GRAS review services
To discuss your needs
The U.S. Food and Drug Administration (FDA), under direction from HHS, has proposed eliminating the “self-affirmed GRAS” (Generally Recognised as Safe) pathway. Under the current system, manufacturers can independently determine the GRAS status of an ingredient without notifying the FDA. The anticipated policy would mean that companies may no longer be allowed to introduce ingredients into the food supply without notifying the FDA. Instead, they would likely be required to submit a GRAS notification to the FDA, before the ingredient can be used in food.
What is the Challenge?
- Product development: Ingredients previously used under self-determination may become non-compliant
- Reformulation efforts: Companies may need to identify and substitute ingredients not yet reviewed by FDA
- Regulatory implications: If the pathway is removed, continued use of “self-GRAS” substances could result in enforcement actions
A targeted service that reviews your product portfolio to:
- Verify the regulatory status of all ingredients/additives (including flavours, colour additives, GRAS substances)
- Provide a scoring matrix outlining:
- Ingredient category (e.g. additive, colour additive, GRAS)
- Current regulatory basis (e.g. GRAS notification, GRAS self-determination, food additive approval)
- Score (low, medium, high) based on regulatory implications
- Recommended actions (e.g. replace, notify, reformulate, monitor)
We can also provide ongoing monitoring of regulatory developments, and deliver horizon scanning updates, presented in a simple format for decision-makers.
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Food labelling compliance
We answer ad hoc questions, we also offer a service to evaluate your food labels compliance.
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Where we refer to UKAS Accreditation
The Campden BRI group companies listed below are accredited in accordance with the recognised International Standard ISO17025:2017 by the United Kingdom Accreditation Service (UKAS). The accreditation demonstrates technical competence for a defined scope of methods, specific to each site, as detailed in the schedules of accreditation bearing the testing laboratory number. The schedules may be revised from time to time and reissued by UKAS. The most recent issue of the schedules are available from the UKAS website www.ukas.com. Campden BRI (Chipping Campden) Limited is a UKAS accredited testing laboratory No. 1079