Risk Management Evaluation Endosulfan

72.Industry stakeholders have identified use in semiconductor industry as potentially critical. The Semiconductor Industry Association (SIA) surveyed its member companies and found that several companies continue to use PFOA and related chemicals in the photo-lithography process, a key step in the manufacturing process to produce advanced semiconductors (SIA Comments on 1st draft RME). This sector is responsible for a very low share of total emissions of PFOA and PFOA-related compounds. The volume used in the sector is a minor part of the total volumes used in the EU and the substances are reported to be used under strictly controlled conditions. Typical control measures are documented in the OECD Emissions Scenario Document No. 9, Photoresist Uses in Semiconductor Manufacturing (OECD, 2010; SIA, 2016). 24

73.Information submitted by the sector tends to demonstrate that substitution is currently not possible, and that the timeframes for substitution are long (10 years). 24

74.The public consultations within the EU confirmed that the costs incurred would be high if this use was not derogated. Because of the low amounts used and the fact that emissions are expected to be low, a time limited derogation (until 4 July 2022) for the equipment used to manufacture semiconductors is given in the EU restriction. 24

75.Besides, derogation without time limitation is given for photo-lithography processes for semiconductors or etching processes for compound semiconductors and for semiconductors or compound semiconductor under the EU restriction (see ECHA 2015c and European Commission, 2017). 24

76.In Canada, semiconductors in manufactured items are exempted, whereas in Norway an exemption for adhesives, foil or tape in semiconductors terminated in 2016. 24

77.SEMI (a global industry association serving the manufacturing supply chain for the micro- and nano-electronics industries) supports the exemption for photo-lithography processes for semiconductor manufacturing and highlights that this exemption should take the form of an “acceptable purpose” (SEMI Comments on 2nd draft RME). 25

78.Besides, SEMI proposes a number of additional proposals for exemptions and acceptable purposes. In addition to the manufacturing equipment, an exemption without time limit is proposed for their replacement and spare parts. Further, SEMI proposes a five-year exemption for facility-related chemical, gas, and air distribution and control systems for semiconductor manufacturing fabrication facilities as well as a five-year exemption for chemical container systems for the storage, conveyance, and transport of substances or mixtures (SEMI Comments on 2nd draft RME). In addition, SIA requests that suppliers are provided with an acceptable purpose exemption under Annex B for its uses of PFOA and related compounds in manufacturing “tools” and ancillary equipment. The incorporation of small amounts of PFOA and related compounds into the fluoropolymers used in tools and ancillary equipment, including seals, coatings, valves, gaskets, and containers found in these tools, as well as spare parts is needed to achieve critical performance and functional requirements. These complex pieces of equipment are used in fabrication facilities with minimal potential for exposure. In conclusion, SIA calls for an exemption under Annex B of the Convention for the industry’s uses of PFOA and related compounds in its manufacturing processes and the use of these chemicals in advanced manufacturing equipment (SIA Comments on 1st draft RME). 25

79.For non-technical textiles used in outdoor applications (e.g. awnings and outdoor furnishing, camping gear), alternatives are available and an exemption is not justified in the EU. 25

80.For filter materials for oil and fuel filtration some companies claim that no alternatives are available. However, other companies report the availability of alternatives (short-chain fluorinated chemicals) in high performance areas (ECHA, 2014a, 2015a). Overall, it cannot be fully assessed whether an exemption is justified in the professional sector due to data gaps mainly on volumes, specific uses and substances. It could be agreed to grant a transitional period for the remaining uses in the professional sector as personal protection equipment needs to fulfil specific requirements, which are established in respective standards (e.g. standard EN 13034 for protective clothing). 25

81.For textiles for the protection of workers from risks to their health and safety a time-limited derogation (until 4 July 2023) is given in the EU. The ECHA SEAC proposes a similar exemption for membranes intended for use in medical textiles, filtration in water treatment, production processes and effluent treatment (European Commission, 2017). 25

82.In Norway, only textiles for consumer use are restricted, while textiles for professional use are not covered. The Canadian approach does not apply to manufactured items, i.e. import, use, sale and offer for sale of textiles containing PFOA, its salts and its precursors are not restricted in Canada. 25

83.According to the information submitted by the Bavarian Textile and Apparel Association and South-Western Textile Association (VTB SWT), PFOA may occur as an impurity of the production of side-chain fluorinated polymers, which are used as formulations/mixtures for the oil-, water- and chemical-repellent finishing of textiles. Application technique is performed at highest standard and, if at all, only traces of PFOA are transferred by impregnation. As a cross-sectional industry, the professional, technical and protective textile sector of the textile industry has to fulfil many different performance standards in particular medical, chemical, environmental protection as well as
fuel-repellency safety standards for the automotive and aircraft industries. Almost all of these textiles have to be certified in long procedures, which could take years and several textiles are regulated by various other EU- and national laws. These are complemented by standards and regulations of separate enterprises, called in Germany “TL” which could be translated i.e. Technical Performance profile. The German textile industry staff is adequately trained, the occupational health and safety is strictly fulfilled and monitored (VTB SWT, 2016). Technical standards such as those used in Germany could be elaborated as examples of good practice (Netherlands Comments on 2nd draft RME). However, the PFOA amounts and manufacturing process and conditions in other countries and regions are not known and could be substantial; resulting in human exposure and environmental releases (IPEN Comments on 1st draft RME). 26

84.Side chain fluorinated polymers based on PFOA related substances (e.g. 8:2 Fluorotelomer acrylates) used for textile treatment contain 2% unbound residues of PFOA related substances (Russel et al., 2008). These unbound residues can be released to the environment via air and water during the use and waste phase of the treated textile. PFOA related substances can moreover be used in impregnation agents (ECHA 2015a). The European Apparel and Textile Confederation (EURATEX) consider the inclusion of exemption for water, oil- and chemical-repellence crucial for occupational safety. The transitional period of 6 years would enable ongoing and new projects to deliver results for better performing and environmentally friendlier fluorinated and non-fluorinated polymer alternatives within the European REACH process (Euratex, 2016). 26

85.According to Textile+Mode association, a lot can be done to meet the risk reduction goals. A common practice is the containment technology. It allows the recycling of PFOA and reuse during polymerization and the retention from contaminated air and process wastewater. During the textile refinement, the minimization of emissions is a common practice. The use of best environmental practice (BEP) in production is a major key to avoid emissions and/or to bring them down to a very low level. In the EU technical textiles are produced respecting the BEP. The treatment with fluorinated products has the aim to minimize the influence of the environment by durable oil- and water repellency. The properties have been developed and optimized within the last decades to reach and keep up this high level of protection. Therefore, an exemption for professional, technical and protective textiles, which must meet durable repellency performance standards, is considered indispensable (TM, 2016). 26

86.Comments from the industry submitted during the EU public consultation indicate that PFOA and related compounds are present in latex inks used in professional printers. This use only continues in printers that are no longer manufactured, and therefore a phase-out is already underway. There seems to be a clear decreasing trend in the amounts used and related emissions. The company that has manufactured the printers and inks in question claims that in absence of a transitional period of 5 years, there would be a need for premature replacement of the printers in use, and the costs would be high because there would be a loss in image quality. The scientific committee of the EU concluded that it is justified to accept a transitional period of 5 years for latex printing (ECHA, 2015c) so that a time limited derogation (until 4 July 2022) is given in the EU (European Commission, 2017). For water-based inks a time limited exemption (until 31 December 2016) was in place in Canada (Canada Comments on 1st draft RME). The Norwegian risk management approach, however, only applies to consumer products and does not restrict PFOA use in inks for professional use/printers. 26

87.According to FluoroCouncil, industry may perform reprocessing of an unavoidable fraction of PFOA and PFOA related substances as isolated intermediates to produce C6 fluorotelomer alternatives in another site than the production site and therefore an exemption for transported isolated intermediates is needed (FluoroCouncil Comments on 2nd draft RME). An exemption for transported isolated intermediates without time limit is given in the EU restriction according to its paragraph 4(c) provided that the conditions in points (a) to (f) of Article 18(4) of the EU Regulation (EC) No 1907/2006 are met (European Commission, 2017). An exemption should also be considered under the Stockholm Convention for transported isolated intermediates in order to enable reprocessing in another site than the production site. The conditions could be similar to what is established under the EU risk management approach, i.e. that the synthesis of (an)other substance(s) from an intermediate takes place on other sites under the following strictly controlled conditions: (1) the substance is rigorously contained by technical means during its whole lifecycle including manufacture, purification, cleaning and maintenance of equipment, sampling, analysis, loading and unloading of equipment or vessels, waste disposal or purification and storage; (2) procedural and control technologies shall be used that minimise emission and any resulting exposure; (3) only properly trained and authorised personnel handle the substance; (4) in the case of cleaning and maintenance works, special procedures such as purging and washing are applied before the system is opened and entered; (5) in cases of accident and where waste is generated, procedural and/or control technologies are used to minimise emissions and the resulting exposure during purification or cleaning and maintenance procedures; (6) substance-handling procedures are well documented and strictly supervised by the site operator. 27

88.According to the Imaging and Printing Association Europe (I&P Europe), the primary control measure adopted voluntarily has been to pursue the development of alternatives. Since 2000, the industry has reformulated/ discontinued a large number of products, resulting in a world-wide reduction in the use of PFOA-related compounds of more than 95%. Although replacements do not currently exist for the remaining few applications, further reduction in use of these substances is anticipated as the transition continues towards digital imaging. I&P Europe believes that additional control measures for ongoing uses are not necessary (I&P Europe, 2016a). 27

89.According to I&P Europe, the non-availability of PFOA-related compounds for the manufacture of the remaining relevant imaging products will also adversely affect involved customer groups such as healthcare and military. In view of the healthcare sector for example, it could be financially challenging for hospitals and doctor's offices with tight budget restraints to invest in new technologies necessitated by discontinuation of current conventional photographic products. It can be expected that such impact is larger in developing countries and in certain EU countries in the medical area such as Italy, Spain, Portugal, Greece and a number of Eastern European countries (I&P Europe, 2016a). 27

90.Within the EU risk management approach, an exemption is given for photographic coatings applied to films, papers or printing plates (European Commission, 2017). The specific exemptions for this use in Norway and Canada expired in 2016.However, the Norwegian risk management approach only applies to consumer products and the Canadian approach does not apply to manufactured items. Hence, the import, use, sale and offer for sale of photo media coatings applied to film, papers or printing plates are not restricted in Canada. 27

91.During the EU public consultation on the restriction dossier, only one company applying coating for smartphone manufacturers requested a derogation for 3 years for pulsed plasma
nano-coating in order to be able to move to an alternative C6 chemical. (ECHA, 2015c). For plasma nano-coating a time-limited exemption (until 4 July 2023) is given in the EU (European Commission, 2017). The Canadian approach does not apply to manufactured items. Hence, the import, use, sale and offer for sale of coatings applied to smartphones (or other electronic equipment) are not restricted in Canada. 28

92.EU industry stakeholders requested an exemption for spare parts of various types (aviation, telecommunication, semiconductors, information and communications technology industry). The concern relates to the possibility to place on the market and use in the EU spare parts already manufactured at the date of entry into force. According to their comments, in the absence of derogation, those spare parts would have to be destroyed, which would represent an economic loss for EU manufacturers. The ECHA RAC and SEAC found that the derogation for spare parts in stock before the entry into force of the restriction was justified for all applications, including the cases mentioned above as well as other cases), given the costs of their elimination and low emissions associated with their prolonged life (ECHA, 2015c). In the EU restriction, there is no exemption for spare parts (European Commission, 2017). 28

93.Further, the Canadian Vehicle Manufacturers’ Association (CVMA) requests specific exemptions for automotive service and replacement parts. According to CVMA, the industry has been proactively phasing out PFOA use for some time. However, service and replacement parts might still contain PFOA. These parts represent a small percentage of PFOA use and will decrease naturally over time as the vehicle fleet turns-over. Automotive manufacturers need to ensure the availability of original equipment and spare parts in order to satisfy customer demand (CVMA 2017).According to the information submitted by IPEN, an exemption would also result in ongoing PFOA releases to humans and the environment from production and use. 28

94.According to SEMI, regarding manufacturing equipment and related infrastructure in the semiconductor industry, a transitional period would be required also for maintenance, spare, replacement, or refurbished parts for legacy equipment or legacy fabrication plant infrastructure (comment SEMI, 2017 on first draft RME). 28

95.AFFF is a generic term for firefighting and/or vapor suppression products used globally to extinguish fires. AFFFs were designed to be especially effective in extinguishing Class B (flammable liquids) fires. AFFFs may contain PFOA or PFOA-related substances. Not every situation will necessarily require the use of firefighting foams. Only a careful consideration of the specific situation at hand (emergency incident or design of fire/property protection system) and review of local building codes and other regulations can determine the proper product selection. Over the past decade, AFFF manufacturers have been replacing PFOS-based products with fluorotelomer-based fluorosurfactants. Today most firefighting foams are manufactured with fluorochemicals/telomers based on a perfluorohexane (C6) chain (further details see UNEP/POPS/POPRC.12/INF/15/Rev.1), but there are fluorine-free foam or other methods of extinguishment alternatives available fulfilling the requirements of efficiency for many areas of use in Class B fires (Swedish Chemicals Agency, 2016a). For firefighting foams containing PFOA-related substances a number of alternatives exist (see paras 158 to 165). 28

96.To be consistent with the exemption for foams already in use, and to avoid the need for early replacement of exempted foams, SEAC proposed to derogate these mixtures from the EU restriction for 20 years. This is the normal lifetime for firefighting foams, and this time period is supported by comments from the public consultations (ECHA, 2015c). In the European process, despite concerns raised by some firefighters and foam manufacturers that, in high risk chemical plants and large storage areas, fluorine containing foams with a PFOA and related substances content of up to 1,000 ppb would be needed for another 10 years, the European Commission received ample information from two different sources, demonstrating the availability and effectiveness of entirely fluorine free foams. In addition, short chain fluorine based foams already exist. Here, impurities of PFOA and PFOA related substances seem to be a problem, rather than their presence being essential to technical performance. The Commission considered that the general deferral of three years should be a reasonable timeframe for the firefighting foam manufacturing industry to adapt their formulations to the restriction. 29

97.According to the information submitted by IPEN, the normal lifetime of firefighting foam varies considerably with temperature and storage conditions. 20 years is an inappropriate length of time for continued dispersive use of POPs, a use which has led to massive contamination of groundwater in many countries. Germany, supported by Austria, proposes to include a short transitional period for the use of foams already placed on the market, since the firefighting foams are very stable and may be stored for very long time until used in the case of fire. To avoid continued emissions to the environment from this source, existing foams should be replaced with sustainable/suitable alternatives (Germany Comments on 1st draft RME; Austria Comments on 2nd draft RME). 29

98.Regarding the placing on the market of new AFFFs for professional use, SEAC notes that during the EU public consultations, some stakeholders (firefighting services, foam manufacturers) have requested higher concentration limits for PFOA-related substances and PFOA, or total exemption of firefighting foams. Overall, given the information provided, SEAC proposed to adopt a higher limit value of 1 000 ppb per substance, for both PFOA or for each PFOA-related substance when used in firefighting foam concentrates, and to reconsider this concentration limit with an aim to lower it in the proposed review of the restriction 5 years after entry into force (ECHA, 2015c). 29

99.Within the EU restriction according to its paragraph 4 (e), an exemption is given for concentrated firefighting foam mixtures that were placed on the market before 4 July 2020 and are to be used, or are used in the production of other firefighting foam mixtures. An exemption is given for firefighting foam mixtures (1) placed on the market before 4 July 2020 or (2) produced in accordance with paragraph 4(e), provided that, where they are used for training purposes, emissions to the environment are minimized and effluents collected are safely disposed of (European Commission, 2017). In Canada, a not-time-limited exemption is given to AFFFs used in firefighting applications (Canada 2016c). There are no exemptions in place for firefighting foams in Norway, however, the risk management approach does not apply since it concerns consumer products and AFFFs are for professional use only. The Canadian Fuels Association (CFA) supports the exemption of AFFFs as proposed in the RME (CFA Comments on 2nd draft RME). 29

100.In the EU public consultation, stakeholders have indicated that substitution is ongoing but is a lengthy process given the complexity of the supply chains and the certification processes. General transitional period of a minimum of 5 years was requested, but for some devices this transitional period could be too short. In the specific case of implantable medical devices, a manufacturer requested a transitional period of 15 years (ECHA, 2015c). 29

101.Within the EU restriction, time-limited exemption (until 4 July 2032) is given for medical devices other than implantable medical devices within the scope of Directive 93/42/EEC. In addition, an exemption without time limitation is given for the production of certain implantable devices (European Commission, 2017). Norway has an exemption in place for medical devices (no time limit). 30

102.According to chemical industry, alternatives have not been developed for all pharmaceutical and some other highly specialized chemicals which use PFOA-related chemicals as their raw material and/or processing media and which have socio-economic benefit in particular performance standards (FluoroCouncil, 2016a). There is no information specifying “other highly specialized chemicals”. In the SAICM context environmentally persistent pharmaceutical pollutants are adopted as a global emerging policy issue, while recognizing that pharmaceuticals have major benefits for human health and animal welfare. Perfluorooctyl bromide (PFOB) is produced from perfluorooctyl iodide (PFOI). PFOI is produced at one single site in Japan during the production of 6:2 fluorotelomer-based substances (telomerisation, separation and distillation in closed system), and then transported as isolated intermediate to another site in Japan to produce PFOB. All the wastes generated from this production of PFOI are collected in closed system and are incinerated. A minor amount of emission to the air can be expected and is estimated to be less than 1 kg per year. Afterwards, PFOB is transported to two sites in the US and Sweden to produce relevant pharmaceutical products (Daikin Comments on 2nd RME and information from IFPMA at POPRC-13). 30

103.PFOB is used as a processing aid in the manufacture of “microporous” particles for pharmaceutical applications. PFOB is not a PFOA related compound. PFOB does, however, contain unintended trace levels of PFOI, a PFOA related compound. The residual PFOB in the finished “microporous” pharmaceutical products is typically 0.1%, which translates to residual PFOI at levels of 0.1 ppm. The detection limit for PFOB in the porous particles is 0.1%. The PFOI residual in all currently produced pharmaceutical products totals to less than 2g per year. Emission of PFOI to the environment from pharmaceutical production is currently less than 30g total per year. PFOB in process waste is captured in serial carbon beds, which is the best available technology and it controls emissions to less than 1% and typically to less than 0.1% (Information from IFPMA at POPRC-13). 30