1 October 2008 [17-08] DRAFT ASSESSMENT REPORT APPLICATION A490 EXEMPTION OF ALLERGEN DECLARATION FOR ISINGLASS DEADLINE FOR PUBLIC SUBMISSIONS: 6pm (Canberra time) 12 November 2008 SUBMISSIONS RECEIVED AFTER THIS DEADLINE WILL NOT BE CONSIDERED (See ‘Invitation for Public Submissions’ for details) For Information on matters relating to this Assessment Report or the assessment process generally, please refer to http://www.foodstandards.gov.au/standardsdevelopment/ Executive Summary Food Standards Australia New Zealand (FSANZ) received an unpaid Application from the Beer, Wine and Spirits Council of New Zealand (BWSCNZ) in 2003 seeking to amend the Table to clause 4 of Standard 1.2.3 – Mandatory Warning and Advisory Statements and Declarations, of the Australia New Zealand Food Standards Code (the Code). Specifically, the Applicant is seeking an exemption from the requirement to declare isinglass (a processing aid commonly derived from dried swim bladders of certain tropical and subtropical fish) on the label, when present in beer and wine as a result of its use as a clarifying agent. The exemption was initially sought on the basis that isinglass has a long history of use as a fining agent in the production of beer and wine and has not been known to cause adverse reactions in susceptible individuals. The Applicant has now provided evidence that dietary exposure to isinglass through beer and wine consumption is extremely low. Results of oral challenge studies have also been provided indicating that isinglass does not cause an allergic reaction to fish sensitive individuals when consumed at levels substantially higher than the potential exposure levels that may be encountered through the consumption of beer and wine. A new isinglass manufacturing protocol designed to minimise the allergen parvalbumin in the final product has also been established. At Draft Assessment, FSANZ has undertaken a robust and extensive assessment of the public health and safety implications of this Application. A summary of the key risk assessment findings and risk management issues are detailed below. The proposed draft Standard is provided at Attachment 1. This Draft Assessment Report has been reviewed by an allergy expert, Dr Rob Loblay, Director of the Allergy Unit at the Royal Prince Alfred Hospital in Sydney. Dr Loblay has endorsed the FSANZ preferred regulatory approach. Risk Assessment At Draft Assessment, the key risk assessment findings include: • the three main components of isinglass (collagen, elastin and gelatin) are not major fish allergens; • parvalbumin is the major allergenic fish protein, and possibly the sole allergen for most individuals with IgE-mediated allergy to fish; • the levels of parvalbumin in isinglass manufactured using the new protocol has been shown to be extremely low and well below the limit of determination of the analytical method; • the Code specifies the use of Good Management Practice in regulating the maximum amount of the isinglass which may be present in the food (i.e. beer and wine in this instance); ii • a significant amount of isinglass introduced for clarifying purposes in beer and wine is removed allowing only a residual amount of isinglass to remain in these alcoholic beverages; • parvalbumin co-sediments with isinglass and is unlikely to be present in the bulk of the beer or wine after the completion of the precipitation process; and • the residual amounts of isinglass that are shown to remain in beer and wine are well below the isinglass dosage used in oral challenge tests that did not provoke an allergic reaction. Therefore taking into account of all of the above, FSANZ considers that isinglass fined beer and wine are not likely to present a risk of allergic reactions in fish allergic consumers. The key risk assessment issues are discussed in Section 8 of this Report. Additional information is provided at Attachment 2 – Risk Assessment Report and Attachment 3 – Food Technology Report. Risk Management This Draft Assessment Report considers, in the context of the findings from the Risk Assessment, issues relevant to the exemption from the requirement to declare isinglass on the label when present in beer and wine as a result of its use as a clarifying agent, including potential changes to conditions that provide the current high level of safety. In addition, other issues raised by submitters in response to the Initial Assessment Report have been addressed in this Report. A summary of submissions to the Initial Assessment Report is at Attachment 4. Preferred Approach The preferred regulatory approach is to prepare a draft variation to the Table to clause 4 of Standard 1.2.3 to grant an exemption from the requirement to declare isinglass on the label, when present in beer and wine as a result of its use as a clarifying agent. Reasons for Preferred Approach FSANZ supports the regulatory approach to grant exemption from the requirement to declare isinglass on the label, when present in beer and wine as a result of its use as a clarifying agent as it: • does not raise any safety concerns for fish allergic consumers; • provides fish allergic consumers with increased choice of beer and wine products; • supports industry with an added choice of clarifying agent that does not require allergen declaration; iii • does not undermine provision of adequate information on the product label to make an informed choice by fish allergic consumers; and • the impact analysis concludes that exemption from the requirement to declare isinglass on the label, when present in beer and wine as a result of its use as a clarifying agent provides a net benefit to affected parties. Consultation FSANZ is seeking comment on this Draft Assessment Report from all interested parties, particularly in relation to the expected impact(s) of the preferred regulatory approach. Comments received will assist in the preparation of a Final Assessment, including a recommended regulatory approach to isinglass labelling, when used in beer and wine production. iv CONTENTS INVITATION FOR PUBLIC SUBMISSIONS.....................................................................3 INTRODUCTION....................................................................................................................4 1. NATURE OF THE APPLICATION ........................................................................................4 1.1 Background to the Application ..............................................................................4 1.2 Basis of the Application .........................................................................................5 1.3 Scope of the Application ........................................................................................6 1.4 Additional information provided by the Applicant since Initial Assessment .........6 2. THE ISSUE .......................................................................................................................6 3. OBJECTIVES ....................................................................................................................7 4. HISTORICAL BACKGROUND ............................................................................................7 5. CURRENT REGULATIONS.................................................................................................8 5.1 Current Domestic Regulations...............................................................................8 5.2 Overseas and International Regulations ...............................................................9 5.3 Regulatory differences and its impact..................................................................11 6 MATTERS OF RELEVANCE .............................................................................................11 6.1 Information on substances relevant to this Application ......................................11 6.2 Development of tests to quantify isinglass and parvalbumin...............................12 6.3 Commercial production of isinglass ....................................................................12 6.4 Isinglass as a Processing Aid/ Clarifying Agent..................................................14 6.5 Residues of isinglass and parvalbumin................................................................14 6.6 Interaction between parvalbumin and isinglass in beer......................................15 6.7 Toxicological Assessment ....................................................................................16 6.8 Allergenicity Assessment......................................................................................16 6.9 Dietary Exposure to isinglass from beer .............................................................18 7. KEY ASSESSMENT QUESTIONS......................................................................................18 RISK ASSESSMENT ............................................................................................................18 8. RISK ASSESSMENT ISSUES ............................................................................................18 8.1 Allergenicity of isinglass......................................................................................18 8.2 Presence of isinglass in beer and wine................................................................19 8.3 Potential of parvalbumin partitioning out into the bulk liquid............................20 RISK MANAGEMENT.........................................................................................................21 9. RISK MANAGEMENT ISSUES..........................................................................................21