Can REACH become the New Global Model?

Helsinki Chemicals Forum20 May 2010

Jukka Malm, Director Jukka Malm, Director ECHA – Directorate of Assessment ECHA – Directorate of Assessment

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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

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→ 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

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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:

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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

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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 38 000 dossiers expected

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Evaluation – tool for authorities to request further information

EVALUATION UNDER REACH

MEMBER STATESECHA

Dossier evaluationExamination

of testingproposals

CORAP-LIST

Substance evaluation

Compliance check of dossiers

Today: ca 80 dossier evaluations initiated - in 2011 ca 500 expected

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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

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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!

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