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Te Pou Oranga Kai O Aotearoa

 
 
 

NOTE: This is an archived issue. The current issue of AgVetLink can be found at http://www.nzfsa.govt.nz/acvm/publications/agvetlink/ 

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C1 applications -

Formulation changes to registered pesticides and licensed animal remedies under the transition provisions of the HSNO Act

Until recently, through an operational agreement between the ACVM Group and ERMA NZ, the ACVM Group processed C1 applications as they were under the previous legislation unless a potential risk to public health or the environment was identified. The ACVM Group only has delegated authority from ERMA NZ to process those variations where there is no change in hazard status.

It has became apparent, however, that although the ACVM Group can identify and manage ‘risks’ associated with a trade name product, it is not possible for us to make the ‘hazard’ classifications that are required by ERMA NZ. (Note that the HSNO Act considers the hazardous properties of all of the ingredients in the whole substance, not just those of the active ingredient.)

It is also possible that ERMA NZ may require information additional to the ACVM Group’s Registration and Product Datasheet on any new proposed formulations to determine whether the new formulation is materially different from the existing approved product. For this reason, although a variation to a formulation can be approved by the ACVM Group as meeting the ACVM requirements, we are unable to issue the new registration/licence until confirmation from ERMA NZ has been received that the hazard status remains unchanged.

Therefore, applications to the ACVM Group for a variation to the formulation of these products (i.e. C1 applications) must be assessed by ERMA NZ to verify whether the proposed formulation changes the hazard status of the product under the Hazardous Substances and New Organisms Act.

ERMA NZ advises that this confirmation can be obtained by submitting a request for advice on the status of a substance to them, and the relevant application form (HS6) can be obtained from the ERMA NZ website (http://www.ermanz.govt.nz/resources/index.html). Alternatively, enquiries can be made directly to ERMA NZ (phone 04 916 2426).

If the hazard status of the trade name product is materially altered by the proposed formulation change, ERMA NZ will require an application for approval of a new substance. In that situation, the ACVM Group will be unable to issue the new registration/licence until the appropriate ERMA NZ approval has been received (if the product is hazardous).

If an ERMA NZ approval is not obtained the registration/licence for the newly formulated product cannot be effected until the product is transferred to the HSNO Act.

Applicants who obtain the confirmation of unchanged hazardous status from ERMA NZ are assured that the ACVM Group will do all within its power to ensure that processing of applications is completed within two working days of this confirmation being received. We apologise for any delay with applications.  Unfortunately this is outside of the ACVM Group’s control.

Vertebrate Pest Control Poisons Update

  • ERMA NZ has been holding meetings with stakeholders to introduce the proposed new system for management of controlled pesticides after their transition to HSNO approvals.

  • MAF is conducting an internal evaluation of what controls will be required under the ACVM Act, and the other acts that MAF administers, to ensure that those risks for which MAF is responsible are properly managed. The MAF view will be conveyed to ERMA NZ for its consideration for setting controls when these products are transferred to HSNO approvals. MAF will then finalise its controls so that where ERMA NZ controls are sufficient to manage those risks MAF will not duplicate them and potentially impose unnecessary compliance costs.

  • The National Registration Authority (NRA) in Australia is undertaking a review of compound 1080 in 2002. The NRA has asked MAF ACVM Group if it will supply information for the review. This we will do provided appropriate confidentiality is maintained.

  • Brodifacoum is being reviewed by MAF because residues in feral game meat being prepared for export continue to be found. A stakeholders meeting will be arranged for mid to late February. For more information contact Warren Hughes (phone 04 460 8760).
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New Zealand Food Safety Authority
68-86 Jervois Quay
PO Box 2835
Wellington
NEW ZEALAND

Phone: +64 4 894 2500
Fax: +64 4 894 2501

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