1. EU implementation of GHS-CLP Regulation
Tatjana Humar- Jurič, M.Sc.

2. Content Basic info on CL Historical background Legal background
Classification of Hazardous Chemicals
Notification
Labelling of Hazardous Chemicals
Translation of the “old classifications”

3. Definitions ECHA =European Chemicals Agency established by REACH
Substance = a chemical element and its compounds in the natural state or obtained by any manufacturing process
Mixture =a mixture or solution composed of two or more substances
Chemical = Substance and Mixture
CLP= Classification, Labelling and Packaging of chemicals
GHS = The Globally Harmonized System of Classification & Labelling of Chemicals

4. Classification & labelling
Data collection
REACH
Classification & labelling
Risk Assessment
Labour protection
Directives
Marketing & Use
Directive
Risk Management
Preparation Directive
In- & Export
Regulation
Consumer
protection
Labour
Drinking water
Waste
Environment, Air,
Water, Soil,
Liability
Products
(Articles)
Risk Management

5. WHAT ARE CLASSIFICATION AND LABELLING
WHAT ARE CLASSIFICATION AND LABELLING? CLASSIFICATION : = evaluation of hazard (NOT risk) of a substance or preparation in accordance with criteria listed in annex VI (67/548/EEC) or annex I (GHS regulation) LABELLING: = the first and often the only information on the hazards of a chemical that reaches the user (consumer, worker …). - a communication of hazard via the label:

6. Classification of Hazardous Chemicals
Risk = Hazard x Exposures
Risk evaluation:
1.Hazard identification = Classification
2. Effects assessment
3. Exposure assessment
4. Human and environment risk determination
Informing of users

7. Goals of Classification and Labelling
Data collection
Informing:
Label Public
awareness
SDS
Hazard identification

8. GHS – Historical Background

9. GHS – Historical Background

10. GHS worldwide
Preparation
Implementation
Activities

11. GHS =The Globally Harmonized System
of Classification & Labelling of Chemicals

12. GHS = global agreement EU GHS ≠ UN GHS 1SUBSTANCE 1 CLASSIFICATION
1 LABEL
1 SAFETY DATA SHEET (SDS)
EU GHS ≠ UN GHS

13. GHS – Historical Background
“Purple book”
(UN GHS Document)

14. GHS – Historical Background
“Purple book”
(UN GHS Document)
ATP of “EU GHS”
(CLP Regulation)

15. EU CLP legislation is in the transition:
OLD NEW

16. Current EU Legislation:
Old:
- Directive (DSD): 67/548/EEC
- Directive (DPD): 99/45/EC
New:
- GHS Regulation 1272/2008/EC
- REACH Regulation 1907/2006/EC
- Regulation on test Methods 440/2008/EC

17. Current EU Legislation:
Additional labelling requirements :
Biocides products: Rules on placing on the market of Biocide Products
Aerosols: Decision on aerosol dispersers
PPA: Rules on additional standardized risk and safety phrases for PPA
Detergents: Regulation on detergents

18. Purpose and scope of CLP (GHS) Regulation
Harmonising the:
- criteria for classification of chemicals
- rules on labelling and packaging for
hazardous chemicals
Providing an obligations for:
- manufacturers, importers and
downstream users to classify chemicals
placed on the market
- suppliers to label and package chemicals
- manufacturers, producers of articles and
importers to classify those substances not
placed on the market that are subject to
registration or notification
Providing an obligations for:
manufacturers and importers of
substances to notify the ECHA
Establishing a list of substances with their harmonised classifications and labelling elements at EU level in
Part 3 of Annex VI;
Establishing a classification and labelling inventory of substances, which is made up of all notifications, submissions and harmonised classifications and labelling elements

19. Regulation shall NOT apply to :
Radioactive substances and mixtures within the scope of Council Directive 96/29/Euratom
Substances and mixtures which are subject to customs supervision,
Non-isolated intermediates
Substances and mixtures for scientific research and development, which are not placed on the market
Waste as defined in Directive 2006/12/EC
Transport of dangerous goods by air, sea, road, rail or inland waterways

20. Medicinal products as defined in Dir.2001/83/EC
Regulation shall NOT use to chemicals in the following FORMS, which are in the FINISHED state, intended for the final user:
Medicinal products as defined in Dir.2001/83/EC
Veterinary medicinal products as defined in Dir.2001/82/EC
Cosmetic products as defined in Dir. 76/768/EEC
Medical devices as defined in Dir. 90/385/EEC and 93/42/EEC,
Food or feeding stuffs as defined in Regulation 178/2002

21. Structure of the CLP Regulation Legal Body Text (principles and general rules)
TITLE I: General Issues
TITLE II: Hazard Classification
TITLE III: Hazard Communication in form of Labelling
TITLE IV: Packaging
TITLE V: Harmonisation of Classification and Labelling of
substances and the Classification and Labelling Inventory
TITLE VI: Competent Authorities and Enforcement
TITLE VII: Common and Final Provisions

22. Structure of CLP Regulation Annexes (technical details)
ANNEX I: Classification and labelling requirements for hazardous substances and mixtures
ANNEX II: Special rules for labelling and packaging of certain substances and mixtures
ANNEX III: List of Hazard Statements, supplemental hazard information and supplemental label elements
ANNEX IV: List of Precautionary Statements
ANNEX V: Hazard Pictograms
ANNEX VI: Harmonised classification and labelling for certain hazardous substances
ANNEX VII: Translation table from classification under Dir. 67/548/EEC to classification and assignment of hazard statements under this Regulation

23. GHS-Transitional period
REACH
2.5 y. > 100 t/a
3.5 y. HPV etc.
5 y. > 1 t/a
3.5 y. Substances
4.5 y. Mixtures
GHS
For substances and mixtures:
EU-System: binding
GHS: optional;
Label: GHS if class.
For substances: GHS: obligatory
SDS must contain EU and GHS classification For mixtures: EU-System: binding GHS: optional; Label: GHS if class.
After the entire transition period:
For substances & mixtures: GHS: obligatory
EU-System: loses its legal status
1 June 2015
1 Dec 2010

24. Classification (1) HAZARD BASED
Hazard identification of intrinsic properties:
- Physical Hazards
- Health Hazards
- Environmental Hazards
Criteria for classification:
Old system: Directive DSD-Annex VI, Directive DPD-Annex I, II, III
New system: GHS - Annex I

25. Classification (2) Substances: Annex I, part 1-5
Preparations/mixtures : Annex I, part 1
Testing
Bridging
Calculation
- Additivity
- Summation (including M-factors)
PPA, BP: also other international recognized test methods

26. Hazard Class Hazard Category
Physical Hazards
Hazard Class
Hazard Category
Explosives
Unstable
Explosives
Div1.1
Div 1.2
Div 1.3
Div 1.4
Div 1.5
Div 1.6
Flammable Gases 1 2
Flammable Aerosols 1 2
Oxidising Gases 1
Pressurised Gases
Compressed Gases 1
Liquefied Gases 1
Refrigerated Liquefied Gases 1
Dissolved Gases 1
Flammable Liquids 1 2 3
Flammable Solids 1 2
Self-reactive Substances
Type A
Type B
Type C
Type D
Type E
Type F
Type G
Pyrophoric Liquids 1
Pyrophoric Solids 1
Self-heating Substances 1 2
Water ReactiveFlammable Gases 1 2 3
Oxidising Liquids 1 2 3
Oxidising Solids 1 2 3
Organic Peroxides
Type A
Type B
Type C
Type D
Type E
Type F
Type G
Corrosive to Metals 1

27. Health Hazards Hazard Class Hazard Category 1 Acute Toxicity, Oral 1 23 4
1 Acute Toxicity, Dermal 1 2 3 4
1 Acute Toxicity, Inhalation 1 2 3 4
2 Skin Corrosion/Irritation 1
1A/B/C 2
3 Eye Damage/Irritation 1 2
4 Respiratory Sensitisation 1
4 Skin Sensitisation 1
5 Germ Cell Mutagenicity 1
1A/B 2
6 Carcinogenicity 1
1A/B 2
7 Reproductive Toxicity 1
1A/B 2
Lactation
8 Target Organ ST – Single Dose 1 2 3
9 Target Organ ST – Repeat Dose 1 2
10 Aspiration Hazard 1

28. Environmental Hazard Classes
Environmental Hazards
Environmental Hazard Classes
Hazard Category
Aquatic Toxicity, Acute 1
Aquatic Toxicity, Chronic 1 2 3 4

29. Classification (3) Data collection
Label of the hazardous chemical
SDS
List of harmonised classified substances in Annex VI of CLP Regulation (obligatory use!)
Inventory list: on the web site of ECHA, Jan →
Tests methods (Regul.440/2008)
Dossier information/data (pesticides, biocides)
Epidemiological data/information ….

30. Classification (4) Data collection PROPOSAL Harmonized classification (Annex VI of CPL Regul.)
Proposals may be submetied by:
- MSCAs: new enteries/hazard classes and revisions
- Industry (Manufacturs/Importers, Downstream Users): new enteries/hazard classes
Which types of substances and enteries/hazard classes ?
- REACH susbtances: - CMR, Respiratory sensitisation
- Other hazard classes on case-by -case basis if need
for Community action
- Pesticides and Biocides active substances: all hazard classes
How many?
-Estimated 90 proposals per year

31. Classification (5) Data collection Notification Inventory list (website of ECHA)
Importers and manufacturers must notify :
- HAZRDOUS substances if they are placing them on the market, on their own or in
mixtures and irrespective of the tonnage.
- substances SUBJECT TO REGISTRATION under the REACH if they are placing them
on the market.
Existing registrations of substances (NONS substances) placed on the market may need to be updated with the CLP classification and labelling.
From 1 December 2010, notification should be made within one month of placing a substance on the market.
Notification is free of charge
Estimated number of notifications:2-3 millions

32. What information should be provided in the notification?
Information requested in Article 40 of the CLP Regulation:
Name and contact details of the notifier;
Identity of the substance
CLP classification of the substance
Specific concentration limits and M-factors, including a justification for setting them; and
Label elements :

33. Only Representative or importer - who should notify?
Only Representatives (OR) may submit the information needed for notification to the
Inventory as part of a REACH registration dossier.
BUT: ORs are not entitled to submit a notification to the Inventory on behalf of
their third country manufacturer.
Notification as a group: If non-EU operators, for confidentiality reasons, do not want to disclose the composition of their substances or mixtures to their EU importers, they may appoint one of the importers to notify on behalf of the other importers
only the selected importer would receive any confidential information needed for notification.
Such an importer could also be an OR who has already been appointed for the purposes of registration under REACH!

34. Labelling GHS Hazard pictograms
Physical hazards
Health hazards
Environmental hazards

35. GHS Label Elements Pictograms Signal Words Hazard Statements
Precautionary Statements or Pictograms
Product Identifiers
Nominal quantity (general use)
No indications of danger, but signal words „Danger“ and „Warning“!

36. Additional Label Requirements
CRF (child-resistant fastening)
Chemicals in general use:
Acute toxicity, categories 1 to 3
Specific target organ toxicity (STOT) - single exposure, category 1
STOT - repeated exposure, category 1
Skin corrosion, category 1
Aspiration hazards (sections  and of Annex I )
Annex II
Special rules for labelling and packaging of certain substances and mixtures

37. Additional Label Requirements
Tactile Warning
Chemicals in general use:
Acute toxicity
Skin corrosion
Germ cell mutagenicity category 2
Carcinogenicity category 2
Reproductive toxicity category 2 respiratory sensitisation
specific target organ toxicity (Stot), categories 1 and 2 aspiration hazard
flammable gases, liquids and solids in categories 1 and 2

38. Translation from old EU system to new one:
Annex VII of CLP Regulation includes a table to assist translation of a
classification made for a substance or a mixture under Directive
67/548/EEC or Directive 1999/45/EC, respectively, into the
corresponding NEW classification.

39. Classification under NEW Regulation Hazard Class and Category
Table for translation from old EU system to new one:
Classification
under Dir.
67/548/EEC
Physical
state of the
substance
when relevant
Classification under NEW Regulation
Note
Hazard Class and Category
Hazard
statement
Xn; R20
gas
Acut. Tox.4
H332
(1)
T; R23
Acut. Str. 4
H331
C; R34
Skin Corr. 1B
H314
(2)
C; R35
Xi; R36
Eye Irrit. 2
H319
Xi; R37
STOT Sing. 3
H335
Xi; R38
Skin Corr.2
H315

40. Guidances on application of REACH and CLP regulations
Preparing the
registration dossier
Guidance on
substance ID
Preparing
the CSR
Guidances on application of REACH and CLP regulations
Guidance on
data-sharing
Information
requirements
Guidance on
applications for
authorisation
Guidance for
downstream users
Requirements
for articles
Guidance
on SEA
3.6: Guidances on
C&L under GHS

41. Conclusions

42. Thank you!