Volume 7: Medicines and Cosmetics
8. Cosmetics and toiletries
1993
March 1993
June/July 1993

8.117 In early January 1993, Dr Fielder wrote to Dr Wight enclosing a copy of the Italian proposals to the Commission of the European Communities (CEC) on medicinal products. He stated that at a 'quick look' the proposals seemed 'reasonable in principle as a basis [for the] consideration of cosmetic products' and he understood that the CTPA had no major problems with this approach. ¹

The ECWPC refers the matter to the Scientific Committee on Cosmetology

8.118 On 22 January 1993, another meeting of the ECWPC was held. ² Dr Gott, who attended the meeting on behalf of DH, reported that while the subject of BSE was raised, no decisions were taken, as most Member States wanted more time to consider the issues. He explained that most Member States were clearly unprepared for detailed discussion and essentially only the French and the English had a grasp of the problem. ³

8.119 The French Higher Council of Public Hygiene was reported to have recommended that bovine material used in the manufacture of cosmetics be supplied from countries free of epidemic, providing the following conditions were met: ⁴

1. Veterinary surveys were held;
2. Consumption of meat flour [MBM] was controlled;
3. Material was class IV or sourced from animals under six months old; and
4. Ovine material was limited to certain classes, provided that the processes used could deactivate infectious agents.

8.120 It was decided that the matter would be referred to the SCC. As explained in the section on regulation in this chapter the SCC provided scientific, in particular toxicological, advice on matters relating to the Cosmetics Directive. The UK offered to send any recent advice from SEAC to aid the SCC's deliberations. ⁵

March 1993

8.121 By 17 March 1993, an English translation of the French proposals from their Higher Council of Public Hygiene became available. Dr Fielder told Dr Wight in a minute that he and the CTPA felt the proposals were satisfactory and should be supported at the May 1993 meeting of the Cosmetics Working Group. ⁶ In the event, however, the topic was not discussed at the May 1993 meeting of ECWPC.

8.122 Miss Kelly told us that the CTPA prepared general guidelines for its members around this time. ⁷ We have a copy of the guidelines dated 22 March 1994. ⁸ It seems likely a first draft may have been produced in 1993 and final guidelines in March 1994.

June/July 1993

MAFF seeks an update on EC discussions

8.123 On 22 June 1993, Mr Howard (Animal Health Division MAFF) asked Dr Wight and Mr Bradley for an update on the EC position. He referred to a discussion between Dr Wight, Mr Bradley and Mr Maslin on the progress of the proposed guidelines before SEAC's April meeting:

[Y]ou undertook to establish the timetable for EC discussions and on that basis decided not to raise the matter at that meeting. Mr Maslin made the point that the Committee should be involved at some point and that this should be before any decision by the EC. ⁹

8.124 Mr Howard asked whether discussions about the proposed guidelines were under way in Brussels and, if so, whether the issue should be raised at or before the next SEAC meeting.

8.125 Mr Bradley replied to Mr Howard the next day. He said he had had no direct contact with the EC on timetabling and no knowledge that Dr Wight was formally asked to do this. He said he had spoken to Dr Wight with the following outcome:

1. She will send me a paper on the subject from Italy.

2. A previous translation of a paper from France was forwarded and suggested changes made. This was copied to Mr Lowson on 26 March with a minute from me.

3. Overall Dr Wight does not see any serious problems.

4. The matter is being dealt with she told me by a technical sub-group of the Consumer Group in DGXI. It is regarded as low priority and is moving very slowly. ¹⁰

8.126 The same day Dr Wight asked Dr Fielder, by means of a handwritten note, whether he had any information about the progress of the discussions with the EC, or what the UK trade was doing. ¹¹

8.127 Dr Fielder updated the position regarding the EC discussions for Dr Wight in early July. He said the matter had been referred to the SCC, one of whose members had been asked to prepare a draft opinion:

4. . . .This should have been discussed at the meeting on 25 June, but a document sent to the CEC in early June must have got misplaced as it was not circulated. It will now be discussed at an SCC meeting on 15 October.

5. This topic will thus not be discussed by the EC Working Party on Cosmetics until its meeting in early 1994 (there are only 2 or at most 3 meetings a year). If agreement is reached at that meeting proposals will be included in a draft Commission Directive, adapting the Cosmetics Directive to technical progress which will be voted on in mid-1994. Such adaptations are only made on a yearly basis and if discussion is not concluded at the Working Group meeting in January/February 1994 the item may be deferred until the 1995 adaptation directive.

6. Thus at best the BSE proposals may be adopted by a Commission Directive in mid 1994 (with implementation by member states in National Legislation in 1995)

7. As I have said earlier the EC pathway is relatively slow. It is not because a particularly low priority is being put on this particular area (ie bovine material) as suggested in Mr Bradley's minute of 23 June. It is an inherent property of the procedures used and the limited number of meetings available. The advantage is that agreements are binding on all member states.

8. If it is considered that the urgency of this area requires the UK to take unilateral action (I hope that is not the case) the way forward should I believe be to try and obtain some 'voluntary' action under the auspices of the CTPA. We could ask them to consider providing guidance to member companies through their Newsletter etc. I do not believe that we should (or need) to ask DTI to take unilateral regulatory action pre-empting the conclusions of the EC discussions in this area. At present CTPA prefer to await the results of the EC discussions, but will be supporting (through the European Trade Association COLIPA) in principle the French proposals.

9. We will need to arrange a meeting with CTPA if we believe the urgency of the situation requires unilateral action. ¹²

8.128 On 6 July 1993, Dr Wight replied to Mr Howard's minute of 22 June 1993 sending copies to Mr Bradley, Mr Eddy, Mr Lister and Dr Fielder. She said that the matter was progressing rather slowly at EC level because of the procedures necessary and the limited numbers of meetings available to the relevant Committee. Dr Wight indicated that the topic was likely to be discussed by the ECWPC at the beginning of 1994, and that following a favourable outcome of these discussions, adaptations would be made as necessary to the Cosmetics Directive and then adopted later in the year. She said she did not perceive any great urgency on the issue:

We seem to be in general agreement on measures to minimise risk with the CTPA . . . who in turn would prefer to support European proposals rather than see any unilateral UK action at this stage. ¹³

8.129 Dr Wight told us that us that, although any change to the Directive was not envisaged until later in 1994, she did not perceive this as a danger to public health that needed to be dealt with swiftly:

I think that the minute makes it clear that there was a feeling - I do not know, I was not involved in any negotiations after the initial discussions with the industry on any sort of legislative basis either in the UK or in Europe. But I think the - my understanding, from colleagues who were involved, was that they would rather progress it on sort of all fronts through Europe rather than the UK acting independently. But there was the guidance that was being drawn up.

. . . we had brought it to the attention of the industry that the industry were taking steps through their own channels to communicate that to their members, I think that is fair to say that over and above that I did not see that there was a pressing need. ¹⁴