欧盟REACH—欧盟发布法规(EU) 2018/2005，修订REACH附录XVII第51项中的邻苯二甲酸盐限制

EU REACH – European Union publishes (EU) 2018/2005 amending the Phthalates Restriction in Entry 51 of REACH Annex XVII

欧盟委员会在欧盟官方公报上发布了(EU) 2018/2005，修订了法规(EC) No 1907/2006附录XVII第51项中的邻苯二甲酸二（2-乙基己基）酯（DEHP），邻苯二甲酸二丁酯（DBP），邻苯二甲酸苄基丁酯（BBP）和邻苯二甲酸二异丁酯（DIBP）。

Regulation (EU) 2018/2005 has been published by The European Commission in the EU Official Journal. The regulation amends Entry 51 of Annex XVII to Regulation (EC) No 1907/2006 on bis (2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP),benzyl butyl phthalate (BBP) and diisobutyl phthalate (DIBP).

四种邻苯二甲酸酯在于各种各样的物品中，最常见的是存在于塑化材料中。这四种邻苯二甲酸酯不应以任何大于或等于重量的0.1％浓度单独存在于物品中，也不应以任何大于或等于重量的0.1％浓度的邻苯二甲酸酯组合的形式存在。

The four phthalates are found in a wide variety of articles as they are commonly present inplasticised materials. These four phthalates should not be present in an article individually or in any combination of the phthalates in a concentration equalto or greater than 0.1 % by weight.

法规(EC) No 1907/2006的附录XVII在特定条件下已经禁止将含有DEHP，DBP和BBP的玩具和儿童护理用品投放市场。 DIBP现在也受到限制，因为它具有类似于DEHP，DBP和BBP的危害特征，并且DIBP可以替代玩具和儿童护理用品中的DBP。第51项法规中对邻苯二甲酸酯的额外限制将从2020年7月7日起生效。

Annex XVII to Regulation (EC) No 1907/2006 already bans the placing on the market of toys and childcare articles containing DEHP, DBP and BBP under certain conditions. DIBP has now also been restricted due to it has a hazard profile similar to that of DEHP, DBP and BBP, and that DIBP can replace DBP in toys and childcare articles. The additional restrictions on the phthalates under Entry 51 will become effective from 7 July 2020. 

限制物具体信息如下：

The restrictions are detailed as below:

新限制物的豁免明细如下：

Exemptions for new restrictions are detailedas below:

1. 专门用于工业或农业用途，或专门用于户外的物品。

   Articles exclusively forindustrial or agricultural use, or for use exclusively in the open air.

2. 2024年1月7日前投放市场的飞机或周边产品。

   Aircraft, placed on themarket before 7 January 2024.

3. 在指令2007/46/EC范围内的机动车辆。

   Motor vehicles within thescope of Directive 2007/46/EC.

4. 2020年7月7日之前投放到市场上的物品。

   Articles placed on themarket before 7 July 2020.

5. 实验室使用的测量装置及其零部件。

   Measuring devices for laboratoryuse, or parts thereof.

6. 在法规(EC) No 1935/2004或(EU) No 10/2011范围内与食品接触的产品和材料。

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

7. 在指令90/385/EEC，93/42/EEC或98/79/EC范围内的医疗设备及其零部件。

   Medical devices within the scope of Directives 90/385/EEC, 93/42/EEC or 98/79/EC, or parts thereof.

8. 在指令2011/65/EU范围内的电子电气产品。

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

9. 在法规(EC) No 726/2004，指令2001/82/EC或指令2001/83/EC范围内药品直接包装。

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

注释：

Definitions for better understanding:

1.“塑化材料”是指以下均质材料：

    "plasticised material" means any of the following homogeneous materials:

    1.1 聚氯乙烯（PVC）、聚偏二氯乙烯（PVDC）、聚乙酸乙烯酯（PVA）、聚氨酯

          polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), polyvinyl acetate (PVA), polyurethanes

     1.2 除硅橡胶和天然乳胶涂层外的任何其他聚合物(包括泡沫聚合物和橡胶材料等高风险材料)  

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

1.3 表面涂层、防滑涂层、饰面、贴花、印刷设计涂层

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

1.4 粘合剂、密封胶、油漆和油墨

      adhesives, sealants, paints and inks

2.“儿童用品”是指任何旨在促进儿童睡眠、舒缓、卫生、喂养或吸吮的产品 

"childcare article" shall mean any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children