Review of the regulatory management of food allergens

1 Introduction

1. Background to the review

In October 2006, the Australia and New Zealand Food Regulation Ministerial Council requested that FSANZ conduct a review of the regulatory management of allergens. If necessary, FSANZ is to recommend a revised regulatory approach based on current scientific evidence which allows consumer choice but does not compromise the safety of allergic consumers.

1.1.1 Scope of the review

The scope of the review was guided by a number of issues that have arisen since the allergen regulations were developed a decade ago. As a first step in the review process, FSANZ released an Issues Paper for stakeholder consultation in March 2008, and held a number of teleconferences with interested stakeholders to facilitate input. Issues identified for review were:

1. 
   New food allergens
   
2. 
   Labelling requirements for the current list of allergenic foods
   
3. 
   Label information
   
4. 
   Allergenic thresholds (level that triggers an allergic reaction)
   
5. 
   Exemption of ingredients derived from allergenic foods
   
6. 
   Food exempt from bearing a label
   

The consultation specifically targeted stakeholder groups with significant interest in food allergens including the food industry, allergic consumers and their carers and allergy specialists in Australia and New Zealand. Australian and New Zealand regulatory partners were also invited to participate in this consultation. Stakeholder submissions received by FSANZ were taken into account in the development of the scope and direction of the review. FSANZ also undertook a number of projects to gather and generate data to inform the review.

The review was established to address the question of whether the regulatory management of food allergens is meeting the needs of allergic consumers in Australia and New Zealand.

The aim is to determine whether, in the context of current knowledge, improvements can be made to the existing regulatory approach which allows consumer choice but does not compromise the safety of allergic consumers.

1.1.2 Process of the review

An important aspect of the review was to assess information from a wide range of sources to ensure emerging evidence and improvements in our understanding of stakeholder issues are reflected in our regulatory and non-regulatory approaches to food allergens. This required FSANZ to undertake a number of information gathering activities including consumer surveys, label monitoring surveys (including labelling surveys conducted by the industry) and scientific research. Developments in international regulations in this area were also considered by FSANZ to benchmark the regulatory approach in Australia and New Zealand to that of other major international regulations.

Based on the information available, FSANZ explored the use of regulatory and non-regulatory options to address the issues of concern to stakeholders. The regulatory pathway includes identifying applications and/or proposals that could address these issues.

The non-regulatory pathway would include mechanisms for the consistent application of guidelines, procedures and risk management tools across various sectors of the food industry to achieve the desired outcomes. Any applications and proposals will be progressed according to the normal FSANZ process.

1.2 Food allergy

1.2.1 General information

Food allergy is an adverse immune reaction to food proteins. A number of factors determine why some people develop food allergy including individual susceptibility and dietary patterns. When food proteins are absorbed through the gut, they eventually interact with the immune system leading, in the majority of consumers, to the development of tolerance to the food. In genetically predisposed individuals, the interaction leads to sensitisation (i.e., the development of antibodies of the immunoglobulin E (IgE) class. The IgE molecules circulate in the body and attach to specialised cells called basophils and mast cells. Mast cells are present throughout the body and are prominent in tissues such as the skin, mucosa of the lungs and digestive tract, as well as in the mouth, eyes and nose. In a sensitised individual, the food proteins bind to the IgE attached to the mast cells triggering the release of chemical mediators such as histamine. The mediators interact with specific receptors present in various parts of the body, mainly the skin, throat, airways, intestines, and heart, leading to the symptoms of allergic reactions. IgE-mediated allergy, or type I hypersensitivity, is characterised by the rapid development of symptoms ranging from mild to life-threatening. Sensitisation, or the presence of food-specific IgE antibodies, is detected by testing the blood or skin of the individual. However, conclusive evidence of food allergy is achieved by double-blind placebo-controlled food challenge (DBPCFC) trials (Sampson, 1999 and 2003; Sicherer and Sampson, 2006).

Coeliac disease is an autoimmune-mediated condition triggered by dietary gluten in genetically predisposed individuals. It is also known as coeliac sprue, gluten-sensitive enteropathy, or nontropical sprue (Chang et al., 2009). The symptoms include abdominal bloating or pain, chronic diarrhoea and vomiting. Dietary exposure to gluten, the insoluble protein present in some cereal grains including wheat, barley and rye and their hybridised strains, triggers the symptoms in coeliac patients. Failure to eliminate gluten from the diet leads to chronic inflammation and damage to the lining of the small intestine. The tissue damage leads to nutrient malabsorption and possible serious complications including involvement of multiple organ systems and an increased risk of some malignancies (Sampson and Burks, 1996; Kagnoff, 2007, Presutti et al., 2007).

1.2.2 Food Allergy in Australia and New Zealand

The prevalence of food allergy in Australia and New Zealand is not known but it is estimated that 1-2% of the adult population and 4-6 % of the paediatric population are affected. Clinical data suggest that food allergy has increased in Australia, as in other countries, in the last decade. A study published in 2007 found a five-fold increase in the number of hospital admissions for food-induced anaphylaxis for zero to four year-olds and a four-fold increase for 5–14 year olds (Mullins 2007). The Australasian Society of Clinical Immunology and Allergy (ASCIA) estimates that 5% of Australian children will develop food allergy by school age.

1.2.3 Regulatory context

In the mid 1990s, food allergy was emerging as a significant public health issue in many countries around the world. As the processed food industry expanded and the volume of international trade in food products increased, the need for national and international regulatory control of food allergens became apparent. Allergen-specific avoidance diets were identified as critical for the safety of allergic consumers (Sporik and Hill, 1996; Hourihane, 1998). Recognising the importance of food allergy as a global issue for food regulation, the World Health Organization (WHO) and the Food and Agriculture Organization (FAO) sought expert advice to determine which foods should always be declared on food labels, because of their allergenic properties. A list of foods was developed based on frequency of severe reactions and estimated prevalence of allergic reactions. The advice was adopted by the Codex Alimentarius Commission in 1999 (Section 4.2.1.4 of General Standards for the Labelling of Prepackaged Foods) thus introducing labelling requirements for eight food allergens: cereals containing gluten, crustacea, egg, fish, peanuts, milk and tree nuts. A requirement for labelling of sulphites was also introduced. Although not typical allergens, sulphites can cause medically reproducible allergy-like reactions.

In Australia and New Zealand, allergen provisions were introduced into the Food Standards Code (the Code) in 2002. The Standard was based on advice from a panel of allergy experts from both countries. The expert panel was convened in 1997 by FSANZ to identify food allergens relevant to the Australia and New Zealand populations. The panel considered the prevalence and severity of allergic reactions to be the main criteria for identifying allergenic foods. The panel acknowledged that data on prevalence are often limited and defined ‘severe’ reactions as those which lead to significant morbidity and mortality. The panel advised that their clinical experience supports the foods listed by the Codex Alimentarius as frequent causes of severe systemic reactions. The Panel also recommended the inclusion of sesame seeds in the list based on clinical evidence that severe reactions to sesame products, including anaphylaxis, were increasing among infants (Sporik and Hill, 1996; Hill et al., 1997). The regulatory requirements were implemented with a two-year transition period and became fully enforceable in December 2002.
In the past few years, the United States of America, the European Union (EU), and Canada have also introduced regulations related to these eight foods and their products. The EU list also includes sesame seeds, celery, mustard, lupin, and molluscs. The Canadian list also includes sesame seeds and mustard.
As a result of the introduction of the allergen provisions in Standard 1.2.3, the listed foods are required to be declared on the label when present in food products. However, these regulations do not specifically address the unintended presence of these foods due to cross contamination. This is also the case in the regulations of the EU, USA and Canada.
There is currently no internationally agreed approach to the declaration of allergen cross-contamination. In June 2010, the European Parliament adopted an amendment that requires the development of common rules for labelling the presence of traces of allergenic substances. While drawing up such common rules is likely to be a complex and lengthy task, it may help improve the regulation of precautionary labelling of allergens.