Document 06N3KND0kRKeGr9LvoDGLmQdJ

Comments on proposed restriction for PFAS Japan Reagent Association is established for the purpose of safe manufacturing and distribution of reagents, and consists of more than 100 manufacturing companies and sales companies in Japan. Reagents are used in an extremely wide range of fields such as research and development, testing, inspection, and analysis, and are indispensable for the development of science and technology and safe society. PFAS is used in a wide range of applications due to its high chemical stability. In the reagent industry as well, PFAS is essential for manufacturing, storing, and distributing reagents. The PFAS restrictions proposed by the five European countries this time threaten the stable supply of reagents, and are considered to be excessive measures that hinder the development of science and the construction of a safe society. 1. Storage and distribution of reagents In general, reagent manufacturers need to supply hundreds of thousands of chemicals used for various purposes in various fields such as chemistry, biology, and materials. Fluororesins are widely used in reagent storage containers, and the PFAS regulations will affect the supply of containers. If PFAS are to be widely regulated, it will be necessary to search for alternative materials that are chemically resistant to a wide variety of reagents as storage containers. This imposes an extremely heavy burden on reagent manufacturers. In addition, reagents are sometimes stored in the same container for a long period of time, and it takes a huge amount of time and effort to verify the absence of elution from alternative materials after longterm storage with a large number of reagents. Reagent manufacturers are often small companies, and few companies can use R&D funds to search for storage containers. Extensive regulation of PFAS, which is used to store chemicals, will destroy the structure of the reagent industry, whose top priority is the stable and safe supply of a wide range of chemicals, and may cause irreversible disruption on the chemical supply chain. 2. Reagent manufacturing One of the reasons that there are a number of reagents is that even products with the same chemical name are treated as products for different uses depending on the amount of residual substances and high purity. Reagent manufacturers commercialize reagents by purifying them, analyzing them for the amount of residues, and providing quality assurance in a form optimized for their intended use. Fluororesins are also used in various parts of the reagent manufacturing process, such as filters, tubes, and piping. As filters and tubes using Fluororesins become unusable, purification and analysis of chemicals will become difficult, and it is thought that some high-purity reagents will be impossible to supply. As mentioned above, reagents are used in various fields such as research and development. In particular, high-purity reagents are used in cutting-edge fields such as pharmaceuticals and semiconductors, so any interruption in the supply of high-purity reagents will have a significant impact on the development of pharmaceuticals and semiconductors. 3. We also agree with the FCJ and other comments that the proposed regulation has problems in consistency with the REACH regulation and the WTO/TBT Agreement.