regulation on Management with Waste Elec- to the administration adopted 26-Nov-2008
trical and Electronic Devices and Equipment Environmental and safety requirements
(WEEE) adopted 13-Jul-2007 applying to certain installations of filling or
Czech Republic distribution of flammable liquids subject to
Amendment of Air Protection Act detailing declaration adopted 19-Dec-2008
EU Regulations on fluorocarbons adopted Order on the transport of dangerous goods by
10-Dec-2008 road amended 09-Dec-2008
Regulation on chemical substances and pre- Environmental and safety requirements
parations with regards to testing amended applying to certain installations using or sto-
27-Oct-2008 ring chlorine and subject to declaration adop-
Estonia ted 17-Dec-2008
Regulation on requirements for ozone-deple- Environmental and safety requirements
ting substances amended 03-Jan-2008 applying to certain flammable liquid storage
Methods and procedure for labeling batteries tanks adopted 22-Dec-2008
and accumulators issued 21-Dec-2007 Environmental and safety requirements apply-
Requirements for handling used batteries and ing to certain installations storing ammonium
accumulators issued 10-Jan-2008 nitrate and subject to declaration adopted
Finland 18-Dec-2008
Adopted a Decree amending the Decree on Decree relating to the placing on the mar-
restricting hazardous substances in vehicles ket of substances and preparations adopted
09-Oct-2008 14-Dec-2008
Adopted a Decree amending the Decree on Hungary
the classification and labelling of chemicals Act on chemical safety with regard to REACH
28-Oct-2008 amended 01-Jun-2008
Adopted the Decree bringing into force the Amendment to Decree on dangerous substan-
ILO Convention No. 187 concerning the pro- ces and preparations with regard to REACH
motional framework for occupational safety adopted 03-Oct-2008
and health 19-Dec-2008 Amendment to Decree on the treatment of
Adopted a Decree bringing into force the electrical and electronic waste published
changes made to the European Agreement 10-Dec-2008
on the international transport of dangerous Amendment to WEEE Take-back Decree
goods by road (ADR 2009) 19-Dec-2008 published 10-Dec-2008
France Act on the promulgation of the ADR 2007
Order relating to the affixing of a pictogram adopted 06-Nov-2007
on the packaging of certain pharmaceutical Decree regulating activities with ozone deple-
products 03-Oct-2008 ting substances and certain fluorinated green-
Environmental and safety requirements house gases published 20-Dec-2008
applying to certain warehouses storing com- Decree on the restriction of dangerous sub-
bustible substances and products adopted stances and preparations amended with
23-Dec-2008 regard to mercury 30-Oct-2008
Environmental and safety requirements Amendment to Decree on the restriction of
applying to certain installations storing paper use of certain hazardous substances in elec-
and cardboard adopted 30-Sep-2008 trical and electronic equipment published
10-Dec-2008
Hazard assessment of existing chemicals con- Notification on Import of Batteries and Accu-
tinued 09-Dec-2008 mulators 2009/15 published 31-Dec-2008
Spain Notification on import of certain explosives
Royal Decree on the notification of new sub- 2009/11 published 31-Dec-2008
stances, classification, packaging and labeling Notification on the registration of user certifi-
of dangerous substances adopted 03-Nov- cates obtained for dual use goods and techno-
2008 logies 2009/12 published 31-Dec-2008
Amendments to the International Maritime New Regulation on Restrictions of Produc-
Dangerous Goods Code (IMDG) published tion, Placing on the Market, and Use of Cer-
12-Nov-2008 tain Hazardous Substances, Preparations and
Switzerland Goods published 26-Dec-2008
Ordinance relating to the transport of dange- New Regulation on Inventory and Control of
rous goods by road amended 30-Sep-2008 Chemicals published to introduce risk assess-
Ordinance relating to the safety advisers for ment of new substances 26-Dec-2008
the transport of dangerous goods by road, rail Regulation on Safety Information Forms
or inland waterway amended 22-Oct-2008 published to comply with the REACH Regu-
Taiwan lation 26-Dec-2008
GHS Labeling and MSDS requirements for Regulation on Classification, Packaging and
1062 dangerous and harmful materials ente- Labelling of Hazardous Preparations and Che-
red into force 19-Oct-2007 micals transposing 67/548/EEC and 1999/45/
Requirements on flammable pressurized gases EC published 26-Dec-2008
detailed 17-Oct-2008 Ukraine
649 dangerous materials subject to GHS Adopted Technical Regulation on Personal
requirements published 05-Dec-2008 Protective Equipment 27-Aug-2008
Turkey Adopted Lists of Chemicals and Goods the
Notification on import of Ozone Depleting Import and Export of Which is Subject to
Substances 2009/14 published to introduce Licencing 27-Dec-2008
more stringent provisions 31-Dec-2008 United States
Notification on Import of Chemical Substan- CAL: 2,4,6–Trinitrotoluene added to Proposi-
ces Attached to the Chemical Weapons Agree- tion 65 List 19-Dec-2008
ment 2009/17 published 31-Dec-2008 CAL: Hexavalent Chromium added to Propo-
Notification on Import of Dyestuffs 2009/15 sition 65 List; Chlorpyrifos, Particulate Mat-
published to introduce risk assessment ter, and Total Trihalomethanes remain under
31-Dec-2008 consideration 19-Dec-2008
Notification on Import of Substances Affecting VIR Adopted revisions to restrictions on lead-
Health and Safety at Work 2009/13 published containing paint 19-Dec-2008
31-Dec-2008 Vietnam
Notification on Import of Solvents and some Decree implementing a number of articles of
Petrol Products 2008/12 repealed 31-Dec- the Chemical Law adopted 07-Oct-2008
2008
Notification on the Control of Chemicals due
to Environmental Protection 2009/6 publis-
hed 31-Dec-2008
New Regulation on Reduction of Ozone
Depleting Substances published 12-Nov-2008
official
publications
publications
dossier was submitted by 30th April 2006, or Federal Register, 27 January 2009, Vol. 74,
for which all participants have withdrawn, No.16, 4751: Availability of the Report ‘ATS-
or none of the dossiers submitted could be DR Studies on Chemical Releases in the Great
accepted as complete under BPD and no-one Lakes Region’. Agency for Toxic Substances
has taken over the role of participant cannot and Disease Registry (ATSDR), Department
be placed on the EU market or subsequently of Health and Human Services (HHS). Notifi-
stored for any purpose (except for export and cation of publication.
disposal) from
21 August 2009.
Reference: http://www.hse.gov.uk/biocides/liveissues/
unsupported.htm
European Union
(period January 2009)
[2009/0043]
[2009/0044]
Auteur:
Dhr. E. Mossel
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Citeertitel
Journaal Stoffen en Preparaten jaartal/nummer
(voorbeeld: Journaal Stoffen en Preparaten 2009/1)
ISSN 1574-1079
content
European Commission REACH informa- sions necessary to comply with this Directive
tion: http://ec.europa.eu/environment/ by 1 June 2009 at the latest.These changes are
chemicals/reach/reach_intro.htm incorporated in the ESIS database on http://
– Bulgarian REACH text: http://eur-lex. ecb.jrc.ec.europa.eu/esis/.
europa.eu/LexUriServ/LexUriServ.do? The final draft of the 31st ATP has been pub-
uri=DD:13:60:32006R1907:BG:PDF lished and can be found on http://ecb.jrc.
– Romanian REACH text: http://eur-lex. ec.europa.eu/classification-labelling. Also this
europa.eu/LexUriServ/LexUriServ.do? ATP will enter into force on 1 June 2009 at the
uri=DD:13:60:32006R1907:RO:PDF latest.
– Norwegian REACH text: http://www. Annex I of the Dangerous Substances Directive
regjeringen.no/upload/UD/Vedlegg/ 67/548/EEC will be transposed to Annex VI
eu/forordning306r1907.pdf (Harmonised classification and labelling for
– Icelandic REACH text:: http://www. certain hazardous substances) of the CLP
reglugerd.is/interpro/dkm/WebGuard. Regulation.
nsf/Attachment/B_nr_750_2008_ Until now, the directive 67/548/EEC has been
fylgiskjal/$FILE/B_nr_750_2008_fyl- amended nine times and adapted to technical
giskjal.pdf progress 30 times. The services of the Euro-
pean Commission have prepared an unofficial
Classification and Labelling: The classifcation consolidated version which takes into account
and labelling of substances is still regulated by changes up to 1 August 2008.
the EU Directives 67/548/EEC (and its several An unofficial consolidated version of Direc-
adaptations) for substances and the Direc- tive 1999/45/EC which takes into account
tive 1999/45/EC (the former 88/379/EEC) changes up to 1 June 2007 is also available on
for the mixtures (preparations). But changes Internet.
are on its way. GHS has been adapted, result- The Directives 67/548/EEC and 1999/45/EC
ing in the its EU version: “Regulation (EC) will be repealed by 1 June 2015.
No 1272/2008 of the European Parliament References: Consolidated 67/548/EEC: http://
and of the Council of 16 December 2008 on ec.europa.eu/environment/chemicals/dan-
classification, labelling and packaging of sub- sub/pdfs/67_548_en.pdf
stances and mixtures, amending and repealing Consolidated 1999/45/EC: http://eur-lex.
Directives 67/548/EEC and 1999/45/EC, and europa.eu/LexUriServ/LexUriServ.do?uri=
amending Regulation (EC) No 1907/2006.” CONSLEG:1999L0045:20070601:EN:PDF
(O.J. L353 of 31 December 2008).
A major change was made by the 30the Safety Data Sheets: The Safety Data Sheet
ATP: “Commission Directive 2008/58/EC of Directice 91/155/EEEC (and its amendments
21 August 2008 amending, for the purpose 93/112/EC and 2001/58/EC) has been repealed
of its adaptation to technical progress, for the on 1 June 2007 and replaced by REACH Arti-
30th time, Council Directive 67/548/EEC on cle 31 and Annex II. Although no transition
the approximation of the laws, regulations period is given, themember states will appy a
and administrative provisions relating to the flexible and pragmatic approach to enforcing
classification, packaging and labelling of dan- the administrative changes. The“Commission
gerous substances. “(O.J. L 246 of 15 Septem- Working Group on the Practical Preparations
ber 2008), changing the classification of many for REACH” has decided that this informal
substances, in particular those of nickel and transition period for non-substantial changes
borates. Member States shall bring into force will end on 1 December 2010.
the laws, regulations and administrative provi-
Occupational exposure limit values: The closely monitoring trade in drug precursors
Commission of the European Communities both within the EU and between the EU and
establishes two kinds of occupational expo- the rest of the world.
sure limit values or OELs (indicative OELs “Council Regulation (EC) No 111/2005 of
and binding OELs) which are published in 22 December 2004 laying down rules for the
various directives. The currently applicable monitoring of trade between the Commu-
indicative limit values can be found in the nity and third countries in drug precursors”
following directives: Directive 2000/39/EC; lays down rules for the monitoring of trade
Directive 2006/15/EC. The Third list will be in drug precursors between the EU and coun-
published soon. tries outside the Union. It requires that all
Reference: http://www.dguv.de/bgia/en/fac/luft/gren- imports – including transhipment, exports
zwerte/index.jsp and intermediary activities involving drug
precursors be documented by operators, and
Restrictions on Marketing and Use: The that precursors be clearly identified as such.
RMU Directive 76/769/EEC and its amend- In addition, businesses trading in precursors
ments will be repealed with effect from 1 June have to hold a licence or be registered.
2009 and replaced by Annex XVII of the The Regulation (EC) No 273/2004 of the
REACH Regulation. European Parliament and of the Council of
11 February 2004 on drug precursors lays
ROHS Directive: An unofficial consolidat- down the rules for the monitoring of trade
ed version of “Directive 2002/95/EC of the within the EU.
European Parliament and of the Council of The third regulation “Commission Regula-
27 January 2003 on the restriction of the use tion (EC) No 1277/2005 of 27 July 2005 lay-
of certain hazardous substances in electrical ing down implementing rules for Regulation
and electronic equipment’ which takes into (EC) No 273/2004 of the European Parlia-
account changes up to 24 May 2008 is avail- ment and of the Council on drug precursors
able. and for Council Regulation (EC) No 111/2005
Frequently Asked Questions on Directive laying down rules for the monitoring of trade
2002/95/EC on the Restriction of the Use of between the Community and third coun-
certain Hazardous Substances in Electrical tries in drug precursors“ lays down detailed
and Electronic Equipment (RoHS) and Direc- implementing rules for the two regulations
tive 2002/96/EC on Waste Electrical and Elec- mentioned above, in order to establish the
tronic Equipment (WEEE) necessary procedures regarding licensing, and
References: ROHS: http://eur-lex.europa.eu/LexU- further detailed rules concerning the moni-
riServ/LexUriServ.do?uri=CONSLEG:20 toring of trade. Imports and exports require
02L0095:20080524:EN:PDF FAQs: http:// prior individual authorisations where specific
ec.europa.eu/environment/waste/pdf/ forms must be used. For transhipment con-
faq_weee.pdf signments the operator must be able to dem-
See also: http://ec.europa.eu/environment/waste/ onstrate the licit purposes of the transaction.
weee/index_en.htm References: Different types of administrations are
involved in drug precursor control, notably
Drug Precursors: European Community Health, Police, and Customs. Today, pre-
legislation cursor specific controls through Customs
A new legal arsenal has been put in place in at the EU external frontier are more impor-
the EU with the entry into force in August tant than ever. When the EU precursor
2005 of a set of three regulations aiming at legislation came into force more than a
decade ago, the EU used to be an exporter Council Regulation (EC) No 1167/2008 of
of drug precursors. Today this is still the 24 October 2008 amending and updating
case, but the EU also imports drug precur- Regulation (EC) No 1334/2000 setting up a
sors. Especially those precursors than can Community regime for the control of exports
be misused in the illicit manufacture of of dual-use items and technology
Amphetamine type Stimulants (ATS) are ‘Dual-use items’ shall mean items, including
generally not produced locally and must be software and technology,which can be used
brought into the EU. This situation requi- for both civil and military purposes, and shall
res particular attention from EU Customs include all goods which can be used for both
when securing the EU external frontier. nonexplosive uses and assisting in any way in
References: http://eur-lex.europa.eu/LexUriServ/LexU- the manufacture of nuclear weapons or other
riServ.do?uri=OJ:L:2005:022:0001:0010:EN nuclear explosive devices
:PDF References: http://europa.eu/scadplus/leg/en/lvb/
http://eur-lex.europa.eu/LexUriServ/LexU- l33247.htm
riServ.do?uri=OJ:L:2004:047:0001:0010:EN http://eur-lex.europa.eu/LexUriServ/LexU-
:PDF riServ.do?uri=CONSLEG:2000R1334:2007
http://eur-lex.europa.eu/LexUriServ/LexU- 1121:EN:PDF
riServ.do?uri=OJ:L:2005:202:0007:0033:EN http://eur-lex.europa.eu/LexUriServ/LexU-
:PDF riServ.do?uri=OJ:L:2008:325:0001:0251:EN
See also: http://ec.europa.eu/enterprise/ :PDF
chemicals/legislation/precursors/index_
en.htm Ozone-depleting substances: “Regulation
http://ec.europa.eu/taxation_customs/cus- (EC) No 2037/2000 of the European Parlia-
toms/customs_controls/drugs_precursors/ ment and of the Council of 29 June 2000 on
legislation/index_en.htm substances that deplete the ozone layer”. An
FAQs: http://ec.europa.eu/taxation_cus- unofficial consolidated version which takes
toms/resources/documents/customs/ into account changes up to 31 July 2007 is
customs_controls/drugs_precursors/legis- available.
lation/drug_precursor_faq_en.pdf Reference: http://eur-lex.europa.eu/LexUriServ/LexU-
riServ.do?uri=CONSLEG:2000R2037:2007
Chemical Weapons: The European Coun- 0731:EN:PDF
cil of 12 and 13 December 2003 adopted the
strategy against proliferation of weapons of Transport: “Directive 2008/68/EC of the
mass destruction, which in particular relates European Parliament and of the Council of
to combating chemical weapons. The present 24 September 2008 on the inland transport of
Joint Action follows on from the European dangerous goods” (text with EEA relevance).
Union (EU) commitment to support the This Directive shall apply to the transport of
activities of the Organisation for the Prohi- dangerous goods by road, by rail or by inland
bition of Chemical Weapons (OPCW) and waterway within or between Member States,
identifies seven priority projects. including the activities of loading and unload-
“Council Regulation (EC) No 1334/2000 of ing, the transfer to or from another mode of
22 June 2000 setting up a Community regime transport and the stops necessitated by the
for the control of exports of dual-use items circumstances of the transport. It shall not
and technology”. An unofficial consolidated apply to the transport of dangerous goods: (a)
version which takes into account changes up by vehicles, wagons or vessels belonging to or
to 21 November 2007 is available. under the responsibility of the armed forces;
Prior Informed Consent: The EU Council has Cosmetic Products: An unofficial consoli-
adopted the “Regulation (EC) No 689/2008 of dated version (up to Commission Direc-
the European Parliament and of the Council tive 2008/14/EC) of the Cosmetics Directive
of 17 June 2008 concerning the export and 76/768/EEC can be found on the Europa/
import of dangerous chemicals” to replace EUR-Lex website.
Regulation (EC) No 304/2003, which was A ‘cosmetic product’ shall mean any substance
annulled. Implementation of the new regula- or preparation intended to be placed in contact
tion will change the legal basis for the export with the various external parts of the human
and import controls of certain hazardous sub- body (epidermis, hair system, nails, lips and
stances and pesticides. The replacement regu- external genital organs) or with the teeth and
lation implements the Prior Informed Con- the mucous membranes of the oral cavity with
sent (PIC) procedure for certain hazardous a view exclusively or mainly to cleaning them,
chemicals and pesticides in international trade perfuming them, changing their appearance
but goes further than the provisions of the and/or correcting body odours and/or protect-
Rotterdam Convention on which the former ing them or keeping them in good condition.
is based. The provisions apply to all countries, Reference: http://eur-lex.europa.eu/LexUriServ/LexU-
not just those that have signed the Rotterdam riServ.do?uri=CONSLEG:1976L0768:2008
Convention. At the moment 39 chemicals 0307:EN:PDF
are covered; 24 pesticides, 4 severely hazard-
ous pesticide formulations and 11 industrial Detergents: Detergent’ means any substance
chemicals. or preparation containing soaps and/or other
surfactants intended for washing and cleaning
the volume trigger set by the regulation for EU-GHS or CLP Regulation (EC)
manufacturing or importing. No. 1272/2008 published
During the screening process ECHA removes
those pre-registrations that are in all evidence [2009/0004]
not substances (for example, pre-registrations
that are articles, such as “shoes”). Moreover, On New Years Eve 2008 the final text of EU-
pre-registrations not submitted bij EU/EEA GHS was published in the Official Journal of
companies will be deleted. the European Union 2008, L353: “Regulation
The List of pre-registered substances can be (EC) No 1272/2008 of the European Parlia-
accessed via a dedicated page in the ECHA ment and of the Council of 16 December 2008
CHEM section of the Agency website. on classification, labelling and packaging of
References: http://echa.europa.eu/doc/press/pr_08_59_ substances and mixtures, amending and repeal-
publication_pre-registered_substances_ ing Directives 67/548/EEC and 1999/45/EC,
list_20081219.pdf and amending Regulation (EC) No 1907/2006,
http://apps.echa.europa.eu/preregistered/ a document of 1355 pages.
pre-registered-sub.aspx. The term ‘mixture’ as defined in this Regu-
lation should have the same meaning as the
The Guidance for Downstream Users term ‘preparation’ previously used in Com-
available in 22 EU languages munity legislation.
The Guidance for Downstream Users is now CLP implementation (key dates):
available in 22 EU languages. One can access 20 January 2009: CLP Regulation (EC) No.
the different language version by changing 1272/2008 entered into
the language of the guidance web pages. The force
guidance pages in Bulgarian and Romanian 1 December 2010: CLP Titles II, III and IV
will be loaded in early 2009. Currently the shall apply in respect of
pages in these language versions contain text substances
in English. 1 June 2015: CLP Titles II, III and IV
Reference: http://guidance.echa.europa.eu/guidance_ shall apply in respect of
en.htm mixtures
This Regulation follows various declarations
ECHA Newsletter whereby the Community confirmed its inten-
ECHA Newsletter, the bimonthly newsletter tion to contribute to the global harmonisation
of the European Chemicals Agency, provides of criteria for classification and labelling, not
regular information on the Agency’s activities only at UN level, but also through the incor-
as well as lively stories and pictures of daily poration of the internationally agreed Global-
life within ECHA. No.1 was published in Ju;y/ ly Harmonised System of Classification and
August 2008, No.2 in September/October Labelling of Chemicals (GHS) criteria into
2008 and No. 3 in Novemver/December 2008. Community law.
References: http://echa.europa.eu/publications_en.asp This Regulation will replace the Dangerous
ECHA Newsletter No. 3: http://echa.euro- Substances Directive 67/548/EEC as well as the
pa.eu/doc/press/newsletter/echa_newslet- Dangerous Preparations Directive 1999/45/
ter_2008_12_11.pdf EC It should maintain the overall current level
of protection of human health and the envi-
ronment provided by those Directives. There-
fore, some hazard classes which are covered by
those Directives but are not yet included in the – Skin corrosion/irritation: Categories 1A,
GHS will be maintained in this Regulation. 1B and 1C have been taken together to
The two instruments foreseen by this Regula- Category 1A/1B/1C
tion to be used to communicate the hazards – Serious eye damage/irritation: Catego-
of substances and mixtures are labels and the ry 2A renamed to Category 2
safety data sheets provided for in REACH – Germ cell mutagenicity/Carcinogenic-
Regulation (EC) No 1907/2006. Of these two, ity/Toxic to reproduction: Categories 1A
the label is the only tool for communication to and 1B have been taken together to Cate
consumers, but it may also serve to draw the gory 1A or Category 1B
attention of workers to the more comprehen- One element has been added to CLP: Hazard-
sive information on substances or mixtures ous to the Ozone Layer (Danger. EUH059:
provided in safety data sheets. Since the provi- Hazardous to the Ozone Layer).
sions on safety data sheets are included in the Supplemental hazard information:
REACH Regulation which uses the safety data EUH001 Explosive when dry
sheet as the main communication tool within EUH006 Explosive with or without contact
the supply chain of substances, it is appropri- with air
ate not to duplicate the same provisions in EUH014 Reacts violently with water
this Regulation. EUH018 In use, may form flammable/
Manufacturers, importers and downstream explosive vapour-air mixture
users shall classify substances or mixtures in EUH019 May form explosive peroxides
accordance with Title II before placing them EUH029 Contact with water liberates toxic
on the market. gas
If a substance is subject to harmonised classi- EUH031 Contact with acids liberates toxic
fication and labelling in accordance with Title gas
V through an entry in Part 3 of Annex VI, that EUH032 Contact with acids liberates very
substance shall be classified in accordance toxic gas
with that entry, and a classification of that EUH044 Risk of explosion if heated under
substance in accordance with Title II shall not confinement
be performed for the hazard classes or differ- EUH066 Repeated exposure may cause skin
entiations covered by that entry. dryness or cracking
Differences between Purple Book and CLP: EUH070 Toxic by eye contact
Annex I: Not all emenents of the GHS Purple EUH071 Corrosive to the respiratory tract
Book Rev. 2 (2007) have been incorporated in EUH201 Contains lead. Should not be used
CLP: on surfaces liable to be chewed or
– Flammable liquids: Category 4 sucked by children
– Acute toxicity, oral/skin/inhalation: Cat- EUH201A Warning! Contains lead
egory 5 EUH202 Cyanoacrylate. Danger. Bonds
– Skin corrosion/irritation: Category 3 skin and eyes in seconds. Keep out
– Serious eye damage/irritation: Catego- of the reach of children
ry 2B EUH203 Contains chromium (VI). May
– Aspiration hazard: Category 2 produce an allergic reaction
– Aquatic toxicity (acute): Category 2, Cate EUH204 Contains isocyanates. May pro-
gory 3 duce an allergic reaction
Furthermore EUH205 Contains epoxy constituents. May
produce an allergic reaction
EUH206 Warning! Do not use together with may produce allergic reactions. There are only
other products. May release dan- a handful of equally potent sensitizers. The
gerous gases (chlorine) extreme sensitizing risk was brought to public
EUH207 Warning! Contains cadmium. attention by the “poison chair” incident, where
Dangerous fumes are formed dur- Chinese manufacturer Linkwise produced two-
ing use. See information supplied seater sofas with dimethyl fumarate sachets
bij the manufacturer. Comply with inside to inhibit mould while they were in stor-
the safety instructions age or transport. In Finland where the chairs
EUH208 Contains <name of sensitising were sold from 2006-2007, sixty users were
substance>. May produce an aller- given serious rashes. The cause was identified
gic reaction as dimethyl fumarate -induced allergic reaction
EUH209 Can become highly flammable in by Tapio Rantanen, M.D. from Finland, and his
use original article became the cover story in the
EUH209A Can become flammable in use July 2008 issue of British Journal of Dermatol-
EUH210 Safety data sheet available on ogy (Volume 159 Issue 1,Pages 218-221). In the
request United Kingdom, sofas sold by Argos, Land of
EUH401 To avoid risks to human health Leather and Walmsley Furnishing containing
and the environment, comply with the chemical caused over a hundred injuries.
the instructions for use. References: http://staatsbladclip.zita.be/staatsblad/wet-
Note: Pictograms have been published in the ten/2009/01/12/wet-2009024003.html
Official Journal in monochrome (contrarily http://en.wikipedia.org/wiki/Dimethyl_
to the UN GHS Purple Book). However, in fumarate
Annex I, section 1.2 it does state that the pic-
tograms shall have a red border.
Reference: http://eur-lex.europa.eu/LexUriServ/LexU- EU Toys Directive: German BfR
riServ.do?uri=OJ:L:2008:353:0001:1355:EN comments
:PDF
[2009/0006]
toxic) – may not be used in toys. On the other Reference: Grenzwerteliste 2008 – Sicherheit und
hand, the limit values of chemical legislation Gesundheitsschutz bei der Arbeit (BGIA-
are to apply in future to toys. According to Report 6/2008)
that, toys may contain up to 0.1 percent of For download or ordering a hardcopy:
these CMR substances. This is not sufficient http://www.dguv.de/bgia/de/pub/rep/
to protect children’s health. rep07/bgia0608/index.jsp
Many substances can also be taken up through
the skin. They include CMR substances, bio- International
cides or allergens. This should be borne in
mind especially in the case of toys that come
into prolonged and intensive contact with the GHS Country Update
skin like fingerpaints or play-dough. (January 2009)
The development of allergies can only be
prevented by keeping contact with allergenic [2009/0008]
substances as far as possible to a minimum.
The new Toys Directive does contain a list of Norway
55 banned allergenic substances. However, The EU-GHS or CLP regulation 1272/2008 is
in reality this ban on use is partially revoked not yet translated into Norwegian. However,
through the introduction of a limit value of the work is ongoing, and wneb finalised it will
0.01 percent for admissible trace levels. be published at www.sft.no hopefully before
Reference: http://www.bfr.bund.de/cd/27588 summer.
Iceland
Germany: Limit Value List 2008 The EU-GHS or CLP regulation 1272/2008 is
(BGIA-Report 6/2008) not yet translated into Icelandic.
See also: Country Profile Taiwan in Journaal Stoffen – proposed lists of products and ingredients
en Preparaten, 2008/6 to be banned or restricted for sale
– the rules for pesticide use on golf courses
– the exceptions to the ban for public health
USA: revision to definition of or safety reasons.
Volatile Organic Compounds – The comments are now being reviewed and
exclusion of propylene carbonate will help finalize a regulation to enforce the
and dimethyl carbonate ban. The ban would eliminate the use of con-
ventional pesticides for cosmetic purposes on
[2009/0009] lawns, gardens, school yards and parks. There
are lower risk alternatives to maintain lawns
On 13 January 2009 the Environmental Pro- and gardens and this is the direction that the
tection Agency (EPA) issued a final rule that Ontario government is taking.
no longer requires propylene carbonate [CAS The Cosmetic Pesticides Ban Act 2008 was
108-32-7] and dimethyl carbonate [ CAS 616- introduced on Earth Day (22 April 2008) and
38-6] to be regulated as volatile organic com- passed by the Ontario Legislative Assembly in
pounds (VOCs) under the Clean Air Act for June 2008.The proposed ban includes excep-
purposes of meeting the national ambient air tions for agriculture, forestry, health or safety,
quality standard for ozone. specialty turf, trees and protection of natural
EPA is excluding these two compounds as areas. Golf courses are also excepted but must
VOCs because scientific evidence shows they report on their pesticide use, and sports fields
are “negligibly reactive,” meaning they con- hosting national or international events may
tribute little or nothing to the formation of be able to obtain an exception.
smog. For a proper understanding of this Act the
By excluding these compounds as VOCs, meaning of ‘cosmetic’ is important: cosmetic
today’s action will make it easier and less means non-essential (esthétique).
expensive for industry to use these com- References: http://www.ontla.on.ca/bills/bills-files/39_
pounds as solvents in a variety of products Parliament/Session1/b064ra.pdf
including paints, inks and adhesives. These http://www.ene.gov.on.ca/en/land/pestici-
compounds may possibly be used as a substi- des/Factsheet-pesticides.pdf
tute for other solvents which are more harm-
ful to the environment and which are more
strictly regulated. Japan: Review of the Chemical
Reference: http://www.epa.gov/ttn/oarpg/t1/fact_ Substances Control Law
sheets/voc_exemp01011309.pdf
[2009/0011]
Conclusions:
– Although the current system is reasonably
effective, it allows a situation where exist-
ing chemical substances (approximately
publications
20 000 chemical substances were in circu-
lation in Japan in 1973, the year when the
Chemical Substance Evaluation Act was
instituted) are produced and used without The Australian Dangerous Goods
sufficient safety evaluation. The system Code 7th edition
should be changed in a way that basically
will subject all the chemical substances to [2009/0012]
step-by-step risk assessment.
– Notification to the authorities should The 7th edition of the Australian Dangerous
be made mandatory with regard to all Goods Code (ADG 7) has been endorsed by
chemical substances that are produced or the Australian Transport Council and it is
imported in excess of certain amounts. expected to be implemented in most juris-
Information contained in notifica- dictions by 31 December 2008. Other juris-
tions should be used to perform screen- dictions have agreed to implement it as soon
ing assessment for narrowing down the as possible after this date on a best endeavors
‘Chemical Substances for Priority Evalua- basis. There will be a transitional period of
tion’ (provisional name). The government 12 months in each State and Territory, com-
should collect safety information on these mencing when ADG 7 is implemented, where
substances step by step, in cooperation compliance with either the 6th edition or
with the companies concerned, and per- the 7th edition will be acceptable. Start and
form risk assessment on them. end dates for this transitional period should
– The government should restrict the pro- be checked with the Competent Authority in
duction, import and use of substances the relevant State or Territory. An electronic
posing a high risk. version of ADG 7 is available at no charge
– By 2020, the government should finish from 1 January 2009. It can be accessed from
taking general measures for all chemical the National Transport Commission web-
substances. site: http://www.ntc.gov.au/ViewPage.aspx?
References: http://www.meti.go.jp/english/press/ documentid=01147
data/20081222_02.html
http://www.meti.go.jp/policy/chemical_ INTERNET
management/english/2nd_joint_commit-
tee_to_review_cscl.html
Ciba EUREG Bulletin
Version 08/01
[2009/0013]
professionals involved in Product Safety and road (ADR) 2009 can now be accessed/down-
Regulatory Affairs as well as Environment, loaded in pdf format via the UNECE website.
Health and Safety. It will also be of interest to Reference: http://www.unece.org/trans/danger/publi/
specialists in Research & Development, Tech- adr/adr2009/09ContentsE.html
nical Operations, Supply Chain and Legal
functions.
In addition to summarising what’s new since USA: OSHA Field Operations
EUREG Bulletin 07/01, this edition (90 pages, Manual revised
September 2008) provides additional infor-
mation on the development of key EU and [2009/0016]
UK chemicals legislation, thereby establishing
a baseline and reference for future editions A revised OSHA Field Operations Manual
of the Bulletin which will focus more on new (formerly called the Field Inspection Reference
developments, new topics and their impact. Manual) is now available to provide OSHA
Reference: http://www.cibaexpertservices.com/Soluti- (U.S. Department of Labor’s Occupational
ons/Regulatory.aspx?contentID=2 or Safety and Health Administration) Compli-
http://www.ciba.com/index/exs-index/exs- ance Officers with a single source of updated
reg/exs-reg-regulatorybulletins.htm information and guidance to more effectively
protect employees from occupational injuries,
illnesses, and fatalities. The manual assists
Norway: REACH-ordbok Compliance Officers in scheduling and con-
ducting inspections, enforcing regulations,
[2009/0014] and encouraging continual improvement in
workplace safety and health.
On the website of the Norwegian Pollution Reference: http://www.osha.gov/OshDoc/Directive_
Control Authority (�������������������������
Statens forurensningstil- pdf/CPL_02-00-148.pdf
syn) an English-Norwegian dictionary (ord-
bok) of REACH terms has been published.
Examples:
Bringe i omsetning – Placing on the market
Fyllestgjørende undersøkelsessammendrag –
Robust study summary
Innfasingsstoff – Phase-in-substance
Nedstrømsbruker – Downstream user
Stoffer som gir stor grunn til bekymring –
Substances of Very High Concern, SVHC:
Reference: http://www.sft.no/seksjonsartikkel_41237.
aspx
ADR 2009
[2009/0015]
The European Agreement concerning the
international carriage of dangerous goods bij
preparations or in articles, in quantities of one tonne or O.J. 2008, C320: Council Decision 2008/C
more per year are registered as from 1 June 2008 in accord- 320/02 of 27 November 2008 appointing three
ance with Article 10 of the REACH Regulation. members of the Management Board of the
Prior to the registration of non phase-in substances, an European Chemicals Agency.
enquiry to the European Chemicals Agency – as foreseen O.J. 2008, L338: Commission Decision
under Article 26 of the REACH Regulation – is required. 2008/953/EC of 8 December 2008 recognising
It is noted that the provisions of the REACH Regulation in principle the completeness of the dossiers
governing the enquiry process entered into force on 1 June submitted for detailed examination in view of
2008. It follows that it was impossible in practice for a non the possible inclusion of Aureobasidium pul-
phase-in substance to be registered on 1 June 2008. In lulans and disodium phosphonate in Annex I
addition, it is also noted that the regulation containing the to Council Directive 91/414/EEC.
test methods for use under REACH, in accordance with O.J. 2008, L340: Commission Directive
Article 13(3) of Regulation (EC) No 1907/2006, was only 2008/123/EC of 18 December 2008 amending
adopted on 30 May 2008. Council Directive 76/768/EEC, concerning
Some substances that have been lawfully manufactured cosmetic products, for the purpose of adapt-
and/or placed on the market before 1 June 2008 may not ing Annexes II and VII thereto to technical
qualify as ‘phase-in substances’ under Article 3(20) of the progress.
REACH Regulation. To avoid disruptions of trade and [Directive 76/768/EEC is amended as follows: (1). In
manufacturing activities regarding such substances, and Annex II, entry 167 ‘Esters of 4-aminobenzoic acid, with
provided that it is demonstrated that the substance was the free amino group, with the exception of that given in
legally on the Community market before 1 June 2008, Annex VII, Part 2’ is replaced by ‘4-aminobenzoic acid and
potential registrants are reminded of the obligation to its esters, with the free amino group’.(2). In Annex VII,
submit an enquiry to the European Chemicals Agency. For entry 1 is deleted. (3). In Annex VII, in entry 28 the words
any specific information item missing, the registrant will ‘in sunscreen products’ are deleted from column ‘c’.]
provide a justification. The missing information will be O.J. 2008, L344: Commission Directive
submitted without undue delay.] 2008/125/EC of 19 December 2008 amend-
O.J. 2008, L335: Commission Decision ing Council Directive 91/414/EEC to include
2008/941/EC of 8 December 2008 concerning aluminium phosphide [cas 20859-73-8],
the non-inclusion of certain active substances calcium phosphide [cas 1305-99-3], magne-
in Annex I to Council Directive 91/414/EEC sium phosphide [cas 12057-74-8], cymoxanil
and the withdrawal of authorisations for [cas 57966-95-7], dodemorph [1593-77-7],
plant protection products containing these 2,5-dichlorobenzoic acid methylester [cas
substances. 2905-69-3], metamitron [CAS 41394-05-2],
O.J. 2008, L335: Commission Decision sulcotrione [CAS 99105-77-8], tebuconazole
2008/943/EC of 12 December 2008 concern- [CAS 107534-96-3] and triadimenol [CAS
ing the non-inclusion of bone oil [CAS 8001- 55219-65-3] as active substances.
85-2] in Annex I to Council Directive 91/414/ O.J. 2008, L344: Commission Decision
EEC and the withdrawal of authorisations 2008/967/EC of 12 December 2008 concern-
for plant protection products containing that ing the non-inclusion of carbon monox-
substance. ide [CAS 630-08-0] in Annex I to Council
O.J. 2008, L337: Commission Directive Directive 91/414/EEC and the withdrawal of
2008/116/EC of 15 December 2008 amend- authorisations for plant protection products
ing Council Directive 91/414/EEC to include containing that substance.
aclonifen [CAS 74070-46-5], imidacloprid O.J. 2008, L344: Commission Directive
[CAS 138261-41-3] and metazachlor [CAS 2008/127/EC of 18 December 2008 amending
67129-08-2] as active substances.
Council Directive 91/414/EEC to include sev- tion, packaging and labelling of dangerous substances and
eral active substances preparations: “- Persons already sensitised to diisocyanates
O.J. 2008, L348: Decision No 1348/2008/EC may develop allergic reactions when using this product. –
of the European Parliament and of the Coun- Persons suffering from asthma, eczema or skin problems
cil of 16 December 2008 amending Council should avoid contact, including dermal contact, with this
Directive 76/769/EEC as regards restrictions product. – This product should not be used under con-
on the marketing and use of 2-(2-meth- ditions of poor ventilation unless a protective mask with
oxyethoxy)ethanol, 2-(2-butoxyethoxy) an appropriate gas filter (i.e. type A1 according to stand-
ethanol, methylenediphenyl diisocyanate, ard EN 14387) is used.” (2) By way of derogation, para-
cyclohexane and ammonium nitrate. graph 1(a) shall not apply to hot melt adhesives.
[In Annex I to Directive 76/769/EEC, the following points 56. Cyclohexane CAS 110-82-7: (1) Shall not be placed on
are added: the market for the first time after 27 June 2010, for supply
53. 2-(2-methoxyethoxy) ethanol (DEGME) CAS 111-77- to the general public, as a constituent of neoprene-based
3: Shall not be placed on the market after 27 June 2010, contact adhesives in concentrations equal to or greater
for supply to the general public, as a constituent of paints, than 0,1 % by mass in package sizes greater than 350 g. (2)
paint strippers, cleaning agents, self-shining emulsions or Neoprene-based contact adhesives containing cyclohex-
Floor sealants in concentrations equal to or greater than ane and not conforming to paragraph 1 shall not be
0,1 % by mass. placed on the market for supply to the general public after
54. 2-(2-butoxyethoxy) ethanol (DEGBE) CAS 112-34-5: 27 December 2010. (3) Without prejudice to other Com-
(1) Shall not be placed on the market for the first time munity legislation concerning the classification, packaging
after 27 June 2010, for supply to the general public, as a and labelling of dangerous substances and preparations,
constituent of spray paints or spray cleaners in aerosol neoprenebased contact adhesives containing cyclohexane
dispensers in concentrations equal to or greater than 3 % in concentrations equal to or greater than 0,1 % by mass
by mass. (2) Spray paints and spray cleaners in aerosol dis- that are placed on the market for supply to the general
pensers containing DEGBE and not conforming to para- public after 27 December 2010 shall be visibly, legibly and
graph 1 shall not be placed on the market for supply to indelibly marked as follows: “- This product is not to be
the general public after 27 December 2010. (3) Without used under conditions of poor ventilation. – This product
prejudice to other Community legislation concerning the is not to be used for carpet laying.”
classification, packaging and labelling of dangerous sub- 57. Ammonium nitrate (AN) CAS 6484-52-2: (1) Shall not
stances and preparations, paints, other than spray paints, be placed on the market for the first time after 27 June
containing DEGBE in concentrations equal to or greater 2010 as a substance, or in preparations that contain more
than 3 % by mass that are placed on the market for supply than 28 % by mass of nitrogen in relation to ammonium
to the general public shall be visibly, legibly and indelibly nitrate, for use as a solid fertiliser, straight or compound,
marked by 27 December 2010 as follows: unless the fertiliser complies with the technical provisions
“Do not use in paint spraying equipment”. for ammonium nitrate fertilisers of high nitrogen content
55. Methylenediphenyl diisocyanate (MDI) CAS 26447-40- set out in Annex III to Regulation (EC) No 2003/2003 of
5: (1) Shall not be placed on the market after 27 December the European Parliament and of the Council of 13 Octo-
2010, as a constituent of preparations in concentrations ber 2003 relating to fertilisers (2) Shall not be placed on
equal to or greater than 0,1% by mass for supply to the the market after 27 June 2010 as a substance, or in prepa-
general public, unless the packaging: (a) contains protec- rations that contain 16 % or more by mass of nitrogen
tive gloves which comply with the requirements of Coun- in relation to ammonium nitrate except for supply to:
cil Directive 89/686/EEC of 21 December 1989 on the (a) downstream users and distributors, including natu-
approximation of the laws of the Member States relating ral or legal persons licensed or authorised in accordance
to personal protective equipment. (b) is marked visibly, with Council Directive 93/15/EEC of 5 April 1993 on the
legibly and indelibly as follows, and without prejudice to harmonisation of the provisions relating to the placing
other Community legislation concerning the classifica- on the market and supervision of explosives for civil use;
(b) farmers for use in agricultural activities, either full time classification, labelling and packaging of sub-
or part time and not For the purposes of this subpara- stances and mixtures.
graph: (i) “farmer” shall mean a natural or legal person, or O.J. 2009, L5: Commission Decision 2009/9/
a group of natural or Legal persons, whatever legal status EC of 8 December 2008 concerning the
is granted to the group and its members bij national law, non-inclusion of nicotine [CAS 54-11-5] in
whose holding is situated within Community territory, as Annex I to Council Directive 91/414/EEC and
referred to in Article 299 of the Treaty, and who exercises the withdrawal of authorisations for plant
an Agricultural activity, (ii) “agricultural activity” shall protection products containing that sub-
mean the production, rearing or growing of agricultural stance.
products including harvesting, milking, breeding animals
and keeping animals for farming purposes, or maintaining
the land in good agricultural and environmental condi- United States of America (period
tion as established under Article 5 of Council Regulation November 2008-January 2009)
(EC) No 1782/2003 of 29 September 2003 establishing
common rules for direct support schemes under the com- [2009/0021]
mon Agricultural policy and establishing certain support
schemes for farmers; (c) natural or legal persons engaged Federal Register, November 17, 2008, Vol. 73,
in professional activities such as horticulture, plant grow- No. 222, 67730: Labeling Requirement for
ing in greenhouses, maintenance of parks, gardens or sport Toy and Game Advertisements; Final Rule.
pitches, forestry or other similar activities. (3) However, Consumer Product Safety Commission. Final
for the restrictions in paragraph 2, Member States may rule.
until 1 July 2014, for socioeconomic reasons, apply a limit Reference: http://edocket.access.gpo.gov/2008/pdf/
of up to 20 % by mass of nitrogen in relation to ammo- E8-26964.pdf
nium nitrate for substances and preparations placed on Federal Register, November 19, 2008, Vol. 73,
the market within their territories. They shall inform the No. 224, 69532: Use of Ozone-Depleting Sub-
Commission and other Member States thereof. ] stances; Removal of Essential-Use Designa-
O.J. 2008, L352: Commission Decision tion (Epinephrine). Food and Drug Adminis-
2008/986/EC of 15 December 2008 concern- tration, HHS. Final rule.
ing the non-inclusion of antraquinone [CAS Federal Register, November 24, 2008, Vol. 73,
84-65-1] in Annex I to Council Directive No. 227, 71003: National Toxicology Program
91/414/EEC and the withdrawal of authorisa- (NTP); NTP Interagency Center for the Eval-
tions for plant protection products containing uation of Alternative Toxicological Methods
that substance. (NICEATM); Availability of the Interagency
O.J. 2008, L353: Regulation (EC) Coordinating Committee on the Validation of
No 1272/2008 of the European Parliament Alternative Methods (ICCVAM) Test Method
and of the Council of 16 December 2008 Evaluation Report: Validation Status of Five
on classification, labelling and packag- In Vitro Test Methods Proposed for Assess-
ing of substances and mixtures, amending ing Potential Pyrogenicity of Pharmaceuticals
and repealing Directives 67/548/EEC and and Other Products and Final Background
1999/45/EC, and amending Regulation (EC) Review.
No 1907/2006. Document: Validation Status of Five In Vitro
O.J. 2008, L354: Regulation (EC) No Test Methods Proposed for Assessing Potential
1336/2008 of the European Parliament and Pyrogenicity of Pharmaceuticals and Other
of the Council of 16 December 2008 amend- Products; Notice of Transmittal of ICCVAM
ing Regulation (EC) No 648/2004 in order to Test Method Recommendations to Federal
adapt it to Regulation (EC) No 1272/2008 on Agencies. National Institute of Environmental
Health Sciences (NIEHS), National Institutes [This final report has two primary purposes. The first is
of Health (NIH). Availability of the ICCVAM to convey the approaches taken to characterize human
Test Method Evaluation Report and Final exposures and health risks associated with ambient NO2
Background Review Document. and to present the results of these analyses. The second is
Federal Register, December 2, 2008, Vol. 73, to present a discussion of the NO2 scientific evidence and
No. 232, 73329: Proposed Substances To Be the exposureand risk-based information specifically as it
Evaluated for Set 23 Toxicological Profiles. relates to the current and potential alternative NO2 stand-
Agency for Toxic Substances and Disease ards. This final document is available online at: http://
Registry (ATSDR), Department of Health www.epa.gov/ttn/naaqs/standards/nox/s_nox_cr_rea.html.]
and Human Services (HHS). Request for Federal Register, December 8, 2008, Vol. 73,
comments on the proposed substances to be No. 236, 74488: U.S. Government’s Proc-
evaluated for Set 23 toxicological profiles [80 ess for Obtaining Stakeholder Information
substances will be evaluated]. for Chemicals Proposed for Addition to the
Federal Register, December 4, 2008, Vol. 73, Stockholm Convention on Persistent Organic
No. 233, 73620: Formaldehyde [CAS 50-00-0] Pollutants. Environmental Protection Agency
Emissions From Pressed Wood Products. (EPA). Notice.
Environmental Protection Agency (EPA). Federal Register, December 12, 2008, Vol. 73,
Advance notice of proposed rulemaking and No. 240, 75568: Clarification of Employer
notice of public meetings. Duty To Provide Personal Protective Equip-
Federal Register, December 4, 2008, Vol. 73, ment and Train Each Employee. Occupational
No. 234, 73930: An Exposure Assessment of Safety and Health Administration (OSHA),
Polybrominated Diphenyl Ethers. Environ- U.S.Department of Labor. Final rule.
mental Protection Agency (EPA). Notice of [In this rulemaking, OSHA is amending its standards to
Public Comment Period. add language clarifying that the personal protective equip-
[The draft ‘‘An Exposure Assessment of Polybrominated ment (PPE) and training requirements impose a compli-
Diphenyl Ethers ‘‘is available primarily via the Internet ance duty to each and every employee covered by the stand-
on the National Center for Environmental Assessment’s ards and that noncompliance may expose the employer to
home page under the Recent Additions and the Data and liability on a per-employee basis. The amendments consist
Publications menus at http://www.epa.gov/ncea.] of new paragraphs added to the introductory sections
Federal Register, December 8, 2008, Vol. 73, of the listed Parts and changes to the language of some
No. 236, 74350: Regulation of Fuel and Fuel existing respirator and training requirements. This action,
Additives: Gasoline and Diesel Fuel Test Meth- which is in accord with OSHA’s longstanding position, is
ods. Environmental Protection Agency (EPA). being taken in response to recent decisions of the Occupa-
Direct final rule. tional Safety and Health Review Commission indicating
Federal Register, December 8, 2008, Vol. 3, that differences in wording among the various PPE and
No. 236, 74403: Regulation of Fuel and Fuel training provisions in OSHA safety and health standards
Additives: Gasoline and Diesel Fuel Test affect the Agency’s ability to treat an employer’s failure to
Methods. Environmental Protection Agency provide PPE or training to each covered employee as a
(EPA). Proposed rule. separate violation. The amendments add no new compli-
Federal Register, December 8, 2008, Vol. 73, ance obligations. Employers are not required to provide
No. 236, 74485: Final Risk and Exposure any new type of PPE or training, to provide PPE or train-
Assessment Report for Nitrogen Dioxide ing to any employee not already covered bij the existing
(NO2)[CAS 10102-44-0]. Environmental requirements, or to provide PPE or training in a different
Protection Agency (EPA). Notice of availabil- manner than that already required. The amendments sim-
ity of final report. ply clarify that the standards apply to each employee.]
Federal Register, December 16, 2008, Vol. 73, costs and burdens of TSCA section 5 notifications for both
No. 242, 76220: National Emission Stand- industry and EPA by establishing standards and require-
ards for Hazardous Air Pollutant Emissions: ments for the use of EPA’s Central Data Exchange (CDX)
Group I Polymers and Resins (Polysulfide to electronically submit premanufacture notices (PMNs)
Rubber Production, Ethylene Propylene Rub- and other TSCA section 5 notices and support documents
ber Production, Butyl Rubber Production, to the Agency. EPA is also proposing to amend the TSCA
Neoprene Production); National Emission section 5 User Fee regulations to add a new User Fee Pay-
Standards for Hazardous Air Pollutants for ment Identity Number field to the PMN form, which
Epoxy Resins Production and Non-Nylon would enable the Agency to match more easily a particular
Polyamides Production; National Emis- user fee with its notice submission. Lastly, EPA is propos-
sion Standards for Hazardous Air Pollutants ing to remove the Agent signature block field on the PMN
for Source Categories: Generic Maximum form, and thus the requirement for designated Agents to
Achievable Control Technology Standards sign the form.]
(Acetal Resins Production and Hydrogen Federal Register, December 24, 2008, Vol. 73,
Fluoride Production) (Risk and Technology No. 248, 78994: National Volatile Organic
Review). Environmental Protection Agency Compound Emission Standards for Aerosol
(EPA). Final rule. Coatings. Environmental Protection Agency
Federal Register, December 16, 2008, Vol. 73, (EPA). Final rule; withdrawal of direct final
No. 242, 76361: Draft Guidance for Industry rule.
on Genotoxic and Carcinogenic Impurities in Federal Register, December 31, 2008, Vol. 73,
Drug Substances and Products: Recommend- No. 251, 80428: Commerce in Explosives; List
ed Approaches; Availability. Food and Drug of Explosive Materials (2008R–17T)
Administration, HHS. Notice. [Pursuant to 18 U.S.C. 841(d) and 27 CFR 555.23, the
Federal Register, December 19, 2008, Vol. 73, Department of Justice (Bureau of Alcohol, Tobacco, Fire-
No. 245, 77492: Ban of Lead-Containing Paint arms and Explosives (ATF)) must publish and revise at
and Certain Consumer Products Bearing least annually in the Federal Register a list of explosives
Lead-Containing Paint. Consumer Product determined to be within the coverage of 18 U.S.C. 841 et
Safety Commission. Final rule. seq. The list covers not only explosives, but also blasting
[Lead-containing paint means paint or other similar sur- agents and detonators, all of which are defined as explo-
face coating materials containing lead or lead compounds sive materials in 18 U.S.C. 841(c). This notice publishes
and in which the lead content (calculated as lead metal) is the 2008 List of Explosive Materials.]
in excess of 0.06 percent (0.06 percent is reduced to 0.009 Federal Register, January 2, 2009, Vol. 74,
percent effective August 14, 2009) by weight of the total No. 1, 21: Protection of Stratospheric Ozone:
nonvolatile content of the paint or the weight of the dried Notice 23 for Significant New Alternatives
paint film.] Policy Program. Environmental Protection
Federal Register, December 22, 2008, Vol. 73, Agency (EPA). Determination of Acceptabil-
No. 246, 78261: TSCA Section 5 Premanufac- ity.
ture and Significant New Use Notification Federal Register, January 2, 2009, Vol. 74,
Electronic Reporting; Revisions to Notifica- No. 1, 41: Identification of Non-Hazardous
tion Regulations. Environmental Protection Materials that are Solid Waste. EPA. Advanced
Agency (EPA). Proposed rule. notice of proposed rulemaking.
[EPA is proposing amendments to the Toxic Substances Federal Register, January 9, 2009, Vol. 74,
Control Act (TSCA) section 5 Premanufacture and Sig- No. 61, 900: Announcement of Final Priority
nificant New Use Notification regulations to facilitate the Data Needs for Two Priority Hazardous Sub-
introduction and use of electronic reporting. This action stances. Agency for Toxic Substances and Dis-
is intended to streamline and reduce the administrative
Alle rechten voorbehouden. Niets uit deze uitgave mag worden verveel-
1 June 2018: voudigd, opgeslagen in een geautomatiseerd gegevensbestand, of openbaar
Deadline for manufacturers/importers gemaakt, in enige vorm of op enige wijze, hetzij elektronisch, mechanisch,
door fotokopieën, opnamen, of enig andere manier, zonder voorafgaande
supplying a substance above 1 tonne per schriftelijke toestemming van de uitgever.
year. Voorzover het maken van kopieën uit deze uitgave is toegestaan op grond
van artikel 16b Auteurswet 1912 jo het Besluit van 20 juni 1974, Stb. 351,
zoals laatstelijk gewijzigd bij het Besluit van 22 december 1997, Stb. 764 en
artikel 17 Auteurswet 1912, dient men de daarvoor wettelijk verschuldigde
CLP (EU-GHS): vergoedingen te voldoen aan de Stichting Reprorecht (Postbus 3060, 2130 KB
CLP implementation (key dates): Hoofddorp). Voor het overnemen van gedeelten(n) uit deze uitgave in bloem-
lezingen, readers en andere compilatiewerken (artikel 16 Auteurswet 1912)
20 January 2009: CLP Regulation (EC) dient ment zich tot de uitgever te wenden. Hoewel bij de samenstelling van
No. 1272/2008 entered into force deze uitgave de uiterste zorg is nagestreefd, kan voor eventuele (druk)fouten
en onvolledigheden niet worden ingestaan en aanvaarden auteurs, redacteuren
1 December 2010: en uitgever deswege geen aansprakelijkheid.
CLP Titles II, III and IV shall apply in Citeertitel
respect of substances Journaal Stoffen en Preparaten jaartal/nummer
(voorbeeld: Journaal Stoffen en Preparaten 2008/1)
Actualities
Chief-editor:
Drs. A.C.H. van Peski European Union
[2009/0048] 30th and 31st ATP to DSD and 1st ATP to CLP
Editorial Board:
Regulation / 63
Dr. M.M. Kops-Werkhoven
[2009/0049] EU Harmonised Classification and
Drs. H.A.F. van Well
Labelling / 63
Dr. J.A.S.J. Razenberg
Dr. L.J.M. Rodenburg [2009/0050] REACH Annex XI adaptation / 64
Drs. G.A. Schouten [2009/0051] REACH, polymers and monomers: Case
Drs. J. Zawierko C‑558/07 / 65
[2009/0052] Two food additives have previously
Advisory Board: unrecognized estrogen-like effects / 66
K. E. Armstrong (U.S.A.) [2009/0053] Belgium: ADR and RID 2009 / 66
Dr. R. Fielding (United Kingdom)
Drs. A. Gondová (The Netherlands) International
G. Koh (Singapore) [2009/0054] Switzerland: GHS introduction / 67
Dr. C. van Lint (Australia) [2009/0055] USA: Enhancing the effectiveness of
Dan Liu (U.S.A.) TSCA / 68
S. Park (S.-Korea) [2009/0056] P.R. of China: Inventory of Existing Chemical
H. Sano (Japan) Substances 2008 / 69
S. Savary (Canada) [2009/0057] P.R. of China: List of Severely Restricted
C. Sieger (Germany) Toxic Chemicals for Export and
J. Simpson (Australia) Import 2009 / 69
Dr. U. Schumacher (China)
[2009/0058] P.R. of China: List of Goods subject to
E. Snyman (South Africa)
Import Licence 2009 / 69
P.G. Tse (New Zealand)
[2009/0059] South-Korea: Hazard Assessment of Existing
Chemicals / 70
[2009/0060] Singapore: draft standards on Occupational
safety and health (OSH) management
No. 3 systems / 70
[2009/0061] Canada: CAN-NEW-Database on ototoxic
April 2009 substances / 70
Volume 6 [2009/0047] Canada: use of engineered nanomaterials / 71
[2009/0062] Canada: Batch 2 substances / 71
Part of Stoffennieuws.nl
[2009/0063] Australia: Hazardous Substances Information
System Update / 72
[2009/0064] Australia: Low Regulatory Concern
Chemicals / 72
content
PUBLICATIONS
Book review
[2009/0070] Fundamental principles of occupational health and safety. 2nd edition / 80
Proceedings
[2009/0071] REACH and GHS – VCI-Seminar / 83
Internet
[2009/0072] United Kingdom: Risk management of carbon nanotubes / 83
[2009/0073] U.S. Army Corps of Engineers Publishes New Safety Manual / 83
[2009/0074] Toxipedia and WLT / 83
OFFICIAL PUBLICATIONS
On 23 February 2009 ECHA has published on Consequently, these criteria for justification
its website the first public consultation on a for the omission of testing should be incorpo‑
proposal to harmonise the classification and rated in Regulation (EC) No 1907/2006.
labelling of two chemical substances. The two
substances in this consultation are: Section 3 of Annex XI to Regulation (EC)
– Epoxiconazole (CAS 135319-73-2 or No 1907/2006 is replaced by the following:
133855-98-8) – a pesticide, used in 3. SUBSTANCE-TAILORED EXPOSURE-
agriculture to control types of fungus DRIVEN TESTING
– Diantimony trioxide (CAS 1309-64-4) – 3.1. Testing in accordance with Sections 8.6
used as a flame retardant in plastics, PVC, and 8.7 of Annex VIII and in accordance with
rubber and textiles; as an additive in glass; Annex IX and Annex X may be omitted, based
and in the manufacture of pigments and on the exposure scenario(s) developed in the
paints. Chemical Safety Report.
Reference: http://echa.europa.eu/doc/press/pr_09_02_ 3.2. In all cases, adequate justification and
cl_consultation_20090223.pdf documentation shall be provided. The justifi‑
cation shall be based on a thorough and rigor‑
ous exposure assessment in accordance with
REACH Annex XI adaptation section 5 of Annex I and shall meet any one of
the following criteria:
[2009/0050] (a) the manufacturer or importer demon‑
strates and documents that all of the
Annex XI allows registrants, under certain following conditions are fulfilled: (i) the
conditions, to omit testing in accordance results of the exposure assessment cover‑
with sections 8.6 and 8.7 of Annex VIII and ing all relevant exposures throughout the
in accordance with Annex IX and Annex X to life cycle of the substance demonstrate the
Regulation (EC) No 1907/2006. Based on ex‑ absence of or no significant exposure in
perience gained through the development of all scenarios of the manufacture and all
guidance for the chemicals safety assessment identified uses as referred to in Annex VI
under Regulation (EC) No 1907/2006, three section 3.5; (ii) a DNEL or a PNEC can
different criteria for exposure-based waiv‑ be derived from results of available test
ing have been identified. The First criterion data for the substance concerned taking
requires that it is demonstrated and docu‑ full account of the increased uncertainty
mented that exposure in all scenarios is well resulting from the omission of the infor‑
below an appropriate derived no-effect level mation requirement, and that DNEL or
(DNEL) or predicted no-effect concentration PNEC is relevant and appropriate both to
(PNEC) derived under specific conditions. the information requirement to be omit‑
The second criterion requires that it is dem‑ ted and for risk assessment purposes (*);
onstrated and documented that strictly con‑ (iii) the comparison of the derived DNEL
trolled conditions apply throughout the life or PNEC with the results of the expo‑
cycle. The third criterion requires that where sure assessment shows that exposures are
the substance is incorporated in an article, the always well below the derived DNEL or
substance is incorporated in such a way that PNEC;
no exposure can take place and the substance (b) where the substance is not incorporated
is not released during its life cycle and is han‑ in an article the manufacturer or importer
dled under strictly controlled conditions dur‑ demonstrates and documents for all rel‑
ing all manufacturing and production stages. evant scenarios that throughout the life
(1) The term ‘monomer substances’ in Article from reduced sperm counts in men to an in‑
6(3) of Regulation (EC) No 1907/2006 creased risk of breast cancer in women.
concerning the Registration, Evaluation, The scientists used the new method to search
Authorisation and Restriction of Chemi‑ a food additive database (the Joint FAO-WHO
cals refers only to reacted monomers, that expert committee database) of 1500 substanc‑
is, monomers which have reacted together es, and verified that the method could iden‑
in such a way that they are bound in the tify xenoestrogens. In the course of that work,
polymer of which they are components. they identified two previous unrecognized
(2) Consideration of Question 2 has not dis‑ xenoestrogens. One was propyl gallate (CAS
closed anything capable of affecting the 121-79-9), a preservative used to prevent fats
validity of Article 6(3) of Regulation No and oils from spoiling. The other was 4-hexy‑
1907/2006 having regard to the princi‑ lresorcinol (CAS 136-77-6), used to prevent
ples of legal certainty, proportionality and discoloration in shrimp and other shellfish.
non-discrimination. References: http://www.sciencedaily.com/relea‑
References: http://eur-lex.europa.eu/LexUriServ/LexU‑ ses/2009/03/090302125924.htm
riServ.do?uri=OJ:C:2008:051:0036:0037:E http://pubs.acs.org/doi/abs/10.1021/
N:PDF tx800048m
http://curia.europa.eu/jurisp/cgi-bin/form.
pl?lang=EN&Submit=Rechercher$docrequ
ire=alldocs&numaff=C-558/07&datefs=&d Belgium: ADR and RID 2009
atefe=&nomusuel=&domaine=&mots=&r
esmax=100 [2009/0053]
stances and continues to believe such change The inventory contains 45290 substances, of
warrants consideration. EPA has a limited which 3080 are marked as confidential. 37125
ability to provide the public with information substances have a CAS number.
on chemical production and risk because of The Inventory can be ordered on CD, but can
TSCA’s prohibitions on the disclosure of con‑ also be accessed by Internet.
fidential business information. About 95 per‑ References: http://www.crc-mep.org.cn/news/NEWS_
cent of the notices companies have provided detailT0.aspx?TitID=113&T0=2&T1=2&T
to EPA on new chemicals contain some in‑ 2=0&T3=0&T4=0&T5=0&T6=0&Languag
formation claimed as confidential. Evaluating eType=CH
the appropriateness of confidentiality claims Webversion: http://www.crc-mep.org.cn/iecscweb/
is time- and resource-intensive, and EPA does default0.aspx
not challenge most claims. State environmen‑
tal agencies and others have said that informa‑
tion claimed as confidential would help them P.R. of China: List of Severely
in such activities as developing contingency Restricted Toxic Chemicals for
plans to alert emergency response personnel Export and Import 2009
to the presence of highly toxic substances at
manufacturing facilities. The European Un‑ [2009/0057]
ion’s chemical control legislation generally
provides greater public access to the chemical The List of Severely Restricted Toxic Chemi‑
information it receives, and GAO has previ‑ cals for Export and Import (2009 version)
ously recommended that Congress consider was published Ministry of Environmental
providing EPA additional authorities to make Protection on 28 December 2008 and came
more chemical information publicly avail‑ into force on 1 January 2009. Any import and/
able. or export of these listed chemicals requires a
References: http://www.gao.gov/products/GAO- Certificate on Import of Toxic Chemicals and
09-428T the Clearance Notification for Environmental
http://www.gao.gov/new.items/d09428t.pdf Management on the Import/Export of Toxic
See also: http://www.americanchemistry.com/s_acc/ Chemicals from the Chemical Registration
sec_news_article.asp?CID=206&DID=9174 Centre.
References: http://www.mep.gov.cn/info/bgw/
bgg/200812/t20081231_133205.htm
P.R. of China: Inventory of List: http://www.mep.gov.cn/info/bgw/
Existing Chemical Substances bgg/200812/W020081231576247755536.
2008 pdf
[2009/0056]
P.R. of China: List of Goods
The Registration Centre of the Ministry of subject to Import Licence 2009
Environmental Protection has published the
2008 version of the ‘Inventory of Existing [2009/0058]
Chemicals’ (IECSC 2008 ) on 25 December
2008. If any company manufactures or im‑ The Ministry of Commerce, the General Ad‑
ports any chemical substances that is not on ministration of Customs, and the General Ad‑
this list, it has to register the chemical. ministration of Quality Supervision, Inspec‑
tion and Quarantine have issued the List of
Goods subject to Import License Control in specifications for the design of a management
2009 on 10 December 2008. An import license system.
is required if importing any of the 57 ozone All the requirements in this standard are in‑
depleting substances and 96 controlled used tended to be incorporated into any OSH man‑
mechanical and electronic products listed in agement system. The extent of the application
the “List of Goods subject to Import License will depend on such factors as the OSH policy
Control in 2009”. of the organisation, the nature of its activities
References: http://beijing.mofcom.gov.cn/aarticle/sjton and the risks and complexity of its opera‑
gzhigg/200901/20090105994295.html tions.
http://www.zhb.gov.cn/info/bgw/ This standard is intended to address occupa‑
bl/200812/t20081216_132482.htm tional safety and health, and is not intended
to address other safety and health areas such
as employee well-being/wellness programs,
South-Korea: Hazard Assessment product safety, property damage or environ‑
of Existing Chemicals mental impacts.
This standard is applicable to any organisa‑
[2009/0059] tion that wishes to establish an OSH manage‑
ment system to eliminate or minimize risks
On 9 December 2008, the National Institute to personnel and other interested parties who
of Environmental Research .issued the Pub‑ could be exposed to OSH hazards associated
lic Notice on Results of Hazard Assessment with its activities.
of Existing Chemicals. This Notice contains – Occupational safety and health (OSH)
hazard assessment results of 13 existing chem‑ management systems – Part 2 : General
icals, which include phosphoric acid, sorbitol, guidelines for the implementation of OSH
calcium silicide, trisodium orthophosphate, management system (SS 506 : Part 2 :
tripotassium orthophosphate, and tripotas- 2004)
sium hexafluoroaluminate. This standard provides generic advice on the
Reference: http://www.me.go.kr application of SS 506 : Part 1. It explains the
underlying principles of SS 506 : Part 1 and
describes the intent, typical inputs, processes
Singapore: draft standards on and typical outputs, against each requirement
Occupational safety and health of SS 506 : Part 1. This is to aid the under‑
(OSH) management systems standing and implementation of SS 506 : Part
1. It is proposed to review the standard so as to
[2009/0060] align the requirements with those of the cur‑
rent BS OHSAS 18002 : 2008.
– Occupational safety and health (OSH) Reference: http://www.spring.gov.sg/Content/Web‑
management systems – Part 1 : Require- Page.aspx?id=0074748d-0996-43d6-95d2-
ments (Revision of SS 506 : Part 1 : 2004) 522fb0456ce0
This standard specifies requirements for an
occupational safety and health (OSH) man‑
agement system to enable an organisation to
control its OSH risks and improve its OSH
performance. It does not state specific OSH
performance criteria, nor does it give detailed
orange, CAS 12656-85-8), isoprene (CAS 78- The HSIS online database is an Internet re‑
79-5) and epichlorohydrin (CAS 106-89-8)) source that allows users to find information on
and three are of concern to the environment substances that have been classified in accord‑
(siloxanes D4 (CAS 556-67-2) and D5 (CAS ance with the Approved Criteria for Classifying
541-02-6), TTBP (2,4,6-tri-tert-butylphenol, Hazardous Substances [NOHSC:1008(2004)]
CAS 732-26-3)). The publication of final as‑ 3rd Edition and/or have National Exposure
sessments moves these substances into risk Standards declared under the NOHSC Adopt‑
management and plans will be developed to ed National Exposure Standards for Atmos‑
control their release to the environment and pheric Contaminants in the Occupational
impact on human health. Environment [NOHSC:1003(1995)].
Although Canadians’ exposure is very low The update comprises of a total of 956 entries
for the five substances of concern to human of which there are 568 amendments to exist‑
health, the Government is proposing that ing entries, 385 new entries and 3 deletions.
regulations similar to Significant New Activity Also, the HSIS Guidance Material for Hazard
(SNAc) provisions be applied to four of these Classifications has been updated to reflect
substances. The provisions will prevent these amendments to Notes H, J and P in the label‑
substances being used in the future without ling column. It is anticipated all changes will
undergoing new health and environmental be finalised by mid 2009.
assessments. Two of these substances, epichlo‑ A full list of the schedule of changes for the
rohydrin and isoprene, will also be added to HSIS online database update can be found at
the Cosmetic Ingredient Hotlist to prevent www.hsis.ascc.gov.au.
their future use in cosmetics. For isoprene, Reference: http://www.ascc.gov.au/ascc/HealthSafety/
Health Canada is proposing that manufactur‑ HazardousSubstances/HSIS/
ers use the best-available technology to con‑
trol releases.
The final assessment concludes that vinyl Australia: Low Regulatory
acetate (CAS 108-05-4) is not a concern for Concern Chemicals
human health.
Reference: http://www.ecoaction.gc.ca/news- [2009/0064]
nouvelles/20090130-2-eng.cfm
Over the past few years NICNAS has im‑
plemented a number of recommendations
Australia: Hazardous Substances from the Low Regulatory Concern Chemicals
Information System Update (LRCC) reform initiative detailed in the 2003
LRCC Final Report and Recommendations.
[2009/0063] However, certain recommendations required
further technical development and consulta‑
The Australian Safety and Compensation tion before they could be implemented. The
Council (Department of Education, Employ‑ Low Regulatory Concern Chemicals (LRCC)
ment and Workplace Relations) (ASCC) is Final Report and Recommendations on the
about to update the Hazardous Substances In‑ outstanding reforms was published in the No‑
formation System (HSIS) online database to vember 2007 issue of the Chemical Gazette.
include information to reflect changes in Eu‑ Amendment of the Regulations will now al‑
rope’s 30th Adaptation to Technical Progress low:
to Directive 67/548/EEC.
Furthermore, notwithstanding the difference notification and assessment regime for indus‑
in definition of ‘hazardous’, some nonhazard‑ trial chemicals, and so the abovementioned
ous chemicals (substances) are not subject to differences identified bij NICNAS and ERMA
notification and/or assessed in New Zealand are relevant. […]
but do require notification and/or assessment
in Australia. Mutual recognition would al‑ Chemical classification, labelling, packaging
low these chemicals (substances) to be sold in and safety data sheets
Australia without the need for the risk assess‑ The Australian Government Department of
ment deemed necessary. Even if a chemical Education, Employment and Workplace Re‑
is classified as nonhazardous in Australia, it lations (DEEWR) and the New Zealand Gov‑
may still be recommended that certain safety ernment noted that a key step towards resolv‑
and risk information be required – ‘nonhaz‑ ing the industrial chemicals special exemption
ardous’ does not necessarily mean safe for all will be for Australia to implement the Global‑
purposes. Australia’s regulatory system covers ly Harmonised System for Classification and
the broad spectrum of chemicals where non‑ Labelling of Chemicals.
hazardous substances still require labelling for No country has fully implemented the GHS,
consumers. This illustrates the difficulties that although New Zealand has made the most
would be likely to arise if mutual recognition progress, and the European Union began
was applied while there are still fundamental phasing in the GHS in December 2008 over a
differences in what Australia and New Zealand period of about seven years: The new Europe‑
consider to be appropriate ways to control an regulation on classification, labelling and
chemical-related risks. Community expecta‑ packaging which is based on the GHS came
tions about those risks are such that achieving into effect on 1 December 2008; the deadline
wholesale mutual recognition seems unlikely, for substance classification according to the
unless it is accompanied by a high degree of new criteria is 1 December 2010 whereas for
regulatory harmonisation, if not uniformity. mixtures the deadline is 1 June 2015. New
[…] Zealand has applied the hazard-classification
Accord Australasia claimed that there would aspects of the original version of the GHS to
be significant benefits from removing cosmet‑ all sectors, and is now updating its arrange‑
ics from the industrial chemicals special ex‑ ments to the latest revised edition. In Austral‑
emption, and that this is feasible because the ia, the Australian Safety and Compensation
relevant regulations are now closely harmo‑ Council (ASCC) has proposed that the GHS
nised between Australia and New Zealand: (first revised edition) be adopted as part of a
Since the Australian Government finalised its new national framework for regulating chem‑
reforms to cosmetic products at the thera‑ icals in workplaces. Progress in finalising this
peutic interface in September 2007 and New proposal has been slow, and its implementa‑
Zealand introduced the Cosmetic Products tion would involve a long phase-in period:
Group Standard on 1 July 2006, the regula‑ Work on the new workplace chemicals frame‑
tory controls for cosmetic products are now work has been ongoing for several years, and
closely harmonised and there is a strong case while significant progress is being made, this
for TTMRA to apply to this class of consumer has occurred slowly […]. Once a new GHS-
goods. The application of TTMRA for this based national standard for workplace chemi‑
class of low-risk, fast-moving consumer prod‑ cals has been declared […] GHS implemen‑
ucts will have significant benefits in facilitat‑ tation in Australia would not actually occur
ing trade and reducing unnecessary barriers. until the new standard has been adopted into,
However, cosmetics are subject to Australia’s or given effect by, the relevant state and terri‑
tory legislation and regulations. This process pect of mutual recognition being achieved
can take a number of years to occur. with New Zealand in relation to the GHS for
In 2006, a draft regulation impact statement domestic poisons: […] work in regard to the
(RIS) supporting the ASCC’s proposal was re‑ implementation of the […] GHS has demon‑
leased for public comment. The Commission strated that [its] adoption […] in Australia is
examined the RIS as part of its recent review likely to require different approaches [com‑
of Australia’s chemical regulations, and con‑ pared to New Zealand] to classification and
cluded that the benefits of adopting the GHS labelling for consumer chemicals that reflect
in the immediate future were overstated. Im‑ different legislative arrangements (eg state/
plementing the GHS now would impose sig‑ territory framework for poisons scheduling),
nificant costs on industry without offsetting differences in risk-management approaches
trade benefits, due to the limited adoption of and the need to align with trading partners.
the GHS by other countries. The Commission Consequently, the Department of Health and
recommended that a further RIS should be Ageing also sees little likelihood of mutual
prepared when some of Australia’s key trading recognition being achieved in relation to the
partners, such as China and the United States, GHS in the consumer-chemical sector. The
have commenced implementing GHS-based New Zealand Government claimed that Aus‑
regulatory regimes for workplace chemicals. tralia’s current consideration of how to apply
There has been even less progress in applying GHS classification criteria ‘creates an oppor‑
the GHS to domestic poisons and agricultural tunity to harmonise the assessments relating
and veterinary (agvet) chemicals in Australia. to the intrinsic hazardous properties of [do‑
New Zealand has a GHS-based code of prac‑ mestic and agvet] chemicals’. […]
tice for labelling agvet chemicals, but the use The industrial chemicals cooperation pro‑
of GHS label elements (such as pictograms) gram has made progress in a range of areas,
is not mandatory, and the code allows for al‑ particularly in establishing greater coopera‑
ternative approaches to labelling. A major is‑ tion between regulators on process issues.
sue for Australia is that domestic poisons and However, the cooperation program has also
agvet chemicals are currently classified and revealed fundamental differences in how
labelled according to the risk they pose (tak‑ Australia and New Zealand control chemical-
ing into account the probability of harm and related risks.
the magnitude of the consequences), whereas Wholesale mutual recognition seems unlikely
the GHS only identifies hazards (potential for unless it is accompanied by a high degree of
harm). regulatory harmonisation, if not uniformity.
Application of the GHS to domestic poi‑ Some areas – particularly the GHS classifi‑
sons is currently being considered as part of cation and labelling of workplace chemicals
the abovementioned five year work plan for – are already in the process of being harmo‑
industrial chemicals under the TTMRA. In nised, but this is expected to take several years
Australia, this is being managed by DOHA in (which is desirable from Australia’s perspec‑
cooperation with state and territory govern‑ tive, given the limited adoption of the GHS by
ments, and with New Zealand as a participant its major trading partners). Harmonisation of
in discussions. many other important areas appears unlikely
December 2009 is the target date for a deci‑ in the foreseeable future, unless New Zealand
sion on how the GHS would be applied to do‑ is prepared to align itself closely with the re‑
mestic poisons and agvet products (NICNAS formed regulatory regime Australia adopts
2008). DOHA observed that this work has al‑ following the Commission’s recent review of
ready led it to conclude that there is little pros‑ chemical regulations.
Version 1 of the Toolbox was publically re‑ Toolbox’, 15-16 May 2008, Utrecht, the Neth‑
leased at the end of March 2008. A first up‑ erlands (2009) is also available.
date, version 1.1 was released in December References: Download Toolbox: http://www.oecd.org/d
2008. The second phase of the project to de‑ ocument/23/0,3343,fr_2649_34379_33957
velop a more comprehensive Toolbox which 015_1_1_1_1,00.html#Download_QSAR_
fully implements the capabilities of the first AT or http://toolbox.oasis-lmc.org/
version was launched in November 2008. Guidance on grouping of chemicals: http://
Further information, including training pres‑ www.oecd.org/dataoecd/53/62/39850072.
entation slides is also available there. pdf
Phase 2 of the Toolbox will be funded by http://www.olis.oecd.org/olis/2009doc.nsf/
ECHA, the new Chemicals Agency in Helsin‑ LinkTo/NT00000CAA/$FILE/JT03260091.
ki. This is foreseen to be a 4 year project with PDF
2 subsequent versions of the Toolbox being For training: http://www.qsari.org/
released in October 2010 and October 2012. Workshop: http://www.olis.oecd.org/olis/2009doc.
nsf/ENGREFCORPLOOK/
The Toolbox is a software application intended NT000009D6/$FILE/JT03258460.PDF
to be used by governments, chemical industry
and other stakeholders in filling gaps in (eco)
toxicity data needed for assessing the hazards Global Update on New Chemicals
of chemicals. The Toolbox incorporates infor‑ Regulations (January 2009)
mation and tools from various sources into a
logical workflow. Crucial to this workflow is [2009/0069]
grouping chemicals into chemical categories.
In January 2009, approximately 152 new reg‑
A chemical category is a group of chemicals ulations relating to chemicals management
whose physicochemical and human health were adopted or published worldwide. These
and/or environmental toxicological proper‑ involve implementation of GHS, updates to
ties and/or environmental fate properties are chemical inventories, new priority chemicals,
likely to be similar or follow a regular pattern several changes to the requirements on trans‑
as a result of structural similarity. Category port and handling, and last but not least re‑
approach, not every chemical needs to be strictions on the marketing and use of chemi‑
tested for every endpoint. Rather, the overall cals like arsenic, chlorofluorocarbons, etc.
data for that category must prove adequate The following overview provides the indica‑
to support a hazard assessment. The over‑ tive title in English and the date of. Further
all data set must allow the estimation of the information on any of these new regulations
hazard for the untested endpoints. Data gap and what they require from industry can be
filing can be done using read-across from one found in the Enhesa Update published by EN‑
tested chemical to an untested chemical. De‑ HESA (www.enhesa.com). To be kept ahead
tailed guidance on grouping of chemicals has of new policy initiatives and developments
also been published in the series on Testing and their implications on your business con‑
and Assessment Number 80 and Number 102 tact ENHESA at +32 2 775 9797.
(ENV/JM/MONO(2007)28 and ENV/JM/ (Selection only)
MONO(2009)5).
Australia
The ‘Report of the Workshop on Structural Water Amendment Bill 2008 introduced
Alerts for the OECD (Q)SAR Application 12-Dec-2008
NSW: Environmental Planning and Assess‑ Significant New Activity Notice No. 15345
ment Regulation 2000 amended for comply‑ adopted regarding tin titanium zinc oxide
ing developments 23-Jan-2009 24-Jan-2009
Clarification on the chemical identity infor‑ Significant New Activity Notice No. 15365
mation required by NICNAS 03-Feb-2009 adopted regarding 1-hexadecanol, manuf. of,
Austria distn. lights, CAS 189233-30-5 24-Jan-2009
Ordinance on emissions register for surface Significant New Activity Notice No. 15416
wastewater discharges adopted 29-Jan-2009 adopted regarding cobalt lithium manganese
Brazil nickel oxide, CAS 346417-97-8 24-Jan-2009
Adopted rules on toiletries, cosmetics and Notice with respect to Batch 8 Challenge Sub‑
perfumes manufactured to be exported 09- stances published 31-Jan-2009
Dec-2008 China
Use of asbestos by the Ministry of the Envi‑ Phenfluoramine hydrochloride banned in
ronment prohibited 28-Jan-2009 pharmaceutical intermediates and medica‑
Bulgaria ments 08-Jan-2009
Law on the Protection of Ambient Air Puri‑ Croatia
ty with regards to VOCs, certain fluorinated Regulation on Management with Wasted Elec‑
greenhouse gases and ozone-depleting sub‑ trical and Electronic Devices and Equipment
stances amended 16-Jan-2009 Requirements amended 11-Nov-2008
for marketing of batteries and accumulators, Estonia
for the treatment and transport of waste bat‑ Water Act amended 03-Dec-2008
teries and accumulators and WEEE amended Finland
30-Dec-2008 Canada Out-of-date Decisions on type approvals of
Ministerial Condition No. 15300 adopted containers for the transport of dangerous
regarding benzene, 1,1′-(1,2-ethanediyl) goods repealed 22-Jan-2009
bis(2,3,4,5,6-pentabromo)-, CAS. 84852-53-9 France
03-Jan-2009 Order relating to the declaration, classifica‑
Significant New Activity Notice No. 15095 tion, packaging and labeling of dangerous
adopted regarding 2,4,7,9-Tetramethyl-4,7- substances amended 16-Jan-2009
decanediol, CAS 17913-76-7 10-Jan-2009 Germany
Significant New Activity Notice No. 15330 Ministry of Labour issues notice on relation
adopted regarding phosphoric acid, iron (2+) between the European CLP Regulation and
lithium salt (1:1:1) 10-Jan-2009 the Ordinance on Dangerous Substances
Orders adopted to amend the Domestic Sub‑ (GefStoffV) 15-Jan-2009
stances List and Non-Domestic Substances Hungary
List 07-Jan-2009 Revised rules on the requirements and con‑
Significant New Activity Notice No. 15310 formity of personal protective equipment
adopted regarding silane homopolymer, hy‑ adopted 03-Dec-2008
drolysis products with magnesium hydroxide National Institute of Chemical Safety (OKBI)
24-Jan-2009 as competent GHS authority appointed 20-
Significant New Activity Notice No. 15329 Jan-2009
adopted regarding carbamic acid, [(butylthio) India
thioxomethyl]-, butyl ester, CAS 1001320-38- Explosive Rules 2008 published to introduce
2 24-Jan-2009 the UN classification of explosives 31-Dec-
2008
Italy
New transport document will be required for
the transport of any kind of goods 15-Jan-
2009
publications
Temporarily extended the definition of sec‑
ondary raw materials 03-Jan-2009
Lithuania
Order on the attestation system of personnel BOOK REVIEW
handling fluorinated GHG issued 13-Jan-
2009
Luxembourg Fundamental principles of
Restrictions on the marketing and use of per‑ occupational health and safety.
fluorooctane sulfonates adopted 08-Jan-2009 2nd edition
New Zealand
New Zealand Inventory of Chemicals updated [2009/0070]
and its usability improved 01-Dec-2007
Poland Part of the executive summary:
Ordinance on Assessment of the Level of Sub‑
stances in the Air issued 17-Dec-2008 Occupational safety and health: A global
Russia perspective
Legislation on wastes amended 30-Dec-2008 Around 270 million people in the world fall
South Africa victim to occupational injuries, fatal and non-
National Environmental Laws Amendment fatal every year. A recent International Labour
Act published 05-Dec-2008 Organization (ILO) report estimates that ap‑
South Korea proximately 2 million occupational fatalities
Exposure to asbestos under stricter health and occur across the world annually. The social
safety control 06-Feb-2009 and economic cost to the workplace as well as
Sweden to individuals is considerable.
Mercury and articles that contain mercury Occupational injuries and accidents are all
will be banned 27-Jan-2009 caused by preventable factors which could be
Regulation (SFS 2006:311) on transport of eliminated by implementing measures and
dangerous goods amended 09-Dec-2009 methods that already exist. Many industrial
Taiwan countries have extensive and comprehensive
Recycling of pharmaceuticals’ containers re‑ systems of occupational safety and health
quired 13-Jan-2009 (OSH) management, and this is demonstrat‑
Thailand ed by consistently reduced accident rates. An
Act on liability for damages caused by unsafe increasing proportion of occupational inju‑
products published 13-Feb-2008 Ukraine ries in the world are occurring in developing
Chemicals (Hazard Information and Packag‑ countries. A factory worker in Pakistan, for
ing for Supply) Regulations 2002 will be re‑ example, is eight times more likely to be killed
placed. at work than a factory worker in France. The
degree of protection against occupational haz‑
ards varies not only by nation but also by eco‑
nomic sector and size of the enterprise. The
highest rates of occupational accidents occur
in agriculture, forestry, mining and construc‑
hampered by fragmented ideals and organi‑ ing on chemical production and use. In these
zation and could not keep up with the shift‑ settings, access to people with experience in
ing demands of the world of work, therefore assessing and controlling exposure to chemi‑
having little impact. Traditional strategies cals is limited. Therefore, a new approach to
and methods for prevention and control need the control of chemicals, control banding, has
radical updating to respond effectively to the been developed. It is a complementary ap‑
fast and continuous changes in the workplace. proach to protecting workers’ health by focus‑
In addition, there is a perpetual need to train ing resources on exposure controls and bands
new generations of workers as they replace re‑ chemicals in different groups according to
tiring ones. Mechanisms and strategies must their dustiness/volatility. This method forms
therefore be developed to always keep occu‑ the basis of the ILO’s International Chemical
pational safety and health at the forefront of Control Toolkit (ICCT).
national and enterprise priorities. Convention
No. 187’s focus on not only the development Conclusion
but also the maintenance of OSH culture ad‑ This book aims to serve as a guide or reference
dresses this need. for the development of OSH policies and pro‑
grammes, including those devoted specifically
OSH management systems to HIV/AIDS. It covers the fundamental prin‑
The book expands on the OSH management ciples of occupational safety and health, based
systems which help companies accept and on the ILO’s philosophy of prevention and
administer the building and maintenance of protection, which stems from the Organiza‑
a culture of health and safety as their prime tion’s mandate in the field. The Conventions,
responsibility. The new edition offers samples Recommendations and codes of practice that
of how a comprehensive evaluation system make up the set of “core” ILO instruments on
would include baseline evaluations, auditing, OSH embody all the principles, provisions
self-inspection and self-correction, incident and technical guidance necessary to establish,
investigation, medical surveillance and man‑ implement and manage OSH systems. They
agement review activities. are presented in this edition in a form that will
be useful for those involved in policymaking
Chemical safety (governments, and employers’ and workers’
This edition also includes a new section on organizations), those within enterprises who
international chemical safety. Amid grow‑ are concerned with the practical implemen‑
ing concerns for human and environmental tation of measures to promote and protect
health, the prevention of exposure to haz‑ the safety and health of workers (managers,
ardous chemicals in the workplace is a major supervisors, workers’ representatives), legisla‑
focus of occupational safety and health. In‑ tors and labour inspectors as well as academic
ternational Chemical Safety Cards (ICSCs), institutions.
designed to serve as an international reference Reference: Benjamin O. Alli:Fundamental principles
for chemical safety information, summarize of occupational health and safety, 2nd ed.,
essential safety and health information on 2008,ISBN 978-92-2-120454-1.
chemical substances in a clear way and are http://www.ilo.org/global/What_we_do/
intended for use at the shop-floor level by Publications/ILOBookstore/Orderonline/
workers and by those responsible for work‑ Books/lang--en/WCMS_093550/index.htm
place safety and health. In recent years, small
and medium-sized enterprises especially in
emerging economies are increasingly rely‑
[2009/0075]
Belgium (Period February 2009) tation documents (ECHA) on the first draft
recommendation for priority substances for
[2009/0076] authorisation and guidance for the formation
of industry Substance Information Exchange
Staatsblad 11 februari 2009: ADR in voege Fora (SIEFs).
op 1 januari 2009. Europees Verdrag betref‑ References: http://www.defra.gov.uk/environment/
fende het internationaal vervoer van gevaar‑ chemicals/index.htm
lijke goederen over de weg http://www.defra.gov.uk/environment/
Staatsblad 17 februari 2009: Besluit van de chemicals/reach/index.htm
Vlaamse Regering van 16 januari 2009 tot wij‑
ziging van het besluit van de Vlaamse Rege‑ CHIP 4
ring van 1 juni 1995 houdende algemene en A consultation on proposals to revise the UK
sectorale bepalingen inzake milieuhygiëne regulations that implement the packaging and
[Artikel 1. Aan deel 2 van het besluit van de Vlaamse Rege‑ labelling requirements of the DSD and DPD to
ring van 1 juni 1995 houdende algemene en sectorale be‑ bring them into line with the new the Europe‑
palingen inzake milieuhygiëne, het laatst gewijzigd bij het an Regulation on the Classification, Labelling
besluit van de Vlaamse Regering van 19 september 2008, and Packaging of Substances and Mixtures,
wordt een hoofdstuk 2.13 toegevoegd, dat luidt als volgt: (Regulation (EC) No. 1272/2008), known as
Hoofdstuk 2.13. Beleidstaken voor de beperking van het the CLP Regulation. Has closed (13 Febru‑
gebruik van perfluoroctaansulfonaten ] ary 2009). The CLP Regulation adopts in the
Staatsblad 9 maart 2009: Koninklijk besluit European Union, the internationally agreed
van 9 februari 2009 tot wijziging van het ko‑ Global Harmonised System on the classifica‑
ninklijk besluit van 15 oktober 1997 betref‑ tion and labelling of chemicals, known as the
fende cosmetica ‘GHS’. The implementing UK regulation will
be known as Chemical (Hazard Information
and Packaging for Supply) Regulations 2009
United Kingdom (Period January- or CHIP 4.
February 2009) The proposed amendments are required to al‑
low CHIP to be aligned with the transitional
[2009/0077] period of the CLP Regulation and to ensure
that the provisions of the CLP Regulation can
UK Policy & REACH be enforced in Great Britain, both throughout
The UK Government policy for identifying the transitional period and beyond.
and managing risks arising from chemicals The Health & Safety Executive has developed
and their use, is developed and publicised by a web page for GHS;and has set out the next
the Department for Environment, Food and steps in the program of work required or ex‑
Rural Affairs (DEFRA). Neither the main page pected (from the UK perspective) under CLP
of the DEFRA website that provides links to as a “legislative dossier under implementa‑
policy information; nor any of the sub pages tion”.
that give guidance on UK, EU and internation‑ References: http://www.hse.gov.uk/ghs/index.htm
al chemicals policy or specific chemical issues http://www.hse.gov.uk/aboutus/europe/
have been updated since May/June last year. euronews/dossiers/ghs.htm
However the sub page for REACH was revised
0n 17 February 2009 with updated guidance
for the status of recovered waste substances,
and contains recently revised links to consul‑
an analytic tool designed to help identify drug and bio‑ termines that it is not technologically feasible to have this
logic names and medical terminology that are phonetically lower limit. Paint, coatings, or electroplating may not be
and orthographically similar to one another. POCA is one considered a barrier that would make the lead content of
analytic tool that FDA uses to review proposed proprietary a product inaccessible to a child or prevent the absorption
drug and biologic names.] of any lead in the human body through normal and rea‑
Federal Register, Vol. 74, No. 30, Febru- sonably foreseeable use and abuse of the product.]
ary 17, 2009, 7386: Schedules of Controlled
Substances: Placement of Tapentadol [CAS
175591-23-8] Into Schedule II. Drug Enforce‑
ment Administration, Department of Justice.
Notice of proposed rulemaking.
[Tapentadol has dual modes of action namely, mu (�������
�����
) opi‑
oid receptor agonistic action and inhibition of reuptake
of norepinephrine at the norepinephrine transporter.
The chemical name of its monohydrochloride salt form
is 3- [(1R,2R)-3-(dimethylamino)-1-ethyl-2- methylpro‑
pyl]phenol hydrochloride.]
Federal Register, Vol. 74, No. 34, February
23, 2009, 8106: In the Matter of Certain R–
134a Coolant (Otherwise Known as 1,1,1,2–
Tetrafluoroethane [CAS 811-97-2]); Enforce‑
ment Proceeding; Order. International Trade
Commission.
Federal Register, Vol. 74, No. 37, February
26, 2009, 8781: Tracking Labels for Children’s
Products Under Section 103 of the Consumer
Product Safety Improvement Act; Notice of
Inquiry; Request for Comments and Informa‑
tion. Consumer Product Safety Commission.
Federal Register, Vol. 74, No. 46, March 11,
2009, 10475: Children’s Products Containing
Lead; Final Rule; Procedures and Require‑
ments for a Commission Determination or
Exclusion. Consumer Product Safety Com‑
mission. Final rule.
[The Consumer Product Safety Improvement Act (CP‑
SIA) establishes specific limits on lead in children’s prod‑
ucts. Section 101(a) of the CPSIA provides that after
10 February 2009, products designed or intended prima‑
rily for children 12 years of age or younger may not con‑
tain more than 600 ppm of lead by weight for any part of
the product. After 14 August 2009, products designed or
intended primarily for children 12 years of age or younger
cannot contain more than 300 ppm of lead by weight for
any part of the product. On 14 August 2011, the limit will
be further reduced to 100 ppm unless the Commission de‑
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Citeertitel
Journaal Stoffen en Preparaten jaartal/nummer
(voorbeeld: Journaal Stoffen en Preparaten 2009/1)
ISSN 1574-1079
Journal
Chemicals
Management
Journaal Content
Stoffen & Preparaten
ARTICLES
Chief-editor:
Drs. A.C.H. van Peski [2009/0081] ChemCon Asia Conference 2009: a summary
on GHS implementation / 91
Editorial Board:
Dr. M.M. Kops-Werkhoven
Actualities
Drs. H.A.F. van Well
Dr. J.A.S.J. Razenberg
European Union
Dr. L.J.M. Rodenburg
Drs. G.A. Schouten [2009/0082] Health Council of The Netherlands Reports
Drs. J. Zawierko (Period August-December 2008) / 101
[2009/0083] 1st ATP to CLP / 103
Advisory Board: [2009/0084] ECHA Publishes an Updated List of
K. E. Armstrong (U.S.A.) Pre-Registered Substances / 103
Dr. R. Fielding (United Kingdom) [2009/0085] ETUC earmarks priority chemicals for
Drs. A. Gondová (The Netherlands) REACH authorisation / 104
G. Koh (Singapore) [2009/0086] PINFA: new Cefic Sector Group / 105
Dr. C. van Lint (Australia)
Dan Liu (U.S.A.) International
S. Park (S.-Korea) [2009/0087] The U.S. Environmental Protection Agency’s
H. Sano (Japan) Strategic Plan for Evaluating the Toxicity of
S. Savary (Canada) Chemicals / 105
Dr. U. Schumacher (China) [2009/0088] OECD Guidance Manual for the Control of
C. Sieger (Germany) Transboundary Movements of Recoverable
J. Simpson (Australia) Wastes / 106
E. Snyman (South Africa)
[2009/0089] Australia: GHS and SUSDP / 106
P.G. Tse (New Zealand)
[2009/0090] Singapore: Strategic Goods (Control) Order
2009 / 108
PUBLICATIONS
No. 4 [2009/0091] Acute systemic toxicity determination / 109
May 2009
Volume 6 OFFICIAL PUBLICATIONS
Part of Stoffennieuws.nl
[2009/0092] The Netherlands (Period March 2009) / 110
[2009/0093] Belgium (Period March 2009) / 111
[2009/0094] United Kingdom (Period March 2009) / 112
content
compulsory; industry may use their own data MEP has tested new chemicals’ eco-toxicolo-
to classify chemicals on the basis of their own gy and assessed their environmental hazard,
judgments. built eco-toxicology testing institutes and
References: http://www.safe.nite.go.jp/english/ghs_ good laboratory practise testing (GLP) fa-
index.html cilities, compiled a test manual for chemicals’
http://www.meti.go.jp/policy/chemical_ eco-toxicology as well as testing method of
management/int/ghs.html chemicals by reference to the GHS require-
ments for aquatic environmental hazards and
P.R. of China the relevant technical guidance of OECD.
Two lectures were dealing with chemicals – AQSIQ
management in the P.R. of China, one on The State General Administration of the P.R. of
Chemicals Control Legislation and aspects of China for Quality Supervision and Inspection
GHS by Zhang Aitong of the China Chamber and Quarantine (AQSIQ) is a law enforcement
of Commerce of Metals, Minerals & Chemi- administrative organ of the State Council in
cals Importers & Exporters (CCCMC), and the field of quality, metrology, entry-exit com-
one on the new Chemical Notification System modities inspection, entry-exit health quaran-
of CRC-MEP by Andrew Burgess of LSR As- tine, entry-exit animal and plant quarantine,
sociates. certification and accreditation and standardi-
CCCMC – with a membership of more than zation.
4,700 companies – acts as a bridge between AQSIQ has begun to build key laboratories
government and enterprises. It was founded in Tianjin, Shanghai and Guangdong Prov-
in Beijing in 1988 and was named as REACH ince for the implementation of GHS and to
Consultancy Centre of the Ministry of Com- respond to REACH; established relevant data
merce in 2008. CCCMC Europe in Helsinki, bases, websites and information platform of
Finland was set up in 2008 and acts as Only chemical data.
Representative for Chinese manufacturers. Other departments, like the State Administra-
tion of Work Safety, the Ministry of Public
Current developments and Government’s Health (MOH), the Ministry of Public Secu-
planning for GHS in China: rity (MPS) and the Ministry of Communica-
– Ministry of Environmental Protection tion (MOC) are actively participating in the
In March 2008 the State Administration of related work of GHS.
Environmental Protection (SAEP) was up- – GHS Standards
graded to Ministry of Environmental Pro- A series of Safety Rules for Classification and
tection (MEP). The tasks of MEP are among Labelling of Chemicals, implementing GHS,
others to formulate and amend environmen- came into force on 1 January 2008. This series
tal protection regulations and standards con- of standards includes 16 types of physical haz-
cerning chemicals in China; to be responsible ards and 10 types of health hazards. It has be-
for the classification and implementation ac- come the basis for uniform classification and
cording to the environmental hazard part of labelling of chemicals and provides technical
GHS; to be involved in the development of guidance.
responding measures and related scientific re-
search, to provide environmental impact data New Chemical Notifications
of chemicals; build and to improve relevant During the last six years, notifiers of new
laboratories. A current activity is the compari- chemical substances in the P.R. of China
son of the GHS classification of imported and have become familiar with the processes for
exported toxic chemicals. registering and exempting new chemical
19 October 2006: CLA announced the amend- this 1,062 chemical list is also welcomed ac-
ed regulation with new title ‘Regulation of cording to the
Labelling and Hazard Communication of CLA. GHS has become Taiwan’s common
Dangerous and Harmful Materials’ adopting standards in most chemical hazard commu-
GHS. nication schemes as recommended by the UN
15 November 2007: 2nd interagency coor- Purple Book.
dination meeting of GHS implementation. It should be noted that GHS has not been fully
Determined the enforcement date of the first adopted in agropesticide and chemical con-
stage implementation (CLA, EPA (Environ- sumer product due to the progress of interna-
mental Protection Administration) and NFA tional harmonization work, i.e. World Health
(National Fire Agency)). COA (Council of Organization (WHO), UN Food and Agricul-
Agriculture, Executive Yuan): plant protec- ture Organization (FAO) and others.
tion agents) is pending on WHO and FAO’s Reference: http://www.sahtech.org
harmonization works. MOEA (Ministry of http://ghs.myweb.hinet.net/EN_GHS/
Economic Affairs) will announce a labelling Taiwan_2008_GHS_Implementation%20
guideline later in 2008 adopting GHS for Update.pdf
chemical consumer products. The need for http://ghs.cla.gov.tw/en/index.php
developing a national hazard chemical in- The CLA list of 1062 prioritized hazardous
ventory for future GHS implementation was chemicals subject to GHS compliance by
identified. CLA is taking the lead for develop- 31 December 2008: http://
ing a national chemical inventory. www.cla.gov.tw/cgi-bin/Message/MM_
19 December 2007: Executive Yuan approved msg_control?mode=viewnews&ts=495847
the implementation date of 31 December 69:1c6&theme=
2008. It will enter a transitional period from
1 January 2008 to convert from current sys- South-Korea
tem to GHS. The paper of OK-Sun Jung of Safe Chemi-
29 December 2008: CNS 15030 standards have cals Co. Ltd., Australia introduced the three
been amended by the Bureau of Standards, new laws for the management of hazardous
Metrology and Inspection, MOEA, to adopt chemicals, information on the change in the
the GHS Purple Book 2007 2nd revised edi- new chemical notification system, and aspect
tion of Korean GHS. In South-Korea, six minis-
31 December 2008: Regulations of CLA, EPA tries and an agency (Ministry of Environ-
and NFA enter into force to bringing in GHS ment (MOE), Ministry of Health, Welfare,
classifications, MSDS and labelling. CLA’s and Family Affairs (MOHWFA), Ministry of
‘Regulation of Labelling and Hazard Commu- Labour (MOL), National Emergency Man-
nication of Dangerous and Harmful Materi- agement Agency (NEMA), Ministry of Know
als’ (the Regulation) has entered into effect on ledge Economy (MKE), Ministry of Food,
December 31st, 2008. The Regulation adopts Agriculture, Forestry and Fisheries (MAFF),
all GHS elements (except the environmental and Ministry of Education, Science and Tech-
aquatic hazard pictogram which is regulated nology (MEST)) with their laws are involved
by the EPA) including classifications, label- in managing chemicals to protect human
ling, MSDS/SDS, and mixture classifications. health or the environment from the hazard
With staged implementation approach, cur- of chemicals. Also, recently several laws have
rent phase of mandatory compliance applies been implemented for the adoption of the
to only 1,062 prioritized chemicals specified international agreements such as Stockholm
by the CLA. Voluntary compliance beyond Convention, Rotterdam Convention, GHS,
etc., and for the regulation of hazardous sub- must follow the form published by MOE.
stances in consumer products. NIER will publish this year the label forms
in accordance with ‘Regulation on Classifica-
Industrial Safety and Health Law (ISHL): tion and Label of Toxic Chemicals, etc. (NIER
Subject to certain exceptions, before any new Notice No. 2008-26)’ for all designated ‘Toxic
chemical is manufactured or imported for Chemicals’.
use at a workplace, the business owner of the
workplace must submit a ‘Hazard Danger The Philippines
Review Report for New Chemical (i.e. new John H. Moore of Lubrizol Company and
chemical notification)’ to MOE (since 2006 Flordeliz Y. Guarin, reported on the develop-
all documents have to be submitted to the ment of the chemicals management systems
National Institute of Environmental Research in The Philippines. A December 2007 draft
(NIER),). MOE sends a copy to MOL for fur- Joint Administrative Order adopts the GHS
ther review. The manufacture or use of cer- elements for labels and MSDSs. The Adoption
tain chemicals hazardous to workers’ health is and Implementation of GHS defines the roles
prohibited or requires approval by MOL. Ex- of government authorities, specifies GHS for-
amples are crocidolite (prohibited) and PCB mat for labels and MSDSs, and allows claims
(requiring permit). for confidential business information. The
Philippine Board of Investments (BOI) chairs
The GHS system was introduced with minor the National GHS Implementation Commit-
differences among the regulations published tee. The Department of Environment and
by three authorities: ‘Regulation on Classifica- Natural Resources (DENR) – Environmental
tion and Label of Toxic Chemicals, etc. (NIER Management Bureau (EMB) is the head of the
Notice No. 2008-26)’ under TCCL (Toxic Subcommittee on Legislation which will un-
Chemicals Control Law), ‘Standards for Pre- dertake the amendment of existing environ-
paring and Keeping on File the Material Safety mental legislation relevant to GHS. National
Data Sheet, etc. (MOL Notice No, 2008-29)’ trade association (chemical industry) has been
under ISHL, and ‘Standard on Classification working closely with the BOI to pilot projects
and Label of Dangerous Substances (NEPA in relation to GHS. Indications are that GHS
Notice No. 2008-18)’ under DSML. However, will be implemented in 2009 with a two year
enforcement of GHS system under TCCL and transition period after publication.
ISHL is delayed as follows: Reference: http://www.emb.gov.ph/
TCCL: – Substances: 1 July 2011 – Mixtures:
1 July 2013 Viet Nam
MOL: – Substances: 1 July 2010 – Mixtures: John H. Moore of Lubrizol Company report-
1 July 2013 ed on the development of the chemicals man-
Before these dates both the present and GHS agement systems in the Socialist Republic of
system can be used. The GHS system of DSML Vietnam.
(Dangerous Material Management Law) has Vietnam has issued a new law on chemi-
been in force since 13 November 2008 for cals (Reference: 2008/QH 12). This law will
Dangerous Substances classified under DSML provide regulations on the safe handling of
only. In case a warning label is attached in chemicals, obligations of organisations and
accordance with one of the three laws men- individuals engaged in chemical activities and
tioned, the warning label is admitted mutu- endorses that state management procedures
ally under the three laws. However for ‘Toxic be put in place. It applies to all organisations
Chemical’ designated under TCCL, the label and individuals handling and engaged in ac-
tivities related to chemicals within Vietnam. cals or chemical consumer products must be
The chemical law was adopted on 1 July 2008. labelled and accompanied by a Safety Data
Decree No. 108/2008/ND-CP of 7 October Sheet (all in Khmer language). There is no
2008, detailing and guiding the implementa- date mentioned for implementation.
tion of a number of articles of the Chemical Reference: http://www2.unitar.org/cwm/publications/
Law, was issued to provide guidelines for the cbl/ghs/Documents_2ed/E_GHS_Capaci-
implementation of the Chemical Law. ty_Building_Projects_and_Initiatives/487_
Classification is in line with GHS and labelling Cambodia_CT-report.pdf
is according to the law and regulations on la-
belling of goods Decree Number 89/2006ND- Indonesia
CP. Hazardous chemicals should be labelled A summary of chemical legislation of the Re-
according to the law and regulations on la- public of Indonesia was presented by Karon E.
belling of goods. The labelling guidelines for Armstrong of 3M, U.S.A. A draft ‘Presidential
chemicals apply to domestic, imported and Decree on Application of GHS Classification
exported goods. It applies to interior and ex- and Labelling of Chemicals’ provides back-
terior packages but is not applicable to food- ground, definitions and guidance to appli-
stuffs. The intent is product identification, cability (industrial and consumer), elements
selection and directions for use; the content (classification, labelling with symbols, signal
is the most critical, with list % – high to low; words, hazard and precautionary phrases, and
name of manufacturer; import; weights/ SDS). While the stated date of GHS imple-
measures; expiry date; storage conditions; mentation is 2008, the draft makes continu-
use instructions; quality, health and environ- ous reference to be ‘determined further in rel-
mental information must be included. For the evant Ministerial Regulations.’
language, Vietnamese is mandatory but other Reference: http://www.kn-rci.or.id/index.
languages are allowed but must be in smaller php?page=static&id=29
font. Export only chemicals may be labelled
in the language of the country of import. It Singapore
is understood that the revision of the Circu- Again it was Karon E. Armstrong of 3M,
lar 12/2006/TT-CN for detailed guidance of U.S.A., who informed the audience on Singa-
GHS implementation is still being worked on pore.
by the government, with a view for adoption The Workplace Safety and Health (General
during July 2009. However, the implementa- Provisions) Regulations 2006 mandates the
tion guidelines, Decree No 108-2008/ND-CP, provision of SDS for hazardous substances,
contains no specific information on adop- and adopted the GHS SDS format.
tion. SS 586 : 2008 Singapore Standard on the Haz-
See also JSP 2008/04, item 2008/0098, ard Communication for Hazardous Chemi-
page 107. cals and Dangerous Goods was published
on 23 October 2008, providing guidelines on
Cambodia Singapore’s Implementation of Globally Har-
A summary of chemical legislation of the monised System of Classification and Label-
Kingdom of Cambodia was presented by ling of Chemicals (GHS) & Caution Labelling
Karon E. Armstrong of 3M, U.S.A. The Royal for the Transport and Storage of Dangerous
Government draft of the sub-decree on clas- Goods
sification and labelling chemicals adopts the SS 586 : 2008 is the result of the revision of SS
principles of GHS, including label elements 286 : 1984 on Caution Labelling for Hazard-
and provisions for Safety Data Sheets. Chemi- ous Substances (five parts) and CP 98 : 2003
on Preparation and Use of Material Safety The Indian Railway Act and the Red Tariff
Data Sheets (MSDS). Rule (No. 20) are also being amended for haz-
Reference: http://www.spring.gov.sg/Content/Module- ardous goods from time to time.
Page.aspx?group=nw&id=a064e55c-b2dd- A specific legislation complying with GHS is
44df-8ae1-81cc465b11e8 being worked on by Federal Government.
For ordering the standards set: http://
www.singaporestandardseshop.sg/package/ Russia/CIS
PackageView.aspx?id=14c06a79-5fdc-4015- Prof. Alexander D. Kozlov of the Russian Sci-
a320-73dc6dd96317 entific and Technical Centre for Information
See also JSP 2008/10, item [2008/0215] on on Standardization, Metrology and Conform-
page 262. ity Assessment ‘Standartinform’ gave its pres-
entation on the existing Russian system of safe
Thailand handling of chemicals.
Karon E. Armstrong of 3M, U.S.A. told in The Commonwealth of Independent States
her paper that Thailand implements GHS in Standard GOST CIS 30333-2007 ‘Chemical
a stepwise manner. Phase I requires GHS la- production Safety Passport. General require-
bel and SDS for single substances only from ments’ (safety data sheets) and GOST CIS
July 2008. Informal information from the au- 31340-2007 ‘Labelling of chemicals. General
thorities indicates that they will implement all requirements’ are implementations of the UN
physical hazards and some health and envi- Purple Book recommendations. GOST CIS
ronment hazards in this first step. Phase II for 30333-2007 complies with the REACH Regu-
mixtures from 2009 at which time additional lation Annex II. The CIS states are: Azerbai-
hazard categories may be added. jan, Armenia, Belarus, Georgia, Kazakhstan,
Kyrgyzstan, Moldova, Russia, Tajikistan, Turk-
India menistan, Uzbekistan and Ukraine.
S.K. Hazra of Aegis Logistics Ltd. (Mumbai) Five Russian national GOST R Standards on
brought us up-to-date with the Indian situa- classification of chemicals will be approved
tion. before the end of this year.
Under the Environmental Protection Act of The Coordinating Informational Service
1986 (after the Bhopal disaster of 3 December Centre for CIS Enterprises (CISC) offers:
1984) several Chemical control legislations (1) Consultations on the registration of sub-
have been formulated e.g. the Manufacture, stances at the European Chemical Agency and
Storage and Im[port of Hazardous Chemicals (2) Consultation on the GHS recommenda-
Rules 1989 (amended 2000), the Hazardous tions (Establishment and Registration of SDS
Waste (Management and Handling Rule 1989, (Passports of Safety); Hazardous classification
in 2008 superseded by the Hazardous Waste of products; Services for the product identifi-
(Management, Handling and Transboundary cation (EC and CAS numbers); Labelling).
Movement Rules and the Chemical Accidents Reference: http://www.wereach.ru/en/index.html
(Emergency Planning, Preparedness and Re-
sponse) Rules 1996. Turkey, Israel, Saudi Arabia, Oman and
In the transportation sector, the Central Mo- Pakistan
tor Vehicle Rules 1989 have been amended to Tamar Szeps-Znaider of 3E provides a brief
bring classification and packaging require- country overview on some of the Middle East
ments mostly in tune with GHS. states.
– Turkey: Before the final publication of
GHS, Turkey expressed interest in receiv-
ing assistance with GHS Capacity Build- gerous goods into a combined standard. The
ing, but there has been no traceable devel- revised standard is also integrating the clas-
opment toward GHS implementation in sification, labelling and safety data sheet re-
Turkey since. quirements of the hazardous substances and
– Israel: There has been no official GHS dangerous goods frameworks, using guidance
activity in Israel. However, a 2005 report from the GHS documentation. The revised
by the Israeli Institute for Occupational draft standard has been subject to public con-
Safety and Hygiene does mention that a sultation and a regulatory impact statement is
number of ministries were collaborating being developed. It is expected that the stand-
on identifying the capacity for Israeli GHS ard will be finalised in 2009 and the revised
implementation through the identifica- standard will be integrated into the national
tion of existing national legislation. occupational health and safety framework,
– Saudi Arabia: Saudi Arabia has expressed which is currently under development. The
some interest in GHS, and participated in implementation timetable has yet to be devel-
the Regional Workshop on Chemical Haz- oped and will be informed by arrangements
ard Communication and GHS Implemen- for implementation of the GHS in Australia’s
tation for Arab Countries (Alexandria, trading partners.
Egypt, 2006). For agricultural and veterinary chemicals,
– Oman: In terms of GHS activities, Oman the Australian government is working with
participated in the Regional Workshop on stakeholders to consider the implications of
Chemical Hazard Communication and the GHS for Australia’s risk-based labelling
GHS Implementation for Arab Countries system for these chemicals. The impact on the
(Alexandria, Egypt, 2006). Oman has also labelling requirements for consumer products
expressed interest in Capacity Building as- and poisons is also under consideration as
sistance from UNITAR/ILO. there are implications for the signal words and
– Pakistan: There has been no significant precautionary statements currently used. The
movement on GHS in Pakistan. From considerations include the implementation
2006-2009 Pakistan has allegedly been schedules of major trading partners.
receiving capacity building advice from
UNITAR/ILO/SAICM, however, there are New Zealand
no reports documenting this activity. From the introduction by John Frangos of
Toxikos Pty Ltd, Australia.
Australia New Zealand was the first country to im-
Marion J. Healy of the National Industrial plement a system of hazard classification
Chemicals Notification and Assessment based on international agreements, in par-
Scheme (NICNAS), Department of Health ticular the original revision of the global
and Ageing, informed us on industrial chemi- harmonised scheme for classifying chemicals
cal control; and GHS in Australia. (GHS). The key dilemma for the regulators
Australia is considering the implications of was that HSNO (Hazardous Substances and
implementing of the GHS across workplace, New Organisms) legislation was enacted in
consumer and agricultural chemicals. In the 1996 and the legislative process required the
workplace sector, national standards and regulations to be in place by 2001. Thus the
codes of practice relating to the use of chemi- regulations produced in 2001 do have some
cals in the workplace have been revised with points of difference with the current GHS
a view to consolidating the requirements for (revision 2). However for practical purposes
workplace hazardous substances and dan- the New Zealand system reflects the GHS clas-
sification criteria. The thresholds and classifi- mentation. (Mercosur full members: Argen-
cation schemes for explosiveness, flammability tina, Brazil, Paraguay, Uruguay, full member
and oxidising capacity are based on the Unit- pending ratification: Venezuela, associate
ed Nations Recommendations for the Trans- members: Bolivia, Chile, Colombia, Ecuador,
port of Dangerous Goods. New Zealand have Peru). Ecuador is accepting GHS labels, Ar-
adopted the lowest hazard classification cut- gentina MSDS guidelines meet the GHS lay-
offs available within the GHS (e.g. flashpoint out requirements.
of ≤ 93°C, acute oral LD50 of 5000 mg/kg).
There are differences in the GHS criteria for
ecotoxicity and those specified within the
HSNO regulations. A revision to align with
GHS 2007 is underway.
The HSNO legislation does not prescribe a
format for MSDS. However an approved code
of practice for preparing MSDS has recently
been approved by ERMA NZ. Since July 2008,
New Zealand specific information must be
provided on all MSDS supplied with any haz-
ardous substance in New Zealand. These man-
datory requirements include the New Zealand
supplier’s contact details, an emergency con-
tact number and the HSNO approval number
or title of the Group Standard, together with
the significant Controls.
New Zealand specific product labels for haz-
ardous substances are not required until
31 December 2010 if the product is covered by
a Group Standard and the labels comply with
the labelling requirements of Europe, Austral-
ia, USA or Canada. The New Zealand require-
ments for labelling include pictograms, signal
word, and hazard and precautionary state-
ments based on GHS, first revision 2005.
Latin America
Markus Flink of TechniData AG covered in his
presentation on Middle and South America
also the GHS implementation of that region.
In Brazil the SDS standard NBR 14725 is un-
der revision in order to implement the GHS
requirements (since December 2007. After its
official publication, the transition period will
be 18 months.
In cooperation with the German ‘Gesellschaft
für Technologische Zusammenarbeit’ the
Mercosur members are working on imple-
Epidemiologists are also looking for new ways cological analysis techniques, such as (Q)
of enhancing research quality and increasing SARs and in vitro methodologies, as well
the evidential value of research data. Impor- as modelling techniques, such as physi-
tant developments include the emergence of ologically based kinetic modelling.
validated methods for the estimation of past – At the same time, more widespread use
exposure, the use of biomarkers (early effects and further development of probabilistic
known to serve as predictors of subsequent methodologies is desirable. These meth-
health deterioration) and statistical analysis odologies promise a major improvement
techniques for the combination of data from on the ‘classic’ approach, based on the use
various studies. An uncertainty factor for of default values for uncertainty factors.
shortcomings in the data can then become – In recent years, there has been increasing
smaller or can even become superfluous. interest in methods for the health-based
In parallel with the developments outlined assessment of substances in the absence of
above, probabilistic methodologies are enter- ample toxicity.
ing increasingly widespread use. The problem Reference: Health Council of the Netherlands. Uncer-
with default uncertainty factors is that it is tainty factors in risk assessment. The
unclear how conservative the assigned values Hague: Health Council of the Netherlands,
are. This issue can be addressed by combining 2008; publication no. 2008/13.
probability distributions, rather than absolute http://www.gr.nl/pdf.php?ID=1763&p=1
estimates, and then calculating a health-based
recommended exposure limit on the basis of Prudent precaution
an acceptably low degree of probability that Does the disappearance of many animal and
adverse effects will occur. Good communica- plant species threaten ecosystem function-
tion with regulatory bodies is very important ing and human health? Is the cultivation of
in this context, because such methodologies genetically modified crops a threat to people
have yet to gain formal approval. and the environment? Are people working in
It is sometimes the case that little is known the cosmetics industry at risk from nanopar-
about the toxicity of a substance. ticles? Can variant Creutzfeldt-Jakob’s disease
The next chapter of the report accordingly be communicated in blood and blood pro
outlines a number of methods by which it ducts? Science cannot currently answer these
can sometimes nevertheless be possible to cal- and many other questions. However, the un-
culate recommended exposure limits (albeit certainty that surrounds such issues does not
provisional or indicative limits) under such mean that they can be relegated to the bottom
circumstances. The final chapter of the report of the political and policy agenda. In recent
summarises the main recommendations of decades, there have been increasingly insistent
the committee responsible for the report: calls for the precautionary principle to be ap-
– Allometric scaling factors should be used plied in cases of scientific uncertainty, for the
wherever possible. protection of public health and the environ-
– The definition of chemical-specific ad- ment. The European Union has incorporated
justment factors (CSAFs) is preferable the principle into its treaty and the environ-
whenever enough is known about the mental movement is constantly asking for the
toxic activity of a substance. International precautionary principle to be used to address
cooperation in the definition of CSAFs potential hazards in our surroundings.
should be encouraged. Application of the precautionary principle
– Understanding of toxic activity can be has, however, been the subject of considerable
advanced by the application of new toxi- debate. Critics argue that the precautionary
000 substances which were pre-registered cals in workplaces. About one in three of the
by 65 000 companies between 1 June and occupational diseases recognised each year
1 December 2008. The new list is important in Europe is due to the exposure to hazard-
for companies who manufacture or import ous chemicals, according to ‘REACHing the
substances and who wish to find the correct workplace’, a study published by the European
SIEF (Substance Information Exchange Fo- Trade Union Institute in 2006.
rum) for their substance. The list will help For chemicals of very high concern, industri-
verify whether, in reality, certain pre-SIEFS alists must also get authorisation for each use
cover the same substance and hence whether in order to continue marketing them. An esti-
they should merge. Finally, it will also help mated 30,000 or so chemicals will have to be
identify similar substances for read-across REACH-registered. The number of substances
and formation of chemical categories. As a of very high concern on the European market
result, the list will help to ensure that data is could be anywhere between 1500 and 2000.
shared and hence to minimise animal testing. Although the European Chemical Industry
Please note that the list is made up of pre-reg- Council (Cefic) contributes actively to the ap-
istrations submitted by industry. In ECHA’s plication of the legislation on occupational
opinion the list contains many preparations safety and of REACH, it regrets the publica-
and substances that did not require registra- tion of such a list, which has no legal value and
tion. ECHA advises companies to verify what is not part of the REACH process. It includes a
registrations they need to make. whole range of high volume substances, which
Reference: http://apps.echa.europa.eu/preregistered/ are only used as intermediates and therefore
prsDownload.aspx do not even fall under authorisation.
The REACH process is governed by the Euro-
pean Chemicals Agency, which is the sole body
ETUC earmarks priority chemicals responsible for publishing the Candidate List
for REACH authorisation of substances that will undergo further evalu-
ation and which might end up on the official
[2009/0085] Candidate List, i.e. the substances eligible to
come under the authorisation element of
On 31 March 2009, the European Trade Un- REACH. On 30 June 2008 ECHA published
ion Confederation (ETUC) presented a list a first list including sixteen substances. This
of priority chemicals for authorisation under list will be complemented by additional sub-
REACH to the European Parliament. ETUC is stances proposed by the member states.
calling on the Member States and European References: http://hesa.etui.org/uk/newsevents/newsfi-
Commission for the 306 substances of very che.asp?pk=1224
high concern on its list – especially the 191 http://www.cefic.org/Files/NewsReleases/
that cause recognised occupational diseases – Chem_Industry-REACH_list.doc
to be included on the candidate list of sub- REACHing the workplace: http://hesa.etui-
stances for authorisation under the REACH rehs.org/uk/publications/files/REACH-EN.
rules. pdf
Chemicals bring benefits with which our so- Trade Union Priority List for REACH Aut-
ciety could not do without and there is no horisation:
denying that the EU chemicals industry also http://hesa.etui.org/uk/newsevents/files/
contributes to our economic prosperity in Trade%20Union%20Priority%20List%20
terms of trade and jobs. However, European for%20REACH%20authorisation-final.
workers pay a high price for the use of chemi- doc.pdf
See also: SIN: Journaal Stoffen en Preparaten, 2008, and other stakeholders such as regulators. The
08, item 2008/0185, page 222. objective is to establish a cooperative dialogue
with OEMs (Original Equipment Manufac-
turers) in order to identify their needs and
PINFA: new Cefic Sector Group technologies they are looking for.
Reference: http://www.cefic.org/Tem-
[2009/0086] plates/shwNewsFull.
asp?HID=1&NSID=711&P=1&NID=469
The European Chemical Industry Council
(Cefic) has formed a new sector group: the International
Phosphorus, Inorganic and Nitrogen Flame
Retardants Association (PINFA). Phosphorus
(non-halogenated), inorganic and nitrogen The U.S. Environmental Protection
flame retardants (PIN FRs) are additives that Agency’s Strategic Plan for
can be added to or applied as a treatment to Evaluating the Toxicity
organic materials such as plastics and textiles of Chemicals
to impart fire protection to these materials.
The members of PINFA believe that their [2009/0087]
products form an essential part of environ-
mentally compatible fire safety solutions and To fulfill its mission to protect human health
share the common concept of an ideal flame and the environment, EPA must evaluate the
retardant as one which is not toxic to humans, risks of adverse health effects resulting from
animals and plants, does not migrate out of exposure to chemicals in the environment.
finished products, does not release additional The traditional risk assessment approach relies
toxic or corrosive gases in case of fire, does heavily on data generated through the inten-
no impede the recycling of finished articles, tional dosing of experimental animals. While
and is either degradable in the environment this approach has provided EPA with sound
or remains neutral as naturally occurring sub- science to support regulatory decision making
stances. over the past several decades, EPA must ad-
The main objective of the sector group is to dress ever-increasing demands, including con-
co-operate with members of the value chain sideration of complex issues such as cumula-
including industry organisations involved in tive exposures, life-stage vulnerabilities, and
the use of non-halogenated phosphorus, in- genetic susceptibilities, not to mention the
organic and nitrogen flame retardants in or- increasing number of chemicals and cost of
der to communicate the advantages of this toxicity testing. A new approach is proposed to
technology for the safe use of otherwise eas- address these demands, an approach based on
ily flammable materials. Member companies the application of advances in molecular biol-
include Chemische Fabrik Budenheim, Ciba ogy and computational sciences to transform
Inc., Clariant Produkte (D) GmbH, Ital- toxicity testing and risk assessment practices.
match Chemicals S.p.A., Lanxess Deutschland
GmbH and Nabaltec AG. This Strategic Plan is centered on three in-
As part of its starting activities, PINFA will terrelated components: (1) the use of toxic-
be organising a workshop on ‘Green Elec- ity pathways identification and use of this
tronics & Innovative Flame Retardants’ on 24 information in screening and prioritization
June 2009, in Brussels. The workshop aims at of chemicals for further testing; (2) the use
interacting with the direct users of PIN FRs of toxicity pathways information in risk as-
sessment; and (3) the institutional transition tic and consumer chemicals, including pesti-
necessary to implement such practices across cides.
EPA. This Strategic Plan describes an ambi-
tious and substantive improvement in the This discussion paper explores the options
efficiency and effectiveness of the process by and possible implications that might arise
which environmental pollutants are evaluated from the adoption of the GHS in respect to
for toxicity and risk. domestic and consumer chemicals (includ-
Reference: Report # K-09/001. March 2009. Office of ing pesticides) within the Australian regula-
the Science Advisor Science Policy Council tory framework for the uniform scheduling
U.S. Environmental Protection Agency of drugs and poisons. The paper also provides
Washington, DC 20460 a comparative analysis of the health hazard
http://www.epa.gov/osa/spc/toxicitytesting/ criteria used in the current system of poisons
docs/toxtest_strategy_032309.pdf scheduling for domestic and consumer chem-
icals in Australia with those proposed in the
Globally Harmonised System of Classification
OECD Guidance Manual for and Labelling of Chemicals (GHS). The pa-
the Control of Transboundary per outlines the options for possibly adopting
Movements of Recoverable Wastes the GHS, the likely costs and benefits of those
options and a technical assessment of the
[2009/0088] similarities and differences between current
poisons scheduling criteria and GHS criteria
The successive amendments of Council which may have a bearing on the scope of any
Decision C(2001)107/FINAL [C(2004)20; future proposal to implement the GHS.
C(2005)141; and C(2008)156] on the control The considerations in this document recog-
of transboundary movements of waste des- nise the fact that the toxicological assessment
tined for recovery operations, which concern of chemicals for classification purposes is
the lists of wastes, necessitate the update of the undertaken at a Commonwealth level while
relevant Guidance Manual for the implemen- scheduling (based on classification proposals)
tation of this Decision. This document is a re- and elements of chemical labelling such as
vised version of the former Guidance Manual signal words, pictograms, hazard and precau-
[ENV/EPOC/WGWPR(2001)6/FINAL]. tionary statements as defined by the Standard
Reference: OECD 2009 http://www.oecd.org/data- for the Uniform Scheduling of Drugs and Poi-
oecd/57/1/42262259.pdf sons (SUSDP) are implemented under State
and Territory legislation. The main purpose
of the GHS is to introduce an internationally
Australia: GHS and SUSDP harmonised approach to classification and
labelling of chemical substances which will
[2009/0089] provide the foundation for the development
of national programs to ensure the safe man-
The Australian Office of Chemical Safety and agement of chemicals during their entire life
Environmental Health is seeking public com- cycle. The GHS is intended to cover hazard-
ment on a Discussion Paper which outlines ous chemicals, either in their pure form, as
possible options for the adoption of the Glo- dilute solutions or in mixtures. Human and
bally Harmonised System of Classification veterinary pharmaceuticals, food additives,
and Labelling of Chemicals (GHS) within the pesticide residues in food and cosmetics are
system of public health regulation of domes- not covered by the GHS in terms of labelling
at the point of intake/administration. How- ing the status quo ie rejecting the adoption of
ever, the GHS may apply to these chemicals in the GHS classification criteria and labelling
the manufacturing environment where work- elements. (2). Adoption of GHS classification
place health and safety and/or public health is- criteria, adoption of the GHS hazard and pre-
sues may be of prime importance. The need to cautionary statements, rejection of the GHS
adopt a single classification system within the signal words and pictograms, preserving exist-
scheduling framework and desirably across all ing SUSDP Schedules 5, 6 and 7 with GHS clas-
sectors may, however, have consequences for sification criteria being appropriately aligned
the classification and scheduling of classes e.g. with these existing schedules. (3). Adoption
veterinary medicines which are to be exempt- of GHS classification criteria (with significant
ed from the GHS harmonisation process. change to schedules 5, 6 and 7 to align with
The GHS specifies criteria for classifying GHS criteria), acceptance of the GHS hazard
chemicals according to their physical, health and precautionary statements, rejection of the
and environmental hazards and for harmo- GHS signal words and pictograms. (4). Full
nised hazard communication. Adoption of adoption of the GHS through adoption of the
the GHS system places certain obligations on GHS classification criteria and GHS labelling
government authorities in terms of the clas- elements with a consequential overhaul of the
sification criteria specified by the GHS. How- current poisons scheduling system to align
ever, competent authorities are allowed some with GHS categories.
degree of flexibility in the adoption of the Of these, option 2 is considered by the NDPSC
various labelling elements. to be the most pragmatic approach for Aus-
In examining the appropriateness of adopt- tralia, considering the overall need to main-
ing the GHS in relation to domestic use and tain existing standards in protecting public
consumer chemicals (including pesticides), a health, as well as balancing the likely risks,
number of possible options for implementa- benefits and costs involved in implementing
tion of the GHS have been previously con- the GHS.
sidered by the National Drugs and Poisons Based on the present analysis, adoption of
Schedule Committee (NDPSC) in an effort the GHS classification system into the poi-
to promote a harmonised approach between sons scheduling framework provides for an
States and Territories in regard to the GHS. improved classification system representing
The NDPSC is mindful that there may be a best practice approaches. Only slight changes
range of options for achieving integration of to the current poisons scheduling criteria are
the GHS within the scheduling system. How- required. Overall, there would be minimal
ever, having regard to the extensive NDPSC impact to existing regulation and industry
discussion to date, the operating environment arising from the need to amend product la-
for the scheduling of domestic and consumer bels to comply with a GHS-aligned classifica-
chemicals and the possible impact changes in tion (scheduling) system. There would also be
scheduling practices and procedures may have minimal, if any, impact on the States and Ter-
on existing legislation and other elements of ritories as no change to legislation would be
the wider regulatory system, including the im- required and little or no necessity for retrain-
plications for users of chemicals both profes- ing of chemical users in label interpretation.
sional and the general public, the NDPSC has Certain GHS labelling elements are identi-
identified four options for further discussion. fied as not adding value or in fact, potentially
Consideration of other options is not pre- weakening the current level of protection
cluded. The four options now identified for achieved through existing SUSDP require-
further consideration include: (1). Maintain- ments. As such, GHS signal words and picto-
grams, which have not been evaluated for user ing from its use. The labelling, packaging and
comprehensibility within the Australian com- presentation of a substance may also be taken
munity would not be recommended for adop- into account.
tion at this time. However, hazard and precau- Reference: Discussion Paper: Possible Adoption within
tionary statements are generally in alignment the Public Health Sector of the Globally
with existing statements and offer opportuni- Harmonised System for the Classification
ties to further enhance and harmonise label and Labelling of Chemicals (GHS) in
text. Not adopting GHS signal words and regard to Domestic and Consumer Chemi-
pictograms would, however, prevent Australia cals (including Pesticides). An Analysis of
from being considered ‘fully harmonised’ with the Possible Implications Associated with the
the GHS in regard to domestic and consumer Adoption of GHS Classification Criteria and
chemicals labelling. Labelling Elements within the Framework
The favoured approach offered by way of for the Uniform Scheduling of Drugs and
adoption of option 2 into the SUSDP is Poisons (SUSDP). Paper Prepared by the
evaluated as maintaining existing standards Office of Chemical Safety and Environ-
of public health protection, having minimal mental Health, Department of Health and
impact on existing scheduling classifications Ageing http://www.health.gov.au/internet/
and product labelling (with consequent im- main/publishing.nsf/Content/ghs-discussi-
plications for industry) and avoiding the need on-paper.html
for amendment to State/Territory legislation For the SUSDP: see Journaal Stoffen en
and the training of chemical users, including Preparaten, 2009, no.8, item 2008/0172,
the broad public, in the interpretation of new page 203.
and unfamiliar label elements. The lack of
Australian data on user comprehension and
acceptance of GHS pictograms is of particular Singapore: Strategic Goods
concern. (Control) Order 2009
It is stressed that risk based labelling would be
retained and in relation to the responsibilities [2009/0090]
of the NDPSC would continue to be guided by
legislative provisions outlined in S52E of the The Strategic Goods (Control) Order 2007
Therapeutic Goods Act, 1989, which include: has been replaced with the Strategic Goods
(a) the toxicity and safety of a substance; (Control) Order 2009 which has come into
(b) the risks and benefits associated with the effect on 1 April 2009.
use of a substance; (c) the potential hazards The new Strategic Goods Control List with
associated with the use of a substance; (d) Product Codes is available on the STGC web-
the extent and patterns of use of a substance; site.
(e) the dosage and formulation of a substance; Reference: http://www.customs.gov.sg/stgc/leftNav/
(f) the need for access to a substance, taking str/
into account its toxicity compared with other
substances available for a similar purpose;
(g) the potential for abuse of a substance;
(h) the purposes for which a substance is to
be used; (i) any other matters that the Com-
mittee considers necessary to protect public
health, including the risks (whether imminent
or long-term) of death, illness or injury result-
[2009/0091]
official ligheid,
11° Warenwetbesluit Azo-kleurstoffen,
3. Dit artikel is niet van toepassing op verpakkingen met ontstaan tussen de belangen van bedrijven en het belang
producten bestemd voor de persoonlijke verzorging, van openbaarheid van milieu-informatie. Regelmatig wil-
waaronder spuitbussen. len bedrijven uit concurrentieoverwegingen hun brand-
4. Het bevoegd gezag kan maatwerkvoorschriften stel- stofgebruik, energiegegevens, productiegegevens en emis-
len met betrekking tot een andere wijze van opslag siegegevens op installatieniveau alleen ter beschikking
dan genoemd in het tweede lid op basis van een door stellen aan hun bevoegd gezag (het bestuursorgaan) en
de inrichtinghouder ingediend Programma van Ei- niet openbaar maken. Tegelijkertijd kunnen derden, zoals
sen met betrekking tot de bouwkundige, installatie- milieuorganisaties, verzoeken om toegang tot dergelijke
technische en organisatorische maatregelen, waarin informatie. In de praktijk bestaat nog veel onduidelijkheid
is aangetoond dat de opslag van gevaarlijke stoffen over de wet- regelgeving die hierbij van toepassing is. Met
in verpakking en CMR-stoffen in verpakking in een deze circulaire wordt beoogd de relevante wet- en regelge-
voor het publiek toegankelijke verkoopruimte brand- ving toe te lichten.]
veilig is. Voordat de betreffende verkoopruimte in ge-
bruik wordt genomen, is door een inspectieinstelling, Kamerstuk 2008-2009, 31894, nr. 4, Tweede
die geaccrediteerd is door een accreditatie-instelling Kamer: Uitbreiding en wijziging van de Wet
volgens NEN-EN-ISO/IEC 17020, door middel van milieubeheer in verband met de uitvoering
een goedkeurend inspectierapport aangetoond dat de van de verordening (EG) nr. 1272/2008 van
met het oog op de brandveiligheid getroffen voorzie- het Europees Parlement en de Raad van de
ningen en maatregelen zijn uitgevoerd overeenkom- Europese Unie van 16 december 2008 betref-
stig het Programma van Eisen. Dit inspectierapport is fende de indeling, etikettering en verpakking
binnen de inrichting aanwezig. van stoffen en mengsels en tot wijziging en
5. Een lekbak als bedoeld in tabel 4.8 is onbrandbaar intrekking van de Richtlijnen 67/548/EEG
en productbestendig en kan ten minste 100% van de en 1999/45/EEG en tot wijziging van Veror-
daarboven opgeslagen vloeistoffen bevatten. ...] dening (EG) nr. 1907/2006 alsmede daarmee
Staatscourant 2009, 61: Regeling tot wijzi- samenhangende wijzigingen van andere wet-
ging van de Regeling vervoer over de spoor- ten (Uitvoeringswet EG-verordening inde-
weg van gevaarlijke stoffen in verband met de ling, etikettering en verpakking van stoffen en
tweejaarlijkse revisie van internationale voor- mengsels).
schriften en de inwerkingtreding van de richt-
lijn nr. 2008/68/EG. 25 maart 2009 Nr. CEND/
HDJZ-2009/223 Sector I&O Belgium (Period March 2009)
Staatscourant 2009, 64: Regeling tot wijziging
van de Regeling vervoer over land van gevaar- [2009/0093]
lijke stoffen in verband met de tweejaarlijkse
revisie van internationale voorschriften en de Staatsblad 23 maart 2009: Koninklijk be-
inwerkingtreding van de richtlijn nr. 2008/68/ sluit van 8 maart 2009 tot wijziging van het
EG. 25 maart 2009 Nr. CEND/HDJZ-2009/222 koninklijk besluit van 3 juli 2005 betreffende
sector I&O materialen en voorwerpen van kunststof be-
Staatscourant 2009, 66: Circulaire vertrouwe- stemd om met voedingsmiddelen in aanra-
lijke behandeling bedrijfs-, fabricage- en naw- king te komen
gegevens [naw= Naam, Adres, Woonplaats] Staatsblad 2 april 2009: Wet van 4 juni 2007
[Voor de uitvoering van het milieubeleid is het noodza- houdende instemming met het Samenwer-
kelijk dat bestuursorganen beschikken over informatie kingsakkoord van 2 maart 2007 betreffende
van bedrijven, onder meer in het kader van vergunning- de uitvoering van de overeenkomst tot verbod
verlening, toezicht, monitoring van milieuconvenanten van de ontwikkeling, de productie, de aanleg
en milieuverslaglegging. Daarbij kan een spanningsveld van voorraden en het gebruik van chemische
wapens en inzake de vernietiging van deze wa- sure to chemical carcinogens. The report pro-
pens vides an overview of the issues discussed and
Staatsblad 9 april 2009: Wet van 16 februari the main outcomes and agreements reached
2009 houdende instemming met het Proto- in both plenary and syndicate groups during
col betreffende registers inzake de uitstoot en the workshop.
overbrenging van verontreinigende stoffen, Reference: http://www.hse.gov.uk/drp/workshop08.
gedaan te Kiev op 21 mei 2003 pdf
In this context, the Steering Committees has European Union (Period March
developed a process and criteria by which na- 2009)
tionally the UK can develop a list of priority
substances on which the UK REACH CA will [2009/0095]
work.
Reference: http://www.hse.gov.uk/reach/substances. OJ 2009, L71: Commission Decision
htm 2009/240/EC of 4 March 2009 authorising
Member States to adopt certain derogations
REACH – Bitesize advice pursuant to Directive 2008/68/EC of the Eu-
A set of brief leaflets has been produced by ropean Parliament and of the Council on the
the UK HSE in collaboration with other UK inland transport of dangerous goods.
Government Departments. They are intended OJ 2009, L71: Commission Decision
to cover the key issues of various aspects of 2009/240/EC of 16 March 2009 concern-
REACH: ing the non-inclusion of triflumuron [CAS
Number 1 – REACH is here 64628-44-0] in Annex I to Council Directive
Number 2 – What REACH means for manu- 91/414/EEC and the withdrawal of authorisa-
facturers tions for plant protection products containing
Number 3 – What REACH means for EU im- that substance.
porters OJ 2009, L74: Commission Decision
Number 4 – What REACH means for users of 2009/251/EC of 17 March 2009 requiring
chemicals Member States to ensure that products con-
Number 5 – REACH – The basics taining the biocide dimethylfumarate [CAS
Number 6 – REACH – Timeline 624-49-7] are not placed or made available
Number 7 – REACH – Pre-registration on the market.
Number 8 – REACH – Exemptions Reference: http://eur-lex.europa.eu/LexUriServ/LexU-
Number 9 – REACH – Articles riServ.do?uri=OJ:L:2009:074:0032:0034:
Number 10 – REACH – Guidance for dis- EN:PDF
tributors See also: – Journaal Stoffen en Preparaten, 2009,
Number 11 – REACH – Creating an inventory No.1, item 2009/0005, p. 15 (Belgium)
for downstream users – French legislation: ‘Arrêté du 4 décem-
Number 12 – REACH – Substances of very bre 2008 portant suspension de mise
high concern (SVHCs) sur le marché des sièges et des articles
Number 13 – REACH – Safety data sheets chaussants contenant du fumarate de
(SDS) diméthyle’.
Number 14 – REACH – Substances recovered – Risk Alert Announcement No.1 of
from waste 2009 of the General Administration
Number 15 – REACH – Guidance on biodie- of Quality Supervision, Inspection
sel and Quarantine – Announcement
Reference: http://www.hse.gov.uk/reach/bitesize.htm on the Decisions of the European
Commission on Prohibiting Products
Containing Dimethylfumarate from
Launching into Market. (30 March
2009).
– iSinoLaw Weekly, Vol. 11, 20 March-5
April 2009.
Citeertitel
Journaal Stoffen en Preparaten jaartal/nummer
(voorbeeld: Journaal Stoffen en Preparaten 2009/1)
ISSN 1574-1079
Journal
Chemicals
Management
Journaal Content
Stoffen & Preparaten
ARTICLES
Chief-editor:
Drs. A.C.H. van Peski [2009/0098] Chemical Categories: Filling data gaps by
Read-across and Trend analysis / 119
Editorial Board:
[2009/0099] Recent progress in GHS implementation –
Dr. M.M. Kops-Werkhoven
Republic of South Korea / 129
Drs. H.A.F. van Well
Dr. J.A.S.J. Razenberg
Dr. L.J.M. Rodenburg ACTUALITIES
Drs. G.A. Schouten
Drs. J. Zawierko European Union
[2009/0100] The Netherlands: Changes in Product
Advisory Board: Registration / 131
K. E. Armstrong (U.S.A.) [2009/0101] Updated version of the EC inventory and the
Dr. R. Fielding (United Kingdom) ‘list numbers’ available / 132
Drs. A. Gondová (The Netherlands) [2009/0102] Nanomaterials: EU, Emergnano, VCI &
G. Koh (Singapore) OECD reports / 132
Dr. C. van Lint (Australia)
Dan Liu (U.S.A.) International
S. Park (S.-Korea) [2009/0103] GHS third revised edition / 133
H. Sano (Japan) [2009/0104] Safe Work Australia / 133
S. Savary (Canada) [2009/0105] New Zealand: Group Standard Amendment
Dr. U. Schumacher (China) Consultation / 134
C. Sieger (Germany) [2009/0106] Global Update on New Chemicals
J. Simpson (Australia)
Regulations (February-March 2009) / 134
E. Snyman (South Africa)
P.G. Tse (New Zealand)
PUBLICATIONS
Books
[2009/0107] REACH + GHS, 3. Auflage / 140
No. 5 [2009/0108] ADR 2009. Vervoer van gevaarlijke stoffen
over de weg. VLG/ADR / 140
June 2009 [2009/0109] The Dangerous Goods Emergency Action
Volume 6 Codes List 2009 / 140
Part of Stoffennieuws.nl
Internet
[2009/0110] Pesticide Action Network UK List of Lists / 141
[2009/0111] CEFIC ERICards / 141
[2009/0112] CAS Common Chemistry / 141
OFFICIAL PUBLICATIONS
based on measured data for any one particular gue or between methylcarbamate and ethyl-
substance alone. carbamate. This may be the result of specific
The successful use of a category approach differences in metabolism, such as the dif-
should lead to the identification and charac- ferences in carcinogenicity between benzene
terisation (qualitative or quantitative) of the and toluene, due to the possibility of meta-
hazards for all the members of the category. bolism of the methyl group with carboxylate
A category of chemicals will often show the formation.
presence, absence or modulation of a parti- The presence of a breakpoint can indicate a
cular effect for all members of the category, change in the mode of action or the effect of a
based on the presumption of a common me- consistent tendency across a category. In a ho-
chanism of action. This can be expected to mologous series of organic compounds, there
apply to many different categories of chemi- is often a breakpoint e.g. the loss of aquatic
cals for many aliphatic hydrocarbons, alipha- toxicity as carbon chain length increases and
tic amines, nitriles, aldehydes, alcohols, and solubility decreases.
ethers. The importance of a common mechanism of
If the data for a category includes one or action is also a factor in deciding what che-
more exceptions to the effects expected from micals would not be expected to be relevant
a common mechanism of action, a review of members of a category. Variations in chemi-
the toxicological data for the category should cal structure can affect both toxicokinetics
be able to explain the difference in behaviour. (uptake and bioavailability) and toxicody-
The presence of such ‘outlying’ effects under- namics (e.g. interactions with receptors and
lines the importance of developing an under- enzymes). For example, the introduction of a
standing of the (toxic) mechanisms of action carboxylate or sulphate function often decre-
within categories. ases bioavailability and toxicity to mammals,
In principle, a category is not endpoint-spe- whilst halogen substituents tend to increase
cific, since the structural changes across the lipophilicity and increase toxicological acti-
category would be expected to produce chan- vity.
ges that would affect the whole spectrum of
properties of the individual members in a co- Approaches to data gap filling in chemical
herent and consistent manner. The changes in categories
properties across a category, for each parame- Within a chemical category, data gaps may
ter, would be the result of related rather than be filled by read-across, trend analysis and
purely arbitrary differences. However, it is re- QSARs. Read-across is a technique used to
cognised that in practice it may be possible to predict endpoint information for one che-
identify the trends and changes for some but mical by using data from the same endpoint
not all of the properties of potential interest, from another chemical which is considered to
and hence it may not be possible to use a cate- be ‘similar’ in some way (on the basis of struc-
gory approach to identify all relevant effects. tural similarity and similar properties and/or
For some series of compounds, the lower or activities). For a given category endpoint, the
upper end of the series may show marked category members are often related by a trend
changes in effects. At the lower end of the (e.g. increasing, decreasing or constant) in an
series, the methyl analogue may have excep- effect, and a trend analysis can be carried out
tional properties. Examples are the differences using a model based on the data for the mem-
shown in acute toxicity between methyl alco- bers of the category. Data gaps can also be
hol and ethyl alcohol, and for carcinogenicity filled by an external QSAR model, where the
between butter yellow and its ethyl homolo-
Property 1 SAR/Read-across
Property 2 Interpolation
Property 3 Extrapolation
Activity 1 SAR/Read-across
Activity 2 Interpolation
Activity 3 Extrapolation
Figure 1. Graphical representation of a chemical category and some approaches for filling data
gaps
demonstrate the genotoxicity of the group of on the need, extent and type of additional
chemicals, then a conclusion that the category testing.
would not be mutagenic would not be valid. For a given category endpoint, the category
It is particularly important to adequately members are often related by a trend (e.g. in-
justify read-across of negative findings. The creasing, decreasing or constant). The trend
read-across approach is most robust when a could be related to molecular mass, carbon
quantitative trend between the analogues can chain length, or to some other physicochemi-
be established. cal property. For larger categories, it is possi-
It is important to provide supporting informa- ble that several different relationships can be
tion to strengthen the rationale for the read- established for a single endpoint, thereby defi-
across. Thus, in addition to the property/ ning subcategories. A chemical that identifies
endpoint being read-across, it is also useful a turning point in a trend is called a break-
to show that additional properties, relevant to point chemical. Category members falling at
the endpoint, are also (qualitatively or quanti- the opposite extremes of a trend and within
tatively) similar between the source and target which interpolations are considered reliable
chemicals. Such properties could be known or are called sentinel (boundary) chemicals.
suspected determinants of the endpoint, or A demonstration of consistent trends in the
they could be limiting factors. behaviour of a group of chemicals is one of
Relevant molecular properties of the source the desirable attributes of a chemical category
chemical should be of comparable value to and one of the indicators that a common me-
those of the target chemical. The selection of chanism for all chemicals is involved. When
relevant molecular properties depends on the some chemicals in a category have measured
endpoint for which the read-across is being values and a consistent trend is observed, mis-
performed. The identification of these pro- sing values can be estimated by simple scaling
perties could be based on expert knowledge, from the measured values to fill in the data
or could be based on the use of properties gaps.
(molecular descriptors) that have been found The observation of a trend (increasing, decre-
to be useful predictors of the endpoint in asing or constant) in the experimental data for
QSAR models. a given endpoint across chemicals can be used
In the case of single substances, irrespective of as the basis for interpolation and possibly also
the endpoint being read-across, useful consi- extrapolation (see Figure 1). Interpolation is
derations might include: the estimation of a value for a member using
a) the presence or absence of additional func- measured values from other members on
tional groups or substituents that could ‘both sides’ of that member within the defined
influence the behaviour of a chemical; category spectrum, whereas extrapolation re-
b) similarity in physicochemical profiles (e.g. fers to the estimation of a value for a member
MW, logKow, water solubility); that is near or at the category boundary using
c) similarity in other toxicological and/or measured values from internal category mem-
ecotoxicological data; bers. Interpolation between measured analo-
d) the likely toxicokinetics of the substances, gues may give a more reliable result depen-
including the possibility of different meta- ding on the reliability of the measured data.
bolic pathways coming into play, needs to Interpolation can be performed when the
be considered where possible; series of values is monotonic (all increasing
e) information from valid (Q)SARs may be or decreasing) or when non-monotonic (e.g.
used where possible to inform decisions parabolic). In such circumstances the extent
to which the available data describe the trend
will determine the level of confidence in the General guidance on a stepwise procedure to
prediction. develop categories
When establishing trends in data, laboratory In order to use the results from a category, it is
and experimental variations should be consi- necessary to demonstrate that a chemical ca-
dered. Similar species/strains, endpoints and tegory is robust, and to do this, certain types
test protocols should be compared. Deviati- of information should be documented. In or-
ons from a trend should be clearly identified der to collect this information in a systematic
and possible reasons for the deviations laid and transparent manner, it is recommended
out in the category analysis. to follow a stepwise approach (Figure 2).
In principle, it is possible to predict the presen-
ce or absence of a property/effect by applying Step 0: Check whether the chemical is a mem-
trend analysis. The category approach is most ber of an existing category
robust when a quantitative trend between the Before considering whether to develop a ca-
category members can be established. A lack tegory for a group of substances, the first
of observed toxic effects for a chemical sub- step should be to determine whether the
stance in a study of a specific endpoint (espe- chemical(s) is (are) a named member of a
cially if no dose-relationship can be establis- category that has already been evaluated. In-
hed because no effects are observed at some formation sources on existing categories in-
of the doses tested) requires further conside- clude:
ration and. in such circumstances, the data a) US HPV Challenge Program
need to be carefully evaluated. It is important b) OECD HPV Chemicals Program.
to distinguish between cases where the lack of The results from both programmes are acces-
response can be explained on the basis of the sible via the OECD Global Portal to Informa-
mechanistic understanding for that endpoint, tion on Chemical Substances (eChemPortal,
or whether the tests have failed to demonstra- http://www.oecd.org/ehs/eChemPortal).
te the absence of an effect for the category as If the chemical is a member of a category that
a whole. has already been evaluated, its inclusion into
The larger the category, the more likely that the new category should be justified. It is usu-
there may be breaks in trends which may af- ally sufficient to refer to the evaluation of the
fect the reliability of interpolation or extrapo- category when assessing the chemical, and to
lation. The observation of a ‘break’ in a trend refer to the results that have been agreed for
among some members of a category is a war- the category, taking account of the position of
ning sign, but is not necessarily an indication the chemical in the category. Where new data
that the chemicals with different trends exhibit are available for some endpoints, these may be
different toxicity pathways. Bioassay measure- used to verify the existing category and could,
ments frequently are only comparable over a depending on the results, lead to a revision of
narrow range of chemical properties with the the category.
result that different pharmacodynamic factors In some cases, a relevant category may exist,
are controlling the bioassay results for diffe- but where the chemical of interest has not
rent chemicals. The bilinear or multilinear na- been specifically included in the category. In
ture of trends in measured data, if observed, this case, it would be appropriate to extend
can be used to confine the methods for scaling the membership of the currently defined cate-
intensity of the endpoint to specific members gory to include the chemical of interest.
of the category.
Step 2: Gather data for each category tal results are available. It may be possible
member to apply a weight-of-evidence approach to
For each member of the category, published all the data, which could lead to the same
and unpublished data should be gathered on hazard identification for all the members
physicochemical property(ies), environmen- of the category, irrespective of the data
tal fate parameter(s), toxicological (human available for the individual compounds.
health) and ecotoxicity (environmental spe- – An effect that is defined by a particular
cies) effect(s). This should include all exi- numerical cut-off may lead to different
sting relevant data and not be limited to the conclusions for individual compounds.
endpoints that are mandatory within a given This type of data should be studied
programme. In some cases where estimated carefully to ensure that the compounds
data have been included in an internationally are evaluated in a way that reflects the
accepted evaluation, these estimates can be underlying trends across a category. For
included on the same basis as other data that instance, a series of compounds may give
have been critically evaluated. rise to data that shows a borderline posi-
tive irritant effect for some members of
Step 3: Evaluate available data for adequacy the category and a borderline negative
Available data should be evaluated for its effect for others. The data should be care-
adequacy using e.g. the OECD Guidance for fully evaluated to decide whether (a) this
Determining the Quality of Data for the SIDS reflects accurately a trend across the whole
Dossier (see section 3.1 of the OECD Manual category or whether (b) the uncertainties
for Investigation of HPV Chemicals, in the experimental data justify allocating
http://www.oecd.org/document/7/0,3343,en_ the compounds to different subcategories
2649_34379_1947463_1_1_1_1,00.html). (in this example, classifying some catego-
In evaluating the available data for a category, ry members as irritant and not classifying
a number of additional factors will apply that others). If the second option is considered
are not relevant when evaluating test results as the most biologically plausible explana-
for individual compounds. tion, the conclusion of the evaluation will
– Different types of data may be available lead in some cases to a different conclu-
for the same endpoint. It is clear that the sion than that based on a simple evalua-
scope of the estimated results for a mem- tion of the data taken in isolation. Hence,
ber of a category cannot exceed the scope a borderline positive effect can be inter-
of the underlying data for the other mem- preted as a negative effect in the light of
bers of the category, e.g. if for genotoxic- evidence from other compounds in the
ity, only in vitro results are available for category. Similarly, a borderline negative
some members of the category (source effect can be interpreted as positive taking
chemicals), only conclusions on in vitro into account the data from the whole cat-
genotoxicity can be reached for the mem- egory.
bers of the category for which experimen- – Where the data suggests possible break-
tal results are lacking (target chemical). If points, the data should be evaluated to
the scope of the underlying experimental ensure that these reflect a genuine change
results for an endpoint vary (e.g. a mix in properties or effects and are not due to
of results from screening tests and high- comparison of results from testing carried
er tier tests), it is necessary to clarify the out in different laboratories, at different
scope of the estimated results for the cat- times, with different animal strains, etc.
egory members for which no experimen-
– The data set may contain an apparent out- is closely related to the approach chosen for
lier, i.e. one category member where there filling data gaps for any particular endpoint. If
are experimental data that shows the pres- the initial assessment indicates that both cri-
ence of an effect not seen in other category teria are satisfied for a particular endpoint, the
members. This difference can be real, and data gaps can be filled.
provide evidence of special conditions In applying these techniques, the background
relevant to the particular substance (e.g. for the basis on which the category is formed
the chronic and reproductive toxicity of should be reflected in the way techniques are
hexane compared to other lower alkanes). chosen and applied. Hence for some effects,
Such results need to be evaluated with par- where the test data suggest a uniform property
ticular care to establish whether the result across a group, read-across from the existing
reflects a real difference in a mechanism of data would normally be considered appropri-
action across the category or whether the ate. In other cases, where there is a trend in
test result should be questioned. aquatic toxicity related to a change in logKow
and based on a narcotic mechanism of action,
Step 4: Construct a matrix of data the data gaps may be filled by data from a va-
availability lid QSAR for the category. Alternatively, the
A matrix of data availability (category end- category can be sub-divided into a number of
points vs. members) should be constructed subcategories defined by the breakpoints in
with the category members arranged in a the category, and members evaluated within
suitable order (e.g. according to molecular each subcategory.
weight). The ordering of the members should If the initial category does not satisfy both of
reflect any trends or progression seen within these criteria, the following options should be
the category. The cells of the matrix should considered:
indicate whether data are available or unavai- a) If further examination of the data sug-
lable. If possible, the cells should also indicate gests that there is a pattern of effects for a
the available reliable key study results. limited number of chemicals in the group,
then the analysis might suggest that the
Step 5: Perform a preliminary evaluation of category should be modified e.g. divided
the category and fill data gaps into subcategories (return to step 1).
A preliminary assessment of the category b) If adequate data do not exist, but the
should be carried out to determine whether: structure-based category is reliable for
a) the category rationale is supported, i.e. the one or more endpoints, then a category
category does in fact exhibit one or more approach may still be proposed for these
of trends postulated in Step 1; and endpoints. Testing of some chemical cat-
b) the category is sufficiently robust (i.e. con- egory members for some endpoints would
tains sufficient, relevant and reliable infor- still be necessary (go to Step 6). The choice
mation on the category members) for the of chemicals and endpoints for testing
assessment purpose. should be scientifically motivated, but is
This assessment should be carried out for each also likely to involve animal welfare and
endpoint, as the category rationale may lead financial considerations, especially in the
to a relevant assessment for some endpoints case of more ‘expensive’ endpoints.
and not for others. This assessment is largely c) If there are adequate data for a given end-
a matter of expert judgement. Assessment of point, but no apparent pattern, the pro-
the category rationale and robustness of the posed category may not be appropriate
category for the particular regulatory purpose and so testing may be required for all re-
START
Step 4: Construct a
matrix of data availability
Not adequate
STOP
maining category members for that end- Step 7: Perform a further assessment of
point (i.e. the category is abandoned). the category
If new test data are generated, the category
Step 6: Perform and/or propose testing should be revised and further assessment to
If the preliminary assessment supports the ca- determine whether the criteria outlined in
tegory rationale (i.e. a pattern or trend is ob- Step 5 are satisfied and therefore whether the
served), but the category does not appear to category can be finalised and documented. If
contain sufficient, relevant and reliable infor- the results support the category, the testing
mation to assess all category members, it may phase is complete and the chemical category
be necessary to perform or propose testing. can be finalised and documented. Remaining
In proposing additional testing, a number of data gaps can be filled. If the results do not
factors should be taken into consideration. support the category, further testing may be
– Since a category may contain com- carried out, members of the category may be
pounds of different production volumes, changed (e.g. dividing the category as appro-
the standard information requirements priate), or the category proposal may be drop-
may vary from compound to compound ped altogether. The latter implies that testing
within a category. However, there may be will then be done to fill all appropriate end-
strong scientific reasons that the recom- points for each category member.
mended testing should be conducted on
lower tonnage category member(s) in Step 8: Document the finalised category
order to identify the actual hazards of the The finalised category should be documented
category. in the form of a suitable reporting format.
– The choice of test will be influenced by
the results of the preliminary evaluation
of the category.
– If there are no data for any of the mem-
bers of a category for a particular end-
point, full testing of a limited number of
carefully selected category members may
be considered appropriate.
– When data are already available indicat-
ing the presence or absence of a particular
effect, tests may be chosen to provide evi-
dence that compounds selected for testing
show the effects that have been predicted
from the trend of the property. Hence, for
a substance in a category where e.g. skin
irritation is predicted, a simple in vitro test
would be sufficient to provide confirma-
tion of the effect.
When selecting a sample to test, it should be
representative of the substance marketed, in-
cluding the presence of any manufacturing
impurities.
is essential to perform an adequate risk as- In addition it contains the European LIst of
sessment in case of an accidental intoxication Notified Chemical Substances (ELINCS) in-
with their product. ventory numbers that were allocated up until
– Optimal requirements: January 2009. Additional information such
Exact composition: all ingredients without as the chemical name is only present if pub-
concentration threshold lished in the 6th publication of ELINCS. This
Exact concentrations of all ingredients updated version of the EC inventory contains
– Alternative requirements: 106 208 entries.
Exact composition: all ingredients without In addition, the ‘list numbers’ assigned to pre-
concentration threshold registered substances without a current EC
Exact concentration for ingredients in hazard number have been gathered in two ‘list num-
class: T+, T, C, Xi, Xn. Translated in CLP this bers’ IUCLID files. A first file contains 17087
corresponds to all health hazard classes. substances that have been pre-registered with
Defined concentration ranges for the other a CAS number (series 600 of the ‘list num-
ingredients bers’) while the second file contains 22015
– Minimum requirements: substances pre-registered as multi-constitu-
Exact composition: all ingredients without ent substances or with only a chemical name
concentration threshold as identifier (series 900 of the ‘list numbers’).
Defined concentration ranges: The ‘list numbers’ should be used to make the
<0,1%, 0,1-1%, 1-5%, 5-10%, 10-20%, 20- registration of these substances easier.
30%, 30-50%, 50-75%, 75-100% Reference: The new EC inventory and the ‘list num-
Alternative: <0,1%, 0,1-1%, 1-5%, 5-10%, 10- bers’ IUCLID files can be downloaded
15%, 15-30%, 30-60%,60-100% from http://iuclid.echa.europa.eu/index.
The internationally accepted chemical names php?fuseaction=home.ecinventory
for the ingredients must be used with the cor-
responding CAS-numbers.
In exceptional cases products can be notified Nanomaterials: EU, Emergnano,
in groups. For example with paints of different VCI & OECD reports
colours and almost the same composition.
Reference: https://www.productnotification.nl/opn/ [2009/0102]
legislation.htm
EU: regulatory aspects
The European Parliament is conducting
Updated version of the EC work in the area of nanomaterials. The ‘Re-
inventory and the ‘list numbers’ port on regulatory aspects of nanomaterials
available (2008/2208(INI))’ of the Committee on the
Environment, Public Health and Food Safety
[2009/0101] (7 April 2009) is available on the europar.eu-
ropa.eu website.
A new version of the EC inventory (version 1.1)
is now available for downloading at the IU- U.K.: Emergnano report
CLID website. This version of the EC inven- ‘A review of completed and near completed en-
tory contains the whole of the European vironment, health and safety research on nano-
INventory of Existing commercial Chemical materials and nanotechnology’
Substances (EINECS) and the No-Longer Pol- The Emergnano report was commissioned
ymer (NLP) inventories as published on ESIS. by Department for Environment, Food, and
Buenos Aires Province: Resolution on the re- cals and Pesticides in International Trade is-
covery of vegetable oils used for biodiesel is- sued 20-Mar-2009
sued 19-Feb-2009 Canada
Limits on pollutants emissions, noise and ra- ONTARIO: Amendments to the Pesticides Act
diations from vehicles adopted 23-Feb-2009 to ban the use and sale of pesticides for cos-
Resolution 54 establishing quotas for the im- metic purposes enter into force 22-Apr-2009
port of ODS adopted 24-Feb-2009 Regulations Adding Perfluorooctane Sulfo-
Australia nate and Its Salts to the Virtual Elimination
NICNAS issues alert on Perfluorooctane sul- List adopted 04-Feb-2009
fonate and Perfluoroalkyl sulfonate 01-Dec- Notice with respect to Batch 9 Challenge Sub-
2008 stances published 14-Mar-2009
Ozone depleting substances regulations ONTARIO: Regulation 63/09 adopted to im-
amended to include new offences and record- plement the Cosmetic Pesticides Ban Act 2008
keeping requirements 05-Feb-2009 03-Mar-2009
Greenhouse gas emissions data under further Significant New Activity Notice No. 15274
scrutiny 25-Feb-2009 adopted regarding lithium cobalt manganese
Hazardous Substances Information System nickel oxide, CAS No. 182442-95-1 21-Feb-
(HSIS) being updated 01-Mar-2009 2009
Austria Significant New Activity Notice EAU-455
ADR 2009 published 27-Feb-2009 adopted regarding benzoic acid, 2-hydroxy-,
Brazil 2-butyloctyl ester, CAS No. 190085-41-7
Ordinance INMETRO on conformity assess- 14-Feb-2009
ment of re-conditioned packaging for road Orders adopted to amend the Domestic Sub-
transport of dangerous goods adopted 19- stances List and Non-domestic Substances
Dec-2008 List 04-Mar-2009
Ordinance INMETRO on conformity assess- Significant New Activity Notice No. 14503
ment of large packaging for road transport of adopted regarding aliphatic alkyl diester of
dangerous goods adopted 19-Dec-2008 succinic acid 28-Feb-2009
Ordinance INMETRO on conformity assess- BRITISH COLUMBIA: Recycling Regulation
ment of portable containers used in the road amended with regard to an expanded list of
transport of dangerous goods adopted 19- electronic products 10-Dec-2009
Dec-2008 QUEBEC: 2007 fees on the marketing of pac-
Requirements for toxicological test methods kaging published 13-Mar-2009
for toys 27-Sep-2007 Chile
CONAMA composition and internal organi- Amendment to the Water Code issued 02-
zation modified 10-Mar-2009 Mar-2009
Bulgaria China
Regulation on Classification, Labeling and Regulation on Recycling and Treatment of
Packaging of substances and mixtures (CLP) Discarded Electrical and Electronic Products
adopted 16-Dec-2008 adopted 25-Feb-2009
Law on Protection from the Harmful Impact National Standards published in 2008 30-Jan-
of Chemical Substances and Preparations 2009
amended 28-Sep-2007 2008 Update List of Air Environmental Pro-
Amended Annex III of the Convention on the tection Standards 01-Jul-2008
PIC Procedure for Certain Hazardous Chemi-
Regulation on Discarded Electric and Electro- Adopted a Decree on the transport of dange-
nic Products Recycling and Disposal publis- rous goods by road 04-Mar-2009
hed 25-Feb-2009 France
Supervision and Inspection for Toys Import Environmental and safety requirements ap-
and Export required 02-Mar-2009 plying to installations storing or using organic
Colombia peroxides and subject to declaration adopted
Decree 377 adopting the Stockholm Conven- 10-Nov-2008
tion on Persistent Organic Pollutants issued Notice relating to the approval of certain
09-Feb-2009 combination packagings intended for the
Croatia transport of dangerous goods published
Act on General Safety of Products adopted 08-Feb-2009
20-Feb-2009 Scope of the Order on the operation report of
Regulation on Management of Waste Elec- classified installations amended 18-Feb-2009
trical and Electronic Devices and Equipment Order on the limited cases where mercury,
(WEEE) amended 04-Mar-2009 cadmium, lead, chromium VI, PBB and PBDE
Regulation on Management of Waste Batteries can be used in EEA amended 25-Feb-2009
and Accumulators amended 04-Mar-2009 Decree amending certain parts of the Labour
Regulation on Management of Packaging and Code adopted 13-Mar-2009
Packaging Waste amended 05-Apr-2009 Germany
Regulation on Conditions and Manner of HH: New version of the Act on Access to In-
Implementation of Security Measures for the formation published 27-Feb-2009
Storage of Explosives adopted 23-Feb-2009 Srl: Ordinance on Inspections for Risk Avoi-
Regulation on Amendments and Supplements dance published replacing Ordinance on Fire
of the Regulation on Waste Oil Management Inspections 26-Feb-2009
adopted 04-Mar-2009 Th: Administrative Guideline Implementing
Denmark the Ordinance on Storage of Water Hazardous
Statutory Order amending the Statutory Or- Substances published 02-Feb-2009
der on shipment of waste has been adopted Hungary
27-Nov-2008 Decree on the authorization of transboundary
Statutory Order on batteries and accumula- shipment of radioactive waste and spent fuel
tors and discarded batteries and accumulators adopted 21-Feb-2009
has been adopted 11-Dec-2008 Indonesia
Statutory Order banning mercury in measu- Technical Guidance and Monitoring Procedu-
ring devices adopted 12-Feb-2009 re for the Implementation of Non CFC and/or
Ecuador Non Halon Logos 14-Nov-2008
Technical Standard on environmental decla- Ireland
rations and labeling issued 03-Mar-2009 The Arsenic, Cadmium, Mercury, Nickel and
Egypt Polycyclic Aromatic Hydrocarbons in Am-
Amendment of Law No.4 of 1994 on Protec- bient Air Regulations 2009 adopted 12-Feb-
tion of the Environment published 01-Mar- 2009
2009 Israel
Finland Adopted Regulations to make environmental
Adopted a Decree repealing regulation 24(a) information available to the public 02-Feb-
of Decree 1512/1991 on radiation 26-Feb- 2009
2009
[2009/0109]
The Netherlands (Period April Staatsblad 2009, 195: Besluit van 16 april
2009) 2009, houdende wijziging van het Besluit
organisch-halogeengehalte van brandstoffen,
[2009/0113] het Besluit overige niet-meldingplichtige ge-
vallen bodemsanering en het P.C.B.-P.C.T.- en
Tractatenblad 2009, 67: Verdrag van Rotter- chlooretheen-besluit milieubeheer in verband
dam inzake de procedure met betrekking tot met een wijziging van de Wet verontreiniging
voorafgaande geïnformeerde toestemming zeewater (wijziging amvb’s vanwege wijziging
ten aanzien van bepaalde gevaarlijke chemi- Wet verontreiniging zeewater)
sche stoffen en pesticiden in de internationale Staatsblad 2009, 199: Wet van 29 april 2009
handel tot wijziging van de Waterschapswet, de Wet
[… Satisfied that all the requirements for listing in Annex verontreiniging oppervlaktewateren en de
III of the Rotterdam Convention have been met with re- Wet modernisering waterschapsbestel, tot
spect to tributyltin compounds, aanbrenging van verbeteringen van wetstech-
1. Decides to amend Annex III of the Rotterdam Conven- nische en inhoudelijk ondergeschikte aard
tion to list the following chemicals in the three columns
after the entry for ‘Toxaphene’: All tributyltin compounds Staatscourant 2009, 74: Besluit van de Minis-
(Category Pesticide), including: Tributyltin oxide CAS ter van Sociale Zaken en Werkgelegenheid van
56-35-9; Tributyltin fluoride CAS 1983-10-4; Tributyltin 25 maart 2009, nr. G&VW/AA/2009/6681, tot
methacrylate CAS 2155-70-6; Tributyltin benzoate CAS wijziging van de Beleidsregel arbocatalogi in
4342-36-3; Tributyltin chloride CAS 1461-22-9; Tribu- verband met de toevoeging van enkele nieuwe
tyltin linoleate CAS 24124-25-2; Tributyltin naphthenate arbocatalogi
CAS 85409-17-2; Staatscourant 2009, 80: Regeling van de Mi-
2. Decides that this amendment shall enter into force for all nister van Sociale Zaken en Werkgelegenheid
Parties on 1 February 2009. …] van 17 april 2009, nr. AI//2009/7285, houden-
de de inrichting van de directie AI Major Ha-
Kamerstuk 2008-2009, 21501-08, nr. 305, zard Control alsmede de toedeling van taken
Tweede Kamer: Milieuraad; Brief minister en vertegenwoordigingsbevoegdheden aan de
over de belangrijkste ontwikkelingen in het onder de directeur ressorterende functionaris-
REACH dossier sen (Organisatie-, mandaat- en volmachtbe-
Kamerstuk 2008-2009, 31894, nr. 5, Tweede sluit directie AI Major Hazard Control 2009)
Kamer: Uitbreiding en wijziging van de Wet Staatscourant 2009, 80: Regeling van de Mi-
milieubeheer in verband met de uitvoering nister van Volksgezondheid, Welzijn en Sport
van de verordening (EG) nr. 1272/2008 van van 15 april 2009, VGP/PSL 2923751, hou-
het Europees Parlement en de Raad van de dende tijdelijke regels inzake producten die
Europese Unie van 16 december 2008 betref- dimethylfumaraat [dimethylfumarate, CAS
fende de indeling, etikettering en verpakking 624-49-7] bevatten ter uitvoering van beschik-
van stoffen en mengsels en tot wijziging en king 2009/251/EG (Warenwetregeling DMF)
intrekking van de Richtlijnen 67/548/EEG
what they should consider when operating In practice, all sites are likely to be top tier
within a SIEF. sites.
Another is a starting point to help understand The decision means that the same regulatory
what needs to do to fulfil registration duties regime applies to storage in man-made (salt)
under Registration, Evaluation, Authorisation caverns and natural strata.
& restriction of Chemicals (REACH). Reference: http://www.hse.gov.uk/comah/gasstorage.
References: http://www.hse.gov.uk/reach/substances. htm
htm
http://www.hse.gov.uk/reach/ Biocidal Products
resources/17sief.pdf A guide has been produced for applicants who
http://www.hse.gov.uk/reach/ wish to seek product authorisation for biocid-
resources/16registration.pdf al products.
Reference: http://www.hse.gov.uk/biocides/bpd/pdfs/
Working Group on Action to Control applicationguide.pdf
Chemicals (WATCH)
Papers and minutes from the most recent (17 Chemical Carcinogens Workshop Report
June 2008) meeting of the sub-committee of The report of a stakeholder workshop in June
the Advisory Committee on Toxic Substances 2008, involving technical experts, academics,
are now available. union representatives, industry experts, in-
Reference: http://www.hse.gov.uk/aboutus/meetings/ dustry associations and government depart-
iacs/acts/watch/170608/agenda.htm ments which sought agreement on criteria
for setting priorities for future activities and
Natural Gas Storage (COMAH) possible interventions to tackle the risk of
The COMAH Competent Authority (com- exposure to chemical carcinogens has been
prising of the Health and Safety Executive, published.
Environment Agency and the Scottish Envi- Reference: http://www.hse.gov.uk/drp/workshop08.
ronmental Protection Agency) has recently pdf
concluded that the on-shore storage of natu-
ral gas in underground natural strata, such as A Report on the State of Hazardous Product
depleted reservoirs, is subject to the Control Labelling and Packaging in the UK
of Major Accident Hazards Regulations 1999 The Chemical Hazards Communication So-
(COMAH). This decision was effected from ciety (CHCS) has made available the report
26 February 2009. of a specially commissioned, independent,
The decision follows an announcement by the systematic, objective and quantitative review
European Commission in October 2008 that of the state of hazardous product labelling in
it expects Member States to apply the Seveso the UK.
II Directive (96/83/EC) to such storage sites Broadly, the objective of the research was to
to ensure that equivalent regulatory require- determine the overall fitness for purpose of
ments apply across the European Union. The product labelling and packaging. i.e.: Do the
Directive is implemented in Great Britain labels convey adequate, relevant and useful
through the COMAH Regulations. information, and is the packaging ‘adequate’
Underground storage sites will come within bearing in mind the hazardous properties of
the scope of COMAH if the quantity of natu- the contents? And also to assess the level of
ral gas stored meets or exceeds the thresholds detailed compliance with the CHIP regula-
in Schedule 1, Part 2 of the Regulations i.e. 50 tions (accuracy).
tonnes (lower tier) and 200 tonnes (top tier).
The study sampled 50 products that were of checked for errors or allow users to change
a type that might be found in any home. The data that should not be changed.
sampling was directed towards purchase of The solution is that both more training and
‘common, inexpensive high volume products’ also simpler, more direct and less ambiguous
from ‘big name’ high street stores and super- regulations are required. It is a matter of con-
markets. It was, perhaps, to be expected that jecture whether or not these will ever be deliv-
these products would exhibit a high level of ered. Certainly in the latest (and last) edition
compliance. In terms of fitness for purpose, of the CHIP regulations this is not the case.
this is indeed what was found and the report While the latest CHIP regulations combine
concludes that the labelling of leading brand and consolidate all earlier versions, they do
products, on sale to the general public in the not offer any simplification.
UK is mostly safe. The report will be of interest to all who are
However in detail nearly all (98%) were de- involved in the supply of chemical products in
ficient. The deficiencies were largely (but not the UK, and since the UK classification and la-
always) of a trivial nature. The main areas of beling and packaging requirements are based
concern were the incorrect and unnecessary upon the EU scheme set out in the Dangerous
use of Safety phrases and the use of chemi- Substances and Dangerous Preparations Di-
cal names. In themselves these are not failures rectives, it will also be of interest to the wider
that significantly impact upon the safe use of European community.
the products, but the fact that the defects were The report from that study is now available
so numerous, and so common is evidence of (for a limited period) free to download from
a systematic failure on the part of the product the CHCS web site.
suppliers and manufacturers to properly un- Reference: http://www.chcs.org.uk/reports/chcs-label-
derstand and implement the detailed technical project-report-0309.pdf
requirements set out in the CHIP regulations.
More worryingly, even in the relatively small
sample, a small number of potentially dan- European Union (Period April
gerous cases where important hazard, risk, or 2009)
safety advice was missing were found.
The survey was unable to pass much com- [2009/0116]
ment on the classification of any product,
but the fact that so many minor, a small but O.J. 2009, L96: Commission Regulation
significant number of more serious and such (EC) No 304/2009 of 14 April 2009 amend-
a wide range of deficiencies were detected by ing Annexes IV and V to Regulation (EC)
the survey, is indicative that quite possibly No 850/2004 of the European Parliament
even greater failings exist. and of the Council as regards the treatment
The findings are interpreted as evidence of of waste containing persistent organic pollut-
a widespread, poor understanding of, or lax ants in thermal and metallurgical production
and casual application of what the regulations processes
require, and partly to the complexity of the O.J. 2009, L96: Commission Decision
regulations. 2009/324/EC of 14 April 2009 concerning the
There may also be an over dependence on non-inclusion of certain substances in Annex I,
computer database systems (and their suppli- IA or IB to Directive 98/8/EC of the European
ers) for deriving classification and developing Parliament and of the Council concerning the
label content. Such systems possibly either placing of biocidal products on the market
contain data that has not been sufficiently well
[2009/0117]
Auteur:
Dhr. E. Mossel
Prijs: € 64,–
Bestelcode:
978 90 12 11865 1
Uitgever:
24-25 June 2009 Drs. A. van Dijk
Fifth International Conference on the
Abonnementen:
Registration, Evaluation and Authorisa- Sdu Klantenservice, Postbus 20014, 2500 EA Den Haag, tel. (070) 37 89 880;
tion of Chemicals www.sdu.nl/service
Stoffennieuws.nl is een nieuws- en documentatieservice, bestaande uit deze
Amsterdam, The Netherlands site, een e-mail nieuwsbrief en een tijdschrift. Op de site vindt u artikelen
Info: over recente wijzigingen in wet- en regelgeving rond chemische stoffen. De
e-mail nieuwsbrief attendeert u op de laatste berichten. Daarnaast ontvangt u
http://www.ismithers.net/ conference- tien keer per jaar het Journaal Stoffen en Preparaten, waarin een selectie van
de belangrijkste artikelen en berichten van Stoffennieuws.nl zijn gebundeld
details.php?id=XREU09- en gepresenteerd.
Een abonnement kost € 295,- per jaar, excl. BTW. Een abonnement geldt voor
een jaar en kan op elk gewenst tijdstip ingaan. Het abonnement wordt automa-
13-16 September 2009 tisch met een jaar verlengd tenzij uiterlijk twee maanden voor het verstrijken
Eurotox 2009: 46th Congress of the Eu- van het abonnementsjaar schriftelijk wordt opgezegd bij Sdu Klantenservice.
Citeertitel
Journaal Stoffen en Preparaten jaartal/nummer
(voorbeeld: Journaal Stoffen en Preparaten 2009/1)
ISSN 1574-1079
PUBLICATIONS
Books
[2009/0146] Room for improvement in EU standards for industrial chemical risk
assessment / 168
Conference Proceedings
[2009/0147] Conference on EU and world-wide rules for classification, labelling and
packaging of chemicals / 169
[2009/0148] REACH Europe 2009 / 169
Internet
[2009/0137] New Jersey: Right to Know Hazardous Substance Fact Sheets / 169
[2009/0138] GADSL 2009 / 170
[2009/0139] Citizens’ Report: Global Outreach Campaign on the Strategic Approach to
International Chemicals Management (SAICM) / 170
[2009/0149] Managing Hazardous Chemicals: Longer-Range Challenges / 170
OFFICIAL PUBLICATIONS
water (irrespective of the composition of the try but also all other manufacturing industry
coal tar distillate). – Prohibition of the plac- sectors.
ing on the market for reuse or the reuse of Active in European affairs since 1958, the
old treated wood in applications involving Confederation represents more than 20 mil-
contact with surface water or groundwater if lion small, medium and large companies.
it is removed from the existing place of appli- Members are 40 central industrial and em-
cation (irrespective of the composition of the ployers’ federations from 34 countries.
coal tar distillate). – Prohibition of the placing On the occasion of the second European
on the second-hand market for reuse of old Chemicals Agency (ECHA)’s Stakeholders’
wood treated with substances and mixtures day in Helsinki (27 May 2009), BUSINESS
which contain: – Benzo[a]pyrene at a concen- EUROPE makes the following two main com-
tration of 0,005 % or more by weight, and – ments:
Water-extractable phenols at a concentration 1. The financial burden of REACH should
of 3 % or more by weight – 42. Alkanes, C10 be reduced by introducing phased pay-
–C13, chloro- (short-chain chlorinated par- ment of registration fees. This could save
affins) (SCCPs) EC No 287-476-5 CAS No around € 200 million for companies which
85535-84-8: have to register chemical substances.
More stringent national provisions: Restric- 2. Companies are still left with legal uncer-
tion on the use of short-chain chlorinated tainties because of inconsistency or lack
paraffins: – as flame retardants in rubber, of coordination between different pieces
plastic or textiles; – as plasticisers in paints, of legislation. Consistent European chem-
coatings or sealants icals legislation and accurate guidance
Reference: O.J. 2009, C130. Communication (2009/C about REACH obligations need to be put
130/03) from the Commission pursuant in place in order to guarantee legal cer-
to Article 67(3) of Regulation (EC) No tainty.
1907/2006 of the European Parliament and BUSINESSEUROPE has identified seven pri-
of the Council on the Registration, Evalu- ority areas for action:
ation, Authorisation and Restriction of 1. The financial burden on companies
Chemicals (REACH) should be reduced. Phased payment of
http://eur-lex.europa.eu/LexUriServ/LexU- registration fees first and lowering of fees
riServ.do?uri=OJ:C:2009:130:0003:0004:E in the longer term is required.
N:PDF 2. Consistent European chemicals legislation
needs to be guaranteed. Chemicals rules
European Union must be set using uniform criteria and
consistently in one place. REACH must be
this place.
REACH and BUSINESSEUROPE 3. The quality of guidance about industry’s
REACH obligations should be improved
[2009/0123] to avoid legal uncertainty. A strong and
timely representation of industry in Part-
Two years after its entry into force, BUSINESS ners Experts Groups and translation of
EUROPE, the Confederation of European Technical Guidance Documents into all
Business a.i.s.b.l., has carried out a first as- EU languages will help improve the situ-
sessment of the implementation of REACH, ation.
which concerns not only the chemical indus- 4. Truly harmonised REACH rules across
Member States should be ensured, espe-
A plasticiser which is used in a wide range cilitate trade between the EU and non-EU
of PVC and other polymers applications, countries?
such as for example flooring, roofing, – Scope: What is a classification? And what
coated fabrics, medical devices or primary is a harmonised classification? What is
packaging of medicinal products, as well the difference between hazard assessment
as in various preparations such as for ex- and risk assessment? What are the main
ample sealants, adhesives and inks; changes compared to the previous legis-
– benzylbutylphthalate – BBP [CAS 85-68- lation, i.e. the Dangerous Substances Di-
7] (Toxic for reproduction). A plasticiser rective 67/548/EEC (DSD) and the Dan-
which is used for example in polymer gerous Preparations Directive 1999/45/
products, and in particular in PVC for EC (DPD)? Will there be a change of
flooring applications, in textile and leather protection level under CLP? Have all GHS
coating, as well as in various other prepa- hazard categories been introduced in the
rations such as sealants, coating and inks CLP? Why is there no additional labelling
or adhesives; of PBT and vPvB substances? Will all sub-
– dibutylphthalate – DBP [CAS 84-74-2] stances and mixtures be within the scope
(Toxic for reproduction). A specialist of CLP? Should articles be classified?
plasticiser which is used in particular in – Obligations: What are the main obliga-
various polymer (PVC/non-PVC) appli- tions under CLP for companies supplying
cations (such as floor covering or primary substances or mixtures? What is the tran-
packaging of medicinal products), and as sitional period and what is it for? Why is
a component of various preparations such there no tonnage threshold for classifica-
as adhesives or paints. tion and labelling in CLP?
Reference: ECHA Press Release 02 June 2009. – Inventory: What is the Classification &
http://echa.europa.eu/doc/press/pr_09_07_ Labelling Inventory and what can it be
annex_xiv_rec_20090602.pdf used for? What will the Classification &
See also JCM/JSP 2008, nr. 9, item 2008/01986 and Labelling Inventory contain? Why must a
nr.10, item 2008/0216. notifier indicate the reason for non-clas-
sification? Do those who have to classify
also have to notify to the Classification &
ECHA: Questions and Answers to Labelling Inventory? Which substances
EU-GHS (CLP) have to be notified to the C&L Inventory?
Why is there no quantitative limit for no-
[2009/0121] tification of classification to the C&L In-
ventory?
Questions (for the answers see the Refer- – Labelling: Why is labelling based on haz-
ence): ard and not on risk? Why are there differ-
– Background: What is the EU legislation ent deadlines for re-labelling and re-pack-
on classification, labelling and packag- aging?
ing about? Why did the UN develop the – Collection and Evaluation of Data: Can
Globally Harmonised System (GHS) for classifications derived under transport leg-
classification and labelling of chemicals? islation be used for the purposes of CLP?
Why did the EU develop a new legislation Is animal testing required for health and
on classification, labelling and packaging? environmental classifications under CLP?
Which non-EU countries are implement- Is testing required for determining physi-
ing GHS? Does the CLP Regulation fa-
cal hazards? How can alternative methods ures of Environmental Management of New
to animal testing be used? Chemical Substances’ (Decree 17) has been
– Safety Data Sheets: Do Safety Data Sheets issued for comments on 21 May 2009. Lots of
need to reflect the new classification and changes have been made comparing to the old
labelling elements according to the CLP version. It may have big effect on the chemical
rules? industry we believe. Now it is open to public
– Harmonised Classification: Within the comments before submission for comments
EU, classifications have been harmonised of WTO. The deadline is June 28, 2009. The
for decades. What happens to Annex I to proposed measures of 21 May 2009 contain
the Dangerous Substance Directive (DSD) provisions impacting and likely disadvantag-
which contains harmonised classifications ing foreign companies to a large extent.
of about 8,000 substances? On entry into
force of the CLP Regulation on 20 January Amongst others, the most significant changes
2009, Annex I to Directive 67/548/EEC was in the proposed Measures of 21 May 2009 are
deleted and transferred to the CLP Regu- as follows:
lation. What should a supplier do with the – A risk management concept for new
substances from the 30th and 31st Adap- chemicals in the Chinese chemical control
tation to Technical Progress (ATP) of DSD system, i.e. hazard and exposure
which are not yet included in Annex VI to – Chemicals would be classified into three
CLP? Who can make proposals for har- categories, i.e. general chemicals, hazard-
monised classification and labelling under ous chemicals, and chemicals of environ-
CLP? Is it possible to harmonise classifi- mental concern
cations for all substances? Why were the – Basics of notification and registration sys-
generic concentration limits (GCLs) con- tem for new chemicals would remain the
tained in Annex I to DSD not transferred same as it was. However, detailed ‘general
to Table 3.2 of Annex VI to CLP? What is notification’ would be required for new
an M-factor? Should there be a UN list of chemicals depending on tonnage (e.g.
harmonised classifications? 1-10 ton, 10-100 tons, 100-1000 tons,
Reference: Questions & Answers on Regulation (EC) >1000 tons) of the chemicals imported
No 1272/2008 on classification, labelling or produced. The principle of notification
and packaging of substances and mixtures information would be ‘higher volume,
http://echa.europa.eu/doc/classification/ more information request’.
questions_and_answers_clp_20090526.pdf – Simplified notification would be available
for new chemicals imported or produced
International less than 1 ton per year. Separate research
and development notification would be
available when producing or importing a
China P.R.: Updated law on new chemical substance less than 0.1 ton
Environmental Management of per year.
New Chemical Substances – Notification of new chemicals could only
be done by a registered Chinese entity.
[2009/0120] – ‘Joint notification’ would also be possible
under the concept of ‘Easy Notification’.
The ‘Provisions of Environmental Manage- – In case of a producer or an importer who
ment of New Chemical Substances’ has been has registered hazardous chemicals or
revised recently and the draft version of ‘Meas- chemicals of environmental concern, s/he
would have to prepare and submit an an- During the 1960s and 1970s, the use of chemi-
nual production or import report and an cals and pesticides in industry and agriculture
annual production or import plan to the increased dramatically. In particular, a cat-
Chemical Registration Center. egory of chemicals known as POPs attracted
international attention due to a growing body
The most potentially problematic issues for of scientific evidence indicating that exposure
foreign chemical manufacturers or exporters to very low doses of POPs can lead to cancer,
are that: damage to the central and peripheral nerv-
– Only China-generated ecotoxicological ous systems, diseases of the immune system,
data would be acceptable for registration reproductive disorders and interference with
– Harmonisation between registration normal infant and child development. POPs
through Chinese entities only and CBI are chemical substances that persist in the
protection would be difficult. environment, bioaccumulate in living organ-
It is clear that the differences between the EU isms, and can cause adverse effects to human
REACH Regulation and the Legal require- health and the environment. With further
ments for (new) chemicals in countries like evidence of the long-range transport of these
P.R. of China are becoming smaller. substances to regions where they have never
References: E-mail of Chemical HSE Regulation Affairs been used or produced, and the consequent
Dept. of CNCIC: heyan@cheminfo.gov.cn; threats they pose to the global environment,
heyan@cncic.gov.cn, liangmy@cheminfo. the international community called for urgent
gov.cn; wangrh@cheminfo.gov.cn. global action to reduce and eliminate their re-
E-mail of Korea Environmental Council in lease into the environment.
Europe (Korea-helpdesk.eu) 9 June 2009: In March 1995, the United Nations Envi-
China REACH: Earlier than Expected! ronment Programme’s Governing Council
(UNEP GC) adopted Decision 18/32 inviting
the Inter-Organization Programme on the
Stockholm Convention on POPs Sound Management of Chemicals, the Inter-
governmental Forum on Chemical Safety
[2009/0119] (IFCS) and the International Programme
on Chemical Safety to initiate an assessment
The fourth Conference of the Parties (COP4) process regarding a list of 12 POPs. The IFCS
to the Stockholm Convention on Persistent Ad Hoc Working Group on POPs concluded
Organic Pollutants (POPs) was held from that sufficient information existed to dem-
4-8 May 2009, in Geneva, Switzerland. Over onstrate the need for international action to
800 participants, representing more than 149 minimize risks from the 12 POPs, includ-
governments, as well as intergovernmental ing a global legally-binding instrument. The
and non-governmental organizations, and meeting forwarded a recommendation to the
UN agencies, attended the meeting. COP4 UNEP GC and the World Health Assembly
considered several reports on activities within (WHA) that immediate international action
the Convention’s mandate and adopted 33 be taken on these substances. In February
decisions on, inter alia, nine new chemicals, 1997, the UNEP GC adopted Decision 19/13C
financial resources, guidance to the financial endorsing the conclusions and recommen-
mechanism, implementation plans, technical dations of the IFCS. The GC requested that
assistance, synergies and effectiveness evalua- UNEP, together with relevant international
tion. organizations, convene an intergovernmen-
History tal negotiating committee with a mandate to
develop, by the end of 2000, an international Switzerland, from 7-11 November 2005.
legally-binding instrument for implementing The Committee considered five chemicals
international action, beginning with the list of proposed for inclusion in the Conven-
12 POPs. In May 1997, the WHA endorsed the tion and agreed that intersessional work-
recommendations of the IFCS and requested ing groups would develop risk profiles
that the World Health Organization partici- on these chemicals, to be assessed by the
pate actively in the negotiations. Committee at its second meeting.
– COP2: This meeting took place from 1-5
Negotiation of the Convention May 2006 in Geneva, Switzerland.
The Intergovernmental Negotiating Com- – POPRC-2: POPRC-2 was held in Ge-
mittee (INC) met five times between June neva, Switzerland, from 6-10 November
1998 and December 2000 to elaborate the 2006. The Committee adopted the risk
convention. The Conference of the Plenipo- profiles for pentabromodiphenyl ether
tentiaries convened from 22-23 May 2001, in (pentaBDE), chlordecone, hexabromobi-
Stockholm, Sweden, where delegates adopted: phenyl (HBB), lindane, and perfluorooc-
the Stockholm Convention; resolutions ad- tane sulfonate (PFOS) and agreed that
dressing interim financial arrangements and intersessional working groups would
issues related to the Basel Convention on the develop draft risk management evalua-
Control of Transboundary Movement of Haz- tions for these chemicals to be assessed by
ardous Waste and their Disposal; resolutions POPRC-3. The Committee also agreed to
forwarded by the Preparatory Meeting; and consider five newly proposed chemicals
the Final Act. for inclusion in the Convention: alpha
The Stockholm Convention calls for interna- hexachlorocyclohexane (alphaHCH), beta
tional action on 12 POPs grouped into three hexachlorocyclohexane (betaHCH), pen-
categories: 1) pesticides: aldrin, chlordane, tachlorobenzene (PeCB), commercial
DDT, dieldrin, endrin, heptachlor, mirex and octabromodiphenyl ether (c-octaBDE)
toxaphene; 2) industrial chemicals: hexachlo- and short-chained chlorinated paraffins
robenzene (HCB) and polychlorinated biphe- (SCCPs), and agreed that intersessional
nyls (PCBs); and 3) unintentionally produced working groups would develop risk pro-
POPs: dioxins and furans. files on these chemicals to be assessed by
The Convention can list chemicals in three the Committee at its third meeting.
annexes: Annex A contains chemicals to be – COP3: Stockholm Convention COP3 was
eliminated; Annex B contains chemicals to be held from 30 April – 4 May 2007 in Dakar,
restricted; and Annex C calls for the minimiza- Senegal.
tion of unintentional releases of listed chemi- – POPRC-3: This meeting took place from
cals. The Stockholm Convention entered into 19-23 November 2007, in Geneva, Swit-
force on 17 May 2004, and currently has 163 zerland. The Committee approved the risk
parties, including the European Community. management evaluation for five chemicals,
and recommended that COP-4 consider
Conferences History listing under Annexes A, B, or C: lindane;
– COP1: The first Conference of the Parties chlordecone; HBB; pentaBDE; and PFOS,
(COP1) to the Stockholm Convention was its salts and PFOS fluoride. Risk profiles
held from 2-6 May 2005 in Punta del Este, were approved for four chemicals, and
Uruguay. POPRC-3 adopted a work programme
– POPRC-1: The first meeting of the PO- to prepare draft risk management evalu-
PRC (POPRC-1) was held in Geneva, ations for those chemicals, namely on:
c-octaBDE, PeCB, and alphaHCH and Issues unresolved and forwarded to COP-
betaHCH, and agreed that intersessional 5 included those on: compliance; effective
working groups would develop draft risk implementation; and listing of chrysotile
profiles on these chemicals to be assessed asbestos, the most commonly used form
by the Committee at its fourth meeting. of asbestos and cause of mesothelomia,
The Committee decided that a proposal and endosulfan, a pesticide widely used in
by the European Community and its cotton production, in Annex III.
member states to consider endosulfan for
inclusion in Annex A, B, or C would be COP4
considered by POPRC-4. The recommendation to list nine new chemi-
– Basel Convention COP-9: This meeting cals to Annexes A, B or C of the Convention
was held from 23-27 June 2008 in Bali, In- was the culmination of four meetings of
donesia. the POPs Review Committee (POPRC), the
– POPRC-4: This meeting convened from 31-member expert group established under
13-17 October 2008, in Geneva, Swit- the Convention to review whether global ac-
zerland. POPRC-4 considered several tion on a substance is warranted. As COP4
operational issues, including conflict-of- was the first opportunity to consider expand-
interest procedures, toxic interactions ing the scope of the Convention, deliberations
between POPs, and activities undertaken on these chemicals were seen by some as a lit-
for effective participation of parties in mus test of the POPRC process. Entering the
its work. The Committee approved the week, delegates expected that those chemicals
risk management evaluations for four no longer in production, the so-called “dead”
chemicals, and recommended that COP- chemicals, would likely be approved more
4 consider listing under Annexes A, B, or easily than those “live” chemicals in wide
C: c-octaBDE, PeCB, and alphaHCH and production and use, such as PFOS, which is
betaHCH. A draft risk profile for SCCPs used in a variety of industrial, firefighting and
was discussed and the Committee agreed pest-control applications. A contact group
to forward it to POPRC-5 for further convened throughout the week to finalize the
consideration. POPRC-4 also evaluated recommendations for listing, and predictably
a proposal to list endosulfan under the many hours were devoted to the study of the
Convention and agreed, by vote, that it uses of PFOS, for which alternatives may not
met the Annex D criteria for listing and be available or affordable.
that a draft risk profile should be prepared Many delegates were surprised by the difficul-
for consideration by POPRC-5. POPRC-4 ties posed by the proposed listing of bromi-
also began an exchange of views on a pro- nated diphenyl ethers (BDEs), namely c-pent-
posal to list hexabromocyclododecane aBDE and c-octaBDE. These substances, used
(HBCD). as flame retardants in bulk plastics and foam
– Rotterdam Convention COP-4: This rubber, are no longer in production, but are
meeting convened from 27-31 October ubiquitous in products. Concerns were raised
2008 in Rome, Italy. COP-4 adopted 13 at the beginning of the week that listing these
decisions, including the addition of trib- chemicals might substantially impact the plas-
utyl tin compounds, pesticides used in tics recycling industry as the Convention pre-
antifouling paints for ship hulls that are cludes the recycling of POPs. Yet it is very dif-
toxic to fish, mollusks and other aquatic ficult to separate BDE-containing plastic from
organisms, to Annex III of the Convention BDE-free plastic. Negotiators had to develop
(Chemicals subject to the PIC procedure). legal language that protects human health and
Global Update on New Chemicals Significant New Activity Notice No. 15441 re-
Regulations (April 2009) garding 2-propenoic acid 18-Apr-2009
British Columbia: Hazardous Waste Regula-
[2009/0136] tion amended 31-Dec-2008
China
In April 2009, approximately 150 new regula- National Standards published in 2008 30-
tions relating to chemicals management were Apr-2009
adopted or published worldwide. These invol- DDT, Chloradane, Hexachlorobenzene (HCB)
ve implementation of GHS, updates to chemi- and Mirex are banned 16-Apr-2009
cal inventories, new priority chemicals, several Procedures for importing used mechanical
changes to the requirements on transport and and electronic equipment simplified 10-Apr-
handling, and last but not least restrictions on 2009 Costa Rica
the marketing and use of chemicals. Circular DAC-UPS-03-09 establishing requi-
The following overview (selection only) rements for the person in charge of the Cos-
provides the indicative title in English and metic products register announced 13-Apr-
the date of adoption. Further information 2009
on any of these new regulations and what Croatia
they require from industry can be found in Ordinance on Rapid Exchange of Official In-
the Enhesa Update published by ENHESA formation about Products Representing Risk
(www.enhesa.com). To be kept ahead of new to Health and Safety of Consumers adopted
policy initiatives and developments and their 25-Mar-2009
implications on your business contact ENHE- New Regulation on Safety Data Sheets adop-
SA at +32 2 775 9797. ted 17-Mar-2009
Argentina [On 17 March 2009, Regulation on Safety Data Sheet
Limit to the content of lead in paints, lacquers was issued by the Ministry of Health and Social Welfare
and varnishes adopted 13-Jan-2009 with an approval of the Ministry of Economy, Labour
Amendment to Law 4980 establishing rules and Entrepreneurship. It specified a new format for the
for marketing of products adopted 21-Apr- safety data sheets (SDS) to be used as of 8 October 2009.
2009 EC/1907/2006 Regulation (REACH) is not applicable to
Australia Croatia at present but it is detailed by Annex to the Re-
NSW: Dangerous Goods (Road and Rail gulation of 17 March 2009, which is based on the Annex
Transport) Regulation 2009 enters into force II of the REACH Regulation. The Regulation of 17 March
17-Apr-2009 2009 requires that an SDS must be compiled by an expert.
Brazil Entities marketing dangerous substances and preparati-
Dangerous products classified in Classes for ons have to provide the training to the experts. The details
their transport 09-Apr-2009 of the training are not established by the Regulation of
Canada 17 March 2009.]
Significant New Activity Notice No. 15446 Ordinance on Categories, Types and Classifi-
adopted regarding 2-propenoic acid 04-Apr- cation of Waste using a Waste Catalog and the
2009 List of Hazardous Waste amended 25-Mar-
Orders amending the Domestic Substances 2009
List and Non-domestic Substances List adop- Denmark
ted 15-Apr-2009 Statutory Order prohibiting the import and
Significant New Activity Notice No. 15359 re- placing on the market of products that con-
garding organic silicone intermediate 18-Apr- tain dimethylfumarate (DMF) has been adop-
2009 ted 28-Apr-2009
Estonia Luxembourg
Provisions on collection, take-back, recovery Law relating to environmental liability adop-
or disposal of waste electrical and electronic ted 27-Apr-2009
equipment, targets and meeting them adop- Norway
ted 20-Apr-2009 Revised Regulations related to transport on
France ground of hazardous goods have been adop-
Circular on the reduction of hazardous sub- ted 01-Apr-2009
stances in wastewater discharges of classified Poland
installations subject to authorization issued Amendment to Ordinance limiting the use of
01-May-2009 substances negatively impacting the environ-
Decree relating to the prevention and reme- ment in electrical and electronic equipment
diation of certain environmental damages adopted 01-Apr-2009
adopted 23-Apr-2009 Ordinance on Labeling of Chemical Substan-
Germany ces and Some Chemical Preparations issued
Products containing dimethyl fumarate 05-Mar-2009
(DMF) banned under the Act on Safety of Russia
Technical Equipment and Consumer Pro- Amended the Law on International Transpor-
ducts (GPSG) 08-May-2008 tation of Goods by Road 05-Apr-2009
Greece The list of objects which are subject to the
Decision on REACH penalties issued 31-Mar- state environmental supervision (control) is
2009 changed 31-Mar-2009
Hungary Adopted Administrative Regulation on the
Decree on the ban to place on the market pro- State Supervision of Major Hazard Installati-
ducts containing dimethylfumarate (DMF) ons 30-Oct-2008
entered into force 29-Apr-2009 Slovenia
Indonesia Rules on professional training of personnel
The government sets a regulation on the in- repairing equipment containing ozone de-
dustrial areas 03-Mar-2009 pleting substances or fluorinated greenhouse
The Minister Regulation about environmen- gases issued 10-Feb-2009
tal laboratories 06-Apr-2009 South Africa
International Consumer Protection Act, 2008 adopted, ma-
IMO Material Safety Data Sheet requirement king way for environmental labelling, provi-
for maritime cargo containing MARPOL sion of information and product liability 15-
73/78 Annex I shipments to go into effect as May-2008
of 1 July 2009 01-Oct-2007 National Environmental Management
Israel Amendment Act changing requirements for
Polluter pays Law adopted 11-Aug-2008 environmental authorisations and manage-
Local authorities law concerning enforcement ment programmes comes into effect 09-Jan-
authorities adopted 11-Jun-2008 2009
Italy Mine Health and Safety Amendment Act
Directive on protection of groundwater adopted 17-Apr-2009
against pollution transposed 04-Apr-2009 South Korea
Fund for projects aiming at substitution of KC Mark, unified national product quality
Substances of Very High Concern (SVHC) mark, adopted 01-Apr-2009
under REACH created 08-Apr-2008 [On 1 April 2009, amendments to the National Standards
New labels for detergents approved Framework Act were adopted by the National Assembly.
study how the scientific process of risk assess- The main features of the CLP Regulation:
ment can help to improve the decision-mak- http://ec.europa.eu/enterprise/reach/docs/
ing process by taking these uncertainties into events/clp_conf_jensen_korte.pdf
consideration. An important aspect of the
decision-making process is the consideration
of whether precautionary measures should be REACH Europe 2009
taken.
The recommendations described in Vermeire’s [2009/0148]
dissertation are geared towards realising a
more transparent decision-making process REACH Europe 2009. Fifth International
and reducing the communication problems Conference on the Registration, Evaluation
between various stakeholders, such as the and Authorisation of Chemicals. Amsterdam,
government, industry and the general popu- 24-25 June 2009.
lation. The current European legal framework Published by iSmithers/Smithers Rapra. ISBN
REACH leaves some room for improved risk 978-1-84735-393-1.
assessment, both in the process and in the
methodology of risk assessment. Internet
The process can be improved through the ap-
plication of a framework for risk assessment
that includes extra attention for the uncer- New Jersey: Right to Know
tainties. The methodology can be improved by Hazardous Substance Fact Sheets
using a phased approach to the analysis of the
uncertainties, starting with a simple approach [2009/0137]
and then moving on to a deeper analysis and
a statistical approach as necessary. Vermeire’s The Fact Sheets are prepared for substanc-
dissertation also describes the qualitative and es on the New Jersey Right to Know Hazardous
quantitative instruments that are currently Substance List. More than 1600 Fact Sheets
available to help improve industrial chemical have been completed and more than 800 have
risk assessment. been translated into Spanish. The Fact Sheets
are prepared on pure substances and contain
Conference Proceedings information on health hazards, exposure lim-
its, personal protective equipment, proper
handling, first aid, and emergency procedures
Conference on EU and world-wide for fires and spills.
rules for classification, labelling Emergency Responders can now access the
and packaging of chemicals Emergency Responders Quick Reference for all
Fact Sheets that have been converted to the
[2009/0147] new format. The Quick Reference (last page
of the RtK Hazardous Substance Fact Sheet)
EU Regulation on Classification, Labelling provides comprehensive safety and health
and Packaging (CLP) of Substances and Mix- information on a hazardous substance when
tures based on the UN Globally Harmonised responding to a chemical emergency. Please
System (GHS). 17 June 2009, Brussels. Orga- note that health and safety information is also
nised by the European Commission. available for Fact Sheets in the old format.
References: http://ec.europa.eu/enterprise/reach/infor- The list of substances with a Quick Reference
mation/events/index_en.htm
vides support and guidance for these regula- (EC 222-191-1; CAS 3383-96-8), for vector mosquito
tions, in particular, through the provision of control in the French overseas departments until 14 May
an on line risk assessment tool “COSHH Es- 2010.]
sentials”. O.J. 2009, L127: Commission Directive
The COSHH website has been re-launched 2009/51/EC of 25 May 2009 amending Coun-
with lots of additional information. cil Directive 91/414/EEC as regards the speci-
Reference: http://www.hse.gov.uk/coshh/index.htm fication of the active substance nicosulfuron
[CAS 111991-09-4]
Status of HSE Guidance Documents O.J. 2009, L135: Commission Regulation
As the Competent Authority for much chemi- (EC) No 450/2009 of 29 May 2009 on active
cal legislation, the Health and Safety Execu- and intelligent materials and articles intended
tive (HSE) has historically seen duty holders to come into contact with food
as important stakeholders and customers, and [For the purpose of this Regulation, the following defini-
as well as producing free to access web sites, tions shall apply: (a) ‘active materials and articles’ means
and occasional free publications, the HSE has materials and articles that are intended to extend the shelf-
also produced detailed and technical guidance life or to maintain or improve the condition of packaged
(Approved Codes of Practice or ACOPs) for food; they are designed to deliberately incorporate compo-
much of the legislation it has to enforce. This nents that would release or absorb substances into or from
higher level guidance has historically been the packaged food or the environment surrounding the
only available to purchase. food; (b) ‘intelligent materials and articles’ means materi-
The Executive has announced that from Sep- als and articles which monitor the condition of packaged
tember 2009 around 250 priced publications food or the environment surrounding the food;(c) …]
that contain health and safety advice and O.J. 2009, L137: Decision No 455/2009/EC of
guidance will be made freely available from the European Parliament and of the Council
HSE’s website in PDF format to view and of 6 May 2009 amending Council Directive
print. The publications cover the full range of 76/769/EEC as regards restrictions on the
HSE’s guidance as well as approved codes of marketing and use of dichloromethane
practice and guidance on regulations. [In Annex I to Directive 76/769/EEC, the fol-
Those that wish to will still have the option to lowing entry is added: (58) Dichloromethane
buy professionally produced printed versions CAS No: 75-09-2 EC No: 200-838-9:
from HSE Books. (1) Paint strippers containing dichlo-
romethane in a concentration equal to or
greater than 0,1 % by weight shall not be: (a)
European Union (Period May placed on the market for the first time for
2009) supply to the general public or to profession-
als after 6 December 2010; (b) placed on the
[2009/0143] market for supply to the general public or to
professionals after 6 December 2011; (c) used
O.J. 2009, L124: Commission Decision by professionals after 6 June 2012. For the
2009/395/EC of 14 May 2009 concerning the purposes of this entry: (i) ‘professional’ means
placing on the market for essential use of bio- any natural or legal person, including workers
cidal products containing temephos in the and self-employed workers undertaking paint
French overseas departments stripping in the course of their professional
[Article 1: By way of derogation from Article 4(1) of Regu- activity outside an industrial installation; (ii)
lation (EC) No 1451/2007, France may allow the placing ‘industrial installation’ means a facility used
on the market of biocidal products containing Temephos for paint stripping activities.
(2) By way of derogation from paragraph 1, (4) Without prejudice to other Community
Member States may allow on their territories worker protection legislation, paint strippers
and for certain activities the use, by specifi- containing dichloromethane in concentra-
cally trained professionals, of paint strippers tions equal to or greater than 0,1 % by weight
containing dichloromethane and may allow may be used in industrial installations only if
the placing on the market of such paint strip- as a minimum the following conditions are
pers for supply to those professionals. Member met: (a) effective ventilation in all process-
States making use of this derogation shall de- ing areas, in particular for the wet processing
fine appropriate provisions for the protection and the drying of stripped articles: local ex-
of the health and safety of those profession- haust ventilation at strip tanks supplemented
als using paint strippers containing dichlo- by forced ventilation in those areas, so as to
romethane and shall inform the Commis- minimise exposure and to ensure compliance,
sion thereof. Those provisions shall include where technically feasible, with relevant occu-
a requirement that a professional shall hold pational exposure limits; (b) measures to min-
a certificate that is accepted by the Member imise evaporation from strip tanks compris-
State in which that professional operates, or ing: lids for covering strip tanks except during
provide other documentary evidence to that loading and unloading; suitable loading and
effect, or be otherwise approved by that Mem- unloading arrangements for strip tanks; and
ber State, so as to demonstrate proper training wash tanks with water or brine to remove
and competence to safely use paint strippers excess solvent after unloading; (c) measures
containing dichlo-romethane. The Commis- for the safe handling of dichloromethane in
sion shall prepare a list of the Member States strip tanks comprising: pumps and pipework
that have made use of the derogation in this for transferring paint stripper to and from
paragraph and make it publicly available over strip tanks; and suitable arrangements for safe
the Internet. cleaning of tanks and removal of sludge; (d)
(3) A professional benefiting from the dero- personal protective equipment that complies
gation referred to in paragraph 2 shall oper- with Directive 89/686/EEC comprising: suit-
ate only in Member States which have made able protective gloves, safety goggles and pro-
use of that derogation. The training referred tective clothing; and appropriate respiratory
to in paragraph 2 shall cover as a minimum: protective equipment where compliance with
(a) awareness, evaluation and management relevant occupational exposure limits cannot
of risks to health, including information on be otherwise achieved; (e) adequate informa-
existing substitutes or processes, which under tion, instruction and training for operators in
their conditions of use are less hazardous to the use of such equipment.
the health and safety of workers; (b) use of (5) Without prejudice to other Community
adequate ventilation; (c) use of appropriate provisions concerning the classification, la-
personal protective equipment that complies belling and packaging of substances and mix-
with Directive 89/686/EEC. Employers and tures, by 6 December 2011 paint strippers
self-employed workers shall by preference re- containing dichloromethane in a concentra-
place dichloromethane with a chemical agent tion equal to or greater than 0,1 % by weight
or process which, under its conditions of use, shall be visibly, legibly and indelibly marked
presents no risk, or a lower risk, to the health as follows: ‘Restricted to industrial use and to
and safety of workers. The professional shall professionals approved in certain EU Member
apply all relevant safety measures in prac- States – verify where use is allowed.’
tice, including the use of personal protective O.J. 2009, L138: Commission Decision
equipment. 2009/424/EC of 28 May 2009 amending, for
the purpose of adapting to technical prog- tegrated Risk Information System (IRIS). En-
ress, Annex I to Council Directive 76/769/ vironmental Protection Agency (EPA). Notice
EEC as regards restrictions on the marketing of listening session.
and use of lamp oils and grill lighter fluids
O.J. 2009, L138: Commission Decision
2009/425/EC of 28 May 2009 amending
Council Directive 76/769/EEC as regards
restrictions on the marketing and use of or-
ganostannic compounds for the purpose of
adapting its Annex I to technical progress
O.J. 2009, L141: Directive 2009/32/EC of the
European Parliament and of the Council of
23 April 2009 on the approximation of the
laws of the Member States on extraction sol-
vents used in the production of foodstuffs and
food ingredients (Recast)
O.J. 2009, C130: Communication (2009/C
130/03) from the Commission pursuant to Ar-
ticle 67(3) of Regulation (EC) No 1907/2006
of the European Parliament and of the Coun-
cil on the Registration, Evaluation, Authorisa-
tion and Restriction of Chemicals (REACH)
[A European Commission Communication has been pub-
lished today listing more stringent Dutch restrictions on
certain hazardous substances than those listed in Annex
XVII of the REACH Regulation. The restrictions, which
are approved until 1 June 2013, affect coatings containing
polyaromatic hydrocarbons as well as short-chain chlori-
nated paraffins.]
[2009/0144]
Citeertitel
Journaal Stoffen en Preparaten jaartal/nummer
(voorbeeld: Journaal Stoffen en Preparaten 2009/1)
ISSN 1574-1079
Journal
Chemicals
Management
Journaal CONTENT
Stoffen & Preparaten
ARTICLES
[2009/0150] Evaluating uncertainties in an integrated
Chief-editor: approach for chemical risk assessment under
Drs. A.C.H. van Peski REACH: more certain decisions? / 181
OFFICIAL PUBLICATIONS
[2009/0164] The Netherlands (Period June-July 2009) / 199
[2009/0165] Belgium (Period June-July 2009) / 200
[2009/0166] United Kingdom (period July 2009) / 200
[2009/0167] European Union (Period June-July 2009) / 202
[2009/0168] USA (Period August 2009) / 204
the regulatory responses can benefit from a for an optimal regulatory decision. Problem
more integrated, interdisciplinary approach formulation is the process by which the risk
leading to sharing of information, decreased assessment is defined and the plan for analys-
uncertainties and fully informed decisions. ing and characterising the risk is developed.
The Uncertainty Management framework
closely parallels the stages in the Integrated The methodology used in Chapter 2 is based
Risk Assessment scheme and is considered on the risk assessment methodology devel-
very useful for highlighting different types of oped and harmonised in Europe as described
uncertainty in risk assessment. in the EU Technical Guidance Documents and
implemented in the PC-application European
Chapter 1 (Introduction) introduces the sub- Union System for the Evaluation of Substances
ject and explains the two frameworks used. – EUSES.
It provides the historical and legal context
of chemical control and risk assessment at The 2004 version of EUSES is described in
UN, OECD and EU level. This chapter also Chapter 3 (European Union System for the Eval-
provides summary information on REACH uation of Substances (EUSES): the second ver-
and on one of its basic principles, the Pre- sion). Adaptations considered necessary for a
cautionary Principle. It is explained that the full application under REACH are discussed
Precautionary principle can be applied when in Chapter 7. In a discussion on the validation
there exist considerable scientific uncertain- status the models used are considered to be
ties about causality, magnitude, and nature of state-of-the-art, providing deterministic con-
harm and that some form of scientific analysis, servative estimates for standard scenarios based
including a thorough uncertainty analysis, is on limited data requirements.
mandatory. Essential is an evaluation of the
reliability of the assessment as well as the re- In the EU risk assessment of industrial chem-
maining uncertainties and a correct typology icals, it is current practice to characterise
of the uncertainties. risks using a deterministic quotient of the
exposure concentration, or the dose, and a
Chapter 2 (Integrated human and ecological no-effect level. A sense of uncertainty is tack-
risk assessment. A case study of organophospho- led by introducing worst-case assumptions in
rous pesticides in the environment) illustrates the methodology.
the concept of integrated human and ecologi-
cal risk assessment. The concept is applied to Chapter 4 (Opportunities for a probabilistic
a case study of the use of organophosphorous risk assessment of chemicals in the European
pesticides in a typical farming community. Union) explains how chemical risk manage-
This case study was developed to commu- ment can benefit from considering those un-
nicate the IRA approach, to illustrate how. certainties, which can be characterised by dis-
IRA assessments might be conducted, and to tributions, in a probabilistic risk assessment
analyse the benefits and drawbacks of integra- (PRA.). It discusses the advantages and pos-
tion. It is argued that this integrated approach sibilities of PRA and illustrates this by provid-
helps both the risk manager and the risk asses- ing an example calculation.
sor in looking more broadly, towards the risk Chapter 5 (A probabilistic human health risk
of the use of organophosphorous esters. The assessment for environmental exposure to dib-
first stage, problem formulation, is particularly utyl phthalate) continues this demonstration
relevant, for both information sharing and de- of the advantages and drawbacks of PRA, tak-
fining what information and advice is required ing the EU risk assessment of the plasticizer
dibutyl phthalate (DBP, CAS Number 84- as an additional layer in the IRA framework
74-2) as starting point. This example shows aiming to improve the management and com-
the possibility of including and comparing munication of uncertainty in decision-mak-
the various uncertainties involved in a typi- ing processes.
cal risk assessment, covering the uncertainty in The main, general conclusion of this thesis is
the exposure estimate, the uncertainty in the that both the process and the methodology
effect parameter modelled by a Benchmark of risk assessment as a decision-support tool
approach, and the uncertainty in assessment under REACH can be improved. The proc-
factors used in the extrapolation from exper- ess can be improved by the introduction of
imental animals to sensitive human beings. an IRA framework with a strong uncertainty
One important aspect of uncertainty analysis management component (IRA*). The meth-
is the widely used application of assessment odology can be improved by a tiered approach
factors to derive human and ecotoxicological for uncertainty analysis, starting with simple
no-effect levels. This subject is reviewed exten- deterministic approaches and, if necessary,
sively in Chapter 6 (Assessment factors for hu- classification and prioritisation of uncertain-
man health risk assessment: a discussion paper) ties and probabilistic approaches. Qualitative
with regard to human assessment factors. In and quantitative tools for uncertainty assess-
addition, this chapter discusses more exten- ment were shown to be available.
sively the probabilistic approach to establish
a human health limit value based on Bench- Conclusions and recommendations on
mark modelling as applied in Chapter 5. the process:
The most important of the perceived benefits
Chapter 7(Evaluating uncertainties in an in- of IRA are increased assessment efficiency
tegrated approach for chemical risk assessment with regard to data collection and methodol-
under REACH: more certain decisions?) finally ogy, increased cost-effectiveness of assessment
discusses the relevant methodological aspects activities in view of shared resources, and
of risk assessment and uncertainty analysis. increased coherence of assessment results in
The EU risk assessment methodology as im- view of shared methodology and risk charac-
plemented in EUSES is compared to the new terization. Decisions should be based on all
REACH guidance. data available and searching for communali-
ties. This will prevent risk reduction or pri-
Although EUSES is based on the Technical oritisation decisions which do not protect all
Guidance Documents operating until mid- human and environmental targets. Or even
2008 under the pre-REACH EU legislation, increase the risk to specific targets. In regis-
much of it is still in line with the updated tering chemicals under REACH, it is strongly
Guidance for REACH. Important changes recommended that industry will interact with
and implications for EUSES are discussed this regulatory bodies and other stakeholders in a
chapter. It further shows how the REACH risk problem formulation approach. The intensity
assessment framework can benefit from the of such communication, especially at registra-
1RA-framework and how the IRA-framework tion, should be proportional to the complexity
in its turn can be improved by taking into ac- of the Chemical Safety Assessment, the degree
count the current understanding of the role of of risk foreseen and the degree of uncertainty
uncertainty analysis in risk assessment and due to lack of knowledge. Further demonstra-
risk management. Uncertainty Management, tions of the scientific, economic and regulatory
including a method for classification of un- benefits of the IRA approach are needed. It is
certainties and a tiered approach, is presented
recommended to perform cost-benefit stud- the limited use of EUSES outside the domain of
ies to this regard. the persistent, non-dissociating substances of
The integration of information could also intermediate lipophilicity.
help to develop testing strategies with the
aim of avoiding vertebrate testing where pos- It has also been shown that a probabilistic
sible. An important aim of REACH, the re- risk assessment in the EU framework assess-
duction of the use of experimental animals. ment of industrial chemicals is feasible with
is an important driver towards integrated ap- currently available techniques. PRA potentially
proaches combining knowledge front in vivo, gives better decision-support to risk manag-
in vitro, in silico experiments, exposure data ers, because it gives more quantitative insight
and information on mechanisms of action into the range of possible outcomes in a risk
across species. Further work is needed to in- assessment and the degree of cumulated con-
vestigate when and how the total Weight-of- servatism in the deterministic risk assess-
Evidence from such integration will show a ment. Sensitivity analysis is able to reveal the
positive balance with regard to costs and ani- relative impact of. uncertainties in parameters
mals saved. on the final result, where the risk assessment
can be improved in the most time- and cost-
The uncertainty management scheme can efficient manner and whether it is neces-
be regarded as an additional layer in the IRA sary and achievable to reduce the uncertainty
framework aiming to improve the management further. The examples discussed show a high
and communication of uncertainty in IRA deci- contribution to the overall quantifiable un-
sion-making processes. This IRA–-framework certainty from uncertainty and variability in
stimulates interactions between risk assessors, emission estimation and in the application of
decision-makers and stakeholders and facili- default assessment factors.
tates the analysis and prioritisation of uncer-
tainties, supported by robust tools for a tiered For a further implementation of ’ PRA, it is
integrated risk and uncertainty assessment. necessary to build up experience. If the tiered
This approach is also needed to support deci- REACH Guidance is followed, PRAs on more
sion-making on the basis of the Precautionary substances wilt become available. Important
Principle. The Precautionary Principle should research areas are the characterisation of
be considered as a risk management tool sup- both default and chemical-specific distribu-
ported by a risk assessment framework which tions for exposure and effects input param-
includes a scientific evaluation, as complete as eters and methods to address environmen-
possible, and an identification of the degree of tal and human variability in the REACH CSA
uncertainty at each stage as proposed in the and to separately address variability, based
IRA+-framework. on experimental data, and uncertainty due
to lack of knowledge. The different stages of
Conclusions and recommendations on uncertainty analysis and PRA would be greatly
methodology: facilitated if firmly integrated with risk assess-
The risk assessment tool EUSES has been ment tools like EUSES.
shown to be fit for purpose under REACH
with some modifications, specifically with In any uncertainty analysis a clear separation
regard to the implementation of the Expo- needs to be made between quantifiable and
sure Scenario concept and more risk reduc- non-quantifiable uncertainties and between
tion options. More work needs to be done to true uncertainty (lack of knowledge) and
increase the domain of applicability. in view of variability to be able to answer different risk
the use, which might be made of the informa- – information about member states, con-
tion. tact details of the relevant competent
This final edition of ELINCS (2009) is com- authorities and poison information cen-
prehensive of all notified substances, conclud- tres as well as relevant and publicly avail-
ed by expiry of the Directive on 31 May 2008, able regulatory inventories and sources of
and contains 8433 notifications, representing electronically available legal texts;
5287 substances in total. On 1 June 2008 the – contributions from authorities and in-
notification scheme was revoked and replaced dustry experts aiming at a European wide
by Regulation (EC) No 1907/2006 concerning harmonised understanding and handling
the Registration, Evaluation, Authorisation of biocides regulations;
and Restriction of Chemicals (REACH). – clarification on specific scope issues;
References: 6th ELINCS publication – COM(2003) – information about test-houses;
642, 29.10.2003: http://ecb.jrc.ec.europa. – contact details of specialised consultants
eu/DOCUMENTS/New-Chemicals/ and overviews of their services;
ELINCS_PUBLICATION/ELINCS_6/ – information and links to scientific jour-
ENGLISH.pdf nals as well as books of relevance to the
ECB ELINCS: http://ecb.jrc.ec.europa.eu/ biocidal scientific and regulatory world;
elincs/ – collection of helpful and publicly available
Final version: http://ecb.jrc.ec.europa.eu/ databases;
DOCUMENTS/New-Chemicals/ELINCS_ – highlights and information of interna-
PUBLICATION/ELINCS_2009.pdf tional organisations with relevant impact
on the biocides regime in Europe such as
OECD and UN; and
European biocides information – news and facts on meetings and trainings
network related to the biocides scientific and regu-
latory world.
[2009/0152]
Feierl-Herzele GmbH is operator of the plat-
The ‘European biocides information network’ form, managing director is Mag. Robert J.
(EBIN) is a non-profit network initiative in Feierl.
cooperation with the Austrian Ministry for An advisory committee, the members of which
Environment. It has been developed to serve are all experts in the field of biocidal regula-
industry, small and medium enterprises and tory and scientific issues, advises and controls
authorities and intends to be continuously and such ensures the quality and high level of
enlarged and updated on a regular basis and information and continuous development of
such performs as a time saving one-stop-shop this network
platform with pre-selected and commented Head of committee: Dr. Karl Hruby (Head of
hyperlinks, articles and documents. Thanks to the Austrian Poison Information Centre)
the commitment of the sponsors of this pro- Deputy head of committee: Dr. Edmund
ject EBIN can provide free password protected Plattner (Head of Department V/3 (Biocides)
access to this source of information for all in- of the Austrian Ministry of Environment)
terested parties. Deputy head of committee: Dr. Geoff Wilson
The content covers: (Consultant).
– background, guidance and information References: www.europeanbiocides.net
on current and upcoming issues concern- www.feierl-herzele.com
ing biocides under the EU regime;
a Category 3 mutagen ( see below for an analyses, the Agency is requesting comment
explanation of the Categories). on alternative approaches for evaluating
– Gallium arsenide (FR), which is used for whether perchlorate occurs at a frequency
example in integrated circuit manufacture and level of health concern.and whether
in the microelectronics industry, is pro- there is a meaningful opportunity for health
posed to be classified as toxic to reproduc- risk reduction through a national primary
tion Category 2, carcinogen Category 3, drinking water regulation (NPDWR) for
and as toxic because of the danger of seri- perchlorate.
ous damage to health by prolonged expo- The analysis presented in the recent notice
sure. announced more directly evaluates children’s
– Indium phosphide (FR), which is used for exposure to perchlorate. This step takes into
example as a semiconducting compound account the fact that infants and children
in electronics, is proposed to be classified consume more water per body weight than
as toxic to reproduction Category 3, car- do adults. EPA is now considering a broader
cinogen Category 2, and as toxic because range of alternatives for interpreting the avail-
of the danger of serious damage to health able data on the level of health concern, the
by prolonged exposure. frequency of occurrence of perchlorate in
– Trixylyl phosphate (NL), which is used for drinking water, and the opportunity for health
example as hydraulic fluid in industrial risk reduction through a national primary
power generators, is proposed to be clas- drinking water standard. These alternative
sified as toxic to reproduction category 2. interpretations may impact the agency’s final
The Dutch and French authorities have sub- regulatory determination for perchlorate.
mitted to ECHA comprehensive dossiers on CAS 7790-98-9 Ammonium perchlorate; CAS
these substances and asked for their classifica- 7791-03-9 Lithium perchlorate; CAS 7778-
tion and labelling to be harmonised across the 74-7 Potassium perchlorate; CAS 7601-89-0
European Union. Sodium perchlorate
References: http://echa.europa.eu/doc/press/pr_09_08_ Reference: http://www.epa.gov/safewater/contami-
second_consultation_cl_20090616.pdf nants/unregulated/perchlorate.html
See also: http://echa.europa.eu/consultati-
ons/harmonised_cl_en.asp
Combustible Dust Hazards
INTERNATIONAL
[2009/0157]
and subsequent fire at a sugar refinery in Port ily prevented. National Fire Protection Asso-
Wentworth, Georgia, caused 14 deaths and ciation standards have long been available to
left many other workers seriously injured with general industry and, if followed, will prevent
severe burns. such accidents. The video features comments
In many of these incidents, workers and man- by the CSB investigators who led each of the
agers were unaware of the potential for dust accident investigations.
explosions, or failed to recognize the serious
nature of dust explosion hazards. The CSB The U.S. Occupational Safety and Health Ad-
reviewed Material Safety Data Sheets (MSDS) ministration (OSHA) has published a new
of 140 known substances that produce com- document titled ‘Hazard Communication
bustible dusts and found poor or inadequate Guidance for Combustible Dusts’ that helps
transmittal of information regarding poten- chemical manufacturers and importers recog-
tial dust hazards; 41% of the MSDSs reviewed nize the potential for dust explosions, identify
by the CSB did not warn users about potential appropriate protective measures, and fulfill
explosion hazards. Of the remaining 59% of the requirements for disseminating this in-
MSDSs sampled, most of the information was formation on material safety data sheets and
either not stated in a place or manner clearly labels.
recognized by workers, or was not specific to References: http://www.csb.gov/videoroom/detail.
hazards related to combustible dusts. aspx?VID=30
http://www.osha.gov/
On 28 July 2009 the U.S. Chemical Safety Publications/3371combustible-dust.pdf
Board (CSB) has released a new safety video
depicting how accumulations of combusti-
ble dust at worksites can provide the fuel for Singapore: Workplace Safety &
devastating explosions that kill and maim Health Guidelines. Cleaning and
workers, shut down plants, and harm local Custodial Services
economies. Entitled ‘Combustible Dust: An
Insidious Hazard’, the new video is available [2009/0158]
online at www.CSB.gov.. It can also be or-
dered free of charge on a new two-DVD set of This guideline serves as a workplace safety and
all CSB safety videos by filling out the CSB’s health resource for workers, supervisors and
online DVD request form. key stakeholders who provide or manage
For each accident, the animations show how cleaning and custodial services in housing
explosive dust accumulated over years on estates.
plant equipment, pipes, floors, ducts, dust It provides safety and health information,
collectors, and other areas. The video shows guidance on the identification of work haz-
how conditions develop needing only an ig- ards and the preventive measures that can be
nition source to set off a primary explosion, taken. For the handling of hazards specific to
which lofts the accumulated dust, leading to other work environment / industries, read-
deadlier secondary explosions. News footage ers should refer to other relevant technical
and still photographs depict actual damage advisories, guidelines or materials where
caused by these explosions, as well as other available.
accidents including last year’s tragedy at the Reference: http://app.wshc.gov.sg/cms/Portals/0/
Imperial Sugar Company. The video points WSH_Guidelines-Cleaning_&_Custo-
out that dust accumulations – and the result- dial_Services.pdf
ing secondary dust explosions – can be read-
Australia: Safe Work Draft and Rail) also includes classification criteria
National Codes on C&L and SDS for the GHS hazards: Category 1 – Acute haz-
ard to the aquatic environment, and Catego-
[2009/0159] ries 1 and 2 – Chronic hazard to the aquatic
environment.
Safe Work Australia is seeking feedback on Note: The document ‘Policy Proposal for
two draft documents: Workplace Chemicals Model Regulations
(National Standard for the Control of Work-
– ‘Draft National Code of Practice for the place Hazardous Chemicals)’ gives useful
Labelling of Workplace Hazardous Chem- background information.
icals’ (July 2009, 100 pages),
This labelling code is intended to provide – draft National Code of Practice for the
practical guidance to manufacturers and im- Preparation of Safety Data Sheets’. (July
porters of hazardous chemicals to meet their 2009, 120 pages)
obligations under the National Standard for This Code of Practice aligns the Australian
Workplace Hazardous Chemicals (the National SDS requirements with the 3rd revised edi-
Standard) to correctly label workplace haz- tion of the “Globally Harmonized System
ardous chemicals. This document replaces the of Classification and Labelling of Chemicals
National Code of Practice for the Labelling of (GHS)”, as published by the United Nations
Workplace Substances [NOHSC:2012(1994)]. from time to time. It supercedes the previous
Safe Work Australia agreed to adopt the Glo- National Code of Practice for the Preparation
bally Harmonized System of Classification of Material Safety Data Sheets 2nd Edition
and Labelling of Chemicals (the GHS) for [NOHSC:2011(2003)]. Implementation of
workplace hazardous chemicals in 2009. This this Code will facilitate the introduction of
Labelling Code conveys the requirements of GHS-consistent overseas SDS into Australia
the GHS. and assist Australian exporters to provide
This National Standard does not require a de- GHS-consistent safety information to over-
termination of whether a substance or mix- seas markets.
ture can be classified into any of the following An SDS prepared overseas by an overseas
GHS hazard classes/categories: manufacturer or supplier will only be consid-
(a) Acute toxicity – oral – category 5; or ered acceptable if it is amended by the writer
(b) Acute toxicity – dermal – category 5; or to comply with the National Standard and this
(c) Acute toxicity – inhalation – category 5; Code of Practice.
or An overseas SDS must:
(d) Skin corrosion/irritation – category 3; or – be written in English;
(e) Serious eye damage/eye irritation – cat- – include classification in accordance with
egory 2B; or the Classification Criteria;
(f) Aspiration hazard – category 2; or – disclose the identities and proportions of
(g) Flammable gas – category 2; or ingredients in a mixture in accordance
(h) Flammable liquid – category 4; or with this Code;
(i) Acute hazard to the aquatic environment – include the Australian Contact details –
– categories 1, 2 and 3; or name of supplier, address and telephone
(j) Chronic hazard to the aquatic environ- number; and
ment – categories 1, 2, 3 and 4. – include the Australian emergency phone
Note: The ADG Code (Australian Code for number that can provide further advice
the Transport of Dangerous Goods by Road about the product).
– include Australian Exposure Standards step guides to aid managers in the design and
where available; and implementation of health risk assessments.
– include relevant Australian regulatory in-
formation. ICMM is currently working on a sister publi-
Note: The address provided in the SDS should cation ‘Health Impact Assessment Good Prac-
not be a PO BOX address as this is not a Legal tice Guidance ‘ that will be published later this
address and is not acceptable on the SDS. year. It focuses on the environmental, social
and health impacts of a mining operation on
These documents, and the template for pro- the people who live near it and how these haz-
viding comments, are available from the Safe ards must be assessed.
Work Australia website. The International Council on Mining and
Reference: http://www.safeworkaustralia.gov.au/ Metals is a CEO-led industry group that ad-
swa/HealthSafety/HazardousSubstances/ dresses key priorities and emerging issues
Proposed+Revisions/ within the industry. It seeks to play a leading
role within the industry in promoting good
practice and improved performance, and
ICMM guidance on Health Risk encourages greater consistency of approach
Assessment nationally and across different commodities
through its association members and member
[2009/0160] companies.
Reference: www.icmm.com
The International Council on Mining and
Minerals (ICMM ) presents the ‘Good Prac-
tice Guidance on Occupational Health Risk International Material Data
Assessment (HRA)’ as an information re- System (IMDS)
source for those conducting or commission-
ing HRAs. [2009/0161]
According to the International Labour Or-
ganization 160 million people in the world The International Material Data System
suffer occupation related illnesses every year. (IMDS) is the automotive industry material
Reducing the number of such cases inside the data system. It is a joint development of Audi,
mining and metals industry is one of the key BMW, Daimler, Ford, Opel, Porsche, VW and
challenges of ICMM members. Occupational the Swedish firm Volvo. Further manufactur-
Health Risk Assessment is the structured and ers have meanwhile joined the community
systematic identification and analysis of work- and talks are being held with others regarding
place hazards to assess their potential risks to their participation in IMDS.
health and determine appropriate control In the IMDS, all materials used for car manu-
measures to protect the health and wellbeing facture are archived and maintained. Only in
of workers. The document describes 13 key this way is it possible to meet the obligations
steps for carrying out a HRA, from identifying placed on car manufacturers, and thus on
the health hazards and their effects, to assess- their suppliers, by national and international
ing exposure levels and analysing the effec- standards, laws and regulations.
tiveness of existing control measures. It offers The materials database set up by the car man-
information on three types of assessments ufacturers will facilitate the recycling of old
and includes several check lists and step-by- cars in future. The companies listed will get
a detailed overview of the materials used in
future old cars. The companies listed have got Global Update on New Chemicals
together to realise the joint aim – the collec- Regulations (Period May-June
tion of materials data. The parent companies 2009)
and subsidiaries of the members have also
been integrated into the system. [2009/0162]
All material information in IMDS is based on
a list of basic substances. In the IMDS there In May and June 2009, approximately 200 new
are about 8000 substances (status 2006) con- regulations relating to chemicals management
tained with their names and CAS-Numbers. were adopted or published worldwide. These
As a subset of these substances the IMDS user involve implementation of GHS, updates
can select one of the following substance lists: to chemical inventories, new priority che-
– GADSL (Global Automotive Declarable micals, several changes to the requirements
Substance List) on transport and handling, and last but not
– VDA 232-101 (List of Declarable Mate- least restrictions on the marketing and use of
rials in Automobile Manufacturing) chemicals.The following overview provides
– Appl. rel. subst. (Application relevant sub- the indicative title in English and the date of
stances) adoption. Further information on any of these
These lists can used as a display filter in the in- new regulations and what they require from
gredients screen and for MDS/module analysis industry can be found in the Enhesa Update
(certificate of expenditure). Currently IMDS published by ENHESA (www.enhesa.com).
uses GADSL as its default substance list. The To be kept ahead of new policy initiatives and
substance attributes “duty-to-declare” and developments and their implications on your
“prohibited” are always displayed according business contact ENHESA at +32 2 775 9797
to this list, independent of which substance (Selection only).
list the user selected. This substance list allows Argentina
the IMDS user to set up a management system Rules on registration medicines reviewed 12-
for dangerous substances for his products to May-2009
query the current status. This is as important Re-registration of facilities manufacturing or
during the design phase as for the end-of-life using drug precursors 19-May-2009
phase. Once the latter has been reached, the Register of environmental offenders establis-
IMDS data can contribute to achieving the re- hed 26-Jun-2009
cycling level of 95 per cent required from the Restrictions on the transport of goods and ha-
year 2015. zardous waste adopted 08-Jun-2009
References: http://www.mdsystem.com/html/en/ Mercosur Technical Regulation on the trans-
home_en.htm port of infectious substances adopted 29-Jun-
http:// www.gadsl.org 2009
http://www.mdsystem.com/html/data/ Mercosur Regulation on good practices du-
vda_232-101_gadsl_en_08-2005.pdf ring transport of pharmaceutical products
adopted 29-Jun-2009
Criteria to carry out agreements to simplify
the sanitary control process of cleaning pro-
ducts, cosmetics and perfumes adopted 29-
Jun-2009
National implementation plan on the Stock- concerning export and import of dangerous
holm convention issued 04-May-2009 chemicals adopted 12-Jun-2009
Law 8705 adopting the Rotterdam Conven- ADR Annexes A and B 2009 promulgated 29-
tion adopted 29-Jun-2009 Jun-2009
Croatia Indonesia
Act on the Ratification of the European Agree- Adopted Regulation on permitting procedu-
ment on International Carriage of Dangerous res for hazardous and toxic waste manage-
Goods by Inland Waterways adopted 15-Dec- ment 22-May-2009
2008 Israel
Regulation on import and export of hazar- Clean air law enters into force 1 January 2011
dous chemicals adopted 02-Jun-2009 31-Jul-2008
Regulation on classification, labeling, marking Amendment to regulation on import and
and packaging of hazardous chemicals amen- export of hazardous waste adopted 28-May-
ded 26-May-2009 2008
Dominican Republic Italy
National implementation plan of the Stock- Deadline for registration of battery producers
holm Convention on POPs issued 07-May- postponed to September 2009 01-Jul-2009
2009 Japan
Estonia Japanese REACH approved by the National
Conditions of labeling the electrical and elec- Assembly 20-May-2009
tronic equipment issued 27-Apr-2009 Lithuania
France Order on inventory of articles containing as-
Notice to producers and exporters of biocidal bestos issued 11-May-2009
products regarding free sale certificates issued Luxembourg
04-Jun-2009 Adaptation of Luxembourg chemicals legis-
Ordinance relating to the registration of cer- lation to the provisions of REACH 08-May-
tain classified installations adopted 11-Jun- 2009
2009 Law on the enforcement of Regulation
Germany EC/689/2008 on chemicals on import and
New Batteries Act adopted 30-Jun-2009 export of dangerous chemicals adopted 28-
Annexes A and B to ADR revised to incorpo- May-2009
rate 2009 changes 21-Apr-2009 Morocco
New Ordinance on Transport of Dangerous Decree on Protection of Workers Against Ha-
Goods by Road, Rail and Internal Waterways zards of Benzene Issued 04-Jun-2009
adopted 24-Jun-2009 Project of Decree on Creation of PolyChlori-
Greece nated Biphenyls (PCB) Commission Adopted
Law on the reorganization of the Labor In- 18-Jun-2009
spectorates provide for health and safety obli- New Zealand
gations Rules for possessing explosives modified to
Hong Kong require a Controlled Substance Licence 04-
Pesticide register updated 01-Jan-2009 Jun-2009
Bromochloromethane banned as an ozone Norway
depleting substance 29-May-2009 Regulations on handling fire hazardous, re-
Hungary action hazardous and pressurized substances
Decree further detailing European Regulation have been adopted 08-Jun-2009
EC/689/2008 on the registration procedure
tions and labeling (Classification List) repea- CALIFORNIA: Proposal to list 30 substances
led 01-Jun-2009 to Proposition 65 List as a result of court or-
The Swedish Chemical Inspectorate Chemical der 12-Jun-2009
Products and Biotechnical Organisms Regula- CALIFORNIA: Adopted emergency regula-
tions (KIFS 2008:2) amended 01-Jun-2009 tions to allow for the storage of bio-diesel in
Ordinance (SFS 2007:846) on fluorinating USTs 12-Jun-2009
greenhouse gases and substances that deplete Significant new use rules adopted for 23 sub-
the ozone layer amended 29-May-2009 stances 24-Aug-2009
Regulation (NFS 2003:24) on Protection MAINE: Passes producer responsibility bill for
against Ground and Water Pollution when mercury-containing light bulbs 08-Jun-2009
Storing Flammable Fluids amended 28-May- TEXAS: Signed into law legislation requiring
2009 the development of greenhouse gas reduction
Swedish national ban on cadmium repealed strategy 19-Jun-2009
01-Jul-2009
Thailand
Dangerous Substance Act entered into force
25-Feb-2008
Turkey
New Regulation on transport by roads publis-
hed 11-Jun-2009
Transitional long and short term limit values
and alert thresholds laid down in the Regula-
tion on Assessment and Management of Air
Quality amended 06-Jun-2008
United Kingdom
NI: The consolidated Chemicals (Hazard In-
formation and Packaging for Supply) Regula-
tions adopted 18-Jun-2009
United States
WASHINGTON: Adopted amendments to
toxic air pollution regulations 20-May-2009
WASHINGTON: Adopted expedited rule to
amend the Employer Chemical Hazards Com-
munication rule to conform with OSHA’s rule
05-May-2009
TEXAS: Governor signed into law legislation
providing an affirmative defense if in compli-
ance with the general duty clause of federal
OHSA 19-Jun-2009
CALIFORNIA: Established final public health
goal for Chlorite in drinking water 22-May-
2009
Connecticut: Legislature passes ban on bisp-
henol-A effective 1 October 2011 03-Jun-
2009
Belgium (Period June-July 2009) [De bijlage III van het koninklijk besluit van 12 oktober
2004 [ …] wordt aangevuld met volgende tekst:
[2009/0165] 30. Cadmiumlegeringen als elektrische/mechanische sol-
deerverbindingen met elektrische geleiders die zich direct
Staatsblad 30 juni 2009: Koninklijk besluit op de stemspoel bevinden van transductoren die gebruikt
van 6 mei 2009 tot wijziging van het konink- worden in krachtige luidsprekers met een geluidsvermo-
lijk besluit van 30 november 2001 houdende gensniveau van 100 dB (A) of meer; 31. Lood in soldeer-
verbod op sommige dierproeven voor wat be- materiaal in kwikvrije platte fluorescerende lampen (die
treft het testen van huidcorrosiviteit bv. worden gebruikt in LCD-schermen, designverlichting
Staatsblad 30 juni 2009: Koninklijk besluit of industriële verlichting);
van 31 mei 2009 tot wijziging van het konink- 32. Loodoxide in fritaansmeltingen van vensters voor ar-
lijk besluit van 15 oktober 1997 betreffende gon- en kryptonlaserbuizen.]
cosmetica Staatsblad 11 augustus 2009: Ministerieel be-
Staatsblad 30 juni 2009: Koninklijk besluit sluit van 17 juli 2009 tot wijziging van het mi-
van 28 juni 2009 betreffende het vervoer via nisterieel besluit van 21 maart 2007 houdende
de weg of per spoor van gevaarlijke stoffen, benoeming van de leden van het Comité voor
met uitzondering van ontplofbare en radioac- advies inzake biociden, opgericht krachtens
tieve stoffen artikel 2 van het koninklijk besluit van 5 au-
Staatsblad 3 juli 2009: Decreet van 8 mei gustus 2006 tot oprichting van een Comité
2009 houdende wijziging van het decreet van voor advies inzake biociden en tot wijziging
5 april 1995 houdende algemene bepalingen van het koninklijk besluit van 22 mei 2003
inzake milieubeleid en van het decreet van betreffende het op de markt brengen en het
21 oktober 1997 betreffende het natuurbe- gebruiken van biociden
houd en het natuurlijk milieu, wat de ver-
plichting tot het opstellen van een milieuef-
fectrapportage betreft United Kingdom (period July
Staatsblad 15 juli 2009: Besluit van de 2009)
Vlaamse Regering van 24 april 2009 tot wijzi-
ging van het besluit van de Vlaamse Regering [2009/0166]
van 6 februari 1991 houdende vaststelling van
het Vlaams reglement betreffende de milieu- by Dr. Ross Fielding
vergunning en van het besluit van de Vlaamse
Regering van 1 juni 1995 houdende algemene Control of Substances Hazardous to Health
en sectorale bepalingen inzake milieuhygiëne, (COSHH)
ter uitvoering van correcties en ter uitvoering The UK regulations that are intended to con-
van bepalingen van het decreet van 12 decem- trol exposure to hazardous substances in the
ber 2008 houdende diverse bepalingen inzake work place are the The Control of Substances
energie, leefmilieu, openbare werken, land- Hazardous to Health Regulations 2002 (SI
bouw en visserij en tot bepaling van de inwer- 2002:2677). The Health and Safety Executive
kingtreding van artikel 88 van dit decreet (HSE) has a website that provides support
Staatsblad 17 juli 2009: Koninklijk besluit and guidance for these regulations. The re-
van 2 juli 2009 tot wijziging van het koninklijk launch of the COSHH website was reported
besluit van 12 oktober 2004 inzake het voor- in the last issue, but new content continues to
komen van gevaarlijke stoffen in elektrische be developed. Newly available are;
en elektronische apparatuur – A new advisory leaflet which describes
how to control hazardous substances at
work so that they do not cause ill health. gerous for the environment’. The effect is to
It is intended to help users to understand classify products containing small quantities
what they need to do to comply with of powerful biocides that are typically present
the Control of Substances Hazardous to at concentrations around 0.1 – 0.5% in water-
Health (COSHH) Regulations 2002 (as based products such as emulsion paints, and
amended). at higher concentrations (between 0.5% and
– Examples of COSHH risk assessments for 5%) in products such as anti-fungal paints,
a wide range of workplaces. These include wood preservatives, detergents and pesticides.
a paving company, die caster, warehouse As a consequence, some premises storing sig-
and DIY (Do it yourself) store. nificant quantities of these preparations, such
as very large retail and wholesale warehouses,
Changes to COMAH arising from CHIP could be brought within scope of COMAH
2008 (probably through applying the aggregation
The Chemicals (Hazard Information and rule in Schedule 1 part 3).
Packaging for Supply) (Amendment) Regula- References: http://www.hse.gov.uk/coshh/whatsnews.
tions 2008 came into force on 1 October 2008. htm
These regulations implement into national http://news.hse.gov.uk/2009/06/30/chan-
legislation European Commission Directive ges-to-comah-arising-from-chip-2008/
2006/8/EC, commonly known as the second
Adaptation to Technical Progress of the Dan-
gerous Preparations Directive (the 2nd ATP).
The changes do not affect the main legal du-
ties but do adjust:
– the rules and procedures for classifying
and labelling a chemical preparation con-
taining carcinogens, mutagens and sub-
stances toxic for reproduction;
– the generic concentration limits to be
used for the evaluation of the hazards for
the aquatic environment;
– the classification and labelling require-
ments for preparations containing ozone
depleting substances;
– the specified warning phrases on labels for
certain preparations to make them clearer
and more consistent.
The COMAH Regulations refer to CHIP to
determine categories of dangerous substances
and therefore changes to the way substances
and preparations are classified in CHIP can
affect the scope of COMAH.
One of the changes in CHIP 2008, namely a
lowering of the generic concentration limits
used to evaluate hazards to the aquatic en-
vironment, has the potential to increase the
number of preparations classified as ‘dan-
sulfuryl fluoride [CAS 2699-79-8] as an active ber to the Management Board of the Euro-
substance in Annex I thereto pean Chemicals Agency
O.J. L198, 2009: Commission Directive [Article 1: Mr Johannes Karel Barend Henri Kwisthout of
2009/85/EC of 29 July 2009 amending Direc- Dutch nationality, born on 6 June 1964, shall be appointed
tive 98/8/EC of the European Parliament and to the Management Board of the European Chemicals
of the Council to include coumatetralyl [CAS Agency in place of Dr Arnoldus Wilhelmus van der Wielen
5836-29-3] as an active substance in Annex I for the period from 1 August 2009 to 31 May 2013.]
thereto O.J. C178, 2009: Council Decision 2009/C
O.J. L198, 2009: Commission Directive 178/09 of 27 July 2009 appointing one mem-
2009/86/EC of 29 July 2009 amending Di- ber to the Management Board of the Euro-
rective 98/8/EC of the European Parliament pean Chemicals Agency
and of the Council to include fenpropimorph [Article 1: Ms Catherine Mir of French nationality, born
[CAS 67564-91-4] as an active substance in on 20 February 1955, shall be appointed to the Manage-
Annex I thereto ment Board of the European Chemicals Agency in place
O.J. L198, 2009: Commission Directive of Ms Odile Gauthier for the period from 1 August 2009
2009/87/EC of 29 July 2009 amending Direc- to 31 May 2013.]
tive 98/8/EC of the European Parliament and O.J. L201, 2009: Commission Directive
of the Council to include indoxacarb [CAS S- 2009/90/EC of 31 July 2009 laying down, pur-
enantiomer: 173584-44-6 and R-enantiomer: suant to Directive 2000/60/EC of the Euro-
185608-75-7] as an active substance in Annex pean Parliament and of the Council, technical
I thereto specifications for chemical analysis and moni-
O.J. L198, 2009: Commission Decision toring of water status
2009/579/EC of 29 July 2009 allowing Mem- O.J. L201, 2009: Commission Directive
ber States to extend provisional authorisations 2009/91/EC of 31 July 2009 amending Direc-
granted for the new active substances acequi- tive 98/8/EC of the European Parliament and
nocyl, aminopyralid, ascorbic acid, benalaxyl- of the Council to include disodium tetrabo-
M, mandipropamid, novaluron, proquinazid, rate [CAS (anhydrous): 1330-43-4, CAS (pen-
spirodiclofen and spiromesifen [Council tahydrate): 12267-73-1, CAS (decahydrate):
Directive 91/414/EEC of 15 July 1991 con- 1303-96-4] as an active substance in Annex I
cerning the placing of plant protection prod- thereto
ucts on the market] O.J. L201, 2009: Commission Directive
O.J. L199, 2009: Commission Directive 2009/92/EC of 31 July 2009 amending Direc-
2009/88/EC of 30 July 2009 amending Direc- tive 98/8/EC of the European Parliament and
tive 98/8/EC of the European Parliament and of the Council to include bromadiolone [CAS
of the Council to include thiacloprid [CAS 28772-56-7] as an active substance in Annex
111988- 49-9] as an active substance in Annex I thereto
I thereto O.J. L201, 2009: Commission Directive
O.J. L199, 2009: Commission Directive 2009/93/EC of 31 July 2009 amending Di-
2009/89/EC of 30 July 2009 amending Di- rective 98/8/EC of the European Parliament
rective 98/8/EC of the European Parliament and of the Council to include alphachloralose
and of the Council to include nitrogen [CAS [CAS 15879-93-3] as an active substance in
7727-37-9] as an active substance in Annex I Annex I thereto
thereto O.J. L201, 2009: Commission Directive
O.J. C178, 2009: Council Decision 2009/C 2009/94/EC of 31 July 2009 amending Direc-
178/10 of 27 July 2009 appointing one mem- tive 98/8/EC of the European Parliament and
of the Council to include boric acid [CAS
17 – 19 June 2010
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Citeertitel
Journaal Stoffen en Preparaten jaartal/nummer
(voorbeeld: Journaal Stoffen en Preparaten 2009/1)
ISSN 1574-1079
Journal
Chemicals
Management
Journaal CONTENT
Stoffen & Preparaten
ACTUALITIES
OFFICIAL PUBLICATIONS
No. 8
Oktober 2009 [2009/0181]
[2009/0182]
United Kingdom (Period August 2009)
European Union (Period Period August
Volume 6
2009)
Part of Stoffennieuws.nl
actualities
Reference: http://eur-lex.europa.eu/LexUriServ/LexU-
riServ.do?uri=OJ:L:2009:235:0001:0439:EN
actualities :PDF
re-evaluated with respect to other applicabil- ure the size distribution of MMMF diameters
ity ranges. At the thermodynamic equilibrium because these diameters usually have size dis-
the vapour pressure of a pure substance is a tributions that approximate to log normal.
function of temperature only. No single meas- Measuring length as well as diameter is both
urement procedure is applicable to the entire tedious and time consuming but, if only those
range of vapour pressures from less than 10–10 fibres that touch an infinitely thin line on a
to 105 Pa. Eight methods for measuring va- scanning electron microscope (SEM) field of
pour pressure are included in this method view are measured, then the probability of
which can be applied in different vapour pres- selecting a given fibre is proportional to its
sure ranges. The methods can only be applied length. As this takes care of the length in the
for compounds that do not decompose under length weighting calculations, the only mea-
the conditions of the test. In cases where the surement required is the diameter and the
experimental methods cannot be applied due LWGMD-2SE can be calculated as described.
to technical reasons, the vapour pressure can [Note: Definitions:
also be estimated. – Particle: An object with a length to width ratio of less
[Note: Definition: than 3:1.
– The vapour pressure of a substance is defined as the – Fibre: An object with a length to with ratio (aspect
saturation pressure above a solid or liquid substance. ratio) of at least 3:1.]
The SI unit of pressure, which is the pascal (Pa),
should be used.] B.46. In vitro skin irritation: reconstructed
human epidermis model test
A.22. Length weighted geometric mean It is appropriate to update Regulation (EC)
diameter of fibres No 440/2008 to include with priority a new
It is necessary to add a new method to meas- in vitro test method for skin irritation, in
ure length weighted geometric mean diameter order to obtain a reduction of the number
of fibres. This method describes a procedure of animals to be used for experimental pur-
to measure the Length Weighted Geometric poses, in accordance with Council Directive
Mean Diameter (LWGMD) of bulk Man Made 86/609/EEC on the approximation of laws,
Mineral Fibres (MMMF). As the LWGMD of regulations and administrative provisions of
the population will have a 95 % probability the Member States regarding the protection
of being between the 95 % confidence levels of animals used for experimental and other
(LWGMD ± two standard errors) of the sam- scientific purposes. Although a draft in vitro
ple, the value reported (the test value) will be test method for skin irritation is still under
the lower 95 % confidence limit of the sam- discussion within the OECD, it is appropri-
ple (i.e. LWGMD — 2 standard errors). This ate in this exceptional case to include method
measurement method can be used to char- B 46 in this Regulation. Method B 46 should
acterise the fibre diameter of bulk substances be updated as soon as possible once an agree-
or products containing MMMFs including ment has been reached within the OECD or if
refractory ceramic fibres (RCF), man-made further information justifying such a revision
vitreous fibres (MMVF), crystalline and poly- becomes available.
crystalline fibres.
Length weighting is a means of compensat- Skin irritation refers to the production of re-
ing for the effect on the diameter distribution versible damage to the skin following the ap-
caused by the breakage of long fibres when plication of a test substance for up to 4 hours
sampling or handling the material. Geometric [as defined by the United Nations (UN) Glo-
statistics (geometric mean) are used to meas- bally Harmonized System of Classification
and Labelling of Chemicals (GHS)]. This Test substances are identified by their ability to
Method provides an in vitro procedure that, decrease cell viability below defined threshold
depending on information requirements, levels (i.e. ≤ 50 %, for UN GHS category 2 irri-
may allow determining the skin irritancy of tants). Substances that produce cell viabilities
substances as a stand-alone replacement test above the defined threshold level, will not be
within a testing strategy, in a weight of evi- classified (i.e. > 50 %, no category).
dence approach. A list of reference substances is given in the
The assessment of skin irritation has typi- Annex to the method.
cally involved the use of laboratory animals [Note: Definition:
(See Method B.4). In relation to animal wel- – Skin irritation: The production of reversible damage
fare concerns, method B.4 allows for the de- to the skin following the application of a test sub-
termination of skin corrosion/irritation by stance for up to 4 hours. Skin irritation is a locally
applying a sequential testing strategy, using arising, non-immunogenic reaction, which appears
validated in vitro and ex vivo methods, thus shortly after stimulation. Its main characteristic is its
avoiding pain and suffering of animals. Three reversible process involving inflammatory reactions
validated in vitro Test Methods or Test Guide- and most of the clinical characteristic signs of irrita-
lines, B.40, B.40bis and TG 435, are useful for tion (erythema, oedema, itching and pain) related to
the corrosivity part of the sequential testing an inflammatory process.]
strategy of B.4.
This Test Method is based on reconstructed C.3. Freshwater algae and cyanobacteria,
human epidermis models, which in their over- growth inhibition test
all design (the use of human derived epider- The provisions concerning the algal inhibition
mis keratinocytes as cell source, representative test need to be revised to include additional
tissue and cytoarchitecture) closely mimic the species and to meet the requirements for haz-
biochemical and physiological properties of ard assessment and classification of chemi-
the upper parts of the human skin, i.e. the cals. This method is equivalent to OECD TG
epidermis. The procedure described under 201 (2006).
this Test Method allows the hazard identifi- Testing Methods are periodically reviewed
cation of irritant substances in accordance and updated in the light of scientific progress.
with UN GHS category 2. This Test Method Testing Method C.3 needed to be revised to
also includes a set of performance standards include additional species and to meet the
for the assessment of similar and modified requirements for hazard assessment and clas-
reconstructed human epidermis based test sification of chemicals. The revision has been
methods. completed on the basis of extensive practical
The principle of the reconstructed human experience, scientific progress in the field of
epidermis model test is based on the premise algal toxicity studies, and extensive regulatory
that irritant substances are able to penetrate use, which has occurred since the original
the stratum corneum by diffusion and are adoption.
cytotoxic to the cells in the underlying layers.
Cell viability is measured by dehydrogenase C.25. Aerobic mineralisation in surface
conversion of the vital dye MTT [3-(4,5-Di- water – simulation biodegradation test
methylthiazol-2-yl)-2,5-diphenyltetrazolium It is necessary to add a new method to meas-
bromide, Thiazolyl blue; EINECS number ure aerobic mineralisation in surface water,
206-069-5, CAS number 298-93-1)], into a by virtue of a simulation biodegradation test.
blue formazan salt that is quantitatively mea- This method is equivalent to OECD TG 309
sured after extraction from tissues. Irritant (2004).
The purpose of this test is to measure the time – Mineralisation: The breakdown of a chemical sub-
course of biodegradation of a test substance stance or organic matter by microorganisms in the
at low concentration in aerobic natural water presence of oxygen to carbon dioxide, water and min-
and to quantify the observations in the form eral salts of any other elements present.]
of kinetic rate expressions. This simulation
test is a laboratory shake flask batch test to de- C.26. Lemna SP. growth inhibition test
termine rates of aerobic biodegradation of or- It is necessary to add a new method to meas-
ganic substances in samples of natural surface ure aerobic mineralisation in surface water, by
water (fresh, brackish or marine). It is based virtue of a simulation biodegradation test and
on the ISO/DIS 14592-1 and it also includes a new method to assess toxicity to the genus
elements from the testing methods C.23 and Lemna, by virtue of a growth inhibition test.
C.24. Optionally, with long test times, semi- This method is equivalent to OECD TG 221
continuous operation replaces batch opera- (2006). There has been broad agreement by
tion in order to prevent deterioration of the EU authorities that the Lemna test is a suit-
test microcosm. The principal objective of able alternative to an algal test for strongly
the simulation test is to determine the miner- coloured substances.
alisation of the test substance in surface water, This Testing Method is designed to assess the
and mineralisation constitutes the basis for toxicity of substances to freshwater aquatic
expressing degradation kinetics. However, an plants of the genus Lemna (duckweed). It
optional secondary objective of the test is to is based on existing guidelines but includes
obtain information on the primary degrada- modifications of those methods to reflect re-
tion and the formation of major transforma- cent research and consultation on a number
tion products. Identification of transforma- of key issues. The proposed method has been
tion products, and if possible quantification validated by an international ring-test.
of their concentrations, are especially impor- [Note: definition:
tant for substances that are very slowly min- – ECx: is the concentration of the test substance dis-
eralised (e.g. with half-lives for total residual solved in test medium that results in an x % (e.g. 50
14C exceeding 60 days). Higher concentrations %) reduction in growth of Lemna within a stated ex-
of the test substance (e.g. > 100 μg/l) should posure period (to be mentioned explicitly if deviating
normally be used for identification and quan- from full or normal test duration)].
tification of major transformation products Reference: http://eur-lex.europa.eu/LexUriServ/LexU-
due to analytical limitations. riServ.do?uri=OJ:L:2009:220:0001:0094:EN
[Note: Definitions: :PDF
– Primary biodegradation: The structural change
(transformation) of a chemical substance by micro-
organisms resulting in the loss of chemical identity. EuroChlor: Sodium hypochlorite
– Functional biodegradation: The structural change classification reviewed
(transformation) of a chemical substance by micro-
organisms resulting in the loss of a specific property. [2009/0173]
– Ultimate aerobic biodegradation: The breakdown of
a chemical substance by microorganisms in the pres- The EU Directive 67/548/EEC listed a specific
ence of oxygen to carbon dioxide, water and mineral concentration limit of 25% active chlorine,
salts of any other elements present (mineralisation) above which solutions of sodium hypochlorite
and the production of new biomass and organic mi- were classified as “Dangerous for the Environ-
crobial biosynthesis products. ment” and labelled N; R50, whereas solutions
or mixtures containing < 25% active chlo-
rine were not. When the new EU Regulation The new CLP hazard statements are H314
on Classification, Labelling and Packaging (Causes severe skin burns and eye damage),
of Substances and Mixtures (EC 1272/2008) H400 (Very toxic to aquatic life ) (c ≥ 2.5 %)
(CLP) came into force in January 2009, it in- and EUH031 (Contact with acids liberates
troduced a change in the way that solutions of toxic gas) (c ≥ 5 %).
sodium hypochlorite had to be classified and Reference: http://www.eurochlor.org/news/detail/
labelled as ‘Dangerous to the Environment’. index.asp?id=302
The specific concentration limit has been de-
leted in the new regulation and replaced by a
general provision, the ‘M-factor’. The M-fac- ECHA: public consultations
tor is a number allocated to individual highly
toxic substances that is derived from the data [2009/0174]
on their acute toxicity to aquatic species.
However, the available eco-toxicity data on so- On 2 September 2009 the European Chemi-
dium hypochlorite showed some weaknesses. cals Agency has published on its website a
As a consequence, it was decided that further public consultation on the proposal to har-
testing was required to realistically assess the monise the classification and labelling of three
toxicity of sodium hypochlorite solutions (12 chemical substances. Comments are welcome
– 14 % active chlorine) to aquatic species and on the proposal within the next 45 days. All
a new acute toxicity study in Daphnia magna comments will be taken into account in the
was commissioned. subsequent decision-making process. The
The new data is considered to be more reli- substances in this consultation, submitted by
able than previous data from invertebrate Ireland, France and the Netherlands, are:
toxicity studies. This new result, combined – Tris[2-chloro-1-(chloromethyl)ethyl]
with other available reliable data, shows that phosphate (TDCP, CAS 13674-87-8) (Ire-
invertebrates and fish are equally sensitive to land) – which is used as an additive flame
the toxic effects of sodium hypochlorite and retardant (i.e. it is physically combined
allows one to conclude, based on the weight with the material being treated rather than
of evidence, that the acute toxicity of sodium chemically combined) and is proposed to
hypochlorite to freshwater species lies in the be classified as a category 3 carcinogen.
range: 10 < L(E)C50 ≤ 100 μg/L. – Tetrahydrofuran (CAS 109-99-9) (France)
This means that an M-factor of 10 should – which is used as a solvent or for synthe-
be assigned to sodium hypochlorite which, sis (e.g. motor fuels, pharmaceuticals, syn-
in turn, means that if classification is based thetic perfumes and insecticides) and is
on the calculation method, solutions of ≥ proposed to be classified as a category 3
2.5% active chlorine will need to be clas- carcinogen; irritating to the eyes and the
sified as “Dangerous to the Environment respiratory system; highly flammable; and
(N; R50). Solutions containing < 2.5% ac- because it may form explosive peroxides.
tive chlorine do not need to be classified – Abamectin (a combination of Avermectin
in this way. An M-factor of 10 must also be B1a and Avermectin B1b) (CAS 71751-
applied when classifying mixtures/prepara- 41-2, 65195-55-3, 65195-56-4, 65195-55-
tions containing hypochlorite according to 3) (Netherlands) – which is used as an
the calculation method. Other results based insecticide and acaricide (a chemical that
on the testing of specific formulations may kills mites). Abamectin is proposed to be
give rise to a different, specific concentration classified as category 3 for reproductive
for the classification of these formulations. toxicity (posing a possible risk of harm to
the unborn child); as very toxic when in- – Acrylamide (CAS 79-06-1) Carcinogen,
haled or swallowed; as toxic because of the category 2; mutagen, category 2
danger of serious damage to health of pro- – Aluminiosilicate, Refractory Ceramic Fi-
longed exposure; and as very toxic to the bres (CAS --) Carcinogen, category 2
aquatic environment. Abamectin has to – Zirconia Aluminosilicate, Refractory Ce-
have a harmonised classification because ramic Fibres (CAS --) Carcinogen, cat-
it is a pesticide active substance. egory 2
– 2,4-Dinitrotoluene (CAS 121-14-2) Car-
On 1 September 2009 the European Chemicals cinogen, category 2
Agency (ECHA) has published on its website – Diisobutyl phthalate (CAS 84-69-5)Toxic
proposals to identify chemicals as Substances for reproduction, category 2
of Very High Concern (SVHC). Interested – Lead chromate (CAS 7758-97-6) Carcino-
parties are welcome to comment on these 15 gen, category 2; toxic for reproduction,
substances within the next 45 days. The com- category 1
ments will be taken into account when de- – Lead chromate molybdate sulphate red
ciding whether the substances will be added (C.I. Pigment Red 104) (CAS 12656-85-8)
to the Candidate List from which substances Carcinogen, category 2; toxic for repro-
are selected for authorisation. Nine out of duction, category 1
the 15 substances are proposed to be identi- – Lead sulfochromate yellow (C.I. Pigment
fied as SVHCs because of their carcinogenic, Yellow 34) (CAS 1344-37-2) Carcinogen,
mutagenic and/or reprotoxic (CMR) proper- category 2; toxic for reproduction, catego-
ties, having thus potentially serious effects on ry 1
human health. Five substances are proposed – Tris(2-chloroethyl)phosphate (CAS 115-
to be identified as persistent, bioaccumulative 96-8)Toxic for for reproduction, catego-
and toxic and as very persistent and very bio- ry 2
accumulative (PBT), having potentially seri-
ous negative effects on the environment. One
substance is proposed because it is considered
both as CMR and PBT. The substances are:
– Anthracene oil (CAS 90640-80-5) Persis-
tent, bioaccumulative and toxic
– Anthracene oil, anthracene paste, distn.
lights (CAS 91995-17-4) Persistent, bioac-
cumulative and toxic
– Anthracene oil, anthracene paste, anthra-
cene fraction (CAS 91995-15-2) Persis-
tent, bioaccumulative and toxic
– Anthracene oil, anthracene-low (CAS
90640-82-7) Persistent, bioaccumulative
and toxic
– Anthracene oil, anthracene paste (CAS
90640-81-6) Persistent, bioaccumulative
and toxic
– Coal tar pitch, high temperature (CAS
65996-93-2) Persistent, bioaccumulative
and toxic; carcinogen, category 2
paints and coatings, as well as chemicals and Assessment) Act 1989. The complete
used in the home, such as cleaning prod- handbook is currently being revised, however
ucts, cosmetics and toiletries. the updated 2009 individual sections can al-
– excluded use, in relation to a chemical, ready be downloaded (latest amendment: ver-
means: (a) use as an agricultural chemical sion 8 of March 2009).
or a constituent of an agricultural chemi-
cal; or (b) use as a veterinary chemical or New chemical assessments: All new industrial
a constituent of a veterinary chemical; or chemicals must be notified to NICNAS and
(c) therapeutic use or use as an ingredient assessed prior to their import or manufacture
or component in the preparation or man- in Australia. Certain new industrial chemicals
ufacture of goods for therapeutic use; or are exempt from notification provided they
(d) use as food intended for consumption meet certain criteria including use; volume;
by humans or animals or a constituent of concentration and risk to human health or
such food; or (e) use as a food additive in the environment. All exemption categories
food referred to in paragraph (d). have an annual reporting obligation.
– relevant industrial chemical means In general, the chemicals subject to new chem-
an industrial chemical: (a) that is not ical assessment under NICNAS are those that
intended for an excluded use; and (b) that are not listed on the Australian Inventory of
is not: (i) a naturally‑occurring chemical; Chemical Substances (AICS) or those whose
or (ii) biological material; or (iii) an importation and/or manufacture is subject to
incidentally‑produced chemical; or (iv) a a condition of use. In general, the chemicals
reaction intermediate. subject to new chemical assessment under
NICNAS are those that are not listed on the
The ‘NICNAS Handbook for Notifiers’ assist Australian Inventory of Chemical Substances
manufacturers and importers of industrial (AICS) or those whose importation and/or
chemicals comply with their obligations un- manufacture is subject to a condition of use.
der the Industrial Chemicals (Notifications
Chapter Section II– New Chemicals aims to allows introduction of the chemical before the
help to decide whether a substance one is im- certificate assessment is complete. The certifi-
porting or manufacturing is subject to new cate notification categories are for chemicals
chemicals assessment under NICNAS. If it which do not meet the permit criteria or
is, one will need to refer to Chapters 2-8 in where the introducer prefers a certificate no-
Section II and Section IV in the handbook for tification to a permit notification. Certificate
more information about new chemical assess- categories result in an assessment report, the
ment. If after reading this chapter, one discov- issue of an assessment certificate, publication
ers the chemical is not subject to new chemi- of a summary report in the Chemical Gazette
cal assessment, no further action is required and a full public report on the NICNAS web-
in most cases. However, annual reporting re- site and the eventual addition of the assessed
quirements exist for all chemicals introduced chemical to the AICS. There are different fees
under an exemption category and record for each category.
keeping requirements and advice prior to in-
troduction is required for certain exempt cat- Overview of Permit Categories
egories. These categories (and the procedures Section II, 3.2 is intended to give an overview
to follow in order to supply information) are of the different permit categories, the circum-
outlined at the end of this chapter. Any forms stances for which each permit category is in-
referred to in this chapter can be downloaded tended and the criteria that apply:
from the NICNAS website. – Commercial Evaluation Chemical (CEC)
permit notifications are for limited
Determining the Appropriate Notification volume chemicals to be introduced solely for
Category the purpose of market evaluation where the
– Permit notification maximum quantity to be introduced is 4000
There are a number of categories relating to kg in a maximum period of 2 years. A CEC
notification for a new chemical assessment, may be renewed once only provided certain
with each category depending on the type of criteria are met. Although there is no statu-
chemical, the amount being introduced, the tory deadline for NICNAS to finalise a CEC
use of the chemical and the period of use re- application, the process is usually completed
quired. Permit notification categories are suit- within 14 days. Examples of possible uses are:
able for chemicals which meet certain criteria. – To test a new polymer in a surface coating
These notification categories result in the issue when a large quantity is required to fill paint
of a permit allowing the introduction of fixed lines; or – To evaluate a new process which re-
quantities of the chemical for the duration of quires a new industrial chemical.
the permit. They also result in the publica- Information from Part B of the Schedule re-
tion of a notice of the permit in the Chemi- lating to occupational health and safety risks;
cal Gazette. The chemical is not added to the environmental impacts; and public health ef-
AICS. The assessment timeframes for permit fects must be provided. Copies of proposed
categories are shorter and the fees lower than labels and a proposed MSDS must also be
certificate notification categories. An applica- submitted for the chemical.No toxicity data
tion to renew an existing permit can be made need be generated under this category. How-
in certain circumstances. ever, copies of existing test reports available to
– Certificate notificatiom the notifier must be submitted with the CEC
A special type of permit may be applied for in Notification.
certain circumstances in conjunction with an – Low Volume Chemical (LVC) permit noti-
application for a certificate notification. This fications are for small volume chemicals
to be introduced at a rate of up to 100 kg per ing test reports available to the notifier must
year or 1000 kg per year for a maximum of 3 be submitted with the LVC Notification.
years. A LVC permit may be renewed any num- – Controlled Use Permit (CUP) notifications
ber of times provided certain criteria are met. are for the introduction of low risk new
LVC permits and permit renewals are issued chemicals used in highly controlled cir-
within 20 days of receipt of a complete noti- cumstances for a maximum of three years.
fication. A number of low regulatory concern There is no volume restriction provided
chemicals introduced at up to 100 kg per year all the following criteria are met:
are exempt from notification to NICNAS. (a) the chemical does not have any of the
The LVC permit allows the chemical to be in- following hazard classifications for
troduced at a maximum quantity of 1000 kg human health effects: (i) carcinogenic
per annum where the following low-hazard- effects (R40, R45, R49); (ii) mutagenic
ous criteria are met (otherwise the volume effects (R46); (iii) reproductive effects
limit is 100 kg): For chemicals (including (R60-64); (iv) toxic and very toxic
polymers with a NAMW <1000), the chemi- acute lethal effects (R23-28); (v) cor-
cal is not a hazardous substance according to rosive effects (R34, R35); (vi) sensitis-
the Approved Criteria for Classifying Hazard- ing effects (R42, R43); (vii) non-lethal
ous Substance, or is a hazardous chemical that irreversible effects after a single expo-
is classified as R36 (irritating to eyes) or R38 sure (R39, R68); (viii) severe effects
(irritating to skin) according to the Approved after repeated or prolonged exposure
Criteria for Classifying Hazardous Substances (R48); AND
(irritation reversible); and is not a dangerous (b) the chemical does not have a toxicity:
good according to the Australian Code for the (i) to fish, expressed as an LC50, that
Transport of Dangerous Goods by Road and is less than or equal to10 mg/litre, as
Rail (ADG code) or is a dangerous good that determined using the Fish Acute Tox-
is a Class 3 flammable liquid as defined in the icity Test (continuous exposure of fish
ADG code; and has a very low aquatic toxicity to a series of concentrations of the
to fish, aquatic invertebrates and algae, that is, chemical in water for 4 days); and (ii)
LC50 or EC50 100 mg/l or greater. to aquatic invertebrates, expressed as
For polymers with NAMW that is 1000 or an EC50, that is less than or equal to
greater: see the Handbook. 10 mg/litre, as determined using the
LVC Notifications must detail the purpose for Daphnia sp, Acute Immobilisation
which the chemical is being introduced and Test and Reproduction Test (daphnids
include information about its proposed use, exposed to a series of concentrations
the expected total volume for the first year, of the chemical in water); and (iii) to
and the total time period for introduction. A algae expressed as IC50, that is less
summary of the chemical’s health and envi- than or equal to 10 mg/litre, as deter-
ronmental effects under Part A of the Schedule mined using the Algal Growth Inhibi-
is required, as well as additional information tion Test (algae exposed to a series of
from Part B relating to occupational health concentrations of the chemical in wa-
and safety risks; environmental impacts; and ter for at least 3 days); AND
public health effects. Copies of proposed la- (c) for human exposure: (i) there are no
bels and a proposed MSDS must also be sub- exposures to consumers or the gen-
mitted. No toxicity data need be generated eral public inherent in the proposed
under this category. However, copies of exist- manufacturing, processing or uses
of the substance; and (ii) any worker
the criteria to be eligible for notification and Standard Notifications must include all infor-
assessment as a PLC. mation required under Part A and Part B of
A polymer of low concern can be either a syn- the Schedule, and if the chemical is a polymer,
thetic polymer or biopolymer. In addition, Part D data are also required. In addition, tox-
the residual monomer content will no longer icity studies and other data under Part C must
impact the classification of the polymer as a be submitted. Data required under Part C in-
low concern polymer. However, information clude acute toxicity data; skin/eye irritation
regarding the residual monomer content will and sensitization data; data from a repeated
still need to be provided. dose study; in vitro and in vivo toxicological
Further information on PLC criteria is given and ecotoxicological data; as well as biode-
in Appendix 10 of the NICNAS Handbook for gradability and bioaccumulation data. Tox-
Notifiers. icity results must include observations and
– Limited Notifications are for chemicals results obtained for individual animals. Full
that fit into the following categories: a. reports of all testing must be included and
small volume chemicals, biopolymers and must specify whether good laboratory prac-
low molecular weight synthetic polymers tices were used to obtain data.
(NAMW < 1000), i.e. those which are to
be imported or manufactured at a rate of 2009-2010 Fees and Charges for New Chemi-
up to one tonne per 12 month period (but calsSchedule for Data Requirements.
which do not qualify for a commercial Appendix 4 of the Handbook referms to the
evaluation or low volume chemical per- NICNAS website forfees and charges.
mit); or b. site-limited chemicals, biopoly-
mers and low molecular weight synthetic Price $
polymers (NAMW < 1000), i.e. those re- (see note a)
stricted to their manufacturing site and New Chemical fees
manufactured at a rate of not more than Certificate Apllications
10 tonnes per 12 month period; or c. syn- Standard Assessment 16,199
thetic polymers with NAMW greater than Limited Assessment 13,569
1000 and which do not meet the PLC cri- Polymeer of Low Concern 4,570
teria. Application for Extension of Assessment 2,908
Certficate
Limited Notifications must include all infor-
Self-assessment Certificate Applications
mation required under Part A and Part B of
Self-Assessment Application 9,719
the Schedule, and if the chemical is a polymer, Non-hazardous chemicals
additional data required under Part D must Self-Assessment Application 8,140
also be submitted. Limited Notifications do Non-hazardous polymer
not require new toxicity data to be developed, Polymer of Low Concern (SAPLC) 2,742
but copies of existing test reports available to Self-Assessment Application
the notifier must be submitted with the noti- Permit Applications
fication. Commercial Evaluation (CEC) Permit 3,600
– Standard Notifications are for chemicals, Application
biopolymers and low molecular weight Low Volume Chemical (LVC) Permit 3,600
Application
synthetic polymers imported or manufac-
Controlled Use Permit Application 3,600
tured at greater than one tonne per year
(Export Only)
and which do not fulfil the requirements Controlled Use Permit Application (Other) 3,600
of any other category.
Application for Early Introduction Permit 693 c) Modular & Foreign Scheme Assessments
(EIP)
entry fees are applicable on the:
Section 30 Permit Aplication 7,851
i) Provision of an assessment report
Permit Renewal Application
by Environment Canada and Health
Commercial Evaluation (CER) Renewal 711
Application
Canada; or
Low Volume Chemical (LVCR) Permit 711 ii) Provision of an assessment report by a
Renewal Application chemicals notification and assessment
Controlled Use Prmit Renuwal Application 711 scheme operating under the OECD
Others Applications (other than Canada); or
Secondary notification of new chmicals, 8,971 iii) Provision of an assessment report by
other than synthetic TGA, APVMA and FSANZ; or
Secondary notification of a new chemical 3,878 iv) The chemical is similar to a chemical
that is a synthetic PLC
which has been previously assessed by
Reduced Fee Options
NICNAS
Alternate State Law Applicationb 9,691
d) Modular – Secondary Chemical fee is ap-
Modular & Foreign Sheme – Standard 9,719
plicable if the chemical is being notified at
Assessment Applicatione Entry fee
Modular & Foreign Sheme – Limited 8,140
the same time as a similar chemical (pri-
Assessment Application Entry Fee mary chemical) and for a similar use.
Modularc & Foreign Scheme – Polymer of 2,742 # The entry fee may not represent the final
Low Concern Applicationc Entry Fee fee. The appropriate fee will be advised fol-
Modular – Secondary Chemicald 711 lowing screening of the application. For more
New Chemicals Charges information on foreign scheme options see
New Chemical Assessment the December 2008 Chemical Gazette and for
Variation of Schadule Data Requirements 1,281 modular assessment options see the May 2009
Nomination of Foreign Scheme 6,658 Chemical Gazette.
Exempt Information 711
Application to Vary Assessment Report 711 Schedule for Data Requirements
Application to Vary Full Public Report 711 Appendix 12 of the Handbook contains the
AICS Schedule for Data Requirements and provides
Confidential Listing of a New Indusrtial 1,424 guidance concerning the data necessary to
Chemical
submit with the application for new or exist-
Application to Retain Confidential Listing 1,919
ing chemical assessments.
Application for Early Non-confidential 711
Listing with fee
Part A requires administrative information, a
Application to be a Holder of a 639
summary of the chemical’s health and envi-
Confidence ronmental effects, and a bibliography of refer-
Transfer to Confidential listing 1,908 ences used in the notification.
Part B requires physico-chemical informa-
tion, information on the chemical’s use and
Notes: estimated volume, occupational health and
a) All NICNAS fees and charges are in Aus- safety risks, environmental impacts, public
tralian Dollars and are GST free. All health effects, proposed labels and an MSDS,
amounts are rounded to nearest $. 1 AU $ and a description of emergency procedures.
= 0.59 € = 0.86 US $. Part C requires results of in vitro and in vivo
b) Whilst fees have been set for this applica- toxicological and ecotoxicological studies and
tion, at present there are no Alternate State biodegradability/bioaccumulation data.
Laws in Australia.
for submission. In case no CA proposed from the time six months prior to the expiry
name is available, IUPAC name may also of protection. Extension will be granted only
be used. “Other names” will include ver- once.
nacular names, abbreviation and trade
name etc. 2. New Chemical Substance Notification
4) Six tonnage bands are set based on the (NCN)
average quantity of production/import Definition and Exclusion
in the three years prior to notification: (a) New Chemical Substances (NCS) are defined
more than 1000 ton/year; (b) 100 to 1000 as those that are not listed on the Taiwan In-
ton/year; (c) 10 to 100 ton/year; (d) 1 to ventory of Existing Chemicals. Manufacturer
10 ton/year; (e) 10 to 1000 kg/year and (f) or importer of a new chemical substance
less than 10 kg/year. should file a prior notification with CLA to-
Interestingly, although tonnage band needs to gether with a risk assessment report to ob-
be reported, there is no differentiated data re- tain specific permission unless the substance
quirement for each tonnage band. And there is categorically excluded from the obligation
is no need to submit the evidence of prior of notification. The categorical exclusions are
production/import in submission although not different from those for ‘grandfathering’
the agency reserves the right to demand such existing chemical substances. These exclu-
evidence if necessary. sions are listed as below:
Data Protection (a) Substances and polymers that occur in na-
The general company information of nomi- ture, without physicochemical treatment;
nators and the quantity of production/import (b) Chemical substances contained in experi-
will be automatically under protection and mental machines and equipments;
not be publicly accessible. Nominators may (c) Non-isolated intermediates in reactors or
also request protection of the CAS Registry reaction process;
Number and chemical names of the notified (d) Chemical substances for military uses;
substances if the following conditions are (e) Incidental reaction products (by-prod-
met: ucts) or impurities with no commercial
(1) The data to be protected are the nomina- value;
tor’s confidential business information; (f) Chemical substances under the supervi-
(2) The nominator has taken and will con- sion of customs (stored in bonded ware-
tinue to take actions to maintain the con- house or otherwise not yet cleared thor-
fidentiality of the information; and ough the Customs of ROC);
(3) No third party has acquired the informa- (g) Mixtures (but the only substances in the
tion lawfully except at the consent of the mixture are not excluded);
nominator. (h) Wastes;
A generic name for the nominated substance (i) Polymers for which the 2% rule is appli-
should be provided if the nominator requires cable;
protection of the chemical name and the CAS (j) New chemical substances that are regu-
Registry Number. CLA will review the appro- lated by other government agencies (such
priateness of the generic name. If the request as radioactive materials, active ingredients
is accepted, the chemical name and the CAS for pesticides, active ingredients for envi-
Registry Number of the substance can be pro- ronmental agents, food additives, phar-
tected for five years. The nominator may re- maceuticals, controlled drugs and so on)
quest an extension of data protection for an- Notifier
other five years. Such request should be made
According to the draft regulation, only legal are all in the existing chemical substances
entities located in Taiwan can file notifications inventory.
for new chemical substances. However, if a substance is classified according
Types of Notification to the GHS standards as a CMR substance or
There are three types of notification/notice: as aqueous hazardous, it will not be entitled to
Notice, Simplified Notification and Full No- Simplified Notification procedure.
tification. Data required for filing Simplified Notifica-
I. Notice tion include the following:
New chemical substances manufactured or (a) General information about notifier and
imported with quantity between 10 to 100 kg/ the notified substance;
year are entitled to this convenient notice pro- (b) GHS-based classification and labeling;
cedure. The following information need to be (c) Safe use information; and
included in a notice filing: (d) Polymer identification data if the sub-
(a) Basic information of the manufacturer/ stance is a polymer.
importer and the contact details; No toxicological or ecotoxicological data are
(b) Location of manufacturing or import of needed for Simplified Notification.
the new substance; III. Full Notification
(c) Chemical names in Chinese and English For any new chemical substances that are not
and CAS Registry Number (if available) of categorically excluded and not entitled
the new substance; to the Notice or Simplified Notification pro-
(d) Description of appearance, colour and cedure, a Full Notification shall be filed.
other physical properties of the sub- A substance will be entitled to an expedited re-
stance; view and registration process if it has already
(e) Safe use information (handling, storage been listed on at least two Inventories among
and transportation) the following six jurisdictions: USA, Europe-
The agency will reserve the right to ask for an Union, Japan, P.R. of China (PRC), Canada
more information if needed. and Australia. Full data entries accepted by
II. Simplified Notification these agencies as well as the approval docu-
The following substances are entitled to the ments should also be provided.
Simplified Notification procedure: The data required for Full Notification are as
1) Substances with quantity of manufactur- follows:
ing/import between 100 to 1000 kg/year; (a) General information of the notifier and
2) Polymers that meet the following defini- the notified substance;
tion (low loncern criteria): (i) the number (b) GHS-based classification and labeling;
average molecular weight (Mn) is between (c) Manufacture, use and exposure;
1000 and 10000 Dalton, no active function (d) Physical and chemical properties;
group exists, polymers of weight average (e) Environmental fate and pathways;
molecular weight (MW) below 500 Dal- (f) Ecotoxicological information;
ton is less than 10% and polymers of MW (g) Toxicological information;
below 1000 Dalton is less than 25%; (ii) (h) Analytical methods;
Mn is above 10000 Dalton, no active func- (i) Guidance on safe use;
tion group exists, polymers of MW below (j) Literature search
500 Dalton is less than 2% and polymers (k) Assessment reports.
of MW below 1000 Dalton is less than Timelines
5% or (iii) the blocks and branch chains The timelines for the Notice/Notifications
above are summarized in the following chart:
provides direct access to a consolidated list of TI), including the ICAO TI-Supplement, and
all the classified substances contained in the the International Air Transport Authority –
HSIS database. Dangerous Goods Regulations (IATA DGR)
Safe Work Australia has updated the Hazard- apply for air transport. The International
ous Substances Information System (HSIS) Maritime Dangerous Goods Code (IMDG
online database to reflect changes in Europe’s Code) applies to transport by sea.
30th Adaptation to Technical Progress to Di- It is envisaged that this Code will be adopted
rective 67/548/EEC. in the explosives legislation of the Common-
The update comprised of a total of 958 entries wealth and all States and Territories.
of which there are 564 amendments to exist- This Code is the primary reference for explo-
ing entries, 391 new entries and 3 deletions. sives and has been designed to complement
Also, the HSIS Guidance Material for Hazard and be consistent with the 7th Edition of the
Classifications has been updated to reflect Australian Code for the Transport of Danger-
amendments to Notes H, J and P in the label- ous Goods by Road and Rail (ADG Code),
ling column. which currently includes limited and/or advi-
Reference: http://hsis.ascc.gov.au/TheList.aspx sory provisions regarding explosives (danger-
ous goods of Class 1).
References: ISBN 978 0 642 32747 5 (online PDF)
Australian Code for the Transport ISBN 978 0 642 32753 6 (print)
of Explosives by Road and Rail
[2009/0179]
Hoofdredactie:
Drs. A.C.H. van Peski
Redactie:
Mw. dr. M.M. Kops-Werkhoven
Drs. H.A.F. van Well
Dr. J.A.S.J. Razenberg
Drs. J. Zawierko
Uitgever:
Drs. A. van Dijk
Abonnementen:
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site, een e-mail nieuwsbrief en een tijdschrift. Op de site vindt u artikelen
over recente wijzigingen in wet- en regelgeving rond chemische stoffen. De
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schriftelijke toestemming van de uitgever.
Voorzover het maken van kopieën uit deze uitgave is toegestaan op grond
van artikel 16b Auteurswet 1912 jo het Besluit van 20 juni 1974, Stb. 351,
zoals laatstelijk gewijzigd bij het Besluit van 22 december 1997, Stb. 764 en
artikel 17 Auteurswet 1912, dient men de daarvoor wettelijk verschuldigde
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deze uitgave de uiterste zorg is nagestreefd, kan voor eventuele (druk)fouten
en onvolledigheden niet worden ingestaan en aanvaarden auteurs, redacteuren
en uitgever deswege geen aansprakelijkheid.
Citeertitel
Journaal Stoffen en Preparaten jaartal/nummer
(voorbeeld: Journaal Stoffen en Preparaten 2009/1)
ISSN 1574-1079
Journal
Chemicals
Management
Journaal CONTENT
Stoffen & Preparaten
ARTICLES
[2009/0183] Country Profile: Serbia / 237
Chief-editor:
Drs. A.C.H. van Peski ACTUALITIES
OFFICIAL PUBLICATIONS
No. 9 [2009/0193] The Netherlands (Period August-October
November 2009 2009) / 253
Volume 6 [2009/0194] Belgium (Period August-September
2009) / 254
Part of Stoffennieuws.nl
[2009/0195] United Kingdom (Period September
2009) / 254
inhoud
ca, Kovin, Opovo, Pancevo, Plandiste, Vrsac; 1. Legal Requirements for Producing,
North Backa: Backa Topola, Mali Idjos, Subot- Importing/Exporting and Placing Chemicals
ica; North Banat: Ada, Coka, Kanjiza, Kikinda, on the Market
Novi Knezevac, Senta; Central Banat: Nova Serbia follows the EU requirements for
Crnja, Novi Becej, Secanj, Zitiste, Zrenjanin; producing, importing/exporting and plac-
Srem: Indija, Irig, Pecinci, Ruma, Sid, Sremska ing chemicals on the market. The currently
Mitrovica, Stara Pazova; West Backa: Apatin, adopted Law on Chemicals provides the basis
Kula, Odzaci, Sombor for the sound management of chemicals in
Population: 7 379 339; Serbia; it also establishes the responsibilities
note: does not include the population of Kos- for chemical policy and management as well
ovo (July 2009 est.) as the legal basis for the Chemicals Agency.
Area: total: total: 77 474 sq km
Languages: Serbian 88.3% (official), Hun- 2. A List of Laws and Regulations currently
garian 3.8%, Bosniak 1.8%, Romany (Gypsy) in Force
1.1%, other 4.1%, unknown 0.9% (2002 cen- Following is the list of laws and regulations in
sus) place:
note: Romanian, Hungarian, Slovak, Ukrain- – Law on Environmental Protection of Ser-
ian, and Croatian all official in Vojvodina. bia (1991) (http://www.basel.int/legal-
Environment – international agreements: matters/natleg/serbia-01e.pdf)
party to: Air Pollution, Biodiversity, Climate – Regulation on methodology for Risk As-
Change, ADR, Climate Change-Kyoto Pro- sessment regarding Chemical Accident
tocol, Desertification, Endangered Species, and Environmental Pollution, Preven-
Hazardous Wastes, Law of the Sea, Marine tive Measures and Remediation Measures
Dumping, Marine Life Conservation, Ozone (1994)
Layer Protection, Ship Pollution, Wetlands; – The Federal Law on the Production of and
signed, but not ratified: none of the selected Trade in Poisons Substances (1995) (Of-
agreements ficial gazette SRY no.15/95, 28/96 ; SCG
Source: https://www.cia.gov/library/publications/the- no.37/2002, RS no.101/2005 )
world-factbook/geos/ri.html# – The Federal Law on the Transport of
European Union Relationship: Accession of Hazardous Substances (1990, 1994, 1996,
Serbia to the European Union depends on 1999)
several factors. While both the Serbian gov- (Official gazette SRY, no.27/90, SCG
ernment and the European Union agree that no.1/2003)
Serbia could eventually become a member – The Law on Explosive Substances (1994)
of the EU, the need for internal reform both – The Federal Custom Act (1992)
within Serbia and the EU means that Serbia – The Federal Law on Protection against
will not join EU before 2012, and perhaps not Ionizing Radiation (1996)
before 2015. – The Federal Law on Standardization
Serbia is currently not recognised as a candi- (1996)
date country, but only as ‘potential candidate
country’. Recent legislative developments
During 2004 and 2005 Laws on chemicals and
biocidal products were drafted. The Swedish
Chemicals Agency (KeMI) helped preparing
legislation on chemicals and biocidal prod-
ucts, subsequently two laws were adopted
in May 2009 by the National Assembly; now 3. New Chemicals Notification Process
Serbia is preparing the associated subsidiary There is no new chemical notification scheme
legislation. in place and no chemical inventory like EI-
The new Law on Chemicals is harmonized NECS/ELINCS, TSCA, DSL or PICCS…
with the following EU legislation:
1. Regulation (EC) No 1907/2006 concern- 4. Classification and Labelling; Hazard
ing the Registration, Evaluation, Au- Communication (SDS...): Risk Assessment
thorization and Restriction of Chemicals Serbia follows the EU requirements regarding
(REACH) – this is a partial harmonisation classification, labelling, SDS, risk assessment
with the REACH Regulation of chemicals.
2. Regulation (EC) No 1272/2008 on clas-
sification, labelling and packaging of sub- 5. Industry’s Experience with the System;
stances and mixtures Trade Impacts; Problem Areas
3. Directive 67/548/EEC on the approxima- Serbia moves toward the full implementation
tion of laws, regulations and administra- of the EU legislation regarding chemicals. Ex-
tive provisions relating to the classifica- isting laws and regulations are not yet fully
tion, packaging and labelling of dangerous harmonized with the EU ones but lot of initi-
substances atives are taking place in this respect. There is
4. Council Directive 99/45/EC concerning no major barrier/impact for the industry that
the approximation of the laws, regula- would restrict chemical businesses.
tions and administrative provisions of the
Member States relating to the classifica- 6. Future Developments in Chemical Safety
tion, packaging and labelling of dangerous Legislation
preparations Serbia’s main strategic objective is to move
5. Council Directive 2004/42/EC on the forward along with the rest of the region by
limitation of emissions of volatile organic working towards full reintegration into the
compounds due to the use of organic sol- international community in the near and me-
vents in certain paints and vehicle refin- dium-term; in the medium-term is achieve-
ishing products and amending Directive ment of a self-sustaining economy and acces-
1999/13/EC sion to the European Union in the long-term.
6. Regulation (EC) no 689/2008 concern- One of the key priorities is to adequately
ing the export and import of dangerous control trade, transport and use of chemicals
chemicals and harmful substances. The development of
7. Regulation (EC) No 648/2004 on deter- sectoral laws on chemicals regarding classifi-
gents cation of chemicals and labelling will follow
8. Commission Regulation (EC) laying down the GHS system.
test methods pursuant to Regulation (EC) New environmental framework has been de-
No 1907/2006 of the European Parliament signed to modernize the legal framework, to
and of the Council on the Registration, ensure compliance with EU requirements (for
Evaluation, Authorization and Restriction example IPPC-Integrated Prevention & Pollu-
of Chemicals (REACH) tion Control).
The new Law on Biocidal products is harmo- Reference: National Profile for Chemicals Manage-
nized with Directive 98/8/EC of the European ment (Updated 2008):
Parliament and of the Council of 16 February http://www2.unitar.org/cwm/publications/
1998 concerning the placing of biocidal prod- cw/np/np_pdf/Serbia_National_Pro-
ucts on the market. file_2008.pdf
European Union
actualities
Cefic GER group: Coherent global
approach to chemical control
needed to avoid unmanageable
situation
Germany
[2009/0185]
cal control regulations as similar to, or at least stakeholders may take the form of govern-
compatible with, existing regulations, whilst mental regulators, institutions such as OECD,
keeping in mind the requirements of that par- the UN or the EU Commission together with
ticular region. trade associations in many counties. Over the
One of the major roles of the Global Emerg- coming issues of CEFIC GER will be giving
ing Regulations (GER) Issue Team of Cefic more details of specific pieces of legislation in
(European Chemical Industry Council) is to counties such as Malaysia, Taiwan or Turkey.
raise member’s awareness of new legislation The first regulatory update will focus on the
or amendments. Their second, but equally People’s Republic of China and their propos-
important goal is to advocate for the sound als to amend their New Substance Notifica-
management of chemicals either via regula- tion requirements.
tion or voluntary schemes. Reference: Sunanda Banerjee sba@cefic.be
The GER Issue Team is made up of regulatory
professionals from member companies and
has been in existence within Cefic for approxi- An example of bad EU regulation:
mately 13 years, during which time it has sup- A nasty surprise hidden in the
ported Cefic and its members in developing new Classification and Labeling
their knowledge about global legislation re- Regulation
lated to chemicals. The Team has also played
an important role in the development of sev- [2009/0186]
eral pieces of chemicals legislation around the
world. The Cefic GER Group proactively seeks by Vito Buonsante & Thierry Dumortier
to understand emerging legislation and advo-
cates for the establishment and acceptance of On 20 January 2009, a hidden change in the
global standards for the safe management of EU Regulations was introduced. It triggers
chemicals where applicable, so as to facilitate thousands of cleaning products to become
the ability of member companies to trade classified as dangerous chemical products and
and/or operate in world markets. causes hundreds of industrial facilities in the
Practically, this Group: EU to become major accident hazard facilities.
– Encourages the development of the sound As such nothing new, except that it was trig-
management of chemicals based on global gered by hidden change in the text, and that
standards in countries in which we trade. the competent EU officials seem to attempt to
– Advocates for the acceptance of Mutual hide their mistake.
Acceptance of Notification and Data to re- At stake is the Regulation (EC) No. 1272/2008
duce duplicative testing of chemicals and (the CLP Regulation), which implements the
facilitate information sharing and capac- United Nations Globally Harmonised System
ity building. for Classification and Labelling of Chemicals
– Co-operates with other industry associa- in the European Union and enters into force
tions around the world to achieve these on 20 January 2009. The CLP Regulation will
aims. overhaul the present system of classification
– Monitors global, regional and national and labelling of substances in 2010. The new
legislative developments. classification and labelling system for mix-
– Acts as a forum for information exchange tures and preparations begins in 2015.
and dissemination within Cefic. While the major reforms do not begin until
The GER Issue Team is presently working 2010, immediate consequences for companies
with stakeholders in several countries. These are already appearing. In order to provide
operators during the transition period with confusion and improve readability between
only one text to refer to for the harmonized the tables. Thus, according to ECHA, the
classification of chemical substances, recital elimination of generic concentration limits
53 to the CLP Regulation states that “all exist- was only a cleaning up exercise and no conse-
ing harmonised classifications should also be quence is mentioned.
placed unchanged in an annex to this Regu- Despite the silence of the European Commis-
lation”. Despite the clear intention to transfer sion on the omission of the generic concen-
the harmonized classifications unchanged, tration limits, the changes do have important
some changes were made in transferring An- consequences. The modification affects many
nex I of the Dangerous Substances Directive substances, but it is not immediately obvi-
67/548/EEC to Annex VI Part III to the CLP ous how many nor which ones are affected.
Regulation. In order to seek clarification, Enhesa experts
Most significantly, harmonized classifications called the competent EU official in charge
no longer include the generic concentration of classification, but the surprising response
limits. Generic concentration limits (25%, was that the change was known to everyone
2.5% and 0.25%) were introduced by Direc- and that one could contact the industry asso-
tive 1999/45/EC to define the classification ciations to figure it out. We used to get this
of the preparation based on the quantity of type of response several decades ago, when
the component substances and their environ- the government regarded regulations as top
mental classification. Also, in the transfer to secret. This attitude undermines the ideas of
the CLP Regulation, the specific concentra- better regulation and open access to informa-
tion limits that corresponded to the generic tion – two concepts that the EU has attempted
ones were cancelled. to defend.
There has been little explanation of these Taking the official on her word, we called her
changes. The changes, and their consequenc- colleague next door in charge of major-acci-
es, are not mentioned in the Regulation, the dent hazard facilities, and got the surprising
explanatory documents or the web-sites of answer he was not aware of any change.
the European Commission. More-over the Most significantly, harmonized classifications
changes are not mentioned in the interim re- no longer include the generic concentration
port from the Technical Working Group on limits. Generic concentration limits (25%,
Seveso and GHS, which was established in 2.5% and 0.25%) were introduced by Direc-
order to review the potential impact of GHS tive 1999/45/EC to define the classification
classification rules in a Seveso context. of the preparation based on the quantity of
Only the Q&A document issued by the Euro- the component substances and their environ-
pean Chemicals Agency (ECHA) in May 2009 mental classification. Also, in the transfer to
makes mention of the change. The ECHA the CLP Regulation, the specific concentra-
states that the primary idea behind inclusion tion limits that corresponded to the generic
of the generic concentration limits in Annex I ones were cancelled.
to Directive 67/548/EEC was to provide clas- There has been little explanation of these
sifiers with an “all in one” table. As the CLP changes. The changes, and their consequenc-
Regulation contains the classifications (in Ta- es, are not mentioned in the Regulation, the
ble 3.1 of Annex VI) in accordance with the explanatory documents or the websites of the
CLP criteria which no longer provide for any European Commission. Moreover the chang-
generic concentration limits, it was decided to es are not mentioned in the interim report
delete them from Table 3.2 (classifications in from the Technical Working Group on Seveso
accordance with 67/548/EEC) as well, to avoid and GHS, which was established in order to
review the potential impact of GHS classifica- aware of any change. Only three Member
tion rules in a Seveso context. States seem to have understood what has hap-
Only the Q&A document issued by the Euro- pened and have attempted to clarify the situ-
pean Chemicals Agency (ECHA) in May 2009 ation. But surprise again, their analysis differs
makes mention of the change. The ECHA greatly 222 chemicals are affected according to
states that the primary idea be-hind inclusion the Italian Ministry of Health; 98 have been
of the generic concentration limits in Annex I identified by the Hungarian authorities; while
to Directive 67/548/EEC was to provide clas- the French authorities have identified 86 af-
sifiers with an “all in one” table. As the CLP fected chemicals. The Italian and French au-
Regulation contains the classifications (in Ta- thorities have issued circulars on the issue to
ble 3.1 of Annex VI) in accordance with the help clarify the situation.
CLP criteria which no longer provide for any For most of these substances, the changes
generic concentration limits, it was decided have no consequences. But about 20 to 40
to delete them from Table 3.2 (classifications substances are affected in terms of classifi-
in accor-dance with 67/548/EEC) as well, to cation of mixtures that contain them. Sub-
avoid confusion and improve readability be- stances that are assigned the risk phrase R50
tween the tables. Thus, according to ECHA, or R50/53 (very toxic to the aquatic environ-
the elimination of generic concentration lim- ment) are, in the absence of a specific limit,
its was only a cleaning up exercise and no con- subject to Directive 2006/8/EC. According to
sequence is mentioned. this Directive, for these substances the spe-
Despite the silence of the European Commis- cific limit to be adopted has to be identified
sion on the omission of the generic concen- in function of the effective value of CL50 or
tration limits, the changes do have important EC50. This way, the 25% limit may remain the
consequences. The modification affects many same, but it can also be divided by 10 or 100
substances, but it is not immediately obvi- and thus become 2.5% or 0.25% through the
ous how many nor which ones are affected. identification of an M-factor. An M-factor is
In order to seek clarification, Enhesa experts a multiplying factor. The concept of M-fac-
called the competent EU official in charge tors has been established to give an increased
of classification, but the surprising response weight to substances that are very toxic for the
was that the change was known to everyone aquatic environment when classifying mix-
and that one could contact the industry asso- tures containing these substances.
ciations to figure it out. We used to get this Particularly striking is the classification of So-
type of response several decades ago, when dium hypochlorite, commonly used as bleach.
the government regarded regulations as top The specific concentration limit has been de-
secret. This attitude undermines the ideas of leted in the new CLP Regulation and replaced
better regulation and open access to informa- by a general provision with the M-factor.
tion two concepts that the EU has attempted Where there is no harmonised M-factor listed
to defend. in Annex VI to CLP for a specific substance,
Taking the official on her word, we called her manufacturers, importers and downstream
colleague next door in charge of major-acci- users should set an M-factor themselves when
dent hazard facilities, and got the surprising classifying substances for acute aquatic toxic-
answer he was not aware of any change. ity category 1 or chronic aquatic toxicity cat-
The EU adopts the Regulation, and the Mem- egory 1. Tests reveal an M-factor of 10 should
ber States have to enforce it. So we called the be assigned to sodium hypochlorite which
competent enforcement agencies in a dozen means that solutions of 2.5% active chlorine
member states and most of them were not
will need to be classified as “Dangerous to the rective 67/548/EEC, many industrial facilities
Environment” (N; R50). are at risk of operating illegally without the
This means that there are immediate conse- proper permit. Enhesa recommends that fa-
quences for some companies. From 20 Janu- cilities check their chemical inventory against
ary 2009, when the CLP Regulation entered Annex VI Part III of the CLP Regulation. If
into force, mixtures containing substances for there are consequences in terms of the facil-
which the generic or specific concentration ity’s Seveso classification, the facility should
value was cancelled had to be reclassified and check the transition period granted by the
relabelled according to Annex VI Table 3.2 of transposition of the Seveso II Directive. De-
the CLP Regulation. There is no grace or tran- pending on the Member State concerned, this
sition period included in the CLP Regulation, transition period will often be 6 months (20
probably because when this “clean-up” was July 2009) or 12 months (20 January 2010).
carried out, these consequences were not fore- Neither the intent of the regulators or the fi-
seen and communicated to the enforcement nal outcome is the problem. However, the lack
agencies in the EU member states. Companies of communication on the issue and the lack
placing mixtures on the market that should of transition periods are deplorable, and put
be labelled differently, as a consequence of the both industrial operators and enforcement
changed concentration limits, must immedi- agencies in a difficult position.
ately change the labels of all mixtures placed
on the market. Failure to do this exposes the
company to substantial liability. REACH for non-Europeans
In addition, the introduced change affects the
classification of installations under Directive [2009/0187]
96/82/EC on the control of major-accident
hazards involving dangerous substances (the Companies that import substances and prep-
Seveso II Directive). Concerned substances arations (mixtures) within the EU/EEA and
classified as dangerous for the environment wish to inform their non-European suppli-
and assigned R-phrase R50 (very toxic to ers on the REACH legislation, some countries
aquatic organisms) contained in certain con- may refer to the following web sites explain-
centrations in mixtures manufactured or used ing their suppliers in their own language this
by companies could now, due to stricter con- complex regulation.
centration limits, be caught up by the Seveso PR of China: www.reach-helpdesk.cn
II Directive. A facility will fall under the Seveso Japan: www.nikkakyo.org
II Directive if dangerous substances exceeding Korea: www.korea helpdesk.eu
the thresholds as listed in Annex I Part 1 or 2 www.reach.or.kr
to Directive 96/82/EC are present on site. For www.coreach.net
substances classified as dangerous for the en- Turkey: reach.immib.org.tr
vironment and assigned R-phrase R50 (very Reference: http://www.essenscia.be/NL/essenscia/
toxic to aquatic organisms), the qualifying REACH-portal-essenscia/page.aspx/1950
quantities to become a Seveso II site are 100
tons (for facilities subject to Article 6 and 7
of Directive 96/82/EC) or 200 tons (for facili-
ties falling under Article 9 of Directive 96/82/
EC).
Due to this accident in the transposition of the
harmonized classification from Annex I of Di-
Similar to the REACH Candidate list, the creasing the quality and consistency of infor-
Turkish Regulation also establishes a prior- mation provided to workers, employers and
ity list for substances or substance groups chemical users. Under the GHS, labels would
which require specific attention due to their include signal words, pictograms, and hazard
potential effects on human health and the en- and precautionary statements. Additionally,
vironment. In addition, substances with car- information on safety data sheets would be
cinogenic and/or mutagenic effect and toxic presented in a designated order.
effect on reproduction will be under specific Under the Occupational Safety and Health
scrutiny. The substances listed in the prior- Act of 1970, OSHA’s role is to promote safe
ity list will undergo a risk assessment under and healthful working conditions for Ameri-
which the notifier may be required to provide ca’s men and women by setting and enforcing
further information. standards and providing training, outreach,
Reference: http://www.khlaw.com/showpublication. and education.
aspx?Show=3109
Background
In 2003, the United Nations (UN) adopted the
USA: OSHA issues proposed rule Globally Harmonized System of Classifica-
to adopt the GHS System tion and Labelling of Chemicals (GHS). The
GHS includes criteria for the classification of
[2009/0189] health, physical and environmental hazards,
as well as specifying what information should
A proposed rule to align the Occupational be included on labels of hazardous chemicals
Safety and Health Administration’s Hazard as well as safety data sheets. The United States
Communication Standard (HCS) with provi- was an active participant in the development
sions of the United Nations Globally Harmo- of the GHS, and is a member of the UN bod-
nized System of Classification and Labelling ies established to maintain and coordinate
of Chemicals (GHS) has been published in implementation of the system.
the 30 September 2009 Federal Register. The
current HCS requires chemical manufactur- OSHA GHS Proposal
ers and importers to evaluate the hazards of OSHA published a proposed rulemaking on
the chemicals they produce or import and 30 September 2009 to align OSHA’s Hazard
provide information to subsequent users. The Communication standard (HCS) with the
current standard requires all employers to GHS. This is a significant step in the rule-
have a hazard communication program for making process. OSHA has provided a 90-
workers exposed to hazardous chemicals. The day comment period ending on December
program includes materials such as container 29, 2009. To aide in the understanding of the
labels, safety data sheets, and employee train- HCS proposal OSHA is providing additional
ing. information:
A number of countries, including the United – Proposed HCS regulatory text
States, international organizations and stake- – Proposal HCS regulatory text (redline
holders participated in developing the GHS strikeout)
to address inconsistencies in hazard classifi- – Proposal side-by-side comparison to the
cation and communications. The GHS was current HCS and the Proposal
developed to provide a single, harmonized – Facts on Aligning the Hazard Communi-
system to classify chemicals, labels and safety cation Standard to the GHS
data sheets with the primary benefit of in-
Also, the HSIS Guidance Material for Hazard and be consistent with the 7th Edition of the
Classifications has been updated to reflect Australian Code for the Transport of Danger-
amendments to Notes H, J and P in the label- ous Goods by Road and Rail (ADG Code),
ling column. which currently includes limited and/or advi-
Reference: http://hsis.ascc.gov.au/TheList.aspx sory provisions regarding explosives (danger-
ous goods of Class 1).
References: ISBN 978 0 642 32747 5 (online PDF)
Australian Code for the Transport ISBN 978 0 642 32753 6 (print)
of Explosives by Road and Rail
Belgium China, PR of
Federal: Royal Order on the prevention of ha- Shanghai: List of WEEE disposers updated
zardous substances in electrical and electronic 05-Jul-2009
equipment 02-Jul-2009 Identification of serious hazard source of ha-
Brazil zardous chemicals amended 31-Mar-2009
Use of products containing asbestos prohibi- Beijing: Certain chemicals subject to stricter
ted to the Ministry of Health 21-Jul-2009 control for the 60th anniversary of Chinese
Bulgaria National Day 23-Jul-2009
Norms for admissible emissions of VOC re- Methyl chloroform (TCA) banned for use and
leased into the ambient air as a result of use of manufacture from 2010 20-Jul-2009
solvents by particular installations amended Colombia
21-Aug-2009 Decree No. 2350 regulating controlled chemi-
Canada cal substances issued 07-Jul-2009
An Act to amend the Transportation of Dan- Costa Rica
gerous Goods Act adopted 21-Jul-2009 Decree for a registration fee and sanitary sur-
Final screening assessment documents publis- veillance of cosmetics adopted 03-Jul-2009
hed on Batch 4 Challenge substances specified Czech Republic
on the Domestic Substances List 01-Aug- Regulation on emission of ozone depleting
2009 substances and fluorinated greenhouse gases
Volatile Organic Compound (VOC) Con- detailing Regulation (EC) No. 842/2006 adop-
centration Limits for Automotive Refinishing ted 15-Aug-2009
Products Regulations 08-Jul-2009 Denmark
Ministerial Condition No. 15543 published Directive on certain paints and varnishes and
regarding poly[oxy(methyl-1,2-ethanediyl)], vehicle refinishing transposed and entered
a-sulfo-w-hydroxy-, branched alkyl ethers, into force. 29-Aug-2009
sodium salts 18-Jul-2009 Estonia
Orders amending the Domestic Substances Terms and conditions of classification, pac-
List and the Non-domestic Substances List kaging and labelling of hazardous chemicals
adopted 08-Jul-2009 amended 28-May-2009
Ontario: Legislation adopted to revoke Onta- Finland
rio Regulations regarding sewage systems 11- Decree amending the Decree on the safety ad-
Jul-2009 visor for the transport of dangerous goods by
Alberta: Adopted amendments prohibiting road adopted 23-Apr-2009
the use of certain pesticides 21-Jul-2009 France
Significant New Activity Notice No. 15414 Order relating to the procedures of registra-
adopted regarding oleic acid, compound with tion and declaration to the electrical and elec-
alkaneamine 22-Aug-2009 tronic equipment national register adopted
Significant New Activity Notice No. EAU-455a 30-Jun-2009
adopted to amend Significant New Activity Circular on the implementation of the first
Notice No. EAU-455 regarding benzoic acid, applicable measures of the CLP Regulation
CAS No. 190085-41-7 22-Aug-2009 with respect to classified installations 23-Jun-
Chile 2009
Activities involving the use of asbestos require Order relating to the terrestrial transport of
prior authorization 08-Aug-2009 dangerous goods adopted 29-May-2009
Directive on marketing and use of certain
dangerous substances and preparations in-
corporated into REACH with amendments New document required for the transport of
01-Jun-2009 any kind of goods 15-Jan-2009
Germany Health and Safety Code amendments publis-
Act on the Transport of Dangerous Goods hed 05-Aug-2009
amended and published as consolidated ver- Latvia
sion 15-Jul-2009 Requirements for Use and Marking of Listed
Revised Water Act adopted 06-Aug-2009 Equipment and Products Containing Dange-
Act amending several Federal environmental rous Chemical Substances and List of Harm-
pieces of legislation published 17-Aug-2009 ful Goods amended 21-Jul-2009
Hong Kong Regulations Regarding the Management of
Air Pollution Control (Specified Processes) Electrical and Electronic Equipment Waste
(Amendment) Regulation published 29-May- amended 04-Aug-2009
2009 Luxembourg
Hungary Transposition of 30th and 31st Adaptation
Decree on the national implementation of to Technical Progress of the list of dangerous
Annexes A and B to the ADR adopted 07-Aug- substances in Annex I to Directive 67/548/
2009 EEC 22-Jul-2009
Decree on Environmental Impact Assessment Malaysia
and on Integrated Pollution Prevention and Poisons (Amendment of Poisons List) (No. 2)
Control (IPPC) permitting procedures amen- Order 2009 is adopted 16-Jul-2009
ded 23-Jul-2009 Safety standards for toys are adopted 28-Jul-
Amendment to several environmental and 2009
health and safety legislation adopted 01-Oct- Regulations on certificate of approval and
2009 conformity mark of safety standards 28-Jul-
India 2009
MoEF issues new Hazardous Waste Rule for [On 28 July 2009 the Minister of Domestic Trade, Co-
transboundary movement of paper and me- operatives and Consumerism issued the Consumer Pro-
tallic waste, and proposes State registration tection (Certificate of Approval and Conformity Mark of
for recycling facilities 21-Jul-2009 Safety Standards) Regulations 2009. The conformity as-
The Ministry of Environment and Forests re- sessment report aimed at facilities supplying, offering or
quires publishing of environmental clearance advertising to supply or import any products specified in
information online 30-Jun-2009 the First Schedule of the Regulations. At this point in time,
Indonesia the First Schedule lists only toys as products that require
Traffic and Road Transportation Act is rene- a conformity assessment report and that conformity as-
wed. 22-Jun-2009 sessment will be carried out by SIRIM QAS International
Ministry Regulation to control goods and ser- Sdn. Bhd.]
vices is renewed 26-May-2009 Panama
International Resolution 210 prohibiting commercial pur-
IMO adopts amendments to MARPOL to pre- poses, use and consumption of products con-
vent pollution during ship-to-ship oil transfer taining lindane adopted 21-Jul-2009
operations 17-Jul-2009 Philippines
Italy Joint Administrative Order on Implemen-
Community Act for year 2008 foresees new tation of the Globally Harmonized System
regulations on waste, air quality and noise 14- (GHS) for Hazard Classification and Label-
Jul-2009 ling of Chemicals Adopted 29-May-2009
Proposed Allergen Regulatory Act of 2009 10- oromethane sulfonate designated as toxic
Jun-2009 substances 20-Aug-2009
Poland Scope of waste containing dioxin clarified and
New detailed requirements for the marking of reduced 25-Aug-2009
packaged goods adopted 20-Jul-2009 Sweden
New Ordinance on certification of waste elec- Stricter rule on the safety of toys will be adop-
trical and electronic equipment by treatment ted 10-Sep-2009
facilities issued 16-Jul-2009 Ordinance on producers responsibility for
New Ordinance on a database of waste electri- batteries amended 28-Jul-2009
cal and electronic equipment issued 10-Aug- Switzerland
2009 Ordinance on the safety of toys amended 13-
Ordinance on occupational health and safety Jul-2009
during municipal waste management issued Taiwan
16-Jun-2009 Liability insurance required to handle Class 1,
Ordinance on the Method of Maintenance of Class 2 and Class 3 toxic chemical substances
the Registry of Installations and Equipment 29-Jul-2009
Including PCB by the authorities issued 23- [On 29 July 2009, the Management Measures on Third
Jul-2009 Party Liability Insurance for the Handling of Toxic Che-
Ordinance on submission to Voivodship Mar- mical Substances (毒性化學物質運作責任保險辦法) were amended by the En-
shal information on substances particularly vironmental Protection Administration. Compared to
dangerous for the environment issued 23-Jul- the Management Measures of 26 July 2007, Section 1 of
2009 Article 3 has now been revised by deleting the phrase of
Romania “due to intentional act, gross negligence, or force majeure”
Conditions for preparation of environmental (故意,過失或者不可抗力).]
protection studies adopted 27-Jul-2009 Fewer types of goods under the Sensitive
Russia Commodities List to North Korea and Iran
Law on Technical Regulation Amended 18- are subject for export control 24-Jul-2009
Jul-2009 Measures on the control of hydrochloroflu-
Adopted Decree on Regulating Import and orocarbon consumption levels amended 28-
Export of Ozone Depleting Substances 20- Apr-2009
Aug-2009 Restriction on the handling of toxic chemical
Slovakia substances amended 31-Jul-2009
Act on Fluorinated Greenhouse Gases adop- Turkey
ted 19-Jun-2009 Regulation on Transport of Dangerous Sub-
Decree Implementing the Act on Fluorinated stances on Roads will enter into force in 2011
Greenhouse Gases adopted 15-Jul-2009 10-Jul-2009
Act on Ambient Air proposed 28-Aug-2009 Circular on Import of Controlled Substances
Decree Implementing Certain Provisions of 2009/3 published 09-Jan-2009
the Air Protection Act issued 23-Jul-2009 Regulation on Control of Air Pollution Cau-
South Africa sed by Industry published repealing the Regu-
Leaded paint declared as Group 1 hazardous lation on the same issue 03-Jul-2009
substance under the Hazardous Substances Adopted procedure for the issue of import
Act (Act No. 15 of 1973) 31-Jul-2009 and export licences for ozone depleting sub-
South Korea stances 23-Jun-2009
Dimethylsulfamoyl chloride, triphenylsulfo-
nium 4-oxo-1-adamantyloxycarbonyldiflu-
No 72623-86-0 and CAS No 97862-82-3 as ac- O.J. L268, 2009: Commission Directive
tive substances 2009/130/EC of 12 October 2009 amending
O.J. L237, 2009: Council Directive 2009/117/ Council Directive 76/768/EEC, concerning
EC of 25 June 2009 amending Directive cosmetic products, for the purpose of adapt-
91/414/EEC to include paraffin oil CAS ing Annex III thereto to technical progress
No 8042-47-5 as an active substance […Substances p-phenylenediamine (PPD) and tolu-
O.J. L240, 2009: Commission Decision ene-2,5- diamine (PTD)…]
2009/700/EC of 10 September 2009 recog-
nising in principle the completeness of the
dossier submitted for detailed examination USA (Period September-October
in view of the possible inclusion of bixafen 2009)
[N-(3′,4′-dichloro-5-fluorobiphenyl-2-yl)-
3-(difluoromethyl)-1-methylpyrazole-4- [2009/0197]
carboxamide; CAS 581809-46-3] in Annex I
to Council Directive 91/414/EEC Federal Register, Vol. 74, No. 146, 31 July
O.J. L251, 2009: Commission Decision 2009, 38878: Nanoscale Titanium Dioxide in
2009/715/EC of 23 September 2009 concern- Water Treatment and Topical Sunscreen. En-
ing the non-inclusion of chlorthal-dimethyl vironmental Protection Agency (EPA). Notice
[dimethyl tetrachloroterephthalate ; CAS of Public Comment Period.
1861-32-1] in Annex I to Council Directive Federal Register, Vol. 74, No. 148, 4 August
91/414/EEC and the withdrawal of authorisa- 2009, 38878: Sixty-Fourth Report of the
tions for plant protection products containing TSCA Interagency Testing Committee to the
that substance Administrator of the Environmental Protec-
O.J. L262, 2009: Directive 2009/107/EC of the tion Agency; Receipt of Report and Request
European Parliament and of the Council of for Comments. Environmental Protection
16 September 2009 amending Directive 98/8/ Agency (EPA). Notice.
EC concerning the placing of biocidal prod- Federal Register, Vol. 74, No. 161, 21 Au-
ucts on the market as regards the extension of gust 2009, 42217: Schedules of Controlled
certain time periods Substances: Placement of 5-Methoxy-N,N-
O.J. L267, 2009: Commission Directive Dimethyltryptamine [5-MeO-DMT, CAS
2009/129/EC of 9 October 2009 amending 1019-45-0] into Schedule I of the Controlled
Council Directive 76/768/EEC concerning Substances Act. Drug Enforcement Adminis-
cosmetic products for the purposes of adapt- tration (DEA), Department of Justice. Notice
ing Annex III thereto to technical progress of Proposed Rulemaking.
[In column ‘f ’ corresponding to reference numbers 26 to Federal Register, Vol. 74, No. 163, 25 August
43, 47 and 56 of Part 1 of Annex III to Directive 6/768/ 2009, 42896: Toxic Chemical Release Report-
EEC, the text after the first sentence is replaced by the fol- ing; Community Right-To-Know; Request for
lowing sentences: Comment on Change of Contractor Handling
‘For any toothpaste with compounds containing fluorine Trade Secret Claims. Environmental Protec-
in a concentration of 0,1 to 0,15 % calculated as F unless tion Agency (EPA). Notice.
it is already labelled as contra-indicated for children (e.g. Federal Register, Vol. 74, No. 164, 26 August
“for adult use only”) the following labelling is obligatory: 2009, 43031: Acrylamide in Food; Request for
“Children of 6 years and younger: use a pea-sized amount Comments and for Scientific Data and In-
for supervised brushing to minimise swallowing. In case formation. Food and Drug Administration,
of intake of fluoride from other sources consult a dentist HHS. Notice; request for comments and sci-
or doctor”.] entific data and information.
[….In 2002, scientists in Sweden announced the discovery for PM2.5. Environmental Protection Agency
of the chemical acrylamide in a variety of heated foods. (EPA). Final rule
Further research subsequently determined that acrylamide Federal Register, Vol. 74, No. 188, 30 Septem-
can form in some Foods during certain types of high- ber 2009, 50280: Hazard Communication.
temperature cooking . Acrylamide in food is a concern [OSHA is proposing to modify its existing Hazard Com-
because it has been found to be carcinogenic in rodents munication Standard (HCS) to conform with the United
and is therefore considered a potential carcinogen for Nations’ (UN) Globally Harmonized System of Classifi-
humans…. Acrylamide forms in foods primarily from a cation and Labelling of Chemicals (GHS). OSHA has
reaction between asparagine, an amino acid, and reducing made a preliminary determination that the proposed
sugars such as glucose and fructose. This reaction is part modifications will improve the quality and consistency
of the Maillard reaction, which leads to color, flavor, and of information provided to employers and employees
aroma changes in cooked foods. Acrylamide formation regarding chemical hazards and associated protective
usually occurs at elevated temperatures used when frying measures. The Agency anticipates this improved in-
or baking (above 120 °C) and in low moisture conditions, formation will enhance the effectiveness of the HCS in
although acrylamide has also been identified in some fruit ensuring that employees are apprised of the chemical
and vegetable products heated at lower temperatures or hazards to which they may be exposed, and in reducing
higher moisture conditions. …] the incidence of chemical-related occupational illnesses
Federal Register, Vol. 74, No. 164, 26 August and injuries.
2009, 43031: Children’s Products Containing The proposed modifications to the standard include
Lead; Determinations Regarding Lead Con- revised criteria for classification of chemical hazards;
tent Limits on Certain Materials or Products; revised labeling provisions that include requirements
Final Rule. Consumer Product Safety Com- for use of standardized signal words, pictograms, haz-
mission. Final rule. ard statements, and precautionary statements; a speci-
[The Consumer Product Safety Commission (Commis- fied format for safety data sheets; and related revisions
sion) is issuing a final rule on determinations that certain to definitions of terms used in the standard, require-
materials do not exceed the lead content limits specified ments for employee training on labels and safety data
under section 101(a) of the Consumer Product Safety Im- sheets. OSHA is also proposing to modify provisions of
provement Act of 2008 (CPSIA). This regulation becomes a number of other standards, including standards for
effective on August 26, 2009.] flammable and combustible liquids, process safety man-
Federal Register, Vol. 74, No. 167, 31 August agement, and most substance-specific health standards,
2009, 44845: National Toxicology Program to ensure consistency with the modified HCS require-
(NTP): Report on Carcinogens (RoC); Avail- ments.]
ability of the Draft Background Document Reference: http://www.osha.gov/SLTC/hazardcommu-
for Formaldehyde; Request for Comments on nications/global.html
the Draft Background Document; Announce- Side-by-Side Comparison of Proposed
ment of the Formaldehyde Expert Panel Hazard Communication Standard and Exi-
Meeting. National Institute of Environmental sting Rule:
Health Sciences (NIEHS); National Institutes http://www.osha.gov/SLTC/hazardcommu-
of Health (NIH). Availability of background nications/hcs_side_by_side_draft_100109.
document; request for comments; and an- pdf]
nouncement of a meeting Federal Register, Vol. 74, No. 192, 6 Octo-
Federal Register, Vol. 74, No. 182, 22 Septem- ber 2009, 51234: Schedules of Controlled
ber 2009, 48153: Implementation of the New Substances; Placement of Fospropofol [CAS
Source Review (NSR) Program for Particulate 258516-89-1] into Schedule IV. Drug Enforce-
Matter less than 2.5 micrometers (PM2.5); Fi- ment Administration, Department of Justice.
nal Rule to Stay the Grandfathering Provision Final rule.
Federal Register, Vol. 74, No. 193, 7 October Materials Safety Administration (PHMSA).
2009, 51592: Exposure Factors Handbook: Direct final rule.
2009 Update. Environmental Protection [This direct final rule amends the Hazardous Materials
Agency (EPA). Notice of public comment pe- Regulations to revise the quantity limitation from 25 kg
riod. ‘‘gross’’ to 25 kg ‘‘net’’ for packages of chemical oxygen
[The Exposure Factors Handbook provides a summary generators transported aboard cargo aircraft only.]
of the available statistical data on various factors used in Federal Register, Vol. 74, No. 200, 19 October
assessing human exposure. This Handbook is aimed at 2009, 53498: Review of the National Ambient
exposure assessors inside the Agency as well as those out- Air Quality Standards for Ozone. Environ-
side who use data on standard factors to calculate human mental Protection Agency (EPA). Availability
exposure to toxic chemicals. These factors include: drink- of draft document for public review and com-
ing water consumption; mouthing behavior; soil ingestion ment.
rates; inhalation rates; dermal factors, including skin area Federal Register, Vol. 74, No. 202, 21 October
and soil adherence factors; consumption of fruits and veg- 2009, 53982: Hazardous Materials: Harmoni-
etables, fish, meats, dairy products, and homegrown foods; zation with the United Nations Recommen-
breast milk intake; human activity factors; consumer prod- dations on the Transport of Dangerous Goods
uct use; and residential characteristics. Recommended Model Regulations, International Maritime
values are for the general population and also for various Dangerous Goods Code, International Civil
segments of the population who may have characteristics Aviation Organization Technical Instructions
different from the general population.] for the Safe Transport of Dangerous Goods
Reference: http://cfpub.epa.gov/ncea/cfm/recordis- by Air, and Transport Canada’s Transport of
play.cfm?deid=209866 (1265 pages)] Dangerous Goods Regulations. Pipeline and
Federal Register, Vol. 74, No. 193, 7 October Hazardous Materials Safety Administration
2009, 51643: Advisory Guidance; Transporta- (PHMSA), DOT. Advanced notice of pro-
tion of Batteries and Battery-Powered Devic- posed rulemaking (ANPRM).
es. Pipeline and Hazardous Materials Safety Federal Register, Vol. 74, No. 200, 19 October
Administration (PHMSA), DOT. Safety advi- 2009, 54334: Combustible Dust. Occupation-
sory. al Safety and Health Administration (OSHA),
Federal Register, Vol. 74, No. 194, 8 October Labor. Advance notice of proposed
2009, 51850: Drinking Water Contaminant rulemaking.
Candidate List 3 – Final Environmental Pro- [In this advance notice of proposed rulemaking (ANPR),
tection Agency (EPA). Notice. OSHA is requesting comments, including data and other
[The Environmental Protection Agency is publishing information, on issues related to the hazards of combus-
the third Contaminant Candidate List (CCL 3) since the tible dust in the workplace. For the purposes of this notice,
Safe Drinking Water Act (SDWA) amendments of 1996. the term ‘‘combustible dust’’ includes all combustible par-
The CCL 3 is a list of contaminants that are currently not ticulate solids of any size, shape, or chemical composition
subject to any proposed or promulgated national primary that could present a fire or deflagration hazard when sus-
drinking water regulations, that are known or anticipated pended in air or other oxidizing medium. OSHA plans to
to occur in public water systems, and which may require use the information received in response to this notice in
regulation under SDWA. Today’s final CCL 3 includes 104 developing a proposed standard for combustible dust.]
chemicals or chemical groups and 12 microbiological con-
taminants.]
Federal Register, Vol. 74, No. 198, 15 October
2009, 52896: Hazardous Materials: Chemical
Oxygen Generators. Pipeline and Hazardous
Hoofdredactie:
Drs. A.C.H. van Peski
Redactie:
Mw. dr. M.M. Kops-Werkhoven
Drs. H.A.F. van Well
Dr. J.A.S.J. Razenberg
Drs. J. Zawierko
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Citeertitel
Journaal Stoffen en Preparaten jaartal/nummer
(voorbeeld: Journaal Stoffen en Preparaten 2009/1)
ISSN 1574-1079
Journal
Chemicals
Management
Journaal CONTENT
Stoffen & Preparaten
ARTICLES
[2009/0200] P.R. of China: Notification of new
Chief-editor: chemicals / 265
Drs. A.C.H. van Peski [2009/0201] P.R.of China: Revised regime for ‘new’
chemicals / 269
Editorial Board: [2009/0202] Status of the Implementation of GHS in
Dr. M.M. Kops-Werkhoven China / 274
Drs. H.A.F. van Well
Dr. J.A.S.J. Razenberg ACTUALITIES
Dr. L.J.M. Rodenburg
Drs. G.A. Schouten European Union
Drs. J. Zawierko [2009/0203] ECHA: New publications
November 2009) / 277
Advisory Board: International
K. E. Armstrong (U.S.A.) [2009/0204] Singapore: Occupational Safety and Health
Dr. R. Fielding (United Kingdom) Management Standards / 278
Drs. A. Gondová [2009/0205] Australia: Proposal for Regulatory Reform of
G. Koh (Singapore) Industrial Nanomaterials / 279
Dr. C. van Lint (Australia) [2009/0206] Australia: Disinfectants / 279
Dan Liu (U.S.A.) [2009/0207] Australia: Stevedoring information
S. Park (S.-Korea) booklets / 280
H. Sano (Japan) [2009/0208] Nanosilver and nanotechnology / 281
S. Savary (Canada) [2009/0209] Global Update on New Chemicals
Ir. C. Sieger (Germany) Regulations (Period September-October
J. Simpson (Australia) 2009) / 282
Dr. U. Schumacher (China)
E. Snyman (South Africa) OFFICIAL PUBLICATIONS
P.G. Tse (New Zealand)
[2009/0210] The Netherlands
(Period November 2009) / 286
No. 10 [2009/0211] United Kingdom (Period October 2009) / 286
[2009/0212] European Union (Period October-
December 2009 November 2009) / 287
Volume 6 [2009/0213] USA Federal Register publications (Period
October-November 2009) / 287
Part of Stoffennieuws.nl
[2009/0214] World Trade Organization
(Period November 2009) / 289
inhoud
Internet
[2009/0215] Official Journal of the European Union / 289
[2009/0216] Thesis Dr. Theo Vermeire / 289
four countries or regional economic integration In case that the testing data were completed out
organizations, the notifier is only required to of China, the testing entity(ies) involved shall
complete and submit the notification form and have been accredited by qualifications the com-
the report of eco-toxicological testing performed petent authorities of the country in which the
in China. entity(ies) is(are) located.
Ecotoxicity testing must be completed by an The ecotoxicological data of new chemical sub-
approved laboratory in China. Other test- stances shall include those obtained through
ing completed outside of China is subject to biological tests performed in China by the
approval for use by MEP. On 23 March 2009, application of China’s test organisms.
the Notice on Issuing the List of Qualified Article 10: The notifiers may make a serial noti-
Testing Centres for New Chemical Substances fication on the new chemical substances with
Registration was published by the Ministry of similarities in molecular constitutions, simi-
Environmental Protection. This notice was larities or sameness in use(s) and testing data,
issued in accordance with the Notice on Car- whereas the registration certificate shall be
rying out Inspections on Testing Centres for applied for each new chemical substance.
New Chemical Substances Registration and
Guidance on Qualified Chemical Testing Cen- The standard HJ/T 154-2004 contains the
tres (HJ/T155-2004) and listed seven testing schedule for the data requirements (evalu-
centres which are qualified to carry out eco- ation levels), as well as the requirements for
toxicological test for new chemical substances each level.
registration. If the single quantity or the annual cumula-
‘Chinese creature for test ‘refer to creatures culti- tive quantity Q < 10.000kg, evaluate accord-
vated and bred in China complying with stand- ing to the basic level; if 10.000 kg ≤ Q <
ard for designated test, including Gobiocypris 1.000.000 kg, evaluate according to the first
rarus (rare gudgeon), Xiphophorus helleri level; if Q ≥ 1.000.000 kg, evaluate according
(green swordtail), zebra fish, active sludge, etc. to the second level.
Chapter 6 contains the minimum data require-
Article 8: The notifiers shall, prior to the manu- ments for the physical characteristics evalua-
facture or import of new chemical substances, tion: The evaluation shall explain the data that
complete and submit the notification forms and reflect the physical characteristics of the notified
the testing reports of new chemical substances, chemical substances, such as melting point,
together with a copy of the document on the qual- boiling point relative density, vapour tension,
ification of the testing entity(ies), to the Chemical surface tension, water-solubility, grease-sol-
Registration Centre of SEPA (CRC-SEPA). ubility, pH, n-octyl alcohol/water partition
The contents of the notification form shall coefficient, flash point, particle size, and so on.
include information of the new chemical sub- Chapter 7 describes the data requirements for
stance notified: the name(s) and the molecular the toxicology evaluation:
structure; the method(s) applied in measuring; Basic level: acute toxicity: acute oral toxicity,
the use(s) of the new chemical substance; the acute inhalation toxicity, acute dermal toxic-
scheduled annual amount of manufacture or ity, skin irritation, eye irritation, and skin sen-
import; the physico-chemical properties, toxi- sitization; short-term repeated dose toxicity:
cological and eco-toxicological characteristics; oral toxicity, dermal toxicity, and inhalation
the measures for accident prevention and emer- toxicity; mutagenicity: bacterial back muta-
gency responses; and the measures for pollution tion test and mammalian extracellular chro-
prevention and elimination and for waste dis- mosome aberration test.
posal, etc..
ing substances are exempt from notification tion of the new chemical notification require-
under China’s law: ments. SEPA is also authorized to record and
Article 13: In one of the following cases, the publicize violations and refuse approval of
notifier may apply for exemption from the noti- future notifications for up to 3 years. SEPA has
fication: issued guidelines for submitting new chemi-
(a) The annual amount of manufacture or cal substance notifications; however, these
import of the new chemical substance does guidelines are not readily available in English.
not exceed 100 kilograms and they are only Many of the specifics for implementing this
used for scientific research purpose; law, such as required data protocols; the status
(b) A polymer containing a new chemical sub- of impurities and articles; when notified sub-
stance monomer less than 2% (w/w); stances will be added to the Inventory; and a
(c) The total amount of the manufacture or fee schedule for notification have not yet been
import of a new chemical substance does developed. However, SEPA officials stress that
not exceed 1000 kilograms and they are spe- the law is currently effective.
cifically used for technologies research and
development. In this case, the manufacturer – Standards: On 13 April 2004 the Ministry
or importer may apply for one-year exemp- of Environmental Protection of The Peoples
tion from notification and no extension will Republic of China made an announcement
be granted; on the issuance of three industry standards
(d) Samples of new chemical substances im- for environmental protection:
ported for the purpose of performing the HJ/T 153-2004: The Guidelines for the Testing
eco-toxicological tests in China as required of Chemicals
by this Provisions. HJ/T 154-2004: The Guidelines for the Haz-
Any notifier intending to apply for the exemp- ard Evaluation of New Chemical Substances
tion from notification shall submit the appli- HJ/T 155-2004: The Guidelines for Chemical
cation form for exemption from notification to Testing Good Laboratory Practices
CRC-SEPA, provide the necessary documents
demonstrating the conformities to the afore- Address:
said provision and is obliged to keep a record Branch of New Chemical Substance Manage-
of the information on the scientific research ment
of the substance, the research and develop- Chemical Registration Centre of MEP
ment of relevant technologies, the quantities No.115 Xizhimennei Nanxiaojie, Xicheng
of the substance manufactured or imported, District,
the names of the customers, and others. Beijing, P.R. of China (100035)
http://english.mep.gov.cn/contact/200712/
Chemicals Under the Management of Other t20071204_113785.htm
Existing Laws and Regulations: Radioactive References: Provisions on the Environmental Admini-
substances; Military industry products; Pyro- stration of New Chemical substances
technics; Biological substances; Pesticides; http://www.crc-mep.org.cn/newchem/ene-
Veterinary drugs; Pharmaceuticals; Cosmet- wchem.htm
ics; Foods; Food additives; Feed; Feed addi- Keller and Heckman LLP: Notification of
tives; Tobacco and tobacco products. New Chemical Substances in China (March
2004)
– Enforcement: The enforcement provi- http://www.khlaw.com/showpublication.
sions of China’s new law provide for fines of aspx?Show=1118
up to 30 000 RMB (3625 USD) for each viola-
Key points
– China is consulting on new measures to
overhaul its existing regime for the noti-
fication of new chemical substances. If
adopted in the current form, the new rules
would come into force in October 2010.
– The new rules would apply only to ‘new’
chemical substances – ie chemicals other
than the approximately 45 000 substances
currently listed on the Inventory of Exist-
ing Chemical Substances Produced or
Imported in China (IECSC). Substances
listed on IECSC would continue to enjoy
lighter touch regulation.
– The proposed new regime draws on many
elements of the EU’s chemicals regulatory
framework, REACH, and has been dubbed
‘China REACH’. The similarities relate
to risk assessment, risk management and listed on IECSC, as at December 2008, and
data submission. It would expand on Chi- these are and would remain subject to piece-
na’s existing registration regime for new meal regulation. (There are specific occupa-
chemical substances by increasing the vol- tional health and safety rules governing the
ume and complexity of data that must be marketing and use of hazardous and toxic
supplied to the authorities before import chemicals, but no generally applicable rules.
or production. The manufacture, import Managerial and enforcement responsibilities
or use of a new chemical substance that are shared between a plethora of district, pro-
had not been properly registered would be vincial and state entities).
expressly prohibited. Already, under the 2003 Measures, manufac-
– It appears from the current legislative draft turers and importers of new chemical sub-
that data to support product registration stances must obtain a ‘registration certificate’
may be submitted only by Chinese-regis- prior to manufacture/import. They do so by
tered entities. If so, non-Chinese compa- notifying toxicological and other data to the
nies wishing to export innovative products Chemical Registration Centre (the CRC)
to China, or to have them manufactured of the Ministry of Environmental Protec-
there, would have to rely on local agents tion. The 2009 Measures would not change
or affiliates. Moreover, it would be manda- this basic structure, but would significantly
tory under the regime to use Chinese test- increase the burden on industry in terms of
ing laboratories to generate certain of this data production and ongoing risk manage-
data. As with any other sharing of product ment obligations.
data with a third party, steps will need to The main features of the new regime are:
be taken to protect confidentiality. – Under the 2009 Measures, the CRC must
– Financial penalties for breach of the new be notified, and a registration certificate
regime would not, on their face, be sig- obtained, before a new chemical sub-
nificant. However, the practical costs of stance may be manufactured in China or
non-compliance – e.g. an inability to pro- imported into China. The manufacture,
duce, import or use a particular product import or use of a new chemical substance
– might be more substantial, and the rel- that has not been so registered is expressly
evant authorities can also require correc- prohibited. For example, a valid registra-
tive action to be taken in case of breach. tion certificate will need to be provided to
– Compliance with the new regime may be the General Administration of Customs
challenging for those whose products fall before any import is permitted (Article 5).
within its scope. – On notification of a new chemical sub-
stance manufactured or imported at over
In detail: the new proposals 1 tonne per year, the manufacturer or
On 21 May 2009, China’s Ministry of Envi- importer must provide:
ronmental Protection launched an internal, – the appropriate notification form;
inter-ministries consultation on a proposal – a test report detailing the substance’s
(the 2009 Measures) to replace its existing physicochemical properties and its toxic-
Measures on Environmental Management of ity and eco‑toxicity;
New Chemical Substances, which date from – an environmental risk assessment report
2003 (the 2003 Measures). (covering a variety of areas, including
The 2009 Measures would, like the 2003 Meas- exposure scenarios, control measures,
ures, apply only to substances that are not list- pollution prevention control and waste
ed on IECSC. There were 45 290 substances disposal);
since, unlike REACH, a notification will still fying party and a previous registrant of the
need to be made in the case of new chemical same substance will operate; how ‘adminis-
substances manufactured/imported at under trative control notices’ served by the relevant
1 tonne per year (although, as noted, there local regulators may affect a business’s ability
are reduced data submission requirements in freely to market its products; and, more gen-
these cases). erally, the impact of the designation of a new
As well as the practical challenges involved in chemical substance as hazardous or of envi-
generating the datasets required to support ronmental
notification/registration, the proposed meas- concern. The Ministry of Environmental Pro-
ures raise concerns from the perspective of tection is expected to update its existing Guid-
commercial confidentiality. If, ultimately, it ance for New Substance Notification after the
remains the case that notifications may only draft measures come into effect, and other
be filed by Chinese-registered entities, foreign elements of the regime should become more
exporters with no affiliates in the territory are certain with time.
likely to have to appoint an agent in China for
these purposes. In addition, the need for eco- Preparing for compliance
toxicological test reports to include China- – Establish whether any products that you
generated test data means that sensitive prod- are planning to bring to market in, say, the
uct information may also have to be shared next five years are likely to be caught by
with testing houses there. As with any instance the new regime. In other words: do you
in which sensitive information is shared with plan to export any new product to China,
a third party, businesses would be advised to or produce any new product there, that
ensure that robust arrangements are in place contains substances that are not listed on
to protect confidentiality. IECSC? If so, are you planning to do so
In the short to medium term, there may also after the 2009 Measures come into force?
be questions as to the capacity of China’s – Consider whether it might be possible to
existing technical infrastructure to support accelerate your plans, in order to be able
the services required of it by the measures. to notify under the less onerous current
Possibilities for influencing the legislative text regime.
appear limited. The current consultation was – Consider whether your products might
scheduled to close on 28 June 2009 and is in fall within one of the categories for which
any event only open to designated government less onerous obligations will apply under
authorities and to certain trade associations the 2009 Measures.
(the China Petroleum and Chemical Indus- – For products that will require a full noti-
try Association, the Chinese Chemical Soci- fication dossier, work out what the data
ety, the Association of International Chemical requirements are likely to be (on the basis
Manufacturers and the European Chamber of of the applicable guidance) and consider
Commerce in China). your strategy for gathering the necessary
Since the 2009 Measures are currently sched- data and presenting it in due course. It
uled to come into force on 15 October 2010, may be possible to repackage existing data
businesses that may be affected should start that is being or has been generated in the
planning for compliance now. context of, for example, REACH registra-
Finally, it is currently unclear how a number tion.
of elements of the proposed regime will func- Previous experience suggests that managing
tion in practice. Key issues include how joint registration effectively will involve bringing
notification or cost-sharing between a noti- together a number of different perspectives
in April 2002; Regulations for adminis- hazards currently); The guidelines for
tration of precursors and chemicals used the hazard evaluation of new chemical
in production of narcotic drugs and psy- substances(HJ/T 154-2004); 16 standards
chotropic substances, promulgated by the on Chemical hazardous properties test
State Council in May 2005. methods (GB 19458-04, GB 19452-04, GB
– … and Ministerial Regulations: Measures 19455-04, GB 19456-04, GB 19521.1-04
for the administration of operating licens- up to GB 19521.10-04, GB 19521.13-04,
es for hazardous chemicals, issued by the GB 19521.14-04);
former State Economy and Trade Com- The principle of classification of trans-
mission (SETC) in 2002; Measures for the port Packaging groups of dangerous
administration of registration of hazard- goods (GB/T 15098-94); Rule for the
ous chemicals, issued by SETC in 2002; Storage of Common Dangerous Chemi-
Measures for the administration of pack- cals (GB15603-1995); Symbols for the
aging and container fixed-point produc- Transport of Dangerous Goods (GB191-
tion, issued by SETC in 2002; Regulation 2000); Material Safety Data Sheet (GB/T
of environmental management on the first 17519.1-1998): Part 1 content and order
import of chemicals and the import and of sections (replaced by GB/T16483-
export of toxic chemicals, jointly issued 2008); Material Safety Data Sheet (GB/T
by the former SEPA, SETC and General 17519.2-2003): Part 2 detailed rules for
Administration of Customs (GAC) of in preparation; General rule for classification
1994; Measures for environmental man- and hazard communication of chemicals
agement of new chemical substances, (already sent to WTO according to TBT
issued by SEPA in 2003; Agreement and waiting for reply).
Management measure for pesticide label GHs implementation is a complex process in
and instruction, issued by Ministry of China, several institutions play a role: Joint
Agriculture (MoA) in November 2007, to promotion by ministries and committees:
specifically provide the label and introduc- Lead Department: National Development
tion of pesticide, including the content, and Reform Commission (NDRC); Partici-
symbol, production, usage and manage- pating departments: MEP, Ministry of Health
ment requirement which need to be noted (MoH), Ministry of Commerce (MoC), Min-
in the label and introduction. istry of Public Security (MPS), Ministry of
– and National Standards for chemical Transport (MoT), General Administration of
classification: Classification and code of Quality Supervision, Inspection and Quar-
dangerous goods (GB6944-2005); List of antine (AQSIQ), the State Administration of
dangerous goods (GB12268-2005); Classi- Work Safety (SAWS), etc.
fication and labels of dangerous chemical The problems and challenges for implement-
substances commonly used (GB13690- ing GHS are: Multi-departments involved,
1992); Levels, Classification and Code of not yet formed AN inter-ministerial coordi-
Hypertoxic Substance (GA57-93); Clas- nation mechanism; Lack of uniform plan for
sification of health hazard levels from GHS implementation; Distempered system of
occupational exposure to toxic substanc- chemical management laws; Technically dif-
es (GB5044-85); Safety rules for clas- ficult for China to ensure the timeliness of
sification, precautionary labelling and GHS, due to quick update of GHS; Lack of
precautionary statements of chemicals experts and experiences of GHS classification;
(26 items) (note: the 26 items are fully Authoritative data information of the sub-
transferred from UN-GHS, no aspiration
stances is severely in short; Lack of domestic also the requirements for toxicological and
propaganda. ecological data are revised according to GHS.
So the recommendations by Mr.Yingxin are: – Labelling of Chemicals Based on GHS
Establish and perfect chemical management (GB/T 22234-2008); Adopts the contents
law and regulation system; Revise the existing of JIS Z 7251:2006 (Labelling of Chemi-
national standards such as chemical classifi- cals Based on GHS, Japanese version;
cation, label according to GHS classification Stipulates the GHS hazards categories
requirements; Enhance international coop- and their label elements (symbol, warning
eration and GHS information communion; statements, hazard instruction, etc.).
Strengthen personnel and technical training – General rules for preparation of Chemical
about chemical identification and classifica- Safety Label (GB15258-1999); Made par-
tion; Promote the propaganda of GHS, etc. ticular provisions on the definition, con-
tents, compiling requirements, produc-
National Standards based on GHS tion and usage of chemical safety label. (at
– Safety data sheet for chemical products present, the revision has already been done
– Content and Order of sections (GB/T and sent to WTO, but not issued yet).
16483-2008) – Labels for packages of dangerous
Revised according to GHS requirement of goods(GB190-1990); Stipulates the clas-
safety data sheet for chemical products, replac- sification symbol, size, colour, methods
es GB/T17519.1-1998 and GB16483-2000; of usage and so on of the package label of
Stipulates the content and general format of dangerous goods. (at present, the revision
SDS; Appendix provides the requirements for has already been done and sent to WTO,
the preparation of the 16 items information, but not issued yet).
European Union
[2009/0203]
describes the intent, typical inputs, processes In particular, noting the NICNAS’s guiding
and typical outputs, against each require- principles for managing risks posed by new
ment of SS 506 : Part 1. This will aid in the Technologies it is seeking input as to whe
understanding and implementation of SS 506 ther:
: Part 1. – this strategy provides for the sound man-
agement of industrial nanomaterials;
SS 506 Part 1 and SS 506 Part 2 can be pur- – the options meet the needs of all stake-
chased online at http://www.singaporestand- holders to have confidence in the regula-
ardseshop.sg or via E-mail: singaporestand- tory system through protecting human
ardseshop@toppanleefung.com health and the environment and by pro-
viding a clear regulatory path for indus-
try;
Australia: Proposal for – there are other options which could be
Regulatory Reform of Industrial considered; and
Nanomaterials – any imposts on industry are balanced
against the objectives of government and
[2009/0205] the expectations of the community to
ensure public health, worker safety and
This public discussion paper provides NIC- environmental standards are maintained.
NAS’s stakeholders (the community, indus- Attachment 2 contains an Indicative List of
try and government) with the opportunity to Nanomaterials, attachment 4 an Overview of
comment to NICNAS on a reform initiative international activities addressing regulation
to introduce new approaches to the regulation of industrial nanomaterials.
of industrial nanomaterials. The proposal uti- Reference: http://www.nicnas.gov.au/Current_Issues/
lises the existing NICNAS framework, and Nanotechnology/Stakeholder_Consulta-
proposes some adjustments to address uncer- tion.asp
tainties in potential risks posed by these novel
materials to health, safety and the environ-
ment. NICNAS has a specific role in the over- Australia: Disinfectants
all regulatory framework for industrial chem-
icals in Australia, under legislation provided [2009/0206]
by the ‘Industrial Chemical (Notification and
Assessment) Act 1989’. Other government NICNAS and the TGA have finalised details of
agencies are responsible for regulation of the upcoming Public Consultation to deter-
nanomaterials in medicines, food, pesticides mine impact of proposed changes to the regu-
and veterinary medicines. lation of disinfectants on business, the com-
The proposal addresses three elements: munity and government.
– Regulation of nanoforms of new chemi- Currently disinfectants are regulated by the
cals; Therapeutic Goods Administration (TGA) as
– Regulation of nanoforms of existing therapeutic goods:
chemicals; – hospital, household and commercial
– The principle of an integrated approach grade disinfectants (with ‘specific claims)
for industrial nanomaterials within the undergo a pre-market evaluation for qual-
NICNAS framework as a longer term ity, safety and effectiveness prior to entry
strategy. on the Australian Register of Therapeutic
Goods (ARTG):
– Such products must comply with Thera- infectants (without specific claims) and
peutic Goods Order (TGO) 54 which other products. These products fall within
describes requirements in relation to the TGA regulatory framework but are
composition, packaging labelling and per- exempt from entry on the ARTG.
formance; – There is no provision under the Thera-
– hospital grade disinfectants (without ‘spe- peutic Goods Act 1989 for the TGA to
cific claims’) are regulated as listed thera- undertake a pre-market risk assessment
peutic devices. This means that they are or toxicological evaluation for new chem-
not subject to formal pre-market evalu- ical entities contained in these products.
ation by the TGA, however information Equally, NICNAS has no jurisdiction to
that reasonably demonstrates the safety undertake such assessments because the
and quality of these goods is required and products do not fall within the regulatory
they must still be entered on the ARTG remit of NICNAS.
and comply with TGO 54; and – This poses potential public health and
– household and commercial grade disin- safety risks and is inconsistent with public
fectants (without specific claims) as well expectations that such products are ade-
as sanitizers, sanitary fluids and antibacte- quately regulated. The likelihood or extent
rial surface wipes are exempt from entry of the potential public health and safety
on the ARTG but are expected to comply risks is not currently known, particularly
with TGO 54. as the identity of the chemicals within dis-
Sterilants and instrument grade disinfectants infectant products that are exempt under
have been regulated since October 2002 under the TGA regulatory system is not known.
the regulatory system for medical devices. – Household and commercial disinfectants
These products are outside of the scope of (without specific claims) and other prod-
this review. ucts do not comfortably fit within the
TGA regulatory system (even as exempt
Government seeks to address the following products) because the products have less
problems identified with the current regula- connection to a therapeutic purpose,
tion of disinfectants: such as the prevention of disease. This is
– An absence of adequate regulation, com- by contrast to hospital grade disinfect-
mensurate with potential risk, for house- ants or disinfectants with specific claims,
hold and commercial grade disinfectants where there is a clear expectation that the
(without specific claims), sanitizers, sani- products serve to minimise or prevent the
tary fluids and antibacterial surface wipes spread of disease.
(referred to in this RIS as ‘other prod- Reference: http://www.nicnas.gov.au/Current_Issues/
ucts’). Disinfectants/Consultation_Disinfectants.
– Currently, listable or registrable disinfect- asp.
ants that contain a new chemical entity
undergo a toxicological evaluation by the
TGA. In the case of other chemical prod- Australia: Stevedoring
ucts (not regulated by the TGA), NICNAS information booklets
applies a legislated risk framework and,
where necessary, undertakes toxicologi- [2009/0207]
cal evaluation of new chemical entities.
However, there is a regulatory anomaly Safe Work Australia has announced the
for household and commercial grade dis- release of three guidance publications for the
Australia Chile
Measures to control the use of lead in surface Text of the Sanitary Code adopted 09-Jun-
coatings and inks implemented 05-Feb-2008 2009
NICNAS publishes guidance and application Toys regulation modified 22-Oct-2009
forms for introduction of low regulatory con- China
cern chemicals List of eco-label products subject to govern-
South Australia: Amendments impose great- ment procurement updated 31-Aug-2009
er controls on drug precursors and related Inspection and quarantine system for the
equipment 10-Oct-2009 imports of solid waste which can be used as
Austria raw material adopted 21-Aug-2009
Ordinance on aerosol dispensers 2009 adopt- National Standards containing technical cri-
ed 29-Sep-2009 teria on several environmental and health and
Act on fluorinated greenhouse gases adopted safety in September 2009 01-Sep-2009
22-Sep-2009 Procedures for importing and exporting toxic
Bahrain chemicals specified 18-Sep-2009
Decree on Implementation of Law No. 33 of Distilled residue of DMF (N,N’-Dimethyl-
2006 on Wastewater and Surface Water Issued formamide) classified as hazardous waste
01-Oct-2009 22-Sep-2009
Brazil Registration rules for consignees importing
Standard partially implementing the Harmo- solid waste that can be used as raw materials
nized System of Classification and Labelling put on trial 25-Sep-2009
of Chemicals (GHS) in Brazil entered into The use of HCFCs (hydrochlorofluorocar-
force 26-Aug-2009 bons) in 5 types of newly established facilities
Bulgaria is prohibited 13-Oct-2009
Consolidated version of the Act on the Protec- Standards on general specifications for trans-
tion of Environment issued 10-Jun-2009 port packages of dangerous goods amended
Canada 21-Jun-2009
Orders amending the Domestic Substances Costa Rica
List and the Non-domestic Substances List Guidance for the transport of dangerous
adopted 16-Sep-2009 goods in case of emergencies adopted 23-Sep-
Notices published with respect to chemicals 2009
and micro-organisms on the Domestic Sub- Croatia
stances List 03-Oct-2009 Act on Air Quality Protection amended
Significant New Activity Notice No. 15513 Czech Republic
adopted regarding tungsten carbide (W2C), Battery Directive transposed by amendment
CAS 12070-13-2, 05-Sep-2009 of the Waste Act 22-Jul-2009
Notice with respect to Batch 11 Challenge Regulation on aerosol dispensers harmonized
substances published 26-Sep-2009 with the EU legislation 17-Aug-2009
Orders Amending the Domestic and Non- Estonia
domestic Substances List published 14-Oct- List of chemicals banned in products of con-
2009 cern and restrictions concerning products of
Significant New Activity Notice No. EAU-461 concern amended 22-Oct-2009
adopted regarding fatty acids, CAS 519050-
73-8, 24-Oct-2009
United Kingdom
official (Period October 2009)
publications [2009/0211]
by Dr Ross Fielding
uled for January 2013), has ended (5 October information, PHMSA is requiring basic identifying infor-
2009). mation (offeror name or contract number) to be included
on shipping papers. This information will enable the
emergency response information provider to identify the
European Union offeror on whose behalf it is accepting responsibility for
(Period October-November 2009) providing emergency response information in the event
of a hazardous materials incident and obtain additional
[2009/0212] information about the hazardous material as needed.
This new rule also clarified that emergency telephone
O.J. L274, 2009: Commission Regulation (EC) numbers outside of the United States, the international
No 975/2009 of 19 October 2009 amending access code or the + (plus) sign, country code, and city
Directive 2002/72/EC relating to plastic ma- code must also be included, as appropriate.
terials and articles intended to come into con- Effective Date: The effective date of this final rule is
tact with foodstuffs 1 October 2010. Voluntary Compliance Date: PHMSA is
O.J. L282, 2009: Commission Directive authorizing immediate voluntary compliance beginning
2009/134/EC of 28 October 2009 amending 18 November 2009.]
Council Directive 76/768/EEC concerning FR, Vol. 74, No. 206, 27 October 2009, 55163:
cosmetic products for the purposes of adapt- Hazardous Waste Management System: Iden-
ing Annex III thereto to technical progress tification and Listing of Hazardous Waste:
O.J. L286, 2009: Regulation (EC) No 1005/2009 Conditional Exclusion From Hazardous
of the European Parliament and of the Coun- Waste and Solid Waste for Solvent-Contam-
cil of 16 September 2009 on substances that inated Industrial Wipes. Environmental Pro-
deplete the ozone layer (recast) tection Agency. Data availability, management
O.J. L292, 2009: Commission Recommenda- approaches, and request for comment.
tion 2009/824/EC of 29 October 2009 on the FR, Vol. 74, No. 207, 28 October 2009, 55502:
use of the International Standard Classifica- Schedules of Controlled Substances: Place-
tion of Occupations (ISCO-08) ment of 5-Methoxy-N,NDimethyltryptamine
Into Schedule I of the Controlled Substanc-
es Act. Drug Enforcement Administration
USA Federal Register publications (DEA), Department of
(Period October-November 2009) Justice. Notice of proposed rulemaking; reo-
pening of comment period.
[2009/0213] FR, Vol. 74, No. 207, 28 October 2009, 55502:
Lead; Amendment to the Opt-out and Record-
FR, Vol. 74, No. 200, 19 October 2009, 53413: keeping Provisions in the Renovation, Repair,
Hazardous Materials: Revision of Require- and Painting Program. Environmental Pro-
ments for Emergency Response Telephone tection Agency (EPA). Proposed rule.
Numbers. Pipeline and Hazardous Materials FR, Vol. 74, No. 208, 29 October 2009, 55843:
Safety Administration (PHMSA), DOT. Final Release of Draft Document Related to the
rule. Review of the National Ambient Air Quality
[In this final rule, PHMSA is amending the Hazardous Standards for Carbon Monoxide. Environ-
Materials Regulations to clarify requirements governing mental Protection Agency (EPA). Availability
emergency response information services provided by of draft document for public comment.
arrangement with hazardous materials offerors (shippers). FR, Vol. 74, No. 211, 03 November 2009,
In order to preserve the effectiveness of these arrangements 56834: Draft Toxicological Review of Trichlo-
for providing accurate and timely emergency response roethylene: In Support of the Summary Infor-
mation in the Integrated Risk Information FR, Vol. 74, No. 216, 10 November 2009,
System (IRIS). Environmental Protection 57974: Combustible Dust. Occupational Safe-
Agency (EPA). Notice of public comment ty and Health Administration (OSHA), Labor.
period. Notice of stakeholder meetings.
FR, Vol. 74, No. 211, 03 November 2009, FR, Vol. 74, No. 216, 10 November 2009,
56842: Draft Guidance for Industry on List- 58003: Impact of Implementation of the
ing of Ingredients in Tobacco Products; Avail- Chemical Weapons Convention on Commer-
ability. Food and Drug Administration, cial Activities Involving ‘Schedule 1’ Chemi-
HHS. Notice. cals Through Calendar Year 2009. Bureau of
FR, Vol. 74, No. 213, 05 November 2009, Industry and Security, Commerce. Notice of
57278: Hazard Communication; Correction. inquiry.
Occupational Safety and Health Administra- FR, Vol. 74, No. 216, 10 November 2009,
tion (OSHA), DOL. Proposed rule: correc- 58014: Draft Toxicological Review of cis- and
tion. trans-1,2-Dichloroethylene: In Support of the
[This document corrects the OSHA Hazard Communi- Summary Information in the Integrated Risk
cation standard proposed rule and request for comment, Information System (IRIS). Environmental
published in the Federal Register of 30 September 2009. Protection Agency (EPA). Notice of peer-
This notice corrects eight errors, four in the preamble and review workshop.
four that appear in Appendix A: Table A.1.1, Table A.1.2, FR, Vol. 74, No. 216, 10 November 2009,
Table A.2.3, and Table A7.1.] 58015: Draft Toxicological Review of Hydro-
FR, Vol. 74, No. 213, 05 November 2009, gen Cyanide and Cyanide Salts: In Support of
57313: Draft Toxicological Review of Chloro- the Summary Information on the Integrated
prene: In Support of the Summary Informa- Risk Information System (IRIS). Environ-
tion in the Integrated Risk Information Sys- mental Protection Agency (EPA). Notice of
tem (IRIS). Environmental Protection Agency peer-review workshop.
(EPA). Notice of listening session. FR, Vol. 74, No. 216, 10 November 2009,
FR, Vol. 74, No. 214, 06 November 2009, 58015: Draft Toxicological Review of Trichlo-
57424: Significant New Use Rules on Certain roacetic Acid: In Support of the Summary
Chemical Substances; Technical Amendment. Information in the Integrated Risk Informa-
Environmental Protection Agency (EPA). tion System (IRIS). Environmental Protection
Final rule; technical amendment. Agency (EPA). Notice of peer-review work-
[In the Federal Register of 5 November 2008 EPA issued shop.
direct final significant new use rules (SNURs) for 56 FR, Vol. 74, No. 217, 12 November 2009,
chemical substances which were the subject of preman- 58278: Dimethyldithiocarbamate Salts;
ufacture notices (PMNs). For the chemical substance Amendment to Terminate Uses. Environmen-
identified as Oxetane, 3,3′-[oxybis(methylene)] bis[3- tal Protection Agency (EPA). Notice.
ethyl- (PMN P–03–471; CAS 18934–00–4), the citation at FR, Vol. 74, No. 217, 12 November 2009,
§ 721.10095(a)(2)(ii) incorrectly identified one of the haz- 58279: Certain New Chemicals; Receipt and
ard communication program requirements. This action Status Information. Environmental Protec-
corrects the final regulation.] tion Agency (EPA). Notice.
FR, Vol. 74, No. 216, 10 November 2009, FR, Vol. 74, No. 218, 13 November 2009,
57883: Revising Standards Referenced in the 58688: Air Quality Designations for the 2006
Acetylene Standard. Occupational Safety and 24-Hour Fine Particle (PM2.5) National
Health Administration (OSHA), Department Ambient Air Quality Standards. Environmen-
of Labor. Final rule; confirmation of effective tal Protection Agency (EPA). Final rule.
date.
FR, Vol. 74, No. 220, 17 November 2009, that activity. The required notification would
59112: Schedules of Controlled Substances: provide EPA with the opportunity to evaluate
Placement of Carisoprodol Into Schedule IV. the intended use and, if necessary, to prohibit
Drug Enforcement Administration, Depart- or limit that activity before it occurs.
ment of Justice. Notice of proposed rulemak- References: G/TBT/N/USA/499 of 10 November 2009
ing. http://edocket.access.gpo.gov/2009/pdf/
FR, Vol. 74, No. 220, 17 November 2009, E9-26818.pdf
59183: Office of Environmental Information;
Announcement of Availability and Comment INTERNET
Period for Revised Environmental Sampling,
Analysis and Results Data Standards (ESAR).
Environmental Protection Official Journal of the European
Agency (EPA). Notice of data availability and Union
request for comment.
[2009/0215]
[2009/0217] Hoofdredactie:
Drs. A.C.H. van Peski
27-28 January 2010 Redactie:
Managing SVHCs under REACH and Mw. dr. M.M. Kops-Werkhoven
Understanding CLP Drs. H.A.F. van Well
Brussels, Belgium Dr. J.A.S.J. Razenberg
Info: http://www.ismithers.net/confer- Drs. J. Zawierko
ences/XDAN10/ Uitgever:
Dhr. B. Pijfers
13-14 April 2010
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Journaal Stoffen en Preparaten jaartal/nummer
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