It may sometimes be unclear whether a product is a cosmetic within the definition in the cosmetics legislation or whether it falls under other sectoral legislation. Some common borderlines are medicines, medical devices, biocidal products and general products.
A product may fall on the cosmetic/medicine borderline i.e. it may fulfil the criteria above but also have a medicinal property.
The Fifth Recital to Directive 76/768, the Cosmetic Directive, foresees cosmetic products having a secondary preventative (but not curative) purpose. In deciding whether a product is:
- a cosmetic with a secondary preventative cause or
- a medicinal product, subject to licensing
account will be taken of the main purpose of the product, the claims made for it, the composition of the product and the purpose for which it is likely to be used by the consumer. The Medicines and Healthcare Products Regulatory Agency produce a guideline on borderline products. In the first instance a copy of this document should be obtained.
Claims for Antimicrobial Hand Cleansing Products
Companies are reminded that the Medicines Healthcare products Regulatory Agency’s (MHRA) stated position is that any hand wash or hand cleansing products making claims to kill named or specific pathogens are medicines. We understand that action is currently being taken against at least one company making such claims and presenting their product as a cosmetic.
The MHRA decided to take action in 2005 when a rash of products started to make claims regarding MRSA. In 2006, claims about bird flu have started to appear and there have been articles in the national press and in Chemist & Druggist.
The MHRA issued guidance in November 2005 titled:
- Guidance on Topical Products for Antibacterial, Antiseptic, Antimicrobial, General Disinfection and Cleansing of Skin
It is an offence to sell, supply or advertise a medicinal product that does not have a medicines’ authorisation issued by the MHRA.
General claims about killing germs or micro organisms are still acceptable.
Copies of the MHRA guidance document may be downloaded (pdf file).
- The MHRA is an executive government agency that is solely responsible for regulating medicines in the UK. Products may be classified as medicines because of active ingredients they contain, claims made for the product, or the way the product is presented.
- The MHRA has extensive powers both to regulate the supply of medicines and their advertising, and to enforce the operation of the marketplace, including criminal prosecution. Offending companies may be required to remove their products from the market and either amend inappropriate claims or get a medicines' marketing authorisation for the product before placing that product on the market once more.
The Fifth Recital to Cosmetic Directive
The Fifth Recital to Directive 76/768/EEC reads:
"Whereas this Directive relates only to cosmetic products and not to pharmaceutical specialities and medicinal products; whereas for this purpose it is necessary to define the scope of the Directive by delimiting the field of cosmetics from that of pharmaceuticals; whereas this delimitation follows in particular from the detailed definition of cosmetic products, which refers both to their areas of application and to the purposes of their use; whereas this Directive is not applicable to the products that fall under the definition of cosmetic product but are exclusively intended to protect from disease; whereas, moreover, it is advisable to specify that certain products come under this definition, whilst products containing substances or preparations intended to be ingested, inhaled, injected or implanted in the human body do not come under the field of cosmetics."
This specifically excludes from the scope of the Directive products "which fall under the definition of cosmetic product but are exclusively intended to protect from disease". Accordingly the primary purpose of the product is critical in establishing its legal status.
Products which are used in association with a device, e.g. products for use on or with false teeth, are likely to be classified as medical devices; and not as medical device accessories. Further advice can be sought from the Medical Devices Agency.
Directive 2001/83/EEC defines a medicinal product as:
"(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis."
Definition of medical device
Council Directive 93/42/EEC concerning medical devices defines them as follows:
"(a) 'Medical device' means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
- investigation, replacement or modification of the anatomy or of a physiological process,
- control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;"
Definition of medical device accessory
Accessories are treated as medical devices in their own right and are defined as:
"(b) 'Accessory' means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device."
Medicines and Healthcare Products Regulatory Agency (MHRA)
1 Nine Elms Lane
T: 020 7084 2000
Cosmetics are generally exempted from the biocides regulation but exceptions may arise in very rare cases.
Cosmetic products with a primary cosmetic function can make secondary biocidal claims without being classified as biocidal products. The classification of these products is made on a case by case basis.
Directive 98/8/EC concerning the placing of biocidal products on the market defines biocidal products as:
(a) Biocidal products
Active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means.
N.B: An exhaustive list of 23 product types with an indicative set of descriptions within each type is given in Annex V.
Health and Safety Executive (HSE)
Companies may be involved in the manufacturing of “beauty accessories” not classified as cosmetic but as general products i.e.: false eyelashes, false nails …
The General Product Safety Regulations 2005
“product” means a product which is intended for consumers or likely, under reasonably foreseeable conditions, to be used by consumers even if not intended for them and which is supplied or made available, whether for consideration or not, in the course of a commercial activity and whether it is new, used or reconditioned and includes a product that is supplied or made available to consumers for their own use in the context of providing a service. “product” does not include equipment used by service providers themselves to supply a service to consumers, in particular equipment on which consumers ride or travel which is operated by a service provider;
Department for Business, Innovation & Skills
1 Victoria Street
London SW1H 0ET