P1026 Lupin as an Allergen cfs

1.3 Reasons for preparing the Proposal

This Proposal was prepared to consider the risk management of potential health or safety issues arising from foods containing lupin as assessed as part of an internal FSANZ risk assessment on lupin as a food allergen (FSANZ, 2010).
In October 2006, the then Australia and New Zealand Food Regulation Ministerial Council (now known as the Australia and New Zealand Ministerial Forum on Food Regulation (Forum)) requested FSANZ to review the regulatory management of food allergens. In December 2010, FSANZ released the report of this review (FSANZ, 2010). One of the recommendations of the report was to develop a proposal to assess whether lupin and lupin-derived products should be included in the list of allergens requiring mandatory declaration in Standard 1.2.3 – Information requirements, warning statements, advisory statements and declarations in the Australia New Zealand Food Standards Code (the Code).
The 2010 FSANZ Report states that The purpose of the mandatory declaration list in the Code is to prioritise the regulatory management of food allergens. Therefore, the guiding principle is that inclusion on the list should be determined by the public health significance of the food allergen of concern. To help determine whether lupin and lupin-derived products should be included in Standard 1.2.3, the FSANZ report listed the data requirements to allow an evaluation of the population health significance of possible new allergens. This approach is consistent with international criteria and relevant scientific information; the risk assessment procedure undertaken as part of this proposal used these identified data requirements.

1.4 Procedure for assessment

The Proposal is being assessed under the General Procedure.

2 Summary of the assessment

2.1 Risk assessment

FSANZ’s risk assessment for lupin and lupin-derived products as a potential food allergen is at SD1. A summary of the risk assessment findings from SD1, prevalence data contained in the COAG⁷ Consultation Regulation Impact Statement (SD2) and risks arising from the current regulatory regime are provided below.
In Europe, lupin allergy is well documented in the medical literature including case reports of severe allergic reactions to lupin in a range of food products, and clinical studies using double blind placebo-controlled food challenges (DBPCFC). Lupin has been recognised as a significant allergen in the European Union food regulations since 2007. In other jurisdictions e.g. USA, it is recognised as a food allergen but not categorised as “significant/major”.
Cases of lupin allergy in Australia were first reported in the medical literature in 2004 (Smith, 2004). Severe allergic reactions, including anaphylaxis, to lupin and lupin-containing food products have been reported from South Australia, Western Australia and the Australian Capital Territory. A Lupin Anaphylaxis Register set-up by Dr W Smith at the Royal Adelaide Hospital in 2004 contains 14 well-documented cases of lupin-induced anaphylaxis in Australia (this register is no longer updated). In addition to these 14 cases, there have also been reports of at least ten individuals in Western Australia being allergic to ingested lupin (Goggin et al, 2008). FSANZ is not aware of any clinically confirmed incidences of lupin allergy in New Zealand.
Australia and New Zealand have among the highest prevalence of allergic disorders in the developed world. The true prevalence of various food allergies in the population is uncertain. However, prevalence estimates reported in the medical literature for peanut allergy range between 0.71.4% of the population in Australia and New Zealand. In view of the known immunological cross-reactivity between peanut and lupin antigens the number of people ‘at risk’ may be estimated from the prevalence of peanut allergies in Australia and New Zealand. If we assume 1.1% (the mid-point of the reported range estimates) of the population then that would equate to around 250,000 individuals in Australia and around 50,000 in New Zealand who are peanut allergic and therefore may cross-react to lupin. This estimate does not take into account other individuals who are allergic to lupin-specific proteins i.e. their immune system may not cross-react to peanut-specific protein or where allergy to lupin is associated with cross-reactivity with other legumes, for example soy.
The rate of lupin sensitisation will be higher than that of lupin allergy, as sensitisation precedes allergy. As a result of the potential progression from sensitisation and to allergy, sensitisation can be used as a risk marker for allergy (although not all sensitised individuals will progress to an allergic state).
The international criteria (original criteria WHO 2000, and revised criteria Bjőrkstén et al., 2008 and van Bilsen et al., 2011) for evaluating whether a substance is a food allergen of public health significance use a weight-of-evidence type-approach, taking account of:

the existence of credible cause and effect relationships

reports of severe systemic reactions after exposure

data on prevalence

confirmation that an IgE-meditated reaction is involved

potency of allergen in comparison with other known food allergens

impact of processing on potency

cross-reactivity with other known allergens.

These criteria have been used to evaluate the significance of lupin allergy in Australia and New Zealand (see SD1 for further information). The outcome of this assessment is that in Australia, lupin and lupin products represent a significant new allergen that presents a risk to allergic consumers.
Although the presence of lupin in food is currently limited, in both Australia and New Zealand, it is likely to increase in the next few years. As a consequence, there will be higher dietary exposure to lupin in Australasia, which could result in a greater number of susceptible individuals exhibiting allergy to lupin.
In summary: The FSANZ lupin risk assessment concluded that lupin satisfied the criteria to be classed as a significant new food allergen and in Australia should be classed as an emerging food allergen of public health significance. Due to the expected increase in the use of lupin in food in the near future in Australia, which in turn leads to a potential increase in risk, it was also concluded an assessment of risk management options was needed. For New Zealand, based on the current low use and/or market for lupin in food and the consequential lack of, or very low, dietary exposure, lupin in food was not concluded to be of public health significance at the time of the FSANZ risk assessment.
FSANZ also has access to external allergy clinicians through the FSANZ Food Allergy and Intolerance Scientific Advisory Group (FAISAG) who are called on to provide expert advice on relevant allergy matters as needed. The conclusions of the FSANZ lupin risk assessment were supported by the FAISAG.

2.1.1 Current regulatory requirements and residual risk

Currently (as far as FSANZ is aware) all packaged labelled products in Australia and New Zealand containing lupin or lupin products declare the use of lupin as an ingredient on the label. When foods are not required to bear a label (e.g. unpackaged foods, or foods that are made and packaged on the premises such as bakery items), FSANZ is aware of situations where the use of lupin as an ingredient is still declared to consumers. However, as this is voluntary, there may also be cases, including in the case of imported food, where lupin is used but not declared.
As lupin is not currently listed in section 1.2.3—4 as a food allergen requiring mandatory declaration (see section 1.2.2 above), the growing use of lupin and lupin products in food together with new and alternative uses, means that there is a risk that the presence of lupin in packaged food may not be declared to consumers. This could lead to an increased risk for susceptible individuals, since some packaged foods would declare lupin on the label and others may not.
Further examples of potential uses of lupin in food products in Australia and New Zealand which could lead to instances where the presence of lupin is not declared on the label of packaged food are listed below:
The use of lupin as a processing aid. Processing aids are exempt from ingredient labelling (section 1.2.4—3)

Food additives derived from lupin, such as lecithin. The food additive name or number (e.g. ‘lecithin’ or ‘322’) would be required to be declared but not the lupin source (section 1.2.4—7)

The use of lupin as an ingredient of a compound ingredient would not be required to be declared if the compound ingredient makes up less than 5% of the final food and the lupin does not perform a technological purpose (section 1.2.4—5).