REACH Implementation in INA

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REACH Implementation in INA
4 December 2009 Zagreb, Croatia Tatjana Benko,
SD HSE
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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

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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

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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

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List of INA pre-registered substances
SUBSTANCE NAME CAS NUMBER CROATIAN TRADE NAME
Propane, liquefied C3H8 74-98-6 Trgovacki propan Procišceni propan
Butane, pure C4H10 106-97-8 Procišceni butan Procišceni n-butan Trgovacki butan
Hydrocarbons, C3-4 68476-40-4 Propan butan smjesa
Gasoline, straight-run, topping-plant 68606-11-1 Primarni benzin
Gasoline 86290-81-5 Avionski benzin TIP 100 LL Motorni benzin s olovom SUPER 98, Bezolovni motorni benzini (3 vrste) Ekstrakt FCC benzina, FCC benzin izvoz
Fuel Oil No.4 270-673-5 Vakuum plinsko ulje
Kerosine (petroleum) 8008-20-6 Gorivo za mlazne motore JET A-1, Petroleji (za motore, bušotine i industrijski)
Kerosine (petroleum), hydrodesulfurized 64742-81-0 Gorivo za mlazne motore JET A-1, Petroleji (za motore, bušotine i industrijski)
Sulphur 7704-34-9 Sumpor
Fuels, diesel 68334-30-5 Brodska goriva destilatna Dizelsko gorivo (3 vrste) Loživo ulje ekstra lako LU EL Loživo ulje ekstra lako s 0,2 S i Loživo ulje ekstra lako s 0,3 S
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List of INA pre-registered substances
SUBSTANCE NAME CAS NUMBER CROATIAN TRADE NAME
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), calcined 64743-05-1 Kalcinirani naftni koks reg.-II
Asphalt, oxidized 64742-93-4 Bitumen
Isobutane 75-28-5 Procišceni i-butan (LOA)
Residues (petroleum), atmospheric 68333-22-2 Atmosferski ostatak ? late pre-registration
Naphtha (petroleum) isomerisation 64741-70-4 Izomerizat ? late pre-registration
Hydrocarbons, Cgt5, C5-6-rich 68476-50-6 Naphtha b-cut ?late pre-registration
Naphtha (petrolum) heavy catalytic reformed 64741-68-0 Platformat ? late pre-registration
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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

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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.

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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
• Technical documents
• - contains a set of information about identity
  of the M/I, identity of the substance, CL,
  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)

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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

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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 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

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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

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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

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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

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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

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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)

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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

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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.

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• Thank you very much for your attention!

Thank you very much for your attention!