EFSA updates the Food Additives Guidance: what it means for Companies
The European regulatory landscape for food additives has taken an important step forward. On 20 January 2026, EFSA (European Food Safety Authority) officially published the updated “Guidance on the scientific data requirements for an application for authorisation of a food additive submitted under Regulation (EC) No 1331/2008”.
This guidance eliminates interpretative uncertainties by clearly specifying the type and quality of data required from applicants for authorization requests.
Context: Food Additives, EU Regulation and re‑evaluation
Under Regulation (EC) No 1333/2008, food additives are substances intentionally added to food to perform specific technological functions, such as preservation, stabilization, or enhancing appearance. Subject to pre-market authorization, they may only be placed on the EU market following a favorable scientific evaluation by EFSA and subsequent regulatory approval.
The revision of the Guidance does not overhaul the system but provides an essential methodological update. It fits into a framework of systematic re-evaluation of additives already authorized, which represents one of the pillars of EFSA’s scientific activity in the food additives sector. In recent years, this process has already led to a revision of the Acceptable Daily Intakes (ADI) for numerous substances, the introduction of new restrictions, and, in some cases, the withdrawal of authorizations.
Complete, robust, and coherent scientific dossiers are indispensable to meet EFSA’s rigorous standards.
The Guidance outlines requirements for accurate, transparent evaluations, applicable from 20 July 2026 (6 months post-publication).
Scope of application
The guidance applies to:
- Requests for authorization of new food additives.
- Requests for new uses or modifications to conditions of use for already authorized additives.
- Re-evaluation and review dossiers, in part or as needed for specific investigations.
The three pillars of the scientific assessment
For a favorable opinion, the dossier must rest on three key informational pillars:
- Characterization and Specifications (Section 3)
This section represents the foundation of the dossier, providing an exhaustive description of the additive, including:
- Chemical identity: name, molecular structure, molecular weight, chemical formula, and any isomers.
- Manufacturing process: synthesis/extraction phases, raw materials, contaminant controls.
- Impurities characterization: purity levels, impurity profiles, contaminants like heavy metals and residual solvents.
- Stability and behavior in food: chemical transformations and interactions with the food matrix, with particular emphasis on consistency between technical specifications and the commercialized product.
- Proposed uses and exposure assessment (Section 4)
Detailed information on food categories, use levels, and technological justification. Based on this, a dietary exposure assessment is conducted using updated models (FAIM and DietEx), with a mandatory focus on vulnerable groups (infants and children) and realistic consumption scenarios. - Toxicological Data (Section 5)
This is the scientific heart of the dossier, analyzing metabolic fate (ADME) and the safety profile through the updated Tiered Approach. The framework requires a mandatory Tier 1 (core genotoxicity and toxicity data) to identify scientific “triggers” that dictate progression to higher tiers. The approach prioritizes New Approach Methodologies (NAMs) and the principles of the 3Rs (Replacement, Reduction, Refinement), shifting from “checklist” to data-driven safety demonstration.
Key methodological updates
The revision clarifies fast-evolving areas:
- Focus on nanoparticles (Section 5.2.2): specific requirements for nanoscale fractions.
- Vulnerable populations (Section 1.3 & 4.2.2): specific assessments for infants (under 16 weeks) and children, addressing physiological specificities.
- Environmental safety (Section 6): for the first time, ecosystem protection is formally integrated into the assessment. For xenobiotic substances (chemical compounds foreign to biological systems and not naturally occurring), applicants must document their environmental fate, essentially demonstrating what happens to the substance after it is excreted and enters the ecosystem.
What applicants need
The complexity of the new EFSA 2026 guidance demands a tight synergy between analytical rigor and regulatory vision. In this increasingly complex landscape, specialized technical‑scientific consultancy, integrated with advanced testing services, is essential to align dossiers with EFSA’s expectations and guide applicants through all submission phases.
>>> We provide step-by-step support through Strategic Regulatory Consultancy and Laboratory Testing Services in full compliance with the guidance.
