FOOD STANDARDS NOTIFICATION SERVICE

NOTIFICATION CIRCULAR [5-05]

3 August 2005

Further information about the applications, proposals and other matters mentioned below, including assessment reports and – where applicable – reasons for decisions, can be accessed on the FSANZ website at www.foodstandards.gov.au under  <StandardsDevelopment> and then <Documents for Public Comment>.   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 address above.   Queries concerning the matters in this Circular or application or submission processes should be directed to the Standards Management Officer at slo@foodstandards.gov.au .

PROGRESS ON APPLICATIONS AND PROPOSALS

NOTICES.  The notice below was published on 3 August 2005 in The Australian and TheNew Zealand Herald newspapers as well as on the Food Standards Australia New Zealand website.

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 Initial Assessments of them; will make Draft Assessments of these Applications; and invites written submissions on matters relevant to the Applications to be made to FSANZ by  6pm (Canberra time) 14 September 2005:

• Application A560 – Phytosterols in Fruit Juice & Fruit Juice Drinks:   to seek permission to add unesterified vegetable oil-derived phytosterols to fruit juices and fruit drinks (minimum 20% juice). [Received 13 April 2005]
  
  
• Application A561 – Phospholipase A1 as a Processing Aid:   to seek the approval for a new enzyme produced from a genetically modified strain of Aspergillus oryzae for use in cheese manufacture. [received 26 April 2005]
  
  
• Application A564 – Food derived from Insect-protected Corn Line MIR604:   To seek permission for insect-protected corn line MIR604 to be listed in Standard 1.5.2 - Food Produced using Gene Technology. [Received 1 June 2005]

INITIAL ASSESSMENT - PROPOSALS [s.14A(1)]

FSANZ has prepared a Proposal for the development or variation of the following food regulatory measure; will make a Draft Assessment of this Proposal; and invites written submissions on matters relevant to the Proposal to be made to FSANZ by  6pm (Canberra time)14 September 2005:

• Proposal P298– Benzoate & Sulphite Permissions in Food:   to consider benzoate and sulphite permissions in all foods in response to findings of FSANZ’s 21st Australian Total Diet Survey, which found some population sub-groups in Australia consume amounts of benzoates and sulphites in excess of the Acceptable Daily Intake levels.  

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)14 September 2005:

• Application A500 – Fortification of Cereal-based Beverages:   to amend Standard 1.3.2 to permit fortification of beverages derived from cereals with selected vitamins and minerals.
  
  
• Application A553 – Food derived from Glyphosate-tolerant Cotton Line MON88913:   to seek permission for glyphosate-tolerant cotton MON88913 to be listed in Standard 1.5.2 – Food Produced using Gene Technology.

FINAL ASSESSMENT AND COUNCIL NOTIFICATION – APPLICATIONS AND PROPOSALS – DRAFT STANDARDS [s.19(1), s.20(4A)]

After making Final Assessments in relation to draft variations for the following Applications and Proposal, 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:

• Application A499 – To permit the Sale of Roquefort Cheese.
  
  
• Application A528 – Maximum Iodine Limit in Formulated Supplementary Foods for Young Children.
  
  
• Application A543 – Food from Insect-protected, Glufosinate Ammonium-tolerant Corn Line 59122-7.

• Application A547 – Maximum Residue Limits (September, October, November, December 2004).#
  
  
• Proposal P297 – Maximum Residue Limits – 2,4-D in Grapes.

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 theFood Standards Gazette) and New ZealandGazettesand 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 – APPROVED DRAFT STANDARDS (s.21 - 23))

In accordance with these requirements, FSANZ has completed its First Review in relation to the following Applications and re-affirmed its approval of the draft variations in relation to Applications A464 and A535, and re-affirmed its approval of the draft variations, subject to amendment in relation to Applications A433, A434 and A508:

• Application A433–Phytosterol Esters derived from Vegetable Oils in Breakfast Cereals.
  
  
• Application A434 – Phytosterol Esters derived from Vegetable Oils in Low-fat Milk & Yoghurt.
  
  
• Application A464 – Definition of ‘Wholegrain’.
  
  
• Application A508 – Phytosterols derived from Tall Oils as Ingredients in Low-fat Milk.
  
  
• Application A535 – Maximum Residue Limits – Neomycin (Antibiotic).
  
  

OTHER MATTERS

Amendment 78 Published

Amendment 78 to the Australia New Zealand Food Standards Code was published by FSANZ on 26 May 2005.   It included amendments resulting from the following Applications and Proposals:

• Application A493 – Iodine as a Processing Aid
• Application A513 – Octanoic Acid as a Processing Aid
• Application A522 – DHA-rich Micro-algal Oil fromUlkeniasp. as a Novel Food
• Application A534 – Maximum Residue Limits (March, April, May 2004)
• Application A539 – Maximum Residue Limits - Avilamycin (Antibiotic)
• Proposal P265 – Primary Production & Processing Standard for Seafood
• Proposal P284 – Minor Amendments Omnibus V

Amendment 79 Published

Amendment 79 to the Australia New Zealand Food Standards Code was published by FSANZ on 11 July 2005 in Australia and on 14 July 2005 in New Zealand.   It included an amendment resulting from the following Proposal:

• Proposal P297 – Maximum Residue Limits – 2,4-D in Grapes.

Amendment 80 Published

Amendment 80 to the Australia New Zealand Food Standards Code was published by FSANZ on 21 July 2005.   It included amendments resulting from the following Applications:

• Application A469 – Saccharin in Water-based Flavoured Drinks
• Application A541 – Maximum Residue Limits (June, July, August 2004)

*  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.