13 March 2002
08/02
Initial Assessment [Preliminary Assessment - s.13]
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DEADLINE FOR PUBLIC SUBMISSIONS to the Authority in relation to this matter : |
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Summary
An application has been received from Novozymes A/S to amend the Australia New Zealand Food Standards Code to approve the use of the enzyme, glucose oxidase, as a processing aid under Standard A16 (Volume 1 -Food Standards Code) and Standard 1.3.3 (Volume 2 - Australia New Zealand Food Standards Code).The enzyme was produced using recombinant DNA techniques from the host bacterial strain, Aspergillus oryzae, and contains a donor gene coding for glucose oxidase from Aspergillus niger.
ANZFA' s primary objective is to ensure that the proposed use of the enzyme as a processing aid is safe for human consumption. The purpose of this initial report is to publicly notify receipt of a new application by ANZFA. It is not an assessment of the application. It is therefore based on available information provided by the applicant. The report 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.
Public submissions are now invited on this preliminary assessment report.
Introduction
The Australia New Zealand Food Authority (ANZFA) is a bi-national statutory body responsible for developing draft food standards and draft variations of standards, in order to make recommendations to the Australia New Zealand Food Standards Council (Ministerial Council), and to review standards. The Ministerial Council then may decide to adopt the standards or draft variations of standards, which results in their incorporation into food laws of the Australian States and Territories and New Zealand.
On 24, November 2000, the Ministerial Council adopted the Australia New Zealand Food Standards Code (known as Volume 2 of the Food Standards Code) that applies both in Australia and New Zealand. A two-year transitional period has been implemented at the conclusion of which Volume 2 of the Food Standards Code will be the sole code for both countries. In the interim, for the majority of food standards, there are two standards operating in Australia and three in New Zealand (including the New Zealand Food Regulations).
Problem
Standards A16 (Volume 1) and Standard 1.3.3 (Volume 2) of the Food Standards Code makes provision for the appropriate use of approved processing aids in food manufacture. A processing aid is a substance used in the processing of raw materials, foods or ingredients, to fulfil a technological purpose relating to treatment or processing, but does not perform a technological function in the final food. There is currently no permission for the use of glucose oxidase sourced from Aspergillus oryzae which carries a gene coding for a glucose oxidase isolated from Aspergillus niger .
Objecive
The application from Novozymes A/S is seeking to amend Standard A16 (Volume 1) and Standard 1.3.3 of the recently adopted joint Australia New Zealand Food Standards Code (Volume 2) to approve a new source of the enzyme, glucose oxidase (EC 1.1.3.4) , as a processing aid. The application is for glucose oxidase sourced from Aspergillus oryzae that carries a gene coding for glucose oxidase isolated from Aspergillus niger .
The objective of this application is to determine whether the food regulatory measures can be amended to approve the use of a new source of the enzyme glucose oxidase. Such an amendment to the Food Standards Code will need to be consistent with the section 10 objectives of ANZFA Act. The three primary objectives of the Authority are:
- the protection of public health and safety;
- the provision of adequate information relating to food to enable consumers to make informed choices; and
- the prevention of misleading or deceptive conduct.
In developing and varying standards, ANZFA must also have regard to:
- the need for standards to be based on risk analysis using the best available scientific evidence;
- the promotion of consistency between domestic and international food standards;
- the desirability of an efficient and internationally competitive food industry; and
- the promotion of fair trading in food.
Issues to be addressed during Assessment
Purpose and Efficacy of the Processing Aid
The applicant has indicated that the enzyme is to be used in the baking industry as a processing aid to strengthen gluten in dough systems. It causes a more elastic and stronger gluten network similar to that obtained by traditional oxidising agents such as potassium bromate or ascorbic acid. The enzyme is active in the dough and the leavening of the unbaked bread, but normally inactivated by high temperatures during the baking. The enzyme is used as a processing aid only, and is not expected to be present in the final food. Any residue would be in the form of inactivated enzyme, which would be metabolised like any other protein.
The applicant has stated that glucose oxidase complies with the purity criteria recommended for enzyme preparations in Food Chemicals codex (FCC) 4th Edition, 1996, and also conforms to the General Specifications for Enzyme Preparations as proposed by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), in the Compendium of Food Additives Specifications, Vol. 1, Annex 1, FAO 1992.
The source (production) organism - Aspergillus oryzae
The safety of the source organism is an important consideration in the safety assessment for recombinant lipase.A. oryzaeis not considered to be pathogenic, is widely distributed in nature and is commonly found in foods (Barbesgaard et al, 1992). Enzymes fromA. oryzae are extensively used in production of a variety of foods such as syrups, alcohol, fruit juices, brewing, chocolate syrup, baking and meat tenderising , and have been for many years (Rogers, 1977). Further information on the safety ofA. oryzae will be provided at Draft Assessment.
The donor organism - Aspergillus niger
The organism from which the glucose oxidase gene is derived isAspergillus niger. Glucose oxidase from a non-genetically modified Aspergillus niger is already permitted by Standard 1.3.3 of the Australia New Zealand Food Standards Code and has been evaluated by JECFA. The nauture of the DNA fragment from the donor strain used in the construction of the genetically modified strain of A. oryzaewill be considered during Draft Assessment .
Nature of the genetic modification
The genetic modification process involved the transfer of the glucose oxidase gene from A. niger to A. oryzae. The applicant has provided information to indicate that the recombinant organism was found to be stable during production fermentations. Southern blotting was used to investigate the stability of the integration of the glucose oxidase gene after large-scale fermentation, and found that the inserted DNA was stably integrated into the host genome. The DNA used for transforming the A. oryzae host strain does not contain antibiotic resistance genes. These issues will be further considered during Draft Assessment.
Purity of enzyme preparation and proposed specifications
Historically, enzymes used in food processing have been found to be non-toxic, and the main toxicological consideration is in relation to possible contaminants. The production organism in this case is non-toxic and non-pathogenic.
Labelling of food when glucose oxidase is used
Processing aids are not currently required to appear in ingredient lists under general labelling provisions in the Food Standards Code and the New Zealand Food Regulations. There are a number of enzyme processing aids derived from genetically modified organisms used by the food industry. Processing aids are generally present to fulfil a technological purpose relating to treatment or processing, but do not perform a technological function in the final food.
The labelling of foods produced using gene technology, was decided on at the Australia New Zealand Food Standards Council (ANZFSC) meeting on 28 July 2000. The ANZFSC decided to exempt processing aids and food additives except where novel DNA and/or protein is present in the final food. While the gene coding for the glucose oxidase enzyme from the donor strain is novel, neither the gene nor the enzyme is expected to be present in the final food, nor is the enzyme itself considered novel.
Options
Parties affected by the options listed below include:
- State, Territory and New Zealand Health Departments;
- manufacturers and producers of food products that use glucose oxidase as a processing aid;
- suppliers and importers; and
- consumers.
The suggestions in the sections below under possible options, affected parties and potential impacts are preliminary only and are based on available information or on information supplied by the applicant. These sections are designed to assist in the process of identifying the affected parties, alternative options apart from the objective of the application, 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 initial assessment now invites public comment on these areas.
Option 1. Not approve the use of glucose oxidase produced by Aspergillus oryzae carrying the lipase gene fromAspergillus niger.
There are no perceived benefits to the stakeholders, government, consumers and industry, by maintaining the status quo and not giving specific permission in the Food Standards Code for the use of this enzyme.
Although there is no perceived cost for the government at present, if, in the future, other countries approve glucose oxidase from the new genetically modified source organism, lack of approval in Australia or New Zealand may be construed as a non-tariff barrier to trade. industry would also suffer from the non-availability of an alternative source of glucose oxidase.
Parties disadvantaged by not permitting this particular processing aid, are the manufacturers of glucose oxidase and producers who wish to use it in the manufacture of their final food products.
Option 2. Approve the use of glucose oxidase produced by Aspergillus oryzae carrying the glucose oxidase gene fromAspergillus niger.
This option would allow an alternative safe source of glucose oxidase with no cost to government, industry or consumers.
Approval of glucose oxidase from a new genetically modified source organism would promote international trade and reduce technical barriers to trade, while continuing to protect public health and safety. From the industry point of view, this option will promote fair trade in food and will allow manufacturers to use an alternative source of glucose oxidase.
Impact Analysis
The objective of regulatory impact analysis is to examine the impact of the options to permission or not permit the use of glucose oxidase from a new source organism, as a processing aid in Standard 1.3.3.
As the use of glucose oxidase from genetically modified source organism A. oryzae requires pre-market approval, it is not appropriate to consider non-regulatory options to address this application. Processing aids used in Australia and New Zealand are required to be listed in Standard 1.3.3. - Processing Aids. New entries in the schedule to Standard 1.3.3 are required to undergo an evaluation to ensure there are no public health and safety concerns.
Option 2, which supports the use of glucose oxidase produced by Aspergillus oryzae carrying the glucose oxidase gene from Aspergillus niger is the preferred option, as approval would allow an alternative safe source of glucose oxidase with no additional cost to government, industry or consumers.
Consultation
ANZFA is seeking public comment in order to assist in assessing this application. A further call for public submissions will be made when the Draft Risk Assessment is released. Comments that would be useful could cover:
- Scientific aspects of this application;
- Other issues, including labelling of processing aids.
Commercial in Confidence (C-I-C) data
Commercial-in-confidence claims have been made in relation to this application. These relate to the genetic modification and the method of production of the enzyme.
Workplan Classification
ANZFA' s initial assessment of this application for placement on the Workplan was Group 3, Category 2 (see ANZFA website for further information about the workplan and the different groups and categories). The initial assessment confirms that this grouping is appropriate.
WTO Implications
As a member of the World Trade Organisation (WTO), Australia and New Zealand are obligated to notify WTO member nations where proposed mandatory regulatory measures are inconsistent with any existing or imminent international standards and the proposed measure may have a significant effect on trade.
The Australia New Zealand Food Standards Code is mandatory legislation applying to both domestic and imported food products. Suppliers of food products are not required to take up permissions granted through amendments to the code however food products not complying with the code cannot legally be supplied in Australia.
Amending the code to approve foods developed using processing aids such as glucose oxidase is unlikely to have a significant effect on trade, however this issue will be fully considered in the context of the Regulatory Impact Statement at Draft Assessment (i.e. Full Assessment) and, if necessary, notification will be made in accordance with the WTO Technical Barrier to Trade (TBT) or Sanitary and Phytosanitary Measure (SPS) agreements.
Conclusions
The above application fulfils the requirements for preliminary assessment as prescribed in section 13 of the Australia New Zealand Food Authority Act 1991.
Accordingly the Authority will now proceed to the Draft Assessment Report (ie Full Assessment).
Full Report [ pdf 45kb ]