GHS (CLP/GHS system) IN PRACTICE - Agencija za hemikalije

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Timeline of SDS changing:1 Oct 2011 1 Dec 2012 1 Jun 2015 1 Jun 2017Placed on the market :before 1 Oct 2011SUBMIXPlaced on the market :between 1 Oct 2011 and1 Jun 2015SUBMIXPlaced on the market :SUBfrom 1 Jun 2015Placed on the market :MIXfrom 1 Jun 2017 DSD/DPD system could be used in SDS (unless the substances shall be re-labelledor re-packaged DSD/DPD and CLP/GHS system shall be used in SDS only CLP/GHS system shall be used in SDSSUB SDS for substancesMIX SDS for mixtures4.3 DATA FROM THE LIST OF CLASSIFIED SUBSTANCES4.3.1 Am I obligated to use classification of my substances from the List of classified substances?14
Yes, the use of a harmonised classification from the List of Classified Substances is mandatory formanufacturers, importers and downstream users (see also point 5.1).4.3.2 Where can I find the data needed for classification of substances which are NOT included in the Listof Classified Substances?The classification of a substance is based on the relevant information available on its hazardous properties. Youshould gather these information to help determine the classification for each of your substances. This informationmay include:• results of tests carried out according to the Test Method Regulation (OG No will be added after publishing.)• results of testing carried out according to sound scientific principles that are internationally recognized ormethods validated according to international procedures. This includes results of testing based on methods orstandards as laid down in the UN Manual of Tests and Criteria and which are referred to in Part 2 of Annex I ofCLP/GHS Rulebook;• results of the application of non-test methods such as (Q)SAR ((Quantitative) Structure Activity Relationships),read-across, category approach ;• human experience for all types of hazards, including epidemiological data, data from accident databases andoccupational data;• any new scientific information and• any other information generated under internationally recognised chemical programmes.Note that where the substance has a harmonised classification and a related entry in the List ofClassified Substances, you are not required to gather available information for thatspecified hazard.Check the List of Classified Substances first before starting to gather information!4.3.3 Where can I find the data needed for classification of substances which ARE included in theList of classified substances, but are NOT classified for ALL type of hazards (for example hazardclasses related to physical hazards)?In such cases a supplier shall provide the data reliable and adequate for the purpose of hazard classification.Further to this, available studies should be sufficiently documented to assess their quality and adequacy. Thephysical hazards of substances and mixtures should be determined through testing based on the methods orstandards referred to in Part 2 of Annex I to CLP/GHS Rulebook. These methods can be found for example in theUN Manual of Tests and Criteria, see the website: http://www.unece.org/trans/danger/publi/manual/manual_e.html,which is normally used to classify substances and mixtures for transport.However, testing is not mandatory in cases where adequate and reliable information from reference literature ordatabases is already available and where the substance to be classified and the substance described in thereference are comparable with regard to homogeneity, impurities, particle size etc.Open literature or databases often use secondary data sources. When such data is used, the original sourceshould be cited and checked by an expert. This should involve the check that there is sufficient documentation toassess the suitability of the test used, and that the test was carried out using an acceptable level of qualityassurance. Useful data compilations containing physicochemical data are listed in section R.7.1.1.2 of theGuidance on information requirements and chemical safety assessment on European Chemicals Agency’swebsite.4.4 DATA FROM INVENTORY LIST4. 4.1 What is the Classification & Labelling Inventory and what can it be us for?The Classification & Labelling Inventory is an EU database which will contain basic classification and labellinginformation on notified and registered substances. It will also contain the list of harmonised classifications (AnnexVI of EU GHS Regulation). It will be established and maintained by European Chemicals Agency (ECHA).15
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GHS (CLP/GHS system) IN PRACTICE - Agencija za hemikalije

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