Food Safety Practices Guidance for Fresh Non-Filled Alimentary Paste Manufacturers

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Table of Contents

Preface

Alimentary paste, also known as pasta, macaroni or noodles, has been a food staple for many years and continues to be a healthy, convenient and affordable food. Traditionally this commodity was prepared and sold uncooked and dry, allowing it to be stored safely at room temperatures for long periods of time while still retaining its characteristic flavour and texture. With new technology and packaging techniques, it is now common to see alimentary paste sold in a fully cooked, partially cooked, or fresh uncooked form, with a refrigerated shelf life of 60 days or more.

While dry alimentary paste has had a relatively safe food history, it is not without risk. Pasta has been implicated in a number of outbreaks of staphylococcal food poisoning and salmonellosis (ICMSF 1988). Flour, the principle ingredient, is a raw agricultural commodity as there is generally no kill step in milling that will eliminate microbes. As a result, microbes, including pathogens such as Salmonella, are not eliminated and have been found at low incidence (Sperber 2003). Egg, also used in some forms of pasta, can be a possible source of Salmonella and Staphylococcus aureus (ICMSF 1988). Other risks of alimentary paste include mycotoxin contamination, associated with flour from grain contaminated with mycotoxigenic fungi (Lund et al. 2000), and the presence of undeclared food allergens. The presence of undeclared allergens in pre-packaged foods is an industry wide issue and has resulted in a number of recalls of alimentary paste products.

Fresh alimentary paste manufacturers have to deal with the concerns associated with dry alimentary paste, as well as those concerns associated with high moisture, refrigerated foods with an extended shelf life. These could include the growth of pathogenic microorganisms such as Listeria monocytogenes, Bacillus cereus and Clostridium botulinum.

Risk can be significantly reduced by the manufacturer through strict adherence to Good Manufacturing Practices (GMPs), especially where the principles of Hazard Analysis Critical Control Point (HACCP) are applied to the process.

In an effort to help reduce the risks associated with fresh alimentary paste and assist manufacturers that wish to adopt the HACCP approach, CFIA has developed the Food Safety Practices Guidance for Fresh Non-Filled Alimentary Paste Manufacturers document. The core of the guide is the General Principles of Food Hygiene Composition and Labelling (GPFHCL) and it is supplemented with additional reference material, in an attempt to provide fresh alimentary paste manufacturers with specific guidance on potential hazards and controls related to a HACCP approach. This guidance document is also designed to address other factors that affect integrity of the product including composition, compliance to standards and labelling requirements. It was developed by CFIA with input from a number of interested parties, including the Canadian alimentary paste industry, Health Canada and provincial government representatives, and is being offered to manufacturers as a food safety resource.

HACCP is a systematic approach that assesses each step in a food manufacturing process for potential hazards and identifies controls to prevent their occurrence. HACCP is recognized by regulators, industry and academia as a reliable food safety approach available to the food industry. Prior to the application of HACCP, an establishment should be operating in accordance with GMPs, applicable food safety legislation and have the guidance of a person trained in HACCP. The GMPs (prerequisite programs) serve as the building blocks upon which a HACCP plan is built.

A HACCP system is developed following a careful review and analysis of the unique processing facility in which it is to be implemented. Chapter 1 of this guidance document primarily provides guidance related to hazard analysis and control of the manufacturing process, while chapters 2 to 8 provide guidance related to a generic prerequisite program. The intent of this guidance document is that manufacturers wishing to develop their own HACCP program can modify or adapt this generic guide to suit their particular facility and operation.

It is hoped that this document will complement existing references and the initiatives of other agencies, to make it easier for fresh alimentary paste manufacturers to adopt a HACCP approach and ultimately produce the safest product possible.

Scope

The scope of this guidance document includes fresh, non-filled, alimentary paste composed of a flour source (e.g. durum semolina, whole wheat, soy and/or rice flour), water, egg, other ingredients (e.g. spinach powder and tomato powder) and spices or seasonings (e.g. garlic powder). Products included in the scope of this guidance document cover long and short, cut and extruded alimentary pastes, as described in Section B.13.051 of the Food and Drug Regulations (FDR) (e.g. macaroni, spaghetti, noodles and other similar alimentary pastes).

The following are not included in the scope of this guidance document: fully cooked ready-to-eat pasta; dry pasta; filled pasta (e.g. with meat, cheese or vegetables); and dough to which cheese, meat or potato has been added. Although fortified flour may be used in the production of fresh alimentary paste, this guidance document does not include fortification of fresh alimentary paste at the manufacturing level.

Packaging includes consumer and institutional packages in varying materials and types of packaging processes (e.g. foil, plastic and cardboard, modified atmosphere packaging [MAP], including vacuum packaging, and non-modified atmosphere packaging).

Food items that are included in the scope of this document are products that are sold fresh at refrigerated temperatures or that are sold as frozen. Fresh alimentary paste is not considered ready-to-eat as it requires a cooking step before consumption.

Hazard Summary for Fresh Non-Filled Alimentary Paste

The following table illustrates potential hazards and possible control measures associated with the manufacture of fresh alimentary paste. This table may not cover all possible ingredients, process steps or all potential hazards associated with fresh alimentary paste. The manufacturer is responsible for identifying hazards specific to their operation and for determining how each hazard could be controlled. For additional information, refer to specific sections of this document as provided in the Reference column.

Hazard Summary for Fresh Non-Filled Alimentary Paste
Process Step Potential Hazards Control Measures Reference
Incoming Materials/ Receiving Presence of pathogenic microorganisms (e.g. Salmonella spp., pathogenic strains of Escherichia coli, Listeria monocytogenes) in flour, and/or in other ingredients (e.g. liquid whole egg, spices and other dry ingredients) and on packaging material.

Obtain a guarantee from supplier(s) that incoming materials and ingredients (e.g. flour, spices, other dry ingredients, liquid whole egg and packaging materials) meet the manufacturer's purchase specifications (e.g. the supplier provides a Letter of Guarantee).

Obtain a Certificate of Analysis for each lot of flour or other ingredients at risk (e.g. spices and liquid whole egg) to confirm that they do not contain Salmonella spp., pathogenic strains of E. coli or pose any other microbial hazard.

Inspect each carrier prior to receiving incoming materials and ingredients to ensure that no conditions exist (e.g. unclean vehicle, state of disrepair) that could have resulted in contamination.

Inspect all incoming ingredients and materials at receiving to confirm purchase specifications are met.

Do not accept and/or use incoming ingredients and materials that do not meet specifications.

At a scheduled frequency, analyze representative samples of incoming ingredients and materials to verify the accuracy of Certificates of Analysis and/or that the incoming ingredients and materials meet purchase specifications as indicated in Letter(s) of Guarantee.

1.4
6.1
1.11
Incoming Materials/ Receiving Growth of microorganisms in liquid whole egg during transportation.

Obtain a guarantee from supplier(s) that liquid whole egg meets the manufacturer's purchase specifications (e.g. the supplier provides a Letter of Guarantee).

Check temperature of incoming liquid whole egg at receiving (4°C or less).

Do not accept and/or use incoming ingredients and materials that do not meet specifications.

1.4
Incoming Materials/ Receiving Presence of nutrients (vitamins and minerals) above the maximum or below the minimum allowable limits in fortified flour.

Obtain a guarantee from supplier(s) that incoming flour meets the manufacturer's purchase specifications (e.g. the supplier provides a Letter of Guarantee).

Inspect all incoming ingredients and materials at receiving to confirm purchase specifications are met.

Do not accept and/or use incoming ingredients and materials that do not meet specifications.

At a scheduled frequency, analyze representative samples of incoming goods to verify the accuracy of Certificates of Analysis and/or that the incoming goods meet purchase specifications as indicated in Letter(s) of Guarantee.

1.4
1.11
Incoming Materials/ Receiving Presence of mycotoxins (e.g. vomitoxin, aflatoxin, ochratoxin) in flour, spices and other dry ingredients.

Obtain a guarantee from supplier(s) that incoming ingredients (e.g. flour, spices, other dry ingredients) meet the manufacturer's purchase specifications (e.g. the supplier provides a Letter of Guarantee).

Inspect all incoming ingredients and materials at receiving to confirm purchase specifications are met.

Do not accept and/or use incoming ingredients and materials that do not meet specifications.

At a scheduled frequency, analyze representative samples of incoming ingredients to verify the accuracy of Certificates of Analysis and/or that the incoming ingredients meet purchase specifications as indicated in Letter(s) of Guarantee.

1.4
1.11
Incoming Materials/ Receiving Presence of ethylene chlorohydrin above limits allowed by regulation and/or presence of irradiation by-products in spices.

Obtain a guarantee from supplier(s) that spices meet the manufacturer's purchase specifications (e.g. the supplier provides a Letter of Guarantee).

At a scheduled frequency, analyze representative samples of spices to verify the accuracy of Certificates of Analysis and/or that the incoming spices meet purchase specifications as indicated in Letter(s) of Guarantee.

1.4
1.11
Incoming Materials/ Receiving Presence of undeclared allergens (e.g. soy, wheat, egg, sulphites, milk, tree nuts, peanuts, sesame seeds, fish) in incoming ingredients and/or packaging materials.

Obtain a guarantee from supplier(s) that incoming materials and ingredients (e.g. flour, spices, other dry ingredients, liquid whole egg, packaging materials and gas) meet the manufacturer's purchase specifications (e.g. the supplier provides a Letter of Guarantee).

Inspect each carrier prior to receiving incoming materials and ingredients to ensure that no conditions exist (e.g. unclean vehicle, state of disrepair) that could have resulted in contamination.

Inspect all incoming ingredients and materials at receiving to confirm purchase specifications are met.

Do not accept and/or use incoming ingredients and materials that do not meet specifications.

At a scheduled frequency, analyze representative samples of incoming goods to verify the accuracy of Certificates of Analysis and/or that the incoming goods meet purchase specifications as indicated in Letter(s) of Guarantee.

1.4
6.1
1.11
Incoming Materials/ Receiving Presence of hazardous extraneous material in incoming ingredients and/or packaging materials (e.g. glass, stones, metal, wood).

Obtain a guarantee from supplier(s) that incoming materials and ingredients (e.g. flour, spices, other dry ingredients, liquid whole egg, packaging materials and gas) meet the manufacturer's purchase specifications (e.g. the supplier provides a Letter of Guarantee).

Inspect each carrier prior to receiving incoming materials and ingredients to ensure that no conditions exist (e.g. unclean vehicle, state of disrepair) that could have resulted in contamination.

Inspect all incoming ingredients and materials at receiving to confirm purchase specifications are met.

Do not accept and/or use incoming ingredients and materials that do not meet specifications.

1.4
6.1
Incoming Materials/ Receiving Presence of potentially hazardous chemicals in excess of safe levels (e.g. food additives, pesticides, heavy metals) in ingredients.

Obtain a guarantee from supplier(s) that incoming ingredients (e.g. flour, spices, other dry ingredients, liquid whole egg) meet the manufacturer's purchase specifications (e.g. the supplier provides a Letter of Guarantee).

Inspect each carrier prior to receiving incoming ingredients to ensure that no conditions exist (e.g. unclean vehicle, state of disrepair) that could have resulted in contamination.

Inspect all incoming ingredients at receiving to confirm purchase specifications are met.

Do not accept and/or use incoming ingredients that do not meet specifications.

At a scheduled frequency, analyze representative samples of incoming ingredients to verify the accuracy of Certificates of Analysis and/or that the incoming ingredients meet purchase specifications as indicated in Letter(s) of Guarantee.

1.4
6.1
1.11
Storage of Incoming Materials Growth of microorganisms in liquid whole egg due to elevated storage temperatures (e.g. above 4°C) for an extended period of time (time/temperature abuse). Monitor storage temperatures regularly to ensure that temperatures are controlled to minimize growth of microorganisms. 6.2
Storage of Incoming Materials Growth of microoganisms in liquid whole egg in storage due to a failure to rotate incoming products. Monitor rotation of liquid whole egg in storage regularly to minimize the growth of microorganisms. 6.2
Storage of Incoming Materials Contamination of ingredients with allergens due to inadequate separation from allergens or product containing allergens in storage.

Clearly identify allergens and/or products that contain allergens in storage.

Store allergens and products containing allergens separately from other ingredients and/or products that do not contain allergens.

6.2
Storage of Incoming Materials Contamination of flour stored in a silo where flour containing an allergen was previously stored. Monitor the storage of flour in silos to ensure that dedicated silos are used for flour containing allergens and/or silos are emptied and cleaned prior to the addition of each load of flour. 6.2
Storage of Incoming Materials Contamination of ingredients with non-food chemicals (e.g. cleaning product) due to improper storage procedures. Store non-food chemicals separately from food ingredients and packaging materials. 6.2
Sifting/ Screening Contamination of flour and dry ingredients with hazardous extraneous material due to inadequate cleaning and/or damaged screens. Monitor cleaning of screens and inspect them regularly to ensure that they are free from accumulated material and are in good operating condition (i.e. free from damage). 1.8
2.1
Sifting/ Screening Contamination of ingredients by metal fragments due to equipment and utensil wear and tear. Monitor equipment and utensils regularly to ensure that they are in good operating condition (e.g. not showing signs of wear, no cracks) as part of an effective preventive maintenance program. 1.8
2.1
Ingredient Weighing/ Measuring/ Mixing Presence of undeclared allergens in dough due to the incorrect addition of allergens or rework containing allergens that do not appear in the recipe or in the list of ingredients. Monitor the addition of ingredients, including rework, regularly to ensure that the correct ingredients are added as indicated in the recipe and on the list of ingredients of the final product. 1.6
1.8
Ingredient Weighing/ Measuring/ Mixing Contamination of dough with undeclared allergens due to ingredient changes, substitutions and/or additions that are not properly identified in recipes, formulations and/or on product label.

Update written product formulae to reflect ingredient changes or substitutions.

Review formulae regularly to ensure that allergens present in the recipe are clearly identified.

Assess changes in formula and make appropriate changes (where required) to product labelling.

1.1
1.6
Ingredient Weighing/ Measuring/ Mixing Contamination of dough with undeclared allergens due to a failure to control dust containing allergenic ingredients. Monitor air intake systems and filters regularly to ensure that they are in good operating condition as part of an effective preventive maintenance program. 2.1
3.2
Ingredient Weighing/ Measuring/ Mixing Contamination of dough due to pathogenic microorganisms in the water.

Use only potable water.

Test water and, where necessary, treat water (e.g. filter and/or chlorinate) regularly to ensure it meets Health Canada's Guidelines for Canadian Drinking Water Quality.

3.4
Sheeting/ Forming/ Extruding Contamination of dough and/or rework with pathogenic microorganisms due to incorrect addition of defective or suspect product that was not appropriately identified and/or isolated to prevent its use. Control returned, defective or suspect products (e.g. clearly identify and isolate in a designated area) until appropriate safe disposition has been made. 1.10
6.2
Sheeting/ Forming/ Extruding Contamination of dough by metal fragments due to equipment and utensil wear and tear. Monitor equipment and utensils regularly to ensure that they are in good operating condition (e.g. not showing signs of wear, no cracks) as part of an effective preventive maintenance program. 2.1
Cooling/ Drying Contamination of alimentary paste with pathogenic microorganisms due to contact with inappropriately sourced and/or contaminated air used for cooling and/or drying.

Use an appropriate and acceptable source of air and, where necessary, ensure air is filtered.

Monitor air intake systems and filters regularly to ensure that they are in good operating condition as part of an effective preventive maintenance program.

2.1
3.2
Cooling/ Drying Growth of pathogenic microorganisms in alimentary paste due to ineffective cooling/drying caused by malfunctioning equipment (e.g. warm alimentary paste allowing for growth of pathogenic microorganisms). Monitor cooling and drying equipment regularly to ensure that they are in good working condition as part of an effective preventive maintenance program. 2.1
Cooling/ Drying Contamination of alimentary paste by non-food chemicals (e.g. refrigerant) due to a refrigerant leak during cooling. Monitor cooling units regularly to ensure that they are in good condition (e.g. not leaking refrigerant) as part of an effective preventive maintenance program. 2.1
Cutting Contamination of alimentary paste by metal fragments due to equipment and utensil wear and tear. Monitor equipment and utensils regularly to ensure that they are in good operating condition (e.g. not showing signs of wear, no cracks) as part of an effective preventive maintenance program. 2.1
Weighing/ Packaging/ Labelling/ Coding Presence of undeclared allergens (e.g. soy, wheat, eggs) in the finished product due to incorrect label application, use of incorrect packaging and/or use of incorrect list of ingredients on the label and/or illegible label. Monitor labelling procedures regularly to ensure that the label has the correct list of ingredients and that the correct label is applied to the correct product. 1.2
1.9
Weighing/ Packaging/ Labelling/ Coding Incorrect/illegible or missing code and/or best before date on finished product label resulting in an inability to recall product. Monitor product code and/or best before date regularly to ensure correct code and/or best before date is applied to product and the code is accurate and legible. 1.2
1.7
Weighing/ Packaging/ Labelling/ Coding Growth of pathogenic microorganisms, specifically Listeria monocytogenes, Clostridium botulinum and Staphylococcus aureus in Modified Atmosphere Packaged finished product, in conjunction with an excessive shelf life (best before date). Ensure that the product best before date is supported by an appropriate scientific reference or shelf life study that is related to the product's safety rather than just its quality. The manufacturer could choose to incorporate measures that minimize microbial growth (e.g. pH, water activity (aW), preservatives) into the product formulation. 1.3
Metal Detection Contamination of finished product with metal fragments due to improper calibration of the metal detector. Calibrate the metal detector regularly to ensure that it is functioning as intended. 1.8
2.1
Metal Detection Contamination of finished product with metal fragments due to ineffective detection by the metal detector and/or failure of the metal detector to function appropriately when metal is detected. Monitor and control the function of the metal detector regularly. 1.8
Finished Product Storage Growth of pathogenic microorganisms in finished product due to elevated storage temperatures (above 4°C) for an extended period of time. Monitor storage temperatures regularly to ensure that the temperatures are controlled to minimize growth of pathogenic microorganisms. 6.2
Finished Product Storage Cross-contamination of finished product (e.g. unpackaged product) with allergens due to inadequate separation from product containing allergens in storage.

Clearly identify products that contain allergens in storage.

Store products containing allergens separately from other products that do not contain allergens.

6.2
Finished Product Storage Contamination of finished product with non-food chemicals (e.g. cleaning product) due to improper storage procedures. Store chemicals in a separate location from all food and packaging materials. 6.2
Finished Product Storage Contamination of finished product with pathogenic microorganisms and/or allergens due to a failure to identify and/or isolate returned, defective or suspect product. Control (e.g. clearly identify and isolate in a designated area) returned, defective or suspect products until appropriate safe disposition. 6.2
Shipping/ Distribution Contamination of finished product with pathogenic microorganisms, hazardous extraneous material and/or chemicals due to unsanitary carriers, and/or damaged packaging. Monitor carrier regularly while loading to ensure that transportation conditions (including temperature requirements) meet the requirements for the product being shipped. 6.1
Shipping/ Distribution Growth of pathogenic microorganisms in finished product due to improper distribution temperatures. Monitor carrier regularly while loading to ensure that transportation conditions (including temperature requirements) meet the requirements for the product being shipped. 6.1
All Process Steps Contamination of alimentary paste with pathogenic microorganisms, chemicals, allergens and hazardous extraneous material due to employee error as a result of a lack of training and/or a failure to understand the importance of following written standard operating procedures (SOPs) and/or Good Manufacturing Practices (GMPs).

Regularly provide employees (including appropriate managers and responsible persons) with training in standard operating procedures (SOPs) and/or Good Manufacturing Practices (GMPs) appropriate to their position and the work being done.

Monitor employees performing their duties regularly while work is being done.

5.2
All Process Steps Contamination of alimentary paste with pathogenic microorganisms, chemicals, allergens and/or hazardous extraneous material due to improper employee handling practices.

Provide employee training in proper hygiene and correct handling procedures regularly.

Monitor employee practices regularly.

5.1
5.2
All Process Steps Contamination of alimentary paste with pathogenic microorganisms and/or chemicals (e.g. cleaning products) due to improper cleaning and/or sanitizing of utensils, equipment and facilities and/or the inadequate separation of equipment cleaning and sanitizing facilities.

Monitor sanitation procedures regularly and verify the effectiveness of the sanitation program.

Monitor facilities for cleaning and sanitizing equipment regularly to ensure they are adequately designed, constructed and maintained to prevent contamination.

3.3
4.1
All Process Steps Cross-contamination of alimentary paste with allergens (e.g. soy, wheat, egg) due to a failure to use dedicated equipment and utensils. Monitor procedures regularly to ensure that, where applicable, products containing allergenic ingredients are manufactured in dedicated equipment using dedicated utensils. 3.2
All Process Steps Cross-contamination of alimentary paste with undeclared allergens as a result of improper cleaning of equipment and utensils between products that contain allergens and products that do not contain allergens.

Monitor sanitation procedures regularly and verify the effectiveness of the sanitation program.

Monitor the use of utensils and equipment regularly to ensure that there is no cross-utilization between products and/or between product lines to prevent cross-contamination of allergens between products containing allergens and products that do not.

3.2
4.1
All Process Steps Cross-contamination of alimentary paste with allergens from one production line to an adjoining line due to inadequate separation as the result of poor plant design. Ensure plant layout (design) provides adequate separation from one production line to another in order to prevent cross-contamination of allergenic ingredients. 2.1
3.2
All Process Steps Growth of pathogenic microorganisms in liquid whole egg, rework, in-line alimentary paste and/or finished product due to exposure to elevated processing room temperatures (e.g. above 4°C) for an extended period of time (time/temperature abuse). Monitor the time, temperature and, where applicable, humidity regularly during preparation, mixing and holding of ingredients (e.g. liquid whole egg), in-process products (e.g. dough) and finished products to minimize growth of microorganisms. 1.6
1.8
All Process Steps Contamination of alimentary paste from pathogenic microorganisms, hazardous extraneous material, and/or chemicals (including lubricants) due to improper equipment design (including construction materials), improper equipment installation and/or improper equipment maintenance (including inadequate clean up after maintenance).

Use only equipment that has been properly designed and installed to ensure that it will not contaminate food.

Monitor equipment maintenance (including clean-up after maintenance) regularly to ensure maintenance activities are effective and procedures and program are effective.

2.1
All Process Steps Contamination of alimentary paste from pathogenic microorganisms, chemicals and/or hazardous extraneous material due to contamination from overhead structures (e.g. leaking pipes, flaking paint). Monitor overheads regularly to ensure that they are in good condition (e.g. no leaking pipes or flaking paint) as part of an effective preventive maintenance program. 3.2
All Process Steps Contamination of alimentary paste with pathogenic microorganisms due to contaminated air. Monitor air intake systems and filters regularly to ensure that they are in good operating condition as part of an effective preventive maintenance program. 2.1
3.2
All Process Steps Contamination of alimentary paste with pathogenic microorganisms or allergens due to lack of adherence by employees and visitors to rules controlling cross-contamination between rooms or areas in the processing facility (e.g. use of foot dips, hand dips, change of clothing).

Develop policies and/or protocols for the movement of employees and visitors in processing areas.

Regularly provide employees (including appropriate managers and responsible persons) with training in standard operating procedures (SOPs) and/or Good Manufacturing Practices (GMPs) appropriate to their position and the work being done.

Monitor the movement and activities of employees and visitors.

Post instructional signs.

5.1
5.2
All Process Steps Contamination of alimentary paste with pathogenic microorganisms due to a failure to maintain the concentration of sanitizers in hand dips/foot dips at a level adequate to control pathogenic microorganisms. Monitor the concentration of sanitizers in hand dips/foot dips regularly. 3.3
All Process Steps Contamination of alimentary paste with non-food chemicals, cleaning solutions, sanitizers and/or their residues as a result of improper usage, storage, handling or sanitation procedures.

Store non-food chemicals separately from food in a manner that prevents contamination.

Store and mix non-food chemicals in clean, correctly labelled containers that include instructions for use.

Monitor employees dispensing and handling non-food chemicals regularly to ensure that these tasks are only performed by authorized and properly trained personnel.

5.2
6.2
All Process Steps Contamination of alimentary paste with pathogenic microorganisms due to the presence of rodents, birds or insects. Monitor the effectiveness of the pest control program regularly. 4.2

Using the Guidance Document

Principle Statement

Principle statements are outcome-based generic statements of objectives similar to those found in the Recommended International Code of Practice – General Principles of Food Hygiene adopted by the Codex Alimentarius Commission (Codex). They are intended to capture the intent of the guideline while allowing flexibility in addressing specific products or processes.

Rationale

Rationales are included only when required to explain the principle statement. They are included in several chapters of this guidance document (Control of Operation, Equipment, Records and Complaint Handling and Recalls) to explain the nature of the concern or potential hazard(s) and the need for control.

Anticipated Outcomes

Anticipated Outcomes are intended to guide the industry by describing the factors influencing the objective underpinning the principle statement. The CFIA recognizes that there may be alternate means of meeting the intent of the principle statement other than those described in this guidance document. For example, these alternative means may include a specific process step that will be used to control an associated food safety risk or meet a regulatory requirement.

Chapter 1: Control of Operation

1.1 Product Formulation and Composition

1.1.1 Availability and Accuracy of Product Formulae

Current written formulae are available for each fresh alimentary paste product processed.

Rationale

Current written formulae provide a basis for assessment of food additives, composition, labelling, nutritional requirements and food allergens; and contribute to the production of a consistent product.

Anticipated Outcomes
  • Current, written formulae are available for each product.
  • A current technical data sheet is available for each raw material.
  • The formulae contain all details of the formulation as follows:
    • identification of all ingredients (e.g. brand/supplier, concentration, type, common name, specific name of food colours) and components (ingredients of ingredients);
    • amounts of all ingredients, including food additives and added nutrients.
  • Products are formulated to comply with food standards, where they exist (see FDR Sections B.13.051 and B.13.052 on Alimentary Paste).
  • Products are formulated to ensure accurate nutrition declarations (see Section 1.1.3 Compositional Requirements for further details).
  • Written formulae clearly identify allergens present in the formulation.
  • Written formulae are updated to reflect ingredient changes or substitutions to ensure that when allergens are present as an ingredient and/or a component of an ingredient, allergens are declared on finished product labels.

1.1.2 Identification of Factors Significant to Food Safety in Product Formulation

Any factors in the product formulation that are significant to a safe process and to the delivery of a product with a uniform composition are identified.

Rationale

Inadequate identification of either significant ingredients and their specifications, or key preparation/process steps, may indicate a lack of awareness or a lack of control of significant factors. This could result in an inadequate process, which could affect product safety or lead to inaccurate nutrient composition.

Anticipated Outcomes
  • Ingredients significant to the product's composition, nutritional profile, and to the safety of the process, are identified with their specifications and limits. For example:
    • freedom from Salmonella spp. in egg products, used in the manufacture of alimentary paste.
      Note: shell eggs may be contaminated with Salmonella spp., as a result, the use of shell eggs is discouraged. Where shell eggs are used, the manufacturer should confirm the safety of the finished product.
    • presence of possible allergens in flavours/colorants.
  • Formulation factors significant to the safety and integrity of the product are identified. This includes preparation/process steps and microbiological, chemical (e.g. allergens) or physical concerns (e.g. extraneous material). Their specifications and limits are identified (e.g. identification of the pH and/or water activity of the final product, freedom from Salmonella spp., etc.).
  • Manufacturers producing specialty products with allergen-"free" claims (e.g. no egg or egg-free fresh alimentary paste) ensure the allergen of concern (e.g. egg) is not present in the ingredients being used.

1.1.3 Compositional Requirements

The nutrient content of the food is controlled to meet declared label values and applicable requirements found in the Food and Drugs Act and Regulations. Foods for which nutrient content claims and health claims are made meet the compositional requirements of the Food and Drug Regulations. Products comply with food standards where they exist.

Rationale

Inaccurate nutrition information and nutrient content claims may pose a health risk for those who are making food choices based on the nutrient content of the food. Inadequate control of formulations and food composition may also result in product misrepresentation. Consumers expect that the declared composition, compositional standards, nutrition information and claims accurately reflect the food's composition.

Note: Manufacturers wishing to label their product as "enriched" fresh alimentary paste ensure the product's composition meets the regulatory requirements set out in Section B.13.052 of the Food and Drug Regulations.

Anticipated Outcomes
  • The manufacturer has control over the formulation to ensure that all nutrient content declarations and regulatory requirements are met.
  • The manufacturer ensures nutrient content claims on the label or in any advertisement (e.g. low in fat), are met by controlling product formulations and composition.
  • Product formulations are designed to ensure compositional requirements for products meet the regulated standards of identity and composition (e.g. products represented as egg noodles or egg alimentary paste have sufficient levels of egg to meet the compositional requirements set out in B.13.051).
  • The nutrient content of the product is accurately reflected on the label and is in compliance with the Food and Drug Regulations (e.g. the list of ingredients and Nutrition Facts Table are accurate and in compliance with the FDR).

Note: The following CFIA documents provide further guidance on composition and labelling issues:

  1. The Evaluation Standard for Nutrition Labelling addresses, in detail, the requirements of the Nutrition Facts table and the factors involved in determining nutrient content and producing a product with a consistent nutrient profile. This document may be found within the Nutrition Labelling Toolkit.
  2. The Guide to Food Labelling and Advertising provides detailed guidance on the requirements for nutrient content and diet-related health claims.
  3. The Nutritional Labelling Compliance Test constitutes the CFIA methodology for assessing the accuracy of nutrition labelling and claims (See section 6.11 of the Guide to Food Labelling and Advertising).

1.1.4 Food Additives

Food additives are controlled to meet the requirements of the Food and Drugs Act and Regulations.

Rationale

Inadequate control of food additives and/or processing aids could result in chemical or biological hazards.

Anticipated Outcomes
  • The manufacturer ensures that all food additives (e.g. food colors and/or preservatives) which are used are permitted for use in the particular food and meet the requirements of the Food and Drug Regulations (Division 16 for food additives) and other applicable regulations.
  • The manufacturer has chemical specifications (e.g. composition and concentration) for all food additives and/or processing aids and ensures that all specifications are met.
  • Where there are no specifications in the Food and Drugs Act and Regulations, the manufacturer ensures that all food additives and/or processing aids meet Food Chemical Codex (FCC) grade specifications or equivalent (e.g. specification sheets, clear identification of the grade on the additive package or blanket guarantees).
  • The manufacturer ensures that processing aids are used at levels in accordance with Good Manufacturing Practices (as per label instructions) and can demonstrate through calculations that food additives are used within the maximum level specified in the Food and Drug Regulations.

Note: A food processing aid is a substance that is used for a technical effect in food processing or manufacture, the use of which does not affect the intrinsic characteristics of the food and results in no or negligible residues of the substance or its by-products in or on the finished food. Upon request, the Food Directorate's Bureau of Chemical Safety, Health Canada will conduct a pre-market assessment and offer advisory comments on the status of a substance as a food additive or a processing aid, and its acceptability for use in food manufacturing or processing.

For additional information see Health Canada's Policy for Differentiating Food Additives and Processing Aids.

Also see the Guide to Food Labelling and Advertising, Chapter 2, Section 2.8.3, for further information relating to processing aids.

1.2 Labelling and Net Quantity

1.2.1 Labelling / 1.2.2 Net Quantity

The manufacturer has controls in place to ensure that the labels are complete and accurate, and meet the requirements of the Food and Drugs Act and Regulations, the Consumer Packaging and Labelling Act and Regulations and the Weights and Measures Act and Regulations, where applicable.

Rationale

Mandatory information on food labels allows consumers to make informed choices by providing:

  • Basic product information (e.g. the product's common name, list of ingredients, net quantity, durable life date, name and address of the manufacturer);
  • Health, safety and nutritional information (e.g. instructions for safe storage and handling, nutritional information in the form of a Nutrition Facts table).

Inadequate information on the label, such as storage and/or cooking instructions, may result in a biological hazard, as the product may become susceptible to temperature abuse and/or inadequate cooking.

Inaccurate labels may be considered false and misleading and in violation of Section 5(1) of the Food and Drugs Act.

Note: Mandatory information is determined, in part, by the regulatory requirements specific to the commodity in question.

Refer to Chapter 2 (Basic Labelling Requirements) and Chapters 5 to 8 (Nutrition Labelling and Claims) of the Guide to Food Labelling and Advertising for further details.

Labelling of Food Allergens

Inadequate allergen labelling could mislead consumers and could pose a potential health hazard to segments of the population with allergies.

Precautionary labelling may be used to alert consumers with food allergies to the potential presence of a food allergen in a food. Where priority food allergens may inadvertently be present in a food despite Good Manufacturing Practices (GMPs), a precautionary statement may be used following the ingredient list. Precautionary statements are not to be used when an allergen or allergen-containing ingredient is deliberately added to a food. Precautionary labels should be truthful, clear and non-ambiguous and should not be used in lieu of Good Manufacturing Practices.

Note: The CFIA website contains information and guidance for the food industry regarding food allergens, including more information on Canada's priority allergens and a Tool for Managing Allergen Risk in Food Products.

For additional information see Health Canada's policy on The Use of Food Allergen Precautionary Statements on Prepackaged Foods.

Anticipated Outcomes
  • The manufacturer has procedures in place to ensure that all mandatory information is properly declared on food labels in accordance with Canadian food labelling legislation, and that all label claims are accurate and not misleading.
  • Foods that contain or may contain ingredients that are on Canada's list of priority food allergens are labelled so that consumers are aware of their possible presence.
  • Where suppliers have labelled raw materials with a precautionary statement, such as "may contain soy", and the allergen is not present in the list of ingredients of the finished product, the manufacturer also uses an appropriate precautionary statement on the finished product label.
  • Where oils, starches or other allergen derived foods, such as lecithin or hydrolyzed protein, may contain any protein from the original allergen source, the manufacturer declares the food allergen source (e.g. soy oil, soy lecithin, egg lecithin or wheat starch).
  • Labels are reviewed both for compliance with Canadian legislation (e.g. presence of mandatory labelling), and for accuracy and correctness of information (e.g. complete list of ingredients, and where required, the components of those ingredients, presence of allergens). This may also include the assessment of compositional claims (e.g. "no preservatives") or nutritional claims (e.g. "enriched").
  • New labels and changes to current labels (e.g. changes to artwork, text and layout) are reviewed for compliance with Canadian legislation.
  • Incoming labels from labelling and/or printing companies are reviewed against signed-off proofs.
  • Corrective labels applied to products to bring them into compliance are reviewed against signed-off proofs.
  • Changes in packaging or formulation are assessed for their impact on product labelling.
  • The manufacturer has controls in place to ensure that the product's net quantity, as stated on the label, is in compliance with Section 39 of the Consumer Packaging and Labelling Regulations (CPLR) and Section 52 of the Weights and Measures Regulations (WMR).
  • Coding – Best Before Date

    Pre-packaged fresh alimentary paste products having a durable life of less than 90 days are labelled with a best before date code to advise the consumer the date by which the product should be consumed.

    • The manufacturer applies a best before date code in the specified format as per B.01.007 of the Food and Drug Regulations.
    • The best before date is permanent, visible and legible.
    • The best before date corresponds to the shelf life determined in the shelf life study
  • Labelling – Storage Temperature

    Proper labelling is applied to ensure that all persons handling the product are aware of the storage temperature requirements.

    Note: "Refrigeration" means exposure to a temperature of 4°C or less, but does not mean frozen.

    • All finished products are labelled with the statement "Keep Refrigerated".

      Note: Where fresh alimentary paste products are sold frozen they are labelled "Keep Frozen" with adequate storage instructions.

  • Labelling – Cooking Instructions

    Packages of fresh alimentary paste are not considered ready-to-eat and are therefore labelled with instructions that clearly advise the consumer to cook the product before consumption.

    • Finished products are labelled with adequate cooking instructions.
    • Cooking instructions are validated to achieve the desired outcome, which includes eliminating any risk from microorganisms of public health concern.
    • Cooking instructions are simple and easy to follow by the consumer.
    Note: where fresh alimentary paste products are sold frozen, instructions for thawing are applied where applicable.

1.3 Process Design

1.3.1 Process Design

The manufacturer demonstrates that foods do not develop any safety hazards (biological, physical or chemical) as a result of process design and that labelling inaccuracies are prevented.

Rationale

Written scientific evidence is necessary to demonstrate that each process adequately ensures the production of a safe product. An inadequate process could result in unintentional incorporation of ingredients (e.g. undeclared allergens) or in the lack of control of pathogenic microorganisms, toxins and other hazards.

Anticipated Outcomes
  • For every product, a written description of the process, including procedures, is available. Document control policies are in-place to ensure that copies of operational procedures and supporting information, available to personnel are always current (e.g. signed and dated).
  • The process is designed to result in finished products that meet Health Canada's guidelines for the microbiological safety of food. Health Canada has recommended limits on certain microorganisms in Fresh and Dry Alimentary Paste. For more detailed information see Health Canada's Compendium of Analytical Methods, Volume 1. Interpretive Summary, Standards and Guidelines for Microbiological Safety of Food.
  • The process is established using accepted scientific methods to minimize the risk associated with biological, chemical and physical hazards. Details of actual experimental methods are available.
  • Where dedicated processing lines are not used to control food allergen contamination, the manufacturer has established and validated procedures for product changeovers that do not result in undeclared allergens.
  • Food safety systems such as HACCP should be used to identify and control food hazards. All Critical Control Points (CCPs) for each product, including the critical limits for each CCP, are identified, tested, evaluated and validated in the development of the process. See the following Process Flow Diagram for a generic process flow and potential CCPs. For further information regarding CCP rationale, see the CFIA's HACCP Generic Model for Fresh Non-Filled Alimentary Paste.

    Note: Pasteurization is not included as a step in the accompanying example of a process flow diagram for the production of fresh non-filled alimentary paste. Nevertheless, where pasteurization or heat treatment is used, whether to extend the shelf life of the product or as an essential step intended to make the finished product safe to eat, the manufacturer needs to ensure the following: the process and associated operating parameters and procedures are validated, use of appropriately designed pasteurization equipment and information to support the effectiveness of this control measure are available. The manufacturer should evaluate the pasteurization step, using the HACCP decision tree, to determine if a CCP is appropriate to control the identified hazards. Further information regarding CCP determination may be found in the CFIA's Food Safety Enhancement Program Manual.

  • Any changes to the product formulation or the process are assessed to ensure there is no impact on the safety or composition of the product (e.g. changes to the type and/or amount of preservative used in the product or gas ratio used for Modified Atmosphere Packaging, which may have an impact on the shelf life of the product).

    Note: Products may become contaminated with pathogenic microorganisms by contaminated ingredients, improper handling, inadequate process controls or cross-contamination. Temperature abuse may further permit the growth of harmful pathogenic microorganisms such as Salmonella spp., Staphylococcus aureus, and Escherichia coli. Certain packaging methods (e.g. controlled or modified atmosphere packaging [including vacuum packaging]) slow the growth rate of aerobic microorganisms, largely responsible for signs of physical deterioration (e.g. discolouration or odour), but may not inhibit the growth of other pathogenic microorganisms, such as Clostridium botulinum or Listeria monocytogenes. The extended shelf life achieved by this type of packaging can increase the risk of serious food poisoning. To reduce the risk associated with pathogenic microorganisms, it is important for refrigerated foods with extended shelf life to be appropriately labelled with a validated best before date and instructions for storage such as "Keep Refrigerated". A validated best before date is one that is determined by food processing experts through shelf life tests carried out to verify the safety of the product at an assigned shelf life. The manufacturer may also choose to incorporate additional hurdles to existing process control measures (e.g. pH, water activity and/or preservatives) to further restrict the growth of pathogenic microorganisms.

  • The manufacturer has all information (records of tests or references) necessary to demonstrate that refrigerated fresh alimentary paste with extended shelf life will meet the microbiological guidelines recommended by Health Canada for these products, for the period of their assigned best before date.

See Section 7.2.1 for expected Process Design Records.

A Hazard Analysis and Critical Control Point (HACCP) system is a prevention-based food safety system designed to prevent, reduce to acceptable levels, or eliminate the biological, chemical, and physical hazards associated with food production. One strength of HACCP is its proactive approach to food safety that consists in preventing food contamination rather than trying to identify and control contamination after it has occurred. Fresh alimentary paste manufacturers may control food hazards through a system based on Hazard Analysis and Critical Control Point (HACCP) principles. They may:

  • identify hazards potentially associated with fresh alimentary paste and the fresh alimentary paste process;
  • identify any steps in their operations that are critical for controlling the safety of fresh alimentary paste;
  • implement effective control procedures at those steps by establishing critical limits;
  • monitor control procedures to ensure their continuing effectiveness;
  • have procedures in place for dealing with deviations from critical limits;
  • verify control procedures periodically and whenever the operations change; and
  • maintain records as specified in Chapter 7 of this guidance document.

A HACCP type program will reduce the risk of unsafe food by taking preventive measures to assure the safety and suitability of food at an appropriate stage in the operation by controlling food hazards.

The HACCP team at each establishment is responsible for the validation of the HACCP system; that is, first validating the hazards that exist in the facility and then validating that the standards for the prerequisite programs (GMPs) and the standards for the critical limits of the Critical Control Point(s) are able to control the hazards. A validation is also to be conducted whenever new procedures, policies or control measures are introduced. If scientific studies and/or government regulations exist in relation to the standard or critical limit, the facility may quote this information as the validation. If not, the facility conducts a validation study to validate the control measure through testing. Once the initial validation is completed during development of the HACCP system, the facility should conduct a validation of control measures at least once yearly. This yearly validation reviews all of the standards of the prerequisite programs (GMPs), as well as the critical limits of the control points, to ensure that these control measures continue to be effective in controlling the identified hazards.

For additional information on how to build a HACCP system see, Appendix A (Hazard Analysis And Critical Control Point (HACCP) Summary) of this guidance document, the HACCP Generic Model for Fresh Non-Filled Alimentary Paste and the CFIA's Food Safety Enhancement Program (FSEP) Manual.

Generic Process Flow Diagram identifying suggested Critical Control Points (CCPs) for Fresh Non-Filled Alimentary Paste

See the HACCP Generic Model for Fresh Non-Filled Alimentary Paste for more details.

Diagram - Generic Process Flow Diagram identifying suggested Critical Control Points (CCPs) for Fresh Non-Filled Alimentary Paste. Diagram

Description for the Generic Process Flow Diagram

This diagram is a flow chart showing the process for producing fresh non-filled alimentary paste.

The diagram lists the necessary steps from 1 - 14 to be taken in the fresh non-filled alimentary paste production process.

Identified in pink ovals are the Critical Control Points (CCPs). These are next to boxes 7, Ingredient weighing/measuring/mixing; 11, Weighing/packaging/labelling/coding; and 12, Metal detection.

Identified in an orange oval is water. This inputs to step 7, Ingredient weighing/ measuring/mixing. Also identified in an orange oval is rework. This receives inputs from steps 8, Sheeter/former/extruder; 9, Cooling/drying; and 10, Cutting; and leads to steps 7, Ingredient weighing/measuring/mixing; and 8, Sheeter/former/extruder.

Identified in a beige oval is returned product which leads to disposal, identified in a grey oval.

Potential for Biological (B), Chemical (C) and/or Physical (P) hazards is indicated in parentheses next to each process step.

  • Step 1 Receiving (BCP). Leading to steps 2, Flour storage; 3, Dry storage ; 4, Liquid whole egg (pasteurized) storage; and 5, Packaging material storage.
  • Step 2 Flour storage (BCP). Leading to step 6, Sifting/screening.
  • Step 3 Dry storage (spices and other ingredients). (BCP). Leading to steps 6, Sifting/screening; and 7, Ingredient weighing/measuring/mixing.
  • Step 4 Liquid whole egg (pasteurized) storage (BCP). Leading to step 7, Ingredient weighing/measuring/mixing.
  • Step 5 Packaging material storage (BCP). Leading to step 11, Weighing/packaging/labelling/coding.
  • Step 6 Sifting/screening (BCP). Leading to step 7, Ingredient weighing/measuring/mixing.
  • Step 7 Ingredient weighing/measuring/mixing (BCP). CCP-1C. Leading to step 8, Sheeter/former/extruder.
  • Step 8 Sheeter/former/extruder (BCP). Leading to/receiving input from rework. Leading to steps 9, Cooling/drying; and 10, Cutting.
  • Step 9 Cooling/drying (BCP). Receiving input from step 10. Leading to rework and steps 10, Cutting; and 11, Weighing/packaging/labelling/coding.
  • Step 10 Cutting (BCP). Leading to rework.
  • Step 11 Weighing/packaging/labelling/coding (BCP). CCP-2C. Leading to step 12, Metal detection.
  • Step 12 Metal detection (BCP). CCP-3P. Leading to step 13, Storage.
  • Step 13 Storage (BCP). Leading to step 14, Shipping/distribution.
  • Step 14 Shipping/distribution (BCP).

1.4 Incoming Material Control

Note: Where this document is adapted as a Prerequisite Program as part of a HACCP Plan, Section 1.4 Incoming Materials Control (Receiving) and all of its anticipated outcomes may be incorporated into Chapter 6 – Transportation and Storage, following the Food Safety Enhancement Program (FSEP) approach. Chapter 6 in turn may be renamed Transportation, Receiving and Storage.

1.4.1 Incoming Ingredients and Other Non-Packaging Inputs

The manufacturer controls incoming ingredients and other non-packaging inputs so that foods are not exposed to safety hazards (biological, physical and chemical), and they remain both safe and correctly labelled.

Rationale

Prevention of health hazards begins with control of incoming ingredients and other non-packaging inputs. Inadequate incoming product controls, such as a lack of appropriate product testing and sorting, or a failure to verify labels, could result in the sale of contaminated products or products that do not meet compositional standards. Specifications provide standards against which the manufacturer can assess the acceptability of the components necessary for the production of the finished product.

Note: The degree of control exercised is appropriate to the level of risk posed by the ingredient to the safety or compositional integrity of the food.

Anticipated Outcomes
  • The manufacturer has written specifications for all ingredients and obtains certificates of analysis (or equivalent supporting information, e.g. Allergen Checklist for Food Suppliers and Manufacturers) to demonstrate adherence to specifications, applicable regulations, and to ensure ingredients are free of hazards. For example:
    • Freedom from Salmonella spp. in eggs and other ingredients;

      Note: Flour is a minimally processed agricultural product and may contain pathogenic microorganisms (e.g. Salmonella) at very low levels. In addition, sampling of flour may not indicate the presence of pathogenic microorganisms. As a result, the manufacturer should obtain information regarding the supplying flour mill's control of pathogenic microorganisms (e.g. GMPs).

      Spices can be heavily contaminated with microorganisms due to growth, harvesting and processing conditions. Pathogens of concern include Salmonella spp., certain E. coli, Clostridium perfringens, Bacillus cereus and Staphylococcus aureus. This microbiological risk can be reduced by using treated spices. Spices can be treated with fumigants such as ethylene oxide, sterilized with steam, or irradiated to reduce the microbial load, including pathogens.

      Microbiological guidelines have been established for fresh and dry alimentary paste by Health Canada. These guidelines specify that fresh and dry alimentary paste should be free of Salmonella. See Health Canada's Compendium of Analytical Methods Volume 1. Interpretive Summary, Standards and Guidelines for Microbiological Safety of Food for additional information.

    • mycotoxins (e.g. vomitoxin in flour) if present are not at levels that would pose a health concern.
    • freedom from undeclared allergens (e.g. soy, wheat, etc.) in ingredients;
    • freedom from hazardous extraneous material (e.g. glass, wood, metal) in flour and other ingredients.
  • The manufacturer receives certificates of analysis (or equivalent supporting information) to demonstrate that ingredients meet compositional specifications and applicable regulatory standards, and to ensure that all components of ingredients are declared. For example:
    • where fresh alimentary paste is labelled as "enriched", the manufacturer ensures the fortified flour used for these products will yield nutrient levels in finished products that meet compositional and regulatory requirements.
  • The manufacturer has written specifications for gases (e.g. where Modified Atmosphere Packaging is used) and receives Letters of Guarantee (or equivalent supporting information) to demonstrate the acceptability for food use (e.g. purity and grade of gases). Controls are in place to confirm gas cylinders contain the correct gas (at the concentration required).
  • Each lot of incoming material is examined for damaged containers (e.g. holes from rodents) and for signs of contamination (e.g. stains, pests, insects, rodent activity and bird droppings, mould, foreign material, lubricants or other industrial chemicals from field equipment).
  • The temperature of refrigerated ingredients (e.g. liquid whole egg) is verified when received.
  • The manufacturer has specifications and procedures in place to properly identify and control returned product.
  • The manufacturer maintains a list of acceptable suppliers based on a documented history of adherence to specifications.

Note: Establishments requiring additional information for importing flour or fresh alimentary paste should refer to the Good Importing Practices (GIP) document on the CFIA website.

See Section 1.11.1 Verification Procedures of this guidance document for information regarding sampling and analysis of incoming ingredients.

See Section 1.1.4 Food Additives of this guidance document for information to assess specifications for food additives.

See Section 7.2.2 for expected incoming material control records.

Non-Conforming Ingredients

When ingredients fail to meet specifications that impact food safety, the manufacturer investigates and identifies the root cause. The manufacturer initiates corrective action by determining whether food safety is compromised and by taking the necessary actions. See Section 1.10 – Deviations and Corrective Action and Section 7.2.5 – Deviations and Corrective Action Records.

1.4.2 Packaging Materials

The manufacturer controls incoming packaging materials to meet the requirements of Division 23 of the Food and Drug Regulations, such that no biological, physical or chemical hazards result in the food.

Rationale

Controls are necessary to ensure that packaging materials meet the manufacturer's specifications. Inadequate controls could result in the use of packaging that may contaminate the product, or may permit physical, chemical or biological contamination of the product.

Anticipated Outcomes
  • The manufacturer demonstrates that the packaging material is appropriate for the use intended and is used in accordance with the packaging manufacturer's instructions. The appropriateness of packaging material will vary with the product and process and the associated contamination risks.
  • Packaging material should be fully compatible with the packaging equipment in use.
  • Written specifications for packaging materials that identify criteria essential for the manufacturing process and product safety have been identified by the manufacturer (e.g. permeability of packaging materials where Modified Atmosphere Packaging is used).
  • The manufacturer obtains Letter of Guarantee from the supplier to demonstrate conformance to written specifications.
  • Each lot of packaging material is examined for physical damage, signs of contamination (e.g. stains, bird droppings, rodent activity [e.g. faeces, urine], insects and foreign material [e.g. wood, metal, glass]) at receiving. The manufacturer does not use contaminated or potentially contaminated packaging material

See Section 7.2.2 for expected Incoming Material Control Records.

1.5 Packaging Control

1.5.1 Packaging

Handling and use of packaging is controlled to prevent product contamination.

Rationale

Inadequate control of packaging materials may result in the use of damaged, defective or contaminated packaging, which may lead to contamination of the product.

Anticipated Outcomes
  • The manufacturer has an effective system in place to prevent the use of contaminated, damaged or defective containers (e.g. receiving and storage controls and visual examination prior to use).
  • Only packaging materials required for immediate use are kept in the packaging or filling area.
  • Packaging materials are used only for their intended purpose.
  • When using MAP, the manufacturer has controls in place to prevent accidental use of packaging not intended for MAP product.
  • Packing is performed under hygienic conditions that preclude the introduction of contaminants into the product.

Note: It is imperative to prevent the cross-contamination of packaging material used in MAP, particularly from raw fish, meat and vegetables. These can be a source of microbiological pathogens that are capable of growth at refrigeration temperatures and that could pose a serious hazard in refrigerated extended shelf life products.

1.6 Product Preparation/Blending

1.6.1 Control of Preparation, Composition and Blending

Factors significant to food safety in the formulation, which may be CCPs, are controlled during preparation and blending to minimize physical, chemical and biological hazards, and, to ensure accuracy of composition, nutrient content and product claims.

Rationale

Inadequate control of significant factors and/or CCPs associated with product preparation/mixing could result in inadequate processing, the production of toxins or the presence of undeclared allergens (e.g. egg, wheat, soy, etc.). The product may violate permissible levels of food additives or may fail to meet compositional standards, and/or the product's nutrient content declaration may be inaccurate.

Anticipated Outcomes

The manufacturer has controls in place to prevent hazards associated with the preparation or mixing of the product. Areas significant to food safety are outlined below.

  • Controls are in place to ensure ingredients and food additives are clearly identified to avoid the use of the wrong ingredient/food additive.
  • Controls are in place to ensure ingredients/food additives are accurately measured and properly mixed for homogeneity as per formulations and/or recipes so that those that may be critical to the safety of the product are present at the proper concentration. This includes ingredients or food additives that may affect water activity, pH or act as preservatives.
  • Controls are in place to ensure that the food additives used are permitted and used within regulatory limits.
  • The manufacturer controls the time and/or temperature during preparation, mixing and holding of in-process materials (e.g. processed liquid egg and moist dough) to minimize microbial growth or the production of metabolic by-products of microbial growth (e.g. Staphylococcus aureus, Bacillus cereus and their toxins). At temperatures above refrigeration temperature, microorganisms can grow and multiply in processed liquid egg, moist dough or their residue on equipment.
  • Controls are in place to ensure ingredients are accurately measured and properly mixed as per formulations and/or recipes so that those that are nutritionally important are present at the levels declared on the product label. Manufacturers may require controls to prevent the following:
    • misdirection of ingredients;
    • improper addition of rework;
    • ingredient carryover;
    • improper ingredient substitutions;
    • carryover from equipment (e.g. product changeovers).
  • The manufacturer monitors factors significant to food safety and/or CCPs (under a HACCP System) at a scheduled frequency. For further information regarding CCP rationale see Appendix A and the CFIA HACCP Generic Model for Fresh Non-Filled Alimentary Paste.
Allergens

The manufacturer has controls in place to prevent the presence of undeclared allergens. Allergens are those ingredients that will elicit an allergic response in sensitive individuals. Areas that may require control include:

  • ingredient carryover from equipment (e.g. following product changeovers);
  • inappropriate use of rework;
  • ingredient changes, substitutions or additions (e.g. ingredients purchased from a new supplier and changes to the components of ingredients);
  • contamination by undeclared allergens in ingredients;
  • incorrect labels;
  • incorrect or incomplete list of ingredients;
  • addition of an incorrect ingredient.

Note: The CFIA website contains information and guidance for the food industry regarding food allergens, including more information on Canada's priority allergens and a Tool for Managing Allergen Risk in Food Products.

See Section 7.2.3 for expected product preparation/blending records.

1.6.2 Cleaning/Sorting – Contamination Control

Raw materials and ingredients are sorted and/or prepared in such a manner as to prevent contamination of the finished product.

Rationale

Adequate sorting and/or preparation of ingredients is necessary to prevent, reduce or remove contamination with biological, chemical and/or physical hazards, particularly when they are received directly from harvesting at the farm level.

Anticipated Outcomes

The manufacturer screens ingredients as necessary to address any potential biological, chemical or physical risks. The extent of this activity will vary depending on a manufacturer's specifications and control over incoming raw materials and ingredients to eliminate potential hazards.

  • When flour is received in bulk, it is sifted prior to use to eliminate any possible harmful or objectionable extraneous material (e.g. stones, glass, metal, wood, insects, etc.).

Refer to Section 1.8.1 Processing Controls for additional information, as well as, the CFIA's Reference Database for Hazard Identification for more hazard information.

1.7 Product Coding Control

1.7.1 Product Coding

Pre-packaged fresh alimentary paste is identified with code marks or lot numbers on the label or container.

Rationale

Coding control can permit products to be traced through the distribution chain and provides information on the shelf life and safe consumption of the product.

Note: Coding is not a mandatory labelling requirement, however this practice is recommended under Section 8.2.1 (Recall Procedure) to enhance the effectiveness of a recall.

Anticipated Outcomes
  • The manufacturer ensures that pre-packaged fresh alimentary paste products are permanently marked with a legible code or lot identification on the label, the package or container.
  • The coding system identifies where the product was manufactured (facility, line, etc.) and when (shift, day, month, year, etc.).
  • Where applicable, the code accurately reflects the best-before date, expiration date, or shelf life of the product.
  • The exact meaning of all code marks used is available from the manufacturer.
  • Where used, case codes are legible and correspond to the identifying marks on the product within.

1.8 Process Control

1.8.1 Processing Controls

All significant processing factors and/or CCPs are controlled to ensure the safety and compositional integrity of the product.

Rationale

Inadequate control of significant processing factors and/or CCPs could result in biological, chemical or physical hazards.

Anticipated Outcomes
  • The manufacturer evaluates the process and identifies all significant factors and/or CCPs that have an impact on the safety of the final product.
  • The manufacturer ensures all appropriate significant processing factors and/or CCPs are addressed, and that they are controlled within acceptable limits.
  • The manufacturer monitors factors significant to food safety and/or CCPs at a scheduled frequency.
  • Food allergen controls are in place if applicable. For example:
    • wherever possible dedicated lines are used.
    • if common equipment is used for products with allergens and those without, the process does not result in undeclared allergens.
    • the manufacturer has established and verified procedures for product changeover that does not result in undeclared allergens.
    • the process flows from incoming materials to the finished product with no cross-overs or other areas that can cause undeclared allergens (e.g. conveyor belts, shared equipment).
Common Processing Steps and Controls
Sifting/Screening
  • Screening of bulk flour is controlled to reduce or eliminate physical hazards and extraneous material. Screening equipment is inspected regularly to ensure proper function (torn screens are repaired, etc.). Extraneous material captured by the screening equipment is examined to determine the source and follow-up is conducted as necessary.
Ingredient Weighing/Measuring
  • Weighing and measuring equipment is adequate to achieve the accuracy required. Refer to Section 2.1.4 Instrumentation Maintenance and Calibration Program for further information regarding the calibration of scales.
  • Weighing and measuring is carried out by qualified personnel.
  • Product formulations and/or recipes are available to personnel controlling the weighing and measuring of ingredients.
  • Adjustments to formulations and/or recipes are confirmed by qualified personnel.
  • Where certain ingredients are essential to the safety of the formulation, the weight or volume of each ingredient added to a lot of product is recorded.
  • Ingredients are weighed and measured in a hygienic manner to minimize the possibility for contamination with pathogenic microorganisms and/or physical contaminants.
  • The weighing and measuring of ingredients is conducted in a manner that prevents the cross-contamination of products with undeclared allergens (e.g. use of dedicated equipment, utensils and/or containers, appropriate production scheduling, cleaning between product changeover). Dust generated from weighing and measuring is controlled to prevent the cross-contamination of products with undeclared allergens that may be transferred by air.
Mixing
  • Ingredients are added as per mixing and blending formulations and/or recipes.
  • Ingredients are added in a hygienic manner to prevent contamination with pathogenic microoganisms, undeclared allergens and/or physical contaminants (e.g. the outer surface of ingredient bags are removed or cleaned before emptying bags into mixers, dedicated equipment is used and dust is controlled to prevent the contamination of products with undeclared allergens transferred by air).
  • Processing time and/or temperature are controlled to avoid the growth of microorganisms. Where in-line product is at a temperature that could permit microbial growth, the length of time at this processing phase is kept to a minimum to slow microbial growth.
  • Product residue does not remain in or on equipment to be a source of microbiological or allergen contamination for subsequent batches of product.
Sheeting/ Forming/ Extrusion/ Cutting
  • The dough produced at the mixing step is protected from biological, chemical or physical contamination during any transfer between processing equipment (e.g. possible contamination from direct hand contact).
  • Processing time and/or temperature are controlled to avoid the growth of microorganisms.
  • Product residue does not remain in or on equipment to be a source of microbiological or allergen contamination for subsequent batches of product.
Heat Treatment
  • Heat treatment equipment (e.g. pasteurizer) is properly designed with controls in place to ensure the process delivers the intended results.
  • Employees are trained as necessary to properly operate heat treatment equipment.
  • Where water or steam may be in direct contact with the product, there are no hazardous chemical residues.

Note: See Section 1.3.1 for information on Pasteurization.

Cooling/Drying
  • Time and/or temperature of cooling and drying are controlled to avoid growth of microorganisms.
  • The alimentary paste is protected from biological, chemical or physical contamination during this step and/or during any transfer between processing equipment.
  • Product residue does not remain in or on equipment to be a source of microbiological or allergen contamination for subsequent batches of product.
Packaging/Weighing
  • Where product is weighed immediately prior to packaging, the process is conducted in a manner that prevents the cross-contamination of products with undeclared allergens (e.g. dedicated equipment, utensils and/or containers, production scheduling).
  • Container filling and sealing are controlled to meet the criteria outlined in the process design and/or shelf life study. See Section 1.3.1 – Process Design for additional information on shelf life studies.
  • Processing time and/or temperature are controlled to avoid growth of microorganisms.
  • The manufacturer identifies and controls all factors in the packaging process determined to be significant to maintaining the safety of the product (e.g. package specification, product weight or volume, etc.).

Note: See Sections 1.2.1 and 1.9.1 for additional information regarding labelling and coding. See Section 1.5.1 for additional information regarding packaging.

Modified Atmosphere Packaging (MAP)
  • With respect to MAP the following practices are in place:
    • employees operating MAP packaging equipment are adequately trained and are following written procedures. Management and employees are aware of Good Manufacturing Practices specific to the preparation of MAP refrigerated foods;
    • controls to ensure the gas or gas mixture used for MAP is the same as recommended by the MAP expert that provided the initial MAP packaging instructions;
    • controls to ensure the proper gas cylinders are connected to the packaging machine;
    • controls to ensure an appropriate vacuum is achieved and/or the correct volume and mixture of gas is added to the package;
    • the seal integrity and internal atmosphere of packaging are routinely tested to confirm acceptability.

Note: The extended shelf life of refrigerated fresh alimentary paste achieved with the use of MAP is also accompanied by some increased food safety risk. Microbial pathogens such as Listeria monocytogenes and certain types of Clostridium botulinum are capable of growth in MAP products at refrigerated temperatures. If these pathogens are present, the longer the product shelf life, the greater the risk. It is imperative that ingredients used in MAP products are of superior microbiological quality and there is rigorous control of sanitary practices from the receipt of ingredients to the preparation and packaging of MAP products.

Metal Detector
  • The metal detector functions as intended when metal is detected (e.g. line stops, alarm sounds or product is ejected from the line).
  • Proper functioning is monitored by passing test wands (ferrous, non-ferrous and stainless steel) through the detector at an established frequency.

Note: See Section 2.1.4 Instrumentation Maintenance and Calibration Program for further information relating to the maintenance and calibration of metal detectors.

Rework
  • In-process materials considered acceptable for rework are collected and handled in a hygienic manner to avoid contamination and are processed without delay to minimize the growth of microorganisms.
  • Should it be necessary to collect rework for later use, it is immediately refrigerated and containers are clearly identified with relevant information (e.g. contents and time of production).
  • Rework is controlled to ensure like products are added to like products (i.e. containing the same allergen) that declares the allergen.

Note: See Section 7.2.4 for expected Process Control Records.

1.9 Labelling Control

1.9.1 Prevention of Mislabelling

The manufacturer has controls in place to prevent mislabelling.

Rationale

Control of labelling is important to ensure that the correct label is applied to each product. Use of incorrect labels could mislead the consumer and could pose a potential health hazard to segments of the population with allergies (e.g. egg, wheat, soy).

Anticipated Outcomes

The manufacturer has procedures in place to ensure that the correct label is applied to the correct product. Typical controls are listed below.

  • During storage, care is taken to prevent mixing of individual labels or bundles of labels (e.g. labels are stored in separate boxes, no labels are loose and unused labels are returned to the correct boxes).
  • Different product labels or pre-labelled packaging are effectively separated, and the number of product label types is kept to a minimum.
  • Identifying marks and/or colours are utilized on labels to ensure correct labels are being loaded into the labeller or manually put on the product.
  • Tops and bottoms of label bundles are visually checked for mixed labels prior to use.
  • Product types are effectively separated during changeovers (e.g. appropriate breaks between products, visual inspection to ensure products are not mixed prior to labelling).
  • Procedures are in place to ensure the product being supplied or added to the labelling operation corresponds to the labels in use (e.g. on-line checks to ensure that products are correctly labelled).
  • Corroborate the product label information with the following data: recipes, including processing aids, components of ingredients, composition of reworked products and composition of food packaging.

Note: The CFIA website contains information and guidance for the food industry regarding food allergens, including more information on Canada's priority allergens and a Tool for Managing Allergen Risk in Food Products.

1.10 Deviations and Corrective Action

1.10.1 Deviation Control

When critical limits or limits of acceptability are exceeded or defects occur which could affect product safety or composition, procedures are in place to identify, isolate and evaluate products.

Rationale

Deviations from critical limits, limits of acceptability and procedures, or the occurrence of defects, may affect the safety of the product. Inadequate deviation procedures or non-adherence to procedures could result in the sale of unsafe product or could result in misrepresented product.

Note: Deviation procedures apply to all sections of this guidance document, where appropriate.

Anticipated Outcomes

The manufacturer has a pre-determined and documented deviation procedure to identify deviations in either the product and/or the procedures, isolate defective products and take appropriate corrective actions.

Identification of Deviation
  • The manufacturer has a system in place to identify deviations when they occur.
Isolation of Affected Product
  • The manufacturer has effective procedures in place to isolate, clearly mark and control all product manufactured during the deviation period. All unsatisfactory product is isolated back to the point where the process was last in control. This could be beyond the last satisfactory record.
  • Isolated product is clearly marked (e.g. firmly attached tags contain the following information: hold number, product, the amount, the date held, the reason for the hold, and the name of the person holding the product).
  • The manufacturer maintains control of the product from the hold date to the date of final disposition.
Evaluation of Affected Product
  • Product evaluation is conducted by a qualified person.
  • Action on affected product (e.g. returning unused ingredients/materials to the supplier, sorting of suspect lots, re-processing, disposal) is conducted in an appropriate manner by adequately trained personnel.
  • Evaluation is adequate to detect potential health hazards, or to identify misrepresentation. For example:
    • sampling is adequate to identify the extent of the problem;
    • tests are appropriate;
    • judgement is based on sound science; and
    • the product is not released until the evaluation has determined that no health hazard exists and the product is in compliance with appropriate legislation.

See the HACCP Generic Model for Fresh Non-Filled Alimentary Paste for suggested deviation procedures and corrective actions.

1.10.2 Corrective Action

Corrective action taken following any deviation is effective to rectify and to prevent recurrence of the deviation.

Rationale

Corrective action procedures are necessary to determine the cause of the problem and to take action to prevent recurrence. It is essential to follow-up any corrective action with monitoring and reassessment to ensure that the correction has been effective.

Anticipated Outcomes
  • As part of the deviation procedure, the manufacturer has a set of documented corrective actions that include:
    • an investigation to determine the cause of the deviation;
    • preventive measures taken to prevent recurrence of the deviation; and
    • verification by the manufacturer of the effectiveness of the corrective action and preventive measures taken.

See Section 7.2.5 for expected Deviations and Corrective Action Records.

See the HACCP Generic Model for Fresh Non-Filled Alimentary Paste for suggested deviation procedures and corrective actions.

1.11 Verification of Product Safety

1.11.1 Verification Procedures

The manufacturer uses supplementary methods of evaluation to verify the conformance and effectiveness of controls affecting product safety, composition and compliance with Canadian legislation.

Rationale

The purpose of verification is to assess the conformance and effectiveness of existing controls in preventing health hazards and to indicate areas where improvements are required.

Note: Verification applies to all sections of this guidance document, where appropriate.

Anticipated Outcomes
  • The manufacturer verifies the conformance and effectiveness of controls affecting product safety.
  • Individuals or organizations responsible for verification are identified. These individuals or organizations are suitably qualified.
  • The verification frequency and methods are appropriate to the hazards associated with the product and process.
  • Methods of verification may include the following:
    • review of all specifications for incoming ingredients and materials as well as Letters of Agreement at an adequate frequency and/or whenever any changes are made;
    • a representative sample of incoming ingredients is taken at a scheduled frequency and analyzed by the manufacturer to verify the accuracy of the certificates of analysis and conformance to specifications;
    • sampling and analyses of in-process and finished products for the appropriate biological hazard (e.g. Salmonella spp., Listeria monocytogenes, Staphylococcus aureus, E. coli), chemical hazard (e.g. Allergen detection test) or physical hazard;

      Refer to Health Canada's Compendium of Analytical Methods, Volume 1, Interpretive Summary, Standards and Guidelines for Microbiological Safety of Food for microbiological guidelines for fresh alimentary paste.

    • microbiological environmental sampling of food contact and non-food contact surfaces in processing areas to confirm the control of biological hazards (e.g. Salmonella spp. andListeria monocytogenes);
    • chemical environmental sampling of food contact and non-food contact surfaces in processing areas to identify chemical hazards (e.g. allergens);
    • evaluation of finished packaged products to confirm adequacy of the shelf life as predetermined by the shelf life study;
    • evaluation of finished products to confirm the composition and nutrient profile, ensuring compositional claims (e.g. enriched) and nutrient claims (e.g. low in fat) are accurate;
    • ensure that employees adhere to sampling programs if applicable;
    • on-site assessment of the monitoring procedures (e.g. GMPs and Critical Control Points);
    • review of records for completeness;
    • review of deviation records to ensure that appropriate corrective actions and preventive measures are taken and recorded in the event of a deficiency;
    • independent external or internal audits; and/or
    • analysis of consumer complaint trends.

Note: where shell eggs are used to produce fresh alimentary paste products, the manufacturer should use supplementary methods of evaluation to confirm freedom from Salmonella spp. in finished products.

See Section 7.2.6 for expected Verification Record.

Chapter 2: Equipment

2.1 General Equipment

2.1.1 Design, Construction and Installation

All equipment and utensils are designed, constructed and installed to function as intended, to permit effective cleaning and sanitation and to prevent contamination of fresh alimentary paste.

Anticipated Outcomes
  • Equipment is designed, constructed and installed to ensure that:
    • the process is capable of delivering the results which are anticipated (e.g. effective package sealing, control of gas flush composition and time, where MAP is used);
    • it can be adequately and easily cleaned, sanitized, maintained and inspected to prevent contamination of the product during operations;
    • contamination of the product during operation is prevented (e.g. location of lubricant reservoirs);
    • equipment is exhausted to the outside to prevent excessive condensation where necessary; and
    • proper drainage is permitted and where appropriate, equipment is connected directly to drains. Where applicable, drains are fitted with backflow preventers.

2.1.2 Food Contact Surfaces

Food contact surfaces are constructed of appropriate materials and are maintained in a manner to prevent contamination of foods.

Anticipated Outcomes
  • Food contact surfaces of equipment, containers and utensils are smooth, non-corrosive, non-absorbent, non-toxic, free from pitting, cracks or crevices, and able to withstand repeated cleaning and sanitation.
  • When coatings, paints, chemicals, lubricants and other materials are used for food contact surfaces or utilized on equipment where there is a possibility of contact with food, the substances are appropriate for the intended use and are used in accordance with the manufacturer's instructions.
  • Equipment and utensils used to handle inedible material are not used to handle edible material.

2.1.3 Equipment Maintenance and Calibration Program

An effective maintenance and calibration program is in place to ensure that equipment performs consistently as intended and prevents contamination of the product.

Anticipated Outcomes
  • The manufacturer has an effective written preventive maintenance and calibration program to ensure that equipment which may impact on food safety functions as intended. This includes:
    • a list of equipment requiring regular maintenance; and
    • maintenance procedures and frequencies (e.g. equipment inspection instructions, a schedule of adjustments and part replacements based on the equipment manufacturer's manual or equivalent or based on operating conditions that could affect the condition of the equipment).
  • The manufacturer establishes written protocols, including calibration methods and frequencies, for equipment monitoring and/or controlling devices that may impact on food safety.
  • Equipment is maintained in a manner which ensures that there is no potential for the development of physical or chemical hazards (e.g. hazards resulting from inappropriate repairs, flaking paint and rust, excessive lubrication).
  • Maintenance and calibration of equipment are performed by appropriately trained personnel.
  • When routine or emergency repairs are made to equipment, in direct or indirect contact with food, an inspection to assess the compliance of the repair is performed before the equipment is used.
  • The preventive maintenance and calibration programs and associated written protocol are followed.

See Section 7.3.1 for expected Equipment/Instrumentation Maintenance and Calibration Records.

2.1.4 Instrumentation Maintenance and Calibration Program

Instrumentation is designed, constructed, installed, calibrated and maintained such that the equipment is capable of delivering the required process, thereby ensuring product safety.

Rationale

Improper design, installation, calibration or maintenance of instruments can lead to inadequate processing of the product, misuse of food additives, nutritional inaccuracies or composition violations.

Anticipated Outcomes
  • The manufacturer has an effective written preventive maintenance and calibration program to ensure that instrumentation which may impact on food safety functions as intended. This includes:
    • a list of instrumentation requiring regular maintenance and calibration; and
    • the maintenance and calibration procedures and frequencies
  • Instruments which control factors that may have an impact on food safety are designed, installed, constructed, calibrated and maintained as necessary to ensure that they function as intended.
  • Maintenance and calibration of instrumentation are performed by appropriately trained personnel.
  • Preventive maintenance, calibration programs and associated written protocols are followed.

The following are some examples of instrumentation that may be required to control factors significant to the process:

Temperature Measuring Devices
  • The manufacturer uses one temperature scale consistently throughout the processing system (e.g. Celsius or Fahrenheit).
  • Temperature measuring devices are calibrated against a known standard just prior to installation, and a minimum of once per year thereafter (or more frequently as recommended in the equipment manufacturer's manual), and are maintained as necessary to ensure accuracy.
Temperature Recorders
  • The scale of the temperature recording chart is not more than 12°C/cm (55°F/in) within the range of 10°C (18°F) of process temperature, and the chart graduation does not exceed 1°C (2°F) within 6°C (11°F) of processing temperature.
  • The accuracy of temperature recorders is verified upon installation, and thereafter, a minimum of once per year (or more frequently as necessary to ensure their accuracy).
Timing Devices
  • Timing devices and recorders are verified upon installation, and thereafter annually (or more frequently as necessary to ensure accuracy).
  • Where timing devices are not equipped with a power backup, controls are in place to verify that process time requirements are met.
  • Any official timing device is located so that it can be easily and accurately read by the operators.
Pressure Gauges
  • Each pressure gauge is calibrated at least annually or more frequently as necessary to ensure accuracy.
Metal Detectors
  • Metal detection equipment is designed, constructed, installed, calibrated and maintained in accordance with the equipment manufacturer's manual, to ensure effective removal of metals. This may include adjustment for product effect, selection of target metal and size, timing of the reject mechanism and suitability for environmental conditions.
Scales/Metering Devices
  • The sensitivity is appropriate to the use.
  • Scales are designed and installed to withstand the environmental conditions or are adequately protected (e.g. away from drafts, rust, corrosion, etc.).
  • Scales and meters are calibrated in accordance with the equipment manufacturer's manual to ensure accuracy at all times.
Other Instrumentation
  • Other specialized instrumentation when used to control factors significant to food safety, are calibrated as necessary.

Note: The manufacturer initiates corrective action as per Section 1.10, Deviations and Corrective Action when critical limits or limits of acceptability are exceeded, or whenever products could have been affected and found not to meet specifications.

See Section 7.3.1 for expected Equipment/Instrumentation Maintenance and Calibration Records.

Chapter 3: Premises

3.1 Building Exterior

3.1.1 Outside Property and Buildings

Buildings and surrounding areas are designed, constructed and maintained in a manner which prevents conditions which may result in the contamination of food.

Anticipated Outcomes
Grounds, Roadways and Drainage
  • The surrounding land is maintained to control sources of contamination such as debris and pest harbourage areas.
  • The building is not located in close proximity to any environmental contaminants.
  • Roadways are properly graded, compacted, dust proofed and drained.
  • The surrounding property is adequately drained.
Exterior Building Structure
  • The building exterior is designed, constructed and maintained to prevent entry of contaminants and pests. For example, the exterior has no unprotected openings; air intakes are appropriately located; and the roof, walls and foundation are maintained to prevent leakage.

3.2 Building Interior

3.2.1 Design, Construction and Maintenance

Building interiors and structures are designed, constructed and maintained to prevent conditions which may result in the contamination of food.

Anticipated Outcomes
Floors, Walls and Ceilings
  • Floors, walls and ceilings are constructed of materials that are durable, impervious, smooth, cleanable, and suitable for the production conditions in the area (e.g. materials will not result in the contamination of the environment or food).
  • Where appropriate, wall, floor and ceiling joints are sealed and angles are coved to prevent contamination and facilitate cleaning.
  • Floors are sufficiently sloped to permit liquids to drain to trapped outlets.
  • Ceilings, overhead structures, stairs and elevators are designed and constructed to prevent contamination.
  • Floors, walls, ceilings and all overhead structures are maintained to prevent deterioration (e.g. rust, flaking paint) and contamination (e.g. dust, mould).
Windows and Doors
  • Windows are sealed or equipped with close-fitting screens.
  • Where there is a likelihood of breakage of glass windows that could result in the contamination of food, the windows are constructed of alternative materials or are adequately protected.
  • Doors have smooth, non-absorbent surfaces and are close-fitting and self-closing where appropriate to prevent the entry of pests and vermin.
Process Flow Separation
  • Buildings and facilities are designed to facilitate hygienic operations (e.g. there is regulated flow in the process, from the arrival of the raw material at the premises to the finished product).
  • Activities are adequately separated by physical or other effective means where cross-contamination (e.g. biological, chemical [e.g. allergens], physical) may result. For example:
    • all untreated raw ingredients or materials are kept separate from in line or finished products to prevent microbiological cross-contamination.
    • potential allergens are controlled to avoid the possibility of cross-contamination.
  • It is preferred that dedicated processing lines and utensils are used for allergen containing products.
  • Where common pieces of equipment are used for the processing of allergen containing products and non-allergen containing products, the manufacturer has established a procedure that does not result in the contamination of food products with allergens.
  • The manufacturer has established a process flow from incoming materials to finished products with no cross-over or areas of concern that can cause undeclared allergens to be present in the finished products (e.g. conveyor belts, shared equipment).
  • Where mobile equipment (such as fork lifts or equivalent) moves between incompatible areas, measures are taken to minimize cross-contamination.
  • Pallet's design, condition and use are specified to avoid contamination.

3.2.2 Lighting

Lighting is adequate for the activity being conducted. Where appropriate, light bulbs and fixtures are protected to prevent contamination of food or packaging material.

Anticipated Outcomes
  • Lighting is appropriate such that the intended production or inspection activity can be effectively conducted. The lighting does not alter food colour and is not be less than the following;
    • 540 lux (50 foot candles) in inspection areas (Inspection areas are defined as any point where the food product or container is visually inspected or instruments are monitored)
    • 220 lux (20 foot candles) in work areas
    • 110 lux (10 foot candles) in other areas
  • Light bulbs and fixtures located in areas where there is exposed food or packaging material are of a safety type or are protected to prevent the contamination of food or packaging material in case of breakage (e.g. shatterproof bulbs or bulb covers).

3.2.3 Ventilation

Adequate ventilation is provided to prevent excessive heat, steam, condensation and dust, as well as to remove and minimize entry of contaminated air. Air used for processing techniques is appropriately sourced and treated.

Anticipated Outcomes
  • Ventilation provides sufficient air exchange to prevent unacceptable accumulations of steam, condensation, dust or excessive heat and to minimize entry of contaminated air.
  • Ventilation systems are constructed to avoid air flow from less clean areas (e.g. the receiving area) to clean areas (e.g. packaging and finished product storage) and designed to be adequately maintained and cleaned.
  • Ventilation openings are equipped with close-fitting screens or filters as appropriate to prevent the intake of contaminated air (dust, dirt) or entry of insects and rodents. Air filters (e.g. filters for intake air and compressed air) are checked, cleaned or replaced at least as often as the manufacturer specifies or more frequently if a problem is indicated (e.g. evidence of filter fouling or perforation).
  • Air used as a processing technique (e.g. air blows, air dryers, etc.) is appropriately sourced and treated (air intakes, filters, compressors) to reduce any source of contamination.

3.2.4 Waste Disposal

Sewage, effluent and waste storage and disposal systems are designed, constructed and maintained to prevent contamination.

Anticipated Outcomes
  • Drainage and sewage systems are equipped with appropriate traps and vents.
  • Establishments are designed and constructed so that there is no cross-connection between the sewage system and any other waste effluent system in the establishment.
  • Effluent or sewage lines do not pass directly over or through production areas unless they are controlled to prevent contamination.
  • Adequate facilities and equipment are provided and maintained for the storage of waste and inedible material prior to their removal from the establishment. These facilities are designed to prevent contamination.
  • Containers used for waste are clearly identified, leakproof, moisture resistant, easy to clean and, where appropriate, covered.
  • Waste is removed and containers are cleaned and sanitized at an appropriate frequency to minimize the potential for contamination.

3.3 Sanitary Facilities

3.3.1 Employee Facilities

Employee facilities are designed, constructed and maintained to permit effective employee hygiene and to prevent contamination.

Anticipated Outcomes
  • Processing areas are provided with an adequate number of conveniently located hand-washing stations (preferably hands-free) with trapped waste pipes to drains.
  • Washrooms, lunchrooms and change rooms are adequately ventilated and maintained in clean condition. They are separate from and do not lead directly into food processing areas.
  • Washrooms have hand-washing facilities with a sufficient number of maintained sinks that are properly trapped to drains.
  • Hand-washing facilities are adequately maintained and have hot and cold running potable water distributed from a single nozzle, soap, sanitary hand-drying supplies or devices, and, where required, a cleanable waste receptacle.
  • Hand-washing stations, hand dips and footbaths are maintained in all applicable areas of the facility.
  • Notices to wash hands are posted in appropriate areas.

3.3.2 Equipment Cleaning and Sanitizing Facilities

Facilities for cleaning and sanitizing equipment are adequately designed, constructed and maintained to prevent contamination.

Anticipated Outcomes
  • Facilities are constructed of corrosion resistant materials which are capable of being easily cleaned, and are provided with potable water at temperatures appropriate for the cleaning chemicals used.
  • Equipment cleaning and sanitizing facilities are adequately separated from food storage, processing and packaging areas, to prevent contamination.

3.4 Water/Ice/Steam Quality

3.4.1 Water and Ice

The potability of hot and cold water is controlled to prevent contamination.

Anticipated Outcomes
  • Potable water meets the requirements of Health Canada's Guidelines for Canadian Drinking Water Quality and any applicable provincial and municipal requirements.
  • Water is analysed by the fresh alimentary paste manufacturer at a frequency adequate to confirm its potability. For microbial analysis, water from a municipal water source is analysed semi-annually and water from other sources is analysed on a monthly basis. For chemical analysis, water from non-municipal sources is adequately analysed at least at the initial start-up of the well.
  • The fresh alimentary paste manufacturer has contingency plans in place to deal with provincial/municipal orders to boil water and unsatisfactory water analysis results.
  • There are no cross-connections between potable and non-potable water supplies. All hoses, taps and other similar sources of potential contamination are designed to prevent back-flow or back siphonage.
  • Water treatment chemicals, where used, are appropriate for the intended use and are used in accordance with the chemical manufacturer's instructions.
  • The chemical treatment is monitored and controlled to deliver the desired concentration and to prevent contamination.
  • Recirculated water is treated, monitored and maintained as appropriate to the intended purpose. Recirculated water has a separate distribution system, which is clearly identified.
  • Where filters are used they are kept effective and maintained in a sanitary manner.
  • In areas for food processing, handling, packaging and storage, water temperatures and pressures are adequate for all operational and clean-up needs.
  • Ice used as an ingredient or ice used in direct contact with food is made from potable water and is protected from contamination.

Note: Ice purchased by the manufacturer is treated as an ingredient and is assessed under Section 1.4.1, Incoming Material Control – Ingredients.

See Section 7.4.1 for expected Water, Ice and Steam Quality Records.

3.4.2 Steam

The potability of steam which is in direct contact with food or food contact surfaces is controlled to prevent product contamination. Steam supply is adequate to meet operational requirements.

Note: Where steam is not in direct contact with food or food contact surfaces, this section is not applicable.

Anticipated Outcomes
  • Boiler treatment chemicals used are appropriate for the intended use and are used in accordance with the chemical manufacturer's instructions.
  • Boiler feed water is tested regularly and the chemical treatment is controlled to prevent contamination.
  • The steam supply is generated from potable water and is adequate to meet operational requirements.
  • Traps are provided as necessary to ensure adequate condensate removal and elimination of foreign materials.

See Section 7.4.1 for expected Water, Ice and Steam Quality Records.

Chapter 4: Sanitation and Pest Control

4.1 Sanitation

4.1.1 Sanitation Program

An effective sanitation program for equipment and premises is in place to prevent contamination of food.

Note: With respect to allergen control, if dedicated equipment is not used for non-allergen containing products, the sanitation program should be performed in a manner to prevent the possibility of cross-contamination from allergens.

Anticipated Outcomes
  • The fresh alimentary paste manufacturer has a written cleaning and sanitation program for all equipment which includes:
    • the responsible person;
    • the frequency of the activity;
    • chemicals and concentrations used;
    • temperature requirements;
    • procedures for cleaning and sanitizing that:
      1. identify lines, equipment and utensils;
      2. outline disassembly/reassembly instructions as required for cleaning and inspection;
      3. identify areas on equipment requiring special attention (e.g. dead spots where residue may accumulate);
      4. outline the method of cleaning, sanitizing and rinsing.
    • the type and frequency of inspection to verify the effectiveness of the program.
  • Cleaned equipment is properly protected and/or stored to maintain in a sanitary condition.
  • The fresh alimentary paste manufacturer has a written cleaning and sanitation program for premises (production and storage areas) which specifies areas to be cleaned, the method of cleaning, the person responsible and the frequency of the activity. Special sanitation and housekeeping procedures required during production are specified within the document (e.g. removal of product residues [e.g. dough] from mixers, extruders, cutters or hoppers between batches or during breaks).
  • Chemicals are appropriate for the intended use and are used in accordance with the manufacturer's instructions.
  • Cleaning and sanitizing equipment is designed for its intended use and is properly maintained.
  • The sanitation program is carried out in a manner that does not contaminate food or packaging materials during, or subsequent to, cleaning and sanitizing (e.g. no contamination from aerosols or chemical residues).
  • Unscheduled, emergency repairs or maintenance to processing equipment or building interior (e.g. walls, ceilings, plumbing) is followed by thorough cleaning and sanitizing.
  • Effectiveness of the sanitation program, including cleaning following emergency repairs, is monitored and verified (e.g. by a pre-operational inspection of premises and equipment, where appropriate, by microbiological sampling and allergen testing) and where necessary, the program is adjusted accordingly.
  • The sanitation program is adjusted as necessary to incorporate new cleaning procedures (e.g. new equipment, new chemicals).
  • The sanitation program may be used to provide control over cross-contamination issues associated with the production of non-allergenic and allergenic products. Equipment is cleaned in a manner to prevent cross-contamination between allergen containing products and non-allergen containing products.
  • Operations begin only after sanitation requirements have been met.

See Section 7.5.1 for expected Sanitation Records.

4.2 Pest Control

4.2.1 Pest Control Program

Effective pest control programs are in place to prevent entry of pests, to detect and eliminate pests and to prevent the contamination of food.

Anticipated Outcomes
  • There is an effective written pest control program for the premises and equipment that includes:
    • the person to whom the manufacturer assigned responsibility for pest control;
    • where applicable, the name of the pest control company or the name of the person contracted for the pest control program;
    • the list of chemicals used, the concentration, the location where they were applied, and the method and frequency of application;
    • a map of trap locations;
    • the type and frequency of inspection to verify the effectiveness of the program.
  • Pesticides used are registered with the Pest Management Regulatory Agency under the Pest Control Products Act and Regulations and have been issued a PCP Registration Number. Pesticides are used in accordance with the label instructions.
  • Chemical treatment of equipment, premises or ingredients to control pests is conducted in a manner to ensure that the maximum residue limit of the Food and Drugs Act and Regulations is not exceeded (e.g. the number of fumigation treatments per lot is limited).
  • Poisonous rodenticides are not used in food processing or storage areas.
  • Birds and animals are excluded from establishments.

See Section 7.5.2 for expected Pest Control Records.

Chapter 5: Personnel

5.1 Hygiene and Health Requirements

5.1.1 Cleanliness and Conduct

All persons entering food handling areas maintain an appropriate degree of personal cleanliness and take the appropriate precautions to prevent the contamination of food.

Anticipated Outcomes
  • All persons wash and sanitize their hands upon entering food handling areas, before starting work, after handling contaminated materials (e.g. picking objects off the floor, handling garbage, cleaning chemicals or raw incoming materials), after breaks, after using toilet facilities or after blowing their nose and whenever there is a risk of contamination of the products. Fingernails are kept clean without nail polish.
  • Disposable gloves are changed whenever contamination is a possibility.
  • Protective clothing, hair and/or beard covering, footwear and/or gloves appropriate to the operation in which the employee is engaged, are worn and maintained in clean and sanitary manner.
  • Any behaviour which could result in contamination of fresh alimentary paste, such as eating or drinking, use of tobacco, gum chewing or unhygienic practices such as spitting, are prohibited in food handling areas.
  • All persons entering fresh alimentary paste handling areas remove jewellery and other objects which may fall into or otherwise contaminate food. Jewellery which cannot be removed, including wedding bands and medical alerts, is covered (e.g. employees wear rubber gloves).
  • For maintenance work in the production areas, strict hygiene standards and precautions are applied to avoid any possible source of contamination.
  • Access of personnel and visitors is controlled to prevent contamination. The traffic pattern of employees prevents cross-contamination of the product (For example, the employees avoid going back and forth to various stages of production. The employees do not go from a potentially contaminated area to the processing and/or packaging area unless they have washed their hands and changed to clean protective clothing).
  • Personal effects and street clothing are not kept in fresh alimentary paste handling areas and are stored in a manner to prevent contamination.
  • Responsibility for ensuring compliance by all personnel with the requirements of this section should be specifically allocated to competent supervisory personnel.

5.1.2 Communicable Diseases and Injuries

No person who is known to be infected with a disease likely to be transmitted through food, or who has open cuts or wounds, is permitted to work in food handling areas where there is a likelihood of the person directly or indirectly contaminating the food.

Anticipated Outcomes
  • The manufacturer has and enforces a policy, to prevent personnel from working in food handling areas if they are known to be suffering from a disease, or are known to be carriers of a disease transmissible through food.
  • The manufacturer requires that employees advise management when they are suffering from a communicable disease likely to be transmitted through food. Conditions which are to be reported include:
    • jaundice;
    • diarrhoea;
    • vomiting;
    • fever;
    • sore throat with fever; and
    • discharges from the ear, eye or nose.
  • Employees having open cuts or wounds do not handle food or food contact surfaces unless the injury is completely protected by a secure waterproof covering (e.g. rubber gloves).

5.2 Training

5.2.1 General Food Hygiene Training

Food handlers are trained in personal hygiene and hygienic handling of food, and they understand the precautions necessary to prevent contamination of fresh alimentary paste.

Anticipated Outcomes
  • The manufacturer has a written training program for employees, and maintains appropriate records.
  • Appropriate training in personal hygiene and hygienic handling of food is provided to all food handlers at the beginning of their employment.
  • Training is reinforced and updated at appropriate intervals, and whenever the employee's duties change

5.2.2 Technical Training

To ensure food safety, personnel are trained such that they have adequate technical knowledge and understanding of the operation(s) or process(es) for which they are responsible.

Anticipated Outcomes

Training is appropriate to the complexity of the manufacturing process and the tasks assigned. The manufacturer has a written training program for employees, and maintains appropriate records. Examples are listed below.

  • Personnel are trained to understand the importance of the critical factors for which they are responsible; the critical limits and/or company standards; the procedures for monitoring; the action to be taken if the limits and/or standards are not met; and the records to be kept.
  • Managers and supervisors for fresh alimentary paste manufacturing have the necessary knowledge of food hygiene principles and practices to be able to judge potential risks in order to take the appropriate action necessary to remedy deficiencies.
  • All employees, including maintenance and customer services employees, are trained to implement allergen controls.
  • Operators are trained to have current knowledge of equipment and process technology (e.g. Modified Atmosphere Packaging equipment, if used).
  • Personnel responsible for the maintenance and calibration of equipment impacting on food safety have been appropriately trained to identify deficiencies that could affect product safety, and to take the appropriate corrective action (e.g. in house repairs, contract repairs). Individuals performing maintenance on specific equipment are appropriately trained.
  • Personnel and supervisors responsible for the sanitation program are appropriately trained to understand the principles and methods required for effective cleaning and sanitizing.
  • Personnel and supervisors responsible for water treatment and water safety monitoring are appropriately trained to understand the principles and methods and are competent in procedures to protect the safety of food.
  • Personnel who handle potentially hazardous chemicals are instructed in safe handling and disposal techniques.
  • Additional training is provided as necessary to keep knowledge of equipment and processing technology current.
  • Periodic assessments of the effectiveness of training and instruction programs are made as well as routine supervision and checks to ensure that procedures are being carried out effectively.

Chapter 6: Transportation and Storage

Note: If control of incoming materials (Receiving) is included in this chapter (e.g. part of the prerequisite program) the chapter should be re-named Transportation, Receiving and Storage and all of the anticipated outcomes for Sections 1.4.1 and 1.4.2 should be achieved.

6.1 Transportation

6.1.1 Food Carriers

Carriers used by the manufacturer are designed, constructed, maintained, cleaned and utilized in a manner that prevents food contamination and minimizes microbial growth.

Anticipated Outcomes
  • Carriers, including bulk tanks, are clean, dry, weatherproof, free of infestation and sealed to prevent water, rodents or insects from reaching the products.
  • The manufacturer can demonstrate that the carrier has an adequate cleaning and sanitizing program in place. All tankers delivering raw ingredients, such as flour, are thoroughly cleaned on a set schedule and each time there is a possibility of cross-contamination with allergens between shipments, in a cleaning station before being loaded. The adequacy of cleaning is verified.
  • The manufacturers should have specifications for the handling of raw materials during transportation.
  • Where direct contact with food may occur, materials used in carrier construction are suitable for food contact.
  • Conveyances and containers are inspected by the manufacturer upon receipt of incoming ingredients and prior to loading of final products to ensure they are free from contamination (e.g. pests, residues) and suitable for the transportation of food.
  • Proper environmental conditions such as temperature and humidity are controlled, monitored, and documented to assure raw material and finished product safety and wholesomeness.
  • Where the same carriers are used for food and non-food loads, procedures are in place to restrict the type of non-food loads to those that do not pose a risk to food loads in the same shipment, or to subsequent food loads after an acceptable clean out.
  • Fresh alimentary paste products are loaded, transported and unloaded in a manner that protects them from any damage and/or contamination.
  • Bulk tanks are designed and constructed to permit complete drainage and to prevent contamination.
  • Carriers are loaded, arranged and unloaded in manner that prevents damage and/or contamination of the food.

6.1.2 Temperature Controls

Ingredients and finished product requiring temperature controls are transported in a manner to prevent temperature abuse that could result in deterioration of the product and affect its safety.

Anticipated Outcomes
  • Ingredients requiring refrigeration are transported at 4°C (39°F) or less and the temperature is appropriately monitored. Frozen ingredients are transported at temperatures that do not permit thawing and the temperature is appropriately monitored.
  • Finished product is transported under conditions that minimize microbiological, physical and chemical deterioration.

6.2 Storage

6.2.1 Incoming Materials Storage

Storage and handling of incoming ingredients and packaging materials is controlled to prevent damage and contamination.

Anticipated Outcomes
  • Ingredients requiring refrigeration are stored at 4°C (39°F) or less and the temperatures are appropriately monitored. Frozen ingredients are stored at temperatures that do not permit thawing and the temperatures are appropriately monitored.
  • Humidity sensitive ingredients and packaging materials are stored under appropriate conditions to prevent deterioration.
  • Incoming materials and packaging materials are handled and stored in a manner that prevents damage and/or contamination (including cross-contamination with allergens).
  • Incoming materials containing allergens are clearly identified (using a color code or other identification system).
  • Incoming materials and packaging materials are stored off the floor and away from walls to permit access for cleaning and pest control.
  • All raw materials are kept separate from packaging material or finished product.
  • Stock rotation (of ingredients and where appropriate, packaging materials) is controlled to prevent deterioration and spoilage (e.g. first-in, first-out).
  • Defective or suspect product or ingredients are clearly identified and isolated in a designated area for appropriate disposition.

6.2.2 Non-Food Chemicals – Receiving and Storage

Non-food chemicals are received and stored in a manner that prevents contamination of food, packaging materials and food contact surfaces.

Anticipated Outcomes
  • Non-food chemicals are received and stored in a dry, well ventilated area.
  • Non-food chemicals are stored in designated areas such that there is no possibility for cross-contamination of food or food contact surfaces.
  • Where required for ongoing use in food handling areas (e.g. conveyor lubricants), these chemicals are stored separate from food and located in a manner that prevents contamination of food, food contact surfaces or packaging materials.
  • Non-food chemicals are stored and mixed in clean, correctly labelled containers that include instructions for use.
  • Non-food chemicals are dispensed and handled only by authorized and properly trained personnel.

6.2.3 Finished Product Storage

Finished product is stored and handled under conditions that prevent damage and contamination.

  • Fresh alimentary paste products are stored and handled under conditions that minimize damage, deterioration and prevent contamination including allergen contamination.
  • Finished products are stored off the floor and away from walls to permit access for cleaning and pest control.
  • Finished products requiring refrigeration are stored at 4°C (39°F) or less and are appropriately monitored. Frozen finished products are stored at a temperature that does not permit thawing.
  • Stock rotation is controlled to prevent deterioration and prevent spoilage of products that could present a health hazard (e.g. products exceeding shelf life).
  • Returned, defective or suspect product is clearly identified and isolated in a designated area for appropriate disposition.
  • Finished product is stored and handled in a manner that minimizes damage (e.g. forklift damage or damage due to uncontrolled stacking heights).

Chapter 7: Records

7.1 General Records

7.1.1 General Record Requirements

Information is recorded in a manner which represents an accurate history of the product or process. Records are retained for an appropriate period of time.

Anticipated Outcomes
  • Records are legible, permanent and accurately reflect the actual events, conditions or activities.
  • Errors or changes are identified so that the original record remains clear (e.g. strike out with a single stroke and initial the correction/change).
  • Each entry on a record is made by the responsible person at the time that the specific event occurred. The completed records are signed and dated by the responsible person.
  • Critical Control Point records and other records significant to food safety are signed by a qualified individual designated by management prior to distribution of product. All other records are reviewed at an appropriate frequency to provide an early indication of potentially serious deficiencies.
  • Records are retained for at least one year after the durable life date on the label or container or if there is no durable life date, for at least two years after the date of manufacture.
  • Records are maintained and are available upon request.

7.2 Records on Control of Operation

7.2.1 Process Design Records

Records are kept to demonstrate the adequacy of procedures and methods used in process development.

Rationale

Records are necessary to verify that factors significant to food safety, including Critical Control Points, are adequate to produce a safe product.

Anticipated Outcomes
  • Records are kept which verify that reliable procedures have been followed in designing the process, e.g. copies of scientific type references, studies containing the information supporting food safety.
  • Records are kept which document the required processing, packaging, etc. parameters that need to be in place or followed to attain a safe product. This includes procedures and/or specifications).

7.2.2 Incoming Material Control Records

  • The manufacturer keeps records that demonstrate the adequacy of incoming materials control.
Rationale

Adequate records are necessary to verify the manufacturer's control over biological, physical and/or chemical hazards associated with incoming materials.

Anticipated Outcomes
Incoming Ingredients
  • Appropriate records are kept to demonstrate that incoming lots of ingredients were inspected for signs of contamination and adherence to written specifications.
Incoming Packaging Materials
  • Appropriate records are kept to demonstrate adherence to written specification.
Non-Conforming Incoming Materials (including ingredients and packaging material)
  • The manufacturer has records to:
    • identify the material;
    • identify the deficiency; and
    • specify the preventive measures and corrective actions taken.

7.2.3 Product Preparation/Blending Records

Records for factors significant to food safety and/or Critical Control Points are maintained.

Rationale

Records are necessary to verify that factors significant to food safety and/or Critical Control Points during preparation are controlled.

Anticipated Outcomes

The manufacturer keeps records that demonstrate control of product preparation/mixing through adherence to limits of acceptability and/or critical limits where applicable (e.g. allergens, food additives, nutrient addition).

7.2.4 Process Control Records

Written records that adequately reflect the control of factors significant to food safety and/or Critical Control Points during processing are kept.

Rationale

Records are necessary to verify the safety of the process.

Anticipated Outcomes
  • The manufacturer has records that demonstrate control of Critical Control Points and/or factors significant to food safety during processing. These could include the following:
    • records that demonstrate control of physical hazards (e.g. screening of bulk flour, metal detection screening of finished product ).
    • records that confirm all processing time and temperature requirements have been met.
    • where applicable, records that demonstrate food allergen control.
  • Deviations are noted on the records by the operator.

7.2.5 Deviation and Corrective Action Records

Records are kept to demonstrate the control of deviations and the effectiveness of corrective actions taken.

Rationale

Records are required to verify that the manufacturer has control of deviations and that corrective action has been effective.

Anticipated Outcomes
Deviation/Hold

Deviation records include information such as:

  • product and code;
  • date when the product was manufactured, held, released or destroyed;
  • description of deviation and reason for the hold;
  • amount of product held, e.g. back to the point where the process was last in control;
  • results of evaluation/sort, e.g. amount analysed, analysis report of the number and nature of defects;
  • disposition of held product, e.g. amount sorted, destroyed, employee sales, distress or salvage, reconditioning, and retail sales;
  • signature of personnel responsible for hold and evaluation; and
  • signed authorization for disposition.
Corrective Action

Corrective action records include information such as:

  • cause of deviation identified;
  • corrective action taken to correct deficiency;
  • preventive measures taken to prevent recurrence of the deviation;
  • follow-up/assessment of effectiveness of corrective action and preventive measures;
  • date corrective action was taken and verified; and
  • signature of person responsible.

7.2.6 Verification Records

Records are kept to demonstrate the adequacy of verification procedures.

Rationale

Records show the results of verification and confirm the conformance and effectiveness of manufacturing controls.

Anticipated Outcomes
  • Records of verification include the methods utilized, the date, the individuals/organizations responsible, the results/findings and the actions taken (corrective action when a deviation is found).

7.3 Records on Equipment

7.3.1 Equipment/Instrumentation Maintenance and Calibration Records

Records are kept to demonstrate adherence to the maintenance and calibration program for equipment and instrumentation that may impact on food safety.

Rationale

Records permit verification of the effectiveness of the equipment/instrumentation maintenance and calibration program.

Anticipated Outcomes
  • In Maintenance Records for equipment and/or instrumentation that may impact on food safety, the manufacturer typically includes an identification of the equipment and/or instrumentation, the maintenance activity, the date of maintenance, the person responsible and the reason for the activity.
  • In Calibration Records for equipment and/or instrumentation that may impact on food safety, the manufacturer typically includes an identification of the equipment and/or instrumentation, the date of calibration, the person responsible, the calibration results and corrective actions.

7.4 Records on Premises

7.4.1 Water/Ice/Steam Quality Records

Written records that adequately reflect control of water and steam quality and treatment are kept.

Anticipated Outcomes
  • The manufacturer keeps records to demonstrate the adequacy of the microbiological and chemical safety of the water and steam supply as outlined below.
Water Potability Records Water Treatment Records Boiler Feed water
Treatment Records
water source method of treatment method of treatment
sample site sample site analytical results
analytical results analytical results analyst
analyst analyst date
date date

7.5 Records on Sanitation And Pest Control

7.5.1 Sanitation Records

Records are kept to demonstrate the effectiveness of the sanitation program.

Anticipated Outcomes
  • The records of sanitation activities include the date, the person responsible, the findings, the corrective action taken, and the microbiological test results where appropriate.

7.5.2 Pest Control Records

Records are kept to demonstrate the effectiveness of the pest control program.

Anticipated Outcomes
  • Minimum pest control records include:
    1. the results of the inspection programs and the corrective action taken (e.g. the findings in traps, the location of insect infestations);
    2. a record of pest control activities (e.g. the pesticide used, the method and location of application, the dates of fumigation); and
    3. the date and the person responsible.

7.6 Records on Complaint Handling And Recalls

7.6.1 Complaint Records

Records of product complaints, investigation findings and action taken are kept.

Rationale

Records provide verification that the appropriate action was taken within a reasonable time frame.

Anticipated Outcomes
  • The establishment maintains detailed records of consumer complaints received and of the subsequent investigation, including corrective action taken. Complaint records include the information listed below.
Consumer Information
  • The manufacturer's records contain, at a minimum:
    1. the name, address and telephone number of the complainant, and the date the complaint was received;
    2. details of the complaint and/or illness;
    3. the product's name, code and size; and
    4. the retail outlet where the product was purchased.
Investigation
  • The manufacturer's records contain, at a minimum:
    1. the name of person responsible for the investigation;
    2. the action taken (concerning the product and/or the process) as a result of the investigation;
    3. the corrective action taken to prevent a recurrence; and
    4. a follow-up/assessment of the effectiveness of the corrective action.

7.6.2 Distribution Records

Product distribution records are kept to enable the manufacturer to recall any lot of food in a timely fashion.

Anticipated Outcomes

Distribution records contain sufficient information to permit traceability to a particular code or lot number. The following minimum information is required for distribution records:

  1. the product identification and size;
  2. the lot number or code;
  3. the quantity; and
  4. name and type of the account, (e.g. manufacturer, distributor, retailer), addresses and phone numbers of recipients.

Chapter 8: Complaint Handling and Recalls

8.1 Complaint Handling

8.1.1 Product Complaints

The establishment has an effective system for handling and investigating complaints.

Rationale

Product complaints are an important indicator of possible deficiencies in manufacturing controls and/or deficiencies in the distribution handling system. When the complaint handling system itself is deficient, it could result in failure to identify and eliminate risks.

Anticipated Outcomes
  • The manufacturer has a system to handle and investigate product complaints which identifies the person or persons responsible for receiving, evaluating, categorizing and/or investigating complaints.
  • Complaints are accurately categorized according to safety, composition and other regulatory concerns.
  • Potentially serious complaints are forwarded immediately to appropriate personnel for action.
  • Safety and contamination complaints are investigated by appropriately trained technical personnel.
  • Examination of the complainant's specimen, the retail product or other product of the same code is conducted on complaints related to food safety.
  • Complaints pertaining to composition, fraud and other regulatory concerns are investigated in an effective manner.
  • The depth of the investigation is appropriate to the risk and similar complaint trends.
  • Appropriate corrective action is taken for deviations identified during the investigation.

See Section 7.6.1 for expected Complaint Records.

8.2 Recalls

8.2.1 Recall Procedure

The fresh alimentary paste manufacturer establishes a written procedure to permit the complete, rapid recall of any lots of fresh alimentary paste from the market.

Anticipated Outcomes
  • A written procedure is in place to enable the recall of any lot of product and provide detailed information to assist in the investigation of any identified produce contamination.
    Note: In some instances, the establishment may be required to recall a product because of the use of a raw ingredient or packaging material which has been determined to be unsafe. By linking raw ingredient lot codes to the finished product code, the establishment will be able to identify which of the finished products need to be recalled.
  • The written procedure identifies the person or persons responsible (e.g. recall coordinators) and the roles and responsibilities of those who coordinate and implement a recall.
  • The procedure specifies methods to identify, locate and control recalled product, and includes a requirement to investigate other products that may be affected by the hazard and should be included in the recall.
  • The procedure requires that the recall be monitored to assess its effectiveness (e.g. an "effectiveness check" is conducted to the appropriate level of distribution specified in the recall notice).
  • The Canadian Food Inspection Agency is immediately notified in the region where the manufacturer is located. This notification includes the following:
    • the amount of product produced, the amount in inventory and the amount distributed;
    • the name, size, code or lot numbers of the food recalled;
    • the area in which the product was distributed (e.g. local, national, international); and,
    • the reason for the recall.

Note: For additional information on developing a recall plan, please refer to the Food Recalls: Make a Plan and Action It! Manufacturers' Guide on the CFIA website.

See Section 7.6.2 for expected Distribution Records.

8.2.2 Recall Capability

Recall procedures are tested periodically to verify the manufacturer's capability to rapidly identify and remove product from the market.

Anticipated Outcomes
  • The manufacturer demonstrates the capability to provide accurate information on a timely basis, to verify that all affected product can be rapidly identified and removed from the marketplace. For example:
    • the manufacturer conducts periodic testing (internal simulations) to verify the capability of the procedure to rapidly identify and control a code lot of potentially affected product, and to reconcile the amount of product produced with the amount in inventory and the amount in distribution; and
    • the manufacturer identifies and corrects any deficiencies in the recall procedure.

Glossary

For the purpose of this guidance document, the following expressions have the stated definitions:

Allergens
any substance capable of producing an abnormal immune response in sensitive individuals. Priority food allergens of concern in Canada include: peanuts, tree nuts, milk, soy, wheat, sulphites, sesame seeds, egg and seafood (fish, crustaceans and shellfish).
Capability
a standardized evaluation of the inherent capability of equipment to consistently perform a specified function under actual operating conditions after significant causes of variation have been eliminated.
Contamination
the transfer of harmful substances or disease-causing microorganisms to fresh alimentary paste by hands, food-contact surfaces and utensils that touch contaminated food.
Control
means that an operation performs consistently within pre-determined limits based on process capability, meets process requirements, provides a mechanism to maintain the stability of the process and consistently results in a safe product.
Corrective action
the actions to be taken when the results of any monitoring indicates a loss of control. In addition this term refers to any action taken to bring the process into control and deal with any affected product when critical limits or other criteria are not met. The action should be prompt and appropriate to the seriousness of the deficiency.
Critical Control Point (CCP)
a point, step or procedure at which control can be applied and a food safety hazard can be prevented, eliminated, or reduced to acceptable levels.
Critical limit
A criterion which separates acceptability from unacceptability.
Cross-contamination
contamination of foods or packaging material by direct or indirect contact with material from an earlier stage of the process. A regulated process flow and good employee practices will minimize the risk of cross-contamination occurrences.
Deterioration
for the purposes of this document, deterioration can be used interchangeably with spoilage; however, deterioration can also apply to non-food products such as packaging materials. For non-food items, deterioration is a physical or chemical change in the material that may adversely affect the safety of the food.
Deviation
failure to meet the critical limits for a Critical Control Point or failure to meet the limits of acceptability for factors significant to food safety.
Deviation procedure
a pre-determined and documented set of corrective actions (immediate and preventive) which are implemented when a deviation occurs.
Documents
for the purposes of this document, documents refer to written formulae, procedures or specifications used by or required of a manufacturer.
Factors significant to food safety
means any property, characteristic, condition, aspect, or other parameter, variation of which may affect the safety of the product or the process.
Food contact surface
any equipment or utensil which normally comes in contact with the food product or surfaces normally in contact with the product.
Fresh alimentary paste
shaped raw dough, comprised of flour and liquid, and which may also contain egg, colour, added nutrients, as well as, seasoning and spices. This includes but is not limited to macaroni, spaghetti and noodles.
Hazard
An agent, condition or circumstance that has the potential to cause illness or injury in the absence of control. Hazards can be biological, chemical or physical.

Biological include:

  • pathogenic bacteria that cause illness by infection (e.g. Salmonella) or intoxication (e.g. Clostridium botulinum, Staphylococcus aureus) and so include bacterial toxins (e.g. botulinum toxin, staphylococcus toxin);
  • viruses and parasites that cause illness by infection.

Chemical include:

  • substances or toxins that are naturally occurring and derived from plants, animals, algae and fungi (e.g. mycotoxins, poisonous mushroom) but not including bacterial toxins;
  • substances intentionally added to the food during growth or food processing and considered safe below certain established limits but unsafe above established limits (e.g. sodium, nitrate);
  • substances that contaminate food accidentally (e.g. cleaning chemicals);
  • food allergens (e.g. peanuts, tree nuts, milk, soy, seafood [fish, crustaceans and shellfish], wheat, sulphites, sesame seeds and egg).

Physical include:

  • material not normally found in food that can cause physical injury to the person consuming the food (e.g. broken glass, metal fragments, stones, wood slivers, bone pieces).
Hazard Analysis Critical Control Points (HACCP)
a systematic approach to identifying and assessing hazards and risks associated with a food operation and defining the means of their control.
Inspection areas
(definition with respect to lighting requirements), inspection areas are defined as any point where food products or containers are visually inspected or instruments are monitored.
Lot
means the amount of product of a specific container size, product style and code produced by a food establishment during a specified period of time.
Microorganisms
include yeasts, moulds, bacteria, viruses and parasites. When used as an adjective the term "microbial" is used.
Modified Atmosphere Packaging (MAP)
packaging of the product in an atmosphere which is different than air (e.g. vacuum packaging, gas packaging).
Monitoring
a planned sequence of observations or measurements to assess whether a CCP (or other activity) is under control.
Mycotoxins
are substances produced by certain fungi (e.g. mould) in agricultural products that are susceptible to fungal infection. Some mycotoxins including aflatoxin, ochratoxin, zearalenone, patulin, ergot alkaloids, vomitoxin and fumonisin are known to constitute a food safety hazard.
Pasteurization
with respect to food safety is a heat treatment intended to destroy microorganisms that could cause disease.
Recall, Periodic testing (Recall)
internal activities conducted on a periodic basis to verify the capability of the manufacturer to rapidly identify and control a given lot of product. These activities do not necessarily require the manufacturer to contact customers.
Potable water
water which meets the requirements of the Guidelines for Canadian Drinking Water Quality published by Health Canada and any applicable provincial and municipal requirements.
Pre-packaged product
as per the Food and Drugs Act, any food that is contained in a package in the manner in which it is ordinarily sold to or used or purchased by a person.
Prerequisite program
Universal steps or procedures (e.g. Good Manufacturing Practices [GMP]) that control the operational conditions within a food establishment and promote environmental conditions that are favourable for the production of safe food.
Recall (noun)
denotes the process of recalling the affected product and encompasses all tiers of the affected product distribution system.
Recall (verb)
means for an establishment to remove from further sale or use, or to correct, a marketed product that contravenes legislation administered and/or enforced by CFIA.
Records
observations and measurements recorded by a manufacturer to determine adherence to critical limits, limits of acceptability or other specified requirements (for a Critical Control Point or for factors significant to food safety).
Refrigeration
means exposure to a temperature of 4°C or less, but does not mean frozen.
Risk
an estimate of the likelihood of occurrence of a hazard.
Sanitizing
the application of heat or chemical treatments to destroy or substantially reduce the number of microorganisms that have the potential to cause adverse health effects.
Spoilage
a process whereby food is rendered unacceptable for consumption through microbiological or chemical reaction.
Validation
the obtaining of evidence showing that control measures are capable of being consistently effective. Validation is performed when new control measures or a new food safety control system is designed, or when changes indicate the need for re-validation, in order to confirm that the control measures or food safety control systems, when implemented as intended, are capable of controlling the hazard to the appropriate level and that this level of control can be achieved consistently.
Verification
examination of the accuracy, correctness or effectiveness of validated processes or process controls through testing, investigation or comparison against a standard.

References

Lund, B.M., Baird-Parker, T.C., Gould, G.W. 2000. Microbiological Safety and Quality of Food. Volumes 1- 2. Aspen Publishers, Inc. Gaithersburg, Maryland, p. 763.

International Commission on Microbiological Specifications of Foods (ICMSF). 1988. HACCP in Microbiological Safety and Quality. Blackwell Scientific Publications, London, p.258.

Sperber, W.H. 2003. Microbiology of milled cereal grains: issues in customer specifications. Int. Assoc. Oper. Millers Tech. Bull. 3: 7929-7931.

Additional Resources :

Acts and Regulations

Canadian Food Inspection Agency

Agriculture and Agri-Food Canada

  • Canadian Code of Recommended Manufacturing Practices for Pasteurized/Modified Atmosphere Packaged/Refrigerated Food. Ottawa. 1990. Ottawa, Canada.

Health Canada

International

Other Resources

  • Berghofer, L.K., Hocking, A.D., Miskelly, Di, Jansson E. 2003. Microbiology of wheat and flour milling in Australia. Int. J. Food Microbiol. 85: 137-149.
  • Kent, N.L., Evers, A.D. 1994. Technology of Cereals. 4th Edition, Pergamon Press. Oxford.
  • Sperber, W.H. and the North American Millers' Association Microbiology Working Group. 2007. Role of microbiological guidelines in the production and commercial use of milled cereal grains: a practical approach for the 21st century. J. Food Prot. 70: 1041-1053.

Appendix A: Hazard Analysis and Critical Control Point (HACCP) Summary

This guidance document and the HACCP Generic Model for fresh non-filled alimentary paste were developed by the Canadian Food Inspection Agency (CFIA) in an effort to reduce the health risk(s) posed by the consumption of higher risk foods.

HACCP (Hazard Analysis Critical Control Point) is recognized as the most respected food processing concept in the world for enhancing the production of safe food. The HACCP approach involves the review of each step of the food manufacturing process, from start to finish, in order to identify every possible hazard or source of contamination. Hazards can be biological (e.g. pathogenic microorganisms), chemical (e.g. pesticides, allergens) or physical (e.g. extraneous material). For each identified hazard or source of contamination a reliable control or procedure is put in place to ensure that contamination does not occur or is controlled to an acceptable level.

A HACCP system is built on an establishment's existing food safety control program. The standard operating procedures developed and written by the establishment can be Good Manufacturing Practices (GMPs) or an adopted food safety code. In many HACCP guideline documents, these GMPs are referred to as prerequisite programs that represent the foundation of the HACCP Plan. The GMPs must be equivalent to the Recommended International Code of Practice – General Principles of Food Hygiene adopted by the Codex Alimentarius Commission (Codex) to ensure that adequate control exists over the environment in which the food processing is taking place.

It is generally recognized that in adopting the HACCP approach, a food processing establishment needs to carry out the following five preliminary tasks:

  1. Assemble a HACCP team with the expertise and knowledge to develop the HACCP Plan.
  2. Thoroughly describe the product and its intended use (e.g. common name, important product characteristic, shelf life, labelling instructions, etc.).
  3. List all product ingredients and incoming materials that come in contact with the product or are used in preparing the product.
  4. Develop an accurate and detailed Process Flow Diagram (from raw material receiving to finished product shipping) and Plant Schematic/Blueprint showing product and traffic flow.
  5. Verify the Process Flow Diagram and Plant Schematic on-site.

After completing the preliminary tasks, the HACCP team develops the HACCP Plan by applying the seven principles of HACCP to each food category processed.

Principle 1

Conduct a hazard analysis (HA) from the receiving of raw materials to the use of the finished product by the consumer.

Note: Information on food hazards (e.g. biological, chemical and physical hazards) can be obtained from scientific publications and industry associations.

Principle 2

Apply the HACCP decision tree to determine Critical Control Points (CCPs).

Principle 3

Establish critical limits, i.e. criteria that define acceptability and unacceptability of food products.

Principle 4

Establish monitoring procedures to ensure that the critical limits are being met.

Principle 5

Establish deviation procedures when monitoring at a CCP indicates a deviation from an established critical limit.

Principle 6

Establish procedures for verification to confirm the company's conformance to and the effectiveness of the HACCP Plan.

Principle 7

Establish documentation and records, including the HACCP Plan details, processing records, as well as HACCP-related monitoring and verification records.

The HACCP Generic Model, developed following the CFIA's Food Safety Enhancement Program (FSEP) approach, includes all of the seven principles outlined above. It provides information to be used by the establishment in developing a plant-specific HACCP Plan. The Generic Model includes an example of a process flow diagram and identifies possible food safety hazards associated with each step in the process. Using the Codex Alimentarius decision tree, the Generic Model determines the points in the process where Good Manufacturing Practices (GMPs) in place at the facility do not control the potential hazard (Critical Control Points). For each of the Critical Control Points in the process, the Generic Model provides examples of:

  • procedures to be implemented in order to ensure that the hazard is controlled (i.e. monitoring procedures);
  • procedures to be implemented when monitoring determines that the hazard is no longer controlled and a possible food safety hazard could exist (i.e. deviation procedures); and,
  • procedures to be implemented to ensure that both the monitoring procedures and the deviation procedures are being followed and are effective in controlling the identified hazards (i.e. verification procedures).

It is hoped the HACCP Generic Model will provide guidance and information to manufacturers in developing their own HACCP Plan. Each manufacturer must create its own process flow diagram according to its specific practices and procedures. Moreover, hazards and how they are controlled as described in the Generic Model will need to be changed where necessary to reflect a manufacturer's unique flow diagram and/or product characteristics.

Additional information on developing a HACCP Plan can be found in the FSEP Manual on the CFIA website.

This guidance document includes a proposed GMPs guide that could serve as a prerequisite program. As mentioned above, by implementing GMPs the manufacturer could control many of the hazards identified for each step in the process. This document also includes information on process controls. Both the Generic Model and this guidance document are intended to be tools for the food industry's voluntary use in creating a food safety control system.

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