Last Thursday, November 6, 2008, the European Parliament's Committee on Internal Market and Consumer Protection unanimously adopted a draft report intended to significantly update the European Union's 20-year-old Toy Safety Directive 88/378/EEC. In its report, the Committee accepted a new draft Toy Safety Directive that the European Commission proposed in January 2008, but added a long series of amendments that will, among other things, tighten restrictions on the use of certain chemicals and allergenic fragrances and clarify the rules on warnings. A summary of the draft report appears below.

1.  What Toys are Covered by the Proposed Toy Safety Directive? The proposed legislation covers toys intended for children under 14. It now includes children's jewelry, but specifically excludes such products as video games and game consoles and detailed scale models.

2.  What are the Chemical Restrictions? Toys will need to comply with the general requirements of the EU’s REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) legislation (Regulation (EC) No. 1907/2006 and Directive 2006/121/EC) as it applies to children, who are considered a particularly vulnerable group of consumers. This will require new risk-analysis-based restrictions on chemicals that are classified as being carcinogens, mutagens or reproductive toxins. Such chemicals will be banned from toys above established concentrations (generally 0.1%, except where existing law has set a lower maximum), unless they are contained in components or distinct parts that are not under any circumstances accessible to children.

A total of 64 allergenic fragrances will be banned from toys unless present in technically unavoidable trace quantities. The list of metals subject to migration testing will be twice as long as the current list of eight in the EN71 and ASTM F963 toy safety standards, and will apply to all accessible components of toys, not just coatings. The additional metals include aluminum, trivalent chromium, copper, nickel and tin. Toys designed to be placed in the mouth, regardless of the intended age group, will have to comply with the EU’s migration limits for chemicals used in food-contact packaging. Toys will have to be capable of being washed, scrubbed and disinfected. In addition, toys given away in food will have to be separately packaged, and the packaging must not present any choking hazard.

3.  What Will the Manufacturers’ and Importers’ Responsibilities Include?  Before placing a toy on the market, a manufacturer will have to assess the chemical, physical, mechanical, electrical, flammability and radioactivity hazards that the toy may present, and a child’s potential exposure to them. The proposed directive stresses that, by affixing the “CE” conformity marking, manufacturers will be declaring that their toys are in full conformity with all applicable requirements, and that they accept full responsibility for the toys being in conformance. In addition, an importer will have to ensure that the manufacturer has followed the appropriate conformity assessment procedure, prepared the required technical documentation, and correctly applied the “CE” marking.  Manufacturers and importers will be required to keep toys' technical documentation and declarations of conformity for 10 years after their introduction into the market. Likewise, any operator who acquires or sells toys in commerce will need to keep records over a period of 10 years on its corporate suppliers and customers. Toys (or their packaging, if the size of the toy does not allow it) will have to bear an identifying mark, such as a batch, serial or model number, together with the names of the manufacturer and the importer and the addresses at which they can be contacted.

4.  What is the Likely Time-Frame for Implementation? The full European Parliament is expected to vote on the proposed legislation in mid-December, with enactment fast-tracked for early 2009 if the legislation passes and is ratified by Member States. It will provide a two-year transition period to give toy manufacturers time to adjust to the new requirements, and to guarantee uniform implementation across the EU. EU member states will be required to establish surveillance authorities to monitor conformance with the new requirements once they go into effect.

Related Documents:

• Report of Internal Market and Consumer Protection Committee on Safety of Toys

• European Commission Proposal for a Directive on the Safety of Toys
  

Georgia Ravitz
ravitz.georgia@arentfox.com
202.857.8939

James R. Ravitz
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202.857.8903

Robert G. Edwards, PhD
edwards.robert@arentfox.com
202.857.6346

Scott A. Cohn
cohn.scott@arentfox.com
212.484.3984

Amy S. Colvin
colvin.amy@arentfox.com
202.857.6338