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AgVetLink: Number 52, October 2005

Chemical approvals

The ACVM Group has been assessing applications and issuing approvals for the use of chemicals in animal product production and processing. Approvals relate to the safety and suitability of chemicals that may directly or indirectly come into contact with the animal produce. (Although the ACVM Group issues the approvals, they are issued under the Animal Products Act 1991, not under the ACVM Act.)

The scope of these approvals is likely to be broader in the near future as the Domestic Food Review identifies the need to manage risks associated with the use of processing chemicals in the production, manufacture and processing of other kinds of foods, such as horticultural produce and wine, and in the preparation of food.

Policy change

The underlying policy for chemical approvals has been changed because of the potential hazard to NZFSA staff as a result of handling and testing samples. This will result in changes in the approval process itself. The new chemical approval process will be designed around the principles that:

• no samples will be required

• approvals and the application of codes will be issued on the basis of declarations from the applicant regarding the formulation of the product and its intended uses. This aspect of the process will be strengthened, e.g. the nature of the declaration etc.

• one communication will be provided about information deficiencies with a specified time to provide the information; if the information is not provided in the time frame set, the approval will be refused

• approvals will be issued with a reference to the product formulation and intended use(s), and a warning that the approval is valid only if the product complies with the formulation as declared in the application and only if the product is used for the purposes appropriate for the code that has been approved.

No significant risk

NZFSA considers that issuing approvals without examining samples does not pose a significant risk if, along with the changes in the process, NZFSA makes it clear to all parties, including the food processing industry using the chemicals, exactly what the approvals are based on and how they can be nullified by not complying with the product specifications.

NZFSA will also initiate communications with users to educate them about the significance of the codes and to warn them that approvals are issued on the basis of the formulations provided. When an approved chemical is used in a process, users should be aware that it is possible the product may not comply.

An adverse event reporting system will be introduced to handle reports from users about products. Suspicions or allegations that products do not comply with their approvals will be investigated and approvals may be withdrawn if necessary. NZFSA is confident that such a process with appropriate ties to verification and compliance will provide at least as robust a regulatory environment as the present system.

At the moment, all chemical approvals are being revalidated using the existing process, including the testing of some samples. Approval holders have been advised that they have an obligation to provide the necessary information and take care if samples need to be submitted for testing. Once the present revalidation process is completed, the new process will come into effect and parties will be advised. An update will be published in AgVetLink as well.