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.
Medicines
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 EU 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 EU Directive was implemented into UK domestic law by The Human Medicines Regulation 2012. The Medicines and Healthcare Products Regulatory Agency (MHRA) provide 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 rush 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.
CTPA has often advised on antiviral claims. Following discussions with the MHRA, the following information is the current advice.
Hand sanitisers which make general, broad spectrum anti-viral claims are not necessarily regarded to be medicinal but they would otherwise be classed as biocides. However, assessment will be made on a case-by-case basis considering the overall context and presentation for the product and the understanding of the averagely well-informed consumer.
For example, an ‘antiviral’ claim could still fall into the medicinal remit if it is associated to pictures of a specific virus; so even if the wording doesn’t mention any specific virus, a picture or a symbol may well do so and therefore change the meaning of the claim. The MHRA recognised that nowadays, the averagely well-informed consumer may take general antiviral claims to mean that the product is effective against Covid-19. Therefore the MHRA’s assessment will really look at the broad presentation and understanding of the consumer when deciding whether a claim is medicinal or not.
Specific claims on viruses, like ‘kills/protects against -virus name-‘ will be instead deemed as medicinal. It is MHRA’s position that any claim that a product can be used to treat or prevent a virus or an infection associated with specifically named pathogens, will be deemed as medicinal. The MHRA focus is particularly on specifically named pathogens such as MRSA, E.coli and now Covid-19. The kind of claim that would be considered medicinal would include ‘Kills/effective against Covid-19/SARS-CoV-2’ as this is an implied medicinal claim to treat or prevent infections caused by Covid-19.
For any further information, companies can contact the MHRA directly via their online advice request form.
Copies of the MHRA guidance document may be downloaded (pdf file). Companies are advised to consult Appendix 5 of the MHRA guidance document, specifically for this type of products.
Note:
- 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 EU 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.
MHRA Position on Adverse Skin Conditions
Products intended to treat or prevent eczema, psoriasis, dermatitis or other adverse skin conditions will be considered to be medicinal products. They do not fit under the definition of cosmetic products.
In cases where a product is on the borderline between cosmetics and medicines, MHRA will look at the overall presentation of the product, including the product name, and apply the tests set out in Directive 2001/83/EC. If a product appears to fall within both the definition of a cosmetic and the definition of a medicinal product it will be classified as a medicinal product. Therefore, care must be taken to ensure a cosmetic does not become a medicine by virtue of its presentation, its claims or its composition. Additional guidance on medicinal claims can be found in MHRA's Guidance Note 8.
It is recognised that consumers with an existing adverse skin condition may wish to know if a cosmetic product is appropriate for them to use. Where this can be substantiated, the following wording may be added to the presentation:
"Also suitable (or safe) for people who may be prone to eczema / psoriasis / dermatitis / rosacea / acne / spots"
However, MHRA's position is that use of this wording should not take the form of a claim. It is acceptable as long as it is not too prominent, does not distract from the cosmetic use of the product and only implies that a product will not exacerbate a skin condition. Only the exact wording, in full, should be used (inserting relevant adverse condition as required).
"For eczema/dermatitis/psoriasis etc. prone skin"
This claim would be interpreted to be a medicinal claim as it specifically targets consumers with adverse skin conditions who may therefore expect the products to treat, prevent or at least soothe the symptoms of adverse conditions.
Classification is always done on a case-by-case basis as one of the key criteria to take into consideration is the overall presentation of the product. The only competent authority in the UK to decide if a product is classed as a medicinal product is MHRA.
CTPA Guide on Common Understanding of Borderline Toothpaste Claims
In collaboration with the MHRA, CTPA has created a guide on common understanding of the cosmetic/medicine borderline for toothpaste claims. The objective of this guidance is to set a common understanding on the types of claims made for toothpastes and what this means in terms of the regulations that will apply to individual products in light of those claims.
In relation to this topic, the Advertising Standards Authority (ASA) has recently issued an online guide to advise companies on toothpaste claims based on previously upheld adjudications.
Medical Devices
For more information on how medical devices are regulated in the UK, please visit the UK Government website. The UK Regulation is transposed EU law, and it is therefore keeping regulatory provisions and safety standards similar to those of the EU.
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.
EU 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
EU 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."
Additional Information:
Medicines and Healthcare Products Regulatory Agency (MHRA)
Borderline Section
10 South Colonnade - Canary Wharf
E14 4PU - London
T: 020 7084 2000
Website: www.mhra.gov.uk
Biocidal Products
For more information on how medical devices are regulated in the UK, please visit the UK Government website. The UK Regulation is transposed EU law, and it is therefore keeping regulatory provisions and safety standards similar to those of the EU.
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.
EU 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.
Additional Information:
Health and Safety Executive (HSE)
Redgrave Court
Merton Road
Bootle
Merseyside
L20 7HS
Website: http://www.hse.gov.uk/biocides
General Products
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;
Additional Information:
Department for Business, Innovation & Skills
1 Victoria Street
London SW1H 0ET
