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 REACH (Regulation (EC) No. 1907/2006).

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)).

Effective date:

• Paragraph 4(b) and 4(g) shall apply from 17 October 2023.

• Paragraph 5(c) shall apply from 22 June 2028.

URL：

https://eur-lex.europa.eu/eli/reg/2026/1168/oj

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