Classification & Labellingand ECHA Support toIndustry
The Latest Trends in the EU
Chemicals Management: REACH, CLP &BPR
Petteri Mäkelä

CLP Regulation• Classification• Labelling• Packaging ofsubstances & mixtures
CLP entered into force inJanuary 2009
Introduces the GHS criteria
in the EU
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CLP transitional periods

Mixtures
Substances
1 Dec 2010

3 Jan 2011

1 June 2015

Deadline for notification tothe C&L Inventory
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ECHA’s main tasks under CLP• Classification and Labelling InventoryoNotifications on self-classifications of hazardous
substances on the EU market• Proposals for Harmonised Classificationand Labelling (CLH)oRisk Assessment Committee• Applications for Alternative chemicalnames for substances in mixtures
oFormulators of mixtures apply for use of alternative
names for hazardous substances on labels and safety
data sheets
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Harmonised Classification & Labelling• Harmonisation of classification at EU-level• CLP Regulation focuses on substances which
are of most concern to humans
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Carcinogenic (C)Mutagenic (M)Reproductive toxicants (R)Respiratory sensitisers (RS)• Active substances in plant protection
products (PPPs) and biocidal products (BPs)are normally harmonised
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CLH process overview

Main actors

Dossier submitter (Member states or industry)
ECHA/RAC
Parties Concerned
European Commission

Dossierpreparation

PublicConsultation
45 days

RAC opinion

Annex VI to CLP bythe Commission

Max 18 months to adopt anopinion

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Harmonised C&L - status• ~100 RAC opinions adopted• ~100 CLH proposals under processing• Annex VI to CLPOver 4,000 entries
o New entries included by Adaptation to technical progress(currently three ATPs)oPUBLIC

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Classification and Labelling InventoryManufacturers/Importers are obliged to notifyooAll hazardous substances (under CLP), andAll substances subject to REACH registration…
…which are placed on the market

Notifications should containooSubstance Identity
Classification and Labelling according to CLP

ECHAomaintains a public classification and labellinginventory in the form of a database
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Classification and Labelling Inventory• Notifications to the C&L Inventory
oCurrently over 6 million notifications for over 120,000
substances• C&L Inventory available since Feb 2012:oUp-to-date information on the substances on the EUmarketPUBLIC

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Public Classification & Labelling inventory

Contains information on 110,000 substances

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on notified substances• And on harmonised entries according to CLP Regulation

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REACH, CLP & Biocides• Require ECHA toprovide:o technical andscientific guidance
and tools
o Helpdesk support
o explanatory

informationecha.europa.eu

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INDUSTRY(Draft) Decisions
Reports

CASPER

Workflow
Dissemination

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14PUBLICIUCLID 5• IT application to collect,store & exchange
information on chemicals• Designed to serve
REACH & otherregulatory programmes
ooOECD HPV Chemicals
EU Biocidal Products• Key tool for industry insubmitting data to ECHAPUBLICWebsite:www.iuclid.eu
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Where to get IUCLID

Available free of charge on the IUCLID 5
website at:
http://iuclid.eu

Accessible via the ECHA website
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ECHA makes its work available globally• IUCLID• Developed in coordination with OECD to promote global use• Core: OECD Harmonised templates for reportingchemical properties in a standard way and ensuring dataexchange• 50,000 users worldwideUserrequirementsIndustry

IUCLID 5 is used for different
chemical programmes, e.g.

Regulatory
Authorities• OECD HPVC Program• US HPV Challenge Program• Japan HPV Challenge Program• Swiss new chemicals notification• EU Biocidal Products Regulation• EU REACH• EU CLP

OECD

OECD IUCLID User
Group Expert Panel
Development
IUCLID Helpdesk

ECHAPUBLIC

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In progress: IUCLID 6Full modularity and customisation:
templates and user interface can becustomised for individual regulations

Concept

IUCLID core

• IUCLID templates

Modularity• Specific templates
for legislations

Transversalfunctions• OECD Harmonised
Templates

Biocides- Prod. composition- Packaging

REACH- Est. quantities- InquiryJapan- Document#1- Document#2• Printing / Reporting• Validation• Filtering

Search, datamining

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Generation of Removing
confidential
reports,
info. forprinting
publication

Validation ofinformation:
information
requirements
fulfilled,quality ofprovided data

REACH plug-ins•

Technical
completeness check•Fee calculation•

Dissemination•

Chemical safety
report•Dossier Quality
Assistant

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Where to get support?

Support section on IUCLID 5 website
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REACH-IT• Web based application• Ensure IT-support for the implementationof the new EU chemicals legislation• Daily workflow in ECHA and MemberStates• The main objectives:
oEnable ECHA to receive, process and store dossiers andoEnable the dissemination of non-confidential registration
dossier data and other relevant data

payments

REACH-IT Overview
Industry

Agency / Member States

PublicCompany
homepage

ECHA / MSCA
homepage

Dissemination
homepageCompany sign-up

Submit dossier

Pre-registration
Pre-SIEF participation
Dossier submission
Joint submission
Invoice downloadConsultation
Submission status
NONS Claim
Legal entity management
Search and view

Dossier management
Invoice management
Dissemination
Search & View
Administrative functions
Confidentiality
assessment workflow
Comments
Communications anddecisions

REACH-IT

Dissemination
data:
SearchView
Publicconsultation

CHESAR(CHEmical Safety Assessment and Reporting tool)• Purpose:• REACH requires ECHA tosupport registrants for
preparing their CSR• Links to:• IUCLID• Users:• Registrants
www.chesar.echa.europa.eu
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PUBLICeChem portal• OECD project• Free public access to
information onchemicals• Search
simultaneously
multiple databasesaround the world

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Global Use of eChemPortal
The top ten visitors are: USA, Germany, Japan,France, UK, Italy, India, Canada, China and South Korea

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QSAR Toolbox• Purpose:oSoftware for groupingchemicals into categories
and filling (eco)toxicity
data gaps for assessing
the hazard of chemicals• Links to:oIUCLID; upload of own
experimental databases
possible• Users:
oECHA, industry,authorities …

www.qsartoolbox.org
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PUBLICNavigator• Helps industry to determine its obligations
under REACH• Find the appropriate guidance on how tofulfil obligations• Updated when Guidance is updated• A Navigator session applies to a specificsubstance

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• REACH, CLP & BPR
ooterms and definitions
22 languages• Search & consultation• Around 1,000 entries•Users in 60 countries
around the globe•Typically 350 queries/d•> 600 registered users• Data export possible
http://echa.cdt.europa.eu
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REACH & CLP

ECHA Helpdesk

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ECHA Helpdesk

Assisting companies: Regulatory/technical advice
1st level
The Helpdesk Unit takes
care of all questions
2nd level
ECHA experts contribute toanswering questions, ifneeded
3rd level
COM provides legal
interpretation and theexternal IT service provider
fixes bugs as the last resort
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ECHA Helpdesk Statistics

Origin of the received REACH, CLP & BPR questions(January 2013 - present)** And territories

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Guidance• Assist stakeholders in implementing theirobligations – but not legally bindingo Developed with stakeholders to ensure broad

support of all important players
o Documents are updated• Shows the “safest” way for industry tofulfil their obligations
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ECHA Actively Support Duty Holders

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Worth to Remember• GHS criteria applies already tosubstances and start applying tomixtures in 2015
• Over 4,000 substances have
harmonised EU C&L• Public C&L Inventory provides
information on over 100,000substances• IT is essential for functioning of theEU chemicals legislation• ECHA provides extensive guidanceand IT tools free of charge
petteri.makela@echa.europa.eu

Thank you !