Appendix 2 – Applications and Proposals processed
Section 69 of the Food Standards Australia New Zealand Act 1991(FSANZ Act) requires FSANZ to report on its processing of Applications and Proposals in the following manner:
(a) The number of A pplications made to FSANZ under section 12 of the FSANZ Act in 2006-07:
24
(b) The number of Applications so made that were disposed of during 2006-07 and the manner of their disposal:
(i) 0 were withdrawn by the Applicants;
(ii) 0 were rejected by FSANZ;
(iii) 2 were finalised and notified to ANZFRMC;
(iv) 0 were considered after a request for a review and notified to ANZFRMC; and
(v) 22 were either placed on the standards Work Plan as provided under section 10A, or being progressed as at 30 June 2007.
In addition, during 2006-2007, FSANZ progressed 48 Applications received prior to 1 July 2006:
(v) 5 were withdrawn by the Applicant;
(vi) 0 were rejected by FSANZ;
(vii) 12 were finalised and notified to ANZFRMC;
(viii) 5 were considered after a request for a review and notified to ANZFRMC; and
(ix) 27were still being progressed as at 30 June 2007.
(c) The number of Proposals made by FSANZ under section 12AA of the FSANZ Act during 2006-07:
1
(d) The number of Proposals so made that were disposed of during 2006-07 and the manner of their disposal:
(i) 0 were abandoned by FSANZ;
(ii) 0 was finalised and notified to ANZFRMC;
(iii) 0 were considered after a request for a review and notified to ANZFRMC; and
(iv) 1 was still being progressed as at 30 June 2007.
In addition, during 2006-2007, FSANZ progressed 20 Proposals prepared prior to 1 July 2006:
(v) 0were abandoned by FSANZ;
(vi) 5were finalised and notified to ANZFRMC;
(vii) 2were considered after a request for a review and notified to ANZFRMC; and
(viii) 14 were still being progressed as at 30 June 2007.
(e) Any occasion during that year that FSANZ, after preparing a draft standard or a draft variation of a standard, failed to make a decision under section 18 of the FSANZ Act within the period required under section 35 and a statement of the reasons for that failure; and
A569 Due 17 August 2006, Final Assessment made 21 September 2006.
FSANZ did not complete the assessment of Application A569 within the required 12 months. Due to an oversight, FSANZ did not request an extension of time. This oversight was partly brought about by staff changes with responsibility for coordinating the project.
(f) Extensions of time FSANZ granted under subsection 35(2) of the FSANZ Act during 2006-07 and the reasons for those extensions:
A512 (6 months) Public submissions received in the first round indicated support for the request to change the definition of meat pies, but raised many issues concerning other aspects of the Application. Additional time was required to fully address the issues raised in the submissions.
A532 (2 months) The complexity of the Draft Assessment stage increased because of developments and opinions occurring at the international level. In response to these developments, the Applicant changed the intent of the Application. As a result, FSANZ is developing a more rigorous scientific assessment, which is causing the Draft Assessment to take longer than expected.
A542 (6 months) At the request of t he Victorian Department of Human Services, FSANZ had to consider the implications of antimicrobial resistance resulting in humans from the extension of use of natamycin in foods, particularly as natamycin is apparently used in a number of human treatments for fungal conditions. Natamycin is used clinically to treat minor skin infections in New Zealand, and there is anecdotal evidence that topical ointments containing natamycin are also available in Australia, although there are no current listings of such medications on the Australian Register of Therapeutic Goods.
A549 (3 months) Following Draft Assessment, FSANZ received a significant submission from the New Zealand Centre for Integrated Biosafety. This submission, of almost 100 pages, raised a number of issues that require substantial work by FSANZ staff to address. A further extension of time was necessary to complete the Application.
A577 (6 months) An extension of time was necessary due to the complexity of issues that the Application poses for FSANZ. These issues include whether the Application should be assessed on the grounds of nutritional benefit and/or health benefit, and what level of evidence will be required; and potential policy implications. The Application also raises issues on the potential for consumers to be misled.
Additional time to undertake a robust assessment of this Application, particularly in relation to the efficacy and bioavailability of the proposed fortification is also required.
A580 (6 months) This is the first GM application dealing with a genetically modified crop developed for an industrial purpose, i.e. ethanol production. FSANZ staff have been considering the appropriateness of, and potential alternatives to granting a full regulatory approval for this corn line and other GM crops not intended for, but capable of being used in the food supply.
The unique characteristics of this particular genetic modification also raise questions of potential impacts on human nutrition and food technological processes. In addition to our routine GM food safety assessment, an additional human nutritional assessment and a food technological assessment were required. As a measure of scientific rigor, the draft safety assessment report was also peer-reviewed.
(g) The number of applications made to the Administrative Appeals Tribunal during 2006-07 for a review of a decision made by FSANZ.
Nil
(h) The results of the applications made to the Administrative Appeals Tribunal that were determined during that year:
Nil
(i) The number of standards made under the FSANZ Act during 2006-2007:
25 (this includes both standards and variations to standards gazetted)
(j) The number of draft standards and draft variations approved during 2006-2007 under:
(i) section 18 of the FSANZ Act; or
19
(ii) subsection 26(1) of the FSANZ Act
0
(k) The number of occasions during that year when requests were made under section 21 of the FSANZ Act for a review of a draft standard or draft variation:
4
(l) The number of occasions during that year when requests were made under section 22 of the FSANZ Act for a review of a draft standard or draft variation:
0
(m) The number of occasions during that year when a draft standard or draft variation was rejected under section 23 of the FSANZ Act:
Nil
(n) The number of occasions during that year when requests were made under section 28A of the FSANZ Act for a review of a standard or variation:
Nil
(o) The number of occasions during that year when requests were made under section 28B of the FSANZ Act for a review of a standard or variation:
Nil
(p) The number of occasions during that year when a standard or variation was revoked or amended under section 28C of the FSANZ Act:
Nil
(q) A summary of policy guidelines notified to FSANZ during 2006-07 under paragraph 10(2)(e) of the FSANZ Act:
Policy Guideline on the Regulation of Residues of Agricultural and Veterinary Chemicals in Food (notified to FSANZ on 31 October 2006).
The purpose of this Guideline is to form a framework within which FSANZ is to consider alternative approaches to address the issues surrounding the current zero tolerance approach to the regulation of residues of agricultural and veterinary chemicals in food.
(r) such other matters (if any) as are specified in the regulations:
Nil