Exporting Food Additives to the EU in 2026: Detailed Interpretation of the Updated EFSA Administrative and Scientific Guidance

In January 2026, the European Food Safety Authority published updated scientific guidance and administrative guidance for food additive authorisation applications. These updates reflect recent technological advancements in food additives. Compared with previous versions, the new guidance improves both comprehensiveness and clarity, offering more specific and actionable instructions. Below is a summary of the key updates for industry reference.

• Scientific guidance: Data requirements for dossiers, updated on January 20, 2026; effective from July 20, 2026

Guidance on the scientific data requirements for an application for authorisation of a food additive submitted under Regulation (EC) No 1331/2008 – Link

• Administrative guidance: Administrative (procedural) guidance for applications, updated on January 27, 2026, effective immediately.

Administrative guidance for the preparation of applications on food improvement agents (food enzymes, food additives and food flavourings) – Link

The new scientific guidance will take effect on July 20, 2026. At present, EFSA encourages applicants to prepare dossiers according to the new guidance. However, dossiers submitted before the implementation date can still follow the previous version if preparation is already at an advanced stage.

Key Updates in Scientific Guidance

1. Manufacturing Process

• Explicit requirement to describe control and quality assurance measures for food additive production. Production must comply with Regulation (EC) No 852/200419 on food hygiene, and be based on HACCP principles, as well as current GMP.
• More detailed safety data requirements depending on production method (chemical synthesis, fermentation, enzymatic synthesis) and source (plants, fungi, algae, animals).

2. Specifications

Standardised format for presenting specifications, aligned with EU requirements.

3. Physicochemical Properties

For powder products, increased emphasis on assessing risks from small particles (including nanoparticles), in line with the latest guidance on nanomaterials.

4. Dietary Exposure Assessment

• Mandatory use of updated tools: FAIM (Food Additive Intake Model) and DietEx.
• Additional guidance for assessing exposure in infants below 16 weeks and in consumer-only scenarios (specific population groups).

5. Toxicological Data

• Integration of cross-cutting guidance documents on genotoxicity and toxicology published since 2012.
• All toxicokinetic and toxicity studies must comply with Good Laboratory Practice and follow Organisation for Economic Co-operation and Development Test Guidelines.

Key Updates in Administrative Guidance

Before this update, the European Food Safety Authority had already carried out a consolidated revision of the administrative guidance for food additives together with those for novel foods and feed additives on November 27, 2025. Key changes from that revision were summarized in this article. To align with the newly updated scientific guidance for food additives and the revised guidance on microbial characterization and risk assessment, EFSA has responded rapidly with further updates in a short period of time. Companies are therefore advised to closely monitor developments in EU guidance, stay informed of key changes, and ensure the compliance and validity of their application dossiers.

The updated administrative guidance outlines the main revisions, replacing references to previous guidance documents and introducing three new appendices. These updates can be summarized as follows:

1. Standardized data templates for proposed use levels

Appendix D (see below) provides the template for submitting proposed use levels of food additives, while Appendix E offers instructions for completing Appendix D. These appendices support applicants in preparing and submitting data for both new food additive applications and modifications to the use levels of already authorized additives.

2 Transitional requirements for dossier documentation

In alignment with the new scientific guidance, applicants submitting food additive dossiers before July 20, 2026, are required to complete Appendix F as a checklist for the applicability and completeness of the technical dossier.

Summary

Following the refinement of key guidance for novel food applications (see this insight article), the guidance framework for food additives has also undergone systematic updates. Building on its extensive evaluation experience, the EFSA has further strengthened the requirements for the standardization and completeness of scientific data in application dossiers, while enhancing the rigor, transparency, and efficiency of the approval process. The updated guidance sets out clearer requirements and stricter details. Companies need to thoroughly understand the underlying scientific principles and procedural requirements, and carefully implement the dossier preparation step by step to secure market access in the EU.

About CIRS Group

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Leveraging strong technical expertise, diverse resources, and a global network, CIRS provides comprehensive services including: applications for China's “Three New Foods” (new food ingredients, new food additive varieties, and new food-related product varieties, including synthetic biology products), U.S. GRAS notice, EU Novel Food applications, health food registration and filing, registration of foods for special medical purposes, infant formula registration, general food compliance, laboratory services, regulatory intelligence tracking, and training. These services help clients achieve compliance, accelerate market access, and enhance competitiveness.

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