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REACH Implementation in INA 4 December 2009 Zagreb, Croatia Tatjana Benko, SD & HSE REACH in Croatia Croatia is in a specific situation because it is still not a member of EU, but is expected to become in 2012 All Croatian companies which export substances on the EU market for pre-registration and for registration must to have OR (Only Representative) OR is a company from the EU OR and Croatian companies have an agreement about rights and obligations MOL, Plc. is OR for INA Plc. Other substances which are not exported to the EU market, INA will pre-register and register when Croatia becomes a member of EU Tatjana Benko, SD&HSE REACH - Registration, Evaluation, Authorization and restriction of Chemicals Content: Pre-registration & late pre-registration Registration Evaluation Authorisation Restriction SIEF and Consortium – Concawe, LOA SDS – Safety Data Sheet CLP- Classification, Labeling and Packaging Tatjana Benko, SD&HSE PRE-REGISTRATION & LATE PRE-REGISTRATION Pre-registration – The pre-registration period for all substances independed of volume and properties is over (1 June 2008 – 1 December 2008) After 1 December 2008 Companies who manufacture or import for the first time substance in quantities of ≥1t/y, can submit a late pre-registration provided they do so at least 12 months before the relevant transitional deadline period 30 November 2009 is late pre-registration deadline for substances which meet the REACH requirements for registration by 30 November 2010 (≥ 1000 t/y; ≥ 1t/y CMR; ≥ 100 t/y R50/53) free of charge Tatjana Benko, SD&HSE List of INA pre-registered substances SUBSTANCE CAS NAME NUMBER CROATIAN TRADE NAME Propane, liquefied 74-98-6 Trgovački propan; Pročišćeni propan C3H8 Butane, pure C4H10 106-97-8 Pročišćeni butan; Pročišćeni n-butan; Trgovački butan Hydrocarbons, C3-4 68476-40-4 Propan butan smjesa Gasoline, straight- 68606-11-1 Primarni benzin run, topping-plant Avionski benzin TIP 100 LL; Motorni benzin s olovom Gasoline 86290-81-5 SUPER 98, Bezolovni motorni benzini (3 vrste); Ekstrakt FCC benzina, FCC benzin – izvoz Fuel Oil No.4 270-673-5 Vakuum plinsko ulje Kerosine 8008-20-6 Gorivo za mlazne motore JET A-1, Petroleji (za motore, (petroleum) bušotine i industrijski) Kerosine Gorivo za mlazne motore JET A-1, Petroleji (za motore, (petroleum), 64742-81-0 bušotine i industrijski) hydrodesulfurized Sulphur 7704-34-9 Sumpor Brodska goriva destilatna; Dizelsko gorivo (3 vrste); Fuels, diesel 68334-30-5 Loživo ulje ekstra lako LU EL; Loživo ulje ekstra lako s 0,2% S i Loživo ulje ekstra lako s 0,3% S Tatjana Benko, SD&HSE List of INA pre-registered substances SUBSTANCE CAS CROATIAN TRADE NAME NAME NUMBER Fuel oil, residual 68476-33-5 Brodska goriva ostatna Fuel oil, no. 6 68553-00-4 Loživo ulje teško, LU T-II; Loživo ulje srednje, LU S-II Coke (petroleum) 64741-79-3 Zeleni naftni koks – II Coke (petroleum), 64743-05-1 Kalcinirani naftni koks reg.-II calcined Asphalt, oxidized 64742-93-4 Bitumen Isobutane 75-28-5 Pročišćeni i-butan (LOA) Residues (petroleum), 68333-22-2 Atmosferski ostatak → late pre-registration atmospheric Naphtha (petroleum) 64741-70-4 Izomerizat → late pre-registration isomerisation Hydrocarbons, 68476-50-6 Naphtha b-cut →late pre-registration C>=5, C5-6-rich Naphtha (petrolum) heavy 64741-68-0 Platformat → late pre-registration catalytic reformed Tatjana Benko, SD&HSE REGISTRATION REACH – DEADLINE FOR REGISTRATION Three registration periods which depend on volume and properties of substances 1) 30 November 2010 ≥1 t/y CMR ≥ 100 t/y very toxic for aquatic environment ≥1000 t/y 2) 31 May 2013 100-1000 t/y 3) 31 May 2018 1-100 t/y Deadline for INA substances is 30 November 2010. Without registration export to EU market will not be possible. Registration fee - for SUBSTANCES - joint submission 23 250 €/ substance - for INTERMEDIATE – 1200 €/ intermediate Tatjana Benko, SD&HSE INTERMEDIATES Intermediate is a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance (REACH definition). Types of intermediates: Non isolated intermediates Isolated intermediates a) On - site (transported) isolated intermediates b) Transported isolated intermediates SCC - Strictly Controlled Conditions INA has 4 transported isolated intermediates. We are waiting for SCC confirmation from our customers. Tatjana Benko, SD&HSE DOSSIER Registration includes creating dossier for substances IT tools for creating registration dossier: REACH - IT & IUCLID 5 → contains 8000 figures for each substance in 13 headings Dossier consists of two main parts: 1. Technical documents - contains a set of information about identity of the M/I, identity of the substance, C&L, guidance on its safe use, study summaries of the information on the intrinsic properties, proposals for further testing, exposure related information for substances in quantities between 1-10 t/y 2. Chemical Safety Report (CSR) is required for the substances produced in quantities above 10 t/y - the relevant information from the CSR is compiled into one or more exposure scenarios (ES) to be annexed to the extended safety data sheet (eSDS) EVALUATION of registration dossiers will be made by ECHA (European Chemical Agency) Tatjana Benko, SD&HSE CONSORTIUM INA is a member of two consortiums: 1. Concawe - CONservation of Clean Air and Water in Europe Dossiers in the field of petroleum industry will be prepared by Concawe members joint work Subgroups in Concawe: SDS; GHS/CLP; Health; Safety; IUCLID 5 Policies Team; Water Quality; Subgroup for analytical/phys - chem. properties; Ecology Group; Subgroup Trade Issues; Risk Assessment Coordination Group… INA has 19 substances in Concawe consortium. 2. LOA - Lower Olefins and Aromatics Reach Consortium CONCAWE has agreed to collaborate with LOA. The common parts of the registration dossiers for petroleum gases will be prepared by LOA. INA has only one substance in LOA (i-buthane) LPG will be hopefully exempt according to Annex V of REACH Regulation Tatjana Benko, SD&HSE WORKING IN CONCAWE CONCAWE will prepare the common parts of the Registration Dossiers for the following “categories of substances” 1. low boiling point naphthas / gasolines 2. kerosines 3. straight run gas oils 4. vacuum gas oils, hydrocracked gas oils and distillate fuels 5. cracked gas oils 6. other gas oils 7. heavy fuel oil components 8. white mineral oils 9. unrefined / acid treated oils 10. other lubricant base oils 11. foots oils 12. paraffin and hydrocarbon waxes 13. slack waxes 14. petrolatums 15. untreated distillate aromatic extracts 16. treated distillate aromatic extracts 17. residual aromatic extracts 18. bitumen 19. petroleum coke In addition CONCAWE will prepare the registration dossier for sulphur INA has substances in 7 Concawe categories Tatjana Benko, SD&HSE SIEF Substance Information Exchange Forum As the name suggests, SIEFs are there to ensure that data is shared SIEFs consist of companies that pre-registered substances with the same chemical identity, and other organizations that have indicated their own data on the substance. The Lead Registrant (LR) is a mandatory role in a SIEF When potential registrants in a SIEF have shared and assessed the available data, the LR prepares the common parts of their registration dossier, the so-called joint submission The various Substance Information Exchange Forum (SIEFs) for petroleum substances in the same category have been combined in “Super-SIEFs”. The 19 categories of petroleum substances are therefore being dealt with in 19 Super-SIEFs Tatjana Benko, SD&HSE Working in MOL Group MOL Group has 8 members (MOL, Plc., MOL DS, MOL-LUB, Slovnaft, SPC; IES-Mantova, INA, Plc., Maziva (Zagreb),TVK) Subgroups in MOL Group IUCLID 5 CLP SDS Change Management Data & Inventory Supplier Communication Customer Communication ACTIVITIES IUCLID 5 trainings Implementation ExESS application Substance Inventory Management System (SIMS) ExESS is an integrated IT solution in a chemicals Management concept ExESS SDS management Tatjana Benko, SD&HSE AUTHORIZATION In the next years more and more substances will appear on the “List of substances subject to authorization” (Annex XIV of REACH Regulation) This is for substances which are identified as Substances of Very High Concern (SVHC) Substances subject to authorization are mainly substances meeting criteria for classification, such as: 1. CMR (carcinogenic, mutagenic toxic for reproduction category 1 or 2 in accordance with Directive 67/548/EEC) 2. Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) according to the criteria in Annex XIII of the REACH Currently this list has 30 substances published on ECHA site Authorization fee 50 000 €/substance Tatjana Benko, SD&HSE RESTRICTION List of restricted chemicals is in Annex XVII REACH Regulation Restriction process to regulate the manufacture, placing on the market or use of certain substances if they pose an unacceptable risk to health or the environment Manufacturer and importer of chemicals must check this list in Annex XVII Information about marketing and use of chemical must be included in SDS Tatjana Benko, SD&HSE SDS – SAFETY DATA SHEET SDSs are governed by the REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) Regulation 1907/2006 not by the CLP Regulation 1272/2008 (Classification, Labeling and Packaging of substances and mixtures) FEES have to be paid for: - authorisation in Croatian Institute for Toxicology - translation in an official language of the Member State(s) where the substance or preparation is placed on the market, unless the Member State(s) concerned provide otherwise After registration, ES (Exposure Scenario) and CSR (Chemical Safety Report) have to be included in SDS and then we have an extended SDS (eSDS) Tatjana Benko, SD&HSE CLP – Classification, Labeling and Packaging substances and mixtures CLP regulation entered into force on 20 January 2009 CLP - new pictograms and new classification end terms CLP for all substances – deadline is 1 December 2010 CLP for all mixtures – deadline is 1 June 2015 Implementing REACH and CLP at the same time – complex operation with significant implication Tatjana Benko, SD&HSE CONCLUSION pre-registration and late pre-registration - free of charge Registration 23 250 €/substance (joint submission) 31 000 €/substance (individual submission) 1 200 €/intermediate Authorisation 50 000 €/substance Consortiums’ fee depend of each Consortium SDS costs of authorisation and translation it depends on size of text and number of languages REACH has a huge influence on chemicals’ market because it causes an increase of chemicals’ price. Tatjana Benko, SD&HSE Thank you very much for your attention! Tatjana Benko, SD&HSE
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