歐盟通報 WTO 提議限制玩具中的甲醛

EU Notified WTO about the Proposal to Restrict

Formaldehyde in Toys 2018 年 12 月 18 日，歐盟通報 1世界貿(mào)易組織（WTO），提議在玩具安全指令（TSD）2009/48/EC2附件 II的附錄 C 下新增特定玩具材料的甲醛限制，預計生效期為 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根據(jù) TSD，被 CLP 法規(guī)（EC）1272/2008 分類為致癌、致畸及生殖毒性的化學物質(zhì)（CMR），禁止在玩具中使用。甲醛被分類為致癌 1B 及致畸 2 類，對應的普通分類限值分別為 0.1% 及 1%。

TSD 附件 II 下的附錄 C 根據(jù)此要求，已限定多種化學物質(zhì)在 36 個月以下兒童玩耍的玩具或其它意圖被放入口的玩具中使用。然而，甲醛目前未在此清單中。依照 TSD 附件 II 第 III 部分第 4（a）及（b）條，含量超過0.1%的甲醛作為 CMR 物質(zhì)（致癌 1B 類），禁止在玩具中使用，除非其不會被兒童接觸（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，甲醛亦被分類為皮膚致敏 1 類物質(zhì)，其特定分類限值為 0.2%。據(jù)經(jīng)濟合作與發(fā)展組織（OECD）在2002 年發(fā)布的報告顯示，含甲醛織物導致的過敏接觸性皮炎最低閾值濃度為 30mg/kg，但迄今為止 TSD 普通限制未有明確禁止致敏類物質(zhì)的使用。

鑒于現(xiàn)有科學數(shù)據(jù)及玩具安全專家組”玩具化學工作小組”的建議，針對不同玩具材料的風險設(shè)定推薦甲醛限制迫在眉睫， TSD 附件 II 下的附錄 C 因而被提議修訂。

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 之附錄 C 提議甲醛限制概要

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

*暴露危害類似紡織品玩具材料

*may lead to an exposure similar to textile toy material

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