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.

Ixoreal Biomed recognizes consumer safety as an very important aspect. The data shared in the reports demonstrate that Ixoreal Biomed has been highly proactive in ensuring the safety of KSM-66®. In addition to numerous clinical studies, KSM-66® has been studied for several toxicological effects in various in vitro and animal models. The extract has undergone all the main toxicological preclinical studies required by the European Food Safety Authority (EFSA) for novel foods over the past decades.

As Ixoreal has extensively studied the safety of their own Withania somnifera root extract product, they want to bring to the attention of the authorities at this stage the preclinical and clinical studies demonstrating the safety of the product with KSM-66®. Some of the studies have been published, some have not yet been published. These have not previously been reviewed by the risk assessors.

On the request of Ixoreal, our scientists have done a comprehensive summary of all safety tests and studies conducted by Ixoreal.

Bijlage