On 27 September 2023, the European Union’s Official Journal (OJEU) published Regulation (EU) 2023/2055, introducing a new restriction on microplastics under Annex XVII to REACH regulation which will enter into force from 17 October 2023 with some exemptions and with transition period for some items.
The new restriction aims to reduce emission of intentional microplastics from the products. It covers all synthetic polymer particles below five millimeters that are organic, insoluble and resistant to degradation. The new restriction and some items have longer transition period.
The In Vitro Diagnostic devices under Regulation (EU) 2017/746 are excluded from this restriction but:
From 17 October 2026, the manufacturers shall provide instructions for use and disposal explaining to professional users and the general public how to prevent releases of synthetic polymer microparticles to the environment. From 2027, the manufacturers/suppliers shall submit a report to the Agency* by 31 May of each year containing information on the synthetic polymer microparticles (such as description of the end uses, identity of the polymers, quantity released to the environment ....)
The Medical devices under Regulation (EU) 2017/745 are not excluded but take the benefit of a transition period of 6 years considered as necessary for reformulation and transition to suitable alternatives. So, the application date is 17 October 2029.
Attached are the details of the Regulation (EU) 2023/2055 which impact IVDs and MDs
