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AgVetLink October 2003

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Redraft of the standard for oral nutritional compounds

The period for comment on the Draft Standard for Oral Nutritional Compounds has closed. Three submissions were received. While they were in support of the need for the standard, there were aspects that needed further consideration.

The main issue was in regard to the level of regulatory control needed for oral nutritional compounds with added therapeutic or pharmacological substances. These were called ‘medicated oral nutritional compounds‘ in the first draft, but this term was not considered helpful so it has been removed.

The revised draft has subdivided oral nutritional compounds into groups depending on whether or not the product:

• contains only generally regarded as safe (GRAS) feed additives;
• is offered for general sale; and 
• has only registered therapeutic or pharmacological products added.

Some concern was expressed that feed manufacturers and transport companies would not be able to comply with the standard in regard to labelling bulk product and ensuring the appropriate feed went to the specified animals. These concerns are being investigated by the ACVM Group to see if they are valid. However, this is not likely to alter the standard materially because the ACVM Group considers it essential that feed (including bulk feed) be labelled correctly and supplied to the specified animal(s) in a reliable manner.

The ACVM Group has revised its draft standard for oral nutritional compounds. It can be found on the ACVM Group website and people are invited to comment on this revised version. Comments should be sent to Chris Boland, Programme Manager (Technical Policy), by 1 November 2003.

Registration and Product Datasheets

When submitting applications under the ACVM Act for either plant compounds or veterinary medicines, applicants have been requested to forward an electronic copy of the Registration and Product Datasheet to datasheet@nzfsa.govt.nz. This request was made with a view to supplying a copy to ERMA New Zealand, should the need arise.

Applicants should note that this is no longer necessary and the direction at the top of the Product Datasheet to forward an electronic copy will be removed at the next review of the document.

In addition, some applicants are forwarding an electronic copy of the ‘draft’ label content at the time of submitting their application. This is not a requirement. We remind applicants that the only electronic copy of the label content required is the ‘final’ version requested by us once the application has been approved.

Low Risk Registration Replacement

In the April 2003 edition of AgVetLink it was signalled that the Registration Information Requirements for Low Risk Products was to be replaced.

Work on the replacement is now in the advanced stages. It will take the format of individualised standard and guideline documents, which will act as stand alone registration information requirements. Each document will detail exactly what information and documentation must be supplied to the ACVM Group to achieve product registration. Products registered via this option will be collectively known as ‘Specified Requirements Products’. An abbreviated Product Data Sheet has been developed and should be used when registering a Specified Requirements Product.

The first standard and guideline that is being developed is specific to oral nutritional compounds with non-GRAS ingredients. It is expected that the final version will be available on the ACVM website by late October.

The ACVM Group will continue to identify groups of products that are suitable to be registered via this option.