The EU publishes Regulation (EU) 2026/1168 with adjustments to the microplastics restriction under REACH

The European Commission has published Regulation (EU) 2026/1168, introducing clarifications and adjustments to the restriction on microplastics under REACH, with an impact on sectors such as pharmaceuticals, research and development, and certain solid matrix uses.

The European Commission published Regulation (EU) 2026/1168 on June 2, 2026, incorporating relevant modifications to the application of the microplastics restriction within the REACH Regulation. This update primarily aims to improve clarity in the interpretation of the rule and facilitate its practical implementation by industry.

Among the most noteworthy aspects of this regulatory update are:

• Medicinal products: The exemption is updated to include those products used in clinical trials.
• Research and Development (PPORD): An exemption is introduced for synthetic polymer microparticles intended for R&D activities, limited to quantities not exceeding 1 ton per year and per operator.
• Solid matrix materials: It is clarified that the derogation for microplastics permanently incorporated into a solid matrix applies only if the intended use lasts at least one year. For applications where the matrix is frequently removed or replaced, the deadline is October 17, 2026.

These changes do not alter the main objective of the regulation but have a direct impact on how companies must assess their products and processes. In particular, it will be necessary to review the classification of uses, potential applicable exemptions, and supporting documentation, especially in sectors where synthetic polymer microparticles are commonly used.

In addition, this update reinforces the importance of continuously monitoring the regulatory framework, as the regulation of microplastics under REACH is evolving and may continue to develop through new guidance, interpretations, or specific amendments.

At Siam, we support companies operating in the European Union in adapting to the microplastics restriction under the REACH Regulation, including the evaluation of substances and uses and their alignment with applicable regulatory requirements in the European market.