Health & safety / Respirable Crystalline Silica :

Respirable Crystalline Silica

In brief

Crystalline silica is an essential component in a multitude of materials used in industrial production and life. Respirable crystalline silica (RCS) is the respirable dust fraction of crystalline silica which enters the body by inhalation. Although crystalline silica is ubiquitous in nature, the inhalation of RCS may constitute a hazard to workers.

In December 2017, the amended Carcinogens and Mutagens Directive (CMD) was published in the Official Journal. The reviewed directive sets a European Binding Occupational Exposure Limit (BOEL) for RCS generated by a work process at 0.1 mg/m³. From this date forth, the Member States have 2 years to transpose it into national legislation. Nevertheless, most European Member States have already set national RCS OEL values, some of which are stricter than the European value.

Article 18a of the CMD specifies that the European Commission will evaluate the need to modify this limit value as part of the next evaluation of the implementation of the Directive. Article 17a of the directive 89/391/EEC further specifies that “Member States have 5 years to submit an implementation report after CMD enters into force and that the Commission has to inform the results of their evaluation within 36 months”. As a result, the RCS BOELV will not be revised before 8 years.

Our view

CEMBUREAU is a NEPSI Social Dialogue Agreement (SDA) partner, and continues to advocate strongly in favour of formal recognition of the work undertaken by NEPSI under the CMD. The reason for this is that, through the NEPSI Social Dialogue Agreement (SDA), a comprehensive set of guidance and assessments that address the minimisation obligations have been developed, taking into account the wide diversity of industrial circumstances and the best ways to address them with specific sectoral expertise. As such, the SDA is complementary to the general requirements of the Directive and, by following the NEPSI Guidance, the signatories implement these requirements in an informed and tailored way.  

NEPSI Social Partners acknowledge the positive recognition of the role of the Good Practices of the Social Dialogue "Agreement on Workers' Health Protection Through the Good Handling and Use of Crystalline Silica and Products Containing it" (the so-called NEPSI Agreement) within the first revision of the Carcinogens and Mutagens at Work Directive (CMD), Directive (EU) 2017/2398, as a valuable and necessary instrument to complement the regulatory requirements and to support their effective implementation. An additional recognition of NEPSI Agreement is under the second CMD revision, Directive (EU) 2019/130, where in Article 13a,  Social Partners' agreements possibly concluded in the field of this Directive shall be listed on the website of the European Agency for Safety and Health at Work (EU-OSHA).

The latest NEPSI reporting year was 2018. CEMBUREAU is proud to report that, thanks to the efforts of its members, 100% reporting of the identified sites has been achieved, and 98.93% of employees potentially exposed to Respirable Crystalline Silica (RCS) are covered by a risk assessment and an improvement was seen in relation to all Key Performance Indicators (KPI).

NEPSI website

COREPER agreement - Press Release

Health & safety / REACH & CLP :


In brief

When it comes to health and safety and communicating with downstream users, the most relevant legislative texts are as follows:

  • REACH (Registration, Evaluation, Authorisation and Restrictions of Chemical substances), the role of which is to improve the protection of human health and the environment from the risks that can be posed by chemicals.  Under REACH, every substance manufactured or imported in the EU above 1 tonne must be registered by the entity that imports or manufactures it, unless it is exempt from registration. Furthermore, there is an obligation to communicate upstream (towards suppliers) and downstream (to customers) on substances by means of Safety Data Sheets (SDS) and chemical safety reports as the case may be. As defined by REACH, SDS are the key tool for hazard and risk management communication in the supply chain.
  • Classification, Labelling & Packaging (CLP) Regulation, which harmonises requirements concerning the classification, labelling and packaging of chemical substances and mixtures in line with the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) approved by the United Nations.

Our view

Clinker is a substance and is thus exempt from REACH registration. Nevertheless, it must be classified and labelled and a Safety Data Sheet (SDS) must be provided, if it is placed on the market, and this C&L has been notified to the European Chemicals Agency.   Cement is a preparation and is therefore also not subject to REACH registration, although it must also be classified and labelled. Nevertheless, because it is a preparation, no C&L notification to ECHA is necessary. An SDS, possibly with an exposure scenario, must be provided.  In terms of CLP, please refer to image for classification used by all CEMBUREAU members, for Portland cement clinker and common cements. 

Furthermore, CEMBUREAU has prepared safety data sheet templates for its Members (covering both “Portland cement clinker” and “Common cements”) which take into account the REACH requirements.