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歐盟發布新鄰苯二甲酸鹽限制(EU) 2018/20051

2018 年 12 月 17 日，歐盟于官方期刊（OJEU）發布法規(EU) 2018/20051， 修訂 REACH 法規(EC)1907/2006 附錄 XVII 第 51 條鄰苯二甲酸鹽要求，新法規自 2019 年 1 月 7 日生效。管制范圍從玩具及兒童護理產品擴大至其它消費品；同時新引入鄰苯 DIBP，綜合原有 DEHP、DBP 及 BBP，加嚴玩具及兒童護理產品的要求一共限制 4 個鄰苯的使用。

On 17 December 2018, the European Commission published Regulation (EU) 2018/20051 in the Official Journal of the European (OJEU) to amend the phthalates requirement under entry 51 of Annex XVII to Regulation (EC) No 1907/2006 (REACH Annex XVII). The regulation shall enter into force from 7 January 2019, the scope of restriction is extended from toys and childcare articles to cover all other articles. A new restriction on the use of DIBP, in addition to the current restriction on DEHP, DBP and BBP, is introduced which means there will have a restriction on 4 phthalates and a stricter requirement will be applied for toys and childcare articles.

背景

Background 分類為致生殖毒性 1B 的 DEHP、DBP、BBP 及 DIBP（簡稱 4 個鄰苯）在現有 REACH 法規附錄 XIV2授權清單下，其日落日期為 2015 年 2 月 21 日。歐盟化學管理署（ECHA）考慮到使用這些鄰苯的產品可能影響人類健康或環境的風險不能充分避免，因此起草卷宗（REACH 附錄 XV 卷宗）向歐盟員會提議日落日期后限制4 個鄰苯的使用。綜合考量利益相關方意見，歐盟委員會認為更多可能使用到 4 個鄰苯的產品風險需處理，REACH 附錄 XVII 第 51 條因而被修訂。REACH 附錄 XVII 第 51 條現已限制 DEHP、DBP 及 BBP 在玩具及兒童護理產品中的使用，因 DIBP 具相似的危害且可作為 DBP 替代增塑劑使用，歐盟委員會認為需限制 DIBP 在玩具及兒童護理產品中的使用，即玩具及兒童護理產品在相應的生效日后 REACH 附錄 XVII 第 51 條限制 4 個鄰苯的用。實際上，作為致癌致畸及生殖毒性（CMR）類物質，DIBP 在玩具中的使用不可超過其分類毒性的最大濃度 0.3 % (w/w)，因為根據玩具安全指令 2009/48/EC3附件 II 第 III 部分第 3 條要求，任何被 CLP 法規 1272/2008 分類為第 1A、1B 及 2類的 CMR 物質禁止在玩具、玩具部件中使用，除非其不會被兒童接觸（包括吸入暴露）。DEHP, DBP, BBP and DIBP (‘the four phthalates’) are listed in Annex XIV2 to REACH regulation as substances toxic for reproduction, category 1B, with a sunset date of 21 February 2015. The European Chemicals Agency (ECHA) consider the use in articles of these substances poses a risk to human health or the environment that is not adequately controlled and hence, prepared a dossier (Annex XV dossier) for a restriction proposal to the European Commission (EC) after the sunset date of the four phthalates. After considering the opinions from different stakeholders, the EC considered that risk for the four phthalates needs to be addressed in the EU to cover a wider scope of products and hence, the entry 51 of REACH Annex XVII is revised accordingly. The REACH Annex XVII is currently restricting toys and childcare articles containing DEHP, DBP and BBP to be placed on the EU market. By considering DIBP has a similar hazard profile to the other 3 phthalates and DIBP can replace DBP, the EC takes the view that the placing on the market of toys and childcare articles containing DIBP should also be restricted. Thus, REACH Annex XVII entry 51 will be a restriction of four phthalates in toys and childcare articles after the corresponding effective date. Actually, as a substance being classified as carcinogenic, mutagenic or toxic for reproduction (CMR), DIBP is already forbidden in toys according to the general prohibitions of the Toy Safety Directive 2009/48/EC3 with a requirement of no more than 0.3 % (w/w). This is because substances that are classified as CMR of category 1A, 1B or 2 under Regulation (EC) No 1272/2008 shall not be used in toys, in components of toys or in microstructurally distinct parts of toys, unless they are inaccessible to children in any form, including inhalation, according to point 3 of Part III to Annex II to Toys Safety Directive 2009/48/EC.

 除以上 DEHP、DBP、BBP 及 DIBP 要求，現行 REACH 附錄 XVII 第 52 條仍限制 DINP、DIDP 及 DNOP 在玩具及兒童護理產品可被放入口的塑化材料中的使用。現行及新修訂限制比對詳見表 1。

Apart from the bans of DEHP, DBP, BBP and DIBP, plasticized materials in toys and childcare articles which can be placed in the mouth by children are also being banned from containing other 3 phthalates (DINP,DIDP and DNOP) currently under entry 52 of REACH Annex XVII. Table 1 shows a comparison on the original and the new restrictions.

 表 1：REACH 附錄 XVII 第 51 條現行限制及新修訂比對

Table 1 Summary of the original and the new restrictions in REACH Annex XVII entry 51

注釋

Denote*塑化材料定義為以下均一材料

Plasticised material is defined as the following homogeneous materials

a) 聚氯乙烯（PVC）、聚偏二氯乙烯（PVDC）、聚醋酸乙烯酯（PVA）及聚氨酯 (PU)Polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), polyvinyl acetate (PVA), polyurethanes(PU)

b) 其它聚合物（尤其泡沫塑料及發泡橡膠）除硅膠及天然乳膠涂層

Any other polymer (including, inter alia, polymer foams and rubber material) except silicone rubber and natural latex coatings

c) 表面涂層、防滑涂層、拋光劑、貼花轉印及其他印刷設計

Surface coatings, non-slip coatings, finishes, decals, printed designs

d) 膠粘劑、密封劑、油漆及墨水

Adhesives, sealants, paints and inks #不在限制范圍內的產品

Examples of articles that are excluded from the restriction

1) 專供工業、農業用途或專業戶外用品，如果產品沒有接觸人體黏膜或長期皮膚接觸（比如持續接觸時間超過 10 分鐘或每天間斷接觸超過 30 分鐘）的塑化材料

Articles exclusively for industrial / agricultural use / use in open air, provided that no plasticised material comes into contact with human mucous membranes or into prolonged contact with human skin (i.e. Continuous contact of more than 10 minutes duration or intermittent contact over a period of 30 minutes, per day.)

2) 2024 年 1 月 7 日前上市的飛行器及指令 2007/46/EC 管控的汽車，或僅用于維護或修理的產品

Aircraft and motor vehicles (Directive 2007/46/EC) placed on the market before 7 January 2024, or articles for use exclusively in the maintenance or repair of them

3) 實驗室測量設備

Measuring devices for laboratory use;

4) 受法規(EC) No1935/2004 或(EU) No10/2011 管控的食品接觸類材料及產品

Food contact material and articles within the scope of Regulation (EC) No 1935/2004 or Commission Regulation(EU) No 10/2011

5) 醫療器械（指令 90/385/EEC，93/42/EEC 或 98/79/EC）

Medical devices (Directive 90/385/EEC, 93/42/EEC or 98/79/EC)

6) RoHS 指令 2011/65/EU 下的電子電氣產品

Electrical and electronic equipment within the scope of Directive 2011/65/EU

7) 藥品直接包裝（法規(EC) No 726/2004、指令2001/82/EC或指令2001/83/EC）

Immediate packaging of medicinal products (Regulation (EC) No 726/2004, Directive 2001/82/EC or Directive 2001/83/EC)

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