Food Standards Australia New Zealand

FOOD STANDARDS NOTIFICATION CIRCULAR

12 December 2007

[8-07]

This Notification Circular includes notices that are required to be given to the public, submitters and appropriate government agencies, under the Food Standards Australia New Zealand Act 1991 (FSANZ Act). All references below to sections of legislation, are to the FSANZ Act unless otherwise indicated.

Further information about the applications, proposals and other matters mentioned below, including assessment reports, processes and – where applicable – reasons for decisions, can be accessed on the FSANZ website at  www.foodstandards.gov.au under < Standards Development>, then < Documents for Public Comment> and then. Persons may contact FSANZ at one of the addresses below to arrange alternative access to these documents:

The Information Officer

The Office Administrator

Food Standards Australia New Zealand

Food Standards Australia New Zealand

PO Box 7186

PO Box 10559

CANBERRA BC   ACT   2610

WELLINGTON   6036

AUSTRALIA

NEW ZEALAND

Tel   +61 2 6271 2241      Fax   +61 2 6271 2278

Tel   +64 4 978 5630        Fax   +64 4 473 9855

Email:   info@foodstandards.gov.au

Email:   info@foodstandards.govt.nz

General questions on the work of FSANZ should be directed to the Information Officer at the either of the addresses above. Queries concerning the matters in this Circular on assessment or submission processes should be directed to the Standards Management Officer at standards.management@foodstandards.gov.au .

PROGRESS ON APPLICATIONS AND PROPOSALS

Details on Final Assessments, notifications to Council, Council processes and Gazettals from the notice below were published on 12 December 2007 in The Australian and The New Zealand Herald newspapers, as well as on the Food Standards Australia New Zealand website.

NEW APPLICATIONS

(Note that this section is not a call for public comment)

FSANZ has received the following Applications and placed them on the FSANZ Food Standards Development Work Plan:  

GENERAL PROCEDURE

  • Application A1002 – Conjugated Linoleic Acid Triglycerides as a Novel Food: to approve a chemically defined mixture of conjugated linoleic acid triglycerides derived from food-grade safflower oil with a high linoleic acid content as a novel food [17 October 2007] [Cognis GmbH via Axiome Pty Ltd]

Information on the each application, including the proposed Work Plan Category, an anticipated timetable for assessment and consultation opportunities, is provided in the FSANZ Food Standards Development Work Plan which is available on the FSANZ website at http://www.foodstandards.gov.au/standardsdevelopment/standardsworkplan.cfm . In relation to Application A1002, the Administrative Assessment Report can be accessed on the FSANZ website at http://www.foodstandards.gov.au/standardsdevelopment/applications/index.cfm .

If you wish to be advised of any developments relating to the above Applications, such as calls for public submissions, please contact the Standards Management Officer at standards.management@foodstandards.gov.au .  Please note that the above section is not a call for public comment.

APPLICATIONS AND PROPOSALS

(Received or prepared before 1 October 2007)

Initial Assessment – Applications[s.14(1)]

FSANZ received Applications for the development or variation of the following food regulatory measures; accepted the Applications after making an Initial Assessment of them; will make Draft Assessments of these Applications; and invites written submissions on matters relevant to the Applications (with the exception of Applications A607, A610 and A612 – see Draft Assessment below) to be made to FSANZ by 6pm (Canberra time) 6 February 2008:

  • Application A576 – Labelling of Alcoholic Beverages with a Pregnancy Health Advisory Label:   to require a health advisory label on alcoholic beverage containers advising of the risks of consuming alcohol when planning to become pregnant and during pregnancy   [Received 17 February 2006]
  • Application A583 – Country of Origin Labelling Requirements for Unpackaged Pork Products:   to remove the country of origin labelling requirements for pork, whole or cut, that has been preserved by curing, drying, smoking or other means   [Received 12 April 2006] [Australia only]
  • Application A607 – Maximum Residue Limits (April, May, June 2007):   to amend maximum residue limits for a number of agricultural and veterinary chemicals   [Received 15 May 2007] [Australia only]*
  • Application A610 – Maximum Residue Limits (July, August 2007):   to amend maximum residue limits for a number of agricultural and veterinary chemicals   [Received 8 August 2007] [Australia only]*
  • Application A612 – Maximum Residue Limits – Dimetridazole (Antibiotic):   To reduce maximum residue limits for the antibiotic dimetridazole   [Received 20 August 2007] [Australia only]*
  • Application A614 – Food derived from Glyphosate-tolerant Cotton Line GHB614:   to approve food derived from cotton genetically modified to provide tolerance to the herbicide glyphosate [Received 27 September 2007]
  • Application A615 – Food derived from Insect-protected Cotton Line COT67B:   to approve food derived from cotton genetically modified to provide resistance to Lepidopteran species [Received 27 September 2007]

Draft Assessment – Applications[s.17(2), s.17A(2)]

FSANZ has prepared draft food regulatory measures or variations for the following Applications; will make Final Assessments in relation to each of these drafts; and invites written submissions for the purpose of making a Final Assessment by 6pm (Canberra time) 6 February 2008:

  • Application A566 – L-5-Methyltetrahydrofolate, Calcium as a Permitted Form of Folate:   to allow L-5-methyltetrahydrofolate, calcium salt (L-MTHF) as a permitted form of folate in Standard 1.1.1
  • Application A570 – Ferric Sodium Edetate as a Permitted Form of Iron:   to amend Standard 1.1.1 to include ferric sodium edetate as a permitted form of iron
  • Application A577 – Calcium in Chewing Gum containing no more than 0.2% Residual Sugars:   to permit the addition of calcium to chewing gum (containing no more than 0.2% residual sugars) at a maximum claim level of 100 mg (12.5 % of the RDI) per serve, allowing all forms of calcium currently permitted in the Schedule to Standard 1.1.1
  • Application A595 – Food derived from Insect-Protected Corn Line MON89034:   to seek permission for food derived from maize genetically modified to provide protection against Lepidopteran pests
  • Application A602 – Extraneous Residue Limit in Honey (Paradichlorobenzene):   to include an Extraneous Residue Limit (ERL) in Schedule 2 of Standard 1.4.2 for paradichlorobenzene in honey [Australia only]*
  • Application A606 – Asparaginase as a Processing Aid (Enzyme):   to seek the approval for a new enzyme preparation produced from a genetically modified strain ofAspergillus oryzaefor use in food production to reduce the risk of acrylamide formation
  • Application A607 – Maximum Residue Limits (April, May, June 2007):   to amend maximum residue limits for a number of agricultural and veterinary chemicals [Australia only]*
  • Application A610 – Maximum Residue Limits (July, August 2007):   to amend maximum residue limits for a number of agricultural and veterinary chemicals [Australia only]*
  • Application A612 – Maximum Residue Limits – Dimetridazole (Antibiotic):   to reduce maximum residue limits for the antibiotic dimetridazole [Australia only]*

Draft Assessment – Proposals [s.17AA(1), s.17AB(1)]

FSANZ has prepared draft food regulatory measures or variations for the following Proposal; will make a Final Assessment in relation to the draft; and invites written submissions for the purpose of making a Final Assessment by 6pm (Canberra time) 5 March 2008:


  • Proposal P290 –Food Safety Programs for Catering Operations to the General Public:   to amend Standard 3.2.1 to make food safety programs mandatory in catering operations serving food to the general public [Australia only]

After making a Draft Assessment of the following Proposal, FSANZ decided to abandon the Proposal:

  • Proposal P260 –Use of Non-culinary Herbs in Food:   To consider the issues associated with the use of non-culinary herbs in food and, if necessary, to review the current food standards to ensure that public health and   safety is adequately protected

Final Assessment and Council Notification – Applications And Proposals – Draft Standards [s.19(1), s.20(4A)]

After making a Final Assessment in relation to draft variation for the following Applications and Proposals, FSANZ decided to approve the draft variations under section 18 of the FSANZ Act.   FSANZ has given the Australia and New Zealand Food Regulation Ministerial Council (Ministerial Council) written notification of these approvals:

EFFECT OF DIVISIONS 3 AND 4 OF PART 3 OF THE FSANZ ACT

A standard or variation approved by FSANZ does not become legally enforceable until:

  • the Ministerial Council has been notified of the standard or variation; and
  • the Ministerial Council process in relation to the standard or variation is finalised; and
  • FSANZ has fulfilled the publication requirements under the FSANZ Act.  

Once FSANZ has notified the Ministerial Council that it has approved the draft standard or variation, the Ministerial Council has 60 days to either request FSANZ to review the approved standard or inform FSANZ that it does not intend to request a review.

If the Ministerial Council requests a review, FSANZ must, within 3 months (or longer if the Ministerial Council allows), complete the review and notify the Ministerial Council of a decision to either:

  • maintain its original approval; or
  • to amend its approval; or
  • withdraw its approval; and

give the Ministerial Council FSANZ’s reasons for its decision.

If FSANZ has not withdrawn its approval, the Ministerial Council has another 60 days to either request a second review or inform FSANZ that it does not intend to request a second review.  

If the Ministerial Council requests a second review, the procedures and timeframe are the same as for the first review.   Once an approved standard has been reviewed twice, the Ministerial Council has 60 days to inform FSANZ that the Council does not intend to amend or reject the approved standard, or to amend or reject the approved standard.  

If the Ministerial Council informs FSANZ that:

  • it does not intend to request a review of the approved standard; or
  • it does not intend to amend or reject the approved standard; or
  • it has amended the approved standard after the second review;

FSANZ will publish a notice in the Commonwealth (published by FSANZ as the Food Standards Gazette) and New Zealand Gazettes and in newspapers stating when the standard or variation comes into effect. FSANZ will also publish this notice along with the text of the standard on the FSANZ website and make copies of these available for inspection by the public. The standard becomes legally effective on the date specified in the notice.

MINISTERIAL COUNCIL REVIEW PROCESS (s.21-23)

In accordance with these requirements, FSANZ has completed its First Review in relation to the following Proposal and re-affirmed its approval of the approved draft Standard:

  • Proposal P272 – Labelling Requirements for Food for Catering Purposes & Retail Sale

GAZETTAL [s.23A]

Amendment 94 Published

Amendment No. 94 to the Australia New Zealand Food Standards Code was published by FSANZ on 11 October 2007 (FSC 36). It included amendments resulting from the following Applications and Proposal:

APPLICATION REJECTED [ s.13(2)]

The following Applications have been rejected by FSANZ at Initial Assessment under s.13(2)(b) of FSANZ Act as they are identical to another Application (Application A611):

  • Application A616 – Labelling of Fluoridated & Non-fluoridated Water in Ingredients List 2
  • Application A617 – Labelling of Fluoridated & Non-fluoridated Water in Ingredients List 3

APPLICATION WITHDRAWN [s.12A(2)]

The following Application has been withdrawn by the Applicant:

  • Application A529 – Definition of Lactose-Free Infant Formula Products

OTHER MATTERS

Consultation Paper – Proposal P293 – Nutrition, Health & Related Claims

Prior to the completion of the Final Assessment of Proposal P293, FSANZ is releasing a Consultation paper on specific issues for public comment. FSANZ invites written submissions for the purpose of making a Final Assessment by 6pm (Canberra time) 1 February 2008.

Amendments to the FSANZ Act

Major amendments to the Food Standards Australia New Zealand Act 1991 passed the Australian Parliament on 20 June 2007 and were proclaimed on 1 July 2007. These amendments affect how FSANZ assesses applications received and proposals prepared to amend the Australia New Zealand Food Standards Code from 1 October 2007 onwards. Further information on these changes is available from the FSANZ website at http://www.foodstandards.gov.au/standardsdevelopment/informationforapplicants/index.cfm

Email address changes

The email address ‘slo@foodstandards.gov.au’ has been discontinued. Two new email addresses, standards.management@foodstandards.gov.au (for all general inquiries about standards issues) and submissions@foodstandards.gov.au (for public submissions on assessment reports only) have been created. Any emails sent to ‘slo’ will be automatically redirected to the new ‘standards.management’ email address.

*Indicates a matter in relation to which FSANZ has decided not to hold a round of consultation between Initial and Draft Assessment, as it is satisfied that omitting to hold such consultation will not have a significant adverse effect on the interests of anyone/the Application raises issues of minor significance or complexity only (s. 36(1C)). A person whose interests are affected by this decision may: subject to the Administrative Appeals Tribunal Act 1975, make an application to the Administrative Appeals Tribunal for review of FSANZ’s decision; and except where subsection 28(4) of that Act applies, in accordance with section 28, may apply for a statement in writing setting out the findings of material questions of fact, referring to the evidence or other materials on which those findings were based and giving the reasons for the decision.  

[Australia only] These matters relate to ‘Australia only’ standards that are not part of the joint regulatory arrangements with New Zealand. However, food from Australia complying with these standards may be supplied in New Zealand. Anyone may provide submissions in relation to these matters, if the matter is open for public comment.