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Expert opinion

Revision of the opinion on Carbon Black (nano-form)

Final Opinion

Details

Publication date
15 December 2015
Author
Scientific Committee on Consumer Safety (SCCS)

Description

WG on Nano-materials
SCCS members: U. Bernauer, Q. Chaudhry (chairman), M. Dusinska, W. Lilienblum, Th. Platzek, S. Ch. Rastogi, J. van Benthem
SCENIHR members: P. H. M. Hoet, K. Rydzynski
External experts: O. Bussolati, W. H. de Jong, S. H. Doak,Th. Jung, T. Sanner (rapporteur), N. von Götz
Contact:SANTE-C2-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1515/13
Doi: 10.2772/7205
Adopted on: 15 December 2015

Conclusion of the opinion:

1. Does the SCCS consider Carbon Black, CI 77266 in its nano form safe for use as a colorant with a concentration up to 10 % in cosmetic products taking into account the scientific data provided?
On the basis of the available evidence, the SCCS has concluded that the use of carbon black CI 77266 in 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.

This opinion, however, does not apply to applications that might lead to inhalation exposure to carbon black nanoparticles, where the preparation might lead to inhalable particles.

2. Does the SCCS have any further scientific concern with regard to the use of Carbon Black, CI 77266 in its nano form as a colorant in cosmetic products?

The purity of carbon black nanomaterials used in cosmetic products should be >97%. The impurity profile of carbon black should be comparable with those nanomaterials tested for toxicity in this submission should comply with the EU specifications of carbon black materials as used in food contact materials, and should also comply with FDA specifications with respect to carbon black produced by furnace method.

In the evidence provided in the submission, imaging was considered the only practical method by the applicant for investigating skin penetration. The use of this method is considered by the SCCS as only semi-quantitative. Other methods need to be explored.

This opinion is based on the currently available scientific evidence, which shows an overall lack of dermal absorption of carbon black nanoparticles. If any new evidence emerges in the future to show that the carbon black nanoparticles used in cosmetic products can penetrate skin (healthy, compromised, sunburnt or damaged skin) to reach viable cells, then the SCCS may consider revising this assessment.

Since the skin absorbance studies have only been performed with carbon black nanoparticles ≥ 20 nm, the current opinion applies to nano-structured form of carbon black with a particle size of 20 nm or larger. Additional information will be required on the use of carbon black with particles smaller than 20 nm size intended for use in cosmetic products.

Keywords:

SCCS, scientific opinion, carbon black, nano-form, CI 77266, Regulation 1223/2009, CAS 1333-86-4, EC 215-609-9

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion on carbon black (nano-form), 12 December 2013, SCCS/1515/13, first revision of 27 March 2014, second revision of 15 December 2015.

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sccs_o_144.pdf
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