Final assessment report



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9. Conclusion and Recommendation

Major changes to the food regulatory environment have impacted on the review of Proposal P234. In particular, the separation of responsibilities for development of food policy and the development of food standards has meant that the criteria for nutrition content and related claims have not been considered in the context of other health and related claims, as provided by the Policy Guideline.


Therefore, in order to give adequate consideration to the Policy Guideline, it is proposed that a fresh approach needs to be taken. It is recommended that Proposal P234 be rejected. Relevant issues raised by P234 will be considered in a new proposal, Proposal P293 – Nutrition, Health and Related Claims which will have regard to the Ministerial Council’s policy guidance and involve consultation on new options.

These options will be formulated in the context of Australian and New Zealand national policies and legislation and will be consistent with the information needs of consumers and with international trade agreements. Preparing a new proposal will allow FSANZ to undertake further consultation, maximising and focussing stakeholder input on the new options rather than relying on consultation from the Draft Assessment for Proposal P234, which pre-dated the Policy Guideline. Proposal P293 will also minimise any confusion that might result from a continuation of Proposal P234. Those issues that are relevant to the new options canvassed in the new Proposal and which were raised in Proposal P234 will be considered in the new Proposal. The Office of Regulatory Review (ORR) will also consider the regulatory impact statement for the new Proposal.


Current provisions for nutrition content and related claims will be retained until a new Standard for the regulation of nutrition, health and related claims has been developed.

10. Implementation and review

As Proposal P234 is rejected, there will be no need for an implementation or review strategy.


FSANZ has prepared a new proposal, Proposal P293, Nutrition, Health and Related Claims to take into consideration the changes to the food regulatory environment and the Policy Guideline for Nutrition, Health and Related Claims, which was notified to FSANZ by the Ministerial Council. Issues raised in submissions to Proposal P234 will be taken into account during the assessment process for the new Proposal. Stakeholders are encouraged to submit new submissions to the new Proposal.

ATTACHMENTS




  1. Draft variations to Standard 1.2.8 of the Australia New Zealand Food Standards Code

  2. Australia and New Zealand Food Regulation Ministerial Policy Guideline on Nutrition, Health and Related Claims

  3. Membership of the External Advisory Group for Proposal P234 and their Terms of Reference

  4. List of Proposal P234 Submitters to the Draft Assessment Report

  5. Summary of submissions raised by Proposal P234 submitters to the Draft Assessment Report

ATTACHMENT 1

DRAFT VARIATIONS TO AUSTRALIA NEW ZEALAND FOOD STANDARDS CODE



To commence: on gazettal
[1] Standard 1.2.8 of Volume 2 of the Food Standards Code is varied by –
[1.1] omitting the Table of Provisions, and substituting –
Table of Provisions
Division 1 – Interpretation

1 Definitions



  1. Energy factors

Division 2 – Nutrition information panels

3 Nutrition information requirements and exemptions

4 Requirements for nutrition information panels where nutrition claims are made in relation to food

5 Prescribed declarations in a nutrition information panel

6 Expression of average energy content and quantities of nutrients and biologically active substances

7 Percentage daily intake information

8 Food in small packages

9 Food in dehydrated or concentrated form

10 Food that must be drained before consumption

11 Food to be prepared or consumed with other food
Division 3 – Conditions for making certain nutrition claims

12 General conditions for making nutrition claims

13 Comparative claims

14 ‘Free’ claims

15 Light and lite claims

16 Energy claims

17 Protein claims

18 General fat claims

19 Saturated fat claims

20 Polyunsaturated or monounsaturated fatty acid claims

21 Omega fatty acid claims

22 Cholesterol claims prohibition

23 Sugar, sugars and sweetening claims

24 Fibre claims

25 Salt and sodium claims

26 Lactose claims

27 Gluten claims
Division 4 – Miscellaneous

28 Methods of analysis to determine total dietary fibre and specifically named fibre content of food


[1.2] inserting in clause 1, immediately after the definition of carbohydrate –
comparative nutrition claim means a nutrition claim that expressly or impliedly compares a food with a similar food or class of food.
Editorial note:

Examples of comparative nutrition claims are nutrition claims using the terms ‘reduced’, ‘less than’ or ‘increased’.


[1.3] inserting in clause 1, immediately after the definition of gluten –
intense sweetener has the same meaning as in Standard 1.3.1.
main meal product means a pre-packaged prepared food product designed to constitute a complete main meal.
[1.4] omitting from clause 1, paragraph (c) of the definition of nutrition claim, and substituting –
(c) amino acids, carbohydrate, fat, fatty acids, fibre, protein, starch or sugars; or
[1.5] inserting in clause 1, immediately after the Editorial note after the definition of nutrition claim –
nutrition claim to the effect that a food is a low energy food includes use of the terms –
(a) low joule;

(b) low calorie;

(c) low energy; and

(d) diet.


[1.6] inserting in clause 1, immediately after the definition of polyunsaturated fatty acids –
reference food means, in respect of a food in relation to which a nutrition claim is made, the regular counterpart food or class of foods.
Editorial note:
The reference food may be the regular counterpart food produced by the manufacturer; or the most similar food whose composition is referenced in published food composition databases; or the average of regular counterpart foods on the market.
For example, the reference food for high fibre white bread may be regular white bread, either as produced by the manufacturer, as referenced in published food composition tables or the average of regular white breads on the market.

[1.7] omitting paragraph 5(1)(e), and substituting


(e) subject to clause 20, the average quantity, expressed in grams of, protein, fat, saturated fat, carbohydrate and sugars, in a serving of the food and in a unit quantity of the food; and
[1.8] omitting subclause 5(4), and substituting –
(4) The nutrition information panel must include declarations of the trans, polyunsaturated and monounsaturated fatty acids in accordance with subclause (7), where a nutrition claim is made in respect of -
(a) saturated, trans, polyunsaturated or monounsaturated fatty acids; or

(b) omega-3, omega-6 or omega-9 fatty acids.


[1.9] deleting from the Nutrition Information Panel format in subclause 5(7), the entry for Cholesterol
[1.10] omitting paragraph 8(1)(c), and substituting –
(c) saturated, trans, polyunsaturated and monounsaturated fatty acids content of the food where a nutrition claim is made in respect of –
(i) saturated, trans, polyunsaturated or monounsaturated fatty acids; or

(ii) omega-3, omega-6 or omega-9 fatty acids; and


[1.11] omitting paragraph 8(1)(d), and substituting –
(d) average quantity of energy present per unit quantity of the food where a nutrition claim is made to the effect that the food is a low energy food.
[1.12] omitting Division 3, and substituting –
Division 3 – Conditions for making certain nutrition claims
Editorial note:
Clause 13 of Standard 1.1.1 prohibits advertisements for food from containing any statement, information, design or representations that the Code prohibits from being included in a label for the food.
Subclauses 5(4) and 5(5) of this Standard contain requirements for nutrition information panels to include additional declarations where nutrition claims are made in respect of certain nutrients.
12 General conditions for making nutrition claims
(1) Where a nutrition claim is made in relation to a property of a food that is inherent to the category of food to which the particular food belongs, the claim must refer to that category of food, and not only to the particular food in question.

Editorial note:
For example –

‘[category of the food] is a low joule food’


(2) Where a food is of a type described in clause 9 of this Standard, any nutrition claim in relation to that food must be in relation to the food as reconstituted.
(3) Where a food is of a type described in clause 10 of this Standard, any nutrition claim in relation to that food must be in relation to the drained food.
13 Comparative claims
(1) A comparative nutrition claim must not be made unless:


  1. for the food in relation to which the claim is made, the characteristic to which the claim relates is at least 25 %:

(i) greater, where the claim indicates a higher value; or

(ii) lesser, where the claim indicates a lower value;
than in the same quantity of reference food; and

(b) the foods being compared are identified; and

(c) the proportion by which the food differs from the same quantity of reference food is stated in conjunction with the claim.
Editorial note:
For example –
A comparative nutrition claim to the effect that a food is reduced fat may only be made if the food contains at least 25% less fat than the same quantity of reference food. The food being used for comparison must be identified, and the difference in fat content of the food compared with the reference food must be stated in conjunction with the claim. These requirements could be satisfied by the following –
Reduced fat

Contains 30% less fat than [reference food].


14 ‘Free’ claims
A nutrition claim that a food does not have a nutritional property must not be made unless expressly permitted by this Code.
15 Light and lite claims
(1) A nutrition claim that a food is –
(a) light; or

(b) lite;

must not be made unless –
(c) the nutritional property to which the claim relates is stated in conjunction with the claim; and

(d) the food meets the requirements for making a nutrition claim to the effect that the food is very low, low or reduced in relation to that nutritional property.


16 Energy claims
(1) A nutrition claim to the effect that a food is a low energy food, must not be made unless the average energy content of the food is no more than –
(a) 80 kJ per 100 mL for beverages or other liquid foods; and

(b) 170 kJ per 100 g for all other foods.


(2) Where a food in dehydrated or concentrated form is labelled with directions that indicate that the food should be reconstituted before consumption, the average energy content of the food must be calculated for the food as so reconstituted.
(3) Where a nutrition claim is made –
(a) in accordance with subclause (1) or subclause (2); and

(b) uses the term ‘calorie’;


the declarations of energy in the nutrition information panel must be made in terms of calories as well as kilojoules.
17 Protein claims
A nutrition claim to the effect that a food is high in protein must not be made unless the food provides –
(a) no less than 5g of protein per 100 mL for beverages and other liquid foods; and

(b) no less than 10 g of protein per 100 g for all other foods.


18 General fat claims
(1) A nutrition claim to the effect that a food is low in fat must not be made unless the food contains –
(a) no more than 1.5 g of fat per 100 mL for beverages and other liquid foods; and

(b) no more than 3 g of fat per 100 g for all other foods.


(2) A nutrition claim to the effect that a food is very low in fat must not be made unless the food contains no more than 0.15 g of fat per 100 g of the food.
(3) A nutrition claim to the effect that a food is a certain percentage fat free must not be made unless –
(a) the food meets the requirements for making a claim to the effect that a food is low in fat; and

(b) the fat content of the food expressed as a percentage is stated in conjunction with the claim.


Editorial note:
For example –

98% fat free

contains 2% fat
19 Saturated fatty acid claims
(1) A nutrition claim to the effect that a food is low in saturated fatty acid must not be made unless the food contains –
(a) no more than 0.75 g of saturated fatty acids and trans fatty acids in total per 100 mL for beverages and other liquid foods; and

(b) no more than 1.5 g of saturated fatty acids and trans fatty acids in total per 100 g for all other foods.


20 Polyunsaturated or monounsaturated fatty acid claims
(1) A nutrition claim must not be made in relation to the polyunsaturated fatty acid content or monounsaturated fatty acid content of a food unless –
(a) the total of saturated fatty acids and trans fatty acids comprises no more than 28 per cent of the total fatty acid content of the food; and

(b) the fatty acid in respect of which the nutrition claim is made comprises no less than 40 per cent of the total fatty acid content of the food.


(2) Where a nutrition claim is made in relation to the polyunsaturated fatty acid content or monounsaturated fatty acid content of foods for which there are compositional requirements specified in Standard 2.4.1 or Standard 2.4.2, the quantity of saturated fatty acids, polyunsaturated fatty acids, monounsaturated fatty acids and trans fatty acids may be set out in the nutrition information panel as a minimum or maximum quantity in a serving of the food.
Editorial note:
Subclause 20(2) provides manufacturers of edible oils and edible oil spreads with the option of setting out the minimum and maximum fatty acid content of the types of fatty acids referred to in subclause 20(2) instead of their average quantity. Total fat must still be expressed as an average quantity in accordance with paragraph 5(1)(e).
21 Omega fatty acid claims
(1) Where a nutrition claim using the word ‘omega’ is made in relation to the omega fatty acid content of a food, the word ‘omega’ must be qualified by the type of omega fatty acid present and this qualification must appear immediately after the word ‘omega’.
Editorial note:
For example, in the format ‘Omega-3’, ‘Omega-6’ or ‘Omega-9’.
(2) Subject to subclause (3) and subclause (4), a nutrition claim must not be made in relation to the omega-3 fatty acid content of a food, other than fish or fish products that have no added saturated fatty acids, unless the –
(a) total of saturated fatty acids and trans fatty acids is less than 28 per cent of the total fatty acid content of the food; or

(b) food contains no more than 5 g of saturated fatty acids and trans fatty acids per 100 g of the food.


(3) A nutrition claim must not be made in relation to the omega-3 fatty acid content of a food, unless the food satisfies the requirements of subclause (2) and contains no less than –
(a) 200 mg alpha-linolenic acid per serving; or

(b) 30 mg total eicosapentaenoic acid and docosahexaenoic acid per serving.


(4) A nutrition claim to the effect that a food is a ‘good source’ of omega-3 fatty acid must not be made, unless the food satisfies the requirements of subclause (2) and contains no less than 60 mg total eicosapentaenoic acid and docosahexaenoic acid per serving.
(5) Where a nutrition claim is made in accordance with subclause (3) or subclause (4), the declarations in the nutrition information panel must indicate the source of omega 3 fatty acids, namely, alpha-linolenic acid, docosahexaenoic acid and/or eicosapentaenoic acid.
(6) A nutrition claim must not be made in relation to the omega-6 or omega-9 fatty acid content of a food, unless the –
(a) total of saturated fatty acids and trans fatty acids content of the food is no more than 28 per cent of the total fatty acid content of the food; and

(b) fatty acid in respect of which the nutrition claim is made comprises no less than 40 per cent of the total fatty acid content of the food.


Editorial note:
The omega-3, omega-6 or omega-9 fatty acid content of a food that is the subject of such a claim should be set out in the nutrition information panel in the format specified in subclause 5(7) as a sub-sub-group of polyunsaturated fatty acids or monounsaturated fatty acids, as the case may be.
22 Cholesterol claims prohibition
A nutrition claim must not be made in relation to the cholesterol content of a food.
23 Sugar, sugars and sweetening claims
(1) A nutrition claim to the effect that a food contains no –
(a) added sugar; or

(b) added sugars;


must not be made unless:
(c) the food contains no added:
(i) hexose monosaccharides and disaccharides, including dextrose, fructose, sucrose and lactose; or

(ii) starch hydrolysate; or

(iii) glucose syrups, maltodextrin and similar products; or

(iv) products derived at a sugar refinery, including brown sugar and molasses; or

(v) icing sugar; or

(vi) invert sugar; or

(vii) fruit sugar syrup;

(viii) malt or malt extracts; or

(ix) honey; or


  1. concentrated and/or deionised fruit juice; and

(d) a reference to the declaration of the sugars in the nutrition information panel is made in conjunction with the claim.


Editorial note:
For example –

No added sugars

This product contains natural sugars. See nutrition information panel for details.
(2) A nutrition claim to the effect that a food is unsweetened must not be made unless the food contains –
(a) no added –
(i) hexose monosaccharides and disaccharides, including dextrose, fructose, sucrose and lactose; or

(ii) starch hydrolysate; or

(iii) glucose syrups, maltodextrin and similar products; or

(iv) products derived at a sugar refinery, including brown sugar and molasses; or

(v) icing sugar; or

(vi) invert sugar; or

(vii) fruit sugar syrup;

(viii) malt or malt extracts; or

(ix) honey; or

(x) concentrated and/or deionised fruit juice; and


(b) no –
(i) intense sweeteners; or

(ii) sorbitol, mannitol, glycerol, xylitol, isomalt, maltitol syrup or lactitol; and


a reference to the declaration of the sugars in the nutrition information panel is made in conjunction with the claim.
(3) A nutrition claim to the effect that a food is very low in sugar must not be made unless the food contains –
(a) no more than 0.1 g of sugars per 100 ml for beverages or other liquid food; and

(b) no more than 0.2 g of sugars per 100 g for all other food.


(4) A nutrition claim to the effect that a food is low in sugar must not be made unless the food contains –
(a) no more than 2.5 g of sugars per 100 ml for beverages or other liquid food; and

(b) no more than 5 g of sugars per 100 g for all other food.


24 Fibre claims
(1) A nutrition claim must not be made in relation to the fibre content of a food unless a food derives –
(a) less than 30 per cent of its average energy content from fat; and

(b) less than 10 per cent of its average energy content from saturated fatty acids and trans fatty acids.


(2) A nutrition claim to the effect that a food is a source of fibre must not be made unless the food contains –
(a) no less than 2 g of dietary fibre per 100 g for main meal products; and

(b) no less than 1.5 g of dietary fibre per serving for all other foods.


(3) A nutrition claim to the effect that a food is a good source of fibre must not be made unless the food contains -
(a) no less than 4 g of dietary fibre per 100g for main meal products; and

(b) no less than 3 g of dietary fibre per serving for all other foods.


(4) A nutrition claim to the effect that a food is an excellent source of fibre must not be made unless the food contains –
(a) no less than 8 g of dietary fibre per 100 g for main meal products; and

(b) no less than 6 g of dietary fibre per serving for all other foods.


(5) A nutrition claim to the effect that a food is fibre enriched must not be made unless the food contains -
(a) no less than 1.5 g of dietary fibre per serving, where the fibre enrichment component of the dietary fibre has been discounted; and

(b) no less than 3 g of dietary fibre per serving.


25 Salt and sodium claims
(1) A nutrition claim to the effect that a food has no added salt or sodium must not be made unless the food is –
(a) unsalted; and

(b) a reference to the declaration of the sodium in the nutrition information panel is made in conjunction with the claim.


(2) A nutrition claim to the effect that a food is very low in salt or sodium must not be made unless the food contains no more than 40 mg of sodium per 100 g of the food.
(3) A nutrition claim to the effect that a food is low in salt or sodium must not be made unless the food contains no more than 120 mg of sodium per 100 g of the food.
(4) Where a nutrition claim is made in respect of the salt, sodium or potassium content of a food, or any two or all of them, then particulars, including particulars relating to both the sodium and potassium content of the food, must be provided in relation to the food in accordance with subclause 5(1).
26 Lactose claims
(1) A nutrition claim to the effect that a food is low lactose must not be made unless the food contains no more than 0.3 g of lactose per 100 g of the food.
(2) A nutrition claim to the effect that a food is lactose free must not be made unless the food contains no detectable lactose.
(3) Where a nutrition claim is made in relation to the lactose content of a food, particulars of the lactose and galactose content of the food must be provided in accordance with subclause 5(1).
Editorial note:
The declaration of the lactose and galactose content of a food in the nutrition information panel should be in the following form:
Carbohydrate

- sugars


- lactose

- galactose


27 Gluten claims
(1) A nutrition claim in relation to the gluten content of food must not be made unless expressly permitted by this Code.
Editorial note:
This subclause does not prohibit the declaration of the presence of gluten, for example, in an ingredient list on the label on a food.
(2) A nutrition claim to the effect that a food is gluten free must not be made in relation to a food unless the food contains no -
(a) detectable gluten; and

(b) oats or malt.


(3) A nutrition claim to the effect that a food has a low gluten content, must not be made in relation to a food unless the food contains no –
(a) more than 20 mg gluten per 100 g of the food; and

(b) oats or malt.


Editorial note:
Subclauses (2) and (3) of this clause permit nutrition claims to the effect that a food is gluten free or has a low gluten content, providing certain specified conditions are met.
(4) A nutrition claim to the effect that a food contains gluten or is high in gluten may be made in relation to a food.
Editorial note:
Subclause 16(1) prohibits all nutrition claims about gluten unless expressly permitted. Subclauses 16(2), (3) and (4) provide those express permissions.
[1.13] omitting Division 4, and substituting –
Division 4 – Miscellaneous
29 Methods of analysis to determine total dietary fibre and specifically named fibre content of food
(1) Subject to subclause (2), the methods set out in the Table to this subclause are the prescribed methods of analysis for the determination of total dietary fibre and any specifically named fibre content of food for the purposes of nutrition labelling in this standard.
Table to subclause 29(1)


Column 1

Column 2

Food Component

Method of analysis

Total dietary fibre

Section 985.29 of the AOAC, 17th Edition (2000), or

Section 991.43 of the AOAC, 17th Edition (2000).



Inulin and fructooligosaccharide

Section 997.08 of the AOAC, 17th Edition (2000).

Inulin

Section 999.03 of the AOAC, 17th Edition (2000).

(2) The results obtained using the analytical methods outlined in column 2 of the Table to subclause 29(1) must be summed together after ensuring that there is no double counting of any specifically named fibre.


Editorial note:
For the purposes of subclause 29(2), where a manufacturer chooses to include a specifically named fibre in the declaration of dietary fibre, the manufacturer must first work out which food components in column 1 are present in the food and then use the appropriate methods of analysis in column 2, or in the case of total dietary fibre, choose which method of analysis to use. The results of the chosen methods of analysis are then added together. If any substance has been measured by more than one analysis, then allowance must then be made by discounting for double counting of that amount to arrive at the total figure.
For example, the dietary fibre content of a cereal bar with added inulin is calculated by adding the result of the analysis for total dietary fibre, using one of the two possible methods of analysis, to the result of the analysis for inulin, and subtracting from the total that part of the inulin content that was included in the result of the analysis for total dietary fibre.
[2] Standard 1.3.1 of Volume 2 of the Food Standards Code is varied by omitting from clause 4, the Editorial Note immediately following, and substituting –
Editorial Note:
In general, the use of intense sweeteners is limited to:
1. foods meeting the definition of ‘reduced joule’ or ‘low joule’;

2. ‘no added sugar or sugars’ food e.g. artificially sweetened canned fruit without added sugar or sugars; or

3. specific foods in which the use of the sweetener is in addition to sugar rather than as an alternative e.g. chewing gum, brewed soft drink (these foods are listed in Schedule 1 on a case-by-case basis).

Conditions relating to the use of reduced/low joule, no added sugar, sugars and unsweetened claims can be found in Standard 1.2.8.


Polyols, isomalt and polydextrose may be considered to be food additives when used as humectants and texturisers. Where these substances constitute a significant part of the final food they would be regarded as a food in their own right rather than food additives. Polyols, isomalt and polydextrose are not considered to be bulking agents if used in large amounts to replace sugars as they may contribute significantly to the available energy of the food.
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