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.
Task 1: Market analysis
The market volume of production and import of PFOA and related substances has a decreasing trend from 2002 onwards in the EU-27 Member States. For the period 2004-2008 the average market volume is estimated to be maximal 100 tonnes per annum, 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 annum, including direct and indirect sources . In the following figure (after Prevedouros et al, 2006) the various direct and indirect sources of PFCAs since 1950 are shown.
Uncertainties of the Market Analysis
imported consumer articles. More research needs to be done on the levels of PFOA in consumer articles,The largest uncertainty in the market analysis lies in the levels of PFOA as an unintended by-product in imported fluorotelomer based products used in consumer products and in the residual levels of PFOA in especially those consumer articles that are not produced in the EU-27.
Furthermore it should be noted that the information presented in this report is based on the questionnaires received from the industrial stakeholders and that due to the confidential business information (CBI) nature of this information only a range or a rounded figure could be presented in this report.
Task 2: General assessment and analysis
Using 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. However, due to uncertainties with regard to carcinogenic and developmental effects 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 for PBT or vPvB substances.
Regarding the risk for the environment, it can be 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.
However, these outcomes may be challenged due to various uncertainties which can be summarised as follows.
Uncertainties in the human health risk assessment
First of all there is evidence that PFOA shows developmental toxicity in experimental animals. From general human health studies there is a suggestion of a negative association between estimates of maternal exposure to PFOA and fetal growth or fertility in humans. However, a number of concerns have been raised about these data including the possibility that they may not be the result of a true causal relationship.
From epidemiological occupational exposure and general human health studies there is only an association between PFOA and prostate cancer, the evidence is not conclusive. Some increases in prostate cancer have been seen, but the cause is not certain.
From Canadian sources a final report on the possible carcinogenic properties is expected by the end of 2009. Furthermore, other epidemiological results from the US C8 research project are expected to be published by the end of 2009 as well.
From the above information it seems to be clear that PFOA and related compounds will most probably be classified as a Category 2 Reprotoxicant. This classification of PFOA as Reprotoxicant 2 is also foreseen in the Risk assessment of perfluorooctanic Acid (PFOA) as part of a strategic partnership between German authorities and industry (2009). The classification of PFOA and its salts as Reprotoxicity Category 2 was agreed in the former TC C&L group in exECB 2006 after the closure of the 31ATP to Directive 67/548/EEC, and was therefore not included in the 1ATP to the CLP Regulation 1272/2008/EC. The Norwegian rapporteur will update their Annex XV C&L dossier on PFOA and send it to ECHA in December 2009. This updated dossier might serve as a basis for possible restrictions for the direct and/or indirect use
Uncertainties regarding the PBT-criteria
Although in the strict sense PFOA is not bioaccumulative according to the REACH Annex XIII criteria, another bioaccumulation mechanism 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.
Uncertainties regarding the environmental risk assessment
From the information in the Risk assessment of perflourooctanic Acid (PFOA) as part of a strategic partnerschip between German authorities and industry (2009) there seems to be no risk for the environment. No new data were found which could be used for the revision of risk assessment for the environment.
Task 3: Alternatives evaluation
Alternatives for the direct uses of PFOA in fluoropolymer production
It is clear that given the commitment of industry to the US EPA PFOA Stewardship Programme it is important that alternatives must perform technically and meet HSE conditions as a first priority and that the cost of the alternative although important is a secondary issue. It should be recognised that there are different processes and different process conditions which are needed to be met. 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.
At this moment accurate information on the economic feasibility of alternatives could not be given as most alternatives are still under development for the different processes and different process conditions. One alternative is already being produced. However, the prising information of this alternative could not be provided as the manufacturer does not sell it on the open market and considers this information as confidential business information (CBI). This manufacurer pointed out that the use of the alternative is not a major cost/prising component in the fluoropolymer production.
The fluoropolymer production is the major direct user of PFOA as processing aid. In this production sector alternatives of PFOA are being developed. Other direct uses include that in the semiconductor industry and in the photografic industry. In these industries no suitable alternative for PFOA for some critical applications are available yet. See task 4.
Alternatives of other indirect sources of PFOA
The direct uses of PFOA in the fluoropolymer production, the semiconductor industry and the photographic industry are considered as direct sources of PFOA in the environment.
Indirect sources of PFOA in the environment are related to fluorotelomer production as unintended byproduct, use of resins and dispersions contaminated with PFOA and the use of alternatives to PFOS which may contain trace levels of PFOA) in fluoropolymer industry. The development of short-chain fluorotelomer products without PFOA as unintended by-product and the development of alternatives to PFOS without trace levels of PFOA are already available or will become available before 2015.
Task 4: Identification & definition of specific uses without alternatives
In photographic industry as well as semiconductor industry certain critical uses of PFOA are identified.
In the semiconductor industry non–PFOA based alternatives appear to be available for some non-critical applications like the uses as a surfactant. However, there still remain critical uses in the semiconductor industry. These mainly concern uses of PFOA related substances as a constituent material in process chemical formulations for very specialized application steps, such as for the photolithographic applications.
In the photographic industry PFOS and PFOA have comparable critical photographic applications but can not be substitutes by each other. Some individual companies use PFOS for their critical photographic application while others use PFOA for comparable photographic applications. For those companies which use PFOA within their critical photographic applications the same derogations based on the same argumentation as for PFOS will be necessary to continue their production.
In both other derogated uses of PFOS that is in the hydraulic fluids and in the electroplating process, no PFOA is presently being used and therefore no derogations for PFOA will be required for these specific applications.
Task 5: Conclusions and recommendations
Based on the information gathered and processed during this study 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. From discussions with competent authorities in the various EU Member States it has become clear that a legal framework is lacking to further investigate these levels of PFOA in consumer articles. In case a legal framework is to be developed for this prupose the nomenclature for perfluorinated compounds need to be made more uniform. Industry and its associations are currently working on this aspect. Furthermore, a normalised analytical standard needs to be developed to enable comparison of the results from the various EU Member States.
Further, uncertainty appears to be unclarity as 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 will have to be done on the precursors of PFOA and more efforts have to be made to gather information on international level using the available information of the various international bodies to come to a internationally/globally recognised list of precursor substances. The OECD could be the platform best used for bringing together all this international information. However, the OECD has already put up a list of possible precursor substances that is used by international bodies as well as industry.
When new information on the risks for human health and environment will become available and when based on that information further restrictions on the use of PFOA will be imposed, a number of derogations might be considered. These derogations 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:
– The direct uses of APFO and APFN in the fluoropolymer industry as a direct source in the environment;
– The proces applications as indirect sources of PFOA in fluorotelomer production as unintended byproduct, use of resins and dispersions contaminated with PFOA and the use of alternatives to PFOS which may contain trace levels of PFOA in fluoropolymer industry.
– Certain critical uses of PFOA and related substances in photographic and semiconductor industry.
It is required that these industries further define these critical uses and that PFOA and related substances are only used under strictly controlled conditions.
Given the goal of the PFOA Stewardship Programme the ultimate phase-out deadline for the direct use of PFOA and related compounds of 2015 might be considered as a starting point.