The Cosmetic Products (Safety) Regulations 2004

Regulation 3(1), 5(7), (9) and (12)

SCHEDULE 12 List of Alternative Methods to Animal Testing

PART 1

Part 1 of this Schedule lists the alternative methods validated by the European Centre for the Validation of Alternative Methods (“ECVAM”) which are necessary to meet the requirements of these Regulations and which are listed in Annex V to Council Directive 67/548/EEC of 27th June 1967 on the approximation of laws, regulations and administrative provisions relating to classification, packaging and labelling of dangerous substances (1).

The reference number given in the second column of the table in Part 1 refers to the reference number under which the type of test is listed in Annex V to Directive 67/548/EEC.

Entry Number	Reference Number	Type of Test (toxicological endpoint)	Alternative Test Method	Date after which this method is required to be used
1	B40	Skin corrosion	Rat skin TER assay	11.9.04
2	B40	Skin corrosion	Human skin model assay	11.9.04
3	B41	Phototoxicity	In vitro 3T3 NRU phototoxicity test	11.9.04

PART 2

Part 2 of this Schedule lists the alternative methods validated by ECVAM which are necessary to meet the requirements of these Regulations and which are listed in Annex IX to the Directive. As an alternative method may not replace completely the experimentation on animals, column 3 of the table below specifies whether the alternative method fully or partially replaces the animal test.

Entry Number	Reference Number	Nature of replacement	Alternative Test Method	Date after which this method is required to be used
Note: There are no entries in this Part at the date that these Regulations are made.

(1)

O.J. l 196, 16.8.1967, p.1 as last amended by Directive 2004/73/EC (O.J. L152, 30.4.2004, p.1)