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On September 27, 2023, the European Union (EU) issued Commission Regulation (EU) 2023/2055 (hereinafter referred to as the Regulation) to introduce regulation on synthetic polymer microparticles (‘microplastics’) under Annex XVII of REACH. The Regulation shall come into force on October 17, 2023.
Definition
As per the Regulation, synthetic polymer microparticles refer to polymers that are solid and which fulfil the following conditions:
Are contained in particles and constitute at least 1% by weight of those particles; or build a continuous surface coating on particles;
At least 1% by weight of the particles which fulfill the following conditions:
a. All dimensions of the particles ≤5mm;
b. Length of the particles ≤5mm and length to diameter ratio >3.
Polymers that meet the following conditions are excluded from this designation:
Are the result of a polymerisation process
Are degradable as proved in accordance with Appendix 15 provided in the Regulation
Have a solubility greater than 2g/L in accordance with Appendix 16 provided in the Regulation
Do not contain carbon atoms in their chemical structure
Restriction
Starting from October 17, 2023, synthetic polymer microparticles shall not be placed on the market as substances on their own or in mixtures in a concentration equal to or greater than 0.01% by weight. They shall be phased out from 2027-2035 for the following uses:
| No. | Scope of synthetic polymer microparticles | Exemption | Effective date |
| 1 | Rinse-off products defined in Regulation(EC) No 1223/2009 | For uses covered by No.5 or as an abrasive, i.e. namely to exfoliate, polish or clean (“microbeads”) | October 17, 2027 |
| 2 | Detergents defined in Regulation (EC) No 648/2004, waxes, polishes and air care products | For uses covered by No.5 or contain microbeads | October 17, 2028 |
| 3 | Fertilising products | Under the scope of Regulation (EU) 2019/1009 | October 17, 2028 |
| 4 | Products for agricultural and horticultural uses | For uses covered by No.3 or No.8 | October 17, 2028 |
| 5 | Synthetic polymer microparticles for use in the encapsulation of fragrances | - | October 17, 2029 |
| 6 | Leave-on products defined in Regulation (EC) No 1223/2009 | For uses covered by No.5 or No.10 | October 17, 2029 |
| 7 | "Devices" defined in Regulation (EU) 2017/745 | Devices containing mircobeads | October 17, 2029 |
| 8 | Plant protection products defined in Regulation (EC) No 1107/2009 and seeds treated with those products, and biocidal products defined in Regulation (EU) No 528/2012 | - | October 17, 2031 |
| 9 | Granular infill for use on synthetic sports surfaces | - | October 17, 2031 |
| 10 | Lip products, nail products and make-up products defined in Regulation (EC) No 1223/2009 | For uses covered by No.1 or No. 5, or contain microbeads | October 17, 2035 |
In particular, the following cases are exempted from the Regulation:
For use at industrial sites;
For use in medicinal products, veterinary medicinal products, EU fertilising products, food additives and vitro diagnostic devices;
Contained by technical means so that releases to the environment are prevented;
Permanently incorporated into a solid matrix during intended end use.
| Note: To prevent unnecessary product recalls and reduce waste, synthetic polymers microparticles, on their own or in mixtures, that have been placed on the market before 17 October 2023 may continued to be used. |
Submit information
Manufacturers and downstream users of synthetic polymer microparticles shall submit the following information to the Agency by May 31 of each year:
A description of the uses in the previous calendar year
Generic information on the identity
An estimate of quantity of releases to the environment
A reference to the exempted cases
This obligation shall apply:
From 2026 for manufacturers and industrial downstream users of synthetic polymer microparticles in the form of pellets, flakes, and powders used as feedstock in plastic manufacturing at industrial sites;
From 2027 for other manufacturers and industrial downstream users using synthetic polymer microparticles at industrial sites.
The regulation can be downloaded here.
