Classification and labelling of RCS

RCS under REACH

No registration duty for crystalline silica under REACH

The REACH (Registration, Evaluation, Authorisation and restriction of CHemicals) Regulation (EC)1907/2006 states that "minerals which occur in nature, if they are not chemically modified" are explicitly exempted from registration and evaluation (Article 2 § 7(b) and Annex V point 7) because such a registration is deemed inappropriate or unnecessary for these substances and their exemption from these requirements does not prejudice the objectives of this Regulation. Consequently, crystalline silica – quartz or cristobalite and related products- which do not result from a chemical modification and are manufactured or imported and placed on the market in Europe fall under this exemption and were not registered under REACH.

RCS under the CLP Regulation

For many years, industry had chosen to self classify crystalline silica flours as harmful with the label Xn (Harmful) and the risk phrases R48/20 (danger of serious damage to health by prolonged exposure through inhalation) even though there is no harmonised EU classification for crystalline silica under the Dangerous Substances Directive.

As of 1 December 2010, suppliers have to classify, label and package hazardous substances according to the new Classification, Labelling and Packaging Regulation (EC) 1272/2008 (CLP Regulation), which will replace the Dangerous Substances Directive in 2015.

In accordance with the new CLP Regulation, industrial minerals producers have conducted a Review and Hazard Assessment of the health effects of respirable crystalline silica (see summary) and have jointly determined it best and appropriate to classify respirable crystalline silica (quartz respirable fraction and cristobalite respirable fraction) as STOT RE 1 for the silicosis hazard.

STOT refers to Specific Target Organ Toxicant. RE refers to “Repeated Exposure”. Based upon scientific evidence, it is generally necessary to inhale significant quantities of RCS in an occupational setting for prolonged and repeated periods of time before any possible long-term health effect may occur.

This classification applies to the respirable form of quartz and cristobalite only, because it is scientifically demonstrated that it is only this fraction of crystalline silica which may cause health effects. It is also in compliance with the new CLP Regulation which allows consideration of the physical form(s) or physical state(s) of substance or mixture.

As a consequence of this classification, mixtures and substances containing RCS, whether in the form of an identified impurity, additive or individual constituent, are classified as:
STOT RE 1, if the RCS concentration is equal to, or greater than 10%;
STOT RE 2, if the RCS concentration is between 1 and 10%.
If the RCS content in mixtures and substances is below 1%, no classification is required.