Food Safety Practices Guidance for Moulded Chocolate Manufacturers
Hazard Summary for Moulded Dark Chocolate With Almonds

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In developing the following table, the manufacture of moulded dark chocolate with almonds was used as an example to illustrate potential hazards and possible control measures associated with the manufacture of moulded chocolate products. This table may not cover all possible ingredients, process steps or all potential hazards associated with moulded chocolate production. The manufacturer is responsible for identifying hazards specific to their operation and for determining how each hazard could be controlled. For additional information, refer to specific sections of this document as provided in the Reference column.

Process StepPotential HazardsControl MeasuresReference
Incoming Materials/ Receiving Presence of pathogenic microorganisms (e.g. Salmonella spp.) in chocolate blocks and/or other ingredients at risk (e.g. raw almonds).

Obtain a guarantee from the supplier(s) that the chocolate blocks, roasted almonds, and packaging materials provided meet the establishment's purchase specifications (e.g. the supplier provides a Letter of Guarantee).

Obtain a Certificates of Analysis for each lot of chocolate or other ingredients at risk (e.g. raw almonds) to confirm that they do not contain Salmonella spp. and pose no other microbial hazard.

Check incoming materials against predetermined screening criteria when received (e.g. company purchase specifications).

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

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

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

1.4, 1.11
Incoming Materials/ Receiving Presence of undeclared allergens (e.g. milk, tree nuts, peanuts) in incoming ingredients and/or packaging materials.

Obtain a guarantee from the supplier(s) that the chocolate blocks, roasted almonds, and packaging materials provided meet the establishment's purchase specifications (e.g. the supplier provides a Letter of Guarantee).

Check incoming ingredients and materials against predetermined screening criteria when received (e.g. company purchase specifications).

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

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

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

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

Obtain a guarantee from the supplier(s) that the chocolate blocks, roasted almonds and packaging materials meet the establishment's purchase specifications (e.g. the supplier provides a Letter of Guarantee).

Check incoming materials and materials against predetermined screening criteria when received (e.g. company purchase specifications).

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

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

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

Obtain a guarantee from the supplier(s) that the chocolate blocks and roasted almonds meet the establishment's purchase specifications (e.g. the supplier provides a Letter of Guarantee).

Check incoming ingredients against predetermined screening criteria when received (e.g. company purchase specifications).

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

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

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

1.4, 1.11
Materials/ Receiving (packaging material) Presence of potentially hazardous chemicals associated with non-food grade packaging materials.

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

Check incoming materials against predetermined screening criteria when received (e.g. company purchase specifications).

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

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

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

1.4, 1.11
Incoming Materials/ Receiving (dark chocolate blocks, roasted almonds, returned product) Presence of mycotoxins (e.g. aflatoxin, ochratoxin A) in ingredients (e.g. almonds).

Obtain a guarantee from the supplier(s) that the chocolate blocks and roasted almonds meet the establishment's purchase specifications (e.g. the supplier provides a Letter of Guarantee).

Check incoming ingredients against predetermined screening criteria when received (e.g. company purchase specifications).

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

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

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

1.4, 1.11
Storage of Incoming Materials
/Rework
Growth of pathogenic microorganisms and/or mycotoxin (e.g. aflatoxin, ochratoxin A) producing mould in almonds due to inappropriate temperature and humidity control during storage. Control temperature/humidity and storage practices to minimize growth of microorganisms and moulds. 1.5, 6.2
Storage of Incoming Materials
/Rework
Contamination of ingredients with allergens due to inadequate separation from allergens or products containing allergens in storage.

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

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

6.2
Storage of Incoming Materials
/Rework
Contamination of ingredients with non-food chemicals (e.g. cleaning product) due to improper storage procedures. Store non-food chemicals in a separate location from all food ingredients and packaging materials. 6.2
Cutting/
Breaking Chocolate Blocks
Contamination of chocolate by metal fragments due to equipment and utensil wear and tear. Monitor equipment and utensils regularly to ensure that they are in good operating condition (e.g. not showing signs of wear, no cracks) as part of an effective preventive maintenance program. 1.8, 2.1
Melting Tank Presence of undeclared allergens in finished products due to the incorrect addition of dark chocolate containing allergens. Regularly monitor the addition of ingredients to ensure that the correct ingredients are added as indicated in the recipe and/or formulation. 1.6, 1.8
Melting Tank Presence of undeclared allergens in finished product due to the incorrect addition of rework and/or returned product containing allergens. Regularly monitor the addition of rework and/or returned product to ensure that like product is added to like product. 1.6, 1.8, 6.2
Melting Tank Contamination of chocolate by metal fragments due to equipment and utensil wear and tear. Regularly monitor equipment and utensils to ensure that they are in good operating condition (e.g. not showing signs of wear, no cracks) as part of an effective preventive maintenance program. 1.8, 2.1
Screening/
Magnet
Contamination of the chocolate with hazardous extraneous material (metallic and/or non-metallic) due to accumulation of hazardous extraneous material and/or damage as a result of inadequate inspection and/or cleaning of the screens.

Regularly monitor equipment (e.g. screens) to ensure that it is in good operating condition (e.g. no holes) as part of an effective preventive maintenance program.

Regularly clean screens to ensure that they are in good operation condition (e.g. no accumulation of hazardous extraneous material) as part of an effective sanitation program.

1.8, 2.1
Screening/
Magnet
Contamination of chocolate with metal fragments due to failure of the magnet to remove metal. Regularly monitor equipment (e.g. magnets) to ensure that it is in good operating condition (e.g. functioning normally) as part of an effective preventive maintenance program. 1.8, 2.1
Screening/
Magnet
Contamination of chocolate with hazardous extraneous material (i.e. metal accumulated on magnet is released into final product) due to inadequate inspection and/or cleaning of magnet to remove accumulated metal. Regularly clean magnet to ensure that it is in good operating condition (e.g. no accumulation of metal) as part of an effective preventive maintenance program. 1.8, 2.1
Mixing/
Blending
Presence of undeclared allergens in finished products due to the incorrect addition of allergens that do not appear on the recipe/formulation. Regularly monitor the addition of ingredients to ensure that the correct ingredients are added as indicated in the recipe and/or formulation. 1.6, 1.8, 2.1
Mixing/
Blending
Contamination of chocolate by metal fragments due to equipment and utensil wear and tear. Regularly monitor equipment and utensils (e.g. mixers and blenders) to ensure that they are in good operating condition (e.g. not showing signs of wear, no cracks) as part of an effective preventive maintenance program. 1.8, 2.1
Depositing/ Moulding/ Demoulding Contamination of chocolate with metallic and/or non-metallic (e.g. plastic) hazardous extraneous material from broken/cracked chocolate moulds.

Regularly monitor moulds to ensure that they are in good condition (e.g. not cracked or broken) as part of an effective preventive maintenance program.

Use chocolate moulds that are resistant to cracking or breaking.

1.8, 2.1
Air Cooling Contamination of chocolate with pathogenic microorganisms due to contact with inappropriately sourced and/or contaminated air used for cooling.

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

Regularly monitor air filter to ensure that it is in good condition as part of an effective preventive maintenance program.

1.8, 3.2, 2.1
Air Cooling Presence of non-food chemicals (e.g. refrigerant) on chocolate due to a refrigerant leak during cooling. Regularly monitor cooling units to ensure that they are in good condition (e.g. not leaking refrigerant) as part of an effective preventive maintenance program. 1.8, 2.1
Packaging/
Labelling/
Coding
Presence of undeclared allergens in finished product due to incorrect label application and/or incorrect list of ingredients on the label (e.g. failure to identify almonds as an ingredient on the label) and/or illegible label. Regularly monitor label on product to ensure that the correct label is applied to product and that the label is accurate (includes correct list of ingredients) and legible. 1.2, 1.9
Packaging/
Labelling/
Coding
Incorrect/illegible or missing code on finished product label resulting in an inability to recall product. Regularly monitor product code to ensure that the correct code is applied to product and that the code is accurate and legible. 1.7
Metal Detection Contamination of finished product with metal fragments due to improper calibration of the metal detector. Regularly calibrate the metal detector to ensure that it is functioning as intended. 1.8, 2.1
Metal Detection Contamination of finished product with metal fragments due to ineffective detection by the metal detector and/or failure of the metal detector to function appropriately when metal is detected. Regularly monitor and control the function of the metal detector. 1.8, 2.1
Finished Product Storage Cross-contamination of finished product (e.g. unpackaged product) with allergens due to inadequate separation from product containing allergens in storage.

Clearly identify products that contain allergens in storage.

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

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

Provide employees with training in standard operating procedures (SOPs) and/or Good Manufacturing Practices (GMPs) appropriate to their position and the work being done.

Regularly monitor employee practices while work is being done.

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

Regularly provide employee training in proper hygiene and correct handling procedures.

Monitor employee practices regularly.

5.1, 5.2
All Process Steps Contamination of chocolate with pathogenic microorganisms and/or chemicals (e.g. cleaning products) due to improper cleaning and/or sanitizing of equipment and facilities. Regularly monitor sanitation procedures and verify the effectiveness of the sanitation program. 4.1
All Process Steps Cross-contamination of finished product with undeclared allergens (e.g. milk ingredients, tree nuts, peanuts) due to failure to use dedicated equipment, moulds and utensils. Regularly monitor to ensure that, where applicable, products containing allergenic ingredients are manufactured in dedicated equipment using dedicated moulds and utensils. 3.2
All Process Steps Cross-contamination of finished product with undeclared allergens as a result of improper cleaning of equipment, moulds and utensils between products containing allergens and products not containing the same allergens. Regularly monitor the sanitation activities and ensure the effectiveness of the procedures and program. 4.1
All Process Steps Cross-contamination of chocolate with allergens from one production line to an adjoining line due to inadequate separation as a result of poor plant design. Ensure plant layout (design) provides adequate separation from one production line to another in order to prevent cross-contamination of allergenic ingredients. 2.1, 3.2
All Process Steps Cross-contamination of chocolate with allergens due to cross-utilization of moulds, utensils and/or equipment between products and/or between product lines. Regularly monitor the use of moulds, utensils and equipment to ensure that there is no cross-utilization between products and/or between product lines to prevent cross-contamination with allergens. 3.2
All Process Steps Cross-contamination of chocolate from pathogenic microorganisms, hazardous extraneous material, and/or chemicals (including lubricants) due to improper equipment design, improper equipment installation and/or improper equipment maintenance (including inadequate cleanup after maintenance).

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

Regularly monitor equipment maintenance (including clean-up after maintenance) to ensure that maintenance activities are effective and procedures and programs are effective.

2.1
All Process Steps Contamination of chocolate from pathogenic microorganisms, chemicals and/or hazardous extraneous material due to contamination from overhead structures (e.g. leaking pipes, flaking paint). Regularly monitor overheads to ensure that they are in good condition (e.g. no leaking pipes or flaking paint) as part of an effective preventive maintenance program. 3.2
All Process Steps Contamination of chocolate with pathogenic microorganisms due to contaminated air. Regularly monitor air intake systems and filters to ensure that they are in good operating condition as part of an effective preventive maintenance program. 2.1, 3.2
All Process Steps Contamination of chocolate with pathogenic microorganisms due to the presence of rodents, birds or insects. Regularly monitor the effectiveness of the pest control program. 4.2
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