SP015 Safety evaluation of botanical ingredients used in cosmetics products: regulatory proposal

Resumen

Botanicals extracts, a complex aggregate of chemicals, are used as ingredients in cosmetic products, which could be distributed in many parts of the plant, in different concentrations, therefore, does not present, in natura, a standardized composition. It is known that the source of the ingredient does not determine its safety. Many plants, organically grown or not, contain substances that can cause adverse reactions. Therefore, as new botanical cosmetic ingredients may contain unknown substances with toxicological properties, broad approaches to assess its safety are required. Currently, the toxicological data required by agencies such as ANVISA, FDA and EU appear to be suitable for assessing the safety of chemically well defined ingredients, but less suitable for assessing the safety of plant-derived ingredients. While regulators have issued specific guidance for the safety assessment of botanicals ingredients for use as food, similar approaches have not been considered for the safety assessment of botanical cosmetic ingredients. Thus, only after evaluation of the many natural variables set, the extraction, purification and identification, the safety of these ingredients can be conclusive. From the above it is quite clear that the establishment of specifications for quality control of botanical ingredients has been constituted as a strategic design fairly comprehensive and should include strict control of raw material.