Novel Food Notifications & Food Additive Submissions

Navigate Canadian, U.S., and EU regulatory pathways with confidence. dicentra’s experts streamline approvals for novel foods, additives, and innovative ingredients to help you reach global markets faster.

Comply with Canada’s Pre-Market Authorization Requirements

Health Canada requires Novel Food Notifications or Food Additive Submissions before your product can be sold in Canada. We handle strategy, dossier preparation, and government communications to help you secure approval quickly.

Key Services:

Assess eligibility to confirm whether your product is novel or can be classified as non-novel
Coordinate pre-submission meetings with Health Canada’s Food Directorate
Compile comprehensive safety data packages: history of use, dietary exposure, production process, source organism, toxicology, allergenicity, and more
Prepare Food Additive Submissions, including chemical identity, intended use, efficacy, residue data, analytical methods, safety data, and labeling
Provide supporting evidence such as consumer benefits, food quality impacts, and international evaluations
Manage all communications with the Food Directorate and respond to clarification requests (CRs and IRNs)

Secure U.S. Market Entry with the Right Regulatory Pathway

Whether your ingredient qualifies as GRAS, a New Dietary Ingredient (NDI), or requires a Food Additive Petition, dicentra’s experts will guide you to the most efficient route to compliance.

GRAS (Generally Recognized as Safe): FDA GRAS Notifications or Self-Affirmed GRAS with expert panel review
NDI Notifications: Required for dietary ingredients new to the U.S. after October 15, 1994
Food Additive Petitions: For ingredients or uses that cannot be classified under GRAS or NDI
Ingredient classification and feasibility reviews to select the correct pathway
Literature searches, data gap analyses, and coordination of required toxicology studies
Dossier preparation and FDA liaison to manage submissions and address clarification requests

Access the EU Market with Confidence

Foods and ingredients not consumed to a significant degree in the EU before May 15, 1997, require Novel Food Authorization by the European Commission. We provide the strategy, data, and EFSA-compliant dossiers you need to gain approval.

Determine Novel Food status and eligibility for traditional food routes
Conduct feasibility assessments and identify data gaps
Prepare EFSA-compliant dossiers covering product identity, production, ADME, toxicity, and allergenicity
Aggregate scientific literature and historical use data to substantiate safety
Oversee required toxicology, stability, or clinical studies
Liaise with EFSA and the European Commission during the full review process
Provide post-authorization compliance guidance for labeling, claims, and surveillance

Why Choose dicentra?

23+ years of cross-border regulatory expertise
23,000+ projects completed for clients worldwide
Multi-disciplinary team of toxicologists, scientists, and compliance experts
Strategic guidance to reduce risk and shorten approval timelines
End-to-end support from feasibility to post-market compliance

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