Volume 7: Medicines and Cosmetics
8. Cosmetics and toiletries
Regulatory framework
Enforcement
DTI handling of cosmetics
DH's role in cosmetics safety

8.13 The regulation of cosmetics is based on the EU Cosmetics Directive (1976), which was implemented in the UK by regulations made under the Consumer Protection Act 1987. Under this system, cosmetic products must meet various safety requirements, but, unlike medicinal products, they do not require a licence.

8.14 The Cosmetics Directive seeks to ensure the safety of cosmetics and their unhindered trade throughout the EU. In relation to safety, Article 2 provides:

Cosmetic products put on the market within the Community must not be liable to cause damage to human health when applied under normal conditions of use. ¹

8.15 Dr Robin Fielder of DH told us that the Cosmetics Directive places the onus on manufacturers and suppliers to ensure that the product is safe for the use intended. ²

8.16 Member States have a duty to 'take all necessary measures to ensure that only cosmetic products which conform to [the Directive] may be put on the market'. ³ The Annexes to the Cosmetics Directive list substances that must not be used in cosmetics and substances whose use is regulated. They also contain lists of substances ('the prescribed lists') permitted for certain uses (preservatives, colourants, sun screens) and only these substances may be used for those purposes in cosmetic products. ⁴ The prescribed lists may be amended following consideration by the European Commission's Cosmetic Products Working Party, which consists of representatives from the Member States and the industry. DTI led for the UK on this with DH also having a role. The final decision is taken by the Committee on the Adaptation to Technical Progress, which is chaired by the Commission and consists of representatives from Member States. Both the Working Party and the Commission have access to the opinions of the Scientific Committee on Cosmetology (SCC), an independent multidisciplinary body of scientists appointed by the Commission to assess the safety of cosmetics ingredients, as well as to advice from their own national scientific advisers. ⁵

8.17 The Cosmetics Directive limits the action individual Member States can take to regulate cosmetics. ⁶ If a product complies with the relevant Annex, the UK Government cannot prohibit its use unless, on the basis of a 'substantiated justification', it represents a hazard to health. ⁷

8.18 Regulations made, in part, under section 11 of the Consumer Protection Act 1987 give effect to the Cosmetics Directive in UK law. The Cosmetic Products (Safety) Regulations 1984 (made under a predecessor of the Act) were replaced on 1 January 1990 by the Cosmetic Products (Safety) Regulations 1989 ('the 1989 Regulations').

8.19 The main provisions of the 1989 Regulations are as follows: ⁸

1. A cosmetic product shall not be liable to cause damage to human health when it is applied under normal conditions of use (reg. 3(1)).
2. No cosmetic product may contain any substance listed in column 2 of Schedule 1, unless it is only a trace that could not reasonably have been removed during or after manufacture (reg. 4(2)).
3. A cosmetic product must not contain any substance listed in column 2 of Schedule 2 unless specified requirements in that schedule are satisfied (reg. 4(3)).
4. The Secretary of State may authorise the use in a cosmetic product of any substance not listed in either schedule 1 or 2 (reg. 5(1)). In giving authorisation the Secretary of State may impose conditions relating to the use of the substance (reg. 5(2)).
5. There are various conditions and standards for labelling and packaging (reg. 6).

8.20 The Consumer Protection Act imposes a general safety requirement on all consumer goods. Section 10 of the Act makes it an offence to supply consumer goods that fail to comply with the general safety requirement. For this purpose, consumer goods fail to comply with the safety requirement if they are not reasonably safe having regard to all the circumstances. 'Safe' means that there is no risk (apart from one reduced to a minimum) that the goods will (whether immediately or later) cause death or personal injury to any person. ⁹

8.21 The Cosmetics Directive and the 1989 Regulations left only limited scope for the application of section 10 of the Act. Since the introduction of the General Product Safety Regulations 1994 ¹⁰ there has been virtually no scope for its application.

8.22 In practice informal contact and voluntary cooperation played an important part in the regulation of the cosmetics industry.

Enforcement

8.23 DTI had policy responsibility for the safety of cosmetics in the UK. Day-to-day enforcement of safety regulations such as the 1989 Regulations fell to the trading standards departments of local authorities. ¹¹

8.24 Supplying consumer goods that failed to comply with the general safety requirement or with certain requirements of safety regulations was an offence and punishable in the courts. ¹²

8.25 In addition, enforcement authorities (which for these purposes meant DTI and the trading standards departments of local authorities) had power to serve a suspension notice prohibiting the person on whom it was served from supplying goods for up to six months; power to apply to the court for a forfeiture order; ¹³ and power for an authorised officer of the enforcement authority to enter any premises, inspect any goods, or examine any procedure, or in appropriate circumstances to seize and detain goods. ¹⁴

8.26 The Secretary of State also had the power to serve a notice on a person prohibiting the person from selling consumer goods if the Secretary of State considered them to be unsafe (a prohibition notice), or requiring the person to publish a warning about such goods (a notice to warn). ¹⁵ However, these powers applied only to the person on whom the notice was served or against whom the order was sought, rather than to a general category of goods, and no power existed to recall products under these provisions. ¹⁶

8.27 DTI told us that it was unaware of any instance in which these powers had been used in respect of a BSE risk in cosmetics. ¹⁷

DTI handling of cosmetics

8.28 Within DTI overall responsibility for the safety of cosmetics lay with the Consumer Safety Unit (CSU). Within the CSU, the Chemical Hazards Section (CHS) had day-to-day responsibility for cosmetics. ¹⁸

8.29 Mr David Jones, a Grade 5 official, was Head of the CSU until 1995. Mr Roscoe, a Grade 7 official, was Head of the CHS from 1983 to 1992, with specific responsibility for ensuring the safety of cosmetics sold in the UK. ¹⁹ He was succeeded by Mr John Walker. Mrs M L Payne, a Higher Executive Officer in the CSU from 1990, was responsible for developing policy on regulation covering chemicals, including ingredients used in cosmetics. ²⁰

8.30 The CTPA was the peak representative body for the UK cosmetics industry and the channel through which DTI distributed cautionary guidance on BSE to cosmetics manufacturers.

DH's role in cosmetics safety

8.31 Although DTI had overall regulatory responsibility for cosmetics, DH also played a role as DTI's adviser on toxicity. ²¹ The relevant Division in DH was MED TEP (Medical Toxicology Environmental Protection), ²² later evolving into the HEF M (Health Aspects of Environment and Food Medical), ²³ which would give advice when necessary.

8.32 Mr Roscoe told us that whenever the CHS was alerted to the presence of a potentially 'risky' ingredient in a particular cosmetic product it would refer the matter to DH. ²⁴ Upon receipt of advice from DH, the CHS would then decide on a course of action. According to Mr Roscoe, DTI would always act on this advice 'unless there were very strong reasons for not doing so'. ²⁵

8.33 Mr Roscoe also told the Inquiry that he believed that when DH encountered a new risk it was its responsibility to pass on the information to DTI. ²⁶

8.34 The DH adviser on toxicology over the period of concern was Dr Fielder, who was assisted by Dr Dewhurst (1988-90), Dr Gott (1991-93) and Ms Mulholland (1993-97). ²⁷