Understanding the Safe Food for Canadians Regulations: A Focus on Sanitation, Hygiene and Material Handling Requirements

The CFIA enforces the Safe Food for Canadians regulations to establish a modern legislative framework that is aligned with internationally recognized standards. The regulations fit well with the Codex Alimentarius Principles for food safety, as well as key consumer protection requirements. Through this, Canadian businesses, importers and exporters are mandated to meet the relevant licensing, preventive controls, and traceability requirements.

 Outline of the Safe Food for Canadians Regulations

According to the Public Health Agency of Canada, 1 in 8 (or about 4 million) Canadians are affected by foodborne diseases annually that lead to over 11,500 hospitalizations and 240 deaths. Acute bacterial foodborne illnesses alone are known to cost the economy close to $ 1.1 billion a year. As a result, the Canadian Food Inspection Agency (CFIA) found it necessary to adopt a more preventive, streamlined, and modernized approach toward food safety in the interest of protecting public health – and, with this in mind, the Safe Food for Canadians Act was enacted into law on November 2012. This important piece of legislation allowed the CFIA to develop administration provisions for implementing the new food safety policies in the form of the Safe Food for Canadians Regulations (SFCR).

The SFCR requirements were published on June 13, 2018, and came into force on 15 January 2019. The scope of these regulations generally applies to food businesses that:

  • manufacture, process, treat, preserve, grade, package, or label food to be exported or sent across provincial or territorial borders;
  • grow or harvest fresh fruits or vegetables to be exported or sent across provincial or territorial borders;
  • handle fish on a conveyance to be exported or sent across provincial or territorial borders;
  • slaughter food animals from which meat products are derived to be exported or sent across provincial or territorial borders;
  • store and handle a meat product in its imported condition for inspection by the CFIA
  • import food; and
  • some of the traceability, labelling, and advertising provisions of SFCR also apply to intra-provincially traded foods.

The Safe Food for Canadians Regulations is a legal document comprising of 16 parts, which has been developed so that the following parties can benefit from the administrative provisions:

Consumers

  • The emphasis on developing a robust food safety system that facilitates the prevention of foodborne illness, and faster removal of an adulterated product from commerce.
  • Enhanced traceability, labeling, and grading requirements to assure consumer protection.
  • Improved import controls that ensure foreign food products are as safe and wholesome.

Regulatory authorities

  • SFCR combines and streamlines the provisions relating to food from about 14 sets of regulations into one document, therefore creating a consistent, outcome-based regulatory inspection regime framework. The new consolidated regulations shall replace the following administrative provisions:
    • Dairy products regulations;
    • Egg regulations;
    • Fresh fruit and vegetable regulations;
    • Honey regulations;
    • Ice-wine regulations;
    • Licensing and arbitration regulations;
    • Livestock and poultry carcass grading regulations;
    • Organic products regulations;
    • Maple products regulations;
    • Processed egg regulations;
    • Processed products regulations;
    • Consumer packaging and labelling regulations;
    • Fish inspection regulations; and
    • Meat inspection regulations.
  • CFIA’s inspection and enforcement powers are clarified and this reduces the administrative burden, which would allow the agency to make more inspections, and enhance food safety compliance at the licensed sites.

Industry stakeholders

  • The SFCR simplifies the compliance process, and this enables industry to innovate through its outcome-based provisions, adopt best practices and create greater market access opportunities for the Canadian food products exported abroad.
  • The new regulations improve consistency of rules across all types of foods, and between food industry sectors.

Importers

  • The new consolidated regulations include a requirement that imported food be prepared with the same level of food safety controls as food prepared in Canada.
  • All imported food now must meet applicable Canadian import requirements. Previously, only importers of some foods were required to be licensed and have preventive food safety controls in place. Hence, SFCR provides for a consistent approach across all types of imported foods.

Exporters

  • The SFCR requirements are consistent with international standards and this should help Canadian businesses maintain and improve market access for Canada’s food sector by aligning Canadian food safety regulations with those of key trading partners, including the U.S., European Union, Australia and New Zealand.
  • Based on the U.S.-Canada Comparable Food Safety System Recognition agreement, by acquiring an SFCR license, Canadian food businesses may demonstrate that they meet the requirements under the U.S. Foreign Supplier Verification Program so that they can continue trading with the United States.

In this white paper, we will provide a few examples of how our tools and solutions can assist in complying with sanitation, material handling, and hygiene requirements of the Part 4 or Preventive Control elements of SFCR, as given in the next section.

Preventive Controls – Focus on the Sanitation, Hygiene and Material Handling Requirements

In the new Canadian regulations, prevention of food safety hazards has been given a much greater importance. Such a measure should go a long way in helping avoid or significantly minimize foodborne illnesses, inspectional violations at sites, and market food recalls.

In the U.S. and Canada, one in three food recalls are generally related to sanitation, hygiene and material flow issues within a food processing facility. A significant proportion of these recalls can be avoided by instituting appropriate preventive controls to help reduce food contamination incidents in a plant. Based on industry estimates, having the facility, equipment, utensils, and tools be of sanitary condition could save a company $0.5-1.5 million annually in actual costs of product rejection, recalls, and associated expenses.

According to SFCR, Preventive controls “help to prevent food safety hazards and reduce the likelihood of contaminated food entering the market, whether they are prepared within or outside of Canada.” They are considered to be international best practices employed by businesses to identify and correct food safety issues early in the production process.

Preventive Controls (PCs) are generally classified into three of the following broad categories:

1. People-related PCs:

  • Management team commitment
  • Employee competence
  • Employee hygiene
  • Employee health

2. Facility-related PCs:

  • Unloading (receiving), storing (holding), and loading (shipping) food
  • Maintenance and operations of establishments
  • Equipment, tools, and utensils maintenance and flow
  • Sanitation and pest control
  • Treatments and processes, such as cooking or packaging

3. Procedures-related PCs:

  • Complaints receipt, investigations, and response
  • Market withdrawal and recall

Note – Part 4 [on Preventive Controls] of the Safe Food for Canadians Regulations contains the majority of the food safety provisions.

Also, most businesses need to document their food safety controls in a Preventive Control Plan (PCP), which must include the following elements, as illustrated:

Preventive Control Plan

GMPs or Basic Preventive Controls:

Part 4 of SFCR on Preventive Controls

Division 4: Maintenance and Operation of Establishment

Sections 50-81 (Subdivisions A-G)

Food Safety PCP:

5 Preliminary Steps for Developing a HACCP Plan

+

The 7 Codex Alimentarius Principles

Market Fairness PCP:

– Labelling

– Packaging; Net Quantity

– Grading

– Standards of Identity

– Humane Treatment of Food Animals

– Import/Export Provisions

 

In a nutshell, a written PCP must describe the risks to food (and if applicable, food animals) that need to be identified and controlled. The GMPs and other food safety controls are based on internationally recognized Codex Alimentarius Guidelines. The PCP must also include market-based measures related to packaging, labelling, grades, and standards of identity, etc.

Remember, certain businesses may be exempt from having a written PCP. These are:

  • exporters of food (other than meat products or fish) who do not need an export certificate
  • businesses with $100,000 or less in gross annual food sales. This exception will not apply to businesses that conduct any activity in respect to food animals, meat products, dairy products, fish, eggs, processed egg products, or processed fruits and vegetables

Keep in mind, though, that businesses that do not require a written preventive control plan still must have preventive controls in place, such as sanitation and pest control etc.

Remco can provide high quality tools and solutions to help comply with the relevant sanitary requirements of SFCR, especially as preventive controls, and the following sections in Subdivisions from Division 4 on “Maintenance and Operation of the Establishment”:

Subdivision B on “Sanitation, Pest Control, and Non-Food Agents” requires that sanitation and handling of the materials must be conducted in a manner that does not present a risk of contamination to the food.

Remco provides a range of color-coded cleaning tools for use on product-contact surfaces such as process equipment, and non-food contact areas like floors, or drains. Moreover, color-coded scoops can be used to handle allergens and avoid potential mix-up.

 

Subdivision C on “Conveyances and Equipment” states that such units must be designed, constructed, and maintained in a way to prevent contamination.

Cleaning implements of poor design could jeopardize food safety and quality as they can be a major collection point for pathogens and other contaminants. Vikan’s Ultra Safe Technology brushes and brooms and Ultra Hygiene squeegees are hygienically designed to provide a superior cleaning solution. They are also constructed of Canadian, E.U., and U.S. regulations-compliant material.

Subdivision D on “Conditions Respecting Establishments” requires that the exterior and interior of the food facility be maintained to prevent or control sources of contamination and also permit hygienic employee practices.

Remco and Vikan can provide a range of sanitation, hygiene, and material handling tools and equipment that can be effectively used to help avoid or significantly minimize allergen cross-contact and contamination incidences within the facility. To view our product range, visit our site at https://remcoproducts.com/products/.

Subdivision E on “Unloading, Loading, and Storing” states that the receiving and shipping operations shall be conducted in a way that does not contaminate the food. It also requires that the food, its ingredients, packaging and labels to protected from contamination during storage.

Our tubs (with undercarriage attachment) come in 5 different colors. Also, we have a range of 12 colors to choose from for 35 of our most popular products. This feature supports a facility’s hygienic zoning program.

Subdivision G on Hygiene” requires that appropriate protective clothing shall be worn when handling food.

Remco can provide high quality color-coded garments such as aprons, gowns, and sleeves, which are an effective hygienic wear for food handlers.

Key Comparisons between Canada’s SFCR and U.S. FSMA

The Safe Food for Canadians Regulations requirements are closely aligned with those of the U.S. Food Safety Modernization Act (FSMA). However, there are a few differences in their regulatory approach towards licensing, preventive controls, and documentation requirements.

The table below provides a comparison between the North American and Canadian regulatory regimes based on some of the key elements:

 

FSMA

SFCR

 

Regulatory Agency

 

 

FDA

 

CFIA

 

Licensing

Biennial FDA License under the Bioterrorism Preparedness Act of 2002

Biennial CFIA License under the Safe Food for Canadians Act and Regulations

Key Food Act and Regulations amended (and yet, still in place)

Federal Food, Drug and Cosmetic Act, and related Code(s) of Federal Regulations (CFRs)

Canada’s Food and Drugs Act and Food and Drugs Regulations

 

Primary Reference(s) for Regulatory Compliance

The seven FSMA Final Rules; the most important rule being Preventive Controls for Human Food (PCHF)

The Safe Food for Canadians Regulations (SOR/2018-108) legal document

 

 

Regulatory Scope

 

Federal jurisdiction; Qualified facilities involved in interstate commerce and international trade

 Food businesses involved in inter-provincial and global trade. Some provisions, like labelling, apply also to businesses dealing with intra-provincial trade

 

Key Basis for GMPs (for the processing of human food)

 

The Modernized GMPs under the 21 CFR 117

GMPs (Sections 50-81) listed under Part 4 of the Safe Food for Canadians Regulations on Preventive Controls

 

Food Safety Plan

Hazard Analysis and Risk-based Preventive Controls (HARPC) Plan

Codex Alimentarius based Hazard Analysis and Critical Control Points (HACCP) Plan

 

Preventive Controls (PCs)

Process PC; Sanitation PC, Allergen PC; Supply-Chain PC; Recall Plan; Other PCs appropriate for food safety

Pre-requisites or GMPS; Food safety based Preventive Control Plan (HACCP); Market Fairness PCPs

 

 

Traceability

 

 

One-step forward to the customers, one-step back to the immediate supplier

One-step forward, one-step back. Persons who sell food at retail are required to trace the food back to the immediate supplier, but not trace forward to the consumer

 

The Key Difference

FSMA Rules are related only to the mandated food safety requirements along the supply chain

Canadian Regulations additionally have non-food safety elements i.e. the Market Fairness PCPs

Key SFCR highlights

Here are some essential tips to assist businesses on how to comply with the SFCR requirements:

  1. Revisit the SFCR exemption list: Find out whether your company is required to comply with the SFCR requirements. The Safe Food for Canadians Act (SFCA) and SFCR do not apply to the following businesses:
  • food for personal use, when food is not intended for commercial use, and:
  • the quantity of food falls within the stipulated Maximum Quantity Limits for Personal Use Exemption, and
  • the food is imported, exported, sent, or conveyed from one province to another by an individual other than in the course of business, or
  • the food is imported or exported as part of the personal effects of an immigrant or emigrant
  • food carried on a conveyance, e.g. ferries, airlines, trains, for use by crew and passengers
  • food intended and used for analysis, evaluation, research, or exhibitions, weighing 100 kg or less, or in the case of eggs, is part of a shipment of five or fewer cases
  • food not sold for use as human food (for example pet food, cosmetics), and that are labelled as such
  • foods imported from the United States onto the Akwesasne reserve, for use by a permanent resident of the reserve
  • foods imported in bond (in transit) for use by crew and passengers of a cruise ship or military ship in Canada
  • food inter-provincially traded between federal penitentiaries
  • when transporting a food commodity, if that is the sole of activity of a person

Note: Despite being exempted, such food must still be safe and meet the applicable requirements of Canada’s Food and Drugs Act and Regulations.

 

2. Find out if your business requires an SFCR License: Eligible businesses must apply for an SFCR license that meet their specific requirements. A license is valid for 2 years. As an evaluation aid, use the Licensing Interactive Tool at: https://na1se.voxco.com/SE/93/SFCR_licence/?&lang=en

3. Evaluate if you need to have a Preventive Control Plan (PCP): These contain majority of the food safety requirements, and also consumer protection related sections. A written Preventive Controls Plan (PCP) is required for most businesses with CDN $100,000 in gross sales. As an evaluation aid to determine whether your business requires a PCP, use the Preventive Control Plan (PCP) Interactive Tool at: https://na1se.voxco.com/SE/93/SFCR_PCP/?&lang=en.

4. See if you have to meet any other food-specific preventive controls: There may be additional commodity-related food-safety and/or market fairness controls associated with –

  • Dairy products
  • Egg and processed egg products
  • Fish
  • Fresh fruits or vegetables
  • Honey
  • Maple
  • Meat products
  • Processed fruit or vegetable products

For more information on “food-specific preventive controls,” check out the CFIA link at: http://inspection.gc.ca/food/requirements-and-guidance/preventive-controls-food-businesses/eng/1526472289805/1526472290070.

5. Check if you comply with the traceability requirements: Almost all food businesses must track their food products, materials, and ingredients along the supply chain, at least, one-step forward to the person to whom the food was provided, and one-step backward to the immediate supplier. Comprehensive and complete traceability documentation and records must be kept for at least 2 years. As an evaluation aid, use the Traceability Interactive Tool at: https://na1se.voxco.com/SE/93/traceability/?&lang=en.

6. Become aware of the SFCR compliance timelines for your business: Though some requirements were to be met immediately by Jan. 15, 2019, others are being phased in over a period of 12-30 months. The timelines or complying with licensing, preventive controls, preventive control plan and traceability requirements vary by food, activity, and size of the food business.

Provided below is a Phased Implementation Chart based on sector, size and gross revenue of the food business:

 

 

 

ELEMENT

Meat, Fish, Eggs, Dairy, Processed Fruit or Vegetable Products, Honey, Maple Products

 

 

 

Fresh Fruit and Vegetables

ALL OTHER FOODS

 

 

>$100K and

>5 employees

 

 

>$100K and

<5 employees

 

 

<$100K

License

Jan. 15, 2019

Jan. 15, 2019

July 15, 2020

July 15, 2020

July 15, 2020

Traceability

Jan. 15, 2019

(Jan. 15, 2020 for growers and harvesters only)

 

July 15, 2020

 

 

July 15, 2020

 

 

July 15, 2020

 

Preventive Controls

Jan. 15, 2019

Jan. 15, 2020

July 15, 2020

July 15, 2021

July 15, 2021

Written Preventive Control Plan

 

Jan. 15, 2019

 

Jan. 15, 2020

 

July 15, 2020

 

July 15, 2021

 

Not required

Source: Canadian Food Inspection Agency: ‘Phased Implementation by Sector and Business Size: Presentation to Canadian Society of Custom Brokers’, August 23, 2018

Note that almost all the requirements of the Safe Foods for Canadians Regulations shall come into effect for all remaining food business sectors by July 15, 2020.

For more information on specific SFCR timetables, refer to the CFIA website at: http://www.inspection.gc.ca/food/timelines/eng/1528199762125/1528199763186.

How can Remco help you?

Remco provides specialized solutions and products including color-coded tools for cleaning and material handling where hygiene and safety are critical. We have a 30-year+ partnership with Vikan, a global leader in supplying hygienically designed products. Our combined experience and focus on hygienic design make it a natural partnership and strengthens our ability to provide comprehensive solutions to food processors.

We can assist you in complying with the Safe Food for Canadians Regulations requirements:

Our library of white papers and articles are designed to help you find the right solutions to your food safety challenges. Download our white papers and read our articles at the Remco Knowledge Center, http://remcoproducts.com/knowledge-center/.

Some important white papers that could assist in complying with the Canadian food safety regulatory requirements are as follows –

  • Understanding GMPs in Food Processing:

https://remcoproducts.com/white-paper-understanding-gmps-in-food-processing/

  • HACCP Planning for Food Safety:

https://remcoproducts.com/white-paper-haccp-planning-for-food-safety/

https://remcoproducts.com/ust-white-paper/

  • Color-Coding Toolkit for Food Processing Facilities:

https://remcoproducts.com/toolkit/

By making information on the latest safety news, regulations, and best practices accessible via our social media and our website, we hope to provide the industry with the required support. If you require any technical assistance and additional information about our products and services, kindly contact us at cs@remcoproducts.com

Essential Information

Government of Canada’s Role in Assuring Safe Food for Canadians:

The Public Health Agency of Canada conducts outbreak surveillance and provides advice to protect people’s health.

Health Canada develops food safety standards and policies to help prevent or significantly reduce the risk of foodborne illnesses.

The Canadian Food Inspection Agency (CFIA) carries out inspection of the food industry to ensure that it meets its food safety requirements and responsibilities.

Key Terminologies

SFCA: Safe Food for Canadians Act, S-11, is an enabling law enacted to protect Canadian families from potentially unsafe food. This new act received Royal Assent on Nov. 22, 2012.

SFCR: Safe Food for Canadians Regulations (SOR/2018-108) document was published on June 13, 2018, and came into force on Jan. 15, 2019. These contain the administrative provisions of SFCA that simplify, modernize, and streamline Canadian food safety regulations for the benefit of consumers, regulators, food businesses, global importers, and exporters.

SFCR License: This is issued by the CFIA to a food business whose activities are subject to the new Canadian regulations. Generally, compliance is required of establishments that manufacture, process, treat, preserve, grade, package or label food to be exported or sent across provincial or territorial borders. Also, it applies to companies that deal with intra-provincially traded foods where traceability, labelling and advertising provisions of SFCR could also apply.

Traceability: This is one of the three key requirements of SFCR (besides Licensing and Preventive Controls) required of food businesses. Almost all food businesses must track their food products, materials and ingredients along the supply chain, at least, one-step forward to the person to whom the food was provided, and one-step backward to the immediate supplier.

Preventive Controls: These are measures that help to prevent food safety hazards and reduce the likelihood of contaminated food entering the market, whether they are prepared within or outside of Canada.

GMPs: Also called “pre-requisite programs,” these are general food safety controls that relate to the people, establishment and the procedural practices or required prior to developing a robust HACCP plan. Examples of GMPs include sanitation and pest control, hygiene etc.

HACCP: Hazard Analysis and Critical Control Points is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product.

Market Fairness PCPs: These represent non-food safety related regulatory provisions necessary for consumer protection or market acceptability. Examples include: labelling, grading, packaging, and standards of identity.

U.S.-Canada Comparable Food Safety System Recognition: Systems recognition involves reviewing a foreign country’s food safety regulatory system to determine if it has legal authorities and regulatory tools comparable to domestic requirements. For example, the FDA has an arrangement with CFIA and Health Canada that they recognize each other’s food safety systems and that they can leverage each other’s science-based regulatory systems.

 

Selected References

Canadian Food Inspection Agency, CFIA website: www.inspection.gc.ca

CFIA (2018). Understanding the Safe Food for Canadians Regulations – A Handbook for Food Businesses. Link: http://www.inspection.gc.ca/DAM/DAM-aboutcfia-sujetacia/STAGING/text-texte/regs_safe_food_regulations_handbook_business_1531429195095_eng.pdf

Safe Food for Canadians Regulations (SFCR), Link: https://laws-lois.justice.gc.ca/eng/regulations/SOR-2018-108/page-1.html

 

White Paper: Color-Coding as a Preventive Control

Color-Coding as a Preventive Control in Food Processing

According to the CDC, 1 in 6 Americans become sick by eating contaminated food every year, resulting in an estimated 3,000 deaths. As if the human cost isn’t sobering enough, the Grocery Manufacturers Association also estimates the average cost of a recall to a food company is $10 million in direct costs in addition to brand damage and lost sales.

Considering growing public health concerns and the economic burden of foodborne illnesses, the 2011 Food Safety Modernization Act shifted the FDA’s focus from simply responding to food safety problems to trying to prevent them. FSMA now requires food facilities to conduct a comprehensive hazard analysis and then establish risk-based preventive controls. For a number of facilities, color-coding has become one of the preventive controls to protect food against direct contamination, cross-contact, and cross-contamination incidences.

Defining Preventive Controls

According to 21 CFR 117 Subpart C, preventive controls are risk-based assurances that relevant food safety hazards are significantly minimized or prevented upon application of that control. The same regulations also stipulate that food manufactured, packed, or held by a facility will not be adulterated or misbranded in any way.

As illustrated in the diagram to the right, Preventive Controls are distinguished from the modified Current Good Manufacturing Practices (or CGMPs, which are the minimum, legally required sanitary and processing practices describing the methods, equipment, facilities, and controls for producing safe and wholesome food).

Color-coding as an industry best practice can definitely qualify as a valid preventive control.

Benefits of Color-Coding as a Preventive Control

Color-coding quickly communicates essential information for food safety, regardless of language barriers. It’s this simplicity that makes color-coding an effective preventive control.

Colors can signal the process status – visualize the traffic lights and what each color communicates to a driver. The same concept could apply to material handling across process flows and act as a signal for whether the product should move to the next process level or not.

More importantly, colors act as visual cues to identify the personnel, equipment or tools within an area. If blue-bristled pipe brushes are used for cleaning food conveyance pipes, and black-bristled tube brushes are used for clearing drains, there is a clear identifier between food-contact and non-food contact tools to prevent accidental misuse.

The other function of color-coding is that colors can separate zones and products based on risk. Something as simple as red and blue storage tubs could easily separate low-risk raw meat from high-risk processed product to prevent cross-contamination. It can also be used to separate allergen zones.

Color-Coding as a Preventative Strategy

There are three main ways a color-coding plan can fit into a food safety management system:

  1. As part of the Standard Operating Procedures: A color-coding plan can specify the colors used for scoops for handling different products within an allergen SOP, or cleaning brushes to be used for different surfaces within a Sanitation Standard Operating Procedure (SSOP).
  2. As a Preventive Control within a Food Safety Plan: For this, the plan must be validated or justified, monitored, verified, and reviewed as a food safety control.
  3. As a Standalone Color-Coding Plan: This could reference other procedures and can also follow the same format as the food safety plan.

The facility may decide to reference color-coding within their Current Good Manufacturing Practices (CGMPs), Preventive Controls, or Best Practices framework as long as there’s consistency and a clear process of justifying, verifying, and reviewing the program. m.

Developing a Color-Coding Plan

The steps to establishing any preventive controls are as follows:

  1. Conduct a Comprehensive Hazard Analysis: Do you have areas where there’s a chance of allergen cross-contact or cross-contamination? These could be the right place to establish color-coding zones or use color-coded implements.
  2. Evaluate the Applicability of Color-Coding: Will color-coding prevent issues? If you need to keep scoops separated because they’re not easily identifiable, it would be an appropriate use of color-coding as a preventive control. If raw product is touching finished product because there isn’t enough workspace, color-coding may not help.
  3. Establish Control Measures, Preventive Controls, and Practices: Color-coding may be employed as part of the current Good Manufacturing Practices, or as a risk-based Preventive Control, or as an industry best practice.
  4. Set the Monitoring, Corrective Action, Verification, and Review Criteria: For monitoring, process leaders and managers can effectively watch out for colored-tools being used in the wrong zones. Corrective actions vary from putting affected products on-hold to retraining specific employees. Verification comes through pre-operational inspection and being on the floor to see that the right tools are being used in the right zones. Review the criteria for the plan to ensure it’s working and still fits the need in that area.
  5. Education, Train, and Refresh the Employees on the Plan: Workers should be reminded of color-coding procedures through continuous education. They should be retrained on color-coding at least yearly, or whenever there are changes to the plan.

Evaluating Risks with the Hazard Analysis Cube


The Hazard Analysis Cube is one way of visually identifying the three key variables essential for a comprehensive hazard evaluation:

  1. The Food Safety Hazard refers to the type of contaminant i.e. biological, chemical or physical, that may adversely affect food. Though stating the hazard is still key to the process, FSMA moves hazard analysis beyond this fundamental.
  2. The Mode of Hazard Introduction clarifies how the hazard was introduced—whether it was accidental, naturally occurring in the product, or deliberately added by malicious agents.
  3. The Focus Point of Control refers to where the control strategies to prevent the hazards are put into place. Is it at the lower tier for materials, ingredients, or product, or at a higher level involving processes and personnel practices, or at a much higher, systematic and environmental level?

For each potential hazard, a risk analysis should be conducted based on Likelihood x Severity, as shown in the diagram. Issues that are of a greater public health concern are a high-risk priority and require immediate attention, followed by those with moderate-to-low risk, and then the very low, negligible, or no-risk issues.

As an example, consider wheat and soy cross-contact, a chemical hazard that could be accidentally introduced during processing by personnel. The hazard would be a high-risk issue, and the objective of the preventive control would be to reduce the risk to safe, low levels.

For each potential hazard, a risk analysis should be conducted based on Likelihood x Severity. Issues that are of a greater public health concern are a high-risk priority and require immediate attention, followed by those with moderate-to-low risk, and then the very low, negligible, or no-risk issues.

As an example, consider wheat and soy cross-contact, a chemical hazard that could be accidentally introduced during processing by personnel. The hazard would be a high-risk issue, and the objective of the preventive control would be to reduce the risk to safe, low levels.

Elements of a Color-Coding Plan

The format of the color-coding plan can be similar to a typical food safety plan, so it requires the same standard steps to prove its efficacy. As an example, let’s consider a critical step within a typical food safety plan, where soy and wheat are used together while preventing cross-contact in the main supply of each allergen product container: 

– The Material or Step is adding soy lecithin to wheat flour.

– The Hazard is chemical, and more specifically, the allergen cross-contact between the wheat and soy supplies.

– The Control Type used is allergen control through product handling and personnel practices, and sanitation control by cleaning lines between changeovers. As a justification, color-codingcan also be used because of its role in preventing cross-contact incidences.

– As a Monitoring Action to ensure the color-coding plan is followed, the supervisor may ensure, say, trained operators use blue scoops for handling wheat and use red scoops for handling soy.

– Now if the wheat and soy scoops were accidentally switched, the Corrective Action steps would likely be:

 i) Stop production.

ii) Separate affected product from the good batches and safely dispose of it.

iii) Thoroughly clean scoops and the affected areas.

iv) Start production.

v) Document the action.

vi) Find the root cause and prevent further cross-contact between allergens through employee education, training, and process redesign.

– As part of the Verification Action, Quality Control can take sample allergen swabs before production begins to check if surfaces are allergen clean. QC can also check if the operators are following appropriate allergen handling procedures.

– Some of the Records and Supporting Documents that may be used in the plan are:

  • Color-Coding Maps
  • Allergen Control Plan
  • Sanitation Standard Operating Procedures (SSOPs)
  • GMP Records
  • Corrective Action Records

The color-coding plan is generally reviewed annually, or whenever there are significant changes in allergen handling and processing activities.

Educating and Training Employees on Color-Coding

When it comes to creating companywide awareness on color-coding, it’s not enough to show employees how a task is done. They should also learn, in the best and simplest way, why color-coding will help improve food safety and make their jobs easier. Trainers should clearly lay out the concepts, such as how certain food allergens could make a vulnerable individual seriously ill or cause death, and reinforce why color-coding as a preventive control is so important. When employees are invested in a program and feel like they have a stake in it, even just by knowledge of why and how it works, they’re more likely to follow it.  

After six months or at most a year, refresh the employees and evaluate to see if they know how well and why they are doing the process. It’s also essential to re-educate and re-train employees if there’s a breakdown or a change in the color-coding program.

If an employee is using the wrong scoop to handle allergens, it’s important to re-educate and re-train them to do it right the first time and at all times. If there is a change in the color-coding program, where a yellow scoop instead of red will then be used to handle soy, the plan must be re-developed to reflect the change and employees must be re-educated and re-trained on it.

Deciding Which Products to Color-Code

When it comes to using color-coding as a preventive control, the recently published FDA FSMA Final Rule for Preventive Controls for Human Food recommends the following best practices:

  • Color-coded uniforms, smocks, and footwear to identify employees working in high-risk areas and to minimize pathogen contamination spreading.
  • Color-coded containers to identify and separate waste from useable or edible products.
  • Color-coded equipment in hygienic zones to keep tools from spreading one type of contamination or allergen to other areas in the plant.
  • Color-coded facility maps to differentiate hygienic zones.

Tips on Implementing Color-Coding

Keep the color-coding plan simple. Plans work best with 3-5 colors in most small-to-medium plants. Secondary methods of color-coding, such as using a broom that’s one color with a different colored handle, usually confuse workers and aren’t nearly as effective as a total-color system.

Be consistent with colors. Large changes shouldn’t happen frequently, and should be carefully evaluated for necessity. Each change may cause confusion among the staff and could increase chances of cross-contamination or allergen cross-contact.

Communicate the plan effectively and often. Post signs, hold training meetings, and have managers reinforce the need for color-coding. Such measures can enhance food safety culture among the employees.

Bring in help. Remco Products has a large Knowledge Center full of articles and white papers with tips on developing and maintaining a color-coding plan. We can also send experienced representatives out to your location to assist with creating the best color-coding plan for your facility. Contact cs@remcoproducts.com if you’d like assistance or simply have questions.

White Paper: SQF Edition 8

SQF Edition 8 White Paper

SQF Edition 8: Focus on Hygiene and Sanitation

The SQF certification program can help facilities comply with crucial hygiene and sanitation requirements, as there is an enhanced focus in preventing, eliminating, and significantly minimizing food safety hazards of public health and legal significance. This whitepaper explores the notable contributions of SQF Edition 8 as a global standard, toward developing, implementing, and maintaining sanitation controls and hygiene practices within food and beverage processing sites.

This white paper will help you understand:

  1. Why GFSI-benchmarked programs are worldwide
  2. How SQF Edition 8 focuses on hygiene and sanitation
  3. Significant changes in Edition 8
  4. SQF System Elements for Food Manufacturing
  5. How to prepare for SQF certification

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White Paper: HACCP vs. HARPC

HACCP vs. HARPC: A Comparison White Paper

HACCP vs. HARPC: A Comparison White Paper

HACCP and HARPC share more than just four letters. They’re both food safety standards based on prevention, but they do differ on execution. Their differences and the similarities aren’t as important as the way they fit together for most food processors, though. A HARPC plan shouldn’t be considered as a replacement, but as a necessary upgrade to the conventional HACCP plan. Understanding how the systems fit together is the first step toward implementing both.

This white paper will help you understand:

  1. Key comparison points between
  2. HARPC as an upgrade to HACCP
  3. How HACCP works
  4. 12 steps of HACCP
  5. How HARPC works
  6. 7 steps of HARPC

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White Paper: Cleaning Tool Maintenance

Optimizing Food Safety Through Good Cleaning Tool Maintenance White Paper

Optimizing Food Safety Through Good Cleaning Tool Maintenance
by Debra Smith
Global Hygiene Specialist – Vikan A/S

Cleaning is a critical step in the management of food safety and quality. Consequently, the correct maintenance of cleaning tools by the food industry is essential to minimize the risk of microbial, allergen, and foreign body cross-contamination. This, in turn, aids compliance to relevant regulatory and legal requirements, HACCP prerequisite programs, and audit standards.

This white paper will help you understand:

  1. What the Global food safety schemes say about cleaning tool maintenance
  2. What you need to do to comply with these safety schemes
  3. Identifying the hazards
  4. Risk Assessment
  5. Validation
  6. Monitoring
  7. Verification

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White Paper: The Hygienic Design of Food Industry Brushware

The Hygienic Design of Food Industry Brushware White Paper

Minimising Contamination, Maximising Food Safety
The Hygienic Design of Food Industry Brushware – the good, the bad and the ugly

by Debra Smith
Global Hygiene Specialist – Vikan A/S

Cleaning is a critical step in the management of food safety. Consequently, the correct selection of cleaning equipment by the food manufacturing and food service industries is essential to minimize the risk of product contamination, and aid compliance to relevant regulatory, guidance and standard requirements.

This white paper Vikan will help you understand:

  1. Hygienic design criteria
  2. Hygienic design assessment of food industry brushware
  3. Compare the different types brushware used in the food industry
  4. The benefits of using UST products in hygiene critical areas

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White Paper: Understanding GMPs in Food Processing

Understanding GMPs in Food Processing White PaperTo ensure the safety and quality of our food supply, the Food and Drug Administration (FDA) enforces a set of Current food Good Manufacturing Practices (CGMPs) published in Title 21 of the Code of Federal Regulations, Part 110 (21 CFR 110). These CGMPs describe the methods, equipment, facilities, and controls for producing processed food. As the minimum sanitary and processing requirements for producing safe and wholesome food, they are an important part of regulatory control over the safety of the nation’s food supply. CGMPs also serve as one basis for FDA inspections.

CGMPs apply to every food processing operation, so compliance can have a major impact on your business. This white paper will help you understand:

  1. The basic subparts describing the types CGMPs in 21 CFR 110
  2. How the Food Safety and Modernization Act (FSMA) of 2011 may impact CGMPs
  3. Other preventive controls that may be required as a result of FSMA
  4. A basic outline of exemptions and modified requirements that may result from FSMA

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White Paper: HACCP Planning for Food Safety

HACCP Planning for Food Safety White PaperA HACCP plan, although not required for all food processors, is a great foundation for any food safety program and can help to mitigate the risk from biological, allergen, and physical hazards. Building a HACCP plan provides assurance to customers and food safety agencies that appropriate measures are being taken in a facility to ensure the safe production of food products.

This white paper will help you understand:

  1. The seven HACCP principles
  2. The first steps of putting together a HACCP team
  3. The basic elements of building a HACCP plan

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White Paper: Making the Decision to Apply Color-Coding


Making the Decision to Apply Color-Coding White Paper

With the signing of the Food Safety and Modernization Act (FSMA) in 2011, many food processors are taking proactive steps by instituting color-coding as part of their Good Manufacturing Practices. But in examining the intent of the HACCP procedures, one can easily see how other types of processing facilities could also benefit from color-coding systems. This white paper will help you understand how color-coding is used for a variety of purposes. Don’t wait—it can help you make the decision about applying color-coding in your operation!

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White Paper: Selection, Care, and Maintenance Guide for Food Contact Tools and Equipment

Selection, Care, and Maintenance Guide for Food Contact Tools and Equipment White Paper

In food processing, proper maintenance is important for assuring a sanitary processing facility. Properly selecting and using the right tools and equipment for each assigned task is essential to success, as well as ongoing care, cleaning, and maintenance of those tools and equipment.

Remco has developed a guide to proper selection, care, and maintenance of food contact tools and equipment to assist food processors in considering the related aspects of such equipment. Since hygienic cleaning is a necessary step in maintaining an efficient, clean and code-compliant processing facility, it is important that the proper tools, cleaning and storage methods, and maintenance practices are utilized to assure the highest level of integrity.

This guide will help you to:

  1. Identify features that contribute to the hygienic design of food contact tools such as shovels, brushes, scrapers, pails, and more
  2. Learn the basics about proper storage that contributes to sanitary conditions instead of creating more potential risk
  3. Better understand industry standards regarding the proper cleaning of food contact equipment and tools
  4. Recognize the signs that it is time to replace food contact tools

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