EU Amends List of Substances Restricted in Food Supplements

On 1 December 2022 the Official Journal of the European Union published an amendment to Regulation (EC) No. 1925/2006 on the Addition of Vitamins and Minerals and of Certain Other Substances to Foods that introduces green tea extracts containing (-)-epigallocatechin-3-gallate (EGCG) as restricted or under Community Scrutiny substances. The amendment will enter into force on 12 December 2022.

3E Review

Commission Regulation (EU) 2022/2340 Amending Annex III to Regulation (EC) No. 1925/2006 of the European Parliament and of the Council as Regards Green Tea Extracts Containing (-)-Epigallocatechin-3-gallate amends Annex III, Part B on Restricted Substances and Annex III, Part C on Substances under Community Scrutiny by listing the substance green tea extracts containing EGCG under Annex III, Part B and C.

The amendment requires the inclusion of the following information on the labels of products:

• Maximum number of portions of the food for daily consumption
• Warning not to exceed the stated recommended daily dose of 800 milligrams or more of green tea extracts containing EGCG
• Content of EGCG per portion of the product

The following phrases should be used on the labeling:

• “Should not be consumed if you are consuming other products containing green tea on the same day.”
• “Should not be consumed by pregnant or lactating women and children below 18 years old.”
• “Should not be consumed on an empty stomach.”

This amendment excludes aqueous green tea extracts containing EGCG that have a composition comparable to traditional green tea infusions after being reconstituted in beverages.

3E Analysis

Business operators that specialize in the manufacture, import, and distribution of food supplements should take into account the published amendment.

Food products that have green tea extracts containing EGCG that have been placed on the market before the entry into force of the amending Commission Regulation (EU) 2022/2340 are allowed to remain on the market until 21 June 2023.