Outcome of the Workshop on PFOA organised by the Commission 4 th of May 2010 Christine Wistuba, DG ENV, D3

Starting point The current restriction on PFOS, entry 53 of Annex XVII, REACH: “The Commission shall keep under review the ongoing risk assessment activities and the availability of safer alternative substances or technologies related to the uses of perfluorooctanoic acid (PFOA) and related substances and propose all necessary measures to reduce identified risks, including restrictions on marketing and use, in particular when safer alternative substances or technologies, that are technically and economically feasible, are available”

In December 2008: launch of a study to evaluate the risk of the use of PFOA during industrial process and in consumer products. This study was finalised by the consultant RPS in January 2010 and published in DG Enterprise website.

Workshop 04 May 2010: There were presentations  on the ongoing studies on the hazard and risk assessment of PFOA/APFO related to human health and the environment  on the use of PFOA/APFO during the fluoropolymerization process, in photographic application, and in articles.  on activities at OECD level and  on the regulatory possibilities to address the identified concerns.

Main conclusions from the workshop: Presentations concerning hazard and risk assessment on Human Health  The derivation of a DNEL for the risk characterization to human health is still under debate resulting in uncertainties with respect to DNEL- derivation and with respect to exposure assessment.  Further discussion on the basis of the new data as mentioned by the German Authority and the US study is needed.

Presentations concerning hazard and risk assessment on Environment Concerning the PBT criteria of PFOA:  on P criterion: large consensus.  On B criterion: increasing tendency to bioaccumulation over the years.  On T criterion: Annex XV dossier for the classification as toxic for reproduction 1B submitted by Norway. Discussion will be followed. Particular attention will be given also the recent in vitro studies from Germany on toxicity in liver cells as presented during the workshop. Presentations of studies addressing the presence of PFOA in blood samples in humans and in arctic species, both with increasing tendency over the years. Another presentation on PFOA in surface-, ground- and drinking water showed increased values in some regions. On precursors or substances which degrade to PFOA need for further discussion; there will be input from OECD.

Industrial application and use in consumer products Industrial application  PFOA widely used as  processing aid in the fluoropolymer production,  in photographic applications.  Voluntary programme of Industry to reduce PFOA emissions by Consumer products  Call for more screening about the presence of PFOA in carpets, leather and textile and other sources.  Although levels might seem low, the high amount of these products used could result in a considerable source of emission to the ecosystem, especially as waste.

Other items raised Alternatives:  need to follow also the activities at OECD level. Method of analysis:  Perfluorinated compounds (PFCs) analytical methods exist, but need for improvement  The European analytical standard method on PFOS cannot be fully applied.

Regulatory measures Several suggestions made:  Definition of Environmental Quality Standards for soil and water including drinking water.  possible regulatory steps to be taken under REACH, such as restrictions on PFOA and/ or including PFOA in the candidate list.  If PFOA is classified as toxic for reproduction 1B or if it is identified as fulfilling the PBT criteria then it would be eligible for inclusion in the candidate list.  More discussion on the best risk management option on PFOA is therefore needed.

Thank you for your attention!