The European Commission transmitted to WTO a draft regulation aimed to amend two annexes to the Cosmetics Regulation 1223/2009. On the agenda: the introduction of Zinc Oxide in the anti-UV filters’ list, and the authorisation of nano colorant Black Carbon.
Notification date
July 28, 2015.
Content
This draft Commission Regulation aims at authorizing Zinc Oxide, including as a nanomaterial, as a UV-filter, and Carbon Black (nano), as a colorant, in cosmetics.
Carbon black
In Annex IV, entry 126 is amended, and entry 126a is added.
Entry 126: Carbon Black
• Conditions of use: Purity >97%, with the following impurity profile: Ash content ≤0.15%, total sulphur ≤0.65%, total PAH ≤500 ppb and benzo(a)pyrene ≤5 ppb, dibenz(a,h)anthracene ≤5 ppb, total As ≤3 ppm, total Pb ≤10 ppm, and total Hg ≤1 ppm
Entry 126a, Carbon Black [nano]
• Maximum concentration in ready for use preparation: 10%
• Conditions of use: Not to be used in applications that may lead to exposure of the end user’s lungs by inhalation.
• Only nanomaterials having the following characteristics are allowed:
> Purity >97%, with the following impurity profile: Ash content ≤0.15%, total sulphur ≤0.65%, total PAH ≤500 ppb and benzo(a)pyrene ≤5 ppb, dibenz(a,h)anthracene ≤5 ppb, total As ≤3 ppm, total Pb ≤10 ppm, and total Hg ≤1 ppm
> Primary particle size ≥20 nm
• Warnings: For eye products: ‘May cause eye irritation’*
*The sentence ‘May cause eye irritation’ is still subject to discussion.
