P1026 Lupin as an Allergen cfs

16 June 2016

[15–16]
Call for submissions – Proposal P1026
Lupin as an Allergen

FSANZ has assessed a proposal prepared to assess the risk management options to regulate food containing lupin as an allergen and has prepared a draft food regulatory measure. Pursuant to section 61 of the Food Standards Australia New Zealand Act 1991 (FSANZ Act), FSANZ now calls for submissions to assist consideration of the draft food regulatory measure.

For information about making a submission, visit the FSANZ website at information for submitters.
All submissions on applications and proposals will be published on our website. We will not publish material that is provided in-confidence, but will record that such information is held. In-confidence submissions may be subject to release under the provisions of the Freedom of Information Act 1991. Submissions will be published as soon as possible after the end of the public comment period. Where large numbers of documents are involved, FSANZ will make these available on CD, rather than on the website.
Under section 114 of the FSANZ Act, some information provided to FSANZ cannot be disclosed. More information about the disclosure of confidential commercial information is available on the FSANZ website at information for submitters.
Submissions should be made in writing; be marked clearly with the word ‘Submission’ and quote the correct project number and name. While FSANZ accepts submissions in hard copy to our offices, it is more convenient and quicker to receive submissions electronically through the FSANZ website via the link on documents for public comment. You can also email your submission directly to [e-mail].
There is no need to send a hard copy of your submission if you have submitted it by email or via the FSANZ website. FSANZ endeavours to formally acknowledge receipt of submissions within 3 business days.
DEADLINE FOR SUBMISSIONS: 6pm (Canberra time) 28 July 2016
Submissions received after this date will not be considered unless an extension had been given before the closing date. Extensions will only be granted due to extraordinary circumstances during the submission period. Any agreed extension will be notified on the FSANZ website and will apply to all submitters.
Questions about making submissions or the application process can be sent to [e-mail].
Hard copy submissions may be sent to one of the following addresses:
Food Standards Australia New Zealand Food Standards Australia New Zealand

PO Box 5423 PO Box 10559

KINGSTON ACT 2604 The Terrace WELLINGTON 6143

AUSTRALIA NEW ZEALAND

Tel [phone] Tel [phone]
Table of Contents

Executive summary 4

1 Introduction 5

1.1 The Proposal 5

1.2 The current standards 6

1.2.1 Lupin and natural contaminants 6

1.2.2 Lupin and mandatory declaration of food allergens 6

1.2.3 Ingredient labelling for lupin 6

1.2.4 Regulation of lupin in food in other countries 7

1.3 Reasons for preparing the Proposal 8

1.4 Procedure for assessment 8

2 Summary of the assessment 8

2.1 Risk assessment 8

2.1.1 Current regulatory requirements and residual risk 10

2.2 Risk management 10

2.2.1 Options 11

2.2.2 Impact analysis 11

2.4 FSANZ Act assessment requirements 14

2.4.1 Section 59 14

2.4.2. Subsection 18(1) 15

2.4.3 Subsection 18(2) considerations 15

2.5 Risk communication 16

2.5.1 Consultation 16

2.5.2 World Trade Organization (WTO) 17

3 Draft variation 17

3.1 Transitional arrangements 17

4 References 18

Attachment A – Draft variation to the Australia New Zealand Food Standards Code 19

Attachment B – Draft Explanatory Statement 22

Supporting documents
The following documents which informed the assessment of this Proposal are available on the FSANZ website at

http://www.foodstandards.govt.nz/code/proposals/Pages/proposalp1026lupinas5830.aspx

SD1 Risk Assessment

SD2 Consultation Regulation Impact Statement

Executive summary

Some foods can cause allergic reactions in susceptible individuals. As our choice of food options expands due to new foods and ingredients entering the food supply, there is an increased likelihood that new food allergens will emerge.
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) requested FSANZ to review the regulatory management of food allergens. In December 2010, FSANZ released the report of this review, Review of Regulatory Management of Food Allergens (FSANZ, 2010). In relation to lupin, the report recommended FSANZ should develop a proposal to assess whether lupin and lupin-derived products should be included in the list of allergens requiring mandatory declaration in the Australia New Zealand Food Standards Code (the Code).
Lupin is a legume and is related to other legumes, 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, it is currently not as well-known or as prevalent an allergen as peanut or soy. This lower prevalence may be at least partly due to the current lower use of lupin-derived ingredients, 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 reports of lupin food allergy cases in Australia appeared in the scientific literature in 2004. At that time, a register of lupin-induced allergic food responses was introduced. Fourteen cases of lupin food allergy were recorded whilst the register was active; in addition there have been reports of at least another ten individuals in 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 over the last few years, and the lupin industry sees strong potential in the development of uses of various lupin products in food. Lupin flour and bran are used in a variety of baked goods such as bread, muffins and cakes and pasta products. Information received by FSANZ indicates lupin-containing food products for human consumption are not widely available in New Zealand. The lower potential exposure to lupin from food in New Zealand compared with Australia is considered by FSANZ to be a major factor in the lack of reported lupin allergy cases in New Zealand. However, this may change over time as lupin products gain popularity in Australia and information on the potential health benefits spreads. The lupin market is more highly developed in other parts of the world, in particular various countries in Europe, where lupin has a long history in food products.
In order to manage the risk of allergy from consumption of lupin or lupin-derived products, FSANZ has prepared a draft variation to the Code which will require lupin to be declared whenever present in a food in the form of: an ingredient, an ingredient of a compound ingredient, a food additive or processing aid (including when used as an ingredient or component of these). FSANZ is also proposing a consequential amendment which will require oil derived from lupin to be named “lupin oil”, rather than use the generic term “vegetable oil”.