Review of the regulatory management of food allergens

2.3 Consideration of lupin as a new allergen

There is evidence that lupin is emerging as an allergen in Australia and lupin is increasingly used in food products in Australia. Here we provide a preliminary discussion and make a recommendation to further investigate the potential medical significance of lupin allergy.

2.3.1 Lupin allergy

Allergic reactions to lupin have been reported in the medical literature since 1994. More reports followed, mainly from Europe where lupin flour was increasingly used in food. The symptoms of lupin allergy are typical of severe Ig-E mediated allergic reactions and cases of lupin anaphylaxis have been reported by Matheu et al. (1999), Smith (2004), and Radcliffe et al. (2005). Lupin proteins show cross-reactivity in vitro with proteins from peanut and other legumes. The prevalence of lupin allergy is not known. Some peanut allergic individuals may also be allergic to lupin (Hefle et al., 1994; Moneret-Vautrin et al., 1999; Kim et al., 2007; Goggin et al., 2008; Shaw et al., 2008).

Lupin allergy was reported for the first time in Australia by Smith et al. (2004). The report, published in the Medical Journal of Australia, documented three cases of allergic reaction to lupin. The patients had reacted to food containing lupin flour, two requiring emergency care. None of the three patients was allergic to peanuts. The authors called for lupin to be included on the mandatory food allergy declaration.
FSANZ is aware that a few more patients have been diagnosed with allergy to lupin in Australia since 2004 (Dr William Smith, personal communications). To date, lupin allergy has not been reported in New Zealand.
Researchers in Australia sought to determine the clinical significance of lupin allergy among peanut sensitised individuals. The research aims to:

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  Establish the prevalence of lupin allergy in peanut allergic individuals
  
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  Identify lupin allergenic proteins
  
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  Determine the relationship between lupin and peanut allergens
  

The research team is currently preparing the study for publication. FSANZ is communicating with the researchers to access the information as part of the risk assessment of lupin allergenicity.

2.3.2 Lupin in the food supply

Lupinus angustifolios, also known as Australian sweet lupin, is a major crop in Western Australia. Until recently, most of the Australian lupin crop was used for animal feed or exported to overseas markets. Now lupin is recognised for its high protein and fibre content as a valuable addition to the human food supply. Two other cultivated lupin species, Lupinus albus (white lupin) and Lupinus luteus (yellow lupin), are used widely in food in Europe. Trials of the yellow lupin are also underway in Australia. Lupin is related to other legumes, including peanuts and soy (Government of Western Australia, 2008).

In recent years, the use of lupin flour in food products has increased in Australia. The high protein and dietary fibre and low fat content of lupin make it attractive for human nutrition. Lupin flour and lupin bran are now used in a range of packaged and unpackaged food products such as pasta, bread, and bakery products. In addition, the Australian food industry sees a strong potential in the development and use of lupin-derived ingredients with potential use in dairy substitutes, sausage fillings (including vegetarian sausages), emulsions for salad dressings, baby food and diet products and scent and taste transporters. Lupin ice cream has already been introduced in Germany (Drake, 2008).

Information on the extent to which lupin is currently used in the food supply in Australia and New Zealand is not readily available. To address this information gap, FSANZ developed a research project in collaboration with Ms Alison Woo supervised by Professor Ken Buckle at the UNSW. The research provides evidence that a number of lupin-containing food products, either manufactured in Australia or imported, are available to consumers in Australia. In addition, lupin flour is used by bakeries in a variety of products, including bread, muffins and cakes. In New Zealand, it appears that, at this stage, lupin-containing products are not widely available to consumers (Woo – UNSW, 2008; NZFSA, personal communications).
FSANZ considers that information available on lupin allergy warrants further consideration through a proposal. This would allow FSANZ to formalise the process including the involvement of allergy experts and the public in discussions. Some members of the food industry have indicated their willingness to support such a proposal and would support the inclusion of lupin in the list of allergens in the Code.
One issue in particular that requires further discussion with stakeholders is the cross-reactivity between peanut and lupin, and the potential risk to peanut allergic consumers in Australia and New Zealand.
FSANZ has contacted a number of allergy specialists and scientists seeking their participation in a Scientific Advisory Group to discuss issues related to lupin allergy.

2.3.3 Conclusions

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  Food allergy is a global issue that affects consumers, food manufacturers, health providers and regulators.
  

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  The rigorous declaration requirements which apply to known presence of food allergens provide an effective risk management tool at the population level. These rigorous requirements are justified on the basis that such food allergens are of major public health significance.
  

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  New food allergens may emerge that need to be considered for inclusion in the list for mandatory declaration. While the lists of food allergens may vary between countries, there is a need for an internationally consistent approach. Information requirements have been developed to underpin an evaluation of the significance of new allergens in a consistent and transparent manner.
  

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  There is evidence that lupin is emerging as a food allergen in Australia. The significance of lupin allergy and cross reactivity with peanut needs to be evaluated by FSANZ.
  

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  As information available from the published literature on food allergy in Australia and New Zealand is limited, FSANZ will seek evidence and advice from allergy experts.
  

2.3.4 Recommendations

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  FSANZ to establish a Scientific Advisory Group on food allergy and intolerance for consultations on relevant matters.
  

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  FSANZ to develop a Proposal to consider whether an amendment to the Code to include lupin is justified.