REACH – the horizon & beyond Simon Brearley The REACH Centre Ltd

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

Progress on Registration First phase-in deadline for registration – 1 st December 2010 Anticipated number of registrations – 25-75,000 for 2010 deadline substances Registration dossiers accepted for processing –2009 full 363intermediate394 –2010 (end May)full 343intermediate337

Registration deadline – 1 st 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. 1 st March 2011) for submissions on phase-in substances made within 2 months of the deadline

Registration deadline – 1 st Dec 2010 Where a dossier is submitted before 30 th 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 30 th September the registrant may not know if the registration is accepted until 1 st March If it is rejected then they are out of compliance with REACH (and have effectively been so since 1 st December 2010)!!

Progress on Registration 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 TopicDescriptionSolution outline SIEF operationLate 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 activitySIEF 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

Directors contact group –main issues TopicDescriptionSolution outline Dependency on LR by rest of SIEFIf 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 changeNeed 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 registrationDifficulties for SME’s who may need to complete CSA Solution awaited

Directors contact group –main issues TopicDescriptionSolution outline Completeness of dossiersTime 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

Progress on Registration 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 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 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 Acrylamide

Candidate list – June 2010 additions Trichloromethylene Cat 2 Carcinogen Boric acid / Cat 2 Repro-toxic Disodium tetraborate anhydrous Cat 2 Repro-toxic Tetraboron disodium heptoxide, hydrate Cat 2 Repro-toxic Sodium chromate Cat 2 CMR Potassium chromate Cat 2CMR Ammonium dichromate Cat 2 CMR Potassium dichromate 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 30 th 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 1 st 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

Exposure scenarios format - 2

Exposure scenarios format - 3

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

Enforcement activity MSCA’s co-ordinate their enforcement programme –EN-FORCE-1: May Jan 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 – 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: