Cosmetic Products (Safety) Regulations (1996)
The above regulations came into force on 16 December 1996 and were implemented in stages over a period of 18 months. I have detailed below the main requirements of the Regulations.
The manufacturer or importer into the community shall not supply a product which is liable to cause damage to human health when applied under normal and reasonably foreseeable conditions of use.
Specific substances are prohibited and the use of others is controlled by Regulation 4 and Schedules 1, 2, 3, 4 and 5. This requirement came into force on 16 December 1996 for the majority of substances, with a later implementation date of 1 July 1997 for certain of the substances.
There is a prohibition on the supply of cosmetic products containing ingredients which are tested on animals where the testing takes place after 1 January 1998.
As from 1 January 1998 any reference to testing on animals in either the labelling or advertising of a product must clearly state whether the tests carried out involved the product itself or its ingredients.
As from 16 December 1996 products have to be labelled in accordance with the Regulations. Ingredient labelling is a new requirement which was compulsory as from 1 January 1997. Please see the enclosed flow diagram for how to label cosmetic products.
The responsible person can submit a request for confidentiality if, for trade secrecy reasons, he does not want to list a certain ingredient. The request should be made to the Secretary of State.
The following are not regarded as ingredients for the purposes of the compilation of the ingredient list: -
- impurities in the raw materials used
- subsidiary technical materials used in the preparation of the cosmetic product but not present in the final product.
- Materials used in strictly necessary quantities as solvents or as carriers for perfumes and aromatic compositions.
- Perfumes and aromatic compositions and their raw materials shall be referred to by the words ‘perfume’ or ‘flavour’.
In the case of ingredients in concentrations of less than 1% they may be listed in any order after those in concentrations of 1% or more. Colouring agents may be listed in any order after the other ingredients, in accordance with the colour index number or denominations found in schedule 3 to the Regulations. Also, for decorative cosmetic products marketed in several colour shades, all colouring agents used in the range may be listed, provided that the words "may contain" are added.
The name used for an ingredient shall be identified by its common name as provided for in the common ingredients nomenclature or, in the absence of the nomenclature or of a common name, by its chemical name, its CTFA name1, its European Pharmacopoeia name, its International Non-proprietary name as recommended by the World Health Organisation, its EINECS2, IUPAC3 or CAS4 identification reference or its colour index number5.
Where a product is manufactured or supplied in the UK, the responsible person (the manufacturer, his agent or the person ordering the manufacture but if none of the preceding are situated in the European Community, then the responsible person is the first supplier of the product in the Community) has to keep accessible to a UK local authority a product information file. It has to include the following:-
- Qualitative and quantitative composition. For perfume content only the name, code number and supplier of the perfume need to be recorded.
- The physio-chemical and microbiological specifications of the raw materials and finished product. The purity and microbiological control criteria of the product.
- The method of manufacture
- Safety assessment of the product
- Name and address of the person responsible for the safety assessment
- Existing data on undesirable effects on humans
- Proof of the effect claimed
This file has to be accessible via the address or registered office which is specified on the container. The requirement came into force on 16 December 1996.
Where the manufacturer manufactures a product at two or more places within the community and one of the places is in the UK, the responsible person may choose a single place of manufacture within the community where the file is kept available.
As from 16 December 1996, where the place of manufacture or initial importation is in the UK, the responsible person shall notify a UK competent authority of the address of the place of manufacture or importation, before its first supply in the Community. At the time of writing, the ‘competent authority’ for the purposes of this regulation is yet to be confirmed but it will be a section of the DTI. Also uncertain is whether or not notification will be required in respect of each product. The best advice I can give at this time is to contact the Department of Trade and Industry for more information.
1 Name given by the Cosmetics Toiletries and Fragrances Association and listed in the sixth edition of the International Cosmetic Ingredient Dictionary published in 1995
2 The reference given in the European Inventory of Existing Commercial Chemical Substances.
3 Identification reference is given by the International Union of Pure and Applied Chemistry.
4 Identification reference assigned by the Chemical Abstracts Service.
5 The number specified in the 3rd edition of the Colour Index published in 1971 by the Society of Dyers and Colourists.
All cosmetic products have to be safety assessed as from 16 December 1996. This assessment has to be carried out in accordance with the principles of good laboratory practice and by a registered pharmacist or a registered medical practitioner.
The draft Regulations contained contradictory requirements as to where the ingredients list should appear. I understand that this was because the Directive itself was unclear on this point. Whilst the situation has been clarified for the UK, there is no guarantee that our European partners will interpret the Directive in the same way. If you supply products to other member states you will have to ensure compliance with the legislation in force in that state.
Further information
We are happy to provide further advice or literature to assist you in complying. We also enforce a range of other consumer or trading legislation which might affect you. Examples include furniture, gas appliances and toys.
If you need further advice on this, or other trading issues, please contact the Duty Officer on (01925) 442658, Monday to Friday between 9.00 a.m. and 5.00 p.m.
Please note that ultimately only the Courts can interpret the law with any authority.
The information contained in this guidance note is, to the best of our knowledge and ability, correct on the date of publishing. The law may change at a future date.
Please click here to view a Cosmetic Products (Safety) Regulations Flowchart
