Volume 7: Medicines and Cosmetics
8. Cosmetics and toiletries
Discussion
Was DTI promptly and adequately informed?
Did DTI on being informed take appropriate action?
What happened next
The causes of delays and diversions
Consequences for the course of events after 1991
Following up the guidance
Getting sidetracked
Holding the ring and the EC minuet
The consequences
General conclusions

8.147 Cosmetic and medicinal products shared many characteristics in terms of exposing humans to potential risk from BSE. For that reason there was some read across in considering them in relation to BSE.

8.148 A general difficulty for those concerned with human risk was lack of knowledge of what ingredients were actually used in cosmetics, and where they were sourced. We look at this below. Responsibility for the safety of cosmetics sold in the UK and for their regulation lay not with MAFF or DH but with DTI, although DTI relied on DH toxicological expertise. The immediate and obvious first step for MAFF and DH, therefore, was to alert and advise DTI. Thereafter, those producing or overseeing the safety of cosmetic products needed to be kept up to date on the evolving understanding of BSE as a disease and to be in a position to take appropriate measures to block possible channels of transmission to humans.

8.149 We considered three questions on cosmetic products:

• Was DTI promptly and adequately informed?
• Did DTI on being informed take appropriate initial action?
• Was effective action taken thereafter?

We discuss each of these below.

Was DTI promptly and adequately informed?

8.150 Once the Tyrrell Committee had submitted its interim report in June 1989, the question of potential human risk via cosmetics clearly lay on the table. Whatever might be involved in setting up a study of the fate of all bovine and ovine tissues (a proposal we discuss separately in the next chapter), the Report had specifically identified cosmetics as an area that had not been 'considered and appropriate action taken'. DTI needed to be alerted to this. However, no information was passed to DTI until it sought this itself in early 1990.

8.151 Mr Roscoe, head of chemical safety section in DTI at the time, told us he would have expected DH to contact him when it first became aware of the BSE risk for cosmetics. ¹ We put this to Dr Pickles. She told us her initial view in 1988 was that 'the risk of BSE to humans from non-parenteral routes of transmission through licensed medicinal products was so slight that effectively it could be disregarded' and that the CSM/BSEWG at its meeting the following November considered no action on unlicensed topical products was warranted. ²

8.152 We thought this was an unsatisfactory explanation. First, it did not address the need to alert the Department with policy responsibility and knowledge about the topic. Secondly, it seemed to us that an informed judgement could not be reached without knowing the nature of the products involved. Indeed MCA officials were to make that very point in January 1990. Dr Pickles could not be expected to possess this knowledge as a basis for deciding that DTI need not be informed. When we explored the matter further with her at an oral hearing along with the apparent shift in her degree of concern by January 1990, as evinced in her advice to Dr Singh, she said that she gradually began to learn more during 1989:

DR PICKLES: Obviously I have been trying to work out what changed in the year between the initial view we had, I think with expert advice, that we did not need to be concerned about cosmetics, and writing this. I suspect we probably did learn about some of the ingredients in cosmetics, that, you know, thymus and some of the SBOs were used in cosmetics. So if we had gone to DTI, we would have found that out earlier. You are quite right on this.

The other thing that obviously happened during this time period was the offal ban was being brought in and new scientific evidence was coming through in any case about BSE. And I think just generally the atmosphere was shifting and changing. I mean if you ask me why this could not have been said six months earlier, I would find it very difficult to answer. ³

8.153 An admirable feature of Dr Pickles's involvement in the BSE story was her many prompt initiatives to ensure that all those who should be thinking about issues were alerted to them and carrying action forward. Sadly, in the particular case of informing DTI in 1989, Homer nodded. She acknowledged to us that had she informed them, DTI could have addressed the issues six months earlier than they did. She should have done so; but this lapse is minor in comparison with the commendable action taken by her in many other respects.

8.154 We explored whether Mr Lowson, Dr Pickles's MAFF counterpart in handling BSE and joint customer for the findings in the Tyrrell Report, shared with her the responsibility to inform DTI, or should have ensured DH did so. When we asked him about this he replied:

I am quite sure I at that time would have had the most hazy notion of the DTI's involvement in the cosmetics industry . . . this was a report delivered to both Departments. The question of any risk or any exposure to the agent associated with cosmetics is clearly a human health matter and, therefore, something where one would expect other Departments to take the lead, particularly the Department of Health. ⁴

8.155 This too was an unsatisfactory explanation. The Tyrrell Report was commissioned jointly by MAFF and DH to take a comprehensive view of animal and human health research needs on BSE, and submitted to them jointly. They each had policy interests in its package of recommendations. MAFF took the lead in negotiating how research monies might be found and in the briefing for publication. There is no question in our minds that MAFF had at least equal responsibility with DH, which included ensuring that matters on which recommendations were made were properly followed up as a basis for developing effective policies.

8.156 Did this administrative responsibility lie with Mr Lowson as head of Animal Health Division? We think it did, although others took the lead within the Department in reviewing how a specific programme of research on the recommendations might be drawn up and funded. Action on cosmetics at this stage was a straightforward matter of notifying DTI. We acknowledge that Mr Lowson was new to the Division and had been plunged into handling many novel and pressing issues. His evidence has made plain that he lacks a clear recollection of events surrounding the recommendations made in the Report. No doubt at that stage he relied heavily on his staff in dealing with some matters.

8.157 However, in so doing, he did not thereby relinquish responsibility as head of Division for ensuring policy matters raised in the Report were properly assessed and followed up.

8.158 So far as alerting DTI was concerned, his previous experience should have meant he was well versed in the conventions and processes for informing sponsoring Departments about 'official' recommendations impinging on their field of responsibility. Mr Lowson could not recall any discussion or agreement between himself and DH about who would carry matters forward on cosmetics. He quoted to us minutes passing in DH in January 1990 about the DTI query to it as evidence that he did not need to take such action, but these were irrelevant to the period up to then. In the draft Parliamentary Answer he saw in January 1990, to which he drew our attention, the sentence 'I have no comparable information about the cosmetic industry' should have jangled warning bells rather than reassured Mr Lowson. ⁵

8.159 We consider that, jointly with Dr Pickles, Mr Lowson ought to have promptly ensured that what the Report said on cosmetics was drawn to the attention of DTI. The failure to do so contributed to several months' delay in the start of action to secure the safety of cosmetic products.

Did DTI on being informed take appropriate action?

8.160 The powers available to DTI to take action against the BSE threat, once it was seized of the problem, were limited.

8.161 As in the pharmaceutical industry, cosmetic product manufacturers had their own closely guarded formulae. Unlike the pharmaceutical industry, however, there were no statutory licensing, testing or inspection requirements covering safety, potency or efficacy, and no associated databases held in Departments about what was being used. DTI had poor leverage to require firms to provide such information or to change their ingredients.

8.162 The cosmetics industry also differed from the food industry, in that it was not protected and governed by controls designed to eliminate suspect animal raw material at source. The lack of this protection was something the industry raised in 1992 and is discussed below. Indeed, a feature of the SBO regulations was that they specifically contained provisions exempting material sent to non-food manufacturers. Even where a cosmetics manufacturer wished to ensure that ingredients such as the tallow he was using had not originated from SBO, this might be difficult to achieve.

8.163 DTI, as noted earlier, did have powers to put a prohibition notice on individual products or to forbid the use of listed ingredients. However, the former required proof of harm and was of only limited application, while the latter involved securing agreement at EU level - an extremely slow process with an intangible human risk such as BSE, as we have seen.

8.164 On learning about the possible risk from BSE, therefore, the only realistic course open to DTI was to persuade the industry to take voluntary action and to seek to assure itself, so far as feasible, that this was being done.

8.165 We do not consider any criticism attaches to DTI for failing to take action prior to January 1990. As we have noted, it was unaware of the Tyrrell Report, still under wraps within MAFF walls. We consider Mr Roscoe, head of the DTI Chemical Hazards Section, is entitled to credit for registering the significance of the possible connection between BSE and cosmetics in the light of his conversation with Professor Dayan and for thereafter himself taking up the matter with DH. Had he not done so, further months might have been lost.

8.166 We also think Mr Roscoe deserves credit for promptly contacting the cosmetics industry's trade association, the CTPA, as soon as he had Dr Fielder's advice. The CTPA had noted the Parliamentary Answer referred to above and also acted commendably promptly in writing to its Perfumery Working Group, asking members to confirm that if they used any bovine offal extracts they would ensure these were from cattle reared outside the British Isles. This was followed up by a newsletter in March to all members asking whether they used bovine material and what products it was used for.

8.167 This was a valuable initiative and the most significant single action taken to address the risk to cosmetics. However, DTI, DH and MAFF all needed to know the outcome. This did not happen. Moreover, although it was the major trade association of which all mainstream manufacturers were members, CTPA did not cover the whole of the industry. Mr Roscoe referred in a statement to 90 per cent coverage. ⁶ DTI had no list of firms outside the CTPA, and thus lacked the means to inform them other than through a general press release.

8.168 Mr Roscoe told us he considered that a press notice as an alternative way of alerting non-member companies would have been a 'blunt instrument' that would only have risked attracting irresponsible media coverage. ⁷ In the light of the DH advice that the risk was remote, this would have caused unnecessary panic. For similar reasons, Mr David Jones, Head of the CSU at DTI, has supported this view. ⁸ We accept this was a reasonable judgement.

8.169 However, the alternative was to make special efforts to identify non-members of the CTPA. This was not done. Mr Roscoe stated:

There were so many small manufacturers making cosmetic products, that in my view it would be impossible to compile a list of manufacturers who are not members of the CTPA . . . I do not know of anybody who has compiled a list of manufacturers who were not members of the CTPA. ⁹

8.170 By way of testing this proposition, we consulted the Dun & Bradstreet publication Key British Enterprises, a trade directory. It took only a few hours' work to extract a list of cosmetics companies who were not members of the CPTA. We think it was unfortunate that Mr Roscoe did not explore the option of doing something similar. Such a list might have been useful to the Department for other purposes.

8.171 When we asked him about this, Mr Roscoe said:

At the time I was unaware of the existence of the Dun and Bradstreet publication 'Key British Enterprises'. Had I been aware of its existence I might well have consulted it and endeavoured to make contact with those manufacturers who were there listed who were not members of the CTPA. However I was not particularly worried since I had been advised that the risk was, in any event, likely to be remote; I had warned 90% of the industry through the CTPA, including all of those we knew had been using bovine material. ¹⁰

8.172 His reference to known users of bovine products concerned a DTI investigation a couple of years earlier into extravagant claims of skin regeneration through such material.

8.173 We noted from Mr Roscoe's evidence that the over-simplified and apparently reassuring message 'the risk is remote' influenced perceptions in this part of Whitehall as elsewhere. DH had not indicated that any special efforts were needed, or called for reports about the outcome. Indeed, as we have seen, MAFF and DH at this stage had given little thought to cosmetics as a possible pathway of infection.

8.174 None the less, the thrust of Dr Fielder's advice to DTI was clear. It would be prudent to eliminate the risk by reformulating products or sourcing outside the British Isles and these recommendations should be transmitted to the industry. This kind of guidance is not lightly given by Government. Indeed, as we discuss below, its implications were to cause Mr Meldrum some concern in April 1990 when he registered the contents of Dr Pickles's draft paper to SEAC (see paragraphs 8.193-8.194). We consider that on a matter that justified issuing national guidance about switching away from UK materials it was unfortunate that Mr Roscoe did not endeavour to identify and contact firms outside the CTPA. It was indeed, as he said, a 'flaw in the system . . . that we could not reach all manufacturers'. ¹¹

8.175 We believe that DTI should regularly check that an up-to-date communication system is in place with each of the industries it sponsors to enable it to contact and advise all those who need to know in the event of future questions arising over the safety of an ingredient or process in general use.

What happened next

8.176 We now turn to consider some shortcomings in the way matters were handled thereafter. We do not suggest that individuals should be criticised in relation to these. Some of them had wider causes and some are clear only with the benefit of hindsight. However, they raised some general questions over the way cosmetics safety was administered and we revert to these at the end of this chapter.

8.177 The most striking feature of the handling of the BSE risk to cosmetics after 1990 was its erratic and leisurely pace. We considered the reasons for this.

The causes of delays and diversions

8.178 We saw four main causes.

(1) The risk was perceived as remote, and action therefore not urgent.

8.179 As in other areas, a simplistic reading of the Southwood findings diluted the response. It was not appreciated that the Southwood Report was not intended to be definitive. As Sir Richard Southwood told us, the members of the working party thought their report was a statement of the position at the time. ¹² They hoped that there would be enough research done and enough new discoveries that it would soon be out of date. Indeed, this was emphasised in the Report itself. ¹³ We believe that had those concerned had a different understanding about the expert advice on risk, this would have influenced the urgency with which various matters were addressed. They would not have allowed the best to become the enemy of the good.

(2) The differences between the statutory regime on cosmetics and those on food and medicines provided a poorer repertoire of possible responses.

8.180 The SBO regulations screened out suspect ingredients from food, but did not do so for cosmetics. Nor, as was the case for medicines under the Medicines Act, did the Consumer Protection Act or relevant regulations impose any licensing requirement on cosmetics. There was no ready way of identifying immediately all relevant manufacturers and products. The Secretary of State had powers, for example, to obtain information and to prohibit the supply of unsafe goods on an individual basis, but there were different criteria and statutory powers from those that applied to food and medicines. Relevant European legislation limited the action that could be taken.

(3) Since cosmetics were largely EU 'occupied territory' UK action had to interact with EU requirements.

8.181 Even with a sense of urgency, it would have been difficult to secure swift action on an EU-wide basis. Cosmetics were an internationally traded product and largely 'occupied territory' under Community legislation. International negotiations are by their nature far more protracted than decision-taking within an individual country, particularly where the problem being addressed principally concerns only one Member State. As a long-term strategy it made good sense for the UK to seek EU-wide action since cosmetics were so widely sourced and traded. But what was also needed was to ensure that matters were satisfactorily carried forward on an interim basis within the UK while the issues edged through the toils of EU committees.

(4) There was confusion about who was holding the ring.

8.182 As we have discussed earlier, there was initial delay in informing DTI. Thereafter there was to be further confusion about what fell to DH and DTI respectively to do. Effective management of the situation to ensure the safety of cosmetics using bovine products and negotiation in the EU required shared perceptions and good working relations between DTI and the cosmetics industry it sponsored. It also required good communication and policy coordination between DTI, DH and MAFF. Somebody, to use an apt phrase adopted by Mr Roscoe, needed to hold the ring in managing the various interests. This proved to be a weakness as events unrolled.

8.183 Mr Roscoe told us that throughout his time on cosmetics safety:

I kept complete control of events taking place between the Department of Health, the industry and DTI.

I 'held the ring' between my advisers at the Department of Health and the members of the cosmetics industry. ¹⁴

8.184 However, the fact was that DH engaged in direct action about BSE with the trade association without informing DTI. When Mr Roscoe moved to new duties in February 1992, his role on cosmetics safety was inherited by his HEO, Mrs Payne. She told us her first involvement with BSE was when the CTPA invited her to its meeting with DH and MAFF in September 1992. ¹⁵ She carried the Departmental lead in international negotiations, working closely with Dr Fielder, but so far as cosmetics safety within the UK was concerned her actions indicate that she did not see her role as keeping 'complete control of events'. Indeed, such an approach in dealing with far more senior officers in other Departments, as well as a well-organised trade association, might have been a difficult one for her to pursue.

8.185 If DTI was not doing so, who then was holding the ring? Was it DH and if so who was responsible? Dr Fielder clearly had an important continuing function throughout the whole story, and was UK expert representative in EC discussions. He received copies of most of the papers and on at least two occasions he offered important handling advice to Dr Wight and Mr Murray. However, his job was as professional adviser to DTI and his colleagues. He did not hold the administrative lead.

8.186 Dr Pickles, who had been energetically chivvying action forward on BSE generally, moved to different duties in 1991 and her role on BSE was divided between Mr Murray and Dr Wight. Mr Murray was the DH half of the joint secretariat of SEAC, and in that capacity was asked by Mr Lowson and then by Dr Pickles to follow up SEAC concerns with DTI on the administrative network and ensure they reported back. His HEO, Mrs Whyte, who was active in promoting the action that then ensued, told us she had a purely executive role, taking all her instructions from Mr Murray and Dr Wight. ¹⁶

8.187 Dr Wight inherited Dr Pickles's general coordinating role on BSE and human health in September 1991. She told us: 'I took the DH lead on drawing BSE to the attention of the cosmetics industry.' ¹⁷ However, her understanding, as she came, brand new, from her previous post as a hospital registrar to take up the BSE job in DH, was that all the significant action on BSE had by now been taken and her role was principally a watching brief. ¹⁸ We noted that most of her contributions were responses to requests for comments from Mr Murray's team.

8.188 We were led to the conclusion that the policy responsibility within DH for carrying matters purposefully forward from summer 1991 onwards to ensure the rapid elimination of bovine materials in cosmetics was ill-defined. Insofar as there was a moving spirit, it was at a relatively junior level in the form of Mrs Whyte, who showed considerable perseverance in her attempts to bring to fruition the matters she was asked to pursue.

Consequences for the course of events after 1991

8.189 We considered how these four factors operated at critical points and opportunities for handling policy on cosmetics and BSE between 1991 and 1996.

Following up the guidance

8.190 Things got off to a prompt start. Once DTI had issued its guidance, Dr Pickles did not let the grass grow under her feet in preparing a draft discussion paper for SEAC's first meeting on 1 May 1990.

8.191 However, her draft fell foul of Mr Meldrum's opposition to what appeared to him to be encouragement to SEAC to regard the British Isles as an 'infected area'; a situation he was striving to avoid both on cattle and on meat and bonemeal. As she pointed out, her draft reflected the fact that such advice had already been given on medicinal products and that the cosmetics advice mirrored this. No doubt Mr Meldrum acted from the best of motives, but his intervention was unhelpful and resulted in delay. Not surprisingly and quite properly, Dr Pickles withdrew her paper until the differences between them could be sorted out and consistent advice offered. This is perhaps an example of allowing desire for perfection to hinder the taking of any action.

8.192 We discuss in Volume 10 Mr Meldrum's general concern about trade implications for the UK.

8.193 The original momentum having been lost, another year was to pass before, in March 1991, SEAC itself called for a paper on cosmetics following its discussion about tallow - widely used in products applied to the skin. However, we noted that a paper on cosmetics and topical products was discussed by BSEWG in July 1990 and that the SEAC Chairman, Dr Tyrrell, and two other members of his Committee were present for this. Since this paper indicated DTI had been informed and taken action, it was understandable that SEAC was not moved to seek a general discussion itself for some time thereafter.

8.194 In fact, unknown to it, DTI had taken no further action after sending guidance to the CTPA on DH's advice. It had done all that DH had advised and believed that no more was required of it given that the risk was remote. It did not learn of the more recent developments until August 1992.

8.195 DTI officials' illusion was fostered by a DH misapprehension about roles that had the effect of keeping them in the dark. DH, unknown to DTI, was dealing directly with the trade association, the CTPA, rather than via Mr Roscoe and his team as the Department responsible for oversight and regulation of cosmetic safety. This was contrary to the usual Whitehall practice, which exists for sound reasons.

Getting sidetracked

8.196 A further twist was that the action on cosmetics within DH became sidetracked in autumn 1991. Following the SEAC meeting in June 1991 Dr Pickles had given Mr Murray prompt advice, raising among other issues the continuing SEAC concern about excessive contact with SBOs, the risk to workers in the cosmetics industry and the need for DTI to accept responsibility for contacting companies who were not members of trade associations. She advised that DTI should be asked to keep DH properly informed about action taken and suggested that Mr Murray's Division should write to DTI. A draft letter to Mr Roscoe was prepared by 1 August for Mr Murray's signature covering all the points raised by SEAC and Dr Pickles. Had it been sent, it might not only have carried matters forward, taking account of the EC dimension, but might also have paved the way to a better information base than exists today about what was actually happening in the industry.

8.197 It appears that the letter was never sent. Instead Dr Wight, newly arrived in the Department, was sent Mr Murray's papers about the SEAC concerns in mid-October, and invited to discuss them urgently. ¹⁹ Shortly after, she suggested a robust form of words about not using bovine or ovine tissues such as brain, spinal cord, spleen, thymus, tonsils and intestines. They 'should not under any circumstances be used in the manufacture of cosmetics or beauty treatments'. ²⁰

8.198 At some point around then, there was a shift in handling plans within DH and a detailed questionnaire was drawn up to send to the CTPA. The proposal now was that, depending on the outcome, a meeting with the CTPA might be arranged and, if need be, guidance would be considered later.

8.199 The letter eventually sent to the CTPA in April 1992 made no reference to the emergence of BSE in other countries. There was no mention of the SEAC request or of Dr Pickles's points, and it spatchcocked Dr Wight's forthright warning against using bovine and ovine tissues together with a polite request to CTPA to supply the information covered by the questionnaire. This, it said, would be helpful basic information in 'an attempt to gauge the extent' of usage. It asked for a reply within three weeks. ²¹

8.200 Admirable though the aim of getting basic information might have been, it struck us as a job for DTI. Timely discussion with it about the DH proposed approach might not only have alerted officials there to the concerns in SEAC, DH and MAFF, but might also have elicited their views about the realism of expecting the CTPA to supply DH with the wealth of confidential detail sought at three weeks' notice, if indeed at all.

8.201 Not surprisingly the DH request received a cool response. The letter failed to elicit the desired information. There was no statutory reason for the industry to provide such material, and the situation was not being painted as one where it was in the industry's own interests to do so. Moreover, the questionnaire appears to have diverted attention away from the strictures in the letter against the use of bovine materials. These were not quoted by CTPA in its bulletin for its members in May. Instead the bulletin simply reported a DH 'enquiry' about the use of a list of ingredients and asked firms using them to contact the CTPA.

8.202 Consultation with DTI might also have identified rather sooner the need to handle the situation in its EC context. That in turn might have led to earlier processing through the EC committee system, where it missed at least one time slot. The EC context does not appear to have been taken on board until Dr Fielder's intervention in July 1992, when he saw the draft guidance that Mrs Whyte was struggling to get agreed within DH. He suggested a meeting with DTI to agree a line before meeting with the CTPA. Dr Wight spoke truly when she observed in responses 'we on the SE (spongiform encephalopathy) side have a rather scanty knowledge of the cosmetics industry'. ²²

Holding the ring and the EC minuet

8.203 When, eventually, on 21 September 1992 a meeting about BSE and cosmetics took place between the CTPA, DH, DTI and MAFF, confusion about where the lead lay still reigned. Whose meeting was it? Mrs Payne's statement indicates she thought it was called by the CTPA. ²³ Certainly the somewhat tentatively worded letter from DH proposing the meeting gave the clear impression that the CTPA was the arbiter of whether and when it might take place. ²⁴

8.204 The minutes produced by Dr Wight do not indicate who chaired the meeting or who was perceived to be calling the shots. ²⁵ Not only were three divisions of DH and DTI at the table, apparently on an equal footing, but also MAFF, who suggested that firms should come to them direct to get advice on questions to ask their suppliers.

8.205 None the less, it is clear this was an important and useful meeting, if long overdue. It provided the first substantive information exchange between all the Departments involved and the industry. It identified issues to be pursued, such as the safety of tallow and gelatine.

8.206 It appeared to us from the minutes and subsequent events that this was the point where de facto the trade association took over the holding of the ring. It was left with them to provide a list of cosmetics at risk. It was also left with them to decide whether and when to issue guidance. This was a somewhat unusual approach for Departments to accept on a matter of public safety. It differed from the approach to other forms of advice on BSE where there was a possible risk to human and animal health.

8.207 Moreover, shortly afterwards, the centre of gravity for considering guidance moved to the EC arena, and the CTPA became a major party to the negotiations along with the EC cosmetic trade association, COLIPA. A protracted minuet between all concerned ensued at European level.

8.208 Although it had been agreed at the September meeting that the CTPA advice would be subject to consultation and agreement with DH and MAFF, Dr Wight told us that she could not recall whether this happened. ²⁶ Mrs Payne said that she was told the CTPA Council subsequently agreed it would draft joint guidelines with the French industry, drawing on advice from MAFF and DH. ²⁷ Dr Wight later wrote to the CTPA commending its action but adding the concern that it should not be delayed. She also relayed SEAC advice that tallow and gelatine did not pose high risks. ²⁸ None the less, she indicated that it would be advisable for the purchasing company to ensure SBOs were not used in the production process. She did not suggest how this might be achieved.

8.209 When we asked Dr Wight about her role during this period she told us she 'was not involved in any negotiations'. ²⁹ Her understanding from 'colleagues who were involved, was that they would rather process it on . . . all fronts through Europe rather than the UK acting independently'. ³⁰ It is not clear precisely which colleagues she had in mind - though we infer this must have been Dr Fielder and Mr Murray - or where she thought the last word on this lay. Having brought matters to the attention of the industry she considered it was up to it and there was no pressing need for her to do more. ³¹

8.210 It seems to us that Dr Fielder's minute of July 1992 rightly warning about the need to work within the Cosmetics Directive had the unfortunate effect of derailing Mrs Whyte's efforts to get guidance out. Had the matter been viewed as urgent, the process need not have been derailed. We accept that Dr Fielder's words of caution were sound, and that they were pointing up an obvious flaw in the way matters were being handled. In his minute a year later he pointed out that, given the slow international progress, there were other ways of getting guidance out if the matter were urgent. Indeed, that had been indicated by the CTPA at the September meeting; but, as we have seen, the matter was not viewed as urgent. The risk was believed to be remote.

8.211 In the event the CTPA did not issue its own guidelines until May 1994, almost three years after the original SEAC advice.

The consequences

8.212 We have considered the consequences of the three-year delay in getting out what was a relatively straightforward update of guidance, albeit to safeguard against a remote risk. It appeared to us that nothing was gained by the delay in terms of better advice and better protection for consumers on the BSE risk. The guidelines the CTPA eventually issued drew heavily on 1991 WHO guidelines, which themselves stemmed from earlier UK guidelines on medicinal products. Most of the information they contained and that firms needed to know could have been issued far earlier. Certainly they could have been advised as SEAC proposed about the need to respond to the emergence of BSE in other countries.

8.213 Instead, it was left to manufacturers to use up stocks and to decide at leisure whether and when to reformulate their products. They were not informed about the strictures in Mrs Whyte's letter of April 1992. There was little or no pressure on them to act. Was it relevant that the CTPA was effectively taking the lead on progress, working with its international partners in COLIPA? We think it was. We do not criticise the trade association. The general message was that the risk was remote. It had stepped into the gap left by the fragmented Departmental leadership. Departmental correspondence on BSE was now taking place with the CTPA through at least four channels: Mrs Whyte, Dr Wight, Dr Fielder and Mrs Payne. At the meeting on 22 September 1992, it was proposed that it should also deal directly with yet another party, the CVL, on what questions to ask its suppliers.

8.214 Much of what the CTPA did appears sensible and useful. Miss Kelly told us its efforts were vindicated because none of its members used suspect UK material after 1996. ³² Even taking that as gospel, it still leaves unanswered the same questions as arose on medicines: how long did production runs continue? On what scale? What happened to stocks? Would earlier warning have led to action being taken sooner to eliminate them?

8.215 Trade associations do not exist to serve the public interest or to recommend actions that impose costs on their industry. Their duty is to the members who pay their subscriptions. It is not satisfactory to expect them to conduct public business or to reflect wider considerations outside those of their own industry. Nor can they be expected to collect information and offer views from firms who are not their members. With hindsight it seems to us that had there been a clearer and earlier lead from Whitehall, rather than a tacit agreement to let the CTPA make the running, not only would updated guidance have been issued to UK firms much sooner than in May 1994, but the issues might have figured sooner on the agenda of the EC Cosmetics Working Party. It was unfortunate that the DH efforts to get information through a questionnaire backfired and contributed to the delays.

General conclusions

8.216 For an industry as unregulated as the cosmetics industry, whose products were used so widely in relation to skin and eyes, the issue of guidance was particularly important. No other realistic approach was available. The issue of guidance in 1990 as a result of Mr Roscoe's inquiries, and getting the trade association on board, was a crucial first step which we welcome.

8.217 However, it was only the first step. In what followed we identified three general lessons. First, there needed to be clear collective understanding about what mattered and who was responsible for taking the lead, both interdepartmentally and within DH, in following matters up. In that process it was important not to delegate responsibility to relatively junior levels when clout was needed to make things happen. This was not the course that events took. The outcome was that opportunities were missed, sometimes because of gaps in understanding about the processes.

8.218 Second, the best should not be allowed to become the enemy of the good. Without the pressure of a timetable, this was allowed to happen. Enthusiasm for an elaborate questionnaire led to delay on other action. Time was allowed to drift by while drafts were worked on. The perception that by waiting for the EC directive a more comprehensive outcome would be achieved was allowed to block interim action.

8.219 Third, a striking moral of this tale is that it is not a good idea to leave the sponsor Department for an industry outside a process in which it would normally have been taking the lead.

8.220 In considering these shortcomings and associated delays in moving matters forward, we asked ourselves whether they prolonged any risks to humans from cosmetics.

8.221 It appears that the types of product that might pose the most serious risk - the exotica - were quickly identified. The manufacturers who were trade association members were alerted immediately, though others, if there were any, were not. We noted from the CTPA's letter of 30 September 1992 that a range of products still included brain material and that they would not be phased out until 1993.

8.222 We were reassured by what we were told on the licensing of collagen implants. On the generality of products the only concerns raised from time to time were about gelatine and tallow. These products are widely used in food and medicine preparation as well as in cosmetic products. It appeared to us that appropriate steps were taken in the light of knowledge at the time and the advice of SEAC to ensure that these did not pose risks.

8.223 A problem for us in assessing all this was the basic and continuing absence of information about what products were on offer and what precisely they contained. Little information on these, other than the purely anecdotal, was amassed by DTI and DH. Infectivity studies were not carried out. No direct action was taken comparable to Mr Bradley's first-hand investigation in respect of tripe, casings and rennet. We do not know where they were sourced or in what conditions they were harvested. The CTPA assurances without any supporting data are all that are available, since it has disposed of the details it collected at the time.

8.224 Thus it is impossible to know today whether the delays we have described in this chapter significantly protracted the period in which people were exposed to such products either because manufacture continued or because existing stocks were not withdrawn.

8.225 We recognise the reasons why so little information exists today in DTI on these matters. However, it seems to us unfortunate that so little is apparently known about the basic constituents of widely used products of an industry with so many features in common with the pharmaceutical industry. If this information gap still persists, we suggest that it might be reviewed.

8.226 We also believe attention should be given to the absence of effective statutory powers to destroy at source slaughterhouse materials for human non-food use, such as cosmetics, that are deemed too dangerous to be used for food or medicinal purposes. We noted that this question was raised by the CTPA and that it exercised both DH and MAFF.

8.227 These matters stretch well beyond our remit. However, it appears to us, as it did to the Tyrrell Committee, that cosmetics were indeed a potential pathway for pathogens, and that not enough was known about this. Future occasions could arise when, as with BSE, there needs to be a means of turning off the tap at source, rather than catching droplets downstream. Consideration might usefully be given to what powers and processes would assist this.