Volume 7: Medicines and Cosmetics
8. Cosmetics and toiletries
1994
February to April
May 1994
July-November 1994

February to April

8.130 In February 1994, the ECWPC held another meeting. At this meeting the German delegation called for measures to ban the use of bovine-derived substances in cosmetics, as had been done with medicinal products. The Commission pointed out that the SCC was investigating the problem. ¹

The Germans issue their own guidelines

8.131 On 30 March 1994, at a special meeting of the EC Health Council, all Member States except Germany supported the UK and Commission view that existing measures to control BSE and protect public health were sufficient. The German Health Minister expressed dissatisfaction with the outcome and issued a statement reserving Germany's right to unilateral action. ² Among Germany's proposed restrictions was:

4. The issuing of recommendations to producers of cosmetics, based on the existing recommendations for the production of medicines. Such a measure is necessary since the theoretical risk of BSE transmission by cosmetics is on a par with that in the case of medicines for external use. ³

8.132 In April, Mr Stelchens (EC Agriculture Commissioner) announced in a press release that the Commission was developing guidelines for the manufacture of cosmetics in order to supplement those already adopted for medicinal products. ⁴

May 1994

The CTPA releases guidelines

8.133 The CTPA released its own updated, voluntary guidelines to members in May 1994. ⁵ These drew upon WHO guidelines for inactivating spongiform encephalopathies as well as its four categories of relative scrapie infectivity titres. ⁶ Dr Wight told us that she could not recall whether the guidelines were issued in consultation with DH and MAFF, as had been agreed at the meeting on 21 September 1992. ⁷

8.134 The CTPA guidelines stated that, although cosmetics were generally applied to healthy skin, the risk of infection from application to broken skin was of the 'same order of magnitude, for the same infecting dose, as the risk from ingestion'. However, tallow, used in soap and lipstick, was not considered to be a risk. The CTPA recommended that bovine ingredients could be sourced from countries free from BSE (or where only sporadic outbreaks were known), on condition that these countries had effective veterinary surveillance and the consumption of feed supplements was strictly controlled. In the absence of this guarantee the following bovine ingredients could be used:

1. Bovine or ovine extracts conforming to class IV of WHO classification;
2. Bovine and ovine extracts from animals less than six months old; and
3. Bovine and ovine extracts from animals classified as I, II or III of WHO classification, on condition that suppliers used processes known to inactivate or reduce infection, such as those recommended by WHO for the protection of public health concerning BSE, or other valid procedures. ⁸

July-November 1994

8.135 On 15 July 1994, following reports that the French and Germans were calling for a European ban on British beef, Mrs Payne alerted Mr John Walker, now head of the Chemical Safety Section in DTI, that it was possible France and Germany might again question the safety of UK cosmetic products at the next meeting of the ECWPC (scheduled for 9 September 1994): ⁹

3. Although there is no proof that 'mad cow' disease can be transmitted to humans if, in the unlikely event, the French and Germans call for a ban on UK cosmetics the effect would be that soap manufacturers will need to source from UK herds which are certified 'BSE-free' or import bovine extracts (see point 4). The other alternative is to replace bovine extracts with other comparable ingredients, for example coconut oil. Small firms which cannot adapt quickly and have low liquidity, will go under. As for manufacturers of 'exotica' products, they are virtually all based in France or Japan.

4. If it is possible for humans to contract 'mad cow' disease from cosmetics, the risk is greater from 'exotica' products because, unlike soap ingredients, the ingredients are not subject to repeated boiling and some are just merely chilled. MAFF have advised the CTPA that the only safe source is Australasia. Along with other European countries, France and Germany have imported from the UK infected feedstuff and live cattle. There have been reports of BSE outbreaks in Germany and France and even in the USA, a prime market for Jersey cattle. The Germans claim that they have 'cured' their infected cattle by bathing them in a special dip they have developed but MAFF say there is no magic German cure. The French are masters at suppressing bad news. However, their higher scientific committee has issued 'approved BSE guidelines' for French industry to follow. These guidelines cover, amongst other things, cosmetic products and are based on guidelines issued by MAFF. The French have not credited MAFF at all and are touting their guidelines around the Commission.

8.136 On 9 September 1994, the ECWPC met to discuss SCC reports on the safety of cosmetic ingredients. Mr Walker and Miss Mulholland, HEF(M), who worked for Dr Fielder, attended. Mr Walker's note of the meeting, dated 12 September 1994, records:

The Germans sought a Community approach on the issue of using animal derived ingredients from stock containing BSE. The SCC chair Mr Kemper said SCC had had a look at the matter and said BSE-containing animal products were undesirable in cosmetics, but there was still a problem about data. ¹⁰

8.137 The German proposals on the control of animal products were submitted to the SCC in October 1994.

The SCC issues advice on BSE and Cosmetics

8.138 On 21 October 1994, the SCC issued an interim statement advising 'since animal extracts may be contaminated with the causative agent of BSE, materials with the potential of transmitting such agents should not be used in cosmetics'. ¹¹

8.139 On 25 November 1994, Miss Mulholland minuted Dr Wight that the German proposals for control of animal products had been submitted to the SCC but were 'not very enthusiastically received as they were felt to be impractical and unwieldy'. Miss Mulholland went on: ¹²

Nothing very much has happened since then. At the last SCC meeting (October), as we understand it, a statement was made to the effect that materials derived from animals should not contain transmissible agents. However, this does not seem to have translated into concrete proposals. The discussion became rather confused with the issue of the use of human material (ie placenta) in cosmetics. The French have recently introduced domestic legislation with this intention and the SCC (and member states) support this. It is thought that proposals on both subjects will be forthcoming but it is unclear how long this might take.