Guide for addressing chemicals in standards for consumer-relevant products

This document provides guidance on addressing chemicals in the development of standards for
consumer-relevant articles. The aim is to minimize the impacts of chemicals of concern on human
health and the environment by complying with, complementing or going beyond legal obligations for these chemicals. Emphasis is given to chemicals in articles posing risks to human health during use. The
environmental dimension is considered, where feasible and where appropriate, for instance by
addressing environmental exposure or persistent or bio-accumulative chemicals.
The Guide is intended to assist in the development of normative provisions for chemicals, particularly in
those areas where specific regulatory provisions (e.g. limit values) for chemicals are absent and are not
envisaged to be implemented in the foreseeable future such as articles covered by the General Product
Safety Directive (2001/95/EC). In so doing, the Guide aims to facilitate the placing on the market of safe
products. In addition, these guidelines can assist those with a general professional interest in consumer
safety.
The Guide including the associated background information document presents a comprehensive
overview of approaches taken on chemicals in various legislative and voluntary tools. It is not intended
to override legal obligations. Both documents reflect the status as of April 2017.
Electrical and electronic equipment, and ICT products, are excluded from the scope as these products
fall under the lead of CENELEC and ETSI, respectively. Food contact materials, materials used in the
supply of drinking water, medical devices, and construction products are also excluded. This is because
comprehensive, detailed and specific regulation on chemicals in these products is either already
available or subject to consideration and debate; because specific approaches are required; or because
performance requirements are supposed to be addressed at national level; or a combination of all these.
Nonetheless, some of the guidance may be useful in areas excluded from the scope of the Guide.
It is envisaged that sector specific guides or standards dealing with chemical hazards in standards for
consumer-relevant articles, where available, should be used in conjunction with the present Guide.
NOTE The Bibliography includes relevant CEN sector guidance documents.

Vodilo za obravnavanje kemikalij v standardih za proizvode, ki so pomembni za porabnike

Ta dokument podaja smernice za obravnavanje kemikalij pri oblikovanju standardov za proizvode, ki so pomembni za porabnike. Namen je zmanjšati vpliv problematičnih kemikalij na človeško zdravje in okolje, tako da se upošteva ali dopolni pravne zahteve glede teh kemikalij oziroma se uvede ukrepe, ki presegajo te pravne zahteve. Poudarek je na kemikalijah v proizvodih, ki pri uporabi predstavljajo tveganje za človeško zdravje. Okoljski vidik se upošteva, kjer je to mogoče in potrebno, na primer z obravnavanjem okoljske izpostavljenosti obstojnih ali bioakumulativnih kemikalij.
Vodilo je namenjeno kot pomoč pri oblikovanju normativnih določb za kemikalije, predvsem na področjih, kjer posebne regulativne določbe (npr. mejne vrednosti) za kemikalije ne obstajajo in ne bodo oblikovane v bližnji prihodnosti, kot so določbe, zajete v Direktivi o splošni varnosti proizvodov (2001/95/ES). Vodilo tako poskuša poenostaviti dajanje varnih proizvodov na trg. Poleg tega so lahko te smernice v pomoč osebam s splošnim strokovnim interesom za varnost uporabnikov.
Vodilo, vključno s povezanim dokumentom z dodatnimi informacijami, predstavlja celovit pregled pristopov za urejanje področja kemikalij v različnih zakonodajnih in prostovoljnih orodjih. Vodilo ne
nadomešča pravnih zahtev. Dokumenta prikazujeta stanje iz aprila 2017.
Električna in elektronska oprema ter izdelki IKT ne spadajo na področje uporabe teh dokumentov, ker
jih urejata odbora CENELEC in ETSI: Materiali, ki so v stiku s hrano, materiali, ki se uporabljajo za
dobavo pitne vode, zdravstvene naprave in gradbeni izdelki ne spadajo na področje uporabe. Celoviti, podrobni in posebni predpisi glede kemikalij v teh izdelkih namreč že obstajajo ali o njih že potekajo pogovori, so zanje potrebni posebni pristopi ali morajo biti zahteve glede njihove vsebine obravnavane na nacionalni ravni oziroma zanje velja vse od naštetega.
Kljub temu so nekatere smernice lahko uporabne tudi na področjih, ki jih to vodilo ne ureja. Predvideva se, da se vodila ali standardi, povezani z določenimi področji, ki obravnavajo kemične nevarnosti v standardih za proizvode, ki so pomembni za porabnike, uporabljajo skupaj s tem vodilom.
OPOMBA: Bibliografija vključuje ustrezne dokumente CEN s smernicami za področje.

General Information

Status
Published
Publication Date
15-Oct-2017
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
07-Aug-2017
Due Date
12-Oct-2017
Completion Date
16-Oct-2017

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SLOVENSKI STANDARD
SIST-V CEN Guide 16:2017
01-december-2017
Vodilo za obravnavanje kemikalij v standardih za proizvode, ki so pomembni za
porabnike
Guide for addressing chemicals in standards for consumer-relevant products
Ta slovenski standard je istoveten z: CEN Guide 16:2017
ICS:
01.120 Standardizacija. Splošna Standardization. General
pravila rules
03.080.30 Storitve za potrošnike Services for consumers
71.020 Proizvodnja v kemijski Production in the chemical
industriji industry
SIST-V CEN Guide 16:2017 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-V CEN Guide 16:2017
CEN
GUIDE
Guide for addressing chemicals in
standards for consumer-relevant
products
Edition 1, 2017-07-19
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SIST-V CEN Guide 16:2017
CEN Guide 16:2017 (E)
Contents Page

Foreword .......................................................................................................................................................................... 6

Introduction .................................................................................................................................................................... 7

1 Scope .................................................................................................................................................................... 7

2 Terms and definitions ................................................................................................................................... 8

3 Regulatory, normative and policy background .................................................................................... 8

3.1 General ................................................................................................................................................................ 8

3.2 Chemicals legislation ..................................................................................................................................... 9

3.2.1 REACH Regulation ........................................................................................................................................... 9

3.2.2 CLP Regulation .............................................................................................................................................. 10

3.2.3 Other relevant chemicals legislation .................................................................................................... 11

3.3 Relevant EU regulation for articles and associated standards .................................................... 11

3.3.1 General considerations .............................................................................................................................. 11

3.3.2 General Product Safety Directive (GPSD) and related standards ............................................... 12

3.3.3 Toy Safety Directive (TSD) and related standards ........................................................................... 12

3.4 EU policy developments, discussions, scientific opinions and tools relevant to

chemicals ......................................................................................................................................................... 13

3.5 Relevant national product regulation and policy developments ............................................... 14

3.6 Voluntary specifications (ecolabel criteria, industry initiatives and standards) ................. 15

3.7 International developments .................................................................................................................... 16

4 Basics of Chemical Safety Assessment (CSA) ...................................................................................... 16

5 Chemical requirements for consumer-relevant articles ............................................................... 17

5.1 General aspects ............................................................................................................................................. 17

5.2 Substances of Very High Concern (SVHC) included in Annex XIV of REACH ........................... 18

5.3 Carcinogenic, mutagenic and toxic to reproduction (CMR) substances – generic

provisions ....................................................................................................................................................... 18

5.4 Generic provisions for other hazard classes in the CLP Regulation .......................................... 20

5.5 Generic provisions for other hazard properties not covered by the CLP Regulation ......... 20

5.5.1 Endocrine disrupting chemicals (EDCs) .............................................................................................. 20

5.5.2 Persistent, bio-accumulative and toxic (PBT) and very persistent and very bio-

accumulative (vPvB) substances ............................................................................................................ 21

5.6 Nanomaterials ............................................................................................................................................... 21

5.7 Certain elements (metals) ........................................................................................................................ 22

5.7.1 REACH restrictions for consumer-relevant articles ........................................................................ 22

5.7.2 Other regulatory provisions for articles and related standards................................................. 24

5.7.3 Voluntary specifications for consumer-relevant articles .............................................................. 25

5.7.4 Remarks ........................................................................................................................................................... 29

5.8 Flame retardants .......................................................................................................................................... 30

5.8.1 REACH restrictions for consumer-relevant articles ........................................................................ 30

5.8.2 Other regulatory provisions for articles and related standards................................................. 31

5.8.3 Voluntary specifications for consumer-relevant articles .............................................................. 32

5.8.4 Remarks ........................................................................................................................................................... 33

5.9 Colourants ....................................................................................................................................................... 34

5.9.1 REACH restrictions for consumer-relevant articles ........................................................................ 34

5.9.2 Other regulatory provisions for articles and related standards................................................. 35

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5.9.3 Voluntary specifications for consumer-relevant articles .............................................................. 36

5.9.4 Remarks ........................................................................................................................................................... 39

5.10 Primary aromatic amines .......................................................................................................................... 41

5.10.1 REACH restrictions for consumer-relevant articles ......................................................................... 41

5.10.2 Other regulatory provisions for articles and related standards ................................................. 41

5.10.3 Voluntary specifications for consumer-relevant articles .............................................................. 41

5.10.4 Remarks ........................................................................................................................................................... 42

5.11 Monomers ........................................................................................................................................................ 42

5.11.1 REACH restrictions for consumer-relevant articles ......................................................................... 42

5.11.2 Other regulatory provisions for articles and related standards ................................................. 42

5.11.3 Voluntary specifications for consumer-relevant articles .............................................................. 43

5.11.4 Remarks ........................................................................................................................................................... 43

5.12 Plasticizers ...................................................................................................................................................... 44

5.12.1 REACH restrictions for consumer-relevant articles ......................................................................... 44

5.12.2 Other regulatory provisions for articles and related standards ................................................. 45

5.12.3 Voluntary specifications for consumer-relevant articles .............................................................. 45

5.12.4 Remarks ........................................................................................................................................................... 46

5.13 Solvents (content or migration) .............................................................................................................. 47

5.13.1 REACH restrictions for consumer-relevant articles ......................................................................... 48

5.13.2 Other regulatory provisions for articles and related standards ................................................. 48

5.13.3 Voluntary specifications for consumer-relevant articles .............................................................. 49

5.13.4 Remarks ........................................................................................................................................................... 49

5.14 Volatile organic compounds (VOC) ........................................................................................................ 49

5.14.1 REACH restrictions for consumer-relevant articles ......................................................................... 50

5.14.2 Other regulatory provisions for articles and related standards ................................................. 50

5.14.3 Voluntary specifications for consumer-relevant articles .............................................................. 52

5.14.4 Remarks ........................................................................................................................................................... 57

5.15 Allergenic fragrances .................................................................................................................................. 58

5.15.1 REACH restrictions for consumer-relevant articles ......................................................................... 58

5.15.2 Other regulatory provisions for articles and related standards ................................................. 58

5.15.3 Voluntary specifications for consumer-relevant articles .............................................................. 61

5.15.4 Remarks ........................................................................................................................................................... 61

5.16 Other substances .......................................................................................................................................... 62

5.16.1 Formaldehyde (not covered by requirements above) .................................................................... 62

5.16.2 N-Nitrosamines and N-Nitrosatable substances ................................................................................ 64

5.16.3 Per- and polyfluorinated compounds (PFCs) ..................................................................................... 65

5.16.4 Alkylphenols and Alkylphenolethoxylates (APEOs) ........................................................................ 69

5.16.5 Chlorinated benzenes and toluenes ....................................................................................................... 70

5.16.6 Polycyclic aromatic hydrocarbons (PAHs) .......................................................................................... 71

5.16.7 Pesticide residues ......................................................................................................................................... 74

5.16.8 Biocides ............................................................................................................................................................ 76

5.17 Other aspects not related to chemical safety assessment .............................................................. 78

5.17.1 Colour fastness .............................................................................................................................................. 78

5.17.2 Sensory evaluation (smell/odour) ......................................................................................................... 80

6 Information provision requirements for chemicals in articles ................................................... 81

6.1 REACH information provisions for consumer-relevant articles .................................................. 81

6.2 Other regulatory information provisions for consumer-relevant articles .............................. 81

6.3 Information provisions in voluntary specifications for consumer-relevant articles .......... 82

6.4 Remarks ........................................................................................................................................................... 82

Annex A (informative) List of recommendations ............................................................................................ 84

A.1 General ............................................................................................................................................................. 84

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A.2 REACH Regulation ........................................................................................................................................ 84

A.3 CLP Regulation .............................................................................................................................................. 84

A.4 Other relevant chemicals legislation .................................................................................................... 84

A.5 Relevant EU regulation for articles and associated standards .................................................... 85

A.6 Chemicals relevant EU policy developments, discussions, related scientific opinions

and tools .......................................................................................................................................................... 85

A.7 Relevant national product regulation and policy developments ............................................... 85

A.8 Voluntary specifications (ecolabel criteria, industry initiatives and standards) ................. 85

A.9 Basics of Chemical Safety Assessment (CSA) ...................................................................................... 85

A.10 Chemical requirements for consumer-relevant articles - General aspects ............................ 85

A.11 REACH Substances of Very High Concern (SVHC) ............................................................................. 86

A.12 Carcinogenic, mutagenic and toxic to reproduction (CMR) substances - generic

provisions ....................................................................................................................................................... 86

A.13 Generic provisions for other hazard classes according to the CLP Regulation ..................... 86

A.14 Generic provisions for other hazard properties not covered by the CLP Regulation -

Endocrine disrupting chemicals (EDCs) .............................................................................................. 87

A.15 Generic provisions for other hazard properties not covered by the CLP Regulation -

Persistent, bio-accumulative and toxic (PBT) and very persistent and very bio-

accumulative (vPvB) substances ............................................................................................................ 87

A.16 Nanomaterials ............................................................................................................................................... 87

A.17 Certain elements (metals) ........................................................................................................................ 87

A.18 Flame retardants .......................................................................................................................................... 88

A.19 Colourants ....................................................................................................................................................... 88

A.20 Primary aromatic amines ......................................................................................................................... 88

A.21 Monomers ....................................................................................................................................................... 89

A.22 Plasticizers ..................................................................................................................................................... 89

A.23 Solvents (content or migration) ............................................................................................................. 89

A.24 Volatile organic compounds (VOC) ........................................................................................................ 89

A.25 Allergenic fragrances .................................................................................................................................. 90

A.26 Formaldehyde (not covered by requirements above) .................................................................... 90

A.27 N-Nitrosamines and N-Nitrosatable substances ............................................................................... 90

A.28 Per- and polyfluorinated Compounds (PFCs) .................................................................................... 90

A.29 Alkylphenols and Alkylphenolethoxylates (APEOs) ....................................................................... 91

A.30 Chlorinated benzenes and toluenes ...................................................................................................... 91

A.31 Polycyclic aromatic hydrocarbons (PAHs) ......................................................................................... 91

A.32 Pesticide residues ........................................................................................................................................ 91

A.33 Biocides ............................................................................................................................................................ 92

A.34 Colour fastness .............................................................................................................................................. 92

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A.35 Sensory evaluation (smell/odour) ......................................................................................................... 92

A.36 Information provision and labelling requirements for chemicals in articles ........................ 92

Annex B (informative) Template for information provision ..................................................................... 93

Bibliography ................................................................................................................................................................. 95

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Foreword

In March 2010, CEN adopted a guidance document entitled “CEN approach on addressing

environmental issues in product and service standards”. The key objective of this approach was to

establish a general framework to promote and ensure better inclusion of environmental aspects in

European Standards. The document acknowledged that in addition to generic instruments in support of

the incorporation of environmental considerations into European product and service standards,

tailored environmental programmes for Technical Committees addressing specific issues may be

needed.

Subsequently, it was decided to initiate a project with the aim to address chemicals in product

standards and a project proposal was developed by the project partners: ASI, DS, ECOS and UNE. CEN’s

Strategic Advisory Body on Environment (CEN/SABE) approved the project proposal in March 2013

(Decision 03/2013) and financial support was granted by the European Commission in December 2014.

In the context of the project, “product” is understood as “article”, as defined in the REACH Regulation.

The main aim of the project is to ensure that chemicals are adequately addressed in standards for

articles (i.e. products other than chemical mixtures) which are intended for consumers, which are likely

to be used by consumers even if not intended for them, or to which consumers may be exposed (e.g. in

the context of a service).

The project supports the EU objectives to minimize the health and environmental impacts of chemicals

most recently repeated in the 7th Environmental Action Programme, and can contribute to the

development of a “Union strategy for a non-toxic environment” envisaged for 2018.

The project consists of 3 key activities:
— Setting up of a multi-stakeholder panel of experts;

— Development of a guidance document including the preparation of a literature review report;

— Development of a strategy for the implementation of the guidance document.

The stakeholder panel consulted in the development of the Guide was made up of representatives from

consumer organisations, industry, research and testing institutes, the European Commission, the

European Chemicals Agency and public authorities.

This “Guide for addressing chemicals in standards for consumer-relevant products” includes a

framework and recommendations for normative provisions relating to chemicals which should be taken

into consideration when developing standards for consumer-relevant articles.

A separate background information to the Guide provides information including regulatory provisions

for chemical substances, for specific articles, and related standards, as well as internet links where most

up-to-date information can be found. Information is also provided for voluntary instruments and policy

developments in the EU and in some Member States. This information aims to put into a wider context

issues relating to chemicals that could be addressed in standards for consumer-relevant articles.

Publication of a Guide by CEN requires approval by simple majority of the national bodies casting a

vote.
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Introduction

This Guide is intended for use by anyone involved in drafting standards for consumer-relevant products

other than chemical mixtures (i.e. the Guide covers “articles” as defined in REACH) with the aim of

minimizing exposure to chemicals which may constitute a health risk while also bearing in mind

environmental burdens.

Establishing standards provisions on chemicals is a complex task requiring specialist knowledge. Not all

standards writers have expertise in scientific disciplines such as chemistry and (eco)toxicology but, by

using this Guide, they are encouraged to:

— identify and understand basic principles that need to be considered when thinking about

incorporation of chemicals provisions into standards for consumer-relevant articles;

— identify and understand the regulatory and political background as well as existing voluntary

initiatives and tools relevant to chemicals in articles;

— assess the relevance of existing information sources with respect to a particular group of articles;

— identify and consult with competent and experienced chemistry and (eco)toxicology experts from a

broad range of stakeholders;

— integrate chemicals provisions in standards for consumer-relevant articles, where appropriate.

The need for external expertise will vary depending on the availability of experts familiar with

monitoring and establishing chemicals provisions in articles. In any case it may be useful to establish

specific Working Groups (or Task Groups) composed of experts possessing the necessary skills with the

aim to develop chemicals related (parts of) standards addressing chemicals in articles.

Naturally a broad Guide like this can only constitute a starting point for the development of article-

specific requirements. It cannot provide article-specific solutions which can be copied and pasted into

standards. Consequently, the adequacy of any particular recommendation in the Guide including

referenced sources for a specific article and/or material needs to be checked by the Technical

Committee in charge of preparing a standard for a specific article, particularly when making use of

requirements developed for other sectors or articles. The data quality needs and scientific rigour of

assessments to derive limit values may vary in the specifications presented in the Guide. It should also

be borne in mind that the level of ambition in certain approaches (e.g. the European Ecolabel) is higher

compared to others which aim to set baseline criteria. Hence, the final responsibility of the Technical

Committee to assess the scientific validity of limits to be used in a standard and to determine the

chemical provisions appropriate for a specific article and/or material is underlined.

Normally some information is readily available when identifying chemicals of concern which are or may

be present in a specific article. The compilation of available data sources (regulatory provisions,

voluntary instruments, test reports, scientific literature and assessments, etc.) will be begun at the start

of any normative project. The separate background information to this Guide provides information

including references to many data sources and may be of help in this regards.

In some areas there are already sector-specific approaches (e.g. guidelines and certification schemes)

available and should be considered in addition to the present Guide.
1 Scope

This document provides guidance on addressing chemicals in the development of standards for

consumer-relevant articles. The aim is to minimize the impacts of chemicals of concern on human

health and the environment by complying with, complementing or going beyond legal obligations for

---------------------- Page: 9 ----------------------
SIST-V CEN Guide 16:2017
CEN Guide 16:2017 (E)

these chemicals. Emphasis is given to chemicals in articles posing risks to human health during use. The

environmental dimension is considered, where feasible and where appropriate, for instance by

addressing environmental exposure or persistent or bio-accumulative chemicals.

The Guide is intended to assist in the development of normative provisions for chemicals, particularly in

those areas where specific regulatory provisions (e.g. limit values) for chemicals are absent and are not

envisaged to be implemented in the foreseeable future such as articles covered by the General Product

Safety Directive (2001/95/EC). In so doing, the Guide aims to facilitate the placing on the market of safe

products. In addition, these guidelines can assist those with a general professional interest in consumer

safety.

The Guide including the associated background information document presents a comprehensive

overview of approaches taken on chemicals in various legislative and voluntary tools. It is not intended

to override legal obligations. Both documents reflect the status as of April 2017.

Electrical and electronic equipment, and ICT products, are excluded from the scope as these products

fall under the lead of CENELEC and ETSI, respectively. Food contact materials, materials used in the

supply of drinking water, medical devices, and construction products are also excluded. This is because

comprehensive, detailed and specific regulation on chemicals in these products is either already

available or subject to consideration and debate; because specific approaches are required; or because

performance requirements are supposed to be addressed at national level; or a combination of all these.

Nonetheless, some of the guidance may be useful in areas excluded from the scope of the Guide.

It is envisaged that sector specific guides or standards dealing with chemical hazards in standards for

consumer-relevant articles, where available, should be used in conjunct
...

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