Food Regulations

Experience as part of the Negotiation team for the Free Trade Agreement between Mexico and the EU in Agri-food and spirits access, Sanitary and Phytosanitary Measures (SPS) and Geographical indications. Regarding the SPS we participated on the pre-listing, audit visits, among other issues.

We have the experience on the field, from 2014 to 2019 on Planning, Organising and Preparing Inspection Visits from the EU to Mexico on Bovine and equine meat. As well as the inspection visits from Mexico to the EU on pork meat.

We could help you to implement a Food Safety Management System and also audit your actual System, we especialize on slaughterhouse, cutting and deboning complying with EU, USA and Mexico Regulations.

Food Safety Management System

A food safety management system is a group of procedures and practices that work together to prevent foodborne illness.

It does this by actively controlling risks and hazards throughout the flow of food.

There is concern on Food Safety Hazards among consumers and also among producers.

Caused by:

  • Food Poisoning incidents and subsequent Recall actions
  • Food comes from all over the world and so the production is an uncertain factor
    • Consumers and Producers want safe and high quality food in the supermarkets, shops and marketplaces
    • Consumers and Producers want:
  • Legislation and food safety control
  • Quality systems
  • A safe Food Supply Chain

Consumers and Producers want to prevent food hazards and incidents.

Foodborne Illness Risk Factors

The Food and Drug Administration has identified five risk factors that contribute to most foodborne illnesses in the U.S.

  • Food from unsafe source
  • Inadequate cooking
  • Improper holding temperature
  • Contaminated equipment
  • Poor personal hygiene

Programs that should be in place:

  • Personal Hygiene program
  • Supplier selection and specification program
  • Cleaning and sanitation program
  • Facility design and equipment maintenance program
  • Food safety training program
  • Quality control and assurance programs
  • Standard operating procedures (SOPs)


Hazard Types

"A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect"

(Codex Alimentarius Commission)

"A condition or physical situation with a potential for an undesirable consequence"


a situation involving exposure to danger

the possibility that something unpleasant will happen

is the chance, high or low, that any hazard will actually cause somebody harm.

Risk vs Hazard:

Hazard: something with the potential to cause harm.

Risk: the likelihood of occurrence and the magnitude of consequences of a specified hazard being realized

There are many hazards associated with food that can and do result in injury and harm to human health.

Millions of people worldwide suffer from some sort of "food poisoning" each year.

Uncontrolled application of agricultural chemicals, environmental contamination, use of unauthorized additives, microbiological hazards and other abuses of food along the food chain can all contribute to the potential of introducing or failing to reduce hazards related to food.

With increased awareness of the effects of food hazards on human health, the increasing importance and rapid growth of world food trade and the demand by consumers for a safe food supply, analysis of the risks associated with food has become more important than ever before.

Risk assessment is a quantitative evaluation of information on potential health hazards from exposure to various agents.

It involves four interrelated steps:

  • Identification of the hazard and comprehension of the danger it represents, the impact in terms of human health and the circumstances under which the danger is present (hazard identification)
  • Qualitative and/or quantitative evaluation of the adverse effects of the hazard on human health (hazard characterization)
  • Qualitative and/or quantitative evaluation of the likely degree of consumption or intake of the hazardous agent (exposure assessment)
  • Integration of the first three steps into an estimate of the likely adverse effect in the target population (risk characterization).

The entire risk assessment process requires the use of sound and scientifically derived information and the application of established scientific procedures carried out in a transparent manner.

Unfortunately, sound scientific data are not always available for the qualitative and quantitative evaluations necessary for an absolutely sure final decision; consequently a degree of uncertainty must be factored into the decision.

The importance of risk assessment lies not only in its capacity for estimating human risk, but also in its function as a framework for organizing data as well as for allocating responsibility for analysis.

The risk assessment process can include a variety of models for reaching conclusions; for example, the concept of acceptable daily intake (ADI) may be considered a component of risk assessment.

Main Regulations and certifications around the globe

Regulations and Certifications

Legal requirements, International Standards and Private Voluntary Standards

  • ISO 22000:2005 - Traceability in the Feed and FoodChain
  • Global Food Safety Initiative (GFSI) Guidance Document – CIES The Food Business Forum
  • European Union Food Regulation Directive 178/2002
  • US Bioterrorism Act 2002
  • USDA Food Safety and Inspection Service (FSIS) Directive 8080
  • Safe Food for Canadians Regulations (SFCR)
  • Canada TraceCanadian Food Traceability Data Standard (CFTDS)
  • Canadian Food Inspection Agency recall system
  • The British Retail Consortium Global Food Standard
  • SQF (Safe Quality Food) - SQFI is a Division of the Food Marketing Institute
  • International Featured Standards (IFS)
  • GS1 Traceability Standard – from GSMP’s Traceability Industry requirements team (IRT)
  • Agricultural Industries Confederation (AIC) Feed Materials Assurance Scheme
Safety Management Process

The foundations of the diferent Food Safety Management System is HACCP.

The HACCP system is the system that is required for any food business or organisation in most countries by legislation.

The joint FAO / WHO Codex Alimentarius Commission recommends the HACCP approach to enhance Food Safety.


Hazard Analysis and Critical Control Point (HACCP)

The HACCP system was originally developed for use in aerospace manufacturing under the name “Failure Mode Effect Analysis”. It was first adapted to food processing by the Pillsbury Company in 1959 in a project for the NASA space program. At that time, HACCP was used to guarantee that food used in the U.S. space program would be 100% free of viral and bacterial pathogens.

By the late 1960s, Pillsbury was using a HACCP system to manufacture consumer goods.

In late 1989, the Food Safety and Inspection Service (FSIS) announced its intention to implement HACCP in meat and poultry inspection operations. FSIS embarked on a 3 year study to determine how best to implement HACCP.

  • International accepted approach for assuring the safety of Food-strongly recommended by codex
  • HACCP system is a tool used to access hazards, estimate risk and establish risk or reduce it to an acceptable level
  • HACCP emphasizes prevention and control rather than end product testing and traditional inspection methods.
  • Science based
  • The principles are very much in line with the Quality Management principles (ISO 9001), and environment (ISO 14000)
  • Promotes good Agricultural Practices
  • Promotes good Hygienic Practice (CHP)
  • Considers risk management
  • Promotes more effect control by putting emphasis on audit and training than on physical inspection and laboratory analysis of end products. or consignment
  • HACCP contribute to reducing the cost of poor quality
  • Accreditation or certification body certify the system
  • Step wise process:
    • Identifies hazards
    • Installs preventative measures to eliminate or reduce hazards in foods
  • Proactive rather than reactive
  • Risk based
  • Does not rely on end product testing
    • hazards not be evenly distributed and can be missed in sampling
    • need to test large quantities
    • product would need to be destroyed or reworked
  • Starts from the beginning of the process
  • Receiving of ingredients, packaging
    • through process steps
    • to final product and shipping

HACCP - Answers 3 questions

  • WHAT hazards can enter the product?
  • Where do these hazards occur?
  • How can we control or eliminate these hazards?

Traditionally, the Hazard Analysis and Critical Control Point (HACCP) methodology has been considered to be a food safety management system.

It aims to prevent known hazards and to reduce the risks that they will occur at specific points in the food chain. The same principles are also increasingly being applied in other industries, such as the car industry, aviation and the chemical industry.

Hazards affecting quality are controlled to a certain extent through the validation of critical operations and processes in the manufacture of finished products in accordance with Good Manufacturing Practices (GMP).

However, GMP do not cover the safety of the personnel engaged in manufacture, while both aspects are covered by HACCP.

The following elements of the HACCP methodology are integral parts of the validation master file:

  • development of a flow diagram of the process;
  • verification of the flow diagram on site.

Benefits of HACCP

  • A preventative approach to food safety
  • Can help identify process improvements
  • Reduces the need for, and the cost of end product testing
  • Is complementary to quality management systems such as ISO 9000
  • Provides evidence of due diligence
  • Reduces the likelihood of product recall & adverse publicity
  • Enhances customer satisfaction / reduces dissatisfaction
  • Facilitates better understanding of food packaging safety issues throughout the organization.
  • Improves staff performance through the promotion of team spirit
  • Improves staff morale and motivation through a cleaner working environment

HACCP should not replace GMP; however, its application may be used as a first step towards GMP.


The HACCP system is based on seven principles.

In applying these principles, 12 stages are recommended and are discussed below.

Some stages are linked to specific principles while others serve as an introduction to the concept.

HACCP Principles

The seven principles are:

  • Conduct a hazard analysis.
  • Determine the critical control points (CCPs).
  • Establish target levels and critical limit(s).
  • Establish a system to monitor the CCPs.
  • Establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control.
  • Establish procedures to verify that the HACCP system is working effectively.
  • Establish documentation concerning all procedures and keep records appropriate to these principles and their application.

Guidelines for the application of the HACCP system

The following guidelines will be found useful in applying the HACCP system:

  • Before HACCP is applied to any sector, that sector should be operating in accordance with the principles of good practices and the relevant legislation.
  • Management commitment is necessary if an effective HACCP system is to be implemented.
  • HACCP should be applied to each specific operation separately.
  • CCPs identified in any given example in any reference document (including GMP guidelines) may not be the only ones identified for a specific application or may be of a different nature.
  • The HACCP application should be reviewed and necessary changes made when any modification is made in the product or process, or in any step.
  • It is important, when applying HACCP, to take into account the nature and size of the operation.
  • There should be a HACCP plan. The format of such plans may vary, but they should preferably be specific to a particular product, process or operation. Generic HACCP plans can serve as useful guides in the development of product and process HACCP plans; however, it is essential that the unique conditions within each facility are considered during the development of all components of the HACCP plan.
HACCP Stages

Application / Stages

The application of HACCP principles consists of the 12 stages, as identified in the logic sequence for application of HACCP.

  • Assemble a HACCP team
  • Describe the product and process
  • Identify the intended use
  • Construct a flow diagram
  • On-site confirmation of flow diagram
  • List all potential hazards associated with each step, conduct a hazard analysis, and consider any measures to control identified hazards (Principle 1)
  • Determine critical control points (Principle 2)
  • Establish critical limits for each CCP (Principle 3)
  • Establish a monitoring system for each CCP (Principle 4)
  • Establish corrective actions (Principle 5)
  • Establish verification procedures (Principle 6)
  • Establish documentation and record keeping (Principle 7)

1. Assemble a HACCP team

The pharmaceutical manufacturer should assure that product-specific knowledge and expertise are available for the development of an effective HACCP plan. This may be best accomplished by assembling a multidisciplinary team.

Team members should therefore represent all the relevant disciplines, such as research and development, production, quality control, quality assurance, microbiology, engineering and distribution or others as applicable. Team members should have specific knowledge and expertise regarding the product and process. Where such expertise is not available on site, expert advice should be obtained from other sources.

Team members should be able to:

  • conduct a hazard analysis;
  • identify potential hazards;
  • identify hazards which should be controlled;
  • recommend controls and critical limits;
  • devise procedures for monitoring and verification;
  • recommend appropriate corrective action where deviations occur;
  • verify the HACCP plan.

The scope of the HACCP plan should be defined. The scope should describe the segment of the process involved and the classes of hazards to be addressed should be identified.

2. Describe the product and process

A full description of the product and the process should be drawn up, including relevant quality information such as the composition, physical/chemical properties, structure, pH, temperatures, method of cleaning, bactericidal/ bacteriostatic treatments (e.g. heat-treatment), drying, screening, mixing, blending, packaging, and the storage conditions. The method of distribution and transport should also be described, especially where products are thermolabile.

3. Identify the intended use

The intended use should be based on the expected uses of the product by the end-user or consumer. In specific cases, vulnerable population groups, e.g. geriatric patients, infants and immunocompromised patients, may have to be considered.

4. Construct a flow diagram

The flow diagram should be constructed by the HACCP team, and should cover all operations and decisions in a process.

When applying HACCP to a given operation, the steps preceding and following that operation should also be considered.

A block-type diagram may be sufficiently descriptive.

5. On-site confirmation of flow diagram

The HACCP team should confirm the processing operation against the flow diagram during all stages and hours of operation. Amendments to the flow diagram may be made where appropriate, and should be documented.

6. List all potential hazards associated with each step, conduct a hazard analysis, and consider any measures to control identified hazards (Principle 1)

When hazard analysis is conducted, safety concerns must be distinguished from quality concerns.

The HACCP team should list all the hazards that may be reasonably expected to occur at each step from production, testing and distribution up to the point of use. It should then conduct a hazard analysis to identify for the HACCP plan which hazards are of such a nature that their elimination or reduction to acceptable levels is essential.

A thorough hazard analysis is required to ensure an effective control point. A two-stage hazard analysis is recommended. During the first stage, the team should review the materials, activities, equipment, storage, distribution and intended use of the product. A list of the potential hazards (biological, chemical and physical) which may be introduced, increased or controlled in each step should be drawn up.

In the hazard analysis, the following should be included wherever possible:

  • the probable occurrence of hazards and the severity of their adverse health effects;
  • the qualitative and/or quantitative evaluation of the presence of hazards;
  • the survival or multiplication of microorganisms of concern;
  • the production or persistence in drugs of toxins, chemicals or physical agents;

During the second stage, a hazard evaluation should be conducted, i.e. the severity of the potential hazards and the probability of their occurrence should be estimated.

The team should then decide which potential hazards should be addressed in the HACCP plan, and what control measures, if any, exist that can be applied for each hazard. More than one control measure may be required to control a specific hazard(s) and more than one hazard may be controlled by a specified control measure.

Potential hazards in relation to at least the following should be considered:

  • materials and ingredients;
  • physical characteristics and composition of the product;
  • processing procedures;
  • microbial limits, where applicable;
  • premises;
  • equipment;
  • packaging;
  • sanitation and hygiene;
  • personnel;
  • risk of explosions;
  • mix-ups.

7. Determine critical control points (Principle 2)

A CCP in the HACCP system can be more easily determined by the use of a decision-tree, which facilitates a logical approach. The way that a decision-tree is used will depend on the operation concerned, e.g. production, packing, reprocessing, storage, distribution. Training in the use of decision-trees should be given.

If a hazard has been identified at a step where control is necessary for safety, and no control measure exists at that step, or any other, the product or process should be modified at that step, or at an earlier or later stage, to include such a control measure.

8. Establish critical limits for each CCP (Principle 3)

Critical limits must be specified and verified, if possible, for each critical control point. More than one critical limit may sometimes be elaborated at a particular step. The criteria used often include measurements of temperature, time, moisture level, pH, and sensory parameters, such as visual appearance and texture.

Critical limits should be scientifically based.

9. Establish a monitoring system for each CCP (Principle 4)

Monitoring is the scheduled measurement or observation of a CCP relative to its critical limits. Monitoring should be recorded.

The monitoring procedures used must be able to detect loss of control at the CCP, and this information should ideally be available in time to make adjustments to ensure control of the process and prevent violations of the critical limits. Where possible, process adjustments should be made when the monitoring results indicate a trend towards loss of control at a CCP. These adjustments should be made before a deviation occurs.

Data derived from monitoring must be evaluated by a designated person with the knowledge and authority to carry out corrective actions when indicated.

If monitoring is not continuous, the amount or frequency of monitoring must be sufficient to guarantee that the CCP is under control.

Most monitoring procedures for CCPs will need to be done rapidly because they relate to on-line processes and there will not be time for lengthy analytical testing. For this reason, physical and chemical measurements are often preferred to microbiological tests because they can be done rapidly and can often indicate the microbiological control of the product.

The personnel conducting the monitoring of CCPs and control measures should be engaged in production (e.g. line supervisors, maintenance staff) and, where appropriate, staff from quality control. They should be trained in monitoring procedures.

Where continuous monitoring is possible, a reliable monitoring procedure and frequency should be identified. Statistically designed data collection or sampling systems should then be used.

All records and documents associated with monitoring CCPs must be signed and dated by the person(s) carrying out the monitoring and by a responsible reviewing official(s) of the company.

10. Establish corrective actions (Principle 5)

Specific corrective actions should be developed for each CCP in the HACCP system in order to deal with deviations when they occur. These actions should ensure that the CCP is brought under control. Corrective actions should include at least the following:

  • determination and correction of the cause of non-compliance;
  • determination of the disposition of the non-compliant product;
  • recording of the corrective actions that have been taken.

Specific corrective actions should be developed in advance for each CCP and included in the HACCP plan. As a minimum, this plan should specify what is to be done when a deviation occurs, who is responsible for implementing the corrective actions, and that a record will be kept and maintained of the actions taken. Individuals who have a thorough understanding of the process, product and HACCP plan should be assigned the responsibility for the oversight of corrective actions.

As appropriate, experts may be consulted to review the information available and to assist in determining the disposition of non-compliant product.

Actions taken must also include the proper disposition of the affected product.

Deviation and product disposition procedures must be documented in the HACCP records.

11. Establish verification procedures (Principle 6)

Procedures should be established for verification. Verification and auditing methods, procedures and tests, including random sampling and analysis, can be used to determine whether the HACCP system is working correctly. The frequency of verification should be sufficient to confirm the proper functioning of the HACCP system.

Examples of verification activities include:

  • review of deviations and product dispositions;
  • confirmation that CCPs are kept under control.

Initial verification of the HACCP plan is necessary to determine whether it is scientifically and technically sound, that all hazards have been identified, and that, if the HACCP plan is properly implemented, these hazards will be effectively controlled.

Information reviewed to verify the HACCP plan should include:

  • expert advice and scientific studies;
  • in-plant observations, measurements and evaluations.
  • For example, verification of the moist heat sterilization process for sterile injectables should include the scientific justification of the heating times, pressure and temperatures needed to obtain an appropriate destruction of pathogenic microorganisms (i.e. enteric pathogens) and studies to confirm that the sterilization conditions ensure that the whole load is kept at the required temperature for the time required.

Subsequent verifications should be performed and documented by a HACCP team or an independent expert, as needed. For example, verifications may be conducted when there is an unexplained system failure, a significant change in product, process or packaging occurs, or new hazards are recognized.

In addition, a periodic comprehensive evaluation of the HACCP system by an unbiased, independent third party is useful. This should include a technical evaluation of the hazard analysis and each element of the HACCP plan as well as an on-site review of all flow diagrams and appropriate records of the operation of the plan. Such a comprehensive verification is independent of other verification procedures and must be performed in order to ensure that the HACCP plan is resulting in the control of the hazards. If the results of the comprehensive verification identify deficiencies, the HACCP team should modify the HACCP plan as necessary.

Individuals doing verification should have appropriate technical expertise to perform this function.

Where possible, verification should include actions to confirm the efficacy of all elements of the HACCP plan.

12. Establish documentation and record keeping (Principle 7)

Efficient and accurate documentation and record keeping are essential to the application of a HACCP system and should be appropriate to the nature and size of the operation.

Examples of activities for which documentation is required include:

  • hazard analysis;
  • CCP determination;
  • HACCP plan;
  • critical limit determination.

Examples of activities for which records are required include:

  • CCP monitoring activities;
  • process steps;
  • associated hazards;
  • critical limits;
  • verification procedures and schedule;
  • deviations;
  • associated corrective actions;
  • modifications to the HACCP system.

To recover from a foodborne-Illness outbreak:

  • Investigate to find the cause of the outbreak
  • Work with the regulatory authority to resolve issues
  • Throw out all suspected food
  • Clean and sanitize all areas of the operation
  • Establish new procedures or revise existing ones based on the investigation results
  • Develop a plan to reassure customers that the food served in your operation is safe

For more details, please visit our Recall Section.


  • Foundation to a HACCP program
  • Includes Good Manufacturing Practices
  • Addresses food safety at all stages from receiving to shipping
    • Including indirect hazards
HACCP Prerequisites

For the importance of Sanitation, Recall and Allergen Control, we procced to detail these 3 Prerequisites.


What is "Sanitation"? - The process of creating conditions that promote the safe production of food.

The broad term 'Sanitation' can be divided into two components:

  • GRPs - Good Retail Practices. These are the basic requirements to ensure production of wholesome food including employee practices, buildings/facilities, equipment/utensils and production and process controls. For example the GRP for employee practices should include policies for hair restraints, clean clothing, jewelry, fingernails, etc. A GRP for buildings and facilities should cover construction and maintenance of floors, walls and ceilings.
  • SSOPs - Sanitation Standard Operating Procedures. They are the specific steps taken to perform the sanitation tasks including the details of your sanitation procedures and frequency or how often to clean.

Why is Sanitation important?

  • Many cases of foodborne illness are associated with sanitation problems. Contaminated equipment, including food contact surfaces that have not been properly cleaned and sanitized is one of the 5 major risk factors contributing to foodborne illness..
  • The complete sanitation process will reduce the numbers of bacteria and viruses that could be present on equipment and utensils and cause a wide variety of foodborne illnesses.
    • Essential to programs such as HACCP.
  • Ensures quality and consistency of food products.
  • Controls allergen cross-contamination.

Benefits of Sanitation & Sanitary Design

  • Allergen control
  • Micro control
  • Foreign material control
  • Pest control
  • Regulatory compliance
  • Life cycle cost reduction
  • Quick changeover execution
  • Product quality
  • Human safety
  • Housekeeping
  • Equipment reliability
  • Dietary compliance (Kosher, Halal, organic, gluten free)
Sanitation Steps

Cleaning and Sanitizing

Multiple Step Process

  • Pre-cleaning – Scrape and rinse to remove loose food.
  • Wash - Use detergent solutions to remove stuck-on food.
  • Rinse to remove food and detergent.
  • Sanitize to kill attached surviving bacteria and viruses.
  • Air Dry.

Each of these steps must be done – in this order – for the process to be effective.

Two Critical Components

  • Cleaning.- the chemical and physical process of removing dirt, food, or soil from surfaces
  • Sanitizing.- results in removing or killing bacteria and viruses

These two steps are two completely separate operations; you must clean a surface before sanitizing can be effective. Each step is important, for different reasons, in achieving food safety.

A clean surface is needed so that the bacteria or viruses will be killed by the action of the sanitizer. If a sanitizer is applied to a surface that has not been ‘cleaned’ – its action will not be effective against the microbes.

While microbes are killed in the sanitizing step, food allergens are controlled at the cleaning/washing step.

Clean Factors

Types of Cleaners

Each type has a specific function – choose an appropriate product for your needs

  • Soap/Detergent
  • Heavy Duty Detergent
    • Properties of the detergent used:
      • pH (acidic. alkaline or neutral)
      • surfactants for wetting and soil suspension. Surfactants increase detergency, wetting, emulsification, solubilization & dispersion of soils.
      • sequestrants and chelants to match water conditions and break calcium bonds
      • foam free
      • compatible with process material gaskets, metals and resin coatings
      • minimal impact on effluent
  • Abrasive Cleaners
  • Acid Cleaners
  • Degreasers

You must use the proper type of cleaner in correct proportions for each cleaning task.

There are some disadvantages with some types of cleaners; they may react with some types of surfaces. For example, highly alkaline detergents shouldn’t be used on aluminum pans or cooler walls because they will pit the surface.

Cleaning Process

  • The proper strength of the detergent wash solution – be sure to use enough to loosen stuck on foods and cut through the grease. Too much could harm employees or leave residues.
  • The temperature of the detergent solution – detergents may not perform properly if the solution is too cool.
  • Contact time of the solution with the food contact surface.
  • Mechanical action or scrubbing helps move dirt and microbes to the drain.
  • Be sure to change the wash solutions when they become dirty. Use clean cloths and brushes.

Following these steps will result in a clean surface!

Biofilms: A Hidden Hazard

  • Biofilm.- It is a very thin, not visible layer of food and bacteria that can build up on a surface.
  • Biofilms can form over a long period of time as a result of poor cleaning procedures.
  • They prevent cleaners and sanitizers from effectively reaching all surfaces.


  • Hot Water.- Must maintain appropriate water temperature
  • Chemical
    • Chlorine
    • Iodine
    • Quaternary ammonium compounds
    • Acid–Detergent Sanitizer
    • Others

Sanitizing Process

  • A clean surface
  • Clean sanitizing solution
  • Proper strength of sanitizing solution
  • Proper water temperature
  • Sufficient contact time for effectiveness

The temperature of water is specific to the type of sanitizer being used. For example, water that is too hot can cause chlorine to evaporate from the solution.

Allow the equipment and utensils to remain in the sanitizing solution for enough time. The proper time will vary depending on the sanitizer that is being used.


Chemicals: Read the Label

  • All chemicals must be used according to the label directions.
  • A chemical sanitizer must be labeled and approved for use on food contact surfaces. For example store brands of bleach are often not labeled for use on food preparation surfaces or in commercial operations. Sanitizers approved for use in commercial operations must have an EPA registration number on the label.
  • Use proper water temperature and rate as stated on the label.
  • Material Safety Data Sheets (MSDS) contain information on proper use, storage, and emergency procedures for each specific chemical. MSDSs must be available at each facility and employees must be trained so they understand the information.

Chemical Safety


  • Hazardous reactions will occur
  • Cause injury or illness to employees or consumers
  • May decrease effectiveness of either product

Chemical Dispensing Systems

  • Automatically measure cleaning and sanitizing chemicals
  • Must have adequate backflow protection
  • Must still monitor sanitizer concentration

Frequency of Cleaning & Sanitizing

Is determined by many factors like:

  • Time
  • Temperature in the work area
  • Change in foods being processed
    • Raw to ready-to-eat
    • Allergen to non-allergen
    • Different meat species

Who’s job is it?

  • Employee training should include the basics of sanitation.
  • Training requires understanding and support from management.

Sanitation is everyone’s responsibility! And training is critical; employees can’t do what they don’t know!

Developing SSOP’s

Written Procedures

  • Detailed procedures for cleaning and sanitizing.
  • A checklist of equipment to be cleaned and the frequency to be cleaned.
  • Steps for the tear-down and re-assembly of equipment.
  • Procedures and schedule for cleaning non-food contact surfaces and facilities.
  • Instructions for use of sanitation chemicals.
  • Employee practices
  • Steps for preparing and storing foods
    • Monitoring temperatures
    • Preventing cross contamination
  • Pest Control
  • Facility and Grounds Maintenance

Monitoring Sanitation

  • Do a ‘walk through’ of the facility
  • LOOK - see that equipment is clean
  • Watch employee handwashing
  • Use test strips to check sanitizer strength
  • Use a bioluminator or other tool like swab tests to check for bacteria

Results of Monitoring

  • Use a check list and write down what you find.
  • Are employees following procedures?
  • How effective are your cleaning procedures?
  • Use your results to solve or prevent problems and re-occurrences

When problems are found, solve the problem and retrain the employees with the proper procedures. Encourage employee feedback to improve procedures. Communication and follow-up are key to effective monitoring

Corrective Action

  • When an item on the check list is missed or poorly done, make sure it is corrected.
  • Be sure to re-check and then write down that it was corrected.

Results of Poor Sanitation

  • Reduced shelf life
  • Poor quality product
  • Customer illnesses
  • Medical claims, lawsuits
  • Food recalls
  • Fines or other regulatory action
  • Bad publicity
  • Loss of customers
  • Loss of your job


  • Cleaning and sanitizing is a multiple step process
  • Differences between cleaning and sanitizing
  • Develop written SSOPs
  • Monitoring is critical to identifying sanitation failures

Food Allergens: A Hidden Hazard

Food allergens are truly the newest food safety hazard.

It is a protein in some foods that cause allergic reactions in some people.

The USFDA clasiffied eight food groups that are the cause of 90% of food allergic reactions. Those 8 food groups are milk, eggs, peanuts, tree nuts, wheat, soy, fish, and shellfish

México and the European Union they include more products in their regulations.

Foods must be labeled accurately. It is critical that food labels contain a complete list of ingredients that declare all allergens.

Effective cleaning procedures eliminate residues that cause food allergies, avoid cross contamination.

Allergens groups


For a more detailed presentation please visit our Recall Section.

HACCP Audits

  • Systematic and independent examination to
    • determine whether activities and results comply with the documented procedures
    • whether the procedures are implemented effectively
    • suitable to achieve the objectives

Rationale – HACCP audit

  • The outcome of the audit is to have established whether the manufacturer has
    • implemented a sound HACCP system
    • the knowledge and experience needed to maintain it
    • the necessary support (or prerequisite) programmes in place to assess adherence to GAPs, GHPs, GMPs

Components of HACCP Audit

  • Assessment of the management commitment to support the system
  • Assessment of the knowledge, competency and decision-making capabilities of the HACCP team members to apply the system and maintain it
  • Assessment of performance of HACCP system

Types of Audits

  • Internal HACCP audits
    • Internal/external resources
  • External HACCP audits
    • Raw materials, processes
  • Investigative audits

Frequency of audits

  • Frequency of HACCP audits should be based on:
    • the risk category of the product being processed
    • the level of commitment of management and the decision-making leverage of the HACCP team
    • the reputation of the company
    • previous safety and quality records
    • HACCP manual and implementation classification
    • training and qualification
Audit Process

Decide to partnership with Espiga Exports

Espiga Exports has the experience in Food Safety Management System, Recalls, Traceability, Audits and relevant food regulations in the European Union, the Unitede States and Mexico and could provide a wide range of consulting servicies tailored to your company.

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Espiga Exports has the experience in Food Safety Management System, Recalls, Traceability, Audits and relevant food regulations in the European Union, the Unitede States and Mexico and could provide a wide range of consulting servicies tailored to your company.

We are ready to exceed your expectations and help you achieve your goals.

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