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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.1–3 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. …
Footnotes
↵*Joop van Hemmen passed away 10 October 2008.
Competing interests: None declared.
↵i Dangerous substances are defined in the Directive on Dangerous Substances (http://ec.europa.eu/environment/chemicals/dansub/consolidated_en.htm).
↵ii Safe use has not (yet) been formally defined. The current understanding is that the predicted or measured exposure levels are below toxicological thresholds (Derived No Effect Level; DNEL and Predicted No Effect Concentration; PNEC (see later)).
↵iii Article means an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition.
↵vi A European chemicals agency is established for the purposes of managing and in some cases carrying out the technical, scientific and administrative aspects of this regulation and to ensure consistency at community level in relation to these aspects.
↵vii Phase-in substance means a substance which meets at least one of the following criteria: (a) it is listed in the EINECS; (b) it was manufactured in the community, or in the countries acceding to the European Union on 1 January 1995 or on 1 May 2004, but not placed on the market by the manufacturer or importer, at least once in the 15 years before the entry into force of REACH, provided the manufacturer or importer has documentary evidence of this.
↵viii The DNEL is derived for threshold effects and the Derived Minimal Effect Level (DMEL) for non-threshold effects
↵x The reader is referred to the guidance on information requirements and chemical safety assessment5 for the details and references on the proposed predictive models.
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