Perfluorooctanoic acid (PFOA) and its derivative (APFO): hazard and risk assessment for human health and the environment in the EU

A strict interpretation of the results of the PFOA risk assessment in this report leads to the conclusion that there seems to be no risk for human health in the EU-27 Member States.

Regarding the risk for the environment, it was concluded that there seems to be no risk for the aquatic, terrestrial and atmospheric compartment. No risk could be identified for the microbial activity in sewage treatment systems.

This report published in January 2010 is the result of a ‘Request for Service’ which was set out  by the Directorate-General Enterprise and Industry of the EU Commission.

Analysis of the risks arising from the industrial use of Perfuorooctanoic acid (PFOA) and Ammonium Perfluorooctanoate (APFO) and from their use in consumer articles. Evaluation of the risk reduction measures for potential restrictions on the manufacture, placing on the market and use of PFOA and APFO.”

 http://ec.europa.eu/enterprise/sectors/chemicals/files/docs_studies/final_report_pfoa_pfos_en.pdf

A draft version of the report was presented at a EU Workshop on PFOA organized in May 2009.

Excerpts of the report summary selected by GreenFacts:

Risk assessment for human health and the environment

Although there seems to be no risk for human health in the EU-27 Member States, due to uncertainties with regard to carcinogenic and developmental effects, the authors state that firm conclusions on health risks are not possible.

Furthermore, PFOA and APFO, at the present level of understanding, do not meet the criteria as given in Annex XIII of the REACH regulation EC/1907/2006 to be classified as Persistant, Bioaccumulative and Toxic (PBT) substances or very Persistant, very Bioaccumulative (vPvB) substances.

PFOA has been detected in human blood, plasma, liver, seminal fluid, breast milk, and umbilical cord blood of a wide array of individuals, most prominently among those working with the compound as well as individuals residing in the vicinity of facilities that manufacture PFOA.

Remaining uncertainties in these risk assessments

 The report underline that these outcomes may be challenged due to various uncertainties underlined in the report’s conclusions and summary :

For the hazard and human health risk assessment,  the report conclude that there is evidence that PFOA shows developmental toxicity in experimental animals. From general human health studies, the authors consider that there is a suggestion of a negative association between estimates of maternal exposure to PFOA and fetal growth or fertility in humans but there is a possibility that they may not be the result of a true causal relationship.

For cancer risk, according to the report there is only an association between PFOA and prostate cancer but the evidence is not conclusive. Some increases in prostate cancer have been seen, but the cause is not certain.

Although in the strict sense PFOA is not bioaccumulative according to the EU REACH Regulation criteria,  the report refers to another bioaccumulation mechanism that seems to take place due to the fact that PFOA is found in the blood of the general public with a half-life of approximately 4 years. This effect might be judged as of equivalent concern although blood levels of PFOA seem to be decreasing. The decrease might be a result of the decreasing trend in the direct use of PFOA from 2002 onwards.

The conclusions and recommendations of the report

Based on the information gathered and processed during this study, the authors consider that there seems to be no foundation to impose further restrictions on the use of PFOA/APFO. However, due to the uncertainty in PFOA levels in imported consumer articles, it is recommended that detailed research is done on the levels of PFOA in consumer articles, especially those consumer articles that are not produced in the EU-27.

Uncertainty is related to whether and to which extent PFOA may be formed from precursor substances, and which are the most relevant precursor substances. It is recommended that more research is done on the precursors of PFOA and more efforts made to gather information on international level, using the available information of the various international bodies, in order to come to a internationally/globally recognised list of precursor substances.

Given the goal of the PFOA Stewardship Programme of the US-EPA, the authors consider that the ultimate phase-out deadline for the direct use of PFOA and related compounds of 2015 might be considered as a starting point.

About the classification of PFOA,  the development of alternatives and potential derogations to its substitution

The authors considered clear that PFOA and related compounds would most probably be classified as  Category 2 “Reprotoxicants” (toxic for the reproduction) of the EU classification of chemical substances. The classification of PFOA and its salts as Reprotoxicity Category 2 was agreed and was and these substances therefore were not included in the appropriate annex of  the new EU Regulation on Classification, Labelling and Packaging  (CLP) of substances 1272/2008/EC. This  might serve as a basis for possible restrictions for the direct and/or indirect use of PFOA.

When further information and restrictions on the use of PFOA will be imposed, a number of derogations might be considered. These derogations, says the report,  are to be time-limited based on the expectations that the PFOA Stewardship Programme when executed by the OECD will have a more global coverage. Time limited derogations might include a number of critical uses.

Given the commitment of the fluoropolymer industry to the US EPA PFOA Stewardship Programme to substitute PFOA completely by 2015, the authors of the report consider as a first priority that alternatives must perform technically and meet Health, Safety and Environmental  and that the cost of the alternatives, although important, is a secondary issue.

The report considers also that it should be recognised that there are different processes and different process conditions which are needed to be met in the substitution. It is highly unlikely that there will be only one single alternative of APFO that can be applied for all the different processes and different process conditions in which PFOA is presently being used. Only experience gained on the longer term will allow to determine the optimum replacements.

Direct and indirect sources of PFOA and APFO in the environment

The production of some but not all fluorinated polymers is the major direct use of PFOA as a processing aid (surfactant). In this production sector, alternatives to PFOA are being developed.

Other direct uses include those in the semiconductor industry and in the photographic industry. For some critical applications in these industries,  no suitable alternatives for PFOA are available yet, says the report.

Indirect sources of PFOA in the environment are related to fluorotelomer production, as unintended byproduct, use of resins and, in the fluoropolymer industry, dispersions contaminated with PFOA and the use of alternatives to PFOS which may contain trace levels of PFOA.  .

According to the report, normally, PFOA is not present in the consumer products after production as the direct use of PFOA is mainly limited to be a processing aid for the polymerisation of fluoropolymers. Although, residues of PFOA in consumer articles can be detected,  potential exposure to PFOA from consumer articles is said in the report, on basis of various studies and reports, to be negligible.

EU Market of PFOA

For the period 2004-2008 the average EU market volume was estimated in the report to be maximum 100 tonnes per year, including direct and indirect sources. The trend in the use of PFOA and related compounds is further decreasing and the market volume outlook for 2010 will most probably be less than 50 tonnes per year, including direct and indirect sources .

Further information on PFOA :

The OECD published a hazard assessment on APFO. Details can be found on: http://www.oecd.org/dataoecd/63/49/42565413.zip

A presentation of the OECD activities on perfluorinated chemicals was presented at the EU workshop of 4 May 2009: OECD activities on Perfluorinated chemicals 

LIST OF CONSUMER PRODUCTS THAT MAY CONTAIN A SOURCE OF PFOA (exerpt from the report)

Direct use of APFO in (imported) consumer products:

– non-stick (PTFE-coated) cookware,  flexible (PTFE) inlays for frying pans,  non-stick (PTFE-coated) kitchen utensils,  tread sealant (PTFE) and tape, apparel membranes, dental floss and tape, fluoro-ethylene propylene copolymer (FEP) tubing,

Indirect PFOA (trace) levels possible:

in various household cleaning products with water, oil, grease & dirt resistance/protection and/or anti-static properties. Also in stain repellent home textile & upholstery, stain & water repellent (all weather) clothing (textile and leather), fat resistant food contact materials, including animal food and many other products : wallpaper,  hand held foam fire extinguishers,  latex paint, printing inks, …

Source document : FINAL REPORT (20.12.2008 – 20.10.2009) Date : 14 January 2010

European Commission Enterprise and Industry Directorate-General Principal

Contact : Mrs Luvara;  Address : Unit G.2 – Chemicals Avenue d’Auderghem, 45

B-1040 Bruxelles Telephone :+32.2.2952737

RPS Advies B.V. Business unit : TOX Contact : Iksan van der Putte E-mail : ike.vanderputte@rps.nl

Report reference : TOX08.7049.FR03

note : the content of the short presentations of scientific reports in the blog of Greenfacts is not verified by its Scientific Board

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