Eurosil - The European Association of Industrial Silica Producers

1.14. What are the regulatory measures taken at EU level since IARC’s Monograph publication?

In 1998 and in September 2002, the European Commission (EC) Working Group on the Classification and Labelling of Dangerous Substances considered whether crystalline silica should be discussed, and concluded that it was not a priority. This implies that they considered that neither the general public nor the environment is at risk– as acknowledged by the IARC.

In 1998 the European Union Council requested the EC, through its Scientific Committee for Occupational Exposure Limits (SCOEL), to consider whether a respirable crystalline silica exposure limit should be established at EU level. This limit would be published either in the Annex III of the Directive on Carcinogens at Work (2004/37/EEC) or in the Directive on Chemical Agents at Work (98/24/EC).

The SCOEL’s final recommendation was released in June 2003:
The main effect in human of the inhalation of respirable silica dust is silicosis. There is sufficient information to conclude that the relative risk of lung cancer is increased in persons with silicosis (and apparently, not in employees without silicosis exposed to silica dust in quarries and in the ceramic industry). Therefore preventing the onset of silicosis will also reduce the cancer risk. Since a clear threshold for silicosis development cannot be identified, any reduction of exposure will reduce the risk of silicosis. It arises that an OEL should lie below 0.05 mg/m3. (SCOEL SUM Doc 94-final, June 2003).
On the basis of SCOEL's final recommendation, the EC could make a proposal to the Council for a limit value. The tri-partite (Authorities, Employees and Employers) Advisory Committee on Safety and Health at Work (ACSHW) would then give its advice on the EC's proposal.
On 25 April 2006, in the presence of Commissioner Spidla, 14 industry sectors and their employees’ representatives signed the European Social Dialogue “Agreement on Workers’ Health Protection through the Good Handling and Use of Crystalline Silica and products Containing It”, see question 1.17.

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On 6 April 2004, the European Commission launched the first stage consultation of the social partners on the protection of workers from risks related to exposure to carcinogens, mutagens and substances which are toxic for human reproduction. Crystalline silica was listed among other substances such as solar radiation, environmental tobacco smoke (passive smoking) and diesel exhaust as one of the most common workplace exposures.

In its reply to this consultation, IMA-Europe notably informed the European Commission that the European silica industry had developed a Good Practice Guide on the handling and use of crystalline silica and that it was exploring the possibility of broadening these Good Practices to other silica manufacturing and downstream user industries and to make them binding through a Social Dialogue Agreement in collaboration with the Employees concerned. The negotiations were launched between 14 industry sectors and their Employee representatives in 2005, with the support of the European Commission. The European Social Dialogue “Agreement on Workers’ Health Protection through the Good Handling and Use of Crystalline Silica and products Containing It” was signed on 25 April 2006, and entered into force six months later. Full information available at www.nepsi.eu. Crystalline silica is no longer explicitly mentioned in the second phase Consultation of social partners on the protection of workers from risks related to exposure to carcinogens, mutagens and substances launched in May 2007. Instead the European Commission encouraged “Social Dialogue initiatives that may complement existing legislation in reducing the exposure of workers to carcinogens, mutagens and reprotoxic substances”. The Commission has made clear that it will be closely monitoring the implementation and results of the Agreement on silica. In April 2009, the European Commission launched an “analysis at EU-level of health, socioeconomic and environmental aspects in connection with possible amendments to Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work”. Respirable crystalline silica is mentioned among the 25 substances which have to be considered by the contractor doing the impact assessment. The impact assessment study is due beginning of 2011.

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