Document Jw3OXVnZ8KQonxzqXeJ2ke9e

SANTE/2835 - Meeting Animalhealtheurope/SANTE D4 Meeting date and place Meeting held on 14/09/2023 10:00 Brussels (B232) Participating organisation(s) representative(s) AnimalhealthEurope Participant AnimalhealthEurope Participant AnimalhealthEurope Contact, Participant, Requester Main issues discussed Summary Restriction on Per- and polyfluoroalkyl substances (PFAS) Concerns raised by AnimalHealth Europe (AhE): The first draft of the ECHA advice has been leaked in Politico and seems to go in the right direction for the pharmaceutical industry considered that production of APIs for medicinal products is out of scope. However, indirect impact on the pharmaceutical industry is feared (manufacturing of bottles, tubes, stoppers, etc. containing PFAS is still in scope). Industry is willing to reduce the use of PFAS. However, packaging, etc. is part of the marketing authorisation and any replacement or change of packaging might be impactful and requires variations to be introduced and approved. The whole process to replace packaging takes time and add costs. SANTE D4 informed that DG SANTE is not the main actor at this stage and that it is important to provide ECHA with all relevant information for the scientific assessment. AhE informed the Commission that AhE, together with EFPIA, have submitted in May 2023 a position paper with all relevant information in view of an early drafting of the advice. The leaked advice indicated some missing information and AhE is going to submit additional information before the end of the public consultation period in order to provide the information which ECHA identified as missing. - out of scope - - out of scope - Directorate or unit SANTE.D.4 Internal participants Author(s) of minutes SANTE D/4 ( ) SANTE D/4 ( Validator and validation date @ec.europa.eu Participant @ec.europa.eu) Notetaker, Participant