Carbon Black, CI 77266, CAS no. 1333-86-4, EC no. 215-609-9, listed in
Annex IV as reference number 126 of the Cosmetic Regulation (EC) No. 1223/2009, is
used as colorant in cosmetics, specifically make up products.
Typical
use concentrations range from 0.001% to 10% with 0.001% for skin products, 5%
for nail enamels and mascaras and up to 10% for other eye decorative products
such as eyeliners, eye pencils and eye shadows.
According
to the definition established in the Cosmetic Regulation under art. 2. (k),
Carbon Black is a nanomaterial.
In
fact, the different carbon black materials are characterized by their primary
particles size, their aggregation and agglomeration status as well as their
impurity profile.
Typically, the average primary particle diameter of
commercial carbon black materials range from 10 to 100 nm, while the
average aggregate/agglomerate size is in the range 100-800 nm or above. Carbon black is initially formed as roughly
spherical primary particles, which, in most cases, rapidly form aggregates.
Accordingly, on the basis of their primary
particle size, all Carbon Black/CI 77266 materials are considered as
nano-structured materials.
The
present dossier evaluates the safety of Carbon Black taking into account most
recent recommendations for the safety evaluation of nanomaterials, as the
SCCS/1484/12 and ECHA 2012, and it provides an
overall safety assessment for this ingredient in nano-form, which takes into
account the available information.
On
the basis of the available evidence, SCCS
has concluded that the use of carbon black in its nano-structured form with a
size of 20 nm or larger at a concentration up to 10% as a colorant in cosmetic
products, is considered to not pose any risk of adverse effects in humans after
application on healthy, intact skin.
Since
the skin absorbance studies have only been performed with carbon black
nanoparticles 20 nm, additional
information will be required on the use of carbon black with particles smaller
than 20 nm size intended for use in cosmetic products.
For
what concern mucous membrane irritation studies, an eye irritation potential of carbon black cannot be completely
excluded.
Moreover,
for cosmetics application, the purity of carbon black nanomaterials should be
> 97%, and its impurity profile should comply with FDA specifications with
respect to carbon black produced by furnace method.
