1. The general obligations regarding self-classification under the CLP Regulation (EC) No 1272/2008
Sylvain BINTEIN

2. CLP Regulation - Basics
Entry into force 20 January 2009
Transition periods: 1 December 2010 for substances
1 June 2015 for mixtures when both DSD and DPD will be repealed
Scope
substances and mixtures including Plant Protection Products and Biocides but excluding: Medicinal, veterinary and cosmetic products and medical devices and food or feeding stuffs.
Main features: no tonnage threshold!!!
Self-classification + harmonised C&L
Common rules within the EU on C&L & Packaging
Classification and labelling Inventory (moved from REACH)

3. CLP Regulation- Principles
Applies the general principles of the GHS
Introduces the GHS criteria for data interpretation, classification and labelling
Stays as close as possible to the GHS format and terminology (e.g.“mixtures” not “preparations”)
Uses the GHS Building Block Approach
Keeps the scope as close as possible to the previous EU system

4. Respecting the principles
Takes up all GHS Hazard Classes
Uses building block approach to omit categories not in old EU system
Flammable liquids category 4
Acute Toxicity category 5
Skin corrosion / irritation category 3
Aspiration hazard category 2
Acute aquatic toxicity category 2 and 3

5. CLP Regulation - Overview
Legal text containing principles and general rules
TITLE I - General Issues
TITLE II – Hazard Classification
Chapter 1 Identification and Examination of Information
Chapter 2 Evaluation of Hazard Information and Decision on Classification
TITLE III – Hazard Communication in Form of Labelling
Chapter 1 Content of the Label
Chapter 2 Application of Labels
TITLE IV - Packaging
TITLE V – Harmonisation of C&L of Substances and the C&L Inventory
Chapter 1 Establishing Harmonised Classification and Labelling of Substances
Chapter 2 Classification and Labelling Inventory
TITLE VI – Competent Authorities and Enforcement
TITLE VII – Common and Final Provisions

6. CLP Regulation - Overview
Annexes on technical details
Annex I: Classification and labelling requirements for hazardous substances and mixtures
Annex II: Special rules for labelling and packaging
Annex III: List of Hazard Statements
Annex IV: List of Precautionary Statements
Annex V: Pictograms
Annex VI: Harmonised List of Hazardous Substances
Annex VII: Translation Table for classification

7. Main roles and obligations of suppliers (M/I, downstream user and distributor) with regards self-classification
Classify subtances/mixtures:
before placing on the market if under the scope of the Regulation
When not placed on market if REACH requires classification; e.g. on-site isolated intermediate, PPORD
Respect harmonised classification (Annex VI: 4485 entries only substances!!!) and/or self-classify ( entries only substances!!!)
Ensure appropriate Labelling and Packaging

8. Main roles and obligations of suppliers (M/I, downstream user and distributor) with regards self-classification
Downstream users:
may use classification from supplier, provided no change of composition.
Distributors:
- no obligation to classify;
- for purposes of L+P, may use classification from their supplier.
Cooperate with others in the supply chain for meeting requirements (both under CLP (article 15) but also under REACH (article 34 on SDS)

9. Main roles and obligations of suppliers (M/I, downstream user and distributor) with regards self-classification
Entry into force of a new or updated harmonised C&L:
18 months after the publication of the corresponding amendment of the CLP Regulation.
BUT:
On a voluntary basis before the 18 months or even before for new harmonised C&L by using RAC recommendations.
Same transitional measure for new C&L criteria.

10. Classification: several steps like in DSD/DPD
Identification and Examination of Information
Collect information (experimental data (in vivo, in vitro), read-across, QSAR, category approach: OECD QSAR tool box) on the hazardous properties of the substance/mixture.
Source of info: in house, occupational data, database (OECD ECHA website…) but mainly for substances than for mixtures.
Testing for phys-chem properties should be generate unless reliable data available
SDS provided by their suppliers

11. Classification: several steps like in DSD/DPD
Evaluation of Hazard Information and Decision on Classification
Examine the information to ensure its adequate and reliable (expert judgment)
Evaluate available information against classification criteria (annex I)
Decide on appropriate classification
no data = > no classification

12. Classification: Specificity for mixture
Available data on mixture as a whole should be primarily used (but not for CMR and bioaccumulation, degradation)
Alternatives
Bridging principle: data available on similar mixtures
Calculation methods based on C&L of substances, including impurities: need to take into account Specific concentration limit (for human health) and M-factors (for the environment)

13. Hazard Communication: Safety Data Sheets (Annex II REACH) for "hazardous" substances and mixtures
SDSs specified in Annex II to REACH
One of the most important source of information for DU allowing to classify mixtures
Regulation (EU) No 453/2010 of 20 May 2010 revised Annex II to align with UN GHS and CLP
Key principles:
stays as close as possible to requirements laid down in Annex 4 to GHS
includes elements of version of Annex II to REACH which are essential or specific to REACH
includes transitional periods
two versions of Annex II, one effective 1 Dec 2010 and one 1 June 2015

14. SDS - Content 16 Sections: the most important for self-C&L are
Section 1: Identifications of substances/mixtures (ID, identified uses and uses advised against, supplier details, emergency phone N°)
Section 2: C&L (also DSD/DPD)
Section 3: Composition/information on relevant ingredients (including relevant impurities)
Section 9: Basic physico-chemical properties
Section 10: Toxicological effects: Brief summaries of info (not limited to experimental data) for any of the hazard classes : results + test method used for the whole mixture or any substance listed in section 3
Ecological information: Toxicity, biodegradability, bioaccumulation… see section 10
Section 15: Regulatory information: e.g: Seveso category

15. SDS - transitional period
Today /12/ /12/ /6/2015
Double classification
Annex II REACH
Reg. 453/2010
Art. 1(1)(a)
Annex I
Reg. 453/2010
Art. 1(2)
Annex II
Substances *
Annex II REACH
Reg. 453/2010
Art. 1(1)(a)
Annex I
Reg. 453 /2010
Art. 1(2)
Annex II
Mixtures **
***
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Voluntary early application substances (Art. 2(1)) including new format *
Voluntary early application mixtures (Art. 2(2)) including new format
Directive 67/548
Directive 1999/45 **
***
Derogation for SDS already handed out once Art. 2(7))
Reg. 1272/2008 (CLP)
****
Voluntary early application mixtures (Art. 2(3))
New format#
Derogation for already placed on the market (Art. 2(6))
- substances until 1/12/2012
- mixtures until 1/06/2017 #

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