EFSA has responded to pressure from the European Commission by updating not only the scientific guidelines for submitting applications for novel food authorisation to the EU, but also the administrative guidelines.
These two updates, which are based on stakeholder feedback, provide a better understanding of the complex processes that food and beverage manufacturers must follow to obtain approval for novel foods.
Ermolaos Ververis, Chief Scientist in EFSA’s Nutrition and Food Innovation Unit: “First of all, the scientific guidelines describe the scientific information that applicants must provide.” The administrative guidelines clarify the application procedure and are managed by the Intake Support Team.
Only businesses, such as producers of foods derived from cell cultures, can request the updated guidelines.
The updates have been made to reflect both the EU legal framework on novel foods and recent advances in food research.
Safety assessment of novel foods
Ververis continues: “The novel food industry is evolving rapidly and our safety assessment process must keep pace.”
The update has been updated to reflect the increasing number of new applications for novel food authorization.
Since the first implementation of the Novel Food Regulation in 2018, significant data have been collected. EFSA has gained further knowledge and experience through the implementation of the Novel Food Regulation in 2018.
UK FSA pushes for faster novel food approval process
The updated scientific guidance describes how to describe and identify novel foods, as well as processing, composition and specifications, and details of proposed uses.
Should be included the anticipated consumption of the product by consumers, any past use and safety information, including nutritional, toxicological and allergy data.
Ververis continues: “The administrative guidelines complement this by outlining the practical steps for preparing and submitting an application.”
EU animal testing for novel foods
EFSA must complete its risk assessment on novel food applications within nine months. EFSA could streamline the application process by providing more information to applicants at an early stage. This would reduce the number of consultations between EFSA, the applicant and EFSA for clarification or additional information.
Ververis says that “thoroughness is always first.” Consumer safety is the top priority. The time required for the evaluation depends on the complexity and quality of the information submitted.
Following EFSA approval, companies must seek advice from the EC, national and local authorities on labelling and marketing requirements.
The new guidelines will not eliminate the need for animal testing, but they could reduce it in some applications for novel food authorisation.
Ververis continues: “Our aim is to minimise animal testing as part of the European strategy to phase it out.”
We recommend that applicants always use validated alternative methods. Animal studies must meet EU standards. Before proceeding with in vivo tests, applicants should perform a literature review.
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