EFSA’s New Guidance on Food Additives: What You Need to Know

In the European Union, food additives can be used in food and beverages only if they have been carefully assessed and deemed safe by the European Food Safety Authority (EFSA)
This update, the first in over a decade, brings greater clarity to the regulatory framework.

What is this new EFSA guidance about?

In 2026, EFSA published the updated guidance defining the scientific data required to obtain authorization for food additives under Regulation (EC) No 1331/2008.
Replacing the 2012 version, it reflects major advances in toxicology, exposure assessment, and regulatory science.

Why was an update necessary?

Risk assessment science has undergone significant evolution over the last decade. New testing methods, digital exposure tools, and environmental concerns required a modern framework to ensure that additives on the EU market are assessed using state-of-the-art methodologies.

What data must be provide now?

Applicants must submit detailed information on the additive’s identity, manufacturing process, and specifications, along with analytical data from multiple production batches. They must also provide proposed uses and calculate dietary exposure using EFSA’s FAIM and DietEx tools. Toxicological data are required, following a tiered testing strategy that starts with non-animal methods whenever possible.

What are the main scientific innovations in the guidance?

Key novelties include the integration of New Approach Methodologies (in vitro and in silico tools), specific requirements for nanomaterials and small particles, and the Extended OECD TG 422 study, which combines repeated-dose and reproductive screening endpoints. For the first time, environmental risk assessment is also explicitly required.

What role do New Approach Methodologies (NAMs) play?

A key innovation of the guidance is the formal integration of New Approach Methodologies, including in vitro, in silico, and in chemico methods. These tools provide mechanistic insight into potential hazards and support the replacement, reduction, and refinement (3Rs) of animal testing. When combined with the tiered testing strategy, NAMs can help demonstrate safety at early stages and reduce the need for extensive in vivo studies.

What practical impact will this have on applications?

Dossiers will become more complex and data-rich, but also more transparent and scientifically robust. The guidance aims to improve the predictability of EFSA evaluations, increase confidence in safety decisions, and reduce unnecessary animal testing..

Understanding the new EFSA guidance can feel overwhelming, especially when companies must inegrate NAMs, toxicological stratefies and exposure assessments into a single, coherent dossier. We support companies throughout the entire regulatory process and provide dietary exposure assessments using also (but not only) EFSA’s FAIM and DietEx tools, ensuring compliant, robust, and transparent intake calculations.

With Chemsafe as your regulatory food consultant, you can confidently navigate the new EFSA requirements. Contact us today to ensure your dossier meets the latest standards for compliance and success.