Risk Management Evaluation Endosulfan

Conclusions of the POPs Review Committee regarding Annex E information

26.At its eleventh meeting (decision POPRC-11/4), the Committee concluded that the proposal by the EU to list pentadecafluorooctanoic acid (CAS No: 335-67-1, PFOA, perfluorooctanoic acid), its salts and PFOA-related compounds meets the criteria set out in Annex D to the Convention (UNEP/POPS/POPRC.12/11).

27.Based on the draft risk profile for pentadecafluorooctanoic acid (CAS No: 335-67-1, PFOA, perfluorooctanoic acid), its salts and PFOA-related compounds in accordance with paragraph 6 of Article 8 of the Convention (UNEP/POPS/POPRC.12/11), the Committee adopted the risk profile for pentadecafluorooctanoic acid (CAS No: 335-67-1, PFOA, perfluorooctanoic acid), its salts and

PFOA-related compounds (UNEP/POPS/POPRC.12/11/Add.2) and:

28.Decided, in accordance with paragraph 7 (a) of Article 8 of the Convention, that pentadecafluorooctanoic acid (CAS No: 335-67-1, PFOA, perfluorooctanoic acid), its salts and

PFOA-related compounds are likely as a result of their longrange environmental transport to lead to significant adverse human health and/or environmental effects such that global action is warranted;

29.Also decided, in accordance with paragraph 7 (a) of Article 8 of the Convention and paragraph 29 of the annex to decision SC-1/7 of the Conference of the Parties, to establish an intersessional working group to prepare a risk management evaluation that includes an analysis of possible control measures for pentadecafluorooctanoic acid (CAS No: 335-67-1, PFOA, perfluorooctanoic acid), its salts and PFOA-related compounds in accordance with Annex F to the Convention;

30.Invited in accordance with paragraph 7 (a) of Article 8 of the Convention, Parties and observers to submit to the Secretariat the information specified in Annex F before 9 December 2016.

Data sources

Overview of data submitted by Parties and observers

31.This risk management evaluation is primarily based on information that has been provided by Parties to the Convention and observers. Information specified in Annex F forms was submitted by the following Parties:

1. 
   Parties: Australia, Austria, Azerbaijan, Canada, China, Colombia, Denmark, India, Japan, Mauritius, Monaco, Norway, Serbia;
   
2. 
   Observers: Bavarian Textile and Apparel Association (VTB) in cooperation with South-western Textile Association (SWT), European Apparel and Textile Confederation (Euratex), Global Industry Council for Fluoro Technology (Fluoro Council), Confederation of the German Textile and Fashion Industry, Imaging and Printing Association Europe (I&P Europe), International POPs Elimination Network (IPEN), Semiconductor Industry Association (SIA).
   

Other key data sources

32.In addition to the above-mentioned references and comments received from Parties and observers,⁶ information has been used from open information sources as well as scientific literature (see list of references). The following key references were used as a basis to develop the present document:

1. 
   The risk profile for PFOA, its salts and PFOA-related compounds (UNEP/POPS/POPRC.12/11/Add.2);
   
2. 
   The regulatory impact analyses statement related to the Canadian risk management approach (Canada 2016c);
   
3. 
   The report for an EU proposal for a restriction for PFOA, PFOA salts and
   PFOA-related substances (ECHA, 2014a) and related opinions of scientific committees in the EU (ECHA, 2015b, 2015c), the amended version of the report (ECHA, 2015a) and the current EU restriction (European Commission, 2017).
   

Status of the chemical under international conventions and frameworks

33.A review of PFOS and PFOA was conducted under the Oslo/Paris Commission for the Protection of Marine Environment of the North East Atlantic (OSPAR) in order to assess the potential impact upon the environment. This resulted in the inclusion of PFOS on the list of chemicals for priority action in 2003, while PFOA was not added to the list at that time (OSPAR, 2006).

34.Perfluorinated chemicals and the transition to safer alternatives is one of the issues of concern recognised by the Strategic Approach to International Chemicals Management (SAICM). Activities by SAICM focus on gathering and exchanging information on perfluorinated chemicals and to support the transition to safer alternatives. This work has been coordinated by the Global Perfluorinated Chemicals Group, which is supported by the Organization for Economic Co-operation and Development (OECD) and UNEP.

National or regional control actions

35.An overview related to risk reduction approaches for PFASs was provided by OECD (OECD, 2015). The document includes information on existing risk reduction approaches in countries including voluntary risk reduction measures taken by corporations (see pp. 61 to 64 in OECD, 2015). According to the risk profile (UNEP/POPS/POPRC.12/11/Add.2) and Annex F submissions, national and/or regional regulations related to PFOA comprise the following:

1. 
   In 2013, the EU identified both PFOA and its ammonium salt (APFO) as Substances of Very High Concern (SVHC) due to their persistent, bioaccumulative and toxic properties, and PFOA and APFO were included into the REACH-Candidate List (ECHA, 2013a, 2013b). On request industry is obliged to inform consumers on the occurrence to the listed substances in consumer articles if the SVHC in those articles is present in a concentration of more than 0.1 % (w/w). PFOA/APFO is restricted as a substance or in a mixture for the supply to consumers according to regulation (EU) 317/2014;
   
2. 
   In 2014, Germany and Norway submitted a joint restriction proposal for the inclusion of PFOA within Annex XVII (restriction) of the REACH regulation within the EU (ECHA, 2014a). The aim of the proposal was a total ban on manufacture, placing on the market and use (including import) of PFOA and its salts, including substances that may degrade to PFOA (PFOA-related compounds). The restriction also covers articles containing these substances. The EU restriction entered into force on 4 July 2017. The restriction applies from 4 July 2020( European Commission, 2017);
   
3. 
   PFOA was included in Annex VI of the Classification, Labelling and Packaging (CLP) Regulation (Regulation (EC) No 1272/2008), by the Commission Regulation (EU) No 944/2013 of 2 October 2013 (index number: 607-704-00-2). PFOA has been classified as Carc. 2 H351, Repr 1B H360D, Lact H362, STOT RE 1 (liver) H372, Acute tox 4 H332, Acute tox 4 H302 and Eye dam 1 H318;
   
4. 
   The Norwegian Environment Agency published an amendment to the consumer products regulation in 2014, banning the use of PFOA in consumer products and textiles. This has a transitional period allowing the import and sale of products manufactured before the phase-out. Since 1 June 2014, it has been prohibited to manufacture, import, export and make available on the market textiles, carpets, other coated consumer products and consumer products that contain PFOA and individual salts and esters of PFOA with specified exemptions (Norway, 2016; more details in section 2.2);
   
5. 
   In June 2006, the Government of Canada published a Notice of Action Plan for the assessment and management of perfluorocarboxylic acids and their precursors. The Action Plan included measures to prevent the introduction of new substances into Canada that would contribute to the level of perfluorocarboxylic acids in the environment, and to seek action from industry to address sources of PFCAs already in Canadian commerce. To this end, a voluntary Environmental Performance Agreement was signed on 30 March 2010. Signatories to the Performance Agreement agreed to reduce the amount of PFOA and long-chain perfluorocarboxylic acids in perfluorinated chemicals in Canadian commerce by 95% by 31 December 2010, and to virtually eliminate them by 31 December 2015. Participating companies met the targets under the Agreement and the final report was published on 1 June 2017.⁷ Within Canada following the screening assessment conducted in 2012, PFOA, its salts and precursors were found to meet the criterion of Section 64(a) of the Canadian Environmental Protection Act, 1999 (CEPA) and were added to the List of Toxic Substances in Schedule 1 of the Act. Furthermore, in October 2016, the Regulations Amending the Prohibition of Certain Toxic Substances Regulations, 2012, were published in Canada. As of 23 December 2016, these amendments prohibit PFOA, its salts and precursors and products containing them, unless present in manufactured items.⁸ Furthermore, the amendments provide time-limited exemptions and ongoing permitted uses for certain applications where the development of alternatives is underway or where there are currently no known alternatives (Canada, 2016c; more details see section 2.2);
   
6. 
   In the US, the United States Environment Protection Agency (USEPA) established the PFOA Stewardship Programme in 2006. This is a programme that includes eight major OECD based manufacturers of PFOA, its salts and PFOA-related compounds (Arkema, Asahi, BASF, Clariant, Daikin, 3M/Dyneon, DuPont and Solvay Solexis). The programme was a voluntary initiative to the substantial phase-out the manufacture and use of PFOA, PFOA precursors and related higher homologue substances (USEPA, 2015). It was successfully completed at the end of 2015. On 21 January 2015, the USEPA proposed a Significant New Use Rule under the Toxic Substances Control Act (TSCA) to require manufacturers of PFOA and PFOA-related chemicals, including as part of articles, and processors of these chemicals to notify USEPA at least 90 days before starting or resuming new uses of these chemicals in any products. This notification would allow USEPA the opportunity to evaluate the new use and, if necessary, take action to prohibit or limit the activity.⁹ While in general, eligible polymers are exempted from the full USEPA new chemical premanufacture notice and review process, effective 26 January 2010 the USEPA rescinded the exemption for polymers containing as an integral part of their composition, except as impurities, certain perfluoroalkyl moieties consisting of a CF₃- or longer chain length. This exclusion included polymers that contain any one or more of the following: perfluoroalkyl sulfonates (PFAS), perfluoroalkyl carboxylates (PFAC), fluorotelomers, or perfluoroalkyl moieties that are covalently bound to either a carbon or sulfur atom where the carbon or sulfur atom is an integral part of the polymer molecule (FR 2010 01-27);
   
7. 
   In China several national actions were taken in 2011 to restrict new installations of PFOA production facilities, to eliminate PFOA-containing paints and fluoropolymers that use PFOA in the polymerization and to encourage the development of alternatives to PFOA. In 2013, fluoropolymer coatings for non-stick pans, kitchenware and food processing equipment that use PFOA in the polymerisation were recognized as products with high pollution and high environmental risk in the Comprehensive Catalogue for Environmental Protection. In January 2017, new technical requirements for textile products came into force, in particular establishing limits of PFOA levels to 0.05 mg/kg in coated infant textile products and to 0.1 mg/kg in all other coated textile products, respectively (see section VI of FOEN, 2017).