Food Safety Practices Guidance for Moulded Chocolate 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 product processed.

Rationale

By providing a basis for the assessment of food additives, composition, labelling, nutritional requirements and food allergens, current written formulae provide information aimed at ensuring 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, such as corn starch and vegetable oil on raisins);
    • amounts of all ingredients, including food additives.
  • Products are formulated to comply with food standards where they exist (see Division 4, of the FDR for chocolate standards).
  • 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 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 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.

Anticipated Outcomes

  • Ingredients significant to the safety of the process are identified with their specifications.
  • Formulation factors that are key to the safety and integrity of the product are identified. This includes preparation/process steps and microbiological, chemical (e.g. allergens) or physical (e.g. hazardous extraneous material) concerns. Their specifications and limits are identified (e.g. water activity as well as freedom from Salmonella spp.).
  • Manufacturers producing specialty allergen-free products (e.g. peanut-free) ensure the allergen of concern (e.g. peanut) 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 (Division 4, of the FDR for chocolate standards).

Rationale

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

Anticipated Outcomes

  • The manufacturer has control over the formulation to ensure that all nutrient content declarations and regulatory requirements are met.
  • Product formulations are designed to ensure that standardized food products meet the regulated standards of identity and composition.
  • The manufacturer verifies, as often as necessary, that the Nutrition Facts table is accurate and within tolerance.

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 (GFLA) 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 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 used (e.g. food colouring agents) 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 (see Division 4 of the FDR for standards of chocolate).
  • 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 requires 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, where permitted, 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 of 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. common name, list of ingredients, net quantity and name and address of the manufacturer);
  • Nutrition Facts table.

Inaccurate labels may also 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. They 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, guidance on the Labelling of Foods Causing Allergens and Sensitivities, a Tool for Managing Allergen Risk in Food Products, and Food Allergies and Allergen Labelling.

For additional information, see Health Canada's policy on The Use of Food Allergen Precautionary Statements on Pre-packaged 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, such as "X free" allergen claims.
  • 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.
  • Labels are reviewed both for compliance with Canadian legislation (e.g. presence of mandatory labelling), and for accuracy and correctness of information (e.g. presence of allergens).
  • Where suppliers have labelled raw materials with a precautionary statement, such as "may contain milk", 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).
  • 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 formulations, including ingredients and/or their components, are assessed for their possible 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).

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.

Rationale

Written scientific evidence is necessary to demonstrate that each process adequately ensures the safety of the 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 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 CCPs rationale see the CFIA's HACCP Generic Model for Moulded Dark Chocolate with Almonds.

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 of preventing food contamination rather than trying to identify and control contamination after it has occurred. Chocolate 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 chocolate and chocolate processing;
  • identify any steps in their operations that are critical for controlling the safety of chocolate;
  • 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 should conduct 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 Moulded Dark Chocolate with Almonds and the CFIA's Food Safety Enhancement Program (FSEP) Manual.

Flow Diagram - Generic Process identifying suggested Critical Control Points (CCPs) for Moulded Chocolate.

See the HACCP Generic Model for Moulded Dark Chocolate with Almonds for more details.

Flow Diagram - Generic Process identifying suggested Critical Control Points (CCPs) for Moulded Chocolate

Description for Generic Process Flow Diagram For Moulded Chocolate

This diagram is a flow chart showing the process for producing moulded chocolate.

The diagram lists the necessary steps from 1 - 19 to be taken in the moulded chocolate production process.

Identified in pink ovals are the Critical Control Points (CCPs). These are next to boxes 6, Melting tank; 12, Mixing/blending; 16, Metal detection; and 17, Packaging/labelling/coding.

Identified in an orange oval is rework. This receives input from steps 13, Depositing/moulding; 14, Air cooling; and 15, Demoulding; and leads to steps 2, Chocolate storage; and 6, Melting tank.

Identified in a green oval is returned product which leads to step 1, Receiving.

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

  1. Receiving (BCP). Leading to steps 2, Chocolate storage; 3, Almond storage; and 4, Packaging material storage. Receives input from returns.
  2. Chocolate storage (BCP). Leading to steps 5, Cutting/breaking chocolate blocks; and 6, Melting tank. Receives input from rework.
  3. Almond storage (BCP). Leading to step 12, Mixing/blending.
  4. Packaging material storage (BCP). Leading to steps 13, Depositing/moulding; and 17, Packaging/labelling/coding.
  5. Cutting/breaking chocolate blocks (BCP). Leading to step 6, Melting tank.
  6. Melting tank (BCP). CCP-1C. Leading to steps 7, Screening/magnet; and 8, Holding tank. Receives input from rework.
  7. Screening/magnet (BCP). Leading to step 8, Holding tank.
  8. Holding tank (BCP). Leading to step 9, Screening/magnet. Melted chocolate with rework leads to step 12, Mixing/blending.
  9. Screening/magnet (BCP). Leading to step 10, Tempering.
  10. Tempering (BCP). Leading to step 11, Screening/magnet.
  11. Screening/magnet (BCP). Leading to step 12, Mixing/blending.
  12. Mixing/blending (BCP). CCP-2C. Leading to and receives input from step 13, Depositing/moulding.
  13. Depositing/moulding (BCP). Leading to step 14, Air cooling; and rework.
  14. Air cooling (BCP). Leading to step 15, Demoulding; and rework.
  15. Demoulding (BCP). Leading to step 16, Metal detection; and rework. Product packaged prior to metal detection leads to step 17, Packaging/labelling/coding.
  16. Metal detection (BCP). CCP-3P. Leading to step 17, Packaging/labelling/coding. Product packaged prior to metal detection from step 17 is received. This product then proceeds to step 18, Storage; after metal detection.
  17. Packaging/labelling/coding (BCP). CCP-4C. Leading to step 18, Storage. Product packaged prior to metal detection leads to step 16, Metal detection.
  18. Storage (BCP). Leading to step 19, Shipping/distribution.
  19. 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 Chocolate and Other Non-Packaging Inputs

The manufacturer controls incoming chocolate 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 chocolate and other non-packaging inputs. Inadequate incoming product controls, such as a lack of appropriate product testing or a failure to verify labels, could result in the sale of contaminated product or misrepresented product. 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 of the food.

Anticipated Outcomes

  • The manufacturer has written microbiological specifications for chocolate and obtains certificates of analysis for each lot of chocolate to confirm that it does not contain Salmonella spp. and poses no other biological hazard.
    Note: for all ingredients, including chocolate, certificates of analysis may also include: enterobacteriaceae or coliforms, E. coli, moulds, yeasts, and Aerobic Colony Count [ACC] including aerobic sporeformers.
  • The manufacturer has written specifications and obtains a Letter of Guarantee from suppliers of chocolate (e.g. CFIA's Allergen Checklist for Food Suppliers and Manufacturers) for information relating to the control of chemical hazards, (e.g. undeclared allergens such as milk ingredients, tree nuts, peanuts, mycotoxins [such as Aflatoxin and Ochratoxin A] and food additives exceeding permitted levels).
  • The manufacturer has written specifications and obtains a Letter of Guarantee from suppliers of chocolate for information relating to the control of physical hazards such as metal.
  • The manufacturer has written specifications for all other ingredients. Supporting information, such as certificates of analysis or Letters of Guarantee, is obtained to confirm that these specifications are met. For example:
    • raw or roasted tree nuts – Salmonella spp., undeclared peanuts or other allergens, mycotoxins such as Aflatoxin (Nut and nut products that contain more than fifteen parts per billion of aflatoxin are considered adulterated and in violation of Section B.01.046 of the Food and Drug Regulations.) and extraneous material such as shells or stones.
    • raw or roasted peanuts – Salmonella spp., undeclared allergens such as tree nuts, mycotoxins such as Aflatoxin (Nut and nut products that contain more than fifteen parts per billion of aflatoxin are considered adulterated and in violation of Section B.01.046 of the Food and Drug Regulations) and extraneous material such as metal or stones.
    • raisins – pesticide residues, heavy metals, sulfites, stones, wood, insects, etc.
    • flavour – non-permitted colours and undeclared allergens.
  • Each lot of incoming material is examined for damaged containers and for signs of contamination (e.g. pests, insects, rodent activity including faeces and urine, mould, foreign material and lubricants).
  • 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 on importing chocolate or other ingredients should refer to the Good Importing Practices (GIP) document on the CFIA website.

Refer to Health Canada's Compendium of Analytical Methods for microbiological guidelines for chocolate.

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 containers 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 intended use 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.
  • The manufacturer has written specifications for packaging materials that identify criteria essential for the manufacturing process and product safety.
  • Each lot of packaging material is examined for physical damage, signs of contamination (e.g. stains, bird droppings, rodent activity [e.g. faeces, urine] and 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, visual examination prior to use).
  • Only packaging materials required for immediate use are kept in the packaging or filling area.
  • Packaging is performed under hygienic conditions that preclude the introduction of contamination into the product.
  • Containers are used only for their intended purpose.

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.

Rationale

Inadequate control of factors associated with product preparation/blending could result in inadequate processing or the presence of undeclared allergens. 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 blending of the product. Areas significant to food safety are outlined below.
  • The manufacturer monitors factors significant to food safety and/or Critical Control Points (under a HACCP System) at a scheduled frequency. For further information regarding Critical Control Point rationale see Appendix A and the CFIA HACCP Generic Model for Moulded Dark Chocolate with Almonds.

Allergens

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

  • cross-contamination or carry-over;
  • inappropriate use of rework;
  • ingredient changes, substitutions or additions, changes to the components of ingredients;
  • incorrect labels;
  • incorrect or incomplete list of ingredients; and
  • unknown ingredients (e.g. ingredients purchased from a new supplier and without specifications).

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

Food Additives

The manufacturer has controls in place to ensure that the food additives that are used are permitted, and are used within allowable levels. Specifically, controls ensure:

  • clear identification of additives;
  • accurate measurement;
  • adequate blending for homogeneity; and
  • checks against unauthorized substitution.

Composition

The manufacturer has controls in place to ensure the composition of the product accurately reflects the formulation. Manufacturers may require controls to prevent the following:

  • misdirection of ingredients;
  • inappropriate use of rework;
  • ingredient carryover;
  • inappropriate ingredient substitutions;
  • carryover from equipment (e.g. product changeovers).

See Section 7.2.3 for expected product preparation/blending records.

1.6.2 Cleaning/Sorting – Contamination Control

Raw materials and ingredients are cleaned, sorted, and/or inspected in such a manner as to reduce biological, physical and chemical contamination and to prevent contamination of the finished product.

Rationale

Adequate cleaning, sorting and/or inspection of raw materials and ingredients (e.g. tree nuts, peanuts and raisins) are necessary to prevent, reduce or remove contamination of a biological, chemical and/or physical nature.

Anticipated Outcomes

  • The manufacturer screens ingredients as necessary to address any 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.
  • Visual inspection can identify physical hazards (e.g. hazardous extraneous material, such as shells, stones and metal), as well as visible signs of damage that could indicate possible biological or chemical contamination.
  • Use of screens, magnets and/or metal detectors can reduce the risk from hazardous extraneous material in tree nuts, peanuts, raisins and melted chocolate.

Note: Refer to the CFIA's Reference Database for Hazard Identification for more hazard information.

Refer to Section 1.8.1 Processing Controls for details on cutting/breaking, melting & tempering, screening, magnets, mixing & blending, depositing & moulding, cooling, demoulding, rework and metal detectors.

1.7 Product Coding Control

1.7.1 Product Coding

Pre-packaged chocolate products are identified with code marks or lot numbers on the label or container to allow the identification of product in the event of a recall.

Rationale

Coding control permits products to be traced through the distribution chain and could provide manufacturing details.

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 chocolate 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.).
  • 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 (Cutting/Breaking, Melting & Tempering, Screening, Magnets, Mixing & Blending, Depositing & Moulding, Cooling, Demoulding, Rework and Metal Detectors)

All processing factors are controlled to ensure the safety of the product.

Rationale

Inadequate control of processing factors could result in biological, chemical or physical hazards.

Anticipated Outcomes

  • The manufacturer evaluates the process and identifies all factors that have an impact on the safety of the final product.
  • The manufacturer ensures all appropriate processing factors are controlled within acceptable limits.
  • The manufacturer monitors factors significant to food safety and/or Critical Control Points at a scheduled frequency.
  • With respect to food allergen control:
    • 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
  • Cutting/Breaking
    • Handling of chocolate is conducted in a hygienic manner to avoid contamination of chocolate as it is broken into manageable pieces before melting.
    • Utensils and equipment used for cutting and/or breaking are clean, acceptable for food contact, and maintained in good operating condition to minimize the potential for physical contamination of the product with metallic extraneous material.

    Note: See Section 2.1.3 Equipment Maintenance and Calibration Program for further information relating to the maintenance of equipment.

  • Melting & Tempering
    • To prevent the occurrence of undeclared allergens in food products, chocolate (e.g. dark, milk or white) is melted and tempered as per formulations and recipes. Caution is exercised to ensure rework and/or returned products are only added to end products containing the same allergens (e.g. peanuts, almonds and/or milk ingredients).
    • Water-jacketed melting, tempering and holding tanks are maintained in good operating condition to minimize the contamination of chocolate with water as the presence of water may permit the growth of pathogenic microorganisms. Agitators used in tanks are maintained in good operating condition to minimize contamination with hazardous extraneous material. Melting, tempering and holding tanks are adequately covered to minimize contamination.
  • Screening
    • Screening operations are controlled to reduce or eliminate physical hazards. Screening equipment is maintained in good operating condition to minimize the contamination of chocolate with hazardous extraneous material. Screening equipment is cleaned and inspected regularly to ensure proper function (torn screens are repaired, etc.). Hazardous extraneous material captured by the screening equipment is examined to determine the source and follow-up is conducted as necessary.
  • Magnets
    • Magnets are situated inline so that all product must pass over them. They are checked and cleaned regularly (at the beginning and end of product at a minimum).
    • Objects captured by the magnets are examined to identify their source and follow-up is conducted as necessary.

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

  • Mixing & Blending
    • Ingredients are added as per mixing and blending formulations and/or recipes. Adjustments to formulations and/or recipes are confirmed by qualified personnel.
    • Mixing and blending equipment is maintained in good operating condition to minimize the contamination of chocolate with extraneous material or lubricants. Ingredients are added in a hygienic manner.
  • Depositing & Moulding
    • Moulds used in the process have been adequately cleaned. Following sanitation, moulds are adequately protected to prevent contamination prior to depositing.
    • Moulds are of sound condition, free of cracks and dents and are handled to prevent damage to minimize the likelihood of physical contamination.
    • Moulds are constructed of material that is easy to clean and are able to withstand the demands of the operation without contributing to the physical contamination of the product.
    • The moulding or depositing area is adequately protected to minimize the potential of physical contamination.
  • Cooling
    • Air used for the cooling of products is acceptable for direct food contact.
    • Air filters, when used, are frequently examined (visually) to ensure their integrity and effectiveness.
    • Cool surfaces in warm areas are insulated to prevent any formation of condensate. Insulation is kept in sound condition.
    • Cooling tunnels are adequately protected to minimize the potential for physical contamination.
    • Equipment is maintained in good operating condition to minimize the potential contamination of chocolate products from leaking cooling agents.
  • Demoulding
    • Demoulding is performed in a hygienic manner using equipment of sound condition and is performed in a manner that does not compromise the integrity of moulds leading to the possible contamination of the product.
  • Rework
    • In-process materials considered acceptable for rework are collected, handled and stored in a hygienic manner to avoid contamination.
    • Rework in containers is clearly identified, including composition and batch identification.
    • Rework is controlled to ensure like products are added to like products (i.e. contains the same allergens) that declare the allergen.
  • Metal Detectors
    • 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) 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.

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 people with allergies (e.g. milk, tree nut, peanut).

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.

  • 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).
  • Product types are effectively separated during changeovers (e.g. appropriate breaks between products, visual inspection to ensure products are not mixed prior to labelling).
  • 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 applied on the product.
  • At a minimum, tops and bottoms of label bundles are visually checked for mixed labels prior to use. Similarly, pre-labelled packages are also visually checked prior to use.
  • During storage, care is taken to prevent mixing of individual labels, bundles of labels and pre-labelled packages (e.g. labels and/or pre-labelled packages are stored in separate boxes, no labels or pre-labelled packages are loose, unused labels or pre-labelled packages are returned to the correct boxes).
  • 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, guidance on the Labelling of Foods Causing Allergens and Sensitivities, a Tool for Managing Allergen Risk in Food Products, and Food Allergies and Allergen Labelling.

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 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 designed 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 Moulded Dark Chocolate with Almonds 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 the HACCP Generic Model for Moulded Dark Chocolate with Almonds for suggested deviation procedures and corrective actions.

See Section 7.2.5 for expected Deviations and Corrective Action Records.

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.

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;
    • manufacturers testing incoming lots of chocolate use statistically valid sampling methods for the detection of Salmonella spp. in chocolate;
    • sampling and analyses of in-process and finished product for the appropriate biological hazard (e.g. Salmonella spp., Coliform, and Aerobic Colony Count [ACC] includes aerobic sporeformers), chemical hazard (e.g. Allergen detection test) or physical hazard;
    • refer to Health Canada's Compendium of Analytical Methods, volume 1 for microbiological standard (B.04.012, FDR) and guidelines for chocolate.
      Note: analysis for pathogenic microorganisms should be performed in a separated or external test laboratory to avoid the potential for cross-contamination.
    • microbiological environmental sampling of food contact and non-food contact surfaces in processing areas to identify biological hazards (e.g. Salmonella spp., coliforms and ACC including aerobic sporeformers);
    • chemical environmental sampling of food contact and non-food contact surfaces in processing areas to identify chemical hazards (e.g. allergens);
    • 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.

See Section 7.2.6 for expected Verification Record.

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