The draft Order has been revised taking into account the results of consultations with stakeholders and now incorporates editorial amendments and clarifications, including those related to terminology.
The revision clarifies the approach to the lists of substances used in dietary supplements and their safety characteristics. In order to eliminate ambiguous interpretations and ensure a unified approach, column 6 "Substances that are assessed in accordance with the requirements of permanent procedures based on the principles of the Hazard Analysis system" has been removed from List I "Plants, algae and fungi permitted for use in dietary supplements" of Annex 3 to the Hygiene Requirements for Dietary Supplements.
The above-mentioned List I has also been updated by clarifying the names of plants, plant parts and the relevant warnings and restrictions, based on authoritative scientific sources and European Union practice.
In List IV "Substances with a nutritional or physiological effect" of the same Annex, thesubstance "proanthocyanidins" has been clarified as "oligo-proanthocyanidins," which is in line with the available scientific conclusions of EFSA and other reliable sources; no separate daily intake limit has been set for this substance.
The terminology related to dosage and safety parameters has been aligned with Ukrainian legislation through the use of the terms "acceptable daily intake" and "maximum permissible levels". The term "daily intake" is used as a descriptive indicator of recommended consumption within the established maximum permissible values.
The final version also provides for the following: diosmin – without setting a separate maximum permissible daily level; hesperidin – 70 mg; flavonoids – 1 g, with the exception of flavonoids derived from Glycyrrhiza glabra, which are classified as novel food products. These amendments are intended to minimize the risk of products being perceived as medicines.
In addition, the above–mentioned List IV has been supplemented with maltodextrin and casein hydrolysate, while List I has been supplemented with the fungus Tremella fuciformis Berk., which is permitted for use in dietary supplements.
The draft Order is also notified under the TBT Agreement.