Microplastics: Restriction of Synthetic Polymer Microparticles (SPM) – Entry 78 of Annex XVII of the REACH Regulation
The increasing presence of microplastics in the environment, in food, and even in the human body has been a subject of intense discussion for several years. To reduce the generation and release of microplastics, the EU has taken various measures, such as the Single-Use Plastics Directive 2019/904. Another significant step in this development is the restriction on the marketing of products containing synthetic polymer microparticles (SPM), which is regulated by Regulation (EU) 2023/2055.
What are Synthetic Polymer Microparticles (SPM)?
Synthetic polymer microparticles (SPM) are microscopic particles made from synthetic polymers. They are used in various fields, including medicine, pharmaceuticals, chemistry, materials science, and environmental technology. Due to their small size, they can enter biological systems and are often used for targeted drug delivery, diagnostic procedures, or as carrier materials.
Since October 17, 2023, a new EU regulation has imposed strict restrictions on the use of microplastics that are intentionally included in products. This regulation applies to poorly degradable plastic particles (often smaller than 5 mm), which are found in cosmetics, cleaning agents, fertilizers, and sports surfaces, among others.
Entry 78 of Annex XVII of the REACH Regulation requires manufacturers and downstream industrial users of synthetic polymer microparticles to report a range of information to the ECHA. This includes the identity of the polymer, its intended use, and the amount of microplastic released.
Definition and Scope
SPM (synthetic polymer microparticles) are solid polymers that:
- Make up at least 1% of the particles or fully cover the surface of the particles, and
- For ≥ 1% (weight) of the particles, have a size of ≤ 5 mm (for fibers ≤ 15 mm with an L/D ratio > 3).
The following are excluded from this definition:
- Liquid polymers
- Natural polymers
- Soluble polymers (solubility > 2 g/l)
- Biodegradable polymers (proof according to REACH Annex 15)
- Polymers without a carbon backbone
In summary: Only solid, insoluble, and non-biodegradable polymers within the critical size range fall under the restriction.
Key Contents of Entry 78
Principle: Prohibition of marketing SPM in mixtures if they perform a desired function and the concentration exceeds 0.01% by weight.
Gradual Prohibition Deadlines:
- 2027: Wash-off/leave-on products (e.g., cosmetics)
- 2028: Detergents, waxes, polishes, air fresheners, fertilizers
- 2029: Fragrance encapsulation, skin and hair products, medical devices
- 2031: Plant protection products, biocides, infill granules for sports fields
- 2035: Lipstick, nail, and makeup products
Exemptions: Products where SPM are fully encapsulated, transformed during use, or bound in a solid matrix.
Information and Reporting Obligations
Suppliers and importers must:
- Provide information along the entire supply chain, including usage, handling, disposal, and avoidance of release.
- Apply mandatory labeling: “The supplied synthetic polymer microparticles are subject to the conditions of Entry 78 of Annex XVII of Regulation (EC) No. 1907/2006 of the European Parliament and of the Council.”
- Provide detailed data upon request from authorities, including: identity, function, molecular and structural formula, molecular weight, spectra/analytics, and identification methods.
- For certain applications, annual reports to the ECHA are required, including usage, polymer identity, and amounts released.
Conclusion
The restriction of synthetic polymer microparticles represents one of the most comprehensive regulatory steps in chemical law in recent years. For importers, this means clear documentation requirements, close collaboration with suppliers, and proactive product planning. Companies that examine early whether their polymers are solid, soluble, or biodegradable, and build the necessary documentation, can avoid risks in importing and meet upcoming deadlines with confidence.