Supporting Regulatory Approval of Alternative Protein Food Ingredients

Intertek’s scientific and regulatory consulting services provide full multi-jurisdictional support for regulatory approval of alternative protein ingredients.

The need for a sustainable, nutritious food supply has driven significant innovation in the food industry. Some major newly developed alternative proteins include plant-derived protein, mycoprotein, protein biomass derived from fungal or bacterial sources, and protein-based sweeteners. These ingredients can be introduced to the food supply through the food additive, Generally Recognized as Safe (GRAS), or novel food routes that pertain to various regulatory jurisdictions. In any case, the technical and safety data requirements for regulatory approval vary depending on the market of interest. Navigating these regulatory nuances requires a firm understanding of the specific data requirements, and strategic planning based on a company’s commercial objectives.

Intertek has the advanced scientific expertise and practical experience needed to navigate regulatory nuances and access multi-jurisdiction markets.

Diets are changing around the world! The use of protein-rich ingredients sourced from plants, insects, and fungi, and/or developed through tissue cultures is rapidly growing. Due to the innovative and novel nature of many of the ingredients and processes, this industry faces many unique regulatory challenges (i.e., the use of novel processing aids and ingredients, product identification and labelling).

Intertek Assuris understands the unique challenges faced by the alternative protein industry and provides custom regulatory and scientific solutions to help bring products to the global marketplace.

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Our solutions are custom-tailored to a company’s specific circumstances and business objectives. Some of the services we offer include:

Conducting regulatory assessments, novelty determinations, and due diligence
Assessing the feasibility of market entry and identifying gaps in existing data
Preparing scientific publications and safety assessments to support regulatory applications
Providing regulatory agency representation and stewardship
Preparing pre-market dossiers including, but not limited to, GRAS dossiers, food additive petitions, and novel food applications
Providing global regulatory strategy support (the United States, Canada, the European Union and the United Kingdom, China, Japan, Australia and New Zealand, and many others)
Conducting bioinformatic assessments
Planning and managing pre-clinical and clinical studies
Reviewing and substantiating claims

Intertek Supports The Following Jurisdictions: