The European Commission clarifies the restriction for medicinal products, R&D and certain solid matrix uses
The European Commission has adopted a correcting regulation amending Entry 78 of Annex XVII to the REACH Regulation related to the restriction on synthetic polymer microparticles (SPM).
The amendment aims to correct legal ambiguities identified during its practical implementation, in order to align the wording of the law with the original legislative intent.
Since the entry into force of the restriction on 17 October 2023, a number of operators have faced unexpected compliance risks, particularly in the pharmaceutical and research sectors. The Commission now explicitly acknowledges that these situations were not intended and introduces targeted clarifications to address them.
The first clarification concerns human and veterinary medicinal products. The existing derogation is expanded to explicitly cover all medicinal products, including those used in clinical trials and in pre-clinical testing activities, such as analytical, physical, toxicological, stability and batch release testing. This clarification is significant, as the initial wording of Entry 78 did not clearly encompass these essential stages of pharmaceutical development. To ensure legal certainty, this amendment applies retroactively from 17 October 2023.
The correcting regulation also introduces an important clarification for product and process-oriented research and development (PPORD) activities. While the original intention was to exempt PPORD uses below one tonne per year, the initial text implicitly assumed that such activities would take place exclusively at industrial sites. In practice, however, PPORD activities are frequently carried out in universities, hospitals, and public research laboratories. A new explicit derogation is therefore introduced to cover PPORD uses outside of industrial sites, thereby addressing a significant regulatory grey area.
Finally, the Commission clarifies the scope of the derogation applicable to synthetic polymer microparticles permanently incorporated into a solid matrix. This exemption is now limited to intended uses with a duration of at least one year. The objective is to prevent short duration uses, involving frequently removed or replaced matrices, from benefiting from a derogation that would undermine the goal of minimising microplastic emissions. To allow sufficient time for adaptation, this amendment will apply two years after the entry into force of the correcting regulation.
Overall, this amendment provides welcome legal certainty for several key sectors, while maintaining the environmental ambition of microplastics restriction. Companies concerned are nevertheless encouraged to review their compliance assessments, carefully document the applicability of relevant derogations, and ensure that information, labelling and reporting obligations under REACH remain fully implemented.
Do you want to anticipate the impact of this change on your products or check your compliance?
Contact our REACH experts to secure your regulatory obligations and adjust your strategy today.
The European Commission clarifies the restriction for medicinal products, R&D and certain solid matrix uses
The European Commission has adopted a correcting regulation amending Entry 78 of Annex XVII to the REACH Regulation related to the restriction on synthetic polymer microparticles (SPM).
The amendment aims to correct legal ambiguities identified during its practical implementation, in order to align the wording of the law with the original legislative intent.
Since the entry into force of the restriction on 17 October 2023, a number of operators have faced unexpected compliance risks, particularly in the pharmaceutical and research sectors. The Commission now explicitly acknowledges that these situations were not intended and introduces targeted clarifications to address them.
The first clarification concerns human and veterinary medicinal products. The existing derogation is expanded to explicitly cover all medicinal products, including those used in clinical trials and in pre-clinical testing activities, such as analytical, physical, toxicological, stability and batch release testing. This clarification is significant, as the initial wording of Entry 78 did not clearly encompass these essential stages of pharmaceutical development. To ensure legal certainty, this amendment applies retroactively from 17 October 2023.
The correcting regulation also introduces an important clarification for product and process-oriented research and development (PPORD) activities. While the original intention was to exempt PPORD uses below one tonne per year, the initial text implicitly assumed that such activities would take place exclusively at industrial sites. In practice, however, PPORD activities are frequently carried out in universities, hospitals, and public research laboratories. A new explicit derogation is therefore introduced to cover PPORD uses outside of industrial sites, thereby addressing a significant regulatory grey area.
Finally, the Commission clarifies the scope of the derogation applicable to synthetic polymer microparticles permanently incorporated into a solid matrix. This exemption is now limited to intended uses with a duration of at least one year. The objective is to prevent short duration uses, involving frequently removed or replaced matrices, from benefiting from a derogation that would undermine the goal of minimising microplastic emissions. To allow sufficient time for adaptation, this amendment will apply two years after the entry into force of the correcting regulation.
Overall, this amendment provides welcome legal certainty for several key sectors, while maintaining the environmental ambition of microplastics restriction. Companies concerned are nevertheless encouraged to review their compliance assessments, carefully document the applicability of relevant derogations, and ensure that information, labelling and reporting obligations under REACH remain fully implemented.
Do you want to anticipate the impact of this change on your products or check your compliance?
Contact our REACH experts to secure your regulatory obligations and adjust your strategy today.
