SG 081/26
The European Union (EU) has amended several derogations for microplastics under the REACH regulation.
On June 2, 2026, the EU published Commission Regulation (EU) 2026/1168, amending entry 78 on synthetic polymer microparticles (SPMs, aka microplastics) under Annex XVII of Regulation (EC) No. 1907/2006 ‘Registration, Evaluation, Authorization and Restriction of Chemicals (Annex XVII of REACH, current consolidated version to October 2025).
What does this regulation require?
Key changes to derogations include:
- Updating the exemption for medicinal products to include those used in clinical trials and preclinical safety testing (paragraph 4(b))
- Introducing an exception for SPMs, on their own or in mixtures, for product and process-oriented research and development (PPORD), in quantities of no more than one tonne per year (paragraph 4(g))
- Clarifying that the derogation for SPMs permanently incorporated into a solid matrix applies only where the intended end use is expected to last for at least one year, and excludes applications where the matrix is designed to be frequently removed and replaced (paragraph 5(c), see Table 1 below)
| Regulation (EU) 2026/1168, amending entry 78 to Annex XVII of REACH ‘SPMs” | Entry 78 to Annex XVII of REACH ‘SPMs’ | |
|---|---|---|
| Paragraph 5(c) (derogation for placing on the market of SPMs on their own or in mixtures under paragraph 1) | SPMs permanently incorporated into a solid matrix during an intended end use lasting at least one year | SPMs which are permanently incorporated into a solid matrix during intended end use |
| Effective date | June 22, 2028 | In force |
Table 1
Who is impacted?
The amendment affects stakeholders across the consumer products supply chain, including manufacturers, importers, retailers and other intermediaries operating in the EU market.
When does it apply?
The first two points mentioned above will apply retroactively from October 17, 2023.
Our global network of laboratories and highly trained specialists offers a comprehensive suite of services to help you comply with REACH, from initial registration to consulting, testing, auditing and verification solutions that support ongoing compliance. Contact us to learn more, or visit our website. In the end, it’s only trusted because it’s tested.
© SGS Société Générale de Surveillance SA. This publication or website is a property of SGS Société Générale de Surveillance SA. All contents including website designs, text, and graphics contained herein are owned by or licensed to SGS Société Générale de Surveillance SA. The information provided is for technical and general information purposes only and offers no legal advice. The information is no substitute for professional legal advice to ensure compliance with the applicable laws and regulations. All information is provided in good faith “as is”, and SGS Société Générale de Surveillance SA makes no representation or warranty of any kind, express or implied, and does not warrant that the information will be error-free or meet any particular criteria of performance or quality.
