HACCP Generic Model for Moulded Dark Chocolate with Almonds

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The General Principles of Food Hygiene, Composition and Labelling continues to be the current Canadian regulatory guide for chocolate manufacturers. The HACCP Generic Model for Moulded Dark Chocolate With Almonds and its companion document, Food Safety Practices Guidance for Moulded Chocolate Manufacturers were developed by a committee consisting of representatives from the Canadian Food Inspection Agency (CFIA) with input from a number of interested parties, including the Canadian chocolate industry, Health Canada and provincial government representatives. These documents are intended to be food safety resources for the chocolate industry.

The generic model was developed using the (CFIA) Food Safety Enhancement Program (FSEP) approach and tools: Sections 1, 2 and 3 of the FSEP Manual, including the ten forms it contains. Form 8, CCP Determination (based on the Codex Alimentarius Decision Tree), was used to determine the Critical Control Points (CCPs). It is expected that prior to the development of a facility-specific HACCP Plan, the manufacturer will first develop and implement Good Manufacturing Practices or prerequisite programs as they are called in the FSEP approach. This includes the development of programs and procedures associated with Premises, Transportation, Purchasing/Receiving/Shipping and Storage, Equipment, Personnel, Sanitation and Pest Control, Recall and Allergen Control. Following the development and implementation of the prerequisite programs, this generic model can be used as a practical example by the chocolate manufacturer to design a facility-specific HACCP Plan. Information on the FSEP approach can be found in the FSEP Manual.

The Food Safety Practices Guidance document was referenced by the committee during the development of the HACCP Generic Model for Moulded Dark Chocolate with Almonds. This guidance document incorporates Chapters 1 to 8 of the GPFHCL, in addition to other reference materials. Using a HACCP approach, it provides guidance to the chocolate manufacturer on controlling potential hazards. Chapter 1 provides information about developing operational controls for controlling hazards, while Chapters 2 to 8 provide information about developing Good Manufacturing Practices (GMPs). A hazard summary is provided after the Scope section in the guidance document.

Together, the generic model and its companion guidance document provide information for moulded chocolate manufacturers to use to review all potential health and safety hazards in their operations. It allows them to focus on controlling the points that are critical to the safety of the finished product. For additional information on prerequisite programs and the use of generic models, the FSEP Manual should be consulted.

I. Developing a Facility-Specific HACCP Plan

The HACCP team at each establishment is responsible for identifying and controlling all hazards specific to its operation and for determining how each hazard is controlled. In order to identify all possible hazards, the HACCP team should consult the Reference Database for Hazard Identification developed by the (CFIA), along with reference texts and scientific publications, as well as industry associations.

Using the HACCP Generic Model for Moulded Dark Chocolate with Almonds as a guideline, the HACCP team should develop a HACCP Plan specific to their facility beginning with Forms 1 to 4. A review of the manufacturer's processes and procedures should then be conducted to determine what hazards exist in the facility. Using the FSEP approach, these hazards are recorded on Forms 5, 6 and 7. Then using Form 8, the manufacturer determines how each of those hazards is controlled for incoming material and ingredients and at each step in the process. Where a step in the process is determined to be a CCP, the hazard is transferred to Form 10, and critical limits, monitoring procedures, deviation procedures and verification procedures should be developed. Following this process, the manufacturer should compare its facility-specific HACCP Plan to the generic model for completeness. If the manufacturer determines a prerequisite program is fully controlling a hazard in its facility but the generic model indicates a CCP as the control measure, the manufacturer should validate that the identified prerequisite program is able to fully control the hazard as described. For products or processes that differ significantly from this generic model, the HACCP team must still follow the seven principles of HACCP as described in the FSEP Manual.

II. Limitations for the Use of the Moulded Dark Chocolate with Almonds Generic Model

The committee wishes to emphasize that the model described here is a generic model. It does not cover all possible processes, nor does it list all possible associated hazards. This generic model is an example or guide that can be adapted to most facilities producing chocolate. The process flow diagram in this generic model does not reflect the characteristics of the specific manufacturing process of any one of the companies consulted by the committee, but rather represents the basic processing steps of all companies consulted. The model reflects the entire process from receipt of dark chocolate blocks through to the shipping/distribution of the moulded dark chocolate with almonds to hospitals, restaurants, institutions or retail outlets.

This generic model deals only with the manufacture of moulded dark chocolate with almonds from chocolate blocks. Where ingredients, procedures or processes in the facility differ from those in the generic model, the HACCP team should determine whether ingredients and/or process steps should be added or removed. Here are some examples:

Manufacture of chocolate from beans
This generic model does not include the manufacture of any intermediate products of chocolate or the manufacture of the chocolate blocks from cocoa beans. If these processes are conducted, the manufacturer should consider adding product information to Form 1, as well as adding the beans and/or the intermediate products to the list of incoming materials and ingredients (Form 2) and adding any additional process steps in the manufacturing process to the process flow diagram (Form 3).
Roasting of almonds
This generic model does not include the roasting of almonds. If almonds are being roasted at the facility, the HACCP team should consider making the required changes to the product information on Form 1 and Form 2 of the generic model as well as to the process flow diagram (Form 3) (adding the appropriate steps).
This generic model does not include the addition of a filling to moulded chocolate. If a filling is being added with or without almonds (e.g. caramel, nougat, cherry), the HACCP team should consider adding the product information to Form 1 of the generic model, the filling and/or its components to the list of incoming ingredients and materials on Form 2 and, if required, adding the necessary process steps to the process flow diagram (Form 3).
Chocolate product with no inclusions
If a manufacturer is making moulded chocolate that does not contain almonds (an allergen), the HACCP team should consider whether a possibility exists of chemical cross contamination with allergens from other ingredients and/or other production lines within the facility. The HACCP team should consider whether any additional information is required on the label and whether this information should be identified on Form 1 of the generic model. Consideration should also be given to removing ingredients that no longer apply from the list of incoming ingredients and materials on Form 2 of the generic model, and, if required, renaming and/or removing any process steps on the process flow diagram (Form 3).
Presence of additional ingredients (e.g. milk ingredients, raisins, sweeteners)
This generic model does not include milk ingredients as a component of the dark chocolate blocks (see definition of dark chocolate below). Nor does it include raisins, sweeteners, or milk ingredients as ingredients in the moulded chocolate. If the manufacturer is adding any additional ingredients, or if a component of any ingredient differs from the generic model, the HACCP team should consider adding the ingredient and/or the component to the list of incoming ingredients and materials (Form 2) in the generic model, and if required, the HACCP team should consider adding any additional steps to the process flow diagram (Form 3).
Single product line
This generic model assumes that the moulded chocolate with almonds is being manufactured on a dedicated manufacturing line where no products, other than moulded dark chocolate with almonds, are manufactured. This generic model also assumes that the moulded chocolate with almonds is made in a facility that has several different product lines with different ingredients, including different allergens. If a manufacturer has only one product and there is no chance of contamination from other ingredients or processes, the HACCP team should consider whether any changes should be made to the generic model on Form 1, Form 2, Form 3 and/or Form 4.

For each change made to Forms 1 through 4, appropriate changes must be made to Forms 5, 6, 7, 8, 9 and 10 where applicable, to ensure that the hazard analysis is complete.

III. Validation of the HACCP System

The HACCP team at each establishment is also responsible for the validation of the HACCP system. The team should first validate the hazards that exist in the facility, and then validate the standards for the prerequisite programs (i.e. GMPs) as well as the critical limits of the critical control points. If the manufacturer is unable to find a scientific study or government regulation supporting the standards and critical limits used in the prerequisite programs and HACCP Plan, facility personnel should conduct a validation study to validate the control measure being contemplated through testing. This step is generally completed during the development of the HACCP system. Once the control measure has been established and validated, facility personnel should carry out a validation to show that the process is able to consistently meet the standard. The manufacturer should reassess the adequacy of the HACCP system at least once a year and whenever changes occur that could affect the hazard analysis or alter the HACCP system. For additional information on validation and reassessment of the HACCP system, the FSEP Manual should be consulted.

IV. Decisions and Assumptions Made During the Development of the Generic Model

During the development of the generic model, as it worked through hazard identification and analysis, the committee discussed and dealt with the several issues. The following decisions and/or assumptions were made and are reflected in the generic model:

  1. This generic model, while based on the FSEP approach, endeavoured to adhere to the GPFHCL and the information found in the guidance document wherever possible. However, the committee recognized that differences exist between the GPFHCL and the FSEP approach. For example, in the FSEP approach, transportation, receiving and storage of all incoming ingredients and materials is covered in the prerequisite program, Transportation, Purchasing/Receiving/Shipping and Storage. The GPFHCL and the guidance document consider the criteria for receiving of incoming ingredients and packaging materials to be process related. This information can be found in Chapter 1 - Operational Controls (Section 1.4.1 and Section 1.4.2). All other information for receiving is found in Chapter 6 - Transportation and Storage (Section 6.1) of the GPFHCL and the guidance document. In order to be consistent with the FSEP approach, it is assumed that manufacturers will identify the receiving step as a prerequisite program. A note has been added to both Chapter 1 and Chapter 6 of the guidance document to indicate that if a manufacturer chooses to do this, the information from Sections 1.4.1 and 1.4.2 should be included with the information found in Section 6.1 (a prerequisite program). If the manufacturer wishes to maintain a CCP at Receiving, this will be considered acceptable.
  2. Where applicable, in the "Controlled at" column on Forms 5, 6 and 7, and when answering the question, 'Is the hazard fully controlled by a prerequisite program?' in the second column on Form 8, the FSEP prerequisite program is identified by the name it is given in the guidance document (i.e. "Transportation and Storage" not "Transportation, Purchasing/Receiving/Shipping and Storage" as it is identified in the FSEP Manual).
  3. The committee recognizes the importance of document control; however, in an attempt to avoid prescribing a specific method, we have not recorded information such as 'Written By', 'Approved By', 'Version Number' or 'Revision Date' on each page of the Generic Model.
  4. Dark chocolate is received as blocks and is not manufactured at the facility. It is considered ready-to-eat as received. There is no step identified in the manufacture of the moulded dark chocolate with almonds that will eliminate or reduce the risk of pathogen contamination in chocolate; therefore, the manufacturer should ensure that chocolate, almonds and other ingredients are free from pathogenic microorganisms (e.g. Salmonella spp.) before use. This may include obtaining certificates of analysis for each lot of chocolate received or conducting appropriate testing on incoming ingredients.
  5. Chocolate, because of its low water activity, prevents the growth of microbial hazards and prevents microbial spoilage problems. However, there is potential for Salmonella contamination from added ingredients such as cocoa, coconut, milk powder, and egg albumen, all of which may contain Salmonella. The addition of nuts, peanuts and cocoa may also introduce mycotoxins (e.g. aflatoxins and ochratoxin A). In this generic model, only almonds have been added to the chocolate.
  6. For the purposes of this generic model, it is assumed that the facility does not roast almonds as part of the manufacturing process. In other words, only roasted almonds are received at the facility.
  7. Water, ice and steam do not appear on Form 2 because they are not used as ingredients in the process.
  8. The dark chocolate in this generic model does not contain 'milk ingredients'. Manufacturers are reminded that while the definition of dark chocolate indicates that it may contain less than 5 percent total milk solids from milk ingredients (see definition of dark chocolate below), milk ingredients are considered an allergen. Where milk ingredients are present in the dark chocolate, these must be declared on the list of ingredients (as per B.01.008 of the Food and Drug Regulations) for the benefit of those individuals who are allergic to, or have a sensitivity to, milk products.
  9. The cooling step in this generic model is assumed to be conducted using refrigerated air circulated by fans.
  10. This generic model includes a metal detector. It is considered a safety measure to control hazardous extraneous (metallic) materials that are not controlled by the prerequisite programs (e.g. wear and tear of equipment resulting in metal shavings in the product during the grinding process). If a metal detector is part of the process, the hazards associated with that metal detector should be evaluated and controlled. The manufacturer should realize that the metal detector is only considered a safety measure to the level of the sensitivity of the machine. Below the sensitivity level of the machine, the hazard can no longer be controlled by the metal detector and the facility should determine how the hazard is controlled.
  11. In an attempt to condense the generic model, where it was determined that a common hazard exists for multiple process steps on Forms 5, 6, 7, 8 and 9, the process steps are grouped together with a single hazard description.
  12. On Form 10, this generic model assumes that the manufacturer will develop facility-specific Standard Operating Procedures (SOPs) that are validated to ensure that when the procedures are followed as written, the critical limit will be met and therefore the hazard will be controlled.

V. Definitions:

Dark Chocolate (as per B.04.006 of the Food and Drug Regulations)
  1. shall be one or more of the following combined with a sweetening ingredient,
    1. cocoa liquor,
    2. cocoa liquor and cocoa butter,
    3. cocoa butter and cocoa powder;
  2. shall contain not less than 35 per cent total cocoa solids, of which not less than 18 per cent is cocoa butter, and not less than 14 per cent is fat-free cocoa solids; and
  3. may contain less than 5 per cent total milk solids from milk ingredients, spices, flavouring preparations (other than those that imitate the flavour of chocolate or milk) to balance flavour, salt, and any of the following emulsifying agents, which singly shall not exceed the maximum level of use set out in column III of Table IV to section B.16.100, and in combination shall not exceed 1.5 per cent by mass of chocolate product, mono-glycerides and mono- and diglycerides, lecithin and hydroxylated lecithin, ammonium salts of phosphorylated glycerides, polyglycerol esters of interesterified castor oil fatty acids, and sorbitan monostearate.
Food Additives (as per B.01.001 of the Food and Drug Regulations)
Means any substance the use of which results, or may reasonably be expected to result, in it or its by-products becoming a part of or affecting the characteristics of a food, but does not include:
  1. any nutritive material that is used, recognized or commonly sold as an article or ingredient of food;
  2. vitamins, mineral nutrients and amino acids, other than those listed in the tables to Division 16,
  3. spices, seasonings, flavouring preparations, essential oils, oleoresins and natural extractives;
  4. agricultural chemicals, other than those listed in the tables to Division 16,
  5. food packaging materials and components thereof; and
  6. drugs recommended for administration to animals that may be consumed as food.
Pathogenic Microorganisms
In this generic model may include: Salmonella spp., Clostridium botulinum, Clostridium perfringens, Staphylococcus aureus, Bacillus spp., Escherichia coli, and viruses (Hepatitis A and Norovirus).
Prerequisite Program
Universal steps or procedures that control the operational conditions within a food establishment and promote environmental conditions that are favourable for the production of safe food.
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