Document 6RY1v93pnKXnMDRGLDKxpkbo4
Ref. Ares(2023)218982897560 - 27/03/2023
3/11/2022
Impact of additional mandatory safety factor under REACH
+ Mandatory inclusion of an additional safety factor in substance DNEL would invalidate already conservative safety conclusions of most UV Filters; 8 out of 10 UV filters could be considered as no longer safe;
+ Adequate consumer protection against UV radiation would not be possible with the [EE
+ Impossibtloe rapidly `innovate out' of artificial constraint; Possiblysignificant impact on public health in the EU;
factor into PNEC under in environmental assessment 3
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Malignant Melanoma
The global burden of skin cancer: A
longitudinal analysis from the Global
Burden of Disease Study, 1990-2017
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Breast cancer Colorectal cancer
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Every death from skin cancer is an avoidable tragedy. And... many more people live with
skin cancer than die from it.
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A minority will develop skin cancer.
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Conclusions
Impact for cosmetics is not limited to UV filters but can affect other ingredient classes (e.g. preservatives, hair dyes, ...);
Addition of a simplistic default safety factor can have significant unintended consequences for whole product categories and even for public health;
MAF concept should be limited to unintentional environmental mixtures of substances of high concern;
Any application should be done at the level of risk assessment, not at the level of hazard characterisation
Conservatisms already built into risk assessment should be considered Detailed data should always be accepted to overrule Tier 1 default values
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