On 30 August 2022, the European Commission published its long-awaited proposal to restrict the placing on the market of microplastics, including where they are added to certain products. The restriction will be adopted under the REACH Regulation, which establishes the EU chemicals framework.
Several categories of products will be impacted by the proposed restriction and very few exceptions are provided for. As a result, we anticipate that the proposal will have far reaching consequences on a broad range of businesses including those manufacturing and placing on the market fragrances, cosmetics, medical devices and biocidal products containing microplastics.
Below we provide a brief overview of the restriction proposal and what it entails.
What is it called?
Commission Regulation (EU) 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.
What is being proposed?
The proposed restriction provides that synthetic polymer microparticles (“microplastics”) cannot be placed on the market on their own or, where the synthetic polymer microparticles are present to confer a sought-after characteristic (i.e. intentionally added), in mixtures in a concentration equal to or greater than 0.01% by weight.
The restriction will affect the use of microplastics themselves and when they are used in a variety of products, including fragrances, certain cosmetic products, fertilizing products, plant protection products, and biocidal products.
Only certain types of polymers are excluded from the definition of microplastics (e.g. degradable polymers) and only few products are exempted from the proposed restriction (e.g. medicinal products, certain fertilizing products, food additives and in-vitro diagnostic devices).
For specific uses concerned by the restriction, the proposed restriction includes transitional periods aimed at providing sufficient time to concerned stakeholders to comply with the restriction and transition to suitable alternatives, such as degradable polymers. More specifically, the restriction proposal sets the following transitional periods:
- 4 years after the entry into force for the use of microplastics in rinse-off cosmetic products;
- 5 years after the entry into force for the use of microplastics in detergents/waxes/polishes and air care products, fertilising products outside the scope of application of Regulation (EU) 2019/1009, for products for agricultural and horticultural uses;
- 6 years after the entry into force for the use of microplastics in the encapsulation of fragrances, leave-on cosmetic products, medical devices within the scope of Regulation (EU) 2017/745, granular infill for use on synthetic sports surfaces;
- 8 years after the entry into force for the use of microplastics in plant protection products and biocidal products;
- 12 years after the entry into force for the use of microplastics in lip products, nail products and make-up.
In addition to the ban on placing on the market, the proposed restriction introduces information requirements for certain suppliers of microplastics and products containing microplastics.
For example, during the transition period for lip products, nail products and make-up, suppliers will have to include on the label, the packaging, the safety data sheet or the package leaflet the following statement: “This product contains microplastics”.
Reporting obligations will also apply to certain manufacturers, downstream users of microplastics and suppliers of certain products containing microplastics.
Who will it apply to?
The restriction proposal on microplastics will apply to manufacturers, importers and downstream users of microplastics and of products concerned by the proposal.
Why does it matter?
The proposed restriction on microplastics is noteworthy for its wide and general scope. It will not only apply to microplastics as such, but will also impact a broad range of manufacturers of consumer products who will have to modify the composition of their products to become compliant and may have also to comply with new labelling and/or reporting obligations. The breadth of the restriction proposal might make compliance particularly challenging and enforcement even more so, considering the uses concerned.
What are the next steps?
A first discussion on the proposal will take place on September 23, 2022 in the REACH Committee, which is a committee composed of Member State representatives that supports the European Commission on its work under the REACH Regulation. Member States sitting in the REACH Committee will have to vote on the proposal by a qualified majority, before the Commission can send the proposal to the European Parliament and the Council. The European Parliament and Council have a 3-month scrutiny period and, if they do not oppose the proposal during that period, the proposal will be adopted.
Where can I find it?
The draft Commission Regulation and its Annex can be found here.