{"id":8447,"date":"2022-06-20T16:45:22","date_gmt":"2022-06-20T15:45:22","guid":{"rendered":"https:\/\/science-nutrition.com\/?p=8447"},"modified":"2022-06-24T07:42:41","modified_gmt":"2022-06-24T06:42:41","slug":"monacolins-from-red-yeast-rice-new-restrictions","status":"publish","type":"post","link":"https:\/\/science-nutrition.com\/en\/2022\/06\/20\/monacolins-from-red-yeast-rice-new-restrictions\/","title":{"rendered":"Monacolins from red yeast rice: new restrictions"},"content":{"rendered":"<div class=\"l-subsection\"><div class=\"l-subsection-h\"><div class=\"l-subsection-hh g-html i-cf\">\n<p style=\"text-align: center;\"><em>The conditions of use of the ingredient are now set by Regulation (EU) 2022\/860.<\/em><\/p>\n<p>In recent years, there has been much discussion about the safety of monacolins from red yeast rice. Red yeast rice is considered a novel food, with the exception of its use in food supplements. The ingredient contains, as a result of fermentation by the yeast <em>Monascus purpureus<\/em>, several compounds including the family of monacolins, represented by monacolin K. A health claim is associated with the latter: &#8220;contributes to the maintenance of normal blood cholesterol levels&#8221;, at daily intakes of 10 mg.<\/p>\n<p><strong>The regulatory context of the ingredient is about to change<\/strong>, following the publication of <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32022R0860&amp;from=EN\" target=\"_blank\" rel=\"noopener noreferrer\">Regulation (EU) 2022\/860<\/a> on June 1st. The Regulation amends <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32006R1925&amp;from=FR\" target=\"_blank\" rel=\"noopener noreferrer\">Regulation (EU) 1925\/2006<\/a> on the addition of vitamins and minerals and of certain other substances to foods, by adding monacolins from red yeast rice to Part B (<em>restricted substances<\/em>) and Part C (<em>substances under Community scrutiny<\/em>) of Annex III (<em>substances whose use in foods is prohibited, restricted or under community scrutiny<\/em>). Restrictions of use introduced by the new Regulation include the establishment of a <strong>maximum daily portion<\/strong> (set at 3 mg, which precludes the possibility of using the health claim) <strong>and additional requirements<\/strong> on label warnings (mainly about the characteristics of the product and about the sub-populations for which the product is not recommended).<\/p>\n<ul>\n<li><em>Restrictions on the use of monacolins from red yeast rice:<\/em><\/li>\n<\/ul>\n<p>As for the addition of monacolins from red yeast rice to Part C of Annex III, this implies that within four years, new decisions regarding the ingredient could be made, possibly based on emerging evidence.<\/p>\n<p><strong>The Regulation will come into force on June 21st, without a transition period.<\/strong><\/p>\n<p>To provide context, it should be noted that Regulation (EU) 2022\/860 was developed taking into account the <a href=\"https:\/\/efsa.onlinelibrary.wiley.com\/doi\/epdf\/10.2903\/j.efsa.2018.5368\" target=\"_blank\" rel=\"noopener noreferrer\">EFSA Opinion of June 25th, 2018 on the safety of monacolins in red yeast rice<\/a>, which was published following the initiative of the European Commission to open the procedure under Article 8 (<em>substances subject to prohibitions, restrictions or under Community control<\/em>) of Regulation (EU) 1925\/2006, after the positions taken on the subject by national institutions, such as the <a href=\"https:\/\/www.anses.fr\/fr\/system\/files\/NUT2012sa0228.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">ANSES Opinion on the risks associated with the presence of &#8220;red yeast rice&#8221; in food supplements<\/a>* published in 2014. Last year, the application of the Article 8 procedure had led to restrictions on botanical species containing hydroxyanthracene derivatives through <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32021R0468&amp;from=EN\" target=\"_blank\" rel=\"noopener noreferrer\">Regulation (EU) 2021\/468<\/a> (<a href=\"https:\/\/science-nutrition.com\/en\/2021\/03\/26\/publication-du-reglement-n2021-468-sur-les-derives-hydroxyanthraceniques\/\">see our article on the matter<\/a>); the same course will most likely affect other ingredients in the future.<\/p>\n<p>&nbsp;<\/p>\n<p><em>* : link in French.<\/em>\n<\/div><\/div><\/div><!-- AddThis Advanced Settings generic via filter on the_content --><!-- AddThis Share Buttons generic via filter on the_content -->","protected":false},"excerpt":{"rendered":"<p>The conditions of use of the ingredient are now set by Regulation (EU) 2022\/860.<!-- AddThis Advanced Settings generic via filter on get_the_excerpt --><!-- AddThis Share Buttons generic via filter on get_the_excerpt --><\/p>\n","protected":false},"author":4,"featured_media":2808,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[736,53,297],"tags":[948,627,1412,853,1411,1413,1414,54,854,23,522],"class_list":["post-8447","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-complements-alimentaires","category-novel-food","category-reglementation-2","tag-complement-alimentaire","tag-food-supplement","tag-levures-de-riz-rouge","tag-monacolin-k","tag-monacoline-k","tag-monascus-purpureus","tag-nouvel-aliment","tag-novel-food-2","tag-red-yeast-rice","tag-reglementation","tag-regulation"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - 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