2. Product Information and Characteristics

2.7. 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.

Registration, Evaluation and Authorisation of Chemicals (known as 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 styrene. 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 Commission expects entry into force of the Regulation for spring 2007. The operational requirements of REACH are expected to start to be applied from 2008 onwards.

Please review the following websites for more information and to stay on top of developments related to REACH:

http://ecb.jrc.it/REACH/
http://europa.eu.int/comm/enterprise/reach
http://europa.eu.int/comm/environment/chemicals/reach.htm
http://www.chemicalspolicyreview.org/

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, styrene 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 styrene 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 totalling 141 priority substances have been published since 1994. Styrene 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). Styrene is being assessed by the United Kingdom as the member state rapporteur. The final Risk Assessment Report (RAR) for the environmental part was published on the European Chemicals Bureau (ECB) website (http://ecb.jrc.it/) in 2002 (EUR 20541 EN European Risk Assessment Report: Styrene – Part I – Environment, Volume 27). The human health Risk Assessment was presented by the rapporteur for a last visit discussion at the 8th Technical Committee on New and Existing Substances in November 2005 at Arona and the conclusion was that no classification for carcinogenicity and mutagenicity would be required. Denmark, however, announced counterproposal, but failed to submit on time to be discussed during the Classification & Labelling meeting in October 2006. Styrene has therefore on request of Denmark been moved to the waiting list. Further discussion is expected to happen in spring 2007. The Commission Working Group on the Classification and Labelling of Dangerous Substances: Environmental Effects has agreed not to classify styrene (Annex I Index No.: 601-023-00-4) as dangerous to the environment on the basis of the data in the Risk Assessment Report (Summary Record ECBI/60/99 - Rev. 4; 15-17 September 1999). 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).

Styrene 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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