These Regulations give effect to European Parliament and Council Directive 2002/61/EC on azocolourants, as amended by Commission Directive 2003/3/EC on “blue colourant”. To the extent that the Regulations apply to azocolourants, they also apply to Northern Ireland.

Both Directives make amendments to the regime established under Council Directive 76/769/EEC on the approximation of laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations. The Regulations apply from 8th January 2004 in relation to azocolourants and from 30th June 2004 in relation to “blue colourant”.

Regulation 3 sets out exclusions from the scope of the Regulations.

Regulation 4 provides that azo dyes may not be used in textile and leather articles which may come into direct and prolonged contact with the human skin or oral cavity where such substances, by reductive cleavage of one or more azo groups, may release in detectable concentrations one or more of the aromatic amines listed in Schedule 1. The supply of textile and leather articles which do not comply with regulation 4(1) is prohibited by regulation 4(3).

Regulation 4(4) contains transitional provisions permitting the supply of leather and textile articles placed on the market in a Member State before 11th September 2003 and articles made of recycled fibres placed on the market before 1st January 2005.

Regulation 5 prohibits the supply and the use of “blue colourant” defined in Schedule 2 for colouring textile and leather articles as a substance or constituent of preparations in concentrations higher than 0.1% by mass. The prohibition on supply does not apply to “blue colourant” which is placed on the market before 30th June 2004 (regulation 5(2)).

Regulation 6 makes it an offence to contravene regulation 5 and specifies the penalties for such an offence. By virtue of regulation 7, regulation 4 and other regulations insofar as they relate to regulation 4, are safety regulations made under the Consumer Protection Act 1987. This Act makes the supply of goods in contravention of safety regulations an offence and makes other provisions for the enforcement of safety regulations.

Regulation 8 specifies the powers of the Environment Agency, in England and Wales, and the Scottish Environment Protection Agency, in Scotland, to enforce regulation 5.

In these Regulations, the substances in Schedules 1 and 2 are identified by reference to their CAS Numbers, Index Numbers and EC Numbers. The CAS Number is given in the CAS Registry Handbook, ISSN 0093-058X, which may be inspected at the Royal Society of Chemistry, Burlington House, Piccadilly, London W1V 0BN. The Index Number is the identification code given to the substance in amended Annex I of Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (O.J. No. P196, 16.8.67, p. 1) and published in the European List of Notified Chemical Substances (Elincs). The EC Number is the identification code given to the substance and published in the European Inventory of Existing Commercial Chemical Substances (Einecs).

A Regulatory Impact Assessment and a Transposition Note in relation to these Regulations have been prepared and placed in the library of each House of Parliament. Copies of either of these documents can be obtained from Defra, Chemicals and GM Policy Division, Ashdown House, 123 Victoria Street, London SW1E 6DE or from Department of Trade and Industry, Bay 432, 1 Victoria Street, London SW1H 0ET.