311 Design and content of a Risk Analysis

Design and content of a Risk Analysis

Centrally in the legislation is the duty of each company to carry out a Risk Analysis of the health risks the products represent and how the company will relate to this in terms of traceability.

Risk Analysis

The purpose of the analysis is to reduce / prevent risk through

  • Withdrawal of products from the market, or
  • Efficient notification or recall of products from the consumer

This assumes that the parties are aware of the risks the products may pose and have a preparedness that ensures that they react quickly, correctly and effectively in unwanted incidents. A Risk Analysis should therefore be performed on new products based on an intended relevant incident, so that it can be implemented as quickly as possible should a real incident occur for the product.

The Risk Analysis consists of three elements that both the government and industry should work on in an equal way:

  • Risk Assessment
  • Risk Management
  • Risk Communication

Risk Assessment

When assessing risk, other elements than food safety can also be included, such as products with quality defects coming out on the market, which can have major reputational and financial consequences.

Elements included in a Risk Assessment of the product are:

Type of risk

  • Consumer health and safety
  • Corporate reputation
  • Economic aspects.

Subjective assessment of the probability of an incident occurring

  • Low (rare)
  • Medium (occasionally)
  • High (often occurring)

Subjective assessment of consequences, especially the health, if an incident occurs

  • = Low
  • = Medium
  • = High

The compilation and treatment of the above factors gives an assessment of the risk that the company must decide on.

When assessing risk, risk should always be evaluated based on the worst possible incident that can occur.

Risk Management

Procedures, crisis procedures and the like must be prepared. which ensures that the incident is handled in a fast, correct and efficient manner.
Based on the Risk Assessment, it is necessary to decide what actions are to be implemented for the product.

Current actions are:


This is a type of action that can be implemented as soon as an incident has been identified, pending further investigation. A blocking should trigger an activity with the distributor / retailer to prevent the product from reaching the consumer.

Recall is the procedure initiated when the product may have reached the consumer.
There is a potential high risk that the products may be hazardous to health.
It is crucial for the company that the public is informed about the recall.
In accordance with the Matloven (Food Law), the operators have a notification requirement.

Withdrawal means that the product is withdrawn from the distribution chain / store. The purpose is to prevent products from reaching the consumer.
Withdrawal implies that consumers do not need to be notified.

Risk Communication
This includes communication measures within the company, towards other parties in the value chain, the authorities, the press and the consumers. The communication must be open and correct.

Distributors have built their own systems and routines for notification of incidents and crisis situations. In this way, a uniform and effective handling of withdrawal, recall or blocking within the companies is ensured.

Published on: 27. September 2019