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AgVetLink: Number 62, June 2007

Inclusion of registered products in oral nutritional compounds

Confusion and poor labelling compliance frequently occur when registered products are included in animal feeds. Often insufficient information is provided on labels for end users to be able to make decisions on the amount of feed required to achieve the claimed effects of the registered products. It is important for end users to have this information so that correct disease management decisions can be made.

Varying levels of compliance on such feeds were found at the recent Fieldays (see page 3) and the need for clear guidance in this area is apparent. A brochure, with a sample label, was handed out to many affected applicants. The following information was included in the brochure.

The inclusion of registered products in oral nutritional compounds is allowed by an exemption under schedule 4 of the ACVM Amendment Regulations 2005.

As well as meeting the usual requirements for an oral nutritional compound exempt under schedule 4, the exemption states:

"Agricultural compounds that are therapeutic or pharmacological substances or preparations may be incorporated into oral nutritional compounds only if:

• the agricultural compounds are registered under the Act; and

• the incorporation of the agricultural compounds is consistent with any conditions of their registration".

In other words, registered products that are available over the counter (such as coccidiostats) can be incorporated into feeds only if they meet the conditions of registration for that product. This means that the following must be considered and included on the label if necessary.

• Any relevant warnings on the registered product label should be included on the label of the feed (eg for ionophores the warnings about feeding to dogs and horses and not using other ionophores at the same time should be included).

• The inclusion rate of the active ingredient should be included so the concentration of the active ingredient in the finished feed is known.

• The recommended feeding rate (grams of feed to be fed per kilogram of live weight) to achieve the required dose rate as stated on the registered product's label should be included.

• Only claims that are approved on the registered product label can be included on the label of the feed. The correct dose of active ingredient must be given for the particular claims made (for example, some ionophores will have a higher inclusion rate for prevention of coccidiosis than for other claims. Claims can be made only if the correct feeding rate to achieve the recommended dose for that claim is provided.)

For further information on labelling requirements see the website (www.nzfsa.govt.nz/acvm).