Hormonal growth promotants (HGPs)

1. Background

Due to the sensitivity of certain overseas export markets to hormonal growth promotant (HGP) residues, controls apply to the supply of HGPs in Australia. These controls are contained within various laws of the Commonwealth and states and territories. The HGP controls made under the Agricultural and Veterinary Chemicals Code (Agvet Code) as scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 reflect the division of responsibilities between the Commonwealth and the states and territories under the National Registration Scheme for Agricultural and Veterinary Chemicals. Accordingly, regulations relating to the supply of HGPs have been made under the Agricultural and Veterinary Chemicals Code Regulations 1995 (Agvet Regulations).

Hormonal growth promotant is defined by regulation 3 of the Agvet Regulations as follows:

hormonal growth promotant means a veterinary chemical product containing a substance that is, or a mixture of substances that are, responsible for oestrogenic, androgenic or gestagenic activity to enhance growth or production in bovines or bubalines.

Controls applying to the use of HGP are primarily located in state and territory laws. The information supplied below relates only to the HGP requirements under the Agvet Regulations. Persons using HGPs should ensure that they contact their state or territory authority regarding the use requirements for HGPs.

2. Supply of HGPs – requirement to possess a notification number

It is an offence to supply HGPs in Australia without a notification number (Regulation 47C). Notification numbers are assigned to suppliers by the Australian Pesticides and Veterinary Medicines Authority (APVMA).

If a person wishes to supply HGPs within Australia, the person must give the APVMA written notice of their intention to supply HGPs. The written notice must contain the following information (Regulation 47):

  • A declaration that the person intends to supply an HGP; and
  • The address of each premises from which the person intends to supply the HGP.

The person must provide the written notice to the APVMA, along with payment of the prescribed fee for each premises from which a supply is intended to be made.? The prescribed fee is set out in regulation 47(2).

Upon provision of the written notice, and payment of the prescribed fee, the APVMA will assign an HGP notification number for each premises from which HGPs will be supplied.? A notification number is assigned for a 12 month period, and must be renewed by the end of that period if the person intends to continue to supply HGPs in Australia (Regulation 47B).? Failure to renew a notification number means that a person cannot continue to supply HGPs and will be committing an offence if they do so.

To renew the notification number, a person is required to give the APVMA written notice of their intention to continue to supply HGPs.? The written notice must contain the following information (Regulation 47):

  • A declaration that the person intends to continue to supply an HGP; and
  • The address of each premises from which the person intends to supply the HGP.

If it appears to the APVMA that a premises that has been assigned a notification number are no longer used for the supply of HGPs, the APVMA may inform the person that it intends to withdraw the assigned notification number (Regulation 47A)

3. Supply of HGPs –?requirements before supply

A person must not supply an HGP to another person unless the recipient of the HGP:

  • has been assigned a notification number by the APVMA, and that notification number has not ceased to have effect and has not been withdrawn

OR

  • has given to the supplier a declaration in the form approved by the APVMA (hyperlink) stating the following:
    • The total quantity and type of the HGP acquired.
    • The batch number of the HGP.
    • The purchaser declaration number for the premises where animals proposed to be treated with the promotant are to be kept.
  • and acknowledging that the recipient is aware that an animal treated with an HGP must be marked as an animal so treated, as required by the law of this jurisdiction (that is, by making in its ear an equilateral triangular hole 20 millimetres on each side)

Supply under any other circumstances is a contravention of the Agvet Regulations.

A supplier must keep all purchaser declarations they have received for a period of at least 2 years after they are received (Regulation 54).

4. Supply of HGPs – where supply is made to a nominated pick up point

Where a recipient wishes to acquire HGPs through a registered supplier, and the recipient is located remotely or does not receive postal service, the recipient may request that the supplier deliver the packaged and unopened HGPs to the local post office or to a local retailer who does not trade in HGPs and therefore does not possess a notification number (Regulation 47C(2)).? This is known as the ‘post office system’.

Where a supplier is to supply HGPs to a recipient using the post office system, the supplier must not send the HGPs to the nominated pick up point without first obtaining the purchaser declaration from the recipient (unless the recipient has been assigned a notification number).

Once the supplier has been provided with the purchaser declaration, or has been provided with proof that the recipient has been assigned a notification number by the APVMA, the supplier may deliver the packaged and unopened HGPs to the nominated pick up point.? It is the supplier’s responsibility to ensure that they obtain the purchaser declaration.

A supplier must keep all purchaser declarations they have received for a period of at least 2 years after they are received (Regulation 54).

5. Disposal of date expired HGPs

Date-expired stocks of HGPs can only be destroyed or returned to the manufacturer. A record must be kept of the disposal and this must be supported by documentation which is evidence of disposal. This may include a receipt from the manufacturer for the return of the date expired stock, and HGP supply and acquisition records at both the supplier and manufacturer’s premises.

6. Disposal of surplus or unwanted HGPs

Surplus or unwanted stock of HGPs may be:

  • destroyed
  • returned to the manufacturer
  • returned to the original supplier, who may supply it to another premises that has been assigned a notification number by the APVMA, or
  • if the person in possession of the HGPs has been assigned a notification number by the APVMA, that person may supply the surplus or unwanted stock to another premises that has been assigned a notification number by the APVMA.

A record must be kept of the disposal and this must be supported by documentation which is evidence of disposal. This may include a receipt from the manufacturer or supplier for the return of the stock, and HGP supply and acquisition records at both the supplier and recipient’s premises.

7. Record keeping requirements – manufacture and supply

On each occasion that a person manufactures and supplies HGPs to another person, the supplier must make a written record of the following information at the time of the supply (Regulation 49):

  • The distinguishing name of the HGP entered in the Register of Chemical Products,
  • The name and address of the manufacturer of the HGP.
  • The notification number assigned to the premises from which the HGP was supplied to the recipient.
  • The quantity of the HGP supplied.
  • The date of manufacture of the HGP.
  • The batch number of the HGP.
  • The quantity of HGP manufactured in that batch.
  • The date of supply of the HGP.
  • The name and address of the recipient.
  • If one?or more notification numbers have been allotted to the recipient:
    • the notification number, and address, of each premises to which the HGP is supplied; and
    • the quantity of the HGP supplied to each of those premises.
  • If no notification number has been allotted to the recipient – the purchaser declaration number for the premises where animals treated with the HGP are to be kept.

Failure to?record?the information specified in regulation 49 of the Agvet Regulations is an offence.

The record may be made in written or electronic form, and must be easily accessible for audit by APVMA inspectors (Regulation 52).

Copies of all records made under regulation 49 must be given to the APVMA within 14 days after the end of the month in which the record was made (Regulation 53).

Failure to give the record to the APVMA in the manner and by the time specified in regulation 49 is an offence.

8. Record keeping requirements – import and supply

On each occasion that a person imports and supplies HGPs to another person, the supplier must make a written record of the following information at the time of the supply (Regulation 50):

  • The distinguishing name of the HGP entered in the Register of Chemical Products.
  • The name and address of the importer.
  • The notification number assigned to the premises from which the HGP was supplied to the recipient.
  • The quantity of the HGP supplied.
  • The date of importation of the HGP.
  • The batch number of the HGP.
  • The quantity of HGP imported from that batch.
  • The date of supply of the HGP.
  • The name and address of the recipient.
  • If one?or more notification numbers have been allotted to the recipient:
    • the notification number, and address, of each premises to which the HGP is supplied; and
    • the quantity of the HGP supplied to each of those premises.
  • If no notification number has been allotted to the recipient – the purchaser declaration number for the premises where animals treated with the HGP are to be kept.

Failure to?record?the information specified in regulation 50 of the Agvet Regulations is an offence.

The record may be made in written or electronic form, and must be easily accessible for audit by APVMA inspectors (Regulation 52).

Copies of all records made under regulation 50 must be given to the APVMA within 14 days after the end of the month in which the record was made (Regulation 53).

Failure to give the record to the APVMA in the manner and by the time specified in regulation 50 is an offence.

9. Record keeping requirements – supply only

On each occasion that a person receives HGPs from a supplier (the previous supplier) and supplies HGPs to another person, the supplier must make a written record of the following information at the time of the supply (Regulation 51):

  • The distinguishing name of the promotant entered in the Register of Chemical Products.
  • The name and address of the supplier.
  • The notification number assigned to the premises from which the promotant was supplied to the recipient.
  • The batch number of the promotant.
  • The name and address of the recipient.
  • The date of supply of the promotant to the recipient.
  • The quantity of the promotant supplied to the recipient.
  • The total quantity of the promotant remaining in the supplier’s possession after supply.
  • The name and address of the previous supplier.
  • The notification number (if any) assigned under this Division to the previous supplier for the premises from which the promotant was supplied by the previous supplier.
  • The date of supply of the promotant by the previous supplier.
  • The total quantity of the promotant supplied by the previous supplier.
  • If one?or more notification numbers have been allotted to the recipient:
    • the notification number, and address, of each premises to which the promotant is supplied; and
    • the quantity of the promotant supplied to each of those premises.
  • If no notification number has been allotted to the recipient – the purchaser declaration number for the premises where animals treated with the promotant are to be kept.

Failure to?record?the information specified in regulation 51 of the Agvet Regulations is an offence.

The record may be made in written or electronic form, and must be easily accessible for audit by APVMA inspectors (Regulation 52).

Copies of all records made under regulation 51 must be given to the APVMA within 14 days after the end of the month in which the record was made (Regulation 53).

Failure to give the record to the APVMA in the manner and by the time specified in regulation 51 is an offence.

10. Forms

Visit our forms page to view all HGP forms.

11. More information

11.1. To update licence details

If at any time there has been a change in any of the details of the person or entity who has been assigned an HGP notification number we request that you complete a change of contact details for supplier of hormonal growth promotants form and send it to hgp@www.plural-consulting.com.

11.2. If your notification number will expire soon

Please complete the?notification of intention to supply HGPs form?and email it to hgp@www.plural-consulting.com. The notice must be accompanied by payment of the prescribed fee on or before the date of expiry or it will not be accepted. Payment details are included on this form.

If you do not intend to continue to supply HGPs after the expiry date of your notification number, you should return all stock on hand to the supplier, importer or manufacturer of the product prior to that date and complete a final monthly return.

12. Contact

Please address any queries to:

Hormonal growth promotants (HGP) Contact Officer

Phone: +61 2 6770 2302
Email: hgp@www.plural-consulting.com

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