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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

REACHImplementation 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

REACH in Croatia
reach r egistration e valuation a uthorization and restriction of ch emicals
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
pre registration late pre registration
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
registration
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
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.

INTERMEDIATES
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, 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
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

CONSORTIUM
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 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
slide12
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
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

Working in MOL Group
authorization
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
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

RESTRICTION
sds s afety d ata s heet
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
clp c lassification l abeling and p ack ag ing 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 significantimplication

CLP – Classification, Labeling and Packaging substances and mixtures
conclusion
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
slide19
Thank you very much for your attention!

Thank you very much

for your attention!