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

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

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

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

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:

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

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

GHS – Historical Background

GHS – Historical Background

GHS worldwide Preparation Implementation Activities

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

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

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

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

EU CLP legislation is in the transition: OLD NEW

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 http://europa.eu.int/eur-lex/

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

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

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

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

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

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

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

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

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

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

Health Hazards Hazard Class Hazard Category 1 Acute Toxicity, Oral 1 2 3 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

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

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. 2010 → Tests methods (Regul.440/2008) Dossier information/data (pesticides, biocides) Epidemiological data/information ….

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

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

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 :

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!

Labelling GHS Hazard pictograms Physical hazards Health hazards Environmental hazards

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“!

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 3.10.2 and 3.10.3 of Annex I ) Annex II Special rules for labelling and packaging of certain substances and mixtures

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

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.

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

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

Conclusions

Thank you! Tatjana.Humar-Juric@gov.si