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--- algae:food:novel_food [2026-09-06 11:07] – [The Novel Food Catalogue] robert
+++ algae:food:novel_food [2026-09-13 17:30] (current) – Mostly rename EURlex robert
@@ Line 7: / Line 7: @@
 ==== The Novel Food Concept ====
-Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001, OJ L 327, 11.12.2015, p. 1. [[https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02015R2283-20210327|EUR-Lex]]
+Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001, OJ L 327, 11.12.2015, p. 1. [[https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02015R2283-20210327|EURlex]]
 Under Article 3(2)(a), __"novel food"__ means any food that was not used for human consumption to a significant degree within the EU before __15 May 1997__, irrespective of the date of accession of individual member states, and that falls under at least one of several categories. Of these, the category with by far the greatest relevance to algae is:
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 We have to distinguish between the __Novel Food Catalogue__ and __Union List of Novel Food__, described in the Authorisation Pathway section. The first is an informative, searchable resource, while the second one is a formal regulation.
-The __not novel__ categorization (with the caveat that it is informative) means that the species is just food, no other novel food restrictions apply. We can treat it in the usual way, the same as with any other food, the food business operators is responsible for safety of food. A very common question arises if derived products from non-novel food are food and there is no other answer here as for derived products from any other food (e.g. you can produce PAH containing food from potato and you can di as well from spirulina - food safety is your responsibility).
+The __not novel__ categorization (with the caveat that it is informative) means that the species is just food, no other novel food restrictions apply. We can treat it in the usual way, the same as with any other food, the food business operators is responsible for safety of food. A very common question arises if derived products from non-novel food are food and there is no other answer here as for derived products from any other food (e.g. you can produce PAH containing food from potato and you can do this as well from spirulina - food safety is your responsibility). Novel food is different; the safety approval has been granted for a specific process, specific extract for specific use and specific safe dosage. It does not transfer automatically to an extract or any other treatment or different usage model.
 __Important limitations of the catalogue:__
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   * __EFSA risk assessment__: the Commission requests EFSA to carry out a safety assessment. EFSA's NDA Panel (Nutrition, Novel Foods and Food Allergens) is responsible for this evaluation. EFSA publishes administrative and scientific guidance for applicants, including a Scientific Guidance on the preparation of novel food applications and specific guidance addressing the data requirements for foods consisting of, isolated from or produced from micro-organisms, fungi or algae.
   * __Authorisation__: if EFSA's opinion is favourable, the Commission adopts an Implementing Regulation authorising the novel food and adding it to the __Union list of novel foods__, specifying conditions of use, labelling requirements and, where relevant, post-market monitoring requirements.
-  * __Union list__: maintained via Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283, OJ L 351, 30.12.2017, p. 72. [[https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R2470-20260316|EUR-Lex]] This list is amended frequently to add newly authorised novel foods, including several algae-derived ingredients (for example, oil rich in DHA and EPA from //Schizochytrium// sp., which has been the subject of several amending Implementing Regulations updating permitted conditions of use).
+  * __Union list__: maintained via Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283, OJ L 351, 30.12.2017, p. 72. [[https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R2470-20260316|EURlex]] This list is amended frequently to add newly authorised novel foods, including several algae-derived ingredients (for example, oil rich in DHA and EPA from //Schizochytrium// sp., which has been the subject of several amending Implementing Regulations updating permitted conditions of use).
 === Authorisation versus notification: two distinct routes ===