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法规资讯丨欧盟REACH修订附件XVII的D4、D5、D6条款要求


发布时间:

2024-05-27

法规资讯丨欧盟REACH修订附件XVII的D4、D5、D6条款要求

          2024年5月17日,欧盟官方公报发布(EU)2024/1328 ,对REACH法规附录XVII限制物质清单中的第70项进行修订,对物质或混合物中的 八甲基环四硅氧烷(D4)、十甲基环五硅氧烷(D5)和十二甲基环六硅氧烷(D6)进行限制。本法规自其在欧盟官方公报上公布之日起第20天生效,且该法规具有整体约束力,并直接适用于所有欧盟成员国

      以下为法规修改前后要求对比:
 

修订前

 

限制物质

限制要求

70.

Octamethylcyclotetrasiloxane (D4)

八甲基环四硅氧烷(D4)

CAS号: 556-67-2

EC号: 209-136-7

 

Decamethylcyclopentasiloxane (D5)

十甲基环戊硅氧烷(D5)

CAS号: 541-02-6

EC号: 208-764-9

 

1. Shall not be placed on the market in wash-off cosmetic products in a concentration equal to or greater than 0,1 % by weight of either substance, after 31 January 2020.

1.从 2020 年 1 月 31 日起,“可水洗的化妆品”中该两种限制物质的任一物质的质量浓度大于等于 0.1%时,不得投放市场。

2. For the purposes of this entry, ‘wash-off cosmetic products’ means cosmetic products as defined in Article 2(1)(a) of Regulation (EC) No 1223/2009 that, under normal conditions of use, are washed off with water after application

2.本条的“可水洗的化妆品”是指符合法规(EC)1223/2009 第 2(1)条定义的化妆品,且在正常使用条件下,该化妆品在使用后能被水冲洗掉。

 

修订后

 

限制

物质

限制要求

70.

Octamethylcyclotetrasiloxane (D4)

八甲基环四硅氧烷(D4)

CAS号: 556-67-2

EC号: 209-136-7

 

Decamethylcyclopentasiloxane (D5)

十甲基环戊硅氧烷(D5)

CAS号: 541-02-6

EC号: 208-764-9

 

Dodecamethylcyclohexasiloxane (D6)

十二甲基环己硅氧烷(D6)

CAS号: 540-97-6

EC号: 208-762-8

1.Shall not be placed on the market

1.不得投放市场:

(a) as a substance on its own;

(a)作为一种物质本身;

(b) as a constituent of other substances; or

(b)作为其他物质的组成成分;或

(c) in mixtures;

(c)混合物;

in a concentration equal to or greater than 0,1 % by weight of the respective substance after 6 June 2026.

在 2026 年6月6日之后,浓度等于或大于相应物质重量的 0.1%

2. Shall not be used as a solvent for the dry cleaning of textiles, leather and fur after 6 June 2026.

2.2026年6月6日后不得用作纺织品、皮革和毛皮的干洗溶剂。

3. By way of derogation:

3.作为豁免:

(a) for D4 and D5 in wash-off cosmetic products, paragraph 1, point (c), shall apply after 31 January 2020.

(a)对于水洗型化妆品中的D4和D5,第1段(c)点应在2020年1月31日后适用。

For the purposes of this point, “wash-off cosmetic products” means cosmetic products as defined in Article 2(1), point (a), of Regulation (EC) No 1223/2009 of the European Parliament and of the Council that, under normal conditions of use, are washed off with water after application;

就这一点而言,“水洗型化妆品”是指欧洲议会和理事会法规(EC)No 1223/2009 第 2(1)条(a)点中定义的化妆品,在正常使用条件下,该化妆品在使用后能用水冲洗掉;

(b) for all cosmetic products other than the ones mentioned in paragraph 3(a), paragraph 1 shall apply after 6 June 2027;

(b)除第 3(a)段提到的产品外的所有化妆品,第1段应在 2027 年 6 月 6 日之后适用;

(c) for devices as defined in Article 1(4) of Regulation (EU) 2017/745 of the European Parliament and of the Council and in Article 1(2) of Regulation (EU) 2017/746 of the European Parliament and the Council, paragraph 1 shall apply after 6 June 2031;

(c)对于欧洲议会和理事会法规(EU)2017/745 第 1(4)条和欧洲议会和理事会法规(EU)2017/746 第 1(2)条中定义的(医疗)器械, 第1段应在2031年6月6日之后适用;

(d) for medicinal products, as defined in Article 1, point 2, of Directive 2001/83/EC, and for veterinary medicinal products, as defined in Article 4(1) of Regulation (EU) 2019/6 , paragraph 1 shall apply after 6 June 2031;

(d)对于 2001/83/EC 指令第1条第2点定义的药品,以及法规(EU)2019/6第4(1)条定义的兽药,第1段应在 2031 年 6月6日之 后适用;

(e) for D5 as a solvent in the dry cleaning of textiles, leather and fur, paragraphs 1 and 2 shall apply after 6 June 2034.

(e)就D5作为溶剂干洗纺织品、皮革及毛皮而言,第1及2段须于2034年6月6日

4. By way of derogation, paragraph 1 shall not apply to the:

4.作为豁免,第 1 款不适用于:

(a) placing on the market of D4, D5 and D6 for the following industrial uses:

(a)将 D4、D5 和 D6 产品投放市场,用作下列工业用途:

— as a monomer in the production of silicone polymer,

—作为生产有机硅聚合物的单体,

— as an intermediate in the production of other silicon substances,

—作为生产其他硅物质的中间体,

— as a monomer in polymerisation,

—作为聚合中的单体,

— in the formulation or (re)packing of mixtures,

—用于混合物的配方或(重新)包装;

— in the production of articles,

—用于生产物品;

— in non-metal surface treatment;

—非用于金属表面处理

(b) placing on the market of D5 and D6 for use as devices, as defined in Article 1(4) of Regulation (EU) 2017/745, for the treatment and care of scars and wounds, the prevention of wounds and the care of stoma;

(b)将D5和D6投放市场,作为法规(EU)2017/745第 1(4)条所定义(医疗)器械使用,用于疤痕和伤口的治疗和护理,伤口的 预防和造口的护理;

(c) placing on the market of D5 for professional use in the cleaning or restoration of art and antiques;

(c)将D5投放市场,供专业人士清洁或修复艺术品及古董;

(d) placing on the market of D4, D5 and D6 for use as laboratory reagent in research and development activities carried out under controlled conditions.

(d)将D4、D5 及D6投放市场,作为实验室试剂,在受管制的条件下进行研究及开发活动。

5. By way of derogation, paragraph 1, point (b), shall not apply to the placing on the market of D4, D5 and D6:

5.作为豁免,第 1 段(b)点不适用于在市场上投放的 D4、D5 和 D6:

— as a constituent of a silicone polymer on its own

—作为有机硅聚合物的组成部分,

— as a constituent of a silicone polymer in a mixture derogated under paragraph 6.

—作为第 6 段规定的混合物中有机硅聚合物的组

6. By way of derogation, paragraph 1, point (c), shall not apply to the placing on the market of mixtures that contain D4, D5 or D6 as residues from silicone polymers, under the following conditions:

6.作为豁免,在以下条件下,第 1 段(c)点不适用于作为有机硅聚合物残留物含有D4、D5或D6的混合物投放市场:

(a) D4, D5 or D6 in a concentration equal to or less than 1 % by weight of the respective substance in the mixture, for use in adhesion, sealing, gluing and casting;

(a) D4、D5或D6的浓度等于或少于混合物中相应物质重量的1%,用于粘合、密封、胶合和铸造;

(b) D4 in a concentration equal to or less than 0,5 % by weight, or D5 or D6 in a concentration equal to or less than 0,3 % by weight of either substance in the mixture for use as protective coatings (including marine coatings);

(c) D4的浓度等于或小于0.5%的重量,或D5或D6的浓度等于或小于0.3%的重量作为保护涂层(包括船舶涂层)的混合物;

(d) D4, D5 or D6 in a concentration equal to or less than 0,2 % by weight of the respective substance in the mixture, for use as devices as defined in Article 1(4) of Regulation (EU) 2017/745 and in Article 1(2) of Regulation (EU) 2017/746, other than the devices referred to in paragraph 6(d);

(b) D4、D5或D6的浓度等于或小于混合物中相应物质重量的0.2%,用作法规(EU)2017/745第1(4)条和法规(EU)2017/746 第 1(2)条定义的(医疗)设备,第 6(d)段提及的设备除外;

(c) D5 in a concentration equal to or less than 0,3 % by weight in the mixture or D6 in a concentration equal to or less than 1 % by weight in the mixture, for use as devices as defined in Article 1(4) of Regulation (EU) 2017/745, for dental impression;

(d) D5浓度等于或小于混合物中重量的0.3%或D6浓度等于或小于混合物中重量的1%,用作法规(EU)2017/745第1(4)条定义的 器械,用于牙科印模;

(e) D4 in a concentration equal to or less than 0,2 % by weight in the mixture, or D5 or D6 in a concentration equal to or less than 1 % by weight of either substance in the mixture for use as silicone insoles for horses, or as horseshoes;

(e) D4在混合物中的浓度等于或小于 0.2%的重量,或D5或D6 在混合物中任一物质的浓度等于或小于1%的重量,用作马用硅鞋垫或马蹄铁;

(f) D4, D5 or D6 in a concentration equal to or less than 0,5 % by weight of the respective substance in the mixture, for use as adhesion promoters;

(f)D4、D5或D6的浓度等于或小于混合物中相应物质重量的 0.5%,用作附着力促进剂;

 (g) D4, D5 or D6 in a concentration equal to or less than 1 % by weight of the respective substance in the mixture, for use in 3D-printing;

(g)D4、D5或D6的浓度等于或小于混合物中相应物质重量的1%,用于3d打印;

(h) D5 in a concentration equal to or less than 1 % by weight in the mixture or D6 in a concentration equal to or less than 3 % by weight in the mixture, for rapid prototyping and mould making, or high performance uses stabilised by quartz filler;

(h) D5在混合物中的浓度等于或小于1%的重量,或D6在混合物中的浓度等于或小于 3%的重量,用于快速成型和模具制造,或由 石英填料稳定的高性能用途;

 (i) D5 or D6 in a concentration equal to or less than 1 % by weight of either substance in the mixture, for use in pad printing, or manufacturing of printing pads;

(i) D5或D6浓度等于或少于混合物中任一物质重量的1%,用于移印或制造印垫;

(j) D6 in a concentration equal to or less than 1 % by weight of the mixture, for professional use in the cleaning or restoration of art and antiques.

(j) D6浓度等于或小于混合物重量的1%,用于专业清洗或修复艺术品和古董。

7. By way of derogation, paragraphs 1 and 2 shall not apply to the placing on the market for use, or to the use, of D5 as a solvent in strictly controlled closed dry cleaning systems for textile, leather and fur, where the cleaning solvent is recycled or incinerated.

7.作为豁免,第1段和第2段不适用于在纺织品、皮革和毛皮的严格控制的封闭式干洗系统中投放市场或使用 D5 作为溶剂,其中清洁溶剂是回收或焚烧的。

 

REACH法规是关于化学品注册,评估,授权,限制的法规,是欧盟对进入其市场的所有消费品进行预防性管理的法规,是欧盟对消费品环保要求的基本条款,通用条款,是出口欧盟的通行证。物质、混合物、物品不符合附录XVII规定的限制要求时将不得生产、使用及投放市场,建议相关企业应关注自身产品的合规性,消除技术性贸易壁垒。

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