新版玩具指令2009/48/EC于2009年6月30日予以发布。新版指令将于2011年7月20日正式生效(2年过渡期),但指令中新的化学要求将于2013年7月20日生效(4年过渡期)。
The new EU Toy Safety Directive (2009/48/EC) was published on 30 Jun, 2009. The new Directive will come into force on 20 Jul, 2011 after a transitional period of 2 years, but its new chemical requirement will come into force until 20 Jul, 2013 with a transitional period of 4 years.
新指令化学方面的主要挑战:
Main challenge on chemical compliance:
◎ 玩具应符合欧盟REACH法规 Toys must comply with EU Reach legislation
◎ 对CMR类物质(致癌、诱导有机体突变或对生殖系统有毒害的物质)的禁令 Ban on substances classified as CMR (Carcinogenic, Mutagenic or Toxic for Reproduction)
◎ 55种致敏性芳香物质不能用于玩具,仅允许技术上无法避免的含量在100 ppm (百万分之)以下的痕量存在 55 allergenic fragrances may not be used in toys, only technically unavoidable traces are allowed up to 100 ppm
◎ 化妆品玩具应符合指令欧盟化妆品指令76/768/EEC的要求 Cosmetic toys shall comply with directive EU Cosmetic Directive 76/768/EEC
◎ 如果玩具含有76/768/EEC附件II中列举的11种致敏性芳香物质,当含量超过重量的0.01%,应在玩具上注明 11 allergenic fragrances in Annex II of 76/768/EEC shall be listed on toys at concentration exceeding 0.01% by weight
◎ 36个月以下儿童使用的玩具或与嘴部接触的玩具中不得含有亚硝胺和亚硝基胺物质 Nitrosamines and Nitrosatable substances are banned in toys for children under 36 months or mouth-contact toys
新指令其它方面的主要挑战:
Main challenge on other compliance:
◎ Ec合格声明 EC declaration of conformity
◎ 安全评估确保符合要求 Safety Assessment to ensure that toys comply with the requirement
◎ 制造流程的生产控制 Internal manufacturing production control
◎ 食品中的玩具必须有独立包装 Toys sold together with food must have their own packaging
◎ 玩具不得牢固地粘附于食品 Toys firmly attached to food are prohibited
◎ 有关发声玩具的新规定 New provisions on sound-emitting toys
◎ 有关警告和标签的新规定 New rules on warnings and labels
◎ 供36个月以下儿童使用的玩具必须被设计和制作为可以清洁的 It can be cleaned for toys designed for children under 36 months
新的19项受限制元素迁移限值(详见下文)
New migration limits for 19 restricted elements(See below)
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