Chemical name:

Final regulatory action has been taken for the category: Industrial

Final regulatory action: The chemical is Severely Restricted

Use or uses prohibited by the final regulatory action:

Firstly, PFOS may not be placed on the market or used as a substance or constituent of preparations in a concentration equal to or higher than 0.005% by weight.

Secondly, PFOS may not be placed on the market in semi-finished products or articles, or parts thereof, if the concentration of PFOS is equal to or higher than 0.1 % by weight calculated with reference to the mass of structurally or microstructurally distinct parts that contain PFOS or, for textiles or other coated materials, if the amount of PFOS is equal to or higher than 1 µg/m2 of the coated material.

Use or uses that remain allowed:

These restrictions shall not apply to products that were in use in the European Community before 27 June 2008.

The use and the first placing on the market of the following items, as well as the use of the substances and preparations needed to produce them remain allowed:

(a) photo-resists or anti reflective coatings for photolithography processes,

(b) photographic coatings applied to films, papers, or printing plates,

(c) mist suppressants for non-decorative hard chromium (VI) plating and wetting agents for use in controlled electroplating systems where the amount of PFOS released into the environment is minimised, by fully applying relevant best available techniques developed within the framework of Directive 2008/1/EC of 15 January 2008 concerning integrated pollution prevention and control (OJ L 24, 29.01.2008, p. 8),

(d) hydraulic fluids for aviation.

Until 27 June 2011 the fire-fighting foams that have been placed on the market before 27 December 2006 are also allowed, in order to limit emissions to that of the existing stocks of fire-fighting foams. It should also be noted that the ban shall apply without prejudice to Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents (OJ L 104, 08.04.2004, p. 1).

The final regulatory action was based on a risk or hazard evaluation: Yes

Summary of the final regulatory action:

The placing on the market and the use of PFOS as a substance or in mixtures in concentrations equal to or greater than 50 mglkg (0.005 % by weight) is prohibited pursuant to Regulation (EC) 1907/2006 concerning the registration, evaluation, authorization and restriction of chemicals (REACH) as amended by Commission Regulation (EC) No 55212009 amending Regulation (EC) No 1907/2006.

In addition PFOS shall not be placed on the market in semi-finished products or articles, or parts thereof, if the concentration of PFOS is equal to or greater than 0.1 % by weight calculated 'with reference to the mass of structurally or micro structurally distinct parts that contain PFOS or, for textiles or other coated materials, if the amount of PFOS is equal to or greater than 1 µg/m2 of the coated material.

However, certain uses remain allowed, as mentioned in paragraph 3 to 5 of point 53 of the Annex to Commission Regulation (EC) No 552/2009.

The European Commission is requested to review each of the derogations in paragraph 3 as soon as new information on details of uses and safer alternative substances or technologies for the uses become available.

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 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.

The reasons for the final regulatory action were relevant to: Human health and environment

Summary of known hazards and risks to human health:

Considering the oral assimilation in fish and mammals and the low elimination rate, the SCHER concluded that PFOS poses similar environmental concerns for bioaccumulation to substances which are very bio-accumulative. The toxicity associated with oral route exposure is confirmed as well as its high persistency. Therefore a scientifically based assessment of persistence, bioaccumulation and toxicity indicates that PFOS fulfils the criteria for very Persistent, very Bio-accumulative and Toxic substances.

To be considered as a Persistent Organic Pollutant under the Stockholm Convention, a substance has to be persistent, bio-accumulative, have a potential for long range environmental transport and have the potential to give adverse effects. PFOS fulfils the criteria for all these properties given in Annex D of the Stockholm Convention.

The OECD Hazard Assessment also concluded that PFOS is persistent, bio-accumulative and toxic in mammals. PFOS has been detected in the serum of occupational and general populations. There is a statistically significant association between PFOS exposure and bladder cancer and there appears to be an increased risk of episodes of neoplasm of the male reproductive system, the overall category of cancers and benign growths, and neoplasms of the gastrointestinal tract.

The SCHER considered that the on-going critical uses in the aviation industry, the semiconductor industry and the photographic industry do not pose a relevant risk provided that releases into the environment and workplace exposure are minimised, while for fire-fighting foams, the risks of substitutes should be assessed before reaching a final decision. It also considered that the use of PFOS in the plating industry shall also be minimised by applying the best available techniques.

Expected effect of the final regulatory action in relation to human health:

The severe restriction is intended to cover the major part of the exposure risks, while the other minor uses exempted do not seem to pose a risk. Although PFOS is persistent, it is considered that, as long as re-occurrence of former major uses is not allowed, the concentrations of PFOS in the environment may eventually diminish.

Summary of known hazards and risks to the environment:

Considering the oral assimilation in fish and mammals and the low elimination rate, the SCHER concluded that PFOS poses similar environmental concerns for bioaccumulation to substances which are very bio-accumulative. The toxicity associated with oral route exposure is confirmed as well as its high persistency. Therefore a scientifically based assessment of persistence, bioaccumulation and toxicity indicates that PFOS fulfils the criteria for very Persistent, very Bio-accumulative and Toxic substances.

To be considered as a Persistent Organic Pollutant under the Stockholm Convention, a substance has to be persistent, bio-accumulative, have a potential for long range environmental transport and have the potential to give adverse effects. PFOS fulfils the criteria for all these properties given in Annex D of the Stockholm Convention.

The OECD Hazard Assessment indicates that PFOS is persistent and bio-accumulative. It is highly, acutely toxic to honey bees and bio-concentrates in fish and it has been detected in tissues of wild birds and fish, in surface water and sediment, in wastewater treatment plant effluent, sewage sludge and in landfill leachate.

Expected effect of the final regulatory action in relation to the environment:

The severe restriction is intended to cover the major part of the exposure risks. While the other minor uses exempted do not seem to pose a risk. Although PFOS is persistent, it is considered that, as long as re-occurrence of former major uses are not allowed, the concentrations of PFOS in the environment may eventually diminish.

Date of entry into force of the final regulatory action: 27/06/2009

Commission Regulation (EC) No 552/2009 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII entered into force on 27 June 2009.