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The Belgian authorities notified an amending draft decree for the Royal Decree on Botanicals [1]. They will implement several important changes to the lists in the annex of the Decree. Most importantly, several plants and parts deemed novel will be removed from the list of plants authorized in food supplements (list 3).

On July 29th the Belgian Department of Health notified the draft decree to the EC in the Technical Regulations Information System (TRIS), following the procedure established by Directive (EU) 2015/1535 (N° 2022/532/B).

The main grounds for the new decree are:

  • 29 plants and certain plant parts of 10 plants are removed from list 3, because there is insufficient proof of history of consumption, in regard to Regulation (EU) 2015/2283 on novel foods. [2]
  • A few plants and parts are added; and some conditions of use are changed in list 3, following review by the Advisory Commission for Plant Preparations; [3]
  • For the plants on list 1, which can only be used in food when an exception is granted, the Derived-No-Effect-Level (DNEL) is introduced for specific substances of concern. For Cannabis sativa, the maximum level of THC was lowered.

Especially the removal of the plants and parts is a deplorable move because these are almost all still authorized in Italy, France, and other Member States. The progress made with the BELFRIT project is being negated. All these plants and parts will now be considered novel in food supplements.

Very characteristic is the removal of the root of Pelargonium sidoides, which is now considered novel. The Belgian authorities confirmed this was done after a complaint of the firm Dr. Wilmar Schwabe, who has a registered traditional herbal medicine with their extract of this plant, based on a traditional use monograph.

The amending decree provides for a transition period of two years after the entry into force of the Decree.

[1] Royal Decree amending the Royal Decree of 31 August 2021 on the production of and trade in foodstuffs composed of or containing plants or plant preparations

[2] The list of plants and plant part which will be removed from the list of plants authorized in food supplements.

[3] The draft annex of the new Royal Decree on Botanicals, with the changes marked in green.

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