To define detail, scope and purpose.
To establish the developed detail in a viewable format to facilitate information.
To facilitate the application of the documentation.
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This information can be used to develop food safety and quality programs that meet the requirements of modern Regulatory, Customer and Industry Standards:
When considering the development, documentation, and implementation of Edible Cannabis Standards within food safety and quality management systems, the following information should be considered to ensure effective outcomes:
As Edible Cannabis Products become increasingly more popular within some jurisdictions, the scope of related Food Safety and Quality considerations for such products has also grown.
As a substance with many lauded (and sometimes debated) human health benefits, Cannabis straddles the line between a therapeutic and recreational substance. Edible Cannabis Products may be consumed by a broad range of individuals, including those who may be suffering from illnesses or undergoing medical treatments that may render them immunocompromised and more susceptible to Food-Borne Illness or related complications.
Because Edible Cannabis Products have a delayed effect on consumers following consumption, it is important to consider that excess consumption to experience the effects of the product may have health impacts. In this regard, it is important to facilitate clear and accurate product labeling to ensure the dosing of THC and other cannabinoids for consumer consideration.
The following information is intended to be used as guidance as it does not constitute legal advice. It is not the intention of this information to support or oppose the use of Cannabis within Food Production; this information is provided as a resource for the consideration of the application of ‘Best Practice’ Food Safety and Quality Programs. Food Businesses involved with the production, packaging, and/or sale of Edible Cannabis Products must be aware of the legal requirements both within the jurisdiction of production and also for the jurisdiction of sale.
The range and types of foods that may contain Cannabis are broad and varied. As the trend of Edible Cannabis Products has evolved, so too has the innovation spectrum. Common types of Edible Cannabis Foodstuffs may include:
Along with the standard elements of Product Design and Development for the food sector, the following elements require additional consideration for Edible Cannabis Products:
As Edible Cannabis Products typically have a delayed onset of effect, it is generally considered best practice for packaging and labeling to include details of Serving Size (including individually identified servings) and the amount of THC per milligram per Serving Size and Package. This is important as Users may consume too much product, resulting in an excessively high or potential overdose where Serving Size recommendations are not defined or are not accurate.
Because of the psychoactive (mind-altering) effect of Edible Cannabis Products, they must be restricted from access by Children. In this regard, Product Design and Development protocols must consider the clear identification of Edible Cannabis Products to avoid consumption by Children. Packaging formats and materials should also reduce the risk of inadvertent consumption by Children.
To ensure the amount of THC per serving and per Package is correct, it is important to facilitate a uniform distribution of THC throughout the product. Ensuring Homogeneity of THC within an Edible Cannabis Product means that the THC is evenly distributed throughout the product to ensure the consumer can reply to the specified Serving Size to deliver the related volume of THC. In some jurisdictions, a limit may be mandated for the total volume of THC permitted per Serving and/or per THC per Package.
As part of the Edible Cannabis Product Design and Development processes, it is important to consider the available Homogeneity testing methods and whether these are suitable for the product being manufactured. The outcomes of Homogeneity testing are commonly linked to defined acceptable variance tolerances (These are commonly referenced as a percentage variance tolerance).
Contamination of Edible Cannabis Products can be significantly reduced by the application of well-structured Food Safety and Quality Programs based on the HACCP methodology. The following risk areas should be considered as part of any HACCP risk assessment for the use of Cannabis Materials for the production of Edible Cannabis Products:
As with any other analytical activity, the Testing and Assessment of Cannabis Materials and Products must be facilitated in a manner that provides consistent robust science-based outcomes. The following considerations are important to achieving ‘best practice’ Testing and Assessment outcomes:
Where external laboratories are utilized, their scope of accreditation and licensing should be verified to ensure they meet testing standards both within the region of manufacture and also for the region of sale and/or use of related Cannabis Materials and Finished Products.
Some jurisdictions may have specific testing and assessment criteria for Cannabis Materials and Products. The general scope of testing and assessment for Cannabis Materials and Products includes:
Chemistry testing and assessments often cover:
Microbiology testing and assessments often cover:
Physical testing and assessments often cover:
Testing and assessment results are often provided from a laboratory as a Certificate of Analysis or as a Certificate of Compliance.
As the global Cannabis sector grows, so too will laboratory standards and testing protocols for related materials and finished products.
Economically Motivated Adulteration is a Food Fraud Risk generally facilitated from within the Food Sector itself, with the intent of increasing profits or lowering costs. This can be done either by intentionally manipulating monetary outcomes of which an otherwise inexpensive material is sold for a higher price or perhaps where an inexpensive ingredient is used to extend or replace the more expensive one. The primary goal of EMA is to gain a financial advantage from selling food products in a way that deceives both customers and consumers, but sometimes it may cause human harm or even death.
In the context of Edible Cannabis Products, the full or partial substitution of naturally derived Cannabinoids (including THC) by synthetically derived Cannabinoids is a potential Food Fraud Risk that can be mitigated through the implementation of a well-structured Food Fraud Risk Management Plan.
You can find out more about Food Fraud Risk Management at haccp.com!
The following requirements within Edible Cannabis Product production systems are covered within this information package:
As a controlled material in most jurisdictions, Cannabis (and its many forms) may only be accessed as per prescribed Legislative requirements. In many cases, such materials may only be accessible to those who are of a certain age or who have a Legal permit for use.
Procedures and schedules for Training, Competency, and Resources Requirements must be developed, documented, and implemented to ensure personnel, visitors and contractors have the skills and knowledge necessary to maintain required food safety, food quality, and regulatory standards. Training, Competency, and Resources Requirements must be reviewed and verified on an ongoing basis to ensure ongoing positive outcomes.
The nomination of training as a component of a Food Safety Program is to assess the skills and knowledge of participating personnel roles in Food Safety activities. It is not generally the intention of this inclusion to require mandatory training, as it is generally recognized that skills and knowledge may be gained in different ways. Depending on the location and type of business activities, you may be required to display details of officially recognized training on specified roles within the Food Safety Program. Persons managing or participating in food handling and/or processing operations must possess skills and knowledge about the scope of their workplace activities.
As with any Food Business, the application of Identification and Traceability for Edible Cannabis Products is paramount to ensuring adequate product and process control. Many jurisdictions require specific levels of identification and traceability to be applied to each Marijuana plant from ‘seed’ to ‘sale’. Though this may seem cumbersome, it is indeed not too dissimilar from the expected requirements for the identification and traceability of other food ingredients from ‘farm’ to ‘fork’. Strong identification and traceability systems provide confidence and accountability for the use of controlled materials such as Cannabis.
Identification and Traceability requirements for Cannabis Materials, Edible Cannabis Products, and Sensitive Waste Materials may include:
Some jurisdictions may also require the accountability of Cannabis Materials and/or Finished Edible Cannabis Products by weight or volume. Where applicable, this should be considered as part of implemented Identification and Traceability Programs.
The data captured as part of Identification and Traceability of Cannabis Materials and Finished Edible Cannabis Products commonly includes:
Primary production requires special attention regarding the identification and control of all food safety hazards, as it is most often the first step in the food supply chain. This factor can define the safety of the foods involved at later steps including supply, processing, and customer availability.
The control of chemical use is paramount within Primary Production, as it is a point at which chemicals such as pesticides, insecticides, fertilizers, antibiotics, and fungicides among others are applied directly to foods or their surroundings. This produces issues of concern where the chemical content within, or on the foods produced are still present at the time the products become available to consumers. Adhering to the prescribed application rates and procedures for chemicals, in conjunction with allowing the appropriate withholding periods form the basis upon which such hazards are controlled.
Primary Production is also the step at which foods are readily exposed to higher than acceptable levels of pathogenic bacteria, whether it is through the soil, animal feces, or other environmental factors. These types of hazards are generally controlled through well-structured and developed procedures, which define practices that facilitate the production of safe and suitable foodstuffs for consumers.
Procedures must be developed, documented, and implemented to ensure a food business facilitating Primary Production does not introduce hazards to food consumption or further processing.
The Premises and Facilities applicable to any segment of the Edible Cannabis Products sector must facilitate the safe and suitable storage of related materials and products as per established Food Premises Regulations. Edible Cannabis Product Related Premises and Facilities must:
Food business Storage and Handling Requirements must be managed appropriately to ensure food safety and quality standards are maintained. It is important to consider that Storage and Handling Requirements may differ significantly for raw materials, packaging, chemicals, work in progress, and finished products. Appropriate Storage and Handling Requirements must also be managed through transport and other peripheral process steps.
Depending on the nature of the food operations undertaken within any food business, adequate Storage and Handling facilities should be available for cooling, cooking, refrigerating, and freezing food, and for controlling critical process control elements such as humidity and light controls where applicable.
Foods can be placed in two general classes depending on their ability to cause foodborne illness:
It is of utmost importance to identify the Storage and Handling Requirements for both classes of foods, along with ensuring that they are obtained from approved suppliers, then stored and handled appropriately to prevent cross-contamination and the growth of microorganisms.
Storage and Handling activities for Edible Cannabis Products must be facilitated in a manner that provides:
Above and beyond the packaging requirements for regular foods, additional specific requirements may apply to the packaging of Finished Edible Cannabis Products and Cannabis Materials for sale to consumers. Packaging requirements may include:
Above and beyond the labeling requirements for regular foods, additional specific requirements may apply to the labeling of Finished Edible Cannabis Products and Cannabis Materials for sale to consumers. Labeling requirements may include:
In cases where packaging units are used to define the specified Serving Size, it is commonplace for key labeling details to be placed on the individual packaging units (as well as the larger package).
Some jurisdictions may also mandate the use of prescriptive wording on Edible Cannabis Products and Cannabis Materials, such as “THIS IS A MARIJUANA PRODUCT” or “THIS PRODUCT CONTAINS CANNABIS”.
Requirements for the Transport and Distribution of Cannabis Materials and/or Finished Products may include:
Some jurisdictions also require the definition of ‘transport’ as part of Edible Cannabis programs. This is intended to ensure at all times that required controls are fully implemented.
The food industry produces a large number of by-products or waste, which must be disposed of or recycled. Suitable provision must be made for the removal and storage of all waste variants that occur as a consequence of operating any food business. Waste and Recyclable materials must not be allowed to accumulate in food handling, storage, or other operational working areas and the adjoining environment except so far as is unavoidable for the proper functioning of the food business. Waste storage, processing, and handling areas must be kept appropriately clean and sanitized. Waste and Recyclables Management systems should be monitored for effectiveness and periodically verified by methods such as pre-operational inspections or, where appropriate, microbiological sampling of the operational environment.
It is important to consider that ‘waste’ by definition may also include items such as out-of-specification products, which may need to be held until a decision is made regarding their disposal.
Waste Management within the Edible Cannabis sector needs to cover:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Edible Cannabis Standards Development requirements in relation to their items.
Document: A document provides guidance and/or direction for performing work, making decisions, or rendering judgments which affect the safety or quality of the products or services that customers receive.
Documented policies, procedures, work instructions and schedules form the basis of any food safety and quality management system. The following documentation formats may be considered to ensure ongoing compliance with specified requirements for Edible Cannabis Standards:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Edible Cannabis Standards Documentation requirements in relation to their items.
You may wish to visit the Edible Cannabis Standards Templates section of haccp.com for examples of Edible Cannabis Standards documentation, record and resource formats commonly applied within food safety and quality systems.
Implementation: Implementation is the application of documented food safety and quality system elements into the actual business operation.
The implementation of Edible Cannabis Standards within any food business requires genuine commitment from senior management, staff, and visitors to ensure the nominated goals of implementation are achievable on an ongoing basis. It is a step that requires significant planning and consideration of general and specific food business circumstances to ensure the outcomes of Edible Cannabis Standards do not negatively impact the safety and quality of the food items dispatched from the business.
Implementation of Edible Cannabis Standards must include a clear definition of responsibilities and authorities for all levels of participation by senior management, staff, and visitors to the site.
When implementing Edible Cannabis Standards within the food safety and quality system, you may wish to consider the following requirements before completion:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Edible Cannabis Standards Implementation requirements in relation to their items.
Monitoring: Monitoring is the act of reviewing and confirming measurable parameters of a defined process or product status.
Monitoring requirements within food industry sectors are generally identified against limits of acceptability defined within Edible Cannabis Standards plans, implementation procedures, and work instructions. Monitoring usually includes some element of record-keeping, which may be maintained manually or through digital systems. It is important to consider that advancements in technology have spawned many systems and processes which are self-monitored and or self-adjusted when variances are identified. Regardless of the system used; The goal of any monitoring activity is to provide sufficient evidence that any limit of acceptability has been met.
Traditional Edible Cannabis Standards monitoring requirements include manual recording and the application of corrective actions when the results of monitoring are found to be outside acceptable limits. Corrective Actions should also generally be strongly linked to the monitoring process where applied to ensure full traceability of the applied actions.
Common monitoring activities and record formats may apply to Edible Cannabis Standards:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Edible Cannabis Standards Monitoring requirements in relation to their items.
You may wish to visit the Edible Cannabis Standards Templates section of haccp.com for examples of Edible Cannabis Standards documentation, record, and resource formats commonly applied within food safety and quality systems.
Corrective Action: Corrective action is mandatory action to be taken when a deviation to the Quality System occurs, particularly with a Critical Control Point.
Preventative Action: At any step in the process where a hazard has been identified, preventative action must be put into place to prevent re-occurrence.
Corrective Action and Preventative Action are implemented to ensure that any identified non-conformance issues are documented, investigated, and rectified within appropriate time frames. Corrective action is any action applied to regain control over a product, process, policy, or procedure that has been identified as being non-conforming or outside nominated limits of acceptability. Preventative action is any action applied to prevent any identified non-conformance from reoccurring.
The outcomes of corrective and preventative actions should result in regained process control after effective application. Specified corrective actions are commonly linked to the Edible Cannabis Standards Plans and the food business certification process.
Below are Corrective Action and Preventative Action examples which may be associated with Edible Cannabis Standards related non-conformance:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Edible Cannabis Standards Corrective Action requirements in relation to their items.
You may wish to visit the Corrective Action and Preventative Action section of haccp.com for examples of best practice applications for this food safety and quality system element.
Verification: The act of reviewing, inspecting, testing, checking, auditing, or otherwise establishing and documenting whether items, processes, services, or documents conform to specified requirements.
Verification is the detailed review of all food safety and quality system elements to confirm that they are effectively developed, documented, implemented, monitored, and reviewed. All food safety and quality system elements, including documented policies, procedures, training, Edible Cannabis Standards plans, and their operational applications must be verified on an ongoing scheduled basis. The verification process commonly includes a defined schedule for which verification activities are required, how often they are conducted, who is responsible, and detailed documented procedures for each nominated verification activity.
The general goal of an established verification process is to ensure any systemic non-conformance issues are identified and rectified within an appropriate time frame. When non-conformance issues are identified through the verification process, Corrective Actions and Preventative Actions should be implemented to ensure they do not impact the effectiveness of the food safety and quality system.
The following examples of verification activities may apply to Edible Cannabis Standards:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Edible Cannabis Standards Verification requirements in relation to their items.
You may wish to visit the Verification Activities section of haccp.com for examples of best practice applications for this food safety and quality system element.
Validation: The process of gathering evidence to provide a scientific basis for the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the qualification of systems and equipment.
Validation is the provision of evidence to support the limits of control or acceptability for food safety or quality parameters nominated within systemic elements. Limits of control or acceptability are commonly included within documented food safety and quality systems elements such as procedures, Edible Cannabis Standards plans, and specifications.
Common sources of validation include regulatory and legislative standards, finished product specifications and customer requirements, industry codes of practice and guidelines, verified and validated research, historical product, and process control outcomes, and analytical testing.
The general goal of an established validation process is to ensure any systemic non-conformance issues are identified and rectified within an appropriate time frame. When non-conformance issues are identified through the verification process, Corrective Actions and Preventative Actions should be implemented to ensure they do not impact the effectiveness of the food safety and quality system.
Validation activities are commonly defined within the verification schedules and procedures of established food safety and quality management systems.
The following examples may apply to validation of the limits of control or acceptability for Edible Cannabis Standards:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Edible Cannabis Standards Validation requirements in relation to their items.
You may wish to visit the Validation Activities section of haccp.com for examples of best practice applications for this food safety and quality system element.
Skills and Knowledge: Skills and knowledge are attributes of human interactions commonly linked to competency within any specified job-related task.
Training and competency requirements for Edible Cannabis Standards must be ongoing, including regularly scheduled reviews to ensure the effectiveness of training and competency outcomes.
Team members who have defined responsibilities regarding Edible Cannabis Standards should have knowledge including:
Team members who have defined responsibilities regarding Edible Cannabis Standards should have skills including:
Team members who have defined responsibilities regarding Edible Cannabis Standards should have access to resources including:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Edible Cannabis Standards Training, Competency, and Resources requirements in relation to their items.
You may wish to visit the Training, Competency, and Resources section of haccp.com for examples of best practice applications for this food safety and quality system element.
haccp.com was created to support food businesses and food industry professionals in achieving and maintaining the stringent requirements of food industry compliance.