CEN Guide 16:2017
(Main)Guide for addressing chemicals in standards for consumer-relevant products
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 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
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
CEN
GUIDE
Guide for addressing chemicals in
standards for consumer-relevant
products
Edition 1, 2017-07-19
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
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
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
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
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.
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
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.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
article
an object which during production is given a special shape, surface or design which determines its
function to a greater degree than does its chemical composition
[SOURCE: REACH, Article 3.3]
2.2
consumer-relevant article
an article which is intended for consumer use, is likely, under reasonably foreseeable conditions, 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)
3 Regulatory, normative and policy background
3.1 General
In Europe consumer-relevant articles are covered by a wide range of regulatory requirements
addressing the use of chemical substances in their production, the content of chemical substances in
them, and the release of chemical substances from such products. In addition, national, European and
international standards and other voluntary specifications which include chemical provisions are
available.
In determining the need for, the kind of and the specific characteristics of any envisaged chemical
provision it is essential to investigate the existing regulatory provisions including related standards for
the article in question as well as applicable voluntary specifications. In addition, it is advisable to
include further subjects in the research including European and national policy developments,
envisaged legislative measures, scientific opinions, and identified concerns.
The following clauses provide a brief overview of some of the most relevant information sources which
should be investigated prior to establishing chemical requirements for consumer-relevant articles.
Recommendation:
The background information to this Guide provides documentation and a more comprehensive
description of some of the issues covered in this Guide including links to important reference
documents on the internet and may provide useful additional information. Readers of the Guide are
recommended to review and make use of the information included in this complementary document.
NOTE A list of all recommendations is provided in Annex A.
3.2 Chemicals legislation
3.2.1 REACH Regulation
The EU’s horizontal chemicals management legislation is known as REACH - Registration, Evaluation,
Authorization and Restriction of Chemicals (Regulation (EC) No 1907/2006). It aims to improve the
protection of human health and the environment through better and earlier identification of the
intrinsic properties of chemical substances, and to enhance innovation and competitiveness of the EU
chemicals industry.
Through REACH, all chemical substances on their own or in mixtures manufactured or imported in
quantities of at least 1 tonne per year per manufacturer or importer must be registered with the
European Chemicals Agency (ECHA) unless they are exempted from the scope of registration. The
registration obligations for substances in articles (when the chemical substance is intended to be
released apply to quantities totalling over 1 tonne per producer or importer per year. Registration
requirements include the provision of information about the chemical’s physicochemical, toxicological
and ecotoxicological properties.
Chemical substances in articles do not need to be registered under REACH, except chemical substances
intended to be released from articles (e.g. a scented eraser), and then only if the annual substance
production levels are greater than 1 tonne per manufacturer/importer. Chemical substances
unintentionally released during use are not in the scope of registration, such as plasticizers migrating
from a product over time.
Chemicals with certain hazardous properties may be identified as “substances of very high concern”
(SVHC) and may be subject to authorization before being allowed to be manufactured or used in the
European Union. These properties are carcinogenic, mutagenic and toxic for reproduction (CMRs),
persistent, bio-accumulating and toxic/very persistent and very bio-accumulating (PBTs/vPvBs), and
chemical substances identified as causing serious and irreversible effects to humans or the environment
equivalent to the effects mentioned earlier. As a first step, such chemical substances are incorporated in
a “candidate list” of SVHCs, and may eventually be included in an Authorization list (Annex XIV list).
These chemical substances cannot be placed on the market or used for manufacturing in Europe after a
given date, unless an authorization is granted for their specific use, or the use is exempted from
authorization.
If articles including articles in complex products (consisting of several articles) contain chemical
substances on the “candidate list” (SVHC list) in a concentration above 0,1 % (w/w), the supplier or
importer must provide sufficient information (as a minimum the name of the chemical substance) to the
recipient of the article to allow for its safe use. For consumers the information about these chemical
substances in the article must only be given upon request and within 45 days of the request (Article 33).
This requirement is independent of the total tonnage of the chemical substance. No such requirement
exists for other chemical substances in articles.
If a SVHC is present in a concentration above 0,1 % in the article including articles in complex products,
and its import or manufacturing quantities are above 1 tonne per year per company, EU producers or
importers of articles must notify the European Chemicals Agency (ECHA) of the presence of the SVHC
unless exposure during normal and reasonably foreseeable conditions of use and disposal can be
excluded (Article 7). Such notification requirement does not exist for other chemical substances in
articles.
Chemical substances can be restricted where there is an unacceptable risk to health or the environment,
and these limits also apply to imported products. By April 2017 the REACH Restricted Substance list
(Annex XVII list) contained 67 entries including specific restrictions on 62 chemical substances or
groups of substances (5 entries have been deleted: 33, 39, 42, 44, 53). These may apply to all uses of the
substance or more specifically to certain product types or types of uses. In some cases, the REACH
restrictions are complemented by European standards which provide test methods. Some “harmonised”
standards address test methods for the release of nickel. Appendix 8 of Annex XVII includes a list of test
methods for determination of certain aromatic amines derived from azo colorants.
Recommendation:
The relevant REACH provisions including ongoing developments and how they apply to the concerned
product category should be taken into account. This particularly applies to restrictions contained or
envisaged to be included in the list of restricted substances (Annex XVII).
When establishing normative chemical provisions for consumer-relevant articles substances covered by
Annex XVII relating to the articles and/or materials in question normally do not need to be addressed
(since the legal requirements apply anyway) unless there are exceptionally specific reasons to do so, e.g.
if only a specific risk or material is addressed in the REACH restriction or lower limits seem preferable
in line with sector-specific considerations and established practices and based on a sound scientific
assessment in accordance with the state-of-the art of chemical safety assessment. In any case a proper
justification should be given where such requirements are established.
3.2.2 CLP Regulation
The Classification, Labelling and Packaging of substances and mixtures Regulation (Regulation
EC/1272/2008) also known as the CLP Regulation sets out chemical substance classification criteria
and labelling rules. These criteria and rules are based on the United Nations Globally Harmonized
System of classification and labelling of chemicals (GHS), providing an internationally harmonized
approach.
The main purpose of the CLP Regulation is to identify and communicate the hazardous properties of
chemicals to manufacturers, workers and consumers through classification and labelling of chemicals.
To this end the Regulation provides a standardized system for classification of substances and mixtures
in accordance with identified hazards as well as standardized hazard statements and pictograms.
Manufacturers, importers and downstream users of substances or mixtures are responsible for
classification (“self-classification”).
In some cases, classification of a chemical is harmonized and obligatory at Community level
(“harmonised classification”). In any case, self-classification of a substance must be performed for those
hazard classes not covered by the harmonized classification. Of particular importance is Part 3 of
Annex VI which includes a list of harmonized classification and labelling of hazardous substances
(Table 3.1). An unofficial updated table of harmonized entries in Annex VI to CLP is available on the
ECHA website: http://echa.europa.eu/information-on-chemicals/annex-vi-to-clp
Information on the classification of substances covering harmonized classification and self-classification
is available in an inventory of classification and labelling (the “C&L Inventory”) accessible on the ECHA
website. The inventory includes classification information from REACH registrations and CLP
notifications: http://echa.europa.eu/information-on-chemicals/cl-inventory-database
It should be noted that self-classification may not always be backed by adequate data (e.g. required in a
REACH registration dossier) and, therefore, may not always be correct. Also substances may be
classified differently by different manufacturers.
The classification of a substance is not only a relevant parameter in a chemical safety assessment, it may
also be an important reference for a product-related provision (e.g. banning of CMRs). However,
absence of a classification (especially in the case of self-classified substances) does not guarantee that a
given substance may not receive a classification e.g. due to improved data availability in the future.
NOTE ECHA offers more comprehensive information on chemicals in a database structured in three layers:
infocard, brief profile and detailed source data: http://echa.europa.eu/information-on-chemicals
Recommendation:
Standards writers should include experts that are familiar at least with the basic principles of the CLP
Regulation, hazard classification and related standardized hazard statements and pictograms. Of
particular importance is Part 3 of Annex VI which includes a list of substances subject to a harmonized
classification and labelling of hazardous substances (Table 3.1) and information on classification of
substances by industry (self-classification). This and other substance related information is accessible
via the ECHA website. Ongoing developments concerning new or amended classifications should be
monitored.
3.2.3 Other relevant chemicals legislation
The Regulation on Persistent Organic Pollutants (POP, Regulation (EC) No 850/2004) restricts
production, placing on the market and use of chemical substances listed in Annex I of the Regulation
whether on their own, in preparations or as constituents of articles. The Regulation is mainly important
to identify specific substances which do not need to be addressed in developing standards.
The Biocidal Products Regulation (BPR, Regulation (EU) No 528/2012) is covered in 5.16.8.2.
Recommendation:
The substances covered by Annex I of the Regulation on Persistent Organic Pollutants (POPs) apply to
articles and normally do not need to be addressed (since the legal requirements apply anyway) unless
there are exceptionally specific reasons to do so, e.g. if lower limits seem preferable in line with sector-
specific considerations and established practices and based on a sound scientific assessment in
accordance with the state-of-the art of chemical safety assessment. In any case a proper justification
should be given where such requirements are established.
3.3 Relevant EU regulation for articles and associated standards
3.3.1 General considerations
European product-specific legislation covers a broad range of articles including: toys, food contact
materials, packaging, electrical and electronic equipment, batteries, energy-related products, personal
protective equipment, construction products, medical devices, gas appliances, pyrotechnic articles,
recreational craft as well as machinery and motor vehicles. In addition, articles not covered in any of the
specific laws are addressed by the provisions of the General Product Safety Directive (GPSD) which
provides a generic definition of a safe product and applies when no specific regulations exist for a given
product. The background information to this Guide contains a summary of the relevant pieces of
legislation and associated standards covering articles focusing on chemical provisions. It includes
articles beyond the scope of this Guide as the related information may be of use in the present context.
For instance, test methods developed for measuring emissions from construction products can be used
in other areas such as furniture. Standardization committees addressing chemicals in specific articles
will need to be familiar with the relevant provisions included in the applicable legislation. In addition, it
may be useful to understand how chemicals are addressed in legislation in other product areas,
particularly where similar materials and/or chemicals are used or exposure situations are comparable.
In this section two directly relevant Directives are briefly described: the General Product Safety
Directive (GPSD) and the Toy Safety Directive (TSD). The GPSD covers a broad range of articles and will
be relevant for many products which could be covered by normative chemical requirements. The TSD is
one of the few examples of legislation for consumer-relevant articles establishing chemical provisions
which may also be relevant for a range of articles which are not toys, particularly for children.
Recommendation:
Standardization bodies should include experts that are familiar with the chemicals-related regulatory
provisions and developments applicable to the articles in question. It is a
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