Document mZdmGe68B7jem6o7zbqazV0k

From: Sent: To: Cc: Subject: Selma Abdel-Qader< @fieldfisher.com> den 24 januari 2022 09:23 Jenny lvarsson; kemi Claudio Mereu; lacopoZonca Scope of the upcoming PFAS restriction [FFW-DOCS.FID6618317] Follow Up Flag: Flag Status: Folj upp Flagged Dear Ms. Ivarsson, We write you on behalf of one of our clients in the context of the preparation of the REACH Annex XV dossier for PFAS substances. By way of background, our client is a well-known multinational company active in the health care sector. In particular, our client manufactures endoscopy and x-ray diagnostic medical devices as well as contrast media and injectors. For years, our client has been investing substantial resources in research, pre-clinical and clinical development of contrast agents for in vivo imaging. These contrast agents are used with special equipment to provide physicians with detailed information for diagnoses and to monitor minimally invasive operating procedures. Technological advances in equipment, combined with contrast agents, permit a very high level of diagnostic accuracy and procedure monitoring for most pathologies. As part of its research programme, our client is developing a new ultrasound contrast agent whose active ingredient is perfluorobutane (C4F10). The development of ultrasound contrast agents is the result of ten years of intense research as well as significant investments in research and development. Ultrasound contrast agents consist of the formation of microbubbles composed of inert gas, stabilized by means of an envelope of lipids or protein. These gas microbubbles are then administered to patients, mainly intravenously, and are then detected in the body using an ultrasound machine. The choice to use perfluorobutane (C4F10), one of the active ingredients being developed for use in a new ultrasound contrast agent, stems from the need to meet strict safety requirements. The selected gas must: Confer stability to the contrast agent allowing it to persist for the duration of the imaging examination (ideally 10-20 min, this by resisting passage through the heart and the capillary network of the lungs); Be physiologically inert and safe in clinical use for the patient; Be echogenic in order to allow an acoustic response and thus its detection by means of the ultrasound device. C4F10 has all these properties and is an ideal gas for new ultrasound contrast agents. However, this active ingredient falls under the scope of the current restriction proposal being elaborated by Sweden, Germany, Denmark, the Netherlands and Norway. On the basis of the two calls for evidence carried out in 2020 and 2022, we understand that PFAS substances used in medicinal products might fall under the scope of the restriction proposal as well. Within this context, we would like to kindly ask you whether Sweden, Germany, Denmark, the Netherlands and Norway are considering to extend the upcoming PFAS restriction to the use of these substances in medicinal products or whether they are considering possible exemptions in connection with this essential use. As we understand that the REACH competent authorities of Sweden, Germany, Denmark, the Netherlands and Norway are currently developing the Annex XV dossier, which is expected to be