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RESPONSE TO THE SUBMISSION #4184 (Made during the consultation period of the proposal to restrict the manufacture, placing on the market and use of PFAS) Assessment of Aculon's ECHA Submission: "A Close Shave -- New PFAS Free Alternatives to PTFE Surface Lubricating Coatings for Razor Blades Could Mean Great Shaving and A Better Environment" FROM: Razor Blades Manufacturers DATE: 21 09 2023 PREPARED BY: EPPA SA/NV Place du Luxembourg 2 1050 Brussels, Belgium EU transparency register: 3136750124992 Summary This response to Aculon's submission is made on behalf of four major manufacturers of razor blades for shaving: BIC, Edgewell, Harry's, and Procter & Gamble, representing 9095% of the European Economic Area razor blades market. The Blades and Razor (B&R) industry is aware of Aculon's development of nonfluorinated coatings for blade edges. However, there is currently insufficient supporting data that demonstrates a shave capable alternative to PTFE from Aculon that would be considered technically or commercially ready within several years. The recently shared data from the PFASfree alternatives from Aculon lacks technical support for the achievement of the minimum standards of performance for acceptable consumer performance. Moreover, we note that in its submission, Aculon does not provide any information on the risks to human health or the environment related to the manufacture or use of their material. Accurate evaluation of blade performance requires significant testing of the product on the intended subject of use (i.e., human skin).1 Aculon's submission states that their coating still needs to be evaluated on humans, suggesting that safety assessments on the coating have not been done yet. Therefore, it is not possible to establish if the proposed coating is regulatory viable or could be a regrettable substitution. Aculon's submission also lacks data on the economic feasibility, availability in sufficient volume to meet the market demand, the time needed to develop and validate the alternative in the future and the time needed to adapt product design and production process. We estimate that at least 12 years of coating development, process scaleup, safety assessment and significant capital investment would be needed to make Aculon's coatings potentially viable as PTFE alternative coatings on an industrial scale. Therefore, it can be concluded that Aculon's material cannot yet be considered as an available technically suitable and economically viable alternative to PTFE. The four razor blades manufacturers have prepared and submitted a detailed and highly representative assessment of the alternatives and the anticipated socioeconomic impacts of the potential restriction of the use of PFAS in the manufacturing of razor blades (see Submission by Razor Blades Manufacturers during the proposed PFAS restriction public consultation submission reference number: bfa1e646ad254afa8232 df12ca9a3396). 1 Aziz, H.A., 2017. Comparison between field research and controlled laboratory research. Archives of Clinical and Biomedical Research, 1(2), pp.101104. Available at: https://www.researchgate.net/publication/316543113_Comparison_be tween_Field_Research_and_Controlled_Laboratory_Research (Accessed in September 2023). 1 CONFIDENTIAL EPPA sa/nv Overview The Blades and Razor (B&R) industry is aware of Aculon's purported low friction; nonfluorinated coatings being developed for blade edges. Based upon technical expert assessment of the recently reported data and other historical evidence supplied by Aculon, it is believed the underlying technologies are early in the Discovery Phase of the typical 12 to 15year product and process development cycle. As such, it is believed that their proposed coating is more than a decade away from becoming a viable, scalable, and safe alternative to a PTFE coating. Furthermore, any such coating will require substantial R&D effort, capital investment and employee retraining to deploy on an industrial scale. The B&R industry remains committed and is acting with the highest urgency to continue working with Aculon and others to accelerate the development of PTFE alternative blade coatings, but significantly more time is needed. Background Over the past 15 years, at least two major B&R companies have been actively tracking and reviewing publicly available information on Aculon's blade edge coating to determine acceptability as a PTFE replacement. Based upon its extensive experience in the field, no extended technical performance testing or consumer testing of these blade populations was pursued by the B&R company. Significant improvements in the materials or coating processes will be needed on Aculon's coatings to deliver acceptable results for two key technical tests: Single fiber cutting (U.S. patent # 9,255,858)2 and extended wool felt cutting (U.S. patent # 10118304)3. In combination, these two technical assessments set the minimum standard essential for shave performance. Review of Aculon's Technical Performance Assessment Data Data provided by Aculon ("A Close Shave -- New PFAS Free Alternatives to PTFE Surface Lubricating Coatings for Razor Blades Could Mean Great Shaving and A Better Environment", Qian He PhD, Eric Hanons PhD, Edward Hughes) showed cutting forces, both wet and dry, that are related to hair engagement force (C. T. McCarthy, M. Hussey, M. D. Gilchrist, Eng. Fract. Mech., 74 (14), 2007, 2205). However, the data Aculon reported is highly correlated to the blade edge tip geometry in a region of less than 1 micron from the ultimate blade edge tip. Alone, the data provided is not sufficiently indicative of the coating's friction reduction and does not capture the related hair cutting forces that drive the consumerperceived sensations of tug and pull. (Note: Tug and pull directly relates to comfort 2 Vallon et al., (2016). United States Patent: Method for measuring fiber cutting force. Available at: https://patentimages.stor age.googleapis.com/0a/c5/2c/4f4067e369f117/US9255858.pdf (Accessed in September 2023). 3 Duff Jr., et al., (2018). United States Patent: Method of treating razor blade cutting edges. Available at: https://patenti mages.storage.googleapis.com/5a/d8/6a/dd49793f1d0e50/US10118304.pdf (Accessed in September 2023). 2 CONFIDENTIAL EPPA sa/nv during shaving and postshave irritation consumer use ratings of a product; lower tug and pull being highly desired and necessary for an acceptable shave). A much stronger technical measure to reflect shaving performance is single fiber cutting. To date, no data or evidence of acceptable single fiber cutting (or similar measure) values has been reported to warrant a more focused investigation. As reported by Aculon (See Figure 4 in article "A Close Shave -- New PFAS Free Alternatives to PTFE Surface Lubricating Coatings for Razor Blades Could Mean Great Shaving and A Better Environment", Qian He PhD, Eric Hanons PhD, Edward Hughes), the blades with their best nonPFAS material have an average cutting force which is about ~44% higher than PTFE coated blades as measured by dry felt cutting test and ~22% higher as measured by wet felt cutting test. Despite the noted interpretive limitations in their reported data, such differences in blade performance in the above lab tests would be noticeable and negatively perceived by the user in actual shaving leading to an unacceptable and uncomfortable shave. At least two major B&R companies have performed shaving tests with alternative materials other than those presented by Aculon with even better performance in similar lab tests (wet and dry felt cutting) but the respective performance in shaving tests as evaluated from external shaving panel were still unacceptable by the shaving test participants. Therefore, the reported performance of Aculon's nonPFAS material in lab tests does not guarantee their suitability for a comfortable shave even for a single use. The second key measure of a low friction coating's performance is durability: a suitable blade coating must withstand multiple shaves (~10 to ~14 shaves). An accepted standard measure of durability is extended cutting cycles of the wool felt cutter as described above. Note: The wear impact of a single shave is roughly equivalent to 50 cuts through a wet wool felt media. The minimum technical standard of performance is less than 2.3 lbf after 500 cuts/10 shave equivalent; with 1.7 lbf being equivalent to a PTFE coated blade). The extremely limited data set supplied by Aculon does not support durability of the coating over extended use and much more testing and evidence is required. Overall Technical Readiness Assessment To successfully move beyond the Discovery Phase and into the subsequent Development phase, the candidate blade edge coating will need to have demonstrated both adequate cutting forces relative to a PTFE coated blade edge and sufficient coating durability. During the Development phase, a significant set of required and essential evaluations will be required to gauge and progress the performance, safety and scaleup potential. An abbreviated summary of these evaluations is included below: 3 CONFIDENTIAL EPPA sa/nv Table 1: Summary of assessments that need to be performed during the development phase. Property Assessment Purpose Hair Peak Cutting Force Single Fiber Cutter (U.S. Patent # 9,255,858) Quality, comfort and safety of product in use Quality of Hair Cutting Single Fiber Cutter Quality of hair cutting and closeness postuse Coating Durability Wool Felt Cutting (U.S. patent # 10118304) Product longevity and life cycle prediction Edge Strength and Durability Edge strength, mechanical durability testing Product longevity and life cycle prediction and safety Consumer related attributes Multiple consumer use assessments Direct consumer performance assessment Safety and Environmental Multiple Health and Toxicology Profile, Exposure Limits Measures Safety and hazard identification and assessment: Product material, process materials, byproducts, waste streams, decomposition materials Process and Manufacturing Scaleup Material Transformation and Process Development Models and Measures Equipment/process complexity, raw material and conversion costs, energy consumption Manufacturing compatibility Multitude of assessment techniques Quality measures and controls, process capability, factory space conversion (HVAC, controls, ...) Stability testing Multitude of assessment techniques Shipping, storage, inuse and end of life Source: Consultation with one of the Participating Manufacturers, 2023 Of particular interest and consideration will be the safety profile of the coating material, the process materials used and/or process related waste streams. These include the volume or mass of byproducts, waste disposal methods, safety requirements for processing, storage, and shipping. It is important to note that extensive data is available in detail in these areas for the current coating material (PTFE) indicating a high confidence in usage of this material. If the Development phase is successfully completed, the Implementation and Launch phases still remain to be completed in order to achieve industrial scale. Given the range of products and the scale of operations that would be affected across the B&R manufacturers, these phases alone could take five or more years, significant capital investment and extensive process operator retraining to achieve industrial scale. 4 CONFIDENTIAL EPPA sa/nv Fluoropolymers Additionally, in Aculon's submission, they refer to PFAS in general and highlight their persistence regarding the environmental impacts. However, the Blades and Razor (B&R) companies would like to emphasise that their used PFAS (i.e., PTFE) is a fluoropolymer. According to studies, when incinerated under representative European municipal incinerators conditions, fluoropolymers do not generate any measurable levels of PFAS emissions at their end of life during incineration.4 Furthermore, as PTFE is chemically, thermally, and biologically stable, PTFE coated razor blades are not expected to lead to dispersive nonpolymeric PFAS when disposed of in a landfill.5 Therefore, at the endoflife stage, PTFE coated razor blades are not expected to lead to PFAS emissions. 4 Aleksandrov, K., Gehrmann, H.J., Hauser, M., Mtzing, H., Pigeon, D., Stapf, D. and Wexler, M., 2019. Waste incineration of Polytetrafluoroethylene (PTFE) to evaluate potential formation of perand PolyFluorinated Alkyl Substances (PFAS) in flue gas. Chemosphere, 226, pp.898906. 5 Korzeniowski, S.H., Buck, R.C., Newkold, R.M., Kassmi, A.E., Laganis, E., Matsuoka, Y., Dinelli, B., Beauchet, S., Adamsky, F., Weilandt, K., Soni, V.K., Kapoor, D., Gunasekar, P., Malvasi, M., Brinati, G., Musio, S., 2023. A critical review of the application of polymer of low concern regulatory criteria to fluoropolymers II: fluoroplastics and fluoroelastomers. Integrated Environmental Assessment and Management, 19(2), 326354. 5 CONFIDENTIAL EPPA sa/nv ePPo eppa SINCE 1987 interfacing business government society 2 Place du Luxembourg I be-1050 Brussels +32 2 735 82 30 @eppa.com www.eppa.com 00 00 00