Food Safety: ISO 22000 & HACCP

The ISO 22000 describes the core principles and the framework for a Food Safety Management System (FSMS). The ISO 22000 is applicable to the whole food chain.

A/ ISO 22000 & HACCP theoretical approach:

There are four ISO 22000 FSMS principles and seven quality management principles:

ISO 22000 FSMS four principles:

    1. System Management.
      • (policy, commitment, organisation, resources).
    2. HACCP (stands for Hazard Analysis Critical Control Point) plan.
      • Critical Control Points controlled in the classical way (see below)
    3. Prerequisite Programs (PRP).
      • Everything else that needs to be controlled.
    4. Interactive communication.
      • Active internal & external communication is required.

Seven quality management principles:

    1. Customer focus
    2. Leadership
    3. Engagement of People
    4. Process approach (see below)
    5. Continuous improvement
    6. Evidence based decision making
    7. Relationship management.

FSMS is a risk based preventive approach whereby risks are analysed and opportunities are identified to mitigate the risks. A PDCA (Plan / Do / Check / Act) approach towards any process ensures continual improvement and effective implementation of FSMS, while the Leadership commitment towards establishing the FSMS is further evidenced by resources and support provided by the Management.

HACCP (second of the four ISO 22000 FSMS Principles) is a systematic approach to the identification, evaluation, and control of food safety hazards.

The paramount goal underlying any HACCP system is ensuring food safety and preventing the food from any significant hazard (physical, chemical, biological, allergens etc)

It is based on the following seven principles:

                   Principle 1: Conduct a hazard analysis.

Principle 2: Determine the critical control points (CCPs).

Principle 3: Establish critical limits.

Principle 4: Establish monitoring procedures.

Principle 5: Establish corrective actions.

Principle 6: Establish verification procedures.

Principle 7: Establish record-keeping and documentation procedures.

To determine whether a control point is a critical control point, the following decision tree should be followed:

B/ Flexible packaging sealing integrity and ISO 22000:

An excessive leak in the flexible packaging can lead to the fact that food may not be safe to consume until the last day of the shelf life. The leakage can cause chemical changes in food and also lead to bacteriological contamination from the atmosphere. According to the decision tree, the leak in flexible packaging is a Critical Point, in other words a hazard of sufficient likelihood of occurrence and severity. Therefore, the sealing process needs to be strictly controlled to ensure that the packaging integrity has been maximized.

Not controlling this hazard could have important consequences, in the worst-case scenario, a product would have to be withdrawn or recalled.

C/ Potential consequences of an excessive leak:

Salami Packed under MAP

This salami packed under MAP have largely exceeded the shelf life, or an excessive leak has caused the gas mix charged to preserve the food to escape before the end of the shelf life.

Bread Buns showing Traces of Fungus

These bread buns packed under MAP are showing traces of fungus. They have visibly exceeded the shelf life, or an excessive leak has caused the gas mix charged to preserve the buns to escape before the end of the shelf life.

Mould on Sausage

A closeup of Penicillium fungus & colony of Penicillium mould on the surface of a smoked sausage. Many species produce highly toxic mycotoxins. Penicillium fungus growth in packed food depends on the relative humidity increase in the flexible packaging.

Excessive leaks facilitate the infiltration of humidity and bacteria into your package and compromise the taste of your products. Food becomes unsafe to be consumed before the end of the shelf-life. For seafood packed under MAP for example, consumption may become hazardous if too much gas inside the packaging has escaped. With regard to potato crisps, the crispiness could become affected, and the pillow effect may not be effective enough to protect the goods from being crushed.

A product recall could have following consequences

Direct consequences:

      1. Root cause investigation under pressure of the failure.
      2. Notifications to regulatory bodies, supply chain, consumers.
      3. Product retrieval (reverse logistics), storage.
      4. Unsafe product destruction.
      5. Unsalable product.
      6. Labour costs associated with the above activities

Indirect consequences:

      1. Impact to the company’s market value.
      2. Brand damage.
      3. Lost sales.
      4. Potential litigation costs.

D/ Legal obligation to implement HACCP:

The Food Industry in under increasing pressure to comply with stringent food safety rules and regulations. It is likely that this trend will increase. In addition, there are legal frameworks and you may have to comply with national or international food safety legislation.

In the U.S.A, the Food Safety Modernization Act 2010 (FDA) requires all Food Processing Businesses to adhere to HACCP ( 21 U.S.C. 350g; regulation is codified at 21 CFR part 117). There are specific regulations for meat and poultry (USDA) (9 CFR part 417), juice (FDA) (21 CFR part 120) and seafood (FDA) (21 CFR part 123).

In Europe and the UK, it is a legal obligation for Food Manufacturers to follow HACCP: “Food business operators shall put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles”. Extract from REGULATION (EC) No 852/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004 on the hygiene of foodstuffs, Chapter 2, Article 5.

Links to official U.S. & European websites are provided at the bottom of this page. The European page has .pdf attachment in 23 languages. 

E/ What can Astaara do for you?

Our Astaara Range of products will assist you to implement a preventive approach and will enable you to identify the value of the Critical Limit. This will help to identify the root cause of leaks above the Critical Limit, and aid you in implementing corrective action.

If you are part of the Food Safety Policy Team or a Food Safety Team Leader, a Qualified Internal Auditor (ISO 22000 & HACCP) in our Astaara Team is ready to assist you. We can contribute to analyze your actual packaging process, and help you with the evaluation of the current situation and the best solution for your Business.


Please remember that the paramount goal underlying any HACCP system is to prevent problems from occurring.

It is always wise to timely implement a preventive approach for your Food Safety Management System rather than to be under pressure to mitigate consequences when problems have already occurred.

We are here to help, so please do contact us.

Sources: US FDA & European Union websites: