REACH classification and labelling
The producers of crystalline silica and products containing it adhere to the principles of product stewardship: they manage their products in a responsible way by minimising the health, safety, environmental, and social impacts of a product throughout all lifecycle stages.
Regarding the potential risks from exposure to respirable crystalline silica, the producers have the objectives of:
- Protecting people who may be exposed to RCS at work
- Assuring compliance with legal requirements
- Satisfying stakeholder expectations
Together, via their trade associations, the producers have developed a standardised approach towards the following aspects:
- Classification and labelling
- Safety Data Sheets
This co-ordinated approach by industry helps to ensure appropriate risk management information is passed to relevant stakeholders.
No registration duty for crystalline silica under REACH
The REACH (Registration, Evaluation, Authorisation and restriction of Chemicals) Regulation (EC) 1907/2006 is a legislation which establishes procedures for collecting and assessing information on the properties and hazards of chemical substances across the European Union. In principle, REACH applies to all chemical substances, however, there are certain exemptions.
The Regulation 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). 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 are not registered under REACH.
Classification and labelling
In accordance with the CLP Regulation EC) 1272/2008, industrial minerals producers have commissioned a team of independent scientific experts to do 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% (w/w);
STOT RE 2, if the crystalline silica (fine fraction) concentration is between 1,0 and 10% (w/w).
If the crystalline silica (fine fraction) content in mixtures and substances is below 1,0% (w/w), no classification is required.