Understanding the current landscape and how to balance between innovation and regulation.
The debate surrounding the regulatory status of functional ingredients has become increasingly relevant for the entire food sector in the last few years. The lack of regulatory clarity surrounding their classification and distinction with the food additives category remains a significant challenge for businesses across the EU, including the European bakery industry.
The criteria for classifying and distinguishing these ingredients are primarily based on the definition of food additive as set out in the 2008 EU Food Additives Regulation. That said, differing national interpretations of the criteria set in the Regulation have created obstacles to a harmonized approach across Europe.
Ingredients regulatory status is generally assessed on a case-by-case basis and national authorities do not always follow the same approach. For example, while some authorities adopt a rather simplistic approach and classify ingredients based solely on their technological function, others rely on a more comprehensive multi-criteria analysis which considers the different elements that compose the three cumulative criteria for an ingredient to be considered a food additive, in line with the spirit and definition of the Regulation.
This inconsistency creates hurdles for the food sector and therefore for bakery ingredient suppliers operating across borders, as the same ingredient may be classified differently depending on its use or jurisdiction. To tackle this, Fedima has been addressing the topic as part of its 2025 Work Program, collaborating with key industry stakeholders and food industry partners in view of promoting consistent and harmonized approaches that support business certainty and innovation.
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Fedima’s vision for clear classification
Fedima advocates for a clear and harmonized approach to distinguishing functional ingredients and food additives. A harmonized approach should adhere to the cumulative criteria set by the Food Additives Regulation ensuring, for instance, that functional ingredients are assessed holistically rather than relying solely on their technological effects.
Ingredients like acerola, valued for its natural preservative qualities, or coloring foods derived from natural sources like dried vegetables, should not automatically fall within the additive framework if that can be considered, and are commonly recognized, as food on their own or ‘food per se’. A clear and harmonized interpretation of the Regulation’s definition, based on the existing cumulative criteria, will prevent misclassification, ensuring compliance while fostering innovation.
At the same time, food safety remains at the heart of any regulatory discussion on functional ingredients and additives. Ensuring consumer health while balancing innovation requires coherent, science-based approaches to classification, labeling and use. Fedima stresses that regulations must account for the safety profile and intended use of ingredients to ensure consistent product quality without compromising food safety standards.
Navigating challenges and opportunities
As the bakery industry strives to meet evolving consumer preferences and regulatory demands, formulations are adapting to balance tradition, innovation and compliance. In today’s European bakery landscape, ‘must-have’ formulations focus on meeting safety, quality, and regulatory requirements. ‘Best-possible’ formulations go a step further. Driven by consumer demand, they incorporate functional ingredients to deliver clean labels, improved nutritional profiles, and enhanced sustainability, all while adhering to EU food safety standards. However, achieving these formulations requires regulatory clarity, innovation, and cross-sector collaboration to balance functionality, food safety, and consumer demands.
In this context, it is worth reminding that certain categories of ingredients, such as coloring foods derived from natural sources, benefitted from relatively clearer guidelines in recent years, thanks to the publication of specific interpretative guidance from the European Commission, which was however later removed from its website. Establishing similar guidance at the EU level for functional and multifunctional ingredients would allow for further clarity for manufacturers within the bakery and the broader food sector, driving innovation and sustainability.
Current efforts and next steps
To support its members, Fedima has been working at multiple levels. Firstly, Fedima’s Technical Committee and Ingredients Expert Group have played an active role in addressing these regulatory challenges, liaising with key partners and institutions.
Secondly, the Association provides regular updates and resources to its members, helping them navigate complex regulatory environments and address compliance challenges effectively.
Looking ahead, Fedima anticipates and calls for further discussions and additional harmonized interpretative guidance at the EU level regarding functional ingredients and additives, for instance through initiatives like the one on the European Commission’s website. Efforts to harmonize classification and ensure alignment with existing EU food safety regulations remain top priorities.
To achieve this, Fedima will continue to support its members by focusing on:
+ Regulatory harmonization: Actively promoting consistent interpretations across Member States of the classification between additive and functional ingredients to reduce legal uncertainty.
+ Data collection and collaboration: Supporting EFSA and European Commission’s initiatives and data collections while working alongside key food industry partners to align advocacy efforts, share best practices, and ensure additives and multifunctional ingredients remain available for bakery production.
+ Innovation and education: Encouraging research and development of functional ingredients that meet clean label demands while maintaining safety and quality standards.
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Conclusion: shaping the future of the bakery sector
As the bakery industry and the regulatory landscape evolve, achieving clarity in the classification of ingredients is essential for fostering innovation while maintaining the highest standards of safety and quality. Businesses in the food industry are trying to strike a balance between key regulatory requirements and developments on one side, and consumer demands and market trends on the other. By advocating for harmonized and balanced regulation and interpretation, and fostering collaboration, Fedima is committed to supporting a resilient and innovative bakery sector that meets both consumer and regulatory expectations.
