Commission Regulation (EU) 2023/2055 of 25 September 2023 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards synthetic polymer microparticles (Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (1), and in particular Article 68(1) thereof,

Whereas:

(1) The ubiquitous presence of tiny fragments of synthetic or chemically-modified natural polymers, which are insoluble in water, degrade very slowly and can easily be ingested by living organisms, raises concerns about their general impact on the environment and, potentially, on human health. Those polymers are widespread in the environment and have also been found in drinking water and food. They accumulate in the environment and contribute to microplastic pollution.

(2) A big part of microplastic pollution forms unintentionally, for example as a result of the breakdown of larger pieces of plastic waste, or the wear and tear of tyres and road paint, or the washing of synthetic clothes. However, tiny fragments of synthetic or chemically-modified natural polymers are also manufactured to be used as such or added to products.

(3) The Council, in its conclusions of 20 June 2016 on the EU action plan for the circular economy (2) and of 24 March 2017 on international ocean governance (3), called upon the Commission to propose measures to reduce the discharge of macro- and micro-sized plastic debris in the marine environment, including a proposal for a ban on polymers in cosmetics, personal care products and detergents.

(4) In a bid to tackle plastic pollution, in January 2018, the Commission adopted a plastics strategy (4) which aimed, among other things, to reduce all sources contributing to microplastic pollution. This commitment was renewed with the publication of the European Green Deal (5) in December 2019, the new Circular Economy Action Plan (6) in March 2020 and the Zero Pollution Action Plan (7) in May 2021. The latter, in particular, includes reducing by 30 % the amount of microplastics released into the environment among its 2030 targets.

(5) In September 2018, the European Parliament called (8) on the Commission to introduce a ban on microplastics in cosmetics, personal care products, detergents and cleaning products, by 2020.

(6) The potential impacts of microplastic pollution on the environment and possibly human health have raised concerns in various parts of the world. Several Member States have adopted or proposed dedicated measures. However, a patchwork of national restrictions potentially hampers the functioning of the internal market and therefore requires harmonisation at Union level.

(7) On 9 November 2017, the Commission asked (9) the European Chemicals Agency (‘the Agency’), pursuant to Article 69(1) of Regulation (EC) No 1907/2006, to prepare a dossier with a view to a possible restriction of synthetic, water-insoluble polymers of 5 mm or less (‘synthetic polymer microparticles’) that are present in products to confer a sought-after characteristic (‘intentionally-present’), in order to address the risk that those microparticles may pose to the aquatic environment (‘the Annex XV dossier’).

(8) On 29 January 2019, the Agency published the Annex XV dossier (10) where it concludes that the intentional use of synthetic polymer microparticles, resulting in releases to the environment, poses a risk to the environment that is not adequately controlled and needs to be addressed on a Union-wide basis. The Agency estimated that, currently, more than 42 000 tonnes of intentionally-present microplastics are eventually released into the environment every year (11). The Annex XV dossier proposed a differentiated risk management approach to address the risks from such synthetic polymer microparticles that are not adequately controlled. A complete ban on the placing on the market was proposed for sectors and applications where the releases were considered unavoidable. Instructions for use and disposal were proposed to minimise avoidable releases. A reporting requirement to obtain information on releases from uses excluded from the ban on the placing on the market was also suggested.

(9) More specifically, the Annex XV dossier proposed a prohibition of the placing on the market of any solid polymer contained in microparticles or microparticles which have a solid polymer surface coating, as a substance on their own or in a mixture in a concentration equal to or greater than 0,01 % by weight. This is estimated to result in a cumulative emission reduction of approximately 500 000 tonnes of microplastics over the 20-year period following the introduction of the prohibition. That corresponds to a reduction of 70 % of quantified emissions that would otherwise occur. The concentration limit of 0,01 % corresponds to the lowest concentration level reported where synthetic polymer microparticles could still have an influence on the function of a product.

(10) Due to large variability in the composition, properties and dimensions of synthetic polymer microparticles, the Annex XV dossier did not address specific polymers or any additives or other substances that the polymers may contain, but analysed a group of polymers sharing the same intrinsic properties with regard to size, dimension ratio, solid state, synthetic origin and extreme persistence in the environment.

(11) The Annex XV dossier proposed to exclude degradable or water-soluble polymers and natural polymers that have not been chemically modified, as they do not possess the same long-term persistence and, therefore, do not contribute to the identified risk.

(12) The Annex XV dossier proposed a framework of standardised test methods and pass criteria to identify degradability for the purpose of a restriction. The test methods were designed to measure biotic degradation, although it cannot be excluded that some abiotic degradation takes place during the test and contributes to the test results. The test methods were grouped according to their test design and rationale. Groups 1 to 3 include relatively rapid but stringent screening tests. Groups 4 and 5 include screening and simulation studies which are increasingly more sophisticated, technically demanding and lengthy, but use testing conditions that are more environmentally relevant. The Annex XV dossier proposed that meeting the pass criteria in any of the permitted test methods in groups 1 to 5 be sufficient to demonstrate degradability for the purpose of the restriction.

(13) Water-soluble solid polymers lose their solid state after their release into the environment, and therefore do not contribute to the identified concern. The Annex XV dossier therefore proposed internationally-accepted methods to test solubility and to exclude those water-soluble polymers from the scope of the restriction.

(14) The Annex XV dossier furthermore proposed a 5 mm diameter in any dimension as an upper size limit for the synthetic polymer microparticles addressed. This value is widely used in the scientific community and in legal acts in some Member States. Such limit is also consistent with the upper limit for micro-litter (including microplastics) specified in the Annex to Commission Decision (EU) 2017/848 (12) and used for the implementation of Directive 2008/56/EC of the European Parliament and of the Council (13). Finally, according to Annex XV dossier, particles below that size are more likely to be ingested by biota than larger items.

(15) Certain fibre-like synthetic polymer particles have a length exceeding 5 mm but lower than 15 mm, for example the particles used for the reinforcement of adhesives and concrete. As those fibre-like particles are very persistent and contribute to the identified risk, the Annex XV dossier considered that they should be included in the scope of the restriction.

(16) To avoid regrettable substitution, i.e. the replacement of synthetic polymer microparticles with even smaller persistent polymer particles that may pose an equal or even larger risk to the environment, the Annex XV dossier initially included particles below the microscale in the scope of the restriction. To be consistent with the lower size limit already recommended by Commission Recommendation C(2022) 3689 (14), a lower size limit of 1 nm for particles and 3 nm for fibre-like particles was proposed. However, comments received during the consultation on the Annex XV dossier pointed out significant practical concerns, including regarding enforcement. To ensure enforceability, the Annex XV dossier was adjusted and the lower size limit for the synthetic polymer microparticles increased from 1 nm to 0,1 μm for particles and from 3 nm to 0,3 μm for fibre-like particles.

(17) Particles containing or coated by a synthetic or chemically-modified natural polymer that is solid and insoluble in water come in a variety of sizes. When added to a product, only some of those particles meet the size limits laid down in the Annex XV dossier and contribute to the identified concern. The Annex XV dossier therefore proposed that a polymer should be considered within the scope of restriction if, among other things, at least 1 % by weight of the particles containing or coated by that polymer meet those size limits.

(18) The Annex XV dossier proposed to exclude several uses or sectors from the prohibition on placing on the market. It was proposed to exclude synthetic polymer microparticles for use at industrial sites because it is easier to control emissions from such uses than, for example, emissions from consumer or professional uses. To avoid over-regulation regarding certain uses and sectors, it was proposed to exclude medicinal products within the scope of Directive 2001/83/EC of the European Parliament and of the Council (15) and veterinary medicinal products within the scope of Regulation (EU) 2019/6 of the European Parliament and of the Council (16), EU fertilising products within the scope of Regulation (EU) 2019/1009 of the European Parliament and of the Council (17) and food additives within the scope of Regulation (EC) No 1333/2008 of the European Parliament and of the Council (18). In the view of the Agency, potential releases from in-vitro diagnostic devices can be minimised by setting conditions of use and disposal while ensuring continued socioeconomic benefits of use of such devices. Moreover, derogations from the ban on placing on the market are proposed where the risk from releases is expected to be minimised because synthetic polymer microparticles are contained by technical means, such as those in chromatography columns, water filtering cartridges or printer toners, or permanently lose their particle form because, for example, they swell or form a film, like in diapers, nail polish or paint, or are permanently enclosed in a solid matrix during end use, such as fibres added to concrete or pellets used as feedstock for moulded articles.

(19) The Annex XV dossier assessed several restriction options for granular infill for use on synthetic sports surfaces and suggested either a ban on the placing on the market with a transitional period of 6 years, without exemptions, or a ban on the placing on the market with a transitional period of 3 years, with an exemption from that ban in case of use of specific risk management measures ensuring that annual releases of synthetic polymer microparticles from a synthetic sports pitch do not exceed 7 g/m2.

(20) Regarding the prohibition of the placing on the market, for sectors or products identified during the restrictions process, specific transitional periods were proposed to allow sufficient time for concerned stakeholders to comply with the restriction and transition to suitable alternatives, for example, degradable polymers. Such transitional periods are also necessary for the Member States to prepare for the enforcement of the restriction. Finally, they minimise costs to society, without causing unnecessary delay in emission reduction. No transitional periods were proposed for other uses and products not individually identified during the restriction process.

(21) Concerning the ban on the placing on the market of ‘microbeads’, i.e. synthetic polymer microparticles for use as an abrasive, i.e. namely to exfoliate, polish or clean, mainly used in rinse-off cosmetic products or detergents, no transitional period was proposed, as industry was expected to have voluntarily phased out their use by 2020. For ‘rinse-off’ and ‘leave-on’ cosmetic products without microbeads, the Annex XV dossier proposed a 4-year and a 6-year transitional period.

(22) For synthetic polymer microparticles encapsulating fragrances, the Annex XV dossier considered that transitional periods of 5 or 8 years may both be appropriate in terms of their economic costs and their economic benefits. For detergents, waxes, polishes and air care products, a transitional period of 5 years was considered appropriate to give industry sufficient time to reformulate their products and substitute synthetic polymer microparticles.

(23) For controlled-release fertilisers, a transitional period of 5 years was considered justified to allow manufacturers to reformulate their products so that they achieve appropriate degradability in the environment. For plant protection products covered by Regulation (EC) No 1107/2009 of the European Parliament and of the Council (19) and seeds treated with those products, and biocidal products covered by Regulation (EU) No 528/2012 of the European Parliament and of the Council (20), a transitional period of 8 years was considered necessary to give industry sufficient time to reformulate their products, obtain an authorisation and place them on the market, while maintaining the benefits of the encapsulation technology in the interim period. As regards other agricultural and horticultural uses, such as seeds coated with colorants or lubricants or other products which are not or do not contain plant protection products, a transitional period of 5 years was considered appropriate.

(24) For devices covered by Regulation (EU) 2017/745 of the European Parliament and of the Council (21) which are substances or mixtures, 6 years were considered necessary for reformulation and transition to suitable alternatives.

(25) Where pollution in the environment from synthetic polymer microparticles can be minimised by the requirement to provide instructions for use and disposal, the Annex XV dossier proposed a derogation from the prohibition of placing on the market. Those instructions should explain how to properly use and dispose of products in order to minimise releases to the environment.

(26) Furthermore, the Annex XV dossier proposed annual reporting requirements to monitor the effectiveness of the requirement to provide instructions for use and disposal and improve the evidence base available for the risk management of the uses of synthetic polymer microparticles exempted from the prohibition of placing on the market.

(27) On 3 June 2020, the Agency’s Committee for Risk Assessment (RAC) adopted an opinion (22) pursuant to Article 70 of Regulation (EC) No 1907/2006 with respect to the Annex XV dossier. In that opinion, RAC concurred with the Annex XV dossier’s conclusions about the identified risks and that the proposed restriction is an appropriate Union-wide measure to reduce those risks.

(28) RAC considered that, from a risk-reduction perspective, it is more appropriate to set no lower size limit for polymer microparticles, i.e. include all fibre-like particles smaller than 15 mm (with regard to the longest dimension of the fibres) and all other particles smaller than 5 mm. RAC considered that the omission of synthetic polymer microparticles smaller than 0,1 μm from the scope of the restriction could either provide for the continued use of synthetic polymer microparticles or even promote a shift to smaller particle sizes to circumvent the restriction. This could compromise the effectiveness of the proposed restriction, since the toxicity of particles is expected to increase the smaller their size.

(29) Furthermore, RAC considered that the criteria for excluding degradable polymers from the restriction should be more stringent than those proposed by the Annex XV dossier. Specifically, RAC considered that where it is necessary to perform tests from groups 4 and 5 to justify an exclusion, those tests should be performed and passed in three relevant environmental compartments and not only in the most relevant compartment, as proposed in the Annex XV dossier.

(30) With regard to the placing on the market of infill material for use on synthetic sports surfaces, taking into account considerations of emissions reduction, practicality and enforceability, RAC expressed a clear preference for a ban on the placing on the market after a transitional period over an exception from the ban conditional on the implementation of risk management measures. The main reason for RAC’s preference was that infill material for use on synthetic turf sport surfaces is the largest contributor in terms of use of microplastics in products as well as the largest source of environmental emissions of intentionally-present synthetic polymer microparticles at European level. RAC had also concerns regarding the effectiveness of the proposed risk management measures, in particular in relation to existing sport surfaces and smaller size particles. It also stated that it does not endorse the referred limit of 7 g/m2/year as any sort of acceptable threshold, as this on its own still implies substantial releases to the environment on a continued basis.

(31) On 10 December 2020, the Agency’s Committee for Socioeconomic Analysis (SEAC) adopted an opinion pursuant to Article 71(1) of Regulation (EC) No 1907/2006, concluding that the proposed restriction is an appropriate Union-wide measure to address the identified risks taking into account its socioeconomic benefits and costs.

(32) Taking into account RAC’s opinion, SEAC proposed modifications to the restrictions proposed in the Annex XV dossier and considered that the definition of synthetic polymer microparticles should contain a lower size limit of 1 nm. However, in order to ensure that it is possible to implement, enforce and monitor the proposed restriction, SEAC acknowledged that it would be at least temporarily necessary to set a lower size limit at 0,1 μm (100 nm) when analytical methods or accompanying documentation cannot confirm the concentration of synthetic polymer microparticles below that size and thus the compliance with the concentration limit of the restriction cannot be verified.

(33) In addition to the exclusion of natural, degradable, and soluble polymers from the definition of synthetic polymer microparticles, as proposed by the Annex XV dossier, SEAC suggested excluding polymers that do not contain carbon in their chemical structure as, in its view, current tools to prove persistence are not suitable for such polymers. However SEAC considered that such exclusion would need to be confirmed by RAC.