This Regulation of 11 July 2016, published in Official Journal of the European Union on 12 July, amends Annex IV (colorants) to Cosmetics Regulation 1223/2009, to introduce Carbon Black in its nano-form, and updates the purity criteria of non-nano Carbon Black.
The whereas of Regulation 2016/1120
(1) Carbon Black is authorized as a colorant in cosmetics under entry 126 of Annex IV to Regulation (EC) No 1223/2009. The Scientific Committee on Consumer Safety (‘SCCS’) carried out a risk assessment of Carbon Black (nano) and adopted an opinion on 12 December 2013, in which it concluded that the use of Carbon Black in its nano-structured form (with a primary particle size of 20 nm or larger) at a concentration up to 10% w/w as a colorant in cosmetic products does not pose any risk of adverse effects in humans after application on healthy, intact skin.
(2) Moreover, the SCCS indicated, in a further opinion of 23 September 2014 for clarification of the meaning of the term ‘sprayable applications/products’ for the nano forms of Carbon Black CI 77266, Titanium Dioxide and Zinc Oxide, that the opinion on Carbon Black (nano) does not apply to applications that might lead to exposure of the consumer’s lungs to Carbon Black nanoparticles by inhalation.
(3) The SCCS conclusions apply to Carbon Black (nano) with a defined purity and impurity profile. Furthermore, the purity criteria set out for non-nano Carbon Black are no longer up-to-date and should …
