Volume 7: Medicines and Cosmetics
8. Cosmetics and toiletries
1992
May 1992
July 1992
September 1992
October 1992
November 1992

A questionnaire on cosmetics

8.84 Work continued on the advice to be given to the cosmetics industry. By now the main purpose had changed to a fact-finding exercise. On 28 February, Mrs Whyte sent Dr Wight a suggested set of questions which it was envisaged might 'determine whether a meeting was needed, with possible guidance issued later'. Mrs Whyte's suggested questions were as follows:

- How widely was the DH/DTI Guidance issued in February 1990 disseminated to the Trade?

- What about companies/outlets not members of Trade Association?

- Were any other organisations included in this exercise?

- Was there any feedback on the 1990 Guidance?

- Was there any check on what was happening at that time?

- Has there been any subsequent check on the use of bovine material in cosmetics?

- Is there a list of suppliers of bovine material for use in the production of these products?

- If not, how easy/difficult would it be to produce?

- What is the geographical source of this material?

- Do you know the scale of usage of bovine material?

- Do you know what type of bovine material is used?

- Is there a list of products of which bovine material is an ingredient, no matter how small in quantity?

- Are any products made in the UK and exported, and if so to where?

- Are any products imported to the UK which use bovine material in their preparation?

- Are there likely to be other beauty products other than cosmetics or toiletries which use bovine material?

- Have there been any products rejected or discontinued because of the type of bovine material used in their preparation?

- Have you received any enquiries from the industry on the safety of bovine material?

- Have you received any enquiries from the public or consumer associations on the use of bovine material in cosmetics?

- Have you received any queries, from any source, on cosmetics and related products and BSE?

Once we have agreed the questions to be put to the CTPA we can write to them fairly quickly. I will copy any correspondence to MAFF to keep them informed of our action. I look forward to hearing from you. ¹

8.85 By 1 April 1992, Mrs Whyte had completed a draft letter to the CTPA. She sent this and the questionnaire to be cleared by Mr Murray. In her cover minute she noted that the contents of the questionnaire had been agreed by Dr Wight. ²

8.86 The next day, having incorporated amendments suggested by Dr Fielder, Mrs Whyte sent the letter and the questionnaire to Mr Phillipson of the CTPA. We set the letter out in full:

I am writing further to our discussion last year about the Tyrrell Committee which was looking at the use of bovine material in non-food products in the light of the problem with Bovine Spongiform Encephalopathy (BSE).

You will recall I was enquiring about the action taken by the Cosmetics Industry following the issue of Departmental advice on 1 February 1990, on the safe use of extracts of bovine offal in certain products, such as skin products claimed to have 'anti-aging' properties. At the time you confirmed that this advice had been disseminated to the Cosmetics Industry through the 'CTPA Scientific News' and the CTPA European Scientific Committee.

As it is some time since the Departmental advice was issued it is possible that some ruminant-derived materials are again being incorporated into cosmetics or beauty treatments which are then marketed as 'natural' products. As an example, an article on 'natural beauty products' has appeared in a Sunday supplement which stated that 'sheep's placenta and cows' brain tissue are included in (cosmetic) treatment products as "fresh cells" and "biological extracts" '. This is exactly the type of use and product about which the Tyrrell Committee was concerned. The particular materials which should not, under any circumstances, be used in the manufacture of cosmetics or beauty treatments are:

1. Bovine (cattle)-derived offals, or proteins derived from these offals, such as: brain, spinal cord, spleen, thymus, tonsils, intestines. These are the specified offals covered by the Bovine Offal (Prohibition) Regulations 1989.

Ovine (sheep)-derived offals and ovine placenta.

In an attempt to gauge the extent to which bovine and ovine material may be used in the production of cosmetics and beauty products it would be helpful to have some basic information relating to this subject. This is set out in the attached questionnaire and I would be grateful if you could complete the form as fully as possible and return it to me by 24 April. ³

The CTPA's response

8.87 Miss Kelly of the CTPA told Mrs Whyte that she could not obtain answers to the questionnaire by 24 April 1992, as the cosmetics in question were manufactured by companies all over the world. ⁴ She added:

On the basis of our knowledge that these substances are used in relatively few products and that these products have a relatively small turnover we have assumed that the number of companies supplying the ingredients would, for economic reasons, be fairly limited . . .

If you would like us to try to get answers to all your questions it would be most helpful if you could identify, on a worldwide basis, the sources which would be of concern to you . . . The work involved in following this up will be considerable and if there are geographical areas which are considered to be 'clean' in relation to BSE the task may be manageable. ⁵

8.88 Having seen Miss Kelly's response, Dr Wight sent a minute to Mr Murray. ⁶ She pointed out that feedback had not been received from all of the companies notified at the time:

We can only assume they heeded the advice. Non-member companies may still be unaware of previous advice, assuming that they make these type of products (which given the target market Ms Kelly describes may perhaps be unlikely). Do we have any way of estimating this likelihood (through CTPA or DTI?) or the extent of non-membership? ⁷

8.89 She went on to note that they knew France and Switzerland had some BSE cases and therefore it would be appropriate to update the 1990 advice to include these countries as an unacceptable source for bovine material. She also observed that the manufacturing country was not always the same as the source country of raw material. Therefore the message should be conveyed that 'these products should not contain sbo's or other ruminant offal/placenta materials at all, as we do not [know] how the ruminant SE situation could develop globally'. ⁸

May 1992

The CTPA asks its membership for further information

8.90 In May 1992 the CTPA contacted its membership through its scientific newsletter, the 'Blue Pages'. We set out the reference to BSE use in full:

Use of Bovine and Ovine Material in Cosmetic Products.

We have received an enquiry from the Department of Health about the use of the above materials in cosmetic products. In particular the following ingredients were specified.

Bovine (cattle)-derived offals, or proteins derived from these offals, such as: brain, spinal cord, spleen, thymus, tonsils, intestines. These are the specified offals covered by the Bovine Offal (Prohibition) Regulations 1989.

Ovine (sheep)-derived offals and ovine placenta.

Attention is drawn to the Bovine Offal (Prohibition) Regulations 1989 and members using these ingredients are asked to contact Ian Phillipson at CTPA as soon as possible. ⁹

8.91 Miss Kelly of the CTPA told us that there was no positive response to the newsletter request and that this indicated to the CTPA that members were not using these products. ¹⁰

July 1992

DH prepares updated advice for the CTPA

8.92 In early July 1992, a draft of a further letter to the CTPA giving updated advice on the BSE issue was prepared by Mrs Whyte and circulated to Dr Wight and Dr Fielder for comment. In her cover minute Mrs Whyte suggested that the advice would be difficult for the CTPA to enforce, particularly as it did not know about smaller manufacturers not covered by the Association. ¹¹ The draft letter explained:

Since February 1990 epidemiological information on BSE has increased, and it is evident that BSE cases have occurred outside the UK including France, Switzerland, the Falklands and Oman. As trade in feedstuffs and cattle is international it is possible that BSE cases could occur in other countries. Therefore it is difficult to give precise advice on where bovine material for inclusion in cosmetics can be safely sourced.

. . . your Association may think it prudent to advise your members that bovine materials generally, including{DN: specified bovine offals, other offals and ?} placenta etc, should not be used in cosmetics whether or not they are sourced from countries with reported cases of BSE. This would ensure that the public is not exposed to the admittedly very remote risk of exposure to BSE infected material {DN: or any other SE agent?}, in some cosmetics. ¹²

A warning of possible European involvement

8.93 On 6 July, Dr Fielder replied to Mrs Whyte, pointing out that the situation was now somewhat more complicated than when the CTPA was asked only to give advice on the source of bovine material. If what was wanted was a voluntary ban on bovine materials, regardless of their country of origin, action would have to be taken at the European level to amend the Cosmetics Directive. He set out the reasons why:

. . . Cosmetics products marketed in the EC are covered by the Cosmetics Directive which is implemented in the UK by DTIs Cosmetic Products Safety Regulations. We (HEF(M)2) advise DTI on the toxicity of chemicals used in cosmetics and have regular meetings with DTI/CTPA prior to attending meetings of the EC Working Group on Cosmetics which is the forum for discussing all aspects of the Cosmetics Directive, and for agreeing alterations in the 'permitted lists' of ingredients or the prohibited list.

. . . Even if we seek a voluntary ban on bovine material in cosmetic products marketed in the UK, we are likely to be challenged at the EC level with regard to barriers to trade, unless we then take our case to the EC Working Group on Cosmetics and argue for a ban throughout Europe. This could be accomplished by the inclusion of 'bovine material' in Annex II of the Directive (ie the prohibited list). We would however need to have a strong enough case to convince the other EC Member States (or sufficient to give us a weighted majority when it came to a vote!). In practice the matter is likely to be referred in the first instance to the CECs Scientific Committee on Cosmetology (SCC) for an opinion. This is the Committee of experts established under the terms of the Cosmetics Directive to advise on all aspects of the safety of cosmetics. Dr Ian White (consultant dermatologist from St Thomas) and I are the UK members.

. . . It is particularly pertinent in this instance for us to seek action at the European Level since (in addition to our Cosmetics Directive obligations) the concern is very predominately with companies from outside the UK, in particular France. ¹³

8.94 Dr Fielder suggested they have a meeting to discuss the issue. He also suggested involving DTI's Consumer Safety Division to agree a line, before meeting with the CTPA. ¹⁴

8.95 Dr Wight agreed with this suggestion. She identified some discussion points:

2. Firstly, we on the SE side have a rather scanty knowledge of the cosmetics industry. It would be helpful if you could provide any background information on the trade.

As part of this, what about current controls - regulations and otherwise - governing the use of raw materials, with respect to microbiological rather than chemical safety, and how is the safety of the production process and the end product monitored?

3. Is it possible to compare any trade controls with controls used in the drug industry?

4. How do our controls relate to EC requirements and how, if necessary, are these enforced?

5. Do you have any idea as to what sort of products are likely to be a problem with bovine/ruminant derived materials and is it possible to have details of the handling of these materials in the production process? Would any of the likely compounds be for non-topical use?

6. We recognise that we are discussing theoretical rather than proven risks, which makes deciding on a course of action more difficult, particularly if any action would have repercussions in the EC.

While we feel there is a need to update the previous DH advice, we need to think how this might best be done, and how it can reach all parts of the trade effectively. ¹⁵

8.96 It was agreed that the best way to proceed would be to hold a meeting involving DTI/CSU, the CTPA and a team of MAFF/DH experts to give advice on BSE. The earliest date that this could be arranged was for September 1992. ¹⁶

8.97 Mr Lowson, who was sent a copy of the draft letter inviting the CTPA to the meeting, recommended that Mr Bradley attend as the MAFF representative. ¹⁷

September 1992

Meeting between DH, MAFF, DTI and the CTPA

8.98 The meeting on 21 September 1992 was attended by Dr Wight and Dr Fielder (DH), Mrs Payne, an HEO from the CSU in DTI, Mr Bradley and Mr Dixon (MAFF), Miss Kelly (CTPA) as well as representatives from three of the larger cosmetics manufacturers: Proctor & Gamble, L'Oréal, and Unilever. ¹⁸

8.99 Dr Wight began the meeting by stating that its purpose was:

to reappraise the situation with respect to BSE and the use of bovine and other materials derived from animal origin in cosmetics manufacture. The situation, both in the UK and worldwide, had changed since the CTPA last issued advice to their members in February 1990 with respect to the risks associated with the use of bovine offals. ¹⁹

8.100 Mr Bradley confirmed that BSE had by now spread to the Republic of Ireland, Northern Ireland, France, Switzerland, Denmark, Oman and the Falklands.

8.101 Miss Kelly advised the meeting that the cosmetics of concern could be divided into two categories: 10 per cent expensive 'exotica' containing materials like cerebrocides and placenta, and 90 per cent 'routine' products, many based on collagen, elastin or gelatine. The main producers of 'exotica' were French and American companies; the final products were very expensive and the manufacturers were in a position to ensure the safety of their products by sourcing from countries, such as Australia, where no BSE or scrapie had been identified. French manufacturers were about to agree with their Department of Health to discontinue using placental material.

8.102 The CTPA believed that small UK companies would most probably be relying on vegetable materials. They were not thought likely to be incorporating materials of concern and the same could be said for producers who were not members of the CTPA. ²⁰

8.103 There was discussion of the risks associated with gelatine and tallow. As far as tallow was concerned, Mr Bradley observed that it should be derived from the rendering of protein and fat waste from cattle only after SBO had been removed. In general, the extraction processes used meant that there was not a problem. ²¹ The CTPA was told that DH would inform it of the results of MAFF/DH discussions on gelatine. ²²

8.104 Miss Kelly told us that the use of gelatine in cosmetics was rare and mostly confined to pharmaceutical grade. ²³

8.105 DH and MAFF felt that a list of cosmetics incorporating the discussed materials would be useful to aid estimation of their frequency and extent of use when considering any associated risks. Dr Wight's minute of the meeting notes that this list was to be followed up with the CTPA. ²⁴

8.106 The meeting concluded that concrete advice might well not be feasible and guidance would probably need to focus on enabling the industry to formulate questions for their suppliers when obtaining source material. The CVL offered to act as a contact point to assist in formulating the relevant questions and to provide answers where possible. ²⁵ The CTPA indicated that it would consider the information that had been put forward at the meeting and then reach its own conclusions on what advice to give on which materials could be used. Miss Kelly felt that the safest and most logical course would probably be to advise against the inclusion of animal offals altogether. It was agreed that the advice that the CTPA would issue to its members would be subject to consultation and agreement with DH and MAFF. ²⁶

8.107 Dr Wight told us that, although there was ongoing discussion after the meeting, she could not recall whether the consultation and agreement referred to took place. ²⁷

8.108 After the meeting Mrs Payne telephoned Dr Fielder. ²⁸ She told us that she and Dr Fielder:

. . . recalled that the CTPA had mentioned that the French cosmetics industry would be discussing the issue of bovine materials in cosmetics with their Ministry of Health and that this could lead to the industry producing Europe-wide guidelines, in consultation with COLIPA, the European cosmetics trade association. We agreed that we should ensure that whatever the outcome of the meeting in France, UK industry should be issued with guidelines, the content of which would need to be agreed by experts in MAFF and DoH before being circulated to the industry. Dr Fielder said he would let Dr Wight know what we had decided. ²⁹

8.109 After speaking to Dr Fielder, Mrs Payne contacted Miss Kelly at the CTPA to check whether she had received any feedback from the French cosmetics industry and if any progress had been made in drafting the industry's guidelines. She was told that the French Ministry of Health had expressed concern to its industry over the use of bovine material in cosmetics. In view of this, the CTPA had agreed with its French counterparts that they should jointly draft guidelines for the use of both their industries. They also agreed to discuss the provision of guidelines with other cosmetics trade associations in Europe. She was advised further that COLIPA would be hosting a meeting to facilitate the latter and, in the meantime, Miss Kelly would be raising the issue of guidelines with the CTPA. Mrs Payne was later informed by Miss Kelly that the CTPA Council had agreed that draft guidelines should be prepared for the UK industry and that these would be drafted jointly with the French industry, drawing on advice from MAFF and DH. ³⁰

8.110 The agreed draft of the minutes of the 21 September meeting was circulated by Dr Wight on 1 October 1992, together with a suggestion that Mr Bradley, Dr Fielder and anyone else who was interested could get together to discuss the CTPA proposals for advice when they arrived. ³¹ Dr Wight also requested Mrs Whyte to ask Dr Fielder to get in touch with the French authorities for feedback on their discussions with their Health Ministry. ³²

8.111 On 30 September 1992, Miss Kelly wrote to Dr Wight. The letter followed up on the request made at the 21 September meeting by MAFF and DH for a list of cosmetics incorporating bovine materials:

Following our meeting on 21 September I have contacted the company which promotes a range of products based on cerebrosides. I understand that materials of bovine origin are now being replaced by a synthetic alternative and that this change will be completed by early 1993.

I have not yet received a report from the French Federation about their meeting with the French Ministry of Health, I am writing again today to move this along. In relation to materials such as tallow, collagen, etc which are widely used in the UK I have asked one company to prepare a brief outline for each ingredient, including the treatments used in its preparation and any 'best practice' advice. ³³

October 1992

DTI and DH attend a meeting of the EC Working Party on Cosmetics

8.112 As outlined in the section on regulation and enforcement in this chapter, the EC Working Party on Cosmetics (ECWPC) was the forum through which the Cosmetics Directive could be amended. On 2 October 1992, Mrs Payne attended a meeting of the ECWPC together with representatives from DH. ³⁴ At the meeting the Italian delegation raised the question of whether there might be contamination by the BSE agent in medicinal products based on animal extracts. They asked the Commission for an assessment of the categories of cosmetic products that contained animal extracts - principally based on brain or marrow - so that they could be withdrawn from the market. The Italians felt that products applied to the mucous membrane or around the eyes were the most dangerous and it was agreed that they would provide the Commission with all their documentation on the matter. ³⁵

8.113 In late October Mr Phillipson wrote to Mrs Whyte. He said that the subject of BSE and cosmetics and the production of guidelines for members was 'now the subject of discussion among our sister associations in the EEC and the matter will be discussed at a technical committee of our European association in Brussels in the middle of November. Following this it is hoped that guidelines will be produced for use by European industry.' ³⁶

November 1992

8.114 In early November Mr Murray sent Mr Phillipson's letter to Dr Fielder. He commented that the development of guidance at an EC level was promising as it 'should avoid the impression the problem is one for only the UK cosmetics industry'. He qualified this with two concerns: ³⁷

Firstly, we must ensure the content of the guidance is accurate and does not unduly single out the UK for restrictions. Secondly, on timing I hope the exercise will not drag on for an overlong period when the guidance needs to go out as soon as possible.

. . . Can I leave it to you to be proactive in tracking developments on the guidance, copying papers to me for information and comments as appropriate. I will in turn ensure HEF(M) (Dr Wight) and MAFF colleagues are fully involved in any action we think necessary at Government level.

8.115 On 17 November 1992, Dr Wight sent Mr Murray and Mrs Whyte a draft letter which she proposed to send to the CTPA. The draft letter echoed Mr Murray's satisfaction that the matter was being taken up at European level, as well as his concern that the matter should not be delayed. It also reported that SEAC had reaffirmed its view that tallow was not a high-risk product, and that gelatine was also felt not to pose a risk. None the less, it remained advisable for the purchasing company to ensure SBOs were not used in the production process. ³⁸

8.116 Dr Wight's letter was sent to Mr Phillipson in early December. ³⁹