Document oD568Z30zR1GxaRYZoxJrJEGE

BISPHENOL AF Consortium Initial input into public consultation on the restriction of BPA and Bisphenols of Similar Concern Brussels, 25 January,2023 The Bisphenol AF and related substances REACH registration Consortium groups the registrants of Bisphenol AF in Europe, both manufacturers and importers. Members of the Bisphenol AF and related substances REACH registration Consortium are; Central Glass Europe, Chemours Netherlands BV, Daikin Chemical Europe GmbH, Solvay Specialty Polymers Italy SpA. During this initial submission we will focus on the following topics. Bisphenol AF is not a substitute to BPA Clarification of Bisphenol AF uses Comments on restriction wording Information on exposure in industrial premises We intend to further complement our submission by end of March. Page 1|9 1. Restriction conditions and testing Do you consider that the restriction conditions (including derogations listed in Appendix Y) and the conditions and methods for migration testing (as described in Annex Z) are clear? Are there conditions that require further clarification? Do you consider that the conditions and methods for migration testing as described in Annex Z are representative to assess migration during the entire article service life? If not, can you propose a more reliable testing? 1.1. Definitions Gum : uncured fluoroelastomer rubber (not cross-linked). The terms gum, raw gum and basepolymer are used as synonyms in the market. Pre-compound : mixture of gum, unreacted Bisphenol AF and accelerator. Typical precompound may contain up to 4% Bisphenol AF. Masterbach : Concentrated precompound including gum, unreacted BPAF and accelerators. Bisphenol AF content may be between 4 and 50% Full compound : a mixture containing gum, unreacted BPAF, accelerator and additives such as metal oxides, carbon black etc...Bisphenol AF concentration is below 4%, usually lower Curing : the process by which Bisphenol F reacts as a crosslinking agent and becomes covalently bound to the polymer chain. It takes place at the same time as the moulding operation. The terms curing, cross-linking and vulcanization are commonly used in industry to refer to this reaction. Article : fluoroelastomer product where curing (cross linking reaction) took place. FKM is a family of fluorocarbon-based fluoroelastomer materials defined by ASTM International standard D1418 and ISO standard 1629. 1.2. Wording of the restriction is unclear and leads to legal uncertainty We welcome the intention of the restriction dossier to foresee derogations applicable to the use of bisphenol AF in fluoroelastomers. However, we would like to express concerns as regards the wording of certain provisions and share proposals on how to address them. Indeed, the current wording is unclear and would probably prevent the use of Bisphenol AF in fluoroelastomers if it remains as today. This comes from a simplification/confusion regarding the structure of the fluoroelastomer/FKM supply chain (see section 1.5 for a more detailed description). Indeed, the current restriction wording only foresees that mixtures and articles that are covalently bound to any type of matrix (e.g. via functioning as a crosslinker) or are used as Page 2|9 intermediates in the manufacture of polymers may under certain conditions be exempted from the restriction (no aqueous contact, meeting of a migration limit). This ignores the whole formulation step(s) between manufacturing/importing of the substance and the production and placing on the market of an article. During this step solid mixtures containing unreacted Bisphenol AF are formulated and used. Those mixtures are therefore not yet crosslinked and covalently bound. Furthermore the reference to intermediate use creates legal uncertainty. It is unclear whether or not uses during formulation and use of the obtained compounds in the production of an article can be considered as an intermediate use. Indeed, there is currently controversy in what is an intermediate use. The ECHA guidance supported by EC has a narrow interpretation of the meaning of intermediate. Intermediate use may only be considered for the manufacturing of a substance, not a mixture or an article and it excludes cross-linkers (and therefore Bisphenol AF). Several industry associations contest this interpretation based on ECJ court case C-650/15 P (Acrylamide judgment). In June 2022, the EC proposed to amend the definition of intermediate to confirm its narrow interpretation, even imposing strictly controlled conditions for authorization purposes. Due to the legal uncertainty, it is not appropriate to refer to the use of Bisphenol AF into mixtures and articles as an intermediate use. 1.3. Proposed revised wording As mentioned by the dossier submitter, we do not expect releases to water at industrial stage, which is the stage where mixtures are formulated and used. During the formulation stage Bisphenol AF is incorporated in solid mixtures in dedicated facilities. This greatly reduces the risk of exposure and release to environment by focusing this activity in dedicated facilities, and avoiding the handling of Bisphenol AF in powder form. The solids mixture takes the form of sheets in most cases, sometimes pellets or stripes. The current restriction wording would prevent these operations to take place. This would force the downstream article producers to handle Bisphenol AF in pure form (i.e. powder form), which increases the risk or makes the operation impossible because the article producers are not equipped to handle Bisphenol AF safely. We would therefore propose the following adapted wording for the main restriction conditions: "Bisphenols, HO-(R1)-R2-(R3)-OH with R1 and R3 being phenylene groups bearing any substituents at any ring position and R2 being a methylene group being unsubstituted or bearing any substituents or another bridging unit bearing unspecified substituents, which are listed in Appendix X and their salts. [...] Page 3|9 1. Shall not be placed on the market in mixtures and articles in a concentration equal to or greater than 10 ppm (0.001 % by weight). This limit value refers to the sum of all substances subject to this Annex XVII entry which are present in the respective mixtures and articles. 2. Paragraph 1 shall not apply to mixtures and articles where the bisphenols listed in Annex X are either covalently bound to any type of matrix (e.g. via functioning as a crosslinker), are used or formulated in uncured mixtures used at industrial sites such as masterbatches, precompounds, compounds, uncured elastomers sheets, or are used as intermediates in the manufacture of polymers, and for which i. contact to aqueous media in any form can be excluded during their reasonable and foreseeable use throughout their service life or ii. the migration limit in the respective mixtures and articles does not exceed 0.04 mg/L over the entire service life. Conditions for migration testing are described in Annex Z below. " 1.4. Fluoroelastomers derogation in appendix Y A time limited derogation is foreseen for fluoroelastomers containing less than 50 ppm residual BPA. The derogation therefore is applicable to cured articles and not mixtures (masterbatches, pre-compounds and compounds will always contain much more bisphenol AF in the range of percents). Those upstream industrial uses need to be adequately derogated so that this derogation is applicable. The derogation is foreseen for a period of 10 years. A 10 year period however may be too short to achieve the targeted residual content. We are now evaluating the feasibility and time required for such a target. As highlighted below, test methods are not yet harmonized and we do not yet have sufficient experience to appropriately set a residual content level at 50 ppm. We would therefore recommend the limit to be set at higher concentration for the time being. We are currently developing a reference test method to enable better determine bisphenol AF residual content in articles in an unambiguous way. Page 4|9 1.5. Supply chain structure and actors Bisphenol AF function is as a crosslinking agent in fluoroelastomers/FKMs articles. The supply chain structure is summarized in the graph below : BPAF Manufacture/import Formulation of mixtures Pre-compounds including masterbatches (gum, BPAF and accelerators Full compound (uncured s eet) gum B F accelerators ot er add t es Article Production Own compounding on ert ng and cur ng nto an rt cle ( ngs oses etc) Downstream uses : automotive, transport, aerospace, industry... Different types of mixtures may be prepared by formulators. Those mixtures will usually contain more than one percent of unreacted Bisphenol AF. The mixtures may be used as such by the article manufacturers or added to other ingredients before the finished article is cured. It is during the article manufacturing that the Bisphenol AF reacts as a crosslinking agent and becomes covalently bond to the polymer matrix. After curing (potentially followed by post-curing), residual Bisphenol AF is found in ppm ranges. All compounding and curing operations are performed at industrial sites (industrial uses). There are no consumer or professional uses of uncured mixtures. In accordance with ASTM D1418-17, uncured FKM polymers (also known as `gum') cannot be used by themselves to make a rubber article. The functional properties are not obtained until the polymers are crosslinked. In order to crosslink the polymer, Bisphenol AF is used as the crosslinking agent. Page 5|9 To facilitate ease of operation some FKM manufacturers add Bisphenol AF and other ingredients such as accelerators to t e FKM polymer/gum. T s m xture s called a `pre-compound' and s n an uncrosslinked form (typical Bisphenol AF content up to 4%). The pre-compound may also be placed on the market as a concentrate called a masterbatch (Typical Bisphenol AF content between 4 and 50%). The pre-compound cannot be used by itself to make an article. Article producers use the precompounds and add additional additives and potentially extra gum . A fully formulated and ready to be converted so called "Full compound" may also be sold to art cle manufacturers (i.e it will contain gum, BPAF accelerators, other additives such as metal oxides or colorants). Concentration of BPAF will be below 4%. The Full compound can be supplied in the form of solid pellets, or stripes but most often is delivered as a sheet. Pellets, stripes and sheets at this stage are considered as mixtures according to REACH. The compound is supplied to article producers who mould the compound into an article. During the moulding process, the crosslinking agent becomes active and forms the three-dimensional network of a crosslinked elastomer. Some of the common moulding techniques used are compression, injection and transfer moulding. In other cases, the uncured compound is extruded into articles such as hoses or tubes and then crosslinked. 2. Which analytical methods exist for your sector to test: a. the content of BPA and BoSC in article or mixtures that are covered in the scope of the restriction? b. migration of bisphenols from your articles, part of articles and/or mixtures? In your answer, please specify the aim and purpose of the testing (for example, testing in the context of testing REACH conformity, characterising performance or stability). Which solvent do you use to extract BPA and/or BosC in either content or migration testing? We are developing a reference test method for determining Bisphenol AF content in articles and will submit more information by end of March 2023. Most cured articles containing residual BPAF would not necessitate migration testing since those fluoroelastomers (FKMs) are used in under the hood applications in automotive, transportation and aerospace w c don't a e any contact with water such as : Turbocharger hoses Particle filter hoses/Differential pressure hoses Page 6|9  Fuel hoses/filler neck hoses Seals and gaskets Regarding the limited outdoor applications migration testing, the methods proposed for the tier 1 assessment would be relevant. Given the very low Bisphenol AF residual content in articles and their stable nature, we expect limited migration in environmental conditions. We are further investigating those elements on which we intend to provide more elements by end March 2023. 3. Do you see any challenge in the supply chain communication on the presence of BPA/BoSC in mixtures and articles? Are you aware of any liquid mixture containing more than 10 ppm of BPA/BoSC and for which contact to water cannot be excluded during its service life (and for which according to the proposed restriction conditions migration testing would be required)? Do established methods for the BPA/BosC content analysis for liquids exist in your application at your sector? Please specify. 4. Alternatives The Dossier Submitter identified different alternatives for the different uses of Bisphenol A and BoSC (e.g. in PVC, thermal paper, hardeners for epoxy resins, polycarbonates, epoxy resins, polysulfones, polyesters, phenolic resins, polyurethanes, vinyl ester resins, polyacrylates, syntans, fluoroelastomers). These are described in section E.2 of the Appendix. Do you agree w t t e Doss er Subm tter's conclus on regard ng t e a a lab l ty of alternatives? Do you have additional information on alternatives that should be considered as part of the Impact Assessment. Bisphenol AF is not a substitute for BPA. The dossier submitter mentions that Bisphenol AF could be a substitute for BPA. We want to clarify again that Bisphenol AF is not an alternative to BPA as a crosslinking agent for the manufacture of fluoroelastomers. Tonnages placed on the market in Europe based on the consortium members estimate and market research are several orders of magnitude lower than the quantity to BPA used in different applications esp. the manufacture of PC as mentioned in the annex XV report. Moreover, due to its higher cost, Bisphenol AF is not an economically feasible substitute for BPA in those applications where BPA is used. The price of Bisphenol AF is more than one order of magnitude higher than the one of BPA. There are currently no satisfactory alternatives to the Bisphenol AF based systems. Previously used diamines are associated to odour nuisance, insufficient processing and vulcanization properties, higher reject rates and poorer heat resistance. Likewise peroxide curing systems have lower heat resistance than Bisphenol AF based systems. Page 7|9 5. The Dossier Submitter assessed the impacts of the examined restriction options (See Annex E and section 2.4 of the Annex XV report). Please provide additional information on the economic impacts of the proposed restriction. Please consider both the restriction conditions as described in paragraph 1 and 2, as well as the derogations described in Appendix Y. If the derogations are relevant for your sector, please also describe the economic impacts you would expect in case the derogations are removed. We are currently assessing the impact of removing the derogation on residual content in finished fluoroelastomers articles. This would mean one would have to rely solely on migration testing since meeting the 10 ppm residual concentration limits seems not reachable for the time being. Fluoroelastomer (FKM) articles are essential for the functioning of society as they are used in sealings, O-rings, stators for pumps and engines, gaskets, turbocharger hoses, particle filter hoses/Differential pressure hoses, fuel hoses/filler neck hoses, pressure hoses, pumps, sealing used in automotive engine (fossil and electric), transport (ship, train), aerospace. In industrial applications: mainly valves and seals for oil and gas lines, hose lines, pneumatic cylinders, pumps, sealing plates and hydraulic systems. We will submit a refined evaluation at a later stage of the consultation. 9. Emissions During the manufacture of your products or their use, which measures do you employ to m n m se t e amount of "free" B /Bos n t em? The following risk management measures are recommended by the manufacturers/importers of the substances at all industrial stages (manufacturing, formulation or re-packing, substance formulation and pre-compounding, converting of articles involving curing or post curing. Emission for each compartment are estimated at 1E-4% in the registrants Chemical Safety Report and the following risk management measures considered. "Water : Any wastewater containing the substance should be collected, re-used or suitably treated prior to release to sewage treatment plants to ensure no release of the substance to the environment via wastewater. High levels of containment and zero waste policies should be used where possible. No water is used for the production or cleaning of equipment during the mixing of FKM and Bisphenol AF in the process of formulation, compounding, moulding and extrusion, no Bisphenol AF is released via wastewater or the sewer"1. "Air : Efficient capture of vapours and/or airborne particulates using chemical or mechanical means should be employed to ensure no significant release of the substance to the atmosphere. Waste generated from capture methods containing the substance (if any) should be disposed of accordingly to prevent subsequent environmental release of the substance"2. During moulding and extrusion, processors always use ventilation to remove the fumes from the operators. The fumes are volatile compounds, mainly process aids. The industry uses itself and also recommends the use of Best Available Technology air filter units during the Bisphenol AF production 1 Bisphenol AF Chemical Safety report section 9 2 Ibidem Page 8|9 process and for the additive weighting and curing processes. The filters have an efficiency of 99.9%, max 0.10 mg/m3. "Non agricultural soil : Sumps, bunding, or any other appropriate spill prevention and cleanup procedures should be in place to capture any local releases to non-agricultural soil. Waste generated from capture methods containing the substance (if any) should be disposed of accordingly to prevent subsequent environmental release of the substance"3. 10. Emission estimates are provided in Annexes B8 and H. Please provide any additional information regarding the emission estimates. Additional refined information shall be submitted by the end of March. Overall BPAF emission during service life is considered low since most application are not exposed to water. See enclosed : ap1_2023-01-24_BPAF use description for exposure based waiving. 3 Ibidem Page 9|9