Current regime
The main set of rules is set out in the Cosmetics Regulations 2008 – whose full title is the Cosmetic Products (Safety) Regulations 2008 – and their main aim is to safeguard public health. The regulations implement the 1976 Cosmetics Directive.
What is a cosmetic product?
Under the Cosmetics Regulations 2008, a “cosmetic product” is defined as any substance or preparation intended to be placed in contact with the various external parts of the human body, 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, correcting body odours, protecting them or keeping them in good condition. If there is any chance that the product is a chemical substance or micro-organism (i.e. a biocide), the Health and Safety Executive should be consulted. If there is any possible crossover with a medical device or medical product, then the medicines and healthcare products regulatory agency (MHRA) should be asked for advice.
Borderline products
Many products (such as Botox, for example) are on the borderline between medicines and cosmetics. Medicinal products cannot be placed on the UK market without a marketing authorisation or product licence.
Regulatory obligations
The Cosmetics Regulations 2008 impose a number of obligations:
- A general safety requirement - a product must be safe both under normal and also reasonably foreseeable conditions of use. For example, if a hair shampoo carries a warning “Rinse eyes immediately if product comes into contact with them” and the consumer chooses to ignore this cautionary advice, then the manufacturer cannot be held liable. However, if the product is so strong that it severely damages the consumer’s eyes, then the manufacturer probably will be regarded as at fault.
- Restrictions - there are detailed restrictions on the ingredients and composition of cosmetic products. These are set out in schedules 3 to 7 of the Regulations.
- Animal testing ban - when testing finished cosmetic products or their ingredients to make sure they comply with the Cosmetics Directive, the tests must not be conducted on animals. This prohibition has been in force since 11 September 2004.
- Specific labelling requirements - the regulations require all cosmetic products to be marked with: a list of ingredients, the name and address of the manufacturer or supplier, the product’s country of origin, a best-before date, any necessary warnings or precautionary information, a batch number, (where appropriate) a description of what the product actually does, and a declared quantity of weight. In addition, all lettering on the packaging should be visible and easily legible.
- Notification requirements - where a product is manufactured in the UK, the responsible person must notify the secretary of state (A “responsible person” includes the manufacturer, the manufacturer’s agent or the person to whose order the product is manufactured). Responsible persons must notify the type of product supplied according to the following list: perfumes, decorative cosmetics, skin care, hair care, and toiletries.
Penalties for breach
Failure to comply with the regulations will result in a summary conviction and a fine not exceeding £5,000, imprisonment for up to six months, or both.
Other regulations
The General Product Safety Regulations 2005 – which impose a general obligation to place only safe products in the market – apply to the Cosmetics Regulations. The 2005 rules also cover risks not protected by the Cosmetics Regulations. However, the current regime is unduly complicated. There are almost 50 amendments to the Cosmetics Directive, a lack of coherent terminology and 27 different enacting national provisions. As a result, compliance by the industry is more onerous and costly than necessary.
Future regime
The new EU cosmetic products rules – the Cosmetic Products Regulation 2009 (EC Regulation No 1223/2009) – were adopted on 30 November 2009. It will take full effect from July 2013 but parts of the new regime will be phased in ahead of this date.
The main aims of the new rules are to simplify the procedures while strengthening certain elements of the regulatory framework. The most important changes implemented by Cosmetic Products Regulation 2009 are as follows:
- It replaces the Cosmetic Directive and will be immediately enforceable as law in all EU member states simultaneously. It will therefore negate the requirements of national law in each EU member state.
- It strengthens market control. The new regulation creates a single EU-wide register for cosmetic products and improves the co-operation between market surveillance authorities. This includes an EU-wide compulsory notification system of cosmetic products.
- There will be compulsory labelling and safety assessment of nanomaterials. There is already widespread use of nanomaterials in cosmetics such as sunscreens, toothpaste, face creams and various other care products. Once the Cosmetic Products Regulation 2009 is in force, there will be (for the first time ever) European legislation that tackles the issue of nanoparticles and establishes a safety assessment procedure for all products containing them. If a risk to human health is established, then the product in question will be banned.
- There will be common criteria for product liability claims involving cosmetics.
- Stricter rules will be introduced for substances which are carcinogenic, mutagenic or toxic for reproduction. Such substances will be forbidden in cosmetics, subject to certain exceptions that will be governed by strict controls.
- The ban on animal testing of finished cosmetic products will remain unchanged.
- A new symbol will be introduced to indicate the durability of products that have a shelf life of less than 30 months.
- Product manufacture must comply with good manufacturing practice (GMP). Although this was the preferred standard in the earlier regulations, it will be a requirement in future. Currently, if there is no established GMP, the manufacturer must supply details of the procedures and equipment used.
Implications for the future
Cosmetic manufacturers and their insurers need to keep a beady eye on these regulatory changes so as to ensure compliance and to minimise the risk of very expensive ‘lipstick-liability’ type of litigation, as well as a blemished reputation.
Furthermore, while nanotechnology will certainly continue to be used in makeup products, its long-term effects remain unknown. Given the regular use of cosmetics and the likely absorption of nanoparticles through the skin, inhalation, oral ingestion or contact with the eyes, cosmetic manufacturers and their insurers would be wise to keep an eye on this area as well.