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Notice to the reader: The online consultation is now closed. Comments and suggestions received during the public consultation period are being considered in the finalization of this document. The final report will be made available as soon as possible.
Health Canada has worked with the Canadian Food Inspection Agency (CFIA), health professionals, consumer associations, and the food industry to update the requirements for priority allergen labelling on foods sold in Canada. It is revising the policies that impact how prepackaged foods warn consumers about the presence of priority allergens (like peanuts, eggs, and so on).
There are two ways an allergen can be in food:
A new regulation will make it mandatory for food labels to list ingredients (and ingredients of ingredients) that can cause allergies by their common name to make sure that consumers can easily recognize them.
However, this new regulation will cover only ingredients that the manufacturer intended to put in the food - not any allergens that may inadvertently get into the food.
Since this new regulation does not cover substances that may have been inadvertently added to the food, there is a need to consider how consumers are informed about the possible presence of these allergens.
Precautionary labelling can let consumers know that an allergen might be in the food, even though it is not listed as an ingredient. For example, the chocolate bar mentioned in the example above could carry the warning statement "may contain peanuts," even though the chocolate does not contain added peanuts. The precautionary label statement lets consumers know that eating the chocolate could be dangerous to someone who is allergic to peanuts because the product may inadvertently contain peanuts.
Currently, food allergen precautionary labelling is used on a voluntary basis in Canada and other countries around the world. However, it has been suggested that a new guideline or policy be established in Canada to make allergen precautionary labelling of prepackaged foods more consistent and easier for consumers to understand.
As a result, Health Canada and the Canadian Food Inspection Agency (CFIA) are planning to update the policy and procedures on precautionary labelling for food allergens.
In updating this policy, Health Canada has two goals:
Achieving both these goals is challenging because precautionary labelling is essential when the presence of allergens is real, but should not be used unnecessarily since this will minimize choice for those with food allergies.
As part of the policy review, Health Canada is hosting a public consultation to gather opinions from the public, health professionals, people in the food industry, and others who might be affected by changes to the policy. Health Canada wants to know how Canadians feel about the current policy on allergen precautionary labelling and what direction they feel it should take in the future.
The following key groups are being invited to participate in the consultations:
This public consultation will be carried out in two phases: (I) once online, the Web consultation will be open to the public for a period of 90 days; and (II) regional workshops with key stakeholders will be held in November and December 2009.
A report from the public consultations will be posted on Health Canada's Food Allergen Labelling Web site. A link to the online report will be emailed to all participants when it becomes available.
This consultation document provides some background information and context for the allergen precautionary labelling policy review and outlines the main issues to be considered.
The document presents various options that Health Canada is considering, including the current policy and four (4) alternate options. As you proceed from option 1 to option 4, the combination of the policy tools changes from those supporting a voluntary approach to those supporting a more regulated approach.
Each policy option has been based on all, or some combination of, the following approaches:
Your input about the policy options is very important to the success of Health Canada's policy review. After the background section, each policy option will be presented. Questions about the policy review will be asked at the end of the document, and you will be given space to provide additional comments.
As many as 2 million Canadians, or 6 percent of the population, are affected by food allergies, intolerances, and other sensitivities. There is currently no cure for these conditions and, in some cases, exposure can lead to anaphylactic shock and death. To prevent potentially serious health-related problems, Canadians with food allergies, sensitivities, and intolerances must avoid consuming foods that trigger allergic reactions; however, this avoidance of foods and ingredients can be a burden for these individuals, their families, and caregivers. A warning label can be an important tool in supporting informed food choices that will not trigger their food allergy, sensitivity, or intolerance.
Since allergen precautionary labelling was first introduced in 1994, there has been a large increase in the number and variety of the statements used on prepackaged foods in Canada. This has had two important consequences:
Health Canada is concerned that the increased use of allergen precautionary labelling could downplay the risk of consuming these products. Studies have shown that food allergic consumers may regularly ignore product precautionary labelling when buying or consuming food. Reasons for this include an increase of public advisories, a lack of reaction to products labelled with warnings, and misconceptions that precautionary labelling is for legal rather than health concernsor is used as a cover for poor allergen control standards. An important challenge for public policy-makers is to help consumers obtain the information they need to make informed purchasing and consumption decisions. While precautionary labelling statements can be a useful tool to help achieve this, consumer comments have indicated that there is room for improvement in this area.
In response to these concerns, Health Canada strongly recommends the following:
Health Canada and the Canadian Food Inspection Agency (CFIA) issued updated advice to the food industry in 2007 recommending that only the following allergen precautionary statements be used on food labels:
Health Canada has identified four (4) possible options to replace the current policy on the precautionary labelling of priority allergens for prepackaged foods:
All options are based on a mixture of the following approaches:
As you review the options, you will notice that the specific combination of policy tools being suggested change from those that support a voluntary approach (which leaves more choice to the food industry) to those that support a more regulated approach (which forces the food industry to take certain action in order to sell their products in Canada).
The following section presents an overview of the current policy and the alternative policy options.
The current policy on precautionary labelling of allergen for prepackaged foods was set in 1994 by Health Canada's Food Directorate. The policy allows for voluntary precautionary labelling of products that may inadvertently contain food components that can cause allergic reactions. The precautionary labels warn consumers that certain allergens may be present in prepackaged food, and aim to prevent their consumption by those who are allergic, sensitive, or intolerant.
The current policy does not require the use of specific wording for the allergen labels, but leaves it to manufacturers to decide on the phrasing. However, these statements are subject to the Food and Drugs Act, subsection 5(1), meaning that they have to be truthful, clear, and non-ambiguous. The current policy also requires that precautionary labelling should not be used as a substitute for Good Manufacturing Practices. This means manufacturers cannot choose to use an allergen precautionary statement on the label as a substitute for taking appropriate care during manufacturing.
Subsection 5(1) of the Food and Drugs Act:
ź No person shall label, package, treat, process, sell or advertise any food in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety.╗ Food and Drugs Act (R.S., 1985, c. F-27)
[Summary Table of Options]
Legal actions can be taken if the general requirements are not met.
Under option 1, manufacturers and importers would not be required to use allergen precautionary labelling. However, tools would be developed to help the food industry use precautionary labelling according to set recommendations. These tools would include the following:
As always, legal actions could be taken if the precautionary labelling of priority allergens is found contrary to subsection 5(1) of the Food and Drugs Act, that is, labels must be truthful, clear, and non-ambiguous.
Under option 2, manufacturers and importers would not be required to use allergen precautionary labelling. However, tools would be developed to help the food industry use precautionary labelling in a consistent manner. These tools would include the following (Note: the key difference from option 1 is tool 6 (in bold text)):
Again, legal actions could be taken if the precautionary labelling of priority allergens is found contrary to subsection 5(1) of the Food and Drugs Act, that is, labels must be truthful, clear, and non-ambiguous.
Within this option, all manufacturers, importers, and retailers who voluntarily adopt the above elements would be allowed to use a notification system, which would inform consumers about whether a risk assessment has been completed on products that have, or do not have any precautionary labelling. Consumer notifications might be done via (a) a consumer accessible Web site, (b) a product symbol, or (c) other mechanism(s).
Please note: This option is the one preferred by Health Canada. It represents a more prescriptive policy on precautionary labelling of priority allergens, based on a voluntary adoption of various policy tools.
Under option 3, manufacturers and importers would not be required to use allergen precautionary labelling, but the misuse of allergen precautionary labelling would be prohibited through regulation. This would create the following requirement: for any product to have a precautionary allergen label on it, a Risk Assessment must be performed and properly documented.
In this option, regulations will also specify a small number of statements that can be used as warning statements; manufacturers and importers will be allowed to use only these food allergen precautionary statements.
As with the other options, tools would be developed to help the food industry use precautionary labelling in a consistent manner. These tools would include the following (Note: the key differences from option 2 are: regulated tools 4 and 6, and voluntary tool 5 (in bold text)):
Legal actions could be taken if regulations and guidelines are not followed.
Under option 4, manufacturers and importers would (Note: the key differences from option 3 are: regulated tools 1 and 2 (in bold text)):
Legal actions could be taken if regulations and guidelines are not followed.
The following table summarizes the similarities and differences between each of the policy options proposed by Health Canada.
|Current policy||Option 1||Option 2||Option 3||Option 4|
|Small number of statements||Voluntary||Voluntary||Voluntary||Regulated||Regulated|
|Implementation of Good Manufacturing Practices specifically for allergen handling||----||Voluntary||Voluntary||Voluntary||Regulated|
|Use of a standardized approach to Risk Assessments of potential cross-contamination||----||Voluntary||Voluntary||Voluntary||Regulated|
|Standardized documentation with on-site storage of findings of Risk Assessments||----||Voluntary||Voluntary||Regulated||Regulated|
|Education program for consumers||----||Voluntary||Voluntary||Voluntary||Voluntary|
|Consumer notification system||---||---||Voluntary||---||---|
A series of questions asking for your feedback follows. While many of the questions are for everyone, a few are only for those responding on behalf of an organization.
ID1. Are you responding to this consultation as a private individual or on behalf of an organization/company?
For further information about this public consultation or food allergen labelling please refer to the following Web sites: