Germany and Norway propose a restriction on Perfluorooctanoic acid (PFOA), its salts and PFOA- related substances

Germany and Norway have submitted a report proposing a restriction on the manufacturing, use and placing on the market of Perfluorooctanoic acid (PFOA) and its salts, also including substances that may degrade to PFOA (PFOA-related substances), in concentrations equal to or greater than 2 ppb. The proposed restriction also covers articles containing these substances.

substance name

Scope and conditions of restriction

Perfluorooctanoic acid (PFOA, CAS 335-67-1, EC 206-397-9),
including its salts
and any other substance having linear or branched perfluoroheptyl derivatives with the formula C7F15- as a structural element, including its salts
except those derivatives with the formula C7F15-X, where X= F, Cl, Br
and any other substance having linear or branched perfluorooctyl derivatives with the formula C8F17- as a structural element, including its salts,
except those derivatives with the formula C8F17-X, where X= F, Cl, Br or, C8F17-SO2X', C8F17-C(=O)OH or C8F17-CF2-X' (where X'=any group, including salts)

1. Shall not be manufactured, used or placed on the market
- as substances,
- as constituents of other substances in concentrations equal or above 2 ppb of a single substance,
- in a mixture in concentrations equal or above 2 ppb of a single substance
2. Articles or any parts thereof containing one of the substances in concentrations equal to or greater than 2 ppb of a single substance shall not be placed on the market.
3. Paragraph 1 and 2 shall apply from (18 months after entry into force).
4. By way of derogation, paragraph 2 shall not apply to the placing on the market of second-hand articles which were in end-use in the European Union when the restriction becomes effective.

ECHA has launcheed the public consultation on this proposed restriction , which will end on 17 June 2015. However the rapporteurs of ECHA’s Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC) would welcome any early comments by 1 March 2015, to assist them in the first discussions of this restriction proposal.

PFOA is a persistent, bioaccumulative, and toxic substance (PBT). Due to these properties it may cause severe and irreversible adverse effects on the environment and human health. Based on their PBT and CMR properties, PFOA and its salt (APFO) have been identified as substances of very high concern (SVHC) under REACH.

In general, PFOA-related substances are defined as fluorinated substances that are expected to degrade to PFOA under environmentally relevant conditions. Therefore, the hazard profile of PFOA applies to these substances as well.

PFOA and a number of PFOA-related substances are found ubiquitously in the environment – also in remote areas – since they can be transported over long distances via water and air. This results in findings in rivers, oceans, drinking water, the atmosphere and biota. Moreover, PFOA is present in human blood of the general population. Human exposure takes place via the environment, e.g. consumption of drinking water and food, ingestion or inhalation of contaminated indoor dust (resulting from the use of consumer products).

Annex XV Restriction Report Proposal For A Restriction -PFOA, PFOA salts and PFOA-related substances
PFOA information note

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