P1026 Lupin as an Allergen cfs

1 Introduction

Some foods can cause allergic reactions in susceptible individuals. The most well-known food allergens (also known as “major” food allergens) include wheat, egg, milk, peanuts, tree nuts, fish, crustacea, sesame seeds and soybeans. As food options expand due to new foods and ingredients entering the food supply, the likelihood of new food allergens emerging increases.
Lupin is a legume and is related to peanut and soy, which have allergenic properties for some consumers. Lupin likewise has the potential to be an allergen, though in Australia and New Zealand lupin allergy is currently not as well-known or as prevalent as peanut or soy. This lower prevalence may be at least partly due to the current lower use of lupin-derived ingredients and consequential lower exposure, compared with peanut or soy. In Europe, where lupin is more widely used in food products, there has been mandatory allergen labelling for food products containing lupin since 2007.
The first cases of lupin food allergy in Australia were reported in the scientific literature in 2004 (Smith et al 2004). At the time of these reports Smith commenced a register of lupin-induced allergic food responses. The register (which is no longer active) recorded 14 cases of lupin allergy  10 cases in South Australia and four cases in the Australian Capital Territory. In addition to these 14 cases, there have also been reports of at least ten individuals in Western Australia being allergic to ingested lupin.
The use of lupin-derived ingredients (such as flour, grits and bran) has increased in food products produced in Australia, and the lupin industry sees strong potential in developing uses of various lupin products in food. Lupin flour and bran are used in a variety of products such as pasta and bread and other baked goods such as muffins,cakes and biscuits. Currently lupin-containing food products for human consumption are not widely available in New Zealand, nor is there a lupin primary industry in New Zealand directed at human food production. However, this may change over time as lupin products become more popular in Australia.
Historically, most of the Australian sweet lupin (Lupinus angustifolius) crop was used for animal feed or exported to overseas markets. As a result of the increased interest in using lupin-derived products as a human food source in Australia, it is expected that in addition to the Australian sweet lupin, other varieties of lupin will also be cultivated in Australia or imported to satisfy demand. White lupin (Lupinus albus) and yellow lupin (Lupinus luteus) are two other cultivated species widely used in food production in Europe.

1.1 The Proposal

FSANZ has prepared this Proposal to:
evaluate the population health significance of lupin as a new food allergen in Australia and New Zealand against international criteria for new allergens, including the potential for the cross-reactivity with other legume-based food allergens such as peanut and soy
develop appropriate risk management strategies to manage the identified risks, including consideration of a need for food regulatory measures in the Code.
The assessment has considered lupin in the form of lupin seeds (also known as kernels), which can be consumed whole (either raw or after preparation, such as in brine), plus all products derived from lupin seeds/kernels e.g. flour, meal, hulls, bran, lupin grits and oil. Lupin whenever it is present in a food as an ingredient, ingredient of a compound ingredient, food additive or processing aid (including when used as an ingredient or component of these) is also included as part of the consideration of the Proposal.
Throughout this assessment summary, the term “lupin and lupin-derived products” refers to any edible form of the lupin seed/kernel.

1.2 The current standards

1.2.1 Lupin and natural contaminants

The only permissions in the Code which are specific to lupin and lupin products are in Schedule 19 – Maximum levels of contaminants and natural toxins.
Section S19—5 sets maximum levels for phomopsins in lupin seeds and products of lupin seeds, whilst section S19—6 sets limits for the natural toxicant “Lupin alkaloids” in lupin flour, lupin kernel flour, lupin kernel meal and lupin hulls.
Neither of these requirements is affected by FSANZ’s proposed requirement for mandatory declaration of lupin and lupin-derived products in food.

1.2.2 Lupin and mandatory declaration of food allergens

Section 1.2.3–4 of Standard 1.2.3 – Information requirements – warning, advisory statements and declarations lists certain foods or substances which must be declared when present in a food. Lupin is not currently listed as a food allergen requiring declaration.
The following foods are allergens and currently listed in section 1.2.3—4 as requiring declaration (with some exceptions)¹:
wheat

crustacea

egg

fish

milk

peanuts

soybeans

tree nuts

sesame seeds
These foods, or products of these foods, must be declared when present as an ingredient, an ingredient of a compound ingredient, or as a food additive or processing aid (including when used as an ingredient or component of these).
In accordance with Standard 1.2.1 – Requirements to have labels or otherwise provide information) the declaration required by section 1.2.3—4 must be provided on the label on a package of the food, or where a food is not required to bear a label (e.g. when the food is unpackaged or is made and packaged on the premises), the declaration must be stated in labelling that is displayed in connection with the display of the food, or provided to the purchaser on request.

1.2.3 Ingredient labelling for lupin

The use of lupin as an ingredient in food is subject to the existing ingredient labelling requirements in Standard 1.2.4 – Information requirements – statement of ingredients. This Standard requires most packaged foods to declare each ingredient in a statement of ingredients using the common name of the ingredient, or a name that describes the true nature of the ingredient, or a generic name (listed in Schedule 10). However, foods that are not required to bear a label (e.g. unpackaged foods or foods that are made and packaged on the premises or is supplied in a restaurant or catering establishment) are not required to provide a statement of ingredients.
Currently Schedule 10 – Generic names of ingredients and conditions for their use permits the generic name “vegetable oil” to be used in the statement of ingredients with some conditions. This includes the condition to declare the specific source name if the oil is sourced from peanut, or sesame or some soybean oils, depending on processing (i.e. known food allergens). Lupin is not currently included in this condition. Therefore oil sourced from lupin can currently use the generic name “vegetable oil” in the statement of ingredients, rather than declare the specific source name i.e. “lupin”.

1.2.4 Regulation of lupin in food in other countries

1.2.4.1 Europe

In Europe (since 2007), where lupin and products thereof are present in food, it is mandatory to inform consumers of their presence due to their allergic potential. This requirement was implemented in Commission Directive 2006/142/EC² which required the addition of ‘Lupin and products thereof’ to be added to the lists of allergens in Annex IIIa of Directive 2000/13/EC³ requiring mandatory labelling.
Directive 2000/13/EC has since been repealed by Regulation (EU) No 1169/2011⁴. Annex II of Regulation (EU) No 1169/2011 is a list of substances or products causing allergies or intolerances, which includes lupin and products thereof. Paragraph (24) and Article 9(1)(c) of the EU regulation require information on any ingredient or processing aid listed in Annex II or derived from a substance or product listed in Annex II used in the manufacture or preparation of a food and still present in the finished product, even in an altered form, to be available to the consumer.

1.2.3.2 Other countries

FSANZ has not identified any specific regulatory standards in other countries regarding requirements to label lupin or lupin-derived products on food labels as mandatory allergens.

The United States Food and Drug Administration (USFDA) acknowledges⁵ that some people, including those allergic to peanuts, may have allergic reactions after eating lupin or foods containing ingredients from lupin. However, the Food and Allergen Labeling and Consumer Protection Act currently requires special allergen labelling for lupin or lupin-derived ingredients, as they are not classed as “major” food allergens⁶.
The USFDA labelling rules require ingredients to be declared by name in the ingredients list on the food label, unless they meet the exemption requirements due to being present in “incidental” amounts in a finished food. If an ingredient is present at an incidental amount and has no functional or technical effect in the finished product, then it need not be declared on the label.