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ASHEALTH AND SAFETY

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REACH and Downstream Users

Marie McCarthyREACH GI Inspector

Health and Safety Authority

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ASHEALTH AND SAFETY

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Am I a Downstream User ?

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Registration

As it applies to Downstream Users

(DUs)

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Registration - A Phased Process

Non-phase in SubstancesRegistration required beforemanufacture/import/use

Phase-in Substances– 3 years > 1000 t/yr

CMRs Cat 1&2 >1 t/yrR50/53 > 100t/yr

– 6 years >100 t/yr– 11 years > 1 t/yr

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Registration of Substances in Articles

Required where Substance is present at > 1 t/yr per

producer or importer Substance is intended to be released

under normal or forseeable conditions

Unless substance has alreadybeen registered for that use

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Notification of Substances in Articles

Required where Substance meets criteria in Art 54 and

is identified according to Art 56(1) Substance present at > 1 t/yr/M or I Substance present at > 0.1% w/v

Unless M/I can exclude exposure to humans & environment undernormal & forseeable conditions of use.

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Low Volume (1-10 t/a) Substances

Annex V testing required for Non phase-in substances in all cases Phase-in substances meeting one or both

criteria in Annex I ( c )- Likely to meet criteria for CMR Cat 1,2 or- Wide dispersive use and likely to be

classified as dangerous

Phase-in substances not meeting criteriain Annex I ( c ) only needphysicochemical studies

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Tools used by Industry

CSA used to determine which risk management measures and operational conditions are necessary to ensure risks to human health and environment are adequately controlled

CSR used to document the appropriate risk management measures and operating conditions to ensure adequate control

Exposure scenario (ES) is a description of the set of conditions for use of a substance so that risks are adequately controlled. This must reflect the outcome of the CSA, be documented in the CSR and annexed to SDS

SDS used to communicate risk management measures downstream.

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Chemical Safety Assessment

CSA (Annex I) at > 10t/yr Registrant must ensure that risks are

adequately controlled for manufacture and/or each identified use

Must specify risk management measures for each exposure scenario

DU has a right to identify use to M/I M/I includes this in his CSR if he can support

the use DU may choose not to identify use

but may have to notify Chemicals Agency & perform CSA

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Exposure Scenario - conditions ensuring adequate control

Physicochemical characteristics Process description Operating conditions Risk management measures Populations exposed Must cover entire life cycle including

use in articles, consumer use, waste disposal etc.

Process-specific conditions >>>> broad, generic ESs covering multiple uses/substances

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Derivation of an Exposure Scenario

Exposure Assessment

Exposure Scenarios

Existing Knowledge/data

Classification and labelling

Risk characterisation Adequate control

Hazard Identification

Hazard Assessment

Exposure Scenarios (final)

Documented in CSR and SDS

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Substance X in Paints for Brushing/Application by Roller

Standardised exposure scenario forgroup of substances outlining

• Protective clothing• Maximum periods of exposure• Cleaning of brushes/rollers etc• Disposal of waste

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Substance X used in Spray-painting of Cars

Process- specific exposure scenariooutlining• Maximum periods of exposure• Minimum requirements for the equipment

(booth, breathing apparatus)• Filtering efficiency• Cleaning frequency and procedures • Protective clothing• Hygiene measures• Waste disposal

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Is my use covered by my supplier’s registration ?

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Am I covered by Suppliers CSA ?

DUDU

Am I inside ES?

SDS + Exposure Scenarios (ES)

Apply ES

No

Notify Agency

Do targeted CSA and CSR

No

Make use known to the supplierYes

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Do I need to act?

DU takes no further action in thefollowing situations: He is using less than 1 t/yr He is operating within the conditions of an

exposure scenario communicated via SDS and has implemented recommended RMM on his site

SDS not required for substance (e.g. not dangerous)

CSR not required for M/I ( e.g. < 10 tonnes/yr) He is using it for PPORD

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I need to act

The DU must complete a CSR and reportto Agency in the following situations: CSR required and He is operating outside exposure scenario

communicated in an SDS or He has chosen to keep his use secret or M/I has

not taken account of it Methodology for DU CSA in Annex XI Must implement appropriate Risk Management

measures (RMM) on own site and inform DUs of appropriate RRM for their use

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DU Report

DU Report is not a registration

Limited information on identity of DU and supplier, identity of substance and generic use description

In limited circumstances, testing proposal may be required – dossier evaluation

Reporting not required for small quantities (< 1 tonne)

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Information Flow

Through the Supply Chain

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Information flow through the Supply Chain

SDS main tool Extended scope & role All dangerous substances and prepartions

placed on the market PBTs/vPvBs identified by Annex XII criteria Must be consistent with CSA Exposure scenarios annexed to SDS

Information flow up and down supply chain

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Roles for DUs under REACH

Check compliance with suppliers exposure scenario

If not covered, and where necessary, report to Agency and carry out a CSA

Comply with any authorisation and restriction conditions

Communication upstream & downstream

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Supports for DUs & SMEs

Guidance for downstream users (RIP 3.5)

Guidance on articles (RIP 3.8) Tools for SMEs Trade Associations - development of

standardised use descriptions National helpdesk – Health and Safety

Authority Agency helpdesk

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Benefits for DUs & SMEs

Improved access to information

Better quality of information

Informed decision-making

Improved worker safety

Reduced liability and compensation costs

Increased innovation

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Risks for SMEs and DUs

Increased costs

Withdrawl of substances

Disclosure of confidential business information

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Timelines

Nov 2005 EP First Reading Dec 2005 Council political

agreement Autumn 2006 Second Reading 2006/2007 Development of IT

tools and guidance for industry & MS April 2007 Entry into force April 2008 Agency operational.

Registration and other provisions commence

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What should I do now ?

Monitor development of REACH and Guidance documents

Assess your use of chemicals

Think about implications of REACH for your business

Dialogue a.s.a.p!!!

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Useful Websites

Commission Websiteshttp://europa.eu.int/comm/enterprise/reachhttp://

europa.eu.int/comm/environment/chemicals/reach

ECB Website http://ecb.jrc.it/

Health and Safety Authority Website www.hsa.ie

Queries on REACH wcu@hsa.ie