These Regulations were signed by the Minister on 25 January 2006 and came into operation from that date.
The 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).
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 29th 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).