16 June 2017
Toy Manufacturers to Face Reduced Migration Limit of Hazardous Chemical Bisphenol A
On 25 May 2017, the European Commission published Directive 2017/898 amending framework Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards Bisphenol A (BPA). The newly adopted Directive applies to toys intended for use by children under 36 months or in other toys intended to be placed in the mouth. This law will impact on Hong Kong traders who export these types of toys to the EU.
By means of the Directive, the Commission has now cut the 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, is now reduced to 0.04 mg/l, from the 0.1 mg/l limit that had 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. These chemicals are, currently, Bisphenol A, TCEP, TCPP and TDCP.
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 occasionally present as an additive in certain PVC materials.
Concerns have been raised as to 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 specific test methods laid down in European standards EN 71-10:2005 and EN 71-11:2005. These European Standards specify sample preparation and extraction procedures for establishing the release of organic compounds from toys.
The EN 71-10:2005 standard requires that 10cm2 of a toy material be extracted with 100ml of water during one hour. Compliance with the specific limit value of 0.1 mg/l thus means that during the extraction a maximum of 0.01 mg of Bisphenol A may migrate out of the toy material.
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 – a fact which has been a source of controversy. Hong Kong traders may recall that on 6 October 2016, an overwhelming majority of members of the European Parliament (MEPs) called on the EU to ban the use of Bisphenol A in all food contact materials (see Regulatory Alert-EU: Overwhelming Majority of EU Parliamentarians Call for Ban on BPA in All Food Contact Materials).
The Commission notes 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 reflects current scientific knowledge and ensures 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 companies exporting toys to the EU should take note that Member States have to adopt and publish, by 25 November 2018, the laws, regulations and administrative provisions necessary to comply with new Directive 2017/898 further restricting BPA in toys. The provisions have to be applied from 26 November 2018.
Please click on the following to view Directive 2017/898.