Europe · REACH · Chemical Compliance

The European Commission has amended REACH Annex XVII Entry 78 through Regulation (EU) 2026/1168, introducing clarifications to the EU microplastics restriction. The amendment expands specific exemptions, updates provisions for medicinal and veterinary products, and refines requirements for synthetic polymer microparticles permanently incorporated into solid matrices.

Key Regulatory Changes

Regulation
REACH (EU) 2026/1168
Amends Annex XVII Entry 78 on synthetic polymer microparticles (microplastics).
New Exemption
PPORD Activities
Product and Process Orientated Research & Development exemption for activities up to 1 tonne per year.
Clarification
Medicinal Products
Updated references covering medicinal and veterinary medicinal products.
Scope
Solid Matrix Products
Revised exemption wording for microparticles permanently incorporated into a solid matrix during intended end use.

The amendment clarifies several provisions introduced by Regulation (EU) 2023/2055 without replacing the broader restriction on placing synthetic polymer microparticles on the EU market. Existing labeling, reporting, and information obligations continue to apply where relevant.

Key Dates & Compliance Timeline

  • Official publication: 2 June 2026
  • Entry into force: 22 June 2026
  • PPORD exemption applies: From 17 October 2023
  • Permanent solid matrix amendment applies: 22 June 2028
  • Implementation: Certain provisions apply from different dates as specified in the Regulation.

Compliance Implications

  • Restrictions on placing synthetic polymer microparticles on the EU market remain in force.
  • Expanded exemptions for qualifying products and activities.
  • Continued labeling, reporting and documentation obligations.
  • Review applicability of PPORD exemption.

Who Is Affected

  • Chemical manufacturers
  • Plastic producers
  • Cosmetics and detergent manufacturers
  • Paints, coatings and fertilizers industries
  • Medical device, pharmaceutical and veterinary sectors
  • Automotive, construction and research organizations

What Companies Should Do Now

  • Identify products containing synthetic polymer microparticles.
  • Determine whether revised exemptions apply.
  • Verify PPORD activities remain within the 1 tonne/year threshold.
  • Update REACH compliance documentation and supplier communications.
  • Review labeling, reporting and recordkeeping obligations under Entry 78.
Key Takeaway

The amendment to REACH Annex XVII Entry 78 provides important clarifications to the EU microplastics restriction while expanding selected exemptions. Companies manufacturing, importing or marketing products containing synthetic polymer microparticles should review product portfolios, confirm exemption eligibility, and ensure ongoing compliance with REACH reporting and documentation requirements.

References:
Regulation (EU) 2026/1168 – Official Journal of the European Union
Regulation (EU) 2023/2055 – REACH Annex XVII Entry 78 (Microplastics Restriction)

 

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