Preventive controls for honey products
Requirements for the Safe Food for Canadians Regulations
Although the Safe Food for Canadians Regulations (SFCR) came into force on January 15, 2019, certain requirements may apply in 2020 and 2021 based on food commodity, type of activity and business size. For more information, refer to the SFCR timelines.
On this page
- Control of incoming materials
- Storage of Empty Bulk Containers (e.g. drums, totes)
- Lead residues in honey
- Working residue levels for veterinary drugs in honey
- Appendix 1: A guide to developing a bulk container program
This document describes preventative controls for honey production and for the use and storage of containers and packaging materials. It also provides tips to avoid lead contamination and guidelines for safe levels of veterinary drugs used in honey production.
Control of incoming materials
Ingredients, additives, processing aids and bee treatments
The following are controls for incoming honey, other ingredients, food additives, processing aids and bee treatments to avoid biological, chemical or physical hazards in the honey product.
- Have written specifications for incoming honey and containers in which it is packed, other ingredients, food additives, processing aids and bee treatments, including any requirements in the Food and Drugs Act and Regulations and the Safe Food for Canadians Act and Regulations.
- Obtain a letter of guarantee from suppliers.
- Monitor and test incoming materials to verify adherence to specifications.
- Use bee treatments in accordance with Canadian requirements.
- Keep records of all applications of treatments to the colonies (e.g. medications, colony evacuation for honey removal, mite control).
Honey (packers or pasteurizers)
- Have written procedures in place to ensure incoming honey and containers in which it is packed do not pose any biological, chemical or physical hazards and meet compositional standards of honey.
- Inform suppliers of specifications/requirements for incoming honey when the drum history and/or interior coating type are not known to be suitable.
- Follow up with suppliers on non-compliant issues.
|Criteria||Check if Complete||Comments if incomplete or N/A|
|What||Controls are in place for incoming honey and ingredients (food additives and processing aids).|
For establishments that extract honey:
|Frequency||Per shipment or per colony|
|Who||Establishment contact (Manager, Owner)|
The following are controls for empty containers and all other packaging materials (bulk/retail) to help avoid biological, chemical or physical hazards in the honey product and to help you compliance with Division 23 of the Food and Drug Regulations and the Safe Food for Canadians Act and Regulations.
- All food contact surfaces are safe and suitable for its application. (Section 3 of the CFIA's Guidance for Food Establishments Concerning Construction Materials and Packaging Materials and Non-Food Chemicals provides some options for safe of packaging materials.)
- Keep documentation (e.g. purchasing specifications) showing that packaging materials comply with regulatory requirements.
- Protect all packaging materials from contamination and damage upon arrival.
- Evaluate packaging materials at a set frequency to ensure that correct material is received and free from defects.
- Containers used to pack honey are clean, sanitary, in sound condition and have a tightly fitting lid.
- Every container for prepackaged honey is new.
- Have a written bulk container program (see Appendix 1) that includes controls to ensure that:
- 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 or lined with a plastic liner, where the coating or plastic liner is 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, suitable for their intended use and have a letter of guarantee from the supplier.
- Gaskets and plastic seals are new and suitable for their intended use, or a plastic liner is used.
New or reconditioned metal drums (first time use after reconditioning)
- Obtain a letter of guarantee from the drum re-conditioner or supplier.
Used metal drums
- Use liners that are suitable for their intended use when the historical use of the drums and/or the interior coating are not known.
- Drums are in good repair.
- Use new plastic drums and tote bladders, and have a letter of guarantee from the supplier.
- Ensure that used plastic drums or tote bladders have only been used for honey storage and do not contaminate or impart any odours/flavours to the honey.
Storage of Empty Bulk Containers (e.g. drums, totes)
The following are controls for the storage of empty bulk containers (both incoming and outgoing) to help make sure that they do not become a source of biological, chemical or physical hazards for the honey.
- All empty bulk containers are stored in a manner that prevents deterioration of the containers and prevents the entry of water and contaminants into the containers.
- Empty bulk containers that are stored outside are properly closed, adequately covered and off the ground to prevent deterioration and contamination.
- Residual honey from bulk containers is removed prior to storage to prevent pest harbourage.
Lead residues in honey
Lead is a toxic heavy metal. Chronic low level exposure to lead is known to have adverse effects on human health. Children are particularly vulnerable. Lead in food may result from the environment, processing equipment and storage conditions.
Sources of lead include equipment:
- welded with lead solder (soldered before 1995, especially storage, extractor seams and homemade equipment)
- made from galvanized steel before 1994
- with brass and bronze joints and connections
- with terne plate, a lead containing alloy
Honey is an acidic product and may absorb lead from certain surfaces. Factors that can increase this absorption are:
- contact time
- contact surface
- temperature of the honey
- processing and cleaning practices
Maximum residue limit
There is currently no prescribed maximum residue limit for lead in honey. Lead residues must be as low as reasonably achievable. Lead residues equal to or greater than 0.1 parts per million (ppm) suggest that avoidable lead contamination has taken place. Blending contaminated honey with other honey to reduce lead levels is not permitted.
Reducing the risk of lead in honey
Honey producers and importers need to identify any potential sources of lead and take the necessary steps to eliminate/minimize (control) the hazard at the source.
If you are unsure of your equipment's material composition, contact your supplier or use a lead swab kit to determine if lead is present. Instant lead test kits are available at some equipment supplier stores.
In order to reduce the risk of lead contamination of honey and honey products, you can take the following steps:
- When replacing equipment, choose lead-free equipment. Pay particular attention to settling and packing containers (due to heating and contact time/surface). Even equipment made of stainless steel may have lead soldered seams, and thus should be considered unacceptable. Seams must be made from lead-free solder or welded.
- Where settling, storage or packing equipment is not yet lead-free, minimize the heat and contact time of honey.
- Make sure the equipment is clean before using it, especially in situations where small amounts of honey may remain in a piece of equipment between uses and be in contact with a lead soldered seam during this period. A good example of this is where honey may remain in the bottom of an extractor for an extended period of time and become contaminated with lead, contaminating the subsequent batch.
- Test your honey to help identify different sources of lead and/or confirm the effectiveness of any action taken. Testing can occur at various stages of the process depending of what you are trying to achieve.
The following checklist will help you review your operation to locate possible contamination points and determine corrective actions. Examples of corrective actions include: confirmation that no avoidable lead sources exist, testing of the honey (before and after lead source), modifying production / cleaning practices to minimize contamination, and eventual equipment replacement (short or longer term depending on risk).
|Equipment type||Construction material in contact with food||Corrective action:
If you identified potential(s) source(s) of lead; what is your action plan (see remarks below)?
|Galvanized||Lead solder||Brass||Bronze||Terne plate||Lead free||Suitable for intended use|
|Honey storage tanks|
|Barrels/ Bulk containers|
|Heat treatment equipment|
|Pumps, augers, piping, valves|
|Filtering & filling equipment|
|Overall action items:
- Until lead-containing equipment is replaced, minimize contact-time as much as possible, especially if heated. For example, do not use honey that was stored overnight in an extractor or sump that contains lead.
- All surfaces in direct contact with honey are constructed of food-grade materials. Refer to CFIA's Guidance for Food Establishments Concerning Construction Materials and Packaging Materials and Non-Food Chemicals.
- Any coatings (storage tanks and barrels) or plastic liners are food-grade and appropriate for application. Is the paint used inside and outside of the barrels and honey supers lead free?
Working residue levels for veterinary drugs in honey
The Canadian Food Inspection Agency (CFIA) operates a National Chemical Residue Monitoring Program for honey (and other food) as part of its food safety enforcement and compliance responsibilities. With regard to honey, both domestic and imported honeys are sampled. Samples submitted under this plan are assessed for compliance with the Food and Drugs Act and Regulations and the Safe Food for Canadians Act and Regulations.
Health Canada (HC) has recommended safe Working Residue Levels (WRLs) for a number of veterinary drugs approved for use in other species that may be detected in domestic or imported honey. The emerging resistance to oxytetracycline which is used to treat American Foulbrood infection may lead to "extra label" drug use of other antimicrobials. WRLs do not represent approval of additional drugs for use in beekeeping and must not be interpreted as an encouragement of their use.
These WRLs, in addition to proposed Maximum Residue Limits (proposed MRLs) and Maximum Residue Limits (MRLs), are used by CFIA to assess honey samples. Previously, in the case of veterinary drug residues in honey, the only criteria used for assessment were the MRLs listed in Table III of Division 15 of the FDA/R and the proposed MRLs published on Health Canada's web site. WRLs provide guidance to CFIA to determine the level of compliance and enforcement action that corresponds with the level of risk to human health as it relates to the presence of drug residues in honey.
After consulting with representatives from the Canadian Honey Council and the Canadian Honey Packers and Dealers Association, the use of WRLs in imported and domestic honey has been agreed to by both Health Canada and CFIA as outlined in the document entitled "Policy on Administrative/Maximum Residue Limits and Working Residue Levels for Veterinary Drugs in Food Products. June 2005."
Beekeepers are encouraged to work in conjunction with their provincial apiarist and local veterinarian in the identification, appropriate treatment and management of oxytetracycline- resistant American Foulbrood infection. Provincial governments and the honey industry are encouraged to continue to inform producers to practice hygienic management in beekeeping to prevent disease which will decrease the need for medication.
WRLs for honey provide guidance in an exceptional situation and in the interest of public health. These WRLs will be reviewed periodically to reflect new scientific information and are subject to modification or cancellation.
Health Canada's website provides a table of Current Lowest AMRLs/MRLs in Meats and Recommended WRLs in Honey.
Questions and answers
Q1. What is the issue?
Some beekeepers have been using veterinary drugs in an extra-label manner (using drug products for purposes other than indicated on the label) to control certain honey bee diseases for which either there is no approved veterinary drug or the approved drug was no longer effective. When residues of these drugs are found in honey, the honey may pose a potential risk to human health and is in violation of the Food and Drugs Act and Regulations and the Safe Food for Canadian Act and Regulations.
Drug manufacturers are reluctant to invest in new drugs for minor species, such as honey bees, because there is little, if any return on their costs for research and development. The current Canadian regulatory framework for drug approvals requires that adequate and complete data be provided for all drug submissions. Since there are very few products available anywhere in the world to treat honey bee diseases, there is no available data to inform such a review.
In light of the lack of available drugs, HC and CFIA have identified the requirement for a mechanism to address the honey industry's need for healthy bees while ensuring that honey, a widely-used product by Canadians, does not pose an undue risk to human health.
Q2. What are Maximum Residue Limits (MRLs) and proposed Maximum Residue Limits (proposed MRLs)?
MRLs and proposed MRLs are levels of veterinary drug residues that could safely remain in the tissue or food product derived from a food-producing animal that has been treated with a veterinary drug. This residue is considered to pose no adverse health effects if ingested daily by humans over a lifetime.
- For more information see Health Canada's – Maximum Residue Limits (MRLs) - Frequently Asked Questions
Q3.What are Working Residue Levels (WRLs)?
There are no special provisions under the Food and Drugs Act and Regulations for drug submissions for minor species (i.e., there are few MRLs for honey). It is for this reason that Health Canada reached an agreement with the CFIA to develop a policy on WRLs for antimicrobials, as well as an associated list of antimicrobials.
WRLs are recommended levels for drug residues in honey below which there is considered to be no undue risk to human health. The WRLs for honey have been derived by extrapolating from proposed MRL/MRLs for antimicrobials that are approved for use in other food-producing animals such as chickens, swine and cattle. The WRLs are set conservatively and are not intended to represent proposed MRL/MRLs values in honey. Since WRLs for these drugs are not promulgated into the FDA/R, they do not represent approval for use in beekeeping and must not be interpreted as an encouragement of their use.
The WRLs provide guidance to honey producers on residue levels which are deemed not to pose undue risk to human health. The WRLs also provide guidance to CFIA inspectors for their monitoring and compliance activities.
- For more information see Health Canada's: Working Residue Levels (WRLs) for Antimicrobial Residues in Honey
Q4. Who was involved in the process of developing the WRLs?
Health Canada and the CFIA consulted with representatives from the Canadian Honey Council and the Canadian Honey Packers and Dealers Association before the WRLpolicy and the associated list of antimicrobials was finalized.
Q5. Why are there so many antimicrobial drugs on the list?
Health Canada and the CFIA became aware, through CFIA's National Chemical Residue Sampling Plan, that various antimicrobials are being used in Canada and other countries in the production of honey and had concerns that certain residues of these antimicrobials could lead to a potential risk to human health risk.
Q6. What about honey imported from other countries that use drugs that are banned in Canada?
WRLs are not provided for banned drugs such as chloramphenicol or nitrofurans, since the use of these drugs in Canada is strictly prohibited. Any honey containing residues of banned drugs will not be allowed to be sold in Canada.
Q7. Why is the CFIA allowing WRLs?
In the area of food safety, Health Canada and the CFIA share unique and complementary roles and responsibilities for the safety of Canada's food supply. Health Canada is responsible for establishing policies, standards and regulations for health products and food while the CFIA is responsible for all food inspection, compliance and enforcement activities.
It is important to note that the WRL policy is not a regulation. The public can be confident that this policy does not compromise the safety of the food supply because residue levels in compliance with the WRLs do not pose an undue risk to human health. The CFIA will use the WRLs as guidance in determining the appropriate level of enforcement action including whether any product action is necessary (e.g., product recalls, detentions and seizures).
Q8. How should antimicrobial drugs be used to control honey bee diseases?
If antimicrobial drugs are required to control the spread of disease, honey producers should work with their provincial apiarist/veterinarian to ensure safe and appropriate use of these drugs.
Q9. Are there alternatives to antimicrobial drugs for the control of microbial honey bee diseases?
There are several non-chemical ways of controlling microbial diseases. Honey producers should work with their provincial apiarist/veterinarian to ensure safe and effective use of these methods.
Practicing hygienic management in beekeeping may help to prevent disease and may decrease the need for antimicrobial drugs.
Q10. Are these WRLs permanent?
The WRLs will be reviewed periodically to reflect new scientific information. The WRLs are subject to modification or cancellation (with notice given).
Q11. Will the CFIA continue to monitor honey?
Yes, the CFIA operates a National Chemical Residue Monitoring Program for honey as part of its food safety enforcement and compliance responsibilities.
Q12. What happens to honey that has residues above the WRL?
Honey that has residues above the WRL will be subject to a Health Risk Assessment by Health Canada. Subsequent action by the CFIA will be based on this assessment and could include detention, recall, stop sale, disposal, prosecution and in the case of imported honey, return to the country of origin.
Q13. What happens to honey that has detectable residues within the WRL?
When honey contains drug residues within the WRL, the producer/owner of the honey will receive a letter from the CFIA informing them of the residues that have been detected but that there is no undue risk to human health. The notification will also state that when the use of a veterinary drug not approved for use in beekeeping is required, it should only be administered under the guidance of a professional apiculturist/veterinarian to minimize or eliminate the presence of drug residues in honey.
Q14. Do the WRLs apply also to imported honey?
Imported honey is subject to the same WRL policy and regulatory requirements as domestic honey. The CFIA carries out regular monitoring to verify the compliance of imported honey to Canadian regulations. Importers should refer to the Food imports section of our website to learn more about the requirements for importing honey into Canada. Honey originating from countries with a known history of non-compliance is sampled by the CFIA more frequently than honey from other countries.
Q15. What concerns should honey exporters be aware of?
Exporters of honey are reminded that some countries have a zero tolerance for residues in honey and should be aware of the destination countries' regulations in this regard.
Q16. Can a person with allergies to antibiotics (sulfa, tetracycline etc.) still eat honey?
Yes, honey containing antimicrobial residues within the WRLs is considered by Health Canada not to pose an undue risk to human health. There have been no reports that honey with residues at these levels causes allergic reactions in humans. The antimicrobials on the WRL list are approved for use in other food-producing animals and permitted residue levels in meat, milk and eggs would result in higher exposure of consumers to their residues.
Q17. Are the WRLs in honey higher or lower than the MRL/proposed MRL for the same residue in other foods?
The WRLs are lower because they are incorporating additional safety margins. Since Health Canada does not have the data for use of these drugs in honey bees, these conservative safety margins ensure that there is no undue risk to human health.
Q18. Do other countries use WRLs?
WRLs are unique to Canada. However, many other countries use some type of limit or threshold to guide their enforcement procedures. Canada's WRLs are a more open and transparent version of action thresholds, which are usually not publicized by other countries.
Appendix 1: A guide to developing a bulk container program
The following information provides guidance on how to develop a written bulk container program. There are details about how you can control biological, chemical and physical hazards associated with bulk containers (capacity of more than 5 kg).
Written program components
State the objectives of your bulk container program.
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 safe and suitable for the application
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 Safe Food for Canadians Regulations, Division 23 of the Food and Drug Regulations and the Canadian Honey Council's Honey Industry Bulk Container Standard).
- coated with or lined with a coating that is suitable for its intended use
- 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
- Used drums are washed before filling even when a liner is used.
- Washed drums are turned upside down and left to dry on a clean surface
- If liners are used, where are they sourced and their specifications (e.g. proof that they are suitable for their intended use)
- Describe the type of bulk containers sourced and where.
- What documentation will be obtained to show that the bulk containers are made of materials that are suitable for their intended use?
- 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 for each procedure or task (e.g. daily, weekly, monthly).
- Indicate 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 materials that are suitable for their intended use (e.g. letter of guarantee from suppliers.)
- Keep 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.
Indicate what corrective action you will take when a bulk container does not meet the required specifications.
- Describe how you verify that all elements of the program are implemented and effective, including that:
- procedures are followed.
- corrective actions have been implemented and are effective.
- bulk containers meet the specifications.
- The bulk container program is effective.
- Include details on what, how and when will this be done and what records will be kept.
|Criteria||Check if complete||Comments if incomplete|
|What||Controls for biological, chemical and physical hazards and compliance with regulatory requirements.|
|How||Written procedures to:
An establishment contact (e.g. owner/operator/designated trained employee) has been identified to be responsible for the program.
A position/person is identified to be responsible for carrying out each procedure.
|Frequency||Procedures are set at a frequency adequate to control risks.|
|Records||You have records for:
|Corrective action||A written procedure to determine root cause when a deviation occurs at a critical control point. This includes evaluation of risk to the product.|
A person is identified to verify that all elements of the program are implemented and effective.
What/how will this be done and what records will be kept.
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