Classification & Labelling andECHA Support to Industry
Seminar to Japanese Industry on the EU
Chemicals Legislation: REACH, CLP &BPR
3 April 2015 / Tokyo, JapanPetteri Mäkelä
ECHA International Relations

CLP Regulation• Classification• Labelling• Packaging ofsubstances & mixtures
CLP entered into force inJanuary 2009

Introduces the GHS criteria
in the EU
PUBLIC

2

CLP transitional periods

Mixtures

Substances

1 Dec 2010

3 Jan 2011

1 June 2015

Deadline for notification tothe C&L Inventory
PUBLIC

3

ECHA’s main tasks under CLP• Classification and Labelling InventoryoNotifications on self-classifications of hazardoussubstances on the EU market• Proposals for Harmonised Classificationand Labelling (CLH)oRisk Assessment Committee (RAC)• 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
PUBLIC4

Harmonised Classification & Labelling• Harmonisation of classification at EU-level• CLP Regulation focuses on substances which
are of most concern to humansoCarcinogenic (C)oMutagenic (M)oReproductive toxicants (R)oRespiratory sensitisers (RS)• Active substances in plant protection
products (PPPs) and biocidal products (BPs)are normally harmonised• Legally binding - Annex VI to CLPPUBLIC

5CLH process overview
Main actors
Dossier submitter (EU Member states or industry)

ECHA/RAC
Parties Concerned
European Commission

PublicDossier
preparation

Consultation

RAC opinion

45 daysAnnex VI to CLP bythe Commission

Max 18 months to adopt anopinion

PUBLIC

6

Harmonised C&L - status• Annex VI to CLPo

Around 4,500 entries

oNew entries included by Adaptation to TechnicalProgress (currently 4 ATPs)• 151 RAC opinions adopted• 269 CLH proposals under processing• 42 intentions in the registry• Annex VI and ATPs should be available on
our website in a database format soon
PUBLIC7

Classification and Labelling Inventory
Manufacturers/Importers are obliged to notify
oAll hazardous substances (under CLP), ando

All substances subject to REACH registration…
…which are placed on themarket

Notifications should containoSubstance IdentityoClassification and Labelling according to CLP

ECHAomaintains a public classification and labellinginventory in the form of a database
PUBLIC8

Classification and Labelling Inventory• Notifications to the C&L Inventory
oCurrently over 6 million notifications for over 110,000
substances• C&L Inventory available since Feb 2012:
oUp-to-date information on the substances on the EUmarket

PUBLIC

9

C&L Inventory
Includes1. Industry selfclassificationoMost of thesubstances

2.EU harmonisedclassification
oCertain CMR

substances

PUBLIC

10

Risk reduction based on classification
Labelling&SDS

Pesticides &biocides

REACH

Classification

Hazardous
waste

Storage &transport

SVHC

Restrictions
Cosmetics
PUBLIC

Workingenvironment
11

ECHA & industry challenges in 2015
Classification and labelling•June 2015 deadline for mixture classificationoAs the number of products to be reclassified and relabelled is enormous
this poses a real challenge to industry, and in particular to SMEs

•Agreement on self-classifications
ooIndustries do have different classifications for the same substance inabout 25% of the cases
Stimulating industry to come to an agreement on the classification•Harmonised classification of pesticides and biocidesoo

The timelines under different regulations differ considerably
ECHA cooperates with Member States & European Food Safety Authority(EFSA) to align the processes•Prioritisation of substances
oECHA screens together with Member States the databases to identify
priority substances and decides which regulatory risk management
would be most appropriate
PUBLIC

12

CLP 2015 TOOL KIT• Key messages• video• web banner• poster• leaflet• PPT presentation• email signature• specific webpages

Communication tools
to be used by ECHA’s
communication
partners & in different
contexts

PUBLIC

13

REACH, CLP & Biocides• Require ECHA toprovide:
otechnical andscientific guidanceand tools

oHelpdesk support

oexplanatory
information

ECHA Actively Support Duty Holders

Navigator Helps industry todetermine obligations under REACH
PUBLIC

15

ECHA / Authorities

INDUSTRY(Draft) Decisions
Reports

CASPER

Workflow
Dissemination

PUBLICPUBLIC

16

ECHA Helpdesk
Assisting companies: Regulatory/technical advice
1st level
The Helpdesk takes care ofall questions

2nd level
ECHA experts contribute toanswering questions, if
needed3rd level
COM provides legal
interpretation and theexternal IT service provider
fixes bugs as the last resort

PUBLIC17

Japanese questions

PUBLIC

18

ECHA
Statistics
OriginHelpdeskof the received
REACH, CLP & BPR questions(January 2013 - present)** and territories
PUBLIC

19

Guidance• Assist stakeholders in implementing theirobligations – but not legally binding
oDeveloped with stakeholders to ensure broad
support of all important players

oDocuments are updated• Shows the “safest” way for industry tofulfil their obligations

PUBLIC

20

PUBLIC21

• REACH, CLP & BPR
oterms and definitions

o22 languages• Search & consultation• Around 1,000 entries•Users in 60 countries
around the globe•Typically 350 queries/d•> 600 registered users• Data export possiblehttp://echa.cdt.europa.eu
PUBLIC22

Worth to Remember• GHS criteria applies already tosubstances and start applying to mixturesin 2015• Over 4,000 substances have
harmonised EU C&L• Public C&L Inventory provides
information on over 100,000 substances• Update of IT tools in 2016
• IT is essential for functioning of the EU
chemicals legislation• ECHA provides extensive guidance andIT tools free of charge

petteri.makela@echa.europa.eu

Thank you !