Document rpppOGGppGL7kYMLdq1qyr870

Regulatory Management Option Analysis (RMOA) Fluoropolymers Product Group of Plastics Europe FPP4EU 12 December 2022 What is a Regulatory Management Option Analysis (RMOA)? The purpose of an RMOA is to evaluate all the possible Regulatory Management Options (RMOs) that could be selected to address concerns related to a chemical substance or group of substances, and to identify the most appropriate RMO in terms of effectiveness and proportionality. The methodology used to develop this RMOA is based on a variety of sources such as a tailored RMOA questionnaire delivered to manufacturers, importers, and downstream users (DUs) within the European supply chain, one-on-one calls with FPG Members, scientific literature review related to PFAS and FPs, and a Socio-Economic Analysis (SEA) on fluoropolymers (FPs), amongst others. 2 Consideration of the Possible Regulatory Management Options RMO Voluntary Industry Initiatives to reduce risks at manufacture Harmonised Classification (CLH) under CLP Substance Evaluation under REACH Substance Registration under REACH Restriction under REACH SVHC selection and Candidate Listing Authorisation under REACH Other EU legislation on specific sectors of use Other EU legislation dealing with waste and end-of-life Screening result Relevant, it could help in addressing concerns Not relevant, FPs themselves have a low toxicological profile Not relevant, not applicable to polymers Not relevant, not applicable to polymers Relevant, due to the potential inclusion of FPs in the REACH PFAS restriction Not relevant, SVHC identification would not address potential concerns Not relevant, particularly when restriction is already under discussion Not relevant, particularly if other RMOs on manufacture are implemented Relevant, this could help to address concerns out of scope of other RMOs Considered for further evaluation? YES NO NO NO YES NO NO NO YES Regulatory Management Options Considered by ChemService RMO 1: full restriction leading to a practical ban or elimination of FP manufacture and use across the EU. RMO 2: partial restriction including a derogation of FP manufacture and uses but a ban on the use of PFAS polymerization aids for the manufacture of FPs. RMO 3: restriction including a broad derogation to allow continued manufacture and use of FPs in the EU, linked to a Voluntary Industry Initiative which guarantees that industry will address the situations of concern related to manufacture and use of FPs. RMO 4: update of existing EU regulations on waste that would impact the end-of-life treatment of FP products and articles. 4 Outcome of the RMOA The result of the RMOA concluded that the best regulatory option to deal with concerns from FPs would be a combination of RMOs 3 and 4 A derogation of FPs and relevant monomers from the PFAS REACH restriction should be granted. The use of PFAS-based polymerization aids for the manufacture of FPs should be allowed by the regulators. Industry, however, would need to commit to efficiently address the concerns related to the manufacture and purity of FPs placed on the EU market EU legislation dealing with industrial emissions and waste should be reviewed and updated to address any risk derived from the disposal of FPs and from articles containing FPs. 5 Key Takeaways of the RMOA 1/2 Chemservice's RMOA concludes that a full restriction of FPs is not the most effective tool to meet these objectives set by the five competent authorities A full restriction would put at risk key applications that are necessary to ensure competitiveness and achieving ambitious EU Green Deal goals. Regulatory actions that could lead to limiting the market access for a selected number of types of fluoropolymers could result in the manufacture of any type of these fluoropolymer products becoming economically infeasible. A full restriction could have unpredictable consequences for the critical sectors that rely heavily on fluoropolymers. 6 Key Takeaways of the RMOA 2/2 Fluoropolymers are irreplaceable in many uses without reliable alternatives There are no alternatives that can replace the combined performance provided by fluoropolymers in "virtually every critical application in which they are used". Fluoropolymers are indispensable for applications in the chemical, electronics, semiconductors, healthcare and transport sectors and the deployment of 5G networks. The RMOA study confirms that fluoropolymers are critical materials for innovation and are deemed necessary to achieve the EU goals on areas like decarbonization, renewable energies or competitiveness in the digital transition. 7 Safety of Fluoropolymers During the Use-phase 96% of the global commercially available fluoropolymers meet or exceed the OECD polymers of low concern (PLC) criteria. Fluoropolymers that meet the OECD PLC criteria are non-toxic, bio-compatible, non-soluble and non mobile molecules and they are deemed as such to have insignificant environmental and human health impacts. Fluoropolymers possess distinct physical, chemical and biological properties and should not be grouped with other PFAS for hazard assessment or regulatory purposes. 8 End-of-life of Fluoropolymers Landfill Fluoropolymers are chemically, thermally and biologically stable and are not expected to transform to dispersive non-polymeric PFAS when disposed of in a landfill. Incineration Fluoropolymers are mineralized under commercial waste-to-energy incineration operating conditions. Recycling In primary and secondary recycling, solid fluoropolymer waste is ground and later fed back into the manufacturing cycle of some fluoropolymer products. In secondary recycling, waste is ground, followed by degradation to approximately 1 % of the original degree of polymerization by using electron beams, gamma rays or thermo-mechanical degradation. In tertiary recycling, solid fluoropolymer is ground, then decomposed into the starting monomers at temperatures above 600 C to obtain the same chemical components from which the fluoropolymer was manufactured. 9 9 10 Chemservice fluoropolymers RMAO key takeaways Nicolas Robin Director Fluoropolymers Product Group Plastics Europe @plasticseurope.org