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

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January 2009 Transition periods: 1 December 2010 for substances 1 June 2015 for mixtures when both DSD and DPD will be repealed Scope substances and mixtures including Plant Protection Products and Biocides but excluding: Medicinal, veterinary and cosmetic products and medical devices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)

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

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

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

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

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 (115233 entries only substances!!!) Ensure appropriate Labelling and Packaging

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)

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.

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 www.echemportal.org, 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

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

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)

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

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

SDS - transitional period Today 1/12/2010 1/12/2012 1/6/2015 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 ** *** **** ** 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 #

Thank you! For further information, please, consult the website: http://ec.europa.eu/enterprise/sectors/chemicals/classification/index_en.htm http://ec.europa.eu/environment/chemicals/ghs/index_en.htm http://echa.europa.eu/home_en.asp