Article 2 of the UK Cosmetics Regulation (UKCR - Schedule 34 of the Product Safety and Metrology Statutory Instrument) and the EU Cosmetics Regulation (Regulation (EC) No. 1223/2009) incorporates the following definition of a cosmetic product:
A "cosmetic product" shall mean any substance or mixture intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition.
There are three preliminary questions which should be addressed when deciding whether a product could legally be classified as a cosmetic.
Is the purpose of the product wholly or mainly cosmetic i.e. is it intended to:
- change appearance
- correct body odour
- keep in good condition
If the main purpose of the product is not to perform one of these functions it is unlikely to be a cosmetic.
- a product intended to be applied to a spot in order to treat that spot is not a cosmetic.
- a product intended to be applied to a spot in order to conceal it is a cosmetic.
- a product offered to conceal a spot but having a secondary purpose of preventing the formation of further spots is a cosmetic.
Site of Application
Is the product intended to be applied to the:
- hair system
- external genital organs
- mucous membrane of the oral cavity
If it is not, the product is unlikely to be a cosmetic.
Eye drops, vaginal douches, nose drops and orally ingested tablets intended to improve appearance, are not cosmetics.
Does the composition of the product conform with the EU Cosmetic Regulations.
- ingredients which are prohibited in cosmetic products
- ingredients which are restricted in cosmetic products
- preservatives, UV filters and colourants which are permitted in cosmetic products (preservatives, UV filters and colourants not listed in the Schedules to the Regulations are not permitted in cosmetic products).
If the composition of the product is not in accord with these Regulations it cannot be marketed as a cosmetic, regardless of claims made or the absence of such claims.
Toothwhitening products are cosmetics. However, there is a limit of 0.1% of Hydrogen Peroxide present in the product or released in use. A toothwhitener with hydrogen peroxide in excess of the limit is an illegal cosmetic.
If a product is not a cosmetic, it may fall under another regulatory regime such as that for foods, biocides or general product safety. However, care must be taken to ensure that what is, at first sight, a cosmetic does not become a medicine by virtue of its presentation, its claims or its composition.
The CTPA provides advice to its members on how to classify a product.
It should be noted that EU legal cases and EU agreements can alter the legal status of products, particularly those for which the legal classification is not harmonised across the community. The legal status of these products should be reviewed regularly.
European Commission Borderline Manual for Cosmetics
Medicines and Healthcare products Regulatory Agency Guidance Note 8