Revision of the opinion for clarification on the term "sprayable applications/products" for the nano forms of Carbon Black CI 77266, Titanium Oxide and Zinc Oxide

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: A. Bernard, O. Bussolati, Natalie von Goetz (rapporteur), S. H. Doak, T. Jung, T. Vanhaecke
Contact:SANTE-C2-SCCSec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
SCCS Number: SCCS/1539/14
Doi: 10.2772/49208
Adopted on: 25 June 2015

Conclusion of the opinion:

In view of the foregoing, the SCCS view is that dispensing devices for single-dose cream that do not generate airborne particles or droplets that are either respirable as such, or that dry off while airborne to become small enough to be respirable, should be excluded from the term ‘spray’ or ‘sprayable’. However, the proposed term “pump dispenser” is too inclusive, since not only the type of dispenser, but also the formulation that is dispensed together with the nozzle size, determine the droplet size after dispensing. To reflect this, and for the purpose of clarity, the SCCS will use the following harmonised terminology in the existing and future opinions when describing various dispensing methods as follows:

• The term ‘spray’ or ‘sprayable’ will mean that a formulation is either dispensed by the use of propellant gas as defined in Directive 75/324 (propellant spray), or by a spray bottle with a pump dispenser that forces a liquid through a nozzle generating a spray stream or a mist of a liquid (pump spray). Where this term is used in an SCCS opinion, further clarification will be added. For example, instead of [the use of nano…. in sprayable applications is not recommended.] the recommendation will state [the use of nano…. in sprayable applications that could lead to exposure of the consumer’s lungs to nano…. by inhalation is not recommended.]
• The term ‘dispenser without spray nozzle’ denotes a device by which a formulation is dispensed in the form of a single dose or a foam, where the process does not generate a significant quantity of airborne particles or droplets that are either respirable as such, or become respirable as a result of drying while airborne. Typical formulations that are dispensed with such a device are liquid soap, cream, shaving foam and other formulations that are more viscous than water.

This clarification should prevent any confusion, misinterpretation or unnecessary queries on the issue, and the SCCS suggests replacing the following text in the current opinions on nano-forms of Carbon black, Titanium dioxide and Zinc oxide.

Keywords:

SCCS, scientific opinion, clarification of the meaning of the term "sprayable applications/products" for the nano forms of Carbon Black CI 77266, Titanium Oxide and Zinc Oxide, EU Regulation 1223/2009

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion for clarification of the meaning of the term "sprayable applications/products" for the nano forms of Carbon Black CI 77266, Titanium Oxide and Zinc Oxide, 23 September 2014, SCCS/1539/14, revision of 16 December 2014 and of 25 June 2015.