Foodlaw-Reading
Dr David Jukes, The University of Reading, UK
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Commission consultation, 20 May 2021
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Commission consultation: Restrictions on the use of monacolins from red yeast rice in foods A copy of the draft regulation is available on this site (click on image), For the consultation page, see: Commission consultation - red yeast rice. The consultation closes 17 June 2021 |
Summary
Consumers use food supplements containing red yeast rice to control and maintain normal blood cholesterol levels.
The European Food Safety Authority has adopted a scientific opinion on the safety of monacolins in red yeast rice following reports of adverse effects linked to the use of products containing such rice.
Based on this scientific opinion, the EU proposes to restrict the use of monacolins from red yeast rice to ensure this substance is used safely in foods and food supplements.
The following are the first few recitals to the draft regulation
(1) Pursuant to Article 8(2) of Regulation (EC) No 1925/2006, on its own initiative or on the basis of information provided by Member States, the Commission may initiate a procedure to include a substance or an ingredient containing a substance other than a vitamin or a mineral in Annex III to that Regulation listing the substances whose use in foods is prohibited, restricted or under Union scrutiny, if that substance is associated with a potential risk to consumers as provided for in Article 8(1) of Regulation (EC) No 1925/2006.
(2) In 2010, the European Food Safety Authority (‘the Authority`) was asked to provide an opinion on scientific substantiation of a health claim related to monacolin K submitted pursuant to Article 13 of Regulation (EC) No 1924/2006 [see note 1 below]. On 30 June 2011 [see Note 2 below], the Authority issued a scientific opinion on the substantiation of a health claim related to monacolin K from red yeast rice and maintenance of normal blood LDLcholesterol concentrations. The Authority concluded that a cause and effect relationship has been established between the consumption of monacolin K from red yeast rice and maintenance of normal blood LDL- cholesterol concentrations at the level of 10 mg daily dose.
(3) In 2012, the Authority was asked to provide an opinion on the scientific substantiation of a health claim submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 related to the combination of ingredients, among which monacolin K in red yeast rice. On 12 July 2013 [see note 3 below] , the Authority issued a scientific opinion establishing a cause and effect relationship between the consumption of a product containing 2mg of monacolin K from red yeast rice in combination with other ingredients, and the reduction of blood LDL-cholesterol concentrations.
(4) In the above-mentioned scientific opinions, in relation to restrictions of use, the pAuthority referred to the Summary of Product Characteristics (SmPC) for lovastatin containing medicinal products available on the Union market, as the Authority considered that monacolin K in lactone form is identical to lovastatin. The SmPCprovides information to healthcare professionals on the safe and effective use of these medicinal products. The SmPC for lovastatin-containing medicinal products describesthe properties and officially approved conditions for their use and includes special warnings and precautions for use that refer to the risk of myopathy/rhabdomyolysis, which is increased by concomitant use of lovastatin with certain other medicinal products, and discourages use of lovastatin by pregnant and lactating women.
(5) During discussions of the working group on nutrition and health claims on the abovementioned scientific opinions, the Member States raised potential safety concerns associated with the consumption of foods containing monacolins from red yeast rice.
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