SIST-TP CEN/TR 13695-2:2019
(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 minimization 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 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
Dieses Dokument legt die Verfahrensweise und das Verfahren zur Bestimmung des Vorhandenseins anderer gefährlicher Substanzen und zu deren Minimierung in Zusammenhang mit Anhang II, Absatz 1, Einrückung 3 der Richtlinie 94/62/EG fest. Dieses Dokument ist für den praktischen Gebrauch vorgesehen und soll auch kleinen und mittelständischen Firmen in der Verpackungsindustrie eine wirksame Anwendung der Richtlinie 94/62/EG ermöglichen, indem ihnen ein Verfahren für die Bewertung der Übereinstimmung mit der Richtlinie zur Verfügung gestellt wird.
Dieses Dokument kann nicht eigenständig zur Festlegung der Konformitätsvermutung genutzt werden. Das Vorgehen bei der Anwendung dieses Dokumentes ist in EN 13427 enthalten.
Emballage - 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 les emballages, et leur cession dans l'environnemen
Embalaža - Zahteve za merjenje in overjanje štirih težkih kovin in drugih nevarnih snovi v embalaži ter njihovo sproščanje v okolje - 2. del: Zahteve za merjenje in overjanje nevarnih snovi v embalaži ter njihovo sproščanje v okolje
Ta dokument določa metodologijo in postopek za ugotavljanje prisotnosti drugih nevarnih snovi in njihovo zmanjšanje v zvezi z dodatkom II, 3 alinejo 1. odstavka, direktive 94/62/ES. Ta dokument je predviden za praktično uporabo in učinkovito uporabo direktive 94/62/ES, tudi za mala in srednje velika podjetja v embalažni industriji, tako da jim zagotavlja metodologijo za ocenjevanje skladnosti s to direktivo.
Ta dokument sam ne more zagotoviti domneve o skladnosti. Postopek za uporabo tega dokumenta je naveden v standardu EN 13427.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST-TP CEN/TR 13695-2:2019
01-april-2019
1DGRPHãþD
SIST-TP CEN/TR 13695-2:2005
(PEDODåD=DKWHYH]DPHUMHQMHLQRYHUMDQMHãWLULKWHåNLKNRYLQLQGUXJLKQHYDUQLK
VQRYLYHPEDODåLWHUQMLKRYRVSURãþDQMHYRNROMHGHO =DKWHYH]DPHUMHQMHLQ
RYHUMDQMHQHYDUQLKVQRYLYHPEDODåLWHUQMLKRYRVSURãþDQMHYRNROMH
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
Emballage - 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 les emballages, et leur cession dans l'environnemen
Ta slovenski standard je istoveten z: CEN/TR 13695-2:2019
ICS:
13.020.30 Ocenjevanje vpliva na okolje Environmental impact
assessment
55.020 Pakiranje in distribucija blaga Packaging and distribution of
na splošno goods in general
SIST-TP CEN/TR 13695-2:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST-TP CEN/TR 13695-2:2019
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SIST-TP CEN/TR 13695-2:2019
CEN/TR 13695-2
TECHNICAL REPORT
RAPPORT TECHNIQUE
February 2019
TECHNISCHER BERICHT
ICS 13.020.30; 55.020 Supersedes CEN/TR 13695-2:2004
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
Emballage - Exigences pour la mesure et la vérification Verpackung - Anforderungen zur Messung und
des quatre métaux lourds et autres substances Feststellung der vier Schwermetalle und anderen
dangereuses présents dans l'emballage, et leur cession gefährlichen Substanzen in Verpackungen und deren
dans l'environnement - Partie 2 : Exigences pour la Freisetzung in die Umwelt - Teil 2: Anforderungen zur
mesure et la vérification des substances dangereuses Messung und Feststellung von gefährlichen Substanzen
présentes dans les emballages, et leur cession dans in Verpackungen und deren Freisetzung in die Umwelt
l'environnement
This Technical Report was approved by CEN on 23 December 2018. It has been drawn up by the Technical Committee CEN/TC
261.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 13695-2:2019 E
worldwide for CEN national Members.
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CEN/TR 13695-2:2019 (E)
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 The packaging and packaging waste Directive 94/62/EC requirements . 7
5 Subsequent Directives to be taken in account . 8
5.1 The Incineration Directives . 8
5.2 The Directive on the landfill of waste . 8
6 Summary of the present situation in industry . 8
7 Identification and minimization of dangerous substances in packaging . 9
7.1 General principle . 9
7.2 Identification . 9
7.2.1 The ‘Upstream Approach’ as the basic principle . 9
7.2.2 The Identification procedure . 9
7.2.3 The use of Safety Data Sheets for determination of presence of dangerous substances and
preparations . 10
7.3 Release to the environment . 11
7.4 Minimization . 11
8 Basis for a proposed new standard for presuming compliance with Annex II, paragraph 1,
indent 3 of Directive 94/62/EC . 11
8.1 The principle . 11
8.2 Determination of substances to be considered for minimization . 11
8.3 Conformity with the minimization requirement. 12
9 Conclusions . 12
Annex A (informative) Decision Tree — Minimization of dangerous substances or preparations and
demonstration of conformity . 13
Annex B (informative) Information on current regulation . 14
Bibliography . 17
2
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CEN/TR 13695-2:2019 (E)
European foreword
This document (CEN/TR 13695-2:2019) has been prepared by Technical Committee CEN/TC 261
“Packaging”, the secretariat of which is held by AFNOR.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes CEN/TR 13695-2:2004.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association.
For information on current regulation, see informative Annex B.
This document forms one of a series of standards and reports prepared under Mandate M/200 rev.3 and
the Second Standardization 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 document in conjunction with the
other mandated standards and reports is specified in EN 13427.
3
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CEN/TR 13695-2:2019 (E)
Introduction
The European Commission gave a mandate to CEN for promoting the preparation of European Standards
and CEN Technical Reports in order to support the application of Directive 94/62/EC of
20 December 1994, on Packaging and Packaging Waste, in particular to elaborate a CEN Technical Report
‘Requirements for measuring and verifying heavy metals and other dangerous substances present in
packaging, and their release into the environment’.
NOTE 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/TR / CR 13695 series 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.
The following elements were considered for the development of this work:
— the existing European or national regulations (Directives);
— the CEN standardization on waste (CEN/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 standardized 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
standardized 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 13695-1:2000, 8.1).
Guidelines are provided to identify and minimize dangerous substances and a methodology is proposed
to assess the compliance with the requirements of the Directive.
Since the publication of the previous edition of this document in 2004 a new chemicals regulation has
been introduced within the community (REACH, Regulation (EC) No 1907/2006 concerning the
Registration, Evaluation, Authorisation and Restriction of Chemicals). Also, an adaptation to the Global
Harmonized System (GHS) of Classification and Labelling of Chemicals has been made (CLP,
Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures)
repealing Directive 67/548/EEC (Dangerous Substances) and Directive 1999/45/EC (Dangerous
Preparations). The REACH and CLP legislations now in force use different terminology and description of
hazard statements compared to what is used in this document and in the connected standard EN 13428.
4
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CEN/TR 13695-2:2019 (E)
Due to the lack of mandate for a complete and joint update of the two documents reflecting the changed
legislation, instead this document has been amended with minimum necessary explanatory text to be
able to follow the assessment method. The amended document provides a “translation key” allowing for
continued understanding and use of both CEN/TR 13695-2 and EN 13428.
Key differences relevant for the understanding and use of this document and EN 13428 are summarized
in the table below. Throughout the report text ‘Notes’ are used to highlight differences in terminology,
hazard descriptions and labelling criteria in the legislation now in force compared to what is used in
CEN/TR 13695-2 and EN 13428.
Table 1 — Key differences in chemicals legislation, terminology and description of labelling
criteria relevant for CEN/TR 13695-2 and EN 13428
CEN/TR 13695-2:2004 and EN 13428:2004 CEN/TR 13695-2:2018
Repealed Directives: Replaced by:
Directive 67/548/EEC (Dangerous Substances) REACH, Regulation (EC) No 1907/2006
and Directive 1999/45/EC (Dangerous concerning the Registration, Evaluation,
Preparations) Authorisation and Restriction of Chemicals) and
CLP, Regulation (EC) No 1272/2008 on
Classification, Labelling and Packaging of
Substances and Mixtures
Term ‘Dangerous’ Replaced by term ‘Hazardous’
Term ‘Preparation’ Replaced by term ‘Mixture’
Criteria for identification of ‘noxious and other Recommended interpretation:
hazardous substances’:
‘Meet the criteria of labelling with the
Any substances classified as dangerous to the environmental hazard pictogram’
environment and assigned with the symbol N and
a
corresponding indication of danger’
a
Classification criteria for labelling with the dangerous to the Environment pictogram.
5
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CEN/TR 13695-2:2019 (E)
1 Scope
This document specifies the methodology and procedure for determining the presence and minimization
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 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 documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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
CR 13695-1:2000, 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
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN 13193:2000 and the following
apply.
NOTE See the definitions in Article 3 of Directive 94/62/EC.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
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 1 to entry: 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.
[SOURCE: Directive 67/548/EEC as amended by 2001/59/EC Annex VI, paragraph 1.7.1]
6
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3.2
preparations
mixtures or solutions composed of two or more substances
[SOURCE: Directive 67/548/EEC]
Note 1 to entry: Regulation (EC) No 1907/2006 and Regulation (EC) No 1272/2008 (REACH and CLP) replacing
Directive 67/548/EEC use the term mixtures.
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 1 to entry: 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.
[SOURCE: Article 1(1) of Directive 91/155/EEC as amended by Directive 2001/58/EC]
3.4
packaging component
part of packaging that can be separated by hand or by using simple physical means
[SOURCE: EN 13193:2000, 3.1.1]
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
[SOURCE: EN 13193:2000, 3.1.2]
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 Standardization:
“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”.
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4.4 Annex II, paragraph 1, requires that:
“packaging shall be designed, produced and commercialized in such a way as to permit its reuse or
recovery, including recycling, and to minimize 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 minimized
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.
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 Directive 94/62/EC, the
importance of safety, the protection of health and the hygiene of the packed products is emphasized. A
possible consequence of this may be that considerations related to health and safety have already had the
effect of minimizing 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:
8
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CEN/TR 13695-2:2019 (E)
— 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 minimization of dangerous substances in packaging
7.1 General principle
The individual or organization 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.
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 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 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 1 This is a general list of substances dangerous to the environment and cannot be taken as specifically
relating to substances used in packaging.
NOTE 2 N-classification as an indication for danger and criteria for labelling with Dangerous for the Environment
pictogram does not exist in Regulation (EC) No 1907/2006 and Regulation (EC) No 1272/2008 (REACH and CLP)
replacing 67/548/EEC.
Recommended interpretation:
— any substances classified as hazardous to the environment and meeting the criteria of labelling with
the environmental hazard pictogram according to Regulation (EC) No 1907/2006 and
Regulation (EC) No 1272/2008 (REACH and CLP), (with the exception of lead, cadmium, mercury
and chromium (VI) and their compounds already considered in CR 13695-1).
9
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CEN/TR 13695-2:2019 (E)
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.
NOTE Information on composition is given in heading 3 following Regulation (EC) No 1907/2006 and
Regulation (EC) No 1272/2008 (REACH and CLP).
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)”.
NOTE 1 N-classification as an indication for danger and criteria for labelling with Dangerous for the Environment
pictogram does not exist in Regulation (EC) No 1907/2006 and Regulation (EC) No 1272/2008 (REACH and CLP)
replacing Directive 67/548/EEC.
Recommended interpretation:
— any substances classified as hazardous to the environment and meeting the criteria of labelling with
the environmental hazard pictogram according to Regulation (EC) No 1907/2006 and
Regulation (EC) No 1272/2008 (REACH and CLP), (with the exception of lead, cadmium, mercury
and chromium (VI) and their compounds already considered in CR 13695-1).
NOTE 2 Information on composition is given in heading 3 following Regulation (EC) No 1907/2006 and
Regulation (EC) No 1272/2008 (REACH and CLP).
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 3 More detailed information on t
...
SLOVENSKI STANDARD
kSIST-TP FprCEN/TR 13695-2:2018
01-oktober-2018
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
Ta slovenski standard je istoveten z: FprCEN/TR 13695-2
ICS:
13.020.30 Ocenjevanje vpliva na okolje Environmental impact
assessment
55.020 Pakiranje in distribucija blaga Packaging and distribution of
na splošno goods in general
kSIST-TP FprCEN/TR 13695-2:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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kSIST-TP FprCEN/TR 13695-2:2018
FINAL DRAFT
TECHNICAL REPORT
FprCEN/TR 13695-2
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
August 2018
ICS 13.020.30; 55.020 Will supersede CEN/TR 13695-2:2004
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
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
This draft Technical Report is submitted to CEN members for Vote. It has been drawn up by the Technical Committee CEN/TC
261.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.
Warning : This document is not a Technical Report. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a Technical Report.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. FprCEN/TR 13695-2:2018 E
worldwide for CEN national Members.
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Contents Page
European foreword . 3
Introduction . 4
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 The packaging and packaging waste Directive 94/62/EC requirements . 7
5 Subsequent Directives to be taken in account . 8
5.1 The Incineration Directives . 8
5.2 The Directive on the landfill of waste . 8
6 Summary of the present situation in industry . 8
7 Identification and minimization of dangerous substances in packaging . 9
7.1 General principle . 9
7.2 Identification . 9
7.2.1 The ‘Upstream Approach’ as the basic principle . 9
7.2.2 The Identification procedure . 9
7.2.3 The use of Safety Data Sheets for determination of presence of dangerous substances and
preparations . 10
7.3 Release to the environment . 10
7.4 Minimization . 11
8 Basis for a proposed new standard for presuming compliance with Annex II, paragraph 1,
indent 3 of Directive 94/62/EC . 11
8.1 The principle . 11
8.2 Determination of substances to be considered for minimization . 11
8.3 Conformity with the minimization requirement. 12
9 Conclusions . 12
Annex A (informative) Decision Tree — Minimization of dangerous substances or preparations and
demonstration of conformity . 13
Annex B (informative) Information on current regulation . 14
Bibliography . 17
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European foreword
This document (FprCEN/TR 13695-2:2018) has been prepared by Technical Committee CEN/TC 261
“Packaging”, the secretariat of which is held by AFNOR.
This document is currently submitted to the Vote on TR.
This document will supersede CEN/TR 13695-2:2004.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association.
For Information on current regulation, see informative Annex B.
This document forms one of a series of standards and reports prepared under Mandate M/200 rev.3 and
the Second Standardization 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 document in conjunction with the other
mandated standards and reports is specified in EN 13427.
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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 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/TR / CR 13695 series 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.
The following elements were considered for the development of this work:
— the existing European or national regulations (Directives);
— the CEN standardization on waste (CEN/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 standardized 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
standardized 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 13695-1:2000, 8.1).
Guidelines are provided to identify and minimize dangerous substances and a methodology is proposed
to assess the compliance with the requirements of the Directive.
Since the publication of the previous edition of this document in 2004 a new chemicals regulation has
been introduced within the community (REACH, Regulation (EC) No 1907/2006 concerning the
Registration, Evaluation, Authorization and Restriction of Chemicals). Also, an adaptation to the Global
Harmonized System (GHS) of Classification and Labelling of Chemicals has been made (CLP,
Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures)
repealing Directive 67/548/EEC (Dangerous Substances) and Directive 1999/45/EC (Dangerous
Preparations). The REACH and CLP legislations now in force use different terminology and description of
hazard statements compared to what is used in this document and in the connected standard EN 13428.
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Due to the lack of mandate for a complete and joint update of the two documents reflecting the changed
legislation, instead this document has been amended with minimum necessary explanatory text to be
able to follow the assessment method. The amended document provides a “translation key” allowing for
continued understanding and use of both FprCEN/TR 13695-2 and EN 13428.
Key differences relevant for the understanding and use of this document and EN 13428 are summarized
in the table below. Throughout the report text ‘Notes’ are used to highlight differences in terminology,
hazard descriptions and labelling criteria in the legislation now in force compared to what is used in
FprCEN/TR 13695-2 and EN 13428.
Table 1 — Key differences in chemicals legislation, terminology and description of labelling
criteria relevant for CEN/TR 13695-2 and EN 13428
CEN/TR 13695-2:2004 and EN 13428:2004 FprCEN/TR 13695-2:2018
Repealed Directives: Replaced by:
Directive 67/548/EEC (Dangerous Substances) REACH, Regulation (EC) No 1907/2006
and Directive 1999/45/EC (Dangerous concerning the Registration, Evaluation,
Preparations) Authorization and Restriction of Chemicals) and
CLP, Regulation (EC) No 1272/2008 on
classification, labelling and packaging of
substances and mixtures
Term ‘Dangerous’ Replaced by term ‘Hazardous’
Term ‘Preparation’ Replaced by term ‘Mixture’
Criteria for identification of ‘noxious and other Recommended interpretation:
hazardous substances’:
‘Meet the criteria of labelling with the
Any substances classified as dangerous to the environmental hazard pictogram’
environment and assigned with the symbol N and
a
corresponding indication of danger’
a
Classification criteria for labelling with the dangerous to the Environment pictogram.
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1 Scope
This document specifies the methodology and procedure for determining the presence and minimization
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 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 documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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
CR 13695-1:2000, 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
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN 13193:2000 and the following
apply.
NOTE See the definitions in Article 3 of Directive 94/62/EC.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
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 1 to entry: 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.
[SOURCE: 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
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[SOURCE: Directive 67/548/EEC]
Note 1 to entry: Regulation (EC) No 1907/2006 and Regulation (EC) No 1272/2008 (REACH and CLP) replacing
Directive 67/548/EEC use the term mixtures.
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 1 to entry: 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.
[SOURCE: Article 1(1) of Directive 91/155/EEC as amended by Directive 2001/58/EC]
3.4
packaging component
part of packaging that can be separated by hand or by using simple physical means
[SOURCE: EN 13193:2000, 3.1.1]
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
[SOURCE: EN 13193:2000, 3.1.2]
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 Standardization:
“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 commercialized in such a way as to permit its reuse or
recovery, including recycling, and to minimize its impact on the environment when packaging waste or
residues from packaging management operations are disposed of”.
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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 minimized
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.
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 Directive 94/62/EC, the
importance of safety, the protection of health and the hygiene of the packed products is emphasized. A
possible consequence of this may be that considerations related to health and safety have already had the
effect of minimizing 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.
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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 minimization of dangerous substances in packaging
7.1 General principle
The individual or organization 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.
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 9000:2015 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 1 This is a general list of substances dangerous to the environment and cannot be taken as specifically
relating to substances used in packaging.
NOTE 2 N-classification as an indication for danger and criteria for labelling with Dangerous for the Environment
pictogram does not exist in Regulation (EC) No 1907/2006 and Regulation (EC) No 1272/2008 (REACH and CLP)
replacing 67/548/EEC. Recommended interpretation:
— any substances classified as hazardous to the environment and meeting the criteria of labelling with
the environmental hazard pictogram according to Regulation (EC) No 1907/2006 and
Regulation (EC) No 1272/2008 (REACH and CLP), (with the exception of lead, cadmium, mercury
and chromium (VI) and their compounds already considered in CR 13695-1).
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).
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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.
NOTE Information on composition is given in heading 3 following Regulation (EC) No 1907/2006 and
Regulation (EC) No 1272/2008 (REACH and CLP).
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)”.
NOTE 1 N-classification as an indication for danger and criteria for labelling with Dangerous for the Environment
pictogram does not exist in Regulation (EC) No 1907/2006 and Regulation (EC) No 1272/2008 (REACH and CLP)
replacing Directive 67/548/EEC.
Recommended interpretation:
— any substances classified as hazardous to the environment and meeting the criteria of labelling with
the environmental hazard pictogram according to Regulation (EC) No 1907/2006 and
Regulation (EC) No 1272/2008 (REACH and CLP), (with the exception of lead, cadmium, mercury
and chromium (VI) and their compounds already considered in CR 13695-1).
NOTE 2 Information on composition is given in heading 3 following Regulation (EC) No 1907/2006 and
Regulation (EC) No 1272/2008 (REACH and CLP).
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 3 More detailed information on the current regulation of dangerous substances and preparations is given
in Annex B 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, shall be minimized with regard to their presence in emissions, ash or leachate,
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