2026年6月2日，欧盟委员会发布（EU）2026/1168条例，修订REACH法规（EC）No 1907/2006附件XVII中关于合成聚合物微粒的第78项限制条款。主要包括：

（1）修订第4b条，将用于临床试验及相关临床前安全评价的人用、兽用药品纳入豁免范畴；

（2）新增第4g条，允许年度使用量不超过1吨的合成聚合物微粒用于产品与工艺研发，不受工业场所限制；

（3）修订第5c条，仅预计长期使用（≥1 年）且永久嵌入固体基质的合成聚合物微粒，方可适用该豁免。

 

On 2 June 2026, the European Commission issued Regulation (EU) 2026/1168, which amends Restriction 78 on synthetic polymer microparticles set out in Annex XVII to REACH Regulation (EC) No 1907/2006. The key revisions are as follows: (1) Amendment to 4b: Extends the exemption to human and veterinary medicinal products used in clinical trials and associated pre-clinical safety assessments. (2) New 4g: Introduces an exemption for synthetic polymer microparticles used for product and process research and development, with an annual usage cap of 1 tonne, irrespective of whether the R&D activities take place on industrial premises. (3) Amendment to 5c: Restricts the eligibility of the relevant exemption to synthetic polymer microparticles that are intended for long-term use (≥ 1 year) and permanently embedded within a solid matrix.