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The European Commission is proceeding with a draft Regulation providing for the inclusion in Part A of Annex III to Regulation (EC) No 1925/2006 of certain plant preparations containing hydroxyanthracene derivatives. The draft concerns preparations from the bark of Rhamnus frangula L. or Rhamnus purshiana DC., from the leaf or fruit of Cassia senna L., and from the root or rhizome of Rheum palmatum L., Rheum officinale Baillon and their hybrids.
In 2021, these preparations were placed under Union scrutiny and included in Part C of Annex III. The current draft provides for their deletion from Part C and inclusion in Part A, which would prohibit their addition to foods or their use in the manufacture of foods.
In its opinion of 20 March 2024, EFSA considered the files submitted by two interested parties, as well as additional studies submitted during the public consultation. All the submitted genotoxicity studies showed negative results. However, the studies had been conducted using preparations containing low concentrations of hydroxyanthracene derivatives. According to EFSA, the absence of genotoxic results in those studies could not be used to rule out the genotoxicity concern arising from the presence in the preparations of a component shown to be genotoxic in vivo.
EFSA therefore concluded that the safety of the plant preparations concerned could not be established on the basis of the submitted studies. The Commission consequently considered that the preparations placed under Union scrutiny should be included in Part A of Annex III.
Food lawfully placed on the market before the entry into force of the Regulation, in the manufacture of which the prohibited preparations were used or to which such preparations were added, would be allowed to remain on the market for 12 months following the entry into force of the new act.
The draft does not initiate a new procedure concerning the same preparations. It represents the conclusion of the Union scrutiny procedure initiated by Commission Regulation (EU) 2021/468. However, the matter remains controversial following the judgments of the General Court of 13 November 2024, which annulled significant parts of the 2021 Regulation.
The General Court questioned, among other matters, the use of the broad concept of “preparations” and the imposition of a prohibition irrespective of the amount of hydroxyanthracene derivatives present. The Commission appealed against those judgments, and the proceedings before the Court of Justice are still pending. Meanwhile, the new draft again refers to “preparations” containing hydroxyanthracene derivatives and does not establish a maximum concentration for those substances.
The draft considered on 1 July 2026 is not yet an applicable Regulation. The document made available still has draft status and does not contain a date of formal adoption or a Regulation number. The prohibition will apply only after the Regulation has been formally adopted, published in the Official Journal of the European Union and entered into force.
The report of the Standing Committee meeting shows that the draft also raised concerns among Member States. Three Member States considered that the Commission should wait for the outcome of the appeals pending before the Court of Justice before adopting the Regulation. The Commission explained, however, that Article 8(5) of Regulation (EC) No 1925/2006 requires it to take a decision following the expiry of the period of Union scrutiny. It also confirmed that it had appealed all four judgments and that, according to the Commission’s position, Regulation (EU) 2021/468 remains in force pending the outcome of those appeals.
The Commission also clarified that the proposed one-year transitional period would not prevent the continued enforcement of the existing prohibitions. Where official controls demonstrate the presence of emodin or aloe-emodin prohibited under Regulation (EU) 2021/468, Member States will continue to be able to require the withdrawal of the products concerned from the market. The Commission further confirmed that the approach to the limits of quantification for hydroxyanthracene derivatives agreed in 2020 also applies to the botanical preparations covered by the draft. In practice, food business operators should therefore not regard the transitional period as an unconditional right to continue selling all existing stocks.
Manufacturers and distributors of food supplements should verify whether their products contain preparations from the bark of Rhamnus frangula L. or Rhamnus purshiana DC., from the leaf or fruit of Cassia senna L., or from the root or rhizome of Rheum palmatum L., Rheum officinale Baillon and their hybrids.
The proposed prohibition concerns preparations containing hydroxyanthracene derivatives. Raw-material specifications, the manufacturing processes used and analytical results confirming the composition of the preparations will therefore be particularly important.
Once the Regulation enters into force, it will no longer be permitted to add the preparations covered by the prohibition to foods or to use them in the manufacture of foods. Businesses should therefore assess sufficiently in advance whether product reformulation will be necessary, obtain the relevant documentation from their suppliers and determine which product batches have already been lawfully placed on the market and may benefit from the 12-month transitional period provided for in the draft.
Businesses should also monitor the formal adoption and publication of the Regulation, as well as the proceedings before the Court of Justice concerning Regulation (EU) 2021/468.
