新版玩具指令2009/48/EC于2009年6月30日予以發(fā)布。新版指令將于2011年7月20日正式生效(2年過渡期),但指令中新的化學(xué)要求將于2013年7月20日生效(4年過渡期)。
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.
新指令化學(xué)方面的主要挑戰(zhàn):
Main challenge on chemical compliance:
◎ 玩具應(yīng)符合歐盟REACH法規(guī) Toys must comply with EU Reach legislation
◎ 對CMR類物質(zhì)(致癌、誘導(dǎo)有機(jī)體突變或?qū)ι诚到y(tǒng)有毒害的物質(zhì))的禁令 Ban on substances classified as CMR (Carcinogenic, Mutagenic or Toxic for Reproduction)
◎ 55種致敏性芳香物質(zhì)不能用于玩具,僅允許技術(shù)上無法避免的含量在100 ppm (百萬分之)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
◎ 化妝品玩具應(yīng)符合指令歐盟化妝品指令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中列舉的11種致敏性芳香物質(zhì),當(dāng)含量超過重量的0.01%,應(yīng)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個月以下兒童使用的玩具或與嘴部接觸的玩具中不得含有亞硝胺和亞硝基胺物質(zhì) 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戰(zhàn):
Main challenge on other compliance:
◎ Ec合格聲明 EC declaration of conformity
◎ 安全評估確保符合要求 Safety Assessment to ensure that toys comply with the requirement
◎ 制造流程的生產(chǎn)控制 Internal manufacturing production control
◎ 食品中的玩具必須有獨(dú)立包裝 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
◎ 有關(guān)發(fā)聲玩具的新規(guī)定 New provisions on sound-emitting toys
◎ 有關(guān)警告和標(biāo)簽的新規(guī)定 New rules on warnings and labels
◎ 供36個月以下兒童使用的玩具必須被設(shè)計和制作為可以清潔的 It can be cleaned for toys designed for children under 36 months
新的19項(xiàng)受限制元素遷移限值(詳見下文)
New migration limits for 19 restricted elements(See below)
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