1. 1 Harmonised classification of substances (Annex VI of the CLP Regulation)- Example of substance classification Semira Hajrlahović Mehić, LL.M.

2. 2 Content What is classification Ways of classification Harmonised Classification,Annex VI to CLP Reg. Example of substance classification

3. 3 Classification - Objects To identify all the  physical,  toxicological and  ecotoxicological properties of substances/mixtures which may constitute a risk during normal handling or use To evaluate the hazard (NOT risk) of a substance/ mixture in accordance with criteria To characterize the type and severity of adverse effects which a substance/mixture can cause = ascertaining its properties and placing it into defined classes of hazard

4. 4 Criteria for Classification HAZARD BASED! Hazard identification of intrinsic properties: Physical properties Health properties Environmental properties Criteria for classification → CLP, Annex I

5. 5 Ways of classification I Substances have to be classified using one or both of the following approaches:  Use of harmonised classifications  Self-classification by application of the criteria

6. 6 Ways of classification II Mixtures are always self-classified  they have to be assessed if they meet the criteria for classification  for this assessment any available harmonised classifications of the substances contained in the mixture must be taken into account

7. 7 Harmonised Classification For SUBSTANCES only Determined at Community level Listed in Annex VI to CLP Reg. Attention to ATP (Reg.790/2009, 286/2011) In Srbija: List of classified substances (Official Gazette RS, No. 82/10)

8. 8 Use of harmonised classification Mandatory for:  manufacturers,  importers and  downstream users How to use the CLP harmonised classifications see Figure on:  http://www.echa.europa.eu/clp/classification/u se_of_harmonised_classification_en.asp

9. 9 Proposal for harmonised C&L Article 37(6) of CLP; proposal to change the harmonised classification → EU MS Competent Authority where the substance is placed on the market Not possible for a manufacturer, importer or a downstream user to submit a proposal directly to the Agency to amend an existing harmonised classification for a hazard class or differentiation already listed in Annex VI to CLP Article 37(2) of CLP  manufacturer, importer or downstream user may submit a proposal directly to the agency for harmonized classification of other hazards not yet covered by the Annex VI entry of that substance.

10. 10 Annex VI to CLP Reg. Harmonised C&L for following hazardus properties:  Cancinogenicity, cat. 1A,1B or 2, or/and  Germ cell mutagenicity, cat. 1A, 1B or 2, or/and  Reproductive toxicity, cat. 1A, 1B or 2, or/and  Respiratory sensitisation, cat. 1 Active substance for PPP and BP

11. 11 Annex VI to CLP Reg 3 parts:  introduction to the list of harmonised classifications and labelling Attention : Notes  dossiers for harmonised classification and labelling  harmonised classification and labelling tables

12. 12 Annex VI, Part 1 Provides an introduction to the list of harmonised classification and labelling Includes information listed for each entry and related classifications and hazard statements in Table 3.1  Hazard class and category codes  Labelling codes  Specific concentration limits and M-factors  Notes

13. 13 Annex VI, Part 1-Notes Notes relating to the identification, classification and labelling of substances:  Note P : The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0,1 % w/w benzene (EINECS No 200-753-7). This note applies only to certain complex oil-derived substances in Part 3. Notes relating to the classification and labelling of mixtures  Note 2 :The concentration of isocyanate stated is the percentage by weight of the free monomer calculated with reference to the total weight of the mixture.

14. 14 Annex VI, Part 2 Lays down general principles for preparing dossiers to propose and justify harmonised classification and labelling of substances at Community level.

15. 15 Annex VI, Part 3- Harmonised classification and labelling tables Table 3.1: List of harmonised classification and labelling of hazardous substances Table 3.2: The list of harmonised classification and labelling of hazardous substances from Annex I to Directive 67/548/EEC

16. 16 Minimum classification For certain hazard classes, including acute toxicity and STOT repeated exposure classification according to Directive 67/548/EEC does not correspond directly to the classification in a hazard class and category CLP In these cases the classification in Annex VI shall be considered as a minimum classification Minimum classification is indicated by reference * in the column ‘Classification’ in Table 3.1.

17. 17 Hazards not covered by the entry in Part 3 of Annex VI? Substance listed on Annex VI must be classified in accordance with the entry in Part 3 of Annex VI M/I/DU has to carry out a self-classification in accordance with Title II  for hazard classes or differentiations where no harmonised classification is contained in the entry in Part 3 of Annex VI

18. 18 Hazards not covered in Part 3 of Annex VI-Example Substance has a harmonised classification for acute oral toxicity, but not for acute dermal toxicity Supplier has to:  explore whether the classification criteria for acute dermal toxicity are fulfilled  use the information available  classify accordingly

19. 19 Hazards not covered in Part 3 of Annex VI For harmonised classifications referring to the aquatic hazard classification acute or chronic category 1 where no M-factor appears on Annex VI, the classifier must set an M-factor Self-classification may entail new testing for those physical hazards where no harmonised classification exists and where, adequate and reliable information is not available (CLP Article 8(2))

20. 20 Not harmonised classification Other hazard properties Use of other sources (i.e. transport classification), but limitations More → Principles of classification presentation

21. 21 Example of substance classification Perboric acid, sodium salt, monohydrate EC No. 234-390-0, CAS No.11138-47-9 Example - Reasons What is the substance classification that should be adopted? What other information AVAILABLE in Annex VI are necessary for composing SDS?

22. 22 Classification steps Use Annex VI, Part 3, table 3.1. ATP, timelines Classification ? Specific concentration limits

23. 23 Thank you!