New Zealand is a BSE Free Category 1 Country with a TSE-Free Status - We supply
bovine & ovine animal tissue materials (GBR1) & intermediate formulations.
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NEW ZEALAND'S TSE-FREE STATUS

New Zealand and Australia do not have Transmissible Spongiform Encephalopathy (“TSEs”). No case has ever been diagnosed there of CJD, BSE, scrapie or CWD, the main forms of the disease.

Experimentation in the UK and EU has used New Zealand cattle as guaranteed BSE-free controls.

In 2000, a European Commission study was undertaken by the European Food Safety Authority to assess the risk of finding BSE in a number of countries ('Geographical Risk of Bovine Spongiform Encephalopathy; EC, July 2000’). These studies are updated regularly by way of Annex.

The following are the BSE risk categories as developed and described in the study and subsequent annexes:

GBR level

Presence of one or more cattle clinically or pre- clinically infected with the BSE agent in a geographical region/country

I

Highly unlikely

II

Unlikely but not excluded

III

Likely but not confirmed or confirmed, at a lower level

IV

Confirmed, at a higher level/highly prevalent

New Zealand and Australia were both assigned and have maintained a Category I (GBRI) rating. The United States and Canada were initially placed in Category II, but have subsequently been downgraded to Category III.

Current EU guidelines for human or animal drug manufacturing for TSE transmittal minimalisation (EMEA/410/01 Rev. 2 – October 2003) clearly state that bovine tissue materials used in medical devices and products should be sourced from the lowest Category countries.


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