Chapter 5 - Manufacturing Controls

Table of contents

• 5.1 Manufacturing Controls*
  • 5.1.1 Product Formulation
    • 5.1.1.1 Label Accuracy*
  • 5.1.2 Incoming Material Control
    • 5.1.2.1 Ingredients/Additives and Processing Aids and Bee Treatments*
    • 5.1.2.2 Empty Containers (Bulk and Retail)
  • 5.1.3 In-Process Package Control
    • 5.1.3.1 Empty Container Handling (Bulk and Retail)*
  • 5.1.4 Product Preparation and Blending Controls
    • 5.1.4.1 Honey Batching and Blending
  • 5.1.5 Filling Control
    • 5.1.5.1 Filling of Containers
  • 5.1.6 Container Closure Control
    • 5.1.6.1 Container Closure
  • 5.1.7 Process Control
    • 5.1.7.1 Control of Filling and Labelling

• Appendices - Producer Program Outlines

• Appendix 1 Incoming Honey and Ingredients Controls
• Appendix 2 A Guide to Developing a Bulk Container Program

* Tasks marked with an asterisk are the ones that have the possibility to be rated with a Category I risk which corresponds to the highest level of risk.

---

5.1 Manufacturing Controls

5.1.1 Product Formulation

5.1.1.1 Label Accuracy

5101 Task

Principle

The establishment ensures that the label information accurately represents the composition of the food.

Assessment Criteria

Procedures are in place to ensure that all labels accurately represent product formulation, composition and claims especially where allergens or ingredients which may cause sensitivities are used.

Allergens include milk, eggs, fish, crustaceans, shell fish, tree nuts, peanuts, soy, wheat, sulphites, sesame seed.

Ingredients which may cause sensitivities include lactose, monosodium glutamate (MSG).

The following are examples of such procedures:

• New label review.
• Incoming label review for accuracy and correctness.
• Formulation changes and substitutions.

Rating Examples

Reference

• FSEP Manual: Section 3, F.1.2 - Product Coding and Labelling
• Honey Regulations: Sections 5(1), 5.1, 6, 7, 8, 21(1)(b), 25(a), 34(a), (b) and (d), 35(1), (2), (3), (4) and (5), 36(1), (2) and (3), 37(1), (2) and (3), 52(1) and (2), Schedule I, Tables I, II, III, IV.

5.1.2 Incoming Material Control

5.1.2.1 Ingredients/Additives, Processing Aids and Bee Treatments

5301 Task ***REVISED JUNE 2009***

Principle

The establishment controls incoming honey, other ingredients, food additives, processing aids and bee treatments such that no biological, chemical or physical hazards result in the food.

Assessment Criteria

The establishment controls incoming honey, other ingredients, food additives, processing aids and bee treatments through a program consisting of:

• Written specifications for incoming honey and containers in which it is packed, other ingredients, food additives, processing aids and bee treatments.
• Specifications include a provision for compliance with the Food and Drugs Act and Regulations and Honey Regulations.
• The requirement for a letter of guarantee from the supplier.
• Monitoring and testing to verify adherence to specifications.

Honey (Producer-Graders)

Establishments extracting honey must ensure that:

• Records are kept for all applications of treatments to the colonies (e.g. medications, colony evacuation for honey removal, mite control).
• Treatments used are in accordance with Canadian requirements.

Honey (Packers or Pasteurizers)

Establishments packing and/or pasteurizing honey must ensure that:

• Written procedures are in place to ensure incoming honey and containers in which it is packed do not pose any biological, chemical or physical hazards; and meets compositional standards of honey.
• A system is in place to inform suppliers of specifications/requirements for incoming honey, including the use of food grade liners when the drum history and/or interior coating type are not known to be suitable.
• A mechanism is in place to communicate and follow up on non-compliant issues.

Rating Examples

References

• Honey Regulations: Sections 16(f), 4.1(1).
• Food and Drug Regulations
• Appendix 1: Incoming Honey and Ingredient Controls.

5.1.2.2 Empty Containers (Bulk and Retail)

5302 Task ***REVISED JUNE 2009***

Principle

The establishment controls empty containers and all other packaging materials (bulk/retail) such that no biological, chemical or physical hazards result in the food and to ensure compliance with Division 23 of the Food and Drug Regulations and the Honey Regulations.

Assessment Criteria

All food contact surfaces must be food grade and suitable for its application.

Suppliers of packaging materials should have their products listed in the "Reference Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents" published by the CFIA or have a "Letter of No Objection" from Health Canada.

Documentation (e.g. purchasing specifications) is available to show that the purchased packaging materials comply with the Food and Drug Regulations and Honey Regulations (including standardized container size for honey sold in Canada).

All packaging material is adequately protected from contamination and damage upon arrival.

Packaging materials are evaluated at a set frequency to ensure that correct material is received and free from defects.

Containers to pack honey must be clean, sanitary, in sound condition and have a tightly fitting lid.

Prepackaged

• Every container for prepackaged honey must be new.

Bulk Containers

• The establishment has a written bulk container program that is effectively implemented with maintained records (see "A Guide to Developing a Bulk Container Program").
• All bulk containers (e.g. drums/totes) are free from severe dents or buckling that break the inner coating, and are free from obvious signs of internal rusting.
• All metal drums are either coated with a food grade coating, or lined with a food grade plastic liner, suitable for honey storage.
• The exterior coating is non-toxic and durable (e.g. no excessive peeling which could contaminate the honey).
• All plastic liners are new, food grade and have a letter of compliance from the supplier.
• Gaskets and plastic seals are food grade and new, or a plastic liner is used.

New or Reconditioned Metal Drums (first time use after reconditioning)

• A letter of compliance from the drum re-conditioner or supplier is available.

Used Metal Drums

• Food grade liners are used when the historical use of the drums and/or the interior coating are not known.
• They must be in good repair as indicated above.

Plastic Drums/Totes

• New plastic drums and tote bladders should be used, and have a letter of compliance from the supplier.
• Used plastic drums or tote bladders may be used if traceability is available and have been used only for honey storage and do not contaminate or impart any odours/flavours to the honey.

Rating Examples

References

• Honey Regulations: Sections 16(b), 25(d), 32(1) and (2), 33.
• Food and Drugs Regulations, Division 23.
• Appendix 2: A Guide to Developing a Bulk Container Program.
• Honey Industry Bulk Container Standard: Canadian Honey Council

5.1.3 In-Process Package Control

5.1.3.1 Empty Container Handling (Bulk and Retail)

5401 Task ***REVISED JUNE 2009***

Principle

Empty container handling is controlled to minimize damage and to prevent the use of damaged, defective or contaminated containers.

Assessment Criteria

Containers are handled, transferred and cleaned (when necessary) in a manner that minimizes damage and contamination.

The establishment has an effective cleaning system in place.

The establishment has an effective system in place to prevent the use of damaged, defective or contaminated containers.

This can be accomplished by ensuring that:

• Empty containers are visually or electronically examined to identify, remove and segregate non-compliant containers prior to use.
• If applicable, there is a back-up system in place in case the electronic inspection system fails.
• The establishment has controls in place to prevent contamination of clean containers. For example:
  • No containers and lids are left on the line at breaks, during clean-up or extended downtime unless adequate measures are in place to prevent contamination.
  • Containers are used only for their intended purposes.
  • Lids fit tightly.

Additional Criteria for Bulk Containers

All bulk containers (e.g. drums/totes) are free from severe dents or buckling that break the inner coating, and free from obvious signs of internal rusting.

• New or reconditioned drums that are not washed prior to use must be clean.
• All used drums must be washed before filling even when a food grade liner is used.
• Washed drums are turned upside down and left to dry on a clean surface.

Rating Examples

References

• Honey Regulations: Sections 16(b) and (f), 25(d), 32(1) and (2), 33.
• Appendix 2: A Guide to Developing a Bulk Container Program.

5.1.4 Product Preparation and Blending Controls

5.1.4.1 Honey Batching and Blending

5501 Task

Principle

Factors for each specific batch/lot are controlled during blending to ensure specified requirements in the Honey Regulations are met.

Assessment Criteria

The establishment has controls in place to ensure that the composition of the honey in each batch or lot has been accurately evaluated. Areas which require evaluation are:

• Colour
• Moisture
• Absence of Foreign Material
• Characteristic Flavour
• Floral Source (if declared)
• Lot numbers
• Country of Origin

The establishment has signed verifications of all batch or lot evaluations.

The owner or operator of each registered establishment shall keep and make available to the CFIA at all times, an accurate, up-to-date record of his honey pack that shows:

• The quantity of honey pooled or purchased and the persons from whom it was received or purchased.

Rating Examples

Reference

• Honey Regulations: Sections 4.1(1), 5, 5.1, 6, 7, 8, 21(1)(a)(ii).

5.1.5 Filling Control

5.1.5.1 Filling of Containers

5601 Task

Principle

Controls are in place to prevent damage or contamination of containers, lids and product during the filling process.

Assessment Criteria

The establishment has controls in place to prevent hazards associated with product filling.

The establishment has controls in place to prevent contamination of clean containers and product, for example:

• Filled containers without lids are not left on the line at breaks, during clean-up or extended downtime unless adequate measures are in place to prevent contamination.

Rating Examples

Reference

• FSEP Manual: Section 3.4 - Maintenance and reassessment of the HACCP system

5.1.6 Container Closure Control

5.1.6.1 Container Closure

5701 Task

Principle

Container closure controls are in place to prevent contamination of the food.

Assessment Criteria

The establishment controls the closing equipment to ensure the integrity of the container by:

• Protecting the cap or lid hopper from contamination.
• Adjusting closing equipment to avoid damage to containers.
• Adequate container closure.

Rating Examples

Référence

• Honey Regulations: Sections 4.1(1)(a), (b), (c), (d) and (e), 4.1(4).

5.1.7 Process Control

5.1.7.1 Control of Filling and Labelling

5801 Task

Principle

The establishment has controls in place to prevent mislabelling and improper filling.

Assessment Criteria

The establishment has controls in place to prevent mislabelling and improper filling of containers.

Typical controls should be:

• Container size for product to be sold in Canada.
• Effective separation of products during changeovers with records.
• At the labeller different product labels are effectively separated and the number of product label types are kept to a minimum.
• Tops and bottoms of label bundles are visually checked for mixed labels prior to use.
• Prevention of mixing of individual or bundles of labels during storage (e.g. storage in separate boxes, no loose labels, and ensuring that unused labels are returned to the correct boxes.)
• Effective weight control system to ensure proper filling at the declared weight.
• Effective grading system to ensure correct grade evaluations.

Rating Examples

Reference

• Honey Regulations: Sections 5, 6, 7, 8, 29, 30, 31, 32, 33, 34, 35, 36, 37.

---

Appendix 1 - Incoming Honey and Ingredients Program

The establishment controls incoming honey and ingredients (food additives and processing aids) through a program consisting of:

• Written specifications for honey, incoming ingredients (food additives and processing aids). Specifications include a provision for compliance with the Food and Drugs Act and Regulations.
• The requirements for a letter of guarantee from the supplier.
• Monitoring and testing to verify adherence to specifications.

The establishment that extracts honey must ensure that:

• Medications used have been approved for use for treating bees.
• The recommended preparation and dosage level of the medications have been followed.
• The withdrawal time for the medication has been followed before the honey is harvested.
• Records are kept for all applications of treatments to the colonies (e.g. medications, colony evacuation for honey removal, mite control).

Reference

• Food Allergens, Canadian Food Inspection Agency.
• Reference Listing Of Accepted Construction Materials, Packaging Materials And Non Food Chemical Products, Canadian Food Inspection Agency.

	Assessment Criteria	Check if Complete	Comments if incomplete or N/A
What	The establishment controls incoming honey and ingredients (food additives and processing aids).
How	1. Written specifications for honey and incoming ingredients (food additives and processing aids).
How	2. Specifications are in compliance with the Food and Drugs Act and Regulations (e.g. contaminants and adulterants).
How	3. A letter of guarantee from the supplier, Monitoring and testing to verify adherence to specifications.
How	The establishment that extracts honey must ensure that: 1. Medications used have been approved for use for treating bees.
How	2. The recommended preparation and dosage level of the medications have been followed.
How	3. The withdrawal time for the medication has been followed before the honey is harvested.
How	4. Records are kept for all applications of treatments to the colonies (e.g. medications, colony evacuation for honey removal, mite control.)
Frequency	Per shipment or per colony
Who	Establishment contact (Manager, Owner)

Date:

Signature:

---

Appendix 2 - A Guide to Developing a Bulk Container Program

***Revised June 2009***

Objective

This document is intended to provide guidance on developing a written bulk container program. The program will provide details on how the establishment will control biological, chemical and physical hazards which can be associated with bulk containers (capacity of more than 5 kg).

Regulatory Requirements

• Honey Regulations:
  • 16(b), 32 - Containers are suitable for use
  • 25(d) - Containers are maintained in clean and sanitary condition
  • 30 - Prescribed container sizes
  • 33 - Boxes are suitable and not defaced by old markings
• Food and Drug Regulations: Division 23, Section 4 and 7

References

• Honey Establishment Inspection Manual - Chapter 4: Storage: Sub-sections - 4.2.2.2, 4.2.2.5
• Honey Establishment Inspection Manual - Chapter 5: Incoming Material Control: Sub-sections - 5.1.2.1, 5.1.2.2 and 5.1.3.1
• CFIA Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products
• Canadian Honey Council - Drum Standards

---

Written Program Components

Objective (why)

State the objectives of your bulk container program.

Example:

Bulk containers used in packing honey are received/unloaded, handled, filled, emptied and stored such that no biological, physical or chemical hazard results in the food and to ensure regulatory compliance:

• are clean
• are sanitary
• are of sound condition, durable and non-toxic
• have tightly fitting lids
• are free of severe dents or buckling
• have no obvious signs of internal rusting
• all food-contact surfaces are food grade and suitable for the application

Criteria

A written bulk container program explains:

• Where bulk containers are sourced (e.g. suppliers)
• Type of bulk containers sourced and their specifications (e.g. suitable for storing honey)
• How bulk containers will be evaluated to ensure that specifications are met (e.g. that they meet the requirements of the Honey Regulations, Division 23 of the Food and Drug Regulations and the Honey Industry Bulk Container Standard).

For example, bulk containers are:

• coated with or lined with a food grade coating
• clean, sanitary and in sound condition
• have tight fitting lids
• free from severe dents or buckling
• free from obvious signs of internal rusting
• how containers will be cleaned and maintained to prevent contamination and damage
• if liners are used, where are they sourced and their specifications (e.g. proof that they are food grade)records are available and demonstrate that controls are in place and that the bulk containers meet regulatory requirements.

Procedures/Tasks (what/how)

Describe the type of bulk containers sourced and where.

What documentation will be obtained to show that the bulk containers are made of food grade materials?

• Explain how empty bulk containers will be received and evaluated to ensure that requirements are met.
• Explain where empty bulk containers will be stored to minimize contamination.
• Explain how bulk containers will be cleaned and inspected prior to filling with honey.

Position Responsible (who)

• State the position/name responsible for the bulk container program.
• State the position/name responsible for each procedure or task.

Frequency (when/how often)

• State the frequency each procedure or task will be done (e.g. daily, weekly, monthly).

Records

• What records will be kept to show that the bulk container program has been implemented and is effective.
• Records should include bulk container sources, documentation to show that the bulk containers are made of food grade materials, (e.g. letter of compliance from suppliers.)
• Records to show that bulk containers were evaluated prior to filling and include findings, actions taken to correct an identified problem and to prevent recurrence.

Additional records for bulk container distributors:

• Records indicating client name and contact information, bulk container description, shipping date, number of bulk containers shipped.

Corrective Action

Indicate what corrective action will be taken when a bulk container does not meet the required specifications.

Verification

Who will verify that all elements of the program are implemented and effective:

• The procedures are followed.
• The corrective actions have been implemented.
• The bulk containers meet the specifications.
• The bulk container program is effective again.
• What, how and when will this be done and what records will be kept.

• Approved by (signature):
• Print name:
• Approved date:
• Revision date:

Checklist to assess the bulk container written program

Name of Establishment and Registration Number:

	Evaluation criteria	Check if complete	Comments if incomplete
What	The establishment has established controls for biological, chemical or physical hazards and complies with regulatory requirements.
How	The establishment has effective written procedures to: 1. Purchase acceptable bulk containers
How	2. Evaluate that empty containers meet regulatory requirements at receiving (e.g. free from severe dents, buckling, rust, are sound, clean, sanitary and have tightly fitting lids, food grade as appropriate.)
How	3. Carry out the cleaning, handling and storage of the bulk containers.
How	4. Ensure old labels are removed.
How	5. Inspect bulk containers prior to filling.
Who	An establishment contact (e.g. owner/operator)has been identified to be responsible for the program. A position/person is identified to be responsible for carrying out each procedure.
Who	A position/person is identified to be responsible for carrying out each procedure.
Frequency	Procedures are set at a frequency adequate to address risks.
Records	The establishment has records for: 1. Where bulk containers were sourced.
Records	2. Type of bulk containers sourced.
Records	3. Letter of compliance from drum reconditioner/supplier (for new or reconditioned drums)
Records	4. Documentation to show plastic liners, gaskets and plastic seals are food grade.
Records	5. Records to show that the procedure(s) have been completed and followed.
Records	6. Documentation to show corrective action taken.
Records	7. Documentation to show that the corrective action was verified and the corrective action taken corrected the problem effectively and will not result in recurrence.
Records	8. If drums were distributed, records indicating; date shipped, description of the drum(s), product lot code, quantity, client name and contact information.
Corrective action	The establishment has written procedures to determine root cause when deviations have occurred. This includes evaluation of risk to the product.
Verification	A person is identified to verify that all elements of the program are implemented and effective. What and how will this be done and what records will be kept.

Date:

Name of Inspector:

Previous page: Chapter 4 - Appendixes