EFSA rewrites the playbook: what the 2026 Food Additive Guidance means for your authorisation strategy

On 20 January 2026, the European Food Safety Authority (EFSA) has published a new guidance establishing the scientific data requirements for applications concerning food additives[1] under Regulation (EC) No 1331/2008[2]. Adopted on 18 November 2025 and published on 20 January 2026, this updated framework represents an evolution in the regulatory approach to food additive safety assessment within the European Union. The original guidance was published in June 2012. Although a revision was implemented in March 2021 to align with new transparency provisions, the scientific content remained unchanged until now. The current revision therefore reflects more than a decade of practical experience, scientific advances, and methodological refinements that have emerged through EFSA’s work in evaluating food additives. Importantly, the 2026 guidance incorporates EFSA's latest horizontal guidances and aligns methodologically with the scientific guidance on flavourings (adopted November 2022), reflecting a harmonised approach across food improvement agents where scientifically appropriate.

Regulatory framework and purpose

Regulation (EC) No 1331/2008 establishes the authorisation procedure for food additives, enzymes and flavourings. Applications go to the Commission, which forwards them to EFSA for scientific assessment[3]. The applicant must demonstrate that the substance meets the conditions for safe use, and the Commission may request additional information where needed[4].

The guidance sets out what EFSA needs to assess whether a food additive is safe under the proposed conditions of use. It covers applications for new authorisations as well as modifications to existing ones, and addresses four main areas: characterisation (identity, manufacturing, specifications, stability, behaviour in food, analytical methods); proposed uses and exposure assessment; safety data (genotoxicity and toxicology, using a tiered approach); and environmental safety where relevant.

The guidance deals exclusively with scientific requirements. Procedural matters—submission formats, timelines, administrative compliance—are covered separately in EFSA’s administrative guidance[5].

Evolution and development of the guidance framework

The guidance was originally developed following the adoption of Regulation (EC) No 1331/2008, with first publication in June 2012. The current revision builds on experience accumulated through numerous assessments conducted over more than a decade and incorporates methodological developments in risk assessment that have emerged since 2012. Significantly, the 2026 update integrates multiple horizontal and cross-cutting EFSA guidances published post-2012, such as the guidance on mixtures, benchmark dose modelling, threshold of toxicological concern, allergenicity assessment, genotoxicity/aneugenicity evaluation, and engineered nanomaterials, as well as the latest flavourings guidance (November 2022). This integration reflects EFSA's commitment to a harmonised, evidence-based approach across food improvement agents and demonstrates the maturity and robustness of the assessment framework.

Practical changes and updates 

The new guidance on the scientific data requirements introduces several significant enhancements across multiple domains of the assessment process.

• Characterisation and specifications benefit from improvements in manufacturing techniques and analytical methods since 2012. The guidance now addresses small particles, including nanoparticles, explicitly. Where a particulate fraction is present, applicants must substantiate whether conventional assessment suffices or whether nano-specific requirements apply , using the "Particle-TR" decision process outlined in EFSA's nanomaterials guidance. Analytical methods must now demonstrate fitness-for-purpose for detecting and characterising small particles and nanoparticles where relevant, ensuring robust identification and quantification throughout the product lifecycle.
• For exposure assessment, FAIM (Food Additive Intake Model) is now the mandatory tool for the general population (infants ≥16 weeks through elderly). Applicants may supplement this with DietEx where more detailed analysis using FoodEx2 classification is needed; whilst not mandatory, EFSA encourages its use for enhanced precision.  The guidance pays particular attention to vulnerable populations, with specific provisions for infants below 16 weeks of age. For this age group, FAIM does not apply; instead, applicants must use alternative approaches per EFSA's 2017 guidance, applying conservative infant formula consumption data (200 and 260 ml/kg bw/day). Critically, the standard ADI concept does not apply to infants below 16 weeks. This is a fundamental regulatory distinction that applicants targeting this population must understand.
• On toxicology, the guidance integrates several cross-cutting EFSA documents published since 2012: guidance on mixtures, benchmark dose modelling, threshold of toxicological concern (TTC), allergenicity considerations and genotoxicity/aneugenicity assessment. OECD Test Guidelines referenced have also been updated to current versions. Importantly, the guidance establishes a clear "stop" rule: if a proposed food additive is concluded to be genotoxic in vivo via a relevant route of administration, safety cannot be established and applicants should not perform further toxicological testing. This represents a critical decision point in the assessment pathway.
• A new section addresses environmental protection where relevant under Regulation (EC) No 1333/2008[6]. Full environmental assessment is required on a case-by-case basis, triggered by specific factors: lack of extensive metabolism to innocuous products; persistence or non-degradation in sewage treatment plants (STPs); bioconcentration potential (e.g., log Kow ≥ 3); or literature indicating environmental concern. Environmental assessment is generally not anticipated for non-xenobiotic substances occurring naturally in foods, though literature searching is always expected. Applicants should assess these triggers early to determine whether ecotoxicological expertise will be required alongside traditional food safety specialists..

Practical implications for applicants

The new requirements take effect six months after publication in the EFSA Journal, giving applicants time to adjust their preparation processes.

Several areas warrant particular attention. Enhanced characterisation requirements, especially concerning particles and engineered nanomaterials, may require additional analytical work. The mandatory use of FAIM demands high-quality data on usage levels and consumption patterns across all age groups from 16 weeks onwards. Where products target infants or young children, FAIM does not apply and the standard ADI concept is not used; alternative exposure assessment approaches using conservative infant formula consumption data are required. Environmental assessment introduces a dimension that may require input from ecotoxicologists alongside traditional food safety expertise, particularly for xenobiotic additives with bioconcentration potential or persistence in sewage treatment plants.

The tiered approach to toxicological testing remains central to the framework, allowing efficient use of resources whilst ensuring thorough safety assessment. Applicants should consider carefully which tier suits their substance and intended use. Crucially, if genotoxicity in vivo via a relevant route is established, the assessment pathway stops : no further toxicological testing should be conducted, as safety cannot be demonstrated.

Strategic considerations

The updated guidance reflects EFSA’s commitment to maintaining a science-based, current approach to food additive safety assessment. The integration of multiple horizontal guidances harmonisation with the latest flavourings guidance (November 2022), and incorporation of advances in analytical methods demonstrates how the framework has matured into a robust, evidence-based system aligned across food improvement agents.

Certain developments merit strategic attention. The explicit focus on nanomaterials and small particles may necessitate additional characterisation for some additives, including demonstration that analytical methods are fit-for-purpose. The sophisticated exposure assessment tools require robust usage data. Provisions for very young infants may influence decisions about proposed uses and study design. Environmental considerations, whilst applied case-by-case based on specific triggers (metabolism, persistence, bioconcentration, literature concerns), introduce a dimension that aligns with broader sustainability trends and may call for multidisciplinary collaboration between food safety specialists and ecotoxicologists.

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Conclusion

The revised guidance represents a significant step forward in European food safety regulation. The framework now incorporates scientific advances, reflects practical experience from more than a decade of assessments, integrates horizontal and cross-cutting guidances into a harmonised approach aligned with the latest flavourings guidance, and addresses emerging issues such as nanomaterials and environmental impacts.

For those seeking authorisation of food additives, the guidance clarifies scientific expectations. Success will require technical expertise across multiple disciplines—toxicology, exposure assessment, analytical chemistry, and in some cases ecotoxicology—alongside strategic planning to meet the enhanced requirements efficiently.

The six-month transitional period offers a window for adaptation. Operators who invest time in understanding the new requirements, particularly around nanoparticles, fitness-for-purpose analytical methods, infant exposure and environmental assessment triggers, will be better positioned to navigate the updated regulatory landscape successfully.