Novel foods marketed in the EU are subject to safety evaluation by the European Food Safety Authority (EFSA). Regulation (EU) No 2015/2283 constitutes the legal basis for authorising and using a novel food in the EU.
A “Novel food” is any food that was not used for human consumption to a significant degree within the EU before 15 May 1997 and which falls into one of the categories specified in the EFSA Guidance on novel foods.
EFSA requires the provision of a novel food’s toxicological information to conduct a safety evaluation, including assessing its genotoxicity and systemic toxicity. EFSA Guidance prescribes the process for designing, testing, and documenting the safety of a novel food.
SAXOCON provides you with everything you need to plan, test, and document compliance with regulatory requirements, including:
- A plan to describe and justify your test strategy
- Selecting appropriate laboratories, reviewing protocols, and monitoring tests according to the requirements in the OECD Test Guidelines
- A toxicological risk assessment of results
Why choose us?
SAXOCON services for novel food applicants give you access to:
- Extensive expertise with EFSA requirements
- A multidisciplinary team of highly skilled toxicologists
- High-level experience with state-of-the-art toxicological evaluations according to international standards
SAXOCON compiles all necessary toxicological documentation for the approval of your product.