27 September 2000
06/01
INFORMATION SUMMARY
USE OF SODIUM ACID SULFATE
The Australia New Zealand Food Authority has received an application to amend the AustralianFood Standards Codeon the above matter. The Authority's Preliminary Assessment Report is provided below and provides further detail. The Authority now invites public submissions on any issue raised in the Report for the purposes of making a full assessment.
PRELIMINARY ASSESSMENT REPORT
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SUBJECT: |
APPLICATION A415 |
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PURPOSE |
TO AMEND STANDARD A10 - GROUP III - FOOD ACIDS - TO APPROVE THE USE OF SODIUM ACID SULFATE AS A FOOD ACID. |
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Applicant: |
Jones-Hamilton Co. |
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Date received: |
19 June 2000 |
BACKGROUND
An application has been received from Jones-Hamilton Co. to amend Standard A10 - Group III - Food acids - to approve the use of sodium acid sulfate as a food acid.
Synonyms for sodium acid sulfate include - sulfuric acid monosodium salt, sodium bisulfate, and sodium hydrogen sulfate.
The applicant is seeking permission to use sodium acid sulfate in beverages, leavening systems and general food processing where a food acid is needed.
The applicant claims that sodium acid sulfate is:
· capable of providing the same objectives as other approved food acids such as citric acid, malic acid, tartaric acid or phosphoric acid;
· a cost effective alternative to other food acids;
· greater acid value per unit weight;
· an additive which provides better sensory properties;
· readily soluble in water; and
· safe and easy to handle.
OBJECTIVE
The objective of the application is to allow the use of sodium acid sulfate in foods. The applicant requested that this be achieved by amending Standard A10 - Group III Food acids to include sodium acid sulfate. Consequential amendment may be required to Standard 1.3.1 Food Additives in the joint Food Standards Code.
REGULATORY IMPACT ASSESSMENT
The regulatory impact assessment below is preliminary only and based on available information or on information provided by the applicant. The assessment is designed to assist in identifying the affected parties, any alternative regulatory options, and the potential impacts of any regulatory or non-regulatory provisions. The information needed to make an assessment of this application will include information from public submissions. This preliminary assessment invites public comment on these areas.
Objective of the regulatory impact assessment
To assess the risks and benefits associated with adopting the proposed regulatory change to permit the use of sodium acid sulfate in foods.
Potential regulatory impacts
The potential impacts of the various regulatory options are as follows:
Option 1. Not approve the use of sodium acid sulfate as a food acid in foods.
Option 2. Approve the use of sodium acid sulfate as a food acid in foods.
This option would allow the use of sodium acid sulfate as a food acid in foods
Identification of affected parties
Parties affected by the options outlined above include:
1. Food Industry wishing to use sodium acid sulfate as a food acid.
2. This permission would provide consumers with foods with improved sensory properties at potentially a lower cost.
3. Government agencies enforcing the food regulations.
CONSIDERATION OF ISSUES UNDER SECTION 13
This application does relate to a matter that may be developed as a food regulatory measure, or warrants a variation of a food regulatory measure, and is not so similar to a previous application that it ought not be accepted.
Costs and benefits arising for any food regulatory measure or other measures developed or varied as a result of this application, will be considered at full assessment.
OTHER RELEVANT MATTERS
codex
The specification for sodium acid sulfate is provided in Food Chemicals codex 4th edition.
Approval in other Countries
Jones-Hamilton Co gave GRAS notice GRN 000003 Docket No. 98S -0194 on February 11, 1998 for sodium acid sulfate to the United States Food and Drug Administration as a pH control agent and processing aid in food at levels not to exceed good manufacturing practice. Based on the information provided by Jones-Hamilton Co., as well as information available to the FDA, the agency has no questions at this time regarding the conclusion of Jones-Hamilton Co that sodium acid sulfate is GRAS under the proposed conditions of use. The FDA has not, however, made its own determination regarding the GRAS status of the subject use of sodium acid sulfate.
The CAS registry number is 7681-38-1.
Australia and New Zealand
In the AustralianFood Standards Code, sodium sulphate and sulphuric acid are generally permitted processing aids. Sodium sulphate (514) has a food additive number listed in the schedule to Standard A1 - Labelling and Advertising. TheNew Zealand Food Regulations, 12th schedule lists sodium sulphate as additive (514) and in the 13th schedule sodium sulphate is listed as a form of mineral that may be added to food.
CONCLUSIONS
This application does relate to a matter that may be developed as a food regulatory measure, or warrants a variation of a food regulatory measure, as provided for in section 13 of theANZFA Act 1991. Costs and benefits arising from any food regulatory measure so developed will be assessed at Full Assessment.
Accordingly the Authority has decided to accept the application and will now make a full assessment of it.
If subsequently recommended by the Authority and agreed to by the Australia New Zealand Food Standards Council, an amendment to the Code would allow the addition of sodium acid sulfate to foods as a food acid. Conditions of use such as a requirement to comply with specifications for identity and purity, and to comply with a maximum percentage addition to specific foods may be required.
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).
Matters relating to public health and safety may be notified as a Sanitary or Phytosanitary (SPS) notification, and other matters as a Technical Barrier to Trade (TBT) notification. A decision on whether to make a notification to the WTO will be made during the Authority's full assessment of this matter.
FOOD STANDARDS SETTING IN AUSTRALIA AND NEW ZEALAND
The Governments of Australia and New Zealand entered an Agreement in December 1995 establishing a system for the development of joint food standards. The Australia New Zealand Food Authority is now developing a jointAustralia New Zealand Food Standards Codewhich will provide compositional and labelling standards for food in both Australia and New Zealand.
Until the jointAustralia New Zealand Food Standards Codeis finalised the following arrangements for the two countries apply:
· Food imported into New Zealand other than from Australiamust comply with either the Australian Food Standards Code, as gazetted in New Zealand, or the New ZealandFood Regulations 1984,but not a combination of both. However, in all cases maximum residue limits for agricultural and veterinary chemicals must comply solely with those limits specified in the New ZealandFood Regulations 1984.
· Food imported into Australia other than from New Zealandmust comply solely with the AustralianFood Standards Code.
· Food imported into New Zealand from Australiamust comply with either the AustralianFood Standards Codeor the New Zealand Food Regulations 1984,but not a combination of both.
· Food imported into Australia from New Zealandmust comply with the AustralianFood Standards Code. However, under the provisions of the Trans-Tasman Mutual Recognition Arrangement, food may be imported into Australia from New Zealand if it complies with the New ZealandFood Regulations 1984orDietary Supplements Regulations 1985.
· Food manufactured in Australia and sold in Australiamust comply solely with the Australian Food Standards Code, except for exemptions granted in Standard T1.
In addition to the above, all food sold in New Zealand must comply with the New ZealandFair Trading Act 1986and all food sold in Australia must comply with the AustralianTrade Practices Act 1974,and the respective Australian State and TerritoryFair Trading Acts.
Any person or organisation may apply to ANZFA to have theFood Standards Codeamended. In addition, ANZFA may develop proposals to amend the AustralianFood Standards Codeor to develop joint Australia New Zealand food standards. ANZFA can provide advice on the requirements for applications to amend theFood Standards Code.
INVITATION FOR PUBLIC SUBMISSIONS
Written submissions containing technical or other relevant information which will assist the Authority in undertaking a full assessment on matters relevant to the application, including consideration of its regulatory impact, are invited from interested individuals and organisations. Technical information presented should be in sufficient detail to allow independent scientific assessment.
Submissions providing more general comment and opinion are also invited. The Authority's policy on the management of submissions is available from the Standards Liaison Officer upon request.
The processes of the Authority are open to public scrutiny, and any submissions received will ordinarily be placed on the public register of the Authority and made available for public inspection. If you wish any confidential information contained in a submission to remain confidential to the Authority, you should clearly identify the sensitive information and provide justification for treating it in confidence. TheAustralia New Zealand Food Authority Act1991requires the Authority to treat in confidence trade secrets relating to food and any other information relating to food, the commercial value of which would be or could reasonably be expected to be, destroyed or diminished by disclosure.
Following its full assessment of the application the Authority may prepare a draft standard or draft variation to a standard (and supporting draft regulatory impact statement), or decide to reject the application. If a draft standard or draft variation is prepared, it is then circulated to interested parties, including those from whom submissions were received, with a further invitation to make written submissions on the draft. Any such submissions will then be taken into consideration during the inquiry, which the Authority will hold to consider the draft standard or draft variation to a standard.
All correspondence and submissions on this matter should be addressed to theProject Manager - Dean McCullum, Application A415one of the following addresses:
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Australia New Zealand Food Authority |
Australia New Zealand Food Authority |
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PO Box 7186 |
PO Box 10559 |
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Canberra Mail Centre ACT 2610 |
The Terrace WELLINGTON 6036 |
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AUSTRALIA |
NEW ZEALAND |
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Tel (02) 6271 2222 Fax (02) 6271 2278 |
Tel (04) 473 9942 Fax (04) 473 9855 |
The Authority should receive submissions by8 November 2000.
General queries on this matter and other Authority business can be directed to the Standards Liaison Officer at the above address or by Email on . Submissions should not be sent by Email as the Authority cannot guarantee receipt. Requests for more general information on the Authority can be directed to the Information Officer at the above address or by Email .