Article 8 of Regulation (EC) No. 1925/2006 provides for a procedure that may be used to impose an EU-wide prohibition or restriction on the addition of certain other substances to food if they represent a potential health risk.
These substances are included in Annex III of the Regulation on Fortified Foods in either:
- Part A – If the substance is prohibited
- Part B – If restrictions apply to the use of the substance
A substance may also be put under Community scrutiny if the possibility of harmful effects on health is identified but scientific uncertainty persists. In which case the substance shall be put under Community scrutiny and placed in Annex III, Part C. Food business operators, or any other interested party, may at any time submit for evaluation to the Authority a file containing the scientific data demonstrating the safety of a substance referred to in Part C. Within four years from the date a substance has been listed in Part C, the Commission shall, in compliance with the regulatory procedure, take a decision whether or not to generally allow the use of a substance or to list it in Part A or B as appropriate.
Part A – If the substance is prohibited
- The herb Ephedra and preparations derived from it which are of the genus Ephedra ((EU) 2015/403)
- Yohimbe bark and its preparations originating from Yohimbe (Pausinystalia yohimbe (K. Schum) Pierre ex Beille) (EU No 2019/650)
- Aloe-emodin and all preparations in which this substance is present;
- Emodin and all preparations in which this substance is present;
- Preparations from the leaf of Aloe species containing hydroxyanthracene derivatives;
- Danthron and all preparations in which this substance is present ((EU) 2021/468).
Part B – If restrictions apply to the use of the substance
- Green tea extracts containing (-)- epigallocatechin-3-gallate (excluding aqueous green tea extracts containing (-)- epigallocatechin-3-gallate which after reconstitution in beverages have a composition comparable to traditional green tea infusions) ((EU) 2022/2340, shall apply from 21.12.2022)
- Conditions of use:
- Daily portion of food shall contain less than 800 mg of (-)-epigallocatechin-3-gallate.
- Additional requirements:
- The label shall provide the maximum number of portions of the food for daily consumption and a warning not to consume a daily amount of 800 mg of (-)-epigallocatechin-3-gallate or more.
- The label shall indicate the content of (-)- epigallocatechin-3-gallate per portion of the food.
- The label shall include the following warnings:
- “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”
- Conditions of use:
- Monacolins from red yeast rice ((EU) 2022/860)
- Conditions of use:
- Individual portion of the product for daily consumption shall provide less than 3 mg of
monacolins from red yeast rice.
- Individual portion of the product for daily consumption shall provide less than 3 mg of
- Additional requirements:
- The label shall provide the number of individual portions of the product for maximum daily consumption and a warning not to consume a daily amount of 3 mg of monacolins from red yeast rice or more.
- The label shall indicate the content of monacolins per portion of the product.
- The label shall include the following warnings:
- “Should not be consumed by pregnant or lactating women, children below 18 years
old and adults above 70 years old”. - “Seek advice from a doctor on consumption of this product if you experience any health problems”;
- “Should not be consumed if you are taking cholesterol-lowering medication”;
- “Should not be consumed if you are already consuming other products containing red yeast rice”.’
- “Should not be consumed by pregnant or lactating women, children below 18 years
- Conditions of use:
- Trans fat other than trans fat naturally occurring in fat of animal origin ((EU) 2019/649)
- Conditions of use:
- Maximum 2 grams per 100 grams of fat in food intended for the final consumer and food intended for supply to retail.
- Additional requirements:
- Food business operators supplying other food business operators with food not intended for the final consumer or not intended for supply to retail, shall ensure that supplied food business operators are provided with information on the amount of trans fat, other than trans fat naturally occurring in fat of animal origin, where that amount exceeds 2 grams per 100 grams of fat.
- Conditions of use:
Part C – If the substance is under Community scrutiny
- Green tea extracts containing (-)- epigallocatechin-3-gallate (excluding aqueous green tea extracts containing (-)- epigallocatechin-3-gallate which after reconstitution in beverages have a composition comparable to traditional green tea infusions) ((EU) 2022/2340, shall apply from 21.12.2022)
- Monacolins from red yeast rice ((EU) 2022/860)
- Preparations containing hydroxyanthracene derivatives ((EU) 2021/468) from
- the root or rhizome of Rheum palmatum L., Rheum officinale Baillon and their hybrids containing hydroxyanthracene derivatives;
- the leaf or fruit of Cassia senna L. containing hydroxyanthracene derivatives;
- the bark of Rhamnus frangula L., Rhamnus purshiana DC.
For more information, see the website of the European Commission.