The latest development in EU

Transcription

1 The latest development in EU Hong Kong Toys & Games Fair 2016 Seminar on Toy Safety Christian Wetterberg Chair of CEN/TC 52 and ISO/TC 181 l

2 Agenda The EU-framework for toy safety The Toy Safety Directive The EN 71 and EN standards Other directives and regulations Page 2

3 The standards and Guidance docs vs the TSD Particular safety requirements Standards & Guidance docs Page 3 Mechanical EN 71-1 EN 71-8 EN Toy Safety Directive 2009/48/EC Flammability EN 71-2 Chemical Migration of elements Nitrosamines Other EN 71-3 EN 71-4 EN 71-5 EN 71-7 EN EN CMR Fragrances Other legislation (EN 71-9, -10, -11) Guidance doc Electrical EN Hygiene Guidance doc Radioactivity Guidance doc

4 Standards, guidance docs and the safety assessment Legislation that can be relevant for toys Toy Safety Directive RoHS-directive REACH Phthalates Nickel release Benzene Cadmium Azo-dyes PAHs SVHC-list Packaging & Waste Food Contact Material Regulation Battery Directive R&TTE-directive EMC-directive CLP-regulation POPs-regulation Cosmetics regulation Standards & Guidance documents Safety Assessment according to Article 18 in TSD (also used to determine necessary testing) The above is not an exhaustive list of legislation Page 4

5 The EU-framework for toy safety Specific chemical restrictions (e.g. REACH, POPs and CLP) Food contact materials Regulations 1935/2004 and 10/2011 Specific electrical: (e.g. RoHS, R&TTE and EMC) Toy Safety Directive 2009/48/EC Cosmetic products Regulation 1223/2009 Packaging & Waste Directive 94/62/EC Batteries Directive 2006/66/EC Page 5

6 The TSD Directive 2009/48/EC certain parts can be amended, e.g: Annex II, Section 3, point 13, Migration limits: Sets limits for the migration of 19 elements Appendix A: Lists substances that are classified as Carcinogenic, Mutagenic or Reprotoxic (CMR) but are exempted from the general prohibition on CMR-substances Appendix C: Includes specific limit values for chemicals used in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth. Limits in App C overrule the general requirements for CMR-substances Page 6

7 Changes to TSD after its publication Migration limits Element mg/kg in dry, brittle, powderlike or pliable toy material mg/kg in liquid or sticky toy material mg/kg in scraped-off toy material Old Barium New Cadmium Old 1,9 0,5 23 New 1,3 0,3 17 These limits were changed prior to July 20, 2013 Page 7

8 Changes to TSD that are under discussion Migration limits It has also been discussed to adapt migration limits for Chromium VI that would correspond to the Limit of Quantification (0,053 mg/kg). The discussions on migration limits have been on hold due to a published erratum to the report from RIVM. This is the report which estimated the potential daily intake of different toy materials and thus formed the basis for the present TSD migration requirements. Page 8

9 Changes to TSD after its publication Appendix A Nickel (classified as Carcinogenic Category 2) is permitted in toy components which are intended to conduct an electric current. (It is since before also permitted in toys and toy components made of stainless steel). The new exemption entered into force July 1st, 2015 Page 9

10 Changes to TSD after its publication Appendix C: The following restrictions entered into force December 21, 2015 Expl. guidance doc: TCEP is a phosphate ester used as a flame-retardant plasticiser in polymers. TDCP and TCPP are TCEP's halogenated alternatives. Bisphenol A residual monomer is normally found at trace levels only in polycarbonate and epoxy resins. It can also be present as an additive (polymerisation aid) in certain PVC materials; Page 10

11 Changes to TSD after its publication Appendix C The following restriction for BIT will enter into force May 27, 2017 Note that the restriction applies to aqueous toy materials (e.g. finger paints, window/glass paints, glues and soap bubbles) Page 11

12 Changes to TSD after its publication Appendix C The following restrictions for CMI+MI, CMI and MI will enter into force Nov 27, 2017 Note that the restriction applies to aqueous toy materials (e.g. finger paints, window/glass paints, glues and soap bubbles) General recommendation - preservatives It is expected that the guidance document on Technical Documentation will be updated with a recommendation to proceed with a Toxicological Risk Assessment (in addition to considering limit values e.g. in the TSD and standards) Page 12

13 Changes to TSD after its publication Appendix C The following restriction for Formamide will enter into force May 27, 2017 Expl. guidance doc: Will clarify that the restriction targets EVA, PE and PU foam materials larger than 0,45 m 2 and for indoor use. Examples with pictures will be given (e.g. puzzle mats). Page 13

14 Changes to TSD that are under discussion Appendix C Page 14

15 The EN 71 and EN standards EN 71-1 Mechanical and physical properties EN 71-2 Flammability EN 71-3 Migration of certain elements EN 71-4 Experimental sets for chemistry and related activities EN 71-5 Chemical toys (sets) other than experimental sets EN 71-7 Finger paints EN 71-8 Activity toys for domestic use EN 71-9 Organic chemical compounds Requirements EN Organic chemical compounds Sample preparation EN Organic chemical compounds - Methods of analysis EN N-Nitrosamines and N-nitrosatable substances EN Olfactory board games, cosmetic kits and gustative games EN Trampolines for domestic use EN Electrical toys Blue = Reference not published in the Official Journal of the EU Page 15

16 EN 71-1 MECHANICAL & PHYSICAL PROPERTIES Until 29 February 2016, both EN 71-1:2011+A3:2014 and EN 71-1:2014 give presumption of conformity to TSD. EN 71-1:2011+A3:2014 includes: A1: Legibility of warnings A2: Acoustics A3 Toy books (paper and paperboard) EN 71-1:2014 was published November 26 th 2014 and is an editorially revised version of EN 71-1:2011+A3:2014. Toys that comply with EN 71-1:2011+A3:2014 do not need to be retested to EN 71-1:2014

17 EN 71-1 MECHANICAL & PHYSICAL PROPERTIES Ongoing work affecting EN 71-1 Amendment pra1 to EN 71-1:2014 regarding Cords and drawstrings in toys and packaging is under elaboration. A 3-month public Enquiry is expected to be launched in April Amendment pra2 regards Projectiles, rotors, propellers and flying toys. The ambition is to launch the 3-month public enquiry first half of Amendment pra3 is named Various and the 3-month CEN Enquiry closed 9 October If possible it will be aligned (timewise) and merged with A1 and A2 in order to reduce the number of amendments.

18 EN 71-series continued EN 71-2:2011 Flammability No important changes have been made since the publication. Amd 1 includes only minor corrections EN 71-3:2013 Migration of certain elements Amd 1 was published in October, 2014 and regards ph control/adjustment during testing of certain toy materials. The previous version of the standard can be used until Feb 29, Major revision with financial support from the European Commission will start Publication of the revised standard is expected for The project includes round robin tests with new reference materials

19 EN 71-series continued EN 71-4:2013 Chemical Experimental Sets No changes have been made since the publication. EN 71-5 Chemical toys EN 71-5:2013 published June 2013 EN 71-5: published September 2015 (this version aligns the standard with the requirements for mixtures in the CLP regulation 1272/2008) EN 71-5:2013 can be used until May 31, 2016 EN 71-7:2014 Finger paints An amendment is planned in order to delete CMI/MI from the list of permitted preservatives (due to the published App C restriction)

20 EN 71-series continued EN 71-8:2011 Activity toys for domestic use No changes have been made since the publication A revision of EN 71-8 is however ongoing and a public enquiry is expected to be launched autumn 2016 EN 71-9, -10 and -11 Organic Chemical Compounds Initial discussions have been held about the need to publish methods that support Appendix C restrictions EN 71-12:2013 Nitrosamines and Nitrosatable substances Includes an A-deviation for National German limits The final vote for a revised version of EN will be launched April It includes the national German limit values for certain toys (with the ambition to delete the A- deviation).

21 EN 71-series continued EN 71-13:2013 Olfactory Board Games and Gustative Games No changes have been made since the publication EN 71-14:2014 TRAMPOLINES FOR DOMESTIC USE EN 71-14:2014 was published in December 2014 A proposal for amendment has been launched to change the safety factor from 2,5 to 5 for calculation of the load in the mat deflection test Discussions regarding a revision of are ongoing.

22 CEN TECHNICAL REPORTS CEN Technical Report National translations of warnings and instructions for use in EN 71-standards. The revised 2015-version was made available in August, CEN Technical report Replies to requests for interpretation of EN 71-1, EN 71-2 and EN CEN TR 15371:2014 published May 7, CEN TR :2015 was published in October 2015 CEN Technical report Replies to requests for interpretation of the EN 71 Chemical standards. CEN TR :2015 was published in October 2015

23 CEN TECHNICAL REPORTS New CEN Technical report :2016 Age determination guidelines The TR was approved in parallel in ISO and CEN and is a slightly revised version of ISO TR :2014. Publication is expected early 2016 New CEN Technical report Children s mouthing behaviour in contact with toys. CEN TR 16918:2015 was published December 23, 2015.

24 EN The current referenced standard is EN 62115:2005 plus amendments A2:2011, A11:2012, and A12:2015 A12 was published early 2015 and contains the requirements on the electro-magnetic fields generated by toys, drawing on the requirements of the horizontal standard EN 62233:2008 The previous version of EN (without A12) can be used until 3 June, 2017 The standard is presently undergoing a revision which includes an update of the LED Annex. The final vote for the revised version standard is expected to be launched in the autumn of 2016 (parallel voting in IEC and CENELEC)

25 Other Directives and Regulations REACH: A new restriction at 0,5 mg/kg for 8 PAHs in rubber or plastic components of toys that come into direct as well as prolonged or short-term repetitive contact with the human skin or the oral cavity, under normal or reasonably foreseeable conditions of use. Applies from 27 December, Phthalate content restriction PAH Content restriction Nickel release restriction Benzene content restriction (toy specific) REACH Regulation 1907/2006 Cadmium content restriction Azodyes (aromatic amines content)

26 Other Directives and Regulations REACH: ECHA has published a definition of prolonged contact with the skin for the Nickel release restriction: Prolonged contact with the skin is defined as contact with the skin of nickel of potentially more than 10 minutes on three or more occasions within two weeks, or 30 minutes on one or more occasions within two weeks The European Court of Justice (ECJ) has said the 0,1 % threshold for notifying Substances of Very High Concern in articles, applies to each of the articles incorporated as a component of a complex product rather than to the entire article. ECHA published a quick update of its guidance document on substances and articles in December A more comprehensive update will come in 2016

27 Other Directives and Regulations Textiles - The European Commission has launched a public consultation on a possible restriction of approx. 300 hazardous substances (CMR 1A and 1B) in textile articles and clothing for consumer use (including toys) at 50 ppm under REACH. R&TTE - Directive 1999/5/EC on radio equipment and telecommunications terminal equipment (R&TTE) will be repealed 13 June 2016 and replaced by Directive 2014/53/EU on Radio Equipment (RE) EMC - Directive 2004/108/EC on Electromagnetic Compatibility (EMC) will be repealed 20 April 2016 and replaced by Directive 2014/30/EU on EMC Page 27

28 Other Directives and Regulations RoHS Four phthalates (DEHP, BBP, DBP och DIBP) will be restricted to 0,1 % under the RoHS Directive from 22 July DEHP, BBP and DBP are already restricted in toys through REACH. DIBP (Diisobutyl phthalate) is however not restricted in toys but it is listed as an SVHC. POPs Regulation (EC) No 850/2004 on persistent organic pollutants (POPs) has been amended to include a threshold for Short-Chained Chlorinated Paraffines (SCCPs) at ppm (it was previously covered by a total ban) Page 28

29 That s all for today Page 29