Axiome Pty Ltd on behalf of Cognis GmbH and Food Standards Australia New Zealand

[2012] AATA 551

[2012] AATA 551 

Division	GENERAL ADMINISTRATIVE DIVISION
File Number	2011/2203
Re	Axiome Pty Ltd on behalf of Cognis GmbH
APPLICANT
And	Food Standards Australia New Zealand
RESPONDENT

DECISION

Tribunal	Deputy President R P Handley Emeritus Professor GAR Johnston AM
Date	24 August 2012
Place	Sydney

Decision Summary: The decision under review is affirmed.

............[sgd].................................

Deputy President R P Handley

CATCHWORDS

FOOD STANDARDS – Application to amend Standard 1.5.1 of the Australia New Zealand Food Standards Code – Novel food – Non-traditional food – Interpretation of the definitions ‘novel food’ and ‘non-traditional food’ – Conjugated linoleic acid (CLA) – Use of CLA in other jurisdictions – Assessment of public health and safety considerations – Decision under review affirmed

LEGISLATION

Food Act 2003 (NSW)

Food Act 1981 (NZ)

Imported Food Control Act 1992 (Cth)

Therapeutic Goods Act 1989 (Cth)

CASES

Distilled Spirits Industry Council of Australia Inc and Another v Food Standards Australia New Zealand and Another (2003) 133 FCR 19

NSW Food Authority v Nutricia Australia Pty Ltd (2008) 74 NSWLR 148

SECONDARY MATERIALS

Australia and New Zealand Food Regulation Ministerial Council – Policy Guideline: Addition to Food of Substances other than Vitamins and Minerals

Australia New Zealand Food Standards Code

Food Standards Australia New Zealand Act 1991 (Cth)

New Zealand Food (Supplemented Food) Standard 2010

REASONS FOR DECISION

Deputy President R P Handley
Emeritus Professor GAR Johnston AM

1. Axiome Pty Ltd (the Applicant), on behalf of Cognis GmbH, a company based in Germany, has applied for the review of a decision of a delegate of Food Standards Australia New Zealand (FSANZ) (the Respondent), rejecting an application from the Applicant to amend Standard 1.5.1 of the Australia New Zealand Food Standards Code (the Code) to approve the use of a chemically defined mixture of conjugated linoleic acid triglycerides (CLA), Tonalin CLA, as a novel food in Australia.

2. Standard 1.5.1 of the Code regulates the sale of ‘novel foods’ and novel ingredients and prohibits the sale of these foods unless they are listed in the Table to clause 2 of Standard 1.5.1 and comply with any special conditions of use.  Failure to do so results in significant criminal offences and fines being imposed under the various State and Territory Food Acts (for example, s 21 of the Food Act 2003 (NSW)).

   BACKGROUND

3. On 22 February 2008, the Applicant applied to the Respondent to amend Standard 1.5.1 of the Code for approval of Tonalin CLA as a novel food and for its exclusive use in all classes of food/applications (Application A1005).  (The Respondent’s Novel Food Reference Group (now the Advisory Committee on Novel Foods) had previously published its opinion that CLA was a novel food.) The application stated that Tonalin CLA “meets the definition of a non-traditional food and a Novel Food”, and that its purpose was as “a useful adjunct in weight control programmes and diets” (original emphasis).  Examples of its potential food applications “include milk products, soy beverages, fruit based beverages, yoghurt and yoghurt products, nutrition bars, and table spreads”.

4. According to the Applicant’s Novel Food Application, Tonalin CLA:

   is a mixture of approximately equal quantities of the cis-9, trans-11 and trans-10, cis-12 CLA isomers in the form of triglyceride esters (approximately 80 per cent) and other fatty acids (approximately 20 per cent).  It is produced by chemical isomerisation of safflower oil linoleic acid under alkaline conditions.

5. ‘Novel food’ and ‘non-traditional food’ are defined in clause 1 of Standard 1.5.1 as follows:

   novel food means a non-traditional food and the food requires an assessment of the public health and safety considerations having regard to -

   (a) the potential for adverse effects in humans; or

   (b) the composition or structure of the food; or

   (c) the process by which the food has been prepared; or

   (d) the source from which it is derived; or

   (e) patterns and levels of consumption of the food; or

   (f) any other relevant matters.

   non-traditional food means –

   (a) a food that does not have a history of human consumption in Australia or New Zealand; or

   (b) a substance derived from a food, where that substance does not have a history of human consumption in Australia or New Zealand other than as a component of that food; or

   (c) any other substance, where that substance, or the source from which it is derived, does not have a history of human consumption as a food in Australia or New Zealand.

6. Clause 2 states:

   A novel food must not be sold by way of retail sale as food or for use as a food ingredient unless it is listed in column 1 of the Table to this clause and complies with the conditions of use, if any, specified in column 2.

   In the Table to clause 2 which follows, various novel foods are listed in column 1 and any conditions of use which apply to those foods are specified in column 2.  Clause 3 provides for the sale of a novel food listed in the Table to clause 2 as a food or for use as a food ingredient for an exclusive period of 15 months from the gazettal of the variation of the Standard.

7. Over the course of three years after the application was lodged, the parties corresponded about the application and the Respondent asked for and the Applicant provided further information.  During this period, the Respondent also organised an Epidemiology Scientific Advisory Group (EpiSAG) on CLA to provide an expert opinion on the assessment of CLA as a novel food ingredient.  The EpiSAG, which met on 2 September 2010, agreed the following amongst the key outcomes:

   ·The evidence that CLA lowers HDL-cholesterol (HDL) is convincing and raises health concerns at the population level. …

   ·It is clear from the 95% confidence interval that CLA increases LDL-cholesterol (LDL) in the exposed population but the evidence is insufficient to estimate the magnitude of the effect. …

   ·The adverse effects of CLA on blood lipids are especially important for population groups such as type-2 diabetes, pre-diabetics and those with metabolic syndrome.  This is particularly relevant given the high burden of undiagnosed disease. …

   ·The overall increase in cardiovascular disease (CVD) risk is non-trivial and estimated to be up to 5% at the population level …

   ·The risk for some individuals could be substantially higher and the claimed benefits are unlikely to outweigh this risk.

   EpiSAG discussed various studies, noted insufficient data in relation to some matters and suggested further analysis.

8. On 13 May 2011, Application A1005 was rejected by the Respondent pursuant to s 30(1)(b) of the Food Standards Australia New Zealand Act 1991 (Cth) (the FSANZ Act). The stated reasons for the rejection were as follows:

   (1) In relation to the Respondent’s objective stated in s 18(1)(a) of the FSANZ Act of protecting public health and safety:

   ·The overall evidence base was not sufficient to demonstrate the safety of Tonalin CLA at the recommended intake of 4.5 g/day.

   ·The available evidence suggests that consumption of Tonalin CLA at the levels proposed by the Applicant may have adverse effects on cardiovascular disease and may adversely affect glucose tolerance in consumers with type 2 diabetes. …

   ·Investigation of possible risk management strategies to manage the potential risks identified … concluded that there were concerns that they would not be adequate to mitigate the risks identified.

   (2) In relation to other matters listed in s 29 of the FSANZ Act to which the Respondent must have regard, the Respondent concluded:

   ·The available evidence does not demonstrate that a net benefit would arise from approving the addition of Tonalin CLA to food.

   ·There are no appropriate non-regulatory measures that are relevant in the assessment of this Application.

   ·There are no directly relevant New Zealand standards.  FSANZ is aware that Tonalin CLA is available in New Zealand in capsule form as a dietary supplement; regulated under the Dietary Supplements Regulations.

9. On 6 June 2011, the Applicant applied to the Tribunal for a review of this decision. The Tribunal has jurisdiction to review such decisions pursuant to s 143(1) of the FSANZ Act.

   THE RELEVANT LEGISLATION AND ISSUES

10. The functions of FSANZ set out in s 13(1) of the FSANZ Act include developing, varying and reviewing standards, the content of which is described in s 16, including the composition, production, handling and sale of food. Section 17 states that codes of practice and their variation may deal only with matters that may be included in standards. The objectives of the FSANZ Act are set out in s 18(1) and include “the protection of public health and safety”. Section 22 provides for applications to be made to FSANZ for the development of or variation of a “food regulatory measure”, a term which is defined in s 4(1) as meaning “a standard or a code of practice”. Section 29 requires that FSANZ assesses such an application having regard to, amongst other things, “any other relevant matters”. Section 30 provides that after such an assessment, FSANZ must either:

    (a) prepare in writing a draft food regulatory measure or a draft variation of a food regulatory measure; or

    (b) reject the application.

11. Where FSANZ prepares a draft food regulatory measure or a draft variation of a food regulatory measure, FSANZ must then call for public submissions, after which, the period for receiving such submissions having closed, it must then either approve the draft standard or draft variation, approve the draft standard or variation subject to such amendments as it considers necessary, or reject the draft standard or variation: s 30.

12. The first issue raised by the Applicant is whether Tonalin CLA is a ‘novel food’ as defined in clause 1 of Standard 1.5.1 of the Code.  To be a novel food, Tonalin CLA must be a ‘non-traditional food’ as defined and requires an assessment of the public health and safety considerations.

13. The second issue is whether FSANZ’s decision to reject the Applicant’s application for variation of Standard 1.5.1 is the correct or preferable decision.

14. In relation to the first issue, the Respondent contends that the question of whether or not Tonalin CLA is a ‘novel food’ within the meaning of Standard 1.5.1 is a question for the States and Territories applying their own legislation and not for the Tribunal.  Moreover, the application was made to FSANZ on the basis that Tonalin CLA is a ‘non-traditional food’ and there is insufficient evidence for the Tribunal to be satisfied that Tonalin CLA is other than a ‘non-traditional food’.

    With regard to the second issue, the Respondent contends that the best available evidence does not establish the safety of the consumption of Tonalin CLA.

    THE REGULATION OF CLA IN OTHER JURISDICTIONS

15. The Tribunal was provided with evidence about regulation of the consumption of CLA in the European Union, the US and other countries.

16. European Union. On 30 April 2010, the European Food Safety Authority (EFSA) adopted two scientific opinions on the safety of CLA as a novel food ingredient.  The EFSA Panel on Dietetic Products, Nutrition and Allergies (the Panel) stated:

    Based on the assessment of these [non-human] studies, the Panel considers that CLA consumption does not appear to have adverse effects on insulin sensitivity, blood glucose control or liver function for up to six months, and that observed effects on blood lipids are unlikely to have an impact on cardiovascular risk.  Long-term effects of CLA intake on insulin sensitivity and the arterial wall have not been adequately addressed in humans.  The Panel concludes that the safety of Tonalin TG 80 has been established for the proposed uses at intakes of 4.5 g per day (corresponding to 3.5 g CLA), for up to six months.  The safety of CLA consumption for periods longer than six months has not been established under the proposed conditions of use.  The safety of CLA consumption by type-2 diabetic subjects has not been established.

17. Member States did not subsequently support a European Commission decision authorising the use of CLA as a novel food ingredient but instead provided additional information that was considered relevant for the safety assessment.  The Commission then asked the EFSA to review and update its opinion in the light of the additional information.  This additional information included the FSANZ decision dated 13 May 2011 to reject the Applicant’s application to amend Standard 1.5.1 of the Code.

18. On 27 April 2012, the EFSA adopted the following statement from the Panel:

    The Panel considers that the additional information provided does not contain evidence thath (sic) would modify its previous conclusions regarding the effects of CLA on insulin sensitivity/glucose metabolism, blood lipids, lipid peroxidation, or subclinical inflammation.  The Panel also considers that the new studies provided do not address longer-term (> 6 months) effects on CLA intake on insulin sensitivity, the arterial wall or liver steatosis, or the safety of CLA in type-2 diabetic subjects, under the proposed conditions of use.  The Panel concludes that the safety of Clarinol and Tonalin TG 80 has been established for the proposed uses and daily doses for up to six months.  The safety of CLA consumption for periods longer than six months has not been established under the proposed conditions of use. The safety of CLA consumption by type-2 diabetic subjects has not been established.

19. France. The French Agency for Food, Environmental and Occupational Health and Safety, in an opinion dated 7 October 2011 “on a ‘safety assessment of the use of an oil enriched with Conjugated Linoleic Acid (CLA)’”, stated that “ambiguities still remain as to the harmful effects of these [CLA] mixtures on circulating lipids” and stated the following conclusion on the effects of CLA on insulin sensitivity:

    These new studies do not indicate that CLA mixtures have beneficial effects on glucose homeostasis and may indeed suggest a risk related to the consumption of such mixtures in obese subjects, who are the most likely to consume food supplements containing CLAs or foods enriched with CLAs.  In light of the harmful effects of isomer t10,c12 that have been observed in animals, and the lack of scientific data on this isomer in humans, the safety of its consumption, alone or in a mixture, cannot be guaranteed.

20. UK.  An advice dated September 2011 from the Secretariat to the Advisory Committee on Novel Foods and Processes noted concerns expressed by the EFSA in 2010 about CLA in respect of risk assessment and an appropriate risk management strategy.

21. Spain.  CLA is sold as a supplement without restriction and has been included as an added ingredient in milk, yoghurt, cheese, and fruit juice type products since 2004.

22. US.  In the US, there is a voluntary mechanism known as a GRAS (generally recognised as safe) Notice, whereby a person may notify the US Food and Drug Administration (FDA) of a determination that the use of a substance is GRAS.  The determination will be supported by a report from an expert panel convened by the notifier.  The FDA will then make its own assessment of whether there is a sufficient basis for the GRAS determination.  If the FDA concludes that the expert report and supporting data/evidence does not provide a sufficient basis for a GRAS determination, it will raise questions with the notifier about the determination.  If these questions cannot be answered to the FDA’s satisfaction, the notifier may request that the FDA cease it evaluation of the substance.  Otherwise, the FDA may issue a “no questions” response.

23. In the case of CLA, on 11 July 2008, the FDA responded to a notice that:

    CLA-isomers are GRAS, through scientific procedures, for use as an ingredient in certain specified foods within the general categories of soy milk, meal replacement beverages and bars, milk products and fruit juices at levels not to exceed 1.5 grams (g) per serving. 

    While having “no questions” on this GRAS notice in relation to the intended conditions of use, the FDA stated it was the notifying firms’ responsibility to ensure that the foods marketed are safe.  On 8 September 2009, the FDA gave a similar “no questions” response to a supplementary notice concerning the use of the same CLA isomers as an ingredient in the same foods on the basis of two servings per day, each not exceeding 1.5 grams. 

24. Brazil.  A Technical Report dated 17 April 2007 on CLA concluded that “the scientific evidence evaluated to date does not prove the safety of use and effectiveness of conjugated linoleic acid alone or as food ingredient”.  The Report states that neither CLA alone nor as a food ingredient to be added to various foods should be marketed in Brazil until proof of the safety of their use, mechanisms of action and efficacy are met.

25. Korea.  According to Dr Albert Bär, CLA can be sold as a food supplement/additive in amounts of up to 4.2 grams per day: statement dated 3 November 2011, paragraph 3.3.

26. New Zealand.  Evidence provided by the Applicant indicates that CLA may be sold as a as a dietary supplement in capsule form, regulated under the Food Act 1981 (NZ).  Such dietary supplements are subject to the New Zealand Food (Supplemented Food) Standard 2010 made by the Minister pursuant to s 11C of the Food Act.  The Applicant referred the Tribunal to a table of websites, which is an attachment to Dr Bar’s statement, as evidence of CLA being available for sale in New Zealand.  It appears that Tonalin is available for sale in New Zealand as soft gel capsules as a dietary supplement that is claimed to help promote lean muscle mass and that may assist in the reduction of body fat when used in conjunction with a healthy calorie reduction and exercise program. 

    EXPERT EVIDENCE

27. In the course of the hearing, the Tribunal heard from five expert witnesses: Dr Simon Brooke-Taylor, Dr Albert Bär, and Professor Peter Clifton for the Applicant; and Professor Garry Wittert and Professor Martijn Katan for the Respondent. With the exception of Professor Katan, who gave evidence by videoconference from Amsterdam, all gave evidence in person. Professors Clifton and Katan gave part of their evidence concurrently.  The Tribunal’s understanding and assessment of the expert evidence was enhanced by the expertise of Emeritus Professor Johnston who has considerable experience in the chemical characterisation and pharmacological evaluation of active ingredients from natural sources and is a former President of the Royal Australian Chemical Institute and Chair of their Division of Medicinal and Agricultural Chemistry. 

    Dr Simon Brooke-Taylor

28. Dr Simon Brooke-Taylor, who provided a Statement dated 4 November 2011, describes himself as a consultant in food regulatory affairs and the development of compliance systems.  He has a background in biochemistry and has both scientific and managerial experience, including 10 years (1991-2001) working for the Australia New Zealand Food Authority, now renamed FSANZ.  His evidence was the subject of objections from the Respondent and, as a result, was limited to a description of the regulatory system operating in the US and Europe.  He said his brief was to discuss issues of public safety and he did not, therefore, discuss public health concerns.

29. Dr Brooke-Taylor said that in the US anything added to a food is classified as a ‘food additive’.  Usually, a company wishing to add an ingredient to food will seek a letter of no objection from the FDA, relying on a report prepared by an expert panel convened by the applicant company to establish that the additive is GRAS.  This process was undertaken by the Applicant in the US in 2007 (T-documents, p 405).  Dr Brooke-Taylor said the system in Europe is different and a novel food ingredient must be approved by the European Commission.  The EFSA relies on advice from a committee of experts nominated by member states.  There have been three relevant EFSA evaluations: one of the safety of CLA as a dietary supplement and two of CLA as a novel food ingredient.  

    Professor Peter Clifton

1. Professor Peter Clifton provided a statement dated 27 October 2011.  He is a Fellow of the Royal Australasian College of Physicians and a Member of the Royal College of Physicians (UK).  Professor Clifton has a distinguished record in clinical and experimental work related to cardiovascular disease. His PhD is entitled ‘Factors affecting HDL particle size distribution’.  Professor Clifton holds both research and clinical positions.  His research position is as Laboratory Head of Nutritional Interventions at the Baker IDI Heart and Diabetes Institute.  He states, “My primary research interest is in the prevention and treatment of cardiovascular disease and its risk antecedents, obesity and diabetes, by dietary means...”.  He has been “a researcher in the field of lipid biochemistry and human fat metabolism for the past 28 years”.  Professor Clifton holds clinical positions at Flinders Medical Centre (specialising in lipid management) and the Royal Adelaide Hospital (specialising in the management of diabetes and cardiovascular disease).

2. Professor Clifton stated that he considers “CLA is safe to be added to the food supply in the amounts planned”.  He said:

   In summary, -

   (a) Numerous clinical trials have been performed with CLA.  A meta analysis (sic) that I performed … showed no increase in LDL cholesterol with the use of CLA.

   (b) Adding CLA to the diet of trial subjects did not change HDL cholesterol, although it was lower than when other fats were added to the diet.

   Professor Clifton said the meta-analysis is an analysis of all relevant studies on the effects of CLA “to get a bigger picture” of its effect. 

3. Professor Clifton described his concerns with FSANZ’s safety assessment as follows:

   (a) The claim that CLA increases cardiovascular disease risk cannot be made when LDL is not significantly elevated by CLA.

   (b) HDL is not altered by adding CLA (ie it is not lowered).  It is true that it does not elevate HDL like other fats but saturated fat is the best HDL elevator and it does not decrease the risk of CVD (it increases it).

   (c) The role of HDL changes with diet and drug in changing CVD risk is unknown.

4. In oral evidence, Professor Clifton emphasised the importance of biomarkers (biological indicators) such as LDL cholesterol, HDL cholesterol and high blood pressure as indicators of risk. 

5. Professor Clifton discussed a commissioned meta-analysis he undertook in 2009 for the Commonwealth Scientific and Industrial Research Organisation (CSIRO). The objective of his meta-analysis was to determine whether the ingestion of CLA at dietary levels considered to be useful for body weight management would affect the plasma levels of LDL cholesterol, HDL cholesterol and triglycerides, and also blood lipid levels.  This study had a random factor of +/- 5 per cent and analysed 26 studies with almost 1,500 subjects, with each study being weighted according to its nature.  The studies were of trials involving subjects consuming capsules of CLA.  Professor Clifton noted that a food trial would be very difficult.  The conclusion reached from the meta-analysis was that CLA at “the projected level of intake has no effect on blood lipid parameters that would be suggestive of an adverse effect in terms of an increased risk of CVD”.

6. Professor Clifton said he has recently updated his 2009 meta-analysis to include a further 12 studies including studies to which Dr Bär referred him.  Because of the involvement of Dr Bär as a co-author in the resulting draft paper, and the fact that Dr Bär’s company, Bioresco, has a direct financial interest in the outcome of this matter, the Tribunal gave no further consideration to this later meta-analysis.

7. Professor Clifton said he concluded from his 2009 meta-analysis that CLA levels at the projected levels of intake specified in the relevant studies (1 to 6 grams per day) had no effect that could be measured in terms of LDL cholesterol.  In cross-examination, he accepted that use of CLA will lead to a very small increase in LDL cholesterol, but said the increase is so small as to be biologically insignificant, especially in view of “random biological noise” (as a result of which there is no absolute precision in CLA studies).  Professor Clifton also concluded that there was no increased risk in relation to blood lipid levels from consuming CLA.  He explained that LDL cholesterol, which is generally considered to be ‘bad’ cholesterol (because it deposits cholesterol on the walls of arteries), is accepted as a good biomarker of CVD.  In relation to diabetes, Professor Clifton said that CLA does not have any effect on glucose levels (which is a biomarker for diabetes).

8. Professor Clifton said HDL cholesterol is considered to be ‘good’ cholesterol because it is kept in solution and moved safely through the body without being deposited, and may even, in some instances, ‘snatch’ additional cholesterol already stuck to an artery wall, thereby reducing such deposits.  He said that CLA does not elevate HDL cholesterol and, equally, there is no evidence to show that CLA lowers it.  Even if CLA did lower HDL cholesterol, this would not change the risk of CVD.

9. Professor Clifton said, in his opinion, a study into the effects of consuming CLA for more than six months was unnecessary.  In any trial, the subjects’ compliance with a regime of taking particular substances tends to fall after six months and, in any event, the information sought is usually revealed after the first month of the trial.

10. Professor Clifton was also asked to compare his meta-analysis with that of Professor Martijn Katan.  He concluded that Professor Katan’s analysis was flawed because Professor Katan had not weighted the studies analysed and failed to recognise the existence of random biological noise.

    Professor Martijn B Katan

11. Professor Martijn Katan, a Guest Professor of Nutrition at the University of Amsterdam and Academy Professor of the Royal Netherlands Academy of Sciences, provided a report dated 21 February 2012 (for which he waived payment) and gave evidence by videoconference from Amsterdam. He holds a PhD in Biochemistry from the University of Amsterdam.  Professor Katan has been a major creative force in research on nutrition and heart disease for 35 years.  Among his many landmark achievements is, together with a student, being first to discover the adverse effects of trans fatty acids on blood lipids that led to worldwide concern regarding trans fatty acids in the diet, published in an article in the New England Journal of Medicine in 1990. 

12. In early 2010, Professor Katan and colleagues published what he described to the Tribunal as a quantitative review, as distinct from a meta-analysis, of published data on the effects of trans fatty acids, including CLA on cholesterol levels:  Brouwer IA, Wanders AJ, Katan MB (2010), ‘Effect of Animal and Industrial Trans Fatty Acids on HDL and LDL Cholesterol Levels in Humans – A Quantitative Review’, PLoS ONE 5(3): e9434. doi:10.1371/journal.pone.0009434.  (The journal PLoS One (Public Library of Science One) is an open access peer-reviewed journal that is freely available to the public.)  Professor Katan believes that the evidence for the effect of CLA on LDL and HDL is robust under various scenarios.  His concern is that consumption of CLA for a prolonged period will cause a small but distinct increase in the risk of suffering a heart attack or some other form of coronary heart disease.

13. In early 2012, Professor Katan undertook a further review of published studies on trials conducted on the effect of CLA.  He took into account the dose of CLA used in the trial but did not weight the outcomes.  Professor Katan rejected Professor Clifton’s criticism of his having not weighted the studies. He said it was his expectation that any effect of the number of subjects on the outcome would be very minor.

14. In his report dated 21 February 2012, Professor Katan said CLA is a trans fatty acid, and that “Tonalin and other commercial CLA preparations contain a mixture of two closely related forms or isomers of CLA, namely cis-9, trans-11 CLA and trans-10, cis-12 CLA” (original emphasis).  He concluded from his review and the scientific literature that:

    Both isomers of CLA raise the concentration of LDL [bad] cholesterol and lower the HDL [good] cholesterol in blood.  The uncertainty of the estimated effect is small enough to make a nil effect unlikely. …

    Independent experts are practically unanimous that treatments which raise LDL cholesterol levels will raise the risk of coronary heart disease.  The rise in LDL cholesterol caused by consuming 4.5 gram (sic) of CLA per day will cause a small but definite increase in the risk of suffering a heart attack or similar outcome. The risk depends on the age, sex and risk profile of the consumer, and on the duration of intake.

15. Later in his report, Professor Katan states that “[a] non-significant effect of CLA on LDL cholesterol does not mean that there is no effect”, and that “[d]aily intake of 4.5 gram (sic) of CLA raises LDL cholesterol by 0.068 mmol/L, which translates into a change in the risk of having heart disease by 1.7%.  This is a relative change.”

16. In oral evidence, Professor Katan said he sees no difference between CLA and other trans fatty acids in terms of their effect in raising LDL cholesterol, even if not significantly.  He said increasing the dose magnifies the adverse effect.

    Dr Albert Bär

17. Dr Albert Bär is a Switzerland-based biochemist who is the founder and chief executive of the consultancy firm Bioresco AG.  Cognis GmbH is a client of Bioresco and Dr Bär has advised Cognis for “a couple of years”, mainly on the European regulatory framework.  Dr Bär provided a statement dated 3 November 2011.  The Respondent objected to much of his evidence because of his perceived lack of independence, and the Tribunal only took into account his evidence about the molecular and chemical structure of fatty acids and CLA and the operation of the European regulatory system.

18. Dr Bär explained that CLA is a collective term for a mixture of isomers of linoleic acid in which the two double carbon-carbon bonds are conjugated, ie separated by a single carbon-carbon bond.  CLA is a synthetic preparation manufactured from natural linoleic acid derived from safflower oil. 

19. Dr Bär said his primary task as a consultant for Cognis was prepare its novel food application for Tonalin CLA for submission to the EFSA and to respond when the EFSA requested three further documents.  The EFSA makes a scientific assessment of a novel food at the request of the European Commission when a member state expresses concern about an application for authorisation of a novel food.  Dr Bär referred to the EFSA’s report in April 2010 and to the review conducted in 2012 leading to the issue of EFSA’s further report in May 2012.

    Professor Gary Wittert

20. Professor Gary Wittert is a Consultant Endocrinologist and Professor and Head of the Discipline of Medicine at the University of Adelaide.  He said he spends about 60% of his time on research into obesity and its related complications such as diabetes and CVD.  He has a strong interest in population health.  In his statement dated 22 February 2012, Professor Wittert said he was a member of the EpiSAG which provided an expert opinion on the assessment of CLA as a novel food ingredient.  The consensus view among the EpiSAG members attending the meeting on 2 September 2010, with which he agrees, was that “[t]he evidence that CLA lowers HDL-cholesterol (HDL) is convincing and raises health concerns at the population level”. 

21. Professor Wittert said he has considerable experience in glucose metabolism and CVD, noting EpiSAG’s comment that an improvement in glucose metabolism would be expected in weight loss studies but was not seen in the studies involving the use of CLA.  Professor Wittert said that, in his opinion, there is no evidence of risk with using CLA for six months.  However, no conclusion can be drawn about the safety of CLA beyond the short term (six months), and the effect of CLA on glucose metabolism and lipids is uncertain.  He noted that about 50% of type-2 diabetes is undiagnosed.  Professor Wittert said longer term research is required, for example over a period of five years.  His view is that one should err on the side of safety where the outcome is uncertain.

    DISCUSSION OF THE EXPERT EVIDENCE

    Trans Fatty acids

22. The relationship between increasing dietary intake of trans fatty acids (TFA) and coronary heart disease is well established and, as a result, there is concern over the consumption of TFA in our diet. Fatty acids are either saturated (containing only carbon-carbon single bonds) or unsaturated (containing carbon-carbon double bonds as well as single bonds).  Monounsaturated fatty acids contain only one carbon-carbon double bond, while polyunsaturated fatty acids contain more than one carbon-carbon bond.

23. Carbon-carbon double bonds may exist in a trans configuration where the hydrogen atoms adjacent to the double bond are located on opposite sides of the double bond or in a cis configuration where the hydrogen atoms are on the same side of the double bond.  This difference in configuration results in different chemical, physical and biological properties between trans and cis unsaturated fatty acids.

24. Some polyunsaturated fatty acids, including the two under consideration in the present hearing, contain one cis and one trans double bond that are joined by a single carbon-carbon bond.  Such double bond systems are described as conjugated due to their electronic structure being spread over all three bonds making up the conjugated cis, trans system.   Given the more profound effect of a cis double bond compared with a trans on the shape of an unsaturated fatty acid, it follows that a conjugated cis, trans system is more like a single cis unsaturated fatty acid than a single trans with respect to shape.  As demonstrated to the Tribunal by Dr Bär using molecular models, conjugated cis, trans unsaturated fatty acids have the characteristic bend in the carbon chair found in monounsaturated cis fatty acids. 

    The Expert Evidence of Professors Clifton and Katan

25. An important matter for the Tribunal was the differing interpretation of overlapping data on the effects of CLA on LDL and HDL cholesterol by Professors Clifton and Katan.  While this was not resolved during their giving concurrent evidence, what did become clear was that any effects were small.  Professor Clifton was firmly of the view that CLA was safe at the doses studied.  Professor Katan stood by his peer-reviewed published analysis (Brouwer et al, 2010) that there was cause for concern for a small but distinct risk in the consumption of CLA. 

26. There was much discussion about Figure 3 in the Brouwer paper where the results for CLA were illustrated.  Professor Katan maintained that the CLA data could be analysed in a statistically significant way.  This was disputed by Professor Clifton who questioned the line of ‘best fit’ being forced to go through zero. Professor Katan’s view was that with no fatty acid treatment there should be zero effect.  Professor Clifton pointed out that even with no treatment, there would still be scatter in the data.  The Tribunal agreed with Professor Clifton on this point. One study involving a large dose of CLA constituent fatty acids did clearly show a significant effect.  Professor Katan stated that even without this data point, the evidence was still significant for a small effect of CLA.

27. The Brouwer et al 2010 paper states that “Recent changes in dairy cattle feeding have led to milk with a lower content of saturated fatty acids and a higher content of cis-9, trans-11 CLA”, and “Our data suggest that the effect of these changes on heart disease risk in consumers of milk and meat fat are at the very least equivocal” (original emphasis). While they note that the effect of dietary CLA on cholesterol will be negligible if the data is assumed to be correct, intakes from supplements can easily reach 3 grams of CLA a day. This should increase the LDL to HDL cholesterol ratio by 0.050, which would correspond with a 3 to 12% increase in the risk of cardiovascular disease.  Professor Katan maintained this view before the Tribunal, while Professor Clifton stated that this was not supported by his meta-analysis.

28. While acknowledging the genuine disagreement of the two experts over such studies, the Tribunal’s view is that the studies do not provide sufficient evidence to enable us to reach an unequivocal conclusion as to the safety or otherwise of CLA with respect to LDL and HDL.  Until further studies are carried out, a cautious approach should be adopted.  The Tribunal notes that Professor Clifton’s approach is also a cautious one, maintaining that in his view there is no statistically significant evidence demonstrating that CLA consumption is unsafe.  However, the Tribunal is cognisant of the evidentiary axiom ‘absence of evidence is not evidence of absence’.

    The EpiSAG and EFSA Panel Opinions

29. As noted in paragraph 7, in 2010 FSANZ convened a group of experts from Australia and New Zealand to consider specific questions raised in a preliminary assessment report.  The EpiSAG, who met on 2 September 2010, were all highly qualified professionals appointed on the basis of their expertise relevant to the specific issues.  The group was chaired by Professor Neil Pearce (then Head of the Massey University Centre for Public Health Research in New Zealand and now Professor of Epidemiology and Biostatistics at the London School of Hygiene and Tropical Medicine).  The other members of EpiSAG were Associate Professor Catherine Itsiopoulos, University of Canberra, Associate Professor Damien Jolley, Monash University, Professor Murray Skeaff, University of Otago, Clinical Associate Professor David Sullivan, Royal Prince Alfred Hospital, the University of Sydney, and Professor Gary Wittert, University of Adelaide. In his evidence to the Tribunal, Professor Wittert concurred with what he described as the consensus views of the EpiSAG that are summarised above in paragraph 7.

30. The Applicant in Closing Submissions suggested that “very little weight can be attached to the EpiSAG conclusions due to the undoubted evidence that the Respondent controlled the process from start to end”.  The Applicant suggested that the Respondent “selected the Panel without reference to the Applicant, and in fact went to some pains to hide the entire process from the Applicant in what amounts to a significant denial of transparency and natural justice”.  The Applicant indicated that the “2012 analysis undertaken by EFSA is greatly to be preferred for these reasons”.  The Applicant drew attention to the fact that “the entire safety review of Tonalin CLA took just one day around a conference table (compare this to the Tribunal’s efforts to hear evidence in relation to blood lipids alone)”. The Tribunal noted the Applicant’s criticisms of the EpiSAG but was not satisfied that there was substantive evidence to support them.

31. The EFSA 2012 analysis referred to by the Applicant is the Panel’s Scientific Opinion on Dietetic Products, Nutrition and Allergies ‘Statement on the safety of the conjugated linoleic (CLA)-rich oils Clarinol and Tonalin TG 80 as Novel Food ingredients’ published in the EFSA Journal, 2012:10(5):2700.  This is the report of an expert scientific Panel convened by EFSA not unlike the EpiSAG convened by FSANZ.  There was no evidence before the Tribunal as to the Panel’s procedures but they appear to have involved discussions between 21 Panel members named in the EFSA Journal publication.  The documents before the EFSA Panel appear to be similar to those considered by EpiSAG, including material from FSANZ. 

32. The EpiSAG and the EFSA Panel findings state that the safety of CLA consumption for periods longer than six months has not been established under the proposed conditions of use, and the safety of CLA consumption by type-2 diabetic subjects has not been established.  The EFSA Panel considered that the safety of Tonalin TG 80 “has been established for the proposed uses and daily doses for up to six months”, as the Panel had concluded in 2010.  As noted by the Respondent the “clear position of the EC, based on the 2010 EFSA opinion which has not been altered in the 2012 EFSA opinion, is that Member States could not accept a decision authorising the use of CLA as a novel food”.

1. The EpiSAG opted for a cautious approach finding that more studies were needed for periods of longer than six months in order to establish the safety of Tonalin as a novel food. In line with the conclusions of the EpiSAG, FSANZ rejected the Applicant’s application for amendment of the Code, finding, with reference to the objective in the FSANZ Act to protect public health and safety, that “The overall evidence base was not sufficient to demonstrate the safety of Tonalin CLA at the recommended intake of 4.5 g/day.” Furthermore:

   The available evidence suggests that consumption of Tonalin CLA at the levels proposed by the Applicant may have adverse effects on cardiovascular disease and may adversely affect glucose tolerance in consumers with type 2 diabetes.  Potential adverse effects and potential beneficial effects may not occur in the same individual and individuals would be unlikely to be able to self diagnose relevant risk factors and self-exclude from consumption of Tonalin CLA where appropriate.

2. The Tribunal, on the basis of the evidence before it, including the expert panel reports from EpiSAG and the EFSA Panel, together with the oral evidence of Professors Katan and Wittert, while noting the dissenting evidence of Professor Clifton, finds that the FSANZ position on the potential adverse effects of Tonalin CLA at the recommended intake is reasonable and that further studies are required on this issue.

   ADDRESSING THE ISSUES

3. As stated above, the issues raised by the Applicant are, first, whether Tonalin CLA is a ‘novel food’ as defined in clause 1 of Standard 1.5.1 of the Code and, second, whether FSANZ’s decision to reject the Applicant’s application for variation of Standard 1.5.1 is the correct or preferable decision.

4. The Respondent pointed out that in Australia, a ‘food’ does not include a capsule, which is likely to be considered a ‘therapeutic good’ and subject to regulation under the Therapeutic Goods Act 1989 (Cth). At a meeting of the Complementary Medicines Evaluation Committee dated 1 December 2000, the Committee recommended to the Therapeutic Goods Administration (TGA) that CLA:

   is not suitable for use as an active or excipient ingredient in listable therapeutic goods as there is insufficient evidence of its safety for long-term human use, particularly that associated with the trans-10, cis-12 form of linoleic acid (original emphasis).

5. The Respondent also referred the Tribunal to the Food Act 2003 (NSW) as a typical example of the uniform legislation operating in the States and Territories. Section 5(1) of this Act specifically excludes from the definition of ‘food’ a therapeutic good within the meaning of the Therapeutic Goods Act.  The objects of the Food Act (s 3), which include ensuring food is both safe and suitable for human consumption and providing for the application of the Code in NSW, are conceptually different from those of the FSANZ Act, and include an enforcement regime. Thus, the handling of food in an unsafe manner, the sale of ‘unsafe food’ (defined in s 8(1)), and the handling and sale of ‘unsuitable food’ (also defined in s 9(1)) are offences under the Food Act: s 16 and s 17.  Further, “[a] person must not sell or advertise for sale any food in a manner that contravenes a provision of the Food Standards Code” (s 21(4)) and to do so is an offence attracting a substantial penalty. 

   Is Tonalin CLA a novel food?

6. To be a ‘novel food’ as defined in clause 1 of Standard 1.5.1 of the Code, requires that Tonalin CLA is a ‘non-traditional food’, as defined in clause 1, and also that is a food requiring an assessment of the public health and safety considerations having regard to the matters listed in paragraphs (a) to (f) of the definition. 

7. The Applicant appears to contend both that Tonalin CLA is no longer a non-traditional food, and also that the safety assessments undertaken by the FDA (following the GRAS notification) and by the EFSA, and the permissions and history of consumption of Tonalin CLA in other countries, are sufficient to negate the need for a further assessment of the public health and safety of Tonalin CLA. The Applicant submits that if the Tribunal decides that Tonalin CLA is not a novel food, then it should reject the Applicant’s novel food application under s 30 of the FSANZ Act.

8. The Respondent answers this as follows.  First, it submits that if the Applicant contends that Tonalin CLA is not a ‘novel food’ then it should withdraw its application.  Second, the Respondent submits that the question of whether Tonalin CLA is a novel food is not a question for the Tribunal and any decision by the Tribunal on this question will not bind the States and Territories.  The Respondent contends that questions of construction of the Code are matters to be determined according to relevant uniform legislation operating in the States and Territories, such as the Food Act 2003 (NSW). In the NSW Supreme Court decision in NSW Food Authority v Nutricia Australia Pty Ltd (2008) 74 NSWLR 148, at 161, Simpson J noted that:

   69. ... enforcement and policing of food standards are within the constitutional realm of the states.  For that reason, the Code is given the force of law by the Food Act of NSW.

   70. … construction of the Code falls to be determined by reference to NSW interpretation law.  That is because it is given the force of law by a state Act, and this is a prosecution brought under state law, governed by the rules of evidence and interpretation of NSW law.

9. Third, the Respondent submits that even if the question of whether Tonalin CLA is a novel food was an issue for FSANZ (and, standing in its shoes, the Tribunal), the application to amend Standard 1.5.1 of the Code was made to FSANZ on the basis that Tonalin CLA is a non-traditional food and there is insufficient evidence before the Tribunal for it to be satisfied that Tonalin CLA is not a non-traditional food.

   Whether, if Tonalin CLA is not a ‘novel food’, the Applicant should withdraw its application

10. In relation to the Respondent’s first submission, that if the Applicant contends that Tonalin CLA is not a ‘novel food’, it should withdraw its application to FSANZ, the Tribunal considers this to be an unreasonable stance to take in view of the enforcement and policy regime that resides with the State or Territory agencies and courts.  As the Applicant pointed out, if it withdrew its application and proceeded to sell Tonalin CLA in a State or Territory without approval by FSANZ, it would be liable to prosecution if Tonalin was found to be a novel food and approval for its use in Australia had not been given by FSANZ.  The Applicant could be subject to significant penalties if found guilty of an offence under State or Territory law.  The Tribunal therefore rejects the Respondent’s submission in this regard.

    Who should interpret the relevant statutory provisions?

11. With regard to the Respondent’s second submission, that the question of whether Tonalin CLA is a novel food is not a question for the Tribunal, the Applicant says that the Respondent confuses the enforcement of food law, which is a matter for the States and Territories, with the development of food standards which is a matter for FSANZ and therefore the Tribunal. 

12. The Tribunal recognises that the policing and enforcement of food standards are a matter for the States and Territories and that any questions of statutory construction arising will be matters for State or Territory courts. However, it seems to us that where the Tribunal is exercising its function in reviewing a decision made by FSANZ, or where the Federal Court is hearing an appeal against such a Tribunal decision, if questions arise about the exercise of FSANZ’s powers and the construction of relevant provisions of the FSANZ Act, the Tribunal or the Court will, as a matter of necessity, be required to consider how relevant provisions should be interpreted. Moreover, we note there appears to be nothing in the FSANZ Act to indicate to the contrary.

    Is the evidence insufficient to satisfy the Tribunal that Tonalin CLA is not a non-traditional food?

13. With regard to the Respondent’s third submission that there is insufficient evidence to satisfy the Tribunal that Tonalin CLA is not a non-traditional food, the Applicant says there is evidence that Tonalin CLA is available for sale in New Zealand as a dietary supplement or supplemented food (regulated under the Food Act 1981 (NZ)).  The Applicant refers to a table of websites, which is an attachment to Dr Bär’s statement, as evidence of CLA being available for sale in New Zealand.  The Respondent counters that there is no evidence of CLA being obtained or consumed in New Zealand or Australia and, even if consumed, it would not be a consumption of ‘food’ within the meaning of Standard 1.5.1.

14. The Tribunal notes, as pointed out in the hearing, that an internet search reveals that CLA capsules are available for sale on line in Australia. The Applicant said that persons wishing to import Tonalin CLA food supplements from New Zealand for private consumption in Australia may do so pursuant to s 7 of the Imported Food Control Act 1992 (Cth). However, as the Respondent noted, the local supply of CLA capsules within Australia would presumably fall within the definition of ‘therapeutic goods’ in s 3(1) of the Therapeutic Goods Act 1989 (Cth), being goods represented as being for therapeutic use, and therefore be subject to regulation under that Act. The Respondent referred to the Minutes of the Complementary Medicines Evaluation Committee (CMEC) meeting dated 1 December 2000 (ST 3) which state, in Recommendation 24.3:

    CMEC recommends to the TGA that conjugated linoleic acid 75% is not suitable for use as an active or excipient ingredient in listable therapeutic goods as there is insufficient evidence of its safety for long-term human use, particularly that associated with the trans-10, cis-12 form of linoleic acid (original emphasis).

15. With reference to the definition of ‘non-traditional food’ in clause 1 of Standard 1.5.1, the Tribunal agrees with the Respondent that there is insufficient evidence before it to establish that Tonalin CLA has a history of human consumption in Australia or New Zealand as a food, or substance derived from a food, or other substance, sufficient to satisfy us that it is a non-traditional food. We note the definition of ‘food’ in s 5 of the FSANZ Act specifically excludes “a therapeutic good within the meaning of the Therapeutic Goods Act 1989”. ‘Therapeutic goods’ are defined in s 3(1) of the 1989 Act as including goods that are represented as being for ‘therapeutic use’. ‘Therapeutic use’ is in turn defined to include use in or in connection with preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons, or influencing, inhibiting or modifying a physiological process in persons.

16. It is not clear to us from the evidence in what form Tonalin CLA may be consumed in New Zealand, but it seems likely from Dr Bär’s Table of New Zealand websites that a significant proportion of the consumption is in capsule form and that such capsules are represented as being for ‘therapeutic use’.  Such goods are thereby excluded from consideration as ‘food’.  Thus, the Tribunal is not satisfied on the evidence before us that Tonalin CLA is not a non-traditional food. 

    Is an Assessment of Public Health and Safety Considerations Required?

17. Having so determined, the Tribunal now turns to consider whether Tonalin CLA is a food requiring an assessment of the public health and safety considerations having regard to the matters listed in paragraphs (a) to (f) of the definition of ‘novel food’.  The Applicant submits that extensive and rigorous safety evaluations have been undertaken in 2010 and 2012 by the EFSA and to satisfy the FDA that Tonalin CLA is GRAS, prompting a “no questions” response from the FDA.  In the light of the history of consumption of Tonalin CLA as a food supplement in the USA, Spain and other countries the Applicant contends that no further safety assessment is required.

18. The Tribunal notes that the trials which were the focus of the studies included in the analyses undertaken by Professor Clifton and Professor Katan involved the subject persons taking capsules containing CLA during the trial period.  They were not trials involving the consumption of foods to which CLA had been added.  As Professor Clifton said, a food trial would be very difficult to undertake.

19. We note the conclusion of the EFSA’s two assessments that, on the one hand, CLA consumption was safe for the uses proposed at intakes of 4.5 grams per day for up to six months, on the basis that CLA consumption does not appear to have any adverse effects on insulin sensitivity, blood glucose control or liver function for such a period, and that observed effects on blood lipids are unlikely to have an impact on cardiovascular risk.  On the other hand, the EFSA considered that the safety of CLA consumption for periods longer than six months had not been established.  Moreover, the EFSA also said the safety of CLA consumption by type-2 diabetic subjects has not been established and the long term effects on insulin sensitivity and the arterial wall had not been adequately addressed. 

20. We note Professor Wittert’s evidence that about 50% of type-2 diabetes is undiagnosed.  Professor Wittert was a member of the EpiSAG that provided an expert opinion on the assessment of CLA as a food ingredient, referred to above at paragraph 7, pointing to the risks associated with CLA consumption which for some individuals could be substantially higher than the claimed benefits.  The EpiSAG identified adverse effects of CLA on blood lipids with consequent risks for those suffering from diabetes. 

21. While Professor Clifton’s opinion is that Tonalin CLA is safe for addition to foods in the amounts proposed, we note his concession that the use of CLA will lead to a very small increase in LDL (bad) cholesterol, although he said this was so small as to be biologically insignificant, especially in view of random biological noise.  The EpiSAG finding, with which Professor Wittert agreed, was that CLA increases LDL cholesterol, although the evidence is insufficient to estimate the magnitude of the effect.  The EpiSAG said the overall increase in CVD risk was non-trivial.

22. Professor Katan also concluded from his analysis that CLA raises the concentration of LDL cholesterol thereby causing a small but definite increase in risk for those suffering from coronary heart disease.

23. The Tribunal notes that while Professor Clifton considered studies of the use of CLA for longer than six months to be unnecessary, the EpiSAG suggested further analysis would be of value.  Professor Wittert said longer term research, perhaps over a period of five years, is required.

24. While the Tribunal acknowledges that CLA has apparently been used in Spain as a supplement and food additive since 2004/2005, and is used in the US, the weight of evidence satisfies us that Tonalin CLA requires further assessment of the public health and safety considerations having regard to “the potential for adverse effects in humans” (paragraph (a) of the definition of ‘novel food’ in clause 1 of Standard 1.5.1).

25. Thus, having found that Tonalin CLA is a non-traditional food and that an assessment of the public health and safety considerations is required, the Tribunal concludes that Tonalin CLA is a ‘novel food’ within the meaning of clause 1 of Standard 1.5.1. 

    The Safety of Tonalin CLA

26. The second issue is whether the decision of FSANZ that it would not vary Standard 1.5.1 is the correct and preferable decision. In making such a decision, FSANZ must have regard to the object of the FSANZ Act stated in s 3 which is “to ensure a high standard of public health protection”. This is specifically reinforced by s 18(1) which sets out the objectives of FSANZ in developing or reviewing food regulatory measures and variations of such measures, the most important being “the protection of public health and safety”. In performing such functions, pursuant to s 18(2), FSANZ must have regard, amongst other matters, to “(a) the need for standards to be based on risk analysis using the best available scientific evidence”, and “(e) any written policy guidelines formulated by the Council for the purposes of this paragraph and notified to the Authority”. The ‘Council’ referred to here is the Australia and New Zealand Food Regulation Ministerial Council, and the ‘Authority’ is FSANZ.

27. The Respondent referred the Tribunal to the Council’s ‘Policy Guideline: Addition to Food of Substances other than Vitamins and Minerals’.  This requires consideration of whether “the addition of the substance to food is safe for human consumption”.  

28. In assessing an application, FSANZ is also required to have regard to the matters set out in s 29(2), including whether the costs that would arise from, relevantly, a variation of a food regulatory measure, outweigh the direct and indirect benefits to the community.

29. The Respondent referred the Tribunal to the Federal Court decision in Distilled Spirits Industry Council of Australia Inc and Another v Food Standards Australia New Zealand and Another (2003) 133 FCR 19, decided prior to amendments to the FSANZ Act but in respect of substantially similar provisions. At [77], Madgwick J noted that the FSANZ Act is primarily aimed at public health protection. At [98], His Honour indicated that it was not imposing an onus of proof on the applicants to not disturb the current regulatory measure in the absence of ‘convincing justification’.

30. In the Tribunal’s view, having regard to the protection of public health and safety, the test to be applied is whether we are satisfied from the best available scientific evidence that Tonalin CLA is safe for human consumption as an additive to food.  

31. The Tribunal has already addressed the question whether Tonalin CLA requires an assessment of the public health and safety considerations, and has concluded that it does.  We found the weight of evidence satisfies us that Tonalin CLA requires further assessment of the public health and safety considerations having regard to the potential for adverse effects in humans.  Equally, we are not satisfied from the weight of the best available scientific evidence, discussed above, and having regard to the protection of public health and safety, that Tonalin CLA is safe for human consumption as an additive to food.  In our view, significant questions remain about the safety of permitting Tonalin CLA as an additive for food when the majority of experts in the field to whom we have been referred perceive there to be a risk, even in the short term, to those suffering type-2 diabetes, of whom we are told about 50% are undiagnosed. 

32. With regard to the longer term – over six months, the majority of experts perceive there to be a risk to those suffering from CVD.  While the risk may be small, it may nevertheless be significant to public health and safety.  Further research may shed greater light on this issue but we are not satisfied from the best available scientific evidence presently available to us that Tonalin CLA is safe for human consumption as an additive to food.

    DECISION

33. The decision under review is affirmed.

I certify that the preceding 94 (ninety four) paragraphs are a true copy of the reasons for the decision herein of Deputy President R P Handley and Emeritus Professor GAR Johnston AM.

.........[sgd]...............................................................

Associate

Dated 24 August 2012 

Dates of hearing

9-12 July 2012

Date final submissions received

26 July 2012

Advocate for the Applicant

C Preston, solicitor

Counsel for the Respondent

Solicitors for the Respondent

K Stern SC

Clayton Utz