DMAE and D-chiro-inositol versus Novel Food Classification

• DMAE

    DMAE (Dimethylaminoethanol / Dimethylaminoethanol bitartrate) has recently been categorized as an unauthorized Novel Food in the EU Novel Food Catalogue. However, this ingredient is already present in many products currently available in the EU market.

    We have been informed that certain Trade Associations are seeking evidence of the historical consumption of DMAE to challenge its classification as a Novel Food.

    To demonstrate significant consumption of DMAE in Food Supplements in Europe prior to May 1997, the following documentation will be considered conclusive evidence:

        • Official feedback or viewpoints regarding the use of DMAE in Food Supplements.

        • Supplier invoices that explicitly mention DMAE.

        • Dated product catalogues that reference this substance.

        • Any other relevant documentation demonstrating its presence in the European market.

• D-chiro-inositol

    The initial entry of D-chiro-inositol in the Novel Food Catalogue suggested that all inositol isomers had a history of consumption in the European Union. However, recent changes to this entry have raised questions about its Novel Food status.

    As a result, we have been informed that certain National Authorities are seeking evidence of a history of consumption for D-chiro-inositol. This evidence will contribute to ongoing discussions at the European level regarding the status of this ingredient under the Novel Food Regulation. 

    The types of documentation that are accepted as conclusive evidence include:

        • Supplier invoices explicitly mentioning D-chiro-inositol.

        • Dated product catalogues referencing this substance.

        • Any other relevant documentation demonstrating its presence in the European market.

If you have access to the documentation mentioned above for either DMAE or D-chiro-inositol and would like to contribute, please feel free to reach out to us.

This is a developing narrative; we will update it as new information emerges.