Assessing the impact of authorisation process as a regulatory tool in the European REACH regulation: A study on improving occupational safety for applying companies.

ABSTRACT

This study looks into the effectiveness of the authorisation procedure as a regulatory instrument within the framework of the European REACH regulation. It highlights its impact on enhancing occupational safety and health for both applicants and companies utilising the substances. This procedure encompasses manufacturers, importers, and downstream users of substances, as well as representatives of foreign manufacturers who are also eligible to seek authorisation. When applying for authorisation, the ECHA Risk Assessment Committee (RAC) assesses the risks associated with the intended uses of the substance, including the appropriateness and effectiveness of the Occupational Conditions (OCs) and Risk Management Measures (RMMs) described in the application and the risks posed by potential alternatives. If the RAC determines that the OCs/RMMs are inadequate for managing or controlling the risk, or if the measures to protect workers are deemed insufficient, it may recommend additional measures to enhance occupational safety and health or environmental protection. The 398 processed Applications for Authorisation (AfA) that have been submitted to date were examined to determine these recommended measures, categorised as Conditions for use, Monitoring arrangements, and Recommendations for Review Reports. Overall, a significant improvement concerning occupational safety and health seems necessary, as indicated by the large number of measures recommended by the ECHA Committee for Risk Assessment (RAC) and ECHA Committee for Socio-economic Analysis (SEAC) or supplemented by the European Commission. In addition to the proposed measures, a short assessment provided by the committees as to whether the operational conditions and risk management measures are adequate in controlling the risks is also included in the study.