Foodstuffs, food supplements
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
This draft Decree amends the lists in the Annex to Royal Decree of 31 August 2021 on the production of and trade in foodstuffs composed of or containing plants or plant preparations.
The bilingual document shows the amendments, including the removed text, in green.
Article 1 removes text that is no longer relevant after the preceding amendment.
Article 2 amends the Annex (list 1: hazardous plants not permitted for use as or in foodstuffs, list 2: edible mushrooms and list 3: plants to be notified if in dose form) to the Royal Decree.
For list 1, it should be noted that the Royal Decree of 31 August 2021 provides for an exemption from the prohibition if a toxicological and analytic file can demonstrate that the plant preparations no longer have the toxic properties or substances of the plant from which they are obtained. For a number of plants, the ‘conditions’ section gives an indication of the substances to be evaluated in this file and requires demonstration that the daily dose is less than the toxic value (DNEL or Derived-No-Effect-Level value). For some plants, the text imposed a maximum content for certain substances. For other plants, the ‘conditions’ section includes a general derogation or permits certain plant parts or preparation in food.
For list 3, it should be noted that only the plant parts with a safe and traditional use are permitted in food. For various plants, the text specifies maximum contents and/or mandatory warnings, which are necessary to protect public health and inform consumers. These warnings must appear in the labelling of the foods.
For unlisted plants or plant parts, it is possible to submit a more extensive notification file, which will be forwarded to the Advisory Commission for Plant Preparations for a safety evaluation.
Article 3 provides the transitional measures.