S.I. No. 25/2006 - European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) (Amendment) Regulations 2006

S.I. No. 25 of 2006

European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) (Amendment) Regulations 2006

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.

(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.

(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 -

(a) by substituting for the definition of “Annex I” the following:

“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;

(b) by substituting for the definition of “Annex V” the following:

“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

(c) by substituting for the definition of “notification” the following:

“ “notification” means the documents, with the requisite information, presented to the competent authority of a Member State —

(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;

(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:

“Note K:

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.”.

EXPLANATORY NOTE

(This note is not part of the Instrument and does not purport to be a legal interpretation.)

These Regulations transpose Commission Directive 2004/73/EC of 29 April 2004, the 29^th 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 ).

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.

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.

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.

Commission Directive 2004/73/EC adapts to technical progress for the 29^th time. Annexes 1 and V of Directive 67/548/EEC.

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.

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.

Additional toxicological and eco-toxicological test methods are incorporated into Annex V.

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.

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).

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”,