Eu registration of Fumonisin Esterase

Achieving this standard in case of fumonisin esterase enzyme was a challenge that only one company besides us was able to complete, and thus there are no other products officially registered as enzymes on the world market of anti-mycotoxin preparations. The challenge is well reflected by the fact that in order to register a single enzyme, several efficacy, tolerance and toxicological experiments must be carried out for each animal species and age group, which required five years and nearly EUR 1.500.000 in investment, and thus comes close to the requirements of veterinary medicines.

We asked our researchers about this extraordinary journey. In the interview below, scientific director Dr. Sofia Bata and R&D director Dr. Viviana Molnar-Nagy talk about the biggest challenges.

Dr. Sofia Bata (Scientific Director)

Q1: Could you describe the key scientific challenges you faced during the development and registration of the fumonisin esterase enzyme?

Dr. Sofia Bata: The greatest challenge was optimizing the enzyme’s production and ensuring it met the stringent EU safety standards. Finding the right production strain for fermentation was critical. We needed strains that were not only effective in producing high-quality fumonisin esterase but were also safe for both the environment and users. In the European Union, regulations forbid the use of genetically modified microorganisms in feed additives, which added a layer of complexity. We had to ensure that the production strain was entirely separated from the final product—a process that required both precision and innovation in the lab, especially in terms of optimized analytical technologies in terms of the quality control process.

Q2: How did you manage the requirements for enzyme kinetics and fermentation?

Dr. Sofia Bata: The enzyme kinetics had to be meticulously analyzed to confirm that fumonisin esterase was not only efficient but also stable under varying conditions during feed production. As for fermentation, the strains we identified went through rigorous testing to ensure they could consistently produce the enzyme at a commercial scale. The biggest challenge was  balancing efficacy with regulatory compliance and product requirements, and this took a considerable amount of laboratory research and development.

Q3: Why is the EU registration considered a global benchmark in feed additives?

Dr. Sofia Bata: The EU has one of the most comprehensive regulatory frameworks in the world, particularly in the area of feed safety. Meeting these standards means the product is trusted in various global markets. The registration not only confirms the safety and efficacy of the enzyme but also ensures that the process by which it is produced is transparent and trustworthy.

Dr. Viviana Molnar-Nagy (R&D Director)

Q1: What were the major milestones in the in vivo trials you oversaw?

Dr. Viviana Molnar-Nagy: The in vivo trials were extensive and involved testing the enzyme in multiple trials at different locations, both with piglets and sows. We needed to demonstrate that the enzyme was effective across different farming standards, while also ensuring there were no adverse effects on the animals. The efficacy studies were followed by tolerance experiments, which are critical for ensuring safety. It took three years of carefully controlled studies to gather all the necessary data for submission.

Q2: How did you balance scientific research with compliance and documentation?

Dr. Viviana Molnar-Nagy: Preparing the documentation required for the EU submission was an enormous task. Every experiment, every result needed to be documented in a way that met regulatory standards. It required close collaboration between our analytical department, legal experts, and external consultants to ensure that every piece of data was not only scientifically valid but also compliant with EU guidelines. Acquiring the GLP status for the R&D laboratory also enormously supported our credibility in taking part of such registration procedures.

Q3: What was your most important takeaway from the registration process?

Dr. Viviana Molnar-Nagy: The most significant learning was how science and regulation must go hand in hand. Achieving this registration was more than just developing a unique, targeted mycotoxin  degrading  enzyme - it  was  about  navigating a it was about navigating a highly regulated environment to bring a safe and effective product to the market.