PRODUCTION INGREDIENTS
Safety assessment of botanical ingredients
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New standardized approaches required
The comprehensive characterisation of a plant-derived in- gredient is crucial both from a botanical and chemical point of view
Why has, so far, little attention been paid to the quality and safety of botani- cal PCP ingredients?
Dr. Gerhard No- hynek, Scientific Director, World- wide Safety Evalu- ation, l’Oréal
First of all, there are no national or international guidelines on the quality and safety of botanicals in personal care products. While the safety of chemical ingredients has been a con- stant focus of the public and of regula- tors, there has been no similar concern about the safety of botanicals. So the public and regulators up until now have adhered to the popular miscon- ception that being natural is equal to being safe.
What are the challenges when assess- ing the safety of botanical ingredients for personal care products?
It is all about knowing the material and its quality. Specifications about origin, purity, presence of key ingredi- ents, and data on contamination are the main issues for the safety assess- ment of any plant material. Could you please describe some ap- proaches for the safety assessment of botanical ingredients in personal care products?
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First of all, specifications regarding the origin and quality of the material are required. Then you can review the known characteristics of the material, i.e. known uses in food, herbal teas, herbal medicines and others, as well as known ingredients of the material or materials from similar plants. Ingredi- ents should be checked for the pres- ence of substances that may cause intolerance, sensitisation or phototox- icity.
In addition, the presence of known plant toxins, such as alkaloids has to be checked. Contamination (heavy metals, mycotoxins, other plants) and adulteration (drugs) are other key is- sues. The list of dangerous substances that could be part of the plant extract is quite long. What makes the characterisation of plants particularly difficult and why? The safety assessment of botanical ingredients is complicated due to the number of parameters that may poten- tially affect their safety. For example, the content of ingredients of plant products may show considerable vari- ability due to species variation, geo- graphical origin, plant age, use of dif- ferent parts of the plant, annual climat- ic differences, time and condition of harvest, processing, storage and pack- aging.
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Dr. Gerhard Nohynek, Scientific Director, Worldwide Safety Evaluation at L’Oréal, explains in an interview with COSSMA editor Angelika Meiss that the safety assessment of botanicals is more complex than that of conventional ingredients. Given the fact that novel botanical ingredients used in personal care products may contain unknown substances with novel toxicological properties, new approaches to their safety assessment are needed. So there is a need to develop standardised, pragmatic and conservative approaches for appropriate quality and safety standards of plant- derived ingredients.
Could you please describe the advan- tages and disadvantages of the com- parative approach?
Botanical personal care product ingredients are often obtained from plants that represent traditional foods or food ingredients, such as spices. In these cases, the plant, plant food or plant-derived ingredient may be used as a comparator relative to the per- sonal care product ingredient. Various databases may be consulted in order to establish whether a particular product has a history of safe use as a food or food source. These include national food survey reports and global, region- al, and national surveys of plants with food uses. Overall, the choice of the comparator(s) is a crucial issue since it provides a benchmark against which compositional differences in process- ing and human exposure to the plant- derived cosmetic ingredient may be assessed. Once identified, the com- parator(s) as well as the plant-derived cosmetic ingredient should be accu- rately characterized. This includes a precise plant-derived ingredient identi- fication (e.g. taxonomy, phenotype, genotype) using appropriate method- ologies. The origin, geographical distri- bution, and genetic diversity of the plant-source should be described. The chemical composition of the compara-
photo: L’Oréal
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