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Food improvement agents applications: regulations and guidance

EU legislation and EFSA guidance documents detail how to compile dossiers for food improvement agents applications and what type of scientific data and other information must be included. EFSA regularly updates its guidance documents. Applicants are reminded to ensure they are using the latest version before applying.

Scientific guidance

Scientific guidance

Two scientific guidance documents are complementary to each other and, therefore shall be consulted in parallel for the submission of a dossier on food enzymes.

The updated Guidance for the submission of dossiers on food enzymes is applicable as of 21 April 2022, while the Guidance on food manufacturing processes and technical data used in the exposure assessment of food enzymes is applicable as of 25 January 2024.

The updated EFSA statement on the requirements for WGS analysis of microorganisms intentionally used in the food chain was published on 12 August 2024. This document was prepared by EFSA  to support applicants in the preparation and submission of the data based on WGS for the characterisation of microorganisms intentionally used in the food chain.

For applications submitted by 25 January 2024 the below versions of the EFSA guidance documents apply, depending on the submission date of the application.

Extraction solvents

Extraction solvent applications must be submitted to the European Commission. It is recommended that the applicants follow the requirements set in Regulation (EU) No 234/2011 and in the practical guidance for applicants (more details available at https://food.ec.europa.eu/safety/food-improvement-agents/extraction-solvents_en).

In case a risk assessment is needed, the European Commission will send a mandate to EFSA for evaluation. Then, EFSA will approach the applicants asking them to submit the application via the Portalino e-submission system (https://www.efsa.europa.eu/en/applications/toolkit#portalino).

Regulatory framework