欧盟通报 WTO 提议限制玩具中的甲醛

EU Notified WTO about the Proposal to Restrict

Formaldehyde in Toys 2018 年 12 月 18 日，欧盟通报 1世界贸易组织（WTO），提议在玩具安全指令（TSD）2009/48/EC2附件 II的附录 C 下新增特定玩具材料的甲醛限制，预计生效期为 2020 年第 4 季度。

On 18 December 2018, European Union (EU) notified1 the World Trade Organisation (WTO) to restrict formaldehyde in certain toy materials under Appendix C to Annex II to Toys Safety Directive (TSD) 2009/48/EC2

. The proposed date of enforcement is the fourth quarter of 2020.

 背景

Background根据 TSD，被 CLP 法规（EC）1272/2008 分类为致癌、致畸及生殖毒性的化学物质（CMR），禁止在玩具中使用。甲醛被分类为致癌 1B 及致畸 2 类，对应的普通分类限值分别为 0.1% 及 1%。

TSD 附件 II 下的附录 C 根据此要求，已限定多种化学物质在 36 个月以下儿童玩耍的玩具或其它意图被放入口的玩具中使用。然而，甲醛目前未在此清单中。依照 TSD 附件 II 第 III 部分第 4（a）及（b）条，含量超过0.1%的甲醛作为 CMR 物质（致癌 1B 类），禁止在玩具中使用，除非其不会被儿童接触（包括吸入暴露）。

The TSD establishes certain requirements for chemical substances in toys that are classified as carcinogenic, mutagenic or toxic for reproduction (CMR) under Regulation (EC) No 1272/2008 (CLP Regulation). Formaldehyde is classified as carcinogenic category 1B and mutagenic category 2 which the classification limits (general concentration limit) are 0.1% and 1% respectively in a mixture. Appendix C to Annex II to the TSD lays down specific limit values for chemicals used in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth. But formaldehyde is currently not listed. Pursuant to point 4(a) and (b) of Part III of Annex II to TSD, formaldehyde, classified as  carcinogenic category 1B, may be used up to a concentration of 0.1 % as a general prohibition of CMR substances in toys unless they are inaccessible to children in any form, including inhalation.

此外，甲醛亦被分类为皮肤致敏 1 类物质，其特定分类限值为 0.2%。据经济合作与发展组织（OECD）在2002 年发布的报告显示，含甲醛织物导致的过敏接触性皮炎最低阈值浓度为 30mg/kg，但迄今为止 TSD 普通限制未有明确禁止致敏类物质的使用。

鉴于现有科学数据及玩具安全专家组”玩具化学工作小组”的建议，针对不同玩具材料的风险设定推荐甲醛限制迫在眉睫， TSD 附件 II 下的附录 C 因而被提议修订。

Additionally, formaldehyde is also classified as skin sensitisation category 1 with a specific concentration limit of 0.2% in a mixture. The lowest threshold concentration for allergic contact dermatitis from formaldehyde in textile is 30 mg/kg according to a report from the Organisation for Economic Cooperation and Development (OECD) published in 2002. But a general prohibition in the TSD for allergenic substance is not yet defined.

In light of the available scientific evidence and the recommendations of the subgroup “Working group on Chemicals in Toys” of the Expert Group on Toys Safety, it is necessary to set the recommended limits for formaldehyde in different toy materials based on the risk. Hence, Appendix C to Annex II to Directive 2009/48/EC should therefore be amended accordingly.

玩具安全指令 2009/48/EC 附件 II 之附录 C 提议甲醛限制概要

Summary of the proposed formaldehyde restriction under Appendix C to Annex II to 2009/48/EC

*暴露危害类似纺织品玩具材料

*may lead to an exposure similar to textile toy material

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