REFERENCE DATABASE FOR HAZARD IDENTIFICATION - 1 - 2008-03-01 - 2 - 2008-03-01 TABLE OF CONTENTS Page Introduction 4 Part I Product Ingredients and Incoming Materials 7 Summary Table of Product Ingredients and Incoming Materials - TABLE 1 8 Product Ingredients and Incoming Materials – Details - TABLE 2 12 Food Additive Reference - TABLE 3 49 Food Additives –TABLE 4 49 Part II Processing Steps 64 Summary Table of Processing Steps – TABLE 1 65 Processing Steps – Details – TABLE 2 72 Part III Plant Layout (Cross Contamination Zone) 148 Part IV Biological Hazards Section 151 Fact Sheets for Biological Agents in Food – TABLE 1 153 Part V Chemical Hazards Section 176 Food Causing Adverse Reactions (Allergy and Intolerance) 177 1.0 Introduction, Health Canada /CFIA Priority Allergen List 177 2.0 Causes and Sources of Undeclared Allergens 184 3.0 Regulations Affecting Food Causing Adverse Reactions in Canada 186 4.0 Proposed Regulatory Amendments 189 5.0 Hazard Analysis Critical Control Points (HACCP) Systems 189 6.0 Good Manufacturing Practiecs (GMPs) 191 7.0 Allergen Prevention Plan (APP) 191 8.0 References 191 Annex 1 – Developing your Allergen Prevention Plan 193 Nutrition Hazards Section 195 Nutrition Hazard 195 1.0 Introduction 196 2.0 Information on Vitamins and Mineral Nutrients 197 3.0 List of Acceptable Vitamin Compounds and Mineral Salts which may be used for fortification 225 4.0 Regulations Affecting the Addition of Vitamin and Mineral Nutrients to Food 228 5.0 Proposed Regulatory Amendments 229 6.0 Process Control 230 7.0 References 234 Part VI Physical Hazards Section 236 1.0 Introduction 237 2.0 Extraneous Matter Guidelines 238 3.0 Factors in Determining Risks 239 4.0 Control of Physical Hazards 239 5.0 References 241 Part VII References 242 - 3 - 2008-03-01 INTRODUCTION The Reference Database for Hazard Identification is a tool designed for use by food processors, HACCP coordinators and HACCP consultants to assist in identifying food and food-borne hazards in production and processing when planning and implementing food safety procedures, GMPs or HACCP plans. The manufacturer / importer is responsible for the safety of food sold. The Food and Drugs Act states that: 4. No person shall sell an article of food that (a) has in or on it any poisonous or harmful substance; (b) is unfit for human consumption; (c) consists in whole or in part of any filthy, putrid, disgusting, rotten, decomposed or diseased animal or vegetable substance; (d) is adulterated; or (e) was manufactured, prepared, preserved, packaged or stored under unsanitary conditions. 5. (1) 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. (2) An article of food that is not labelled or packaged as required by, or is labelled or packaged contrary to, the regulations shall be deemed to be labelled or packaged contrary to subsection (1). 7. No person shall manufacture, prepare, preserve, package or store for sale any food under unsanitary conditions. In designing a Hazard Analysis and Critical Control Points (HACCP) program, it is recommended that food enterprises follow the steps of the Logic Sequence for Application of HACCP as identified by the Codex Alimentarius. The first 5 steps include: 1. assemble HACCP team; 2. describe your product and identify its intended use 3. list product ingredients and incoming material 4. construct a process flow diagram and, plant schematic 5. verify on-site , your process flow diagram and plant schmatic - 4 - 2008-03-01 Then, after having completed these 5 steps, the sixth step requires listing all of the potential hazards associated with each product for each processing step. A hazard is a condition or circumstance having the potential to cause illness or harm to a consumer. Hazards can be biological, chemical or physical. Only after identifying all of the potential hazards will the HACCP team then proceed with the steps of conducting hazard analyses and considering measures to control any of the identified hazards. For many establishments working on implementing HACCP, the sixth step – listing all of the potential hazards associated with each product for each processing step - can be a challenging and limiting step. It can be quite difficult to insure that ALL of the potential risks and sources of exposures to hazards are considered within a food production or processing environment. The user can access this database to find a list of known hazard(s) related to incoming materials, processing steps and plant layout (e.g.: cross-contamination zones) that should be considered. The database includes biological, chemical and physical hazards. It is felt that the consultation and use of this database will facilitate the hazard identification exercise and will result in more accurate, effective and uniform HACCP plans. Every effort has been taken to create a complete listing of known hazards. It must be understood that this reference database is a guide to hazard identification and that the HACCP team is responsible to ensure that any additional hazards specific to a food premise will be considered and evaluated. In addition to this database, reference texts, Health Canada reports on food safety related illness, recalls and complaints, your company’s complaints file and other review papers should be consulted. The database is manually organized and overseen, and is continually updated. It is recognized that further revisions will be necessary to ensure that the database reflects changing conditions. Users can submit information or proposed changes or additions to existing data that will be reviewed and verified prior to acceptance. Individuals with expertise on a substance are invited to review information submitted for inclusion in the database system. If the user finds missing, inaccurate or incomplete information, it would be appreciated if comments be sent to: Manager, Inspection Strategies Section Food Policy Coordination Division Food Safety Directorate Telephone: (613) 221-1340 Fax: (613) 228-1384 E-mail: [email protected] DISCLAIMER: Please note that every effort has been made to ensure that the information found within this database is current and accurate. We accept no responsibility for the accuracy, adequacy, or reliability of the information, or for any loss or injury resulting from the use of the information. We would suggest consulting the applicable legislation or appropriate authority for confirmation of all data prior to application. While many aspects related to food safety hazards as found in the data base may be regulatory based, the document itself is meant for use as a general reference tool. Please consult the applicable legislation or appropriate authority for confirmation or discussion regarding specific regulatory requirements. - 5 - 2008-03-01 PART I PRODUCT INGREDIENTS AND INCOMING MATERIALS - 6 - 2008-03-01 PRODUCT INGREDIENTS AND INCOMING MATERIALS Part I Product Ingredients and Incoming Materials With respect to the evaluation of food safety in a food processing environment, one of the initial steps is the identification of hazards as they relate to food ingredients and other incoming materials. There are three broad categories of hazards associated with foods: biological, chemical and physical. This section of the Reference Database for Hazard Identification aims to provide general information on the different hazards that are potentially associated with common product ingredients and incoming materials. Table 1 lists the most common product ingredients and incoming materials that are used in or on food products. On the right side of the table, there are three columns headed by the letters “B”, “C” and “P”. These letters stand for biological, chemical and physical hazards respectively. Table 2 lists hazard information of the most common product ingredients and incoming materials. Additional information such as references to relevant sections in the Regulations, allergen and nutrition information are also included. For more information on specific hazards, please refer to Part IV for biological hazards, Part V for Chemical hazards including allergen and nutrition hazards, and Part VI for physical hazards. It is understood that food additives should not be considered as a threat to consumers’ health and safety when used in accordance with the Food and Drug Regulations (FDR). Table 3 is a list of food additives permitted for use in Canada as per Division 16 of the FDR. The table has eight columns with the additive names, FDR references, Dairy, Egg, Meat, Fruits & Vegetables (includes Fresh and Processed Fruits and Vegetables, Maple and Honey), Fish and Unstandardized Food/Others. The “X” or “X*” appears where the food additive is permitted for use. When only an “X” appears, it means that the food additive should be used in accordance with good manufacturing practices. When an asterisk appears beside the “X’, i.e. “X*”, this indicates a standard exists for the use of the additive in some specific products. Users are recommended to consult the FDR for information on exactly which additives are allowed in which foods and the maximum levels of usage permitted. http://laws.justice.ca/en/F-27/C.R.C.- c.870/124280.html#rid-124284 Please be aware that certain substances and ingredients are not permitted (eg toxic herbs) for use in foods. There are also substances that may be permitted only in natural health products (NHP) or drugs. Novel foods are substances that do not have a history of safe use in foods, and would require a safety assessment from Health Canada before they can be used in foods. Please note that it is the responsibility of the dealer or legal agent to ensure the safety of their products. Note: This section does not contain a complete listing of all possible ingredients and incoming materials and their associated hazards.