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 2003, the Scientific Committee for Occupational Exposure Limits (SCOEL), released the following recommendation for respirable crystalline silica:
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 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.

On December 5, 2012, the European Commission’s Advisory Committee for Safety and Health (‘ACSH’) issued an ‘Opinion on the approach and content of an envisaged proposal by the Commission on the amendment of Directive 2004/37/EC on Carcinogens and Mutagens at the workplace’ [1].

The Opinion includes a chapter regarding the proposed regulatory approach towards Respirable Crystalline Silica (‘RCS’). In particular, the Opinion notes that it is agreed that there should be a binding occupational limit value of 0.1 mg/m3 introduced for RCS and that there are legal possibilities to introduce this limit through Directive 2004/37, Carcinogenic Agents at Work Directive or through Directive 98/24, Chemical Agents at Work Directive.

On 13 May 2016, EU Commissioner Marianne Thyssen presented a proposal to revise the Carcinogens and Mutagens Directive 2004/37/EC (CMD).

On this occasion, the Commission proposed to include in Annex I “work involving exposure to respirable crystalline silica dust generated by a work process” and to establish in Annex III a binding limit value for respirable crystalline (RCS) silica dust ('respirable fraction') at 0.1 mg/m³.

In her press conference, Commissioner Thyssen highlighted the benefit of the NEPSI Agreement.  The proposal in its Recital (6) acknowledges its role as a valuable instrument to complement regulatory requirements and to support their effective implementation.

The Directive proposal will be subject to the ordinary adoption procedure (through the Council and Parliament) which usually last around 6 months, then there will be a transition period of two years after entry into force of the Directive for the Member States to transpose the Directive in their national legislation.

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