SG 126/23
The EU has issued legislation to regulate microplastics under Annex XVII of REACH. The provisions in the new law will be implemented in phases, starting October 17, 2023.
On September 27, 2023, the European Union (EU) issued Commission Regulation (EU) 2023/2055 to regulate synthetic polymer microparticles (‘microplastics’) as substances on their own and in mixtures (the Regulation).
Microplastics are solid plastic particles composed of mixtures of polymers and functional additives that are used in a wide variety of products. These include, but are not limited to, cosmetics, detergents, glitter, granular infill materials used in artificial sports surfaces, medical devices, paints and toys.
According to the definitions in the Regulation, synthetic polymer microparticles means solid polymers meeting both of the following conditions:
- Are contained in particles and constitute at least 1% of those particles; or build a continuous surface coating on particles and
- At least 1% of the particles in the point above meet either of the following requirements:
- ≤ 5 mm for all particle dimensions, or
- ≤ 15 mm for particle length with a length to diameter ratio of more than three
The following are not designated as synthetic polymer microparticles:
- Polymers that are the result of a natural polymerization process and not chemically modified
- Degradable polymers in accordance with Appendix 15 ‘Rules on proving degradability’ in the Regulation
- Polymers with a solubility of more than 2 g/L in accordance with Appendix 16 ‘Rules on proving solubility’ in the Regulation
- Polymers that do not contain carbon atoms in their chemical structure
The Regulation contains, inter alia, several important provisions. It:
- Creates new entry 78 to Annex XVII of Regulation (EC) No.1907/2006 ‘Registration, Evaluation, Authorization and Restriction of Chemicals’ (Annex XVII of REACH, consolidated version to August 2023)
- Exempts the following:
- Microplastics as substances on their own or in mixtures a) that are permanently incorporated into a solid matrix during intended use, b) for use in industrial sites and c) that are contained by technical means and not being released into the environment during intended use
- Medicinal products and veterinary medicinal products, in vitro diagnostic devices and food additives
- Requires suppliers of microplastics for use at industrial sites to provide certain information (effective October 17, 2025)
- Directs suppliers of the following products containing microplastics to provide instructions to professional users and the general public (consumers) for use and disposal on how to prevent microplastics from being released into the environment, from October 17, 2025:
- Microplastics that are permanently incorporated into a solid matrix during intended end use
- Microplastics that are contained by technical means and not being released into the environment during intended use.
- Stipulates the same requirements in the bullet points above for suppliers of in vitro diagnostic devices, but from October 17, 2026
- Requires suppliers of lip, nail and make-up products containing microplastics (see Table 1, item 11 below) to provide the statement ‘This product contains microplastics’ from October 17, 2031, to October 16, 2035
- Products placed on the market before October 17, 2031, are required to bear that statement from December 17, 2031
- Requires manufacturers and industrial downstream users of microplastics in the form of pellets, flakes and powders used as feedstock in plastic manufacturing at industrial sites to submit information to the European Chemicals Agency (ECHA) by May 31 of each year, starting 2026
- Other manufacturers of microplastics and industrial downstream users using microplastics at industrial sites are required to submit the same information by May 31 of each year, starting 2027
- Requires suppliers to submit information to the ECHA by May 31, 2027, and each year thereafter, if they place, among other things, microplastics that are permanently incorporated into a solid matrix during intended end use on the market for the first time for professional users and the general public
- Requires manufacturers, importers and industrial downstream users of products containing microplastics to provide specific information on the identity and function of those polymers in these products if requested by the authorities
- Requires manufacturers, importers and industrial downstream users of products containing polymers that are exempt from the designation of microplastics to prove that they are degradable in accordance with Appendix 15 or soluble in accordance with Appendix 16 of the Regulation
Highlights of the Regulation are summarized in Table 1.
Regulation (EU) 2023/2055 of September 25, 2023, amending Annex XVII of REACH to Regulation (EC) No. 1907/2006 ‘Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) as regards synthetic polymer microparticles
Official Journal of the European Union, September 27, 2023
| Item | Scope of synthetic polymer microparticles | Requirement1,2 | Effective Date |
|---|---|---|---|
| 1 |
| Prohibited (substances on their own) < 0.01% (mixtures) | October 17, 2023 |
| 2 |
| < 0.01% | October 17, 2027 |
| 3 |
| < 0.01% | October 17, 2028 |
| 4 |
| < 0.01% | October 17, 2028 |
| 5 |
| < 0.01% | October 17, 2028 |
| 6 |
| < 0.01% | October 17, 2029 |
| 7 |
| < 0.01% | October 17, 2029 |
| 8 |
| < 0.01% | October 17, 2029 |
| 9 |
| < 0.01% | October 17, 2031 |
| 10 |
| < 0.01% | October 17, 2031 |
| 11 |
| < 0.01% | October 17, 2035 |
1 If the synthetic polymer microparticle concentration cannot be determined by analytical means or accompanying documentation, only particles of at least the following size are to be considered for verification of compliance:
- 0.1µm in any dimension, for particles with ≤ 5 mm in all dimensions
- 0.3 µm in length, for particles with a length of ≤ 15 mm and a length to diameter ratio of more than 3
2 Contains several exemptions, including those which are permanently incorporated into a solid matrix during intended end use
Table 1
The Regulation will enter into force on October 17, 2023 (20 days after its publication in the Official Journal of the EU).
Except for items 2 to 11 of Table 1 above, microplastics on their own or in mixtures that were placed on the market before October 17, 2023, may remain on the market.
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