23 Oct 2018
Enhanced Restriction of BPA in Toys to Enter into Effect
By means of Directive 2017/898, the European Commission cut the permissible level of Bisphenol A in toys by more than half. The migration limit, which is based upon the rate at which the substance leaches into water, has been reduced to 0.04 mg/l, from the 0.1 mg/l limit that has hitherto been in force since December 2015.
Framework Directive 2009/48/EC on the safety of toys outlines, by means of a table in Appendix C of Annex II, specific migration limits for chemicals used in toys intended for children under 36 months or in other toys intended to be placed in the mouth.
Bisphenol A is a chemical used in combination with other chemicals to manufacture plastics and resins. It is frequently present in polycarbonate – a high performance, rigid plastic – and is occasionally present as an additive in certain PVC materials.
Concerns have been raised over human exposure to Bisphenol A and the possible adverse effects it may have on the brain, as well as the endocrine and reproductive system. It is widely thought that young and unborn humans are more susceptible to the harmful effects resulting from BPA exposure in comparison to adults.
Appendix C of Annex II of Directive 2009/48/EC provided a migration limit value for Bisphenol A of 0.1 mg/l as assessed with test methods laid down in specific European standards. These European Standards specify sample preparation and extraction procedures for establishing the release of organic compounds from toys. The new restriction thus reads as follows:
In Appendix C to Annex II to Directive 2009/48/EC, in the table, the restriction entry for bisphenol A is replaced by the following:
The Commission’s decision to revise the migration limits for Bisphenol A in toys has its roots in a recommendation of 1 October 2015 agreed upon by the subgroup “Chemicals” of the Expert Group on Toy Safety. This subgroup is charged with providing advice on chemical substances which may be used in toys. On 14 January 2016, the Expert Group on Toy Safety subsequently voted to support the recommendation.
Hong Kong sellers may also be aware that at EU level, the use of Bisphenol A in the manufacture of baby bottles is prohibited, while the presence of Bisphenol A in certain food contact materials is also subject to specific migration limits.
The Commission noted, in relation to the earlier applicable limit, that “[i]n the light of available scientific evidence and considering the differences between toys and materials which come into contact with food, the currently applicable specific limit value for Bisphenol A in toys is too high and should be revised”.
The Commission explains that the effects of Bisphenol A are still under review in scientific fora and it may be necessary to further review the migration limits if relevant new scientific information becomes available in the future. The revised migration limit displayed above reflects the current scientific knowledge and ensures the adequate protection of children.
The EU’s tightening of migration limits for Bisphenol A in toys could be seen as a result of mounting fears and opposition to the presence of the chemical in certain products in Europe. It may also pave the way for a wider EU crackdown on the use of BPA in other products beyond toys.
Indeed, on 12 January 2017, the European Chemicals Agency (ECHA) placed Bisphenol A on the REACH candidate list for substances of very high concern (SVHC) because of its reprotoxic properties.
Hong Kong’s toy exporters will have to ensure full compliance with the revised BPA restriction from 26 November 2018.
Please click on the following to view Directive 2017/898.