In September and October 2024, the European Food Safety Authority (EFSA) revised its guidance concerning the scientific and administrative requirements for novel food applications[1],[2]. This update is particularly important as it will apply to all novel food applications submitted starting in February 2025.
New requirements have been established, along with further clarifications on the existing ones. So, what has changed? Let’s see the key updates for each section of the technical dossier
SECTION 1: Identity of Novel Foods
Starting with Section 1, which focuses on the Identity of Novel Foods, new requirements have been established for the novel food categories: “Food consisting of, isolated from, or produced from animals or their parts”, “chemical substances, products of mineral origin and polymers and “Foods consisting of, isolated from, or produced from cell culture or tissue culture derived from animals.” In the context of the novel food category “Foods consisting of, isolated from, or produced with microorganisms”, microorganisms have been defined and divided by roles (active agents, biomasses, and production strains). Toxicological requirements have been adjusted accordingly.
SECTION 2: Production process
Section 2 addresses the production process for novel food. The new guidance mandates that materials in contact with food comply with Regulation (EC) No 1935/2004 and other relevant EU regulations, along with a non-confidential summary of the production process. Thus, the manufacturers have to provide a formal statement on the compliance. Additionally, the role of enzymes used as processing aids has been clarified along with some recommendation on the adherence to Directive 2009/32/EC regarding extraction solvents utilized in food production.
SECTION 3: Compositional Data
The new guidance introduces several changes related to analytical issues. It requires that the compositional variability of batches is adequately addressed by evaluating independent batches of raw materials or/and specific group of batches. An accreditation matrix for laboratories is now mandatory, and the sampling plan used for the batch analysis must be clearly explained. Additionally, the protein content of novel foods should be quantified using a nitrogen-to-protein conversion factor of 6.25 or, if the protein content is significant, by summing the anhydrous amino acids. A thorough characterization of the protein and peptide profile is also required for novel foods that are high in protein.
SECTION 6: Estimated Intake
In the context of the section dedicated to the proposed uses and the human intake estimation of the novel food, the EFSA suggests applicants dealing with novel foods intended as new sources of micronutrients and those meant to be consumed as food supplements to refer to their new released Guidance on scientific principles and data requirements for the safety and relative bioavailability assessment of new micronutrient sources[3].
SECTION 7: ADME profile
Section 7 of the guidance indicates how to derive Absorption-Distribution-Metabolism-Excretion (ADME) data for novel foods. It specifies that ADME data may not be necessary if the novel food contains substances commonly found in the body or diet, or if it consists of polymers larger than 1000 Da. Additionally, if the novel food is smaller than 1000 Da and evidence indicates it does not undergo gastrointestinal degradation, ADME data are also not required.
SECTION 8: Toxicological Data
Supporting the safety of the novel food is paramount for the application process, which relies on a deep investigation on the potential toxicity of the novel food. The EFSA suggests applications dealing with mixture novel food to refer to the EFSA statement on Genotoxicity assessment of chemical mixtures. Instead, applications involving nanomaterials or proteins/peptides are advised to test the genotoxicity potential by conducting a Mammalian gene mutation assay (OECD 476) and/or a bacterial reverse mutation test “treat and plate” methodology (OECD 471). In case positive results form in vitro micronucleus test, further testing through kinetochore staining or fluorescence in situ hybridization is required.
SECTION 10: Allergenicity Data
Section 10 is one of the last sections of the technical dossier and collects data related to the allergenicity potential of the novel food. Foods are now divided into 4 types (novel food with no protein derived from the production process, novel food derived from allergenic foods subject to mandatory labelling, novel food derived from allergenic foods not subject to mandatory labelling, and novel food for which the allergenic potential is unknown). Testing requirements differ based on these categories, ensuring appropriate assessments are conducted for each type.
For additional information, ask Chemsafe!
[1] https://www.efsa.europa.eu/en/efsajournal/pub/8961
