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Safety aspects of dietary caffeine

Report from the Expert Working Group

(June 2000)

The Australia New Zealand Food Authority (ANZFA) established an Expert Working Group (consisting of external experts) to examine the wider aspects of the safety of dietary sources of caffeine.
 
The task and terms of reference for the group were to examine the potential for acute toxicological/pharmacological effects at low doses of caffeine (Term of Reference A), the potential for addictive effects (Term of Reference B) and identification of any other caffeine-related hazards particularly in children (Term of Reference C).
 

Preamble

The Australia New Zealand Food Authority (ANZFA) established an Expert Working Group in November 1999 to examine the wider safety aspects of dietary sources of caffeine.
 
The conclusions of the Expert Working Group will be considered by ANZFA in relation to the assessment of specific applications to vary the permissions for the addition of caffeine to food/beverages in relevant food standards in the Australian Food Standards Code.   Current applications for which advice on caffeine is being sought are, an application to extend the use of caffeine in all soft drinks (A344) and, an application to establish a maximum level for caffeine in energy drinks (A394).
 
The conclusions of the Expert Working Group may also be relevant to subsequent applications to vary standards for other foods containing caffeine.
 
1.   The Regulation of Caffeine in Foods (Soft Drinks, Energy Drinks and Sports Foods)in Australia, New Zealand and Internationally

Soft drinks

Australian Food Standards Code
 
The Australian Food Standards Code restricts the addition of caffeine to kola-type soft drinks, flavoured cordials and flavoured syrups. In these drinks, the total caffeine content must not exceed 145 mg/kg (36mg/250ml serve) in the drink as consumed.   The Code does not prescribe limits for naturally occurring caffeine in food - for example, tea, coffee and guarana. The caffeine levels in these foods will not normally exceed 100 mg in a standard serving.  
 
New Zealand Food Regulations
 
In New Zealand, caffeine may be added to any soft drinks, and a maximum level of 200 mg/kg is prescribed.   It is also permitted to be used as a flavouring in any other non-alcoholic beverages where flavourings are permitted, with no maximum level prescribed.
 
International Regulations
 
Internationally, caffeine is permitted in soft drinks at levels ranging from 150 to 300 mg/kg.   The Codex Alimentarius Commission does not prescribe a level for caffeine.

Energy Drinks and Sports foods

Energy drinks are non-alcoholic beverages characterised by the addition of  'energy enhancing' ingredients.   These may include a number of water-soluble B vitamins, amino acids and other substances, and caffeine.   The caffeine is added as pure caffeine or as guarana, a herbal caffeine source.   Most energy drinks do not exceed levels of caffeine of about 80mg/250 mL.   This caffeine level in energy drinks is comparable to the caffeine level in a strong cup of coffee.  
 
Guarana is often added to energy drinks either in combination with caffeine or on its own.   Guarana is made from the crushed seeds of a native Brazilian plant.   The stimulant effect of guarana is related to its caffeine content.   A 1 gram dose of guarana will contain about as much caffeine as a medium strength cup of coffee.
 
Energy drinks are promoted to young people to boost energy and vitality particularly in times of added stress; in New Zealand, they are also promoted as alternatives to alcoholic drinks.   Red Bull Energy drink is one of over 20 energy drinks currently for sale on the New Zealand market.   Energy drinks are available in over 30 countries, and are well established in Europe and the United States of America.
 
New Zealand Food Regulations
 
Energy drinks are regulated in New Zealand under theDietary Supplements Regulations1985, made under the Food Act 1981 but are not regulated underNew Zealand Food Regulations1984 .   The current New Zealand Food Regulations and the Dietary Supplements Regulations do not require that a food or dietary supplement containing guarana is labelled as a source of caffeine.
 
Australian Food Standards Code
 
The AustralianFood Standards Codedoes not have a standard that covers energy drinks.   Prior to the introduction of the Trans Tasman Mutual Recognition Arrangement (TTMRA) in 1998, the current formulations of energy drinks could not be legally sold in Australia.  
 
Products regulated under the New Zealand Dietary Supplements Regulations are considered in Australia as either foods or therapeutic goods; there is no separate dietary supplement category.
 
TTMRA permits the importation of energy drinks from or through New Zealand providing they comply with the New Zealand Dietary Supplements Regulations.

Sports Foods

As noted above energy drinks are regulated in New Zealand under theDietary Supplements Regulations1985.   However, similar products are manufactured in Australia following a re-formulation (and adherence to specified upper limits for ingredients such as vitamins and minerals) of the product under Standard R10-Formulated Supplementary Sports Foods.   The caffeine content of such products is from guarana which is legally a food in the Australian regulations and so escapes the restrictions placed on addition of caffeine.   Foods can be mixed with other foods without special permission under food laws.  
 
2.    Applications currently being assessed by ANZFA
 
Application to extend the use of caffeine in all soft drinks (A344)
 
ANZFA received an application on 9 July 1997 from Kensington Swan, a New Zealand legal firm, to amend the Food Standards Code so as to permit the same uses for caffeine in Australia that are currently permitted in New Zealand.   The application was subsequently amended to limit the request to an extension of use of caffeine into all soft drinks at the maximum permitted level of 145 mg/kg.
 
ANZFA has now stopped-the-clock on application A344 (17 August 1999) awaiting the submission of new data from the applicant arising from the submissions at inquiry and in addition the deliberations from an Expert Working Party (see below).
 
Application for Red Bull energy drink (A394)
 
ANZFA is currently considering an application from Red Bull to develop appropriate regulatory provisions for energy drinks within theFood Standards Code.   The current situation enables product to be imported from New Zealand into Australia but does not permit such energy drinks (in their current formulation) to be manufactured in Australia for domestic consumption because New Zealand food or dietary supplement regulations are not recognised for Australian domestic manufacture.  
 
Although revised formulations of energy drinks could be made in Australia under the Food Standards Code, no single food standard provides all the permissions sought by manufacturers of these drinks.
 
3.   Formation of the Expert Working Group
 
In order to broaden scientific input into the assessment of application A344 and to further address community concerns regarding the effects of caffeine (particularly in relation to behavioural effects in children), ANZFA established an Expert Working Group.
 
Nomination to the Expert Working Group
 
On 21 September 1999, ANZFA sought nominations of scientific or clinical experts in the area of toxicology and/or pharmacology (particularly behavioural aspects) to form the basis of the Expert Working Group.   Nominations were received from State and Territory Governments, industry, consumer organisations and the health sector. The following six individuals, nominated by various groups were appointed to the Expert Working Group:
 
Group Member                       Nominated by:
Dr Alex Proudfoot                      ANZFA (Chair)
Prof. Paul Smith                       New Zealand Ministry of Health
Prof. Andrew Smith                   Australasian Soft Drink Association
Prof. John Miners                      South Australian Department of Health
Prof. John McNeil                     ANZFA (to provide clinical perspective)
Prof. Jack James                      Consumer Food Network of Australia and New Zealand.
 
On 11 November 1999 ANZFA formally established the Expert Working Group on caffeine.   The group indicated both their willingness to participate, and their availability between the period November 1999 to March 2000.   The report of the Expert Group will be considered as part of developing a final position on Applications A344 and A394.
 

ANZFA is currently in the process of establishing a reference group to assist with the development of appropriate regulatory policy on caffeine in food.   ANZFA is currently seeking nominations of people with expertise in the areas of public health/risk management from State and Territory Governments, industry, consumer organisations and/or the health sector to be part of the reference group.   ANZFA intends to select from these nominations a group of approximately 5 people to ensure there is an appropriate representation from all sectors of the community.   Nominees would need to be available to undertake work between June and mid July 2000.

 

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