Safety studies for use in applications
As a unique part of an application for a relevant Authority in food or feed, it is crucial to have the appropriate documentation at hand, especially regarding safety and toxicology.
A novel food or substantial equivalence application requires safety documentation, primarily based on a full set of toxicological studies made explicitly on your ingredient according to WHO guidelines (ICH-Q7)
A safety assessment of a herbal ingredient requires more or less the same documentation but generic data are accepted.
We have major experience with designing a new study on ingredient(s)/products or by using internationally recognized studies as a basis for the report.
Typically the safety study comes to mind in two situations:
- A known ingredient but used in higher dose (National legislation often requires safety documentation, manufacturer is responsible)
- An unknown ingredient (for novel food application)
It is important to remember that it is the responsibility of the company bringing the product to market which bears the responsibility of ensuring the safety of an ingredient or a product in the dosage chosen.
Safety assessment reports
Our safety assessment reports are in English making it easy to use it in all EU countries.
We are very experienced making safety assessment reports. The challenge is to gather all information and documentation necessary and compile the data in a structured way and derive an acceptable conclusion.