From Innovative Concept to EU Market Approval

All new food enzymes marketed in the EU are subject to rigorous safety evaluations by the European Food Safety Authority (EFSA). Under Regulation (EC) No 1332/2008, manufacturers must provide exhaustive toxicological evidence—specifically regarding genotoxicity and systemic toxicity—to secure a place on the Union list of approved enzymes.

SAXOCON transforms the complexity of enzyme regulations into a clear commercial advantage. We provide the strategic oversight and technical expertise required to secure market access, delivering results through:

• Targeted Test Strategies:
  Developing scientific justifications and test plans that satisfy EFSA requirements while optimizing budgets and avoiding redundant studies.
• Study Monitoring:
  Identifying appropriate laboratories and providing active monitoring of protocols to ensure data quality and compliance with OECD Test Guidelines.
• Toxicological Risk Assessment:
  Expert evaluation of analytical results to build a definitive safety narrative that addresses EFSA’s scrutiny head-on.
• Regulatory Risk Analysis:
  Comprehensive gap analysis of existing data against the latest EFSA Guidance on food enzymes.

Why Choose SAXOCON?

Our approach ensures your innovative ingredients meet the highest standards of safety and transparency, with:

• Proven EFSA Expertise:
  A track record of navigating the evolving regulatory expectations and complex technical requirements of the Authority.
• Multidisciplinary Excellence:
  A specialized team of toxicologists and regulatory experts who understand the biochemical complexities of enzyme safety.
• State-of-the-Art Assessments:
  High-level experience in safety evaluations that align with the latest international standards and regional guidelines.
• Commercial Efficiency:
  Smart, defensible test strategies designed to eliminate regulatory roadblocks and accelerate your time-to-market.

Delivery

SAXOCON compiles all necessary toxicological documentation into a robust, submission-ready dossier. Our deliverables are specifically tailored to fulfill the requirements of Regulation (EC) No 1332/2008, ensuring your files are technically sound, professionally structured, and audit-ready.