Classification Following the Definition Principle

All substances which are not listed in annex I of Directive 67/548/EEC [3-1] have to be classified by the person responsible for placing them on the market or by the producer. Therefore all available information has to be used in order to apply the obhgations of annex VI of Directive 67/548/EEC. This can be 

Additionally, in some member states national classifications aside from the legal classification of annex I exist. These classifications are not obligatory for placing products on the market. 

Most chemicals are not officially classified in accordance of annex I of Directive 67/548/EEC [3-lj. Indeed, about 30 000 chemicals with production volumes above one toruie per year are placed on the market, but only approx. 2500 substances are Hsted in annex I. The person responsible for placing a product on the market or the producer of the product has the duty of classification, taking the known properties into consideration. Usually, the assessment of the available data is difficult and requires expert knowledge. Especially the classification of the different toxic properties can only be done after an intensive hterature research. The assessment of the different studies is usually quite difficult, especially if investigations have been done which do not meet the guidelines ofaimex Vof the Directive 67/548/EEC [3-1] or the OECD methods. 

The guidance for classification is laid down in annex VI of Directive 67/548/EEC, and the most important criteria are summarized in Sections 3.1 to 3.4. 

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