P1026 Lupin as an Allergen cfs

2.2 Risk management

Taking into account the risk assessment conclusions, the focus of FSANZ’s risk management measures should be on managing the risk of allergic reactions occurring in susceptible individuals through potential consumption of food containing lupin or lupin-derived products.
Risk management measures are required for foods containing lupin and any substance derived from lupin because consumption of lupin-containing products may result in severe adverse health effects. Furthermore, the allergenicity risk of lupin can remain after processing.

2.2.1 Options

In order to manage the risk of consumption of lupin and lupin products, FSANZ considered the following non-regulatory and regulatory options during its assessment under section 59 of the FSANZ Act:
Option 1: Maintain the status quo. Consumers would rely on existing ingredient labelling requirements and voluntary labelling to inform them about the presence of lupin in food.
Option 2: Develop a Code of Practice for food manufacturing industries.
Option 3: Prepare a draft variation so that a mandatory allergen declaration would be required on the label, or, where a label is not required, businesses would have to provide access to information about the presence of lupin in food being sold.
As explained below, FSANZ’s assessment based on the information currently available was that option 3 would be most efficacious for managing the public health and safety risk. Notwithstanding this assessment and the preparation of a draft variation, stakeholders are encouraged to address the questions posed below in relation to each option. Responses will help inform FSANZ’s decision on whether to approve, vary or reject the draft variation.

2.2.2 Impact analysis

2.2.2.1 Option 1 – Maintain the status quo

Under the status quo, consumers would rely on existing ingredient labelling requirements and voluntary labelling to inform them about the presence of lupin in food.
Under this option, consumers with lupin sensitivity or allergies would not be able to ascertain in some circumstances whether the food they purchased contains lupin (e.g. if it was present in an unpackaged food, or being used as a food additive or processing aid). Accordingly, there is a continued risk of these people having an allergic reaction, which may in a proportion of cases, be a severe anaphylaxis reaction (and could result in death), to undeclared presence of lupin. Alternatively they may continue to incur significant search⁸ and avoidance costs as they attempt to ensure their food is allergen free.
FSANZ invites submissions from stakeholders on whether they see any merit in this risk management option. Information and advice on the costs of this option for government, industry and the community is also sought - see section 5.1, SD2.

2.2.2.2 Option 2 – Prepare a Code of Practice

A Code of Practice developed jointly by FSANZ and the food manufacturing industries could appropriately manage potential health and safety outcomes of lupin allergy in Australia and New Zealand. An industry Code of Practice would be voluntary with no legislation requiring relevant parties to comply with any recommendations.
The Food Industry Guide to Allergen Management and Labelling⁹ prepared by the Australian Food and Grocery Council (AFGC) provides guidance for industry in managing and labelling food allergens and could be used as a basis for a Code of Practice.
The Guide is relevant to all sectors of the food industry involved in the supply, handling, production, distribution and sale of foods. It provides recommendations for the production and labelling of foods containing allergenic substances as listed in the Code.
The Guide recommends a consistent approach in the presentation of allergen information to help allergic consumers more quickly and easily identify foods of concern, helping to minimise accidental consumption of unsuitable foods.
The risk of this approach is that its voluntary nature might mean that some food manufacturers may not participate, leading to confusion and higher level of risk for consumers since some foods would be labelled while others would not. Bakeries and other suppliers of unpackaged foods are not necessarily covered by or familiar with the AFGC guide – which mainly applies to packaged food. Similarly food importers may not know about or follow the AFGC guide.
Stakeholder views are sought on the merit of this approach - see section 5.2, SD2.

2.2.2.3 Option 3 – Prepare a draft variation

This option involves the preparation of a draft variation, with a 12-month transition period, to include lupin and lupin products in section 1.2.3—4 so that mandatory allergen declaration requirements apply; and to include lupin in Schedule 10 so that the specific source name of lupin oil is required. This would mean that for foods that require a label, where lupin is used in food as an ingredient (or an ingredient of a compound ingredient), an additive or as a processing aid (or an ingredient or component of these), the label would have to declare the presence of lupin. Where a label is not required (e.g. where the food is unpackaged or is made and packaged on the premises such as a bakery), consumers would have access to information about the presence of lupin either in connection with the display of the food or provided to them on request.
The benefit of this option is that individuals at risk are better able to avoid lupin and therefore avoid adverse health conditions associated with its consumption. It would help to minimise search and avoidance costs. This option would also be of potential value to people who have other food-based allergies, particularly peanut and soy allergies due to the potential for cross-reactions between these allergens.
FSANZ is not aware of any packaged or unpackaged lupin food product that does not declare the use of lupin. Therefore lupin products appear to be already consistent with the proposed change to the Code as the Code does not specify where and how the mandatory food allergens must be declared on the label. This means there will most likely be no regulatory cost for any food manufacturers presently using lupin.
The current food allergen management framework has been supported and accepted by government and industry. Adding an additional allergen to the existing allergen management framework would only impose a marginal cost of updating an existing framework.
Many Australian and New Zealand food manufacturing companies already require their ingredient suppliers to complete a Product Information Form (PIF) for each ingredient or substance added to food so companies can make risk management decisions to meet their regulatory obligations relating to the Code requirements, which include mandatory allergen declarations.
Including lupin in the list of mandatory allergens is expected to improve awareness of lupin allergy and provide information for allergic individuals who currently may not be able to verify whether lupin is present in foods. As such it should reduce the number of adverse health conditions associated with consuming lupin and lupin products and reduce search and avoidance costs.
Stakeholder views are sought on the merits of this approach. Information and advice on the costs of this option for government, industry and the community is also sought - see section 5.3 of SD2.

2.2.2.4 Proposed risk management option

The FSANZ assessment concludes that based on the information currently available, Option 3, a regulatory approach (amending the Code to require mandatory allergen declarations for lupin and lupin products), is likely to have the greatest net benefit and is therefore the current preferred option.
Other measures are unlikely to be as effective in managing the risk to public health and safety from consuming lupin and lupin products because they rely on voluntary actions, which may not be applied uniformly. For susceptible individuals, consuming lupin containing food represents a significant potential harm (possible death). Taking account of the potential severity of this risk and the potential growth in lupin containing food, a voluntary action is not a commensurate risk management measure.
The determination that the regulatory option is likely to have the greatest net benefit is based on qualitative analysis due to difficulty obtaining quantitative information from industry. Based on the current information FSANZ has to date, the potential costs of the proposed measure will not exceed the value of the anticipated direct and indirect benefits to the public. The consultation Regulation Impact Statement (RIS) in SD2 provides more details on the cost/benefit of each option.
In summary, FSANZ prepared variations to section 1.2.3—4 to apply mandatory allergen declaration requirements and to section S10—2 to specify the source name of lupin oil for generic name ingredient labelling conditions, because:
it lowers the risk of future allergic reactions or developing allergic reactions, in susceptible people, from potentially consuming lupin and lupin products and supports the primary objective of protecting public health and safety
adding an additional allergen to the existing allergen management framework would be expected to only impose a marginal cost, associated with updating the existing framework. The implementation cost of Option 3 would not be expected to be any higher than the costs involved with implementation of an industry Code of Practice.
Option 3 would provide more certainty for those consumers wishing to avoid foods containing lupin.
The proposed variation also provides for a 12-month transitional period. FSANZ considers this appropriate as it balances the risk of a serious health outcome versus the resources needed by industry to comply with the requirement. The current use of lupins in food in Australia and New Zealand is minor; information available to FSANZ suggests affected products already indicate the presence of lupin (either as a consequence of current Code labelling requirements or voluntary labelling). FSANZ is therefore proposing to vary section 1.2.3—4 so that mandatory allergen declaration requirements apply to lupin and lupin products.
The proposed mandatory requirements will require lupin to be declared when it is present in both packaged and unpackaged food as:
an ingredient or as an ingredient of a compound ingredient

a processing aid or as ingredient or component of a processing aid

a food additive or as an ingredient or component of a food additive.
The proposed change to section S10—2 will require the specific source name of lupin oil to be declared for the generic name ingredient labelling conditions.