Helle K. Knutsen (Norway)
Norwegian Institute of Public Health
Food Safety
Helle Katrine Knutsen is Senior Scientist at the Norwegian Institute of Public Health, where she started in 1999. She is toxicologist with PhD from the University in Oslo (1995) in cell and molecular biology and has more than 20 years’ experience in risk assessment of contaminants in food. Dr Knutsen is member of the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) and is chair of the EFSA NDA WG on Novel Foods since 2018. She is former member of the EFSA Panel on Contaminants (CONTAM) (2009-2018) and was CONTAM Chair 2015-2018. Her current research engagement is related to biomonitoring of contaminants and effects of exposure to environmental contaminants on infant and child development, with particular interest in persistent organic pollutants and metals.

Presenter of 1 Presentation

 Conference Calendar

What are they and How to Assess their Safety?

Session Name
0310 - Plenary Session 05: Novel Foods (ID 4)
Session Type
Plenary Session
Date
04/01/2023
Session Time
08:30 AM - 10:00 AM
Room
Platinum Suite Room 1+2
Presenter
Lecture Time
08:30 AM - 08:55 AM

Abstract

Abstract Body

In the EU, Novel Foods are foods or ingredients that have not been used for human consumption to a significant degree in the EU before 15 May 1997 (Regulation 2015/2283). The safety evaluation of all Novel Foods in the EU is performed by the European Food Safety Authority (EFSA).

EFSA evaluates the safety of NF based on dossiers provided by the applicants and according to the “Guidance on the preparation and presentation of an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283” (EFSA Journal 2016;14(11):4594). According to the Regulation, Novel Foods should fall under at least one of the following categories: new production process; new or modified molecular structure; from micro-organisms, fungi algae; vitamins and minerals from new process/nanomaterials; of mineral origin; from animal and their parts; cell or tissue cultures derived from animals/plants/fungi/algae; engineered nanomaterials; exclusively in food supplements. The safety assessment is based on data provided by the applicants as well as additional data requested by EFSA during the assessment in cases of missing or incomplete information. The following topics are addressed: Identity of the novel food; Production process; Compositional data; Specifications; History of use of the novel food and of its source; Proposed uses and use levels and anticipated intake; Absorption, distribution, metabolism, and excretion (ADME); Nutritional information; Toxicological information; Allergenicity. Both the ADME and the toxicological assessments follow tiered approaches. EFSA’s novel food assessments address whether the novel food is safe under the proposed conditions of use and whether the normal consumption of the novel food would be nutritionally disadvantageous. Importantly, benefit(s) are not part of the assessment. All assessments of novel foods are published in the EFSA Journal after adoption. Authorisations of novel foods and placing them on the Union list are under the remit of the EU commission and the member states.

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