Ban on monacolins derived from red yeast rice

The Commission has proposed moving monacolins from red yeast rice in Annex III to Regulation (EC) No 1925/2006 from Part B to Part A. In Part B, they are permitted in foodstuffs subject to a limit of less than 3 mg per day. Part A contains substances that are completely prohibited in food, including food supplements. The Commission bases its proposal on the opinion of the European Food Safety Authority (EFSA) dated 29 January 2025. In that opinion, the EFSA was unable to establish a safe daily intake and confirmed concerns regarding serious adverse effects even at doses of around 3 mg per day.

The measure is being adopted under the regulatory procedure with scrutiny. Under this procedure, Parliament may block it by raising an objection under Rule 115 of the Rules of Procedure. However, such an objection requires an absolute majority of all Members, i.e. 361 votes out of 720, not merely a majority of votes in favour over those against. 291 MEPs voted in favour of the objection, 276 against and 13 abstained; 580 votes were cast. The European Parliament therefore records the result as a rejection: no valid objection was raised and the Commission may adopt the ban.

The objection was tabled by 45 MEPs, 29 from the EPP and 16 from the ECR. Among the EPP signatories, Spanish MEPs predominate, whilst all ECR signatories are from the Italian party Fratelli d’Italia. No MEPs from the S&D, Renew or Greens/EFA groups signed the objection. In the resolution, the proposers called on the Commission to withdraw the proposal.

The vote split the pro-European majority. The EPP voted in favour of the objection (121 in favour, 19 against, 7 abstentions), alongside all three far-right groups: the ECR (69 in favour, 2 against), PfE (63 in favour, 3 against) and ESN (24 in favour, none against). The S&D (98 against, none in favour, 1 abstention), Renew (65 against, 1 in favour, 3 abstentions) and Greens/EFA (44 against, 2 in favour) voted against. The far-left group The Left also voted against (36 against, 1 abstention). None of the four groups comprising the pro-European majority commented on the vote separately; we therefore describe their position based on how they voted.

The EPP, alongside the far right, was therefore on the side of the objection and had more votes. However, 361 votes were required to block the measure, and so the position of the S&D, Renew and Greens/EFA effectively prevailed: the Commission’s proposal remained on the table.

The second objection on the same day met with the same outcome. It was directed against the Commission’s proposal to transfer preparations derived from the plants Rheum, Cassia senna and Rhamnus containing hydroxyanthracene derivatives from Part C to Part A of the same annex, i.e. amongst substances that are completely prohibited. This objection was tabled by Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI), with Pascal Arimont (EPP) as the rapporteur. The committee called for a postponement pending the Court of Justice’s ruling and for a comprehensive, up-to-date scientific assessment. In its judgements of 13 November 2024, the Court of Justice annulled the earlier Regulation (EU) 2021/468 concerning these substances, and, according to the text of the resolution, no decision has yet been taken on the Commission’s appeal. 282 MEPs voted in favour, 259 against and 23 abstained, once again falling short of the 361-vote threshold. The breakdown was as follows: the EPP in favour (111 in favour, 24 against, 7 abstentions) together with the ECR, PfE and ESN; the S&D against (87 against, 7 in favour); Renew (57 against, 1 in favour) and the Greens/EFA (45 against).