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Generally Recognised As Safe (GRAS) registers

The Agricultural Compounds and Veterinary Medicines (ACVM) Group uses GRAS lists to prevent unnecessary reassessment of substances that are generally recognised as safe when they are included in a trade name product used to manage plants or animals. This allows substances that are known to pose a risk to human or animal health, and those where there is insufficient information to conclude that they are safe, to be the focus of our regulatory assessments.

Currently there are three GRAS registers maintained by the ACVM Group. The GRAS Substances for Oral Nutritional Compounds and the GRAS Substances for Plant Compounds registers make up Schedule 7 of the Agricultural Compounds and Veterinary Medicines Regulations 2001, and identify substances that may be used without affecting a product's exemption from registration status.

The Veterinary Medicines Other than Oral Nutritional Compounds GRAS register is not included in the Regulations but is dealt with administratively by the ACVM Group. The purpose of this register is to confirm to both regulators and applicants that a substance may be included in a particular trade name product and does not require repeated, in-depth assessment.

The process of modifying the GRAS registers, either adding or deleting a substance, or modifying an existing entry, requires consultation with experts and the public. In addition, the Regulations require updating, which is a slow process that can be interrupted by other government priorities.

An updated version of the GRAS list is now available on the ACVM website (www.nzfsa.govt.nz/acvm/registers-lists/gras/). This version includes substances already in the existing Regulations and those that are in the process of being added. (It is a searchable list but people need to be aware that the Regulations themselves – also accessible on the website – are the definitive document.) These substances have passed through the public consultation stage of the application process and may be used in the formulation of products, despite not appearing in the Regulations at present. When the Regulations are next updated, the substances will be added.

All substances included in the registers must be used in accordance with the conditions applicable to GRAS substances. Where a product contains only GRAS substances, it may still require assessment depending on the characteristics of the product. A substance declared as GRAS by the ACVM Group when included in agricultural compounds cannot necessarily be considered GRAS when used for other purposes. These substances may pose risks that are managed under New Zealand legislation other than the ACVM Act.

For further information on GRAS registers please see the ACVM website or contact:

Nicola Reeves, Assessor (Technical Standards - Toxicology)
E-mail: nicola.reeves@nzfsa.govt.nz

Neutraceutical product classification status

A growing number of human and veterinary neutraceutical products are becoming available on the New Zealand market. The following substances commonly included in neutraceutical products have been associated with therapeutic actions and are not currently classified as oral nutritional compounds:

• green lipped mussel and its extract
• deer velvet
• shark cartilage and chondroitin sulphate
• glucosamine and glycosaminoglycans.

Consideration would be given to placing any or all of these substances on the Generally Recognised As Safe (GRAS) list if an application was made to the ACVM Group. Such an application would need to establish the levels in the diet consistent with non-therapeutic function.

If approved, products containing those substances at the specified levels as stated on the GRAS list would be given consideration as exempt oral nutritional compounds.

Currently products containing these substances require registration to be marketed or sold. Where product claims are limited to a nutritional context, and non-nutritional therapeutic claims including those for the treatment or control of arthritis, pain, joint damage and dysfunction or inflammation are not made, data requirements for registration will be significantly reduced.