ABSTRACT
Title
Quality criteria for botanicals used in herbal drugs and dietary supplements: a common paradigm
Authors
P. Morazzoni, A. Storzini, V. Bombardelli, A. Riva
Indena S.p.A., Milano, Italy
Indena S.p.A., Milano, Italy
Abstract
Botanical derivatives (mostly multicomponent products such as extracts) are widely used in Europe as phytotherapic medicines and as ingredients for non-pharmaceutical products which are sold as food supplements according to the different national legislations.
Drug registration for extracts is nowadays regulated by Dir. 2001/83/EC that provide for two peculiar pathways based on “well established use” and “traditional use for herbal medicine”. In this scenario it is crucial that the preparation of “Active Pharmaceutical Ingredients” (API) from plants has to fulfil both GAP and GMP guidelines for what harvesting and cultivation of plants and industrial production is respectively concerned. The combination of these two guidelines is essential in order to guarantee quality and reproducibility of the API and also it allows to avoid the risks of pesticides or other harmful agent contaminations and API degradation.
As concerns the use of botanical extracts in the food supplement arena, up till now there is not a common UE legislation and each country are implementing national disposition for this kind of products. For example, in Italy the Ministry of Health has recently (March, 2011) initiated a procedure to transpose into law (as Annex 1 of a draft decree which regulates the use of dietary supplements different from vitamins and minerals) a list of admitted plants which can be utilized for the preparation of food supplements.
The quality criteria for the preparation of these products are those requested by the European regulations on food derivatives. The big challenge is nowadays to keep the quality criteria of botanicals used for food supplements as close as possible to “phytotherapic medicines” in term of batch-to-batch reproducibility, starting from the collection of the biomass through the manufacturing process.
Drug registration for extracts is nowadays regulated by Dir. 2001/83/EC that provide for two peculiar pathways based on “well established use” and “traditional use for herbal medicine”. In this scenario it is crucial that the preparation of “Active Pharmaceutical Ingredients” (API) from plants has to fulfil both GAP and GMP guidelines for what harvesting and cultivation of plants and industrial production is respectively concerned. The combination of these two guidelines is essential in order to guarantee quality and reproducibility of the API and also it allows to avoid the risks of pesticides or other harmful agent contaminations and API degradation.
As concerns the use of botanical extracts in the food supplement arena, up till now there is not a common UE legislation and each country are implementing national disposition for this kind of products. For example, in Italy the Ministry of Health has recently (March, 2011) initiated a procedure to transpose into law (as Annex 1 of a draft decree which regulates the use of dietary supplements different from vitamins and minerals) a list of admitted plants which can be utilized for the preparation of food supplements.
The quality criteria for the preparation of these products are those requested by the European regulations on food derivatives. The big challenge is nowadays to keep the quality criteria of botanicals used for food supplements as close as possible to “phytotherapic medicines” in term of batch-to-batch reproducibility, starting from the collection of the biomass through the manufacturing process.