The Cosmetic Products (Safety) Regulations 2008

Explanatory Note

(This note is not part of the Regulations)

These Regulations revoke and re-enact the Cosmetic Products (Safety) Regulations 2004 (S.I. 2004/2152) (“the 2004 Regulations”). The 2004 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 to Council Directive 2007/22/EC (O.J. No. L101, 18.4.2007, p.11) which amends the Directive by deleting or amending entries in Annexes IV and VI. This Directive requires that the daily bioavailable intake of iodine from cosmetic products should not exceed 20% of the recommended daily intake and bans the use of Iodopropynyl Butylcarbamate (IPBC) in oral hygiene and lip care products. It also reduces the concentrations of IBPCs allowed in other products (particularly for young children). Regulations 2(2) and 2(3) make appropriate amendments to Schedules 5 and 6 which implement those Annexes. Directive 2007/22/EC requires Member States to ensure that cosmetic products which fail to comply with that Directive shall not be placed on the market from 18 October 2008 and that they shall not be supplied to the final consumer after 18 April 2009. Regulation 2(4) implements these provisions.

These Regulations also give effect to Council Directive 2007/53/EC (O.J. No. L226, 30.8.2007, p.19) which amends the Directive by amending entries in Annexe III; Directive 2007/53/EC introduces a labelling requirement for toothpaste containing 0.1% to 0.15% fluoride in respect of use by children of 6 years and younger, and provides that the labelling of the relevant products must contain the obligatory wording after 19 March 2009. Regulation 2(1) makes the necessary amendments to Schedule 4.

These Regulations also give effect to Council Directive 2007/54/EC (O.J. No. L226, 30.8.2007, p.21) which amends the Directive by inserting, amending or deleting entries in Annexes II and III. These entries relate to substances used in hair dye products. Schedules 3 and 4 are amended accordingly.

Regulation 26 includes these Regulations in the list of legislation in Part 3 of the Schedule to the Legislative and Regulatory Reform (Regulatory Functions) Order 2007. This will oblige the bodies enforcing these Regulations to have due regard to the Better Regulation Commission's five principles of good regulation. These principles are that regulatory activities should be carried out in a way which is transparent, accountable, proportionate and consistent and should be targeted only at case in which they are needed.

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 impact assessment of the effect that these Regulations will have on costs to businesses is available from the Consumer and Competition Policy Directorate of the Department for Business, Enterprise and Regulatory Reform, 1 Victoria Street, London SW1H 0ET and on the BERR website (www.berr.gov.uk). 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 for Business, Enterprise and Regulatory Reform, 1 Victoria Street, London SW1H 0ET.