The new European Regulation (EU) 2021/468 was published on March 19, 2021.
" />



Regulation 1925/2006 defines which vitamins, minerals and other substances can be added into foods. For vitamins and minerals, the Regulation is clear, however for other substances Article 8 can be found, which defines the substances restrained to restriction, prohibition, or community control and it is at this point where the legislative changes affect.

Article 8 includes the Annex III, which contains parts A, B and C. We will go through them in detail:

-          Part A: the substance or ingredient and its addition to foods or its use in the manufacture of foods shall be prohibited.

-          Part B: the substance or ingredient and its addition to foods or its use shall only be allowed under the conditions specified therein, such as: limiting the maximum dosage, attaching a warning text on the label, etc.

-          Part C: if the possibility of harmful effects on health is identified but scientific uncertainty persists, the ingredient is added in this Part. However, this is temporary until evidence decides in which category shall it be placed.

Recently, Regulation (UE) 2021/468 has been published, by which Annex III previously cited is modified, and it concerns Aloe vera and hydroxyanthracene derivatives (HAD, from now on).

Before getting down to business, hydroxyanthracene derivatives (HAD) include, among others: anthracenes, anthraquinones, emodin, aloins, cascarosides, glucofrangulines and sennosides.

In the Part A previously mentioned, and therefore the prohibited ingredients category, is included:

-          Aloe-emodin, emodin and danthron and all preparations in which these substances are present.

-          Preparations from the leaf of Aloe species containing HAD.

Part B is not affected by the Regulation 2021/468, so no change is made.

In Part C, substances in which uncertainty remains, waiting for a final decision, it can be found:

-          Preparations from the root or rhizome of rhubarb (Rheum palmatum L., Rheum officinale Baillon) and their hybrids containing HAD.

-          Preparations from the leaf or fruit of senna (Cassia senna L.) containing HAD.

-          Preparations from the bark of alder buckthorn (Rhamnus frangula L.) and cascara buckthorn (Rhamnus purshiana DC.) containing HAD.

EFSA is currently evaluating these substances and we will be alert for the final decision that the European Commission takes in that regard.

This Regulation shall enter into force on April 8, 2021.