EFSA announced changes to the evaluation of food enzymes compiled in a joint dossier in March 2020. If you are part of a joint dossier on food enzymes you may need advice for your toxicological study strategy. SAXOCON’s highly skilled toxicologists can help you in planning, testing, and documenting the safety of your food enzymes.
Joint dossiers have led to several challenges and data gaps in submitted documentation, which is the background for EFSA requiring that enzyme applicants now send a company-specific full data package. Additionally, these requirements will also require a full toxicological package conducted in accordance with current regulatory guidelines.
For years it has been possible for food enzyme producers to group their individual food enzymes under one umbrella application, provided that these enzymes have the same catalytic activities, are manufactured substantially by the same process and originate from the same organism. However, due to confidentiality issues, this procedure has led to a lack of specific information on e.g. the production strain and the chemical composition of each food enzyme.
Check out EFSA’s presentation about these changes here. EFSA also has a presentation of their AMFEP meeting here.
SAXOCON can help you quickly prepare for these regulative changes.
Find out how we can help here.