EXPLANATORY STATEMENT
Amendments to
Food Standards Australia New Zealand
Application Guidelines
(known as Part 3 of the FSANZ Application Handbook)
Amendment No. 1 – 2008
1. Purpose
Section 23 of the Food Standards Australia New Zealand Act 1991 (FSANZ Act) empowers Food Standards Australia New Zealand (FSANZ) to make guidelines by legislative instrument:
(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.
The guidelines are a legislative instrument for the purposes of the Legislative Instruments Act 2003, but are not subject to sunsetting or disallowance. For the purposes of section 23, Part 3 of the FSANZ Application Handbook which was originally approved by the FSANZ Board in March 2007, fulfils these requirements.
Applications to amend the Australia New Zealand Food Standards Code (the Code) need to be supported by all information as determined by FSANZ in writing and in advance – these are contained in Part 3 of the FSANZ Application Handbook. If the information requirements are not met, then FSANZ has the power under the FSANZ Act to reject an application at the ‘Administrative Assessment’ stage.
FSANZ has approved amendments to Part 3 of the Application Handbook for the following reasons:
- Assessments of applications should generally be able to proceed without past delays where FSANZ seeks further information or data from an applicant to enable assessment of the application to proceed. This will assist in ensuring that statutory timeframes are met.
- Part 3 fulfils the intention of the FSANZ Act amendment that there be clearly defined application requirements, including the requirement to provide supporting material with applications.
The amendments cover a number of areas:
- to update text to reflect recent amendments to Standard 1.5.1 – Novel Foods, which allows applicants to seek exclusivity of use of a novel food;
- to respond to comments from applicants since the information requirements in Part 3 took effect, amendments throughout the guideline on novel foods (3.5.2) to change a number of mandatory data requirements to non-mandatory requirements. This will address concerns that the guidelines as they stood, were too rigid, thus stifling industry innovation; and
- to make a number of minor amendments relating to correction and clarification of text, and references.
Details of the amendments are set out in Attachment 1.
1.1 Application ‘Guidelines’
Under section 22 of the FSANZ Act, an application to amend 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.
If the information requirements are not met, then FSANZ has the power under section 26 of the FSANZ Act to reject the application after a 15-day Administrative Assessment.
2. Consultation
A list of approximately 600 people with an interest in the Application Handbook are on a stakeholder mailing list. This list was originally compiled for consultation on the initial development of the Handbook in 2006-07. An alert was also included in the Food Standards Notification Circulars of 11 April and 22 April 2008. Over 3,800 people are on the mailing list for this alert.
The Board initially considered the proposed amendments at the teleconference held on
26 March 2008 and were also alerted to the call for comment.
The proposed amendments were released on 28 March 2008 with a closing date of 28 April 2008. Comments from six submitters were received (see Attachment 2).
Two additional, but very minor, amendments to correct incorrect errors in the checklist of novel foods have been included in these amendments, which were not consulted on, as they were discovered after consultation had commenced.
3. Impact Analysis
The impact analysis represents likely impacts based on available information. The impact analysis is designed to assist in the process of identifying the affected parties, any alternative options consistent with the objective of the proposed changes, and the potential impacts of any regulatory or non-regulatory provisions.
Two options are identified in relation to the proposed amendments:
Option 1 – Not proceed with the amendments to Part 3 of the Application Handbook.
Option 2 – Proceed with the amendments to Part 3 of the Application Handbook.
3.1 Affected Parties
Parties affected by the amendments to Part 3 include:
- potential applicants from industry and consumers generally, who may be affected either positively or negatively; and
- FSANZ.
3.2 Benefit Cost Analysis
3.2.1 Option 1 – Not proceed with the amendments to Part 3 of the Handbook
3.2.1.1 Benefits
- for applicants and FSANZ, this option would not result in any discernable benefits.
3.2.1.2 Costs
- Applicants will be disadvantaged if their completion of the assessment of their applications is delayed due to insufficient information.
- Part 3 of the Application Handbook would not accurately reflect the Code.
- The mandatory data requirements in 3.5.2 will not assist in industry innovation.
3.2.2 Option 2 – Proceed with the amendments to Part 3 of the Application Handbook
3.2.2.1 Benefits
- Applicants will be able to release products into the market in a timely manner.
- FSANZ will not have to assess applications which are deficient in relevant data thus freeing-up resources for other work.
- The data requirements under 3.5.2 will assist in industry innovation.
3.2.2.2 Costs
- for applicants and FSANZ, this option would not result in any discernable costs.
3.3 Comparison of Options
FSANZ considers the impact of various regulatory (and non-regulatory) options on all sectors of the community. There was no other option other than to proceed with the amendments.
4. Commencement
These variations commence on the date of the registration of this instrument.
ATTACHMENTS
1. Details of the Amendments to Part 3 of the FSANZ Application Handbook
2. Consultation on amendments to the FSANZ Application Handbook
ATTACHMENT 1
Details of the Amendments to Part 3 of the FSANZ Application Handbook
Schedule Amendments
Item [1.1], [11.2]
These amendments are to correct typographical errors.
Item [1.2]
This amendment is to clarify the requirements in relation to an exclusive capturable commercial benefit.
Item [2]
These amendments have been made to clarify the meaning of the text.
Items [3], [7], [8], [10]
This amendment is to minimise confusion between mandatory requirements and additional information material by changing the references to additional FSANZ guidance documents to ensure the term ‘guideline’ is not used.
Items [4] and [5]
The proposed amendment is designed to ensure that new and possibly unexpected sources of exposure to known allergens from food additive or processing aid formulations can be systematically and consistently assessed. The provision of this information will enable the risk assessment, risk management and risk communication aspects of the new or potentially unexpected exposure to known allergens to be considered. This information could also facilitate the development of any additional information requirements that may be necessary (e.g. fact sheets).
The Food Industry Guide to Allergen Management and Labelling already includes guidance for industry on providing information about allergens in food additive and processing aid formulations. The proposed amendment complements this guidance.
Item [6]
This has been amended to reflect that FSANZ has no grounds to require demonstration of benefit for nutritive substances (other than vitamins and minerals), when Ministerial Council policy guidelines do not exist.
Item [9], [11.1]
Adjustments have been made to ‘must’ and ‘should’ in response to comments from novel food applicants about guidelines being too restrictive with no flexibility. There has also been the inclusion of a reference to exclusivity of use of novel foods.
ATTACHMENT 2
Stakeholder comments on amendments to Application Handbook – April 2008
Issue | Submitter | FSANZ Comment / Action |
3.2.1 General Food Labelling |
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In relation to This includes both the information contained on the label and the way in which this information is presented on the food product, and the conditions that govern such information. (this is confusing; delete ‘both’, or replace the last ‘and’ with ‘including’.
| Dairy Food Safe Victoria | Amendment made |
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|
|
3.5.2 Novel Foods |
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Note: In The term novel food includes both whole foods and food ingredients – these terms are used both together or separately in this document, depending on the circumstances, replace ‘both’ with ‘either’. | Dairy Food Safe Victoria | Amendment made |
A2 Amendment (a) to read ‘at-risk population groups within the general population;’ | Dairy Food Safe Victoria | To be amended to the phrase after ‘at-risk population groups’ |
A4 Exclusive use of novel foods: Add ‘(c)’ evidence the applicant has entitlement to claim the product is a novel food e.g. patents etc + Amend (a) and (b) to allow for a third item | Dairy Food Safe Victoria | No amendment made – exclusivity of use is not about whether the food is novel – as the food must satisfy the definition of ‘novel food’ in Std 1.5.1. to be allowed exclusivity in the 1st place |
B1 Technical Information on the novel food (Note): In the second last line of the second last paragraph the word ‘or’ should also be removed after the shaded words ‘a nutritive substance’. | Food Technology Association of Australia Dairy Food Safe Victoria | Amendment t made |
B.6 Analytical method for detection: We suggest two minor changes to the text in Item 16 as follows (changes bold and underlined): The application should contain the following information: This part includes a method for detection of the novel food ingredient and, or its degradation products in the foods in which it will be used, where relevant. | NZFSA | Agree with the intent of the suggestion, although prefer alternative wording. This part includes a method for detection of the novel food ingredient or its degradation products (where relevant) in the foods in which it will be used. |
C Note: Amend Therefore, the data required for a safety assessment will vary to The data required for a safety assessment will therefore vary | Dairy Food Safe Victoria | Amendment made |