Directive 2006/122/EC of the European Parliament and of the Council of 12 December 2006 amending for the 30th time Council Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (perfluorooctane sulfonates)   (Text with EEA relevance)
Date: 2006-12-12
Institutions: Council of the European Union, European Parliament
Subjects: approximation of laws, dangerous substance, environmental protection, marketing restriction, public health

L 372/32

EN

Official Journal of the European Union

27.12.2006

DIRECTIVE 2006/122/ECOF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 12 December 2006

amending for the 30th time Council Directive 76/769/EEC on the approximation of the laws,
regulations and administrative provisions of the Member States relating to restrictions on the
marketing and use of certain dangerous substances and preparations (perfluorooctane sulfonates)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Having regard to the Treaty establishing the European Commu-
nity, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the Opinion of the European Economic and
Social Committee (1),

Acting in accordance with the procedure laid down in Article 251
of the Treaty (2),

Whereas:

(1) An OECD (Organisation for Economic Cooperation and
Development) hazard assessment has been done on the
basis of information that was available by July 2002. This
assessment concluded that perfluorooctane sulfonates
(hereinafter ‘PFOS’) are persistent, bioaccumulative and
toxic to mammalian species and, therefore, indicate cause
for concern.

(2)

(3)

The risks posed to health and environment by PFOS have
been assessed in accordance with the principles of Council
Regulation (EEC) No 793/93 of 23 March 1993 on the
the risks of existing sub-
evaluation and control of
stances (3). The risk assessment identified a need to reduce
the risks to health and the environment.

The Scientific Committee on Health and Environmental
Risks (hereinafter ‘SCHER’) has been consulted. SCHER
concluded that PFOS fulfil the criteria for classification as
very persistent, very bioaccumulative and toxic. PFOS also
have a potential for long range environmental transport
and have the potential to produce adverse effects and
therefore fulfil the criteria for being considered as persistent
organic pollutants (POPs) under the Stockholm Conven-
tion (4). SCHER identified a need for further scientific risk
assessment of PFOS but it also agreed that risk reduction
measures might be necessary to avoid the re-occurrence of
former uses. According to SCHER, on-going critical uses in
the aviation industry, the semiconductor industry and the
photographic industry do not appear to pose a relevant risk

(1) OJ C 195, 18.8.2006, p. 10.
(2) Opinion of the European Parliament of 25 October 2006 (not yet
Journal) and Council Decision of

published in the Official
11 December 2006.

(3) OJ L 84, 5.4.1993, p. 1. Regulation as amended by Regulation (EC)
No 1882/2003 of the European Parliament and of the Council (OJ
L 284, 31.10.2003, p. 1).

(4) Council Decision 2006/507/EC of 14 October 2004 concerning the
conclusion, on behalf of the European Community, of the Stock-
holm Convention on Persistent Organic Pollutants (OJ L 209,
31.7.2006, p. 1).

to the environment or human health, if releases into the
environment and workplace exposure are minimised. With
regard to fire-fighting foams, SCHER agrees that health and
environmental risks of substitutes should be assessed before
a final decision can be taken. SCHER also agrees with
restricting the use of PFOS in the plating industry, if there
are no other measures available that could be applied to
reduce the emissions during metal plating to a significantly
lower level.

In order to protect health and the environment, it therefore
appears necessary that the placing on the market and the
use of PFOS should be restricted. This Directive is intended
to cover the major part of the exposure risks. Other minor
uses of PFOS do not seem to pose a risk and they are
therefore currently exempted. However, special attention
should be given to plating processes using PFOS and
therefore the releases from those processes need to be
minimised by applying the best available techniques
(hereinafter ‘BAT’) fully taking into account all relevant
information contained in the BAT reference document on
Surface Treatment of Metals and Plastics as developed for
use under Council Directive 96/61/EC of 24 September
1996 concerning integrated pollution prevention and
control (5)
In addition, Member States
should establish inventories of
those uses in order to
acquire information about the actual quantities used and
released.

(IPPC Directive).

The semi-finished products and articles containing PFOS
should also be restricted in order to protect the environ-
ment. The restriction should cover all the products and
articles to which PFOS are intentionally added, taking into
account that PFOS may have been used only in some
distinct parts or in coatings of certain products and articles,
such as textiles. This Directive should only restrict new
products and should not apply to products already in use or
on the second hand market. However, existing stocks of
fire-fighting foams containing PFOS should be identified
and their use should be allowed to continue only for a
limited time to prevent possible further emissions from the
use of such products.

(4)

(5)

(5) OJ L 257, 10.10.1996, p. 26. Directive as last amended by
Regulation (EC) No 166/2006 of the European Parliament and of
the Council (OJ L 33, 4.2.2006, p. 1).

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Official Journal of the European Union

L 372/33

(6)

(7)

To ensure ultimately the phase-out of uses of PFOS the
Commission should review each derogation under this
Directive when new information on the uses and safer
alternatives developed gives grounds for it. The derogation
should only be allowed to continue for essential uses on the
condition that safer substances or technologies, that are
technically and economically feasible, do not exist and BAT
are applied to minimise emissions of PFOS.

Perfluorooctanoic acid (PFOA) and its salts are suspected to
have a similar risk profile to PFOS, and consequently there
is a need to keep under review the ongoing risk assessment
activities and the availability of safer alternatives and to
define what kind of risk reduction measures,
including
restrictions on marketing and use, if appropriate, should be
applied within the European Union.

(8) Directive 76/769/EEC (1) should be amended accordingly.

(9)

The objective of this Directive is to introduce harmonised
provisions with regard to PFOS, thus preserving the internal
market whilst ensuring a high level of protection of human
health and the environment, as required by Article 95 of
the Treaty.

(10) This Directive is without prejudice to the Community
legislation laying down minimum requirements for the
protection of workers, such as Council Directive 89/391/
EEC of 12 June 1989 on the introduction of measures to
encourage improvements in the safety and health of
workers at work (2), and individual directives based thereon,
in particular Directive 2004/37/EC of
the European
Parliament and of the Council of 29 April 2004 on the
protection of workers from the risks related to exposure to
carcinogens or mutagens at work (Sixth individual Directive
within the meaning of Article 16(1) of Council Directive 89/
391/EEC) (codified version) (3) and Council Directive 98/
24/EC of 7 April 1998 on the protection of the health and
safety of workers from the risks related to chemical agents
at work (fourteenth individual Directive within the meaning
of Article 16(1) of Directive 89/391/EEC) (4),

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Annex I to Directive 76/769/EEC is hereby amended as set out in
the Annex to this Directive.

Article 2

1. 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.

When Member States adopt these measures, they shall contain a
reference to this Directive or shall be accompanied by such
reference on the occasion of
their official publication. The
methods of making such reference shall be laid down by the
Member States.

2. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt in
the field covered by this Directive.

Article 3

This Directive shall enter into force on the day of its publication
in the Official Journal of the European Union.

This Directive is addressed to the Member States.

Article 4

Done at Strasbourg, 12 December 2006.

For the European Parliament
The President
J. BORRELL FONTELLES

For the Council
The President
M. PEKKARINEN

(1) OJ L 262, 27.9.1976, p. 201. Directive as last amended by Directive
2005/90/EC of the European Parliament and of the Council (OJ
L 33, 4.2.2006, p. 28).

(2) OJ L 183, 29.6.1989, p. 1. Directive as amended by Regulation (EC)

No 1882/2003.

(3) OJ L 158, 30.4.2004, p. 50. Corrigendum in OJ L 229, 29.6.2004,

p. 23.

(4) OJ L 131, 5.5.1998, p. 11. Directive as amended by the 2003 Act of

Accession.

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Official Journal of the European Union

27.12.2006

The following point is added to Annex I to Directive 76/769/EEC:

ANNEX

‘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.

(3)

(2) 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 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 1 μg/m2 of the coated material.
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,
photographic coatings applied to films, papers, or printing
plates,

(b)

(c) mist suppressants for non-decorative hard chromium (VI)
plating and wetting agents for use in controlled electroplat-
ing systems where the amount of PFOS released into the
environment is minimised, by fully applying relevant best
available techniques developed within the framework of
Council Directive 96/61/EC of 24 September 1996 con-
cerning integrated pollution prevention and control (*),
hydraulic fluids for aviation.

(d)
By way of derogation from paragraph 1, fire-fighting foams that
have been placed on the market before 27 December 2006 can be
used until 27 June 2011.
Paragraphs 1 and 2 shall apply without prejudice to Regulation
(EC) No 648/2004 of the European Parliament and of the Council
of 31 March 2004 on detergents (**).

(4)

(5)

(6) Not later than 27 December 2008 Member States shall establish

and communicate to the Commission an inventory that covers:
(a)

processes that are subject to derogation in paragraph 3(c)
and the amounts of PFOS used in and released from them,
existing stocks of fire-fighting foams containing PFOS.

(b)

(7) As soon as new information on details of uses and safer alternative
substances or technologies for the uses becomes available, the
Commission shall review each of the derogations in paragraph 3(a)
to (d) so that:
(a)

the uses of PFOS will be phased out as soon as the use of
safer alternatives is technically and economically feasible,
a derogation can only be continued for essential uses for
which safer alternatives do not exist and where the efforts
undertaken to find safer alternatives have been reported on,
releases of PFOS into the environment have been minimised,
by applying best available techniques.

(b)

(c)

(8)

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 (PFOA) 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.’

(*) OJ L 257, 10.10.1996, p. 26. Directive as last amended by Regulation (EC) No 166/2006 of the European Parliament and of the Council

(OJ L 33, 4.2.2006, p. 1).

(**) OJ L 104, 8.4.2004, p. 1. Regulation as amended by Commission Regulation (EC) No 907/2006 (OJ L 168, 21.6.2006, p. 5).