The Commission or a Member State may propose the adoption of Community-wide restrictions for the manufacture, use or placing on the market of any substance., Such restrictions will be imposed if it is demonstrated that there is "an unacceptable risk to human health or the environment" which is not adequately addressed by existing Community measures, and which must be dealt with at Community level.
Based on information in technical dossiers it prepares, the European Chemicals Agency may propose restrictions, which it shall submit to a "risk assessment rapporteur" and a "socio-economic analysis rapporteur" appointed by the Agency . All Dossiers and suggested restrictions are made public for stakeholders' comments. Within an established deadline, the Agency will submit to the Commission the opinions of the Committees for Risk Assessment and Socio-economic Analysis on restrictions suggested for substances, and the Commission may adopt a decision imposing the restrictions included in the opinions from the Agency. The role to be played by the Agency is therefore as a "risk assessor", while the European Commission retains its role as "risk manager".
Issues of concern
What constitutes "an unacceptable risk to human health or the environment" is not defined, leaving significant discretion in the hands of the Agency and the Commission and, arguably, the Member States.
It is not clear whether Member States are allowed to impose restrictions at national level, in case they consider there is "no need" for Community restrictions.
(The provisions related to restrictions are included in Points 56 to 62 of the Regulation.)
Last Updated: May 2003