EU addresses microplastics issue with regulation proposal

EU addresses microplastics issue with regulation proposal

In line with the European Green Deal and the new circular economy action plan, on August 30, 2022, the European Commission issued a proposal to restrict microplastics.

What are Microplastics?

Microplastics are pieces of plastic, usually smaller than 5 mm, which because of their extremely small size, get easily spread within the environment. Plastics cover a wide range of synthetic or semi-synthetic materials derived from fossil fuel-based chemicals. Since not all kinds of plastic are biodegradable, a continuously growing amount of these substances is introduced and absorbed into multiple habitats.

Microplastics are thus increasingly present in seas, food, and drinking water. Their widespread presence raises many concerns regarding their impact on the environment and human health.

What are the goals of the Commission’s proposal?

In light of the above, the European Commission is working on an appropriate legislative piece. The act will therefore aim to amend Annex XVII to REACH Regulation. Such Annex includes a list of restrictions for the marketing and use of certain hazardous substances, mixtures, and articles in the EU. The list now has 71 entries and is constantly updated in line with safety developments.

This Regulation will be the first legislative approach to tackle the issue of microplastics in the EU comprehensively. As such, the proposal has different goals:

  • To develop measures for labelling, standardisation, certification, and regulatory aspects for the unintentional release of microplastics;
  • To implement measures to increase the capture of microplastics throughout the entire product’s lifecycle;
  • To create and harmonise ways of measuring unintentionally released microplastics;
  • To deliver harmonised data on microplastic concentrations in seawater;
  • To further investigate the risks and presence of microplastics in the environment, drinking water and food.

How could this Regulation impact businesses?

Microplastics are widely used throughout a larger quantity of products. In fact, manufacturers intentionally add such substances to exploit their properties. The Regulation will therefore impact products such as:

  • Cosmetics, where microplastics provide exfoliating and cleansing functions, opacity control, illuminating effect on the skin, or are used as carriers for other ingredients, such as in shampoo’s and make-up products;
  • In vitro diagnostic devices, in which microplastics are used as reagents, assays, or calibration in IVDs, and are essential in all automated IVD tests conducted worldwide;
  • Medical devices, in which microplastics are used as polymeric filters, adsorber, and adsorber granulates, and in ultrasound devices;
  • Food additives, for which microplastics are used for the formulation of food supplements;

The Regulation will also touch upon other fields, like detergents and maintenance products, substances or mixtures used as toys, or for arts and crafts, and medicinal products.

What are the next steps?

Following the public consultation and the first committee meeting, the European Commission and the Member States will now be in the policymaking spotlight. Within the next months, the Member State authorities will discuss the matter further. Their aim will be to reach an agreement on the text to submit to the scrutiny of the Council and the European Parliament according to ECHA’s timeline.

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Davide Baldessari

Regulatory Affairs Department



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