Guidance on the scientific requirements for an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283.

The European Commission requested EFSA to update the scientific guidance for the preparation of applications for authorisation of novel foods, previously developed following the adoption of Regulation (EU) 2015/2283 on novel foods. This guidance document provides advice on the scientific information needed to be submitted by the applicant towards demonstrating the safety of the novel food. Requirements pertain to the description of the novel food, production process, compositional data, specifications, proposed uses and use levels and anticipated intake of the novel food.

Guidance on the scientific requirements for a notification and application for authorisation of traditional foods from third countries in the context of Regulation (EU) 2015/2283.

The European Commission requested EFSA to update the scientific guidance for the preparation of notifications for authorisation of traditional foods, previously developed following the adoption of Regulation (EU) 2015/2283 on novel foods. This guidance document provides advice on the scientific information needed to be submitted by applicants when submitting traditional food notifications pursuant to Article 14 and traditional food applications pursuant to Article 16 of Regulation (EU) 2015/2283. The safety of a traditional food should be substantiated by data on its composition, its experience of continued use and its proposed conditions of use.

Guidance on scientific principles and data requirements for the safety and relative bioavailability assessment of new micronutrient sources.

Following the adoption of Regulation (EU) No 1169/2011 on food information to consumers, the European Commission requested EFSA to update its 'Guidance on safety evaluation of sources of nutrients and bioavailability of the nutrient from the sources' regarding the scientific principles and data requirements for the scientific assessment of all new forms of micronutrients and to derive a conversion factor for new micronutrient sources or forms of micronutrients to be authorised for addition to foods, including food supplements. This guidance outlines the scientific principles that the NDA Panel will consider for the assessment of the safety and the quantification of the relative bioavailability of new sources of micronutrients, which applicants are requested to consider when preparing their applications. It also outlines the data requirements for dossiers.

Safety of glucosyl hesperidin as a Novel food pursuant to Regulation (EU) 2015/2283.

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 glucosyl hesperidin (GH) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF, which is produced from hesperidin and dextrin by enzymatic reactions, is a powder consisting mainly of monoglucosyl hesperidin (MGH) and unreacted hesperidin (flavonoid), which account in total for up to 92.8% (on dry basis) of the product.