Division 1.1.3 Historical human dataX1F1

Historical human data, such as epidemiological studies on exposed populations, accidental or occupational exposure data and clinical studies, shall be considered.

The strength of the data for a specific human health effect depends, among other things, on the type of analysis and on the parameters covered and on the magnitude and specificity of the response and consequently the predictability of the effect. Criteria for assessing the adequacy of the data include:

1. (1)

   the proper selection and characterisation of the exposed and control groups;

2. (2)

   adequate characterisation of exposure;

3. (3)

   sufficient length of follow-up for disease occurrence;

4. (4)

   valid method for observing an effect;

5. (5)

   proper consideration of bias and confounding factors; and

6. (6)

   a reasonable statistical reliability to justify the conclusion.

In all cases adequate and reliable documentation shall be provided.

When nanoforms are covered by the registration the above approach shall address the nanoforms separately.