With the Regulation (EU) 2023/2055 of 25 September 2023 amending Annex XVII of Regulation (EC) No. 1907/2006, the European Commission has imposed stringent restrictions on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) concerning synthetic polymer microparticles, which are non-degradable and potentially harmful to the environment and possibly to human health. These polymers are widespread in the environment and have also been found in drinking water and food, contributing to microplastic pollution.
The regulation aims to limit the use of intentionally added microplastics with different technical functions in various products for everyday use, involving many sectors, including Medical Devices.
The restriction uses a broad definition of microplastics that covers all those synthetic polymer particles of 5 millimetres or less that are organic, insoluble and resist degradation.
By adding a specific entry to Annex XVII of Regulation (EC) No. 1907/2006, Regulation (EU) 2023/2055 stipulates that synthetic polymer microparticles (substances as such or present to impart a sought-after characteristic) may not be placed on the market in mixtures in a concentration of 0.01% or more by weight. The limit of 0.01 % corresponds to the lowest reported concentration level when microparticles of synthetic polymers could still affect the function of a product.
This limitation will also apply to Medical Devices that fall within the scope of Regulation (EU) 2017/745 as of October 17, 2029 (end of the transition period), unless the devices include microspheres, for which there is no transition period.
The 0.01% weight limitation does not apply to the placing on the market of in vitro diagnostic devices and does not apply to the placing on the market of the following synthetic polymer microparticles:
- contained by technical means to avoid releases into the environment when used by the instructions for use during the intended end use;
- whose physical properties are permanently changed during the intended end use in such a way that the polymer no longer falls within the scope of the 0.01 % by weight prohibition;
- permanently embedded in a solid matrix during the intended end use.
Polymers resulting from a polymerisation process occurring in nature are also excluded from the restrictions of the Regulation, i.e. when they are substances that have not been chemically modified, regardless of the process by which the polymers were extracted.
>>>> With its Quality and Regulatory consulting services for the medical industry Thema can provide support in product evaluation starting from the design concept, through the drafting of technical documentation and in the collection of data for the demonstration of general safety and performance requirements following European regulations.
Source:
MDR (UE) 2017/745
