9 Dec 2016
New EU Law is Proposed to Practically Eliminate Bisphenol A in Certain Toys
On 24 November 2016, the European Commission published a proposal for a new Directive so as to reduce the concentration of Bisphenol A (BPA) in toys which are intended to be placed in the mouth or to be used by children that are less than three years’ old.
This future law will impact on Hong Kong traders who export these types of toys into the EU and, therefore, its progress through the EU legislative process should be monitored closely up to its eventual adoption and implementation.
Currently, Directive 2009/48/EC on the safety of toys lays down 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.
Concern has been expressed about 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.
To protect against these effects, Appendix C of Annex II has, since 21 December 2015, provided a specific migration limit value for Bisphenol A of 0.1 mg/l as assessed in accordance 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.
However, taking into account existing scientific evidence, the Commission has said that the currently applicable specific limit value for Bisphenol A in toys is no longer appropriate to offer a sufficient level of protection. Applying the existing specific limit values for exposure in the context of a 10 kg child mouthing a toy three hours a day, the Commission found that this led to an exposure of 3 micrograms per kilogram of body weight - a rate which was too high.
In order to offer a better level of protection to children, it has now proposed to reduce further the specific limit value for Bisphenol A to 0.04 mg/l in accordance with the European Standards described above.
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 in recent months. 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: Overwhelming Majority of EU Parliamentarians Call for Ban on BPA in All Food Contact Materials).
Previously, in 2015, the European Food Safety Authority’s Panel on Food Contact Materials (CEF PANEL) recommended a “temporary” tolerable daily intake for Bisphenol A at 4 micrograms per kilogram of body weight per day. The Commission in the present proposal has, however, noted that the basic assumptions for deriving exposure limits are different between toys and materials which come into contact with food.
The EU’s tightening of migration limits for Bisphenol A in toys could, therefore, be seen as a result of the mounting fears and opposition to the presence of the chemical in sensitive products in Europe. It may also pave the way for a wider EU crackdown on its use in other products beyond toys.
As regards the specific changes introduced by the new proposal, for toys intended to be placed in the mouth or to be used by children less than three years’ old, the current migration limit for Bisphenol A is contained in one row, which is found in Annex II’s Appendix C of Directive 2009/48/EC on the safety of toys. The amendment thus signifies replacing the current migration limit with the new migration limit. The implementation in Member State law will lead to the same change. In short:
- Article 1 of the proposed Directive replaces the current migration rate of 0.1 mg/l with a new rate of 0.04 mg/l.
- Article 2 of the proposed Directive provides the obligation for Member States to transpose the amended migration limit by the date falling 18 months after publication in the EU’s official Journal, to apply it from that date, and to communicate the transposition measures to the European Commission.
The Council of Member States has two months in which to approve or reject the amended migration limits. If the Council envisages adopting the proposed measure, or if the Council does not act, the proposed measure is submitted to the European Parliament. If the European Parliament does not oppose the proposed measure within a four month timeframe from the date of referral to the Council, then it must be adopted.
Please click on the following link to view the proposed Directive.