Novel Food is officially defined as food that was not significantly consumed in European Union prior to 15 May 1997 (when its first regulation came into force).
What is a Novel Food Ingredient in Europe?
DEFINITION & REGULATIONS
Products are considered as Novel Food when it is extracted from a new source, or when its production process is new/innovative for example.
So, a substance consisting or produced by a microorganism can be considered as a Novel Food. The last scientific requirements expand the context of microorganisms us in Novel Food processes.
Not only the Novel Food can be produced by or consists (as active agent) of non-GM (Genetically Modified) microorganisms, but it now can also be produced by GM microorganisms.
To produce and sell Novel Food, it necessary goes through the compiling of a dossier substantiating the safety of thesaid Novel Food and its validation after evaluation by the European Food Safety Authority (EFSA).
Challenges of EFSA Safety Evaluation
The EFSA safety evaluation process is notably challenging, characterized by its complexity and extensive requirements, which often introduce uncertainty. Applicants must diligently gather and present detailed data on the safety of the microorganisms involved, meeting stringent analytical and regulatory demands.
This involves providing comprehensive scientific evidence, conducting thorough risk assessments, and ensuring compliance with strict regulatory standards. The process requires extensive documentation and undergoes rigorous scrutiny, which can be overwhelming and necessitates significant time, expertise, and resources. Effectively navigating these challenges is essential to obtaining market approval and ensuring the safety and qualitye of Novel Food products.
Advantages of our Offer
Rigorous Standards
Commitment to upholding the highest quality and regulatory standards, ensuring that all analyses and documentation align with EFSA guidelines.
Accurate and Reliable Results
Dedication to providing precise and trustworthy data, essential for the evaluation of safety and efficacy.
Proven Track Record
A demonstrated history of assisting clients in securing regulatory approvals, showcasing GenoScreen’s expertise in navigating the intricate EFSA evaluation process.
Comprehensive Dossier Preparation
Specialized in preparing detailed, EFSA-compliant dossiers that streamline the approval process.
Complete Solutions
Providing a full range of services, from genomic characterization to dossier preparation, ensuring a smooth and integrated process for meeting EFSA requirements.
Tailored Support
Personalized services designed to address the unique needs of each client, whether for GMM strains, QPS strains, or standard production strains.
… can also require genetical analyses, for example when it comes to insects for human consumption. The genetical analyses needed are also provided to you by GenoScreen.
top-tier genomic expertise
dedicated team
advanced technologies