Search : Electronic And Electrical Testing, Safety Testing, Environmental Monitoring

EU REACH Annex XVII Added Restriction Provisions on Microplastics


Time:

2023-10-10

The European Commission approved and issued Regulation (EU) 2023/2055, adding a new restriction item, item 78, to Annex XVII of the EU REACH Regulation (EC) No 1907/2006, to restrict the use of synthetic polymer microparticles (SPM, "microplastics") for various purposes, except for exemptions. This revision will be implemented from October 17, 2023 (excluding specific products with transition periods).

On September 27, 2023, the European Commission approved and issued Regulation (EU) 2023/2055, adding a new restriction item, item 78, to Annex XVII of the EU REACH Regulation (EC) No 1907/2006, to restrict the use of synthetic polymer microparticles (SPM, "microplastics") for various purposes, except for exemptions. This revision will be implemented from October 17, 2023 (excluding specific products with transition periods).

 

01. Definition

Synthetic polymer microparticles (SPM) are defined as solid polymers that simultaneously meet the following two conditions:
a. Contained in particles and accounting for at least 1% by weight of these particles; Or forming a continuous surface coating on particles;
b. Among the particles mentioned in point (a), at least 1% of the particles (by weight) meet any of the following conditions:
1. All sizes of particles are ≤ 5 mm;
2. The length of the particles is ≤ 15 mm, and their aspect ratio is>3.
However, the following polymers do not fall into the definition of synthetic polymer microparticles (SPMs):
▶ Polymers produced by polymerization processes that occur in nature and are not related to their extraction process, nor do they belong to chemically modified substances;
▶ According to Appendix 15, demonstrate degradable polymers;
▶ According to Appendix 16, it is demonstrated that the solubility of the polymer is>2 g/L;
▶ A polymer without carbon atoms in its chemical structure.
Manufacturers, importers, and downstream industrial users of products containing synthetic polymer microparticles (SPMs) must, upon request from the competent authorities, provide them with the characteristics of the polymers contained in these products and the functions of these polymers in the products. If it is claimed that the product does not fall within the regulatory definition on the grounds of biodegradability or solubility, proof must also be provided to the competent authority in accordance with their requirements.

 

02. Restrictions and Transition Period

According to regulations, synthetic polymer microparticles (SPMs) are not allowed to be placed on the EU market as substances, nor are they allowed to be placed on the EU market in mixtures with a concentration of ≥ 0.01% by weight when they are intended to give the mixture a welcome characteristic.
The regulations provide a transition period for synthetic polymer microparticles (SPMs) in specific products such as cosmetics, detergents, waxes, polishes, air care products, medical devices, agricultural and horticultural products, and particle fillers on artificial sports (venues) surfaces:

 

Product category Transition period (execution date)
Non cosmetic toys No Transition Period (October 17, 2023)
Product 1 containing plastic microspheres (i.e. synthetic polymer microparticles useful as abrasives) No Transition Period (October 17, 2023)
Products that need to be rinsed 2 4 years (October 17, 2027)
Detergent 2, wax 2, polishing agent 2, air care product 2, certain fertilizer products 1, agricultural and horticultural products 3 5 years (October 17, 2028)
Fragrance packaging 1, resident products 4, medical devices 2 6 years (October 17, 2029)
Plant protection product 2, seeds treated with plant protection product 2, biocide product 2, particle fillers for artificial sports (venues) surface 1 8 years (October 17, 2031)
Lip Products 3, Nail Products 3, Cosmetics 3

12 years (October 17, 2035) (must be labeled from the 9th year) (October 17, 2031)


Note: When a product falls into multiple product categories, the transition period shall be based on the product category with the smallest number indicated.

 

03. Exemption

1. The limit value does not apply to the following synthetic polymer microparticles (SPMs):
▶ Synthetic polymer microparticles (SPMs) have been accommodated through technical means to prevent their release into the environment during their intended end use, when used according to the instructions for use; (For example: chromatographic column, water filter box, printer toner)
▶ During the intended end use period, the physical properties of synthesized polymer microparticles (SPM) are permanently altered, so that the polymer no longer falls within the scope of this restriction; (e.g. diapers, nail polish, paint)
▶ Synthetic polymer microparticles (SPMs) that are permanently integrated into a solid matrix during their intended end use. (For example, fibers added to concrete, particles used as raw materials for molded products)
Starting from 2027, suppliers of products containing synthetic polymer microparticles (SPMs) mentioned in point (a), (b) or (c) of paragraph 1, which are first launched on the European Union market for professional users and the public, must notify the European Chemical Administration (ECHA) before May 31 of each year.

2. Restrictions also do not apply to the following situations and products:
▶ Synthetic polymer microparticles (SPMs) used in industrial settings as substances or in mixtures (subject to specific conditions);
▶ Medicines within the scope of Directive 2001/83/EC and veterinary drug products within the scope of Regulation (EU) 2019/6;
▶ EU fertilizer products within the scope of Regulation (EU) 2019/1009;
▶ Food additives within the scope of Regulation (EC) No 1333/2008 (subject to specific conditions);
▶ In vitro diagnostic devices, including devices within the scope of Regulation (EU) 2017/746 (subject to specific conditions);
▶ Food referred to in Article 2 of Regulation (EC) No 178/2002 but not covered by point (d) above, as well as feed as defined in Article 3 (4) of that Regulation;
▶ Synthetic polymer microparticles (SPMs) that have been launched on the European Union market before October 17, 2023 and are not used for the products with transition periods mentioned above.
Starting from 2027, suppliers of products containing synthetic polymer microparticles (SPMs) as described in points (b), (d) or (e) of paragraph 2, which are first launched on the European Union market for professional users and the public, must notify the European Chemical Administration (ECHA) before May 31 of each year.

 
手机官网
手机官网

Wechat Public

Account