CEN TR 13387-2-2018 Child care articles - General safety guidelines - Part 2 Chemical hazards.pdf

1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Child care articles General safety guidelinesPart 2: Chemical hazardsPD CEN/TR 133872:2018National forewordThis Published Document is the UK implementation of CEN/TR 133872:2018. It supersedes PD CEN/TR 133872:2015, whi

2、ch is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CW/1, Safety of child use and child care products.A list of organizations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 committee can be obtained on request to its secretary.This publication does not purport to include all the necess

3、ary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 51987 1ICS 97.190Compliance with a British Standard cannot confer immunity from legal obligations.This Published Document was

4、published under the authority of the Standards Policy and Strategy Committee on 31 July 2018.Amendments/corrigenda issued since publicationDate Text affectedPUBLISHED DOCUMENTPD CEN/TR 133872:2018TECHNICAL REPORTRAPPORT TECHNIQUETECHNISCHER BERICHTCEN/TR 133872July 2018ICS 97.190 Supersedes CEN/TR 1

5、33872:2015EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCENCENELEC Management Centre: Avenue Marnix 17, B1000 Brussels 2018 CEN Ref. No. CEN/TR 133872:2018: EAll rights of exploitation in any form and by any means reserved worldwide for CEN nationa

6、l MembersChild care articles General safety guidelines Part 2: Chemical hazardsArticles de puriculture Conseils relatifs la scurit Partie 2 : Dangers chimiquesArtikel fr Suglinge und Kleinkinder Allgemeine Sicherheitsrichtlinien Teil 2: Chemische GefahrenThis Technical Report was approved by CEN on

7、16 March 2018. 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

8、, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionCEN/TR 133872:2018 (E)European foreword .iv1 Scope . 52 Normative references 53 Terms and definitions . 54 R

9、egulatory, normative and policy background . 54.1 General . 54.2 REACH Short summary . 64.2.1 Registration 64.2.2 Authorization 64.2.3 Restrictions . 64.2.4 Articles 64.2.5 Recommendations 74.3 Toy Safety Directive and related standards 74.3.1 Short summary of Toy Safety Directive 74.3.2 Toy standar

10、ds . 84.3.3 Recommendations 94.4 CEN Approach on addressing environmental issues in product and service standards 104.4.1 Short summary .104.4.2 Recommendations .105 Basics of Chemical Safety Assessment (CSA) 105.1 General 105.2 Hazard assessment . 115.3 Exposure assessment . 125.4 Risk characteriza

11、tion 135.5 Example PAHs 135.6 Example Migration limit values in Toy Safety Directive 145.7 Recommendations 156 Child care articles specific approaches 156.1 General aspects 156.2 Substances of Very High Concern (SVHC) . 156.3 CMR substances 156.4 Certain elements. 166.4.1 Regulatory and normative ba

12、ckground 166.4.2 Specific child care articles considerations 166.5 Flame retardants 176.5.1 Regulatory and normative background 176.5.2 Specific child care articles considerations 176.6 Colourants 176.6.1 Regulatory and normative background 176.6.2 Specific child care articles considerations 186.7 P

13、rimary aromatic amines . 186.7.1 Regulatory and normative background 186.7.2 Specific child care articles considerations 196.8 Monomers 196.8.1 Regulatory and normative background 196.8.2 Specific child care articles considerations 206.9 Solvents (migration) 206.9.1 Regulatory and normative backgrou

14、nd 206.9.2 Specific child care articles considerations 206.10 Solvents (inhalation) . 216.10.1 Regulatory and normative background 216.10.2 Specific child care articles considerations 21iiContents PagePD CEN/TR 133872:2018CEN/TR 133872:2018 (E)6.11 Plasticizers . 216.11.1 Regulatory and normative ba

15、ckground 216.11.2 Specific child care articles considerations 226.12 Sensitizers Fragrances . 226.12.1 Regulatory and normative background 226.12.2 Specific child care articles considerations 246.13 NNitrosamines and NNitrosatable substances.246.13.1 Regulatory and normative background 246.13.2 Spec

16、ific child care articles considerations 246.14 Other Formaldehyde (other than monomer or preservative) .246.14.1 Regulatory and normative background 246.14.2 Specific child care articles considerations 25Annex A (informative) Brief description of EU regulatory chemical requirements applicable to chi

17、ld care articles .26Annex B (informative) Model requirements for use in a standard 31Bibliography .39 ISO ISO pubdate year All rights reserved iiiPD CEN/TR 133872:2018CEN/TR 133872:2018 (E)European forewordThis document (CEN/TR 133872:2018) has been prepared by Technical Committee CEN/TC 252 “Child

18、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 shall not be held responsible for identifying any or all such patent rights.This document supersedes CEN/TR 133872:2015.

19、The chemical part has been updated compared to the previous edition. Apart from some adaptations necessary as a result of relevant reference documents which have been adopted or changed after the publication of the previous edition of the present guidelines some corrections were made. In addition, t

20、he recommendations relating to formaldehyde and preliminary aromatic amines were changed.The CEN/TR 13387 series comprises the following five parts: Safety philosophy and safety assessment (CEN/TR 133871); Chemical hazards (CEN/TR 133872); Mechanical hazards (CEN/TR 133873); Thermal hazards (CEN/TR

21、133874); Product information (CEN/TR 133875).CEN/TR 133872 is intended to be used in conjunction with CEN/TR 133871.ivPD CEN/TR 133872:2018CEN/TR 133872:2018 (E)1 ScopeThis document provides guidance information on chemical hazards that should be taken into consideration when developing safety stand

22、ards for child care articles. In addition, these guidelines can assist those with a general professional interest in child safety.2 Normative referencesThere are no normative references in this document. 3 Terms and definitionsNo terms and definitions are listed in this document.ISO and IEC maintain

23、 terminological databases for use in standardization at the following addresses: IEC Electropedia: available at http:/www.electropedia.org/ ISO Online browsing platform: available at http:/www.iso.org/obp 4 Regulatory, normative and policy background4.1 GeneralIn Europe child care articles are cover

24、ed 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 incl

25、ude limit values for chemical substances in consumer products. Such measures had been adopted for phthalates in toys and child 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.Restric

26、tions 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

27、 preparations” as amended. If applicable to their type of product or material used, these provisions shall 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 che

28、mical substances listed in Annex I of the regulation including constituents of articles. The provisions apply also to child care articles.Other regulatory provisions relating to chemicals may apply to certain products. For instance, drinking equipment is subject to the Regulation on materials and ar

29、ticles 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 Nnitrosamines and Nnitrosata

30、ble 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 am

31、ong 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 providi

32、ng 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.5PD CEN/TR 133872:2018CEN/TR 133872:2018 (E)It is the intention of the present guidelines to complement existing legal obligations

33、 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 consider

34、ations 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.4.2 REACH Short summary4.2.1 RegistrationAll chemical substances manu

35、factured 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 o

36、f whether they are on their own, in a mixture or in an article (when the chemical substance is intended to be released).4.2.2 AuthorizationChemical substances with properties of very high concern may be subject to authorization before being allowed to be manufactured or used in the European Union. T

37、hese 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

38、 to the effects mentioned above. As a first step such chemical substances are incorporated in a socalled “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 identif

39、ied 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

40、 list of SVHC please consult the ECHA website.4.2.3 RestrictionsREACH Annex XVII contained specific restrictions on 61 chemical substances or groups of substances by the end of 2016 (66 entry numbers, 5 empty entries). These may apply to all uses of the substance or more specifically to certain prod

41、uct 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 plasticizers and total content limits for certain flame retardants in textiles where there is prolonged skin contact. Some entri

42、es, 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.4.2.4 ArticlesArticles within REACH are defined as an object, which during production is given a special shape, surface or des

43、ign which determines its function to a greater degree than its chemical composition (Article 3(3). This means that most consumer products including child care articles can be defined as articles. Chemical substances in articles do not need to be registered under REACH, except chemical substances in

44、articles that are intentionally released if present in quantities greater than 1 t 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

45、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 shall provide sufficient information (as a minimum the name of the chemical 6 PD CEN/TR 133872:2018CEN/TR 133872:2018 (E)substance) to the recipient o

46、f 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.

47、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 t

48、he 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

49、. 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.4.2.5 RecommendationsManufacturers 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