Volume 7: Medicines and Cosmetics
8. Cosmetics and toiletries
Introduction
Exotica
Standard topical products
Collagen implants
How the issue was handled

8.1 In this chapter we consider the Government's response to the risks posed by the use of bovine material in cosmetics. Cosmetics, as defined by the Cosmetics Products (Safety) Regulations 1996, include:

any substance or preparation intended to be placed in contact with any part of the external surfaces of the human body (that is to say, the epidermis, hair system, nails, lips and external genital organs) 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, protecting them, keeping them in good condition or correcting body odours except where such cleaning, perfuming, protecting, changing, keeping or correcting is wholly for the purpose of treating or preventing disease. ¹

8.2 Cosmetics using bovine materials fell into three categories: (i) products using lightly treated high-risk bovine offals: 'exotica'; (ii) standard topically applied products using heavily processed bovine by-products; and (iii) implants using bovine collagen.

Exotica

8.3 Concern about a risk of possible BSE contamination focused mainly on those cosmetic products commonly described as 'exotica'. These included 'premium priced facial skin care products' such as certain anti-ageing and anti-wrinkle creams. There was no ban on the use in them of animal material such as 'cellular extracts' that was deemed an unacceptable risk in food and medicines, and accordingly proscribed under the food safety and medicines safety legislation. Such material might be only lightly processed or simply chilled. Possible ingredients identified relatively early on were gangliocides extracted from the brain; and placental material, spleen and thymus. ²

Standard topical products

8.4 Although never considered a serious risk, questions were also raised about how to ensure the safety of more standard cosmetic products. These included the full range of topically applied cosmetics, ie, creams and toiletries applied to the skin, lips and eyelids, and included soaps, skin creams, shaving sticks and stick deodorants. Many of these used heavily processed bovine by-products such as collagen, elastin, gelatine and tallow derivatives. ³

Collagen implants

8.5 Concern was also expressed about bovine collagen used in implants. Although not mentioned in the highly condensed minutes of the CSM/BSC meeting of 2 November 1988, Dr Pickles's own note at the time records that this came up at the meeting as an area of concern: 'Some collagen implants of bovine origin as used by cosmetic clinics are not even licensed.' ⁴ Collagen products intended for correction of contour deficiencies of the skin were considered licensable under the Surgical Materials Order SI 1971 No. 1276. DH has told us that although collagen implants might have been used for 'cosmetic' reasons, this would have been under medical supervision as they were 'prescription only' medicines. ⁵

How the issue was handled

8.6 Although specifically identified in the Tyrrell Report in June 1989 as a small-scale user that might not be covered by the regulations and guidelines then in place, ⁶ the cosmetics industry was not itself the subject of advice or guidance until February 1990.

8.7 In January of that year Mr Richard Roscoe of the Department of Trade and Industry (DTI), the Department with policy responsibility for the safety of cosmetics, had on his own initiative asked DH for advice about the risk from BSE associated with the use of bovine offal in certain cosmetics. ⁷ DH's advice was that although the risk of transmission of BSE was remote, it would be prudent to reformulate, or source bovine material from cattle reared outside the British Isles. ⁸ DTI passed this advice on to the cosmetics industry trade association, the Cosmetics, Toiletries and Perfumery Association (CTPA), which in turn informed its members. ⁹

8.8 SEAC considered the use of bovine material in non-food products generally in June 1991. ¹⁰ By that time, BSE had been identified in countries other than the UK, and it was suggested that the advice issued to the cosmetics industry in February 1990 should be updated to take this into account. Updated advice was not sent to the CTPA until April 1992. ¹¹

8.9 One approach that was considered within DH was the introduction of a voluntary ban on bovine materials from countries in which cases of BSE had been reported. Such a ban, if it were to be introduced, would have to be implemented at EU level, so as not to fall foul of European law. The question of BSE and cosmetics was therefore taken forward in the EC Working Party on Cosmetics (ECWPC). Progress at EC/EU level was slow; by the end of October 1994 the Scientific Committee on Cosmetology (SCC) had produced only an interim statement suggesting that material from animals with the potential to transmit infectious agents should not be used in the manufacture of cosmetics. ¹² In February 1995 the ECWPC decided that the existing Cosmetics Directive did not need alteration. ¹³ This decision was based in part on assurance by COLIPA, the European cosmetics trade association, that its members were following certain approved basic precautions on a voluntary basis. ¹⁴

8.10 When, in March 1996, the EU ban on the export from the UK of bovine products destined for use in cosmetic, medicinal and pharmaceutical products was introduced, ¹⁵ the CTPA conducted a survey of its members and reported that almost all had been using non-UK-sourced bovine material for some time. ¹⁶

8.11 In the sections that follow we look first at the regulatory framework on cosmetics safety, which was markedly different from that on either food or medicinal products safety. The sponsoring Department for the industry, which was also responsible for its regulation, was DTI. As we shall see, there was some confusion at various points in the sequence of events about the respective responsibilities of DTI and DH for minimising risks to human health from the production and use of cosmetic products.

8.12 In the final section of the chapter we review some lessons that emerge from the way BSE was handled.