Semira Hajrlahović Mehić, LL.M.

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

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

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

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. 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. 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. Use of harmonised classification • Mandatory for: • manufacturers, • importers and • downstream users • How to usethe CLP harmonised classifications see Figure on: • http://www.echa.europa.eu/clp/classification/use_of_harmonised_classification_en.asp

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

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

23. Thank you! Thank you!