CEN TR 13387-2-2015 Child use and care articles - General safety guidelines - Part 2 Chemical hazards《儿童用保育品 通用安全指南 第2部分 化学危险性》.pdf

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1、BSI Standards PublicationPD CEN/TR 13387-2:2015Child use and care articles General safety guidelinesPart 2: Chemical hazardsPD CEN/TR 13387-2:2015 PUBLISHED DOCUMENTNational forewordThis Published Document is the UK implementation of CEN/TR 13387-2:2015. Together with PD CEN/TR 13387-1:2015, PD CEN/

2、TR 13387-3:2015, PD CEN/TR 13387-4:2015 and PD CEN/TR 13387-5:2015, it supersedes PD CEN/TR 13387:2004, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CW/1, Safety of child use and child care products.A list of organizations represented on this commit

3、tee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2015. Published by BSI Standards Limited 2015ISBN 978 0 580 87779 7 ICS 97.190

4、 Compliance with a British Standard cannot confer immunity from legal obligations.This Published Document was published under the authority of the Standards Policy and Strategy Committee on 31 July 2015.Amendments/corrigenda issued since publicationDate Text affectedTECHNICAL REPORT RAPPORT TECHNIQU

5、E TECHNISCHER BERICHT CEN/TR 13387-2 July 2015 ICS 97.190 Supersedes CEN/TR 13387:2004English 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/T

6、C 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,

7、 Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploita

8、tion in any form and by any means reserved worldwide for CEN national Members. Ref. No. CEN/TR 13387-2:2015 EPD CEN/TR 13387-2:2015CEN/TR 13387-2:2015 (E) 2 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 Re

9、gistration 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 produ

10、ct 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

11、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

12、 . 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

13、 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 backgr

14、ound 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 PD CEN/TR 13387-2:2015CEN/TR 13387-2:2015 (E) 3 4.11.1 Regulatory an

15、d 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 an

16、d 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

17、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 (P

18、OPs) . 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 retard

19、ants 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 B

20、ibliography 37 PD CEN/TR 13387-2:2015CEN/TR 13387-2:2015 (E) 4 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 el

21、ements 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 13

22、387-1); 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.

23、PD CEN/TR 13387-2:2015CEN/TR 13387-2:2015 (E) 5 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 prof

24、essional 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 s

25、ubstances 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 dim

26、ethylfumarate (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

27、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

28、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 regu

29、latory 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 Reg

30、ulation 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.

31、 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 Direc

32、tive 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 to

33、ys 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 a

34、ddressing 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 inco

35、rporates also recommendations in this regard. PD CEN/TR 13387-2:2015CEN/TR 13387-2:2015 (E) 6 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 Che

36、micals 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 Author

37、ization 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 persist

38、ent 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

39、 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

40、 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

41、 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 phthala

42、te 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 finish

43、ed 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

44、 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 wit

45、h 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 supplie

46、r 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 requ

47、est. (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 qua

48、ntities 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. PD CEN/TR 13387-2:2015CEN/TR 13387-2:2015 (E) 7 Chemica

49、l 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 h