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Reach and the obligations of the chemical industry
  1. J J van Hemmen
  1. Hans Marquart, Department of Food & Chemical Risk Analysis, TNO Quality of Life, Utrechtseweg 48 Zeist, the Netherlands; hans.marquart{at}tno.nl

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A new chemical legislation was introduced in the European Union on 1 June 2007. This framework for chemical substances is called REACH (Registration, Evaluation and Authorisation and restriction of Chemicals) and replaces the patchwork of more than 40 directives and regulations with different rules for so-called new and existing substances.13 Existing substances were defined as being on the market before a certain date (18 September 1981); new substances were not.

The old system had many disadvantages, acknowledged by authorities, non-governmental organisations and the chemical industry, although for different reasons.

“New” chemicals, defined as not being on the European market before 1981, had to be tested for their effects on human health and the environment; such strict provisions were not in place for “existing” substances. The old legislation gave the authorities the responsibility for the risk assessment, whereas Registration, Evaluation and Authorisation and restriction of Chemicals (REACH) lays the full responsibility with industry (largely with the manufacturing and importing industry, but also with the downstream user (DU) industry (industrial users and formulators)).

The current legislation (REACH) demands full chemical safety assessments of all registered uses of dangerousi substances used at rates above 10 tonnes per annum, and a simpler assessment for substances between 1 and 10 tonnes. It will therefore provide detailed information on possible risks, which will then have to be mitigated (risk management), since for each activity with a dangerous chemical substance, safe use,ii must be ascertained. This is the important shift from intrinsic properties of chemicals to their risks with much more focus on exposure.

These demands are very strict and strong and form a major difference with the old legislation, where only 141 (high-volume) chemicals were identified as priority substances for risk assessment. …

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