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REACH and Downstream Users. Marie McCarthy REACH GI Inspector Health and Safety Authority. Am I a Downstream User ?. Registration. As it applies to Downstream Users (DUs). Registration - A Phased Process. Non-phase in Substances Registration required before manufacture/import/use - PowerPoint PPT Presentation
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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
AUTHORITY
Am I a Downstream User ?
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ASHEALTH AND SAFETY
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Registration
As it applies to Downstream Users
(DUs)
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ASHEALTH AND SAFETY
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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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ASHEALTH AND SAFETY
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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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ASHEALTH AND SAFETY
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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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ASHEALTH AND SAFETY
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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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ASHEALTH AND SAFETY
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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
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