Proposal for a Council Directive amending, for the purpose of adapting to technical progress, Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards lead

Author (Corporate)
Series Title
Series Details (2016) 560 final (9.9.16)
Publication Date 09/09/2016
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Directive 2009/48/EC on the safety of toys lays down, in the table under point 13 of part III of Annex II, migration limits, from toys or components of toys, for a range of elements, including lead, in dry, liquid and scraped-off toy material. In order to ensure adequate protection of children, Directive 2009/48/EC empowers the Commission to amend point 13 of part III of Annex II for the purpose of its adaptation to technical and scientific developments.

With the objective of strengthening the limit values for lead in toys on the basis of the latest scientific evidence from the European Food Safety Authority (EFSA), the Commission prepared a draft directive which was put to the vote in the Toy Safety Committee established by Article 47 of Directive 2009/48/EC. The Committee did not deliver an opinion on the draft directive at its meeting of 14 January 2015.

An erratum to the 2008 report of the Dutch National Institute for Public Health and the Environment (RIVM) underlying the migration limits in the table under point 13 of part III of Annex II of Directive 2009/48/EC was published shortly after the Committee meeting of 14 January 2015. The erratum considered that the limits for elements in dry and liquid toy material had been calculated erroneously in 2008. The calculation had been based on amounts of material that were assumed to be ingested by children once every day, however ingestion would happen only once every week.

Consulted by the Commission on the matter, the Scientific Committee for Health and Environmental Risks (SCHER) contended in April 2016 that the daily ingestion was appropriate, thereby confirming that the methodology of the 2008 RIVM report to calculate safe limits for elements in toys is correct. Accordingly, the same methodology should be applied for revising the limits for lead in toys; the present proposal does so.

Source Link Link to Main Source http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2016:560:FIN
Related Links
EUR-Lex: COM(2016)560: Follow the progress of this proposal through the decision-making procedure http://eur-lex.europa.eu/legal-content/EN/HIS/?uri=COM:2016:560:FIN
EUR-Lex: SWD(2016)289: Executive summary of the impact assessment http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=SWD:2016:289:FIN
EUR-Lex: SWD(2016)290: Impact assessment http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=SWD:2016:290:FIN

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