The work of the experts was based on five main themes: a review of the current situation regarding lighting, a presentation of the technology behind LEDs, an analysis of the way light interacts with biological systems (the eyes and skin), a summary of the standards currently applicable to LEDs, an analysis of the potential health effects of LEDs. A special feature of this study concerned the calculations and measurements conducted by the members of the Working Group in their respective laboratories (CSTB, INRS, LNE) to assign some examples of LED lighting systems to specific Risk Groups in accordance with the photobiological standard applicable to LEDs (NF EN 62471). Considering: · the health risks related to blue light emitted by LED lighting systems falling into Risk Groups higher than 1 (according to the NF EN 62 471 standard); · the significant risks of glare induced by LED lighting systems; · the need to protect the general and working population from excessive radiance produced by LED systems and any risk of glare associated with the different uses of these new lighting systems; · the marketing of LED products intended for light therapy, comfort or well-being purposes; ANSES recommends: · limiting the sale of LEDs for domestic use or for the general public to LEDs falling into Risk Groups equal to or less than 1 (when assessed at an observation distance of 200 mm); · regulating the installation of LED lighting systems falling into Risk Groups greater than 1, by limiting them to professional uses, under conditions in which risks can be prevented; · encouraging manufacturers and integrators of LED lighting systems to design lighting systems in which beams of light emitted by LEDs cannot be seen directly, to avoid glare. In particular, ANSES recommends the use of optical devices that reduce the intensity of light perceived directly or by reflection and to make the sources of LED light more diffuse; to take account of the progressive wear of phosphor layers in white LEDs, which in time could lead to devices moving to a higher photobiological risk group. · assessing the safety and compliance of devices for light therapy, comfort or wellbeing and regulating their use. Considering: · that the standards in force for designing LED-based lighting installations are not always applied by professionals (electricians, lighting technicians and designers); · that current photobiological safety standards seem unsuited to lighting systems using LEDs; ANSES recommends: · obliging professionals designing lighting systems using LEDs to apply all standards concerning the quality of lighting: o NF X 35-103 (‘Ergonomics: Ergonomic principles applicable to the lighting of workplaces for visual comfort’); o NF EN 12464-1 (‘Lighting of workplaces – Part 1: indoor workplaces’); o NF EN 12464-2 (‘Lighting of workplaces – Part 2: outdoor workplaces’); o the series of NF EN 13201 standards (‘Street Lighting’); o NF EN 12193 (‘Sports Lighting’). · adapting the NF EN 62 471 standard (‘Photobiological safety of lamps and lamp systems’) to cover lighting systems using LEDs. It is essential to make it easier for manufacturers to take this standard into account and remove any ambiguity concerning how it should apply to LED systems. ANSES therefore recommends: o specifying in the NF EN 62 471 standard the conditions for measuring and evaluating LED systems; o publishing a guide to applying this standard, geared exclusively to LED systems; o determining the risk group for the worst case of observation (at a distance of 200 mm from the system) that will thus constitute the most unfavourable risk group; o adapting the standard to cover children and aphakic or pseudophakic individuals, taking into account the phototoxicity curve of the relevant type of light published by the ICNIRP; o considering proposing sub-groups for each risk group that would allow the risk to be assessed more precisely as a function of exposure time; o in the case of risk groups greater than 0, evaluating safe distances (at which observation corresponds to Risk Group 0) and indicating these explicitly on products intended for consumers (for devices for the general public) or for professionals responsible for installing lighting systems. · introducing photobiological safety requirements in all safety standards concerning LEDs. This mainly concerns the following standards: o the NF EN 60 598 series of standards ‘Luminaires’; o NF EN 62 031: ‘LED modules for general lighting. Safety specifications’; o IEC 62 560: ‘Self-ballasted LED lamps for general lighting services by voltage > 50 V – Safety specifications’; o draft IEC standard 62 663-1 ‘Non-ballasted single capped LED lamps for general lighting – safety requirements’. Concerning use, information and traceability, ANSES recommends that consumer information about health risks related to the use of LED lighting systems be made available immediately pending the implementation of an appropriate regulatory framework. Considering: · the proven risk resulting from acute exposure to blue light and the uncertainty surrounding the effects of chronic exposure at low doses, together with the uncertainty concerning the effects on the biological clock and diminished pupil contraction; · that certain populations are sensitive to light in general (children, aphakics, pseudophakics, patients suffering from certain eye and skin diseases, patients taking photosensitising treatments, etc.); ANSES recommends: · avoiding the use of light sources emitting cold white light (light with a strong blue component) in places frequented by children (maternity wards, nurseries, schools,leisure centres, etc.) or in the objects they use (toys, electronic display panels, game consoles and joysticks, night lights, etc.); · informing patients taking photosensitising drugs about the risks related to exposure to light with a strong blue component. Considering: · that there are populations of workers likely to be exposed to bright LED lighting systems; ANSES recommends: · developing appropriate means of protection (such as safety goggles specifically to protect against exposure to LEDs) for workers highly exposed to LED lighting systems. Considering the lack of information available to the public concerning the LED lighting systems on the market; ANSES recommends: · ensuring that manufacturers and integrators of LEDs carry out quality controls and qualify their products with regard to the different Risk Groups; · setting up a clear, easy-to-understand labelling system for consumers, particularly concerning the technical characteristics of the lighting and any potential health effects; · mandatory indication of the photobiological safety Risk Group on the packaging of LED products, after assessing the product at a distance of 200 mm. For light sources falling into Risk Group 1, the labelling should also indicate the safety distance beyond which the risk moves down to Group 0; · mandatory indication of the photobiological risk group for all types of lighting Considering the lack of data about exposure of the general and working populations to artificial light, ANSES recommends: · enriching the available documentation on exposure of the population to artificial light in both occupational and general environments; · defining a suitable index for evaluating the intensity of glare produced by an LED source, as the Unified Glare Rating used for other types of lighting is unsuitable for LEDs, which are sources of low-angle light. Concerning studies and research on the health effects of LED lighting systems, ANSES recommends: · developing clinical research to define maximum exposure limits for blue light and, for this purpose: o studying the cumulative medium- and long-term effects of exposure to blue light; o carrying out prospective and retrospective studies of populations undergoing light therapy with the use of blue LEDs; · undertaking research to improve characterisation of the effects of artificial light, and in particular light emitted by LED systems, on biological rhythms. ANSES therefore recommends: o further studies to improve characterisation of the spectra of action of the mechanisms by which light regulates the human biological clock; o quantifying the impact of exposure to cold artificial lights on circadian rhythms and pupil contraction; o in general, studying how health is affected by light pollution (linked with possible disruption of the biological clock) and systematic installation of LED lighting systems; · studying the triggering or aggravation of photodermatoses caused by LED lighting; · organising measurement campaigns to characterise the electromagnetic fields generated by LED lighting systems. Concerning studies and research to be carried out on LED technology to prevent potential health risks, ANSES recommends: · encouraging research for the development of new emissive materials coupled with optimised luminophores, to obtain a high quality white light, with the highest possible luminous efficacy; · developing research into the design of lighting units adapted to LEDs with a view to reducing luminance, by applying optical solutions; · studying the mechanisms that cause the degradation of the phosphor layers in white LEDs, potentially leading to an increase in the amount of blue light emitted.