22 April 2026

Microplastics in EU regulations – what does regulation 2023/2055 change

Commission Regulation (EU) 2023/2055 of September 25, 2023, amending Annex XVII to Regulation (EC) No 1907/2006 (REACH), represents one of the most significant examples of the use of restriction instruments provided for in Article 68(1) of REACH. This provision allows for the introduction of restrictions at the EU level on the use of substances that pose unacceptable risks to human health or the environment.

In the case discussed, the regulation concerns microplastics from synthetic polymers, the environmental impact of which has been detailed in the recitals of the regulation.

Physicochemical properties of materials

The justification of the act indicates that the EU legislator has taken the physicochemical properties of these materials as a starting point, particularly their durability, insolubility, and ability to bioaccumulate. The recitals also point to the scale of microplastic emissions into the environment, which, in the European Commission's assessment, justified the application of a general measure covering a broad category of materials, rather than just selected chemical substances. Thus, the regulation fits into a systemic approach characteristic of restriction instruments under REACH.

Definition of microplastics from synthetic polymers

The definition of microplastics from synthetic polymers introduced in Annex XVII is crucial for the application of the provisions. This definition is functional and is based on criteria specified in point 78 of Annex XVII to the REACH Regulation, added by Regulation 2023/2055. According to this provision, microplastics are considered to be particles containing a polymer that constitutes at least 1% of the mass of the particles or forms a continuous coating, with at least 1% of the mass of these particles meeting specified dimensional criteria. These criteria include particles of all dimensions not exceeding 5 mm, as well as particles up to 15 mm in length, provided they meet a specified length-to-diameter ratio. This definition means that the scope of regulation is determined by the properties of the material rather than its chemical classification, which is of significant practical importance in assessing compliance.

Restriction on the marketing of microplastics

The fundamental mechanism introduced by the regulation is a restriction that prohibits the marketing of microplastics from synthetic polymers in their own form or as components of mixtures if they are present to impart specific properties and are at a concentration equal to or greater than 0.01% by weight. This provision also specifies how to determine the presence of microplastics in the case of analytical restrictions, which has evidential significance in the practical application of the law.

For a proper understanding of the scope of the ban, it is crucial to refer to the definition of "placing on the market" contained in Article 3(12) of the REACH Regulation. According to this provision, it means the paid or unpaid supply or making available to a third party, with import treated as placing on the market. Consequently, any activity involving the transfer of a product in the supply chain—regardless of whether it is commercial or free of charge—is subject to evaluation regarding compliance with the restriction. This means that liability for violations of the regulations can arise not only on the part of the manufacturer but also for importers, distributors, and entities engaged in further resale.

Transitional periods

Regulation 2023/2055 also provides for differentiated transitional periods, which are specified in points 78(3–6) of Annex XVII to REACH. The structure of these provisions is based on assigning specific deadlines to certain applications of microplastics from synthetic polymers, including individual product categories and economic sectors. In this context, the regulations contained in points 78(4–6) are particularly significant, as they provide separate solutions for selected applications for which the legislator deemed it appropriate to apply specific regulatory mechanisms, including extended transitional periods or different conditions for the application of the restriction. The provisions accounting for transitional periods include, among others, specific applications in sectors such as: lip products, nail products, or makeup, detergents, waxes, polishing agents, or air fresheners, fertilizers, plant protection products (and others used in the agricultural and horticultural sectors), as well as other categories that take into account the functional and technological specifics of the given application.

This approach reflects the legislator's aim to maintain the proportionality of regulation and to avoid situations where the introduction of a restriction would lead to unjustified disruptions in the functioning of key sectors of the economy. At the same time, it does not mean the exclusion of these applications from regulation as such, but rather their inclusion under a separate temporal or conditional regime, which in practice requires entrepreneurs to conduct a detailed analysis of the regulations applicable to a specific product.

Reporting obligations

In addition to the restriction itself, the regulation also introduces reporting obligations. According to point 78, paragraphs 11–13 of Annex XVII to REACH, manufacturers and downstream users of synthetic polymer microplastics are required to provide the European Chemicals Agency with information regarding their applications and emissions into the environment. This obligation is annual and includes, among other things, data on the identity of the polymers and estimated quantities of released microplastics. The regulations also provide for differentiated deadlines for the commencement of reporting, corresponding to the overall structure of transitional periods.

Exemptions

An important element of the regulation is the exemptions specified in point 78, paragraph 2 of Annex XVII, which primarily concern the properties of the material, such as its origin, biodegradability, or solubility. At the same time, however, the legislator has provided for specific sectoral regulations mentioned in point 78, paragraphs 4 and 5, which means that compliance assessment requires not only an analysis of the polymer's properties but also its specific application.

In practice, this means the necessity to concurrently examine several criteria – both material and functional.

From the perspective of the practical application of the regulations, the construction of the burden of proof is particularly significant. It is the responsibility of the entity introducing the product to the market to demonstrate that the given material meets the criteria for exemption or is subject to a specific sectoral regime. This requires having the appropriate technical documentation, including results of tests conducted in accordance with the requirements specified in the annexes to the regulation, as well as a correct qualification of the product's application.

Summary

The analysis of Commission Regulation (EU) 2023/2055 leads to the conclusion that this regulation significantly expands the scope of obligations for entrepreneurs arising from the REACH system. It is reasonable to take actions aimed at verifying the composition of products, identifying potential applications of synthetic polymer microplastics, and assessing whether exemptions from point 78, paragraph 2, or specific sectoral regulations resulting from point 78, paragraphs 4 and 5 of Annex XVII apply in a given case. At the same time, it is necessary to prepare for the fulfillment of reporting obligations and to ensure appropriate internal procedures that allow for demonstrating compliance in the event of oversight authority inspections.

In practice, many uncertainties concern both the interpretation of the definitions of synthetic polymer microplastics and the application of exemption criteria and sectoral regulations. In such cases, it is reasonable to conduct an in-depth regulatory analysis that will help mitigate the risks associated with placing products on the market and ensure compliance with current EU legal requirements.