Document DGyv4QXga2OeOXVaMvyKavmqQ

PFAS PUBLIC CONSULTATION: BRIEF PFAs FOOD CONTACT MATERIALS AND PACKAGING Brussels, 25 September 2023 EuPC is the leading EU-level Trade Association, based in Brussels, representing European Plastics Converters. EuPC now totals about 51European Plastics Converting national and European industry associations, it represents close to 50,000 companies, producing over 50 million tonnes of plastic products every year. The European plastics industry makes a significant contribution to the welfare in Europe by enabling innovation, creating quality of life to citizens and facilitating resource efficiency and climate protection. More than 1.6 million people are working in about 50,000 companies (mainly small and medium-sized companies in the converting sector) to create a turnover in excess of 280 billion per year Introduction Following our initial submission, EuPC comments on specific applications. Since those are very diverse, each will be covered in a separate submission. This is the brief for Food Contact Material (FCM) and Packaging applications. It does not include medical packaging which was the object of a separate submission. We conducted a survey over the Summer. Companies replying to this survey manufactured more than 900 kt of finished product. We therefore consider this survey to be representative. Use of PFAS in FCM & Packaging applications Per- and polyfluoroalkyl substances, commonly referred to as PFAS, have been widely used in various industrial and commercial applications due to their remarkable properties of heat resistance, chemical stability, and water repellency. These characteristics make them valuable in the field of food contact materials (FCM) and packaging applications. PFAS have been incorporated into FCM and packaging materials primarily for their ability to provide oil and water resistance, preventing leakage and contamination of packaged food items. They are found in paper-based packaging materials. PFAS are also used in coatings for cookware, such as non-stick pans, to prevent food from sticking and enhance the cooking process. We do not cover this application in our submission. One of the most notable benefits of PFAS in FCM and packaging applications is their resistance to high temperatures. This property ensures that the packaging materials do not degrade or release harmful substances when exposed to heat during cooking or microwave use. Additionally, PFAS-coated materials are effective barriers against grease, oil, and liquids, maintaining the visual appeal and quality of the packaged food. PFAS have found a diverse range of applications within the realm of FCM and packaging, including their use as additive in the production of films, primarily those made from polypropylene (PP) and polyethylene (PE). Avenue de Cortenbergh 71- B-1000 Brussels Phone: +32 (0)2 732 41 24 Fax: +32 (0)2 732 42 18 @eupc.org www.plasticsconverters.eu Page 1 of 9 In the production of PP and PE films, PFAS are employed as additives at concentrations typically around 0.1% w/w. These additives facilitate the manufacturing process by reducing friction and enhancing the flow of the polymer during extrusion and molding. The result is smoother and more consistent film production with reduced defects, contributing to improved packaging quality. Toxicity Fluoropolymers are very stable because of their intrinsic physicochemical properties. If lost in the environment, they are therefore currently considered as persistent. However, they do not display any hazardous property/property of concern referred to by the dossier submitter; i.e., bioaccumulation, mobility, long-range transport potential (LRTP), accumulation in plants, ecotoxicity, endocrine activity/endocrine disruption, effects on human health and concerns triggered by a combination of these properties. Fluoropolymers polymer of low concern following OECD critaria [Korzeniowski, S. H. et al. A critical review of the application of polymer of low concern regulatory criteria to fluoropolymers II: Fluoroplastics and fluoroelastomers. 2022. https://setac.onlinelibrary.wiley.com/doi/ful1/10.1002/ieam.46467. Fluoroelastomers may contain residuals such as BPAF but in very low quantitites. Please note that BPAF is studied into the restriction on BPA and Bisphenol of similar concern. We therefore request BPAF and its uses in FKM to be exempted from the scope of this restriction and be addressed in the other restriction which is substance specific and more focused. Fluoropolymers and -elastomers should be excluded from the scope of the restriction Based on the above, fluoropolymers and fluoroelastomers should in our view excluded from the scope of this restriction. We however provide additional information showing both its negligible emission and the disproportionate socio-economic impact that would be linked to its substitution. Needed transition period combined with a review clause In the event it is determined that fluoropolymers and -elastomers would not be excluded from the scope of the restriction, then our analysis suggests that the industry would need a the following transition periods to be granted: Use of PTFE waxes : EiF + 6.5 years Use of fluoropolymer additives for thin polyolefin films extrusion : 6.5 years Transition for polyolefin film containing recyclate: EiF + 6.5 to 10.5 years EiF + 10.5 to 11.5 years EiF + 12.5 years Allowed maximum fluoropolymer concentration 350 ppm 150 ppm 100 ppm Avenue de Cortenbergh 71- B-1000 Brussels Phone: +32 (0)2 732 41 24 Fax: +32 (0)2 732 42 18 @eupc.org www.plasticsconverters.eu Page 2 of 9 Use of fluoropolymers and FKMs in heat and chemical resistant caps and closure : EiF + 12 years Use of fluoropolymers and FKMs in machinery for packaging production: undefinite derogation or at minimum EiF+ 12 years There is currently considerable uncertainty whether or not suitable alternative can be Implemented at industrial level within the proposed transition periods. The restriction should therefore include a review clause and process whereby it may be evaluated whether or not the alternatives could be successfully placed on the market potentially allowing if needed extension of those transition periods. Note: the following sections numbers correspond to the sections numbers from ECHA's Comments for Annex XV restriction report for Per- and polyfluoroalkyl substances (PFAS). 1. Sector and sub-use This comment is related to the following use: Food contact material Plastic Packagings. Use as additives The following fluoropolymers have been reported as additives found into compounds for LLPDE, LDPE and PP (BPP, CPP, OPP) thin film (blown film extrusion, cast film extrusion, coextrusion). They are therefore encapsulated the plastics film matrix: - PVDF HFP (Poly(vinylidene fluoride-co-hexafluoropropylene CAS 9011-17-0) ; - 1-Propene, 1,1,2,3,3,3-hexafluoro-, polymer with 1,1-difluoroethene and tetrafluoroethene, CAS 25190-89-0) Concentration in thin film would be around 1000 ppm. However it is not used in all layers. Converters reported residual content as low as 35 ppm in some structures. In masterbatch (concentrated compound) typical content would be between 1 and 5%. These additives function is to facilitate the manufacturing process by reducing friction and enhancing the flow of the polymer during extrusion. The result is smoother and more consistent film production with higher speed, reduced defects, contributing to improved packaging quality. Flexible packaging from LLPDE, LDPE and PP represent 2750 kT per annum. However only thinner films would use fluoropolymer based compounds. Based on the gathered input, we estimate the overall volume of fluoropolymers in polyolefin based films not to exceed 1000 T. Inks, lacquers and coatings and waxes PTFE (CAS 9002-84-0) waxes are used to modify the surface friction properties of inks, lackers and coatings applied to food contact materials. Avenue de Cortenbergh 71- B-1000 Brussels Phone: +32 (0)2 732 41 24 Fax: +32 (0)2 732 42 18 @eupc.org www.plasticsconverters.eu Page 3 of 9 It will be added in concentrations of typically 3%. Poly[trifluoropropyl(methyl)siloxane] (CAS 6314856-1) may be found in printing inks in concentration of around 1%. Greases, waxes and sprays applied on processing equipment for packaging PTFE (CAS 9002-84-0) waxes maybe directly applied on roller, or in grease tape, gasket, sealing bearing or as a teflon spray . 3,3,4,4,5,5,6,6,7,7,8,8,8-Tridecafluorooctane-1-sulphonic acid (CAS27619-97-2) is applied on gravure printing culinders (mist supressing agent in chrome plating). Grease -- proof paper The following fluoropolymers may be found in grease proof paper used in flexible packaging (typically around 1%) - Perfluoroalkylethyl acrylate(mixture) (CAS 65605-70-1) - Diphosphoric acid, polymers with ethoxylated reduced methyl esters of reduced polymerized oxidized tetrafluoroethylene (CAS 200013-65-6) - 2-Propenoic acid, 2-methyl-, polymer with 2-hydroxyethyl 2-methyl-2-propenoate, a-(1-oxo- 2-propen-1-yl)-w-hydroxypoly(oxy-1,2-ethanediyl) and 3,3,4,4,5,5,6,6,7,7,8,8,8- tridecafluorooctyl 2-propenoate, sodium salt (CAS 1158951-86-0) We were also made aware of the potential presence of short chain and C6 based PFAs. Use in heat and chemical resistant caps and closures (industrial and medical packaging) For this use (sealing rings), mainly 2 PFAS are used: PFTE (fluropolymer) and FKM (fluoroelastomer). FKM provide both chemical and heat resistance. PTFE venting membranes are used to avoid implosion or explosion of packaging. The following fluoropolymers may also be found EFTE, PVDF and PFA. Whilst volumes of fluoropolymers/elastomers used are limited, they perform important functions in packaging critical chemicals/ medical applications. 2. Emissions during the end of life In 2022, plastic packaging end of life was divided as follows : 46% recycling, 17% landfill and 37% incineration [Plastics The Facts (2022), p. 53, https://plasticseurope.org/knowledge-hub/plastics-the-facts-2022/]. We do not have specific number on flexible packaging recycling, but even allowing for low recycling rates, the ratio incineration to landfill should be similar across Europe, resulting as a worst case in 30% landfilling. Residual oligomers for PVDF-HFP are "negligible" and monomer content <50 ppb [Korzeniowski, S. H. et al. (2022) A critical review of the application of polymer of low concern regulatory criteria to fluoropolymers II: Fluoroplastics and fluoroelastomers, https://setac.onlinelibrary.wiley.com/doigull/10.1002/ieam.4646] and this seems to be the case across fluropolymers. Avenue de Cortenbergh 71- B-1000 Brussels Phone: +32 (0)2 732 41 24 Fax: +32 (0)2 732 42 18 @eupc.org www.plasticsconverters.eu Page 4 of 9 Given also the glassy nature of fluoropolymers , leaching of residuals from those would hardly detectable even with more sophisticated equipment. For chemical and heat resistant caps and closures, please refer to the Conversio study on fluoropolymer end of life [Fluoropolymer Waste in Europe 2020 -- End-of-life (EOL) Analysis of Fluoropolymer Applications (2022), Products and Associated Waste Streams." Final Report Made on Behalf of pro-K, Conversio, https://www.ft.dk/samling/20222/almdel/euu/spm/49/syar/1951975/2698345.pda The main end of life option for Chemicals application (CPI) is incineration (83,3% of the polymeric fraction, 12,3% being landfilled. The balance 4,5% would be recycled although this is unlikely for this specific application). We cannot make specific estimates for releases from this application with precision, but taking the same approach as above, releases during landfilling should not exceed a few kg per year. 3. Emissions from incineration Incineration above 850 C does not release PFAS-related materials nor detectable levels of Trifluoroacetic acid (TFA) [Aleksandrov, K. Waste Incineration of Polytetrafluoroethylene (PTFE) to Evaluate Potential Formation of Per- and Poly-Fluorinated Alkyl Substances (PFAS) in Flue Gas. 2019, 226, 898-906., DOI: https://doi.orq/10.1016Achemosphere.2019.03.191; Taylor, P. H. Investigation of Waste Incineration of Fluorotelomer-Based Polymers as a Potential Source of PFOA in the Environment. Chemosphere 2014, 110, 17-22, DOI: https://doi.org/10./0/6/j.chemosphere.20/4.02.037; Bakker, J., et al. (2021) Per- and Polyfluorinated Substances in Waste Incinerator Flue Gases. Rijksinstituut voor Volksgezondheid en Milieu (RIVM) Report 2021-0143.DOI: https://doi.ord//0.2/945/RIVM-2021-0143)1, Gujarat Fluorochemicals Limited (GFL), Karlsruhe Institute of Technology (KIT) & Societe Generale de Surveillance (SGS) consulted by the German Federal Environment Agency (UBA), Incineration study on Fluoropolymers at their End-of-Life, https://www.gfl.co.in/upload/pages/64ca54ee691b6f4a8b2649ec9c7b291f.pdf]. Those temperatures can be found in municipal waste incinerators, as they are mandatory according to the Industrial Emissions Directive 2010/75/EU (Article 50), which prescribes that waste incineration plants must be designed to ensure that flue gases reach a temperature of at least 850 C for at least 2 seconds in order to ensure the proper breakdown of toxic organic substances. 4. Impact on recycling Given the wide use of fluoropolymer additives for thin polyolefin film extrusion with concentration up to 1000 ppm sufficient time must be given to enable continued recycling of those applications. Actually given the mandatory recycled content target foreseen by the packaging and packaging waste directive of 35% by 2030 for non contact sensitive plastics, it would take minimum (years after complete phase out of those additives for new packaging to reach the foreseen 50 ppm TOF limit for fluoroelastomers (1000 ppm x 35% x 35% x 35% = 3 years + 2 years shelf life + 1 year for stocks) by mechanical recycling. One has to note that allowed residual PFAS levels might be decreased on a yearly basis: e.g. 350 ppm in year 4, 150 ppm in year 5 and 100 ppm in year 6 (corresponding to a fluorine level of 50 ppm). Failing to provide this derogation could potentially mean the phasing out of flexible packaging as of 2030 unless chemical recycling is used massively instead. Avenue de Cortenbergh 71- B-1000 Brussels Phone: +32 (0)2 732 41 24 Fax: +32 (0)2 732 42 18 @eupc.org www.plasticsconverters.eu Page 5 of 9 5. Proposed derogation tonnage and emissions 5.1. Volumes of fluoropolymer additives used for thin film extrusion Flexible packaging from LLPDE, LDPE and PP represent 2750 kT per annum. However only thinner films would use fluoropolymer based compounds. Based on the gathered input, we estimate the overall volume of fluoropolymers in polyolefin based films not to exceed 1000 T. 5.2 Related emissions during manufacturing of fluoropolymers Concerning the fluoropolymer manufacturing stage, the Fluoropolymers Product Group (FPG) of Plastics Europe established a program focusing on the emission reduction of non-polymeric PFAS chemicals from European fluoropolymer manufacturing, including average emission targets, promoting state-of-the-art technologies to minimize emissions and a commitment to inform downstream users of fluoropolymers on their safe handling of fluoropolymer resins [The Fluoropolymers Product Group (FPG), Plastics Europe (2023), FPG Manufacturing Programme for European Manufacturing sites, https://fluoropolvmers.eu/wp-content/uploads/2023/09/FPG-Manufacturing-Prociramme-for-European-Manufacturinqsites-Final-September-2023.pdf]. 5.3. Converting of article with masterbatches or compounds containing fluoropolymer additives Typical processing temperature for LLDPE film extrusion would range between 180C and 250C, although in some case blown film extrusion could reach temperature up to 290C. Normal decomposition temperature is expected to be at around 350C. We therefore foresee only negligible emission at converting stage. Regarding solid loss, based on previous EuPC survey we estimate losses at converting plantc to be around 0,01% in the absence of dedicated risk management programme such as Operation Clean Sweep, but assuming a basic level of handling. When dedicated measures are in place releases would not exceed 0,001%. In our case this would result in negligible fluoropolymers negligible releases. 5.4. Service life emission (extruded films containing additives) Fluoropolymers being very stable an in the polymeric form, migration is assumed to be negligible. One reference that could be taken is the OECD exposure scenario document for plastics, 2009 [OECD Environment Health and Safety Publications, Series on Emission Scenario Documents No. 3, Emission Scenario Document Plastics additves, https://www.oecd-ilibrary.org/docserver/9789264221291- en.pdf?expires=1694011368&id=id&accname=guest&checksum=511DD8B4F91DB362643FB439D0FFFC79 Fluoropolymers would very much behave as polymeric impact modifiers. Releases during service life are assumed as 0%. If the RAC would not consider the OECD ESD, we would then strongly suggest to consider the following specific Environmental release category: ERC 11A article service life, low release, indoor (see Echa guidance on chemical safety assessment R16). Packaging is normally used indoor and well controlled. Avenue de Cortenbergh 71- B-1000 Brussels Phone: +32 (0)2 732 41 24 Fax: +32 (0)2 732 42 18 @eupc.org www.plasticsconverters.eu Page 6 of 9 5.5. Emission over all life cycle (extruded films containing additives) From the above, it may be concluded that emissions of PFAS monomer and oligomers from the use of fluoropolymers as additives to be hardly measurable. 6. Missing uses -- Analysis of alternatives and socio-economic analysis 6.1. Analysis of Alternatives (additives used for polyolefin thin film extrusion) 6.1.1. Fluoropolymer additives function These additives function is to facilitate the manufacturing process by reducing friction and enhancing the flow of the polymer during extrusion. The result is smoother and more consistent film production with higher speed, reduced defects, contributing to improved packaging quality. 6.1.2. survey description and methodology We conducted a survey over the Summer. Companies replying to this survey manufactured more than 900 kt of finished product. We therefore consider this survey to be representative since we estimate volumes of think polyolefin films manufactured in Europe to amount to 2750 kT. Methodology: companies had to allocate a score from 0 (property not fulfilled) to 5 (property fully fulfilled). Individual interviews with converters were then conducted. 6.1.3. Discussion of technical properties of alternatives additives and waxes for thin film processing For the time being, the situation is as follows : masterbatchers and compounders are developing alternatives but those have yet to be fully tested by converters. Potential mentioned alternative are PE based waxes (content unknown), boron nitride, silicons but so far none have proved to meet the requirements for end product. The main issues for thin film extrusion is the extrusion speed (expressed in round per minutes). Thin film might get increased surface roughness leading to less glossy, less transparent or even wrinkled film ("shark skin") as result of melt fracture. Another monitored parameter is melt pressure which will have an impact on the film shear rate and therefore stability. So far reported test have resulted in achievable speeds to be reduced by a factor of up to 4 (boron nitride, PE waxes), although some progress seems to be made lately but is not validated. Extrusion at higher temperature consistently fails. Moreover boron nitride is not suitable for transparent application because of its white colour. Avenue de Cortenbergh 71- B-1000 Brussels Phone: +32 (0)2 732 41 24 Fax: +32 (0)2 732 42 18 @eupc.org www.plasticsconverters.eu Page 7 of 9 6.1.4. Discussion of technical properties of alternatives for caps and closure for chemical resistance and high temperature operation No alternative have been found for PTFE venting membranes or FKM O-rings. 6.1.5.PFAs in machinery Fluoropolymers are used in the production of raw materials and machinery for packaging processing for heat resistance, resistance to chemicals, joints, seals and linings. We will address those in a separate briefing, but derogation for those uses is essential. Substances used solely in industrial settings should be derogated with appropriate risk management measures at manufacturing plant level if appropriate. 6.1.6. Cost of substitution Additive for thin film extrusion: Whilst R&D cost would be limited (50 kEUR to 300 KEUR per company), cost for reformulation and requalification were reported to vary between 500 and 2500 /T finished product. Extrapolating those number to all industry would translate in cost ranging between 1,375 billion and 6,875 billion . PTFE and FKM use in caps and closures for heat and chemical resistant packaging : susbstitution currently not feasible. 6.1.7. Time needed for substitution/potential socio-economic effects Fluoropolymer additive and waxes for thin film extrusion: when alternative would be available, it would take about 2 years to implement on converting lines. Additional approval such as food contact would take an extra 2 to 3 years. Therefore Entry into Force +6.5 years would seems an appropriate period to enable substitution. In addition, there should be as highlighted above a transition period of 6 years foreseen after the phase out of fluoropolymer as plastics additives in order to meet the 50 ppm limit and mechanical recycling of those films. In order to make sure that this additional derogation is only allowing recycling, we would recommend the fluoropolymer content in polyolefin plastic film to be limited as follows: EiF + 6.5 to 10.5 EiF + 10.5 to 11.5 EiF + 12.5 Allowed maximum fluoropolymer concentration 350 ppm 150 ppm 100 ppm Avenue de Cortenbergh 71- B-1000 Brussels Phone: +32 (0)2 732 41 24 Fax: +32 (0)2 732 42 18 @eupc.org www.plasticsconverters.eu Page 8 of 9 6.2. Socio-economic impact Fluoropolymer additives in masterbatches and compounds for the extrusion of thin polyolefin films: We have ascertained costs above ranging between 1,375 billion and 6,875 billions for the substitution process to take place. In case of non use (i.e. flexible packaging would stop being produced in case no sufficient transition period is granted ), the related turnover is estimated at 8,25 billion /year, that is over 10 years assuming a growth of 1% (GDP growth) and the standard Echa discount rate of 4% a value of 75,5 billion . Impact on the downstream flexible packaging sector would be the double of this. i.e. 151 billions at the minimum. We estimate employment in film extrusion to be around 11,000 FTE. Employment in our downstream sector (flexible packaging) is 57000 FTE. 6.3. Proportionality Fluoropolymer additives in masterbatches and compounds for the extrusion of thin polyolefin films: Substitution cost due to needed requalification are estimated to exceed 1 billion whilst emission are negligible. The industry is looking for alternative additives for replacing PFAS , but there should be enough time given to enable this. PTFE and FKM use in caps and closures for heat and chemical resistant packaging : Those use are for the time being not substitutable and would disrupt the whole industrial supply chain if a derogation is not granted. 10. Analytical methods Generally, there are still many open questions about PFAS analysis. We would welcome the development of standardized analytical methods for PFAS in plastics at CEN level. Given the number of potential PFAS to detect, compliance will be almost impossible especially for recycled compounds due to the lack of definite approach for calibration material. Whilst it would to a certain extent possible for converters to rely on composition declarations this is not possible for recycled polymer due to the variability of input material and potential contamination. We would therefore recommend to limit the requirement for plastics recyclate or articles containing those to the total organic fluorene content. Depending on the application the TOF should be defined (e.g. for thin polyethylene film TOF should be correlated to the needed transitory limits for fluoropolymers : see section 4 above). It should be noted that it seems that due to interference from other constituents of materials that are subjected to such analysis a practical detection limit with this method cannot be below 10 ppm. Allowed TOF target levels should be aligned to the derogated maximum amount of fluoropolymer material in plastics recyclate. Contact: @eupc.org; @eupc.org Avenue de Cortenbergh 71- B-1000 Brussels Phone: +32 (0)2 732 41 24 Fax: +32 (0)2 732 42 18 @eupc.org www.plasticsconverters.eu Page 9 of 9