Product Stewardship

1 General Principles

Chemical companies have full responsibility for the products they manufacture, purchase, store
and market to their customers. Correct and sufficient classification and labeling of chemical
components and in consequence responsible handling of hazardous materials as well as
compliance with the bluesign® criteria can only be assured if the chemical company is serious
about the principles of Product Stewardship and assures all possible support for this important
part of applied chemistry. BSSL consumer safety limits have to be assured in every case if
chemical products shall be homologated.

2 Important management principles

To make sure that Product Stewardship is appropriately managed it is absolutely important that a
management system is implemented and maintained at the production site which clearly defines
all necessary procedures and organisational conditions with regard to all Product Stewardship
aspects.

2.1 Legal and other requirements

Compliance with legal requirements in the country of origin and destination is mandatory.
Therefore the bluesign® system partner shall install procedures to identify all applicable
regulations for its production sites and products. The management system has to be adapted to
make sure all identified requirements are kept. Consistent with its commitment to compliance, the
company shall establish, implement and maintain procedures for periodically (re-)evaluating
compliance with applicable legal requirements.

2.2 Resources, roles, responsibility and authority

For the appropriate management of Product Stewardship issues it is necessary that the company
provides the necessary resources. Resources include human resources and specialized skills,
organizational infrastructure, technology and financial resources.
Roles, responsibilities and authorities shall be defined, documented and communicated in order to
facilitate effective Product Stewardship.

Factsheet Product Stewardship | February 2013

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2.3 Competence, training and awareness

The company shall ensure that any person performing tasks for it or on its behalf that have the
potential to cause a significant EHS impacts identified by the company is competent on the basis
of appropriate education, training or experience.
The company shall identify training needs associated with its EHS and Product Stewardship
aspects. It shall provide training or take other action to meet these needs. Trainings shall be
repeated in regular intervals and if important changes in laws and regulations or the
manufacturing process take place.

2.4 Focus on the customer and the intended application

In order to provide suitable information on the product the company shall continuously increase
its knowledge on the intended use of its products and the specific situation of application.

2.5 Control of documents and records

The company shall establish, implement and maintain procedures to:

 Review and update as necessary and re-approve documents (national regulations regarding
classification, labelling, transport; specifications, recipes, external and internal MSDS, etc.).
 Ensure that changes and the current revision status of documents are identified.
 Ensure that relevant versions of applicable documents are available at points of use.
 Ensure that documents and records remain legible and readily identifiable.

3 Internal and external communication

With regard to Product Stewardship, the company shall establish, implement and maintain
procedures for:
 internal communication among the various levels and functions of the company;
 receiving, documenting and responding to relevant communication from external interested
parties.
At the end of the day MSDS, TDS and certificate of analysis are the most important
communication instruments in the supply chain. To demonstrate all partners the high level of
knowledge and to follow the principles of the bluesign® criteria the best quality of these
documents shall be achieved and maintained.

4 Raw materials

4.1 General Aspects

It is evident, that the composition of a finished product as for example a dye or an auxiliary is
influenced by the used raw materials. The raw material can be a well-defined substance or already
a preparation (mixture of substances). Each of these substances or preparations will have its own
impurity and by-product spectrum.
Finally, if control of impurities and by-products and compliance with BSSL as well as compliance
with national and international classification and labeling guidelines shall be assured, knowledge
on raw materials is essential and obviously only an intelligent input-stream management

Factsheet Product Stewardship | February 2013

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considering up-stream aspects of the supply chain can help to manage the complexity of EHS
aspects along the supply chain.

4.2 Control of raw materials

Manufacturers and formulators of dyestuffs and textile auxiliaries should carefully select their raw
material suppliers. It is recommended to evaluate their compliance with social and ethical
standards as well as their Environmental, Health and Safety (EHS) performance by an audit and
to clearly agree the specification and documentation needed for each supplied raw material.
Preference should be given to companies that have subscribed to the Responsible Care Program of
their national association. In every case a duly filled out and correct MSDS shall be provided by
the supplier. In addition the supplier shall inform on by-products and impurities especially
regarding BSSL-substances and shall closely cooperate with the bluesign® system partner.

5 Data sources

Homologation as well as national and international regulations on classification and labeling

require an extensive set of physicochemical, toxicological and eco-toxicological data. These data
have to be generated by the manufacturer of the substance or the preparation/mixture and
communicated in the supply chain by means of Material Safety Data Sheets (MSDS), certificates
of analysis, technical leaflets etc.

 Physicochemical data have to be determined on the preparation itself.

 Toxicological and eco-toxicological data should be derived from the data of the substances.
Testing of the preparation itself should be the exception e.g. if derivation of the value from the
component data is not possible or derived values are questionable.
 The quality of the MSDS of the different raw materials in the mixture is therefore of outmost
importance.
 In some cases toxicological and eco-toxicological data can be derived from data of similar
mixtures or general literature. This however has to be done with great care and by EHS experts
only. Similarity of the mixtures/preparation based on an analysis of the analytical profiles
should be a prerequisite. In any case this is only allowed if the content of the main component
and the impurity profiles of the source and the target chemical are comparable. The percentage
and the variation of the main component(s) and the main impurities have to be given. The
closure has to be 100 percent. Impurities have to be identified to the extent possible. If based
on chemical expert judgment critical impurities have to be expected, specific investigations
have to be started.
 IT-systems can support the derivation of EHS data for a preparation from the components
however also for this cases experts know how can not be compensated and is still required.

Note:
Kinds and quantity of impurities and by-products depend strongly on the particular
auxiliary or dyestuff type, the raw material sources and the process conditions in
synthesis and even on the particular production lots; these data can not be derived from
general literature or simple paste and copy from other sources.

Factsheet Product Stewardship | February 2013

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5.1 General toxicological and eco-toxicological data

 If toxicological or eco-toxicological tests are conducted they have to follow international

protocols (OECD; EC etc.) and be performed under Good Laboratory Practice (GLP).
 Before new tests are carried out to determine toxicological and eco-toxicological properties, all
available in vitro data, in vivo data, historical human data, data from valid (Q)SARs and data
from structurally related substances (read-across approach) shall be assessed first.
 Only meaningful test should be conducted. Waving of tests should however only be done based
on clear scientific criteria.

5.2 Tests on impurities, by-products BSSL-substances

The following general approach is proposed to identify whether or not substances, mentioned in
the bluesign® system substances list (BSSL) or which are of interest regarding other needs are
contained in products:
 Narrow down the range of substances which could be present in the products and thus have to
be analysed.
 Exhaust options for obtaining information via the supply chain.
 Only as a last resort, conduct targeted analysis.
 Test routines with focus on impurities and by-products for raw materials shall be defined.

6 Material Safety Data Sheet (MSDS) generation

The standard document to communicate substance/mixture (preparation) related data in the

supply chain is the Material Safety Data Sheet. Great care has to be taken in establishing these
documents. Supplied MSDS have to be checked for completeness and correctness.
 There are several national and international standards for MSDS. More and more legislations
require now MSDS in compliance with the “Global Harmonized System” (GHS).
 There are different expert IT systems on the market that support company experts in
generating MSDS. However these systems do not replace EHS experts. It is their duty to
carefully review the correctness of the proposals made by the systems.
 A check list which allows a fast control on completeness of a data set for a MSDS which is
conform to national/international regulations and accepted by bluesign has to be completed.
Depending on the physicochemical properties of substances not all data have to be provided.
However, if it is stated that a particular property does not apply or if information on a particular
property is not available, the reason shall be given.
 In case of a mixture, the entries in the relevant MSDS chapters shall clearly indicate to which
hazardous substance in the mixture the data apply, unless it is valid for the whole mixture.

Note:
Data reported in a MSDS are subject to national and international mandatory
regulations. The MSDS is a legally binding document.

Factsheet Product Stewardship | February 2013

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7 Data for bluesign® homologation

A correct, reliable and sufficient MSDS is a pre-condition for the bluesign® homologation.
Compliance with the BSSL (consumer safety limits) as well as a complete data set as prescribed in
the bluesign® bluetool is also mandatory for a bluesign ® homologation. In addition a TDS which
clearly defines the recommended as well as non-recommended application fields and process
conditions has to be reported to bluesign technologies and the customers.
Creating special MSDS which are used only for communication with bluesign technologies and not
with the customers is not the intention of the bluesign ® criteria. In fact it is the approach of the
bluesign® criteria that improved MSDS are disseminated to the customers of the chemical
company.

8 bluesign® requirements

The following parameters represent the minimum dataset required for a homologation:

Parameter

BSSL substances Aquatic toxicity against daphnia

Biodegradability (specify method) Aquatic toxicity against bacteria

COD Aquatic toxicity against algae

TOC Organo halogen (AOX)

BOD5 Emission factors (fc, fs)

P, total Fluorine

N, total Irritancy skin

Sulfite Irritancy eye

Sulfate Sensitization skin

Aliphatic hydrocarbons Acute oral tox

Sulfide Acute dermal tox

Aquatic toxicity against fish Mutagenicity / AMES test

Factsheet Product Stewardship | February 2013

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9 Remarks

Data reported in this fact sheet are carefully selected but not exhaustive and do not replace the
extensive background data for homologation according to the bluesign ® criteria.

For further information see comprehensive document “Product Stewardship Guideline

for manufacturers and formulators of dyestuffs and textile auxiliaries” available for
bluesign® system partners.

10 Glossary

Homologation: evaluation and classification of chemical products

blue rating: product complies with the bluesign® criteria
grey rating: product complies with the bluesign® criteria only under certain preconditions

11 Abbreviations

BAT: Best available technique

BSSL: bluesign® system substance list

EC: European Community

EHS: Environmental Health and Safety

GHS: Global Harmonized System

GLP: Good Laboratory Practice

MSDS: Material Safety Data Sheet

OECD: Organization for Economic Co-operation and Development

QSAR: Quantitative Structure Activity Relationship

TDS: Technical Data Sheet

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