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Restricted substances and veterinary medicines

As an agricultural country reliant on retained market access, New Zealand must remain responsive to the requirements of overseas trade partners. Some overseas countries including the EU have banned the use of certain substances in, or on, food producing animals. In consequence, animals that have been treated with these substances in New Zealand may not be sold for entry into the human food chain where it cannot be assured that the animals (or their edible tissues) do not enter a market where the substances are prohibited from use on food producing animals. At the moment the substances in question are:

• Chloramphenicol
• Colchichine
• Chloroform
• Nitrofurans (including but not limited to nitrofurazone, nihydrazone, furazolidone, furaltodone)
• Nitroimidazoles ( including but ot limited to dimetridazole, ronidazole, metronidazole, carnidazole)
• Chlorpromazine
• Dapsone
• Substances with the pyrazolidone moiety within the chemical makeup; for example, but not restricted to, phenylbutazone, ramifenazone, dipyrone
• Arsenilic acid
• Nandrolone

To ensure that the export of any edible product from animals treated with these substances does not occur, the ACVM Group will, from 1 July 2002, no longer approve the registration of products containing these substances with label claims for use in cattle, deer, goats, sheep, llamas, ostriches, emu or fish, unless agreed tagging and tracking programmes were instituted. Trade name products that contain these New Zealand restricted substances and carry claims for use in species other than these animals will still be considered for registration. Where the potential for off-label use of these products in food animals that may supply edible product for export is considered likely, specific conditions will be placed on the product registration to prohibit such use, unless agreed tagging and tracking programmes were instituted. Of particular concern is the potential off-label use of dimetridazole within the ostrich industry in New Zealand. The Animal Products Group of NZFSA intends to address this issue via additional restrictions on the overseas market access requirements for ostriches.

Products currently registered with claims for use in affected species will be required to remove the claims or demonstrate other means of managing the trade risk. Registrants affected by this notice will be contacted by the ACVM Group to ensure that these requirements are met within the agreed timeframe. If you have any comments or concerns on this issue, please send them in writing by 1 September 2002 to:

Jennie Yee
Assessor (Technical Standards-Veterinary Medicines)
ACVM Group
NZFSA
PO Box 2835, WELLINGTON
email: jennie.yee@nzfsa.govt.nz

Certificates of compliance with Good Manufacturing Practice (GMP) issued to manufacturers after inspections will change under the New Zealand Food Safety Authority (NZFSA). The new certificates will be NZFSA certificates, which will be in the form agreed under the mutual recognition agreement for GMP assessment with the European Community (EC).

However, if the manufacturer being inspected produces products that are registered and exported to the EC, then the GMP certificate issued will be a MAF certificate for the time being. This will be in the agreed format and will include the words:

'ISSUED UNDER THE PROVISIONS OF THE
MUTUAL RECOGNITION AGREEMENT
BETWEEN THE EUROPEAN COMMUNITY
AND NEW ZEALAND'.

This is being done because the mutual recognition agreement in place is between MAF as the New Zealand competent authority, and the European Commission as the European one. The process of managing the change to recognise the NZFSA as the competent authority will occur within the next 12 months alongside other official assurances. In the meantime, both certificates will have equal validity in New Zealand and they will be phased in as the inspection programme progresses. The existing Animal Remedies Board certificates also remain valid until a new inspection is carried out.