Risk assessment

The main focus of the work of BfR is on the assessment of risks in the field of consumer health protection and food and feed safety for man. The Institute does this work in different contexts:

• incident-related (e.g. in the case of microbiological or chemical contamination)
• on the basis of a long-term work plan of systematic assessment
• within the framework of public agency procedures
• in conjunction with new findings or concepts which highlight the need for assessment.

For its health assessments BfR has developed a Guidance Document in order to guarantee a consistently high standard of expertise. The assessment work is carried out in line with specified work steps. The results are published in an assessment report.

Definition of a risk

In scientific terms the “risk” characterises the scale of possible damage and the probability that it will occur. A risk results from the hazard presented by a substance or a germ and the frequency and the scale on which consumers come into contact with it. Under certain circumstances almost all substances or germs can harm health and, therefore, develop into a risk. If this hazard potential is identified early on, steps can be taken to prevent or reduce the risk.

Risk assessment steps

By linking the hazard from a substance or germ to the amount of the substance or germ to which humans are exposed, the probability of health impairment and the degree of severity can be estimated. The assessment of a risk consists of the following four steps:

1. Identification of a possible risk source

2. Hazard characterisation
   Once the hazard has been identified, it is described in qualitative (by type) and quantitative (by dose effect) terms.

3. Exposure assessment
   The ensuing exposure assessment provides information on the amount of a substance or germ to which humans may be exposed under various circumstances (scenarios).

4. Risk characterisation
   In the final risk description, the qualitative risk is related to the amount of a substance or the number of germs to which humans may be exposed. The probability that a harmful effect will occur and the expected degree of severity are estimated and assessed.

Uncertainties in risk assessment

The assessment of a risk involves uncertainty. The reasons for this are mainly linked to the availability of data and their lack of accuracy. There are also structural causes which result from the choice of models for hazard identification and characterisation and from the exposure assessment.

Special situation “Food”

In the field of food, health risks may result both from inadequate intake of an essential nutrient and from excessive intake of nutrients. The long-term undersupply of an essential nutrient leads to the appearance of deficiency symptoms (risk of inadequate intake). The excessive intake of some nutrients is, by contrast, linked to specific hazards.

Assessment report

The outcome of assessment is documented in an assessment report. It contains a description of the four assessment steps, the uncertainties and their causes and ends with statements and conclusions on the following questions:

• Is there a risk to health?
• Are further information/studies necessary in order to undertake a definitive assessment?
• What management options does BfR recommend in order to reduce or ward off the risk?