ARCHROMA Management GmbH

Product Stewardship
Neuhofstrasse 11
CH-4153 Reinach
Switzerland

AUTHOR
José Juan Regaño
Product Stewardship

REVIEWER
Eleonore Braun
Product Stewardship
D

APPROVER
Carole Mislin
Head of Product Stewardship

Version
10.08.2016
SHE - Guideline No 26
Product Data Management

Preamble
This guideline establishes the way ARCHROMA follows and implements the Group Regulation and the
Strategies on Safety, Health and Environment with regard to Product Data Management.

Reservation of This document is for internal use only and may not be distributed
Ownership without prior authorization by Archroma Management GmbH. Even
after authorized receipt, this document and its content shall not be
distributed further without approval by Archroma Management GmbH.

1. General
Objective 1 The objective of this Corporate Guideline is to define the scope and
responsibilities for product safety data of substances/mixtures and to
ensure that these data are available in a harmonized, validated,
updated form within Archroma and can be made available in an
appropriate way to employees, customers, the authorities and the
public.
Validity 2 This guideline is valid for the companies of the ARCHROMA Group.

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SHE - Guideline 26 Product Data Management
Scope 3 This guideline applies to the management of product safety data of
substances/ mixtures handled, produced and sold.

Responsibilities 4 The management of the Business/functions, companies, sites and

plants is responsible for the implementation of this guideline in their
respective areas of responsibilities

2. Basic Rules
Laws and Regulations 5 Local laws and regulations are binding. Additional requirements
defined by this guideline are also fulfilled.

Sustainable 6 Archroma conducts its business in due consideration of sustainable

Development development, minimizing adverse impacts of its activities on the
environment and reduces the actual and potential risks associated with
Archroma products throughout their life cycle.

Banned/Restricted 7 International, national, local and internal regulations concerning the

Substances ban or restriction of the use, handling, storage, transportation and
trading of specified substances are strictly observed.

Knowledge on Products 8 The Archroma companies manufacture and sell products only when
sufficient knowledge of environmental, safety and/or health relevant
properties is available

Product Information 9 Information on products sold and advice for handling, labelling, use,
storage and emergency situations are made available to employees,
distributors, customers and authorities in understandable form and
according to legal requirements and industry standards.

New Information 10 New information about a product, which could require more stringent
precautionary measures, is evaluated by Product Stewardship team. As
soon as validated, it is implemented in EH&S database. If additional
precautionary measures are necessary, they are communicated to the
employees and the customers. New information potentially indicating
severe, irreversible health effects as defined in Guideline 5 "Protection
from hazards to health", are communicated to SHE (Safety, Health and
Environment) and via this to companies, sites and plants as well as to
Global Product Stewardship and via those to the Business.

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SHE - Guideline 26 Product Data Management
Development of 11 Only products, which can be safely manufactured, handled and used
New Substances under the prescribed conditions, are developed. Toxicological and/or
ecotoxicological aspects are considered in an early phase of product
development.
Substance Data Management
EH&S Database 12 EH&S is the central database which covers all Environmental, Safety
and Health related data of substances/ mixtures including raw
materials. Sites without access to EH&S collect their data in a local
database/ system.

Data Responsibility/ 13 The responsibility and ownership for all product safety data of sales
Data Ownership products, development products, ingredients, intermediates, raw
materials, formulations and auxiliaries lies with the designated
Business. For substances, which are used by several Business Units
the ownership is assigned to one Business according to the major
user principle.
Minimum Data Set 14 Depending on the status of development a „Minimum Data Set”
(MDS) of the product is necessary. It is laid down in Annex 1. The
MDS is binding throughout the group.
WINS/EH&S 15 WINS material numbers are established during the Archroma Product
Approval Process in close cooperation with the CMDM (Central
Master Data Management) of WINS. WINS Material numbers are
linked to EH&S substance numbers by the EH&S editor.
Identification of 16 All mixtures in EH&S database are characterized chemically by their
Mixtures composition.
Data Quality/ 17 All Environmental, Safety and Health related relevant data are
Integrity/Update validated and stored in the EH&S database and are regularly updated.
Data can be determined via measuring, calculation, literature or via
analogy. Analogy (read across) is allowed if technically applicable,
scientifically meaningful or if testing is not appropriate due to animal
welfare reasons or the intended use of the substance.
Access to EH&S 18 Access to the EH&S database has to be approved by the GCR EH&S and
Database is granted depending on the needs of the users. Every user of EH&S is
obliged to use EH&S properly. Composition data must be treated
confidential. To document this every EH&S user with access to such
data has to sign a confidentiality statement.
The GCR EH&S ensures that access is only granted to appropriate
people.

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SHE - Guideline 26 Product Data Management
EH&S Standards 19 The rules for the use and the database standard in EH&S are defined
by Global Hazard Communication. Changes in these rules are decided
by the Global Product Stewardship Management.
MSDS 20 Material Safety Data Sheets (MSDS) are created taking into account the
local laws and regulations. Relevant changes, according to the
legislation, are communicated to the employees, distributors, the
customers and appropriate person in accordance with legal
requirements.
Documentation 21 Toxicological and ecotoxicological data and reports are kept for at least
40 years, other data for at least 10 years after the last delivery/
handling of the substance/ mixture. Global and local Product
Stewardship are resposible for the custody of concerned data and
reports

3. Tasks

Business

General Issues 22 The Business management is responsible:

 to gather the documentation/data needed to start the Archroma
Product Approval Process (depending on the business case) for any
new or modified sales products
 to start the Archroma Product Approval Process for any new or
modified sales products

Procurement

General Issues 23 Procurement is responsible:

 to gather the documentation/data needed to start the Archroma
Product Approval Process (depending on the business case) for any
new raw material / supplier
 to start the Archroma Product Approval Process for any new raw
material / supplier
 to distribute new version of Suppliers MSDS to Product Stewardship
and other internal stakeholder

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SHE - Guideline 26 Product Data Management
MAKE

General Issues 24 MAKE is responsible:

 to gather the documentation/data needed to start the Archroma
Product Approval Process (depending on the business case) for any
new/changed intermediates
 to start the Archroma Product Approval Process for any new/changed
intermediates

Global Product Stewardship

Data Management 25 The Global Product Stewardship management is responsible for

following activities:
 evaluation of Product Safety data (e.g. classification & labelling) and
assurance of resulting legal compliance (e.g. sentinels in business
process orders of products containing banned and restricted
substances are blocked in SAP)
 storage in EH&S database of all appropriate Environmental,
Safety and Health related data
 to define the rules for storing Environmental , Safety and Health
related data in EH&S concerning the quality, validity, uniformity,
security and integrity. They are supervised by the Global Code
Representative EH&S (GCR EH&S)
 regular update of the data

Companies

Notification/Registra- 26 The company management ensures that all legal requirements in

tion substance notification are fulfilled in cooperation with Global Product
Stewardship “Registration”. This includes informing the authorities on
additional knowledge of hazards as required.
MSDS 27 Local Product Stewardship ensures that the national variant of the
MSDS, when legally required, is in compliance with the local laws and
regulations. Local Product Stewardship is responsible for monitoring
the local legislation.

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SHE - Guideline 26 Product Data Management
Sites/Plants

Data Integrity 28 The management of the site ensures that all substance data needed
for for safe handling, production, packaging, storage, transportation and
Production/Handling disposal are available concerning legal compliance as well as for
handling of emergency situations on site.
Information to 29 Product data concerning the hazards of substances are made
Employees available to employees in a way that can be easily understood.

4. Implementation

Revision Date Change Author

1 21/01/2014 Adaptation of Clariant Guideline to Archroma C.Mislin

2 10/08/2016 Update to Archroma template. Allocation of J.J.Regaño

tasks according to current Archroma
organization

5.
Glossary
For the purpose of this guideline the following terms mean:

Composition Substances and their concentrations as part of a mixture.

Global Product It is composed by: “Global Hazard Communication”, “Global
Stewardship Customer Support”, “Global Registration” and local organization in
the countries/regions
EH&S Database EH&S is the worldwide database containing all Product Safety
relevant properties of Archroma products including intermediates,
raw materials and trading products. The EH&S database is based on
SAP software and has the capability to be linked to the Archroma
(WINS) business processes as well as Archroma emergency
management.

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SHE - Guideline 26 Product Data Management
EH&S Substance Number The EH&S substance number is the unique database key of data sets
of substances and mixtures in EH&S.
GCR EH&S The Global Code Representative EH&S (GCR EH&S) implements and
coordinates the worldwide organization for collecting and updating
product data. He/she defines functional requirements on EH&S. The
GCR is the central contact person concerning requirements on EH&S.
LCR EH&S The Local Code Representative EH&S (LCR EH&S) procures and
updates Environmental, Safety and Health related data in EH&S for
those substances/ mixtures that have been assigned to him/ her by
the GCR EH&S. In addition, the LCR EH&S of a country is responsible
for procuring and updating the product data according to national
regulations for all products handled in that country by Archroma.
Material Safety Datasheet Harmonized information sheet citing Environmental, Safety and
(MSDS) Health related properties of a product with additional country
specific information to ensure compliance with local Legislation.
Mixture Combination of two or more substances (includes also relevant
impurities).
Notification/Registration Legal process for obtaining permission from the authorities to
manufacture and/ or sell a product in the local market.
Product Substance or mixture handled, manufactured or sold by Archroma.
Product Safety Data Product safety data encompass data on the inherent properties of a
substance or a mixture as well as data derived according to
legislative schemes.
Substance Elements and their compounds incl. inseparable mixtures of
homologue compounds.
Sustainable Development Fulfilling the needs of today while considering economical, ecological
and social aspects without restricting the development of future
generations (RIO Conference 1992).
Validation/ Prove of substance data by a specialist and classification of/
Validated Data comments on quality of data.
WINS WINS is the business IT system, based on SAP R3, used by Archroma.
WINS Material Number The WINS material number is the unique database key of the
Archroma Materials in WINS

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SHE - Guideline 26 Product Data Management
6. Index of Annexes

Annex 1: Minimum Data Set

1 According to item 14 of the guideline the following minimum data set
(MDS) is binding throughout the group.
2 Identification and physical/chemical data (if applicable)
Trade name
Chemical name and/ or CAS No.
Physical state description at 20°C and 101,3 kPa (solid, powder, liquid,
gas)
Boiling/ melting point
Flash point (liquids)
Combustibility index (solids)
Water solubility
Density/ bulk density or specific gravity
pH
log POW (partitioning coefficient 1-octanol/ water)
Explosive properties/Explosion limit(s) (flammable liquids and gases)
Auto-ignition
Dust explosion screening (solids, Hartmann Tube )
Vapour pressure
Flammability
Metal Corrosion
Viscosity
Archroma storage category
Toxicological / ecotoxicological information "test only with substances"
and "only when waiving or read across cannot be done"
Acute oral toxicity (OECD test)
Dermal irritation (OECD test)
Eye irritation (OECD test)
Biodegradation/ Elimination (preferably ready test, OECD)
Acute aquatic toxicity (OECD test), daphnia recommended

Validity 3 The MDS is valid for all substances/ mixtures produced or handled
within Archroma.

Toxicological/ 4 Tests should only be made with substances and when waiving or read
Ecotoxicological across cannot be done.
Information

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SHE - Guideline 26 Product Data Management
Laws and Regulations 5 If required by local laws and regulations further data are procured in
addition to the MDS.
Scope 6 The MDS is valid for all products handled in quantities greater than
1000 kg per year including pilot plants production.
Intermediates handled under SCC (Strictly Controlled Conditions, under
REACH Regulation)are exempted from MDS requirements due to low
exposure

Mixtures 7 If methodically possible toxicological/ ecotoxicological data should be

derived from the components.

Exceptions 8 Exception of the MDS is possible if conclusion by analogy is allowed

(e.g. quantitative structure activity relationship consideration), if it is
technically not applicable or scientifically not meaningful, or if testing is
not allowed due to the intended use of the substance. The decision has
to be made by an expert in that field. Documentation is required.

Hazard Potential 9 Where expert judgment or examples of similar structured substances

indicate that there could be specific risks, additional tests should be
considered (e.g. mutagenicity, skin sensitization).

Laboratories; 10 If the knowledge of environmental, safety and/or health properties is

R+D Products not yet available or insufficient, specific precaution measures have to
be applied. It must be indicated that the product is not yet fully tested.

Pilot Plant; 11 Before starting a pilot plant all data needed for the safe and
<1000 kg Production per environmental sound production must be available. If toxicological data
year
are not yet available special precaution is necessary.
Indication of unknown properties is required.

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