P1026 Lupin as an Allergen cfs

2.4 FSANZ Act assessment requirements

When assessing this Proposal and the subsequent development of a food regulatory measure, FSANZ had regard to the following matters in section 59 of the FSANZ Act:

2.4.1 Section 59

2.4.1.1 Cost benefit analysis

Paragraph 59(2) of the FSANZ Act requires FSANZ to have regard to whether the costs arising from a food regulatory measure developed for this Proposal would outweigh the direct and indirect benefits to the community, government or industry that arise from the measure.
A consultation RIS accompanies this call for submissions and assessment summary (SD2). It provides a qualitative cost benefit analysis using the information that was available to FSANZ for its assessment and its decision to prepare the draft variation. Additional information from this call for submissions may enable FSANZ to undertake a more quantitative-based impact analysis of the options for the Decision RIS. This depends, however, on the quality of data/information received from affected parties. The information/data received may result in FSANZ arriving at a different outcome.
The consultation RIS for this Proposal was approved by the Office of Best Practice Regulation (OBPR) in May 2016.
For further information and specific questions on which FSANZ is seeking comment, refer to section 5, SD2.

2.4.1.2 Other measures

For reasons described in section 2.2.3 of this document, FSANZ’s assessment based on the information currently available is that no other measures would be more cost-effective than the proposed draft variation.

2.4.1.3 Any relevant New Zealand standards

There are no relevant New Zealand Standards. The proposed draft variation will amend Standards that apply in both Australia and New Zealand.

2.4.1.4 Any other relevant matters

Although FSANZ is not aware of any confirmed cases of lupin allergy in New Zealand, the proposed draft variation will apply in New Zealand. As lupin food products become more popular in Australia, it is likely that the products will also increase in popularity in New Zealand. This in turn will lead to greater risk of susceptible individuals developing lupin allergy.
In addition, applying the draft variation to both Australia and New Zealand maintains trans-Tasman consistency in food allergen regulation.

2.4.2. Subsection 18(1)

FSANZ has also considered the three objectives in subsection 18(1) of the FSANZ Act during the assessment.

2.4.2.1 Protection of public health and safety

Protection of public health and safety is FSANZ’s most important objective in standards development.
In regard to lupin and lupin products in food, FSANZ has concluded that the mandatory declaration requirements according to section 1.2.3—4, and the proposed requirement to specify the source name of lupin oil in Schedule 10, would support the primary objective of protecting public health and safety. These measures are expected to lower the risk of future lupin allergen based reactions (including possible cross-reactions in people allergic to other food allergens, such as peanuts or soy), in Australia and New Zealand.

2.4.2.2 The provision of adequate information relating to food to enable consumers to make informed choices

The mandatory declaration requirements would ensure that consumers have access to information about the presence of lupin in both packaged and unpackaged foods. People who are allergic to lupin will therefore be able to identify more reliably the presence of lupin in a food and could make a choice to avoid the food product. In addition, for those people who are allergic to other legumes, e.g. peanut and soy, and are aware of the potential for cross-reactivity with lupin, the declaration of lupin will help them to make informed choices.

2.4.2.3 The prevention of misleading or deceptive conduct

The requirement to declare the presence of lupin in food does not raise any issues in relation to this objective.

2.4.3 Subsection 18(2) considerations

FSANZ has also had regard to:
the need for standards to be based on risk analysis using the best available scientific evidence
FSANZ has assessed and characterised the risk of allergy from consumption of lupin in food, (see SD1 and 2). The risk assessments were based on the best scientific evidence available to FSANZ. They considered all available information (national and international), including prevalence and cross-reactivity with other known food allergens.
the promotion of consistency between domestic and international food standards
The proposed variation to require mandatory declaration of the presence of lupin in food is consistent with EU legislation. Similar legislation for lupin as a food allergen does not currently exist in other jurisdictions, however many countries do have required mandatory labelling for the presence of the eight main food allergens, which is consistent with the Code. The lack of requirement for labelling of lupin as a food allergen in a particular country is likely to be due to a variety of reasons, which may include, the prevalence of food containing lupin in the country, the genetic disposition of the population and the country’s approach to food risk.
The requirement for mandatory allergen declaration for lupin in the Code in Australia and New Zealand will be consistent with food standards in Europe, but different to other countries such as Canada and the USA. However FSANZ considers taking the proposed approach to this issue is justified on the grounds of public health and safety, particularly considering that is specific parts of Australia e.g. WA, there is an industry focused on lupin production for human food use.
the desirability of an efficient and internationally competitive food industry
Progression of this Proposal will create a ‘level playing field’ between Australasia and Europe as Europe already requires the declaration of lupin in food, due to its allergenicity potential. Progression of this Proposal will be inconsistent with other Australia and New Zealand trading partners and will be an additional burden on them if they import lupin containing food into Australia or New Zealand. However this is justified on the grounds of public health and safety and the expectation that the major source of lupin containing foods would be from the highly developed production of lupin in Europe, rather than other parts of the world.
the promotion of fair trading in food
No fair trading issues have been identified for the purposes of this Proposal.
any written policy guidelines formulated by the Forum on Food Regulation
There are no relevant policy guidelines for this Proposal.