Document 1gp76XQVRk9OGnKpODYgxve4d

efsa European Food Safety Authority LEGAL AFFAIRS SERVICES Parma, 7 December 2022 Ref. LV/CP/AS/mm (2022) - out-28333665 Stephane Horel Le Monde 67-69 Avenue Pierre Mendes FR- 75013 Paris France E-mail: =Plennonde.fr Re.: Your application for public access to documents of 15 September 2022 Our ref. PAD 2022/132 Dear Ms Horel, I refer to your application of 15 September 2022, registered at EFSA as PAD 2022/132, by means of which you requested access to: "1) Dossier AR-09-0336/SIT-schm. Dated: March 2007. Submitted by Solvay Solexis, Italy as referred to in EFSA Panel on food contact materials, enzymes, flavourings and processing aids (CEF); Scientific Opinion on the safety evaluation of the substance perfluoro acetic acid, a-substituted with the copolymer ofperfluoro-1,2- propylene glycol and perfluoro-1,1-ethylene glycol, terminated with chlorohexafluoropropyloxy groups, CAS No. 329238- 24-6 for use in food contact materials. EFSA Journal 2010; 8(2):1519. [11 pp.]. doi:10.2903/j.efsa.2010.1519" (EFSA-Q-2007-068, "Dossier 1"). "2) Dossier on Perfluorofacetic acid, 2-[(5-methoxy-1,3-dioxolan-4-yl)oxy]}, ammonium salt. April 2013. Submitted on behalf of Solvay Solexis SpA. as referred to in EFSA CEF Panel (EFSA Panel on food contact materials, enzymes, flavourings and processing aids), 2014. Scientific Opinion on the safety assessment of the substance, Perfluorofacetic acid, 2-[(5-methoxy-1,3-dioxolan-4- yl)oxy])-, ammonium salt, CAS No 1190931-27-1, for use in food contact materials. EFSA Journal 2014;12(6):3718, 9 pp. doi:10.2903/j.efsa.2014.3718."(EFSA-Q-2013-00363, "Dossier 2"). By EFSA's disclosure letter of 28 October 2022 (ref. 27236399), EFSA granted you access to Dossier 1) mentioned above. Following our fair solution letter of 23 November 2022 (ref. 27592839) you replied on 25 November 2022 asking for the list of documents in the scope of the second point of your request. By e-mail sent on 29 November 2022 EFSA granted you access to the list of documents requested. Following the abovementioned exchanges, we are pleased to provide you with a second batch and final reply in relation to Dossier 2) as detailed here below. Partial disclosure of Dossier 2 (second batch) After having consulted the food business operator which submitted the food contact materials application dossier on the substance perfluoro{acetic acid, 2-[(5-methoxy-1,3-dioxolan-4-yl)oxy]}, ammonium salt, CAS No 1190931-27-1, (FCM substance No 1045) under Regulation (EC) 1935/2004, in accordance with Article 4(4) of the Regulation 1049/2001 on public access to documents (the "PAD Regulation"), we are pleased to grant you partial access to the non-confidential version of Dossier 2) mentioned above in your query. European Food Safety Authority Via Carlo Magno 1A - 43126 Parma, Italy Tel. www.efsa.europa.eu Kindly note that personal data1 present in the requested dossier (i.e. names, contact details as well as information allowing the identification of data subjects) have been masked in accordance with Article 4(1)(b) of the PAD Regulation. This provision provides that EU bodies shall refuse access to information where the disclosure would undermine the protection of the "privacy and the integrity of the individual, in particular in accordance with Community legislation regarding the protection of personal data". In accordance with settled case law of the Court of Justice of the European Union (CJEU), this exception to disclosure is to be interpreted as a reference to Regulation (EC) No 45/2001 - now repealed by Regulation (EU) 2018/1725 (hereinafter "the EUDPR") - which becomes applicable in its entirety. Regarding the transmissions of personal data, Article 9(1)(b) of the EUDPR provides that "personal data shall only be transmitted to recipients established in the Union (...) if the recipient establishes that it is necessary to have the data transmitted for a specific purpose in the public interest". In application of this provision, further clarified in the case law of the CJEU, EFSA shall determine whether there is any reason to assume that a transmission of the personal data might prejudice the legitimate interests of the concerned individuals and to balance the different interests at stake, based on any express and legitimate justification and convincing arguments you may be able to provide in order to demonstrate that it is necessary for you to receive these data for a specific purpose in the public interest within the meaning of the aforementioned provision. Hence, in the event that you are interested in receiving the personal data, EFSA invites you to submit to us your arguments as to why you consider it necessary to receive these data in accordance with Article 9(1)(b) of the EUDPR. We should point out that personal data contained in these documents were redacted manually, therefore EFSA cannot fully exclude the possibility that certain personal data are inadvertently disclosed to you. Should this be the case, we urge you to treat any such residual personal data with the utmost discretion in order to avoid undermining the privacy and integrity of the individual(s) concerned. We shall remind you about your responsibilities under the EUDPR in case of any further processing by you of any personal data inadvertently disclosed to you. We hope you find the disclosed information useful. I must remind you that, in line with Article 16 of the PAD Regulation, all persons reproducing, redistributing, exploiting or making commercial use of this information are expected to adhere to the terms and conditions asserted by any holder of copyright. 2. Procedure of transmission of data via One Drive The data will be shared with you via Microsoft OneDrive. The invitation to the shared folder will follow by means of a separate e-mail providing you with a link to the folder containing the data. When you open the link to that folder, you will receive an e-mail with a Verification Code in order access the shared content. Please note that the e-mail with the Verification Code may be received your Spam folder. For further guidance, please find here some practical explanations on how to access shared folders via Microsoft OneDrive. 3. Confirmatory application To exercise your right to appeal against this decision by a confirmatory application, you may write to EFSA at the address below. You have fifteen working days from receipt of this letter to appeal. In case you submit a confirmatory application, EFSA will inform you of the outcome of this re-examination of your request within fifteen working days of receipt, either by granting you access to the documents or by confirming the refusal. In the latter case, you will also be informed of any further appeal routes available. 1 Article 3(1) of Regulation (EU) 2018/1725: "`personal data' means any information relating to an identified or identifiable natural person (`data subject'); an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, identification number, location data, an online identifier or to one or more factors specific to physical, physiological, genetic, mental, economic, cultural or social identity of that natural person". 2 Confirmatory applications must be sent to: Introduce a new application in Connect.EFSA Portal mentioning the reference to your initial application in relation to which you would like an administrative review of the initial decision, or Via e-mail to: EFSA Dirk Detken Head of Legal and Affairs Services Via Carlo Magno 1/A IT - 43126 Parma Italy E-mail: efsa.europa.eu Should you require any information or clarification regarding the processing of your request in the meantime, please do not hesitate to contact us by writing to the following functional mail -box: Oefsa.europa.eu. Yours sincerely, Luisa Venier Digitally signed by: Luisa Venier DN: CN = Luisa Venier email = efsa.europe.eu C = IT O = EFSA OU = Legal Affairs Services Date: 2022.12.07 19:10:51 01'00' Luisa Venier Team Leader of Legal Processes Team EFSA Public Access to Documents Cc: Encl.: V. Curtui (EFSA FCM dossier - EFSA-Q-2013-00363 (via One Drive) 3