Food Derived from DHA Canola Line NS-B50027-4

20 December 2017

[35-17]

Approval report – Application A1143

Food derived from DHA Canola Line NS-B50027-4

Food Standards Australia New Zealand (FSANZ) has assessed an Application made by Nuseed Pty Ltd to seek approval for food derived from canola line NS-B50027-4 genetically modified to introduce, into the seed, the pathway for producing the long-chain omega-3 fatty acid docosahexaenoic acid (DHA) from oleic acid.

On 14 September 2017 FSANZ sought submissions on a draft variation and published an associated report. FSANZ received three submissions.

FSANZ approved the draft variation on 6 December 2017. The Australia and New Zealand Ministerial Forum on Food Regulation was notified of FSANZ’s decision on 19 December 2017.

This Report is provided pursuant to paragraph 33(1)(b) of the Food Standards Australia New Zealand Act 1991 (the FSANZ Act).

i

Table of contents

Executive summary 2

1 Introduction 3

1.1 The Applicant 3

1.2 The Application 3

1.3 The current standards 4

1.4 Reasons for accepting Application 5

1.5 Procedure for assessment 5

1.6 Decision 5

2 Summary of the findings 5

2.1 Summary of issues raised in submissions 5

2.2 Safety and nutrition risk assessment 7

2.3 Risk management 8

2.3.1 Nutrition issues 8

2.3.2 Labelling 9

2.3.3 Detection methodology 11

2.4 Risk communication 11

2.4.1 Consultation 11

2.5 FSANZ Act assessment requirements 12

2.5.1 Section 29 12

2.5.2. Subsection 18(1) 14

6 References 15

Attachment A – Approved draft variation to the Australia New Zealand Food Standards Code 17

Attachment B – Explanatory Statement 19

Supporting documents

The following documents[1] which informed the assessment of this Application are available on the FSANZ website:

SD1 Safety Assessment Report (at Approval)

SD2 Nutrition Risk Assessment Report (at Approval)

Executive summary

Food Standards Australia New Zealand (FSANZ) received an Application from Nuseed Pty Ltd on 10 February 2017. The Applicant requested a variation to Schedule 26 in the Australia New Zealand Food Standards Code (the Code) to include food from a new genetically modified (GM) canola (Brassica napus) line, NS-B50027-4 (henceforth referred to as DHA canola). This canola line has been genetically modified to produce omega-3 long chain fatty acids, particularly docosahexaenoic acid, in the seed.

The primary objective of FSANZ in developing or varying a food regulatory measure, as stated in section 18 of the Food Standards Australia New Zealand Act 1991 (FSANZ Act), is the protection of public health and safety. Accordingly, the safety assessment is a central part of considering an application.

Schedule 25 of the Code permits several DHA-rich oils from algal sources to be used as novel foods.

The safety assessment of DHA canola is provided in Supporting Document 1 and the Nutrition Risk Assessment is provided in Supporting Document 2. No potential public health and safety concerns have been identified. Based on the data provided in the present Application, and other available information, food derived from DHA canola is considered to be as safe for human consumption as food derived from conventional canola cultivars.

The FSANZ Board has approved the draft variation to Schedule 26 that includes permission for food derived from DHA canola line NS-B50027-4.

1 Introduction

1.1 The Applicant

Nuseed Pty Ltd (Nuseed), a wholly owned subsidiary of Nufarm Limited, is a specialised global seed company.

1.2 The Application

Application A1143 was submitted by Nuseed on 10 February 2017. It seeks a variation to Schedule 26 in the Australia New Zealand Food Standards Code (the Code) to include food from a new genetically modified (GM) canola (Brassica napus) line NS-B50027-4 (henceforth referred to as DHA canola). This canola line has been genetically modified to introduce, into the seed, the pathway for producing the omega-3 long chain polyunsaturated fatty acid
(n-3 LC PUFA) docosahexaenoic acid (DHA) from oleic acid (OA). Other n-3 LC PUFAs in the DHA synthesis pathway, particularly eicosapentaenoic acid, (EPA) would also be present.

Coding sequences from seven genes in the DHA pathway have been introduced as follows:

·  Δ12 desaturase (Lackl-Δ12D) from the yeast Lachancea kluyveri

·  Δ15-/ ω3 desaturase (Picpa- ω3D) from the yeast Pichia pastoris

·  Δ6 elongase (Pyrco-Δ6E) from the marine microalga Pyramimonas cordata

·  Δ6 desaturase (Micpu-Δ6D) from the marine microalga Micromonas pusilla

·  Δ5 elongase (Pyrco-Δ5E) from the marine microalga Pyramimonas cordata

·  Δ5 desaturase (Pavsa-Δ5D) from the marine microalga Pavlova salina

·  Δ4 desaturase (Pavsa-Δ4D) from the marine microalga Pavlova salina.

In addition, DHA canola also contains the phosphinothricin N-acetyltransferase (pat) gene from Streptomyces viridochromogenes that confers tolerance to the herbicide phosphinothricin – also known as glufosinate ammonium (glufosinate). The glufosinate tolerance was used to select putative transformants during the transformation stage and was not subsequently selected for breeding of the final DHA canola line.

The Applicant has indicated oil from DHA canola may be used as an alternate source of n-3 LC PUFAs in existing food ingredient markets for fish oils or established omega-3 markets. Possible target product examples include:

·  dairy products enriched with fish oil: milk (flavoured or plain), cream cheese products, yoghurts, custard desserts and dairy alternatives (soy milk, soy cheese)

·  bread and cereals enriched with fish oil or omega-3: muesli, breakfast cereal, cereal bars, white bread, multigrain bread

·  spreads, condiments and sauces containing omega-3: margarine (or margarine blends), salad dressings, mayonnaise, dips (e.g. hummus)

·  tinned fish in oil: tinned tuna chunks, tinned tuna sandwich filling (plain or flavoured); tinned bean mix.

DHA oil could be used in the future with new processing or micro-encapsulation/micro-emulsion technologies. These possibilities could include foods like frozen/chilled meals, juice/smoothies or soups.

1.3 The current standards

Pre-market approval is necessary before a GM food may enter the Australian and New Zealand food supply. Approval of such foods is contingent on completion of a comprehensive pre-market safety assessment. Standard 1.5.2 sets out the permission and conditions for the sale and use of food produced using gene technology (a GM food). Foods that have been assessed and approved are listed in Schedule 26.

Section 1.5.2—4 of Standard 1.5.2 also contains specific labelling provisions for approved GM foods. Subject to certain exceptions listed below, GM foods and ingredients (including food additives and processing aids from GM sources) must be identified on labels with the words ‘genetically modified’, if novel DNA or novel protein (as defined in Standard 1.5.2) is present in the food. Foods listed in subsections S26—3(2) and (3) of Schedule 26 must also be labelled with the words ‘genetically modified’, as well as any other additional labelling required by the Schedule, regardless of the presence of novel DNA or novel protein in the foods. These foods are considered to have an altered characteristic, such as an altered composition or nutritional profile, when compared to the existing counterpart food that is not produced using gene technology.

The requirement to label food as ‘genetically modified’ does not apply to GM food that:

·  has been highly refined (other than food that has been altered), where the effect of the refining process is to remove novel DNA or novel protein

·  is a substance used as a processing aid or a food additive, where novel DNA or novel protein from the substance does not remain present in the final food

·  is a flavouring substance present in the food in a concentration of no more than 1 g/kg (0.1%)

·  is intended for immediate consumption and which is prepared and sold from food premises and vending machines, including restaurants, take away outlets, caterers, or self-catering institutions

·  is unintentionally present in the food in an amount of no more than 10 g/kg (or 1%) of each ingredient.

If the GM food for sale is not required to bear a label, the labelling information referred to in section 1.5.2—4 must accompany the food or be displayed in connection with the display of the food (in accordance with subsections 1.2.1—9(2) and (3) of Standard 1.2.1).

Standard 1.5.1 – Novel foods and Schedule 25 – Permitted novel foods, contain permissions for the sale of novel foods that have been assessed and approved by FSANZ. Several DHA-rich oils derived from different marine micro-algae species are listed in Schedule 25 and permitted for use in all foods; only one of these is permitted in infant formula products in accordance with Standard 2.9.1 – Infant formula products (see also discussion in section 2.3.1).

Schedule 3 – Identity and purity, includes specifications for the following oils derived from marine micro-algae species rich in DHA:

·  oil derived from the algae Crypthecodinium cohnii rich in docosahexaenoic acid (DHA)

·  oil derived from marine micro-algae (Schizochytrium sp.) rich in docosahexaenoic acid (DHA) (2 specifications)

·  oil derived from marine micro-algae (Ulkenia sp.) rich in docosahexaenoic acid (DHA).

All of these specifications refer to minimum levels of DHA and maximum trans fatty acids; a maximum EPA level is also established for the Schizochytrium sp oil permitted only for use in infant formula products.

1.4 Reasons for accepting Application

The Application was accepted for assessment because:

·  it complied with the procedural requirements under subsection 22(2) of the FSANZ Act

·  it related to a matter that warranted the variation of a food regulatory measure

·  it was not so similar to a previous application for the variation of a food regulatory measure that it ought to be rejected.

1.5 Procedure for assessment

The Application was assessed under the General Procedure.

1.6 Decision

The draft variation as proposed following assessment was approved without change. The variation takes effect on the date of gazettal. The approved draft variation is at Attachment A.

The related explanatory statement is at Attachment B. An explanatory statement is required to accompany an instrument if it is lodged on the Federal Register of Legislation.

2 Summary of the findings

2.1 Summary of issues raised in submissions

A total of three submissions were received, all from jurisdictions, none of which were opposed to the proposed draft variation to Schedule 26. There were, however, several issues raised and these are addressed in Table 1.

Table 1: Summary of issues

Issue / Raised by / FSANZ response (including any amendments to drafting) /
Policy issues regarding nutritionally modified foods by means of genetic modification were raised, including that:
·  Policy Guidelines should be reviewed to consider new fortification technologies; this matter has been raised with the Food Regulation Standing Committee (FRSC).
·  it is an important precedent that approval be considered in relation to biofortification policy.
·  Codex Alimentarius is currently in the process of drafting a definition for biofortification. / ·  Victorian Government Departments of Health & Human Services and Economic Development, Jobs, Transport & Resources (Vic Govt)
·  SA Health / Noted. Policy review and development is the role of FRSC and the Forum on Food Regulation (the Forum), and not FSANZ.
As above.
The ongoing work by the Codex Committee on Nutrition and Foods for Special Dietary Uses in drafting a biofortification definition is noted. No definition is yet confirmed and cannot be used as clear guidance at this time.
FSANZ should consider a ‘stop clock’ on the application until a biofortification policy is developed. / ·  SA Health / FSANZ must process applications in accordance with the FSANZ Act 1991. Section 109 of that Act sets out when FSANZ may stop the clock on an application. It permits FSANZ to suspend consideration of an application if the Forum has notified FSANZ that the Forum is formulating a policy guideline and the application, in FSANZ’s opinion, would be affected by that policy guideline, once formulated. In addition, if the application is a paid application, suspension of processing can only occur with the applicant’s consent. In this case, no such notification has been received from the Forum. Application A1143 is also a paid application.
Consumers should be informed of the nutritional change through mandatory additional labelling / ·  SA Health / FSANZ provided rationale in the Call for Submissions against mandating an additional labelling statement that this canola line has been modified to contain DHA as an omega-3 fatty acid. This rationale is repeated in section 2.3.2.2 of this report. FSANZ maintains the view that additional labelling should not be mandated.
This aligns with the approach taken for four of the five previously assessed foods that are genetically modified for the purpose of changing the nutritional profile but have no additional labelling requirement:
-  high oleic acid soybean line DP-305423-1
-  herbicide-tolerant high oleic acid soybean line MON87705
-  soybean line MON87769 producing stearidonic acid
-  reduced acrylamide potential and reduced browning potato line E12 (containing reduced levels of asparagine, fructose and glucose).
The drafting excluding the use of oil from DHA canola in infant formula products may be more appropriately placed in Standard 2.9.1 than in Schedule 26 / ·  SA Health / Having the exclusion in Schedule 26, which is linked to Standard 1.5.2, is consistent with the approach taken with similar approvals in the Code e.g. conditions of use of approvals associated with Standard 1.5.1 – Novel Foods, are explicitly stated in Schedule 25 – Permitted novel foods
While it is noted that specific information on the fatty acid profile of DHA canola is currently CCI, it is recommended that high level information be provided in Table 10 of SD1. / ·  New Zealand Ministry for Primary Industries (NZ MPI) / Table 10 in SD1 has been updated to include the probability outcomes of the statistical analysis and to indicate, in an analyte where there was a significant difference between DHA canola and the AV Jade control, whether the DHA canola mean was higher or lower than the AV Jade mean.
Specific information about trans fatty acids in DHA canola should be provided in the SD1 and discussed or cross-referenced in SD2 / ·  NZ MPI / Section 5.3.2 of SD1 has been updated to include the identity of the DHA canola 18:3 trans fatty acids (which make up the greatest contribution to the total trans fatty acids), and recent information provided by the Applicant on the results of testing for trans fatty acids in a laboratory–scale production of refined, bleached and deodorised (RBD) DHA canola oil. Section 1 of SD2 has been updated to include a cross reference to the discussion on the nutritional impact of trans fatty acids in DHA canola in section 6.1 of SD1.
If, in the future, oil from DHA canola were permitted to be used in infant formula products, a specification in Schedule 3 would be needed. / ·  NZ MPI / Noted. Should permission for use in infant formula products be sought and approved in the future, a specification in Schedule 3 – Identity and purity, would be considered.

2.2 Safety and nutrition risk assessment

In conducting an assessment of food derived from DHA canola, a number of criteria have been addressed including: a characterisation of the transferred gene sequences, their origin, function and stability in the canola genome; the changes at the level of DNA and protein in the whole food; compositional analyses; an evaluation of intended and unintended changes; and a nutrition assessment comprising a hazard assessment and a dietary intake assessment.