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Proposal P293 – Nutrition, Health and Related Claims – Consultation Paper for First Review

14 May 2009

Dear Sir/Madam

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

The Ministry of Consumer Affairs supports this submission in principle and in general supports any option that reduces (or maintains low) costs to consumers while providing accurate and clear information.

NZFSA appreciates the huge effort and considerable resources FSANZ has put into the further development of Proposal P293 at First Review and we welcome the extra round of public consultation being offered. We note that the scope of the consultation paper does not consider all of the issues raised in the First Review Request and that the issues not addressed here are still under consideration by FSANZ.

Summary of key issues

Transitional Standard 1.1A.2 and loss of provisions in Standards 1.2.8 and 1.3.2

During the transition period there is an issue regarding provisions from Standard 1.2.8 and 1.3.2 that are proposed to be moved Standard 1.2.7. Because the applicable provisions from Standards 1.2.8 and 1.3.2 will no longer be present in those Standards after the gazettal of Standard 1.2.7 suppliers cannot comply with parts of Standard 1.2.7 and parts of Transitional Standard 1.1A.2 but must comply with one Standard or the other in its entirety. Suppliers wishing to comply with the Transitional Standard 1.1A.2 in its entirety will not be able to use those provisions. To overcome this issue we recommend that the provisions of Standards 1.2.8 and 1.3.2 which will move to Standard 1.2.7 are also simultaneously moved to Transitional Standard 1.1A.2.

Alignment of transition provisions in Standard 1.2.7 with stock in trade provisions of Transitional Standard 1.1A.2.

It remains unclear in the drafting exactly how the stock in trade provisions for Transitional Standard 1.1A.2 aligns with the two year transition period stipulated for Standard 1.2.7. It is clear that the stock in trade provision Standard 1.1.1 does not apply to Standard 1.2.7, however in Transitional Standard 1.1A.2 this stock in trade provision is specifically referred to as applying.

Endorsements

NZFSA recognises that FSANZ is not addressing the issue of the regulation of endorsements in this consultation paper and as such we have confined our comments on endorsements to those directly relating to drafting. NZFSA understands that FSANZ intend to revisit endorsements in more depth within the scope of the First Review and would welcome the opportunity to discuss proposed changes prior to the First Review Report being finalised.

Dietary information

We recommend that a definition of an “authoritative source” be included in Division 8 of the Standard along the lines of the information supplied in paragraph 9.3.1.1 Applications based on authoritative scientific source documents of the consultation paper. However it needs to be ensured that the definition limits the scope of “authoritative source” to those directly applicable to the Australian and New Zealand context.

General Comments

NZFSA considers that the revised text and structure of the draft Standard 1.2.7 Nutrition, Health and Related Claims has improved clarity.

The pre-approval of general level health claims (GLHCs) as proposed under option 2 greatly reduces the resource burden on enforcement agencies with respect to enforcement of those claims. Option 2 also provides clarity for industry with respect to food health relationships. This should enhance the ability of industry to comply with the Standard.

This increase in certainty for GLHCs, and the knowledge that permitted food health relationships have undergone assessment prior to claims based on them being allowed should increase consumer confidence in the food regulation system.

The inclusion of the text in Attachment 2 - Explanatory Statement for the new Standard provides clarity as to the intent of the individual clauses. We suggest that this information should be included in the User Guide that FSANZ is preparing for this Standard.

We have addressed the questions posed in detail below. Please note we have addressed these questions in a different order to which they appear in the consultation paper but have retained the original numbering.

Detailed Response

Revision of the draft Standard

2. Will the new drafting be easier and less resource intensive to monitor and enforce and for industry to comply with?

As an enforcement agency it is our view that the new drafting does facilitate enforceability of the Standard, due both to the re-structuring of the Standard and the pre-approval of GLHCs as proposed in option 2,

The new drafting of the Standard is a great improvement on the drafting proposed at Final Assessment. However, the Standard is still very complex and as such it is important that where one clause refers to another part or clause of the Standard for extra information, this is made explicit. It is important that such clarification is in the body of the Standard and not in the editorial notes.

Option 2 places a greater burden on industry using claims underpinned by food-health relationships based on biologically active substances compared with industry using claims based on food-health relationships based on vitamin and minerals. This is because there is a greater number of entries for vitamin and minerals in Schedule 2.

3. Does the new drafting facilitate compliance by industry and enforcement by regulatory authorities?

The re-drafting of the standard aimed to improve the clarity and ease of comprehension. NZFSA agrees that this has been achieved and therefore should facilitate compliance by industry. The revision of the text and structure of the draft Standard 1.2.7 is much more user friendly. However NZFSA would like to recommend further revision of the drafting in line with our comments in response to ‘1. Does the new drafting improve clarity, and reduce the ambiguity of the draft Standard 1.2.7?’ (see page 6) to further improve the clarity.

The moving of some provisions from Standard 1.2.8 and 1.3.2 into the proposed new Standard 1.2.7 creates an issue during the transition period for those suppliers wishing to comply with the Transitional Standard 1.1A.2 in its entirety. The applicable provisions from Standards 1.2.8 and 1.3.2 will no longer be present in those Standards after the gazettal of Standard 1.2.7, but will be found in Standard 1.2.7. Suppliers cannot comply with parts of Standard 1.2.7 and parts of Transitional Standard 1.1A.2 but must comply with one Standard or the other in its entirety. To overcome this issue we recommend that the provisions of Standards 1.2.8 and 1.3.2 which will move to Standard 1.2.7 are ALSO simultaneously moved to Transitional Standard 1.1A.2. This will enable industry to comply with these requirements if choosing to comply with the transitional standard during this period.

Regulation of GLHCs

1. Preferred Option

NZFSA’s preferred option is Option 2 which provides pre-market approval of GLHC relationships by FSANZ.

This approach provides certainty to both industry and regulators regarding the substantiation of GLHCs. The burden of enforcement by jurisdictions is reduced by this option compared with option 1. This addresses the concern at first review that It is difficult to enforce and/or comply with in both practical or resource terms.

The pre-approval of GLHCs as proposed under option 2 greatly reduces the resource burden on enforcement agencies with respect to those claims as compared to both the proposed Standard at Final Assessment and the proposal under option 1 of this consultation paper. Option 2 also provides clarity for industry with respect to food health relationships which are permitted as the basis for GLHCs, thus enhancing the ability of Industry to comply with the Standard.

We note the FSANZ comment that under the FSANZ Act applications for general level health claims are ordinary applications and consequently do not have the protection of confidentiality or first to market advantage that is conferred by the FSANZ Act on applications for high level claims. The confidentiality or first to market advantage is also conferred by the FSANZ Act on applications for novel foods, however an application for an associated GLHC would not be protected by such confidentiality or first to market advantage. This could potentially negate any advantage gained with the novel food application. We recommend FSANZ consider whether it is appropriate to amend the FSANZ Act to confer the same level of protection to applications relating to all health claims.

Option 1 does not address issues raised at first review, particularly in relation to the regulation and substantiation of GLHCs ie It is difficult to enforce and/or comply with in both practical or resource terms.

Option 1 retains the approach proposed at FAR which placed the onus of assessing the substantiation dossier for claims on the enforcement agencies. NZFSA reiterates its comments made at FAR 1) that it does not have the level of resource required to undertake this assessment and 2) that the level of proof required to enforce non-compliance in a court of law is not believed to be attainable for a food-health relationship and therefore GLHCs substantiated by method four will not be able to be enforced.

2. To what extent does Schedule 2 of the draft Standard cover the GLHCs that are currently in the marketplace?

The range of GLHCs included in Schedule 2 currently includes only two food health relationships for biologically active substances. There are currently a number of claims based on other biologically active substances in the marketplace. We agree with the current drafting of Schedule 2 that allows industry to see which food-health relationships are currently pre approved and which need to be raised with FSANZ during the transition period (to ensure they are assessed for potential inclusion in Schedule 2).

3. Proposed system for transition

It remains unclear in the drafting exactly how the stock in trade provisions for Transitional Standard 1.1A.2 aligns with the two year transition period stipulated for Standard 1.2.7. It is clear that the stock in trade provision Standard 1.1.1 does not apply to Standard 1.2.7, however in Transitional Standard 1.1A.2 this stock in trade provision is specifically referred to as applying. Therefore it remains unclear whether a product made in compliance with Transitional Standard 1.1A.2 close to the end of the 24 month transition period would be subject to a 12 month stock in trade provision. Clarity around this issue is essential to give both industry and enforcement agencies certainty with regard to compliance.

We recommend that guidance on the information required to be submitted to FSANZ to have food health relationships underpinning GLHCs currently in the marketplace assessed for inclusion in Schedule 2 during the transition period is provided before gazettal of the Standard. This will provide clarity to industry on the requirements. It is assumed this information will be the same or very similar to that proposed to be included in the FSANZ Application Handbook to guide applicants on preparing applications for the inclusion of new food-health relationships in Standard 1.2.7 after the end of the transition period.

NZFSA’s preference is for all of Standard 1.2.7 to come into full effect at the end of the proposed 24 month transition period. However if this is not possible due to the volume of assessments we support the suggestion put forward by FSANZ that alternative transition arrangements be made for GLHCs and that the remainder of the Standard come into full effect at the end of the original transition period. The extension of transition time should only apply to food health relationships that have been accepted into the FSANZ process before the end of the 24 month transition period.

It would be beneficial to enforcement agencies and to industry for there to be a consolidated list of the outcomes of assessments of food-health relationships. We suggest FSANZ consider such an approach. The approach used by FSANZ for novel food assessments may be a useful model.

We reiterate here comments made earlier under ‘3. Does the new drafting facilitate compliance by industry and enforcement by regulatory authorities?’ regarding the need to simultaneously shift relevant provisions in Standards 1.2.8 and 1.3.2 into both Standard 1.2.7 and Transitional Standard 1.1A.2.

Revision of the draft Standard

1. Does the new drafting improve clarity, and reduce the ambiguity of the draft Standard 1.2.7?

We note the inclusion throughout the draft standard of “simplified outlines” for particular divisions of the standard. We consider that such outlines serve little purpose legally, and because of their dubious legal status, may in fact create interpretational issues if a court were asked to interpret provisions of the standard. We consider that this explanatory material could and should be included in the user guide to the standard. If it is considered necessary to set out the purpose sought to be achieved by each division of the standard, it would be more useful to have a ‘Purpose Statement’ at the start of each division (for example, division 2, could include the ‘principles’ that claims are prohibited unless permitted, and that claims must never be misleading or deceptive.)

As a matter of good drafting and interpretation, headings should not have the word “etc” in them, because they may be used as an aid to interpretation where the substance of a provision is unclear. Suggested changes for each clause in the draft standard containing “etc” are given in the relevant clauses are discussed below.

NZFSA do not consider it to be best drafting practice to include questions in a clause heading and recommend the headings are redrafted where this occurs.

1 Interpretation

• “Health effect”

The addition of the word “presence of” is an improvement in clarity on the previous draft, but we think the definition could be improved further to reflect the intent, as follows:

• “health effect” means an effect of a specified kind on the functioning of the human body, including

(a) an effect on a disease state or risk factor present in the body; or

(b) an effect on physical or mental performance, or the maintenance of a healthy or functioning body.

Note that we have included “risk factor” (e.g. high cholesterol, which is a pre-disease state but not a disease in itself).

The title of Standard 1.2.7 is “Nutrition, Health and Related Claims”. However the current drafting does not make it clear what a related claim is. We recommend the addition of a definition for “related claim” in this division.

• Editorial note: below reference food

We suggest that the second example is reworded to state “an example for paragraph (b) is milk alternatives compared to milk products”. This change results in both of the examples given having the reference food at the end of the statement.

DIVISION 2 CLAIMS FRAMEWORK AND GENERAL CONDITIONS

We note that the wording in Division 2 header does not align with the header in subdivision 2 and suggest they are changed to state (new text in italics, deleted text strike though):

DIVISION 2 CLAIMS FRAMEWORK AND GENERAL CONDITIONS PRINCIPLES SUBDIVISION 2 – GENERAL PRINCIPLES AND CONDITIONS

SUBDIVISION 1 - CLAIMS FRAMEWORK

6 Certain claims are not claims to which this Standard applies

Sub-clause (2) – in our view there should not be an editorial note accompanying the exemption for claims about ethical, religious or environmental features of food. In our view it would be useful to include some examples of the sorts of claims that are intended to fall within this exemption in the test of the subclause (e.g. kosher food). Otherwise it could be a loophole for manufacturers, and could present a court with interpretational difficulties. As the drafting stands currently it is not clear what ethical and environmental factors are captured under this subclause.

10 Claims must not be therapeutic in nature, etc

As a matter of good drafting and interpretation, headings should not have the word “etc” in them, because they may be used as an aid to interpretation where the substance of a provision is unclear. Since the clause is primarily aimed at prohibiting therapeutic claims, we therefore suggest that the word “etc” is simply deleted.

SUBDIVISION 2 – GENERAL PRINCIPLES AND CONDITIONS

To be consistent with the change suggested for Division 2 we suggest that the word “and conditions” is deleted in Subdivision 2 title which would then read SUBDIVISION 2 – GENERAL PRINCIPLES.

11 Ineligible foods

Rather than being noted in an editorial note, we think that this clause needs to make it very clear (by stating explicitly) that:

a. an ineligible food may not carry a health claim or nutrition content claim; and

b. that ineligible foods are those listed in the table to clause 11

Suggested wording is “An ineligible food means a food listed in the Table to this clause being a food in respect of which nutrition content and health claims may not be made, except as permitted by Clause 16.”

14 Claims comparing vitamin and mineral content

We are unsure as to how this type of claim could be “expressly permitted”. We consider the relevant clauses where this is expressly permitted should be inserted in this clause.

DIVISION 3 NUTRITION CONTENT CLAIMS

16 Ineligible foods must not make nutrition content claims

The heading to this clause is misleading - it is not a food which makes a claim; it is the manufacturer/marketer or processor of food. Thus we suggest the heading be changed to “Nutrition content claims must not be made about ineligible foods”.

In sub-clause (1) (and other clauses which use the same terminology) we find the use of “about” in contrast with “in relation to” confusing. We request clarification on the distinction between these two terms.

19 Nutrition content claims where there is no reference value

Without further explanation (such as inclusion of the example given in the editorial note in the body of the Standard), we consider that sub-clause (2) is unclear, in terms of what it permits. We suggest rewording subclause 2(b) as follows:

"(2) A claim under this clause -

...(b) may include the property of food expressed as a number (e.g. ' GL (clycaemic load) = 12)”

21 Claims about gluten

In (b) after the words “corresponding conditions” the words “in relation to that descriptor” need to be added for clarity.

22 Claims about lactose

In (b) after the words “corresponding conditions” the words “in relation to that descriptor” need to be added for clarity.

23 Diet nutrition content claims must not imply slimming effects, etc

Please delete the word “etc” from the heading to this clause (for the reasons outlined previously).

24 Comparative Claims

In sub-clause (3)(b) we think it may be better to give the manufacturer more flexibility about the way in which they can express a comparison between a “compared food” and a “reference food” that is not just limited to differences in the amounts of a particular property. The comparison could, for example, be expressed as a percentage difference, or a ratio (proportionate) difference.

25 Presentation of nutrition content claims

We find sub-clause (2) confusing, in that the drafting does not clearly achieve its intent (as outlined in the Explanatory Statement), which appears to be to exempt manufacturers from the need to specify the ‘form of the food’ where the form is self-evidently clear, because the product is being sold in a particular form. We suggest rewording this sub clause as follows:

"Despite anything in subclause (1)(b), if the form of the food to which the claim relates is the 'food as sold' (within the meaning set out in the first item in the Table to clause 12), the claim need not expressly mention the form of the food."

DIVISION 4 – GENERAL LEVEL HEALTH CLAIMS

26 Simplified outline of this division

In keeping with our earlier comment that we do not consider the ‘simplified outlines’ to be legally necessary or prudent, we suggest that the ‘simplified outline’ in this clause be deleted and replaced (if necessary) with a purpose statement, that draws out some of the elements of what is currently in the simplified outline (for example):

• General level health claims are those which do not relate to a serious disease or biomarker;

• A General level health claim must only be made if permitted by the Standard and Schedule 2;

• A General level health claim must be based on a substantiated evidential relationship between the food/food property and the claim;

• The food subject to the General level health claim must not be an ineligible food

27 Permission to make certain general level health claims

We suggest the following changes to subclause (1)(b) (for greater clarification):

(b): “the food to which it relates meets the nutrient profile scoring criterion for that food”

And the following change to subclause (2), to clarify that it is food rather than a claim which needs to meet the nutrient profile scoring criterion.

(2) “Despite paragraph (1)(b), where a general level health claim is made about a food in respect of which a standard has been made in Part 2.9 of this Code (Special Purpose Foods), that food does not need to meet the nutrient profiling scoring criterion”

28 What must a general level health claim say?

As indicated under the ‘General comments’ section we do not consider it to be best drafting practice to include questions in a clause heading. On that basis we recommend that the clause heading be reworded along the following lines:

“28 Requirements for a general level health claim”

We suggest the following changes to subclause (1) to improve clarity:

“(1) Subject to clause 29, a general level health claim must include and expressly state all the elements set out in sub-clause (2), in one place on the label or advertisement in which the claim is being made.”

We also suggest some slight amendments to subclauses (2), (3), (5) and (6) to clarify certain issues (changed portions are in italics).

(2) The elements of a general level health claim are:

(a) the property of the food, or if the claim is based on the food itself, the food; and

(b) the specific health effect claimed for the property of the food or (as the case may be) the food; and

(c) if applicable to the claim, the population group to which the specific health effect relates; and

(d) the context statement; and

(e) the form or forms of the food to which the claim relates, except as otherwise provided in subclause (5).

(3) The elements required to be stated for a general level health claim must (as applicable for each element) refer to:

(a) the property of food or food as that property or food is described in Column 1 of Schedule 2;

(b) the specific health effect described in Column 2 of Schedule 2 that is relevant to the claim;

(c) the population statement (if any is applicable) as described in Column 4 of Schedule 2;

(d) the matters required to be included in a context statement as set out in sub.-clause (4).

(e) Except as provided in sub-clause (5), the form of the food to which the claim relates.

(4) [No change]

(5) This subclause should be deleted as it is legally unnecessary.

(6) Despite anything in subclause (2), if the form of the food to which the claim relates is the 'food as sold' (within the meaning set out in the first item in the Table to clause 12), the claim need not expressly mention the form of the food.

31 Nutrition content claims about properties in Schedule 2

In sub-clause (2)(c) of this clause, we recommend that a change is made similar to the one recommended for clause 19(2)(b). Suggested wording is:

“(2) A claim under this clause –

… (c) may include the property of the food expressed as a number”

DIVISION 5 – HIGH LEVEL HEALTH CLAIMS

32 Simplified outline of this division

In keeping with our earlier comment that we do not consider the ‘simplified outlines’ to be legally necessary or prudent, we suggest that the ‘simplified outline’ in this clause be deleted and replaced (if necessary) with a purpose statement, that draws out some of the elements of what is currently in the simplified outline (for example):

• A high level health claim (HLHC) is one that refers to a “serious disease or biomarker”

• A HLHC must only be made if permitted by the Standard and Schedule 3;

• A HLHC must be based on a substantiated evidential relationship set out in Schedule 3

• The food subject to the HLHC must not be an ineligible food

34 What must a high level health claim say?

As indicated we do not consider it to be best drafting practice to include questions in a clause heading. On that basis we recommend that the clause heading be reworded along the following lines:

“34 Requirements for a high level health claim”

Our comments under this clause heading are very similar for HLHCs as for GLHCs.

We suggest the following changes to subclause (1) to improve clarity:

“(1) Subject to clause 29, a high level health claim must include and expressly state all the elements set out in sub-clause (2), in one place on the label or advertisement in which the claim is being made.

We also suggest some slight amendments to subclauses (2), (3), (4) and (5) to clarify certain issues (changed portions are in italics).

(2) The elements of a high level health claim are:

(a) the property of the food, or if the claim is based on the food itself, the food; and

(b) the specific health effect claimed for the property of the food or (as the case may be) the food; and

(c) if applicable to the claim, the population group to which the specific health effect relates; and

(d) the context statement; and

(e) except as provided in sub-clause (5), the form of the food to which the claim relates.

(3) The elements required to be stated for a high level health claim must (as applicable for each particular) refer to:

(a) the property of food or food as that property or food is described in Column 1 of Schedule 3;

(b) the specific health effect described in Column 2 of Schedule 3 that is relevant to the claim;

(c) the population statement (if any is applicable) as described in Column 4 of Schedule 3;

(d) the context statement in Column 4 of Schedule 3.

(4) This subclause should be deleted as it is legally unnecessary.

(5) Despite anything in subclause (2), if the form of the food to which the claim relates is the 'food as sold' (within the meaning set out in the first item in the Table to clause 12), the claim need not expressly mention the form of the food.

36 Nutrition content claims about properties in Schedule 3

In sub-clause (2)(c) of this clause, we recommend that a change is made similar to the one recommended for clause 19(2)(b) ). Suggested wording is:

“(2) A claim under this clause –

… (c) may include the property of the food expressed as a number

DIVISION 6 – ENDORSEMENTS

38 What is an endorsement?

As indicated under the ‘General comments’ section we do not consider it to be best drafting practice to include questions in a clause heading. On that basis we recommend that the clause heading be reworded along the following lines:

“38 Requirements for endorsements”

Further, we find sub-clause (1) of this clause circular, in that it purports to define an endorsement in terms of when that endorsement may lawfully be made (rather than defining the term and then stating that an endorsement is only “lawful” when it is made by a supplier with the permission of another person, body or government agency (the ‘endorsing body’). Thus we suggest clause 38 be reworded as follows:

“38 Requirements for endorsements

1. An endorsement is a claim made by a supplier in respect of a food produced by that supplier, which relies on some form of approval or recommendation (whether qualified or unqualified) given in relation to that food, by a person or body other than the supplier, or by a government agency (the ‘endorsing body’), where that endorsing body—

a. has a nutrition or health purpose or function; and

b. operates on a not-for-profit basis; and

c. is not related to the supplier using the endorsement

2. Without limiting the generality of sub-clause (1)(c), an endorsing body is related to a supplier if the supplier—

a. has a financial or ownership interest in the endorsing body; or

b. established or had a role in the establishment of the endorsing body; or

c. exercises direct or indirect control over the endorsing body;”

40 Record-keeping requirement

Sub-clause (2) – We recommend that this sub-clause stipulate a period of time for which the required records should be kept. It is an unnecessary burden for the records to be kept indefinitely.

Thus we suggest that sub-clause (2)(a) be amended to require the records to be kept until the expiry date of the last product manufactured using that endorsement or (as relevant) until related advertisements are no longer being published, which ever is the later date.

42 What is a cause-related marketing statement?

As indicated under the ‘General comments’ section we do not consider it to be best drafting practice to include questions in a clause heading. On that basis we recommend that clause 42 be amended to state:

“42 Meaning of cause-related marketing statement”

43 Criteria for cause-related marketing statements

Sub-clause (1): We understand the intention behind this clause, but find the wording confusing – partly because it is not clear on what the CRMS must appear (together with the statement to the effect of that in Column 2). In other words, must it appear on all labels and advertisements for the food to which it relates? Also, this requirement needs to be made subject to the exceptions provided in sub-clause (3). We suggest it be reworded along the following lines:

“(1) Subject to sub-clause (3), if a cause-related marketing statement is made it must appear together [on what??] with a statement to the same effect as the statement in Column 2 of Table to subclause 43(1) that corresponds with the type of cause-related marketing statement being made”

We suggest that the editorial note be removed, for the same reasons as we have given in relation to the “simplified outlines” included at the start of each Division. Examples given in editorial notes could be included in the definition of cause-related marketing statement.

Sub-clause (2): To put it beyond doubt that a cause-related marketing statement must comply with Division 7 we suggest this sub-clause be reworded as follows (changes in italics):

“A cause-related marketing statement must comply with clause 10 and this Division 7, but need not comply with any other requirement of this Standard”

DIVISION 8 – DIETARY INFORMATION

44 Simplified outline of this division

In keeping with our earlier comment that we do not consider the ‘simplified outlines’ to be legally necessary or prudent, we suggest that the ‘simplified outline’ in this clause be deleted and replaced (if necessary) with a purpose statement that draws out some of the elements of what is currently in the simplified outline (for example):

• Dietary information is not to be included on labels or in advertisements unless specifically permitted;

• Permitted dietary information about properties of food may only be included if certain specified conditions are met;

• Permitted dietary information about anything other than a property of food may be included without restriction (other than general restrictions in clause 10 regarding therapeutic claims)

45 What is dietary information and what is permitted dietary information?

In keeping with the principle that questions should generally not be included in headings, we suggest that this heading be deleted and replaced with a heading that simply says “Definitions” or “Definitions for Division 8”.

Definition of “dietary information”

In our view this definition is inadequate, in that it is circular (defining “dietary information” by reference to itself). In our view FSANZ needs to substitute a definition that does not use the term “dietary information” again in the descriptive part of the definition (so for example it could say something like “dietary information” means information about the role and functions of particular types of food or food properties in a human diet).

Definition of “permitted dietary information”

It is not clear from this definition what would amount to an “authoritative source”, or whose determination this would be. We recommend that a definition of an “authoritative source” be included in the Standard along the lines of the information supplied in paragraph 9.3.1.1 Applications based on authoritative scientific source documents of the consultation paper. However it needs to be ensured that the definition limits the scope of “authoritative source” to those directly applicable to the Australian and New Zealand context.

It is not clear what the scope of “educational purposes” is. We suggest that the definition be more precise about who is the intended audience for “educational” purpose.

46 Permitted dietary information about properties of foods

Clause 46(c): The use of the term “accords” may be too limiting – i.e. would it be sufficient if dietary information were “consistent with” a nutrition content claim, even though it may be different information from that in the nutrition content claim?

47 Permitted dietary information about matters other than properties of foods

In our view it needs to be sufficiently clear that dietary information about matters other than properties of food is not subject to the same restrictions as dietary information about the properties of food. We recommend that the clause be rephrased as follows (to put the issue beyond doubt):

“permitted dietary information about matters other than properties of food may be included, and is not subject to the restrictions set out in clause 46.”

DIVISION 9 – NUTRIENT PROFILE SCORING CRITERIA

48 Simplified outline of this division

In keeping with our earlier comment that we do not consider the ‘simplified outlines’ to be legally necessary or prudent, we suggest that the ‘simplified outline’ in this clause be deleted and replaced (if necessary) with a purpose statement that draws out some of the elements of what is currently in the simplified outline (for example):

• The Nutrient Profiling Scoring Criterion (NPSC) for food is [describe in general terms what the NPSC is]

• The NPSC for a particular food must be determined using the steps set out in Schedule 4

• Foods that are required to meet the NPSC must also be labelled in a way that meets the requirements set out in Division 9 for labelling.

SCHEDULES

NZFSA raises concerns over FSANZs continued use of a combined “28% saturated fatty acids and trans fatty acids” qualifying criteria and recommends that a distinction be made between the two categories of fats given their different physiological effects on blood cholesterol. The current draft potentially allows provision for manufacturers to formulate/reformulate their products to include higher levels of trans fatty acids than might be desirable from a public health perspective. NZFSA suggests additional wording to the effect that “the food contains no more than 1% trans fatty acids of total fatty acid content” or a declaration on the pack that no partially hydrogenated fats are present in the food.

This issue relates to “fatty acids” entries in both Schedules 1 and 2.

Changes of an editorial nature

NZFSA suggests some changes which are editorial in nature. These are listed below:

9 Claims permitted elsewhere in the Code

In this clause there is a spare “the” which needs to be deleted – “that claim must comply with the clause 10”.

13 Claims about properties naturally present or absent

The intent of this clause can be more clearly stated with the header changed to “13 Claims about a property of a food naturally present or absent”.

17 Nutrition content claims about properties of food in Schedule 1

Sub-clause (2): This should read “about a property of food” not “about the property of food”. Further, because for many of the food properties mentioned in Schedule 1, column 1, there are no corresponding general conditions in column 2, we suggest subclause (2) is reworded as follows:

“(2) Any claim about a property of food mentioned in Column 1 of Schedule 1 must meet the corresponding general claim conditions for that property set out in Column 2”

Sub-clause (3): This should start “Any claim” rather than “A claim” (or else sub-clause (2) should be changed, so that the two are consistent in how they refer to claims), and “the property of food” should be changed to “a property of food”.

Yours sincerely