Classification and labelling
CS 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.
CS 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 Classification, Labelling and Packaging Regulation (EC) 1272/2008 (CLP Regulation).
In accordance with the 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 crystalline silica (fine fraction) (quartz (fine fraction) and cristobalite (fine fraction)) as STOT RE 1 for the silicosis hazard. This is because particles of crystalline silica (fine fraction) may become airborne during handling and use in the workplace, creating respirable crystalline silica (RCS).
STOT refers to Specific Target Organ Toxicity. 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 fine fraction of quartz and cristobalite only, because it is scientifically demonstrated that it is only this fraction of crystalline silica, when made airborne, which may cause health effects. It is also in compliance with the 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 crystalline silica (fine fraction), whether in the form of an identified impurity, additive or individual constituent, are classified as:
STOT RE 1, if the crystalline silica (fine fraction) concentration is equal to, or greater than 10%;
STOT RE 2, if the crystalline silica (fine fraction) concentration is between 1 and 10%.
If the crystalline silica (fine fraction) content in mixtures and substances is below 1%, no classification is required.
- See complete memo on the CS classification decision.
- See hazard elements of the labels.
- See memo on classification of mixtures in liquid form containing crystalline silica
- What is the status of Crystalline Silica under REACH?
- What is the classification and labelling of crystalline silica (fine fraction) under the CLP Regulation?
- Does the CMD proposal have an impact on product labelling?
- Does this mean that crystalline silica should be classified and labelled as a Carcinogen?
- Does the proposed new CMD legislation mean substances containing RCS are being banned from commerce?