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REACH Implementation in INA

REACH Implementation in INA. 4 December 2009 Zagreb, Croatia Tatjana Benko , SD & HSE . Croatia is in a specific situation because it is still not a member of EU, but is expected to become in 2012

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REACH Implementation in INA

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  1. REACHImplementation in INA 4 December 2009 Zagreb, Croatia Tatjana Benko, SD & HSE

  2. 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 REACH in Croatia

  3. Content: Pre-registration & late pre-registration Registration Evaluation Authorisation Restriction SIEF and Consortium–Concawe, LOA SDS – Safety Data Sheet CLP- Classification, Labeling and Packaging REACH - Registration, Evaluation, Authorization and restriction of Chemicals

  4. Pre-registration – The pre-registration period for all substancesindepended 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 least12 months before the relevant transitional deadline period 30 November 2009 is late pre-registration deadlinefor 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 PRE-REGISTRATION & LATE PRE-REGISTRATION

  5. List of INA pre-registered substances

  6. List of INA pre-registered substances

  7. REACH – DEADLINE FOR REGISTRATION Three registration periods which depend on volumeand 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 2013100-1000 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 REGISTRATION

  8. 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. INTERMEDIATES

  9. 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: 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 oneor 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) DOSSIER

  10. 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 CONSORTIUM

  11. 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 oils4.   vacuum gas oils, hydrocracked gas oils and distillate fuels  5.   cracked gas oils   6.   other gas oils7.   heavy fuel oil components  8.   white mineral oils  9.   unrefined / acid treated oils 10.   other lubricant base oils11.   foots oils12.   paraffin and hydrocarbon waxes13.   slack waxes 14.   petrolatums15.   untreated distillate aromatic extracts16.   treated distillate aromatic extracts17.   residual aromatic extracts18.   bitumen19.   petroleum coke In addition CONCAWE will prepare the registration dossier for sulphur INA has substances in 7 Concawe categories WORKING IN CONCAWE

  12. Substance Information Exchange Forum As the name suggests, SIEFs are there to ensurethat 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 aSIEF 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 SIEF

  13. 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 Working in MOL Group

  14. In the nextyears 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 AUTHORIZATION

  15. 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 RESTRICTION

  16. SDSs are governed by the REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) Regulation 1907/2006 notby 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) SDS – SAFETY DATA SHEET

  17. 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 significantimplication CLP – Classification, Labeling and Packaging substances and mixtures

  18. pre-registration and late pre-registration - free of charge Registration 23 250€/substance (joint submission) 31000 €/substance(individual submission) 1 200 €/intermediate Authorisation 50 000 €/substance Consortiums’ fee depend of each Consortium SDScostsof authorisation and translation it depends on sizeof text and number of languages REACH has a huge influence on chemicals’ market because it causes an increase of chemicals’ price. CONCLUSION

  19. Thank you very much for your attention! Thank you very much for your attention!

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