The European Chemicals Agency (ECHA) has recommended removal of the medical device exemption from REACH Authorisation for four phthalates, including DEHP. The dossier is now with the European Commission, which will take the final decision together with the EU Parliament and the Council.
The four substances BBP, DBP, DIBP and DEHP were identified as substances of very high concern (SVHCs) due to endocrine disrupting properties with effects on human health. DEHP was also identified for its effects on the environment. They had earlier been identified as SVHCs and subsequently added to the Authorisation List in due to their classification as toxic for reproduction.
A public consultation on the draft amendment recommendation was held between December 2018 and March 2019. ECHA took into account the comments and the Member States Committee’s opinion when finalising the recommendation. Latest application and sunset dates were recommended for hitherto exempted uses.
The actual amendment of the entries including the final decision on the dates, by which companies will need to apply for authorisation to ECHA and on exemptions of uses, will be made by the European Commission in collaboration with the Member States and the European Parliament.