Volume 1: Findings and Conclusions
7. Medicines and cosmetics
Cosmetics and toiletries
The main products
Regulation
The Tyrrell recommendation on cosmetics
Was the initial action adequate?
Was DTI action adequate?
Action taken thereafter
The adequacy of the response

995 We have grouped our material about the risk of transmission of BSE from cosmetics and toiletries in the same volume (Volume 7) as medicines because these products had much in common. In particular, both might apply animal materials to the skin, the eye or to mucous membranes. But, as we shall see, they were covered by a very different set of safety provisions.

The main products

996 Cosmetics using bovine materials fell into three categories. Those most likely to present a risk of BSE contamination were some 'exotica'. They included anti-ageing and anti-wrinkle creams and 'cellular extracts' such as premium face creams. They might contain only lightly processed brain extracts, placental material, spleen and thymus. This was the most urgent category to tackle.

997 The second category consisted of 'High Street' topically applied products such as creams and toiletries applied to the skin, lips and eyelids. It also included items like soaps, shaving sticks and stick deodorants. The bovine materials used were heavily processed. Although questions were asked about ensuring the safety of this group of products, they were never considered a serious risk.

998 The third category of concern was bovine collagen used in implants. Dr Pickles was concerned initially about their use in unlicensed clinics as beauty preparations. We looked into their status. DH told us that in practice this material was used under medical supervision and thus treated as 'prescription only medicines'. We concluded that we need not explore their cosmetic use separately.

Regulation

999 The Department of Trade and Industry (DTI) had regulatory responsibility for the cosmetics industry. At the time BSE emerged, Mr Richard Roscoe, who was a Grade 7 officer, headed the branch in charge of the safety of cosmetics sold in the UK. DTI looked to DH, and in particular to Dr R J Fielder, for advice about toxicity of products that were causing concern.

1000 The legislation governing safety was the EU Cosmetics Directive and Regulations made under the Consumer Protection Act 1987. We set out details of these provisions in Volume 7. Although cosmetics had to meet various safety requirements, they did not require a licence. Enforcement lay with local authority Trading Standards Departments, which would require some evidence of harm before seeking to intervene. The Secretary of State for Trade and Industry also had certain intervention powers. In practice the regulation of the industry operated very much on an informal and voluntary basis, relying on the industry to cooperate.

1001 Although identified in the Tyrrell Report in June 1989 as needing consideration, the cosmetics industry received no advice or guidance until February 1990. We deal briefly first with how this happened. We then look at what happened thereafter.

The Tyrrell recommendation on cosmetics

1002 The Tyrrell Report submitted in June 1989 had this to say about cosmetics:

Some uncertainty remains as to whether all the possible routes of transmission from bovine (and ovine) tissues to other species have been considered and appropriate action taken. Small scale users of bovine products such as the cosmetic industry, may not be covered by the present regulations and guidelines.

1003 Coupled with a wider proposition about investigating the fate of bovine products passing through as yet unrecognised routes, this item was given a three-star recommendation for further work. We return later to what happened to this wider proposal for an audit of bovine tissues.

1004 Despite what the Report said, no steps were taken by MAFF or DH to contact DTI about cosmetics. By good fortune, Mr Roscoe at DTI learned of the possible risk from BSE and independently decided to ask DH about it in January 1990. After he had consulted medicines licensing officials and Dr Pickles, Dr Fielder provided advice to Mr Roscoe. The gist of it was that DTI should warn the cosmetics industry via its trade association, the Cosmetic, Toiletry and Perfumery Association (CTPA), that it should reformulate products so as to exclude bovine offal or source it from outside the UK.

1005 This Mr Roscoe promptly did. The CTPA in turn relayed this advice in full, first to those of its members that made 'premium skincare products' (the ones most likely to contain offal extracts), and second to members generally. Ms Marion Kelly of the CTPA told us she was confident from members' replies at the time about premium face creams that no products were using UK material. Replies to a request for information from the wider membership had not been retained.

Was the initial action adequate?

1006 We considered first the failure to alert DTI in 1989 to the need to consider cosmetic products in relation to BSE. We think that Dr Pickles, who had the lead on BSE in DH, should have done so. We were not impressed with her argument that the risk had been 'so slight that effectively it could be disregarded'. This ignored the need to inform DTI as the regulatory Department and the fact that she could not have known which products were involved.

1007 Throughout the BSE story, Dr Pickles took many prompt and commendable initiatives to alert those concerned and to carry action forward. Sadly, in this case, Dr Pickles fell short of her normal high standards. She acknowledged to us that had she informed DTI, it could have addressed the issues six months earlier than it did. She should have done so; but this lapse is minor in comparison with the commendable action taken by her in many other respects.

1008 Within MAFF, we considered that responsibility for informing DTI lay with Mr Lowson, the head of Animal Health Division. We were not persuaded by Mr Lowson's argument that he had only a hazy notion of DTI involvement in the cosmetics industry and that this was a human health matter so 'something where one would expect other Departments to take the lead, particularly the Department of Health'. In our view Mr Lowson shared responsibility with Dr Pickles for ensuring the recommendations were properly assessed and followed up. We consider that, jointly with Dr Pickles, Mr Lowson should have promptly ensured that what the Tyrrell Report said on cosmetics was drawn to the attention of DTI. The failure to do so contributed to several months' delay in initiating action to secure the safety of cosmetic products.

Was DTI action adequate?

1009 Mr Roscoe deserves credit for registering that BSE might pose problems for the cosmetics industry, and for acting promptly in seeking advice from DH, and passing it on to the CTPA. We agree that the Department's statutory powers to intervene were not appropriate in these circumstances and that the only realistic course open to DTI was to persuade the industry to take voluntary action. Mr Roscoe's letter and the response by the CTPA were together the most significant single action taken to address the risk from cosmetics.

1010 However, we think it is unfortunate that Mr Roscoe did not make efforts to contact firms which were not members of the CTPA. It was indeed, as he said, a 'flaw in the system . . . that we could not reach all manufacturers'.

Action taken thereafter

1011 We turn now to the way matters were handled after the CTPA had distributed the DTI warning. Initially, everything went quiet. Dr Pickles had included a question about the adequacy of the action taken on cosmetics in a draft paper for the first meeting of SEAC in May 1990, but Mr Meldrum raised some concerns about the paper, and it did not go forward.

1012 Three members of SEAC, Dr Tyrrell, Dr Kimberlin and Dr Will, attended the meeting of the BSEWG in July 1990, at which the DTI action on cosmetics was noted, and topical medicinal products were again given the all-clear.

1013 However, SEAC itself did not turn to cosmetics until March 1991, when it asked for a paper on the topic. This task fell to Mr Murray, who had taken over from Dr Pickles as the DH secretary to SEAC. Mr Murray asked one of his staff to make enquiries of the CTPA into the use of bovine material in cosmetics. It was unusual not to approach DTI as the Department responsible for cosmetics safety. Mr Murray's paper identified the uncertainties about the use of bovine material in cosmetics, and about small-scale producers that were not members of the CTPA.

1014 SEAC discussed Mr Murray's paper in July 1991, along with a paper from Dr Pickles about non-food uses of bovine material more generally. The Committee thought that in general no problems arose, but asked that DTI be reminded of the need to update the guidance to cosmetics manufacturers in the light of the emergence of BSE in other countries. After the meeting, Mr Murray asked Dr Pickles for her view on updated guidance, and she queried whether 'fringe' cosmetics companies were being kept informed by DTI, and advised Mr Murray, when writing to DTI with the guidance, to ask to be told about what happened thereafter.

1015 Although Mrs Diane Whyte in DH drafted a letter to Mr Roscoe, it appears not to have been sent. Work continued somewhat slowly on the text of a draft letter to revise the guidance, but no contact was made with DTI. Meanwhile Mr Bradley of the CVL had told Mr Lawrence with some perspicacity that 'contacts via DH/DTI do not inspire me with confidence'. He felt that MAFF needed either to go out to the industry to assess what kind of bovine material was really used in cosmetics and for what, or to have closer contact with the trade association. He observed:

I am not satisfied yet that the industry is in the clear and it is us that may shoulder some blame if it is later found ladies are rubbing cow brain or placenta on to their faces.

1016 DH, as it happened, shared Mr Bradley's view that they needed hard facts about the situation, and matters now took a different turn. DH had drawn attention to the lack of knowledge in its paper for SEAC. This led the Department in early 1992 to decide to put a series of detailed questions to the industry to clarify the situation and what action was being taken. The plan now was that, depending on the outcome, a meeting with the CTPA might be arranged, and, if need be, guidance considered later. DH officials did not consult DTI about these ideas. Although the object was sound, the exercise proved abortive. It was simply impracticable for the CTPA to provide answers from its members within three weeks to a list of 20 detailed questions asked out of the blue. There was no obligation on the industry to provide such information.

1017 However, the CPTA did put a note in the May edition of its scientific newsletter to say that an enquiry had been received from DH about the use of bovine and ovine materials, and asked any of its members using these to contact the Association urgently. There was no positive response from CTPA members. Ms Kelly told us she read this as meaning the members were not using such materials.

1018 The CTPA's response led DH to press ahead instead with efforts to draft the guidance letter originally called for by SEAC a year earlier. In July, Dr Fielder who, besides being the toxicological adviser to DH, was a UK member of the EU expert committee on cosmetics, took a hand. He pointed out that there was a risk of getting into deep water with the European Commission if they sought a voluntary ban. He suggested a meeting involving DTI before the CTPA was contacted again. This was a timely proposal. Among other things, it brought DTI back into the frame.

1019 A meeting was held in September 1992 between officials from DH, DTI and MAFF and CTPA staff and members. There was a useful exchange of information. The outcome was agreement that DH would provide advice to the CTPA on gelatine; the CTPA would list products using risk materials; the CVL would offer advice about suppliers of material; and the CTPA would consider further what guidance might be prepared. Dr Wight had called this meeting to bring the parties together as suggested by Dr Fielder, but it was not clear whose call it was next. The initiative on preparing guidance had now been passed from government, whose job it was to ensure the safety of cosmetics, to the trade association which would be disseminating it.

1020 However, there was some follow-up contact by telephone and letter. The CTPA subsequently wrote to Dr Wight at DH to say that it had contacted a company using cerebrosides and that this material would be phased out by early 1993.

1021 From this point on, action moved to the European arena, with DTI in the lead. Before long the EU Working Party on Cosmetics became involved, with a view to preparing guidance at the European level. The DH reaction was that this was welcome as it helped to avoid the impression that the problem was solely one for the UK cosmetics industry. However, Dr Fielder flagged up the danger that the exercise might drag on, when in fact guidance needed to go out as soon as possible.

1022 Dr Fielder's fears were realised - the exercise did indeed drag on. Preparation of European guidance became embroiled in slow procedures, infrequent meetings and national differences of view. COLIPA, the European trade association, played an active role providing reassurance that voluntary action had been taken.

1023 In March 1994, at the EU Health Council, all Member States except Germany supported the view that existing measures to contain BSE and protect public health were sufficient. It was eventually decided that the Cosmetics Directive need not be amended to ban the use of bovine material. It was later amended, after the period covered by this Inquiry and the emergence of vCJD.

1024 Meanwhile the CTPA had told DTI that it would prepare UK guidelines jointly with the French industry. The CTPA guidance to UK manufacturers was eventually issued in March 1994. It followed closely guidance from the World Health Organisation that had been issued in 1991 on inactivating TSEs and categorising tissues into four categories of infectivity. It is difficult to see how much, if any, value was added by the long delay.

The adequacy of the response

1025 A problem in assessing the adequacy of the response is the lack of knowledge that persists today about what cosmetics that contained bovine ingredients were on offer at the time and what precisely they were used for. With hindsight, we agree with Mr Bradley's view that first-hand knowledge needed to be sought. We revert to this matter in Chapter 9.

1026 We recognise the handling problem created by the limited powers available to deal with an unproven threat like BSE which affected raw materials. We have commented elsewhere on the desirability of statutory powers to destroy dangerous material at source.

1027 Given these considerations it can be seen with hindsight that two things were needed.

1028 The first was purposeful leadership. There was continuing vagueness about who was in the lead. This confusion operated both between Departments and within DH. We are in no doubt that the lead should have lain with DTI, with professional advice from DH. Dr Pickles's instinct that DTI should be asked to carry forward the guidance and required to report progress was sound.

1029 The second was a sense of urgency. This was patently lacking. DH thought the risk was remote. Dr Wight told us that when she arrived in DH in 1991 to take over from Dr Pickles, she understood that all the significant action on BSE had by now been taken and her role was principally a watching brief. The perception that revised guidance for cosmetics was urgently needed and that certain matters needed to be vigorously followed up had faded away. Manufacturers were left to use up stocks, and checks were not made to ensure that they had reformulated their products.

1030 Taken together, the effect was to leave large gaps in knowledge and to delay inordinately the issue of further advice. As with medicines, this has left unanswered questions about the products affected, how long production continued and on what scale. It seems to us undesirable that so little is known about products which offer a potential pathway to infection. This is a matter we believe DTI should review.