Safety of botanical ingredients in personal care products/cosmetics.

The key issue of the safety assessment of botanical ingredients in personal care products (PCP) is the phytochemical characterisation of the plant source, data on contamination, adulteration and hazardous residues. The comparative approach used in the safety assessment of GM-plants may be applied to novel botanical PCP ingredients. Comparator(s) are the parent plant or varieties of the same species. Chemical grouping includes definition of chemical groups suitable for a read-across approach; it allows the estimation of toxicological endpoints on the basis of data from related substances (congeneric groups) with physical/chemical properties producing similar toxicities. The Threshold of Toxicological Concern (TTC) and Dermal Sensitisation Threshold (DST) are tools for the assessment of trace substances or minor ingredients. The evaluation of skin penetration of substances present in human food is unnecessary, whereas mixtures may be assessed on the basis of physical/chemical properties of individual substances. Adverse dermal effects of botanicals include irritation, sensitisation, phototoxicity and immediate-type allergy. The experience from dietary supplements or herbal medicines showed that being natural is not equivalent to being safe. Pragmatic approaches for quality and safety standards of botanical ingredients are needed; consumer safety should be the first objective of conventional and botanical PCP ingredients.