Standard 1.5.1
Novel Foods
Purpose
This Standard regulates the sale of novel food and novel food ingredients. This Standard prohibits the sale of these foods unless they are listed in the Table to clause 2, and comply with any special conditions of use in that Table. The specific permission may impose conditions relating to matters such as the need for preparation or cooking instructions, warning statements or other advice, or the need to meet specific requirements of composition or purity.
The Authority will assess the safety for human consumption of each novel food prior to its inclusion in the Table. The safety assessment will be performed in accordance with the Authority’s safety assessment guidelines.
Foods produced using gene technology and foods which have been irradiated are regulated in Standards 1.5.2 and 1.5.3 respectively.
Table of Provisions
1 Definitions
2A Foods for Special Medical Purposes
2 Sale of novel foods
3 Exclusive use of novel foods
Clauses
1 Definitions
In this Standard –
non-traditional food means –
(a) a food that does not have a history of human consumption in Australia or New Zealand; or
(b) a substance derived from a food, where that substance does not have a history of human consumption in Australia or New Zealand other than as a component of that food; or
(c) any other substance, where that substance, or the source from which it is derived, does not have a history of human consumption as a food in Australia or New Zealand.
novel food means a non-traditional food and the food requires an assessment of the public health and safety considerations having regard to -
(a) the potential for adverse effects in humans; or
(b) the composition or structure of the food; or
(c) the process by which the food has been prepared; or
(d) the source from which it is derived; or
(e) patterns and levels of consumption of the food; or
(f) any other relevant matters.
Editorial Note:
Novel food includes novel foods used as ingredients in another food.
Possible categories of novel foods are described in the Authority’s guidelines. Categories of novel foods may include, but are not limited to: plants or animals and their components; plant or animal extracts; herbs, including extracts; dietary macro-components; single chemical entities; microorganisms, including probiotics; foods produced from new sources, or by a process not previously applied to food.
2A Foods for Special Medical Purposes
To avoid doubt, the presence of a food in a food for special medical purposes or the use of a food as a food for special medical purposes does not constitute a history of human consumption in Australia or New Zealand in relation to that food for the purposes of this Standard.
Editorial note:
Standard 1.5.1 does not apply to foods for special medical purposes. See paragraph 3(1)(b) of Standard 2.9.5.
2 Sale of novel foods
A novel food must not be sold by way of retail sale as food or for use as a food ingredient unless it is listed in column 1 of the Table to this clause and complies with the conditions of use, if any, specified in column 2.
Table to clause 2
| Column 1 | Column 2 |
| Novel Food | Conditions of Use |
| α-cyclodextrin | The name ‘alpha cyclodextrin’ or ‘α -cyclodextrin’ must be used when declaring the ingredient in the ingredient list, as prescribed in Standard 1.2.4. |
| γ-cyclodextrin | The name ‘gamma cyclodextrin’ or ‘γ -cyclodextrin’ must be used when declaring the ingredient in the ingredient list, as prescribed in Standard 1.2.4. |
| Diacylglycerol oil (DAG-Oil) | The name ‘Diacylglycerol oil’ must be used when declaring the ingredient in the ingredient list, as prescribed in Standard 1.2.4. |
| Dried marine micro-algae (Schizochytrium sp.) rich in docosahexaenoic acid (DHA) | |
| Oil derived from marine micro-algae (Schizochytrium sp.) rich in docosahexaenoic acid (DHA) | |
| Oil derived from marine micro-algae (Ulkenia sp.) rich in docosahexaenoic acid (DHA) | |
| Isomaltulose | |
Table to clause 2 (continued)
| Column 1 | Column 2 |
| Novel Food | Conditions of Use |
| Phytosterols, phytostanols and their esters | The food must comply with requirements in clause 2 of Standard 1.2.3. May only be added to edible oil spreads – (1) according to Standard 2.4.2; and (2) where the total saturated and trans fatty acids present in the food are no more than 28% of the total fatty acid content of the food. May only be added to breakfast cereals, not including breakfast cereal bars, if – (1) the total fibre content of the breakfast cereal is no less than 3 g/50 g serve; (2) the breakfast cereal contains no more than 30g/100g of total sugars; and (3) the total plant sterol equivalents content is no less than 15 g/kg and no more than 19 g/kg. Foods to which phytosterols, phytostanols or their esters have been added must not be used as ingredients in other foods. May only be added to milk in accordance with Standard 2.5.1. May only be added to yoghurt in accordance with Standard 2.5.3. |
| D-Tagatose | |
| Tall oil phytosterol esters | The tall oil phytosterol esters must comply with the specification for tall oil phytosterol esters in the Schedule to Standard 1.3.4. The food must comply with the requirements in clause 2 of Standard 1.2.3. The name ‘tall oil phytosterol esters’ or ‘plant sterol esters’ must be used. May only be added to cheese and processed cheese, in accordance with Standard 2.5.4. Foods to which tall oil phytosterol esters have been added must not be used as ingredients in other foods. |
| Trehalose | |
Editorial note:
See Standard 1.3.4 – Identity and Purity for identity and purity requirements for novel foods.
3 Exclusive use of novel foods
(1) Despite clause 2, the novel food listed in column 1 of the Table to this clause may be sold as food or for use as a food ingredient for an exclusive period in the brand of food listed in column 2, in the class of food listed in column 3 and subject to the novel food complying with the conditions of use, if any, listed in column 4.
(2) The exclusive period commences on gazettal of the variation of this Standard to the Table to this clause.
(3) At the end of the exclusive period the novel food listed in column 1 of the Table to this clause, in the class of food listed in column 3 and the conditions of use, if any listed in column 4 is taken to continue as a novel food under clause 2 of this Standard.
(4) For the purpose of this clause, ‘exclusive period’ means the period of 15 months’ exclusive use of the novel food listed in column 1 of the Table to this clause in the brand listed in column 2 and the class of food listed in column 3.
Table to clause 3
| Column 1 | Column 2 | Column 3 | Column 4 |
| Novel Food | Brand | Class of Food | Conditions of Use |
| | | | |
Editorial note:
Clause 3 of this Standard will be reviewed after 3 years and before 5 years from gazettal of this Standard in accordance with the request of the Ministerial Council on 4 May 2007 for review under section 113 of the Food Standards Australia New Zealand Act 1991.
Under subclause 3 the exclusive use permission reverts to a general permission under clause 2, after the 15-month period (exclusive period) has expired. The Table to clause 2 and the Table to clause 3 will be updated to reflect the operation of subclause 3. Note that the class of food and conditions of use, if any in the Table to clause 3 will be inserted in column 2 of the Table to clause 2.