EU: REACH Annex XVII restriction on microplastics was published

OCTOBER 2023 - ELECTRICAL AND ELECTRONICS, HARDLINES, SOFTLINES, TOYS AND CHILDREN'S PRODUCTS

On 27 September 2023, the European Union’s Official Journal (OJEU) published Regulation (EU) 2023/2055¹, introducing a new restriction on microplastics under Annex XVII to REACH regulation as entry 78.

As stated in the European Green Deal² and the new Circular Economy Action Plan³, the European Commission (EC) is committed to fight microplastics pollution. In 2017, the EC requested the European Chemicals Agency (ECHA) to prepare a dossier with a view to a possible restriction of microplastics. ECHA concluded that microplastics intentionally added to certain products are released into the environment in an uncontrolled manner, and recommended to restrict them.

Based on scientific evidence provided by ECHA, the EC drafted the microplastic restriction proposal under REACH Annex XVII. After that, the proposal was positively voted by the EU countries and passed the scrutiny of the European Parliament and the Council.

The new restriction aims to reduce emission of intentional microplastics from the products. It covers all synthetic polymer particles below five millimetres that are organic, insoluble and resistant to degradation. Some examples of common products in the scope of the restriction are:

The granular infill material used on artificial sport surfaces;
Cosmetics, where microplastics are used for multiple purposes, such as exfoliation (microbeads) or obtaining a specific texture, fragrance or colour;
Detergents, fabric softeners, glitter, fertilisers, plant protection products, toys, medicines and medical devices.

The new restriction will enter into force from 17 October 2023, and some items have longer transition periods from 4 years to 12 years.

Restriction on microplastics

Target substance	Synthetic polymer microparticles Synthetic polymer microparticles means polymers that are solid and which fulfil both of the following conditions: (a) are contained in particles and constitute at least 1 % by weight of those particles; or build a continuous surface coating on particles; (b) at least 1 % by weight of the particles referred to in point (a) fulfil either of the following conditions: (i) all dimensions of the particles are equal to or less than 5 mm; (ii) the length of the particles is equal to or less than 15 mm and their length to diameter ratio is greater than 3. Note: The microparticles which are degradable or solubility greater than 2g/L can be exempted. The rules to proof degradability and solubility are specified in Appendices 15 and 16.
Scope of restriction	Substances on their own or, where the synthetic polymer microparticles are present to confer a sought-after characteristic, in mixtures
Limit	Prohibited as a substance on its own; mixtures: < 0.01% by weight
Exemption	- Synthetic polymer microparticles, as substances on their own or in mixtures, for use at industrial sites; - Medicinal products within the scope of Directive 2001/83/EC and veterinary medicinal products within the scope of Regulation (EU) 2019/6; - EU fertilising products within the scope of Regulation (EU) 2019/1009; - Food additives within the scope of Regulation (EC) No 1333/2008; - Vitro diagnostic devices, including devices within the scope of Regulation (EU) 2017/746; - Food within the meaning of Article 2 of Regulation (EC) No 178/2002, and feed as defined in Article 3(4); - Synthetic polymer microparticles: (i) 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; (ii) 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; (iii) which are permanently incorporated into a solid matrix during intended end use.
Date of application	17 October 2023 Requirements of the below listed items shall start to apply: (a) Synthetic polymer microparticles for use in the encapsulation of fragrances by 17 October 2029; (b) Rinse-off cosmetics by 17 October 2027; (c) Lip products and make-up products by 17 October 2035; (d) Leave-on cosmetics by 17 October 2029; (e) Detergent, waxes, polishes and air care products by 17 October 2028; (f) Medical devices by 17 October 2029; (g) Fertilising products by 17 October 2028; (h) Plant protection products, seeds and biocidal products by 17 October 2031; (i) Other agricultural and horticultural products not covered by item (g) and (h) by 17 October 2028; (j) Granular infill for use on synthetic sports surfaces by 17 October 2031.

[1] Regulation (EU) 2023/2055

[2] European Green Deal

[3] Circular Economy Action Plan

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