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Food Standards News 51

September - October 2004

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In this issue...

Countdown to conference

Changes to health claims on food labels

Flavourings in food and how they should be labelled

FSANZ issues advice to fructose intolerant people

Review of novel foods

New advice on listeria and food

FSANZ International Training

New fees scheme

Come and meet FSANZ ..

Chief Medical Advisor, Dr Bob Boyd discusses claimed health effects of foods

 

Conference

 

Countdown to conference

Food Safety Conference 2004: Future Directions
Gold Coast Exhibition Centre
11 – 12 October 2004

The inaugural Food Safety Conference draws on both domestic and international experience, highlighting the emerging issues, the challenges and the directions for the future. The speakers bring together expertise from within and outside the region. They will set the scene for lively panel discussions that should provide insights for industry, consumers and governments alike. For more information on the program and registration visit our Conference website   www.foodsafetyconference.com.au .

Our key note speaker is Dr Doug Powell

Amongst our other key speakers are:

For more information on the speakers, program and registration visit our Conference website   www.foodsafetyconference.com.au.

 

Changes to Health Claims on food labels underway

Food Standards Australia New Zealand has called for public comment on development of a major new food standard for Nutrition, Health and Related Claims. This follows a recent policy guideline by the Australia and New Zealand Food Regulation Ministerial Council that foreshadows allowing health claims on food labels.

This is one of the biggest changes to food labelling in Australia and New Zealand that we have seen in recent years and it is vital that consumers, industry and health professionals contribute to the development of this new food standard.

Currently high level health claims on food that refer to a serious disease or condition such as ‘reduces your risk of heart disease’ are not permitted on food. Such claims are permitted on medicines. The only exception is a claim about the benefit of mothers consuming folate and reducing the risk of neural tube defects in unborn babies.

The other type of general claims on food labels, statements such as ‘good source of calcium’ or ‘low fat’, are currently allowed. However, only a few are listed in the Food Standards Code, with others covered by an industry code of practice.

FSANZ has prepared an Initial Assessment Report which discusses a number of issues related to permitting these types of claims

The development process for the proposed standard includes two rounds of public consultation. FSANZ staff are working closely with a Scientific Advisory Group and a Standard Development Advisory Committee that has representatives from consumer groups, health professionals, enforcement agencies and the food industry. The first round of public consultation started on 10 August and will continue until 20 October 2004.

We appreciate that not everyone will have the time to make detailed submissions. So, for the first time, we have developed a guide to assist people to make submissions. Copies of the Initial Assessment Report and Submitters’ Response Booklet , as well as details of the stakeholder briefings, can be found on the FSANZ website at www.foodstandards.gov.au or obtained by calling the Information Officer in Australia on (02) 6271 2241 or in New Zealand on (04) 473 9942 or emailing info@foodstandards.gov.au .

photograph      photograph

Caption: Attendees at NZ Stakeholder forum chat with FSANZ Staff

        

Flavourings in foods and how they should be labelled

Within the Australia New Zealand Food Standards Code (the Code) there are a number of provisions that food manufacturers need to be aware of when using flavourings in foods.  

Flavours often contain a number of individual flavouring substances and flavouring preparations may contain other food additives such as antioxidants and colourings.  Preparations of food additives also contain carriers, solvents and diluents which may also require labelling.

Standard 1.2.4 – Labelling of Ingredients.

Clause 8 – Declaration of food additives, requires that food additives must be declared in accordance with ingredient labelling requirements.

Subclause 8 (6) requires that flavours must be declared in the statement of ingredients by either the word ‘flavouring’ or ‘flavour’; or a more specific name or description of the flavouring.

This means that all food additives, including flavourings must be declared whenever there are ingredient labelling requirements.   Flavourings can be declared simply by the generic terms, flavour or flavouring, as there are thousands of individual flavouring substances, many of which have complex chemical names that most consumers would not understand.   Manufacturers can however, still declare individual flavouring substances if they choose. For simpler or better-known substances such as maltol or vanillin, this information may be useful to some consumers.

Clause 6 – Declaration of compound ingredients, generally requires the listing of all the components of compound ingredients in descending order of ingoing weight. In the case where the amount of compound ingredient is less than 5% of the food, most of the ingredients are exempted, but all the food additives in the compound ingredient still need to be included in the statement of ingredients if the food additive is performing a technological function in the final food.

Flavouring preparations often contain more than one component, they may contain many individual flavouring substances, as well as colourings, antioxidants or preservatives.   If an antioxidant or a colouring in a flavouring preparation is still exhibiting a technological function in the final food it needs to be labelled.

Standard 1.2.3 – Mandatory Warning and Advisory Statements and Declarations.

Clause 4 requires that the substances listed that may cause severe adverse reactions in sensitive individuals must be declared when present in food.   This means food additives and components of food additives that are derived from milk, nuts, eggs, crustacean, sesame seeds and fish   and are present in a flavouring need to be declared on labels.

Standard 1.3.1 – Food Additives.

Finally all components of a flavouring need to be approved within the Code. Clause 11 – Permitted flavouring substances, lists the references to flavouring substances that may be used to flavour food.   The food additives used in flavour preparations need to be approved in item 0.1 – Preparations of food additives within Schedule 1 of Standard 1.3.1.

 

FSANZ issues advice to fructose intolerant people to avoid new food ingredient tagatose

Food Standards Australia New Zealand’s Chief Medical Adviser, Dr Bob Boyd, has issued advice for people who are fructose intolerant to avoid the novel food tagatose.

‘Tagatose is a new food ingredient that has recently been approved by FSANZ as a lower kilojoule substitute for sugar. Tagatose occurs naturally at low levels in the gum fromSterculia setigera(an evergreen tree), as well as heated cows milk and other dairy products. It is safe for the general population but , because tagatose is metabolised in the same way as fructose, FSANZ considers that foods containing tagatose would not be suitable for people who are fructose intolerant,’ Dr Boyd said.

‘About one person in every 22,000 of the population may have fructose intolerance where they have an absence of enzymes in the body which digest fructose (a naturally occurring fruit sugar, used as a sweetener in foods and beverages). Such individuals are also unable to tolerate sucrose (table sugar), which is broken down in the gut to glucose and fructose.

‘If they consume foods containing fructose or sucrose it can result in low blood sugar, severe abdominal symptoms, and eventually jaundice and liver damage if consumption continues. The condition is usually detected in early childhood, and the most effective form of treatment is to eliminate fructose and sucrose from the diet and use alternative sweeteners if needed.  

‘ Individuals who are fructose intolerant are also likely to be intolerant to tagatose therefore avoidance is recommended. The best way to avoid tagatose is to check the ingredient list of food products where it will be listed,’ Dr Boyd concluded.

The types of foods that may contain tagatose are:

More information about tagatose, a fact sheet: Information about Tagatose for Individuals with Disorders in Fructose Metabolism  can be found on the FSANZ website at www.foodstandards.gov.au .

 

Review of Novel Foods

FSANZ has raised a pre-Proposal to review Standard 1.5.1 – Novel Foods – of the Code. This review is being undertaken in accordance with policy guidance received from the Australia and New Zealand Food Regulation Ministerial Council in December 2003. The main elements of the policy guidance are that FSANZ:

To assist in the review of novel foods, a Standard Development Advisory Committee (SDAC) has been formed to provide advice to FSANZ. The SDAC has 16 members including representatives from government, industry, public health/nutrition and consumers and Professor Chris Hudson will attend as the FSANZ Board observer. The SDAC met for the first time on 23 September 2004 in Canberra to discuss the relevant issues. The discussion at this meeting will inform the Initial Assessment Report, which, subject to consideration by the FSANZ Board, will subsequently be released for public comment. The SDAC will have an ongoing involvement during the course of the review and will likely meet for the second time in early to mid 2005 to discuss issues that are raised in public submissions to the Initial Assessment Report.

Some of the main issues to be addressed during the review include: options for the regulation of novel foods; the definitions for non-traditional and novel provided in the Standard; the operation of the Standard, including how determinations are made as to whether a food is deemed novel or not; enforcement of the Standard; data requirements for the assessments of novel foods; and examination of the inter-relationships with other Standards and the foods-therapeutic goods interface. The review will also consider the need to regulate food produced from new technologies.

FSANZ has assessed and approved the following novel foods in accordance with Standard 1.5.1: Docosahexaenoic acid derived from marine micro-algae (Schizochytriumsp.); ?-Cyclodextrin; D-Tagatose; Trehalose; Phytosterol esters (for use in certain foods only); and Tall oil phytosterols (for use in certain foods only).   The review of novel foods will not revisit these existing permissions for novel foods. FSANZ is currently assessing a number of Applications for novel foods against the existing Standard, and these Applications will progress in tandem with the review.

 

New Advice on Listeria and Food

FSANZ recently released updated advice on the food poisoning bacteria Listeria for pregnant women and their unborn or newborn babies, people whose immune systems cannot fight off infections and the elderly.

‘Food Standards Australia New Zealand (FSANZ) has prepared this advice using the latest scientific information.’

‘While Listeria infection is uncommon and causes few or no symptoms in most people, it can be very dangerous for unborn or newborn babies, the immuno-compromised and the elderly,’ said Dr Marion Healy, FSANZ's Chief Scientist.

‘The food industry, state and territory regulatory authority and FSANZ have extensive management processes in place to prevent Listeria contamination during food production. However, listeriosis is usually caused by people at risk eating food that has not been stored or handled properly once the food has been produced or cooked.  

‘Listeria bacteria are found widely in nature and may be present in certain types of foods, such as pre-prepared uncooked foods or pre-cooked foods which have been kept for some time after they have cooled down,' said Dr Healy .  

‘If you or anyone in your household is in the higher risk group, it is important you reduce your risk by taking a few simple precautions. You can take precautions to avoid Listeria by eating only freshly prepared and well-washed food, following good food hygiene such as washing and drying hands, by cooking foods thoroughly and by refrigerating leftovers immediately and keeping them no more than a day.

‘This new brochure contains advice on safer alternatives for people at risk to eat in the meat, chicken, salads, seafood and dairy products food categories. It also lists some higher risk foods that people at risk should be wary of consuming especially if they are unsure about how the foods have been stored and handled. However, the higher risk foods become safe if you cook the food or reheat it to steaming hot throughout, and serve it hot.

‘Remember that good nutrition is essential during pregnancy, for those with poor immune systems and the elderly so it is important to replace any food from the ‘avoid’ group with a similar one from the ‘safe’ group. For example you can replace soft cheese with packaged cottage cheese or cheddar or make your own salads fresh instead of buying them pre-prepared,’ said Dr Healy.

More information can be found on the FSANZ website www.foodstandards.gov.au . Brochures can be obtained by emailing info@foodstandards.gov.au or calling (02) 6271 2241.

 

FSANZ International Training

FSANZ held its first Canberra based international training course,Building a More Effective Food Regulatory System,during August 2004.   This was the first course of the FSANZ International Training Program for 2004 – 2005.  

FSANZ’s international training plays a lead role in fulfilling Australia’s obligations to the World Trade Organization (WTO) to assist in the harmonisation of food standards across the Asia Pacific Region.   It is achieved by sharing our knowledge and experience in developing food standards with countries from our region.

FSANZ worked in cooperation with AusAID who provided the funding for the training course.

The 5-day residential training was attended by 28 government food regulators from 8 Asia Pacific countries. These countries included Vietnam, PR China, Vanuatu, Solomon Islands, Indonesia, Thailand, Papua New Guinea, and the Philippines.  

The course consisted of a series of lectures and case studies on the food regulatory system with particular emphasis on the risk analysis, risk management and risk communication   framework and its role in strengthening food safety.   The participants enthusiasm and hard work allowed them to successfully complete the 10 modules of the training course.

At the completion of the course, each participant was awarded a certificate by Graham Peachey, FSANZ’s Chief Executive Officer.

The training course presenters and case study coordinators included Dean McCullum, Glenn Stanley, Lynda Graf, Julie Boorman, Rob Solomon,   Mark Salter, Scott Crerar, Peter Abbott,   Lydia Buchtmann, Paul Brent, Kelly Crouch, Craig Jamieson and Slava Zeman (AQIS).

The next international training course will be held in Canberra in November 2004.

 

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Caption: Participants of the International Training Course held in Canberra, August 2004.

 

Cost Recovery Changes

FSANZ has recently undertaken a review of its cost recovery regime.  Amendments to the Regulations were Gazetted on 26 August 2004. The Food Standards Australia New Zealand Regulations set out details on how the categories of assessment and costs are determined. Link to Regulations: http://scaleplus.law.gov.au/html/pastereg/1/925/top.htm

Only in some circumstances do cost-recovery fees apply to applications made to FSANZ. Fees apply where FSANZ has determined that the applicant would derive an ‘exclusive capturable commercial benefit’ from the sought change to the Code or, where an applicant chooses to pay a fee to expedite the application (see paragraphs 66(6)(a) and (b) of the Food Standards Australia New Zealand Act 1991.

Besides detailing expanded categories of assessment, and a revised fee structure, the main thrust of the amendments is:

 

For applications where the $2800 was paid prior to 26 August 2004, the old fees and charges are:

Category of Complexity

Initial Assessment Fees $AUD 1

Draft & Final AssessmentFees $AUD 1

Total Fees $AUD 1

Indicative Total Fees $NZ 2

1 -Very Simple

$   2,800

$   2,800

$5,600

$6,160

2- Simple

$   2,800

$ 14,000

$16,800

$18,480

3 -Average

$   2,800

$ 33,600

$36,400

$40,040

4 -Complex

$   2,800

$ 56,000

$58,800

$64,680

5 -Highly Complex

$   2,800

$ 84,000

$86,800

$95,480

1. These fees are exempt from GST.  

2. Fees are payable in Australian dollars. However, New Zealand applicants are able to pay fees in New Zealand currency, in which case the New Zealand dollar amount will be calculated on the official exchange rate on the day the fee is paid. The figures above are therefore only indicative, calculated on an exchange rate of $A1 = $NZ1.10.< BR >

For all applications (where no payment made before 26 August 2004, or application sent to FSANZ after 26 August 2004)

Category of Complexity

Initial Assessment Fees $AUD 1

Draft & Final AssessmentFees $AUD 1

Total Fees $AUD 1

Indicative Total Fees $NZ 2

1 -up to 200 hours

$ 4,000

$ 14,700

$18,700

$20,570

2- 201-300 hours

$ 4,000

$ 22,800

$26,800

$29,480

3 -301-450 hours

$ 4,000

$ 36,000

$40,000

$44,000

4 -451-650 hours

$ 4,000

$ 55,000

$59,000

$64,900

5 -651-1050 hours

$ 4,000

$ 87,000

$91,000

$100,100

6 -more than 1050 hours

$ 4,000

$151,0003

$155,000 3

$170,500 3

1.  These fees are exempt from GST.  

2.  Fees are payable in Australian dollars.   However, New Zealand applicants are able to pay fees in New Zealand currency, in which case the New Zealand dollar amount will be calculated on the official exchange rate on the day the fee is paid.   The figures above are therefore only indicative, calculated on an exchange rate of $A1 = $NZ1.10.

3.   Where the total number of hours exceeds 1850, the surcharge will apply for each completed 100 hour block of time calculated on 2.5% of the total for Category 6 (0.025 X $AUD155,000 = $AUD3875).   If a block of 100 hours is not completed, no surcharge will apply.

 

The payment of the fee for Initial Assessment stage must be received before the Initial Assessment can commence, preferably at the time the application is lodged.   The fee for the Draft and Final Assessment stages is to be made as a single payment once the Initial Assessment is completed and the application has been accepted under section 13A of the Act. This payment must be received before work can commence on the Draft Assessment stage. The final determination of the charging category is made after completing the Initial Assessment and applicants will be advised if the application is accepted and a further payment is due.

There have been some increases in the fees chargeable. The fee for Initial Assessment, that covered the cost of preparing the initial assessment report and one round of public notification (payable where either paragraph 66(6) (a) or (b) applies, has been increased from $2800 to $4000. While the fees have increased, it is important to note that the current categories and the proposed categories are not directly comparable. Category 1, under the old structure, has been eliminated completely, as practically no applications received by the Authority have been assessed as Category 1. Therefore the proposed Category 1 is comparable to the current Category 2; proposed Category 2 is comparable to current Category 3, and so forth. The new Category 6 is not comparable to the old structure.   This means in real terms that:

for the new Category 5 fees increase by 5%.  

Old Scheme

New Scheme

Initial Assessment Fee:   $2800

Initial Assessment Fee:   $4000

Category of Assessment

Charges

$   

Category of Assessment

Charges

$

Category 1

$   5,600

 

 

Category 2

$ 16,800

Category 1

$  18,700

Category 3

$ 36,400

Category 2

$  26,800

Category 4

$ 58,800

Category 3

$  40,000

Category 5

$ 86,800

Category 4

$  59,000

 

 

Category 5

$  91,000

 

 

Category 6

$ 155,000*

*Where the total number of hours exceeds 1850, the surcharge will apply for each completed 100 block of time calculated on 2.5% of the total for Category 6:
(0.025 x $155,000.00 = $3875.00)
(Fees are partially refundable, in accordance with the refunds policy, when the assessment of applications does not progress beyond certain stages.)

 

Come and meet FSANZ…

You can visit or speak with staff from FSANZ at the following conferences or events over the next few months. There will also be a range of information available for interested parties wanting to participate or update their resources.

 

DATE

CONFERENCE

LOCATION

October 11 - 12

Food Safety Conference 2004

Gold Coast, Qld

October 12 - 14

Foodtech / Packtech

Auckland, NZ

November 21 - 25

World Dairy Summit

Melbourne, Vic

 

Chief Medical Advisor Dr Bob Boyd discusses current issues

It is exactly a year since I joined FSANZ as its first ever full-time medical advisor, so it is a good time to reflect on some of the human health issues the agency has been involved in over that time and to look at the future, particularly as regards health claims.

Having come from a public health medicine background, I started with the concept of foods as potential carriers of gastro-intestinal infections, as being essential for combating malnutrition in the developing world and as building blocks for a “healthy diet”.   I was quite unprepared for the beneficial functions being ascribed to some of our most common foods and beverages and, conversely, the potential harm the current Australasian diet may be doing to us all.  

Negative Claims

The three issues which have received the most publicity and media interest in the last twelve months have, in fact, been claims of potential harm from commonly consumed foods. These were milk, vegetable oils (eg margarine) and imported prawns and honey.   In all three cases, the public has been presented with a “safer” alternative.   The role of a regulator, like FSANZ, is not to take sides, but to closely scrutinise the available information, seek expert advice and decide how any potential risk to health should be managed in order to protect public health and safety.   Options include developing a new standard or recommending action to enforcement agencies like the States and Territory Governments, AQIS (the Australian border control agency), and the New Zealand Government.   What is not optional is ensuring that the public receives factual, unbiased information and is protected from fraud and deception.  

Consumers have been concerned that they may have been harming themselves and their families by purchasing their usual milk which contains predominantly the A1 beta casein protein.   Other concerns include the purchase of imported prawns and honey only to find that some imported food samples have contained extremely low levels of nitrofuran residues.

In each case, rigorous investigation could not find the scientific evidence to substantiate the claims about the benefits of drinking A2 milk or the level of nitrofuran residues found in imported prawns and honey were hazardous.  

But it is an uphill battle to reassure the public and counsel them not to change their diet unless more compelling scientific evidence is published, when this sort of material is already widely publicised in the media.  

Positive Claims   

Currently FSANZ has out for consultation its Initial Assessment Report on proposal P293, Nutrition, Health and Related Claims.   If implemented as a standard this proposal will permit health claims on foods under certain prescribed conditions, including pre-approval by FSANZ of any claim relating to reducing the risk of serious disease.    Lessons learned in seeking the substantiation of the negative claims referred to above, are applicable to the substantiation of positive health claims which manufacturers may wish to include in their products’ labels and advertisements.

There is a hierarchy of scientific evidence that we would look for, starting with the “gold-standard” of human randomised controlled clinical trials published in reputable scientific / medical journals, through observational and epidemiological studies down to unpublished reports of consumer benefit provided by the manufacturer. With the help of experts, we have come up with a 5 step process for evaluating the quality and completeness of   evidence submitted to substantiate claims of positive health benefits from particular foods.   All this could, if the Standards is adopted, usher in a new age of   functional foods and healthier eating based on consumer knowledge about which foods are good for their health and which foods may be even better. Therefore the link between food regulation and medical practice will need forging even stronger in the coming years.

Dr Bob Boyd
Chief Medical Advisor

 

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