On 17 October 2025, several obligations introduced by Regulation (EU) 2023/2055, which adds entry 78 to Annex XVII of REACH, came into effect.
This new entry establishes that synthetic polymer microparticles (SPMs), whether placed on the market as such or as components of mixtures, must not be placed on the market if present in a concentration equal to or greater than 0.01% w/w.
Exemptions and Obligations
The restriction, however, provides for a number of derogations to the general ban, including the following uses and products:
- under paragraph 4: Products containing SPMs for industrial end use, as well as SPMs in human or veterinary medicinal products, fertilisers, food additives, in vitro diagnostic medical devices, and food and feed.
- under paragraph 5: SPMs that are contained by technical means, permanently modified, or permanently embedded in a solid matrix during their end use, where release into the environment is minimised.
- additional temporary derogations apply to other product types listed in paragraph 6 of the Regulation.
Information Requirements from 17 October 2025
From 17 October 2025, suppliers of synthetic polymer microparticles referred to in paragraph 4(a) (i.e. intended for industrial sites) must provide the following information:
- instructions for use and disposal (IFUD) explaining to downstream industrial users how to prevent the release of synthetic polymer microparticles into the environment.
- the following declaration: “The synthetic polymer microparticles supplied is subject to conditions laid down by entry 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 SPMs present in the substance or mixture.
- generic information on the identity of the polymers contained, enabling manufacturers, downstream users, and other suppliers to fulfil their obligations under paragraphs 11 and 12.
From the same date, suppliers of:
- Products containing SPMs as food additives (derogation under paragraph 4(d)); or
- Other types of products benefitting from derogations under:
- paragraph 5(a) (SPMs contained by technical means),
- paragraph 5(b) (SPMs permanently modified), or
- paragraph 5(c) (SPMs permanently embedded in a solid matrix),
must provide instructions for use and disposal to professional users and consumers, explaining how to avoid releases of SPMs into the environment.
Ensuring Compliance with Restriction 78 Using EPY
The EPY software suite now includes an automated calculation for Restriction 78, developed in full alignment with the REACH Regulation.
This feature automatically determines and reports, within safety data sheets (SDS) and labels where required, all the mandatory information, including: the total percentage of SPMs contained, the identity of the polymers, and the appropriate use and disposal instructions to prevent emissions.
With EPY, achieving and maintaining compliance with the microplastics restriction is faster, simpler, and fully integrated into your product safety workflow. We will explain more about it in our upcoming webinar: register here!
