The current migration limit for Bisphenol A in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth is 0,1 mg/kg as set forth in Appendix C to Annex II to Directive 2009/48/EC. European standards EN 71-10:2005 (sample preparation) and EN 71-11:2005 (measurement) provide the relevant test methods.
New data on bisphenol A and refined methodologies led the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) of the European Food Safety Authority (EFSA) to set a "temporary" tolerable daily intake (TDI) for bisphenol A at 4 microgram per kilogram body weight per day. In the light of the above, the subgroup "Chemicals" of the Expert Group on Toys Safety recommended at its meeting of 1 October 2015 that bisphenol A be limited in toys to 0,04 mg/l (migration limit).
In Appendix C to Annex II to Directive 2009/48/EC, in the table, the entry for bisphenol A is replaced by the following:
| Substance | CAS No. | Limit value |
| Bisphenol A | 80-05-7 | 0,04 mg/l (migration limit) in accordance with the methods laid down in EN 71-10:2005 and EN 71-11:2005. |
In addition, BPA is classified as carcinogenic, mutagenic or toxic for reproduction under Regulation (EC) No 1272/2008 of the European Parliament and of the Council on 20 July 2016 and the amendment will take into force on 1 March 2018. The chemical is likely to be proposed as a substance of high concern (SVHC).
It is obvious that the EU intensifies its regulation on BPA this year (see more news on BPA regulations as linked below). C&K Testing advises related businesses should deal with due care.
|Further Information:
BPA draft
EU to regulate BPA from vanishes and coatings of plastic food contact materials—C&K Testing
Proposal on BPA ban in thermal paper receipts under REACH Annex XVII—C&K Testing
|Our Services: Toys & Children's Products
Toy Safety Directive 2009/48/EC&EN 71
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