FOOD STANDARDS NOTIFICATION CIRCULAR

[8-06]

13 December 2006

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 , then and then.   Persons may contact FSANZ at one of the addresses below to arrange alternative access to these documents:

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

Details on Final Assessments, notifications to Council, Council processes and Gazettals from the notice below were published on 13 December 2006 in The Australian andThe New Zealand Herald newspapers as well as on the Food Standards Australia New Zealand website.

NEW APPLICATIONS

(Public comment is NOT being sought)

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

• Application A588 – Addition of Fluoride to Packaged Waters:   to permit the voluntary addition of fluoride, as a claimable nutrient, to packaged waters at a maximum level of 0.5 mg per 250 mL reference quantity (2 mg/L).   [Received 23 August 2006]
• Application A590 – Maximum Residue Limits – Avoparcin & Oxolinic Acid (Antibiotics)#*
• Application A591 – Maximum Residue Limits (October, November, December 2006)#* [Received 6 October 2006]
• Application A593 – Labelling of Palm Oil:   to amend Standards 1.2.4 and 2.4.1 to include and declare the labelling of Palm Oil [Received 24 October 2006]

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 .  

If you wish to be advised of any developments relating to these applications, such as calls for public submissions, please contact the Standards Management Officer at slo@foodstandards.gov.au .

Please note that public comment is NOT being sought at this stage.

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 (with the exception of Applications A586 and A587) invites written submissions on matters relevant to the Applications to be made to FSANZ by 6pm (Canberra time) 7 February 2007:

• Application A566 – L-5-Methyltetrahydrofolate, Calcium as a Permitted Form of Folate:   to allow L-5-methyltetrahydrofolic acid, calcium salt (L-methylfolate, calcium) as a permitted form of folate in Standard 1.1.1 [Received 6 July 2005]  
• Application A570 – Ferric Sodium Edetate as a Permitted Form of Iron:   To amend Standard 1.1. to include ferric sodium edetate as a permitted form of iron [Received 11 August 2005]
• Application A585 – Dimethyl Dicarbonate as a Processing Aid:   to delete the entries for dimethyl dicarbonate as a food additive in Standard 1.3.1 and insert identical permissions for dimethyl dicarbonate as a processing aid in Standard 1.3.3 [Received 17 May 2006]
• Application A586 – Maximum Residue Limits (July, August, September 2006) #*
• Application A587 – Maximum Residue Limits – Oxytetracycline (Antibiotic) #*
• Application A589 – Food Derived from Glufosinate Ammonium-tolerant Rice LLRICE62:   to seek permission for food derived from rice genetically modified to provide resistance to glufosinate ammonium.   [Received 6 September 2006]
• Application A592 – Food derived from Glyphosate-tolerant Soybean MON89788:   to seek permission for food derived from soybean genetically modified to provide tolerance to the herbicide glyphosate [Received 19 October 2006]

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) 21 February 2007 :

• Proposal P301 – Primary Production & Processing Standard for Eggs & Egg Products:   to develop an Australia only primary production and processing Standard to provide mandatory, nationally-consistent food safety measures that will apply to egg production and processing of egg products.#

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) 7 February 2007:

• Application A573 – Water Use in Winemaking – Amendment to Permitted Level:   to increase the current permitted level of added water to wine from 30 mL/L to 70 mL/L
• Application A578 – Isomaltulose as a Novel Food:   to allow the use of isomaltulose as a source of slow-release carbohydrate
• Application A586 – Maximum Residue Limits (July, August, September 2006) #*
• Application A587 – Maximum Residue Limits – Oxytetracycline (Antibiotic) #*

DRAFT ASSESSMENT – PROPOSALS [s.17AA(1), s.17AB(1)]

FSANZ has prepared draft food regulatory measures or variations for the following Proposals; 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)

7 February 2007 (for Proposal P279) and 6pm (Canberra time) 21 February 2007 (for Proposal P272) :

• Proposal P272 – Labelling Requirements for Food for Catering Purposes & Retail Sale:   to review the labelling requirements, limitations or exemptions for food for retail sale, food for catering purposes, packaged meals provided by delivered meals organisations and meals provided in hospitals and similar institutions
• Proposal P279 – Review of Schedule 1 & Related Clauses, Standard 1.3.1 – Food Additives:   to review food additives permissions to ensure they are correctly gazetted, reflecting intent of original Standard and the cumulative changes since original gazettal in 2000

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 A549 – Food derived from High Lysine Corn LY038
• Application A574 – Maximum Residue Limits (January, February, March 2006)#*
• Application A575 – Food derived from Glyphosate-tolerant Lucerne J101 & J163
• Application A582 – Maximum Residue Limits (April, May, June 2006)#*
• Proposal P277 – Review of Processing Aids (Other than Enzymes)

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 – APPROVED DRAFT STANDARDS (s.21 - 23))

FSANZ has completed its First Review in relation to the following Proposal and re-affirmed its approval of the approved draft Standard:

• Proposal P271 – Liqueur Definition

APPLICATION WITHDRAWN [s.12A(2)]

The following Application has been withdrawn by the Applicant:

• Application A571 – Prescribed Name for Wine Products

OTHER MATTERS

Gazettal of Amendment No. 88

Amendment No. 88 to the Australia New Zealand Food Standards Code was published by FSANZ on 5 October 2006 (FSC 30).   It included amendments resulting from the following Application and Proposals:

• Application A563 – Medium Chain Triglycerides in Infant Formula Products
• Proposal P288 – Food Safety Programs for Food Service to Vulnerable Populations#
• Proposal P296 – Primary Production & Processing Standard for Dairy#
• Proposal P302 – Minor Amendments Omnibus VI

Gazettal of Amendment No. 89

Amendment No. 89 to the Australia New Zealand Food Standards Code was published by FSANZ on 9 November 2006 (FSC 31).   It included amendments resulting from the following Applications:

• 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 A470 – Formulated Beverages
• Application A508 – Phytosterols derived from Tall Oils as Ingredients in Low-fat Milk

Gazettal of Amendment No. 90

Amendment No. 90 to the Australia New Zealand Food Standards Code was published by FSANZ on 7 December 2006 (FSC 32).   It included amendments resulting from the following Applications:

• Application A551 – Amendments to Standard 4.5.1 – Wine Production Requirements#
• Application A569 – Lipase fromHansenula polymorpha  as a Processing Aid (Enzyme)
• Application A572 – Maximum Residue Limits (October, November, December 2005)
• Application A579 – Country of Origin – Print Size for Unpackaged Food in Display Cabinets#

*   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.  

# 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.