REACH Implementation in INA - Biznet by ert554898

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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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