Wijziging van Warenwetregelgeving in verband met de aanwijzing van schadelijke stoffen in voedingssupplementen en kruidenpreparaten

Reactie

Vraag1

On behalf of Ixoreal Biomed, we would like to respond to the proposed amendment to the Regulation.

Commercialised ashwagandha products can have a very different chemical composition that is influenced, for example, by extraction method, the part of the plant used, growth conditions and analytical methodology. The variations in these active compounds can lead to very different safety outcomes in studies. As such, the characterisation and specific part of the plant and its method of manufacture must be considered when drawing conclusions as to a product’s safety. The enclosed report shows that there are the major chemical compositional differences between Withania somnifera leaves and roots. It can be concluded that the chemical composition of roots and leaves are clearly very different and consequently, the toxicological profiles are also different. Thus, the roots and leaves should be considered as two separate entities in risk assessment and any risk management.

Bijlage