The paper presents issues emerging identified for selected cases, when testing the tiered approach proposed by EFSA on for the safety assessment of botanicals and botanical preparations for selected cases. Major issues emerging can be summarised as follows: 1) The botanical must be identified by its scientific (binomial) name, sometimes evenin most cases down to the subspecies level or lower. 2) Adequate description and characterisation of the herbal parts and the different preparation(s) considered is needed. 3) Because adulterations, misclassification, switching of species, and restoration may occur, requirements for quality control seem necessary. 4) The strength of the evidence underlying the concerns over a botanical ingredient should be included in the safety assessment. 5) The composition of a botanical or botanical preparation may vary significantly due to part of the plant, geographical origin, plant maturity at harvest, harvesting techniques, storage conditions and processing (e.g. drying)factors that cannot be easily controlled. 6) Adequate data and even adequate tools to make anfor appropriate exposure assessments are often missing. 7) The sSituation with respect to toxic contaminants may need to be regulated. 8) An assessment based on the available knowledge can result in the conclusion that safety can be presumed, but can also lead to the conclusions that the product is of safety concern or that further data are requested. It is concluded that safety evaluation of botanicals and botanical preparations requires further development of new concepts and approaches in risk assessment.
New approach to the risk assessment of Botanical Food Supplements / M. Marinovich, C.L. Galli. ((Intervento presentato al convegno Botanical food supplements: from regulatory aspects to technical and scientific rules tenutosi a Braşov nel 2011.
New approach to the risk assessment of Botanical Food Supplements
M. MarinovichPrimo
;C.L. GalliUltimo
2011
Abstract
The paper presents issues emerging identified for selected cases, when testing the tiered approach proposed by EFSA on for the safety assessment of botanicals and botanical preparations for selected cases. Major issues emerging can be summarised as follows: 1) The botanical must be identified by its scientific (binomial) name, sometimes evenin most cases down to the subspecies level or lower. 2) Adequate description and characterisation of the herbal parts and the different preparation(s) considered is needed. 3) Because adulterations, misclassification, switching of species, and restoration may occur, requirements for quality control seem necessary. 4) The strength of the evidence underlying the concerns over a botanical ingredient should be included in the safety assessment. 5) The composition of a botanical or botanical preparation may vary significantly due to part of the plant, geographical origin, plant maturity at harvest, harvesting techniques, storage conditions and processing (e.g. drying)factors that cannot be easily controlled. 6) Adequate data and even adequate tools to make anfor appropriate exposure assessments are often missing. 7) The sSituation with respect to toxic contaminants may need to be regulated. 8) An assessment based on the available knowledge can result in the conclusion that safety can be presumed, but can also lead to the conclusions that the product is of safety concern or that further data are requested. It is concluded that safety evaluation of botanicals and botanical preparations requires further development of new concepts and approaches in risk assessment.File | Dimensione | Formato | |
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