Food Safety Practices Guidance For Spice Manufacturers
Chapter 1: Control of Operation

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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

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