reach presentation - key measures in detail · reach presentation - key measures in detail...
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![Page 1: REACH presentation - Key measures in detail · REACH presentation - Key measures in detail Keywords: REACH, presentation, Key measures, Created Date: 6/18/2009 8:53:12 AM](https://reader033.vdocument.in/reader033/viewer/2022050522/5fa5f02d22864b225e2cc422/html5/thumbnails/1.jpg)
REACH –Key measures in detail
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Overview of REACH requirements
Registration
Supply chain
End use
(pre-registration)
EvaluationAuthorisationRestriction
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REACH roles
• Manufacturer / importer / ‘only representative’(registration)
• Supplier / distributor (supply chain)• ‘Downstream user’ (use)
…though a single person may have several roles
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Downstream Users:
• Formulator• End-User• Industrial User• Article Producer• Craftsmen, micro enterprise, professional service
providers• Re-fillers• Re-importers• Importers with non-EU supplier using an ‘only
representative’
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REACH terminology
REACH is concerned about substances, either on their own, or in preparations or articles
Substance PreparationCopper
ZincBrass
Alloy of copper + zinc
Titanium dioxide White Paint[titanium dioxide + …]
Ethylene glycol Antifreeze[ethylene glycol + …]
Ylang-ylang extract Fragrance concentrate(ylang-ylang extract + …)
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Articles
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Exemptions
Substances not covered by REACH:
RadioactiveDangerous goods in transit
In customsNon-isolated intermediates
Waste
Also a defence exemption
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Tailored provisions:
Human and veterinary medicinesFood and foodstuff additives
Plant protection products and biocidesIsolated intermediates
Substances used for R&DPolymers
Substances in Annexes IV and VRecovered and re-imported substances
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Registration
Supply chain
End use
(pre-registration)
EvaluationAuthorisationRestriction
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Registration
Does your company introduce to the EU a substance- by manufacture or importation - at ≥1 tonne per year?
- as the substance itself- within a preparation- within an article, with intended release
If so,
PRE-REGISTRATIONthen
REGISTRATION
ECHAHelsinki
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Key features of registration:
• ‘No data, no market’
• Separate registration required for each manufacturer / importer
• Must submit a technical dossier of information to ECHA
• Information requirements increase with increasing tonnage supplied
• It will cost to register (though the cost will vary)
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Tonnage Range
(tonnes/year)
Standard Fee
1-10 €1,600(Free if full data
package submitted)
10-100 €4,300
100-1000 €11,500
>1000 €31,000
Costs to register under REACH
Reduced fees for SMEs:
Medium: 30% reduction
Small: 60% reduction
Micro: 90% reduction
All: 25% reduction for joint submissions
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Chemical safety assessments are required for +10 tpa registrations:
• essentially a risk assessment, undertaken by the manufacturer / importer
• derived no-effect levels (DNELs)
• ‘exposure scenarios’ – a description of operational conditions and risk management measures
• exposure scenarios to be annexed to SDSs
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Pre-registration
• Not a requirement (though is free)• Between 1 June and 1 December 2008 only (first
time manufacturers / importers can pre-register ‘late’)• Dutyholders can then taken advantage of registration
phases between 2010 and 2018• Substances not pre-registered must be registered by
1 December 2008 or cannot be manufactured, imported or placed on the market (legally!)
• Those that pre-register join with others wanting to register the same substance in a Substance Information Exchange Forum (SIEF)
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Registration phases:
1 Dec 2010PHASE 1
Deadline for registration of substances supplied at: • ≥ 1000 tonnes per annum (tpa) or; • ≥ 100 tpa and classified under CHIP as very
toxic to aquatic organisms or; • ≥ 1 tpa and classified under CHIP as Cat 1
or 2 carcinogens, mutagens or reproductive toxicants
1 June 2013PHASE 2
Deadline for registration of substances supplied at ≥ 100 tpa
1 June 2018PHASE 3
Deadline for registration of substances supplied at ≥ 1 tpa
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UK pre-registration activity
By 1 December 2008:
• Around 21,000 companies pre-registered one or more substances
• Highest number of any Member State (second highest Germany with around 8,500)
• Around 450,000 substances were pre-registered
• Second highest (Germany higher with around 670,000)
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Supply
Supply information up and down the supply chain:• Contact your suppliers:
- with any new information on hazards- if risk management measures not appropriate
• Provide your customers with information:- formulators: if substance is ‘dangerous’ (SDSs)- producers of articles: if article contains substances of very high concern (‘SVHCs’)
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REACH repeals and replaces CHIP requirements as regards safety data sheets
Through registration, safety data sheets will contain more and better information about risk management measures (‘exposure scenarios’)
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Use
Requirements regarding use:
• Identify and apply risk management measures from supply information
• Take action if use is ‘outside’ registration
• Observe duties on suppliers (last slides) if relevant
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All dutyholders
General requirements:
• Obtain authorisation where required (or notify ECHA of use)
• Observe restrictions
• Provide workers access to information
• Keep information
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Registration
Supply chain
End use
(pre-registration)
EvaluationAuthorisationRestriction
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Evaluation
• Completeness check• Compliance check• Dossier evaluation• Substance evaluation
May require further information to be submitted
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Authorisation
Applies to ‘substances of very high concern’(SVHCs) included in Annex XIV. They may be:
• category 1 or 2 carcinogens, mutagens or reproductive toxicants
• persistent, bioaccumulative and toxic (PBT)
• very persistent or very bioaccumulative (vPvB)
• substances giving rise to an equivalent level of concern (e.g. endocrine disruptors)
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• By June 2009 ECHA will produce a list of substances for authorisation (Annex XIV of REACH)
• Dutyholders will then need to submit an application for authorisation to either market or use.
• There will be a cost to apply for an authorisation
• Designed to encourage substitution
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Restriction
• Enters into force 1 June 2009
• Annex XVII contains list of restricted substances
• Restrictions take many forms, not necessarily outright bans
• Illegal to manufacture, market or use a substance outside of the conditions of restriction
• Replaces ‘Marketing and Use Directive’
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Timeline
1 June 2007 REACH came into force (though only supply chain related duties apply)
1 June 2008 All other duties (apart from restrictions) apply
1 Dec 2008 REACH Enforcement Regulations 2008 come into force
1 June 2008 Registration for new substances starts1 June to 30
Nov 2008 Pre-registration for existing substances
1 Dec 2008 Registration for existing substances (that have not been pre-registered) starts
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1 June 2009 Restrictions provisions apply
1 June 2009 Annex XIV published
1 Dec 2010 Deadline for Phase 1 registrations
1 June 2013 Deadline for Phase 2 registrations
1 June 2018 Deadline for Phase 3 registrations
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The role of the UK REACH Competent Authority (CA)
• Delegated to HSE; operating on behalf of UK government(s)
• HSE & Environment Agency will have significant roles; with valuable assistance from other government bodies
• Based in Redgrave Court, Bootle Chemical Assessment Schemes Unit (CASU)
Corporate Specialist Division (CSD)Science and Technology Group (STG)
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CA responsibilities
Enforcement (registration compliance)
Help Awareness raising
Substance evaluation
EU influencePropose substances for authorisation / restriction
UK enforcers liaisonUK CA
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Educational events (4 national conferences, 30+ regional roadshows etc)AWARENESS-
RAISING Supporting events run by others (+150)
publicity e-bulletin
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Helpdesk: enquiries
HELP Website: guidance; info, case studies
Signposting to other sources
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The contact details for the UK CA Helpdesk are:
• Telephone: 0845 408 9575• E-mail: [email protected]• Post: UK REACH CA Helpdesk
2.3 Redgrave Court, BootleMerseyside, L20 7HS
www.hse.gov.uk/reach