On 27 September 2023, the European Commission has approved and published Regulation (EU) 2023/2055, to add a new Entry 78 to Annex XVII to the EU REACH Regulation (EC) No 1907/2006, to restrict synthetic polymer microparticles (SPM) (“Microplastics”) for all uses, unless exempted. The regulation will apply on 17 October 2023, except for certain products with transitional periods given.

Definition

“Synthetic polymer microparticles” (SPM) are defined as polymers that are solid and which fulfil both of the following conditions:

1. are contained in particles and constitute at least 1% by weight of those particles; or build a continuous surface coating on particles;
2. at least 1% by weight of the particles referred to in point (a) fulfil either of the following conditions:
   1. all dimensions of the particles are equal to or less than 5 mm;
   2. the length of the particles is equal to or less than 15 mm and their length to diameter ratio is greater than 3.

However, following polymers are excluded from the designation “synthetic polymer microparticles” (SPM):

1. 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;
2. polymers that are degradable as proved in accordance with Appendix 15;
3. polymers that have a solubility greater than 2 g/L as proved in accordance with Appendix 16;
4. polymers that do not contain carbon atoms in their chemical structure.

Manufacturers, importers and industrial downstream users of products containing SPM shall provide specific information on the identity of polymers covered by this entry contained in those products and the function of those polymers in the products, as well as the proof, if the polymers are claimed to be excluded from the designation of SPM on grounds of degradability or solubility, to competent authorities upon their request.

Restriction and transition period

According to the regulation, synthetic polymer microparticles (SPM) shall not be placed on the EU market as substances on their own or, where the SPM are present to confer a sought-after characteristic, in mixtures in a concentration equal to or greater than 0.01% by weight.

Transition periods are given for the SPM in certain products (e.g., cosmetics, detergents, waxes, polishes, air care products, medical devices, products for agricultural and horticultural uses, granular infill for use on synthetic sports surfaces):

Note: when one product falls into multiple product categories, the transitional period for the product category with the smallest number denoted prevails.

Exemption

1. The restrictions do not apply to the following synthetic polymer microparticles (SPM):

1. SPM 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; (e.g. chromatography columns, water filtering cartridges, printer toners)
2. SPM 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; (e.g. diapers, nail polish, paint)
3. SPM which are permanently incorporated into a solid matrix during intended end use. (e.g. fibres added to concrete, pellets used as feedstock for moulded articles)

From 2027, suppliers of products containing SPM in Points (a), (b) or (c) in above Paragraph 1, placed on the market for the first time to professional users and the general public, shall notify ECHA (European Chemicals Agency) by 31 May of each year.

2. The restrictions do not apply to the following situation and products:

1. SPM, as substances on their own or in mixtures, for use at industrial sites (subject to specific conditions);
2. medicinal products within the scope of Directive 2001/83/EC and veterinary medicinal products within the scope of Regulation (EU) 2019/6;
3. EU fertilising products within the scope of Regulation (EU) 2019/1009;
4. food additives within the scope of Regulation (EC) No 1333/2008 (subject to specific conditions);
5. in vitro diagnostic devices, including devices within the scope of Regulation (EU) 2017/746 (subject to specific conditions);
6. 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;
7. SPM placed on the EU market before 17 October 2023, which are not used for products with transition periods granted.

From 2027, suppliers of products containing SPM in Points (b), (d) or (e) in above Paragraph 2, placed on the market for the first time to professional users and the general public, shall notify ECHA (European Chemicals Agency) by 31 May of each year. 

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