(fra kommisjonsforordningen)

(1) Commission Regulation (EU) 2023/20552 amends Annex XVII to Regulation (EC) No 1907/2006 by adding entry 78 which restricts the placing on the market of synthetic polymer microparticles. Pursuant to paragraphs 4, 5 and 16 of that entry, the prohibition of the placing on the market does not apply to synthetic polymer microparticles (i) for use at industrial sites, in certain products or subject to certain conditions during intended end use, or (ii) placed on the market before 17 October 2023. For most products containing synthetic polymer microparticles derogated from the prohibition of the placing on the market, entry 78 lays down information, labelling and reporting requirements aiming to minimise and monitor emissions of synthetic polymer microparticles. Entry 78 also provides that the prohibition of placing on the market of synthetic polymer microparticles in certain products is deferred by 4 to 12 years, depending on the product. 

(2) Pursuant to paragraph 4, point (b), of entry 78 of Annex XVII to Regulation (EC) No 1907/2006, the restriction of the placing on the market does not apply to synthetic polymer microparticles in medicinal products within the scope of Directive 2001/83/EC of the European Parliament and of the Council3 and veterinary medicinal products within the scope of Regulation (EU) 2019/6 of the European Parliament and of the Council4 . The current wording of that derogation does not reflect the original intention of the Commission and the Member States in the REACH Committee, which was to include the placing on the market of all medicinal products for human and veterinary use in the scope of the derogation. Contrary to the original intention, the derogation does not cover any medicinal product used in clinical trials or in preclinical safety testing preparatory to those trials, such as analytical, physical, toxicological, stability and batch-release testing. Paragraph 4, point (b), of entry 78 of Annex XVII to Regulation (EC) No 1907/2006 should therefore be amended to include all medicinal products used in clinical trials and related pre-clinical safety testing in the scope of the derogation. 

(3) It was the intention of the Commission and the Member States in the REACH Committee to exempt the placing on the market of synthetic polymer microparticles for use in product and process-oriented research and development (‘PPORD’), as defined in Article 3(22) of Regulation (EC) No 1907/2006, in quantities of one tonne per year or less. However, an explicit derogation for PPORD uses was not included in entry 78 of Annex XVII to that Regulation because it was assumed that PPORD would systematically take place at industrial sites and therefore the placing on the market of synthetic polymer microparticles used for PPORD would be covered by the derogation under paragraph 4, point (a), of that entry. Recent experience from the practical implementation of the restriction has shown that PPORD may also take place outside of industrial sites, for example in hospitals and universities. Since the derogation in paragraph 4, point (a), of entry 78 does not apply in those cases, paragraph 4 of that entry should be amended to include a new derogation for the placing on the market of synthetic polymer microparticles used in PPORD that also applies when PPORD takes place outside of industrial sites. 

(4) Paragraph 5, point (c), of entry 78 of Annex XVII to Regulation (EC) No 1907/2006 provides a derogation from the prohibition on the placing on the market of synthetic polymer microparticles where the risk from releases is expected to be minimised because those microparticles are permanently enclosed in a solid matrix during end use. This derogation was not meant to apply to intended end uses of short duration, where the solid matrix is frequently removed or replaced, so that the incorporation of the synthetic polymer microparticles in the solid matrix is short-lived, because this would be contrary to the objective of emission minimisation. Paragraph 5, point (c), of that entry should therefore be amended to clarify that it only covers cases where the end use is foreseen to last for one year or longer. The application of the amendment to paragraph 5, point (c) of the entry should be deferred by two years from the entry into force of this Regulation to allow stakeholders sufficient time to take appropriate measures, such as reformulating products and disposing of existing stocks, to comply with the modified derogation. 

(5) During the process leading to the adoption of Regulation (EU) 2023/2055, Member States and stakeholders were informed of the intention to provide a derogation from the prohibition on the placing on the market for synthetic polymer microparticles (i) in all medicinal products for human and veterinary use, which includes those used in clinical trials and related pre-clinical safety testing and (ii) for PPORD, irrespective of the place where the PPORD takes place. However, the placing on the market of synthetic polymer microparticles for those uses is not completely covered by the wording of the derogations provided for in entry 78 of Annex XVII to Regulation (EC) No 1907/2006. Therefore, such placing on the market would constitute noncompliance with the restriction introduced by that entry, which was not the intention of the restriction. It is necessary that the two corresponding amendments of Annex XVII to that Regulation should exceptionally have retroactive application as from 17 October 2023, when Regulation (EU) 2023/2055 entered into force, to ensure the application of the scope of the restriction as intended, to facilitate its enforcement and to protect the legitimate interests of economic operators who may have relied upon the intention that was communicated in the adoption process. 

(6) Regulation (EC) No 1907/2006 should therefore be amended accordingly. 

(7) The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 133 of Regulation (EC) No 1907/2006,