Document qaBQxmV2zR3E7mY3g981XjmmK

Ref.RAeref.sA(2re0s2(12)061283)35444195-31338/1- 02/22/10201/2018 EUROPEAN COMMISSION INTERNAL MARKET, INDUSTRY, ENTREPRENEURSHIP AND SMEs DIRECTORATE-GENERAL Consumer, Environmental and Health Technologies REACH Meeting with Fluorocouncil On perfluorohexanoic acid (PFHxA) and REACH 3 July 2018 Brussels, 4/7/2018 Participants DG ENV: DG GROW: , Kreab , Chemours , Daikin Chemical Europe , Daikin Chemical Europe , AGC Chemicals Europe , Background The meeting was organized at the request of (Kreab ) for the FluoroCouncil (Global Industry Council for Fluorotechnology), representing several of the world's leading manufacturers of 'fluorotechnology' based on per- and polyfluoroalkyl substances (PFASs). The topic for discussion was planned regulatory activities under REACH related to short-chain PFASs, in particular to perfluorinated hexanoic acid (PFHxA). PFHxA: use and risks PFHxA is a substance that can replace similar, but (a little bit) longer-chain, perfluoroalkyl acids (PFAAs), in particular PFOA (perfluorinated octanoic acid). PFHxA provides e.g. water, oil and dirt repellant properties to textiles, carpets and paper, but is used also in specific, high-hazard class B fire-fighting foams. Recently, the substance has been registered under REACH, because indeed it is used more and more to replace the restricted longer-chain PFOA. Previously PFHxA also was on the market and in the environment, as it is a degradation product of, as well as an impurity in, longer-chain PFASs. Fluorocouncil claims it has data (including from animal tests) to show that PFHxA is not toxic (not carcinogenic, not mutagenic, not genotoxic, not repro- nor developmental toxic) and not an endocrine disruptor. Fluorocouncil also claims that PFHxAs are rapidly eliminated from the human (and all mammalian) bodies because of a lower affinity for binding with proteins, as compared to long-chain PFAAs. Fluorocouncil does not deny that PFHxA is very persistent and mobile, but it claims that different types of (combined) water treatment technologies exist that can remove PFHxA from drinking water to below published safe drinking water levels. Fluorocouncil quotes an EU-funded study (MIDWOR-LIFE) in the textile sector that shows that fluorinefree alternatives only offer a similar level of protection in terms of water repellency, but not for oil or dirt repellency. Legislation The German Competent Authority has published an RMOA in May 2017 concluding that 'the first appropriate risk management option is to assess the concerning intrinsic properties of PFHxA in order to prove whether PFHxA raises equivalent level of concern to a PBT or vPvB substance according to (REACH) article 57(f)'. In addition, 'based on current knowledge ... suggest an overall restriction as the most appropriate measure to be able to include imported articles, too'. The request Fluorocouncil is concerned that PFHxA will be subject to measures taken for a larger group of PFAS substances, some of which are hazardous, and that a restriction on C6 (short-chain) PFAAs will increase the use of the more hazardous long-chain PFAAs (such as PFOA), as long as their use is still allowed. On the other hand, Fluorocouncil is aware of some misuses of PFHxA (through which the substance ends up in the environment, e.g. during fire-fighting trainings) and wants to contribute to preventing this, e.g. by product stewardship actions. They ask whether regulatory measures can be installed to further prevent misuse of PFHxA. Proposed way forward ENV colleagues indicated the possibility for Fluorocouncil to submit a CLH dossier on PFHxA to RAC, to get a definitive and independent conclusion on the PFHxA hazard. Also, they could prepare an industry RMOA and discuss it with Member States, following the example of other sectorial organisations. ENV colleagues also indicate that the restriction process is a way to limit or prevent unwanted and unnecessary emission of PFHxA in the environment. Fluorocouncil will send to ENV and GROW the data to which they referred during the discussion and a corresponding summary note. Documents The following documents related to this meeting are saved in: U:\9. Substances\PFASs\PFHxA\meeting ENV-GROW-Fluorocouncil-20180703 - Summary of the environmental occurrence, human exposure, toxicity, and available remediation technologies for perfluorohexanoic acid (PFHxA), Integral Consulting Inc., May 15, 2018 - Presentation 'Discussion on PFHxA', slides distributed by Fluorocouncil during the 3/7/2018 meeting with DG ENV and DG GROW. , 11/7/2018.