Insight by Sofia Morais, Regulatory Affairs Director at Puratos Group & Chair of Fedima Board.
In today’s complex policy environment, manufacturers and suppliers of bakery ingredients operate in a world where change is the only constant. From food safety to labelling and contaminants, compliance has become both a strategic imperative and a continuous journey. Yet, while EU policymakers often speak of simplification and competitiveness, new legislation continues to multiply, adding complexity rather than reducing it. Legislation tends to evolve retroactively - addressing gaps after issues arise - when simplicity and practicality should be built in from the start. The result is a dense regulatory web that demands agility, technical expertise, and constant adaptation.
The European regulatory framework is shifting, with updates to additive authorisations, contaminant limits, enzymes and allergen labelling. Compliance relies on validated analytical methods, harmonised documentation, and traceable data. Ensuring consumers' safety is key, but the tools to monitor and implement some legislations are not always fully in place. This is the case for example for Mineral Oil Hydrocarbons (MOH), for which reliable analytical methods to measure their levels in complex food matrices are currently still under development. Other examples such as 3MCPD and glycidyl esters (GE), and enzymes labelling illustrate future challenges: rules should be drafted with a scientific basis but also with proportion and feasibility in mind. Simultaneously, the lack of harmonised approaches on important topics as Precautionary Allergen Labelling (PAL), and on the regulatory status of certain functional ingredients creates uncertainty posing a significant challenge for the industry to operate efficiently within the internal market.
Our industry supports transparency and consumer safety, but the pace and complexity of reforms are not always matched by realistic implementation pathways and timelines. A proportional and evidence-based approach remains essential to avoid stifling innovation.
As regulatory requirements expand, so too does the need to safeguard intellectual property (IP) - particularly for proprietary formulations and processing technologies. Balancing transparency with IP protection is becoming a growing technical and strategic issue for ingredient manufacturers.
Compliance is no longer static - it is in motion. Our industry fully supports the ultimate goal of protecting consumers, but the way it is pursued must make sense in practice. True simplification requires starting from clarity, proportionality, and feasibility - not adding layers to existing rules. By combining scientific rigour, open dialogue, and coordinated advocacy, our sector will continue to uphold safety and quality while urging policymakers to make smarter, simpler regulation a shared priority.
