86 755 2523 4088

service@agccert.com

Domain name:agc-cert.com change to agccert.com;cn.agc-cert.com change to agccert.cn

Can we help you find something?

Testing

Amending Annex XVII to REACH regulation to increase the control of the synthetic polymer microparticles Release Time:2023-10-13

On 27 September 2023, the European Union issued Regulation (EU) 2023/2055 in its Official Journal (OJ) to amend Annex XVII to Regulation (EC) No 1907/2006, increase the requirement for restriction of the synthetic polymer microparticles.The Regulation enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.



The new requirements are as follows:


Entry and Substance

Conditions of restriction

78. Synthetic polymer microparticles: 

polymers that are solid and which fulfil both of the following conditions:

a) are contained in particles and constitute at least 1 % by weight of those particles; or build a continuous surface coating on particles;

b) at least 1 % by weight of the particles referred to in point (a) fulfil either of the following conditions:

i) all dimensions of the particles are equal to or less than 5 mm;

ii) the length of the particles is equal to or less than 15 mm and their length to diameter ratio is greater than 3.

 

The following polymers are excluded from this designation:

a) polymers that are the result of a polymerisation process that has taken place in nature, independently of the process through which they have been extracted, which are not chemically modified substances;

b) polymers that are degradable as proved in accordance with Appendix 15;

c) polymers that have a solubility greater than 2 g/L as proved in accordance with Appendix 16;

d) polymers that do not contain carbon atoms in their chemical structure.

 

 

1. Shall not be placed on the market as substances on their own or, where the synthetic polymer microparticles are present to confer a sought-after characteristic, in mixtures in a concentration equal to or greater than 0,01 % by weight.

2. Paragraph 1 shall apply as follows regarding the following uses:

a) from 17 October 2029 to synthetic polymer microparticles for use in the encapsulation of fragrances;

b) from 17 October 2027 for “rinse-off products” as defined in point (1)(a) of the Preamble to Annexes II to VI to Regulation (EC) No 1223/2009 unless such products are covered by point (a) of this paragraph or contain synthetic polymer microparticles for use as an abrasive, i.e. namely to exfoliate, polish or clean (“microbeads”);

c) from 17 October 2035 for lip products as defined in point (1)(e) of the Preamble to Annexes II to VI to Regulation (EC) No 1223/2009, nail products as defined in point (1)(g) of the Preamble to Annexes II to VI to that Regulation, and make-up products within the scope of that Regulation, unless such products are covered by points a) or b) of this paragraph or contain microbeads;

d) from 17 October 2029 for leave-on products, as defined in point (1)(b) of the Preamble to Annexes II to VI to Regulation (EC) No 1223/2009, unless such products are covered by points a) or c) of this paragraph;

e) from 17 October 2028 for detergents, as defined in Article 2(1) of Regulation (EC) No 648/2004, waxes, polishes and air care products, unless those products are covered by point a) of this paragraph or contain microbeads;

f) from 17 October 2029 for “devices”, within the scope of Regulation (EU) 2017/745 of the European Parliament and of the Council , unless those devices contain microbeads;

g) from 17 October 2028 for “fertilising products”, as defined in Article 2, point (1), of Regulation (EU) 2019/1009, which do not fall within the scope of that Regulation;

h) from 17 October 2031 for plant protection products within the meaning of Article 2(1) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council and seeds treated with those products, and biocidal products as defined in Article 3(1), point (a), of Regulation (EU) No 528/2012 of the European Parliament and of the Council ;

i) from 17 October 2028 for products for agricultural and horticultural uses not covered by points g) or h);

j) from 17 October 2031 for granular infill for use on synthetic sports surfaces.

3. Paragraph 1 shall not apply to the placing on the market of the following synthetic polymer microparticles, as substances on their own or in mixtures:

a) synthetic polymer microparticles which are contained by technical means so that releases to the environment are prevented when used in accordance with the instructions for use during the intended end use;

b) synthetic polymer microparticles the physical properties of which are permanently modified during intended end use in such a way that the polymer no longer falls within the scope of this entry;

c) synthetic polymer microparticles which are permanently incorporated into a solid matrix during intended end use.

4. Paragraph 1 shall not apply to the placing on the market of:

a) synthetic polymer microparticles, as substances on their own or in mixtures, for use at industrial sites;

b) medicinal products within the scope of Directive 2001/83/EC and veterinary medicinal products within the scope of Regulation (EU) 2019/6 of the European Parliament and of the Council ;

c) EU fertilising products within the scope of Regulation (EU) 2019/1009 of the European Parliament and of the Council;

d) food additives within the scope of Regulation (EC) No 1333/2008 of the European Parliament and of the Council;

e) in vitro diagnostic devices, including devices within the scope of Regulation (EU) 2017/746 of the European Parliament and of the Council;

f) food within the meaning of Article 2 of Regulation (EC) No 178/2002, not covered by point d) of this paragraph, and feed as defined in Article 3(4) of that Regulation.

5. From 17 October 2031 until 16 October 2035 suppliers of products referred to in paragraph 6, point (c), containing synthetic polymer microparticles shall provide the following statement: “This product contains microplastics.” However, products placed on the market before 17 October 2031 are not required to bear that statement until 17 December 2031. The statement text shall be placed on the label, the packaging, or the package leaflet of the products.

 

Microparticles:

Microplastics are solid plastic particles composed of mixtures of polymers and functional additives. A big part of microplastic pollution forms unintentionally, for example as a result of the breakdown of larger pieces of plastic waste, or the wear and tear of tyres and road paint, or the washing of synthetic clothes. But they are also deliberately manufactured and added to products for specific purposes, such as exfoliating beads in facial or body scrubs. Once in the environment, microplastics do not biodegrade. They accumulate in animals, including fish and shellfish, and are consequently also consumed as food by humans. The potential impacts of microplastic pollution on the environment and possibly human health have raised concerns in various parts of the world.


AGC reminds: 

Faced with increasingly complex regulations, enterprises are facing more and more regulatory requirements, enterprises should pay attention to the laws and regulations in a timely manner, make good response. Ensure products compliance with regulations, that products can be better sold in overseas markets.



Recommended Reading

Australian Issued New Standard 《Consumer Goods (Toys for Children up to and including 36 Months of Age) Safety Standard 2023》

On September 4, 2023,the Australian Government Issued a new...

Amending Annex XVII to REACH regulation to increase the control of the formaldehyde and formaldehyde releasers

On 17 July 2023, the European Union issued Directive (EU) 20...

European Union intends to amend Annex XVII of REACH regulation as regards lead and its compounds in PVC

On 8 June 2022, the European Commission submitted communicat...

European Union intends to amend Annex XVII of REACH regulation to increase the control of formaldehyde emission

On 2 May 2022, the European Commission submitted communicati...

REACH Annex XVII adds Article 76 N, N-dimethylformamide

​On November 22, 2021, the European Union issued the (EU) 2...

Consult us

Does the article solve your problem

Please select the unresolved reason