EU Published New Phthalates Restrictions

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

分类为致生殖毒性 1B 的 DEHP、DBP、BBP 及 DIBP(简称 4 个邻苯)在现有 REACH 法规附录 XIV2 授权清 单下，其日落日期为 2015 年 2 月 21 日。欧盟化学管理署(ECHA)考虑到使用这些邻苯的产品可能影响人类 健康或环境的风险不能充分避免，因此起草卷宗(REACH 附录 XV 卷宗)向欧盟委员会提议日落日期后限制4 个邻苯的使用。综合考量利益相关方意见，欧盟委员会认为更多可能使用到 4 个邻苯的产品风险需处理，REACH 附录 XVII 第 51 条因而被修订。

REACH 附录 XVII 第 51 条现已限制 DEHP、DBP 及 BBP 在玩具及儿童护理产品中的使用，因 DIBP 具相似 的危害且可作为 DBP 替代增塑剂使用，欧盟委员会认为需限制 DIBP 在玩具及儿童护理产品中的使用，即玩 具及儿童护理产品在相应的生效日后 REACH 附录 XVII 第 51 条限制 4 个邻苯的使用。实际上，作为致癌致畸 及生殖毒性(CMR)类物质，DIBP 在玩具中的使用不可超过其分类毒性的最大浓度 0.3 % (w/w)，因为根据 玩具安全指令 2009/48/EC3 附件 II 第 III 部分第 3 条要求，任何被 CLP 法规 1272/2008 分类为第 1A、1B 及 2类的 CMR 物质禁止在玩具、玩具部件中使用，除非其不会被儿童接触(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 micro- structurally 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，现行 REACH 附录 XVII 第 52 条仍限制 DINP、DIDP 及 DNOP 在 玩具及儿童护理产品可被放入口的塑化材料中的使用。现行及新修订限制比对详见表 1。

Apart from the bans of DEHP, DBP, BBP and DIBP, plasticised 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 附录 XVII 第 51 条现行限制及新修订比对

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

注释

Denote

*塑化材料定义为以下均一材料
Plasticised material is defined as the following homogeneous materials

1. 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)

2. b)  其它聚合物(尤其泡沫塑料及发泡橡胶)除硅胶及天然乳胶涂层
   Any other polymer (including, inter alia, polymer foams and rubber material) except silicone rubber and natural

   latex coatings

3. c)  表面涂层、防滑涂层、抛光剂、贴花转印及其他印刷设计
   Surface coatings, non-slip coatings, finishes, decals, printed designs

4. d)  胶粘剂、密封剂、油漆及墨水Adhesives, sealants, paints and inks

#不在限制范围内的产品
Examples of articles that are excluded from the restriction

1. 1)  专供工业、农业用途或专业户外用品，如果产品没有接触人体黏膜或长期皮肤接触(比如持续接触时间超过 10 分钟 或每天间断接触超过 30 分钟)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. 2)  2024 年 1 月 7 日前上市的飞行器及指令 2007/46/EC 管控的汽车，或仅用于维护或修理的产品

   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. 3)  实验室测量设备
   Measuring devices for laboratory use;

4. 4)  受法规(EC) No1935/2004 或(EU) No10/2011 管控的食品接触类材料及产品
   Food contact material and articles within the scope of Regulation (EC) No 1935/2004 or Commission Regulation

   (EU) No 10/2011

5. 5)  医疗器械(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. 6)  RoHS 指令 2011/65/EU 下的电子电气产品
   Electrical and electronic equipment within the scope of Directive 2011/65/EU

7. 7)  药品直接包装(法规(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)

RoHS 邻苯限制

Restriction of phthalates in RoHS

2019 年 7 月 22 日起，RoHS II(指令 2011/65/EU 及其修订指令(EU)2015/8634)附件 II 将限制 4 种邻苯(DEHP、DBP、BBP 及 DIBP)在电子电气产品均一材料中的使用，每单个邻苯不可超过 0.1%，除了第 8 类 (医疗器械)及第 9 类(监视及控制设备)的生效期延缓 2 年至 2021 年 7 月 22 日。玩具豁免 RoHS DEHP、DBP 及 BBP 因现有 REACH 附录 XVII 第 51 条已管控，但 DIBP 需考虑。

Annex II to RoHS recast (Directive 2011/65/EU and its amendment Directive (EU) 2015/8634) will restrict the four phthalates with a requirement of 0.1% (each) in homogeneous materials from 22 July 2019. This is applicable to all electrical and electronic equipment, except category 8 (medical devices) and category 9 (monitoring and control instruments) which will have an additional 2 years transition time and need to comply from 22 July 2021. The restriction of DEHP, DBP and BBP shall not apply to toys which are already subject to the restriction through entry 51 of REACH Annex XVII, but DIBP is still applicable.