FIFTEENTH MEDAL AWARD 69 Of Concern to the Cosmetic Chemist H. D. Goulden* You will agree, I am sure, that science has played an increasingly important role in the development of the cosmetic industry. The scien- tific method has largely replaced the empiricism of the past. Science has become so important that management of the larger companies find it convenient, if not essential, to "house" the company's chief scientist in their executive offices, where he is readily available for con- sultation. I would like to discuss a few matters that are of concern to the cosmetic scientist. There seems to be very little doubt that new cosmetic legislation will be enacted. The question is merely--when? One cannot forecast what this legislation may be, but recently proposed legislation makes certain trends apparent. Such legislation is so interwoven with science that the best interests of the industry will be served if all proposed legis- lation is carefully considered by the scientist. Let me illustrate by example: Recently proposed legislation, among other things, made it quite clear that a New Cosmetic Application would be required before a new cosmetic may be marketed, and such an application must contain a full list of the articles used as components of the new cosmetic and must con- tain a full statement of the composition of the cosmetic. It is not un- reasonable to expect that some did not particularly object to the pro- posal. Most know what ingredients they are using to make a particular cosmetic therefore, they know its composition. But do they? Let us study this in greater detail. A simple lipstick formula was selected, and the chemical constituents in each of the ten ingredients, where known, were listed. Such a simple formula actually contained over 120 individual known chemicals and many unknowns. A perfumer friend supplied a simple perfume for- mula. Similarly, the components of each ingredient were listed where known. This raised the grand total to more than 250 and an undeter- mined number of unknown constituents. Can one forecast what will hap- pen when such a mixture is processed into a lipstick ? It is apparent that a * The Toilet Goods Association, 1270 Avenue of the Americas, New York, N.Y. 10020

7O JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS meaningful full statement of the composition of a cosmetic can only rarely be made, for the addition of perfume to the cosmetic generally adds a complex of many known and many unknown chemicals, making a full statement of composition well nigh impossible. This example has been cited to point out to the reviewing scientist that proposed legisla- tion must be carefully, adequately and completely scrutinized. A New Cosmetic Application, according to proposed legislation, would call for a complete description of the manufacturing process. This would include the kind and quality of ingredients used a detailed description of the manufacturing process, including the packaging and labaling details of the control procedures employed to assure that the ingredients meet specifications, that the manufacturing process is ade- quately controlled, that procedures are employed to prevent mislabeling of the product, and finally, that the finished product is subjected to ade- quate control procedures. Provision should be made so that minor changes in manufacturing, packaging and control procedures would not necessitate amending the petition. It certainly would be particularly burdensome if every time one made a change in processing, control methods or labeling, he would have to wait for an amended petition to be approved. As proposed, a New Cosmerle Application would require the sub- mission of data establishing the safety of the cosmetic, when used as directed or in the customary or usual manner. Certainly the cosmetic chemist developing a new product wants to know all about the physical, chemical and toxicological properties of the various ingredients he in- tends to use in formulating this new cosmetic. He knows that the finished product must be subjected to safety evaluation. It is, of course, a fallacy that one can make a list of hundreds of approved cos- metic ingredients and assume that any and all combinations of those ingredients will result in a safe product. The safety of a new formula- tion can only be assured by evaluating the product. This will undoubtedly result in pharmacological evaluation of the product on animals, followed by clinical evaluation on man. The tests to be employed will be governed to a large extent by the nature of the product and its intended use. The final test, in my opinion, should be carefully planned sales in a very limited geographical area. May I say a few words on the methodology of safety evaluation. As you know, I am supervising a pharmacological evaluation program covering some 25 certified colors and which has to date, cost about half a million dollars. Four species are involved: mice, rats, rabbits and