The Cosmetic Products (Safety) Regulations 2004

Explanatory Note

(This note is not part of the Order)

These Regulations revoke and re-enact the Cosmetic Products (Safety) Regulations 2003 (S.I. 2003/835) (“the 2003 Regulations”). The 2003 Regulations give effect to Council Directive 76/768/EEC (O.J. No. L262, 27.9.76, p.169) (“the Directive”) on the approximation of the laws of the Member States relating to cosmetic products, as amended by the Community instruments listed in Schedule 2 to these Regulations.

These Regulations also give effect for the first time to Council Directive 2003/15/EC (O.J. L66, 11.3.2003, p.26) which amends Directive 67/548/EEC for the 7th time, as follows:

(a) Prohibit the supply of cosmetic products where the final formulation or ingredients have been tested on animals using a method other than an “alternative method”. The Regulations also introduce an outright prohibition in respect of the supply of cosmetic products after specified dates (2009 and 2013);

(b) Prohibit the testing of “finished cosmetic products” on animals with immediate effect;

(c) Prohibit the testing of ingredients for use in cosmetic products after specified dates;

(d) Introduce provisions governing the use by cosmetic product manufacturers of claims in respect of animal testing;

(e) Prohibit the use in cosmetic products of substances which are classified under directive 67/548/EEC as carcinogenic, mutagenic or toxic to reproduction (and listed in the approved supply list) subject to an exemption in respect of substances which have been evaluated as safe by the Scientific Committee on Cosmetic Products(1);

(f) Requires manufacturers to label products with a symbol (contained in Schedule 9, Part 2) indicating the time after opening after which the product may harm the consumer (this only applies to products with a minimum durability of more than 30 months);

(g) Requires certain perfumes and aromatic compositions to be specifically listed on product packaging;

(h) Requires a specific safety assessment to be undertaken in respect of cosmetic products intended for children or for intimate hygiene;

(i) Inserts further entries into Schedule 4 to these Regulations;

These Regulations also give effect to Council Directive 2003/80/EC (O.J. No. 224, 6.9.2003, p.27) which amends the Directive for the 30th time. Directive 2003/80/EC amends the Directive by inserting a new Annex VIIIa containing a symbol to be used by manufacturers to indicate the time after opening after which the product may harm the consumer (as required by Directive 2003/15/EC).

These Regulations also give effect to Council Directive 2003/83 (O.J. No. L238, 25.9.2003, p.23) which amends the Directive by inserting, deleting or amending entries in Annexes II, III and VI. These Regulations make appropriate amendments to Schedules 3,4 and 6, which implement those Annexes. Directive 2003/83/EC requires Member States to ensure that cosmetic products, which fail to comply with that directive, shall not be placed on the market from 24th March 2005 and that they shall not be supplied to the final consumer from 24th September 2005. Accordingly, regulations 1(3) and 1(4) provide that newly inserted or amended entries in the schedules to the regulations shall not have effect until 24th March 2005. Equally, these regulations provide that certain entries, which are amended or deleted by 2003/83, shall continue to operate in their existing form (i.e. as they appear in the Cosmetic Products (Safety) Regulations 2003) until 24th March 2005. Regulation 16(3) provides that no proceedings or enforcement action shall be taken in respect of the new or amended entries where the cosmetic product in question is placed on the market before 24th March 2005 and is supplied before 24th September 2005.

The Colour Index referred to in these Regulations may be obtained from the Society of Dyers and Colourists and the American Society of Textile Chemists and Colourists by on-line subscription at http://www.colour-index.org/.

A full regulatory impact assessment of the effect that this instrument will have on costs to business is available from the Consumer and Competition Policy Directorate of the Department of Trade and Industry, 1 Victoria Street, London SW1H 0ET. Copies of a transposition note relating to these Regulations have been placed in the libraries of both Houses of Parliament. Copies are also available to the public from the Consumer and Competition Policy Directorate of the Department of Trade and Industry, 1 Victoria Street, London SW1H 0ET.

(1)

the Scientific Committee on Cosmetic Products was previously called the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (“SCCNFP”)