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 (EC No 2015/4013)
- Yohimbe bark and its preparations originating from Yohimbe (Pausinystalia yohimbe (K. Schum) Pierre ex Beille) (EU No 2019/650, done 24.4.2019, entered into force on 15.5.2019)
- 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 No 2021/468, done 18.3.2021).
Part B – If restrictions apply to the use of the substance
- Trans fat other than trans fat naturally occurring in fat of animal origin (EU No 2019/649, done 24.4.2019, entered into force on 15.5.2019)
- 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.
- Transitional period:
- Food which does not comply with this Regulation may continue to be placed on the market until 1.4.2021.
- Conditions of use:
Part C – If the substance is under Community scrutiny
- Preparations from the root or rhizome of Rheum palmatum L., Rheum officinale Baillon and their hybrids containing hydroxyanthracene derivatives;
Preparations from the leaf or fruit of Cassia senna L. containing hydroxyanthracene derivatives;
Preparations from the bark of Rhamnus frangula L., Rhamnus purshiana DC. containing hydroxyanthracene derivatives (EU No 2021/468, done 18.3.2021).
For more information, see the website of the European Commission at: