- Print Friendly - Help

Application P293 – Nutrition, health and Related Claims – Preliminary Final Assessment Report

15 May 2007

Dear Sir/Madam

Thank you for the opportunity to comment on this proposal. The New Zealand Food Safety Authority (NZFSA) has the following comments to make.

Preliminary Final Assessment Report (PFAR).

NZFSA appreciates the huge effort and considerable resources FSANZ has put into the further development of Proposal P293 since the Draft Assessment Report and we welcome the extra round of public consultation being offered.

SUMMARY OF KEY ISSUES

Key issues for NZFSA are:

• Advertising and labelling should be captured equally by the requirements of Standard 1.2.7

• Increased importance put on NIP values

• Application of Standard 1.2.7

• Trademarks

DETAILED RESPONSE

In our response we have followed the order of the PFAR. This order is not a reflection of the importance we place on particular issues. Note that the text in italics is taken directly from the FSANZ PFAR, and NZFSA comments are in standard text.

3.1 Application of Standard 1.2.7

NZFSA does not support either of the two options presented at PFAR. We are concerned that under FSANZ’s preferred approach Standard 1.2.7 is only to be applied to food for retail sale. We believe this application is too narrow and that Standard 1.2.7 should be applied to both food for retail sale and food for catering purposes. We support that Standard 1.2.7 should not apply in respect of foods for hospital food services or delivered meal organisations as regulated by subclause 2(4), but would like to suggest that ‘delivered meal organisations’ be defined. Without a definition this could be open to misinterpretation and costly to enforce consistently. For example, a venture could be set up for which there is no retail outlet but which relies solely on deliveries. Such a venture could be considered to be a delivered meal organisation and Standard 1.2.7 would then not apply. We do not believe this is FSANZ’s intention. Any such definition for ‘delivered meal organisation’ would also apply under Proposal P272 Labelling Requirements for Food for Catering Purposes and Retail Sale. Under subclause 2(4)(b) of Standard 1.2.7 it is proposed that the definition referred to in Table to clause 8 in Standard 1.2.1 as included in Proposal P272 should apply. If for any reason this definition is not gazetted before gazettal of Standard 1.2.7 we suggest that a mechanism needs to be put in place for this definition to be gazetted at the same time as Standard 1.2.7.

The disadvantages section of FSANZ’s preferred approach (p20 of the PFAR) states ‘permits provision of some nutrition or health related information that is not regulated by the proposed Standard and may be misused by suppliers’. NZFSA is concerned that accepting option 2 would allow for nutrition and health claims to be made to help sell ingredients when those same claims would not be permitted to be made about the end product sold directly to the public. This is not an acceptable situation to create and suppliers should not be permitted to make these claims.

Standard 1.2.7 applies to both food labels and advertising. This is clearly stated in the Purpose of the Standard. However in several places throughout the draft standard the text states ‘in the one place on the label’. One interpretation of the drafting could be that in these cases, when special emphasis is put on the label, advertisements are excluded. We suggest that, to remove ambiguity, the drafting is amended to include the words ‘and in advertisements’ wherever the text appears so that the text reads ‘in the one place on the label and in advertisements’.

3.2.2 Kava

NZFSA supports Option 2 – Prohibit kava from making nutrition content claims and health claims.

3.2.3 Alcoholic beverages and food containing alcohol / 3.2.4 percentage alcohol by volume

Of the three options presented Option 2 is closest to the view of NZFSA.

Option 2 – Permit nutrition content claims on foods containing alcohol (more than 1.15% alcohol by volume) in relation to alcohol, energy and carbohydrate content only. Permit voluntary nutrition information panels. Require a nutrition information panel when a claim is made in relation to energy or carbohydrate content.

Our preference would be for specific alcohol and energy content claims to be listed in Standard 1.2.7 rather than be open ended. With the current drafting a ‘high’ alcohol claim could be made which we would not support.

NZFSA does not support carbohydrate nutrition content claims being made in relation to a food that contains more than 1.15% alcohol by volume. There are no specific conditions prescribed in draft Standard 1.2.7 regarding low carbohydrate. In our view all beers could be considered to be low carbohydrate and therefore making a claim of low carbohydrate could be deemed to be misleading. The rationale for all beers being low in carbohydrate is from the figures in the tables below:

Property	Conditions applied to ‘low’ in draft 1.2.7	Reference value (Standard 1.2.8)	% of reference value
Fat	<1.5g / 100 ml liquid food	70g	2.1
Energy	<80 kJ / 100 ml liquid food	8700 kJ	0.92
Carbohydrate (CHO)	Not set	310 g

	Carbohydrate content	Reference value (Standard 1.2.8)	% of reference value
Beer, standard, draught and lager	2.0 / 100g	310g	0.65
Beer, strong ale	5.8g / 100g	310g	1.87
Beer, extra stout	3.8g / 100g	310g	1.23

Carbohydrate values are taken form Crop & Food’s ‘The Concise NZ Food Composition Tables’.

We strongly suggest that where a voluntary NIP is declared on a food and/or beverage containing more than 1.15% alcohol by volume the serving size should be regulated to be a ‘standard drink’ rather than being determined by the manufacturer.

4.1 Conditions for making content claims – Percentage Daily Intake Labelling

NZFSA supports Option 2 – Do not require %DI labelling on products carrying health and nutrition content claims.

4.2 Voluntary Percentage Daily Intake Labelling

NZFSA supports Option 2

• Permit %DI labelling information for energy alone to be presented outside the nutrition information panel, provided %DI values for energy, the macronutrients and sodium are all presented in the nutrition information panel; and

• Permit %DI labelling information for energy together with the macronutrients and sodium, to be presented all in one place, outside the nutrition information panel, (without the information being considered a claim) and also requiring this %DI labelling information in the nutrition information panel.

4.3 Conditions for food as prepared or as sold

NZFSA supports Option 2 – Specify conditions in Standard 1.2.7 for eligibility criteria to be based on the food as sold or as prepared/consumed.

5.2 Wholegrain

NZFSA supports Option 2 - Remove specific criteria for wholegrains from draft Standard 1.2.7; regulate wholegrains as biological active substances.

5.3 Saturated and Trans Fatty Acid Claims

NZFSA supports Option 2

• Trans and saturated fatty acids considered in the conditions for low and reduced saturated fatty acid claims;

• Trans and saturated fatty acids considered in the conditions for low and reduced saturated and trans fatty acids claims;

• Conditions prescribed for ‘reduced’ trans fatty acid claims (including no increase in saturated fatty acid level);

• Conditions prescribed for the ‘free in trans fatty acids’ claims and the ‘free in saturated fatty acids’ claim, including levels of both fatty acids;

• Claims about ‘low’ trans fatty acids and ‘x% trans fatty acid free’ expressly prohibited; and

• Voluntary declaration of trans fatty acids in the nutrition information panel permitted

5.4 Fibre nutrition content claims

NZFSA supports Option 3 with the term ‘very high fibre’ used as the descriptor in place of ‘excellent source’.

Option 3 - Remove the definition of meal/main dish products and add nutrition content claim criteria for ‘excellent source’ of fibre or ‘very high fibre’ claims

NZFSA suggests the term ‘very high fibre’ be used to reflect fibre levels higher than ‘good source’. We do not support the use of the term ‘excellent source’ for fibre claims for two reasons. First, we believe ‘excellent source’ could be taken to imply the food vehicle is ‘excellent’ which has connotations relating to the healthiness of the food vehicle. As such a fibre claim, being a nutrition content claim, would not be subject to nutrient profiling in our view this could mislead the consumer as to the quality of the food vehicle on which such a claim is made. Second, excellent source’ may give the impression that fibre needs can be met by a serving of a product making this claim and that no other source of fibre is required. This would also be misleading to the consumer.

We support FSANZ’s view that serving size will need to be monitored with regard to fibre claims and suggest this is undertaken as part of the review of the nutrition, health and related claims standard.

5.5 ‘No added sugar’ claim

NZFSA supports Option 3 - Permit the ‘no added’ claim only on products which meet the criteria for the ‘low’ sugar and do not require the disclaimer. [Criteria for ‘low’ sugar: no more than 2.5g sugar per 100ml for liquid food and 5g per 100g for solid food].

5.6 ‘No added salt’ claim

NZFSA supports a position in line with option 3 for 5.5 ‘No added sugar’ which would permit the ‘no added salt’ claim only on products that meet the criteria for ‘low’ salt and do not require the disclaimer. In the absence of an equivalent option to option 3 for ‘no added sugar’ NZFSA would support option 2 - Status Quo – Do not require the disclaimer stating the food contains naturally occurring sodium on products with the claim ‘no added salt’ over option 1 – Approach taken at Draft Assessment: require the disclaimer stating the food contains naturally occurring sodium on products with the claim ‘no added salt’.

5.7 Glycaemic Index

NZFSA supports Option 2 - GI claims using descriptors do not have to be linked to an endorsement; the descriptors ‘low’, ‘medium’ and ‘high’ are permitted in accordance with values provided in Standard 1.2.7; generic nutrient profile eligibility criteria apply; The method for determining GI of carbohydrates in foods is described in the Standards Australia Australian Standard Glycemic Index of foods (AS 4694 – 2007).

We suggest a small change be made to the format of the GI declaration in the NIP given in Clause 4.5 of Attachment 1 (page 181). The boxed area at the bottom of the NIP should be extended across the whole NIP table rather than being restricted to the first column only. This layout should also be carried through to the examples given on page 183 of the PFAR.

5.8 ‘Lite/light’claims

NZFSA agrees with the rationale to place ‘light/lite’ with each of the ‘reduced’ descriptors, for energy, fat, sodium, sugar, saturated fatty acids, trans fatty acids and cholesterol, in the Table to clause 11’. However, this does not address light/lite claims for carbohydrate. While carbohydrate claims per se will not be specifically regulated, the same conditions applied to other properties should also extend to light/lite carbohydrate claims. By this we mean that the following must apply:

• a reduction in energy or carbohydrate content of at least 25% compared to a reference food,

• the identity of the reference food and the difference in the quantity of the energy or carbohydrate in the claimed food compared to the quantity in the reference food be indicated and

• the claim must be presented so that all elements of the claim are in one place.

NZFSA also suggests the term ‘light/lite’ is captured in Standard 1.1.1. Preliminary Provisions – Application, Interpretation and General Prohibitions with a statement made regarding the need to qualify the property of the food to which the term ‘light/lite’ applies where ever it is used, be that property the subject of a nutrition content claim or when referring to aspects of the food such as flavour or colour. This would prevent misleading ‘light’ claims referring to characteristics other than properties of food which are the subject of nutrition content claims.

5.9 Comparative nutrition content claims and definition of ’reference food’

With regard to the definition of reference food, NZFSA supports Option 2 – Definition of reference food clarified and additional option for comparing ‘dietary substitutes’.

With regard to conditions for ‘increased’ claims NZFSA supports Option 1 – Require the reference food to be a ‘source’ of fibre/protein’

We suggest increased carbohydrate claims needs to be addressed in a similar manner as for light/lite carbohydrate claims as in 5.8, ie there should be a 25% increase in the carbohydrate content as compared to a reference food.

The use of nutrient values declared in the nutrition information panel (NIP) to verify comparative claims places increased importance on these values. Currently there are problems with enforcement of these values as it is difficult to determine whether analytical values obtained by testing a given product, as part of an enforcement investigation, are compliant or not with an average value for that nutrient as stated in the NIP. The use of NIP values to both verify certain health claims and to determine the eligibility of food vehicles to carry health claims places significantly increased importance on these values being correct and on the ability to enforce them. NZFSA has raised the inherent problems with enforcement of average values in the NIP in prior submissions. The proposal at this point exacerbates an already difficult and potentially unenforceable part of the NIP standard. We have indicated our strong desire to see this critically reviewed in FSANZ’s upcoming general review of NIPs.

6.1 Food Composition Eligibility Criteria for General Level Health Claims

NZFSA considers that the use of average nutrient values from the NIP to determine the eligibility of food vehicles to carry health claims places significantly increased importance on these values. They must be enforceable and NZFSA doubts this is the case. See comments above for 5.9.

NZFSA is generally supportive of the Food Composition Eligibility Criteria for General Level Health Claims (model 7). We believe that this system works well to ensure health claims are not permitted on foods that we consider should not be allowed to carry such claims, and is an improvement on the option presented in the DAR.

One area that gives rise to concern is that, in order for beverages to meet the eligibility criteria for a general level health claim, product innovation is likely to make more use of intense sweeteners and this could result in an increase in consumption of intense sweeteners.

From an enforcement point of view, the eligibility of a product to make a general level health claim will be determined using information declared on the label. Values not given on the label will be assumed to be zero. For example, if fibre is not declared in a NIP it will be interpreted that fibre levels have not been used to determine the products eligibility to make a general level health claim.

6.2 Weight management and “Diet’ claims

NZFSA supports Option 2 - Foods making weight management claims or ‘Diet’ nutrition content claims are required to meet the qualifying criteria for ‘low energy’ or must have 40% less energy as the same quantity of a reference food. The criterion of a minimum reduction of energy of 170 kJ per 100g of food, or 80kJ per 100ml for liquid food does not apply to ‘Diet’ nutrition content claims or weight management claims.

6.3 New diet-disease relationships

FSANZ considers that the evidence relating to long chain omega-3 fatty acid consumption and reduction in risk of cardiovascular disease (CVD) is ‘probable’ but not ‘convincing’. Thus there is sufficient evidence to support a general level health claim for the diet disease relationship between long chain omega-3 fatty acids and cardiac health…

There is no mention of this in the Draft variation. Clarification is sought as to where this information will be captured as well as manufacturer’s obligations regarding substantiation if such a general level health claim is made.

Clarification is sought regarding the use of the high level claims for vegetables and fruits. In the current drafting these claims can only be used on products that are greater than or equal to 90% vegetable/fruit. When a meal product contains a serve of vegetable or fruit this product could not make these claims, however if that same vegetable/fruit was to be sold separately these claims could be made even though the end use of the vegetable/fruit is likely be the same (ie part of a meal). We believe this is inconsistent. Consideration should be given to meal products that contain a serve of vegetable or fruit being able to make the claims that those vegetables/fruit could make if they were to be sold alone. This should still be dependant on the product as a whole meeting the nutrient profiling requirements to make a health claim.

6.4 Substantiation framework

It is disappointing that the amended substantiated framework document is not included in the PFAR for public comment. NZFSA agrees with the intent of changes to be made to the substantiation framework document and as there is unlikely to be another round of public consultation we suggest that targeted consultation should be carried out to ensure that the intent is captured in the drafting and a user friendly document is produced. NZFSA would be keen to see this document.

NZFSA agrees with FSANZ’s recommendation that the minimum level of evidence to support a general level health claim be established at ’probable’.

7.1 Dietary Information

Of the options presented Option2 is the closest to the view of NZFSA.

Option 2 – Redefine dietary information and amend the conditions as described in subsection 7.1.6

dietary information means general dietary information provided for educational purposes including information from national nutrition guidelines relating to food or properties of food but not including associated health effects.

NSFSA believes FSANZ has clearly differentiated between what would be considered dietary information and what would be considered a health claim. However we believe another important distinction needs to be drawn, that between dietary information and advertising. We consider the example of dietary information given on page 106 of the PFAR (see below) to be advertising.

Example of dietary information in a brochure

A vegetable producer wants to publish a brochure to inform consumers about the importance of vegetables in the diet. In order to meet the definition of dietary information, the information in the brochure may focus on the food group or class of foods (vegetables and fruits), and must be presented in the context of Australia’s or New Zealand’s Dietary Guidelines. The grower may identify it’s corporate brand (Brand X) of the company and Brand X vegetables in the brochure. However in order to meet the definition of dietary information, the dietary information statement should be educational and should not make a direct reference to a particular brand of food, for example, the claim ‘Eat three serves of Brand X vegetables a day’ would not be considered dietary information.

While the definition of dietary information given in clause 1 of Standard 1.2.7 states that dietary information should be ‘provided for educational purposes’ it does not explicitly rule out this information also being used as advertising.

When used in association with a particular brand of food as in the example given above we would consider this to be for advertising purposes rather than solely for educational purposes. We believe advertising should be explicitly excluded from the definition of dietary information.

User guidance will also clarify that the form of the food should be in accordance with that intended by the dietary guidelines (for example, fruit jam would not qualify as fruit). NZFSA agrees that user guides will play an important role in clarifying the boundaries between claims, advertising and dietary information, and welcomes detailed examples of what is and what is not considered dietary information in both the user guide for industry and the user guide for enforcement agencies.

7.2 Endorsements

NZFSA supports Option 2 - Exclude all endorsements made by endorsing organisations as defined in the Standard from the regulation of the Standard.

8.1 Small packages

NZFSA supports Option 2 – Require all additional labelling from draft standard 1.2.7 and the status quo of other relevant regulation, except the dietary context, regular exercise statements, but must provide if applicable, the reference food for comparative claims, the appropriate population group and the required disclaimer for cause related marketing statements.

8.2 Split claims

NZFSA supports Option 2 - If the property of the food is stated separately from the whole health claim (as a nutrition content claim), the accompanying statement to direct the consumer to the health claim in its entirety, is not required. The requirement for the health claim to be presented in its entirety in one place, and the requirement for the accompanying statement that directs the consumer to the health claim in its entirety, if the property of the food and the specific health effect are stated separately to the entire claim, would remain as proposed at Draft Assessment.

9 Changes to Drafting

While NZFSA supports the intent of the Editorial note added to the Table to clause 11 in Standard 1.2.7, the wording proposed has a wider scope than that intended. Under the proposed wording additional descriptors as well as properties would be permitted. It is our understanding that the Editorial note was added to allow, for example, the property of carbohydrate to be used in nutrition content claims but without having descriptors prescribed. We suggest the text is modified to read ‘The Table to clause 11 provides conditions for specific nutrition content claims that may be made, however, the Table does not provide an exclusive list of properties of food for which nutrition content claims can be made.’ which would meet the intention of the Editorial note.

Standard 1.2.8 Clause 8 Food in small packages, should have the words ‘lactose and’ inserted before the word ‘galactose’ in subclause 2(c) to read ‘the lactose content of a food in a small package, the label must indicate the lactose and galactose content of the food per unit quantity.’

10 Options Proposed at Preliminary Final Assessment

NZFSA supports FSANZ’s preferred approach at PFAR of option 2 in principle, however this support is dependant on changes as outlined in this submission.

Option 2 – Modify the requirements for Nutrition, Health and Related Claims proposed at Draft Assessment by amending draft Standard 1.2.7 as proposed at Preliminary Final Assessment with regard to:

(a) application of Standard 1.2.7

(b) ineligible foods

(c) conditions for making content claims (%Daily Intake)

(d) criteria of specific Nutrition Content claims

(e) ‘no added’ claims

(f) nutrient profile model

(g) weight management and ‘diet’ claims

(h) pre-approved high level health claims

(i) substantiation

(j) dietary information

(k) endorsements

(l) wording conditions

(m) minor editing to drafting

11 Items for Information

11.2 Trademarks

NZFSA is concerned over the exclusion of trademarks from the scope of the health claims standard as per subclause 2(2). If trademarks are excluded from the requirements of Standard 1.2.7 we believe the requirements of the Standard can not then be used to prevent registration of a trademark as suggested by FSANZ on page 137 of PFAR, as there would be no ‘infringement of the provisions in the health claims standard” if that standard does not apply to trademarks. NZFSA strongly suggests subclause 2(2) of Standard 1.2.7.is removed from the drafting. This would allow trademarks that contravene provisions of the Health Claims standard to be challenged during the registration process as suggested by FSANZ in the PFAR. NZFSA is also of the understanding that in New Zealand, even if a trademark is registered it cannot be used in a way that contravenes other law. Thus even if a trademark is registered, any use of that trademark which contravenes provisions in the Food Standards Code can be enforced under the Food Standards Code. This would not be the case however if subclause 2(2) was to remain in Standard 1.2.7.

11.5 New Zealand Medicines Act

NZFSA is progressing the necessary legislative measures to enable the draft Standard 1.2.7 to be applied in New Zealand law. As you are aware there are interface issues with the Medicines Act that need resolving before Standard 1.2.7 can apply. To this end, in April 2007, NZFSA released a public discussion document proposing the replacement of the current Medicines (Related Products (Exempted Foods)) Regulations 2003, which enables application of the Transitional Standard 1.1A.2, with wider regulations exempting foods that comply with the standards of the Australia New Zealand Food Standards Code (the Code) from prohibition as Related Products under section 96 of the Medicines Act 1981. Submissions on the NZFSA discussion document closed on 14 May 2007. It is NZFSA’s intention that legislative measures to enable both the Transitional Standard 1.1A.2 and the draft Standard 1.2.7 be in place by the expiry of the current Medicines (Related Products (Exempted Foods)) Regulations on 13 August 2007.

Attachment 1 Draft variations to the Australia New Zealand Food Standards Code

NZFSA suggests that there are several changes required to the proposed draft variations that would add clarity. These changes are:

• In the Table to clause 7 under the Conditions for Folic acid and neural tube defect the additional foods permitted to contain phytosterol esters or tall oil phytosterols which have been gazetted since the DAR (as per Amendments 89 – 2006) have not been excluded. We suggest that the text is amended to include a generic exclusion of foods containing phytosterol esters or tall oil phytosterols. This removes the need to update this Table if further permissions are granted in the future.

• Subclause 8(1)(d) uses the term ‘joule’ which in other drafting has been superseded by the term ‘energy’ for the purposes of nutrition, health and related claims. We suggest this change in terminology be reflected here also.

• Throughout the Draft variations the first ‘the’ should be removed from the phrase ‘in the one place on the label’ to read ‘in one place on the label’.

Several typographical errors in Attachment 1 are listed below:

Standard 1.2.7

• Table of Provisions 4 – insert the word ‘level’ after ‘General’ to read ‘General level and high level health claims…’

• Under Clause 1 Interpretation there is a ‘)’ missing after ‘or dried’ under food groups (b)

• Under Clause 4 header - insert the word ‘level’ after ‘General’ to read ‘General level and high level health claims…’

• Table to clause 6 – delete the space before the comma in the bottom cell in column 1 to read ‘…food, or consumed as sold’.

• Table to clause 11

• In column 3 relating to Energy and Diet under point (d) an incorrect reference is made ‘(b)(ii)’ should read ‘(c)(ii)’.

• Under the Omega-3 fatty acids entries Omega -3 fatty acids appears twice in column 1. These two cells should be merged so that ‘Omega-3 fatty acids’ only appears once.

• A similar correction to that for Omega-3 fatty acids is required for the ’Salt or sodium’ entry.

• Schedule to Standard 1.2.7 – ‘Schedule X’ should read ‘Schedule’.

Standard 1.2.8

• Under subclause 7(3)(b) ‘;and’ should be deleted at the end of the text.

Standard 2.9.4

• It is not clear what is intended regarding changes to this Standard under paragraph 5(2)(b). What text is intended to be omitted and what is the substituted text requires clarification.

NZFSA suggested changes to drafting

Outlined below are changes to the drafting that would encompass the points raised in our submission.

Standard 1.2.7

• Clause 1 – expand the definition of dietary information to exclude advertising

• Subclause 2(1) - change wording to include food for catering purposes but continue to exclude foods for hospital food services and Delivered Meal Organisations.

• Subclause 4(2) - reword (a) and (b) to limit the nutrition content claims allowed for alcohol and energy to ‘low’ and ‘reduced’ claims. Delete (c).

• Add a subclause 4(4) to the effect that where a voluntary NIP is declared on a food containing more than 1.15% alcohol by volume the serving size should be a ‘standard drink’.

• Table to clause 11

• Dietary fibre – remove descriptor ‘excellent’ and substitute ‘very high’.

• Sugar or sugars – no added – add the nutrition content claim condition “the food meets the conditions for a nutrition content claim in relation to low sugar.

• Salt or sodium - no added – add the nutrition content claim condition “the food meets the conditions for a nutrition content claim in relation to low salt or sodium.

• Properties of food other than those listed – where the descriptors ‘reduced or ‘increased’ are used in relation to a property of a food the reduction or increase should be 25%.

Standard 1.2.8

• Editorial note to clause 7 – extend the box for GI across the whole NIP.

Yours sincerely