Existing Substances

Chemical substances are treated differently in the European Community depending on when they were introduced on the market. New substances (introduced after 1981) are required to be tested and notified before marketing in volumes above 10 kg. For higher volumes more in-depth testing focussing on long-term and chronic effects has to be provided. On the basis of the information, they are assessed on their risks to human health and the environment. The legal basis is laid out in Directive 67/548/EEC.

However, there are no corresponding requirements for chemicals that were deemed to be on the European Community market between 1 January 1971 and 18 September 1981 (the existing chemicals) and listed in the EINECS (European INventory of Existing Commercial chemical Substances). EINECS is listing about 100.000 existing substances – counting for about 99 % of the chemicals’ volume on the market.

In the 1980's a Community Action Programme underlined the need for a legislative instrument, which would provide a comprehensive structure for the evaluation of the risks posed by "existing" chemicals. In particular, the Action Programme stated that such a legislative instrument "will establish a procedure for treating priority lists of chemicals for immediate attention, as well as setting out the means for gathering information, requiring testing and evaluating the risks to people and the environment". Consequently, the European Commission proposed a series of legal instruments, which were aimed at meeting the objectives outlined in the Action Programme. One of these instruments was the Existing Substances Regulation (EEC) 793/93 which was adopted by the European Council on 23 March 1993 and came into force on 4 June 1993. It applies to any manufacturer or importer who produced or imported an existing substance in quantities exceeding 10 tonnes a year. The Council Regulation foresees that an evaluation and control of the risks posed by existing chemicals is carried out in four steps:

The core of the EU's 'Existing Substances Program' is to ensure better management of risks of existing substances to man and the environment. Hence, risk assessment reports and risk reduction strategies create the necessary basis for the implementation of risk reduction measures.

The Process of Assessing a Priority Chemical and Developing a Risk Reduction Strategy under the Existing Substances Regulation (EEC) 793/93.

 

 

 

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