P1026 Lupin as an Allergen cfs

2.5 Risk communication

2.5.1 Consultation

Targeted stakeholder consultation has already been undertaken to obtain information on the likely costs and benefits if lupin is regulated as a new food allergen that requires mandatory declaration.
In September 2013, a targeted consultation was conducted seeking data and/or information on the likely costs (and any possible benefits) if lupin was regulated as a food allergen with subsequent mandatory declaration requirements consistent with current allergens. Identified businesses were approached via email.
FSANZ was also able to link into a survey that the AFGC conducted on their PIFs. The AFGC PIF survey included some questions about lupin and FSANZ was able to follow up with companies who provided relevant responses. FSANZ received 10 responses.
In December 2014, FSANZ staff visited an ingredient manufacturer in NSW and four primary producers of lupin and lupin-derived products in WA to gain information on the supply chain and current practices.
The process by which FSANZ considers standards matters is open, accountable, consultative and transparent. Public submissions are called to obtain the views of interested parties on draft variations to the Code. In particular FSANZ is seeking further information and feedback from industry, consumers and other stakeholders on the proposed regulatory measure for managing the allergen risks associated with lupin in food, including the impacts and costs outlined in the impact analysis in the consultation RIS at SD2. Comments are specifically requested from the lupin industry and allergy susceptible individuals or organisations/groups representing such individuals. Additional information in response to this call for submissions may enable FSANZ to conduct a more quantitative analysis for the Decision RIS, depending on the quality of data/information received from affected parties. This could potentially result in FSANZ arriving at a different preferred option.
All public comments received are reviewed and considered before approval of a variation to the Code by the FSANZ Board. All comments are valued and contribute to the rigour of our assessment.
A communication strategy has been developed for this Proposal, which includes one six-week public consultation period. All calls for submissions are notified via the FSANZ Notification Circular, media release and through FSANZ’s social media tools and Food Standards News. Subscribers and interested parties are also notified via email about the availability of reports from public comment. Individuals and organisations making submissions on this Proposal will be notified at each stage of the assessment.
All submissions (unless an adequate reason is provided) will be published on the FSANZ website as soon as possible after the public consultation period has closed.

2.5.2 World Trade Organization (WTO)

As members of the World Trade Organization (WTO), Australia and New Zealand are obliged to notify WTO members where proposed mandatory regulatory measures are inconsistent with any existing or imminent international standards and the proposed measure may have a significant effect on trade.
With the exception of regulatory requirements in the European Union, there are no relevant international standards and amending the Code to require mandatory declaration of food containing lupin and lupin products as food allergens may have a significant effect on international trade due to new labelling requirements. Therefore, a notification to the WTO under Australia’s and New Zealand’s obligations under the WTO Technical Barriers to Trade Agreement has been made to enable other WTO members to comment on the proposed amendments.

3 Draft variation

The draft variation to the Code and related draft explanatory statement are at Attachment A.
A draft explanatory statement is at Attachment B. An explanatory statement is required to accompany an instrument if it is lodged on the Federal Register of Legislation.

3.1 Transitional arrangements

The draft variations to sections 1.2.3—4 and S10—2, if approved, will commence on the date of gazettal and will have a 12-month transitional period from commencement of the variation. On expiration of the transitional period all products affected by this variation, including stock-in-trade items, must comply with the variation. FSANZ considers a 12-month transitional period is an appropriate time period which balances the risk of a serious health outcome versus the resources needed by industry to comply with the requirement and taking account of labelling costs. The current use of lupins in food in Australia and New Zealand is minor, with, at least some, products already indicating the presence of lupin (either as a consequence of current Code labelling requirements or voluntary labelling).

4 References

Bjőrkstén B, Crevel R, Hischenhuber C, Løvik M, Samuels F, Strobel S, Taylor SL, Wal JM, Ward R (2008) Criteria for identifying allergenic foods of public health importance. Regul Toxicol Pharmacol.; 51:42-52.

FSANZ (2010), Review of the Regulatory Management of Food Allergens. http://www.foodstandards.govt.nz/consumer/foodallergies/review/Documents/Review%20of%20the%20Regulatory%20Management%20of%20Food%20Allergens-FSANZ%20Dec%202010.doc. Accessed 3^rd March 2016.

Goggin DE., Cameron EC, Mir G, Stuckey MS, Smith W and Smith PMC (2008)

Proteomic analysis of lupin seed proteins to identify conglutin β as an allergen Lup an 1. J Agric Food Chem.; 56: 6370-6377.

Lawrence F. Feick, Robert O. Herrmann, and Rex H. Warland (1983) ,"Search For Nutrition Information: Synthesis and Empirical Test", in NA - Advances in Consumer Research Volume 10, eds. Richard P. Bagozzi and Alice M. Tybout, Ann Abor, MI : Association for Consumer Research, Pages: 624-629.

Smith W B, Gillis D and Kette FE (2004) Lessons from Practice: Lupin: a new hidden food allergen. Med J of Australia 181 (4):219–220.

van Bilsen JH, Ronsmans S, Crevel RW, Rona RJ, Przyrembel H, Penninks AH, Contor L, Houben GF (2011). Evaluation of scientific criteria for identifying allergenic foods of public health importance. Regul Toxicol Pharmacol.; 60(3):281-289.

WHO (2000). Technical Report Series-896. Report of an ad hoc panel on food allergens. 53rd Report of JECFA, Annex 4:124-128.

Attachments
A. Draft variation to the Australia New Zealand Food Standards Code

B. Draft Explanatory Statement

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

Food Standards (Proposal P1026 – Lupin as an Allergen) Variation

The Board of Food Standards Australia New Zealand gives notice of the making of this variation under section 92 of the Food Standards Australia New Zealand Act 1991. The variation commences on the date specified in clause 3 of this variation.

Dated [To be completed by Standards Management Officer]
Standards Management Officer

Delegate of the Board of Food Standards Australia New Zealand

Note: 
This variation will be published in the Commonwealth of Australia Gazette No. FSC XX on XX Month 20XX. This means that this date is the gazettal date for the purposes of clause 3 of the variation.

1 Name

This instrument is the Food Standards (Proposal P1026 – Lupin as an Allergen) Variation.

2 Variation to standards in the Australia New Zealand Food Standards Code

The Schedule varies Standards in the Australia New Zealand Food Standards Code.

3 Commencement

The variation commences on the date of gazettal.

Schedule

[1] Standard 1.2.3 is varied by

[1.1] inserting after section 1.2.3—1

1.2.3—1A Transitional arrangements for prescribed variations

(1) For the purposes of this clause:

prescribed variation means the amendment made by the Variation to paragraph 1.2.3—4(1)(b).

transitional period means the period commencing on the Variation’s date of commencement and ending 12 months after the commencement.

the Variation means the Food Standards (Proposal P1026 – Lupin as an Allergen) Variation.

(2) Section 1.1.1—9 of Standard 1.1.1 does not apply to the prescribed variation.

(3) During the transition period, a food product may comply with either:

(a) the Code as in force without the prescribed variation; or

(b) the Code as amended by the prescribed variation;

but not a combination of both.

[1.2] omitting from paragraph 1.2.3—4(1)(b)

(ix) tree nuts, other than coconut from the fruit of the palm Cocos nucifera.”

substituting

(ix) tree nuts, other than coconut from the fruit of the palm Cocos nucifera;

(x) lupin.

[2] Schedule 10 is varied by

[2.1] omitting “1.2.4—4(b)(i)” from Note 1, substituting “1.2.4—4(b)(iii)”

[2.2] inserting after section S10—1

S10—1A Transitional arrangements for prescribed variations

(1) For the purposes of this section –

prescribed variation means the amendment made by the Variation to paragraph (a) under the entry for “fats or oils” in the table to section S10—2.

transitional period means the period commencing on the Variation’s date of commencement and ending 12 months after the commencement.

the Variation means the Food Standards (Proposal P1026 – Lupin as an Allergen) Variation.

(2) Section 1.1.1—9 of Standard 1.1.1 does not apply to the prescribed variation.

(3) During the transition period, a food product may comply with either –

(a) the Code as in force without the prescribed variation; or

(b) the Code as amended by the prescribed variation;

but not a combination of both.

[2.3] omitting from paragraph (a) under the entry for “fats or oils” in the table to section S10—2

“(ii) if the source of oil is peanut or sesame—the specific source name; and”

substituting

“(ii) if the source of oil is lupin, peanut or sesame—the specific source name; and”

Attachment B – Draft Explanatory Statement

1. Authority
Section 13 of the Food Standards Australia New Zealand Act 1991 (the FSANZ Act) provides that the functions of Food Standards Australia New Zealand (the Authority) include the development of standards and variations of standards for inclusion in the Australia New Zealand Food Standards Code (the Code).
Division 2 of Part 3 of the FSANZ Act specifies that the Authority may prepare a proposal for the development or variation of food regulatory measures, including standards. This Division also stipulates the procedure for considering a proposal for the development or variation of food regulatory measures.
FSANZ prepared Proposal P1026 to consider risk management options to mitigate the risk of allergic reactions in sensitive individuals to food containing lupin or lupin products. The Authority considered the Proposal in accordance with Division 2 of Part 3 and has approved a draft variation to Standard 1.2.3 and Schedule 10.
2. Purpose
The Authority has prepared a draft variation to amend Standard 1.2.3 and Schedule 10 to require declarations relating to the presence of lupin and/or lupin products in food; and declarations of the source name of any oil where the source of that oil is lupin. The purpose of the amendments is to mitigate the risk of allergic reactions in sensitive individuals to food containing lupin or lupin products due to the risk to public health and safety of unidentified lupin in food.
The draft variation also deals with an editorial correction to Note 1 to Schedule 10.
3. Documents incorporated by reference
The variations to food regulatory measures do not incorporate any documents by reference.
4. Consultation
In accordance with the procedure in Division 2 of Part 3 of the FSANZ Act, the Authority’s consideration of Proposal P1026 will include one round of public consultation following an assessment and the preparation of a draft variation and associated assessment summary.
5. Statement of compatibility with human rights
This instrument is exempt from the requirements for a statement of compatibility with human rights as it is a non-disallowable instrument under section 94 of the FSANZ Act.
6. Variation
Item 1 amends Standard 1.2.3.
Subitem [1.1] inserts section 1.2.3—1A into Standard 1.2.3 to provide transitional arrangements in relation to the amendment made to paragraph 1.2.3—4(1)(b). The effect of section 1.2.3—1A is that the usual stock-in-trade provision in section 1.1.1—9 of Standard 1.1.1 will not apply to that amendment. Instead, there will be a 12 month transitional period commencing on the Variation’s date of commencement. During that transitional period, a food company will be able to comply with either:

• 
  the Code as in force without the amendment to paragraph 1.2.3—4(1)(b); or
  
• 
  the Code with the amendment to paragraph 1.2.3—4(1)(b),
  

but not a combination of both. When the transitional period expires, all products affected by the amendment to paragraph 1.2.3—4(1)(b), including stock-in-trade items, must comply with that amendment.

Subitem [1.2] inserts a new subparagraph into paragraph 1.2.3—4(1)(b) to include lupin in the list of foods or products of the foods, which if present in a food for sale, must have their presence declared.
The effect of this amendment is that any food for sale, which contains lupin or lupin products as an ingredient; an ingredient of a compound ingredient; a food additive or processing aid (or an ingredient or component of these), must have a declaration of the presence of lupin or lupin products on the label on a package of the food. Where the food is not required to bear a label (for example, when the food is unpackaged or is made and packed on the premises), the declaration of the presence of lupin or lupin products must be provided in connection with the display of the food or to the purchaser on request.
The declaration will be required regardless of the amount of lupin or lupin products present in the food for sale.
Item 2 amends Schedule 10.
Subitem [2.1] corrects an editorial error in Note 1 of Schedule 10 by replacing the reference to “1.2.4—4(b)(i)” with a reference to “1.2.4—4(b)(iii)”. This amendment commences on the date of gazettal of the Variation.
Subitem [2.2] inserts section S10—1A into Schedule 10 to provide transitional arrangements in relation to the amendment to section S10—2. The effect of section S10—1A is that the usual stock-in-trade provision in section 1.1.1—9 of Standard 1.1.1 will not apply to that amendment. Instead, there will be a 12 month transitional period commencing on the Variation’s date of commencement. During that transitional period, a food company will be able to comply with either:

• 
  the Code as in force without the amendment to section S10—2; or
  
• 
  the Code with the amendment to section S10—2,
  

but not a combination of both. When the transitional period expires, all products affected by the amendment to section S10—2, including stock-in-trade items, must comply with that amendment.

Subitem [2.3] amends the table to section S10—2 by including lupin in subparagraph (ii) in paragraph (a) under the entry for “fats or oils” in that table. The effect of this amendment is that if the source of an oil is lupin, the statement of ingredients (as required by Standard 1.2.4) must declare lupin as the source name of the oil.

1^ There are other foods and substances listed in Standard 1.2.3 that also require declaration but as these are not allergens they are not listed here

2^ Commission Directive 2006/142/EC, of 22 December 2006 amending Annex IIIa of Directive 2000/13/EC of the European Parliament and of the Council listing the ingredients which must under all circumstances appear on the labelling of foodstuffs

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:368:0110:0111:EN:PDF

3^ Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2000:109:0029:0042:EN:PDF

4^ Regulation (EU) No 1169/2011 of the European Parliament and the Council of 25 October 2011 on the provision of food information to consumershttp://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32011R1169&from=EN. Accessed 3 March 2016.

5^http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngredients/ucm410111.htm. Accessed 3 March 2016.

6^http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm064880.htm. Accessed 3 March 2016.

7^ Council of Australian Governments

8^ Costs of search are the opportunity cost of time while benefits are derived from the extent to which information has a monetary value and-a preventive health value, and the extent to which consumers regulate current diet. – Lawrence at al 1983

9^ http://allergenbureau.net/wp-content/uploads/2013/11/Allergen_Guide_2007.pdf. Accessed 3 March 2016