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Monacolins from Fermented Red Rice in Food Products, Updates

Last 5th of October 2021, the European Commission gathered in order to discuss the draft Regulation on the use of monacolins from fermented red rice in food products.

Many objections raised by most Member States. A revision of the text by the Commission is therefore necessary. The adoption of the Regulation is not expected before February 2022.

Let’s briefly review the events that led to the safety of monacolin K from fermented red rice being questioned.

In 2013 the European Food Safety Authority (EFSA), when assessing the authorisation of a health claim linking the consumption of products containing monacolin K in combination with other ingredients and the reduction of LDL-Cholesterol in the blood, concluded that monacolin K from fermented red rice in the form of lactone is identical to lovostatin, an active substance found in medicines that can produce the adverse reactions typical of statins. During the working group’s discussion it was concluded that there is a potential safety risk associated with the consumption of foods containing monacolins.

On the 25th of June 2018, under the explicit request of the Commission, EFSA issued a scientific opinion highlighting significant safety concerns for human health with the intake of 10 mg/day of monacolin K. In addition, it also emphasized adverse effects reported at doses of 3 mg/day. It concludes that, based on the available information, it is not possible to identify an intake of monacolins from red rice in foods that would not be of concern for human health.

The long regulatory path of monacolin K seems to have almost come to an end. That was to say that the draft Regulation, in consultation until last 17th of June, was examined on the 5th of October 2021 during the SCOPASS (Standing Committee on Plants, Animals, Food and Feed Section General Food) meeting.

The draft Regulation includes monacolins from fermented red rice in Part B (restricted substances) and Part C (substances under Community surveillance) of Annex III to Regulation (EC) 1925/2006. The Regulation would impose various composition and labelling requirements, one of which is a reduction in the maximum allowed daily intake to less than 3 mg of fermented red rice monacolins.

Within 4 years from the date of inclusion of the substance in Annex III list, section C, the competent Authority may confirm the inclusion of “monacolins from fermented red rice” in section B or express a negative opinion and therefore include the substance in Annex III, section A (prohibited substances).

During this time, food business operators, or any  other stakeholder, may submit documentation supporting the safety of the ingredient which will be examined by the Commission and the Member States and may change the future of monacolins in food supplements.

At national level, monacolin K, is currently included in the list “Other nutrients or substances with a nutritional and physiological effect permitted in food supplements” with the following provisions: maximum daily intake of 10 mg and a warning advising you to consult your doctor before using the product and prohibiting its use during pregnancy, breastfeeding and therapy with hypolipidemic drugs.

Restrictions imposed by the Regulation would inevitably also affect the requirements behind the authorisation of the health claim on monacolin K “monacolin K from red rice contributes to the maintenance of normal blood cholesterol levels”, as it is supported by a 10mg daily dose of monacolin K. Not allowing the claim to be used on the label could lead to consumer confusion as they will no longer see the beneficial effect associated with the ingredient. Furthermore, this event highlighted that an efficacy assessment alone during EFSA’s claims evaluation does not protect the consumer from possible safety issues.

Titanium Dioxide: The Draft Regulation Wants to Exclude it from Authorised Food Additives

The European Commission presented the draft Regulation aimed at excluding titanium dioxide (E171) from authorised EU food additives.

Last year, on the 5th of May EFSA had issued a negative opinion on the additive, classifying it as unsafe for food consumption. This was due to the potential genotoxic risk associated with ingesting titanium dioxide nanoparticles.

At present, it would seem that a transitional period of 6 months following the entry into force of the Regulation is expected, during which time food business operators can adapt to the new requirements by continuing to market products containing the additive, up to their minimum durability date.

The proposed regulation was already discussed during the SCOPAFF meeting on the 28th of September.  The provision will now go to the EU Parliament.

The Proposal for a Regulation on EGCG Titrated Green Tea Extracts is Out for Consultation

In 2018 the European Food Safety Authority (EFSA) issued a scientific opinion stating that catechins in green tea extracts taken as a food supplement could lead to hepatotoxicity.

The draft Regulation restricting the use of green tea extracts titrated at epigallocatechin-3-gallate (EGCG) and including them in Part B (Restricted substances) of Annex III of Regulation (EC) No 1925/2006 is currently under consultation. The conditions of use require that the daily limit does not equal or exceed the threshold of 800 mg of (-)-epigallocatechin-3-gallate. Additional labelling requirements are added, including a warning against use in vulnerable groups. Regulation (CE) n. 1925/2006. Use instructions expect that the maximum daily  are excluded from this Regulation.

Traditionally prepared green tea infusions and reconstituted drinks with a composition equivalent to such infusions are excluded from this Regulation.

The draft Regulation also provides for the inclusion of green tea extracts titrated at EGCG in Part C (substances under Community scrutiny) of Annex III so that more information on the safety of this ingredient can be collected and evaluated.

The consultation period for the draft Regulation will end on 3 November 2021.

Written by: Martina Durighello

Foto di Pexels da Pixabay