FINAL ASSESSMENT REPORT (Inquiry - Section 17)
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EXECUTIVE SUMMARY
Executive Summary from the Full Assessment Report
An Application was received on 19 June 2000 from Devro-Teepak Pty Ltd to allow the use of sorbic acid and its salts in edible collagen casings. Sorbic acid and its salts are already permitted in a variety of other foods, consequently this Application was for an extension of use.
Sorbic acid and its more water-soluble potassium, sodium and calcium salts are collectively known as sorbates and are used widely as anti-microbial agents in various foods. They are most effective against yeasts and moulds.
The edible casings produced by the Applicant are of the type preferred for coarse-cut sausages such as butcher' s style and bratwurst. A clear casing is preferred for these products because it maximises the visual appeal of their coarse texture. The only preservative currently permitted in Australia and New Zealand for use in edible casings is sulphur dioxide, which is unsuitable for use in the manufacturing process used by the Applicant.
The proposed use of sorbic acid as a preservative in the manufacture of edible collagen casings to a maximum level of 100 mg/kg in the final casing was found to be technologically justified.
The Joint FAO/WHO Expert Committee on Food Additives (JECFA) evaluated sorbic acid in 1973 and allocated an Acceptable Daily Intake (ADI) for humans of 0 - 25 mg/kg. Sorbic acid and its salts exhibit low acute and chronic toxicity and are metabolised rapidly in the body.
The proposed use of sorbic acid in edible collagen casings represents only a very small fraction of the total intake of sorbates and only a negligible proportion of the current ADI therefore the extension of use does not raise any apparent public health and safety concerns.
It was concluded in the Regulation Impact Statement that the benefits to consumers, industry and governments of permitting sorbic acid in edible collagen casings outweigh any costs.
Previous ANZFA consideration
Receipt of the Application was first notified on 27 September 2000 when the Australia New Zealand Food Authority (ANZFA) released an information summary of the application and called for public submissions. Submissions were received up until 8 November 2000. ANZFA then undertook a Full Assessment of the Application, taking into account the comments received.
A Full Assessment Report was subsequently released for public comment on 30 May 2001, the public comment period ending on 11 July 2001, although submissions were accepted beyond this date.
Summary of new submissions received at Inquiry
A total of four submissions were received at Final Assessment. The submissions received were from:
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InforMed Systems Ltd (New Zealand);
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National Meat Association of Australia
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Queensland Health; and
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National Council of Women of Australia Inc. Ltd.
All the submissions were supportive of the proposed amendment to Standards 1.3.1 of Volume 2 of the Food Standards Code to permit the extension of use of sorbic acid and its salts to edible collagen casings and agreed with ANZFA' s conclusions that the benefits of the proposed amendment outweigh the costs.
ASSESSMENT OF ISSUES RAISED IN PUBLIC SUBMISSIONS AT FINAL ASSESSMENT
No new issues were raised in the public submissions received at Final Assessment.
CHANGES TO FULL ASSESSMENT/RIS RESULTING FROM FINAL ASSESSMENT
At Full Assessment, a draft variation was proposed to Standard 1.3.1 of Volume 2 of the Food Standards Code. However, Volume 1 of the Food Standards Code also contains Standard 1.3.1 therefore, for consistency between the two volumes, it is now proposed that Standard 1.3.1 of Volume 1 also be amended. The drafting (Attachment 1) has been amended accordingly. No other issues were raised at Inquiry, therefore no other changes are proposed to the Full Assessment previously made.
CONCLUSIONS
As concluded at Full Assessment:
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extending the use of sorbic acid to edible collagen casings at the level of 100 mg/kg is technologically justified and poses no significant risk to public health and safety;
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there is a net benefit to all sectors, but especially to manufacturers of edible casings and producers and retailers of sausage products, from extending the use of sorbic acid to edible collagen casings; and
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the proposed amendment should take effect upon gazettal.
It was also noted at Full Assessment that under the Australian Trade Practices Act 1974, the State and Territory Food Acts, the West Australian Health Act, and in New Zealand, the Fair Trading Act 1986 and the Food Act, it may constitute misleading or deceptive conduct if sausages made with casings containing sorbic acid are labelled as ' preservative free' .
Any person or organisation may apply to ANZFA to have the Food Standards Code amended. In addition, ANZFA may develop proposals to amend the Australian Food Standards Code or to develop joint Australia New Zealand food standards. ANZFA can provide advice on the requirements for applications to amend the Food Standards Code.
FURTHER INFORMATION
Submissions: No submissions on this matter are sought as the Authority has completed its assessment and the matter is now with the Australia New Zealand Food Standards Council for consideration.
Further information on this and other matters should be addressed to the Standards Liaison Officer at the Australia New Zealand Food Authority at one of the following addresses:
PO Box 7186 PO Box 10559
Canberra BC ACT 2610 The Terrace WELLINGTON 6036
AUSTRALIA NEW ZEALAND
Tel (02) 6271 2258 Tel (04) 4739942
Attachments
1. Proposed Draft Variation to Standards 1.3.1 of Volume 1 and Volume 2 of the Food Standards Code;
2. Statement of Reasons.
ATTACHMENT 1
DRAFT VARIATION TO THEFOOD STANDARDS code
APPLICATION 419 -SORBIC ACID IN EDIBLE COLLAGEN CASINGS
To comm ence: On gazettal
Standard 1.3.1 of Volume 1 and Volume 2 of the Food Standards Code is varied by inserting into Schedule 1 in Item 8.4 Edible casings*immediately before the entry for Sulphur dioxide and sodium and potassium sulphites'
|
200 201 202 203 |
Sorbic acid and sodium, potassium and calcium sorbates |
100 mg/kg |
ATTACHMENT 2
STATEMENT OF REASONS
Apllication A419
FOR RECOMMENDING A VARIATION TO STANDARD 1.3.1 - FOOD ADDITIVES IN VOLUME 1 AND VOLUME 2 OF THEFOOD STANDARDS codeTO ALLOW THE USE OF SORBIC ACID AND ITS SALTS IN EDIBLE COLLAGEN CASINGS
The Australia New Zealand Food Authority (ANZFA) has before it an Application received on 19 June 2000 from Devro-Teepak Pty Ltd to amend the Standard 1.3.1 - Food Additives, of Volume 2 of the Food Standards Code to allow the use of sorbic acid and its salts in edible collagen casings.
ANZFA recommends the adoption of the draft variation to allow the use of sorbic acid and its salts as an additive in edible collagen casings for the following reasons:
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the use of sorbic acid and its salts in edible collagen casings at the level of 100 mg/kg is technologically justified;
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the proposed use of sorbic acid and its salts in edible collagen casings represents only a very small fraction of the total intake of sorbates and only a negligible proportion of the current acceptable daily intake and does not raise any public health and safety concerns;
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there is a net benefit to all sectors, but especially to manufacturers of edible casings and producers and retailers of sausage products, from allowing the use of sorbic acid and its salts in edible collagen casings.
Drafting contained in the Full Assessment Report proposed a variation to Standard 1.3.1- Food Additives of Volume 2 of the Food Standards code. However Standard 1.3.1 - Food Additives is also contained in Volume 1 of the Food Standards Code,accordingly in order to maintain consistency between Standard 1.3.1 in Volume 1 and Volume 2 of the Food Standards Code an amendment to the drafting was necessary to include the same draft variation in Volume 1.
The commencement date of the draft variation is to be the date of gazettal.
REGULATION IMPACT
ANZFA has undertaken a regulation impact assessment process that also fulfils the requirement in New Zealand for an assessment of compliance costs. This process concluded that the amendment to the Code is necessary, cost effective and of benefit to both producers and consumers
WORLD TRADE ORGANIZATION (WTO) NOTIFICATION
Australia and New Zealand are members of the WTO and are bound as parties to WTO agreements. In Australia, an agreement developed by the Council of Australian Governments (COAG) requires States and Territories to be bound as parties to those WTO agreements to which the Commonwealth is a signatory.
Under the agreement between the Governments of Australia and New Zealand on Uniform Food Standards, ANZFA is required to ensure that food standards are consistent with the obligations of both countries as members of the WTO.
In certain circumstances Australia and New Zealand have an obligation to notify the WTO of changes to food standards to enable other member countries of the WTO to make comment. Notification is required in the case of any new or changed standards which may have a significant trade effect and which depart from the relevant international standard (or where no international standard exists).
This matter was not notified to the WTO because it represented a minor technical matter involving the extension of use of a food additive.
DRAFT VARIATION TO THEFOOD STANDARDS code
APPLICATION 419 -SORBIC ACID IN EDIBLE COLLAGEN CASINGS
To commence: On gazettal
Standard 1.3.1 of Volume 1 and Volume 2 of the Food Standards Code is varied by inserting into Schedule 1 in Item 8.4 Edible casings*immediately before the entry forSulphur dioxide and sodium and potassium sulphites'
|
200 201 202 203 |
Sorbic acid and sodium, potassium and calcium sorbates |
100 mg/kg |
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