Nutraceuticals as ingredients in oral nutritional compounds

It has come to MAF’s attention that substances are being added to feeds to achieve a non-specific improvement in health and performance. These substances would not be feed addititives as defined in the standards for oral nutritional compounds. Nevertheless, because the substances are of animal or plant origin and, consequently, already found in food stuffs, they are not likely to be of much regulatory interest. Both North America and the European Union define these substances as ‘additives to feeds’. As long as the substances themselves are safe and are manufactured according to good manufacturing practices, then the presence of those substances would not prompt regulatory action.

The term being used to describe these substances is ‘nutraceuticals’. There is no internationally accepted definition for this group, but MAF considers the definition proposed by the North American Nutraceutical Council as reasonable, i.e. “a substance which is produced in a purified or extracted form and administered orally (to a patient) to provide agents required for normal body structure and function and administered with the intent of improving the health and well-being of animals”. This is generally consistent with the ACVM definition of an oral nutritional compound, except that claims are made that go beyond those of a nutritional benefit.

From a risk management point of view, MAF considers that the hazards posed by nutraceuticals could be managed adequately by including them in the standards for oral nutritional compounds. MAF proposes to introduce into that standard the following definition:

A nutraceutical is any substance, not being a therapeutic or pharmacological substance, purified or extracted from animal or plant (not being a plant prohibited in a veterinary medicine exempt from registration) material and incorporated into an oral nutritional preparation for the purpose of improving the general health, well-being or disease resistance of animals.

In effect, nutraceuticals (either as components of oral nutritional preparations or as oral nutritional compounds in their own right) would be exempt from registration on the condition that they comply with the standards for oral nutritional compounds. The ACVM risks would be adequately managed if nutraceuticals had to comply with prescribed standards. In addition to the specifications for all oral nutritional compounds, nutritional products with nutraceuticals added could make claims of a general nature to improve heath, performance, well-being and disease resistance. No claims could be made to prevent, treat or cure particular diseases or artificially modify physiological functions.

Please send any comments on this proposal by 15 March 2000 to:

Chris Boland
Special Advisor (Technical Policy)
ACVM Group
PO Box 2526
WELLINGTON
Email: bolandc@maf.govt.nz