The European Commission has prepared a draft amendment to the microplastics restriction set out in Annex XVII of the REACH Regulation (entry 78). The proposal aims to clarify and adjust the scope of the SPM restriction which introduced the ban on placing synthetic polymer microparticles on the market.
The amendment addresses several technical and legal inconsistencies identified since the adoption of the restriction:
- Broader derogation for medicinal products
The exemption is expanded to include all medicinal products, including those used in clinical trials.
- New derogation for PPORD activities
The text introduces an explicit exemption for product and process-oriented research and development (PPORD), even when conducted outside industrial sites, such as in hospitals or academic laboratories.
- Refinement of the “solid matrix” exemption
The amendment clarifies that the exemption for microparticles permanently embedded in a solid matrix applies only when the intended end use lasts at least one year.
- Retroactive application
All corrections would apply retroactively from 17 October 2023, ensuring alignment with the Commission’s original intention and avoiding unintended non-compliance for operators.
Next discussion on this draft amendment project and a possible vote are scheduled for the December meeting of the REACH Committee.
Would you like to anticipate the impact of this amendment on your products or verify your compliance? Contact our REACH experts to secure your regulatory obligations and adjust your strategy today.
The European Commission has prepared a draft amendment to the microplastics restriction set out in Annex XVII of the REACH Regulation (entry 78). The proposal aims to clarify and adjust the scope of the SPM restriction which introduced the ban on placing synthetic polymer microparticles on the market.
The amendment addresses several technical and legal inconsistencies identified since the adoption of the restriction:
- Broader derogation for medicinal products
The exemption is expanded to include all medicinal products, including those used in clinical trials.
- New derogation for PPORD activities
The text introduces an explicit exemption for product and process-oriented research and development (PPORD), even when conducted outside industrial sites, such as in hospitals or academic laboratories.
- Refinement of the “solid matrix” exemption
The amendment clarifies that the exemption for microparticles permanently embedded in a solid matrix applies only when the intended end use lasts at least one year.
- Retroactive application
All corrections would apply retroactively from 17 October 2023, ensuring alignment with the Commission’s original intention and avoiding unintended non-compliance for operators.
Next discussion on this draft amendment project and a possible vote are scheduled for the December meeting of the REACH Committee.
Would you like to anticipate the impact of this amendment on your products or verify your compliance? Contact our REACH experts to secure your regulatory obligations and adjust your strategy today.
