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),...
Do you use silicone in the medical devices you produce? If so, you need to be aware that the European Chemicals Agency (ECHA) can now classify silicone oligomers, specifically D4, D5, and D6 siloxanes, as Persistent Bioaccumulative and Toxic substances (PBT), Very...
The European Chemical Agency (ECHA) is launching a project to check the compliance of products sold online with REACH and CLP requirements. Currently, chemical products sold online are largely non-compliant. Starting in 2025, ECHA inspectors will check products sold...
We are on the verge to merge. Things in the regulatory space for medical device manufacturers are about to get easier. In a new proposal on Quality System Regulation Amendments for Medical Devices, The FDA has decided to harmonize their GMP requirement for medical...
A recent report by the ECHA found that over half the products sold online in the EU were non-compliant with one or more EU requirements with regard to chemicals. These findings resulted in more than 5000 enforcement actions by national authorities. As a product...
The substances of very high concern (SVHC) candidate list is constantly changing. In a recent update, eight new substances, widely used in consumer products such as cosmetics, scented articles, rubber, and textiles, were added to the candidate list for restriction in...
