EUROPEAN COMMISSION

HEALTH & CONSUMERS DIRECTORATE-GENERAL

Directorate E – Safety of the food chain

Unit E.3 - Chemicals, contaminants and pesticides

Carbendazim
SANCO/13063/2010 final
22 November 2010

Review report for the renewal of active substance carbendazim

finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on
23 November 2010
in view of the renewal of inclusion of carbendazim in Annex I of Directive 91/414/EEC

1. Procedure followed for the re-evaluation process

This review report has been established as a result of the re-evaluation of carbendazim, made in
the context of a new application by the data submitter to renew the inclusion of this active
substance expiring on 14 June 2011.

Carbendazim is a substance that was included in Annex I to Council Directive 91/414/EEC

concerning the placing of plant protection products on the market1, by Commission Directive
2006/135/EC2.

Council Directive 91/414/EEC provides that on the basis of an application by a notifier the
inclusion of a substance can be renewed and that a period shall be granted to complete the
review.

In accordance with the provisions of Article 5(5) of that Directive, the Carbendazim Task Force
notified to the Commission of their wish to secure the renewal of inclusion of the active
substance carbendazim in Annex I to the Directive.

Commission Directives 2009/152/EC3 and 2010/70/EU4 extended until 31 December 2010

respectively 13 June 2011 the period of inclusion in Annex I of Directive 91/414/EEC for
carbendazim to permit the completion of its review.

The renewal of this substance has been based on Article 6(1) of Directive 91/414/EEC with
Germany acting as Rapporteur Member State.

Germany finalised its examination, in the form of a draft re-assessment report. This report
was sent to the applicant and the Commission on 24 July 2009 and included a
recommendation in favour of the renewal of carbendazim in Annex I for the supported uses.
1
OJ No L 230, 19.8.1991, p. 3.
2
OJ No L 349, 12.12.2006, p. 37.
3
OJ No L 314, 1.12.2009, p. 66.
4
OJ L 283, 29.10.2010, p. 27.
 2

On 27 October 2009, the Commission requested EFSA to arrange an expert consultation on

the rapporteur Member State's draft re-assessment report and to deliver its conclusions.

Therefore, EFSA organised an intensive consultation of scientific experts from Member States,
to review that report and the comments received thereon (peer review).

The EFSA sent to the Commission its conclusion on the risk assessment (Conclusions regarding
the peer review of the pesticide risk assessment of the active substance)5. This conclusion
refers to background document A (draft assessment report and draft re-assessment report) and
background document B (EFSA peer review report).

In accordance with the provisions of Article 19 of Directive 91/414/EEC, the Commission

referred a draft review report on renewal to the Standing Committee on the Food Chain and
Animal Health, for final examination. The draft review report on renewal was finalised in the
meeting of the Standing Committee on 23 November 2010.

The present review report on renewal contains the conclusions of the final examination by the
Standing Committee. Given the importance of the conclusion of the EFSA, and the comments
and clarifications submitted after the conclusion of the EFSA (part of background document C),
these documents are also considered to be part of this review report.

2. Purposes of this review report

This review report, including the background documents and appendices thereto, has been
developed and finalised in support of Commission Directive 2011/58/EU6 amending Council
Directive 91/414/EEC to renew the inclusion of carbendazim as active substance, and to assist
the Member States in decisions on individual plant protection products containing carbendazim
they have to take in accordance with the provisions of that Directive, and in particular the
provisions of article 4(1) and the uniform principles laid down in Annex VI.

This review report provides also for the evaluation required under Section A.2.(b) of the above
mentioned uniform principles, as well as under several specific sections of part B of these
principles.

This review report shall be made available for public consultation by any interested parties.

The information in this review report is, at least partly, based on information which is
confidential and/or protected under the provisions of Directive 91/414/EEC. It is therefore
recommended that this review report would not be accepted to support any registration outside
the context of Directive 91/414/EEC, e.g. in third countries, for which the applicant has not
demonstrated to have regulatory access to the information on which this review report is based.

3. Overall conclusion in the context of Directive 91/414/EEC

The overall conclusion from the evaluation is that it may be expected that plant protection
products containing carbendazim will still fulfil the safety requirements laid down in Article

5
EFSA Conclusion on the peer review of the pesticide risk assessment of the active substance carbendazim issued on 30
April 2010, EFSA Journal 2010; 8(5):1598
6
OJ L 122, 11.5.2011, p. 71–75
 3

5(1)(a) and (b) of Directive 91/414/EEC. This conclusion is however subject to compliance with
the particular requirements in sections 4, 5, 6 and 7 of this report, as well as to the
implementation of the provisions of Article 4(1) and the uniform principles laid down in Annex
VI of Directive 91/414/EEC, for each carbendazim containing plant protection product for which
Member States will grant or review the authorisation.

Furthermore, these conclusions were reached within the framework of the uses which were
proposed and supported by the data submitter and mentioned in the list of uses supported by
available data (attached as Appendix II to this review report).

Extension of the use pattern beyond those described above will require an evaluation at Member
State level and, where necessary, the modification of the Directive, in order to establish whether
the proposed extensions of use can satisfy the requirements of Article 4(1) and of the uniform
principles laid down in Annex VI of Directive 91/414/EEC.

The following reference values have been finalised as part of this re-evaluation:

ADI 0.02 mg/kg bw/day

ARfD 0.02 mg/kg bw
AOEL 0.02 mg/kg bw/day

With particular regard to residues, the review has established that the residues arising from the
proposed uses, consequent on application consistent with good plant protection practice, have no
harmful effects on human or animal health. The Theoretical Maximum Daily Intake (TMDI) is
not more than 5 % of the Acceptable Daily Intake (ADI) (DK Child) for all diets included in the
EFSA PRIMo Model rev 2 and not more than 7% for the Acute Reference Dose (ARfD)
according to the EFSA PRIMo Model rev 2.

The review has identified several acceptable exposure scenarios for operators, workers and
bystanders, which require however to be confirmed for each plant protection product in
accordance with the relevant sections of the above mentioned uniform principles.

The review has also concluded that under the proposed and supported conditions of use there are
no unacceptable effects on the environment, as provided for in Article 4 (1) (b) (iv) and (v) of
Directive 91/414/EEC.

4. Identity

The main identity of carbendazim is given in Appendix I.

The active substance shall comply with the FAO specification and there seem not to be reasons for
deviating from that specification; the FAO specification is given in Appendix I of this report.

The review has established that for the active substance notified by the main data submitter the
manufacturing impurities 2-amino-3-hydroxyphenazine (AHP) and 2,3-diaminophenazine (DAP)
are of toxicological concern and must not exceed respectively 0.0005 g/kg and 0.003 g/kg in the
technical material. The toxicological and ecotoxicological relevance of a third impurity
AEF037197 must be established.
 4

5. Endpoints and related information

In order to facilitate Member States, in granting or reviewing authorisations, to apply adequately

the provisions of Article 4(1) of Directive 91/414/EEC and the uniform principles laid down in
Annex VI of that Directive, the most important endpoints were identified during the re-
evaluation process. These endpoints are listed in the conclusion of the EFSA, and at section 3 of
this report.

6. Particular conditions to be taken into account on short term basis by Member

States in relation to the granting of authorisations of plant protection products
containing carbendazim

On the basis of the proposed and supported uses (as listed in Appendix II), the following
particular issues have been identified as requiring particular and short term attention from all
Member States, in the framework of any authorisations to be granted:

Particular attention must be paid to the protection of:

– aquatic organisms. Appropriate drift mitigation measures must be applied to minimise the
exposure of surface water bodies. This should include keeping a distance between treated
areas and surface water bodies alone or in combination with the use of drift-reducing
techniques or devices;
– earthworms and other soil macro-organisms. Conditions of authorisation shall include
risk mitigation measures, such as the selection of the most appropriate combination of
numbers and timing of application, and, if necessary, the degree of concentration of the
active substance;
– birds (long term risk). Depending on the results of the risk assessment for specific uses,
targeted mitigation measures to minimise the exposure may become necessary;
– operators, who must wear suitable protective clothing, in particular gloves, coveralls,
rubber boots and face protection or safety glasses during mixing, loading, application and
cleaning of the equipment, unless the exposure to the substance is adequately precluded by
the design and construction of the equipment itself or by the mounting of specific
protective components on such equipment.

7. List of studies to be generated

Further studies were identified which were at this stage considered necessary in relation to the
renewal of inclusion of a in Annex I under the current inclusion conditions.

The Member States concerned shall request that the applicant provides the following to the
Commission:
- by 1 December 2011 at the latest, information as regards the toxicological and ecotoxicological
relevance of the impurity AEF037197;
- by 1 June 2012 at the latest, the examination of the studies included in the list in the draft re-
assessment report of 16 July 2009 (Volume 1, Level 4 "Further information", pp. 155 – 157);
- by 1 June 2013 at the latest, information on the fate and behaviour (route of aerobic
degradation in soil) and the long term risk to birds.
 5

Some other endpoints may require the generation or submission of additional data to be
submitted to the Member States in order to ensure authorisations for use under certain
conditions. The list of studies to be generated, still ongoing or available but not peer reviewed
can be found in the relevant part of the EFSA Conclusions.

8. Information on studies with claimed data protection

For information of any interested parties, the rapporteur Member State will keep available a
document which gives information about the studies for which the data submitter has claimed
data protection and which during the re-evaluation process were considered as essential with a
view to annex I renewal of inclusion. This information is only given to facilitate the operation of
the provisions of Article 13 of Directive 91/414/EEC in the Member States. It is based on the
best information available but it does not prejudice any rights or obligations of Member States or
operators with regard to its uses in the implementation of the provisions of Article 13 of the
Directive 91/414/EEC and neither does it commit the Commission.

9. Updating of this review report

The information in this report may require to be updated from time to time in order to take
account of technical and scientific developments as well as of the results of the examination of
any information referred to the Commission in the framework of Articles 7, 10 or 11 of Directive
91/414/EEC. Any such adaptation will be finalised in the Standing Committee on the Food
Chain and Animal Health, in connection with any amendment of the inclusion conditions for
carbendazim in Annex I of the Directive.
 -1-
Carbendazim Appendix I
Identity, physical and chemical properties

APPENDIX I

Identity
CARBENDAZIM

Common name (ISO) carbendazim

Chemical name (IUPAC) methyl benzimidazol-2-ylcarbamate or
2-(Methoxycarbonylamino)-benzimidazole
Chemical name (CA) methyl 1H-benzimidazol-2-ylcarbamate
CIPAC No 263
CAS No 10605-21-7
EEC No EEC: 613-048-00-8; EINECS:234-232-0
FAO Specification (including year of AGP: CP/220 (1992); 980 g/kg (+/- 20 g/kg)
publication) AHP 0.0005 g/kg of the carbendazim
content in the TC
DAP 0.003 g/kg of the carbendazim
content in the TC
Minimum purity of the active substance 980 g/kg
as manufactured
Identity of relevant impurities (of AHP 0.0005 g/kg of the carbendazim
toxicological, ecotoxicological and/or content in the TC
environmental concern) in the active DAP 0.003 g/kg of the carbendazim
substance as manufactured content in the TC
Molecular formula ‡ C9H9N3O2
Molecular mass ‡ 191.21 g/mol
Structural formula ‡ H
N
H
N
N O
O
 APPENDIX II
List of uses supported by available data

Crop and/ Member Product F Pests or Application rate per treatment PHI
or State name G Group Preparation Application (for explanation see the text (days) Remarks
situation or or of pests in front of this section)
Country I controll
ed

Type Conc. method growth number interval g as/hL water L/ha g as/ha
(a) (b) (c) of as kind stage & min/ max between (m)
(d-f) season applications min - max min - max min - max
(i) (f-h) (k) (min) (l) (l)
(j)
Cereals: BE, LU Punch SE F Stem, SE Flusiliazole Hydraulic BBCH 2 14 100-400 Flusiliazole N/A*
Wheat, CZ, DE, Harvesan foliar 250 g/L sprayer 69-71 200 g as/ha
Rye, IRL, UK Punch C and ear overall
Triticale PL, Escudo Forte diseases Carbendazim Carbendazim
(winter, 125 g/L 100 g as/ha
spring) 42
FR Punch CS BBCH 100-150 Minimum PHI
59-61 N/A*
SP Punch CS BBCH 100-600
PT Contrast CS 69-71
Cereals: BE, LU Punch SE F Foliar SE Flusiliazole Hydraulic BBCH 2 14 100-400 Flusiliazole 42
Barley DE, Harvesan and ear 250 g/L sprayer 49-51 200 g as/ha
(winter, IRL, UK Punch C diseases overall
spring) PL, Escudo Forte Carbendazim Carbendazim
125 g/L 100 g as/ha

FR Punch CS BBCH 100-150 42 Minimum PHI

59-61
SP Punch CS BBCH 100-600 N/A*
PT Contrast CS 69-71
Sugar and BE, LU Punch SE F Foliar SE Flusiliazole Hydraulic Full crop 2 28 100-150 Flusiliazole 42
fodder DE, Harvesan diseases 250 g/L sprayer cover BBCH 150 g as/ha
beet IRL, UK Punch C overall 49
North Carbendazim Carbendazim
125 g/L 75 g as/ha
Sugar and FR Punch CS F Foliar SE Flusiliazole Hydraulic Full crop 2 28 100-150 Flusiliazole 35 -
fodder diseases 250 g/L sprayer cover BBCH 125 g as/ha 42
beet overall 49
Carbendazim Carbendazim
125 g/L 62.5 g as/ha

Sugar and SP Punch CS F Foliar SE Flusiliazole Hydraulic Full crop 3 14 100-400 Flusiliazole 15
 -2-

Crop and/ Member Product F Pests or Application rate per treatment PHI
or State name G Group Preparation Application (for explanation see the text (days) Remarks
situation or or of pests in front of this section)
Country I controll
ed

Type Conc. method growth number interval g as/hL water L/ha g as/ha
(a) (b) (c) of as kind stage & min/ max between (m)
(d-f) season applications min - max min - max min - max
(i) (f-h) (k) (min) (l) (l)
(j)
fodder PT Contrast CS diseases 250 g/L sprayer cover BBCH 125 g as/ha
beet overall 49
South Carbendazim Carbendazim
125 g/L 62.5 g as/ha
Oil seed FR Punch CS F Foliar SE Flusiliazole Hydraulic Flowering 2 21 100-150 Flusiliazole 63
rape and pod 250 g/L sprayer declining; 200 g as/ha
diseases overall majority of
Carbendazim petals fallen Carbendazim
125 g/L BBCH 67 100 g as/ha
Oil seed UK, Punch SE F Foliar SE Flusiliazole Hydraulic Flowering 2 21 100-400 Flusiliazole N/A*
rape DE Harvesan and pod 250 g/L sprayer declining; 200 g as/ha
diseases overall majority of
Carbendazim petals fallen Carbendazim
125 g/L BBCH 67 100 g as/ha
Maize FR Punch CS F Foliar SE Flusiliazole Hydraulic BBCH 75 2 21 100-150 Flusiliazole 28
diseases 250 g/L sprayer 200 g as/ha
overall
Carbendazim Carbendazim
125 g/L 100 g as/ha

∗ For cereals and oil seed rape, the pre-harvest interval is governed by the growing period remaining between the final application and harvest at crop maturity which may vary depending on local conditions. The residues at
harvest are determined more by growth stage at final application than PHI in days.

(a) For crops, the EU and Codex classifications (both) should be taken into account; where relevant, the use
situation should be described (e.g. fumigation of a structure)
(b) Outdoor or field use (F), greenhouse application (G) or indoor application (I)
(c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds
(d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR)
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989
(f) All abbreviations used must be explained
(g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench
(h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plant- type of equipment
used must be indicated
(i) g/kg or g/L. Normally the rate should be given for the active substance (according to ISO) and not for the
variant in order to compare the rate for same active substances used in different variants (e.g.
fluoroxypyr). In certain cases, where only one variant is synthesised, it is more appropriate to give the
rate for the variant (e.g. benthiavalicarb-isopropyl).
(j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN 3-
8263-3152-4), including where relevant, information on season at time of application
(k) Indicate the minimum and maximum number of application possible under practical conditions of use
(l) The values should be given in g or kg whatever gives the more manageable number (e.g. 200 kg/ha
instead of 200 000 g/ha or 12.5 g/ha instead of 0.0125 kg/ha
(m) PHI - minimum pre-harvest interval