The EU Risk Assessment (“Council Regulation [EEC] 793/93 of 23 March 1993”) is recognised as being a leading independent, transparent and science-based system capable of assessing chemicals and substances in everyday use. It represents the most comprehensive assessment of these substances’ environmental and health impacts throughout their whole life-cycle.

Scope
The scope of the risk assessment covers emissions and consequent environmental impact and human exposures at each stage of the life-cycle of a chemical, from production, through processing, formulation and use, to recycling and disposal.

As regards protection goals for the environment, these include the atmosphere, the aquatic and marine environment, mammals and birds, soil organisms etc.

Exposure to humans from all relevant sources is considered, including exposure from consumer products through air, food, and drinking water and exposure at the workplace. Each exposure scenario is assessed individually, and where appropriate, an overall combined exposure is also estimated.

Which are the substances under risk assessment?

Due to the large number of substances covered by the Regulation, a priority setting approach has been adopted. The lists of priority substances are drawn up and published each year by the Commission. There are currently four priority lists, which can be found at European Chemicals Bureau.

Risk Assessment Procedure

The responsibility for undertaking the “Risk Assessment” of a particular substance is entrusted to an individual EU Member State, known as a rapporteur. The rapporteur is responsible for gathering relevant information and for making recommendations to the European Commission on any control measures it is felt need to be implemented in order to limit any significant risk that may exist (see below on “Risk Management”).

The rapporteur is responsible for assessing the risks to humans and the environment. In order to carry out these tasks, the rapporteur will use all relevant information and may, if necessary, ask for additional information and tests. In such cases, a formal request must be submitted to the Commission which, after consulting a Technical Committee, will pass on the request to the manufacturer or importer.

• Conclusion i) Need for further information and/or testing
• Conclusion ii) No need for further information and/or testing and no need for risk reduction measures
• Conclusion iii) Need for risk reduction measures

If the risk evaluation should indicate that there is a need for limiting the risk, a new process, the “Risk Management” will be carried out. This process is traditionally carried out by the same Member State that did the risk assessment. This may include restriction on the marketing and use of a substance, including control measures and/or monitoring programmes. The Commission may decide to propose measures under Directive 76/769/EEC on partial or total restrictions on the marketing and use of certain dangerous substances and preparations. Furthermore, other Community instruments may be used with a view to reducing the risks posed by the substance under examination such as limitation of emissions, incentives to use alternatives, worker protection measures, industry voluntary agreements etc.

• First draft report / Second draft report
• Technical meetings
• Final report
• Competent authorities review