GRAS, NDI, Novel Food, Food and New Ingredient Registration

   

The food business operator is legally responsible for determining if a food or food ingredient is classified as novel before marketing. To ensure the ingredient is approved and the product is not considered adulterated, it must be safe, not misleading, and not nutritionally disadvantageous.

In the United States, ingredient approval can be obtained through Generally Recognized as Safe (GRAS) or New Dietary Ingredient (NDI) pathways. The equivalent in the EU or UK is Novel Food, which has different regulatory requirements but similar scientific principles.

 

We provide new ingredient registration services, including GRAS, NDI, and Novel Food. Key considerations include:

ㆍ      Has your product or ingredient been consumed in the past?

ㆍ      Has it been consumed outside the target market?

ㆍ      Is the manufacturing process new or novel?

ㆍ      What is the composition of the final product?

Generally Recognized as Safe (GRAS) Notification by the U.S. FDA

Ingredients without a history of common consumption in the United States before 1958 may be subject to GRAS notification. Substances recognized as safe before 1958 can be classified as GRAS, while newer ingredients must undergo a safety evaluation through GRAS notification. Substances added to food generally need FDA pre-market approval unless they are recognized as GRAS by qualified experts. The FDA encourages submissions to its GRAS notification program following its oversight procedures.

Ingredients can be self-affirmed GRAS or FDA GRAS notification.

ㆍ      Self-Affirmed GRAS: The ingredient must be widely used in the food supply. GRAS assessments require publicly available substantiation upon approval, limiting discretion. Evidence of safe historical use or expert safety evaluations is required. These requirements are reviewed and evaluated by qualified experts.

ㆍ      FDA GRAS Notification: GRAS Notification involves submitting a safety assessment to the FDA, which issues a letter following its review. GRAS ingredients must demonstrate reasonable certainty of no harm under intended use and comply with the standards. Although the notification process can be lengthy, it permits broader use of the ingredient in food and dietary supplements. In summary, while it takes time, this process enables the ingredient’s safe application across these categories.

 

New Dietary Ingredient (NDI) Notification by the U.S. FDA

NDI notification must be submitted to the FDA for any dietary ingredient not marketed in the United States as a dietary supplement before October 15, 1994. Unless classified as an old dietary ingredient, It must be submitted and approved by the FDA and approved NDI are limited to use in dietary supplements.

The NDI notification process keeps submitted documentation mostly confidential between the company and the regulator, making it a good option for proprietary research. The FDA review period for an NDIN is 75 days, offering a relatively short timeline.

In summary, while the NDI process is faster, it limits the ingredient's use to dietary supplements only.

 

Novel Food Registration by the EFSA

Novel Food is defined as food that has not been significantly consumed by humans in the EU before May 15, 1997. This category includes newly developed foods, those produced using new technologies, and foods traditionally consumed outside the EU.

Under Regulation (EU) 2015/2283, Novel Foods require authorization before entering the EU market, which includes both an Application Procedure and a Notification Procedure for traditional foods from third countries. The European Food Safety Authority (EFSA) conducts a thorough evaluation of the novel food's safety and potential risks to human health before providing its scientific opinion.

Our Service for Food & Dietary Supplement (Health Functional Food) Product      

	GAP Analysis		Ingredients and Label		Registration
	U.S. Agent		Facility Inspection		Food Safety
	Batch Master File		GRAS, NDI and Novel Food		Food Contact Substance

K-GMP supports international clients in safeguarding the quality, safety, and performance of their supply chain, ensuring full regulatory compliance from raw materials and ingredients through to packaging and final products.

K-GMP network offers a comprehensive range of 1:1 customized consultancy support for all types of food products. We are committed to staying up-to-date with the regulatory environment, trends and industry requirements.

For detailed information about each of the services above, contact directly our expert.

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