EU Amends Microplastic Restrictions: Expanding Pharmaceutical and R&D Exemptions, Tightening Solid Matrix Provisions

On June 2, 2026, the European Commission officially published Regulation (EU) 2026/1168 in the Official Journal, introducing significant amendments to Entry 78 of Annex XVII to the Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH Regulation, EC No 1907/2006) regarding restrictions on synthetic polymer microparticles (commonly known as "microplastics"). CIRS Group provides the following analysis regarding these amendments to use exemptions.

Background

On September 27, 2023, the EU Official Journal published the REACH amendment (EU) 2023/2055, adding Entry 78 to the list of restricted substances in Annex XVII, which established microplastic restrictions effective from October 17, 2023.

According to paragraphs 4, 5, and 16 of this entry, the market placement ban does not apply to microplastics that: (i) are used at industrial sites, incorporated into specific products, or meet specific conditions during their final intended use; or (ii) were placed on the market before October 17, 2023. For most products containing microplastics that are exempt from the market placement ban, Entry 78 specifies information, labeling, and reporting requirements. 

Amendments

1. Expansion of Pharmaceutical Product Exemption Scope

The exemption for human and veterinary medicinal products is explicitly extended to medicinal products used in clinical trials and related preclinical safety testing (such as toxicology, stability, batch release testing, etc.). This amendment applies retroactively from October 17, 2023, to correct the discrepancy between previous legislative intent and the actual text.

2. New R&D Use Exemption

A new exemption for product and process-oriented research and development (PPORD) is added: microplastics used in annual quantities not exceeding 1 tonne are exempt, regardless of whether R&D activities are conducted at industrial sites or non-industrial sites such as hospitals and universities. This amendment also applies retroactively from October 17, 2023.

3. Restriction of "Solid Matrix Embedding" Exemption Conditions

The exemption for microplastics "permanently embedded in a solid matrix during final use" is clarified to apply only to applications where the expected final use lasts one year or more; short-term use (frequent matrix replacement) no longer qualifies for exemption. This provision enters into force on June 22, 2028, providing stakeholders with a two-year adjustment period (e.g., for reformulation and inventory management).

CIRS Insights

These amendments will have direct impacts on the pharmaceutical, R&D, and industrial application sectors.

• For pharmaceutical/veterinary drug companies, clinical trial materials and preclinical testing (toxicology, stability, batch release, etc.) are now explicitly covered by exemptions, eliminating compliance risks for microplastic-containing products used for these purposes.
• For R&D institutions, SMEs and university research groups using less than 1 tonne annually can now legally use microplastic-containing materials for experiments without bearing REACH restriction compliance costs.
• Meanwhile, enterprises in construction materials, coatings, electronic encapsulation, and composite materials that rely on the "permanently embedded in solid matrix" exemption will face pressure to reformulate products and manage existing inventory.

About CIRS

Established in 2007, the CIRS Group is a leading product safety and regulatory consulting firm. CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan, and China. CIRS Group utilizes its technical expertise, various resources, and international network to provide one-stop compliance services from regulatory compliance, laboratory testing, R&D to data services across multiple industries. This includes chemicals, cosmetics, food and food beverages, medical devices, agrochemical products, disinfectants, and consumer goods. It helps clients gain a competitive advantage by reducing business risks associated with regulatory affairs.

Our Services

• EU REACH Only Representative (OR) Service
• EU REACH Inquiry Service
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• Lead Registrant Dossier Evaluation Compliance Response
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If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

Further information

OJ