Safety of botanical ingredients in personal care products/cosmetics |
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Authors: | Eric AntignacGerhard J Nohynek Thomas ReJacques Clouzeau Hervé Toutain |
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Institution: | a L’Oreal Research and Innovation, Global Safety Evaluation, 92600 Asnières, France b L’Oreal USA, Research and Innovation, Clark, NJ 07066, United States |
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Abstract: | 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. |
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Keywords: | CA comparative approach CG congeneric group(s) CIR Cosmetic Ingredient Review COLIPA European Cosmetics Manufacturers Association CS complex substances DST Dermal Sensitisation Threshold EFSA European Food Safety Authority EMEA European Medicines Agency EPA US Environmental Protection Agency FAO Food and Agricultural Organisation FDA US Food and Drug Administration GM genetically modified ICH International Conference on Harmonisation JECFA Joint FAO/WHO Expert Committee on Food Additives NCS natural complex substances NTP US National Toxicology Program PCP personal care products/cosmetics PDEL permissible daily exposure level PCPC US Personal Care Products Council SCCP EU Scientific Committee for Consumer Products SCCS EU Scientific Committee for Consumer Safety SE substantial equivalence TTC Threshold of Toxicological Concern WHO World Health Organisation |
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