The REACH restriction on Synthetic Polymer Microparticles (“SPM”) entered into force on October 17 2023.
However, specific transitional periods are foreseen from the application of the ban for some types of products (medical devices, detergents, some cosmetic products, etc.).
The restriction arises from the European Commission’s intention to reduce “microplastic pollution”, caused by the presence of tiny fragments of synthetic or chemically-modified natural polymers, which are insoluble in water, degrade very slowly and that are widespread in the environment.
Ban on Microplastics: REACH Restriction 78
The restriction introduces a ban to place on the market SPM as substances on their own or, where the synthetic polymer microparticles are present to confer a sought-after characteristic, in mixtures in a concentration equal to or greater than 0,01 % by weight.
With the introduction of Restriction 78 (Reg. EU 2023/2055), companies are now required to know whether their products contain Microplastics.
Deadline for plastic manufacturing at industrial sites by May 31
According to paragraph 11 of the Restriction 78, manufacturers and industrial downstream users of SPM in the form of pellets, flakes, and powders used as feedstock in plastic manufacturing at industrial sites shall submit to ECHA the following information by May 31 2026:
(a) a description of the uses of “SPM” in the previous calendar year.
(b) for each use, generic information on the identity of the polymers used.
(c) for each use, an estimate of the quantity of “SPM” released to the environment in the previous calendar year (considering the quantity of SPM released to the environment during transportation).
(d) for each use, a reference to the derogation laid down in paragraph 4, point (a) (synthetic polymer microparticles, as substances on their own or in mixtures, for use at industrial sites).
Which industries are affected?
The European ban on microplastics affects several significant industries where synthetic polymer microparticles (SPMs) are deliberately used in products.
These industries include:
- Detergents and Maintenance Products: The manufacturers of encapsulated odors, fabric softeners, and waxes will experience significant changes.
It should be emphasized that they will be obliged to replace their technology of using microparticles with biodegradable or water-soluble ones meeting strict criteria set out by ECHA. - Cosmetics and Personal Care: In this industry, the issue is particularly acute regarding the use of microparticles in fragrances, glitters, and leave-on products
Despite the ban on microbeads from exfoliating cosmetics introduced earlier, now decorative glitters and polymer bases of personal care products are under transitional arrangements, requiring their declaration and labeling. - Agricultural Sector: Fertilizers, pesticides, and seeds with synthetic polymer coatings used here should be considered as microplastics.
Though these products enjoy some lenient rules allowing for prolonged transitions, still they should comply with mandatory environmental reporting requirements. - Sports and Recreation: This industry has one of the largest uses of microplastics as granular infill for artificial turf pitches.
- Industrial Facilities: Despite not having any consumer contact, facilities that use abrasive blasting media, binders, and additives have obligations to report synthetic polymer utilization concerning products and processes.
- Medicine and Pharmaceuticals: Although advanced medicine delivery systems and diagnostics benefit from unique derogations based on their medical relevance, it is essential for organizations to keep records to establish their suitability and adhere to labeling guidelines.
Businesses operating within these industries need to assess their product line to check if their items meet the 0.01% concentration requirement.
How to move
This Europe-wide measure aims to combat microplastic pollution and establishes a general ban on the placing on the market of SPMs on their own or in mixtures in a concentration of 0.01% by weight or higher, intentionally added. Now, it is crucial to understand your product formulation to stay compliant and know how to move with regulatory updates.
Contact us to ensure you have a partner guiding you with the evolving regulatory landscape.
