SIST-TP CEN/TR 13695-2:2005
(Main)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
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
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 13427.
Verpackung - Anforderungen zur Messung und Feststellung der vier Schwermetalle und anderen gefährlichen Substanzen in Verpackungen und deren Freisetzung in die Umwelt - Teil 2: Anforderungen zur Messung und Feststellung von gefährlichen Substanzen in Verpackungen und deren Freisetzung in die Umwelt
Emballages - Exigences pour la mesure et la vérification des quatre métaux lourds et autres substances dangereuses présents dans l'emballage, et leur cession dans l'environnement - Partie 2: Exigences pour la mesure et la vérification des substances dangereuses présentes dans l'emballage, et leur cession dans l'environnement
Le présent document spécifie une méthodologie et un mode opératoire permettant de déterminer et de réduire au minimum possible la présence d'autres substances dangereuses conformément a l'alinéa 3 du paragraphe 1 de l'Annexe II de la Directive 94/62/CE. Ce rapport vise a etre d'usage pratique, a permettre la meilleure application possible de la Directive 94/62/CE, y compris pour les petites et moyennes entreprises de l'industrie de l'emballage et a offrir a celles-ci une méthodologie pour évaluer leur conformité a la Directive.
Le présent document ne peut en soi conférer présomption de conformité. Sa procédure d'application figure dans l'EN 13427.
Embalaža – Zahteve za merjenje in overjanje štirih težkih kovin in drugih nevarnih snovi v embalaži ter njihov izpust v okolje - 2. del: Zahteve za merjenje in overjanje nevarnih snovi v embalaži ter njihov izpust v okolje
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST-TP CEN/TR 13695-2:2005
01-marec-2005
1DGRPHãþD
SIST CR 13695-2:2002
Embalaža – Zahteve za merjenje in overjanje štirih težkih kovin in drugih nevarnih
snovi v embalaži ter njihov izpust v okolje - 2. del: Zahteve za merjenje in overjanje
nevarnih snovi v embalaži ter njihov izpust v okolje
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
Verpackung - Anforderungen zur Messung und Feststellung der vier Schwermetalle und
anderen gefährlichen Substanzen in Verpackungen und deren Freisetzung in die Umwelt
- Teil 2: Anforderungen zur Messung und Feststellung von gefährlichen Substanzen in
Verpackungen und deren Freisetzung in die Umwelt
Emballages - Exigences pour la mesure et la vérification des quatre métaux lourds et
autres substances dangereuses présents dans l'emballage, et leur cession dans
l'environnement - Partie 2: Exigences pour la mesure et la vérification des substances
dangereuses présentes dans l'emballage, et leur cession dans l'environnement
Ta slovenski standard je istoveten z: CEN/TR 13695-2:2004
ICS:
13.020.40 Onesnaževanje, nadzor nad Pollution, pollution control
onesnaževanjem in and conservation
ohranjanje
55.020 Pakiranje in distribucija blaga Packaging and distribution of
na splošno goods in general
SIST-TP CEN/TR 13695-2:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST-TP CEN/TR 13695-2:2005
TECHNICAL REPORT
CEN/TR 13695-2
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
September 2004
ICS 13.020.30; 55.020 Supersedes CR 13695-2:2002
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 NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 13695-2:2004: E
worldwide for CEN national Members.
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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 .10
8.3 Conformity with the minimisation requirement.10
9 Conclusions .10
Annex A (informative) Decision Tree - Minimisation of dangerous substances or preparations
and demonstration of conformity .11
Annex B (informative) Information on current regulation .12
Annex C (Informative) Examples of Safety Data Sheets.15
Bibliography .28
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Foreword
This document (CEN/TR 13695-2:2004) has been prepared by Technical Committee CEN/TC 261
“Packaging”, the secretariat of which is held by AFNOR.
This document supersedes CR 13695-2:2002.
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/317 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 13427.
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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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 1994, 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 2004/12/EC of
11 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 13695-1) due to the
priority given in Article 11(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 13695 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 91/155/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 13695-1, 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 13427.
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 13193:2000, Packaging – Packaging and the environment – Terminology.
EN 13428, 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 13193:2000 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 91/155/EEC as amended by Directive 2001/58/EC]
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3.4
packaging component
part of packaging that can be separated by hand or by using simple physical means
[EN 13193:2000]
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 13193:2000]
4 The packaging and packaging waste Directive 94/62/EC requirements
st
4.1 The Packaging and Packaging Waste Directive 94/62/EC explains in the 21 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 10 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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5.2 The Directive on the landfill of waste
More generally, Directive 1999/31/EC on the landfill of waste was adopted on 26 April 1999 (OJ of
16/07/1999), 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 12 December 1991 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
2001/118/EC of 16 January 2001, or if so not have one or more of the properties listed in Annex III 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 13695-1:2000, 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 13695-1).
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 16 obligatory headings. Information on the composition of a
preparation of dangerous substances is given in heading 2. Heading 12 (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 91/155/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 1999/45/EC (unless lower limits are given in Annex I to Directive 67/548/EEC or in Annexes II, III or
V to Directive 1999/45/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 13428 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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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
1999/45/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 be
...
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