Volume 14: Responsibilities for Human and Animal Health
7. Human and veterinary medicines and cosmetics
Cosmetics
Responsibilities
Regulatory framework

Responsibilities

7.107 The Department of Trade and Industry (DTI) had policy responsibility for the safety of cosmetics in the UK. Within DTI, overall responsibility for the safety of cosmetics, as for other consumer products, lay with the Consumer Safety Unit (CSU). Within the CSU, the Chemical Hazards Section (CHS) had day-to-day responsibility for cosmetics. ¹

7.108 Although DTI had overall regulatory responsibility for cosmetics, DH also played a role as DTI's advisers on toxicity. ² The relevant Division in DH was MED TEP (Medical Toxicology Environmental Protection), ³ later HEF M (Health Aspects of Environment and Food Medical), ⁴ which gave advice when necessary.

7.109 Mr Richard Roscoe, Head of CHS from 1983 to 1992, told the Inquiry that whenever CHS was alerted to the presence of a potentially 'risky' ingredient in a particular cosmetic product they would refer the matter to DH. ⁵ Upon receipt of advice from DH, 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'. ⁶

7.110 The Cosmetic, Toiletry and Perfumery Association (CTPA) was the representative body for the UK cosmetics industry and the channel through which DTI distributed cautionary guidance on BSE to cosmetics manufacturers. In written evidence to the Inquiry, Ms Marion Kelly of the CTPA said that

Throughout this period the DTI Consumer Safety Unit (responsible for cosmetic legislation) kept the Association informed of any issue impacting on cosmetic safety and liaised with other relevant DTI divisions and other Government departments. ⁷

Regulatory framework

The Cosmetics Directive

7.111 The regulation of cosmetics was based on the EU Cosmetics Directive (1976), ⁸ which was implemented in the UK by Regulations made under the Consumer Protection Act 1987. Cosmetic products were required to meet various safety requirements but, unlike medicinal products, they did not require a licence.

7.112 The Directive sought to ensure the safety of cosmetics and their unhindered trade throughout the EU. In relation to safety, Article 2 provided that:

Cosmetic products put on the market within the Community must not be liable to cause damage to human health when they are applied under normal conditions of use. ⁹

7.113 Dr Robin Fielder of DH told the Inquiry that the Cosmetics Directive placed the onus on manufacturers and suppliers to ensure that the product was safe for the use intended. ¹⁰

7.114 Article 2 was amended on 14 June 1993 by Directive 93/35/EEC to read:

A cosmetic product put on the market within the Community must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use, taking account, in particular, of the product's presentation, its labelling, any instructions for its use and disposal as well as any other indication or information provided by the manufacturer or his authorised agent or by any other person responsible for placing the product on the Community market.

The provision of such warnings shall not, in any event, exempt any person from compliance with the other requirements laid down in this Directive.

7.115 Member States had a duty to

. . . take all necessary measures to ensure that only cosmetic products which conform to [the Directive] may be put on the market. ¹¹

7.116 Article 4 of the Cosmetics Directive prohibited the marketing of cosmetic products containing:

1. substances listed in Annex II of the Directive;
2. substances listed in Annex III Part 1, beyond specified limits and conditions (eg, concentration limits, labelling requirements);
3. colouring agents other than those listed in Annex III part 2, if these products were intended for application to specified areas of the body; and
4. colouring agents listed in Annex III part 2, beyond specified limits and conditions, if these products were intended for application to the same specified areas of the body.

7.117 These 'prescribed lists' could be amended following consideration by the European Commission's Working Party on Cosmetic Products. Chaired by the Commission, this consisted of representatives from the Member States and from industry. DTI led for the UK on this with a DH professional attending to advise on chemical toxicology. ¹² Decisions to amend were taken by the Committee on the Adaptation to Technical Progress, which was chaired by the Commission and consisted of representatives from Member States. Both the Working Party and the Committee had 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 the advice from their own national scientific advisers. ¹³

7.118 The Cosmetics Directive limited the action individual Member States could take to regulate cosmetics. ¹⁴ If a product complied with the relevant Annex, the UK Government could not prohibit its use unless, on the basis of a 'substantiated justification', it represented a hazard to health. Even then, the prohibition was provisional, pending consideration by the European Commission in consultation with Member States. ¹⁵

Implementation into UK law

7.119 Regulations made, in part, under section 11 of the Consumer Protection Act 1987 gave effect to the Cosmetics Directive in UK law. The Cosmetic Products (Safety) Regulations 1984 (made under a predecessor of the Act) ¹⁶ were replaced on 1 January 1990 by the Cosmetic Products (Safety) Regulations 1989 ('the 1989 Regulations').

7.120 The main provisions of the 1989 Regulations were as follows:

1. A cosmetic product should 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 might contain any substance listed in column 2 of schedule 1, unless it was 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 were satisfied (reg. 4(3)).
4. The Secretary of State might 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 might impose conditions relating to the use of the substance (reg. 5(2)).
5. Various conditions and standards in respect of labelling and packaging (reg. 6). ¹⁷

7.121 The Consumer Protection Act imposed a general safety requirement in respect of all consumer goods. Section 10 of the Act made it an offence to supply consumer goods that failed to comply with this requirement - ie, if consumer goods were not reasonably safe having regard to all the circumstances. 'Safe' meant that there was no risk (apart from one reduced to a minimum) that the goods would (whether immediately or later) cause death or personal injury to any person. ¹⁸

7.122 The Cosmetics Directive and the 1989 Regulations left only limited scope for the application of section 10 of the Consumer Protection Act to cosmetics. Since the introduction of the General Product Safety Regulations 1994 ¹⁹ there has been virtually no scope for its application.

7.123 In practice the regulation of the cosmetics industry operated almost entirely on an informal and voluntary basis, relying on the industry to cooperate.

Enforcement

7.124 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. ²⁰

7.125 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. ²¹ In addition, enforcement authorities (which for these purposes meant DTI and the Trading Standards Departments of local authorities) had power to:

1. serve a suspension notice prohibiting the person on whom it was served from supplying goods for up to six months; and
2. apply to the court for a forfeiture order. ²²

An authorised officer of the enforcement authority could enter any premises, inspect any goods, or examine any procedure, or in appropriate circumstances seize and detain goods. ²³

7.126 The Secretary of State also had the power to serve a notice on a person prohibiting that 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). ²⁴ 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. ²⁵

7.127 DTI told the Inquiry that it was unaware of any instance in which these powers had been used in respect of a BSE risk in cosmetics. ²⁶ The Department considered that in practice, public statements (eg, press notices) offered a quicker and more effective way of protecting the public than notices to warn. ²⁷