Existing Substances Regulation

Priority Lists, Risk Assessment process and tracking system in relation to Council Regulation (EEC) 793/93 also known as Existing Substances Regulation (ESR). 

Under the Existing Substances Regulation, which was passed in 1993, individual member states are allocated substances for which they are responsible for the risk assessment. To date, three priority fists for assessment have been drawn up, which cover just over 100 chemicals. Following the conclusion of four risk assessments, the European Commission has recently issued a recommendation on the results on the risk evaluation and on the risk reduction strategies for the following substances 2-(2-butoxyethoxy) ethanol 2-,(-methoxyethoxy) ethanol alkanes, C10-13, chloro and benzene, C 10-13-alkyl derivatives. For two of the substances, 2-(2-butoxyethoxy) ethanol and 2-(2-methoxyethoxy) ethanol it is concluded that there is a need for specific measures to limit the risks to workers... 

This chapter uses the formal EU risk assessment methodology laid down in the European Commission Regulation (1488/94) and follows closely the principles of the technical Guidance Document [1] of the Existing Substances Regulation (793/93). 

Assessments of risks are, of course, only as good as the information on which they are based. For new substances, information had to be supplied before a chemical could be marketed. This was not the case for existing substances. Under the Existing Substances Regulation (Regulation (EEC) 793/93) manufacturers or importers of more than 10 tonnes per year of a substance listed in the inventory had to supply information on that substance to the European Commission, and as the amount they manufacture or import increased so did the data requirements. Manufacturers and importers had to make all reasonable efforts to obtain data... 

In 1993, a regulation on the evaluation and control of risk from existing substances was published this became known as the Existing Substances Regulation [4] and applied to... 

Guidelines within a process of decision making that may use other information to corroborate success or failure. The outcome might be to seek more information or to impose controls (e.g., use of predicted no effect concentrations [PNECs] in Existing Substances Regulations in the EU). 

Cowan CE, Versteeg DJ, Larson RJ, Kloeppersams PJ. 1995. Integrated approach for environmental assessment of new and existing substances. Regul Toxicol Pharmacol 21 3-31. 

Base-set level testing is the minimum data set that the current Existing Substances Regulation 793/93/EEC requires to carry out an assessment of risk to human health and the environment for a substance. Regulation 793/93/EEC will be replaced by REACH. 

Existing Substance Regulation 793/93/EEC came into effect in 1993... 

Part of UK Competent Authority to assess hazards and risks of substances under the Existing Substances Regulation and the Notification of New Substances... 

Existing substances regulation (793/93). Distearyldimethylammonium has been put on first priority list and a risk assessment for humans has been carried out (CAS 107-64-2). 

REACH was launched in response to the fact that, under the regime of the Existing Substances Regulation 793/93/EC [8-2], in a time period of ten years fewer than 100 substances were completely assessed. Obviously, this Regulation completely failed to achieve its original aim. The intention was for all existing substances, listed in EINECS [8-3], to be assessed by the competent authorities. Undoubtedly, the intrinsic properties most of the substances used are not completely... 

Therefore, in February 2001 the Commission launched the white paper Strategy for a future chemical policy of REACH. In contrast to the Existing Substance Regulation, under REACH industry has to assess all existing substances. The following basic principles are implemented in REACH ... 

The subsequent Existing Substances Regulation (EEC 793/93) specified the requirements for evaluating risks using such data and, if necessary, reducing risks. 

Article 13 of the Sixth Amendment simply required the authorities to inventory existing chemicals. Over a decade later, the assessment of those existing chemicals began with the promulgation of the Existing Substances Regulation. 

Data Collected Under 1993 Existing Substances Regulation... 

The European Communities transmuted these recommendations into a proposed Directive that defined enforceable restrictions on toluene in consumer products. The restrictions reflected both the results of the risk assessment and the regulatory framework of the Existing Substances Regulation. The Proposal fen- a Directive of the European Parliament and of the Council relating... 

The preceding discussion of the Sixth Amendment and the Existing Substances Regulation explains how, of the 105,398 new and existing chemical substances, competent authorities assessed the potential risks from exposure to each of 5,433 substances and ultimately restricted approximately 900 substances under the Limitations Directive. It also illustrates some of the concerns with the legislation that led to calls for reform, and ultimately to the implementation of REACH. 

The proposed restriction on 1,4-dichlorobenzene (1,4-DCB) illustrates the process. Concerns over the potential toxicity of this compound first surfaced under the Dangerous Substances Directive. The European Commission subsequently assessed the risks from exposure to 1,4-EXZB under the Existing Substances Regulation, beginning in the mid-1990s. 

While stakeholders evaluated the results of the risk assessment, the European Union promulgated REACH. Momentum built to control the use of 1,4-DCB under the Existing Substances regulation had to be redirected under the new regulatory paradigm. 

The Existing Substances Regulation passed in 1993 initiated the assessment of existing chemicals. This effort compiled existing information on nearly 3,000 high production volume chemicals and almost 8,000 low production volume chemicals. There were 141 substances identified for risk assessment. Some of these substances were regulated under the Limitations Directive. 

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