{"id":8190,"date":"2022-02-14T21:05:53","date_gmt":"2022-02-14T20:05:53","guid":{"rendered":"https:\/\/science-nutrition.com\/?p=8190"},"modified":"2022-02-17T10:01:08","modified_gmt":"2022-02-17T09:01:08","slug":"safety-of-oil-from-schizochytrium-sp-atcc-strain-20889-as-a-novel-food-nf","status":"publish","type":"post","link":"https:\/\/science-nutrition.com\/en\/2022\/02\/14\/safety-of-oil-from-schizochytrium-sp-atcc-strain-20889-as-a-novel-food-nf\/","title":{"rendered":"Safety of oil from Schizochytrium sp.  (ATCC strain 20889) as a Novel Food (NF)"},"content":{"rendered":"<div class=\"l-subsection\"><div class=\"l-subsection-h\"><div class=\"l-subsection-hh g-html i-cf\">\n<div class=\"field__item\">\n<div class=\"col col--xs-4 col--md-6\">\n<p class=\"blog-article-content__content text text--article\" style=\"text-align: center;\"><em>Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an <a href=\"https:\/\/efsa.onlinelibrary.wiley.com\/doi\/10.2903\/j.efsa.2022.7083\" target=\"_blank\" rel=\"noopener noreferrer\">opinion<\/a> on the safety of Schizochytrium sp. oil as a Novel Food (NF) pursuant to Regulation (EU) 2015\/2283.<\/em><\/p>\n<div class=\"blog-article-content__content text text--article\">\n<p>The NF which is the subject of the application is an oil rich in docosahexaenoic acid (DHA) that is produced by the microalgae Schizochytrium sp. (strain ATCC\u201020889). The applicant proposed to add the NF in infant formulae (IF) and follow\u2010on formulae (FOF) at use levels in accordance with Regulation (EU) No 609\/2013. The evidence provided by the applicant does not demonstrate to which species the strain Schizochytrium sp. ATCC 20889 belongs. As the source organism of the NF is not characterised at species level, no assessment for inclusion in the Qualified Presumption of Safety (QPS) list can be performed by EFSA. Marine biotoxins (including cyanotoxins) in the NF were below their limits of quantification. However, since it is unknown to which species the strain Schizochytrium sp. ATCC\u200920889 belongs, the concern that this strain has the potential to produce other toxins remains. No toxicological studies with the NF were provided by the applicant. Toxicological studies are available with DHA\u2010rich algal oils produced from other strains of Schizochytrium sp. However, the Panel considers that those toxicological studies cannot be used to establish the safety of the oil produced by the strain which is under assessment in this application (Schizochytrium sp. ATCC\u200920889). Therefore, based on the information provided by the applicant, <strong>the Panel concludes that the safety of the NF has not been established.<\/strong><\/p>\n<p><span class=\"VIiyi\" lang=\"en\"><span class=\"JLqJ4b\" data-language-for-alternatives=\"en\" data-language-to-translate-into=\"fr\" data-phrase-index=\"0\" data-number-of-phrases=\"1\">Let us remind you a brief history of the latest EFSA assessments on <em>Schizochytrium<\/em> (NF) oil:<\/span><\/span><\/p>\n<\/div>\n<ul>\n<li class=\"blog-article-content__content text text--article\"><span class=\"VIiyi\" lang=\"en\"><span class=\"JLqJ4b\" data-language-for-alternatives=\"en\" data-language-to-translate-into=\"fr\" data-phrase-index=\"0\" data-number-of-phrases=\"1\">On Jan 18, 2021, in its <a href=\"https:\/\/efsa.onlinelibrary.wiley.com\/doi\/10.2903\/j.efsa.2020.6242\" target=\"_blank\" rel=\"noopener noreferrer\">opinion<\/a> on the &#8220;<em>Safety of Schizochytrium limacinum oil (strain WZU477) for use in infant formula and follow-on formula as a novel food in accordance with Regulation (EU) 2015\/2283<\/em>\u201d, EFSA concluded that \u201c<strong>NF is safe under the proposed conditions of use<\/strong>\u201d.<\/span><\/span><\/li>\n<li><span class=\"VIiyi\" lang=\"en\"><span class=\"JLqJ4b\" data-language-for-alternatives=\"en\" data-language-to-translate-into=\"fr\" data-phrase-index=\"0\" data-number-of-phrases=\"1\">On Nov 24, 2020 , in its <a href=\"https:\/\/efsa.onlinelibrary.wiley.com\/doi\/10.2903\/j.efsa.2021.6345\" target=\"_blank\" rel=\"noopener noreferrer\">opinion<\/a> on the &#8220;<em>Safety of oil of Schizochytrium limacinum (strain FCC-3204) for use in food supplements as a novel food in accordance with Regulation (EU) 2015\/2283<\/em>&#8220;, EFSA concluded that the &#8220;<strong>NF is safe under the proposed conditions of use<\/strong>&#8220;. <\/span><\/span><\/li>\n<\/ul>\n<p><strong><em>Orchidali can help you assess whether or not your new ingredient meets the conditions for a NF.<\/em><\/strong><\/p>\n<\/div>\n<\/div>\n\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>Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the safety of Schizochytrium sp. oil as a Novel Food (NF) pursuant to Regulation (EU) 2015\/2283.<!-- 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":2805,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[53,297],"tags":[32,54,1359,1355],"class_list":["post-8190","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-novel-food","category-reglementation-2","tag-efsa","tag-novel-food-2","tag-oil-from-schizochytrium","tag-schizochytrium"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Safety of oil from Schizochytrium sp. 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