Transcript Slide 1

Simon Brearley
The REACH Centre Ltd
REACH – the horizon & beyond
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Topics
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Registration update
Intermediates
SVHC & Authorisation
Restrictions
Supply chain communication
Downstream user roles & obligations
Enforcement
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Progress on Registration
Pre-registration
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2.7 million pre-registrations
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67,000 companies
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143,000 pre-registered substances
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55,000 with indicated 2010 registration deadline
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Progress on Registration
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First phase-in deadline for registration – 1st December 2010
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Anticipated number of registrations – 25-75,000 for 2010 deadline
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5 -7000 substances
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Registration dossiers accepted for processing
– 2009
full
363
intermediate
394
– 2010 (end May)
full
343
intermediate
337
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Registration deadline – 1st Dec 2010
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A registration dossier is submitted to the Agency by every registrant via REACH IT
using IUCLID5
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Agency on receipt of dossier issues a submission number and submission date
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Agency have 3 weeks to carry out a completeness check (includes checking receipt
of fee!). If OK then Agency issue a registration number
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If dossier is not complete then Agency requests additional information and when this
is provided the 3 weeks check time starts again.
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If no contact within 3 weeks then potential registrant is free to start/continue the
manufacture/import of the substance
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A second failure leads to rejection of dossier and a re-submission has to be made
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However the 3 week period is extended to 3 months from the phase-in deadline
(i.e. 1st March 2011) for submissions on phase-in substances made within 2
months of the deadline
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Registration deadline – 1st Dec 2010
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Where a dossier is submitted before 30th September and it is rejected there is still
time to resubmit before the deadline and therefore remain in compliance
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However; where a dossier is submitted after 30th September the registrant may not
know if the registration is accepted until 1st March 2011. If it is rejected then they are
out of compliance with REACH (and have effectively been so since 1st December
2010)!!
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Progress on Registration
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Directors Contact group established:
– Members from ECHA, Cefic, Eurometaux, REACH Alliance, Concawe,
FECC and UEAPME
– Charged with
• Monitoring overall preparedness of companies
• Identify and resolve priority issues of concern in meeting obligations relevant to the
registration deadline.
• Identify and resolve priority issues of concern to help secure a supply of high volume
substances to downstream users
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Directors contact group –main issues
Topic
Description
Solution outline
SIEF operation
Late disputes over costs &
data sharing + late comers
may delay dossier
preparation
ECHA recommending LR ‘freeze’ the lead dossier 2 months
before planned submission date.
Very late SIEF activity
SIEF activity disrupted by
late changes from ‘dormant’
to ‘active’ status
Lead registrants can ‘freeze’ dossier
SIEF without EU
manufacturer
Where no EU manufacturer
exists it can be difficult for
an OR to take on LR role
DSU should actively consider action – alternative supply,
importing and registration
Parallel submission being allowed
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Directors contact group –main issues
Topic
Description
Solution outline
Dependency on LR by rest of SIEF
If LR fails remainder of joint
registrants are in difficulty
Parallel submission allowed, where
LR fails another registrant takes on
role and submits asap. Individual joint
registrants communicate with MSCA
Legal entity change
Need to accommodate mergers etc
and changes to toll manufacturers in
12 month period before deadline
ECHA has refined legal identity
change facility in REACH –IT.
Affected companies to contact MSCA
asap
Uses not covered by a registration
Difficulties for SME’s who may need
to complete CSA
Solution awaited
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Directors contact group –main issues
Topic
Description
Solution outline
Completeness of dossiers
Time pressure leading to
failure to get test results for
Annex VII or VIII data
Submit incomplete dossier with explanation and
timescale for completion of test – dossier will fail
completeness check.
Registrants adopt precautionary stance on CSR and
SDS
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Progress on Registration
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Implications for chemical users:
– Loss of supply
– Non-compliance
– Customer concern/loss
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ECHA have provided a list of substances that companies have indicated to
them that they intend to register
http://echa.europa.eu/chem_data/list_registration_2010_en.asp
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List currently contains ~5000 substances
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Intermediates
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An intermediate is a substance that is manufactured for and consumed in or
used for chemical processing in order to be transformed into another
chemical substance (synthesis)
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Non-isolated intermediates – exempt
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On- site isolated intermediates (production and synthesis take place on the
same site) – reduced hazard data set requirements
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Transported isolated intermediate (manufacture and synthesis take place on
different sites) – reduced hazard data set requirements
To qualify as intermediates full technical control and containment must
be guaranteed
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Intermediates
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Strictly controlled conditions and rigorous containment
– Must cover whole life-cycle including manufacture, purification, cleaning,
maintenance, sampling, loading/unloading, storage, disposal
– Control mechanisms include
• Process design
• Process control
• Management systems
• Training
• Emergency procedure
• Waste management
• Transport
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ECHA are paying particular attention to Intermediate registrations
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Authorisation
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Authorisation is the mechanism for identifying and controlling the use of substances of very high
concern (SVHC) with the longer term aim of removing from the marketplace.
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The ECHA & MS generate a candidate list of substances considered for authorisation
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On a rolling programme EU Commission will decide to transfer in the list of authorised
substances (Annex XIV) with a ‘sunset date’
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M/I/DSU will need to apply for authorisation to use 18 months before the ‘sunset date’ or apply for
a specific use if substance is already an Authorised Substance (listed in Annex XIV).
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Applicant will need to demonstrate ‘safe use’ (may not be possible) and/or justify use on socioeconomic grounds.
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Considerations of alternatives and plans for substitution will need to be submitted.
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Authorisations are subject to review .
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Authorisation
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Recent statements from EU Commissioners for Environment and Industry have
agreed a common interpretation of the Regulation
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This confirms that substance use may be authorised if socio–economic benefits
outweigh the risks linked to them
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Reinforces the need to explore substitution options and to develop substitution
strategies
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Confirms the long term goal remains removal from market place
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Scope of Authorisations
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Substances used in R&D programmes are not covered by Authorisation
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Use of substances for PPORD (product and process orientated research & development) may be
excluded from Authorisation on a case by case basis
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Authorisation does not apply to use of substance in
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Where the Authorisation relates to CMR or other Human health properties only the Authorisation
does not apply to use in
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Plant protection products (Directive 91/414/EEC
Biocidal products (Directive 98/8/EC)
Motor fuels (covered by Directive 98/70/EC)
Use as fuel in combustion plants.
Cosmetic products (Directive 76/768/EEC)
Food contact materials (Regulation (EC) No. 1935/2004)
The Authorisation of substances does not apply to the use of the substance in preparations
where:
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For PBT and vPvB substances that are present below a concentration of 0.1% (w/w)
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For CMRs they are present below the lowest concentration limits specified in Directive 1999/45/EC or in
Annex I of Directive 67/548/EEC which result in the classification of the preparation as dangerous
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Candidate list – initial
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Anthracene
4,4’- diaminodiphenylmethane
Dibutyl phthalate
Cobalt chloride
Diarsenic pentaoxide
Diarsenic trioxide
Sodium dichromate
5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene)
Bis(2-ethyl(hexyl)phthalate) (DEHP)
Hexabromocyclododecane (HBCDD) + major diastereoisomers
Alkanes, C10-C13, chloro (short chain chlorinated paraffins)
Bis(tributyltin)oxide
Lead hydrogen arsenate
Benzyl butyl phthalate
Triethyl arsenate
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Candidate list – Jan/March 2010 additions
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204-450-0
292-602-7
295-278-5
295-275-9
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2,4 dinitrotoluene
Anthracene oil
Anthracene oil,anthracene paste, distn,Light
Anthracene oil, anthracene paste,
anthracene fraction
Anthracene oil, anthracene low
Anthracene oil, anthracene paste
Diisobutyl phthalate
Aluminosilicate, refractory ceramic fibres
Zirconia, Aluminosilicate, refractory ceramic fibres
Lead Chromate
Lead chromate, molybdate sulphate red
Lead sulphochromate yellow
Tris(2-chloroethyl)phosphate
Coal tar pitch, high temperature
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Acrylamide
201-173-7
292-604-8
292-603-2
201-553-2
231-846-0
235-759-9
215 693-7
204-118-5
266-028-2
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Candidate list – June 2010 additions
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Trichloromethylene
201-167-4
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Boric acid
233-139-2/234-343-4 Cat 2 Repro-toxic
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Disodium tetraborate anhydrous
215-540-4
Cat 2 Repro-toxic
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Tetraboron disodium heptoxide, hydrate
235-73-1
Cat 2 Repro-toxic
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Sodium chromate
231-889-5
Cat 2 CMR
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Potassium chromate
232-140-5
Cat 2CMR
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Ammonium dichromate
232-143-1
Cat 2 CMR
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Potassium dichromate
231-906-6
Cat 2 CMR
Cat 2 Carcinogen
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Candidate list - developments
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Commission want to accelerate the Authorisation process
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A further 106 substances ‘earmarked’ for inclusion on the candidate list
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Progress will be dependant on capacity of ECHA and Member states to
carryout necessary dossier XV work
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Annex XIV proposals
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Public consultation has just opened for eight substances identified for transfer to
Annex XIV
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Di isobutyl phthalate (DIBP)
Di arsenic trioxide
Di arsenic pentaoxide
Lead chromate
Lead sulphochromate yellow (C.I. pigment yellow 34)
Lead chromate molybdate sulphate red (C>I> pigment red 104)
Tris (2-chloroethyl) phosphate (TCEP)
2,4 - dinitro toluene
Consultation periods end 30th September 2010
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Restriction
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REACH adopted the existing restrictions on the chemicals that where
established under the marketing and uses directive
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Restrictions are placed in Annex XVII of REACH
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The Commission or Member States can propose new restrictions
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Restrictions
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New restrictions being considered:
– Near finalisation
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Acrylamide
Cadmium (brazing sticks and skin contact products)
Cadmium in PVC (effects of recycling)
1,4 dichlorobenzene (toilet blocks and air fresheners)
Tris (2-chloroethyl)phosphate (TCEP) (babies toys)
– Under consideration:
– Perfluorooctanoic acid and it ammonium salt (industrial process and consumer
articles)
– Phthalates (re-evaluation of existing measures adopted under Directive
2005/84/EC)
– Mercury in measuring instruments (industrial and professional use)
– Amending existing restriction on imported cement containing Chromium VI
– Short chain chlorinated paraffins (SCCPs)
– Lead & compounds in jewellery
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Supply chain communication
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Currently the safety data sheet (SDS) is the main vehicle for communication of
hazards and risks associate with chemicals
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REACH specifies when a SDS has to be supplied (Title VI) and through Annex II what
information has to be included
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Annex II has been reviewed (May 2010) but revision does not apply until 1st
December 2010
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Supply chain communication - SDS
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The supplier of a substance or a preparation shall provide the recipient with a safety
data sheet (SDS)
– Where a substance or preparation meets the criteria of classification as
dangerous in accordance with Directives 67/548/EEC or 1999/45/EC
– Where the substance is PBT or vPvB (as defined in Annex III of REACH)
– Where the substance is listed in the candidate list
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A supplier of a preparation which does not meet the criteria of dangerous (according
to directive 1999/45/EC) shall supply a recipient at his request with a SDS if the
preparation contains:
– An individual concentration of at least 0.1% by weight for non-gaseous
preparations and at least 0.2% by volume for gaseous preparations at least one
substance posing human health or environmental hazards or
– In an individual concentration of at least 0.1% by weight of a PBT or vPvB or
candidate list substance
– A substance for which there is a Community workplace limit
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Supply chain communication - SDS
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A supplier who is required to prepare an chemical safety report (CSR) in their registration shall
include in an annex to the safety data sheet (SDS) the relevant exposure scenarios (including use
and exposure categories where appropriate) generated in that CSR
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An e-SDS has some new elements to be integrated into the existing SDS system
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The e-SDS is expected to provide use related advice on the operational conditions (OC) and risk
management measures (RMM) suitable to control the risk of a substance
All identified uses relevant to the recipient must be included in section 1.3
the e-SDS must include relevant information to control risk through the whole life-cycle of the substance
The e-SDS should cover RMMs and OC’s related to workers, environment and consumers
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SDS must be provided either by paper or electronically, free of charge and in the language of the
recipient.
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Suppliers shall update an SDS without delay if:
– New information which may affect risk management measures becomes available
– If an authorisation has been granted or refused
– If a restriction has been imposed
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Exposure scenarios format - 1
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Exposure scenarios format - 2
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Exposure scenarios format - 3
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Downstream users and SDS
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DSU will
– need to identify which Exposure Scenario (ES) fits their operation.
– need to gather information on their own operational conditions and risk
management measures.
– need to compare their conditions with those in the ES and note any differences
– where differences exist they will need to apply scaling (if ES permits) to see if
differences can be covered.
– if they meet the ES they should document the process and continue to apply the
operational conditions and risk management measures
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If their use is not covered by an ES they must either:
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Change procedures inline with ES
Find a supplier with ES that fits their operation
Request existing supplier to produce a ES to fit their use
Substitute the substance
Carry out their own CSA and notify the Agency (applicable only where the use
exceeds 1tpa)
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The best option will depend on particular circumstances
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Enforcement activity
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Responsibility for enforcement of REACH remains with individual member states.
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Each MS has appointed a competent authority and legislated for sanctions that apply
to non-compliance
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In the UK the Regulations can be enforced not only by the HSE but by the
Environment Agency (and their regional equivalents) and for some misdemeanours,
by local authorities
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Potential sanctions are:
– Upto £5000 fine and/or 3months imprisonment for summary convictions
– Unlimited fines and/or upto 2 years imprisonment for indictment convictions
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The full enforcement regulation can be found at
http://www.opsi.gov.uk/si/si2008/uksi_20082852_en_1
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Enforcement activity
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MSCA’s co-ordinate their enforcement programme
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EN-FORCE-1: May 2009 - Jan 2010 - Focus on pre-registration and SDS compliance
• Of 1600 investigations non-compliance was found in 24 % of cases
• Extended to April 2011
• Current activity will continue in same areas but also look specifically at
restriction on use of PAH in tyres
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EN-FORCE-2: (in development)
• Focus on DSU compliance – in particular on formulators SDS compliance
and end use compliance
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Enforcement activity
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HSE activity
– 2009 18 improvement notices 1 enforcement notice
– 2010 (Jan – April) 5 improvement notices 1 enforcement notice
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HSE substance specific programme 2010
– Ammonium dichromate
– Methylene diphenyl di-isocyanate
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UKCA enforcement information: http://www.hse.gov.uk/reach/ourwork.htm
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