Document 475J7Q81YoG6nqOkpBq2K4VQ

General comments regarding the specific information request on PFAS Annex XV Consultation from 22.03.2023 to 25.09.2023 Proposed solution: Add general exemption in option 2, column 2, bullet point 4: By way of derogation, paragraphs 1 and 2 shall not apply to the use of thermoplastic fluoropolymers and elastomers in articles within the scope of Directive 2012/19/EU (WEEE Directive). I. Consider the impact of PFAS restrictions that are already in force: From our point of view, the impact of already enacted restrictions of PFOS, PFOA or the most recent activities on PFHxA have not been taken into account sufficiently. Very likely, a large part of the necessary measures to reduce emissions have already been enacted, are currently being implemented and have yet to be evaluated. It should be monitored to which extent recently set maximum levels of PFOS, PFOA and PFHxS are effective and already reduce the PFAS entry into the environment. II. Consider that hazardous substances can be used without risk: The description does not take into account the possibility that hazardous substances can be used without risk. The proposal assumes that all PFAS are released into the environment. This blanket assumption is inappropriate. There is no information that hints to widespread emissions due to, e.g. WEEE treatment, shortcomings. Furthermore, the concentration of a substance in an article alone is not a sufficient measure of the risk of emission of that substance into the environment. It is paramount to consider the conditions of use in order to allow for such an assessment. III. Analysis of components only is insufficient for statements regarding the socioeconomic impact on complex articles: The restriction proposal has essentially focused mainly on the production of PFAS or components e.g., electronic components. The extensive use of these components in, for example, complex electronic devices have, in our view, been insufficiently addressed regarding the following aspects: a. The use in WEEE products, i.e. complex products instead of single components, come with a sophisticated regime for all stages of their lives, particularly in the waste phase. Therefore, analyses of potential emissions and attached risks and costs would have to be undertaken with these specific conditions in mind. b. Some of the components under consideration are spare parts. However, spare parts have to be assessed under specific conditions because they keep already existing products running and therefore reduce the risks related to potential replacements, i.e. additional products. c. Some exceptions are limited to a few special cases, e.g., medical devices. However, the definitions exclude products from this area that are needed for disinfection and sterilization. The exceptions are, thus, not sufficiently applicable. Excepting WEEE devices in the proposed way (see above) would solve this issue. 08.09.2023 PFAS Page 1 mds00802-01.dotm https://miele365-my.sharepoint.com/personal/bernd_rohde_miele_com/Documents/Dokumente/PFAS_PFOA_PFOS/PFAS/EU/Miele Umsetzung/Konsultation Mrz bis Sept 2023/Working Documents/General comments Miele 08092023_EN_FF.docxhttps://miele365-my.sharepoint.com/personal/bernd_rohde_miele_com/Documents/Dokumente/PFAS_PFOA_PFOS/PFAS/EU/Miele Umsetzung/Konsultation Mrz bis Sept 2023/Working Documents/General comments Miele 05092023_EN.docx