Risk Management Evaluation Endosulfan

Summary information relevant to the risk management evaluation

36.PFOA and its salts are, or were, most widely used as processing aids in the production of fluoroelastomers and fluoropolymers, with polytetrafluoroethylene (PTFE) being an important fluoropolymer. PFOA-related compounds, including side-chain fluorinated polymers, are used as surfactants and surface treatment agents (e.g. in textiles, paper and paints, firefighting foams). PFOA, its salts and PFOA-related compounds are used in a wide variety of applications and consumer products across many sectors (UNEP/POPS/POPRC.12/11/Add.2).

37.Releases occur from past and ongoing production and use. Direct releases to the environment occur from the production of the raw substance (including PFOA as impurity in the manufacturing of PFOA-related compounds and some alternatives), during the processing, use and disposal of the chemical, from treated articles and from products contaminated with PFOA. Main emission vectors of PFOA and its salts are water, wastewater and dust particles. Historic releases to the environment from PFOA manufacturing are available from a plant in the US into air and water between 1951 and 2003. Some estimates of releases during the disposal of the chemical are available, particularly from sewage treatment plants, wastewater treatment plants and landfill sites. Indirect releases occur from the degradation or transformation of precursors. PFOA-related compounds are released to air, water, soil and solid waste and will degrade to PFOA in the environment and in organisms. An assessment of sources of PFOA to the Baltic Sea estimated that 30% of the releases were due to transformation of fluorotelomers. Thus, releases of PFOA from degradation of PFOA-related compounds contribute a substantial share to the releases of PFOA to the environment (UNEP/POPS/POPRC.12/11/Add.2). Additional information regarding the transformation/degradation of fluorotelomers to PFOA is summarized in section II of FOEN, 2017. A summary of further risk profile information is given in section 3.1. According to a study from 2008, perfluorocarbons (PFCs) are widely used in aluminium production and emissions of PFCs (possibly including PFOA; not specified in the study) occur during specific electrolysis processes in aluminium manufacturing (see EP 2008).

38.Switzerland provides information on the unintentional formation of PFOA from inadequate incineration of fluoropolymers e.g. from municipal solid waste incineration (MSWI) with inappropriate incineration or open burning facilities at moderate temperatures. Some recent studies qualitatively show that small, but measurable amounts of PFOA and a wide range of other PFCA homologues can be generated during the thermolysis of non-functionalized PTFE (Ellis et al., 2001, 2003; Schlummer, 2015) and functionalized PTFE (Feng et al., 2015) at temperatures between 250°C and 600°C. This may be particularly critical for developing countries and countries with economies in transition, where wastes are often not incinerated to sufficiently high temperatures and without proper treatment of flue gases due to a lack of adequate facilities (see FOEN, 2017).

39.National and regional control actions differ with regard to their chemical scope and exemptions (see Table ). The chemical scope of the possible measures discussed in the present risk management evaluation has a different scope compared to other regulatory risk management approaches and is based on principles and obligations of the Stockholm Convention. It is noteworthy that PFOA-related compounds for the purposes of this risk management evaluation covers degradation to PFOA from long-chain PFASs with more than eight perfluorinated carbon atoms except for those explicitly excluded in the definition of PFOA-related compounds as they do not degrade to PFOA under natural conditions (see para 21). This goes beyond the EU risk management approach which does not cover the degradation to PFOA from long-chain PFASs. The degradation from long-chain PFASs is also not considered in the Norwegian risk management approach. The Canadian risk management approach also applies to long-chain PFCAs, their salts, and their precursors. However, long-chain PFASs have been included on Norway’s priority list of substances whose release to the environment should be eliminated by 2020, and they are included in the US Stewardship Program (IPEN Comments on 2^nd draft risk management evaluation (RME)). A general definition of

“long-chain PFCAs” (C_nF_2n+1COOH, n≥7) is provided by the OECD (OECD, 2017). As a result of the existing production processes, fluorotelomer-based substances have been generally manufactured as mixtures of homologues with a range of perfluoroalkyl chain lengths (for examples, see DuPont, 1998), including those that have more than eight perfluorinated carbon atoms.¹⁰ Therefore, the information provided in the present risk management evaluation covers to a certain extent also those fluorotelomer-based substances with longer chain PFAS (longer than 8:2).

40.Table gives an overview on the regulatory risk management approaches and exemptions in Canada, the EU and Norway. Section 3 in the background document (UNEP/POPS/POPRC.13/INF/6) provides further details on the legislative approaches in these countries.

Table : Overview of regulatory risk management approaches, their chemical scope and exemptions for uses related to PFOA, its salts and PFOA-related compounds in Canada, the EU and Norway (for details see Canada, 2016c, European Commission, 2017 and Norway, 2016)

	Canada	EU	Norway
	Prohibit manufacture, use, sale, offer for sale or import of the substances and products containing these substances	Prohibit manufacturing, use or placing on the market (1) as substances, as constituents of other substances and (2) articles or any parts thereof containing one of the substances	Prohibit to manufacture, import, export and make available on the market (1) textiles, carpets and other coated consumer products that contain the substances and (2) consumer products that contain the substances
Chemical scope	PFOA and its salts; Compounds that consist of a perfluorinated alkyl group that has the molecular formula CnF2n+1 in which n=7 or 8 and that is directly bonded to any chemical moiety other than a fluorine, chlorine or bromine atom; Perfluorocarboxylic acids that have the molecular formula CnF2n+1CO2H in which 8≤n≤20, and their salts; Compounds that consist of a perfluorinated alkyl group that has the molecular formula CnF2n+1 in which 8≤n≤20 and that is directly bonded to any chemical moiety other than a fluorine, chlorine or bromine atom. (see Canada, 2016c)	PFOA and its salts; Any related substance (including its salts and polymers) having a linear or branched perfluoroheptyl group with the formula C7F15- directly attached to another carbon atom, as one of the structural elements. Any related substance (including its salts and polymers) having a linear or branched perfluorooctyl group with the formula C8F17- as one of the structural elements. Exclusions: C8F17-X, where X= F, Cl, Br; C8F17-C(=O)OH, C8F17-C(=O)O-X' or C8F17-CF2-X' (where X'=any group, including salts). Does not apply to PFOS and its derivatives, which are listed in Part A of Annex I to Commission Regulation (EC) No 850/2004 (see European Commission, 2017) PFOA<25ppb, related compounds <1,000 ppb	PFOA and individual salts and esters of PFOA (CAS No: 335-67-1, 3825-26-1, 335-95-5, 2395-00-8, 335-93-3, 335-66-0, 376-27-2, 3108-24-5) (See Norway, 2016)
Exemptions for photo-imaging	Photo media coatings until 31 December 2016 Since then partially captured under exemptions for manufactured items	Photographic coatings applied to films, papers or printing plates	Photographic coatings for film, paper or printing plate until 2016
Exemptions for semiconductor industry	Partially captured under exemptions for manufactured items	- Equipment used to manufacture semiconductors (until 4 July 2022); - Photo-lithography processes for semiconductors or in etching processes for compound semiconductors; -semiconductors or compound semiconductors.	Adhesives, foil or tape in semiconductors until 2016
Exemptions for firefighting	Aqueous film-forming foams used in firefighting applications	- 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; - Firefighting foam mixtures which were: a) placed on the market before 4 July 2020; or b) 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.	Not covered by the restriction
Exemptions for medical uses	Partially captured under exemptions for manufactured items	- Medical devices (until 4 July 2032); - Production of implantable medical devices within the scope of Directive 93/42/EEC.	Medical devices are exempted from restrictions
Exemptions for textiles	Partially captured under exemptions for manufactured items	- Textiles for the protection of workers from risks to their health and safety (until 4 July 2023); - Membranes intended for use in medical textiles, filtration in water treatment, production processes and effluent treatment (until 4 July 2023).	Textiles for consumer use are restricted when PFOA concentration is above 1ug/m^2 for any part of the product.
Exemptions for inks	Water-based inks until 31 December 2016	Latex printing inks (until 4 July 2022)
Exemptions for nano-coating	Partially captured under exemptions for manufactured items	Plasma nano-coating (until 4 July 2023)
Exemptions for food packaging	Partially captured under exemptions for manufactured items		Food packaging, food contact materials are exempted from this regulation

41.Specific information on the long-chain PFASs was not submitted to the Secretariat with the Annex F submissions of Parties and observers. Moreover, the long-chain PFASs are not considered in the socio-economic assessments of the regulatory risk management approaches in the EU and Norway. Accordingly, the information in the present risk management evaluation does not explicitly cover long-chain PFASs so far. At EU level, Germany and Sweden prepared a restriction proposal for the long-chain PFCAs of chain lengths between 9 and 14 carbon atoms and related substances.¹¹ The conclusion of the risk assessment is that, despite that no intentional uses in the EU were identified so far, a restriction on a Union-wide basis is justified to reduce the release of these substances into the environment and to prevent any future manufacturing, placing on the market and use. This EU-wide measure may be the first step for global action.