CLP June 2015 deadline

Transcription

1 CLP June 2015 deadline The new Classification & Labelling and Packaging System Ispra, 27 June 2014 Ari Karjalainen ECHA Classification Unit, D1

2 Why do we classify and label? Worker and consumer safety + environmental protection Ensure correct storage / handling / transport Prevent access to general public / consumers of most dangerous substances Prevention & handling of accidents Instructions how to handle and discard waste 2

3 Legislation CLP Regulation Regulation (EC) No 1272/2008 Entered into force 20 January 2009 => UN GHS classification criteria applied in the EU => similar legislation in large part of the world Replaces previous legislation: Dangerous Substances Directive (DSD; Dir 67/548/EEC) Dangerous Preparations Directive (DPD; Dir 1999/45/EC) REACH, Title XI (Classification & Labelling) GHS Purple book 3

4 CLP - Objectives 1. Protect human health & the environment 2. Consolidate C&L of substances/mixtures 3. Introduce the UN GHS in the EU 4. Facilitate international trade in chemicals 5. Increase transparency INTERNAL PUBLIC 6/27/2014 4

5 What happens after 1 June 2015 DSD and DPD are repealed Both substances and mixtures must be classified, labelled and packaged in accordance with CLP But mixtures classified, labelled and packaged in accordance with DPD and already placed on the market ( on the shelves ) before 1 June 2015, do not have to be relabelled and repackaged in accordance with CLP until 1 June

6 What does classification lead to? Communicate identified hazards in Safety Data Sheets (SDS) and on labels with Hazard pictograms Signal word Warning, Danger Hazard statement, e.g. H200 Unstable explosives H301 Toxic if swallowed Precautionary statements, e.g. P201 Keep out of reach of children P372 Explosion risk in case of fire 6

7 New hazard pictograms (CLP) Physical hazards Explosive Flammable Oxidising Gases Environmental hazards Health hazards Acute Toxicity Category 1-3 Serious Health hazard Health hazard Corrosive Hazardous to the environment 7

8 Old pictograms (DSD) 8

9 Classification also leads to Adequate packaging based on the identified hazards to ensure that The content cannot escape (while stored or during transit) The packaging is strong and solid Tactile warning of danger (warn visually impaired) Child-resistant fastenings 9

10 Label 10

11 Risk reduction measures based on classification impact other legislation Pesticides & biocides Labelling &SDS Hazardous waste REACH SVHC Restrictions Classification Cosmetics Storage and transport Working environment

12 ECHA s main tasks under CLP Proposals for Harmonised Classification and Labelling (CLH) Risk Assessment Committee Classification and Labelling Inventory Notifications on self-classifications of hazardous substances on the EU market Applications for Alternative chemical names for substances in mixtures Formulators of mixtures apply for use of alternative names for hazardous substances on labels and safety data sheets Guidance documents and manuals relating to CLP 12

13 Classification process Determine if a substance (or mixture) is hazardous Classification criteria Compare data on substance (e.g. study results) with criteria Decide on appropriate classification Based on hazard, not risk i.e. classify on intrinsic properties of substance 13

14 Hazard classes and categories under CLP (1) Physical hazards Hazard class Hazard category Explosives Flammable gases Flammable aerosols Oxidising gases Gases under pressure Compressed gas Liquefied gas Refridgerated liquefied gas Dissolved gas Flammable liquids Flammable solids Self-reactive substances Pyrophoric liquids Pyrophoric solids Self-heating substances Substances which in contact with water emit flam. gases Oxidising liquids Oxidising solids Organic peroxides Corrosive to metals Unst. Expl. Div* 1.1 Div* 1.2 Div* 1.3 Div* 1.4 Div* 1.5 Div* Group Group Group Group Type A Type B Type C Type D Type E Type F Type G Type A Type B Type C Type D Type E Type F Type G 1 * Division 14

15 Hazard classes and categories under CLP (2) (Human) Health hazards Hazard class Acute toxicity Hazard category Skin corrosion / irritation (Skin corrosion or serious eye damage) 1A 1B 1C (Skin/ eye irritation) 2 Serious eye damage / eye irritation 1 2 Respiratory sensitisation 1 1A 1B Skin sensitisation 1 1A 1B Germ cell mutagenicity Carcinogenicity Reproductive toxicity sexual functions and fertility development of the offspring 1A 1B 2 1A 1B 2 1A 1B 2 Lactation Specific target organ toxicity single exposure Specific target organ toxicity repeated exposure Respiratory tract Irritation/ Narcotic effects 3 Aspiration hazard 1 echa.europa.eu 27 June

16 Hazard classes and categories under CLP (3) Environmental hazards (hazardous to the aquatic environment) Aquatic acute 1 Aquatic chronic Hazardous to the ozone layer echa.europa.eu 27 June

17 Who is responsible? The manufacturer, importer and downstream user is always responsible for ensuring that their substances or mixtures are correctly classified Harmonised classification vs. selfclassification 17

18 Harmonised classification and labelling

19 Harmonised Classification and Labelling (CLH) Harmonised classifications listed in Annex VI to CLP Regulation Legally binding every manufacture, importer or downstream user of the substance within EU CLP Regulation focuses on substances which are of most concern to humans Carcinogenic (C) Mutagenic (M) Reproductive toxicants (R) Respiratory sensitisers (RS) Other hazard classes can be harmonised on a caseby-case basis justification needed Active substances in plant protection products (PPPs) and biocidal products (BPs) are normally harmonised 19

20 Main actors CLH process overview Dossier submitter (Member states or industry) ECHA/RAC Parties Concerned European Commission Dossier preparation Public Consultation 45 days RAC opinion Annex VI to CLP by the Commission Max 18 months to adopt an opinion 27 June 2014 echa.europa.eu 20

21 Harmonised C&L - status Annex VI to CLP Over 4000 entries (including many group entries) Largely harmonised classifications from the DSD system New or revised entries included by Adaptation to technical progress (currently six ATPs) INTERNAL 6/27/

22 Harmonised C&L entries in Annex VI tables 22

23 Classification and labelling inventory

24 Industry responsibility Self-classification: If no harmonised classification for a particular hazard class or differentiation for a substance exists => manufacturers, importers and down-stream users shall self-classify for these hazard classes/ differentiations Assess the data available against the requirements and criteria in the CLP Regulation, for each hazard class Decide on the classification label and package substances placed on the market accordingly Notify the self-classification of substances to ECHA 24

25 C&L Inventory Industry shall send C&L notifications to ECHA Information on self-classification and labelling of their substances When? Within 1 month after placing on the market Which substances? Substances subject to registration under REACH Other substances (under the scope of CLP) meeting classification criteria or present in mixtures and contributing to the classification of the mixture Regardless of tonnage level 25

26 Notifications should contain: (Art. 40) Identity of the notifier Substance Identity, including composition and impurities/additives Classification and Labelling (including SCLs/M-factors and reason for no classification) However Notifications should be up to date and accurate. ECHA does not verify the correctness of the notifications and displays them as received Guidance and assistance available on the ECHA website 27 June 2014 echa.europa.eu 26

27 Classification and Labelling Inventory The C&L Inventory available since February 2012: Up-to-date information on the hazardous substances on the EU market Notifications to the C&L Inventory (January 2014): 6.1 million notifications for substances 27

28 Search options 27 June 2014 echa.europa.eu 28

29 Classification of mixtures under CLP

30 Classification of mixtures Responsibility of the manufacturer, importer or downstream user who places the substance or mixture on the market To be done according to the criteria in the CLP regulation Complex cases may require special expertise 30

31 Gather all available information The basic information : substance identity, classification and any applied specific concentration limits (SCL) or multiplying factors (M-factors), concentration of the substance in the mixture, where relevant, details of any impurities and additives including their identity, classification and concentration. 31

32 Evaluate information against classification criteria For each hazard class see which approach is prescribed in the legislation Carcinogenicity, germ cell mutagenicity and toxic to reproduction Always classify on ingredients! 32

33 Tiered approach in classification of mixtures CLP Annex I For hazard classes where it is appropriate: 1) Testing (test data as primary source (note CLP Art. 7 and 8)) existing information on whole mixture, tested with adequate, reliable and scientifically valid method (CLP art 6 and 9) classify according to same criteria as for substances 2) Bridging principles (Annex I, part 1 sufficient data available for similar tested mixtures and individual hazardous ingredients) 3) Classification based on concentration of ingredients formulas (acute toxicity, environmental hazards) concentration limits (GCLs and SCLs; for other hazards) 33

34 Review the classification Changes in harmonised and agreed classification The harmonised classification and labelling of substances in Annex VI changed Notifiers of a substance are obliged to try to agree on a self classification Changes in the mixture A change in the concentration of one or more of the hazardous constituents A change in the composition involving the substitution or addition of one or more constituents. Changes in criteria Changes in legislation/guidance 34

35 Summary After 1 June 2015 classification, labelling and packaging of substances and mixtures will need to be conducted exclusively in accordance with the requirements and criteria set out in the CLP Regulation Mixtures with classifications according to the DPD may still be on the shelves until 1 June

36 Thank You. Ari Karjalainen