In 2009 the European market was worth approximately €69.5 billion and represented almost one-third of the global market. This update looks at the key regulations covering cosmetics manufacturers and their insurers in the United Kingdom.
The main set of rules is the Cosmetic Products (Safety) Regulations 2008 (download original pdf), aimed primarily at safeguarding public health. The regulations implement the EU Cosmetics Directive (76/768/EEC).
What is a cosmetic product?
Under the regulations, a ‘cosmetic product’ is any substance or preparation intended to be placed in contact with 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 odour, protecting them or keeping them in good condition.
If there is a possibility that the product may be regarded as a chemical substance or micro-organism (ie, a biocide), the Health and Safety Executive should be consulted. Similarly, if the cosmetic product could potentially be regarded as a medical device or product, the Medicines and Healthcare Products Regulatory Agency should be asked for advice.
Many products, such as cosmetic treatments using Botox, are on the border between medicines and cosmetics. Medicinal products cannot be placed on the UK market without a marketing authorisation or product licence.
The regulations impose a number of obligations.
General safety requirement
A product must be safe under normal and also reasonably foreseeable conditions of use. For example, if a shampoo carries a warning to the consumer to ‘rinse eyes immediately if the product comes into contact with them’, and the consumer chooses to ignore this cautionary advice, the manufacturer cannot be held liable. However, if the product is so strong that it seriously damages the consumer’s eyes, the manufacturer will probably be regarded as being at fault.
The regulations set out detailed restrictions on the ingredients and composition of cosmetic products in Schedules 3 to 7.
Animal testing ban
Tests to ensure that finished cosmetic products or their ingredients comply with the directive may not be conducted on animals. This prohibition has been in force since September 11 2004.
Specific labelling requirements.
The regulations require all cosmetic products to be marked with:
In addition, all lettering on the packaging should be clearly legible.
Where a product is manufactured in the United Kingdom, the responsible person must notify the secretary of state. The term ‘responsible person’ covers the manufacturer, the manufacturer’s agent and the person to whose order the product is manufactured. Responsible persons must notify the type of product according to set categories: perfumes, decorative cosmetics, skin care, hair care and toiletries.
Failure to comply with the regulations will result in a summary conviction and a fine of up to £5,000, up to six months’ imprisonment or both.
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 regulations also cover risks that are not dealt with in the Cosmetics Regulations. However, the current regime is unnecessarily complicated, with almost 50 amendments to the directive, inconsistent terminology and 27 different enacting national provisions. As a result, compliance by the industry is more onerous and costly than it should be.
The EU Cosmetic Products Regulation (1223/2009) was adopted on November 30 2009 and will take full effect from July 2013, although parts of the regime will be phased in earlier. The new rules will be immediately enforceable as law in the United Kingdom and other EU member states. Among other things, they will introduce:
Although nanotechnology will continue to be used in cosmetics, the long-term effects of its innovations remain unknown. Given the regular use of cosmetics and the likely absorption of nanoparticles through the skin or by inhalation, ingestion or contact with the eyes, cosmetics manufacturers and their insurers must remain alert to regulatory changes.
For further information on this topic please contact Karishma Jasani Paroha, Sheena Raikundalia or Shane Sayers at Kennedys by telephone (+44 20 7667 9271), fax (+44 20 7667 9777) or email (firstname.lastname@example.org, email@example.com or firstname.lastname@example.org).