Food Safety Practices Guidance For Spice Manufacturers

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Table of Contents

Preface

Spices have generally been regarded as low risk; however, the incidence of food-borne illness and food recalls associated with this sector has increased significantly in recent years. For example, a U.S. survey conducted by the Center for Food Safety and Applied Nutrition (CFSAN) of the U.S. Food and Drug Administration (FDA) reported at least 16 spice recalls between 2000 and 2004 due to bacterial contamination (Vij et al. 2006). A variety of spice types were involved, including black pepper, cumin, paprika, oregano, sesame seeds, as well as several others. In most cases, the concern was Salmonella contamination. In Canada, seven recalls occurred between January 2011 and December 2012 due to Salmonella contamination in curry powder, dried basil, ginger, coriander, turmeric, and chili powder (CFIA 2013).

Spices are natural products that, without antimicrobial treatment, can harbour large numbers of bacteria, including Salmonella and pathogenic E. coli. Moreover, spices are often added to foods that will not undergo further processing and will be consumed as ready-to-eat products. In 1993, a nationwide food-borne illness outbreak in Germany was caused by potato chips seasoned with Salmonella contaminated paprika (Lehmacher et al. 1995). More recently, in 2009 and 2010, more than 250 people in at least 44 US states were infected with Salmonella Montevideo after the consumption of Italian-style deli meats containing contaminated black and red pepper (CDC 2010). Such outbreaks and recalls highlight the need for hazard prevention systems in the production of spices.

In an effort to help reduce the risk associated with spices and assist manufacturers that wish to adopt a Hazard Analysis Critical Control Point (HACCP) approach, CFIA has developed the Food Safety Practices Guidance for Spice Manufacturers document. The guide uses the General Principles of Food Hygiene and Consumer Packaging and Labelling (GPFHCL) as its core and has incorporated additional reference material to create a suggested prerequisite program. This document provides guidance on potential hazards and controls related to a HACCP approach and is also designed to address other factors that affect product integrity, including composition, compliance with standards and labelling requirements. It was developed by CFIA with input from a number of interested parties, including the Canadian spice industry, Health Canada and provincial government representatives, and is being offered to manufacturers as a food safety resource.

HACCP is a systematic approach that assesses each step in a food manufacturing process for potential hazards and identifies controls to prevent their occurrence. HACCP is recognized by regulators, industry and academia as a reliable food safety approach available to the food industry. Prior to the application of HACCP, an establishment should be operating in accordance with Good Manufacturing Practices (GMPs), food safety legislation and have the guidance of a person trained in HACCP. The GMPs (prerequisite programs) serve as the building blocks upon which a HACCP plan is built. A HACCP system is developed following a careful review and analysis of the unique processing facility in which it is to be implemented. Chapter 1 of this guidance document primarily provides guidance related to hazard analysis and control of the manufacturing process, while chapters 2 to 8 provide guidance related to a generic prerequisite program. The intent of this guidance document is that manufacturers wishing to develop their own HACCP program can modify or adapt this generic guide to suit their particular facility and operation.

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

Scope

This guidance document was developed for manufacturers of whole, ground, broken and standardized spice blends and is limited to those substances listed in Division 7 of the Food and Drug Regulations (FDR) (B.07.001 to B.07.039). The Codex Alimentarius definition of spices includes dried aromatic plants and relates to natural dried components or mixtures thereof, used in foods for flavouring, seasoning and imparting aroma. The term "spices" applies equally to spices in the whole, broken or ground form. According to the United Nations Industrial Development Organization (UNIDO) and the Food and Agriculture Organization of the United Nations (FAO), spices may be derived from many parts of the plant including: bark, buds, flowers, fruits, leaves, rhizomes, roots, seeds, stigmas and styles or the entire plant tops (UNIDO and FAO 2005). Products outside the scope of this document include essential oils and oleoresins derived from spices, unstandardized spice blends, seasoning blends that contain spices in addition to salt, flavours, oils, etc., and blends that contain nitrites.

Packaging includes consumer packages (e.g. sealed pouches, glass or plastic bottles), institutional packages and bulk containers.

Spices are considered ready-to-eat but could equally be used for further processing.

Hazard Summary for Spices

The following table summarizes potential hazards associated with the production of this product and suggests possible control measures. The manufacturer is responsible for identifying hazards specific to the operation and determining how each hazard can be controlled. For additional information, refer to specific sections of this document as listed in the Reference column.

Hazard Summary for Spices
Process Step Potential Hazards Control Measures Reference
Incoming Materials/Receiving Contamination of treated and untreated spices, packaging materials or returned product with pathogenic microorganisms (e.g. Salmonella spp. and pathogenic E. coli). Obtain a guarantee from suppliers that the spices, food additives, packaging materials and chemicals meet purchase specifications (e.g. the supplier provides a Letter of Guarantee).

Examine incoming materials against predetermined screening criteria when received (e.g. Good Agricultural Practices, [GAP]).

At receiving, inspect condition of all incoming materials and confirm that purchase specifications are met. Do not use materials that do not meet specifications.
1.4
Incoming Materials/Receiving Presence of antimicrobial treatment chemicals above maximum allowable limits in previously treated spices. Obtain a guarantee from suppliers that the spices meet purchase specifications (e.g. the supplier provides a Letter of Guarantee).

Examine incoming materials against predetermined screening criteria when received (e.g. Good Agricultural Practices, [GAP]).
1.4
Incoming Materials/Receiving Concentration of antimicrobial treatment chemicals in container is above or below the concentration stated on the label. Obtain a guarantee from suppliers that the chemicals meet purchase specifications (e.g. the supplier provides a Letter of Guarantee).

Examine incoming materials against predetermined screening criteria when received (e.g. Good Agricultural Practices, [GAP]).
1.4
Incoming Materials/Receiving Presence of undeclared allergens in treated and untreated spices and returned product. Obtain a guarantee from suppliers that the spices meet purchase specifications (e.g. the supplier provides a Letter of Guarantee).

Examine incoming materials against predetermined screening criteria when received (e.g. Good Agricultural Practices, [GAP]).

At receiving, inspect condition of all incoming materials and confirm that purchase specifications are met. Do not use materials that do not meet specifications.
1.4
Incoming Materials/Receiving Presence of food additives above maximum allowable limits and/or presence of non-permitted food additives in treated and untreated spices. Obtain a guarantee from suppliers that the spices and food additives meet purchase specifications (e.g. the supplier provides a Letter of Guarantee).

Examine incoming materials against predetermined screening criteria when received (e.g. Good Agricultural Practices, [GAP]).

At receiving, inspect condition of all incoming materials and confirm that purchase specifications are met. Do not use materials that do not meet specifications.
1.4
Incoming Materials/Receiving Presence of mycotoxins in treated and untreated spices and returned product. Obtain a guarantee from suppliers that the spices meet purchase specifications (e.g. the supplier provides a Letter of Guarantee).

Examine incoming materials against predetermined screening criteria when received (e.g. Good Agricultural Practices, [GAP]).

At receiving, inspect condition of all incoming materials and confirm that purchase specifications are met. Do not use materials that do not meet specifications.
1.4
Incoming Materials/Receiving Pesticide residues in treated and untreated spices. Obtain a guarantee from suppliers that the spices meet purchase specifications (e.g. the supplier provides a Letter of Guarantee).

Examine incoming materials against predetermined screening criteria when received (e.g. Good Agricultural Practices, [GAP]).
1.4
Incoming Materials/Receiving Presence of hazardous extraneous material (e.g. stones, glass, metal) in treated and untreated spices, food additives, packaging materials, chemicals and returned product. Obtain a guarantee from suppliers that the spices, food additives, packaging materials and chemicals meet purchase specifications (e.g. the supplier provides a Letter of Guarantee).

Examine incoming materials against predetermined screening criteria when received (e.g. Good Agricultural Practices, [GAP]).

At receiving, inspect condition of all incoming materials and confirm that purchase specifications are met. Do not use materials that do not meet specifications.
1.4
Storage of Incoming Materials (including returned product) Growth of pathogenic microorganisms in untreated spices due to inappropriate temperature and/or humidity control. Control temperature/humidity and storage practices to minimize growth of pathogenic microorganisms. 6.2
Storage of Incoming Materials (including returned product) Contamination with pathogenic microorganisms due to inadequate separation of treated and untreated spices as well as possibly contaminated returned product. Store treated and untreated spices separately.

Adequately identify and isolate returned, defective or suspect product.
6.2
Storage of Incoming Materials (including returned product) Contamination of non-allergen containing products with allergens due to inadequate separation. Adequately separate non-allergen containing products from allergen containing products. 6.2
Storage of Incoming Materials (including returned product) Chemical contamination due to improperly stored chemicals (e.g. cleaning product, antimicrobials). Store chemicals in a separate location from spices and packaging material. 6.2
Inspection and Sorting Cross-contamination of spices with pathogenic microorganisms due to contact with contaminated unacceptable/decomposed/decayed/damaged spices that have not been removed. Inspect and sort spices in a manner that does not lead to the contamination of spices. 1.6.2
Inspection and Sorting Cross-contamination of spices with pathogenic microorganisms due to failure to remove soil/microbial contamination from incoming spices. Adequately remove unacceptable/decomposed/decayed/ damaged spices.

Clean inspection and sorting equipment and areas at an adequate frequency.
3.2.4
4.1.1
Treatment Survival of pathogenic microorganisms due to insufficient application of treatment. Follow validated treatment procedures to ensure the treatment is effective and regulatory limits are not exceeded. 1.8
Treatment Contamination of spices with excess concentrations of antimicrobial treatment and/or residue due to improper chemical application rates. Follow validated treatment procedures to ensure the treatment is effective and regulatory limits are not exceeded. 1.8
Storage of Treated Spices Cross-contamination with pathogenic microorganisms due to inadequate separation between treated and untreated spices. Store treated and untreated spices separately. 6.2
Sifting/Screening Presence of hazardous extraneous material in spices due to holes in the sifting screens. Clean and sort incoming materials for extraneous material which may damage equipment.

Regularly monitor equipment (e.g. sifting screens) to ensure that it is in good operating condition (e.g. no holes) as part of an effective preventive maintenance program.
1.6.2
1.8.1
2.1.3
Cutting/Grinding Contamination of spices with extraneous material as a result of damage to equipment. Regularly monitor equipment to ensure that it is in good operating condition as part of an effective preventive maintenance program. 1.8.1
2.1.3
Cutting/Grinding Contamination of spices with extraneous material due to wear and tear of equipment. Regularly monitor equipment to ensure that it is in good operating condition as part of an effective preventive maintenance program. 1.8.1
2.1.3
Magnets Presence of hazardous extraneous material due to failure of magnet. Regularly monitor equipment to ensure that it is in good operating condition as part of an effective preventive maintenance and calibration program (i.e. confirm strength of magnet). 1.8.1
2.1.4
Magnets Contamination of product with metallic extraneous material due to over-accumulation on magnet. Regularly monitor equipment to ensure that it is in good operating condition as part of an effective preventive maintenance and calibration program (i.e. clean magnet at an adequate frequency). 1.8.1
2.1.4
Batching/Weighing Contamination of products not containing allergens with allergenic ingredients due to improper process separation, batching/weighing and/or sanitation. Adequately separate processes for products containing and not containing allergenic ingredients.

Ensure batched/weighed ingredients are adequately marked/identified.

Clean equipment, utensils and batching/weighing areas to minimize contamination with allergens.
1.6.1
4.1.1
Sifting/Screening Presence of extraneous material (metallic and non metallic) due to holes in screens. Regularly monitor equipment (e.g. sifting screens) to ensure that it is in good operating condition (e.g. no holes) as part of an effective preventive maintenance program. 1.8.1
2.1.3
Mixing/Blending Presence of allergenic ingredients due to the improper addition of ingredients (containing allergens) that do not appear on the label. Confirm that ingredients being added to a product reflect current and up to date master blending/formulation records. 1.1.1
Mixing/Blending Presence of allergenic ingredients due to the improper addition of rework (containing allergens) into spices that do not contain allergens. Clearly identify and label the composition of reworked product.

Control and monitor the addition of rework.
1.6.1
Packaging/Labelling/Coding Contamination with pathogenic microorganisms and/or extraneous material due to improper or faulty package seals. Monitor packaging to ensure packages are sealed appropriately. 1.5.1
Packaging/Labelling/Coding Incorrect/illegible or missing codes due to equipment failure resulting in an inability to recall product. Implement an effective preventive maintenance program to ensure packaging equipment is functioning as appropriate. 2.1.1
2.1.3
Packaging/Labelling/Coding Presence of undeclared allergens due to incorrect label applied to package and/or incorrect list of ingredients. Monitor labels on product (e.g. correct label applied to product, information provided [list of ingredients where applicable] is complete and accurate). 1.7.1
1.9.1
Metal Detection Contamination 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 calibrate the metal detector to ensure that it is functioning as intended.

Monitor and control the function of the metal detector.
2.1.4
1.8.1
Storage of Finished Products Contamination with pathogenic microorganisms and/or foreign matter due to damaged or contaminated packaging material as a result of improper storage procedures. Provide employee training in proper storage procedures and correct handling procedures. 5.1
5.2
Storage of Finished Products Chemical contamination due to improperly stored chemicals (e.g. cleaning products). Store chemicals in a separate location from spices and packaging material. 6.2.3
Shipping/Distribution Contamination with pathogenic microorganisms, chemicals and/or extraneous material due to unsanitary carriers and/or damaged packaging. Monitor carriers and product prior to and during loading to ensure the transportation conditions meet the requirements of the establishment for the product being shipped. 6.1
Shipping/Distribution Contamination with pathogenic microorganisms as a result of transporting treated spices with non-ready-to-eat foods. Monitor carriers and product prior to and during loading to ensure the transportation conditions meet the requirements of the establishment for the product being shipped. 6.1
Shipping/Distribution Contamination with chemicals as a result of transporting spices with non-food items (e.g. cleaning chemicals). Monitor carriers and product prior to and during loading to ensure the transportation conditions meet the requirements of the establishment for the product being shipped. 6.1
Shipping/Distribution Contamination with pathogenic microorganisms, chemicals and/or extraneous material due to damaged packaging as a result of improper loading/stacking. Monitor carriers and product prior to and during loading to ensure the transportation conditions meet the requirements of the establishment for the product being shipped. 6.1
All Process Steps Contamination with pathogenic microorganisms, chemicals and/or extraneous material due to employee error as a result of a lack of training and/or a failure to understand the importance of following written standard operating procedures (SOPs) and/or Good Manufacturing Practices (GMPs). Provide employee training in standard operating procedures (SOPs) and/or Good Manufacturing Practices (GMPs) appropriate to their position and the work being done.

Provide employee training in proper hygiene and correct handling procedures. Monitor employee practices.
5.1
5.2
All Process Steps Contamination with pathogenic microorganisms, chemicals and/or hazardous extraneous material due to improper employee handling practices. Provide employee training in proper storage procedures and correct handling procedures. 5.1
5.2
All Process Steps Contamination with pathogenic microorganisms, foreign material and/or chemicals due to improper equipment design, installation and/or maintenance (e.g. product exposure to non-food grade material, splashing, cleaning problems). Use equipment that has been properly designed and installed for use in a food establishment. Maintain equipment appropriately to ensure that it is functioning effectively and to prevent contamination of product. 2.1
All Process Steps Contamination with pathogenic microorganisms, chemicals and/or allergens due to improper cleaning and sanitizing of equipment, utensils and facilities. Monitor sanitation procedures and verify the effectiveness of the sanitation program. 3.3.2
4.1
All Process Steps Contamination with pathogenic microorganisms from condensation and/or pathogens carried in the air. Control and monitor air flow and the ventilation system to minimize the risk of product contamination. 3.2
All Process Steps Cross-contamination with pathogenic microorganisms and/or allergens due to improper plant layout (e.g. inadequate separation of operations). Separate non-compatible operations through building and process design. 3.2
All Process Steps Cross-contamination with pathogenic microorganisms and allergens due to improper movement of employees or visitors between process steps. Control employee and visitor movement within the plant. 5.1
All Process Steps Contamination with pathogenic microorganisms due to the presence of rodents, birds or insects. Monitor the effectiveness of the pest control program. 4.2

Using the Guidance Document

Principle Statement

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

Rationale

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

Anticipated Outcomes

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

Chapter 1: Control of Operation

1.1 Product Formulation and Composition

1.1.1 Availability and Accuracy of Product Formula

Current written formulae are available for each standardized spice blend produced.

Rationale

Formulae provide information aimed at ensuring the production of a consistent product and to avoid potential hazards (e.g. adding unlisted ingredients which could cause allergic reactions).

Anticipated Outcomes
  • Current written formulae are available for each multi-component product.
  • The formulae contain all details of the formulation such as the identification and amount of ingredients, including food additives if present (e.g. brand/supplier, concentration, type, common name).
  • Products are formulated to comply with food standards, where they exist (Division 7, FDR).
  • Products are formulated to ensure accurate nutrition declarations where required (see Section 1.1.3 Compositional Requirements for further details).

1.1.2 Identification of Critical Processing Factors in Product Formulation

This section does not apply to standardized spices as per the Food and Drug Regulations (FDR) since they are limited in their composition. Manufacturers that produce unstandardized spice products (e.g. spice mixtures) are to identify critical processing factors in product formulations.

1.1.3 Compositional Requirements

Products comply with food standards where they exist (Division 7, FDR).

The nutrient content of the food is controlled to meet declared label values (when presentFootnote *) 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 [Division 24, B.01.503, B.01.600].

Rationale

Inaccurate nutrition information, nutrient content claims and health claims may pose a health risk for those who are making food choices based on the nutrient content of the food.

Anticipated Outcomes
  • The manufacturer has control over the formulation to ensure that all nutrient content declarations (when present) and regulatory requirements are met.
  • Product formulations are designed to ensure that standardized food products meet the regulated standards of identity and composition.

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.

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
  • Chemicals can be considered food additives, processing aids or food contaminants depending on their nature and/or their use (e.g. fumigants such as ethylene oxide) and the amount of residual chemical in the final product.
  • The manufacturer ensures that all food additives used (e.g. anti-caking agent) 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.
  • The manufacturer has specifications for all food additives and processing aids to address chemical and physical hazards such as non-food grade chemicals and harmful extraneous material.
  • 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 permitted 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 (where applicable) on food labels allow consumers to make informed choices by providing:

  • Basic product information (i.e. common name, list of ingredients in the case of multi-component products, net quantity and name and address of the manufacturer);
  • Nutrition Facts table (where applicable); and,
  • Other product information (e.g. proper indications for irradiated products).

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.

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.
Food Irradiation

Spices can be treated with radiation to reduce the microbial load. Products composed wholly or partially of irradiated spices must be properly labelled.

  • Products treated with radiation must be labelled as "treated with radiation", "treated with irradiation", "irradiated" or a similar statement, in close proximity to the Radura symbol The Radura is the international symbol indicating a food product has been irradiated. The Radura is green and resembles a plant in a circle. The top half of the circle is dashed. (B.01.035, FDR).
  • Spices treated with radiation that make up 10% or more of a final product must be labelled as "irradiated" in the list of ingredients [B.01.035(6), FDR].
  • Once a product has reached the maximum permitted absorbed dose (10 kGy), the shipping container is marked with "Do not irradiate again" [B.01.035(7), FDR].

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 lack of control of pathogenic microorganisms, toxins and other hazards.

Anticipated Outcomes
  • A written description of the process(es) including procedures is available upon request.
  • Each process is established using accepted scientific methods. Details of actual experimental methods are available.
  • The fumigation or irradiation step (where applicable) is designed for uniform and sufficient destruction of microbes, in accordance with the Food and Drug Regulations.
  • 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 Spices.
  • 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.

Note: Spices can be heavily contaminated with microorganisms due to growth, harvesting and processing conditions. Pathogens of concern include Salmonella spp., pathogenic E. coli, Clostridium perfringens, Bacillus cereus and Staphylococcus aureus. Spices are generally treated with fumigants such as ethylene oxide, sterilized with steam, or irradiated to reduce the microbial load, including pathogens. Care is to be taken to avoid re-contaminating the spices after the antimicrobial treatment step. Spices on their own do not support microbial growth, but could be an ingredient in a food product that does.

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. Spice 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 spices and the spice process;
  • identify any steps in their operations that are critical for controlling the safety of spices;
  • 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 the 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 should also 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 the development of the HACCP system, the facility conducts 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 Critical 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 (HACCP Summary) of this guidance document, the HACCP Generic Model for Spices and the CFIA's Food Safety Enhancement Program (FSEP) Manual.

Generic Process Flow Diagram identifying suggested Critical Control Points (CCPs) for Spices (see the CFIA HACCP Generic Model for Spices for more details).
flow chart - process for producing spices
Description of the flow chart - Generic Process Flow Diagram for Spices

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

See the CFIA HACCP Generic Model for Spices for more details.

The diagram lists the necessary steps from 1 - 17 to be taken in the spice production process.

Identified in yellow boxes are the Critical Control Points (CCPs). These are next to steps 6, Treatment; 13, Mixing/blending; 14, Packaging/labelling/coding; and 15, Metal detector.

Identified in a blue circle is single spice. This results from step 12, Sifting/screening; and leads to step 14, Packaging/labelling/coding.

Identified in orange boxes is rework. This receives inputs after steps 14, Packaging/labelling/coding; and 15, Metal detector; and leads to steps 1, Receiving; 3, Spice (treated/untreated) storage; 11, Batching/weighing; and 13, Mixing/blending.

Identified in a pink box is returned product. This receives input from step 17, Shipping/distribution; and 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.

Step 1. Receiving (BCP). Leading to steps 2, Chemical storage; 3, Spice (treated/untreated) storage; and 4, Dry storage.

Step 2. Chemical storage (C). Leading to step 6, Treatment.

Step 3. Spice (treated/untreated) storage. (BCP). Leading to steps 5, Inspection and sorting; and 13, Mixing/blending. Leading to and receiving input from steps 6, Treatment; 7, Storage; and 11, Batching/weighing.

Step 4. Dry storage (BCP). Leading to steps 11, Batching/weighing; and 14, Packaging/labelling/coding.

Step 5. Inspection and sorting (BCP). Leading to step 6, Treatment.

Step 6. Treatment (BCP). CCP -1BC. Leading to step 7, Storage. Receiving input from step 2, Chemical storage. Leading to and receiving input from step 3, Spice (treated/untreated) storage.

Step 7. Storage (BCP). Leading to step 8, Sifting/screening. Leading to and receiving input from step 3, Spice (treated/untreated) storage.

Step 8. Sifting/screening (BCP). Leading to step 9, Cutting/grinding.

Step 9. Cutting/grinding (BCP). Leading to step 10, Magnets.

Step 10. Magnets (BCP). Leading to step 11, Batching/weighing.

Step 11. Batching/weighing (BCP). Leading to step 12, Sifting/screening. Receiving input from step 4, Dry storage; and rework. Leading to and receiving input Step 2 from steps 7, Storage; and 3, Spice (treated/untreated) storage.

Step 12. Sifting/screening (BCP). Leading to step 13, Mixing/blending. Single spices result from this step.

Step 13. Mixing/blending (BCP). CCP -2C. Leading to step 14, Packaging/labelling/coding. Receiving input from step 3, Spice (treated/untreated) storage; and rework.

Step 14. Packaging/labelling/coding (BCP). CCP -3C. Leading to step 15, Metal detector; and rework. Receiving input from step 4, Dry storage; and single spices from step 12, Sifting/screening.

Step 15. Metal detector (BP). CCP -4P. Leading to step 16, Storage; and rework.

Step 16. Storage (BCP). Leading to step 17, Shipping/distribution.

Step 17. Shipping/distribution (BCP). Leading to returned product.

1.4 Incoming Material Control

1.4.1 Incoming Ingredients and Other Non-Packaging Inputs

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

Rationale

Prevention of health hazards begins with control of incoming spices 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 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.

Note: For manufacturers not treating spices (e.g. ethylene oxide and irradiation) in their own establishment, the manufacturers obtain specifications (e.g. microbial specifications, treatment validation, certificate of analysis) to ensure the external treatment is adequate before accepting the spices into their plants.

Anticipated Outcomes
  • The manufacturer has written specifications for all food components, including raw spices and ingredients used on or in the products (e.g. biological hazards: pathogenic microorganisms; chemical hazards: antimicrobial residue, mycotoxins such as aflatoxin, pesticides and allergens; physical hazards: harmful extraneous material such as sticks, rocks and metal).
  • The manufacturer has written specifications for other components that identify criteria essential for the manufacturing process and product safety (e.g. processing aids and ethylene oxide).
  • The manufacturer has agreements with suppliers and can demonstrate that spices were grown, harvested and handled under Good Agricultural Practices. For information regarding maximum residue levels refer to the Division 15 of the Food and Drug Regulations.
  • Establishments requiring additional information for importing spices should refer to the CFIA's Good Importing Practices (GIP) document.
  • The manufacturer has specifications to avoid the presence of undeclared allergens (e.g. sesame, sulphites) and acquires a Letter of Agreement from each supplier to indicate that specifications are met.
  • 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, rodents and bird droppings, mould, foreign material, lubricants or other industrial chemicals from field equipment).
  • The manufacturer has specifications and procedures in place to properly identify and control returned product.

Refer to Health Canada's Compendium of Analytical Methods for microbiological guidelines for ready-to-eat spices.

Note: Section 1.1.4 of this document provides guidance for assessing 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 Drugs 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 has written specifications for packaging materials that identify criteria essential for the manufacturing process and product safety (e.g. for biological hazards such as pathogenic microorganisms, chemical hazards such as non-food grade material and physical hazards such as harmful extraneous material).
  • Packaging material is appropriate for the intended use and is used in accordance with the packaging manufacturer's instructions.
  • 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. Contaminated or potentially contaminated packaging material is not to be used by the manufacturer.

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.
  • Containers are inspected immediately before use to ensure that they are in a satisfactory condition and where necessary cleaned and/or disinfected; when washed they are well drained and dried before filling.
  • Only packaging materials required for immediate use are kept in the packaging or filling area.
  • Packing is done 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 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 (e.g. sesame seeds). The product may violate permissible levels of food additives.

Anticipated Outcomes
  • The manufacturer has controls in place to prevent hazards associated with the preparation of the product. Areas significant for food safety are outlined below.
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;
  • incorrect labels;
  • incorrect or incomplete list of ingredients; and
  • unknown ingredients (e.g. spices 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 Precautionary Labelling for Allergens in Pre-packaged Foods.

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.

See Section 7.2.3 for expected product preparation/blending records.

1.6.2 Cleaning /Sorting - Contamination Control

Raw spices 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 spices are necessary to prevent, reduce or remove contamination with biological, chemical and/or physical hazards. Proper cleaning, sorting and inspection reduce the initial microbial load, ensuring the efficacy of the antimicrobial treatment step (if applicable).

Anticipated Outcomes

The manufacturer controls the following hazards (where applicable):

Biological hazards

  • Sorting controls visual inspection and removal of damaged, decomposed and mouldy product from incoming raw ingredients.
  • Cleaning removes dust and dirt and lowers the overall microbial load.

Chemical hazards

  • Sorting controls visual inspection to prevent use of raw spices noticeably contaminated with lubricants, fuels, etc.

Physical hazards

  • Extraneous material controls - visual inspection, and/or sorting and cleaning by various types of machines (employing gravity, air, size exclusion, etc.) to remove stones, pebbles, wood, insects, excreta, glass, etc.
  • Depending on the spices processed and the type of extraneous material, one or more of the following machines may be used to remove physical hazards: aspirator (air separator), rotary knife cutter, destoner, vacuum gravity separator (air table), cylinder separator (indent), sifter aspirator, plain sifter, spiral gravity separator and/or air screen separator.
  • Metal contamination is controlled with magnets and/or metal detectors.

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 Antimicrobial Treatment, Size Reduction, Sifting/Screening and Metal Detection.

1.7 Product Coding Control

1.7.1 Product Coding

Pre-packaged spices are identified with code marks or lot numbers on the label or container to allow for product identification 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 spice products are permanently marked with a legible code or lot identification on the label, the package or the 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 (Antimicrobial Treatment, Size Reduction, Metal Control, Sifting/Screening)

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 at a scheduled frequency.

The typical process involves the following:

Antimicrobial Treatment

Antimicrobial treatments minimize contamination of the finished products with pathogenic organisms such as Salmonella spp. and pathogenic E. coli.

Fumigation

Ethylene oxide gas is used to reduce the microbial load on spices. The prescribed Maximum Level of Use for Ethylene Oxide in whole or ground spice is GMP and ethylene chlorohydrin residue is not to exceed 1500 ppm (Item E.2, Table VIII, Div. 16, (FDR).

Manufacturers ensure documented treatment procedures are followed to ensure the treatment is effective.

Irradiation

Spices can be treated with irradiation to reduce the microbial load. They are generally treated in their final package to avoid recontamination. Consequently, the packaging material must be approved for exposure to radiation. Whole and ground spices can be exposed to an overall absorbed dose of 10.00 kGy, by one or multiple treatments (Item 4 of the table referred to in B.26.003, (FDR).

Steam

Spices can be treated with steam to reduce the microbial load. Exposure to steam is generally limited by loss of quality factors (volatile oils, colour, etc.). The manufacturer ensures the process is controlled so that the water activity and moisture content of the spices does not increase the risk of spoilage and microbial growth.

Note: For manufacturers not treating spices (e.g. ethylene oxide, irradiation and steam treatment) in their own establishment, manufacturers obtain specifications (e.g. microbial specifications, treatment validation, certificate of analysis) to ensure the external treatment is adequate.

Size Reduction (grinding, etc.)

Procedures are in place to minimize contamination with metal and other physical hazards and microbial contaminants during the size reduction process(es). Grinding can produce a considerable quantity of dust. Dust can attract rodents and insects, manufacturers therefore clean up frequently, control dust by physical separation or dust collection equipment, etc.

Metal Control

Metal contamination may be controlled by various means and various locations in the process:

a) Metal Detectors

All product passes through a functioning metal detector (e.g. in-line or after packaging). 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.

and/or

b) Magnets

Magnets are situated inline so that all product passes over them. They are checked and cleaned regularly (at the beginning and end of production 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.

Sifting/Screening

Sifting/screening operations are controlled to reduce or eliminate physical hazards. Sifting/screening equipment is inspected regularly to ensure proper function (torn screens are repaired, etc.). Any extraneous material captured by the sifting/screening equipment is examined to determine the source and follow-up is conducted as necessary.

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. sesame).

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.

  • 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.
  • 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).
  • 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).

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 Precautionary Labelling for Allergens in Pre-packaged Foods.

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; or until other actions are required following product evaluation.

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
    • the tests are appropriate;
    • the judgement is based on sound science; and
    • the product is not released until the evaluation has determined that no health hazard exists and that the product is in compliance with appropriate legislation.

See the HACCP Generic Model for Spices 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 taken.

See Section 7.2.5 for expected Deviations and Corrective Action Records.

See the HACCP Generic Model for Spices 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.

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 appropriated 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 or whenever any changes are made;
    • sampling and analyses of in-process and finished product for the appropriate chemical, physical or biological hazards (e.g. Salmonella spp., pathogenic E. coli, Clostridium perfringens, Bacillus cereus and Staphylococcus aureus); Refer to Health Canada's Compendium of Analytical Methods for microbiological guidelines for ready-to-eat spices.
    • ensure that employees are adhering 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 record to ensure that appropriate corrective actions are taken and recorded in the event of a deficiency;
    • independent external or internal audits; and
    • analysis of consumer complaint trends.

See Section 7.2.6 for expected Verification Records

Chapter 2: Equipment

2.1 General Equipment

2.1.1 Design, Construction and Installation

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

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

2.1.2 Food Contact Surfaces

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

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

2.1.3 Equipment Maintenance and Calibration Program

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

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

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

2.1.4 Instrumentation Maintenance and Calibration Program

Instrumentation is designed, constructed, installed, calibrated and maintained in order to ensure the equipment is capable of delivering the required process, thereby ensuring product safety.

Rationale

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

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

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

Metal Detectors

  • Metal detection equipment is designed, constructed, installed, calibrated and maintained in accordance with the equipment manufacturer's manual, to ensure effective removal of metals. This may include adjustment for product effect, selection of target metal and size, timing of the reject mechanism and suitability for environmental conditions.

Magnets

  • The strength and type of magnets are appropriate to the use.
  • Magnets are installed in a manner to effectively remove ferrous metal prior to, or after, certain operations.
  • The strength of magnets is confirmed with the use of probes or other effective devices as necessary.
  • Magnets are monitored as necessary to ensure effective operation and surface exposure (e.g. adequately cleaned, metal particles removed).

Scales/Metering Devices

  • The sensitivity is appropriate to the use.
  • Scales are designed and installed to withstand the environmental conditions or are adequately protected (e.g. away from drafts, rust, corrosion, etc.).
  • Scales and meters are calibrated in accordance to the equipment manufacturer's manual to ensure accuracy at all times.

Other Instrumentation

  • Other specialized instrumentation necessary for the control of factors significant to food safety is in place and calibrated as necessary.

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

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

Chapter 3: Premises

3.1 Building Exterior

3.1.1 Outside Property and Buildings

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

Anticipated Outcomes

Grounds, Roadways and Drainage

  • The surrounding land is maintained to control sources of contamination such as debris and pest harbourage areas.
  • The building is not located in close proximity to any environmental contaminants.
  • Roadways are properly graded, compacted, dust proofed and drained.
  • The surrounding property is adequately drained.

Exterior Building Structure

  • The building exterior is designed, constructed and maintained to prevent entry of contaminants and pests. For example, the exterior has no unprotected openings; air intakes are appropriately located; and the roof, walls and foundation are maintained to prevent leakage.

3.2 Building Interior

3.2.1 Design, Construction and Maintenance

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

Anticipated Outcomes

Floors, Walls and Ceilings

  • Floors, walls and ceilings are constructed of materials that are durable, impervious, smooth, cleanable, and suitable for the production conditions in the area (i.e. materials will not result in the contamination of the environment or food).
  • Where appropriate, wall, floor and ceiling joints are sealed and angles are coved to prevent contamination and facilitate cleaning.
  • Floors, walls and ceilings are composed of materials that will not result in the contamination of the environment or food.
  • Floors are sufficiently sloped to permit liquids to drain to trapped outlets.
  • Internal window sills, if present, are sloped to prevent use as shelves.
  • Ceilings, overhead structures, stairs and elevators are designed, constructed and maintained to prevent contamination.

Windows and Doors

  • Windows are sealed or equipped with close-fitting screens.
  • Where there is a likelihood of breakage of glass windows that could result in the contamination of food, the windows are constructed of alternative materials or are adequately protected.
  • Doors have smooth, non-absorbent surfaces and are close-fitting and self-closing where appropriate.

Process Flow Separation

  • Buildings and facilities are designed to facilitate hygienic operations (i.e. there is regulated flow in the process, from the arrival of the raw material at the premises to the finished product).
  • Activities are adequately separated by physical or other effective means where cross-contamination (e.g. biological, chemical, allergens) may result.
  • Pallet design, condition and use are specified to avoid contamination.
  • Where mobile equipment (such as hand trucks or fork lifts) moves between incompatible areas, measures are taken to minimize cross-contamination.

3.2.2 Lighting

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

Anticipated Outcomes
  • Lighting is appropriate such that the intended production or inspection activity can be effectively conducted. The lighting does not alter food colour and is not less than the following:
    • 540 lux (50 foot candles) in inspection areasFootnote *
    • 220 lux (20 foot candles) in work areas
    • 110 lux (10 foot candles) in other areas
  • Light bulbs and fixtures located in areas where there is exposed food and packaging material are of a safety type or are protected to prevent contamination of food and packaging material in case of breakage.

3.2.3 Ventilation

Adequate ventilation is provided to prevent excessive heat, steam, condensation and dust, and to minimize entry of contaminated air.

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

3.2.4 Waste Disposal

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

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

3.3 Sanitary Facilities

3.3.1 Employee Facilities

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

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

3.3.2 Equipment Cleaning and Sanitizing Facilities

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

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

3.4 Water/Steam Quality

3.4.1 Water

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

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

See Section 7.4.1 for expected Water/Steam Quality Records.

3.4.2 Steam

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

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

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

See Section 7.4.1 for expected Water/Steam Quality Records.

Chapter 4: Sanitation and Pest Control

4.1 Sanitation

4.1.1 Sanitation Program

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

Anticipated Outcomes

Note: The sanitation program may be a combination of wet and dry cleaning procedures.

  • The spice manufacturer has a written cleaning and sanitation program for all equipment which includes:
    • the responsible person;
    • the frequency of the activity;
    • the chemicals and concentrations used;
    • the temperature requirements;
    • the procedures for cleaning and sanitizing that:
      1. identify lines, equipment and utensils;
      2. outline disassembly/reassembly instructions as required for cleaning and inspection;
      3. identify areas on equipment requiring special attention;
      4. outline the method of cleaning, sanitizing and rinsing.
    • the type and frequency of inspection to verify the effectiveness of the program.
  • The spice manufacturer has a written cleaning and sanitation program for premises (production and storage areas) which specifies areas to be cleaned, the method of cleaning, the person responsible and the frequency of the activity. Special sanitation and housekeeping procedures required during production are specified within the document (e.g. removal of product residues during breaks).
  • Chemicals are appropriate for the intended use and are used in accordance with the chemical manufacturer's instructions.
  • Cleaning and sanitizing equipment is designed for its intended use and is properly maintained.
  • The sanitation program is carried out in a manner that does not contaminate food or packaging materials during, or subsequent to, cleaning and sanitizing (e.g. no contamination by aerosols or chemical residues).
  • Effectiveness of the sanitation program is monitored and verified (e.g. by a pre-operational inspection of premises and equipment or, where appropriate, by microbiological sampling) and where necessary, the program is adjusted accordingly.
  • A vacuum cleaner can be used for cleaning up fine dust as brushing tends to push dust into the air for it to settle elsewhere.
  • The sanitation program is adjusted as necessary to incorporate new cleaning procedures (new equipment, new chemicals, etc.).
  • The sanitation program may be used to provide control over cross-contamination issues associated with the production of non-allergenic and allergenic products. Equipment is cleaned in a manner to prevent cross-contamination between allergen containing products and non-allergen containing products.
  • Operations begin only after sanitation and drying requirements have been met.

See Section 7.5.1 for expected Sanitation Records.

4.2 Pest Control

4.2.1 Pest Control Program

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

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

See Section 7.5.2 for expected Pest Control Records.

Chapter 5: Personnel

5.1 Hygiene and Health Requirements

5.1.1 Cleanliness and Conduct

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

Anticipated Outcomes
  • All persons wash and sanitize their hands upon entering spice handling areas, before starting work, after handling contaminated materials (e.g. picking objects off the floor, handling garbage, cleaning chemicals or raw incoming materials), after breaks, and after using toilet facilities or blowing their nose. Where necessary to minimize microbiological contamination, employees use disinfectant hand dips.
  • Disposable gloves are changed whenever contamination is a possibility.
  • Protective clothing, hair covering, footwear and/or gloves appropriate to the operation in which the employee is engaged, are worn and maintained in clean and sanitary manner.
  • Any behaviour which could result in contamination of spices, such as eating, use of tobacco or chewing gum, or unhygienic practices such as spitting, are prohibited in food handling areas.
  • All persons entering spice handling areas remove jewellery and other objects which may fall into or otherwise contaminate food. Jewellery which cannot be removed, including wedding bands and medical alerts, is covered.
  • Access of personnel and visitors is controlled to prevent contamination. The traffic pattern of employees prevents cross-contamination of the product (e.g. the employees avoid going back and forth to various stages of production. The employees do not go from a potentially contaminated area to the processing and/or packaging area unless they have washed their hands and changed to clean protective clothing.).
  • Personal effects and street clothing are not kept in spice handling areas and are stored in a manner to prevent contamination. Only clean protective clothing is worn in packaging and processing areas.
  • Responsibility for ensuring that all personnel comply with the requirements of this section is specifically allocated to competent supervisory personnel.

5.1.2 Communicable Diseases and Injuries

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

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

5.2 Training

5.2.1 General Food Hygiene Training

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

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

5.2.2 Technical Training

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

Anticipated Outcomes

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

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

Chapter 6: Transportation and Storage

Note: If control of incoming materials (Receiving) is included in this chapter, all of the anticipated outcomes for Sections 1.4.1 and 1.4.2 should be achieved.

6.1 Transportation

6.1.1 Food Carriers

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

Anticipated Outcomes
  • Carriers, including bulk tanks, are clean, dry, weatherproof, free of infestation and sealed to prevent water, rodents or insects from reaching the products. The manufacturer can demonstrate that the carrier has an adequate cleaning and sanitizing program in place. The manufacturers obtain specifications for the handling of raw materials during transportation (domestic and import).
  • Conveyances and containers are inspected by the manufacturer upon receipt of incoming ingredients and prior to loading of final products to ensure they are free from contamination (e.g. pests, residues) and suitable for the transportation of food. Proper environmental conditions such as temperature and humidity are controlled, monitored, and documented to assure raw material and finished product safety and wholesomeness.
  • Where the same carriers are used for food and non-food loads procedures are in place to restrict non-food loads to those that do not pose a risk to food loads in the same shipment, or to subsequent food loads after an acceptable clean-out.
  • Spice products are loaded, transported and unloaded in a manner that protects them from any damage, contamination or water.

6.1.2 Temperature Controls

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

Anticipated Outcomes

Spices transported at low temperatures are brought to ambient temperature slowly so that condensation does not accumulate on their surface (which could increase the surface moisture level and encourage microbial growth).

6.2 Storage

6.2.1 Incoming Materials Storage

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

Anticipated Outcomes
  • Humidity sensitive ingredients are stored under appropriate conditions to prevent deterioration. Spices are stored at a moisture level low enough so that the product can be held under normal storage conditions without development of mould.
  • Incoming materials and packaging materials are handled and stored in a manner that prevents damage and/or contamination (including cross-contamination with allergens). For example, the storage area for spices is clean, dry, protected against pests and separate from the rest of the facility. It is not used to store equipment, chemicals or personal items. Spices are stored off the floor, away from walls and in proper storage conditions to prevent mould and bacterial growth and facilitate pest control inspection. Open bags are stored in closed containers or otherwise protected from contamination.
  • Stock rotation (of ingredients and where appropriate, packaging materials) is controlled to prevent deterioration and spoilage (i.e. first-in, first-out).

6.2.2 Non-Food Chemicals Receiving and Storage

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

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

6.2.3 Finished Product Storage

Spices are stored under conditions that minimize microbial growth (e.g. mould) and they are handled in a way that prevents damage and contamination.

Anticipated Outcomes

  • Spices are stored and handled under conditions that minimize damage, deterioration and prevent contamination including cross-contamination with raw materials and/or allergens.
  • Stock rotation is controlled to prevent deterioration and spoilage (e.g. first-in, first-out).
  • Returned defective or suspect product is clearly identified and isolated in a designated area for appropriate disposition.

Chapter 7: Records

7.1 General Records

7.1.1 General Record Requirements

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

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

7.2 Records on Control of Operation

7.2.1 Process Design Records

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

Rationale

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

Anticipated Outcomes

Records are available upon request to verify that reliable procedures have been followed in designing the process.

7.2.2 Incoming Material Control Records

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

Rationale

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

Anticipated Outcomes

Incoming Ingredients

  • Appropriate records are kept to demonstrate that incoming lots of spices and other ingredients were inspected for signs of contamination and adherence to written specifications.

Incoming Food Chemicals

  • Appropriate records are kept to demonstrate that incoming food chemicals (e.g. food additives) adhere to written specifications.

Incoming Packaging Materials

  • Appropriate records are kept to demonstrate adherence to written specifications.

Non-Conforming Incoming Materials (including ingredients, incoming food chemicals, and packaging material)

  • The manufacturer has records to:
    • identify the material;
    • identify the deficiency; and
    • specify the preventive and corrective actions taken.

7.2.3 Product Preparation/Blending Records

Records for factors significant to food safety are maintained and are available on request.

Rationale

Records are necessary to verify that factors significant to food safety during preparation are controlled.

Anticipated Outcomes

The manufacturer has records that demonstrate control of product preparation/blending through adherence to factors significant to food safety where applicable (e.g. allergens, food additives).

7.2.4 Process Control Records

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

Rationale

Records are necessary to verify the safety of the process.

Anticipated Outcomes
  • The manufacturer has records that demonstrate control of Critical Control Points and/or factors significant to food safety during processing (e.g. records associated with the antimicrobial treatment and metal control).
  • Deviations are noted on the records by the operator during the process, not after the fact.

Note: Minimum information required on records may vary depending on the type of process.

7.2.5 Deviation and Corrective Action Records

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

Rationale

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

Anticipated Outcomes

Deviation/Hold

Deviation records include information such as:

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

Corrective Action

Corrective action records include information such as

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

7.2.6 Verification Records

Records are available to demonstrate the adequacy of verification procedures.

Rationale

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

Anticipated Outcomes

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

7.3 Records on Equipment

7.3.1 Equipment /Instrumentation Maintenance and Calibration Records

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

Rationale

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

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

7.4 Records on Premises

7.4.1 Water/Steam Quality Records

Written records that adequately reflect control of water and steam quality and treatment are available upon request.

Anticipated Outcomes

The manufacturer has records available upon request to demonstrate the adequacy of the microbiological and chemical safety of the water and steam supply (if applicable) as outlined below.

Water Potability Records Water Treatment Records Boiler Feedwater Treatment Records
water source method of treatment method of treatment
sample site sample site analytical results
analytical results analytical results analyst
analyst analyst date
date date

7.5 Records on Sanitation and Pest Control

7.5.1 Sanitation Records

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

Anticipated Outcomes

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

7.5.2 Pest Control Records

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

Anticipated Outcomes

Minimum pest control records include:

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

7.6 Records on Complaint Handling and Recalls

7.6.1 Complaint Records

Records of product complaints, investigation findings and action taken are available upon request.

Rationale

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

Anticipated Outcomes

The establishment maintains detailed records of consumer complaints received and of the subsequent investigation, including corrective action taken. Complaint records include the information listed below.

Consumer Information

The manufacturer's records contain, at a minimum:

  • the name, address and telephone number of the complainant, and the date the complaint was received;
  • details of the complaint and/or illness;
  • the product's name, code and size; and
  • the retail outlet where the product was purchased.

Investigation

The manufacturer's records contain, at a minimum:

  • the name of person responsible for the investigation;
  • the action taken (concerning the product and/or the process) as a result of the investigation;
  • the corrective action taken to prevent a recurrence; and
  • a follow-up/assessment of the effectiveness of the corrective action.

7.6.2 Distribution Records

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

Anticipated Outcomes

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

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

Chapter 8: Complaint Handling and Recalls

8.1 Complaint Handling

8.1.1 Product Complaints

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

Rationale

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

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

See Section 7.6.1 for expected Complaint Records.

8.2 Recalls

8.2.1 Recall Procedure

The spice manufacturer establishes a written procedure to permit the complete, rapid recall of any lots of spices from the market.

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

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

See Section 7.6.2 for expected Distribution Records.

8.2.2 Recall Capability

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

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

Glossary

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

Allergens
any substance capable of producing an abnormal immune response in sensitive individuals. Priority food allergens of concern in Canada include: peanuts, tree nuts, milk, soy, wheat, sulphites, sesame seeds, egg and seafood (fish, crustaceans and shellfish).
Capability
a standardized evaluation of the inherent capability of equipment to consistently perform a specified function under actual operating conditions after significant causes of variation have been eliminated.
Certification
with reference to this document, certification refers to the guarantee a supplier (vendor) provides to a manufacturer that the material meets the manufacturers specifications, e.g. certificate of analysis. This may include periodic monitoring to verify adherence to specifications and audits to validate the status of the supplier certification program.
Change control
the control that a manufacturer maintains over any changes to the formula, ingredients, equipment, packaging, thermal processing and manufacturing process to ensure the safety of the finished product is not directly or indirectly affected.
Contamination
the transfer of harmful substances or disease-causing microorganisms to spices by hands, food-contact surfaces and utensils that touch contaminated spices.
Control
means that an operation performs consistently within pre-determined limits based on process capability, meets process requirements, provides a mechanism to maintain the stability of the process and consistently results in a safe product.
Corrective action
the actions to be taken when the results of any monitoring indicates a loss of control. In addition this term refers to any action taken to bring the process into control and deal with any affected product when critical limits or other criteria are not met. The action should be prompt and appropriate to the seriousness of the deficiency.
Critical Control Point (CCP)
a point, step or procedure at which control can be applied and a food safety hazard can be prevented, eliminated, or reduced to acceptable levels.
Critical limit
a value which separates acceptability from unacceptability.
Cross-contamination
contamination of foods or packaging material by direct or indirect contact with material from an earlier stage of the process. A regulated process flow and good employee practices will minimize the risk of cross-contamination occurrences.
Deterioration
for the purposes of this document, deterioration can be used interchangeably with spoilage; however, deterioration can also apply to non-food products such as packaging materials. For non-food items, deterioration is a physical or chemical change in the material that may adversely affect the safety of the food.
Deviation
failure to meet the critical limits for a Critical Control Point or failure to meet the limits of acceptability for factors significant to food safety.
Deviation procedure
a pre-determined and documented set of corrective actions (immediate and preventive) which are implemented when a deviation occurs.
Documents
for the purposes of this document, documents refer to written formulae, procedures or specifications used by or required of a manufacturer.
Factors significant to food safety
means any property, characteristic, condition, aspect, or other parameter, variation of which may affect the safety of the product or the process.
Food contact surface
any equipment or utensil which normally comes in contact with the food product or surfaces normally in contact with the product.
Good Agricultural Practices (GAP)
the general practices used in the planting, growing, harvesting, sorting, packing, storage and transportation of spices which will reduce and minimize the risks of biological, chemical and physical contamination.
Hazard
the potential to cause harm. A biological, chemical or physical property that may cause an unacceptable consumer health risk.
Hazard Analysis Critical Control Points (HACCP)
a systematic approach to identifying and assessing hazards and risks associated with a food operation and defining the means of their control.
Inspection areas
(definition with respect to lighting requirements), inspection areas are defined as any point where food products or containers are visually inspected or instruments are monitored.
Lot
means the amount of product of a specific container size, product style and code produced by a food establishment during a specified period of time.
Master formula
the master formula is the official formula referenced by a manufacturer for a given product.
Microorganisms
include yeasts, moulds, bacteria, viruses and parasites. When used as an adjective, the term "microbial" is used.
Monitoring
a planned sequence of observations or measurements to assess whether a Critical Control Point (or other activity) is under control.
Periodic testing (Recall)
internal activities conducted periodically to verify the capability of the manufacturer to rapidly identify and control a given lot of product. These activities do not necessarily require that the manufacturer contact customers.
Potable water
water which meets the requirements of the Guidelines for Canadian Drinking Water Quality published by Health Canada and any applicable provincial and municipal requirements.
Pre-packaged product
as per the Food and Drugs Act, any food that is contained in a package in the manner in which it is ordinarily sold to or used or purchased by a person.
Recall (noun)
denotes the process of recalling the affected product and encompasses all tiers of the affected product distribution system.
Recall (verb)
means for an establishment to remove from further sale or use, or to correct, a marketed product that contravenes legislation administered and/or enforced by CFIA.
Records
observations and measurements recorded by a manufacturer to determine adherence to critical limits, limits of acceptability or other specified requirements (for a Critical Control Point or for factors significant to food safety).
Refrigeration
means exposure to a temperature of 4°C or less, but does not mean frozen.
Risk
an estimate of the likelihood of occurrence of a hazard.
Sanitizing
the application of heat or chemical treatments to destroy or substantially reduce the number of microorganisms present that have the potential to cause adverse health effects.
Spices
includes various parts of dried aromatic plants and relates to natural dried components or mixtures thereof, used in food for flavouring, seasoning and imparting aroma. The term applies equally to spices in the whole, broken or ground form.
Spice blends
obtained by grinding and mixing dried and clean selected spices.
Spoilage
a process whereby food is rendered unacceptable for consumption through microbiological or chemical reaction.
Validation
the obtaining of evidence showing that control measures are capable of being consistently effective. Validation is performed when new control measures or a new food safety control system is designed, or when changes indicate the need for revalidation, in order to confirm that the control measures or food safety control systems, when implemented as intended, are capable of controlling the hazard to the appropriate level and that this level of control can be achieved consistently.
Verification
examination of the accuracy, correctness or effectiveness of validated processes or process controls through testing, investigation or comparison against a standard.

References

Canadian Food Inspection Agency (CFIA). 2013. Food recalls and Allergy Alerts - High-risk

Centers for Disease Control and Prevention (CDC). May 4, 2010. Investigation update: Multistate outbreak of human Salmonella Montevideo infections.

Lehmacher A, Bockemuhl J, Aleksic S. 1995. Nationwide outbreak of human salmonellosis in Germany due to contaminated paprika and paprika-powdered potato chips. Epidemiology and Infection 115:501-511.

United Nations Industrial Development Organization (UNIDO) and of the Food and Agriculture Organization of the United Nations (FAO). 2005. Herbs, spices and essential oils. Post-harvest operations in developing countries. - PDF 2,030 (kb) Vienna, Austria.

Vij V, Ailes E, Wolyniak C, Angulo FJ and Klontz KC. 2006. Recalls of spices due to bacterial contamination monitored by the U.S. Food and Drug Administration: the predominance of Salmonellae. Journal of Food Protection 69: 233–237.

Additional Resources:

Acts and Regulations

  • Consumer Packaging and Labelling Act and Regulations
  • Food and Drugs Act
  • Food and Drug Regulations
  • Pest Control Products Act
  • Pest Control Products Regulations
  • Weights and Measures Act and Regulations

Canadian Food Inspection Agency

Health Canada

International

Codex Alimentarius Comission. FAO/WHO Food Standards Programme. 1995. Code of Hygienic Practice for Spices and Dried Aromatic Plants. - PDF (46 kb) CAC/RCP 42 -1995.

Codex Alimentarius Commission. FAO/WHO Food Standards Programme. 2003. Recommended International Code of Practice - General Principles of Food Hygiene. - PDF (234 kb) CAC/RCP 1-1969, Rev. 4.

Other Resources

American Spice Trade Association. February 2006. HACCP Guide for Spices and Seasonings.

International Pepper Community. Code of Hygienic Practice for Pepper and Other Spices.

Schweiggert, U., Carle, R., Schieber, A. 2007. Conventional and alternative processes for spice production – a review. Trends Food Sci. Technol. 18: 260-268.

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

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

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

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

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

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

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

Principle 1

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

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

Principle 2

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

Principle 3

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

Principle 4

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

Principle 5

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

Principle 6

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

Principle 7

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

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

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

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

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

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

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