654 R. J. L. Allen of nationwide publicity to 'persuade' manufacturers to stop production and then formally to ban these products. Later it was found that the original allegations were wholly without foundation and that these adhesive products were completely harmless and the ban was quietly withdrawn in January 1974. No publicity has been given by professional consumerists to the results of an enquiry conducted the following May by Hook and Healy of the New York State Department of Health and the Department of Paediatrics, Albany Medical College among medical genetic centres throughout the US (4). They found that the centres had received no less than 1100 enquiries as a result of widespread publicity in the media and that nine women had actually procured abortions, so terrified were they of giving birth to malformed babies. It is easy for us, as scientists, to under- estimate the effect on the ordinary man or woman of scare headlines that can arise from the false identification of an environmental agent as toxic, whether these relate to cyclamates, aspirin, amaranth, hairdyes, saccharin or whatever. Perhaps the nine unfortunate women in Oklahoma were only the tip of an iceberg? The efficacy--or rather the lack of it--of cosmetics is another favourite consumerist theme. As I have said, with products at the borderline between cosmetics and medicines we are moving towards a requirement to demonstrate efficacy by double blind clinical trials just as rigorous in design and meticulous in execution as with a potent therapeutic agent. There are already problems with trials that require the use of human volunteers, and these will increase. Prior demonstration of safety is tending to become more rigorous, and the withholding of therapy in a placebo group may conflict with the code of ethics for human experimentation enunciated in the Declaration of Helsinki (5). With the great majority of cosmetics, however, efficacy must lie in the eyes of the user and the beholder, but this will not prevent increasing demands by regulatory authorities for objective and statistically valid evidence in support of claims made for product classes traditionally promoted by harmless puffery alone. In this situation, it will be particularly important to insist on an interpretation of efficacy wide enough to take account of the imponderable product characteristics that determine consumer satisfaction or otherwise. When the Directive was going through the Economic & Social Committee, suggestions were made that the interests of the consumer could only be adequately assured by a fully fledged system of product licensing. The French system of dossiers available for government inspection might be regarded as a step in that direction. I have described how product licensing has developed for pharmaceuticals. I do not see how the cosmetics industry as we know it could survive in that kind of strait-jacket, so be on your guard! The first effective Act to regulate the food industry (Sale of Food & Drugs Act, now Food & Drugs Act) was passed as long ago as 1875 but reinforcement of the general provisions of the Act by compositional standards and lists of approved food additives did not start in earnest until the 1940s. It has taken half a century to establish a system of permitted lists for some 300 food additives and even now flavourings (the analogues of fragrances) have yet to be tackled. There are said to be 13 000 compounds in use in cosmetics (6). How long will it take to marshal these in the positive lists to which the authorities are apparently committed? The course of events in the food industry shows how limited, in reality, is the scope for speedy action. We must continuously remind Government of the facts of the situation, and especially perhaps the consumerists, of the stifling effect on initiative of a rigid system of permitted ingredients in an industry which lives by rapid change. I have discussed elsewhere (7) the minimum safeguards that the industry must seek to have built into the system. The record of the consumer representatives in debate on the Directive in the Economic & Social Committee and the

Cosmetics and the future 655 European Parliament, with their facile demands for instant positive lists, is unimpressive. Experience in the food industry in this regard is dispiriting. It is only too easy for an additive to be struck off the list on real or supposed grounds of danger. To get a new additive included in a permitted list is something else again. The time from first applica- tion to the coming into effect of regulations enabling a new compound actually to be used in manufacturing is usually to be measured in years rather than months. Somehow, some better system has got to be found for cosmetics ingredients. There is also the ques- tion of cost. I have had something to do recently with the funding of toxicological studies on six well-known food colourings in order to establish their safety in use by developing new, additional data demanded by the EEC Scientific Committee for Food. The cost of this work will be about oe700 000 at 1976 prices and will take 5 years. What would the cost be of establishing the safety in use to modern toxicological standards of the 400 + colourings now used in cosmetics in the EEC? It is estimated that it will cost oe2.5m to generate the extra toxicological data required for the 215 substances that have been proposed for positive listing as food flavourings. Who can guess what it would cost fully to evaluate the 13 000 cosmetic ingredients to which I have just referred? The CTFA have tackled the problem in a forthright way with their Cosmetic Ingredient Review programme in which independent experts will assess the safety in use of all the compounds (except fragrances) used in the industry and indicate where further toxicological data are required. I very much hope that some means will be found for the European industry to co-operate in this exercise, because otherwise we are going to dissipate money and scarce resources in duplicating their efforts when preparing our own positive lists. A more encouraging lesson from the food industry is to be found in the field of government-industry relations. Over the years a system of informal and formal con- sultation at every stage of the legislative process has been built up. I hope that this tradition of collaboration rather than confrontation will prevail in the new field of cosmetics regulations. The signs so far are good. The Government sought the views of industry in the discussions in Brussels on the Directive, and industry is currently being consulted in the drafting of the necessary implementing legislation. Thus it has been possible at an early stage to suggest the inclusion of legislative features that the food industry have found by long experience to be valuable, for example enforcement through local authorities rather than by an FDA-like monolithic machine. Should the industry go further and seek the establishment of an independent advisory body like the Food Standards Committee (a 'Cosmetic Standards Committee')? This Committee comprises three persons from the scientific field, three from the food industry and three generally representative of the public interest under an independent chairman (8). Together with the similarly structured Food Additives & Contaminants Committee it advises Ministers in the exercising of their regulation making powers under the Food & Drugs Act. You may think that a more formal but also more 'open' system incor- porating an advisory committee of this kind could provide some protection should the industry ever have to negotiate in regulatory afi•tirs in a more hostile political environ- ment than we have at present. Our present good but informal relations with the authori- ties might not necessarily survive the coming to power of elements already active in politics in this country. We can reasonably expect that non-tariff trade barriers will wither away within the Community but there is not much sign of this happening in the wider world scene. In 1962 a few major firms in the food industry got together to provide money to launch the