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Directorate-General for Health and Food Safety
6.1 What type of studies have been done concerning sunbeds?
The health risks associated with the use of sunbeds have been investigated using different approaches such as epidemiologic studies, experimental studies in humans, experimental studies in animals, and cell culture studies.
This updated Opinion draws heavily on information provided in papers and reports published in international peer reviewed scientific journals between the years of 2006 and 2015 (see Annex 1 of the Opinion). Additional sources of information were also used, including web-based information retrieval and other documents in the public domain, e.g. from governmental bodies and authorities and non-governmental organisations (NGOs).
A health risk assessment, which is what this Opinion provides, evaluates the evidence within several areas of concern (skin, eyes and the immune system) and then weighs the evidence across the areas to generate a combined assessment.
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6.2 How exactly are these studies and information used to make a risk assessment?
After evaluating evidence from various relevant fields of study (skin, eyes and the immune system) the SCHEER weighs the evidence across these fields to produce a combined assessment. This combined assessment addresses the question of whether or not a hazard exists, i.e. whether there is a causal relationship between exposure and some adverse health effect. The answer to this is not necessarily a definitive “yes” or “no”, but may be expressed as the weight of evidence for the existence of a hazard. If such a hazard is judged to be present, the risk assessment should also address the magnitude and shape of the effect and the dose-response function including characterising the magnitude of the risk for various exposure levels and exposure patterns.
The weight of evidence for a particular outcome is based on data from human and mechanistic in-vitro studies (the primary evidence) along with exposure. The overall quality of the studies is taken into account, as well as the relevance of the studies for the issue in question. The weighting of evidence also considers whether causality was shown or not in the relevant studies.
Detailed criteria that are used to evaluate the documents which the Opinion is based on and criteria for the weighting process have been described in the SCENIHR memorandum (SCENIHR 2012).
