REACH – the horizon & beyond

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REACH – the horizon & beyond

Simon Brearley

The REACH Centre Ltd

WWW.THEREACHCENTRE.COM

Topics

• Registration update• Intermediates• SVHC & Authorisation• Restrictions• Supply chain communication• Downstream user roles & obligations• Enforcement


Progress on Registration

Pre-registration

• 2.7 million pre-registrations

• 67,000 companies

• 143,000 pre-registered substances

• 55,000 with indicated 2010 registration deadline



• First phase-in deadline for registration – 1st December 2010

• Anticipated number of registrations – 25-75,000 for 2010 deadline

• 5 -7000 substances

• Registration dossiers accepted for processing

– 2009 full 363 intermediate 394

– 2010 (end May) full 343 intermediate 337


Registration deadline – 1st Dec 2010

• A registration dossier is submitted to the Agency by every registrant via REACH IT using IUCLID5

• Agency on receipt of dossier issues a submission number and submission date

• Agency have 3 weeks to carry out a completeness check (includes checking receipt of fee!). If OK then Agency issue a registration number

• If dossier is not complete then Agency requests additional information and when this is provided the 3 weeks check time starts again.

• If no contact within 3 weeks then potential registrant is free to start/continue the manufacture/import of the substance

• A second failure leads to rejection of dossier and a re-submission has to be made

• 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


Registration deadline – 1st Dec 2010

• 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

• 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)!!



• 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


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.

Parallel submission being allowed

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




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




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



• Implications for chemical users:– Loss of supply– Non-compliance– Customer concern/loss

• 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

• List currently contains ~5000 substances


Intermediates

• 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)

• Non-isolated intermediates – exempt

• On- site isolated intermediates (production and synthesis take place on the same site) – reduced hazard data set requirements

• 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


Intermediates

• 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

• ECHA are paying particular attention to Intermediate registrations


Authorisation

• 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.

• The ECHA & MS generate a candidate list of substances considered for authorisation

• On a rolling programme EU Commission will decide to transfer in the list of authorised substances (Annex XIV) with a ‘sunset date’

• 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).

• Applicant will need to demonstrate ‘safe use’ (may not be possible) and/or justify use on socio-economic grounds.

• Considerations of alternatives and plans for substitution will need to be submitted.

• Authorisations are subject to review .


Authorisation

• Recent statements from EU Commissioners for Environment and Industry have agreed a common interpretation of the Regulation

• This confirms that substance use may be authorised if socio–economic benefits outweigh the risks linked to them

• Reinforces the need to explore substitution options and to develop substitution strategies

• Confirms the long term goal remains removal from market place


Scope of Authorisations• Substances used in R&D programmes are not covered by Authorisation

• Use of substances for PPORD (product and process orientated research & development) may be excluded from Authorisation on a case by case basis

• Authorisation does not apply to use of substance in – 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.

• Where the Authorisation relates to CMR or other Human health properties only the Authorisation does not apply to use in

– 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:

– For PBT and vPvB substances that are present below a concentration of 0.1% (w/w)

– 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


Candidate list – initial

• 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


Candidate list – Jan/March 2010 additions

• 2,4 dinitrotoluene 204-450-0• Anthracene oil 292-602-7• Anthracene oil,anthracene paste, distn,Light 295-278-5• Anthracene oil, anthracene paste, 295-275-9

anthracene fraction• Anthracene oil, anthracene low 292-604-8• Anthracene oil, anthracene paste 292-603-2• Diisobutyl phthalate 201-553-2• Aluminosilicate, refractory ceramic fibres -• Zirconia, Aluminosilicate, refractory ceramic fibres -• Lead Chromate 231-846-0• Lead chromate, molybdate sulphate red 235-759-9• Lead sulphochromate yellow 215 693-7• Tris(2-chloroethyl)phosphate 204-118-5 • Coal tar pitch, high temperature 266-028-2

• Acrylamide 201-173-7


Candidate list – June 2010 additions

• Trichloromethylene 201-167-4 Cat 2 Carcinogen

• Boric acid 233-139-2/234-343-4 Cat 2 Repro-toxic

• Disodium tetraborate anhydrous 215-540-4 Cat 2 Repro-toxic

• Tetraboron disodium heptoxide, hydrate 235-73-1 Cat 2 Repro-toxic

• Sodium chromate 231-889-5 Cat 2 CMR

• Potassium chromate 232-140-5 Cat 2CMR

• Ammonium dichromate 232-143-1 Cat 2 CMR

• Potassium dichromate 231-906-6 Cat 2 CMR


Candidate list - developments

• Commission want to accelerate the Authorisation process

• A further 106 substances ‘earmarked’ for inclusion on the candidate list

• Progress will be dependant on capacity of ECHA and Member states to carryout necessary dossier XV work


Annex XIV proposals

• Public consultation has just opened for eight substances identified for transfer to Annex XIV

– 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


Restriction

• REACH adopted the existing restrictions on the chemicals that where established under the marketing and uses directive

• Restrictions are placed in Annex XVII of REACH

• The Commission or Member States can propose new restrictions


Restrictions

• New restrictions being considered:

– Near finalisation– 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


Supply chain communication

• Currently the safety data sheet (SDS) is the main vehicle for communication of hazards and risks associate with chemicals

• REACH specifies when a SDS has to be supplied (Title VI) and through Annex II what information has to be included

• Annex II has been reviewed (May 2010) but revision does not apply until 1st December 2010


Supply chain communication - SDS

• 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

• 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


Supply chain communication - SDS

• 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

• An e-SDS has some new elements to be integrated into the existing SDS system

– 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

• SDS must be provided either by paper or electronically, free of charge and in the language of the recipient.

• 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


Exposure scenarios format - 1






Downstream users and SDS• 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

• If their use is not covered by an ES they must either:– 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)

• The best option will depend on particular circumstances


Enforcement activity

• Responsibility for enforcement of REACH remains with individual member states.

• Each MS has appointed a competent authority and legislated for sanctions that apply to non-compliance

• 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

• Potential sanctions are:– Upto £5000 fine and/or 3months imprisonment for summary convictions– Unlimited fines and/or upto 2 years imprisonment for indictment convictions

• The full enforcement regulation can be found at http://www.opsi.gov.uk/si/si2008/uksi_20082852_en_1


Enforcement activity• MSCA’s co-ordinate their enforcement programme

– 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

– EN-FORCE-2: (in development)

• Focus on DSU compliance – in particular on formulators SDS compliance and end use compliance


Enforcement activity

• HSE activity– 2009 18 improvement notices 1 enforcement notice– 2010 (Jan – April) 5 improvement notices 1 enforcement notice

• HSE substance specific programme 2010– Ammonium dichromate– Methylene diphenyl di-isocyanate

• UKCA enforcement information: http://www.hse.gov.uk/reach/ourwork.htm

Documents

REACH – the horizon & beyond