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Following the request of the European Commission (EC) in the context of Article 8(2) of Regulation (EC) 1925/2006 [1], the European Food Safety Authority (EFSA) launched the following calls for data early July :

  • for the evaluation of safety of the use of preparations from the fruits of sweet and bitter fennel (Foeniculum vulgare) [2];
  • for the Scientific Advice on the evaluation of the safety of the use of plant preparations containing berberine, e.g. Berberis aristata. [3]; and
  • for the Scientific Advice on the evaluation of the safety of plant preparations containing hydroxycitric acid (‘HCA’), e.g. Garcinia gummi-gutta [4].

These calls for data provide stakeholders with the opportunity to submit documented information relevant to the safety assessment of these three substances also used in food supplements.

After an assessment of the available information by EFSA, the EC will take a decision and, if necessary, include the substance or ingredient in Annex III of the Regulation mentioned above. More specifically:

  1. if an adverse health effect is identified, that substance and/or ingredient containing that substance shall be:

    1. included in Part A of Annex III and prohibits its addition to (and its use in the manufacture of) foodstuffs,

    2. included in Part B of Annex III and its addition to (and its use in the manufacture of) foodstuffs is permitted only under the conditions stated;

  2. if the possibility of adverse health effects has been established but there is still scientific uncertainty, the substance shall be included in Part C of Annex III.

In recent years, such evaluations have already been carried out for green tea extracts containing epigallocatechin-3-gallate (‘EGCG’), monacolins from red yeast rice, and plants containing hydroxyanthracene derivatives (e.g. species from the genera Rheum, Rhamnus and Cassia ). Maximum levels were set for these ingredients and warnings on the label were mandatory.

EFSA also announced that the deadlines for the three calls for data have been extended until December 31, 2023.

Several organizations have informed EFSA that they are interested in participating in the three calls for data.

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