1.5 European Regulatory Environment

In February 2001 the European Commission issued a White Paper entitled “Strategy for a Future Chemicals Policy” (COM (2001) 88 Final), aiming at complete revision of the existing legislation on chemicals. The overall goals of the new policy are to ensure the protection of human health and environment, maintenance of the competitiveness of the European chemical industry and preventing the fragmentation of the internal market.

Following the White Paper, the European Commission presented the first draft of a new comprehensive chemicals regulation with the goal of streamlining and updating the current regulatory framework in May 2003. After a public internet consultation, the Commission modified the draft and adopted its final proposal on REACH (Registration, Evaluation and Authorisation of CHemicals) (COM 2003 0644) on 29 October 2003.

REACH will replace the legislative framework for “new” and “existing” chemicals and extend the requirements for new substances to existing ones. Existing substances available commercially between 1 January 1971 and 18 September 1981 were compiled into the European INventory of Existing Commercial Substances (EINECS) in application of Article 13 of Directive 67/548/EEC, as amended by Directive 79/831/EEC, and in accordance with the detailed provisions of Commission Decision 81/437. Among the 100,196 EINECS-listed substances is ethylbenzene. These substances could be produced and sold without meeting the comprehensive and stringent data requirements demanded for new substances. Under REACH, enterprises that manufacture or import more than one tonne of a chemical substance per year would be required to register it in a central database. Higher tonnage of manufacture will attract an increasing degree of testing. REACH would furthermore give greater responsibility to industry to manage the risks from chemicals and to provide users in the supply chain with safety information on the substances. The proposal is now being considered by the European Parliament and by the Council for adoption under the so-called co-decision procedure.

On 9 July 2004 the European Commission and the European chemical industry via Cefic agreed to launch a strategic partnership to test REACH in practice. Please review the following websites for more information and to stay on top of developments related to REACH :

In 1993 the Council of the European Communities adopted Council Regulation (EEC) 793/93 (Existing Substances Regulation (ESR), thereby introducing a comprehensive framework for the evaluation and control of "existing" chemical substances. The Regulation was intended to complement the already existing rules governed by Council Directive 67/548/EEC for "new" chemical substances. The evaluation and control of the risks posed by existing chemicals is carried out in four steps: data collection, priority setting, risk assessment and risk reduction.

In the data collection step, ethylbenzene was determined to be a High Production Volume Chemical (HPVC), i.e. has been imported or produced in quantities exceeding 1000 tonnes per year and produced/imported between 23 March 1990 and 23 March 1994. The data set for ethylbenzene in the required electronic format Harmonised Electronic DataSET (HEDSET) was submitted and is now managed by the International Uniform ChemicaL Information Database (IUCLID).
According to Article 8 of 793/93 EEC, four lists totaling 141 priority substances have been published since 1994. Ethylbenzene was added to the first priority list (1179/94 EC).

Substances on priority lists must undergo an in-depth risk assessment covering the risks posed by the priority chemical to man (covering workers, consumers, and humans exposed via the environment) and the environment itself (covering the terrestrial, aquatic and atmospheric ecosystems and accumulation through the food chain). Ethylbenzene was assessed by Germany as the member state rapporteur for the environmental part only. The first in-depth discussion of this risk assessment took place at the Technical Committee on New and Existing Substances meeting in first quarter of 2004. The draft Risk Assessment Report (RAR) will be published on the European Chemicals Bureau (ECB) website (http://ecb.jrc.it/) in the near future. For more information on the progress made for ethylbenzene, please visit European chemical Substances Information Systems (ESIS) found on the ECB website.

The Commission Working Group on the Classification and Labelling of Dangerous Substances: Environmental Effects has agreed not to classify ethylbenzene (Annex I Index No.: 601-023-00-4) as dangerous to the environment due to its ready biodegradability (Summary Report ECBI/81/95 - Rev. 2; 27-29 September 1995). Ethylbenzene was inserted to Annex I of 67/548/EEC in Commission Directive 93/72/EEC (19th Adaptation to Technical Progress; O.J. Nº L258, 16.10.1993, p. 29; O.J. Nº L258A, 16.10.1993, p. 1).

Ethylbenzene is not listed in the Recommendations of the Technical Committee for Classification and Labelling and Specialised Experts for possible inclusion into the 30th Adaptation to Technical Progress (ATP) or the current 29th ATP (Commission Directive 2004/73/EC).

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Patrick Detournay
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