Australia New Zealand Food Standards Code Standard 1.5.2 Food Produced Using Gene Technology (Cth)

STANDARD 1.5.2

FOOD PRODUCED USING GENE TECHNOLOGY

Simplified outline of this Standard

Division 1 of this Standard sets out the permission and conditions for the sale and use of foods produced using gene technology.

Division 2 of this Standard specifies the labelling and other information requirements for foods produced using gene technology.

Table of Provisions

Division 1 – Sale and use of food produced using gene technology
1             Interpretation
2             General prohibition on the sale and use of food produced using gene technology
3             Deleted

Division 2 – Labelling etc of food produced using gene technology
4             Interpretation and Application
5             Labelling of genetically modified food
6             Labelling of food which is not genetically modified
7             Additional labelling/information requirements

Schedule               Permitted Foods produced using Gene Technology

Clauses

Division 1 – Sale and use of food produced using gene technology

1             Interpretation

(1)           For the purposes of this Standard –

a food produced using gene technology means a food which has been derived or developed from an organism which has been modified by gene technology.

Editorial note:

This definition does not include a food derived from an animal or other organism which has been fed food produced using gene technology, unless the animal or organism itself is a product of gene technology.

conventional breeding means all methods used to produce plants, excluding techniques that use gene technology.

gene technology means recombinant DNA techniques that alter the heritable genetic material of living cells or organisms.

line means –

(a)           a plant, the genetic material of which includes a transformation event or events; or

(b)          any plant, descended from the plant referred to in paragraph (a), that is the result of conventional breeding of that plant with –

(i)            any other plant that does not contain a transformation event or events; or

(ii)           any other plant that contains a transformation event or events, whether expressed as a line or event, that is listed in Column 3 of the Schedule;

but shall not be taken to mean any plant derived solely as a result of conventional breeding.

transformation event means a unique genetic modification arising from the use of gene technology.

(2)           To avoid doubt, columns 1 and 2 of the Schedule contain additional information that is not part of this Code. Information in these columns may be added to or edited in any published version of this Code.

2             General prohibition on the sale and use of food produced using gene technology

A food produced using gene technology, other than a substance regulated as a food additive or processing aid, must not be sold or used as an ingredient or component of any food unless it is listed in Column 3 of the Schedule and complies with any corresponding conditions in Column 4.

3             Deleted

Division 2 – Labelling etc of food produced using gene technology

4             Interpretation and Application

(1)           For the purposes of this Division –

genetically modified food means food that is, or contains as an ingredient, including a processing aid, a food produced using gene technology which –

(a)           contains novel DNA and/or novel protein; or

(b)          has altered characteristics;

but does not include –

(c)           highly refined food, other than that with altered characteristics, where the effect of the refining process is to remove novel DNA and/or novel protein;

(d)          a processing aid or food additive, except where novel DNA and/or novel protein from the processing aid or food additive remains present in the food to which it has been added;

(e)           flavours present in the food in a concentration no more than 1g/kg; or

(f)           a food, ingredient, or processing aid in which genetically modified food is unintentionally present in a quantity of no more than 10g/kg per ingredient.

altered characteristics means any of the matters specified in paragraphs 7(a), (b), (c) or (d) of this Standard.

novel DNA and/or novel protein means DNA or a protein which, as a result of the use of gene technology, is different in chemical sequence or structure from DNA or protein present in counterpart food which has not been produced using gene technology.

(2)           Any statement required by clause 5 may be contained in the statement of ingredients where the genetically modified food is an ingredient or processing aid.

(3)           Where genetically modified food is displayed for retail sale other than in a package, any information that would have been required under clause 5 of this Standard on the label on the food if it was packaged, must be displayed on or in connection with the display of the food.

(4)           This Division does not apply to food intended for immediate consumption which is prepared and sold from food premises and vending vehicles, including restaurants, take away outlets, caterers, or self-catering institutions.

(5)           Deleted

(6)           Deleted

5             Labelling of genetically modified food

The label on a package of genetically modified food must include the statement ‘genetically modified’ in conjunction with the name of that food or ingredient or processing aid.

Editorial note:

An example for single ingredient genetically modified foods:

Soy Flour
Genetically Modified

Soy Flour
From genetically modified soya beans

An example for genetically modified food ingredients:

Ingredients: Soy Protein Isolate (genetically modified); Maltodextrin; Vegetable Oil; Food Acid (332); Emulsifier (471); Vegetable Gum (407); Water Added.

6             Labelling of food which is not genetically modified

The label on a package of food which is not defined as ‘genetically modified food’ in clause 4 of this Standard is not required to include any statement about the genetic status of the food.

7             Additional labelling/information requirements

Notwithstanding the provisions of this Division, Column 4 of the Schedule may specify labelling or other information requirements in relation to food produced using gene technology listed in Column 3 of the Schedule where –

(a)          the genetic modification has resulted in one or more significant composition or nutritional parameters having values outside the normal range of values for existing counterpart food not produced using gene technology;

(b)          the level of anti-nutritional factors or natural toxicants are significantly different in comparison to the existing counterpart food not produced using gene technology;

(c)          the food produced using gene technology contains a new factor known to cause an allergic response in particular sections of the population;

(d)          the intended use of the food produced using gene technology is different to the existing counterpart food not produced using gene technology; or

(e)          the genetic modification raises significant ethical, cultural and religious concerns regarding the origin of the genetic material used in the genetic modification.

SCHEDULE

Permitted Foods produced using Gene Technology

Column 1	Column 2	Column 3	Column 4
Commodity	Item	Food produced using gene technology	Special conditions
Canola	1.1	Food derived from herbicide-tolerant canola line GT73
1.2	Food derived from herbicide-tolerant canola lines Topas 19/2 and T45 and herbicide-tolerant and pollination-controlled lines Ms1, Ms8, Rf1, Rf2, Rf3
1.3	Food derived from herbicide-tolerant canola line Westar-Oxy-235
1.4	Food derived from herbicide-tolerant canola line MON88302
1.5	Food derived from herbicide-tolerant canola line DP-073496-4
Corn	2.1	Food derived from herbicide-tolerant corn line GA21
2.2	Food derived from insect-protected corn line MON810
2.3	Food derived from herbicide-tolerant and insect-protected corn line Bt11
2.4	Food derived from insect-protected corn line Bt176
2.5	Food derived from herbicide-tolerant corn line T25
2.6	Food derived from herbicide-tolerant corn line NK603
2.7	Food derived from herbicide tolerant and insect-protected corn line DBT418
2.8	Food derived from herbicide-tolerant and insect-protected corn line 1507
2.9	Food derived from insect-protected corn line MON863
2.10	Food derived from herbicide-tolerant and insect-protected corn line DAS-59122-7
2.11	Food derived from herbicide-tolerant and insect-protected corn line MON88017
2.12	Food derived from insect-protected corn line MIR604
2.13	Food derived from high lysine corn line LY038	Unless the protein content has been removed as part of a refining process, the label on or attached to a package of a food derived from high lysine corn line LY038 must include a statement to the effect that the food has been genetically modified to contain increased levels of lysine.
2.14	Food derived from amylase modified corn line 3272
2.15	Food derived from insect-protected corn line MON89034
2.16	Food derived from insect-protected corn line MIR162
2.17	Food derived from herbicide-tolerant corn line DP-098140-6
2.18	Food derived from drought-tolerant corn line MON87460
2.19	Food derived from herbicide-tolerant corn line DAS-40278-9
2.20	Food derived from insect-protected corn line 5307
2.21	Food derived from herbicide-tolerant corn line MON87427
2.22	Food derived from herbicide-tolerant and insect-protected corn line MON87411
2.23	Food derived from herbicide-tolerant and insect-protected corn line 4114
Cotton	3.1	Food derived from insect-protected cotton lines 531, 757 and 1076
3.2	Food derived from herbicide-tolerant cotton line 1445
3.3	Food derived from herbicide-tolerant cotton lines 10211 and 10222
3.4	Food derived from insect-protected cotton line 15985
3.5	Food derived from insect-protected cotton line COT102
3.6	Food derived from herbicide-tolerant and insect-protected cotton line MXB-13
3.7	Food derived from herbicide-tolerant cotton line LL25
3.8	Food derived from herbicide-tolerant cotton line MON88913
3.9	Food derived from herbicide-tolerant cotton line GHB614
3.10	Food derived from insect-protected cotton line COT67B
3.11	Food derived from herbicide-tolerant and insect-protected cotton line T304-40
3.12	Food derived from herbicide-tolerant and insect-protected cotton line GHB119
3.13	Food derived from herbicide-tolerant cotton line MON88701
3.14	Food derived from herbicide-tolerant cotton line DAS-81910-7
Lucerne	4.1	Food derived from herbicide-tolerant lucerne lines J101 & J163
4.2	Food derived from reduced lignin lucerne line KK179
Potato	5.1	Food derived from insect-protected potato lines BT-06, ATBT04-06, ATBT04-31, ATBT04-36, and SPBT02-05
5.2	Food derived from insect- and virus-protected potato lines RBMT21-129, RBMT21-350 and   RBMT22-82
5.3	Food derived from insect- and virus-protected potato lines RBMT15-101, SEM15-02 and SEM15-15
Rice	6.1	Food derived from herbicide-tolerant rice line LLRICE62
Soybean	7.1	Food derived from herbicide-tolerant soybean line 40-3-2
7.2	Food derived from herbicide-tolerant soybean lines A2704-12 and A5547-127
7.3	Food derived from herbicide-tolerant soybean line MON89788
7.4	Food derived from herbicide-tolerant soybean line DP-356043-5
7.5	Food derived from high oleic acid soybean line DP-305423-1
7.6	Food derived from insect-protected soybean line MON87701
7.7	Food derived from herbicide-tolerant high oleic acid soybean line MON87705
7.8	Food derived from soybean line MON87769 producing stearidonic acid
7.9	Food derived from herbicide-tolerant soybean line DAS-68416-4
7.10	Food derived from herbicide-tolerant soybean line FG72
7.11	Food derived from herbicide-tolerant soybean line MON87708
7.12	Food derived from herbicide-tolerant soybean line CV127
7.13	Food derived from herbicide-tolerant soybean line DAS-44406-6
7.14	Food derived from herbicide-tolerant soybean line SYHT0H2
7.15	Food derived from insect-protected soybean line DAS-81419-2
Sugarbeet	8.1	Food derived from herbicide-tolerant sugarbeet line 77
8.2	Food derived from herbicide-tolerant sugarbeet line H7-1

Amendment History

The Amendment History provides information about each amendment to the Standard. The information includes commencement or cessation information for relevant amendments.

These amendments are made under section 92 of the Food Standards Australia New Zealand Act 1991 unless otherwise indicated. Amendments do not have a specific date for cessation unless indicated as such.

About this compilation

This is a compilation of Standard 1.5.2 as in force on 7 December 2015 (up to Amendment No. 159). It includes any commenced amendment affecting the compilation to that date.

Prepared by Food Standards Australia New Zealand on 7 December 2015.

Uncommenced amendments or provisions ceasing to have effect

To assist stakeholders, the effect of any uncommenced amendments or provisions which will cease to have effect, may be reflected in the Standard as shaded boxed text with the relevant commencement or cessation date. These amendments will be reflected in a compilation registered on the Federal Register of Legislative Instruments including or omitting those amendments and provided in the Amendment History once the date is passed.

The following abbreviations may be used in the table below:

ad = added or inserted   am = amended
exp = expired or ceased to have effect                  rep = repealed
rs = repealed and substituted

Standard 1.5.2 was published in the Commonwealth of Australia Gazette No. P 30 on 20 December 2000 as part of Amendment No. 53 (F2008B00628 – 2 October 2008) and has been amended as follows:

Clause affected	A’ment No.	FRLI registration Gazette	Commencement (Cessation)	How affected	Description of amendment
Purpose	120	F2011L00062 20 Jan 2011 FSC 62 20 Jan 2011	20 Jan 2011	rs	Purpose replaced with ‘Simplified outline of this Standard’.
Table of Provs	78	F2005L01246 26 May 2005 FSC 19 26 May 2005	26 May 2005	am	Consequential amendment relating to deletion of clause 3.
1	70	F2008B00817 24 Dec 2008 FSC 12 29 April 2004	29 April 2004	ad	Definitions relating to ‘conventional breeding’, ‘line’ and ‘transformation event’.
1	120	F2011L00062 20 Jan 2011 FSC 62 20 Jan 2011	20 Jan 2011	ad, am	To add a new subclause (2) and make a consequential amendment.
1(b)	78	F2005L01246 26 May 2005 FSC 19 26 May 2005	26 May 2005	am	Correct a typographical error in the definition of ‘line’.
1(b)	120	F2011L00062 20 Jan 2011 FSC 62 20 Jan 2011	20 Jan 2011	am	Amend to clarify meaning.
2	120	F2011L00062 20 Jan 2011 FSC 62 20 Jan 2011	20 Jan 2011	rs	Clause
Table to clause 2	55	F2008B00791 9 Dec 2008 P 23 30 Aug 2001	30 Aug 2001	ad	Five GM commodities (potato and corn).
Table to clause 2	59	F2008B00797 10 Dec 2008 FSC 1 9 May 2002	9 May 2002	ad	Four GM commodities (corn, sugar beet, cotton and canola).
Table to clause 2	60	F2008B00798 19 Dec 2008 FSC 2 20 June 2002	20 June 2002	ad	One GM commodity (corn).
Table to clause 2	62	F2008B00798 19 Dec 2008 FSC 4 17 Sept 2002	17 Sept 2002	ad	Two GM commodities (corn and canola).
Table to clause 2	63	F2008B00808 22 Dec 2008 FSC 5 24 Oct 2002	24 Oct 2002	ad	One GM commodity (cotton).
Table to clause 2	67	F2008B00814 24 Dec 2008 FSC 9 31 July 2003	31 July 2003	ad	One GM commodity (corn).
Table to clause 2	69	F2008B00816 24 Dec 2008 FSC 9 17 Dec 2003	17 Dec 2003	ad	One GM commodity (corn).
Table to clause 2	70	F2008B00817 24 Dec 2008 FSC 12 29 April 2004	29 April 2004	ad, am	One GM commodity (soybean) and correct a typographical error.
Table to clause 2	76	F2005L00323 17 Feb 2005 FSC 18 17 Feb 2005	17 Feb 2005	ad	One GM commodity (cotton).
Table to clause 2	77	F2005L00989 28 April 2005 FSC 20 28 April 2005	28 April 2005	ad	One GM commodity (cotton).
Table to clause 2	83	F2005L03673 24 Nov 2005 FSC 25 24 Nov 2005	24 Nov 2005	ad	Two GM commodities (corn and sugar beet).
Table to clause 2	85	F2006L00469 10 Feb 2006 FSC 27 10 Feb 2006	10 Feb 2006	ad	Two GM commodities (cotton).
Table to clause 2	87	F2006L02539 3 Aug 2006 FSC 29 8 Aug 2006	8 Aug 2006	ad	Two GM commodities (corn).
Table to clause 2	91	F2007L00373 15 Feb 2007 FSC 33 15 Feb 2007	15 Feb 2007	ad	One GM commodity (lucerne).
Table to clause 2	92	F2007L02406 2 Aug 2007 FSC 34 2 Aug 2007	2 Aug 2007	ad	One GM commodity (corn).
Table to clause 2	97	F2008L00708 13 March 2008 FSC 39 13 March 2008	13 March 2008	ad	One GM commodity (corn).
Table to clause 2	100	F2008L02396 10 July 2008 FSC 42 10 July 2008	10 July 2008	ad	One GM commodity (soybean).
Table to clause 2	103	F2008L03741 9 Oct 2008 FSC 45 9 Oct 2008	9 Oct 2008	ad	One GM commodity (rice).
Table to clause 2	104	F2008L04541 4 Dec 2008 FSC 46 4 Dec 2008	4 Dec 2008	ad	One GM commodity (corn).
Table to clause 2	106	F2009L00307 12 Feb 2009 FSC 48 12 Feb 2009	12 Feb 2009	ad	One GM commodity (corn).
Table to clause 2	112	F2009L03550 17 Sept 2009 FSC 54 17 Sept 2009	17 Sept 2009	ad	Two GM commodities (cotton).
Table to clause 2	114	F2010L00357 18 Feb 2010 FSC 56 18 Feb 2010	18 Feb 2010	ad	Two GM commodities (soybean).
Table to clause 2	116	F2010L01310 20 May 2010 FSC 58 20 May 2010	20 May 2010	ad, rs	One GM commodity (cotton) and replace ‘oil and linters’ with ‘Food’ where occurring in the Table.
Table to clause 2	117	F2010L01841 29 June 2010 FSC 59 1 July 2010	1 July 2010	ad	One GM commodity (corn).
Table to clause 2	118	F2010L02395 31 Aug 2010 FSC 60 2 Sept 2010	2 Sept 2010	ad	Two GM commodities (corn and soybean).
Table to clause 2	120	F2011L00062 20 Jan 2011 FSC 62 20 Jan 2011	20 Jan 2011	rep	Table with approved GM commodities moved to Schedule.
3	78	F2005L01246 26 May 2005 FSC 19 26 May 2005	26 May 2005	rep	Clause.
4	57	F2008B00795 10 Dec 2008 P 27 1 Nov 2001	1 Nov 2001	am	Insert subclauses (5) and (6) relating to a provision for stock-in-trade for 12 months from 7 December 2001. An Editorial note relating to subclause (5) also inserted.
4(5), 4(6)	88	F2006L03270 5 Oct 2006 FSC 30 5 Oct 2006	5 Oct 2006	rep	Subclauses and Editorial note after 4(5) as they have ceased to have effect.
5	101	F2008L03058 14 Aug 2008 FSC 43 14 Aug 2008	14 Aug 2008	rs	Boxed text following the clause and inserting an Editorial note.
7	88	F2006L03270 5 Oct 2006 FSC 30 5 Oct 2006	5 Oct 2006	am	Omit a reference in the Editorial note to a review of Division 2 as it has been completed.
7	101	F2008L03058 14 Aug 2008 FSC 43 14 Aug 2008	14 Aug 2008	rs	Editorial note.
7	111	F2009L03145 13 Aug 2009 FSC 53 13 Aug 2009	13 Aug 2009	rep	Editorial note
7	120	F2011L00062 20 Jan 2011 FSC 62 20 Jan 2011	20 Jan 2011	am	Consequential change relating to the insertion of a Schedule.
Schedule	120	F2011L00062 20 Jan 2011 FSC 62 20 Jan 2011	20 Jan 2011	ad	Schedule to replace Table to clause 2 and insert a new GM commodity (cotton).
Schedule	124	F2011L01413 5 July 2011 FSC 66 11 July 2011	11 July 2011	ad	One GM commodity (soybean).
Schedule	126	F2011L02065 13 Oct 2011 FSC 68 13 Oct 2011	13 Oct 2011	ad	One GM commodity (corn).
Schedule	127	F2011L02370 15 Nov 2011 FSC 69 17 Nov 2011	17 Nov 2011	ad	One GM commodity (soybean).
Schedule	127	F2011L02372 15 Nov 2011 FSC 69 17 Nov 2011	17 Nov 2011	ad	One GM commodity (soybean).
Schedule	129	F2012L00208 8 Feb 2012 FSC 71 9 Feb 2012	9 Feb 2012	ad	One GM commodity (soybean).
Schedule	130	F2012L00932 26 April 2012 FSC 72 26 April 2012	26 April 2012	ad	One GM commodity (corn).
Schedule	131	F2012L01061 23 May 2012 FSC 73 24 May 2012	24 May 2012	ad	One GM commodity (soybean).
Schedule	133	F2012L01536 11 July 2012 FSC 75 12 July 2012	12 July 2012	ad	One GM commodity (corn).
Schedule	133	F2012L01537 11 July 2012 FSC 75 12 July 2012	12 July 2012	ad	One GM commodity (soybean).
Schedule	135	F2012L02014 10 Oct 2012 FSC 77 11 Oct 2012	11 Oct 2012	am	Correction of typographical error for Item 1.2 (canola).
Schedule	139	F2013L00249 21 Feb 2013 FSC 81 21 Feb 2013	21 Feb 2013	ad	One GM commodity (canola).
Schedule	140	F2013L00662 17 April 2013 FSC 82 18 April 2013	18 April 2013	ad	One GM commodity (soybean).
Schedule	145	F2014L00035 6 Jan 2014 FSC87 9 Jan 2014	9 Jan 2014	ad	One GM commodity (cotton).
Schedule	146	F2014L00189 25 Feb 2014 FSC88 27 Feb 2014	27 Feb 2014	ad	One GM commodity (soybean).
Schedule	147	F2014L00455 30 April 2014 FSC89 1 May 2014	1 May 2014	ad	One GM commodity (lucerne).
Schedule	148	F2014L00528 14 May 2014 FSC90 15 May 2014	15 May 2014	ad	One GM commodity (soybean).
Schedule	148	F2014L00529 14 May 2014 FSC90 15 May 2014	15 May 2014	ad	One GM commodity (canola).
Schedule	150	F2014L01424 28 Oct 2014 FSC92 30 Oct 2014	30 Oct 2014	ad	One GM commodity (cotton).
Schedule	156	F2015L01221 5 Aug 2015 FSC98 6 Aug 2015	6 Aug 2015	ad	One GM commodity (corn).
Schedule	159	F2015L01918 2 Dec 2015 FSC101 7 Dec 2015	7 Dec 2015	ad	One GM commodity (corn).