Document 2R84qjxb5EwOgwN41xLr9nzO7

** FS::: ESF Mr Contribution 2nd consultation on a restriction for PFAS Date : 17/10/2021 The European Safety Federation (ESF) welcomes the opportunity to contribute to the 2nd consultation on a restriction for PFAS. As European organisation representing suppliers of PPE (Personal Protective Equipment), we are committed to protecting the health and safety of all citizens. PPE is about protecting the health and safety of users. Suppliers have it in their DNA to look at that functionality as absolute priority. The PPE Regulation (EU)2016/425 has as one of the, logical requirements for PPE (annex II 1.2.1.1) : "The materials of which the PPE is made, including any of their possible decomposition products, must not adversely affect the health or safety of users". Continuous efforts to substitute potentially dangerous substances and develop new PPE are made by manufacturers and research institutes, while protection of health and safety must remain at the highest possible level. For PPE, a strict conformity assessment system is in place. This takes time additionally to the development of products. This also means that every (small) change in the product must be evaluated and possibly leads to re-testing and recertification of the complete product. The vast majority of PPE need at least type examination by a notified body, so time to market also depends on external assessment. PPE include a huge variety of products (from firefighter equipment to earplugs to safety shoes, to masks) and applications (healthcare, industry, first responders, ...). Also a number of related products that are not in the scope of the PPE Regulation but typically associated with PPE, are produced and/or distributed by the same companies : surgical masks and medical gloves and textiles (covered by the medical device legislation); community face coverings (covered by the general product safety legislation); specific personal equipment for `law and order' (police, army, rescue); workwear; professional skin care; measurement equipment used to warn for risks (gas detection, ...) or to check the efficiency of the PPE (e.g. fit testing for respiratory protection). At the same time, users confronted with a huge variety of risks (chemical, heat and flame, cold, visibility, falling from height, biological, radioactive, ...), often also combined, need adequate protection by PPE. We have the impression that not all PPE or related products are covered by the reports that are made so far. We would also like to draw the attention to the following : The increased awareness on health risks (e.g. chronic diseases, cancers) can lead to an increased use of repellents (see e.g. firefighters). An increased awareness is certainly a positive evolution, while creating the need to higher levels of protection. European Safety Federation ivzw - Bavikhoofsestraat 190 - 8531 Harelbeke - Belgium @eu-esf.org - www.eu-esf.org - T+32 56 70 11 03 VAT BE0454.000.382 - RPR Business Court Gent -- Division Kortrijk EU Transparency Register number : 91447653655-65 - PPE are frequently conceived to protect against multiple risks, e.g. chemical and heat and flame (e.g. for firefighters, industry workers, rescue personnel) - Not only garments, but also other types of PPE need to be considered in the preparation work for the possible restriction of PFAS : gloves - footwear -- respiratory protection -- eye and face protection -- hearing protection -- fall protection -- head protection. At this stage it is known that certainly in some of those PPE, the presence of PFAS (often also as polymer) is essential to guarantee the required protection level. This is e.g. the case where the following is present : o Everywhere where a big variety of chemicals can cause a hazard o Heat and flame protection o CBRN suits and chemical protective ensembles (e.g. also seals between different parts or visors on e.g. gastight garments) - Protecting the characteristics needed for the protection of the wearer -- see e.g. rainwear, visibility clothing, chain saw protection, bullet proof vests, CBRN, riot protection, ... Even if the concerned standards do not always require repellency as such, without proper repellency, it is impossible to keep the protective properties for the lifecycle of the product. - Some PPE include electronic components. It is not uncommon that these contain PFAS coatings. It also needs to be remarked that when used in PPE, these electronic components must be adequately protected to ensure their functioning in the foreseeable use of the PPE. - In some cases, PFAS can be in small but critical parts of a PPE : e.g. seals, tubing, bearings. If these do not withstand the foreseeable use conditions (e.g. heat, exposure to chemicals), the PPE will not function correctly in the most dangerous situations for the user. PPE manufacturing, supplying, and servicing is not an economic sector on its own. The companies active in this field are part of different economic sectors, but then always as a niche in those sectors. However, in cases like this exercise, PPE need to be considered as whole, and not only those parts that fit nicely in an economic sector. This also makes it difficult to get correct and complete data (e.g. no specific custom codes as typically used in statistics). We would also like to draw the attention to the importance of enforcement : many PPE or related products (including materials used for the production of final products) are imported from third countries. If the same rules do not apply to those imports and/or the imports are not strictly controlled, a competitive disadvantage for the EU industry will be created. The recent experience with shortages of certain types of PPE and related products during the COVID crisis only shows the importance of a viable production industry in the EU. Creating additional burdens for EU industry that are not equal or are not strictly enforced for imports, will result in an even less controlled use of PFAS in products and thus have an adverse effect. And of course, will also lead to further job loss in the EU. The PPE sector is typically an SME sector (in manufacturing of PPE, but also in importing/distribution). Only a few bigger international companies are active in some products, but for instance the protective garment production is for the majority done European Safety Federation ivzw - Bavikhoofsestraat 190 - 8531 Harelbeke - Belgium @eu-esf.org - www.eu-esf.org - T+32 56 70 11 03 VAT BE0454.000.382 - RPR Business Court Gent -- Division Kortrijk EU Transparency Register number : 91447653655-65 by SMEs. This is also the case for distribution and services. While SMEs are certainly dedicated to comply with the applicable legislation, a specific approach is necessary to support their efforts. Manufacturers of PPE are only a small part of the complete supply chain. See e.g. the chain for protective garments : fibre and/or fabric manufacturer -- manufacturer of other parts (e.g. closure systems, reflective tapes, ...) -- manufacturer of garment (= the actual PPE manufacturer) -- distribution -- textile service (laundry). PFAS may be used or applied by one of the suppliers of the PPE manufacturer and by the textile service company. Changing a small aspect of the PPE may require retesting and recertification by the PPE manufacturer of the whole PPE or assembly of PPE. The industry understands the responsibility to bring more transparency to all parties in the supply chain, this for the primary function of PPE, but also to be able to further improve sustainability and substitute potentially hazardous substances. Also economic aspects need to be taken into account. If certain types of PFAS that are critical for the PPE (and related) products are banned for general use, chances are that, given the relatively small amounts needed for the PPE sector, these PFAS will no longer be available or at an extremely high cost. The impact for the availability of these PPE or on the cost of them for the users could have a negative effect on the protection of the health and safety of the EU citizens. This aspect cannot be ignored and needs further investigation. As for all products, also sustainability is a concern for the PPE suppliers : - When looking for alternatives, also the total life cycle has to be considered. If a substitute for PFAS shortens the lifetime of a product, this has an influence on the sustainability and needs to be taken into account in the total balance. Shorter lifecycle means more waste, which in case of PPE can be contaminated with hazardous substances. - Not only the product in itself, but e.g. for clothing, also the cleaning cycle needs to be taken into account. E.g. if a product without repellent finish needs to be washed at a higher temperature and/or the amount of (washing) chemicals needs to be increased to get the needed hygienic level, this also has an impact on sustainability and potential hazardous situations. Some - - considerations for textiles specific : see also the contributions of e.g. Euratex and ETSA. Here we specifically want to refer to the Euratex contribution to the SEAC public consultation of the 7th of September 2021. This contribution contains several pieces of evidence valid for PPE. On textiles, silicone, wax or paraffin finishes could be an alternative for fluocarbon finishes. But at this moment there are issues with chemical protection, static electricity and flammability, which can cause new risks for the wearer or even during the application. Further research is necessary to ensure that the alternatives offer the same level of protection, preferably without additional harm to the environment. European Safety Federation ivzw - Bavikhoofsestraat 190 - 8531 Harelbeke - Belgium @eu-esf.org - www.eu-esf.org - T+32 56 70 11 03 VAT BE0454.000.382 - RPR Business Court Gent -- Division Kortrijk EU Transparency Register number : 91447653655-65 - Not only finishes on fabrics, but also coatings and laminates are necessary to provide the required level of protection. Also for those, the industry is working with research laboratories to develop alternatives. - ESF has answered to the questionnaire from KEMI on protective clothing -- this contains more details. As sector organisation, we will continue to work on the awareness of the presence of PFAS in PPE and related products and will support R&D in their search for substitutions. Our members are dedicated to provide the best possible protection, compliant with all applicable EU legislation and this taking into account sustainability. Conclusion : at this stage a general ban for PFAS for PPE and related products would create a situation where the protection against health and safety risks can no longer be guaranteed. Therefore, we ask for an exception for these products that have an essential function for the society. At the same time, further research and development must take place at all levels to make substitutes possible, guaranteeing the adequate protection levels based on the risks encountered by the wearer and taking into account the sustainability issues. With proven efficacy for substitutes, certain applications of PFAS for PPE (and related products) can be banned step by step in the future. About ESF: The European Safety Federation (ESF) was founded in 1991. National organisations each representing the manufacturers and suppliers of PPE (Personal Protective Equipment) in their country decided to group and unite the European manufacturers, importers, distributors and service providers of PPE and to represent them at government level of the European Union and other European institutions and instances. Today, ESF represents over 700 companies, of which at least 70% are SMEs. The members of ESF and the enterprises that affiliated to the national federations (that are a member of ESF) are dedicated and committed to provide compliant CE certified and high-quality PPE. Moreover, they link quality and service by giving expert advice and assistance in the process of risk assessment and analysis as well as training and advice in all aspects related to PPE. Supporting a safety conscious way of life is a common interest to all of us. As all citizens (be it as employee, as self-employed or in his/her free time) use PPE to protect him/her against risks for his/her health or safety, the ESF members have an essential role in the protection of the population. ESF is registered in the EU Transparency Register (91447653655-65) and is a member of the PPE Expert Group of DG GROW. See www.eu-esf.org for more information or contact Henk Vanhoutte, Secretary General ( aeu-esf.org). European Safety Federation ivzw - Bavikhoofsestraat 190 - 8531 Harelbeke - Belgium @eu-esf.org - www.eu-esf.org - T+32 56 70 11 03 VAT BE0454.000.382 - RPR Business Court Gent -- Division Kortrijk EU Transparency Register number : 91447653655-65