Health Canada
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Food and Nutrition

Product-Specific Authorization of Health Claims for Foods

A proposed regulatory framework

Bureau of Nutritional Sciences Food Directorate
Health Products and Food Branch
Health Canada
October 2001

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TABLE OF CONTENTS

1. INTRODUCTION

1.1 About this document
1.2 About this proposed regulatory framework
1.3 How this proposal differs from that for diet-related health claims for foods

2. IMPLEMENTATION OF POLICY ON HEALTH CLAIMS FOR FOODS

2.1 Progress to date
2.2 Legislative framework in Canada governing health claims on foods
2.3 Need for regulatory oversight

3. KEY ELEMENTS OF PROPOSED REGULATORY FRAMEWORK

3.1 Application
3.2 Permitted claims
3.3 Proposed conditions of authorization
3.4 Compliance with authorization
3.5 Notification of change
3.6 Cancellation or suspension of Claim Identification Number

4. ISSUES CONSIDERED IN DEVELOPING THE PROPOSED REGULATORY FRAMEWORK

4.1 Product-specific authorization
4.2 Product-specific claims
4.3 Therapeutic claims
4.4 Claims not requiring premarket assessment
4.5 Timelines for product review
4.6 Transparency of product review process and access to information

5. HOW TO COMMENT

5.1 What I should consider as I prepare my comments
5.2 Submitting comments

6. ANNEXES


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