Document MM8LNEwMna9DBmrRNJOjX1QRL

- Ref. Ares(2022)374440- 18/01/2022 From: Sent: To: Cc: Subject: -- (GROW) lundi 17 janvier 2022 12:51 __ ;....;--(GROW); (GROW); (GROW); GROW Fl; RE: PFAS - urgent request for a meeting Follow Up Flag: Flag Status: Follow up Comp leted Dear .... , Thank you for sharing with us your concerns about PFAS and your interest in the development of the essential use criteria. We are interested in having a meeting with you to discuss it further. We would be available for a one hour meeting on either 7/02 in the morning or 8/02 in the afternoon. Please send us a webex invitation if those dates are convenient. Participants from our side:__, an We will forward your inv itation to our colleagues in DG ENV in case they would like to join us. Best, From: @animalhealtheurope.eu> Sent: Sunday, January 16, 2022 6:48 PM @ec.europa.e u>; GROW -- @ec.europa.eu > Subject: PFAS - urgent request for a meeting . . , @animalhealtheurope.eu>; (GROW) Dear Referring to the suggestion of issue of PFAS. , I would like to reach out to you concerning the AnimalhealthEurope is the association representing manufacturers of animal medicines, vaccines and other animal health products in Europe. We are a Brussels-based not-for-profit body representing both corporate members and national animal health associations in Europe. It represents both innovators and generics alike, as well as large, medium-sized and small companies. AnimalhealthEurope's membership covers 90% of the European market for animal health products. As you may know, some veterinary medicinal products (VMPs), after having been approved by the EMA contain PFAS. However, as a result of the REACH Regulation (Reg 1907/2006) various initiatives are already impacting VMPs either during their manufacture or in their composition, and are in direct conflict with the rules in Reg 2019/6 (Veterinary Medicinal Products Regulation entry into force on 28 January 2022. For example the recently launched proposal for restriction of per and polyfluoro alkyl substances (PFAS) which, given its broad definition of PFAS, threatens a ban on specific VMPs or renders their manufacture impossible as there are no alternatives. E.g. this could eliminate all inhalation anaesthetics currently used in both human and veterinary medicine, and it could cause significant treatment gaps in other areas with implications for animal health but also for public health as some of the conditions that are treated by these medicines (e.g. fleas and ticks, and the diseases they carry) can impact human health if the animals are left insufficiently treated, or even untreated. We would very much value to discuss with you at DG Grow the particularity of our sector and products, exchange on what the definition of "essential use " could entail, be consulted by the consulting firm Wood the Commission is working with and be informed/involved in relevant workshops on the topic. I hope to have an opportunity to discuss these elements with you in a very near future. For information I have also reached out to two of your colleagues in DG Grow but do not know if you work in the same unit or not, these are and both in copy of this mail. Best regards, Animal healthEurope a. i.s.b.l. Avenue de Tervueren 168, box 8 11 SO Brussels, Belgium T : +32 Transparency Register: 63322037415-37 M :+3 2 -@animalhealtheurope.e u Follow @animalhe althEU on Twitter! Like us on Facebook: www.facebook.com/animalhealthEU Follow us on Linkedln : https://www.linkedin.com/company/animalhealtheurope/ Visit our website : www.animalhealtheurope.eu Notice: This e-mail message, together with any attachments, conta ins information that may b e confidential or privileged. It is intended solely for the individual o r entity named on this message. Should you have received it in error, please notify us immediately by reply e-mail and delete it from your system. We comply with the EU General Data Protection Regulat ion (GOPR). All personal data that we gain from personal contacts, mailings and the website are structurally recorded and used in line with the regulation. Please check our privacy policy lli!!!i) for more information.