The European Commission has published Commission Regulation (EU) 2026/1168, amending Annex XVII to Regulation (EC) No 1907/2006 (REACH) with respect to synthetic polymer microparticles under Entry 78. The amendment clarifies the scope of certain derogations under the EU microplastics restriction, including medicinal products, Product and Process Orientated Research and Development (PPORD), and synthetic polymer microparticles permanently incorporated into a solid matrix.
For companies placing products on the EU market, the key compliance message is that pharmaceutical and R&D-related uses gain clearer legal certainty, while certain short-duration solid matrix applications may need to be reassessed before 22 June 2028.
Key Amendments to the REACH Microplastics Regulation
Commission Regulation (EU) 2026/1168 does not introduce a new standalone microplastics regime. Instead, it amends the existing restriction on synthetic polymer microparticles under REACH Annex XVII Entry 78, which was introduced by Commission Regulation (EU) 2023/2055.
The amendment addresses specific legal uncertainties identified during implementation and makes three targeted changes.
1. Clarified Derogation for Medicinal Products
The amendment replaces the wording of paragraph 4(b) of Entry 78. Paragraph 1 of Entry 78 shall not apply to the placing on the market of:
“medicinal products” as defined by Directive 2001/83/EC; or
“veterinary medicinal products” as defined by Regulation (EU) 2019/6.
This revised wording is intended to ensure that the derogation covers medicinal products used in clinical trials and related pre-clinical testing, including analytical, physical, toxicological, stability and batch-release testing where applicable.
This clarification applies from 17 October 2023, the date on which the original REACH microplastics restriction became applicable.
2. New Specific Derogation for PPORD Uses
A new paragraph 4(g) has been added to Entry 78. Under this provision, paragraph 1 shall not apply to the placing on the market of synthetic polymer microparticles, on their own or in mixtures, for use in Product and Process Orientated Research and Development (PPORD), in quantities of 1 tonne per year or less.
This change is important for research activities that may take place outside conventional industrial sites, such as universities, hospitals, research institutes, contract research organisations and pilot-scale development environments.
The PPORD derogation also applies from 17 October 2023.
3. Revised Conditions for the Solid Matrix Derogation
The amendment replaces paragraph 5(c) of Entry 78. Under the revised wording, paragraph 1 shall not apply to synthetic polymer microparticles, as substances on their own or in mixtures, which are permanently incorporated into a solid matrix during an intended end use of a duration of one year or longer.
This change narrows the previous wording, which referred to synthetic polymer microparticles permanently incorporated into a solid matrix during intended end use without specifying a minimum duration.
The revised solid matrix derogation will apply from 22 June 2028.
Why This Matters for Companies Supplying the EU Market
The amendment provides greater regulatory clarity for certain sectors while creating new assessment needs for others.
For pharmaceutical, veterinary medicine, biotechnology and clinical research companies, the revised wording reduces uncertainty around whether medicinal products used in clinical trials and related safety testing fall within the derogation.
For R&D-driven companies and research institutions, the explicit PPORD derogation gives clearer legal grounds for qualifying uses of synthetic polymer microparticles, provided the quantity does not exceed 1 tonne per year and the use meets the PPORD purpose.
For manufacturers of materials and industrial products, the revised solid matrix derogation may require closer review. Products that rely on this derogation will need to demonstrate that the synthetic polymer microparticles are permanently incorporated into a solid matrix during an intended end use lasting one year or longer.
Sectors that may need to review their position include:
coatings and surface treatment products;
construction and building materials;
electronic encapsulation materials;
composite materials;
temporary protective materials;
short-duration industrial moulding or curing systems.
The amendment does not mean that all products containing synthetic polymer microparticles are prohibited. However, companies should confirm whether their products fall within the restriction, benefit from a derogation, or remain subject to information, labelling, instructions for use and disposal, or reporting obligations under Entry 78. For further background on implementation obligations, see REACH24H’s analysis on EU REACH mandatory reporting for Synthetic Polymer Microparticles and ECHA's official page on microplastics reporting.
How REACH24H Can Help
REACH24H provides regulatory support for companies affected by the EU microplastics restriction, REACH Annex XVII Entry 78, and broader EU chemical compliance requirements.
Our services include:
applicability assessment for synthetic polymer microparticles;
product portfolio screening under REACH Annex XVII Entry 78;
derogation assessment for medicinal products, PPORD and solid matrix uses;
review of technical evidence and compliance documentation;
supply chain communication support;
assessment of information, labelling, instructions for use and disposal, and reporting obligations;
compliance strategy for reformulation, substitution or EU market access.
If your products, formulations or R&D materials may contain synthetic polymer microparticles, REACH24H can help you determine whether Regulation (EU) 2026/1168 affects your compliance status and what actions should be taken before the relevant application dates.
