Explanatory Statement
Food Standards (Application A1057 – Endo-protease (EC 3.4.21.26) as a Processing Aid (Enzyme)) Variation
1. Authority
Section 13 of the Food Standards Australia New Zealand Act 1991 (the FSANZ Act) provides that the functions of Food Standards Australia New Zealand (the Authority) include the development of standards and variations of standards for inclusion in the Australia New Zealand Food Standards Code (the Code).`
Division 1 of Part 3 of the FSANZ Act specifies that the Authority may accept applications for the development or variation of food regulatory measures, including standards. This Division also stipulates the procedure for considering an application for the development or variation of food regulatory measures.
FSANZ accepted Application A1057 which sought approval of a new enzyme processing aid, an endo-protease (EC 3.4.21.26) sourced from a genetically modified Aspergillus niger microorganism, to be used as a processing aid. The Authority considered the Application in accordance with Division 1 of Part 3 and approved a variation to Standard 1.3.3. FSANZ notified the Australia and New Zealand Food Regulation Ministerial Council (Ministerial Council) of the approval.
Following consideration by Ministerial Council, section 92 of the FSANZ Act stipulates that the Authority must publish a notice about the draft standard or draft variation of a standard.
Section 94 of the FSANZ Act specifies that a standard, or a variation of a standard, in relation to which a notice is published under section 92 is a legislative instrument, but is not subject to parliamentary disallowance or sunsetting under the Legislative Instruments Act 2003.
2. Purpose and operation
Currently, there is no permission for using this endo-protease sourced from a genetically modified Aspergillus niger microorganism, to process food. The variation is proposed to address this.
3. Documents incorporated by reference
The variation does not incorporate any documents by reference.
4. Consultation
In accordance with the procedure in Division 1 of Part 3 of the FSANZ Act, the Authority’s consideration of Application A1057 has included one round of public consultation following an assessment and the preparation of the draft variation. An Assessment Report (which included the draft Standard) was released for consultation on 18 July 2011 for a six-week consultation period.
A Regulation Impact Statement (RIS) was not required because the variation to Standard 1.3.3 is likely to have a minor impact on business and individuals.
5. Statement of compatibility with human rights
This instrument is exempt from the requirements for a statement of compatibility with human rights as it is a non-disallowable instrument under section 97 of the FSANZ Act.
6. Variations
Item [1] inserts a permission in the Table to clause 17 of Standard 1.3.3 to permit the use of endo-protease (EC 3.4.21.26) sourced from Aspergillus niger as an enzyme processing aid from microbial sources able to be used in the manufacture of any food.
Overview
The Food Standards (Application A1057 – Endo-protease (EC 3.4.21.26) as a Processing Aid (Enzyme)) Variation 2012 was enacted to address the need for regulatory approval of a specific enzyme processing aid, endo-protease sourced from a genetically modified Aspergillus niger microorganism, for use in food processing. This legislative instrument is an outcome of the Food Standards Australia New Zealand Act 1991 (FSANZ Act), enacted by the Parliament of Australia, with the policy objective of ensuring food safety and public health by regulating food standards. FSANZ accepted and approved Application A1057 after a round of public consultation, and the variation was subsequently notified to the Australia and New Zealand Food Regulation Ministerial Council, which considered and endorsed the approval. The variation was published as a legislative instrument under the FSANZ Act and, while subject to certain procedural requirements, is not subject to parliamentary disallowance or sunsetting under the Legislative Instruments Act 2003. This variation aims to fill the existing regulatory gap by legally permitting the use of this specific enzyme in food processing.
Scope and Application
The F2012L00024 legislation pertains to the variation of food regulatory measures concerning the use of a specific enzyme as a processing aid, as outlined in the Food Standards Australia New Zealand Act 1991. This legislation applies to all entities involved in the manufacture of food in Australia, specifically targeting the use of endo-protease (EC 3.4.21.26) sourced from genetically modified Aspergillus niger microorganisms as a processing aid. The variation to Standard 1.3.3 of the Australia New Zealand Food Standards Code allows for the utilisation of this particular enzyme in food processing, which was previously unpermitted. The application of this Act is governed by the Commonwealth and extends to all food manufacturers within Australia. While the Act itself does not specify exclusions or exemptions, the FSANZ Act may provide for such provisions through subordinate instruments. The Authority’s approval and subsequent publication of the variation ensure that it complies with the legislative process outlined in the FSANZ Act.
Key Provisions
The main operative section of this legislation is Item [1], which modifies Standard 1.3.3 of the Australia New Zealand Food Standards Code (the Code). This amendment allows the use of endo-protease (EC 3.4.21.26) sourced from Aspergillus niger as an enzyme processing aid in the manufacture of any food. This is a significant change as, previously, there was no explicit permission for using this specific endo-protease in food processing (Section 2). The Authority has ensured this change follows a structured procedure, including a round of public consultation and an assessment, as mandated by Division 1 of Part 3 of the Food Standards Australia New Zealand Act 1991 (the FSANZ Act) (Section 4).
The Act imposes several obligations on the parties and entities it governs. Food Standards Australia New Zealand (FSANZ) must develop and vary food standards in accordance with the FSANZ Act, which includes accepting applications for new processing aids and ensuring proper consultation processes are followed. The Authority must also notify the Australia and New Zealand Food Regulation Ministerial Council (Ministerial Council) of any approved variations and publish notices about draft standards or variations as required by sections 92 and 94 of the FSANZ Act. Additionally, the variation of Standard 1.3.3 is exempt from the Legislative Instruments Act 2003's disallowance and sunsetting provisions (Section 94).
The legislation does not explicitly outline offences, penalties, or civil/criminal consequences for breaches of the new standard. However, as a legislative instrument under the FSANZ Act, non-compliance with the approved variation might lead to enforcement actions by FSANZ or relevant authorities, which could include recalls, fines, or other regulatory sanctions. The precise consequences for non-compliance would depend on the specific context and severity of the breach, as well as any additional regulations or guidelines set forth by FSANZ or related authorities.
In summary, the key provisions of this legislation focus on updating Standard 1.3.3 to permit the use of endo-protease (EC 3.4.21.26) from Aspergillus niger as a processing aid in food manufacturing. The FSANZ Act mandates the Authority to consider applications, consult the public, and notify relevant councils, ensuring a transparent and regulated process. While specific penalties for non-compliance are not detailed in this instrument, potential consequences could include enforcement actions by FSANZ or related authorities.