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The term Perfluoroctane sulfonates (PFOS), means any substance
containing the PFOS moiety (C8F17SO2) with the potential to
degrade to the anionic form C8F17SO3- in the environment.
These substances include the acid form of PFOS, the metal salts
and the halides of PFOS and also the amides. Polymers including
the PFOS moiety are also within the scope of Directive
2006/122/EC. The limit values in the Directive mean the
concentration of extractable PFOS measured with CEN methods
and expressed as the corresponding amount of PFOS acid.
Official controls for the enforcement of the limits mentioned in the
Directive will make use of CEN standards (currently under
development). The limits in the Directive will therefore, eventually
mean the PFOS content as measured by the CEN methods. The
analytical methods under consideration by CEN are Liquid
Chromatography/Mass Spectroscopy (LC/MS) for anionic PFOS
species, and Gas Chromatography/ Mass Spectroscopy (GC/MS) for
non-ionic PFOS species.
As both methods require liquid samples, for semi-finished products
and articles, solvent extraction of PFOS will be required and a CEN
method for this will be developed. The extracted PFOS species are
expected to be mainly anionic, but non-ionic species may also be
present in the liquid samples. In practice, samples may well contain
several PFOS species and they must all be taken into account for
calculating the total PFOS concentration. However, the molecular
weights of the various PFOS species in a sample can cover a wide
range of values. Aggregation of the amounts of the different
species is therefore best achieved by first calculating the
corresponding amounts of a reference species, i.e. PFOS acid
C8F17SO3H.
Annex I to Directive 76/769/EEC is hereby amended as set out in the Annex to this Directive.
Article 21.
Member States shall adopt and publish, not later than 27 December 2007, the laws, regulations and administrative
provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of
those measures and a table showing the correlation between those measures and this Directive.
They shall apply these measures from 27 June 2008.
The following point is added to Annex I to Directive76/769/EEC: Point 52. Perfluorooctane sulfonates (PFOS)
C8F17SO2X(X=OH, Metal salt(O-M+), halide, amide, and other derivatives including polymers)
(1) 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 mass.
(2) May not be placed on the market in semi-finished products or articles, or parts there of, if the concentration of
PFOS is equal to or higher than 0.1% by mass, 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 1μg/m2 of the coated material.
(3) By way of derogation, paragraphs 1 and 2 shall not apply to the following items, nor to substances
and preparations needed to produce them:
(a) photoresists or anti-reflective coatings for photolithography processes.