Annual Report of 2025 EU Novel Food Additives

Based on publicly available information from the Open EFSA and regulations issued by the European Commission, CIRS conducted a statistical analysis of the 2025 EU food additive submissions for corporate reference.

As of December 31, 2025, the approval status of EU food additives is shown in Figure 1.

Figure 1. Approval status of EU food additives in 2025

EU Approved Food Additives

In 2025, the European Commission approved a total of 18 food additives, all of which were modification applications (see Table 1). According to EC No. 1331/2008 3(1), the food additives list may be updated either proactively by the EC or in response to applications from companies or Member States. Therefore, the application types include new food additives submissions, modification applications for already approved food additives, and re-evaluations of approved food additives.

In 2025, food additive approvals were dominated by modification applications. Compared with new additive approvals, the process for revising usage conditions or quality specifications of existing food additives may be more efficient. Regardless of the application type, careful review of the EU guidance when preparing dossier submissions is essential to ensure compliance and accelerate the approval process.

Table 1. List of food additives approved by the EC in 2025

Food Additives Received and Validated by the EU

In 2025, the EFSA received and validated dossiers for two food additives each. Due to overlapping receipt and acceptance dates for monk fruit extract, a total of three food additives were involved (see Table 2).

Table 2. Food additives submitted and validated by EFSA in 2025

Food Additives Received Scientific Opinions

Among the 14 food additives for which EFSA issued scientific opinions in 2025, 3 new food additives applications, 2 modification applications, and 9 re-evaluations.

Table 3. List of food additives for which EFSA issued scientific opinions in 2025

Submissions from Chinese Companies

In 2025, the following Chinese companies submitted food additive dossiers to the EU, either accepted or having received scientific opinions.

Table 4. Chinese companies submitting food additives to the EU in 2025

CIRS Summary

Among the 2025 food additives submissions, apart from chemical substances, a significant proportion of submissions were plant-derived products, such as tamarind seed polysaccharide, monk fruit extract, pea fibre concentrate, and rebaudioside M from stevia leaves. Among these, sweetener submissions were prominent, reflecting the global sugar reduction trend, which has driven an increase in alternative sweetener applications to enrich consumer options.

Microbially-produced food additives represent a direction for modification applications, including steviol glycosides produced via Saccharomyces cerevisiae fermentation and rebaudioside M from stevia leaves (produced using genetically modified Pichia pastoris CGMCC 7539) for which scientific opinions were issued.

To meet the growing need for microbial strain safety assessment in synthetic biology, EFSA has published a new guidance on the safety assessment of microbial strains intended for the food chain, which provides more detailed scientific guidance, offering clear and efficient technical support for companies preparing food additives submissions.

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