Working Procedures

B. SCIENTIFIC REVIEW AND EVALUATION

5. Summary of data

This section is a summary of data presented in the preceding sections.

(a) Exposure data

Data are summarized, as appropriate, on elements such as characteristics and production or implementation of the intervention, and patterns of use or exposure in human populations. Quantitative data and time trends are given to compare exposure, use or implementation in different regions and settings.

(b) Cancer prevention in humans

Results of epidemiological studies pertinent to an assessment of the cancer-preventive effect in humans are summarized. The target organ(s) or tissue(s) in which a decrease in cancer occurrence was observed is identified. Dose-response and other quantitative data may be summarized when available.

(c) Cancer prevention in experimental animals

Data relevant to an evaluation of a cancer preventive effect in animals are summarized. For each animal species, study design and route of administration, it is stated whether decreased incidence, increased latency, or decreased severity or multiplicity of tumours or preneoplastic lesions were observed, and the tumour sites are indicated. Negative findings, positive relationships, dose-response and other quantitative data are also summarized.

(d) Mechanistic and other relevant data

Human data relevant to the toxicokinetics (absorption, distribution, metabolism, elimination) and the possible mechanism(s) of cancer prevention are summarized. In addition, human studies on cancer susceptibility including on genetic polymorphisms, susceptible populations and life-stages are summarized. This section also reports briefly on adverse effects as well as any additional relevant data from experimental systems that are considered to be influential for the evaluation of a cancer-preventive effect.

Posted 5 July 2016