Food Safety Practices Guidance for Fresh Non-Filled Alimentary Paste Manufacturers
Chapter 1: Control of Operation

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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.

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