Last fall, the European Chemicals Agency (ECHA) won a decisive judgement at the European Court of Justice. This judgement allows the ECHA to classify silicone oligomers, specifically D4, D5, and D6 siloxanes, as Persistent Bioaccumulative and Toxic substances (PBT), Very Persistent and Very Bioaccumulative substances (vPvB), and as suspected to be toxic to human reproduction.
On 16 May 2024, the European Commission approved the new silicone regulations under REACH. Therefore, if you use silicone in the medical devices you produce, you need to be aware that they are now subject to scrutiny by the ECHA and classified as harmful.
Silicone oligomers are an unavoidable result of silicone production processes and must be accounted for before any medical device containing silicone can be approved for sale in the EU.
At SAXOCON, we have the expertise to properly risk-assess the silicone in your products to determine if it meets these new requirements. This new regulatory regime has far-reaching consequences for new and existing products. Contact us to find out how we can help you determine the compliance of your silicone products.
We have several services to help risk assess your products, including:
Materials screening and selection
Surface characterisation
Device-drug safety