Explanatory Statement

Amendments to the FSANZ Application Handbook

Amendment No. 7 – 2016

1. Authority

Under section 22 of the Food Standards Australia New Zealand Act 1991 (FSANZ Act), an application to amend the Australia New Zealand Food Standards Code (the Code) must:

(a) be in writing; and

(b) if the form in which the application is to be made is specified in the guidelines made under section 23—be in the form specified; and

(c) include all of the information that, under the guidelines made under section 23 is to be included with the application; and

(d) include each thing that, under the guidelines made under section 23, is to be included with the application; and

(e) identify the procedure that, in the applicant’s view, applies to the consideration of the application.

Section 23 of the FSANZ Act empowers Food Standards Australia New Zealand (FSANZ) to make guidelines:

(a) specifying the form in which applications for the development of a food regulatory measure, or the variation of a food regulatory measure, are to be made; and

(b) specifying the information, or the kinds of information, to be included with such applications; and

(c) specifying any thing, or kind of thing, to be included with such applications.

If the guidelines are not met, FSANZ has the power under section 26 of the FSANZ Act to reject the application after a 15-day Administrative Assessment. The guidelines referred to in section 23 are contained in Part 3 of the FSANZ Application Handbook (Handbook). The guidelines are a legislative instrument for the purposes of the Legislative Instruments Act 2003.

2 Purpose and operation

The purpose of the Instrument is to amend Part 3 of the Handbook in order to improve the quality of guidance available to potential applicants.

3 Documents incorporated by reference

These amendments do not incorporate any documents by reference.

4 Consultation

Nearly 300 people with an interest in the Handbook are on a stakeholder mailing list for consultation on the amendments. This mailing list contains all previous applicants, in addition to industry representatives, consultants and consumers. Everyone on the mailing list was emailed an alert about the call for submissions. Email alerts were also included as part of the publication of the Food Standards Notification Circular. Nearly 5300 people are on the mailing list for this alert.

Five submissions were received – all generally supportive of the amendments. Most submitters made specific comments on certain issues. FSANZ has addressed each of those comments and either responded by making further amendments or explained why further action was not required. The submissions and FSANZ’s responses are available on the FSANZ website[1].

5. Impact analysis

The Office of Best Practice Regulation has advised FSANZ that a regulation impact statement (RIS) was not required for the amendments to Part 3 as the changes are of a minor nature (RIS ID: 19696).

Two options were identified in relation to the proposed amendments to Part 3:

Option 1 – Proceed with the amendments.

Option 2 – Not proceed with the amendments.

Parties affected by the amendments to Part 3 include:

• potential applicants from industry and consumers generally, who may be affected either positively or negatively
• the Authority.

In relation to Option 1, for applicants and FSANZ, this option would not result in any discernible costs as the information would be required of applicants for an assessment to proceed, whether or not the requirements were mandatory.

FSANZ would not be required to assess applications which do not meet mandatory information requirements, thus freeing-up resources for other work. Applicants, whose applications have been accepted because they have provided the relevant data with their application, would have their applications assessed by FSANZ within statutory timeframes and without undue delays, thus facilitating release of products into the market in a timely manner. FSANZ’s assessments will be more efficient because the required information will be supplied up-front. Staff do not have to wait for key information to be provided, minimising delays.

There will also be an efficiency gain for affected applicants as the mandatory information will be collected and incorporated into applications in a single process, before acceptance by FSANZ. For example, costs associated with responding to FSANZ’s requests for further information after the assessment has commenced will be reduced. In addition, as FSANZ is proposing to remove the requirement for a hard copy of the full application and references, this will result in less direct costs to applicants.  

Option 2 would not result in any discernible benefits. Applicants providing insufficient information would experience protracted assessment timeframes, as FSANZ would not be able to complete its assessment in the absence of missing information.

FSANZ has therefore decided to proceed with Option 1. 

An impact analysis was not required for the associated amendments to Parts 1 and 2 of the Handbook, which are also being made at this time, as these two Parts are provided to stakeholders for information only, and, as such, are not part of the legislative instrument (Part 3).

6 Statement of compatibility with human rights

The instrument is exempt from the requirements for a statement of compatibility with human rights as it is a non-disallowable instrument under subsection 23(4) of the FSANZ Act.

7 Amendments to Part 3 (mandatory requirements)

As the above proposed amendments are wide-ranging and affect every guideline, Part 3 in its entirety will be repealed and replaced.

Many of the amendments are mechanical in nature and relate to:

• correction of typographical errors
• amending terminology used throughout the Handbook to ensure consistency
• reducing duplication of text
• updating hyperlinks and other references
• changing references to standards in the current Code to standards and schedules in the revised Code which takes effect on 1 March 2016
• moving text from notes where that text was considered to included mandatory requirements
• moving text from Parts 1 and 2 and from Part 3 into notes where that text was considered to be explanatory
• clarifying the nature and extent of information that is required from applicants, particularly in the guideline for applications for food produced from gene technology.

7.1 Foods produced from gene technology

Guideline 3.5.1 has been substantially updated to reflect recent scientific developments, improve clarity and transparency, remove superfluous requirements and to introduce a more streamlined form of safety assessment approach for those products which are known through prior knowledge, evidence and experience to be lower risk. The significant changes that have been made include:

• The data requirements for novel substances have been made more explicit in relation to new proteins (B2), non-proteins (B3) and herbicide metabolites (B4) to avoid confusion, improve transparency and clarify the data requirements for each category of novel substance. In particular, under non-proteins, specific reference to RNA interference (RNAi), an increasingly used genetic modification technique, has been included.

• Removal of data requirements that were included for historical reasons but are now considered superfluous to the safety assessment e.g. information on intermediate hosts used in laboratory manipulations (this has no relevance to the safety of the food); details of an analytical method of detection (this requirement is already addressed by the requirement for the provision of the full DNA sequence of the insert and junction regions).

• Clarification of the data required for Open Reading Frames, as this has caused some confusion.

• Reducing the data requirements for those newly-expressed proteins that have previously been assessed by FSANZ or are derived from a species that is cross compatible with the host organism or are absent from the food-producing part of the host organism.

• Clarification of the following:

               the provision of a statistical analysis

               the provision of information on natural variation

               the requirement for experimental plants to be sprayed with the relevant herbicide where the trait is tolerant to that herbicide

               the provision of a whole food toxicity study.

8 Commencement

The Part 3 variations commence on 1 March 2016.

Related amendments to Parts 1 and 2 (information only) will be combined with Part 3 in an updated Handbook compilation and made available to the public on FSANZ’s website[2] on the same day as the registration of Part 3 as a legislative instrument.

[1] http://www.foodstandards.gov.au/code/changes/applying/Pages/consultationopportun3880.aspx

[2] http://www.foodstandards.gov.au/foodstandards/changingthecode/informationforapplicants/