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Implementation of the ACVM Act: Regulatory changes

3 Labelling

In brief, existing minimum label information requirements and labelling specifications will be transferred into the manufacturing regulations. NZFSA proposes to impose a condition on all exempt product groups to comply with the manufacturing regulations. This is only a change in regulatory mechanism; the requirements themselves will not change.

3.1 Current regulatory regime

Label content for products exempt from registration is currently not subject to NZFSA approval, but it is subject to minimum label information requirements in Regulation 6 of the ACVM Regulations. Registered products are subject to the ACVM labelling and advertising guidelines, which set out what an applicant for registration needs to state on the label. In addition, the label content for registered products is approved by NZFSA. The conditions of registration require compliance with the labelling and advertising guidelines. The current minimum labelling requirements are to ensure that labels contain sufficient information to facilitate the safe and appropriate use of the product, and any investigation of the products in regard to compliance with regulatory requirements.

3.2 Proposed regulatory regime

NZFSA proposes to transfer existing minimum label information requirements and labelling specifications from the ACVM Regulations into the manufacturing regulations. A condition will be imposed on all exempt product groups to comply with the manufacturing regulations. Label content for registered products will continue to be approved as part of the registration process. Compliance with the labelling requirements will be additional to the label content approval. This will require a minor adjustment in the conditions of registration, to align labelling with manufacturing rather than with advertising.

The minimum labelling requirements, which are currently in the ACVM guidelines for labelling and advertising, are listed below in no particular order:

• Mandatory label information imposed via the conditions of authorisation must be specified (eg “for the treatment of animals only”).

• Primary and secondary packaging must comply with the minimum labelling requirements.

• Label components attached to restricted size primary packaging must include the active ingredient and trade name, and must always be supplied in secondary packaging with all the required information.

• Outers must identify the product with its trade name, registration statement and number, active ingredients and net contents.

• Packaging and labelling must be defined in the manufacturing specification. This will be considered by NZFSA when approval is required for an operating plan.

• All products must be supplied with a label (or if supplied in unpackaged bulk form must have documentation) containing the following minimum information:

- trade name, if any

- the ACVM authorisation statement and identification number if one has been issued for the product

- the name and address of the manufacturer/producer (and/or registrant if the product is registered)

- active ingredients

- net contents

- use claims

- directions for safe use

- any applicable information specified in its authorisation

- details of any precautions to be taken to prevent or manage the risks described in section 19 of the ACVM Act when using it, particularly potential hazards to animals treated with or exposed to it

- batch number, date of manufacture, or any equivalent information used to link the product to its manufacture

- shelf-life statement, use by date or expiry date, or any equivalent information used to specify the period in which the product should be used

- storage and transport instructions, if necessary

- disposal instructions, if necessary.