SIST-TP CEN/TR 13387-2:2015
(Main)Child use and care articles - General safety guidelines - Part 2: Chemical hazards
Child use and care articles - General safety guidelines - Part 2: Chemical hazards
This document provides guidance information on chemical hazards that should be taken into consideration when developing safety standards for child use and care articles. In addition, these guidelines can assist those with a general professional interest in child safety.
Articles de puériculture - Conseils relatifs à la sécurité - Partie 2 : Dangers chimiques
Le présent Rapport technique fournit des informations de recommandation concernant les dangers chimiques qu’il convient de prendre en considération lors de l’élaboration de normes de sécurité relatives aux articles de puériculture. De plus, le présent guide peut faciliter la tâche des personnes portant un intérêt professionnel général à la sécurité des enfants.
Izdelki za otroke - Smernice o splošni varnosti - 2. del: Kemijske nevarnosti
Ta dokument podaja smernice o kemičnih nevarnostih, ki bi jih bilo treba upoštevati pri razvoju varnostnih standardov za uporabo izdelkov za otroke. Poleg tega lahko te smernice pomagajo ljudem s splošnim strokovnim interesom za varnost otrok.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST-TP CEN/TR 13387-2:2015
01-september-2015
1DGRPHãþD
SIST-TP CEN/TR 13387:2005
Izdelki za otroke - Smernice o splošni varnosti - 2. del: Kemijske nevarnosti
Child use and care articles - General safety guidelines - Part 2: Chemical hazards
Ta slovenski standard je istoveten z: CEN/TR 13387-2:2015
ICS:
97.190 Otroška oprema Equipment for children
SIST-TP CEN/TR 13387-2:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST-TP CEN/TR 13387-2:2015
---------------------- Page: 2 ----------------------
SIST-TP CEN/TR 13387-2:2015
TECHNICAL REPORT
CEN/TR 13387-2
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
July 2015
ICS 97.190 Supersedes CEN/TR 13387:2004
English Version
Child use and care articles - General safety guidelines - Part 2:
Chemical hazards
This Technical Report was approved by CEN on 12 January 2015. It has been drawn up by the Technical Committee CEN/TC 252.
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, 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: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 13387-2:2015 E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST-TP CEN/TR 13387-2:2015
CEN/TR 13387-2:2015 (E)
Contents Page
European foreword .4
1 Scope .5
2 Regulatory, normative and policy background .5
2.1 General .5
2.2 REACH - Short summary .6
2.2.1 Registration .6
2.2.2 Authorization .6
2.2.3 Restrictions .6
2.2.4 Articles .6
2.2.5 Recommendations .7
2.3 Toy Safety Directive and related standards .7
2.3.1 Short summary of Toy Safety Directive .7
2.3.2 Toy standards .8
2.3.3 Recommendations .9
2.4 CEN Approach on addressing environmental issues in product and service standards .9
2.4.1 Short summary .9
2.4.2 Recommendations .9
3 Basics of Chemical Safety Assessment (CSA) . 10
3.1 General . 10
3.2 Hazard assessment . 10
3.3 Exposure assessment . 12
3.4 Risk characterization . 13
3.5 Example – PAHs. 13
3.6 Example – Migration limit values in Toy Safety Directive . 13
3.7 Recommendations . 14
4 Child use and care articles specific approaches . 15
4.1 General aspects . 15
4.2 Substances of Very High Concern (SVHC) . 15
4.3 CMR substances . 15
4.4 Certain elements . 16
4.4.1 Regulatory and normative background . 16
4.4.2 Specific child use and care articles considerations . 16
4.5 Flame retardants . 16
4.5.1 Regulatory and normative background . 16
4.5.2 Specific child use and care articles considerations . 17
4.6 Colourants . 17
4.6.1 Regulatory and normative background . 17
4.6.2 Specific child use and care articles considerations . 18
4.7 Primary aromatic amines . 18
4.7.1 Regulatory and normative background . 18
4.7.2 Specific child use and care articles considerations . 19
4.8 Monomers . 19
4.8.1 Regulatory and normative background . 19
4.8.2 Specific child use and care articles considerations . 19
4.9 Solvents (migration) . 19
4.9.1 Regulatory and normative background . 19
4.9.2 Specific child use and care articles considerations . 20
4.10 Solvents (inhalation) . 20
4.10.1 Regulatory and normative background . 20
4.10.2 Specific child use and care articles considerations . 21
4.11 Plasticizers . 21
2
---------------------- Page: 4 ----------------------
SIST-TP CEN/TR 13387-2:2015
CEN/TR 13387-2:2015 (E)
4.11.1 Regulatory and normative background . 21
4.11.2 Specific child use and care articles considerations . 22
4.12 Sensitizers – Fragrances . 22
4.12.1 Regulatory and normative background . 22
4.12.2 Specific child use and care articles considerations . 24
4.13 N-Nitrosamines and N-Nitrosatable substances . 24
4.13.1 Regulatory and normative background . 24
4.13.2 Specific child use and care articles considerations . 25
4.14 Other . 25
4.14.1 Formaldehyde (other than monomer or preservative) . 25
Annex A (informative) Brief description of EU regulatory chemical requirements applicable to
child use and care articles. 26
A.1 Cadmium . 26
A.2 Nickel . 26
A.3 Flame retardants . 26
A.4 Colourants . 26
A.5 Wood preservatives . 27
A.6 Preservatives (other than wood preservatives) . 27
A.7 Plasticizers . 27
A.8 N-Nitrosamines and N-Nitrosatable substances . 27
A.9 Policyclic Aromatic Hydrocarbons (PAHs) . 28
A.10 Persistent Organic Pollutants (POPs) . 28
A.11 Food contact materials . 28
A.12 Packaging . 28
Annex B (informative) Model requirements for use in a standard . 29
B.1 Introduction . 29
B.2 General chemical requirements . 29
B.3 Substances of Very High Concern (SVHC) . 29
B.4 CMR substances . 29
B.5 Certain elements . 29
B.6 Flame retardants . 30
B.7 Colorants . 30
B.8 Primary aromatic amines . 31
B.9 Monomers. 32
B.10 Solvents (migration) . 32
B.11 Solvents (inhalation) . 33
B.12 Plasticizers . 33
B.13 Sensitizers – Fragrances . 33
B.14 N-Nitrosamines and N-Nitrosatable substances . 36
B.15 Formaldehyde (other than monomer or preservative) . 36
Bibliography . 37
3
---------------------- Page: 5 ----------------------
SIST-TP CEN/TR 13387-2:2015
CEN/TR 13387-2:2015 (E)
European foreword
This document (CEN/TR 13387-2:2015) has been prepared by Technical Committee CEN/TC 252 “Child use
and care articles”, 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 [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes CEN/TR 13387:2004.
CEN/TR 13387 comprises the following five parts:
— Safety philosophy and safety assessment (CEN/TR 13387-1);
— Chemical hazards (CEN/TR 13387-2);
— Mechanical hazards (CEN/TR 13387-3);
— Thermal hazards (CEN/TR 13387-4);
— Product information (CEN/TR 13387-5).
CEN/TR 13387-2 should be used in conjunction with CEN/TR 13387-1.
The chemical part has been completely rewritten compared to the previous edition.
4
---------------------- Page: 6 ----------------------
SIST-TP CEN/TR 13387-2:2015
CEN/TR 13387-2:2015 (E)
1 Scope
This Technical Report provides guidance information on chemical hazards that should be taken into
consideration when developing safety standards for child use and care articles. In addition, these guidelines
can assist those with a general professional interest in child safety.
2 Regulatory, normative and policy background
2.1 General
In Europe child use and care articles are covered by the Directive on general product safety (GPSD, Directive
2001/95/EC). This directive contains a general safety requirement and does not address chemical substances
in particular. However, article 13 of the GPSD provides for the opportunity to adopt temporary “emergency”
measures which may include limit values for chemical substances in consumer products. Such measures had
been adopted for phthalates in toys and child use and care articles and for dimethylfumarate (DMF) and both
have been later incorporated into REACH. In addition, Member States can impose actions on products found
unsafe.
Restrictions for several specific chemical substances can be found in Annex XVII of the Regulation concerning
the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH, Regulation (EC) No
1907/2006) “relating to restrictions on the marketing and use of certain dangerous substances and
preparations” as amended. If applicable to their type of product or material used, these provisions are to be
followed by manufacturers of child care articles.
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 including constituents
of articles. The provisions apply also to child care products.
Other regulatory provisions relating to chemicals may apply to certain products. For instance, drinking
equipment is subject to the Regulation on materials and articles intended to come into contact with food
(Regulation (EC) No 1935/2004) and plastics components of drinking equipment are regulated by the
Regulation relating to materials and articles intended to come into contact with foodstuffs. A Directive covers
the release of N-nitrosamines and N-nitrosatable substances from elastomer or rubber teats and soothers
(Directive 93/11/EEC). Applicable regulation will have to be identified where relevant.
Another example of chemical provisions applicable to child care articles is the Directive on packaging and
packaging waste (94/62/EC) which establishes among others limits for lead, cadmium, mercury and
hexavalent chromium in packaging.
While not directly applicable to child care articles the Directive on the safety of toys (TSD, 2009/48/EC) is an
important reference document addressing a product group with similar exposure characteristics and providing
a high standard of safety in the field of products intended for children. Hence, specific guidance seems
appropriate on how to make use of toys related chemical rules.
It is the intention of the present guidelines to complement existing legal obligations by providing some
practical recommendations keeping in mind legal minimum requirements.
Environmental issues are moving in the spotlight. CEN has adopted a policy: the “CEN Approach on
addressing environmental issues in product and service standards” calls for incorporation of environmental
considerations when product or service standards are elaborated. These aspects are highly relevant in
particular for chemicals as far as child care articles are concerned. Hence, this guide incorporates also
recommendations in this regard.
5
---------------------- Page: 7 ----------------------
SIST-TP CEN/TR 13387-2:2015
CEN/TR 13387-2:2015 (E)
2.2 REACH - Short summary
2.2.1 Registration
All chemical substances manufactured or imported in quantities greater than 1 tonne per year per
manufacturer or importer shall be registered at the European Chemicals Agency (ECHA) unless they are
exempted from the scope of registration. The registration obligations apply to the individual chemical
substances, independently of whether they are on their own, in a mixture or in an article (when the chemical
substance is intended to be released).
2.2.2 Authorization
Chemical substances with properties of very high concern may be subject to authorization before being
allowed to be manufactured or used in the European Union. These are CMRs (carcinogenic, mutagenic and
toxic for reproduction), PBTs/vPvBs (persistent, bio accumulating and toxic/very persistent and very bio
accumulating chemical substances) and chemical substances identified as causing serious and irreversible
effects to humans or the environment equivalent to the effects mentioned above. As a first step such chemical
substances are incorporated in a so-called “candidate list” which is published and periodically updated by
ECHA (twice a year in June and December). The candidate list is also known as the “SVHC list”. Finally,
chemical substances identified as requiring authorization will be taken up in Annex XIV or REACH. 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.
For the current list of SVHC please consult the ECHA website.
2.2.3 Restrictions
REACH Annex XVII contained specific restrictions on 64 chemical substances or groups of substances by the
end of 2014. These may apply to all uses of the substance or more specifically to certain product types or
exposure scenarios. Some restrictions have particular relevance to child care and use articles such as the
limits on total content for certain phthalate based plasticisers and total content limits for certain flame
retardants in textiles where there is prolonged skin contact. Some entries, such as the total content restriction
for cadmium in certain materials, may apply to child care and use articles where that material is used to make
the finished product.
2.2.4 Articles
Articles within REACH are defined as an object, which during production is given a special shape, surface or
design which determines its function to a greater degree than its chemical composition (Article 3(3)). This
means that most consumer products including child use and care articles can be defined as articles. Chemical
substances in articles do not need to be registered under REACH, except chemical substances in articles that
are intentionally released if present in quantities greater than 1 tonne per manufacturer annually. This could
be for example a product with a perfume scent. Chemical substances that are unintentionally released during
use are not in scope for registration, like plasticizers migrating out of a product over time.
If articles contain chemical substances on the “candidate list” (SVHC list) in a concentration above 0,1 %
(w/w), the supplier has to provide sufficient information (as a minimum the name of the chemical substance) to
the recipient of the article to allow for safe use of the article. For consumers the information about these
chemical substances in the article shall only be given upon request and within 45 days of the request. (Article
33 of REACH). This requirement is independent of the total tonnage of the chemical substance. No such
requirement exists for other dangerous chemical substances in articles.
If a SVHC substance is present in a concentration above 0,1 % in the article and its import or manufacturing
quantities are above 1 tonne in total per year per company, EU producers or importers of articles shall notify
the ECHA of the presence of the SVHC substance. Such notification requirement does not exist for other
dangerous substances in articles.
6
---------------------- Page: 8 ----------------------
SIST-TP CEN/TR 13387-2:2015
CEN/TR 13387-2:2015 (E)
Chemical substances integrated in articles are neither subject to registration nor to authorization with the
exception of chemical substances intended to be released. However, SVHC substances used in or for the
manufacturing of articles in Europe may require authorization. Restricted chemical substances (REACH
Annex XVII) cannot be used in articles in the EU, nor can they be present in any article imported into the EU.
2.2.5 Recommendations
Manufacturers and standardization bodies involved with child care and use articles should be aware of the
developments in REACH and how they apply to the product category. Where the developments are deemed
sufficiently protective of children there is generally no further need to elaborate a current or future standard
unless the development of new scientific knowledge indicates otherwise. Where REACH covers child care and
use articles in a limited way (in particular, imported articles) REACH should not be considered as a
replacement for product specific chemical rules.
2.3 Toy Safety Directive and related standards
2.3.1 Short summary of Toy Safety Directive
The Toy Safety Directive (TSD) was published in June 2009 (Directive 2009/48/EC). Part III of Annex II
contains the chemical requirements and are summarized below.
Chemical substances that are carcinogenic, mutagenic or toxic to reproduction (CMR) substances of category
1A, 1B or 2 under the Classification, Labelling and Packaging (CLP) Regulation (Regulation (EC) No
1272/2008) are only allowed in toys if certain conditions are met:
— If the use and presence of the chemical substance is allowed according to Appendix A of Annex II;
— these chemical substances are inaccessible to children in any form, including inhalation;
— the concentration of the chemical substances does not exceed the concentration limits as set for the
classification of mixtures containing these chemical substances in the CLP regulation.
55 listed allergenic fragrances shall not be used in toys only if the presence is technically unavoidable under
good manufacturing practice and does not exceed 100 ppm. Another 11 allergenic fragrances shall be
declared on a product label if they are present in concentrations above 100 ppm.
Requirements on migration of 19 elements (aluminium, antimony, arsenic, barium, boron, cadmium, chromium
(III), chromium (VI), cobalt, copper, lead, manganese, mercury, nickel, selenium, strontium, tin, organic tin,
and zinc) replacing the previous migration restrictions on 8 elements (antimony, arsenic, barium, cadmium,
chromium, lead, mercury and selenium). The migration limits are set for three different types of materials:
1) dry, brittle powder-like or pliable toy material,
2) liquid or sticky toy material and
3) scraped-off toy material.
For the elements arsenic, cadmium, chromium VI, lead, mercury and organic tin, which are particularly toxic,
the limits have been set at levels that are half of those considered safe according to the criteria of the relevant
Scientific Committee, in order to ensure that only traces that are compatible with good manufacturing practice
will be present.
Furthermore, N-nitrosamines and N-nitrosatable substances are prohibited for use in toys intended for use by
children under 36 months or in other toys intended to be placed in the mouth. Specific migration limit values
are set.
7
---------------------- Page: 9 ----------------------
SIST-TP CEN/TR 13387-2:2015
CEN/TR 13387-2:2015 (E)
According to article 46 the Commission may adopt specific limit values for chemical substances used in toys
intended for use by children under 36 months or in other toys intended to be placed in the mouth, taking into
account food contact material legislation (Regulation (EC) No 1935/2004).These specific limit values are listed
in Appendix C of Annex II. By end of 2014 the substances tris (2-chloroethyl) phosphate (TCEP, CAS No 115-
96-8), tris-monochloro-propyl phosphate (TCPP, CAS No 13674-84-5) and tris(1,3-dichloropropyl-2)phosphate
(TDCP, CAS No 13674-87-8) are listed with a specific limit value of 5 mg/kg (content limit). In addition,
bisphenol A (CAS No 80-05-7) is included with a limit of 0,1 mg/l (migration limit).
According to article 18 manufactures shall, before placing a toy on the market, carry out analysis of the
chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards that the toy may
present, as well as an assessment of the potential exposure to such hazards. This is also called a safety
assessment. The manufactures shall furthermore, demonstrate that the toy complies with the requirements set
in Annex II. The assessment shall be kept in the technical documentation.
2.3.2 Toy standards
The following standards dealing with chemical substances in toys relevant for child use and care articles are
currently available:
2.3.2.1 Harmonized standards
— EN 71-3:2013, Safety of toys - Part 3: Migration of certain elements.
This standard contains migration limits and test methods for 19 elements (aluminium, antimony, arsenic,
barium, boron, cadmium, chromium (III), chromium (VI), cobalt, copper, lead, manganese, mercury, nickel,
selenium, strontium, tin, organic tin, and zinc).
— EN 71-12:2013, Safety of toys - Part 12: N-Nitrosamines and N-nitrosatable substances.
This standard contains limits and test method
...
SLOVENSKI STANDARD
kSIST-TP FprCEN/TR 13387-2:2014
01-december-2014
Smernice o splošni varnosti - 2. del: Kemijske nevarnosti
General safety guidelines - Part 2: Chemical hazards
Ta slovenski standard je istoveten z: FprCEN/TR 13387-2
ICS:
97.190 Otroška oprema Equipment for children
kSIST-TP FprCEN/TR 13387-2:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
kSIST-TP FprCEN/TR 13387-2:2014
---------------------- Page: 2 ----------------------
kSIST-TP FprCEN/TR 13387-2:2014
TECHNICAL REPORT
FINAL DRAFT
FprCEN/TR 13387-2
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
September 2014
ICS Will supersede CEN/TR 13387:2004
English Version
General safety guidelines - Part 2: Chemical hazards
This draft Technical Report is submitted to CEN members for Technical Committee Approval. It has been drawn up by the Technical
Committee CEN/TC 252.
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, 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: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. FprCEN/TR 13387-2:2014 E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
kSIST-TP FprCEN/TR 13387-2:2014
FprCEN/TR 13387-2:2014 (E)
Contents
Page
Foreword .4
1 Scope .5
2 Regulatory, normative and policy background .5
2.1 General .5
2.2 REACH - Short summary .6
2.2.1 Registration .6
2.2.2 Authorisation .6
2.2.3 Restrictions .6
2.2.4 Articles .7
2.2.5 Recommendations .7
2.3 Toy Safety Directive and related standards .7
2.3.1 Short summary of Toy Safety Directive .7
2.3.2 Toy standards .8
2.3.3 Recommendations .9
2.4 CEN Approach on addressing environmental issues in product and service standards .9
2.4.1 Short summary .9
2.4.2 Recommendations . 10
3 Basics of Chemical Safety Assessment (CSA) . 10
3.1 Hazard assessment . 11
3.2 Exposure assessment . 13
3.3 Risk characterisation . 14
3.4 Example – PAHs. 14
3.5 Example – Migration limit values in Toy Safety Directive . 15
3.6 Recommendations . 16
4 Child use and care articles specific approaches . 16
4.1 General aspects . 16
4.2 Substances of Very High Concern (SVHC) . 17
4.3 CMR substances . 17
4.4 Certain elements . 17
4.4.1 Regulatory and normative background . 17
4.4.2 Specific child use and care articles considerations . 18
4.5 Flame retardants . 18
4.5.1 Regulatory and normative background . 18
4.5.2 Specific child use and care articles considerations . 19
4.6 Colourants . 19
4.6.1 Regulatory and normative background . 19
4.6.2 Specific child use and care articles considerations . 20
4.7 Primary aromatic amines . 20
4.7.1 Regulatory and normative background . 20
4.7.2 Specific child use and care articles considerations . 20
4.8 Monomers . 21
4.8.1 Regulatory and normative background . 21
4.8.2 Specific child use and care articles considerations . 21
4.9 Solvents (migration) . 21
4.9.1 Regulatory and normative background . 21
4.9.2 Specific child use and care articles considerations . 22
4.10 Solvents (inhalation) . 22
4.10.1 Regulatory and normative background . 22
4.10.2 Specific child use and care articles considerations . 23
2
---------------------- Page: 4 ----------------------
kSIST-TP FprCEN/TR 13387-2:2014
FprCEN/TR 13387-2:2014 (E)
4.11 Plasticizers . 23
4.11.1 Regulatory and normative background . 23
4.11.2 Specific child use and care articles considerations . 24
4.12 Sensitizers – Fragrances . 24
4.12.1 Regulatory and normative background . 24
4.12.2 Specific child use and care articles considerations . 26
4.13 N-Nitrosamines and N-Nitrosatable substances . 27
4.13.1 Regulatory and normative background . 27
4.13.2 Specific child use and care articles considerations . 27
4.14 Other . 27
4.14.1 Formaldehyde (other than monomer or preservative) . 27
Annex A (informative) Brief description of regulatory chemical requirements applicable to child
use and care articles . 28
A.1 Certain elements . 28
A.1.1 Nickel . 28
A.1.2 Flame retardants . 28
A.1.3 Colourants . 28
A.1.4 Wood preservatives . 29
A.1.5 Preservatives (other than wood preservatives) . 29
A.1.6 Plasticizers . 29
A.1.7 N-Nitrosamines and N-Nitrosatable substances . 29
A.1.8 Policyclic Aromatic Hydrocarbons (PAHs) . 30
A.1.9 Persistent Organic Pollutants (POPs) . 30
A.1.10 Food contact materials . 30
A.2 Packaging . 30
Annex B (informative) Specification of a declaration of conformity for chemicals in child use and
care articles . 31
Annex C (informative) Model requirements for use in a standard . 32
C.1 Chemical requirements . 32
C.2 Substances of Very High Concern (SVHC) . 32
C.3 CMR substances . 32
C.4 Certain elements . 32
C.5 Flame retardants . 33
C.6 Colour Fastness . 33
C.7 Colourants . 33
C.8 Primary aromatic amines . 34
C.9 Monomers. 35
C.10 Solvents (migration) . 35
C.11 Solvents (inhalation) . 36
C.12 Plasticizers . 36
C.13 Sensitizers – Fragrances . 36
C.14 N-Nitrosamines and N-Nitrosatable substances . 39
C.15 Formaldehyde (other than monomer or preservative) . 39
Bibliography . 40
3
---------------------- Page: 5 ----------------------
kSIST-TP FprCEN/TR 13387-2:2014
FprCEN/TR 13387-2:2014 (E)
Foreword
This document (FprCEN/TR 13387-2:2014) has been prepared by Technical Committee CEN/TC 252 “Child
use and care articles”, the secretariat of which is held by AFNOR.
This document is currently submitted to the Technical Committee Approval.
This document will supersede CEN/TR 13387:2004.
FprCEN/TR 13387 comprises the following five parts:
Safety philosophy and safety assessment (FprCEN/TR 13387-1)
Chemical hazards (FprCEN/TR 13387-2)
Mechanical hazards (FprCEN/TR 13387-3)
Thermal hazards (FprCEN/TR 13387-4)
Product information (FprCEN/TR 13387-5)
CEN/TR 13387-2 should be used in conjunction with CEN/TR 13387-1.
The chemical part has been completely rewritten compared to the previous edition.
4
---------------------- Page: 6 ----------------------
kSIST-TP FprCEN/TR 13387-2:2014
FprCEN/TR 13387-2:2014 (E)
1 Scope
This Technical Report provides guidance information on chemical hazards that should be taken into
consideration when developing safety standards for child use and care articles. In addition, these guidelines
can assist those with a general professional interest in child safety.
2 Regulatory, normative and policy background
2.1 General
In Europe child use and care articles are covered by the General Product Safety Directive (EC) No 2001/95
(GPSD). This directive contains a general safety requirement and does not address chemical substances in
particular. However, article 13 of the GPSD provides for the opportunity to adopt temporary “emergency”
measures which may include limit values for chemical substances in consumer products. Such measures had
been adopted for phthalates in toys and child use and care articles and for dimethylfumarate (DMF) and both
have been later incorporated into REACH. In addition, Member States can impose actions on products found
unsafe.
Restrictions for several specific chemical substances can be found in Annex XVII of Regulation (EC) No
1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
“relating to restrictions on the marketing and use of certain dangerous substances and preparations” as
amended. If applicable to their type of product or material used, these provisions are to be followed by
manufacturers of child care articles.
Regulation (EC) No 850/2004 on Persistent Organic Pollutants restricts production, placing on the market and
use of listed chemical substances (essentially halogenated organic compounds) including constituents of
articles. The provisions apply also to child care products.
Other regulatory provisions relating to chemicals may apply to certain products. For instance, drinking
equipment is subject to Regulation (EC) No 1935/2004 on materials and articles intended to come into contact
with food and plastics components of drinking equipment are regulated by Regulation (EC) No 10/2011
relating to plastic materials and articles intended to come into contact with foodstuffs. Directive (EEC) No
93/11 covers the release of n-nitrosamine and n-nitrosatable substances from elastomer or rubber teats and
soothers. Applicable regulation will have to be identified where relevant.
Another example of chemical provisions applicable to child care articles is Directive (EC) No 94/62 on
packaging and packaging waste which establishes among other things limits for lead, cadmium, mercury and
hexavalent chromium in packaging.
Whilst not directly applicable to child care articles Directive (EC) No 2009/48 on the safety of toys is an
important reference document addressing a similar product group and providing a high standard of safety in
the field of products intended for children. Hence, specific guidance seems appropriate on how to make use of
toys related chemical rules.
It is the intention of the present guidelines to complement existing legal obligations by providing some
practical recommendations keeping in mind legal minimum requirements.
Environmental issues are moving in the spotlight. CEN has adopted a policy: the “CEN Approach on
addressing environmental issues in product and service standards” calls for incorporation of environmental
considerations when product or service standards are elaborated. These aspects are highly relevant in
particular for chemicals as far as child care articles are concerned. Hence, this guide incorporates also
recommendations in this regard.
5
---------------------- Page: 7 ----------------------
kSIST-TP FprCEN/TR 13387-2:2014
FprCEN/TR 13387-2:2014 (E)
2.2 REACH - Short summary
2.2.1 Registration
All chemical substances manufactured or imported in quantities greater than 1 tonne per year per
manufacturer or importer must be registered at the European Chemicals Agency (ECHA) unless they are
exempted from the scope of registration. The registration obligations apply to the individual chemical
substances, independently of whether they are on their own, in a mixture or in an article (when the chemical
substance is intended to be released).
With the registration the companies must deliver information about the physicochemical, toxicological and
ecotoxicological properties of the chemicals.
NOTE 1 The information required increases with the annual production/importation volume. Therefore dossiers for
chemicals of the low tonnage bands can be incomplete.
For any chemical substances imported or manufactured above 10 tonnes annually, a chemical safety report is
required as part of the registration dossier. The goal of the chemical safety report is to assess and
characterize risks arising from the varied uses of each chemical substance, and to demonstrate that the use of
risk management measures can adequately control the potential risks to human health and the environment.
NOTE 2 Registration means only that a manufacturer or importer has provided a registration dossier to the Agency. It
does not necessarily mean that the chemical substance is safe to be used in or for childcare articles.
2.2.2 Authorisation
Chemical substances with properties of very high concern may be subject to authorisation before being
allowed to be manufactured or used in the European Union. These are CMRs (carcinogenic, mutagenic and
toxic for reproduction), PBTs/vPvBs (persistent, bio accumulating and toxic/very persistent and very bio
accumulating chemical substances) and chemical substances identified as causing serious and irreversible
effects to humans or the environment equivalent to the effects mentioned above. All these chemical
substances will be identified in co-operation with the Member States. As a first step such chemical substances
are incorporated in a so-called “candidate list” which is published and periodically updated by ECHA (twice a
year in June and December). The candidate list is also known as the “SVHC list”. Finally, chemical
substances identified as requiring authorisation will be taken up in Annex XIV or REACH. These chemical
substances cannot be placed on the market or used for manufacturing in Europe after a given date, unless an
authorisation is granted for their specific use, or the use is exempted from authorisation.
It may take many years before all chemical substances of very high concern – potentially 1500-2000
substances – will have been identified and worked through.
For the current list of SVHC please consult the ECHA website:
http://echa.europa.eu/web/guest/candidate-list-table
2.2.3 Restrictions
As in the past chemical substances can banned or restricted where there is an unacceptable risk to health or
the environment. The former “restriction for marketing and use (RMU)” Directive (76/769/EEC) and its
amendments have been incorporated in REACH as Annex XVII “relating to restrictions on the marketing and
use of certain dangerous substances and preparations”
Before a restriction is adopted for inclusion in Annex XVII a so-called Annex XV dossier is required, i.e. a risk
assessment accompanied with a demonstration that current risk management measures are insufficient to
control the risk. This can be done by Member States or the ECHA on behalf of the Commission. In addition,
there is a fast track procedure in accordance with article 68(2) for CMRs category 1A and 1B which provides
the European Commission the opportunity to adopt restrictions using a simplified procedure. By end of 2013
Annex XVII of REACH contained restrictions on 63 chemical substances (or group of substances), like e.g.
use of certain phthalates in toys and child care articles, asbestos, metals, and so forth.
6
---------------------- Page: 8 ----------------------
kSIST-TP FprCEN/TR 13387-2:2014
FprCEN/TR 13387-2:2014 (E)
2.2.4 Articles
Articles within REACH are defined as an object, which during production is given a special shape, surface or
design which determines its function to a greater degree than its chemical composition (Article 3(3)). This
means that most consumer products including child use and care articles can be defined as articles, but there
are special cases such as ball point pens that are defined as containers intended to deliver a chemical
preparation. Chemical products such as cosmetics or paints are not considered articles. Chemical substances
in articles do not need to be registered under REACH, except chemical substances in articles that are
intentionally released if present in quantities greater than 1 tonne per manufacturer annually. This could be for
example a product with a perfume scent. Chemical substances that are unintentionally released during use
are not in scope for registration, like plasticizers migrating out of a product over time.
If articles contain chemical substances on the “candidate list” (SVHC list) in a concentration above 0.1%
(w/w), the supplier has to provide sufficient information (as a minimum the name of the chemical substance) to
the recipient of the article to allow for safe use of the article. 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 of REACH). This requirement is independent of the total tonnage of the chemical substance. No such
requirement exists for other dangerous chemical substances in articles.
If a SVHC substance is present in a concentration above 0.1 % in the article and its import or manufacturing
quantities are above 1 tonne in total per year per company, EU producers or importers of articles must notify
the ECHA of the presence of the SVHC substance. Such notification requirement does not exist for other
dangerous substances in articles.
Chemical substances integrated in articles are neither subject to registration nor to authorization with the
exception of chemical substances intended to be released. However, SVHC substances used in or for the
manufacturing of articles in Europe may require authorization. Restricted chemical substances (REACH
Annex XVII) cannot be used in articles in the EU, nor can they be present in any article imported into the EU.
In conclusion this means that REACH covers articles in a limited way (in particular, imported articles) and,
consequently, REACH should not be considered as a replacement for product specific chemical rules.
2.2.5 Recommendations
Manufacturers and importers of as well as standard setting bodies for child use and care articles should
monitor the development of REACH and, in particular, the inclusion of chemical substances in the “candidate
list”, in annex XIV (authorisation) and in annex XVII (restrictions).
2.3 Toy Safety Directive and related standards
2.3.1 Short summary of Toy Safety Directive
The Toy Safety Directive (TSD) was published in June 2009 (2009/48/EC). Part III of Annex II contains the
chemical requirements and are summarized below.
Chemical substances that are carcinogenic, mutagenic or toxic to reproduction (CMR) substances of category
1A, 1B or 2 under the Classification, Packaging and Labelling (CLP) Regulation (Regulation 1272/2008) are
only allowed in toys if certain conditions are met:
If the use and presence of the chemical substance is allowed according to Appendix A of Annex II;
NOTE At the moment of publication of these guidelines only nickel in stainless steel is listed on Appendix A of Annex
II
these chemical substances are inaccessible to children in any form, including inhalation;
the concentration of the chemical substances does not exceed the concentration limits as set for the
classification of mixtures containing these chemical substances in the CLP regulation. The general
concentration thresholds for carcinogenic and mutagenic substances are 0,1%, 0,1% and 1% (for cat. 1A,
7
---------------------- Page: 9 ----------------------
kSIST-TP FprCEN/TR 13387-2:2014
FprCEN/TR 13387-2:2014 (E)
1B and 2). For substances toxic to reproduction they are 0,3%, 0,3% and 3%. For some substances
specific concentration limits apply in accordance with Annex VI, Table 3.1 of Part 3 of the CLP regulation.
55 listed allergenic fragrances must not be used in toys only if the presence is technically unavoidable under
good manufacturing practice and does not exceed 100 ppm. Another 11 allergenic fragrances must be
declared on a product label if they are present in concentrations above 100 ppm.
Requirements on migration of 19 elements (aluminium, antimony, arsenic, barium, boron, cadmium, chromium
(III), chromium (VI), cobalt, copper, lead, manganese, mercury, nickel, selenium, strontium, tin, organic tin,
and zinc) replacing the previous migration restrictions on 8 elements (antimony, arsenic, barium, cadmium,
chromium, lead, mercury and selenium). The migration limits are set for three different types of materials:
1) dry, brittle powder-like or pliable toy material,
2) liquid or sticky toy mate
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.