SUBSTANCE NAME : Perfluorooctanoic acid (PFOA), PFOA salts and PFOA – related substances
About this report
Perfluorooctanoic acid (PFOA) is one important representative of the substance group of per – and polyfluorinated substances (PFASs). The hazard profile of PFOA is well known: PFOA is a persistent, bioaccumulative, and toxic (PBT – ) substance, which may cause severe and irreversible adverse effects on the environment and human health. PFOA has a harmonised classification in Annex VI of European Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP) as Carc. 2, Repr. 1B and STOT RE 1 (liver). Due to its PBT and CMR properties, PFOA and its ammonium salt (APFO) has been identified as substances of very high concern (SVHC) under REACH by unanimous agreement between EU Member States in July 2013.
Besides PFOA also other substances in the PFASs group have properties of concern, which are targeted by the following international regulations: Perfluorinated carboxylic acids with a carbon chain of eleven to fourteen carbon atoms are also listed as substances of very high concern on the REACH candidate list because of their very persistent and very bioaccumulative properties. Perfluorooctane sulfonic acid (PFOS) is listed as persistent organic pollutant (POP) in Annex B of the Stockholm Convention.
The former restriction of PFOS under REACH and the current entry in Commission Regulation (EU) No 757/2010 (implementing Annex B of the Stockholm Convention) do not only cover PFOS itself, but also PFOS-related substances, which are outlined by the chemical formula: C 8 F 17 SO 2 X (X=OH, metal salt (O – M + ), halide, amide, and other derivates including polymers). The reason for this is that these PFOS-related substances can be degraded to PFOS in the environment.
PFASs consist of carbon chains of different chain length, where the hydrogen atoms are comple tely (perfluorinated) or partly (polyfluorinated) substituted by fluorine atoms. The very stable bond between carbon and fluorine is only breakable with high energy input. Therefore, perfluorinated acids, like PFOA, are not degradable in the environment. Polyfluorinated substances can be degraded to persistent perfluorinated substances like PFOA under environmental conditions and are therefore precursors. Those PFASs, which can be degraded to PFOA in the environment, are referred to as PFOA-related substances in this dossier. PFOA and a number of PFOA – related substances are ubiquitously found in humans and the environment even if there are no natural sources known. This includes findings in remote areas like the Arctic, which indicates their potential for long-range transport. Due to their outstanding technical properties (to provide water, oil, and grease repellency) man-made PFASs are used in various consumer products as well as in industrial applications . These uses lead to the wide-dispersive release of PFOA, its salts and related substances into the environment.
To limit the risk of ubiquitous and long-term exposure of humans and the environment with PFOA, its salts and PFOA- related substances a phase-out of these substances is the only effective measure. To achieve this phase-out a total ban of manufacture, marketing and use is needed. Especially, the import of articles and mixtures containing PFOA, its salts and PFOA-related substances can only be controlled in this way.
In chapter A of this report, the proposed restriction is outlined and a summary of the justification is given. The information on hazard and risk of PFOA, its salts and PFOA-related substances is provided in chapter B . Details on the identity of the substances within the scope of this proposal as well as their physical chemical properties are given in chapter B.1 . The manufacturing and uses of PFOA, PFOA – salts and PFOA – related substances are described in chapter B.2 , respectively. In chapter B. 3 the classification and labeling issues of PFOA are summarized. The structure of chapter B of this proposal has been slightly modified, i.e. the hazard and risk characterization of PFOA, its salts and PFOA – related substances for the environment is presented in chapter B.4 and for human health in chapter B.5 . This change of structure was agreed with ECHA and was considered appropriate to take the following aspects into account: in the EU, PFOA was unanimously identified as a PBT substance. Emissions of PBT substances into the environment need to be stopped, the main objective according to Art. 55 is substitution. In addition to the assessment of PFOA and PFOA-related substances as PBT – substances, a quantitative risk characterization is performed for human health based on the knowledge that PFOA is toxic for reproduction (category 1B) and has been shown to affect cholesterol levels in humans. Overall, emissions to the environment need to be prevented to an extent technically and economically feasible and that will at the same time minimize the risks for human health.
Substitution of PFOA and PFOA – related substances is possible as shown in chapter C , where the available alternatives are described. In Chapter D and E it is described that a community-wide measure is needed and that a restriction as outlined in chapter A is the most appropriate measure. The socio – economic impact s of the proposed restriction are assessed in chapter F. To form an effective restriction proposal reliable data were needed. These were partly obtained in stakeholder consultations , which were performed to address remaining data gaps and are summarised in chapter G.
Only few registration dossiers are so far available for PFOA-related substances. No registration is available (yet) for PFOA itself or its salts. Information was obtained from industry surveys performed by OECD, reports from research and studies conducted by different other institutions. Most of these studies and information show the need for risk management. This needs to cover several substances with different uses and emission pathways.