CLP – the implementationof GHS in the EU
Facts and practical advice
Seminar on the latest trend
regarding revised CSCL, REACH
and CLP
30 March 2010, Tokyo
Gabriele Schöning
ECHA – Classification Unit

Content
•
•
•
•
•
•

Basis facts about CLP
Harmonisation of Classification and Labelling (CLH)
C&L notifications
Alternative chemical name
CLP enforcement
Guidance and Support by ECHA

http://echa.europa.eu

Basic facts about CLP• What is CLP?
• Relation to REACH• ECHA’s Role

CLP Regulation• Regulation (EC) No 1272/2008 on Classification,
Labelling and Packaging entered into force on 20
January 2009
• Replaces– Directive 67/548/EEC (Dangerous Substances Dir., DSD)
– Directive 1999/45/EC (Dangerous Preparations Dir., DPD)
– REACH, Title XI (Classification & Labelling)• Transitional period 2010 – 2015
– Both classification systems to be usedNew hazard pictograms
Physical hazards

Explosive

Flammable

Environmental hazards

OxidisingGases
under pressure

Health hazards

Acute Toxicity
Category 1-3

Serious
Health hazard
Health hazard

Corrosive

Hazardous
to the environment

New classification criteria
Different classification criteria and concentration limits– Explosives (criteria)– Acute toxicity (criteria: new cut-off limits)– Reproductive toxicity(concentration limits for mixtures)– Skin corrosion/irritation (criteria for irritation)– Serious eye damage/eye irritation (criteria for eye irritation)

New classification criteria
Example: Acute toxicity

EU

Very toxic
< 25

Toxic
> 25 - 200

Harmful> 200 - 2000

200 - 300

GHS

Category 1<5Category 2> 5 - < 50

Category 3> 50 - < 300

2000 - 5000

Category 4> 300 - < 2,000

H

Category 5 - option> 2,000 - < 5,000

No Pictogram

What are the time lines?
1) CLP entered into force 20 Jan. 2009.
2) Substances to be classified &labelled according CLP by 1 Dec. 2010
+ Notification to C&L inventory 1 monthafter placing a substance on the market.
3) Mixtures to be classified & labelledaccording CLP criteria by 1 June 2015

2009
1
2

NEW!
3

2015

Transitional provisions:
Substances
CLP entry into force
20.1.2009

Only DSD
used

DSD and
CLP usedIn parallel

1.12.2010

1.6.2015

DSD
Classification,
Labelling andPackaging

DSD
Classification only*

DSD
Classification only*

DSD
Classification only*

CLP Regulation
Classification, Labelling andPackaging

CLP Regulation
Classification, Labelling and Packaging* Applied in practice in the Safety Data Sheet (SDS)

CLP = Regulation (EC) No 1272/2008
DSD = Directive 67/548/EEC

Transitional provisions:
Mixtures
CLP entry into force
20.1.2009

1.6.2015

DPD
Only DPD
Labellingused before Classification,
and Packaging
1.6.2015

DPD + CLP
used inparallelbefore1.6.2015

CLP Regulation
Classification, Labelling andPackaging

DPD
Classification only*
CLP Regulation
Classification, Labelling and Packaging* Applied in practice in the Safety Data Sheet (SDS)

CLP = Regulation (EC) No 1272/2008
DPD = Directive 1999/45/EC

Common objectives of REACH & CLP• High level of protection of human health andenvironment• Free movement of substances, mixtures and articles on
the European market• Enhance competitiveness and innovation• Promote alternative methods for assessment of hazards

European Union
Objective of EU Chemicals Legislation (REACH and CLP)••High level of protection to health and environment
Prevention of barriers to single European market

27 Member States
3 Candidate countries
23 languages

REACH links to Classification &Labelling
REACH does NOT include CRITERIA for C&L••

It refers to:– Substance classificationa Directive 67/548/EEC– Preparation classificationa Directive 1999/45/EC– Safety Data Sheets

a REACH Annex II

But has links to C&L– Registration– Information in the supply chain– C&L Inventory – REACH Title XI à moved to CLP Title V

REACH vs. CLP – Main processes•

REACH: Registration,
Evaluation, Authorisation andRestriction of Chemicals– Registration: Dossiers as
the repository of
information on substances– Evaluation: Dossier
evaluation and substanceevaluation– Authorisation andRestrictions to guarantee
safe use of chemicals•

CLP: Classification, Labellingand Packaging of Substancesand Mixtures– Harmonisation ofClassification and Labelling– Notification of C&L of
substances– Request for use of analternative chemical namefor a substance in a
mixtureECHA’s role under CLP•Manage proposals for harmonised C&L (CLH)•Develop and manage the C&L inventory•Handle requests for use of alternative names•ECHA Forum co-ordinates enforcement activities•Receive MS reports on control & enforcement•Provide guidance and support•C&L awareness•Carry out a study on communication of safe use

Main Industry Responsibilities under CLP• Manufacturers, importers and downstream users shallclassify substances and mixtures before placing them on
the market• If a harmonised classification is available, this shall be
used• Suppliers placing a substance or a mixture on themarket, shall label and package them in accordance withthe classification• (Group of) manufacturers or importers placing asubstance on the market shall notify the Agency

Harmonisation of Classification

C&L Harmonisation• Agreement at EU level on classification• List of harmonised C&L (Annex VI, C&L Inventory)• Suppliers obliged to classify & label accordinglyHarmonisation procedure• Right of initiative– Member State Competent Authorities– Manufacturers, Importers, Downstream Usersi• ECHA: Scientific opinion by Risk Assessment Committeei• Commission decision via Comitology

Harmonisation of C&L (CLH)• Proposals may be submitted by– MSCAs– Industry (Manufacturers/Importers, Downstream Users)• Which types of substances?
– Carcinogenic, Mutagenic, Toxic to Reproduction, Respiratory
Sensitizers– Other hazard classes on case-by-case basis– Pesticidal & biocidal active substances• How many?
– Estimated 90 proposals per year

CLH: Notification of intention• MSCAs & industry are requested to notify intentions topropose harmonised C&L– Web-form available• ECHA checks substance ID• ECHA consults MSCAs via CIRCA• ECHA publishes Register of Intentions– Allows parties concerned to provide information to dossier submitter– Allows parties concerned to prepare for commenting

http://echa.europa.eu/chem_data/reg_int_tables/reg_int_curr_int_en.asp

Risk Assessment Committee (RAC) opinion
Proposal received at ECHAi
Accordance check (RAC rapporteur)i
Publication for commentsi
RAC evaluation of scientific informationi
RAC opinion

CLH Proposals• Notifications of intention*– Total No of intentions:– Proposals submitted:– Intentions withdrawn:– Submissions in 2008:– Submissions in 2009:– Submissions in 2010:

85
56
6
14
33
9

• Harmonisation status– Publication of harmonisation proposals:
Completed: 19
Ongoing: 4– Adoption of RAC opinions: 6– Commission decision (update of Annex VI): pending (1 ATP/year)* As of 18 March 2010

C&L Notification• Basic facts about C&L notification under CLP• Practical steps for the notification• Details of the notification tools and practical manuals

C&L Notification – Who?
• “Any manufacturer or importer, or group of
manufacturers or importers … who place on the market
a substance … shall notify to the Agency …” (CLP, Art.
40(1))• Group of Manufacturers / Importers– Corporate company with different legal entities– Several companies with no specific links– SIEF– Joint Submission …
that agree on a common C&L for the same substance• C&L for a same substance should be agreed (Art. 41)

Only Representatives (OR)?
• Only Representatives under REACH– ORs of non-EU manufacturers can fulfil all obligations ofimporters under REACH, incl. register substances– Importers are then relieved from their obligation to register thesubstances imported• Only Representatives under CLP?
– ORs have no role under CLP, and are not entitled to notify C&L
on behalf of importers– Importers need not notify the C&L, if the substance has beenregistered by OR– If OR is also importer, he can notify C&L on behalf of “Group of
Manufacturers / Importers”

C&L Notification - What and When?
• Which substances? (CLP, Art. 39)– Substances subject to registration under REACH and placed on
the market– Other substances meeting classification criteria and placed on
the market on their own or in a mixture above concentration limit→ Note! No tonnage trigger!

• Exemptions– No notification is required, if the same information has alreadybeen submitted as part of a registration dossier• Deadline for C&L notification– Within 1 month after placing on market on or after 1/12 2010
– First deadline: 3 January 2011

“Placing on the market”
The moment of “placing in the market” is when thesubstance/mixture is introduced physically in thecustoms territory of the Community. So the one monthnotification "delay" applies from the moment theimporter physically introduces the substance/mixture in
the customs territory of the Community.

Practical steps for the notification (I)• Practical guide 7: How to notify substances to theClassification & Labelling Inventory– Will be available on the CLP section of ECHA web site in mid April• Basic information on C&L notification, e.g.
– Helps to identify industry obligations– Provides general information on notification and the Inventory– Advises how to prepare for C&L notification– Describes basic features of the different notification tools (incl.
limitations)– Includes useful links to related guidance and other documents

Practical steps for the notification (II)• Which information is required?
– Name and contact details of the notifier– Identity of the substance (sections 2.1 to 2.3.4 ofAnnex VI of REACH)– Classification of the substance according to CLP– “Reason for no classification”– SCLs or M-factors and justification– Label elements (hazard pictograms, signal words,
hazard statements and supplemental hazard
statements)

How to prepare for notification (I)
1. List the substances and mixtures you manufacture or import
2.

Clarify if any are exempted from CLP (cf. Art 1)

3. Check if any are subject to REACH registration
4. Collect all information on your substances’ identity and composition
5. Name your substances in line with the guidance on SID
6. Check if your substances are listed in Annex VI to CLP
7. Gather all available and reliable information on the hazardous
properties of your substance if the C&L is not harmonised

How to prepare for notification (II)8. Classify your substances by comparing the available information
with the classification criteria
9. Prepare a scientific justification if you specify a M-factor or set a
specific concentration limit (SCL)

10. Decide if you want to establish or join a group of manufacturers
and/or importers
11. Create your C&L notification in the appropriate format
12. Create your REACH-IT account (if not done already) and submit
your notification

Details of the notification tools• Different tools for preparing C&L notifications– IUCLID 5– XML creation and Bulk Submission (for companies with many
notifications)– Online creation and submission via REACH-IT (for companies
with few notifications, e.g. SMEs)• ECHA manuals will be available

Group of Manufacturers/Importers• REACH-IT Industry User Manual, Part 15– Stepwise guide on managing your group– Several screenshots on REACH-IT– Clear indication of possible actions in creation, management andgroup/member details pages• Content– Introduction and concept of group of MI– Navigation overview of the module– Step by step instructions to manage and create new groups;– Common error messages

Group of MI - Example (I)Notification tools: IUCLID 5.2• REACH-IT Industry User Manual, Part 12– Stepwise guide on C&L notification creation and submission– More than 90 screenshots– Active links to other parts of REACH-IT and ECHA guidance• Content– Introduction, creation of Legal entity– Creation of a reference substance and a substance dataset– Details of IUCLID 5.2 sections to be completed– Creation of a dossier using the “CLP notification” template– Export of the notification dossier– Update of a C&L notification dossier– Submission in REACH-IT

IUCLID 5.2 - Example (I)IUCLID 5.2 - Example (II)Notification tools: Bulk submission• Objectives:– Submit in one shot many notifications– Dump C&L from centralised data base
– Reduce the number of submissions• xml file submitted via REACH-IT• ECHA will provide an Excel tool for data creation andtransfer to xml– Will be available in mid AprilBulk submission tool - Limitations• The xml bulk submission can be used only under thefollowing strict conditions:– Substances notified must be identified by CAS or EC number,– Only one composition for each substance,– Not usable if the notifier wants to set an M factor (if not already inAnnex VI to CLP)
– Not usable if the notifier wants to specify a SCL for other hazard
classes than the one already given in Annex VI to CLP
regulation

Bulk submission – Example

Notification tools: On-line notification••••

SMEs… but not only
No need to use IUCLID 5
C&L notification prepared directly in REACH-IT
Pragmatic approach :Þ Reduced fields
Þ On-line help and guide along the wizard
Þ Compulsory fields
Þ Link with the C&L inventory (incl. Annex VI)
Þ “I agree” conceptÞ Generate a IUCLID 5 dataset that you can reuse later• Available in June 2010

On-line notification - Example

Conclusions• IUCLID 5.2 available since 15 February 2010
• Bulk submission and Management of groups ofmanufacturers/importers in REACH-IT since March 2010
• On-line notification will be available in June 2010
• All notification tools compatible with each other• Start preparing your C&L Notifications NOW“Don’t wait until the last minute”

Alternative chemical name

Alternative chemical name (I)• Identifier to be used for a substance in a mixture on thelabel and Safety Data Sheet (Article 24 of CLP)
• Comparable to the process under Article 15 of DPD“Confidentiality of chemical names”• No major changes in the requirements and criteria forthe request in the legal text
• Detailed information on substance identity is needed• COM Fee Regulation at finalisation stage

Alternative chemical name (II)• Who can request the use of an alternative name?
Manufacturer, importer or downstream user of a
substance in a mixture• Who grants the permission?
– MS CAs: Until 1 June 2015 according to Article 15 of DPD– ECHA: From 1 June 2015; before this date only in cases where
CLP is fully applied to classification, labelling and packaging of
mixturesAlternative chemical name (III)• Format– IUCLID 5 and relevant annexes (e.g. SDS)
– On-line application (development planned)• Submission– Web form including attachments– REACH-IT not before second half of 2011

• ECHA process under development

Alternative chemical name (IV)• To be assessed by ECHA
– Substance identity– Relevance of the proposed alternative name
– C&L of the substance– Acceptance criteria (Annex I, 1.4)
– Justification demonstrating that disclosure of the name puts theconfidential nature, particularly intellectual property rights, at risk
– Composition and C&L of the mixture(s)Acceptance criteria (Annex I, 1.4)
Alternative name may be granted only where• No Community workplace exposure limit• Enough information for health and safety precautions in theworkplace• The substance is classified exclusively as one or more of thefollowing hazard categories:– Phys-Chem (Part 2 of Annex I),– Acute toxicity, Cat. 4,– Skin corrosion/irritation Cat. 2,– Serious eye damage/irritation Cat. 2– Specific target organ toxicity, Single exposure Cat. 2 or 3
– Specific target organ toxicity, Repeated exposure Cat. 2 or 3
– Hazardous to the aquatic environment – Chronic Cat. 3 or 4

Acceptance criteria – example
International
Chemical
Identification

Classification

Hazard class andAnnex VI,
Category Code(s)Part 3, Acute Tox. 2
Boron tribromide
Acute Tox. 2
Table 3.1
Acute Tox. 2

Acute Tox. 2
Skin Corr. 1A

Skin Corr. 1A

Labelling

Hazardstatement
Code(s)Pictogram,
Signal Word
Code(s)

Hazard statement
Code(s)Suppl. Hazard
statement
Code(s)

H330
H300
H314

GHS06
GHS05
Dgr

H330
H300
H314

EUH014

à Alternative name may not be granted
Safety Data Sheet *Boron tribromide…

(Index no, EC no or CAS no)

Point 2: Hazards Identification
DANGER
Point 15: Regulatory Information…
…
..

Reacts violently with water
Fatal if swallowed. Fatal if inhaled. Causes severe
Skin burns and eye damage.
Nme P statements (≤ 6)
Address
Telephone

1LCLP- Enforcement

CLP Enforcement - Role of Member States (MS)Article 43 CLP(1) Member states appoint competent authorities (MSCAs)(2) MSCAs for enforcement shall co-operate
Article 46 CLP(1) MS to take measures and maintain a system of official
controls, to ensure that substances and mixtures are notplaced on the market unless they are classified, labelled
and packaged in accordance with CLP.
(2) MS report to ECHA every five years by 1July on results ofofficial controls and other enforcement measures. First
time 20 January 2012

The Forum for Information
Exchange on Enforcement
Same as under REACH•

Coordinates a network of Member States' competentauthorities responsible for enforcement•

Tasks include:– Promotion of best practices & tools (Minimum criteria
for inspections adopted)– Development of electronic info exchange procedures– Identification of enforcement strategies– Coordination and evaluation of harmonised
enforcement projects– Liaison with industry– Advising on enforceability of restriction proposals

Guidance and support• Guidance documents• HelpNet• Further information

CLP guidance to industry & CAs• Module 1: Basic guidance on procedures• Module 2: Detailed guidance on classification & labelling– Part 1: Physico-chemical properties– Part 2: Human health properties– Part 3: Environmental properties– Part 4: General and specific issues
http://echa.europa.eu/classification/clp_guidance_en.asp• Guidance on preparing proposal for harmonised C&L(under revision)Guide available for C&L notification
All relevant guides and manuals will be available on the CLP
section of ECHA web site in mid April 2010
–
–
–
–
–
–

“Practical steps” guide No 7
Industry User Manual Part 6 on dossier submission updated
Industry User Manual Part 12 on C&L notification using IUCLID
Industry User Manual Part 15 on managing groups
Industry User Manual Part 16 on on-line C&L notification
Other CLP guidance and FAQs

http://echa.europa.eu

HelpNet – Principles and Practices• Voluntary network of national REACH and CLP
helpdesks• ECHA acts as focal point• Successor of former REHCORN since October 2009
• Main objectives– Ensure consistent and harmonised advice on REACH and CLP
for industry (FAQs on ECHA web site)– Forum for discussion and exchange of information relevant for
helpdesks– Training / workshops for national helpdesks

HelpNet – Tools• HelpNet Steering Group:– REACH and CLP helpdesk of 27 EU Member States + Norway +Iceland– ECHA and associated members of European Commission– Observers from Turkey and Croatia and of stakeholder helpdesks(A.I.S.E, Cefic, CEPE, CONCAWE, EuPC, IMA-Europe)• HelpNet Exchange (HELPEX)– Web-based IT tool for discussing question and answers bynational helpdesks, ECHA and COM– Observers do not have access to HELPEX, but contribute to FAQ
updateNote: List of national REACH and national CLP helpdesks available
on ECHA website:
http://echa.europa.eu/reach/helpdesk/nationalhelp_contact_en.asp

Further information• CLP Regulation– http://ec.europa.eu/enterprise/sectors/chemicals/documents/classificatio
n/index_en.htm#h2-clp-regulation-(ec)-no-1272/2008• ECHA Guidance– http://guidance.echa.europa.eu/docs/guidance_document/clp_en.htm• ECHA webinar C&L notifications,
9 April 2010 15-17:00 EET (GMT+2)– http://www.echa.europa.eu/news/webinars_en.asp• C&L session at the 4th Stakeholders’ Day on 19 May

Thank you for your attention

http://echa.europa.eu

These slides represent the opinion of the author and do not constitutethe official position of ECHA