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Harmonised classification of substances (Annex VI of the CLP Regulation)- Example of substance classification

Semira Hajrlahović Mehić, LL.M.

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Content

What is classification Ways of classification Harmonised Classification,Annex VI to

CLP Reg. Example of substance classification

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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

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Criteria for Classification

HAZARD BASED!

Hazard identification of intrinsic properties: Physical properties Health properties Environmental properties

Criteria for classification → CLP, Annex I

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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

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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

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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)

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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/

use_of_harmonised_classification_en.asp

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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.

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Annex VI to CLP Reg.

Harmonised C&L for following hazardus properties:Cancinogenicity , cat. 1A,1B or 2, or/andGerm cell mutagenicity, cat. 1A, 1B or 2, or/andReproductive toxicity, cat. 1A, 1B or 2, or/andRespiratory sensitisation, cat. 1

Active substance for PPP and BP

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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

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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

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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.

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Annex VI, Part 2

Lays down general principles for preparing dossiers to propose and justify harmonised classification and labelling of substances at Community level.

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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

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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.

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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

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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 fulfilleduse the information available classify accordingly

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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))

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Not harmonised classification

Other hazard properties Use of other sources (i.e. transport

classification), but limitations More → Principles of classification

presentation

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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?

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Classification steps

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

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Thank you!

Thank you!