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全氟辛烷磺酸 (PFOS) 的銷售與使用限制指令 (2006 122 EC) 原始法規
全氟辛烷磺酸 (PFOS) 的銷售與使用限制指令 (2006 122 EC) 原始法規
2006
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE to the environment or human health, if releases into the
EUROPEAN UNION, environment and workplace exposure are minimised. With
regard to fire-fighting foams, SCHER agrees that health and
Having regard to the Treaty establishing the European Commu- environmental risks of substitutes should be assessed before
nity, and in particular Article 95 thereof, a final decision can be taken. SCHER also agrees with
restricting the use of PFOS in the plating industry, if there
Having regard to the proposal from the Commission, are no other measures available that could be applied to
reduce the emissions during metal plating to a significantly
Having regard to the Opinion of the European Economic and lower level.
Social Committee (1),
Whereas:
(4) In order to protect health and the environment, it therefore
(1) An OECD (Organisation for Economic Cooperation and appears necessary that the placing on the market and the
Development) hazard assessment has been done on the use of PFOS should be restricted. This Directive is intended
basis of information that was available by July 2002. This to cover the major part of the exposure risks. Other minor
assessment concluded that perfluorooctane sulfonates uses of PFOS do not seem to pose a risk and they are
(hereinafter ‘PFOS’) are persistent, bioaccumulative and therefore currently exempted. However, special attention
toxic to mammalian species and, therefore, indicate cause should be given to plating processes using PFOS and
for concern. therefore the releases from those processes need to be
minimised by applying the best available techniques
(2) The risks posed to health and environment by PFOS have (hereinafter ‘BAT’) fully taking into account all relevant
been assessed in accordance with the principles of Council information contained in the BAT reference document on
Regulation (EEC) No 793/93 of 23 March 1993 on the Surface Treatment of Metals and Plastics as developed for
evaluation and control of the risks of existing sub- use under Council Directive 96/61/EC of 24 September
stances (3). The risk assessment identified a need to reduce 1996 concerning integrated pollution prevention and
the risks to health and the environment. control (5) (IPPC Directive). In addition, Member States
should establish inventories of those uses in order to
(3) The Scientific Committee on Health and Environmental acquire information about the actual quantities used and
released.
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 (5) The semi-finished products and articles containing PFOS
assessment of PFOS but it also agreed that risk reduction should also be restricted in order to protect the environ-
measures might be necessary to avoid the re-occurrence of ment. The restriction should cover all the products and
former uses. According to SCHER, on-going critical uses in articles to which PFOS are intentionally added, taking into
the aviation industry, the semiconductor industry and the account that PFOS may have been used only in some
photographic industry do not appear to pose a relevant risk
distinct parts or in coatings of certain products and articles,
such as textiles. This Directive should only restrict new
(1) OJ C 195, 18.8.2006, p. 10. products and should not apply to products already in use or
(2) Opinion of the European Parliament of 25 October 2006 (not yet on the second hand market. However, existing stocks of
published in the Official Journal) and Council Decision of fire-fighting foams containing PFOS should be identified
11 December 2006. and their use should be allowed to continue only for a
(3) OJ L 84, 5.4.1993, p. 1. Regulation as amended by Regulation (EC) limited time to prevent possible further emissions from the
No 1882/2003 of the European Parliament and of the Council (OJ
L 284, 31.10.2003, p. 1).
use of such products.
(4) Council Decision 2006/507/EC of 14 October 2004 concerning the
conclusion, on behalf of the European Community, of the Stock- (5) OJ L 257, 10.10.1996, p. 26. Directive as last amended by
holm Convention on Persistent Organic Pollutants (OJ L 209, Regulation (EC) No 166/2006 of the European Parliament and of
31.7.2006, p. 1). the Council (OJ L 33, 4.2.2006, p. 1).
27.12.2006 EN Official Journal of the European Union L 372/33
(6) To ensure ultimately the phase-out of uses of PFOS the HAVE ADOPTED THIS DIRECTIVE:
Commission should review each derogation under this
Directive when new information on the uses and safer Article 1
alternatives developed gives grounds for it. The derogation Annex I to Directive 76/769/EEC is hereby amended as set out in
should only be allowed to continue for essential uses on the the Annex to this Directive.
condition that safer substances or technologies, that are
technically and economically feasible, do not exist and BAT Article 2
are applied to minimise emissions of PFOS.
1. Member States shall adopt and publish, not later than
(7) Perfluorooctanoic acid (PFOA) and its salts are suspected to 27 December 2007, the laws, regulations and administrative
have a similar risk profile to PFOS, and consequently there provisions necessary to comply with this Directive. They shall
is a need to keep under review the ongoing risk assessment forthwith communicate to the Commission the text of those
activities and the availability of safer alternatives and to measures and a table showing the correlation between those
define what kind of risk reduction measures, including measures and this Directive.
restrictions on marketing and use, if appropriate, should be
They shall apply these measures from 27 June 2008.
applied within the European Union.
When Member States adopt these measures, they shall contain a
(8) Directive 76/769/EEC (1) should be amended accordingly.
reference to this Directive or shall be accompanied by such
(9) The objective of this Directive is to introduce harmonised reference on the occasion of their official publication. The
provisions with regard to PFOS, thus preserving the internal methods of making such reference shall be laid down by the
market whilst ensuring a high level of protection of human Member States.
health and the environment, as required by Article 95 of 2. Member States shall communicate to the Commission the
the Treaty. text of the main provisions of national law which they adopt in
the field covered by this Directive.
(10) This Directive is without prejudice to the Community
legislation laying down minimum requirements for the Article 3
protection of workers, such as Council Directive 89/391/
EEC of 12 June 1989 on the introduction of measures to This Directive shall enter into force on the day of its publication
encourage improvements in the safety and health of in the Official Journal of the European Union.
workers at work (2), and individual directives based thereon,
in particular Directive 2004/37/EC of the European Article 4
Parliament and of the Council of 29 April 2004 on the This Directive is addressed to the Member States.
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/
Done at Strasbourg, 12 December 2006.
391/EEC) (codified version) (3) and Council Directive 98/
24/EC of 7 April 1998 on the protection of the health and For the European Parliament For the Council
safety of workers from the risks related to chemical agents
at work (fourteenth individual Directive within the meaning The President The President
of Article 16(1) of Directive 89/391/EEC) (4), J. BORRELL FONTELLES M. PEKKARINEN
ANNEX