2. Product Information and Characteristics

2.7. European Regulatory Environment

In June 2008, Regulation No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), replaced the legislative framework for “new” and “existing” chemicals (EU Regulation 793/93). Under REACH, enterprises that manufacture or import more than one thousand tonnes of a chemical substance per year are required to register it in a central database by December 2010. REACH gives greater responsibility to manufacturers and importers to manage the risks from chemicals and to provide users in the supply chain with safety information on the substances.

Please review the following website for more information related to REACH:  

http://echa.europa.eu/reach_en.asp

 In December 2008, the UK Health Safety Executive (UK HSE), lead Rapporteur for the Risk Assessment (RAR) of Styrene under the EU Regulation 793/93 on existing substances, submitted an Annex XV transitional dossier to the European Chemicals Agency (EChA) as required by the REACH legislation. This dossier was sent together with 25 other transitional dossiers with the objective of ensuring that the risk assessment work completed under EU Regulation 793/93 is taken forward into REACH and that all information generated and assessed by EU Member States under the previous legislation is made available under REACH. The Styrene Monomer (and Ethyl Benzene) RAR and transitional dossier can be found via the following link:

http://echa.europa.eu/chem_data/transit_measures/annex_xv_trans_reports_en.asp

 The transitional dossiers provide background information only for the preparation of Annex XV dossiers in case authorities decide to develop proposals for either harmonisation of Classification and Labelling (CLH), Authorisation under Title VII of REACH, or Restrictions under Title VIII of REACH.

 The UK HSE recommended waiting until after the completion of Styrene’s registration under REACH in December 2010 before considering the development of restriction measures. It also suggested that in the meantime, risk management measures are implemented for some specific uses based on the conclusions of the scientific Risk Assessment Report (RAR).

In the context of these risk management measures, UK HSE is proposing harmonization of occupational exposure limits (OELs) across the EU. A final decision on these OELs is yet to be made as UK HSE’s recommendations first require a review by the relevant EU committees in the context of REACH Registration.

 The transitional dossier re-confirmed that there should be no classification for Carcinogenicity and Mutagenicity as agreed under the previous legislative framework by the Technical Committee for Classification and Labelling (TC C&L) at the European Chemicals Bureau, DG Joint Research Centre of the European Commission. However, as no agreement could be reached in relation to classification for Reproductive Toxicity classification of this end point has been left to EChA to complete within the remit of the Risk Assessment Committee (RAC) under the REACH process.

 Recommendations by the TC C&L will be considered for future inclusion in Annex VI to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances (CLP Regulation). In order for those substances agreed at TC C&L to be included in Annex VI of the CLP Regulation, they must be processed through the Committee for Risk Assessment (RAC). During its 7th Meeting (June 2009), RAC considered that efficient methods for processing these TC C&L agreed substances should be found. RAC also supported the full utilisation of previous work from TC C&L and to focus its discussions on the impact of any new data that has emerged since TC C&L made its recommendations.

In the case of Styrene Monomer, the RAC will need to conclude on Reproductive Toxicity before it can be included in Annex VI of the CLP regulation. This is expected to take place in 2011.

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