ARCHIVED - Proposed Exemptions from Food Allergen Declaration for Fining Agents and Wax Coatings

As a result of public comments, Heath Canada intends to make modifications to the proposed food allergen labelling regulations with the purpose of removing certain exemptions from declaration of food allergens, gluten sources and added sulphites. These previously proposed exemptions were for:

1. fining agents derived from eggs, fish or milk that are used in the manufacture of bourbon whiskey or alcoholic beverages that are subject to a compositional standard in Division 2 of the Food and Drug Regulations; and
2. wax coating compounds and their components that are used on prepackaged fresh fruits and vegetables.

Health Canada's proposed amendments to the Food and Drug Regulations, entitled 'Enhanced Labelling for Food Allergen and Gluten Sources and Added Sulphites' (project 1220), were published in Canada Gazette, Part I (CGI) on July 26 th, 2008. This regulatory proposal is summarized online: Proposed New Labelling Requirements. The corresponding CGI comment period ended November 28^th, 2008; however, Health Canada continued to accept comments until early December 2008. Over the course of this period, more than 140 comments were received from stakeholders including consumers, health professionals, patient groups, industry associations, industries and other governments. Throughout the comment period, Health Canada also met with interested patient and consumer groups, as well as industry associations. Overall, the comments received indicated a general support for the proposed amendments. Health Canada also received suggestions regarding how specific aspects of the proposed amendments could be improved.

The present document explains Health Canada 's proposal to remove the previously proposed exemptions of individual allergen labelling for fining agents and wax coatings on the label of pre-packaged foods. This updated proposal stems both from the comments received concerning those exemptions and from recent scientific and regulatory information.

The overall objectives of the proposed amendments to the food allergen labelling regulations, entitled 'Regulatory Project 1220 – Enhanced Labelling of Food Allergen and Gluten Sources and Added Sulphites' are:

• To minimize risks associated with inadvertent consumption of undeclared food allergens, gluten sources and added sulphites in food; and
• To maximize choice of safe and nutritious foods for consumers with food allergies, food intolerances and celiac disease.

Health Canada's Proposal as published in Canada Gazette Part I for the Exemption of Declaration for Fining Agents and Wax Coatings on the Labels of Pre-Packaged Food Products

Among few other exemptions, the proposed labelling amendments would not have applied in the following situations:

• fining agents derived from eggs, fish or milk that are used in the manufacture of Bourbon whisky or alcoholic beverages that are subject to a compositional standard in Division 2, whether the Bourbon whisky or the alcoholic beverage is a prepackaged product or added to a prepackaged product;
• wax coating compounds and their components that are used on prepackaged fresh fruits or vegetables.

Health Canada's Revised Approach:

a) Fining Agents

As part of the Canada Gazette, Part I comment period, patient groups, health professionals and consumers questioned the safety of some fining agents for allergic consumers and the reasons why Canada would exempt these substances from the proposed amendments. Some stakeholders suggested that the safety of these products should be evaluated on a case by case basis. As well, industry expressed confusion as to whether or not fining agents, in alcoholic beverages (non-standardized), would need to be declared in view of the proposed exemptions for fining agents in standardized alcoholic beverages. Based on these concerns, and the known possibility that the use of fining agents derived from food allergens could result in the presence of protein fragments from those food allergens in the finished product, Health Canada has reviewed its position to systematically exempt fining agents derived from fish, milk or eggs used in the production of standardized alcoholic beverages from allergen labelling.

The previous proposal to exempt fining agents derived from milk, eggs and fish used during the manufacture of standardized alcoholic beverages was based on conclusions stemming from stakeholder consultations which took place in 2004. Originally, the decision to exempt these fining agents was based both on the nature of these alcoholic beverages and the manufacturing processes through which the removal of the fining agent protein from the final product was expected. However, Health Canada has indicated in its Regulatory Impact Analysis Statement (RIAS) which accompanied its Canada Gazette, Part I proposal, that the Department may reconsider its position in view of any new data developed by the scientific community, nationally and internationally, related to possible protein residues resulting from the presence of such fining agents.

The scientific perspective has evolved with regard to the use of fining agents derived from milk, eggs and fish during the manufacture of standardized alcoholic beverages, particularly wine and beer. Currently there is not enough data available to scientists to indicate with certainty that there would be no risk to allergic individuals in all situations; hence, providing a broad and systematic exemption from allergen labelling is not warranted. It is possible that protein from these food allergens could be present in the final product at levels sufficient to cause an adverse reaction in certain allergic individuals. As a result, providing a blanket exemption from labelling of fining agents from eggs, fish and milk for all standardized alcoholic beverages is considered inappropriate since this could result in the presence of hidden allergens in these products.

By removing the exemption proposed in Canada Gazette Part I, if a protein or a modified protein, including any protein fraction from an allergen source, is present in the prepackaged standardized alcoholic beverage as a result of the use of fining agents from milk, fish or egg, the allergen source would need to appear on the label of the prepackaged product. If no protein, modified protein or protein fraction from an allergen source is present in the standardized alcoholic beverage, then no additional declaration on the label would be required. Therefore, allergic consumers will be better informed when considering the purchase of a prepackaged food by fully extending the coverage of the proposal to both standardized and unstandardized alcoholic beverages.

International Context

In 2007 the European Food Safety Authority provided opinions to the European Commission that wines fined with milk (casein) and egg products, under specific manufacturing / processing conditions, may trigger adverse reactions in susceptible individuals. As of December 31, 2010 fining agents from egg and milk will have to be declared in the EU. Also, in the United States, currently allergen labelling information on wines is voluntary, but must follow certain criteria if used. Any reference made to allergens must declare all major food allergens used in the production of the beverage, including fining or processing agents. An allergen declaration must consist of the word "Contains:" followed by the name of the food source from which each major food allergen is derived. For example, a declaration could be "Contains: milk and egg." In Australia, fining agents derived from egg and milk must be declared on the label of wines.

b) Wax Coatings used on prepackaged fresh fruits or vegetables

Protective edible coatings and waxes are part of the post-harvest and handling technologies routinely used by the fresh produce industry to minimize moisture loss, prolong the shelf life, and to improve the appearance of fresh produce. Currently, under the Food and Drug Regulations, there is no requirement to declare wax coating compounds and their components on the label of prepackaged fresh fruits and vegetables.

In order to protect consumers with food allergies and celiac disease, the Canadian Food Inspection Agency and the Canadian Produce Marketing Association have advised growers, packers and importers to be aware of most common priority allergens such as peanuts, tree nuts, sesame seeds, milk, eggs, soy, fish, shellfish, crustaceans, wheat, gluten and sulphites and that these priority allergens and any proteins derived from them should not be used as components of fruit and vegetable coatings.

Furthermore, as a risk-based policy, when fruit and vegetable coating manufacturers have requested that Health Canada provide support for the acceptability of a specific fruit or vegetable coating formulation containing any priority food allergen or gluten source, notwithstanding the chemical safety of all other components within the formulation, the Food Directorate has not granted any such support.

However, the scope of this voluntary process is limited since Health Canada may not be aware of all the formulations or applications being employed by the food industry at the national and international levels

In the comments received following the publication in CG Part I, stakeholders pointed out that, over the last few years, there has been an increasing diversity of coating formulations which may be used on fresh produce, some of which may contain priority food allergens derived from milk, soy or other allergenic and gluten sources. For example, new edible coatings with improved functionality and performance for fresh fruit have been developed containing soy, chitosan (derived from crustaceans) and caseinate (derived from milk) components.

In general, fresh fruits and vegetables are commonly sold individually at retail and are not required to carry a label and therefore, do not have a list of ingredients. However, some fruits and vegetables are also sold in prepackaged format where, currently under the Food and Drug Regulations, wax coating compounds and their components are not required to be shown on the label.

After analysis, Health Canada will not change the exemption currently present in the Food and Drug Regulations that allows wax coating compounds and their components not to be declared on the label of prepackaged fresh fruits and vegetables. However, Health Canada intends to remove the exemptions for wax coating compounds and their components in the proposed amendments. Thus, if protein or any modified protein, including any protein fraction from an allergen and gluten source, is present in prepackaged fresh fruits and vegetables as a result of the use of a wax coating compound, the allergen or gluten source present in the wax coating compound or its components would be required to be declared on the label of prepackaged fruits and vegetables. There would not be any requirements to declare the components of wax coatings which do not contain any food allergens.

Based on the review of comments received from key stakeholders and on the known use and risks inherent to food allergens components in fruit and vegetable coatings, Health Canada has concluded that removing the proposed labelling exemptions for wax coatings and their components (derived from priority food allergens and gluten sources) would provide further assurances for allergic consumers, and celiac patients when considering the purchase of prepackaged fresh fruits and vegetables.