In 2023, the EU Commission Regulation (EU) 2023/2055, amending Annex XVII to the REACH Regulation by adding Article 78 to restrict the use of synthetic polymer micro - particles (the "micro - plastic restriction") was published. The regulation came into effect on October 17, 2023.
Tiny fragments of synthetic or chemically modified natural polymers are widespread. They are water - insoluble, degrade very slowly, and are highly prone to ingestion by organisms. This has sparked concerns over the environment and human health. These polymers are not only widespread in the environment but also found in drinking water and food. They accumulate in the environment, causing microplastic pollution. Some tiny fragments of synthetic or chemically modified natural polymers are also manufactured for direct use or are added to products.
The restricted synthetic polymer particles under the regulation refer to solid polymers with a diameter of ≤5mm or a length of ≤15mm and an aspect ratio greater than 3. However, the following are excluded: naturally occurring unmodified polymers, biodegradable polymers, polymers with a solubility of over 2g/L, and polymers with no carbon atoms in their chemical structure.
From October 17, 2025, suppliers of synthetic polymer particles are required to provide the following information:
- Instructions for downstream industrial users on preventing the release of synthetic polymer particles into the environment during use and disposal;
- A declaration: "The supplied synthetic polymer particles are subject to the requirements laid down in Article 78 of Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council";
- Information on the quantity or concentration of synthetic polymer particles in the substance or mixture (if applicable);
- General information on the polymers contained in the substance or mixture, enabling manufacturers, downstream industrial users, and other suppliers to comply with the relevant obligations.
In addition, from October 17, 2025, suppliers of food additives containing synthetic polymer particles need to provide related usage and disposal instructions; from October 17, 2026, suppliers of in - vitro diagnostic devices with such particles must also offer relevant instructions; and from October 17, 2031, to October 16, 2035, suppliers of cosmetics containing synthetic polymer particles should declare: "This product contains microplastics." However, products placed on the market before October 17, 2031, are not required to provide this declaration before December 17, 2031.
The information that the above suppliers need to provide must be in clear, legible, and indelible text or pictograms, added to labels, packaging, or package inserts, or the Safety Data Sheet (SDS). Suppliers may also offer digital tools for accessing electronic versions.
Furthermore, the new requirements for SDS preparation in Annex II to the REACH Regulation state that if a product involves nanoforms, they should be indicated in Section 1 of the SDS, with specific nanoforms detailed in Section 3. If a product contains endocrine disruptors, their adverse effects should be listed in Sections 2, 11, and 12. If some microplastics are nano - sized polymer particles or are assessed as endocrine disruptors, the relevant information must be disclosed in the SDS as per the above requirements.
