Compliance Support for Fermentation-derived Ingredients

Intertek’s scientific and regulatory consulting services support compliance with fermentation-derived food ingredients in major jurisdictions across the globe.

Precision fermentation technology is driving unprecedented innovation in the food and supplement industries. The regulatory status of fermentation-derived food ingredients varies depending on jurisdiction and specific ingredient properties. In many cases, even if a final ingredient has a history of use, the manufacturing process may qualify it as “novel.” Distinguishing whether an ingredient produced by fermentation is novel is just one way that Intertek can assist companies seeking to gain market entry.

With varying requirements for novel foods in different countries and an ever-evolving regulatory landscape, successful compliance requires careful planning and a solid strategy.

Intertek has the advanced scientific expertise to navigate biotechnology-based applications like fermentation, and the extensive practical experience to guide companies through a challenging regulatory landscape.

We tailor our solutions to each company’s circumstances and business objectives. Some of the services we offer include:

Regulatory assessments, novelty determinations, and due diligence
Feasibility assessments for market entry and identifying gaps in existing data
Preparation of scientific publications and safety assessments to support regulatory applications
Regulatory agency representation and stewardship
Pre-market dossier preparation including, but not limited to, Generally Recognized as Safe (GRAS) filings, food additive petitions, and novel food applications
Global regulatory strategy support (U.S., Canada, the EU/UK, China, Japan, Australia/New Zealand, and many others)
Bioinformatic assessments
Pre-clinical and clinical study planning and management
Claims review and substantiation

Intertek Supports The Following Jurisdictions: