Review of the regulatory management of food allergens

FOOD STANDARDS

AUSTRALIA NEW ZEALAND


Review of the regulatory management

of food allergens

December 2010

{THIS PAGE IS INTENTIONALLY LEFT BLANK}

Executive Summary

Food allergy is an important health issue due to the potential for severe and life threatening reactions. Rigorous declaration requirements are considered the most appropriate risk management option for food allergens since even small amounts of the allergen may trigger allergic reactions. Australia and New Zealand were among the first countries to recognise the need to regulate food allergens with the introduction, in 2002, of mandatory declaration requirements in the Australia and New Zealand Food Standards Code.
In October 2006, the Australia and New Zealand Food Regulation Ministerial Council requested FSANZ to review the regulatory management of food allergens. The overall aim of the review is to determine whether, in the context of current scientific knowledge, improvements can be made to the existing regulatory approach which allows consumer choice but does not compromise the safety of allergic consumers.
A key task for the review was to identify specific areas of allergen regulation that could benefit from emerging scientific evidence. Six issues were outlined in a consultation paper, released by FSANZ in March 2008, targeting major stakeholders in Australia and New Zealand including allergy support groups, the food industry, allergy clinicians and the jurisdictions.
In reviewing these issues, FSANZ considered information from a variety of sources including allergic consumers, the food industry, the scientific and medical literature and expert opinion, as well as international regulations. Although our understanding of food allergy has improved significantly in the past decade, a number of scientific questions are yet to be resolved.

The review identified information gaps which need to be addressed in order to strengthen the evidence base.

The review also provided an opportunity to consider the current requirements in light of industry initiatives to improve allergen control practices in the food production and processing environment.
This report presents the findings and conclusions of the review, and makes recommendations. One key recommendation, which has already been implemented by FSANZ, is the establishment of a Scientific Advisory Group to facilitate the integration of emerging clinical evidence into regulatory and non-regulatory approaches to food allergens.
A summary of the review findings and recommendations is presented below:

Issues	Main conclusions	Recommendations
New food allergens	New food allergens may emerge that need to be considered for inclusion in the list for mandatory declaration. While the lists of food allergens may vary between countries, there is a need for an internationally consistent approach.	In consultation with the Food Allergy and Intolerance Scientific Advisory Group, FSANZ to develop a Proposal to amend Standard 1.2.3 to include lupin in the list of allergenic substances.
Label information	The use of clear terminology and easily understood names for ingredients present in food assists allergic consumers in recognising products they need to avoid. In general, regulatory requirements and additional voluntary declarations provide adequate information to allergic consumers to assist them in identifying ingredients of concern. Precautionary labelling is recognised internationally as a difficult area to regulate. The science needed to answer relevant questions and to underpin decisions, such as allergen thresholds and the reliability of detection methods, is not available or is incomplete. Research is continuing to improve the evidence base and to establish robust risk assessment methodologies in this area.	FSANZ to continue working with industry to support a voluntary system to improve allergen declaration generally, and to minimise the use of precautionary labelling through management of allergen cross contact. In collaboration with the food industry, FSANZ to put in place a label monitoring program specifically designed to track improvements in allergen labelling practices with a particular focus on ‘source’ and precautionary labelling. The data gained would allow FSANZ to track the effectiveness of voluntary practices and would assist the industry in achieving its goal to provide accurate and useful information to allergic consumers.
Food exempt from bearing a label	Many of the allergic reactions that occur in the population are attributed to unlabelled food eaten outside the home, such as in restaurants and cafes. There are several groups involved in providing resources or implementing new initiatives to enhance the knowledge of the staff in the food service sector in relation to allergens. Overall there is an indication of the need for more effective means of communicating regulatory obligations. There is also a need to establish further education and training for staff at all levels in this sector. It is FSANZ’s view that the current regulatory measures are adequate to manage the food allergy risks from foods exempt from bearing a label. However, there is a need for establishing more effective means of communicating these regulatory obligations and implementing initiatives to enhance the allergen management knowledge of workers in the food service sector.	With respect to allergen declarations in the food service sector, it is recommended that the Implementation Sub- Committee is asked to consider the communication of regulatory obligations to food businesses and to provide access to educational initiatives, with FSANZ’s assistance as required.
Labelling requirements for the current list of allergenic foods	Tree nuts: In line with the European and Canadian approach, a list identifying those tree nuts that are most relevant to food allergy in Australia and New Zealand will improve the clarity of the mandatory requirements. Fish: Molluscs and crustaceans are allergenically distinct from finfish. Therefore, the terms ‘fish’ and ‘seafood’ as defined in the Code, are not useful in the context of allergy to finfish, crustaceans and molluscs. Terms that allow consumers to identify the specific group would be more compatible with the intent and purpose of allergen declaration requirements. Cereals containing gluten: Gluten triggers coeliac disease and also appears to be a major source of allergens in wheat food allergy. It is now widely accepted that small amounts of gluten (around a daily intake of 10–20 mg) are tolerated by the majority of coeliac patients. It has also been suggested that most wheat allergic individuals can tolerate similar amounts of wheat protein.	FSANZ to consult with the Food Allergy and Intolerance Scientific Advisory Group on the development of a list of the tree nuts that are considered important allergens. FSANZ to consider this issue further in consultation with the relevant stakeholders in Australia and New Zealand. In particular, information from the food industry and food service sector in relation to current practices and commonly used terms, would assist in developing options to improve the clarity of the mandatory declaration requirements. FSANZ to consult with the Food Allergy and Intolerance Scientific Advisory Group on the current state of knowledge in relation to the wheat allergy, including cross-reactivity with other cereals, and if necessary, develop options to improve the clarity of the declaration requirements in relation to coeliac and wheat allergic patients.
Exemption of ingredients derived from allergenic foods	Food processing can alter the allergenicity of food. Processes that physically or chemically separate food constituents can result in undetectable, or only residual, levels of protein in the processed products. However, reliable and easy to use protein detection methodologies are generally required to ensure process specifications are consistently achieved. Consideration of clinically relevant data is also required to determine the safety of food products derived from allergenic sources.	FSANZ to consider, on a case-by-case basis, the scientific and clinical data available on the allergenicity of food ingredients derived from allergenic sources. In consultation with the food industry, FSANZ to develop options to reflect the evidence base through guidance and/or regulatory amendments.
Allergen thresholds (level that triggers an allergic reaction)	Significant advances have been made in the area of thresholds in the last decade including improved methodologies for gathering and analysing clinical data. Emerging evidence indicates that statistical modelling approaches can be used to establish population threshold levels to underpin allergen risk assessment and guide allergen control measures in food manufacturing.	In collaboration with the Food Allergy and Intolerance Scientific Advisory Group, FSANZ to maintain a watching brief on scientific developments in the area of allergen thresholds.

Table of Contents

Executive Summary i

1 Introduction 1

1.1Background to the review 1

1.1.1 Scope of the review 1

1

1.1.2 Process of the review 1

1.2 Food allergy 2

1.2.1 General information 2

1.2.2 Food Allergy in Australia and New Zealand 2

1.2.3 Regulatory context 3

2 Emerging food allergens 4

2.1 Allergenic foods – ‘the big eight’ and a few more 4

2.2 Framework for the assessment of new food allergens 4

2.2.1 International approach 4

2.2.2 Data requirements to identify new allergens 5

2.2.3 Sources of information 6

2.3 Consideration of lupin as a new allergen 6

2.3.1 Lupin allergy 6

2.3.2 Lupin in the food supply 6

2.3.3 Conclusions 7

2.3.4 Recommendations 8

3 Label information 8

3.1 Source of allergenic ingredient 8

3.1.1 Australia and New Zealand 8

3.1.2 International regulations 9

3.1.3 Outcome of stakeholder consultation 10

3.1.4 Consumer research 10

3.1.5 Food industry initiatives 11

3.1.6 Label monitoring surveys 12

3.1.7 FSANZ label monitoring surveys 12

3.1.8 FSANZ allergen label monitoring survey 13

3.1.9 Allergen Bureau labelling review survey 2009 13

3.2 Precautionary labelling 14

3.2.1 Allergen cross contact 14

3.2.2 International regulations 14

3.2.3 Outcome of stakeholder consultation 15

3.2.4 Food industry initiatives 15

3.2.5 Consumer research 16

3.2.6 Label monitoring surveys 17

3.3.1 Conclusions 19

3.3.2 Recommendations 20

4 Foods Exempt from Bearing a Label 20

4.1.1 Conclusions 22

4.1.2 Recommendation 22

5 Labelling requirements for the current list of allergens 23

5.1 Collective term ‘tree nuts’ 23

5.1.1 Tree nut allergy 23

5.1.2 Tree nut allergens 24

5.1.3 Cross-reactivity among tree nuts 25

5.1.4 International regulations 25

5.1.5 Conclusions 25

5.1.6 Recommendation 25

5.2 Collective term: ‘fish’ 25

5.2.1 Allergy to finfish 27

5.2.2 Allergy to crustaceans 27

5.2.3 Allergy to molluscs 28

5.2.4 Conclusions 28

5.2.5 Recommendation 29

5.3 Gluten containing cereals 29

5.3.1 Gluten 29

5.3.2 Coeliac disease 30

5.3.3 Allergy to wheat and other cereals 30

5.3.4 Cross reactivity among cereal food allergens 32

5.3.5 Conclusions 32

5.3.6 Recommendation 32

6 Exemption of ingredients derived from allergenic foods 33

6.1 Impact of food processing on protein allergenicity 33

6.1.1 Thermal processing 33

6.1.2 Enzymatic treatment 34

6.1.3 Physical/ chemical separation of proteins 34

6.1.4 Conclusions 37

6.1.5 Recommendation 37

7Allergen thresholds 37

7.1 Clinical data 37

7.1.1 Conclusion 39

7.1.2 Recommendation 39

8 References 40