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Low Risk Oral Nutritional Preparations and Copper and Zinc withholding times

Low Risk Oral Nutritional Preparations

The delay in the commencement of the ACVM Act is preventing MAF from implementing a number of improvements in the regulatory control of certain products. This is particularly evident in regard to oral nutritional preparations.

The Animal Remedies Act definition of an animal remedy is such that any product that claims to improve health or productivity must be licensed. This includes a wide range of nutritional products that are not considered to be remedies or drugs in most other countries. Consequently, products that are readily available over-the-counter in those countries must be licensed in New Zealand.

Under the ACVM Act all oral nutritional preparations were to be exempt from registration under the condition that they comply with a prescribed standard for such products.

That standard cannot be prescribed under the Animal Remedies Act and animal remedies cannot be exempted from licensing under specified conditions. Therefore, while the Animal Remedies Act is still in force, all oral nutritional preparations that are also animal remedies must be licensed.

MAF is developing criteria for low risk products and may incorporate the definitions and specifications in the proposed standard for oral nutritional preparations into the standard for low risk products. However, since feed additives would have to be recognised as safe before the oral nutritional preparation could be considered low risk, this option is limited by the lack of progress in establishing a mechanism to create and maintain a list of generally recognised as safe (GRAS) substances (see insert).

MAF is trying to resolve this dilemma. However, proprietors of oral nutritional preparations are advised that, until the ACVM Act commences or criteria for low risk oral nutritional preparations can be developed, their products will have to be licensed and applications will have to contain the information specified in the ACVM - Information Requirements. The fee for low risk product applications will be advised when this has been resolved.

Copper and Zinc Withholding Times

After several carcases were condemned for being within the withholding time after treatment, requests were made by license holders of products containing copper and zinc as supplements to clarify certain anomalies regarding with-holding times. The ACVM Group, together with the Animal Products Group (Residues) at MAF, are looking into this as a matter of some urgency. The combined group will then decide on a course of action commensurate with the level of risk imposed by the use of these products.

AgVetLink is produced by the ACVM Group for the New Zealand Ministry of Agriculture and Forestry. Enquiries should be directed to:

AgVetLink
ACVM Group
Post Office Box 2526
WELLINGTON, NEW ZEALAND