Explanatory Statement
Issued by Authority of the Minister for Agriculture and Water Resources
Imported Food Control Act 1992
Imported Food Control Regulations 1993
Imported Food Control Amendment (Human Milk and Human Milk Products) Order 2019
Legislative Authority
The Imported Food Control Act 1992 (Act) provides for the inspection and control of food imported into Australia in order to achieve compliance with Australian food standards and the requirements of public health and safety.
Subsection 16(1) of the Act provides that the Governor-General may make regulations setting out particulars of a food inspection scheme. These regulations are the Imported Food Control Regulations 1993 (Regulations) and the food inspection scheme established under these Regulations is the Imported Food Inspection Scheme (Scheme). The Scheme is applicable to all food to which the Act applies.
Paragraph 16(2)(a) of the Act provides that the regulations setting out particulars of the Scheme may empower the Minister, subject to section 17, to make orders identifying food of a particular kind as food of a kind that is required to be inspected, or inspected and analysed, under the Scheme. These orders are the Imported Food Control Order 2001 (Order).
Section 17 of the Act provides that the Minister must not make an order for the purposes of paragraph 16(2)(a) without first consulting Food Standards Australia New Zealand (FSANZ).
Subject to section 17 of the Act, subregulation 7(a) of the Regulations provides that the Minister may make orders:
- identifying food of a particular kind as food of a kind that is to be inspected, or inspected and analysed, under the Scheme; or
- identifying risk food of a particular kind as food that must be covered by a recognised foreign government certificate.
Subregulation 7(b) of the Regulations provides the Minister may vary orders, made under the Regulations, from time to time.
Subregulation 8(a) of the Regulations provides the Minister may make orders classifying food of a particular kind, to which the Act applies, as risk food.
Regulation 9 of the Regulations provides that food of a particular kind may be classified as risk food if, on being consulted as required under section 17 of the Act, FSANZ advises the Minister that the food has the potential to pose a high or medium risk to public health.
Purpose
The purpose of the Imported Food Control Amendment (Human Milk and Human Milk Products) Order 2019 (Amendment Order) is to manage the food safety risks associated with imported human milk and human milk products
It will amend the Order to:
- classify human milk and human milk products as risk foods that require inspection or inspection and analysis for relevant hazards at a rate that is consistent with the Regulations based on the risk to human health; and
- identify human milk and human milk products as risk foods that must be covered by a recognised foreign government certificate to provide evidence and assurance that the food safety risks for these foods are being effectively managed.
Background
FSANZ has assessed that imported human milk and human milk products pose a high or medium risk to public health. The Amendment Order will enable measures to be implemented to manage these risks. In particular, commercial imports of human milk and human milk products will be permitted if they are covered by a recognised foreign government certificate, provided biosecurity conditions are met.
Impact and Effect
The effect of the Amendment Order is that human milk and human milk products which are not covered by a recognised foreign government certificate will be taken to be a ‘failing food’ (see subregulation 18(2) of the Regulations). Failing food may be subject to additional inspections and analysis and may be required to be treated, destroyed or re-exported from Australia (see sections 14, 15, and 20 of the Act and regulations 19, 20 and 24 of the Regulations).
These requirements will benefit the Australian public by providing certainty about the safety of imported human milk and human milk products being fed to infants including premature babies. This will potentially benefit the parents of premature babies by enabling the imports of human milk fortifier which is currently unavailable in Australia. There is evidence that very low birthweight (<1500g) infants benefit from being fed human milk fortified with human milk fortifier. It may also assist with filling any gaps in the market for human milk for feeding to infants.
Consultation
The department consulted with the Department of Health, FSANZ and state and territory food regulators to determine how imported human milk and human milk products should best be regulated at the border. The Department of Health and FSANZ supported this regulatory approach.
As required by section 17 of the Act, the Minister consulted with FSANZ before making the Amendment Order for the purposes of paragraph 16(2)(a) of the Act.
On advice from the Department of Foreign Affairs and Trade, the department did not issue a World Trade Organization notification for the Amendment Order. This is because the Amendment Order is unlikely to have a significant impact on the limited trade in human milk and human milk products. The department will advise overseas producers of human milk and human milk products of the legislative changes that will be made by the Amendment Order.
The department consulted with the Office of Best Practice Regulation (OBPR) in the preparation of this Amendment Order. OBPR advised that a regulation impact statement is not required for the regulation of human milk and human milk products under the Act (ID 24639).
Details/ Operation
Details of the Amendment Order are set out in Attachment A.
Other
The Amendment Order is compatible with the human rights and freedoms recognised or declared under section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. A full statement of compatibility is set out in the Attachment B.
The Amendment Order is a legislative instrument for the purposes of the Legislation Act 2003.
Attachment A
Details of the Imported Food Control Amendment (Human Milk and Human Milk Products) Order 2019
Section 1 – Name
This section provides that the name of the instrument is the Imported Food Control Amendment (Human Milk and Human Milk Products) Order 2019 (Amendment Order).
Section 2 – Commencement
This section provides for the Amendment Order to commence the day after the instrument is registered.
Section 3 – Authority
This section provides that the Amendment Order is made under regulations 7 and 8 of the Imported Food Control Regulations 1993.
Section 4 – Schedules
This section provides that the Imported Food Control Order 2001 is amended as set out in the Schedule.
Schedule 1 – Amendments
Item 1 omits “4A and 10”, and substitutes “4A, 10 and 23” in suborder 5(1) of the Imported Food Control Order 2001 (Order). This adds human milk and human milk products to the risk foods in the table in clause 1 of Schedule 1 that must be covered by a recognised foreign government certificate.
Section 18 of the Act provides that the Secretary may determine in writing, that a certificate issued by an instrumentality of a specified foreign government stating that food of a specified kind meets applicable standards and does not pose a risk to human health is a recognised foreign government certificate. This kind of certification is regularly used by importing countries to ensure certain requirements have been observed in the production of the food in an exporting country.
Item 2 inserts item "23 Human milk and human milk products” in the table in clause 1 of Schedule 1 (after table item 22). The effect of this amendment is to classify human milk and human milk products as risk foods that must be inspected or inspected and analysed in accordance with the Regulations.
Attachment B
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Imported Food Control Amendment (Human Milk and Human Milk Products) Order 2019
This Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Legislative Instrument
The Imported Food Control Amendment (Human Milk and Human Milk Products) Order 2019 will:
- classify human milk and human milk products as risk foods that require inspection or inspection and analysis for relevant hazards at a rate that is consistent with the Regulations based on the risk to human health; and
- identify human milk and human milk products as risk foods that must be covered by a recognised foreign government certificate to provide evidence and assurance that the food safety risks for these foods are being effectively managed.
Human rights implications
The Amendment Order engages the right to health (Article 12) in the International Covenant on Economic, Social and Cultural Rights (ICESCR).
The Amendment Order engages and promotes the right to health in Article 12 of the ICESCR by:
- inspecting, or inspecting and analysing, human milk and human milk products for relevant public health hazards to determine if these products are safe; and
- requiring recognised foreign government certification for human milk and human milk products so these foods are safe.
Conclusion
The Amendment Order is compatible with human rights because it is promoting the right to health through the inspection and certification of imported human milk and human milk products so they are safe for human consumption.
The Hon. David Littleproud MP
Minister for Agriculture and Water Resources