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S.I. No. 25 of 2006
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European Communities (Classification,
Packaging, Labelling and Notification of Dangerous Substances) (Amendment)
Regulations 2006
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I, Micheál Martin, T.D., Minister for Enterprise, Trade, and Employment, in
exercise of the powers conferred on me by section 3 of the European
Communities Act 1972 (No. 27 of 1972), and for the purpose of giving effect
to Commission Directive 2004/73/EC1
hereby make the following regulations:
1. (1) These
Regulations may be cited as the European Communities (Classification,
Packaging, Labelling and Notification of Dangerous Substances) (Amendment)
Regulations 2006.
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(2) These Regulations and the
European Communities (Classification, Packaging, Labelling and Notification
of Dangerous Substances) Regulations 2003 ( S.I.
No. 116 of 2003 ) shall be construed as one and may be cited together as the
European Communities (Classification, Packaging, Labelling and Notification
of Dangerous Substances) Regulations 2003 and 2006.
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(3) In these Regulations,
“Principal Regulations” means the European Communities (Classification,
Packaging, Labelling and Notification of Dangerous Substances) Regulations
2003 (S.I. 116 of 2003).
2. Regulation 2(1) of the
Principal Regulations is amended -
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(a) by substituting for the definition of “Annex
I” the following:
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“Annex I means Annex I to Council Directive 67/548/EEC21 as
lastly amended by Commission Directive 2004/73/EC60 of
29 April 2004, and any reference in the said Annex to “EEC Number” shall be
construed as a reference to “EC Number” and which for convenience of
reference the Foreword to Annex I is set out in Schedule 1;
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(b) by substituting for the definition of “Annex
V” the following:
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“Annex V means Annex V to Council Directive 67/548/EEC as lastly
amended by Commission Directive 2004/73/EC of 29 April 2004;”, and
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(c) by substituting for the definition of
“notification” the following:
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“ “notification” means the documents, with the requisite
information, presented to the competent authority of a Member
State —
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(a) for substances manufactured within the Community, by
the manufacturer who places a substance either on its own or in a
preparation on the market;
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(b) for substances manufactured
outside the Community, by any person established in the Community who is
responsible for placing the substance either on its own or in a preparation
on the Community market, or alternatively by the person established within
the Community who is for the purposes of submitting a notification for a
given substance placed on the Community market, either on its own or in a
preparation, designated by the manufacturer as his or her sole representative;”.
3. Schedule 1 to the Principal
Regulations is amended by substituting for the explanation of Note K the
following:
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“Note K:
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The classification as a carcinogen or mutagen need not apply if it
can be shown that the substance contains less than 0.1 % w/w 1.3-butadiene (Einecs No. 203-450-8). If the substance is not
classified as a carcinogen or mutagen, at least the S-phrases (2)-9-16
should apply. This note applies only to certain complex oil-derived
substances in Annex I.”.
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GIVEN under my Official Seal,
25 January 2006
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Micheál Martin
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Minister for Enterprise,
Trade and Employment
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EXPLANATORY NOTE
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(This note is not part of the Instrument and
does not purport to be a legal interpretation.)
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These Regulations transpose Commission
Directive 2004/73/EC of 29 April
2004, the 29th Adaptation to Technical Progress of
Council Directive 67/548/EEC on the classification, packaging and labelling
of dangerous substances. They amend the European Communities
(Classification, Packaging, Labelling and Notification of Dangerous
Substances) Regulations 2003 ( S.I. No. 116 of 2003
).
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The aim of the Regulations is to protect
people and the environment from the harmful effects of both new substances
and existing dangerous substances. The Regulations apply to all substances
which are intended to be placed on the market either on their own or in a
preparation, with exceptions for certain categories of substances such as medicinal,
cosmetic, pesticide, waste, etc., products which are covered by other
Directives.
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The Regulations require each manufacturer,
importer or other person proposing to place any new chemical on the market
for the first time to submit to the competent authority a notification
dossier containing details of tests to which the substance has been
subjected and the proposed classification and labelling of the substance.
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They also require suppliers to put warning
labels on containers for dangerous substances and to ensure that the
containers are properly designed, constructed and secured to prevent
spillage or seepage during normal use. Safety data sheets must be supplied for
dangerous substances covered by the Regulations.
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Commission Directive 2004/73/EC adapts to
technical progress for the 29th time. Annexes 1 and V of
Directive 67/548/EEC.
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The Directive adds a number of additional
dangerous substances to Annex I, the list of
substances classified and labelled as dangerous in the European Community,
amends the classification and labelling of a number of other dangerous
substances already included in Annex 1, and deletes a number of existing
entries in the Annex. In addition, some entries are split as the
classification no longer applies to all substances under those entries.
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The Foreword to Annex I
(as set out in Schedule 1 to the Principal Regulations) is updated to amend
the text of Note K. This affects the classification and labelling of
substances containing 1.3-butadiene, as this substance has also been
classified as a mutagen by the Directive.
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Additional toxicological and
eco-toxicological test methods are incorporated into Annex V.
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The definition of a “notification” is
expanded to indicate that the notifier must be
established within the European Community in accordance with the definition
in the Directive.
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References to the Safety, Health and Welfare at Work Act 1989 in the
European Communities (Classification, Packaging, Labelling and Notification
of Dangerous Substances) Regulations 2003 should be construed as references
to the Safety, Health and Welfare at Work Act 2005 (No. 10 of 2005).
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1 O.J. L152, 30.4.2004,
p.1 as corrected by Corrigendum to Commission Directive 2004/73/EC of 29
April, 2004 O.J. L216, 16.6.2004, p.3 and
Corrigendum to the Corrigendum to Commission Directive 2004/73/EC of 29
April, 2004 O.J. L236, 17.7.2004, p.18
21 O.J. 196, 16.8.1967, p.
1
79 O.J. L152, 30.4.2004, as
corrected by Corrigendum to Commission Directive 2004/73/EC of 29 April
2004, O.J. L216, 16.6.2004, p. 3 and Corrigendum
to the Corrigendum to Commission Directive 2004/73/EC of 29 April 2004, O.J. L236, 7.7.2004, p. 18”,
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