Document zo3n48N2YBzwdnx4e6E1ODkda

3rd submission - Comment on Proposed Restriction of PFAS Conference of Fluoro-Chemical Product Japan (FCJ) (Regarding the requirement to provide information in paragraph 7) In paragraph 7 of the proposed restriction, the information requirement for derogated applications in paragraph 5 and 6 states that article manufacturers and importers need to provide information related to the identification of substances placed on the market. To satisfy this requirement, the reporting entity needs to obtain relevant substances information from the upstream chemical substance manufacturers. To identify substances, it is anticipated that highly sensitive proprietary information on the type, function, and quantity of PFAS contained in the product may need to be disclosed by the chemical manufacturer through the supply chain. In such cases, the proposed restriction does not provide specific protection measures for such information, and we have the following concerns. As stipulated in paragraph 5 and 6 of the proposed restriction, given that PFAS is essential for products in critical areas such as semiconductors, energy, military, medical, transportation, and construction, national security and social infrastructure may be exposed to various risks if confidential information is not protected, and information related to specifications is shared through the supply chain. Without appropriate measures to protect the confidentiality of information, chemical manufacturers will be forced to disclose confidential information, putting them at a competitive disadvantage in the international marketplace. This could lead to chemical manufacturers choosing to avoid the European market, and as a result, citizens in Europe could lose access to derogated applications that are considered essential in our society. (The above concerns regarding the protection of confidential information are also an issue in complying with the requirements of paragraph 8.) To address such concerns, we request that the definition of information relevant to the identification of substances be clarified and that specific procedures for the protection of confidentiality be provided if such information is a trade secret. As a reference point, it is worth noting that in the United States, during the application process for the registration of a chemical substance under the Toxic Substances Control Act Premanufacture Notice (TSCAPMN), chemical structures can be designated as confidential and reported to regulatory authorities using a designated code (referred to as an Accession Number) that represents the structure. This procedure effectively ensures the preservation of information confidentiality. In addition, we seek clarity regarding the legal framework and mechanisms that will be invoked to address unintentional information leaks to external parties once the requisite submissions have been made in accordance with the requirements.