PREVENTION OF HAZARDS FROM CHRONIC TOXICITY OF COSMETICS 323 CONTROL OF CONSTITUENTS Control over the constituents of cosmetic and toilet preparations is one way in which the exposure to substances having delayed toxic effects could be reduced. The problem of control of these preparations is similar to that of food in general, but different in details*. In the field of food additives the principle of positive lists of suitable products is generally accepted. In cosmetic and toilet preparations the ingredients could be classified as suggested for the colours by the Deutsche Forschungsgerneinschaft-Farbstoff Kommission-Mitteilung 8** as follows: C -- Completely acceptable for use in any cosmetic including those that can be ingested (e.g. in lipstick or dental prepara- tions). C.-Ext. -- For external use only-not necessarily safe for ingestion. C.-W.R. -- For use in washing and rinsing, or as a solvent or pro- pel!ant, provided that the material has only transient application not necessarily safe when ingested or remain- ing on the skin. Classification should depend on the nature of the preparation and, more especially, its usage. The substances in class C which are completely accept- able should either be "generally recognised as safe," or have been approved after testing in at least two species of animal, for example, by feeding to rats over a period of two years and by skin application to mice for 80 weeks. Dogs may be useful for discovering toxic effects in short-term experiments, but appear to be unsuitable animals for the skin testing of cosmetic ingredi- ents, because. dog skin is relatively impermeable, or for life span studies, since they live for 15 years. Substances in the categories C.-Ext. and C.-W.R. may be controlled by negative lists. Products known to be harm- ful under the conditions of use in cosmetics should not be allowed. Substances already in use might be included in provisional positive lists, unless there is reasonable evidence that their use is harmful. As soon as possible the available information, including experience of human use, on these substances should be evaluated and further studies may be called for if the available information is not considered to be adequate to establish acceptability. A reasonable period of time, say five years, for the completion of further tests should be allowed. The evidence on the biological properties of new ingredients proposed for use in cosmetics should be evaluated and inclusion of the substance in appropriate lists should be decided accordingly. *The evaluation of the toxic and carcinogenic hazards of food additives is considered in the 2rid and 5th Reports of the Joint FAO/WHO Committee on Food Additives (1958 and 1961). **Second Edn. 1959 (F. Steiner Verlag, Wiesbaden).
324 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS Substances used in cosmetics should conform to appropriate specifications and standards of purity. Standards acceptable for food additives or pharmacopoeial preparations can be regarded as acceptable for cosmetic materials, although in some cases less stringent specifications may be justified. Cosmetics present special problems of hygiene and health protection because of their frequent use (often daily), without any scientific or medical supervision. The possible hazards should not be considered in isolation but rather in conjunction with other risks, such as those of food additives and contaminants of air and water. RESOLUTIONS 1. The ingredients of cosmetic and toilet preparations, both in the pure state and as formulated, should be subjected to biological testing to ensure, as far as possible, that the use of cosmetics does not constitute a hazard to health. 2. Appropriate control measures are, therefore, necessary. The nature of these must depend on the particular ingredients in the cosmetic prepara- tion, the uses to which it is put and the population groups involved. 3. In general, effective control can be promoted by the compilation of lists of substances that are considered to be either suitable (positive list) or unsuitable (negative list) for use in cosmetics. 4. A positive list and/or negative list, whichever is most appropriate for the group of substances under consideration, should be compiled, after consideration of the available evidence, along the lines indicated in this Report, for the ingredients used or proposed for use in cosmetic prepara- tions. 5. Special measures, such as limitation of concentration used, specified conditions of use and/or labelling regulations, are needed for some substances that may cause unwanted side effects. 6. Substances that may be used for specific therapeutic purposes should, in general, be under medical control the uncontrolled use of potent therapeutic agents, such as antibiotics and hormones, is undesirable. 7. Adequate specifications and standards of purity of ingredients used in the formulation of cosmetic preparations, especially vehicles, solvents and colours, are necessary to ensure the exclusion of harmful impurities. 8. The plan of biological testing for each substance or group of substances
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