Category 19 application
Application for a permit to possess or supply for export, an unapproved active constituent or unregistered chemical product

1.   DEFINITION

Schedule 6 of the Agvet Code Regulations describes a Category 19 application as:

Application for a permit to possess or supply, other than for use in Australia, an active constituent that is not an approved active constituent or a chemical product that is not a registered chemical product.

Applications for permits under Category 19 are usually made because an unregistered product is formulated in Australia for export to other countries, or where Australia will be used as a distribution point for products or active constituents manufactured elsewhere in the world. Permits are typically issued to manufacturers, registrants and distributors.

Permits issued under Category 19 DO NOT allow supply for use of the unapproved active constituent or unregistered product within Australia.

A single Category 19 application may normally include only one unregistered product or unapproved active constituent.

2.   REQUIREMENTS

When making a Category 19 application for a permit to possess or supply for export an unapproved active constituent or unregistered chemical product, applicants must provide:

• one unbound copy of the Permit Application Form (refer to paragraph 2.1)
• the relevant fee (refer to paragraph 2.2).

2.1.   Permit Application Form

The Permit Application Form (KP25F09) is available from the APVMA website, and requires:

• name, Chemical Abstracts Service (CAS) number and standard for the active constituent; and/or
• name and full formulation details for the product; and
• a copy of the product label (all label parts); and
• a declaration that the active constituent and/or registered product are not currently approved and/or registered.

2.2.   Fee and timeframe

The fee for a Category 19 application is $320.

The timeframe is three months.

2.3.   Data

There are no data requirements for a Category 19 application and Category 19 applications do not receive any technical assessment.

2.3.1.  Permit for ongoing exports

For manufacturers who have an ongoing business in manufacturing agricultural or veterinary chemicals for export, the APVMA will consider granting a single permit under Category 19 which will permit possession or supply of unregistered active constituents or chemicals for the purpose of export, for a period of up to two years.

To apply for a permit for a period of two years, applicants must provide in the application form:

• a description of the range of unapproved active constituents or unregistered products likely to be exported for the period of validity of the permit
• a declaration that the active constituents will not be approved active constituents, and/or the products will not be registered products
• a declaration that the unapproved active constituents and/or unregistered products are not of a nature that their possession and/or manufacture and export would be in contravention of either the Rotterdam Convention or Stockholm Convention (see paragraph 3.1 on page 3)

2.3.2.  Extension or re-issue of a permit

When a two-year permit is about to expire, applicants may apply under Category 20 for extension of the identical permit for a further two years.

If the applicant wishes to change the range of product covered by the permit, the applicant may apply under Category 19 for a fresh permit.

2.4.  Consent to import an unapproved active constituent or unregistered chemical product

Active constituents and/or products which are not approved or registered and which will be imported into Australia for manufacture into products for export or for which Australia may be used as a distribution point, require a Consent to import unapproved active constituents or unregistered agricultural or veterinary chemical products.

Details on obtaining a consent may be found on the APVMA website at http://www.apvma.gov.au/qa/consent.shtml.

3.   GUIDELINES

3.1.   PICs and POPS conventions – trading hazardous chemicals

On 18 August 2004, Australia became a party to two international conventions relating to the trading of certain hazardous chemicals. These are the:

• Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for Certain Hazardous Chemicals and Pesticides in International Trade (Rotterdam Convention)
• Stockholm Convention on Persistent Organic Pollutants (POP) (Stockholm Convention).

To implement these conventions, controls on import, manufacture, use and export were introduced. Details of these controls, and products or active constituents subject to them, are in the Agricultural and Veterinary Chemicals (Administration) Regulations 1995. Statutory Rules 1995 no. 28 as amended. See also the Explanatory Statement and other information on the Department of Agriculture, Fisheries and Forestry website at Stockholm and Rotterdam Conventions.

3.2.   Certificate of export

Some importing countries require a certificate of export to be issued by the Australian registration competent authority (the APVMA). The certificate normally makes a declaration about the formulation or registration status of a product, according to the importing country’s requirements.

An application for a Category 19 permit does NOT include provision by the APVMA of a certificate of export. Details of procedures and requirements to obtain a certificate of export are provided in Procedures for making an application in Volume 1.

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