Can REACH become the New Global Model? Helsinki Chemicals Forum 20 May 2010 Jukka Malm, Director ECHA – Directorate of Assessment

Chemicals Management System – Hazard & Risk Assessment Elements Obligations on following elements may be included:  Information on Substances (properties, uses)  Hazard Assessment of Substances  Tailored Risk Management of Substances based on Risk Assessment → One, two or all three elements can be chosen Supplementary critical aspects:  Role of companies vs role of authorities  Technical aspects: what protocols, methods and tools are followed to generate and to assess the information

 Risk assessment for only 140 existing substances which had been prioritised over more than 10 years  Downstream users generally out of the picture  Even less information available to the public Limited knowledge about possible negative effects for humans and the environment of the vast majority of chemicals produced and used in the EU Situation before REACH:

 Inefficient: process took far too much time and resources for assessing existing chemicals  Administrative burden for new, mostly low-volume chemicals, unintentionally discouraging innovation Situation before REACH: Burden of proof that a chemical was unsafe on public authorities

REACH: Registration  Core of REACH: EU/EEA manufacturers and importers of chemicals to collectively obtain and submit information per substance and use it to ensure the safe use  Integrated approach: Information requirements combined with hazard/risk assessment and risk reduction measures proposed by industry  Implements reversed burden of proof  Same requirements for new and existing substances  Non-confidential data publicly available Today: ca 1300 dossiers - End of 2010: ca dossiers expected

Evaluation – tool for authorities to request further information Today: ca 80 dossier evaluations initiated - in 2011 ca 500 expected

Risk Management – authority interventions  Can be triggered by registration data or by other concerns  Applied to limited number of substances  Involve public consultations  Harmonised classification and labelling  CMR and respiratory sensitizers – rest is industry self-classification  Through CLP Regulation - Implement GHS criteria  Authorisation  Substances of very high concern (e.g. CMR, PBT’s)  Applicants to demonstrate safe use or cost/benefit  Restrictions  Safety net

Global effects of REACH – first signs  Companies work globally on REACH – information, assessments, tools and experiences benefit also other programmes  First REACH data publicly available – can be used by countries and programmes all over the world  REACH information is “OECD compatible” and contributes to agreed global chemical management goals  Provides many opportunities for enhanced cooperation  REACH is already a global reference when developing chemicals management systems

Thank you for your attention!