PUBLISHED DOCUMENT PD CEN/TR

13695-2:2004

Packaging —
Requirements for
measuring and
verifying the four
heavy metals and other
dangerous substances
present in packaging,
and their release into
the environment —
Part 2: Requirements for measuring and
verifying dangerous substances present
in packaging, and their release into the
environment

Confirmed
ICS 1 3. 020.30; 55.020 J u n e 200 9

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PD CEN/TR 13695-2:2004

National foreword
This Published Document reproduces verbatim CEN/TR 1 3695-2:2004.

The UK participation in its preparation was entrusted to Technical Committee

PKW/4, Packaging in the environment, which has the responsibility to:

— aid enquirers to understand the text;

— present to the responsible international/European committee any

enquiries on the interpretation, or proposals for change, and keep the
UK interests informed;

— monitor related international and European developments and

promulgate them in the UK.

A list of organizations represented on this committee can be obtained on

request to its secretary.

Cross-references
The British Standards which implement international publications referred to
in this document may be found in the BSI Catalogue under the section entitled
“International Standards Correspondence Index”, or by using the “Search”
BSI Electronic Catalogue
facility of the or of British Standards Online.

This publication does not purport to include all the necessary provisions of a
contract. Users are responsible for its correct application.

Compliance with a British Standard does not of itself confer immunity

from legal obligations.

Summary of pages
This document comprises a front cover, an inside front cover, the CEN/TR title
page, pages 2 to 28, an inside back cover and a back cover.

The BSI copyright notice displayed in this document indicates when the
document was last issued.

Amendments issued since publication

This Published Document was
published under the authority Amd. No. Date Comments
of the Standards Policy and
Strategy Committee on
8 September 2004

© BSI 8 September 2004

ISBN 0 580 44419 8

TECHNICAL REPORT CEN/TR 13695-2
RAPPORT TECHNIQUE
TECHNISCHER BERICHT September 2004

ICS 1 3.020.30; 55.020 Supersedes CR 1 3695-2:2002

English version

Packaging - Requirements for measuring and verifying the four

heavy metals and other dangerous substances present in
packaging, and their release into the environment - Part 2:
Requirements for measuring and verifying dangerous
substances present in packaging, and their release into the
environment
Emballages - Exigences pour la mesure et la vérification Verpackung - Anforderungen zur Messung und Feststellung
des quatre métaux lourds et autres substances der vier Schwermetalle und der anderen gefährlichen
dangereuses présents dans les emballages, et leur cession Substanzen in Verpackungen und deren Freisetzung in die
dans l'environnement - Partie 2: Exigences pour la mesure Umwelt - Teil 2: Anforderungen zur Messung und
et la vérification des substances dangereuses présentes Feststellung von gefährlichen Substanzen in Verpackungen
dans les emballages, et leur cession dans l'environnement und deren Freisetzung in die Umwelt

This Technical Report was approved by CEN on 7 March 2004. It has been drawn up by the Technical Committee CEN/TC 261 .
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION

COMITÉ EUROPÉEN DE NORMALIS ATION
E U R O P Ä I S C H E S K O M I T E E FÜ R N O R M U N G

Management Centre: rue de Stassart, 36 B-1 050 Brussels

© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 1 3695-2:2004: E
worldwide for CEN national Members.
CEN/TR 1 3695-2:2004 (E)

Contents Page

Foreword..............................................................................................................................................................3
Introduction .........................................................................................................................................................4
1 Scope ......................................................................................................................................................5
2 Normative references ............................................................................................................................5
3 Terms and definitions ...........................................................................................................................5
4 The packaging and packaging waste Directive 94/62/EC requirements ..........................................6
5 Subsequent Directives to be taken in account...................................................................................6
5.1 The Incineration Directives...................................................................................................................6
5.2 The Directive on the landfill of waste ..................................................................................................7
6 Summary of the present situation in industry ....................................................................................7
7 Identification and minimisation of dangerous substances in packaging........................................7
7.1 General principle....................................................................................................................................7
7.2 Identification...........................................................................................................................................8
7.2.1 The ‘Upstream Approach’ as the basic principle ...............................................................................8
7.2.2 The Identification procedure ................................................................................................................8
7.2.3 The use of Safety Data Sheets for determination of presence of dangerous substances
and preparations....................................................................................................................................8
7.3 Release to the environment..................................................................................................................9
7.4 Minimisation ...........................................................................................................................................9
8 Basis for a proposed new standard for presuming compliance with Annex II, paragraph 1 ,
indent 3 of Directive 94/62/EC ..............................................................................................................9
8.1 The principle...........................................................................................................................................9
8.2 Determination of substances to be considered for minimisation ..................................................1 0
8.3 Conformity with the minimisation requirement................................................................................1 0
9 Conclusions .........................................................................................................................................1 0
Annex A (informative) Decision Tree - Minimisation of dangerous substances or preparations
and demonstration of conformity ......................................................................................................1 1
Annex B (informative) Information on current regulation ..........................................................................1 2
Annex C (Informative) Examples of Safety Data Sheets.............................................................................1 5
Bibliography ......................................................................................................................................................28

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 CEN/TR 1 3695-2:2004 (E)

Foreword
This document (CEN/TR 1 3695-2:2004) has been prepared by Technical Committee CEN/TC 261
“Packaging”, the secretariat of which is held by AFNOR.
This document supersedes CR 1 3695-2:2002.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directives, see informative Annex B, which is an integral part of this document.
This Technical Report forms one of a series of standards and reports prepared under Mandate M/200 rev.3
and the Second Standardisation Mandate M/31 7 given to CEN by the European Commission and the
European Free Trade Association to support the European Parliament and Council Directive on Packaging
and Packaging Waste [94/62/EC]. The procedure for applying this Technical Report in conjunction with the
other mandated standards and reports is specified in EN 1 3427.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to announce this Technical Report: Austria, Belgium, Cyprus, Czech Republic, Denmark,
Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg,
Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and the
United Kingdom.

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CEN/TR 1 3695-2:2004 (E)

Introduction
The European Commission gave a mandate to CEN for promoting the preparation of European Standards and
CEN Reports in order to support the application of the Directive 94/62/EC of 20 December 1 994, on
Packaging and Packaging Waste, in particular to elaborate a CEN Report ‘Requirements for measuring and
verifying heavy metals and other dangerous substances present in packaging, and their release into the
environment’.
NOTE The Directive 94/62/EC is amended by European Parliament and Council Directive 2004/1 2/EC of
1 1 February 2004
Part 1 of the CEN Report ‘Requirements for measuring and verifying the four heavy metals present in
packaging, and their release into the environment’ has been previously released, (CR 1 3695-1 ) due to the
priority given in Article 1 1 (1 ) of the Directive to the four heavy metals explicitly mentioned: Lead, Cadmium,
Mercury and Chromium VI.
This document is Part 2 to the CEN Report CR 1 3695 related to other dangerous substances. It refers to the
end-of-life treatment of packaging by incineration or landfilling.
The task of the working group WG 8 ‘Heavy metals and other dangerous substances’ had been attributed by a
resolution of CEN TC 261 /SC 4.
Have been considered for the development of this work:
 the existing European or national regulations (Directives);
 the CEN standardisation on waste TC 292;
 the OECD environment monograph series.
A detailed information on the regulatory context is given in Annex B; however this work is expected to be
compatible with any further evolution of the related regulation, as it is independent of any specific case.
With regard to the number and diversity of substances, which may be considered as dangerous to the
environment, there are no currently available general standardised methods for the systematic measurements
of their presence in emissions, ash or leachate, when packaging or residues from management operations or
packaging waste are incinerated or landfilled. The task of elaborating specific standardised methods for each
substance and applicable in each practical case would be extremely complex and time consuming. This is the
reason why a methodology to estimate or calculate these substances based on the use of Safety Data Sheets
(according to Directive 91 /1 55/EEC) has been developed.
A simple and efficient assessment method suitable for small and medium sized suppliers of packaging is
proposed, based preferentially on an upstream approach (CR 1 3695-1 , 8.1 ).
Guidelines are provided to identify and minimise dangerous substances and a methodology is proposed to
assess the compliance with the requirements of the Directive.

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1 Scope
This document specifies the methodology and procedure for determining the presence and minimisation of
other dangerous substances in relation with Annex II Para 1 Indent 3 of Directive 94/62/EC. This document is
intended to be of practical use, and to enable efficient application of the Directive 94/62/EC, even for small
and medium sized companies in the packaging industry, providing them with a methodology for assessing
compliance with the Directive.
This document cannot by itself provide presumption of conformity. The procedure for applying this document
is contained in EN 1 3427.

2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
EN 1 31 93:2000, Packaging – Packaging and the environment – Terminology.
EN 1 3428, Packaging – Requirements specific to manufacturing and composition – Prevention by source
reduction.

3 Terms and definitions

For the purposes of this document, the terms and definitions given in EN 1 31 93:2000 and Article 3 of Directive
94/62/EC and the following apply.
3.1
substances
chemical elements and their compounds in the natural state or obtained by any production process, including
any additive necessary to preserve the stability of the product, and any impurity deriving from the production
process used, but excluding any solvent which may be separated without affecting the stability of the
substance or changing its composition
NOTE A substance may be chemically very well defined (e.g. acetone) or a complex mixture of constituents of
variable composition (e.g. aromatic distillates). For certain complex substances, some individual constituents have been
identified

[Directive 67/548/EEC as amended by 2001 /59/EC Annex VI, paragraph 1 .7.1 ]

3.2
preparations
mixtures or solutions composed of two or more substances
[Directive 67/548/EEC]
3.3
safety data sheet
documentation provided by any person established within the community who is responsible for placing a
dangerous substance or preparation on the market, whether the manufacturer, importer or distributor
NOTE The Directive requires that documentation to be provided to any recipient who is an industrial user of the
substance or preparation and to contain the information required of the dangerous substance or preparation

[taken from Article 1 (1 ) of Directive 91 /1 55/EEC as amended by Directive 2001 /58/EC]

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CEN/TR 1 3695-2:2004 (E)

3.4
packaging component
part of packaging that can be separated by hand or by using simple physical means
[EN 1 31 93:2000]
3.5
packaging constituent
part from which packaging or its components are made and which cannot be separated by hand or by using
simple physical means
[EN 1 31 93:2000]

4 The packaging and packaging waste Directive 94/62/EC requirements

4.1 The Packaging and Packaging Waste Directive 94/62/EC explains in the 21 st recital of the preamble
that:
"the presence of noxious metals and other substances in packaging should be limited in view of their
environmental impact (in particular in the light of their likely presence in emissions or ash when packaging
is incinerated or in leachate when packaging is landfilled)".
4.2 Article 1 of the Packaging and Packaging Waste Directive 94/62/EC requires the responsible body to:
"prevent any impact on the environment (…) or to reduce such impact, thus providing a high level of
environmental protection".
4.3 Article 1 0 refers to Standardisation:
"in particular relating to (…), the methods for measuring and verifying the presence of heavy metals and
other dangerous substances in the packaging and their release into the environment from packaging and
packaging waste".
4.4 Annex II, paragraph 1 , requires that:
"packaging shall be designed, produced and commercialised in such a way as to permit its reuse or
recovery, including recycling, and to minimise its impact on the environment when packaging waste or
residues from packaging management operations are disposed of".
4.5 In addition Annex II, paragraph 1 , requires that :
"packaging shall be so manufactured, that the presence of noxious and other hazardous substances and
materials as constituents of the packaging material or of any of the packaging components is minimised
with regard to their presence in emissions, ash or leachate when packaging or residues from
management operations or packaging waste are incinerated or landfilled".

5 Subsequent Directives to be taken in account

5.1 The Incineration Directives
Directives 94/67/EC and 2000/76/EC on the incineration of waste are regulating the Municipal Solid Waste
(MSW) incinerators which are equipped to meet the technical and environmental requirements for emissions.
The residues from incineration are also subject to regulations.

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 CEN/TR 1 3695-2:2004 (E)

5.2 The Directive on the landfill of waste

More generally, Directive 1 999/31 /EC on the landfill of waste was adopted on 26 April 1 999 (OJ of
1 6/07/1 999), focused on a high level of environmental protection. New requirements have been introduced for
the reduction of the landfilling of biodegradable waste. This Directive states also that:

 hazardous waste that fulfils defined criteria can only be assigned to landfill for hazardous waste;

 landfill for non-hazardous waste may be used for the disposal of municipal and non-hazardous waste;

 non-hazardous waste is defined as not being covered by the definition given in Article 1 (4) of Council
Directive 91 /689/EEC of 1 2 December 1 991 on hazardous waste. They should not appear on the list
annexed to the Commission Decision 2000/532/EC of 3 May 2000 amended by Commission Decision
2001 /1 1 8/EC of 1 6 January 2001 , or if so not have one or more of the properties listed in Annex II I to
Directive 91 /689/EEC.

6 Summary of the present situation in industry

6.1 The working group has not been able to identify current examples where packaging materials or
components of packaging produced in the EU present a risk to the environment due to the presence of
dangerous substances in use or after use.

One reason is that substances that are dangerous to the environment might be dangerous in other respects
as well, e.g. for the health and safety of consumers. In Article 2 of the Directive 94/62/EC, the importance of
safety, the protection of health and the hygiene of the packed products are emphasised. A possible
consequence of this may be that considerations related to health and safety have already had the effect of
minimising or even eliminating the use of this kind of substances in packaging.

6.2 With regard to the number and diversity of substances that may be considered as dangerous to the
environment, simplified lists of such substances by relating to specific industrial sectors could be useful. Such
lists would facilitate the identification of the substances dangerous to the environment, relevant for a given
packaging supplier, especially for small and medium sized companies.

As a first step an enquiry was carried out in order to obtain detailed information on:

 which substances dangerous for the environment may be present in packaging or packaging
components;

 their usual concentration or range of concentrations;

 their functional use in case of intentional introduction.

Feedback received from industry indicated that in practice the use of Safety Data Sheets instead of using
simplified lists could be more helpful especially for small and medium sized companies to identify noxious or
dangerous substances present in packaging.

7 Identification and minimisation of dangerous substances in packaging

7.1 General principle
The individual or organisation responsible for placing a specific packaging on the market shall be able to
demonstrate that only the minimum adequate amount of any dangerous substance or preparation has been
used in the packaging or packaging component, with regard to its presence in emissions, ash or leachate from
landfills.

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7.2 Identification
7.2.1 The ‘Upstream Approach’ as the basic principle
A simple and efficient assessment method for the identification of dangerous substances in packaging and
packaging materials, especially suitable for small and medium sized suppliers of packaging, is needed. This
document proposes the ‘upstream approach’ as elaborated in CR 1 3695-1 :2000, 8.1 for this purpose.

The upstream verification in the sense of EN ISO 9000:2000 should be traceable by means of information
from the suppliers of raw materials or constituents. This document proposes – as a result of the above
mentioned enquiry (see Clause 6) – the consultation of the relevant Safety Data Sheets which provide enough
information to assess compliance with the Directive 94/62/EC.

7.2.2 The Identification procedure

7.2.2.1 For the purpose of the assessment procedure, ‘dangerous substances’ or ‘noxious and other
hazardous substances’ are defined as:

 any substances classified as dangerous to the environment according to Directive 67/548/EEC

(Dangerous Substances Directive) and its amendments and classified with the symbol N and the
corresponding indication of danger (with the exception of lead, cadmium, mercury and chromium (VI)
and their compounds already considered in CR 1 3695-1 ).

NOTE This is a general list of substances dangerous to the environment and cannot be taken as specifically relating
to substances used in packaging.

7.2.2.2 For the purpose of identification the packaging manufacturer should consult the relevant Safety
Data Sheets which he receives from his supplier. The Safety Data Sheets provide necessary information on
dangerous substances or preparations and enable the packaging manufacturer to verify the presence of
dangerous substances or preparations in his packaging (see 7.2.3.3).

7.2.3 The use of Safety Data Sheets for determination of presence of dangerous substances and
preparations
7.2.3.1 A Safety Data Sheet is documentation provided by any person established within the Community
who is responsible for placing a dangerous substance or preparation on the market, whether the manufacturer,
importer or distributor. The safety data sheet information is principally intended for use by professional users
and shall enable them to take the necessary measures as regards the protection of health, safety and the
environment at the place of work. The safety data sheet may be supplied on paper or electronically.

7.2.3.2 The safety data sheet contains 1 6 obligatory headings. Information on the composition of a
preparation of dangerous substances is given in heading 2. Heading 1 2 (ecotoxicology) requires the
description of the most important characteristic likely to have an effect on the environment due to the nature of
the substance or preparation and likely methods of use. Information of the same kind shall be supplied for
dangerous products arising from the degradation of substances or preparations.

7.2.3.3 For the purpose of identification and verifying the presence of substances or preparations
dangerous to the environment (assigned with the symbol “N”) the packaging manufacturer should receive from
his supplier of dangerous substances or preparations a Safety Data Sheet according to Directive 91 /1 55/EEC
and its amendments (the present last amendment is Directive 2001 /58/EC).

The heading 2 “composition/information on ingredients” should indicate the concentration or concentration

range of substances presenting an environmental hazard within the meaning of Directive 67/548/EEC if they
are present in concentrations equal to or greater than those laid down in the table set out in Article 3(3) of
Directive 1 999/45/EC (unless lower limits are given in Annex I to Directive 67/548/EEC or in Annexes II, III or
V to Directive 1 999/45/EC)”.

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The packaging manufacturers can calculate and so measure the presence of dangerous substances in his
packaging on the basis of information associated with the packaging formulation and manufacturing process.
NOTE More detailed information on the current regulation of dangerous substances and preparations and on safety
data sheets are given in Annex B and Annex C of this document.

7.3 Release to the environment

7.3.1 The presence of dangerous substances in constituents of the packaging material, or in any of the
packaging components, has to be minimised with regard to their presence in emissions, ash or leachate,
when packaging or residues from management operations or packaging waste are incinerated or landfilled.
7.3.2 For the purpose of identification, only dangerous substances assigned with the symbol N that are
likely to be released into the environment have to be considered.
7.3.3 With regard to the number and diversity of substances, which may be considered as dangerous to the
environment, there are no currently available general standardised method for the systematic measurement of
their presence in,emissions, ash or leachate, when packaging or residues from management operations or
packaging waste are incinerated or landfilled.
The task of elaborating specific standardised methods for each substance and applicable in each practical
case can be extremely complex .

Nevertheless, it can be possible in some cases to demonstrate with sound evidence that even when a
substance dangerous to the environment is present in the constituents, there is no risk of it being ultimately
released to the environment.
Examples can be dangerous substances of organic chemical nature, which are destroyed by very high
temperatures or combustion processes. The risk of leaching into landfills can also be related to the chemical
or physical nature of the material considered.

7.4 Minimisation
7.4.1 If a constituent is identified to contain substances dangerous to the environment which are likely to be
released into the environment, then the principle of using only a minimum adequate amount of these
substances should be applied.
7.4.2 The principle of using the minimum adequate amount has to be established in relation to the
functional performances or purposes of the substance being used.
The criteria listed in the EN 1 3428 standard, ‘Packaging – Requirements specific to manufacturing and
composition - Prevention by source reduction’ shall be applicable to describe fitness for functional
performance or purpose.

8 Basis for a proposed new standard for presuming compliance with Annex II,
paragraph 1 , indent 3 of Directive 94/62/EC
8.1 The principle
The individual or organisation responsible for placing a specific packaging on the market (‘packaging supplier’)
shall be able to demonstrate that only the minimum adequate amount of any substance dangerous to the
environment has been used as a constituent of the packaging material or any of the packaging components,
with regard to its presence in emissions, ash or leachate from landfills. The steps taken in order to determine
and demonstrate minimisation are explained below and are shown in the decision tree detailed in the
informative Annex A.

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CEN/TR 1 3695-2:2004 (E)

8.2 Determination of substances to be considered for minimisation

8 . 2.1 The packaging supplier shall first determine if any substance or preparation classified as dangerous to
the environment and assigned with the symbol 'N' used in the manufacturing process of the packaging and/or
packaging components is present in the packaging placed on the market. This determination shall be made
using the Safety Data Sheets for the relevant substance or preparation as so classified in the EC Directives -
Dangerous Substance Directive 67/548/EEC (and its amendments) and the Dangerous Preparation Directive
1 999/45/EC.
If no such substances or preparations have been identified the procedure is concluded. In this case proceed
to 8.3.1 .
If such substances or preparations are present, proceed to 8.2.2.
8.2.2 The packaging supplier shall evaluate the possibility that any of the substances or preparations
identified in 8.2.1 are likely to be present in emissions, ash or leachate resulting from incineration or landfilling
of the packaging or the packaging components after it has been used for its purpose as a packaging.
 If the substances or preparations identified are not likely to be released in emissions, ash or leachate, the
procedure is concluded. In this case consideration of the substances or preparations for minimisation is
not applicable. Proceed to 8.3.1 ;
 if any substance or preparation identified is likely to be released in ash, emission or leachate , the
packaging supplier has to demonstrate conformity with the minimisation requirement and shall proceed to
Clause 8.3.2.

8.3 Conformity with the minimisation requirement

8.3.1 If no substance or preparation as so classified as dangerous to the environment and assigned with
the symbol 'N' has been identified and/or is unlikely to be present in emissions, ash or leachate, the packaging
component conforms with the requirements of Annex II of the Directive 94/62/EC. A record of the data shall be
retained.
8.3.2 If a substance or preparation dangerous to the environment and assigned with the symbol N has been
identified according to the procedure described in 8.2, conformity with the minimisation requirement in
Annex II of Directive 94/62/EC must be demonstrated.
For this purpose the packaging supplier shall:
 document the relevant substances identified in 8.2.1 and 8.2.2; and
 document that only the minimum adequate amount of the relevant substances has been used with regard
to their functional purpose. For the assessment, the method and the performance criteria, described in
EN 1 3428 standard ‘Packaging - Requirements specific to manufacturing and composition - Prevention
by source reduction’ are applicable.

9 Conclusions
To assess compliance with the relevant requirements of the Directive 94/62/EC, guidelines are provided to
identify and measure dangerous substances.

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Annex A
(informative)
Decision Tree - Minimisation of dangerous substances or preparations
and demonstration of conformity

Key
P Preparation
S Substance

Figure A.1

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CEN/TR 1 3695-2:2004 (E)

Annex B
(informative)
Information on current regulation

The classification and labelling of dangerous substances and preparations based on their potential hazard
(the intrinsic properties of chemical compounds to cause harm) are controlled by:
1 ) the ‘ Dangerous Substances Directive’, Council Directive 67/548/EEC on the approximation of the
laws, regulations and administrative provisions of the Member States relating to the classification,
packaging and labelling of dangerous substances. This Directive includes namely an Annex VI, the
Labelling Guide describing the rules for the classification and labelling of dangerous substances and
preparations. The Annex I of the Directive contains the list of dangerous substances classified
according to these criteria by the Committee set in Article 29 for the adaptation of the Directive to the
technical progress.

Where impurities, additives or individual constituents of substances have been identified, they shall
be taken into account if their concentration is greater than or equal to the limits specified: 0,1 % for
substances classified as very toxic, toxic, carcinogenic (category 1 or 2), mutagenic (category 1 or 2),
toxic to reproduction (category 1 or 2), or dangerous for the environment (assigned the symbol N for
the aquatic environment, dangerous for the ozone layer),1 % for substances classified as harmful,
corrosive, irritant sensitising, carcinogenic (category 3), mutagenic (category 3), toxic to reproduction
(category 3), or dangerous for the environment (not assigned the symbol N, i.e. harmful to aquatic
organisms, may cause long-term adverse effects), unless lower values have been specified in Annex
I. With the exception of substances listed specifically in Annex I, classification should be carried out
according to the requirements of Articles 5, 6 and 7 of Council Directive 1 999/45/EC (Dangerous
Preparations Directive, see below). Those articles deal with the rules for the classification for
physico-chemical hazard, human toxicity and ecotoxicity.
The 7th Amendment (Council Directive 92/32/EEC of 30 April 1 992, OJ L 1 54 of 05.06.92) modifies
the rules applied to the definitions, the notification of substances, for the last time.
The 28th Adaptation to the Technical Progress - ATP - (Commission Directive 2001 /59/EC of
06 08 2001 , OJ L 225 of 21 .08.2001 includes the last version of the Labelling Guide (Annex VI) and
the last adaptation of the list of dangerous substances;
2) the ‘ Dangerous Preparations Directive’ Directive 1 999/45/EC of the European Parliament and of
the Council of 31 May 1 999 concerning the approximation of the laws, regulations and administrative
provisions of the Member states relating to the classification, packaging and labelling of dangerous
preparations has been published in OJ L200 of 30 July 1 999. The Member States shall apply the
laws, regulations and administrative provisions from 30 July 2002.
Directive 1 999/45/EC states in Article 1 4:
 the safety data sheet information is principally intended for use by professional users and must
enable them to take the necessary measures as regards the protection of health, safety and the
environment at the place of work;
 member States shall take all the necessary measures to ensure that:
a) the person responsible for placing on the market a preparation within the meaning of Article
1 (2) provides a safety data sheet;

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b) the person responsible for placing on the market a preparation provides on request of a
professional user a safety data sheet providing proportionate information for preparations
not classified as dangerous within the meaning of Articles 5, 6 and 7 but containing in an
≥ ≥
individual concentration of 1 % by weight for non-gaseous preparations and 0,2 % by
volume for gaseous preparations at least:
 one substance posing health or environmental hazards; or
 one substance for which there are Community workplace exposure limits;
 the safety data sheet and its supply must comply with the provisions of Directive 91 /1 55/EEC;
 the necessary amendments required to adapt to technical progress Directive 91 /1 55/EEC shall be
adopted in accordance with the procedure laid down in Article 20 of this Directive. In particular,
the necessary amendments to take account of provisions in paragraph 2.1 (b) shall be adopted
before the date specified in Article 22(1 );
 the safety data sheet may be supplied on paper or electronically, provided that the addressee has
the necessary means of receiving it;
3) the ‘ Safety Data Sheet Directive’, Commission Directive 91 /1 55/EEC of 5 March 1 991 , defining and
laying down the detailed arrangements for the system of specific information relating to dangerous
preparations in implementation of Article 1 4 of European Parliament and of Council Directive
1 999/45/EC and relating to dangerous substances in implementation of Article 27 of Council
Directive 67/548/EEC, amended by Directive 2001 /58/EC of 27 July 2001 (OJ L 21 2 of 07.08.2001 ).
Directive 91 /1 55/EEC stipulates the content of the safety data sheets in article 3. The requirements
for filling the safety data sheets are detailed in the Annex. The safety data sheet shall contain the
following obligatory headings:
1 ) identification of the substance/preparation and of the company/undertaking;
2) composition/information on ingredients;
3) hazards identification;
4) first-aid measures;
5) fire-fighting measures;
6) accidental release measures;
7) handling and storage;
8) exposure controls/personal protection;
9) physical and chemical properties;
1 0) stability and reactivity;
1 1 ) toxicological information;
1 2) ecological information;
1 3) disposal considerations;
1 4) 1 4. transport information;

13
CEN/TR 1 3695-2:2004 (E)

1 5) regulatory information;

1 6) other information.

Information on the composition of a preparation of dangerous substances is given in heading 2.

Heading 1 2 (ecotoxicology) requires the description of the most important characteristic likely to have
an effect on the environment owing to the nature of the substance or preparation and likely methods
of use. Information of the same kind shall be supplied for dangerous products arising from the
degradation of substances or preparations.

14
 CEN/TR 1 3695-2:2004 (E)

Annex C
(Informative)
Examples of Safety Data Sheets

Example 1 : Safety Data Sheet

Primer extrusion
Example 2 : Safety Data Sheet

Glass varnish

15
CEN/TR 1 3695-2:2004 (E)

SAFETY DATA SHEET

1 – IDENTIFICATION OF THE PREPARATION AND COMPANY

Product Name: PRIMER EXTRUSION
Code: 80RI993098J04
Intended use: Printing inks and varnishes for professional users.
Company: xxx TEL:
FAX:
Emergency phone: INRS TEL: (33) 01 .45.42.59.59

2 – COMPOSITION / INFORMATION ON INGREDIENTS

SUBSTANCES PRESENTING A HEALTH HAZARD WITHIN THE MEANING OF DANGEROUS
SUBSTANCES DIRECTIVE 67/548/EC.

NAME: EEC/EINECS N° CONC% SYMB R-PHRASES

1 0-20 Xn N R22 R50/53

3 – HAZARDS IDENTIFICATION OF THE PREPARATION

According to Directive 1 999/45/EC, the preparation is not classified as a dangerous preparation.

4 – FIRST AID MEASURES

General:
In case of doubt, when symptoms persist, seek medical attention . NEVER GIVE ANYTHING BY MOUTH TO
AN UNCONCIOUS PERSON.
Inhalation:
No particular measures.
Eye contact:
Irrigate copiously with clean, fresh water for at least 1 0 minutes, holding the eyelids apart and seek medical
advice.
Skin contact:
Remove contaminated clothing. Wash skin thoroughly with soap and water or use recognised skin cleanser.
DO NOT USE SOLVENTS OR THINNERS.
Ingestion:
If accidentally swallowed, obtain immediate medical attention. Keep at rest.
DO NOT INDUCE VOMITING.

16
 CEN/TR 1 3695-2:2004 (E)

5 – FIRE – FIGHTING MEASURES

Extinguishing Media:
Recommended: Alcohol resistant foam, CO2, powders, water spray.
Not to be used: Waterjet.
Recommendations :
Fire may produce dense smoke. Exposure to decomposition products may cause a health hazard. Appropriate
breathing apparatus may be required.

Cool closed containers exposed to fire with water. Do not allow run off from fire fighting to enter drains or
watercourses.

6 – ACCIDENTAL RELEASE MEASURES

Personal related precautionary measures:
See the protection measures mentioned in headings 7 and 8.

Spillage control :
Contain and collect spillage with non-combustible absorbent materials (e.g. sand, earth, vermiculite,… ) and
place in container for disposal according to local regulations (see heading 1 3).

Do not allow to enter drains or watercourses. Clean preferably with a detergent; avoid use of solvents.

Environmental protection :
If the product contaminates lakes, rivers or sewage, inform appropriate authorities in accordance with local
regulations.

7 – HANDLING AND STORAGE

Handling :
Before any handling, see headings 3, 8 and 1 1 .

Avoid skin and eye contact. Avoid inhalation of vapour or dust.

Smoking, eating and drinking should be prohibited in application area. For personal protection see heading 8.

Never use pressure to empty: container is not a pressure vessel. Always keep in containers of same materials
as the original one. Comply with the health and safety at work laws.

Storage:
Observe eventual label precautions. Store secured from frost in a dry well ventilated place away from sources
of heat and direct sunlight. Keep away from sources of ignition. No smoking. Containers which are opened
shall be carefully resealed and kept upright to prevent leakage.

17
CEN/TR 1 3695-2:2004 (E)

8 – EXPOSURE CONTROLS / PERSONAL PROTECTION

Engineering measures:
No particular measures.

Exposure limits :
SUBSTANCES VALUES
Not applicable.

Personal protection :
Respiratory protection:
Not applicable.

Hand protection:
Protective gloves or barrier creams are recommended.

Eye protection:
Safety eyewear designed to protect against splash of liquids are recommended.

Other: Wear appropriate work clothing.

9 – PHYSICAL AND CHEMICAL PROPERTIES

Physical state: LIQUID Colour: colourless Odour:
Solubility in water: NO
Solubility in other solvents:
Density:
pH: Not applicable
Viscosity: Not applicable
Initial distillation temperature: 200 °C
Flash point: Not applicable
Combustibility: YES (according to Norm NF 64-024 – Hydro-alcoholic preparation)
Auto-ignition temperature : Not applicable
Melting point: Not applicable
Lower explosion limit: Not measured
Upper explosion limit: Not measured

18
 CEN/TR 1 3695-2:2004 (E)

1 0 – STABILITY AND REACTIVITY

Stable under recommended storage and handling conditions (see heading 7).
When exposed to high temperatures may produce hazardous decomposition products such as carbon
monoxide and dioxide, smoke, oxides of nitrogen.

1 1 – TOXICOLOGICAL INFORMATION
There are no data available on the preparation itself.

According to the present state of our knowledge, the components of this preparation no not present any
known toxicological risks.

1 2 – ECOLOGICAL INFORMATION
There are no data available on the preparation itself.

The product should not be allowed to enter drains or watercourses.

1 3 – DISPOSAL CONSIDERATIONS
Do not empty into drains or watercourses.

Waste and emptied containers shall be disposed in accordance with local regulations.

Accordance to Directive 1 994/904/EC the ink wastes are classified as follows:

801 02 Waste ink and varnish free of halogenated solvents

080301 Ink wastes containing halogenated solvents

080302 Ink wastes free of halogenated solvents

080305 Ink sludges containing halogenated solvents

080306 Ink sludges free of halogenated solvents

1 401 03 Other solvents and solvent mixes

1 401 05 Aqueous solvent mixes free of halogens

Beware that ink wastes have to be considered as special wastes and require a particular attention. Ink wastes
have to be eliminated by authorized companies according to the local prescriptions.

19
CEN/TR 1 3695-2:2004 (E)

1 4 – TRANSPORT INFORMATION
The preparation shall be transported according to the following regulations:

Not applicable
UN-N°:

ADR/RID/ADN (Road/Rail/Inland waterways) Class :

IMDG (Sea) Class : Packaging group:

EMS-N °:

IATA (Air) Class :

Proper shipping name:

Marine pollutant:

1 5 – REGULATORY INFORMATION
According to Directive 1 999/45/EC, the preparation is not regulated.

1 6 – OTHER INFORMATION
Full text of R-PHRASES with the N° appearing in Clause 2:

R22 Harmful if swallowed.

R50/53 Very toxic to aquatic organisms, may cause long-term

adverse effects in the aquatic environment.

The information of this MSDS is based on the present state of our knowledge and on current EEC and
national laws, as the user’s working conditions are beyond our knowledge and control.

The product is not to be used for other purposes than those specified under heading 1 without first obtaining
written handling instruction.

It is always the responsibility of the user to take all necessary steps in order to fulfil the demand laid down in
the local rules and legislation.

The information in this MSDS is meant as a description on the safety requirements of the product: it is not to
be considered as a guarantee of the product’s properties.

The information in this MSDS is required pursuant to the Directive 2001 /58/EC.

20
 CEN/TR 1 3695-2:2004 (E)

SAFETY DATA SHEET

1 – IDENTIFICATION OF THE PREPARATION AND COMPANY

Product Name: GLASS VARNISH

Code: 1 2SI008881 E01

Intended use: Printing inks and varnishes for professional users.

Company: xxx TEL:

FAX:

Emergency phone: INRS TEL: (33) 01 .45.42.59.59

2 – COMPOSITION / INFORMATION ON INGREDIENTS

SUBSTANCES PRESENTING A HEALTH HAZARD WITHIN THE MEANING OF DANGEROUS
SUBSTANCES DIRECTIVE 67/548/EC.

NAME: EEC/EINECS N° CONC % SYMB R-PHRASES

Trimethylolpropane triacrylate 607-1 1 1 -00-9 5-1 0 Xi R36/38 R43
hexane-1 ,6 - diol diacrylate 607-1 09-88-08 1 0-20 Xi R36/38 R43
Tripropylene glycol diacrylate 1 0-20 Xi N R36/37/38 R43 R51 /5
aromatic hydrocarbone 65-1 99-0 0,1 -1 Xn N R65 R36/38 R22 R51 /2,2
dimethoxy-1 ,2 – diphenylethan-1 -o 2463866 1 -5 N R50/53
Benzophenone 5-1 0 Xn N R22 R38 R50/53
Acrylates 607-1 33-00-9 20-30 Xi R36/37/38

3 – HAZARDS IDENTIFICATION OF THE PREPARATION

Symbols : XI IRRITANT N Dangerous for the environment
R43 May cause sensitisation by skin contact.

R36/37/38 Irritating to eyes, respiratory system and skin.

R51 /53 Toxic to aquatic organisms, may cause long-term

adverse effects in the aquatic environment.

According to Directive 1 999/45/EC, the preparation is not classified as a dangerous preparation.

21
CEN/TR 1 3695-2:2004 (E)

4 – FIRST AID MEASURES

General:
In all cases of doubt, when symptoms persist, seek medical attention. NEVER GIVE ANYTHING BY MOUTH
TO AN UNCONCIOUS PERSON.
Inhalation:
Remove to fresh air, keep patient and at rest. If unconscious, place in recovery position and seek medical
advice.

Eye contact:
Irrigate copiously with clean, fresh water for at least 1 0 minutes, holding the eyelids apart and seek medical
advice.

Skin contact:
Remove contaminated clothing. Wash skin thoroughly with soap and water or use recognised skin cleanser.
DO NOT USE SOLVENTS OR THINNERS.
Ingestion:
If accidentally swallowed, obtain immediate medical attention. Keep at rest. DO NOT INDUCE VOMITING.
5 – FIRE – FIGHTING MEASURES
Extinguishing Media:
Recommended: Alcohol resistant foam, CO2, powders, water spray.
Not to be used: Waterjet.
Recommendations :
Fire may produce dense smoke. Exposure to decomposition products may cause a health hazard. Appropriate
breathing apparatus may be required.

Cool closed containers exposed to fire with water. Do not allow run off from fire fighting to enter drains or
watercourses.

6 – ACCIDENTAL RELEASE MEASURES

Personal related precautionary measures:
See the protection measures mentioned in headings 7 and 8.

Spillage control:
Contain and collect spillage with non-combustible absorbent materials (e.g. sand, earth, vermiculite,… ) and
place in container for disposal according to local regulations (see heading 1 3).

Do not allow to enter drains or watercourses. Clean preferably with a detergent; avoid use of solvents.

Environmental protection:
If the product contaminates lakes, rivers or sewage, inform appropriate authorities in accordance with local
regulations.

22
 CEN/TR 1 3695-2:2004 (E)

7 – HANDLING AND STORAGE

Handling:
Before any handling, see heading 3, 8 and 1 1 .
Persons with a history of skin sensitisation problems should not be employed in any process in which this
preparation is used.
Avoid skin and eye contact. Avoid inhalation of vapour or dust.
Smoking, eating and drinking should be prohibited in application area. For personal protection, see heading 8.
Never use pressure to empty: container is not a pressure vessel. Always keep in containers of same materials
as the original one. Comply with the health and safety at work laws.
Storage:
Observe eventual label precautions. Store secured from frost in a dry well ventilated place away from sources
of ignition. No smoking. Containers which are opened shall be carefully resealed and kept upright to prevent
leakage.

8 – EXPOSURE CONTROLS / PERSONAL PROTECTION

Engineering measures:
Provide adequate ventilation. Where reasonably practicable, this should be achieved by the use of local
exhaust ventilation and good general.

Exposure limits :
SUBSTANCES VALUES
Not applicable

Personal protection:
Respiratory protection:
No particular measures.

Hand protection:
Protective gloves or barrier creams are recommended.

Hand protection:
Wear appropriate protective gloves. Barrier creams may help to protect the exposed areas of the skin, they
should be however not be applied once exposure has occurred.

Eye protection:
Use safety eyewear designed to protect against splash of liquids.

Other: Wear appropriate work clothing.

23
CEN/TR 1 3695-2:2004 (E)

9 – PHYSICAL AND CHEMICAL PROPERTIES

Physical state: LIQUID Colour: Colourless Odour:

Solubility in water: NO

Solubility in other solvents: PARTIAL

Density: pH:

Viscosity: Not applicable

Initial distillation temperature: 1 68 °C

Flash point: 1 01 °C

Combustibility: Not applicable (according to Norm NF 64-024 – Hydro-alcoholic preparation)

Auto-ignition temperature: 1 90 °C

Melting point: Not applicable

Lower explosion limit: Not measured

Upper explosion limit: Not measured

1 0 – STABILITY AND REACTIVITY

Stable under recommended storage and handling conditions (see heading 7).
This preparation contains materials which are unstable under the following conditions:
Exposure to temperature higher than 40 °C – To strong UV sources – Prolonged exposure to light.
These could cause the product to polymerise exothermically.

24
 CEN/TR 1 3695-2:2004 (E)

1 1 – TOXICOLOGICAL INFORMATION
There are no data available on the preparation itself.
The components of the preparation present some known toxicological risks.
Acrylic components of the preparation have irritating properties. Prolonged or repeated contacts with the skin
or mucous membranes may result in irritation symptoms such as redness, blistering, dermatitis, etc… Cases
of allergic skin reactions have been observed.
The liquid splashed in the eyes may cause irritation.
The inhalation of aerial droplets or aerosols may cause irritation of the respiratory tracts.
Ingestion may cause collapses, severe respiratory difficulties and central nervous system stimulations.

1 2 – ECOLOGICAL INFORMATION
There are no data available on the preparation itself.
The product should not be allowed to enter drains or watercourses.

1 3 – DISPOSAL CONSIDERATIONS
Do not empty into drains or watercourses.
Waste and emptied containers shall be disposed in accordance with local regulations.
Accordance to Directive 1 994/904/EC the ink wastes are classified as follows:

801 02 Waste ink and varnish free of halogenated solvents

080301 Ink wastes containing halogenated solvents
080302 Ink wastes free of halogenated solvents
080305 Ink sludges containing halogenated solvents
080306 Ink sludges free of halogenated solvents
1 401 03 Other solvents and solvent mixes
1 401 05 Aqueous solvent mixes free of halogens

Beware that ink wastes have to be considered as special wastes and require a particular attention. Ink wastes
have to be eliminated by authorized companies according to the local prescriptions.

25
CEN/TR 1 3695-2:2004 (E)

1 4 – TRANSPORT INFORMATION
The preparation shall be transported according to the following regulations:

Not applicable
UN-N°:
ADR/RID/ADN (Road/Rail/Inland waterways) Class :
UMDG (Sea) Class : Packaging group:
EMS-N °:
IATA (Air) Class :
Proper shipping name:
Marine pollutant:
1 5 – REGULATORY INFORMATION
According to Directive 1 999/45/EC, the preparation is not regulated as follows:

Symbol: Xi IRRITANT

Contains: Trimethylolpropane triacrylate

Hexane – 1 ,6 – diol diacrylate

Tripropylene glycol diacrylate

R-Phrases : R43 May cause sensitization by skin contact.

R36/37/38 Irrtitating to eyes, respiratory system and skin.

R51 /53 Toxic to aquatic organisms, may cause long-term

adverse effects in the aquatic environment.

S-Phrases : S24 Avoid contact with skin.

S26 In case of contact with eyes, rinse immediately

with plenty of water and seek medical advice.

S37 Wear suitable gloves.

S51 Use only in well–ventilated areas.

26
 CEN/TR 1 3695-2:2004 (E)

1 6 – OTHER INFORMATION
Full text of R-PHRASES with the N° appearing in heading 2:
R36/38 Irritating to eyes and skin.

R43 May cause sensitization by skin contact.

R36/37/38 Irritating to eyes, respiratory system and skin.

R51 /53 Toxic to aquatic organisms, may cause long-term

adverse effects in the aquatic environment.

R22 Harmful is swallowed.

R50/53 Very toxic to aquatic organisms, may cause long-term

adverse effects in the aquatic environment.

R38 Irritating to skin.

S24 Avoid contact with skin.

S26 In case of contact with eyes, rinse immediately

with plenty of water and seek medical advice.

S37 Wear suitable gloves.

S50 Do not mix with … (to be specify by the manufacturer).

The information of this SDS is based on the present state of our knowledge and on current EEC and national
laws, as the user’s working conditions are beyond our knowledge and control.

The product is not to be used for other purposes than specified under heading 1 without first obtaining written
handling instruction.

It is always the responsibility of the user to take all necessary steps in order to fulfil the demand laid down in
the local rules and legislation.

The information in this SDS is meant as a description on the safety requirements of our product: it is not to be
considered as a guarantee of the product’s properties.

The information in this SDS is required pursuant to the Directive 2001 /58/EC.

27
CEN/TR 1 3695-2:2004 (E)

Bibliography

[1 ] EN ISO 9000:2000, Quality management systems – Fundamentals and vocabulary (ISO 9000:2000).
[2] EN 1 3427, Packaging – Requirements for the use of European Standards in the field of packaging and
packaging waste.
[3] CR 1 3695-1 :2000, Packaging – Requirements for measuring and verifying the four heavy metals and
other dangerous substances present in packaging and their release into the environment – Part 1 :
Requirements for measuring and verifying the four heavy metals present in packaging.

28
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PD CEN/TR
13695-2:2004
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