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AgVetLink: Number 55, April 2006

Applying to Have a Feed Additive Registered as Generally Recognised as Safe (GRAS)

The GRAS Register for Oral Nutritional Compounds

The Approvals and ACVM Group maintains a GRAS register for feed additives* for use in oral nutritional compounds in order to avoid the repeated assessment of safety data for substances that are considered safe for this use and of no regulatory interest in terms of the ACVM Act. This allows regulatory interest to focus on substances that are of concern, or substances where there is insufficient evidence to determine their safety as feed additives.

The criteria for inclusion on GRAS registers are conservative so that substances are classified as GRAS only where they have a proven history of safety when used appropriately (i.e. in accordance with Good Manufacturing and Good Feeding Practices).

It must be noted that a substance declared by NZFSA to be GRAS is not necessarily recognised as safe when used for some purpose other than that specified on the GRAS register. The GRAS declaration only applies to regulation under the ACVM legislation, and the substance could still pose risks that are managed under other New Zealand legislation, such as the Hazardous Substances and New Organisms Act 1996 or the Food Act 1981.

GRAS applications

In order to obtain GRAS listing of a substance, applicants must provide a completed application form including documented evidence of international GRAS listings. The international references currently recognised by the Approvals and ACVM Group are the US FDA and EU GRAS lists. It is noted that there are a number of other similar lists maintained by these authorities that are not GRAS lists and, although these are useful as supporting evidence, they must be accompanied by other documented evidence proving the appropriateness of GRAS status for the substance.

If the applicant is unable to provide references to recognised international GRAS registers, he/she must provide a rationale to support GRAS status of the additive. This rationale, with documented evidence, must clearly demonstrate:

• that the proposed GRAS substance is well known, in common use and has a history of safety in the context of use;

• the low potential for and impact of residues in food produced from exposed animals;

• that risks to the safety and welfare of animals treated or exposed will not be compromised. This must include relevant toxicity data to enable us to determine that the proposed addition can be considered safe for its target animals;

• that risks to international trade from the likely substance use(s) are unlikely.

In addition, a number of commonly encountered feed additives are naturally present in food, but when added to an oral nutritional compound fall under the definition of a feed additive. In this situation, it would be useful to provide a comparison (backed up by documented evidence) between levels present naturally in food and levels resulting from the addition of the substance as a feed additive.

GRAS applications that are not clearly structured and accompanied by the relevant and necessary documented evidence will not be sent to the consultation group for consideration and will be returned to the applicant.

Please see the NZFSA website for further GRAS classification information

(http://www.nzfsa.govt.nz/acvm/topics/registration/gras.htm). Alternatively, contact the GRAS administrator by email: toxassessor@nzfsa.govt.nz

*A feed additive is defined as a non-nutrient substance added to a food of animals to improve the preservation, digestion, colour, palatability, texture or nutritive value of food.