Are you ready for the upcoming requirements for submission and approval of your food enzymes?
In March 2020, EFSA announced changes in how food enzymes compiled in joint dossiers will be evaluated. The deadline for meeting the new requirements is 21 April 2022. If you currently have included your food enzymes in a joint dossier, you will need to conduct an updated toxicological study to ensure compliance. SAXOCON’s highly skilled toxicologists can help you plan for the upcoming deadline and test and document the safety of your food enzymes.
Joint dossiers create several challenges and data gaps in currently submitted documentation, which is why EFSA is now requiring that enzyme applicants send a company-specific comprehensive data package. The updated requirements require conducting a toxicological assessment in accordance with regulatory guidelines.
Until now, it has been possible for the producers of food enzymes to group individual food enzymes under one umbrella application, provided the enzymes had the same catalytic activities, were manufactured using a similar process, and originated from the same organism. However, due to confidentiality issues, the current procedure has led to a lack of specific information regarding aspects like the production strain or the chemical composition of each food enzyme.
EFSA provides detailed information about these changes in this article.
SAXOCON can help you prepare for these regulatory changes.