Document zz9Vv8gnJVRgD18KVo5EGQD27

SEAJ as of September 12th, 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan September 12th, 2023 The general comment to the Restriction report on Per- and polyfluoroalkyl substances (PFAS) We, SEAJ, would like to express the gratitude of having the opportunity of stating our opinion to the general comment to the Restriction report on Per- and polyfluoroalkyl substances (PFAS). https://echa.europa.eu/restrictions-under-consideration/-/substance-rev/72301/term EU Commissions, ECHA and the industries not only in the EU but also outside the EU have made a great effort to reduce the hazardous substances over 15 years. We also would like to express deep respect to the efforts. The contact person of this comment: Name: Toshio Sato Organisation: Semiconductor Equipment Association of Japan Email: @seaj.or.jp 0 Introduction 0.1 Agree with the purpose of EU REACH Regulation The REACH Regulation has been carrying out the great role of contributing to human health by reducing the exposure risk to hazardous substances. This Regulation with foresight has been expanding globally due to the advantages and benefits to the Society. We fully understand the importance of the REACH Regulation which shall be respected and has been contributed to the REACH through our technologies. We also have highlighted the contribution to the safety, human health, and the environment through electric and electronic equipment. 0.2 Reasons for Submission of comments If the current proposed restrictions would be applied, we will not be able to put our products on the EU market. As described in Sections 1.1 and 1.2, our products support the social infrastructure of SEAJ as of September 12th, 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan the EU and have a "critical" aspect that differs from general consumer products. Numerous alternative materials have been reported for PFASs that are being restricted, but unfortunately none are applicable for our product applications. As we have shown in some cases in section 1.2.2, if our products cannot be put on the EU market at all, it could have a significant negative impact on the environment and human health in the EU. In order to continue to achieve the protection of the environment and human health that EU REACH aims to achieve, we would like to submit this opinion in the hope that the content of this opinion will be considered. 1 Products handled by this organization 1.1 What are our organization & Examples of products manufactured by its member companies Examples of products manufactured by SEAJ member companies: Mask/reticle manufacturing equipment, Wafer processing equipment, etc. For specific details, see Section IV "The survey result for the usage of PFAS in semiconductor manufacturing related equipment". "Semiconductor manufacturing related equipment" should also be included in the definition of "semiconductor process" when considering transition and substitution periods. "Semiconductor manufacturing related equipment" is also an essential component of the semiconductor process, and the "semiconductor process" cannot be established without "semiconductor manufacturing related equipment". The derogation period, etc., needs to be considered for the "semiconductor industry" as a whole, which includes "semiconductor processes" and "semiconductor manufacturing related equipment". See also the opinion of SEMI Europe GmbH, "Consequences of partial or no derogation outcome". (Part13-4304) 1.2 Features of our products 1.2.1 Our products are "Specialist equipment" As described in Section 1.1, our products are highly specialized instruments used in laboratories, Research and Development, industrial sites, Universities, and SEAJ as of September 12th, 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan academic institutions. Therefore, the user must undergo special training and education in order to use it safely and correctly. In this opinion we will refer to our product as "EEE specialist equipment" to distinguish it from general consumer products. Semiconductor manufacturing related equipment is installed in factory/laboratory clean rooms. As people are required to wear protective clothing, gloves, goggles, and other protective gear when in such rooms, there is almost no possibility of their bodies coming into direct contact with the equipment. The risk of exposure is very low. See also the opinion of SEMI Europe GmbH. (part13-4304) 1.2.2 Critical for social infrastructure We would like to emphasize strongly that EEE specialist equipment we manufacture plays a very important role in the social infrastructure. Below are some examples. We believe that you can understand that the nature is different from the product of "nice to have". < Case SEAJ1: Mask/reticle manufacturing equipment> Mask/reticle manufacturing equipment is used in the semiconductor manufacturing process to produce masks and reticles. High-resolution patterning and precise placement are important, which directly affects the performance and quality of semiconductor devices. Without the relevant equipment, it would be no longer possible to manufacture semiconductor devices themselves. < Case SEAJ2: Wafer processing equipment> Wafer processing equipment, with functionalities such as light exposure, mask alignment and photoresist development for creating circuit patterns on a semiconductor chip, is used in the semiconductor manufacturing process. Highresolution patterning and precise placement are important, which directly affects the performance and quality of semiconductor devices. Without the relevant equipment, it would be no longer possible to manufacture semiconductor devices themselves. See also the opinion of SEMI Europe GmbH. (part13-4304) SEAJ as of September 12th, 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan 1.2.3 Low volume of production, long-life, long supply chain The EEE specialist equipment is made in small numbers, is produced for long periods without modification or changes, and is a long-life product. The instruments would have been replaced typically at least after 10-20 years or more from the release of the products.1 The supply chains are very long and take time to eliminate restricted substances from the supply chain. Table 1 Table comparison of industrial test equipment with mobile phones2 Table 5-4 Amount of EEE (tons) put on the EU market, per year and product category, "Support for the Evaluation of Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment Final Report" shows the percentage of category 8 and 9 products is only 3.5 of all amount of electric and electronic equipment(EEE) (tons) put on the EU market (see the below).3 1 Dr Paul Goodman, Review of Directive 2002/95/EC (RoHS) Categories 8 and 9 - Final Report, ERA Technology, 2006 Page 27-34 https://ec.europa.eu/environment/pdf/waste/weee/era_study_final_report.pdf 2 Dr Paul Goodman, Review of Directive 2002/95/EC (RoHS) Categories 8 and 9 Final Report, ERA Technology, 2006 Page 34 Table 2 https://ec.europa.eu/environment/pdf/waste/weee/era_study_final_report.pdf 3 Table 5-4 Amount of EEE (tons) put on the EU market, per year and product category, Support for the Evaluation of Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment Final Report, p.147 https://op.europa.eu/en/publication-detail/-/publication/5b807311-9d93-11eb-b85c01aa75ed71a1/language-en SEAJ as of September 12th, 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan The picture is produced from Table 5-4 Amount of EEE (tons) put on the EU market, per year and product category, Support for the Evaluation of Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment Final Report, p.147 https://op.europa.eu/en/publication-detail/-/publication/5b807311-9d93-11ebb85c-01aa75ed71a1/language-en 1.2.4 Spare (Repair) parts are necessary Spare parts are necessary to guarantee the expected lifetime (more than 20 years) of EEE specialist equipment. Especially since EEE specialist equipment requires high performance and high reliability, we would like to emphasize that the same spare parts are required throughout the life of the product as when it was first evaluated. Without spare parts, waste minimization according to the principles of "Right to repair" and "Repair as produced" cannot be achieved. 1.2.5 Long development cycle Our products are required to be highly reliable because they are manufactured for a long period of time without modification. Along with this, long-term reliability tests are required. If there is a certification request, a longer period is required to obtain it. As a result, development cycles are longer compared to other consumer products. An example of development process is below: - Searching of parts and materials: 1-2 years - Reliability test: performance test of the product: 1-2 years - Device design: 0.5-1 year - Develop the production line /buy new production equipment: 1-2 years - Create Technical Documentation: 0.5 year SEAJ as of September 12th, 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan - Training at the production site: a few months - Production management (information to customers): 0.5-1 year - Third-party certification: 1 year without clinical trial a few years or more with clinical trial or customer approvals 1.3 Current status of PFAS applications and alternative technologies Current status of PFAS applications and alternative technologies are described in Specific Information, Question 7. See Question 7 and the Annex. 2 Suggestions and requests from us 2.1 The long grace period and extension are required If the alternatives are become available in the future, a long grace period is required until PFAS become restricted The instruments are made in small numbers, are produced for long periods without modification or changes, have to be reliable and need long term test for reliability. The instruments would have been replaced typically after 10-20 years or more from the release of the products. 4 The supply chains are very long and take time to eliminated restricted substances from the supply chain. If the electric and electronic equipment mentioned above cannot use PFAS anymore and PFASs are to be substituted, the long grace period is required in order to test the 4 Dr Paul Goodman, Review of Directive 2002/95/EC (RoHS) Categories 8 and 9 - Final Report, ERA Technology, 2006 Page 27-34 https://ec.europa.eu/environment/pdf/waste/weee/era_study_final_report.pdf SEAJ as of September 12th, 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan product to comply with the safety requirements defined with IEC and other safety standards, and obtain the re-certificates according to the requirements. An example of substitution process is below: - Testing of alternative materials: 1-2 years - Reliability test: performance test of the product: 1-2 years - Device design change: 0.5-1 year - Change the production line /buy new production equipment: 1-2 years - Create Technical Documentation: 0.5 year - Training at the production site: a few months - Production management (information to customers): 0.5-1 year - Third-party certification: 1 year without clinical trial a few years or more with clinical trial or customer approvals As mentioned above, even if an alternative is found, the replacement takes a long time. EEE specialist equipment therefore needs a longer transition period. If " Testing of alternative materials: 1-2 years " and " Reliability test: performance test of the product: 1-2 years " prove unusable to EEE specialist equipment, the process starts over. Then, it is not possible to predict when the replacement will be completed. It is necessary to check the status of alternative materials at regular intervals and extend the transition period if no alternative materials have been found. Our equipment also uses general electronic circuit components (see application information in Japan 4EE Opinion RCOM Part 21, No. 4543, and comments to be submitted). In other words, it may use common parts with general consumer EEE. In this case, even if a replacement part for general consumer EEE is found, it may not be applicable as a replacement part for EEE specialist equipment. As mentioned above, performance and reliability requirements are high for EEE specialist equipment, so even if you try to apply replacement parts for general consumer EEE to EEE specialist equipment, there is a possibility that they will not pass various tests. In that case, too, the extension of the transition period is necessary. "Semiconductor manufacturing related equipment" should also be included in the definition of "semiconductor process" when considering transition and substitution periods. "Semiconductor manufacturing related equipment" is also an essential component of the semiconductor process, and the "semiconductor process" cannot be established without "semiconductor manufacturing related equipment". SEAJ as of September 12th, 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan The derogation period needs to be considered for the "semiconductor industry" as a whole, which includes "semiconductor processes" and "semiconductor manufacturing related equipment". For the semiconductor industry, see also the opinion of SEMI Europe GmbH. (part134304) 2.2 The derogation of spare (repair) parts are required The exclusion of the spare (repair) parts which are used for EEE Specialist Equipment placing on the EU market before the entry into force is required. As explained in the 1.2.4, EEE specialist equipment requires the same spare parts for the life of the product as when first evaluated. If spare parts were not derogated and its equipment had already been in EU market, to repair that equipment after entry into force, only spare parts will become to be design changed. These changes to spare parts can affect to some conformance of related directives and regulations for its EEE. It means the re-evaluation is necessary. The evaluation process is equivalent with that of new products. It would be against the EU green objectives, as expressed in the EU Circular Economy Action Plan, to prematurely end the service life. It is not feasible and is not efficient. Therefore, the derogation for spare(repair) parts are allowed with EU RoHS Directive. It is also related to "Right to repair" and "Repair as produced" principles. We hope the derogation for spare(repair) parts in REACH Regulation would be set. 2.3 Reasonable implementation of Reporting Requirement for EEE Specialist Equipment in case of exempted Although reporting requirements have been proposed for PFASs used in exempt applications, it is recommended that existing mechanisms be used as several similar reporting requirements have already been implemented in other regulations. It also reduces the administrative burden. For example, gases within the PFAS group are subject to the F-gas Regulation, which already has reporting requirements. (https://climate.ec.europa.eu/eu-action/fluorinated-greenhouse-gases/f-gas-portalhfc-licensing-system-quota-allocation-authorisation-and-reporting_en) SEAJ as of September 12th, 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan PFASs are widely used in EEE Specialist equipment. SVHCs in articles are collected in order to meet the obligation of Article 33 of REACH regulation. Information on the uses of chemical substances which are classified with CLP regulation is also collected for chemical products and products which are subject to MDR, in order to meet the obligation of communication on hazardous substances. The following describes the current status of information transmission through the supply chain regarding PFASs. Not all PFASs are designated as SVHC or classified under the CLP regulations. Therefore, we have not obtained the information on use of PFASs. The minimum threshold specified in the Regulations is 0.1%. We cannot obtain the information on uses as the units of ppb as proposed. Our supply chains are very long and take time to obtain the information on the uses from the supply chain. As mentioned above, it is very difficult to obtain information on all PFASs. However, regarding SVHC and CLP classified substances that have been recognized as hazardous or toxic, the information can be collected through the existing communication flow, so this is the most feasible method. PFASs that are found to be harmful or toxic will automatically follow the above information transfer flow and will be transferred to the EU regulatory authorities. 2.4 Information on alternatives is provided in Question 7. However, as described in Section 2.3, our survey has not been completed on all PFAS (the substance group comprising of at least 10,000 different compounds). Having said that, it is practically impossible to continue carrying out the survey because there are PFAS CAS numbers that cannot be identified. For the substance group, also see opinions from the chemical industry such as the Conference of Fluoro-Chemical Product Japan (FCJ). Below is a quotation from FCJ's general comment: We believe that the proposed restriction of PFAS (Per- and Polyfluoroalkyl substances) proposed by 5 European countries is an excessive measure because it restricts more than 10,000 of organofluorine compounds (PFAS) on the grouping basis that they are SEAJ as of September 12th, 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan persistent as substances of concern equivalent to the already regulated PFOS and PFOA. The issues on the risk of PFAS would be covered in details by the opinions from the chemical industries such as Conference of Fluoro-Chemical Product Japan (FCJ). Please refer to their input.