Intertek provides strategic advice and innovative solutions for the regulatory, scientific, and toxicological requirements to market flavouring ingredients in multiple regions, including the EU, the UK, the U.S., Canada, Japan, China, South Korea, Southeast Asia, and Australia and New Zealand.
Flavourings are key ingredients in today’s food markets increasingly dominated by alternative proteins, cultured ingredients, and low-calorie foods.
The regulatory status of flavourings differs across jurisdictions according to source materials, properties, and production processes, among other factors. Understanding the regulatory classification of flavourings – which impacts authorisation and labelling requirements – is critical to a successful global launch.
While flavourings are considered food additives in the U.S. and Japan, their classification in the EU depends on their properties. Specifically, in the EU, flavourings are substances that impart or modify the odour and/or taste of food and are distinct from food additives; however, substances that enhance the existing odour and/or taste of food are classified as flavour enhancers (food additives). As such, organoleptic studies are required to correctly classify the substances (flavouring or flavour enhancer) and determine their route-to-market and labelling requirements.
Authorisation
In recent years, scientific bodies like the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and the European Food Safety Authority (EFSA) have conducted safety evaluations of flavourings by grouping substances with related chemical structures into structural classes, and have integrated concepts like read-across and the Threshold of Toxicological Concern into their risk assessments.
In the U.S., flavouring substances are authorised via the Flavor and Extract Manufacturers Association’s (FEMA’s) Generally Recognized as Safe (GRAS) program (FEMA GRASTM) – whereby experts evaluate the ingredient as GRAS under the conditions of intended use – or via an application to the Food and Drug Administration (FDA) for food additive status.
In the EU, the 2022 EFSA Guidance on the risk assessment of flavourings updates the approach to demonstrating the safety of flavourings in the EU, highlighting the importance of toxicokinetic studies and experimental genotoxicity data to add rigor to the safety process. When additional toxicity data are needed, a tiered approach is followed – similar to that required for the risk assessment of food additives.
The UK currently follows the pre-2022 EU Guidance.
Having a clear understanding of such region-specific safety requirements is critical to developing an impactful global testing strategy plan.
The Intertek Advantage
Intertek’s Food Scientific and Regulatory Consulting service is backed by a network of regulatory, science, and toxicology experts with extensive experience in attaining successful authorisation of regulated food ingredients globally, including additives, novel foods, enzymes, and flavourings. We support companies with strategic advice from concept, to product development, to regulatory classification and substantiation, all the way to successful authorisation.
Intertek can help companies successfully bring their flavouring ingredients to the EU, UK, U.S., Canada, Japan, China, South Korea, Southeast Asia, and Australia and New Zealand. We help businesses:
- Understand the complex regulatory requirements across jurisdictions and develop the appropriate regulatory strategy to market;
- Design, conduct, and interpret the appropriate organoleptic studies to support the regulatory classification of flavourings;
- Ensure only necessary studies are conducted and in the most efficient way, with ongoing support through the entire product life-cycle as part of our toxicology study management service;
- Prepare the necessary regulatory body applications, FEMA GRAS applications, and supporting documentation and assist with electronic filling, where required; and
- Navigate the regulatory approval process to authorisation.
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