Consultation Document on Precautionary Labelling of Priority Allergens in Prepackaged Foods

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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.

 Consultation on Health Canada's Food Allergen Precautionary Labelling Policy Renewal - Summary of Comments from the Online and Face-to-Face Consultation Sessions

Health Canada

October 2009

Table of Contents

1. Introduction
2. Ingredient Regulation
3. Precautionary Labelling for Unintended Allergens
4. The Consultation Process:
5. The Consultation Document:
6. Glossary of Technical Terms in this Document:
7. Instructions:
8. Why is There a Need for the Review of the Precautionary Labelling of Allergens in Prepackaged Foods?
   • Allergen Precautionary Labelling of Prepackaged Foods
9. Toward a Renewed Policyon the Precautionary Labelling of Priority Allergens
   • Identification of Policy Options and Tools
     1. Current Health Canada Policy on Precautionary Labelling
     2. Option 1: Enhanced Voluntary
     3. Option 2: Enhanced Voluntary Approach with Consumer Notification
     4. Option 3: Mixed Voluntary / Regulatory Approach
     5. Option 4: Regulatory Approach
10. Summary Table of Options
11. Consultation Workbook
12. Other Information

Introduction

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:

• as an ingredient or indirectly as an ingredient of an ingredient - something intentionally put in a product; or
• as a substance that gets into a product inadvertently, for example, when equipment is used to make both chocolate bars with peanuts and chocolate bars without peanuts, there is a risk that peanuts may get into the chocolate bars that are not supposed to contain any peanuts despite proper cleaning of the equipment between batches.

Ingredient Regulation

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.

Precautionary Labelling for Unintended Allergens

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:

• to minimize risk for those with food allergies; and
• to maximize choice of safe and nutritious foods for consumers with food allergies.

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.

The Consultation Process:

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:

• the food industry;
• academia/research organizations;
• health professional associations;
• allergy associations and celiac associations;
• consumer and community associations;
• youth organizations; and
• federal/provincial/territorial governments.

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.

The Consultation Document:

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:

• developing guidelines for Good Manufacturing Practices (GMPs) on allergen handling;
• developing guidelines for conducting allergen Risk Assessments;
• developing guidelines for documenting and recording the findings of risk assessments;
• outlining a small number of statements that can be used on labels;
• establishing an education program for consumers; and
• setting up a consumer notification system for the safety of products (for example, a consumer accessible Web site or a product symbol).

Glossary of Technical Terms in this Document:

Allergen:

A substance that can cause an allergic reaction

Allergen precautionary labelling:

Labelling that warns about priority allergens that may be in products, even though they are not in the list of ingredients

Food allergen precautionary labelling statement:

a declaration on the label of a prepackaged food that identifies the priority food allergens that are not among the listed ingredients, but may have been inadvertently added to a product during the manufacturing process.

• Examples of these statements include the following: "may contain..."; "may contain traces of..."; "not suitable for consumption by persons with an allergy to..."

Gluten Sources:

The grains considered to be capable of producing negative effects in individuals with celiac disease include the different species of wheat (e.g., durum, spelt, kamut), barley, rye, and their cross-bred hybrids (e.g., triticale, which is a cross between wheat and rye).

Good Manufacturing Practices (GMPs):

measures taken to assure that a universally accepted approach is applied to ensure the quality of products and in minimizing risk.

Priority food allergens:

the allergens most frequently associated with food allergies and allergic-type reactions. These include:

• almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios, walnuts; peanuts; sesame seeds; wheat, kamut, spelt or triticale; eggs; milk; soybeans; crustaceans; shellfish; fish; and
• sulphites - either those directly added to a food, or when the total amount in the food is enough to be of concern.

Risk Assessment:

A process that involves determining the likelihood that a specific adverse health effect will occur in an individual or population, following exposure to a hazardous agent.

Instructions:

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.

Why is There a Need for the Review of the Precautionary Labelling of Allergens in Prepackaged Foods?

Allergen Precautionary Labelling of Prepackaged Foods

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:

1. Many consumers are confused about the actual meaning of allergen precautionary labelling statements and the reason they are present on some products. This can lead to labels being misunderstood or ignored, which puts consumers with allergies at risk.
2. Overuse of allergen precautionary labelling when there is no real risk can lead to unnecessary restrictions on the range of foods available to allergic consumers.

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:

• Precautionary labelling should be used only when the presence of allergens in food is inadvertent and unavoidable, despite all reasonable measures.
• Precautionary labelling must not be used when an allergen is deliberately added to a food (in this case, the ingredient should appear on the list of ingredients).
• Precautionary labelling should not be used where there is no actual risk of an allergen being present.

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:

1. "may contain [allergen X]"
2. "not suitable for consumption by persons with an allergy to [allergen X ]"

Toward a Renewed Policyon the Precautionary Labelling of Priority Allergens

Identification of Policy Options and Tools

Health Canada has identified four (4) possible options to replace the current policy on the precautionary labelling of priority allergens for prepackaged foods:

• Option 1: Enhanced Voluntary Approach
• Option 2: Enhanced Voluntary Approach with Consumer Notification
• Option 3: Mixed Voluntary/Regulatory Approach
• Option 4: Regulatory Approach

All options are based on a mixture of the following approaches:

1. developing guidelines for Good Manufacturing Practices (GMPs) on allergen handling;
2. developing guidelines to standardize Risk Assessments (using a scientific approach to determine the likelihood of allergen cross-contamination);
3. developing guidelines for documenting or recording the findings of all risk assessments;

   Note: Health Canada is proposing that Items 1, 2 and 3 above would be led by food industry experts, with input and support from government, consumer allergy associations and others.

4. developing a limited list of specific wordings that may be used for precautionary labelling statements, when they are being used;
5. providing an information and education program for consumers to help them understand the meaning of a precautionary labelling statement on a food product (and what it means when no statement is present); and
6. setting up a system to allow consumers to find out whether a risk assessment has been completed on products that may or may not have any precautionary labelling.

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).

Voluntary Approaches:

• Can be achieved in a relatively short period of time
• Provide standards and tools for the industry to refer to and use
• Are voluntary, which may cause uncertainty as to whether or not they are being followed

Regulatory Approaches:

• Would affect all prepackaged food sold in Canada
• Take more time to develop and implement than voluntary approaches
• Can be more expensive to develop and implement than voluntary approaches

The following section presents an overview of the current policy and the alternative policy options.

Current Health Canada Policy on Precautionary Labelling

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:
« 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.

Option 1: Enhanced Voluntary

Policy Overview:

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:

1. guidelines on Good Manufacturing Practices (GMPs) for allergen handling;
2. guidelines to standardize Risk Assessments (using a scientific approach to determine the likelihood of allergen cross-contamination);
3. guidelines for documenting or recording the findings of all risk assessments;
4. a limited list of specific wordings that may be used for precautionary labelling statements, when they are being used; and
5. voluntary implementation of an information and education program for consumers and industry to help them understand the meaning of a precautionary labelling statement on a food product (and what it means when no statement is present).

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.

[Summary Table of Options]

Option 2: Enhanced Voluntary Approach with Consumer Notification

Policy Overview:

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)):

1. guidelines on Good Manufacturing Practices (GMPs) for allergen handling;
2. guidelines to standardize Risk Assessments (using a scientific approach to determine the likelihood of allergen cross-contamination);
3. guidelines for documenting or recording the findings of all risk assessments;
4. a limited list of specific wordings that may be used for precautionary labelling statements, when they are being used;
5. voluntary implementation of an information and education program for consumers and industry to help them understand the meaning of a precautionary labelling statement on a food product (and what it means when no statement is present); and
6. a system to allow consumers to find out whether a manufacturer has completed a risk assessment on products for which it does not provide any precautionary labelling.

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).

[Summary Table of Options]

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.

Option 3: Mixed Voluntary / Regulatory Approach

Policy Overview:

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)):

1. guidelines on Good Manufacturing Practices (GMPs) for allergen handling;
2. guidelines to standardize Risk Assessments (using a scientific approach to determine the likelihood of allergen cross-contamination);
3. guidelines for documenting or recording the findings of all risk assessments;
4. a limited list of specific wordings that are the only ones that may be used for precautionary labelling statements, when they are being used;
5. voluntary implementation of an information and education program for consumers and industry to help them understand the meaning of a precautionary labelling statement on a food product (and what it means when no statement is present); and
6. a requirement that before a food allergen precautionary label can be placed on any product, a Risk Assessment must have been performed on that product and the results of the Risk Assessment properly documented .

Legal actions could be taken if regulations and guidelines are not followed.

[Summary Table of Options]

Option 4: Regulatory Approach

Policy Overview:

Under option 4, manufacturers and importers would (Note: the key differences from option 3 are: regulated tools 1 and 2 (in bold text)):

1. be required to follow the guidelines on Good Manufacturing Practices (GMPs) for allergen handling;
2. be required to perform Risk Assessments on all products (using a scientific approach to determine the likelihood of allergen cross-contamination), rather than choose which products would undergo a Risk Assessment;
3. be required to follow specific guidelines for documenting or recording the findings of all risk assessments;
4. have a limited list of specific wordings that would be the only ones permitted for precautionary labelling statements, when they are being used; and

Legal actions could be taken if regulations and guidelines are not followed.

Summary Table of Options

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	---	---

Consultation Workbook

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?

Organizations include food industry; academia/research organizations; health professional associations; allergy associations and celiac associations; consumer and community associations; youth organizations; and federal/provincial/territorial governments.
As a private individual On behalf of an Organization

A. Small Number of Wordings for Precautionary Labelling Statements

Currently, manufacturers are using approximately 30 different wordings for precautionary labelling statements on prepackaged foods. Health Canada is considering a recommendation of the following two wordings for all precautionary labelling statements on prepackaged foods:

• May contain X
• May be present: X

(a) Do you agree with limiting the wording for allergen precautionary statements to these two wordings?

Yes No Don't know / no answer

If yes, please explain - (100 words max comment field)

(b) Would you like to have any other wording considered for these statements?

Yes No

If yes, please specify below. (100 words max comment field)

B. Guideline Development

[For organizations only; if you are responding as an individual, please skip to question C(c)] Health Canada has proposed the development of guidelines for the following:

Good Manufacturing Practices on allergen handling
Conduct of allergen Risk Assessments
Documentation and on-site storage of findings of Risk Assessments

These activities would be led by food industry experts, with input and support from government, consumer allergy associations, and others.

(a) To what extent is your organization willing to be involved in the development of such guidelines?

Very willing Somewhat willing Not very willing Not at all willing Don't know / No answer

(b) How would your group be able to contribute to these activities? Please explain. (100 words max)

C. Education Program

(a) [For organizations only] To what extent is your organization willing to be involved in the development an education program about food allergen precautionary labelling?

Very willing Somewhat willing Not very willing Not at all willing Don't know / No answer

(b) [For organizations only] How would your group be able to contribute to this activity? (100 words max)

(c) What do you (or the organization you represent) feel are the key issues causing confusion and concern about industry use of precautionary labelling statements?

Difficulty in interpreting the statements being used
Yes No

Not knowing if safety has been assessed when no precautionary statement is present
Yes No

Too many different wordings of precautionary statements
Yes No

Overuse of statements on food products
Yes No

Don't know / No answer
Yes No

Other: specify (max 100 words)

(d) How do you (or the organization you represent) interpret the safety of a product that does not contain a precautionary labelling statement for those with food allergies?

It means the product is safe It means the product is not safe Don't know / No answer Other: specify

Other: specify

D. Consumer Notification System

Policy Option 2 includes a consumer notification system. Several approaches for implementing such a system are being considered.

(a) Use a scale from 1 to 6 where 1 means you (your organization) would feel it is the "best" approach and 6 means you (or your organization) would feel is the "poorest" approach.

Approach

Rank
1. best
6. poorest

A single consumer accessible Web site developed and maintained by (an) allergic consumer association(s)


A single consumer accessible Web site developed and maintained by (an) industry association(s)


A single consumer accessible Web site developed and maintained jointly by (an) allergic consumer association(s) and (an) industry association(s)


Multiple consumer accessible Web sites developed and maintained by different manufacturers, retailers, and importers


Electronic information available in retail locations, perhaps accessed via a hand-held scanner


Use of a package symbol indicating that a risk assessment concluded that no precautionary label was needed

(b) Is there a different approach to a consumer notification system that should be considered? If yes, please provide a brief description. (150 words max)

(c) [For organizations only; if you are responding as an individual, please skip to question E(a)] To what extent is your organization willing to be involved in the development and maintenance of such a system?

Very willing Somewhat willing Not very willing Not at all willing Don't know / No answer

(d) [For organizations only] What would your group be able to contribute to this activity? (100 word max)

E. The Different Policy Options

These questions outlining the current policy and four proposed alternative options for using precautionary labelling on prepackaged foods to minimize risks associated with inadvertent consumption of undeclared food allergens, sulphites and gluten sources in food, while maximizing choice of safe and nutritious foods for consumers with dietary restrictions are listed below.

(a) Please rate your preference for each of the possible policy options for precautionary labelling of food allergens.  Use a scale from 1 to 5 where 1 means you (your organization) would "most prefer" if that option were the policy and 5 means you (or your organization) would "least prefer" if that option were the policy.

Allergen Precautionary Labelling Policy Options

Rating
1.most prefer
5.least prefer

Current policy


Option 1: Enhanced Voluntary Approach


Option 2: Enhanced Voluntary Approach with Consumer Notification


Option 3: Mixed Voluntary/Regulatory Approach


Option 4: Regulatory Approach

(b) Please provide any other feedback you have on these policy options? (200 words max)

(c) Please rate your level of comfort with each option:

Current policy
Very comfortable Somewhat comfortable Not very comfortable Not at all comfortable Don't know / No answer

Option 1: Enhanced Voluntary Approach
Very comfortable Somewhat comfortable Not very comfortable Not at all comfortable Don't know / No answer

Option 2: Enhanced Voluntary Approach with Consumer Notification
Very comfortable Somewhat comfortable Not very comfortable Not at all comfortable Don't know / No answer

Option 3: Mixed Voluntary/Regulatory Approach
Very comfortable Somewhat comfortable Not very comfortable Not at all comfortable Don't know / No answer

Option 4: Regulatory Approach
Very comfortable Somewhat comfortable Not very comfortable Not at all comfortable Don't know / No answer

(d) If there are any additional policy options that Health Canada and the Canadian Food Inspection Agency (CFIA) should consider, please provide a brief description below. (max 100 words)

F. Additional Feedback

Please list any other issues or perspectives regarding precautionary labelling of priority allergens that Health Canada should consider as part of this consultation?

G. Identifying Information

For individuals:

ID2. Which of the following best explains your personal situation:

(a) I have food allergies (b) I am the parent of a child with food allergies (c) both a and b Other: specify

Other: specify

For organizations:

ID2. On behalf of what organization are you responding to this consultation?

ID3. What type of organization is this?

a. Academia b. Industry c. Government d. Allergic Consumer Association e. Health Professional Association f. Youth Organizations g. Other: please specify

Approximately how many members?

Other: specify

ID4. What is your role within this organization?

Other Information

For further information about this public consultation or food allergen labelling please refer to the following Web sites:

• Allergen Labelling
• Comments on Food Allergen Regulatory Project
• Food Allergies
• Food Allergies and Intolerances
• Food Allergen Precautionary Statements