GHS (CLP/GHS system) IN PRACTICE1. INTRODUCTION   1.0 Background   1.1 What is GHS? How it is developed and its goal?   1....
5.1 What is a classification? And what is a harmonised classification?   5.2 What are the main differences between CLP/GHS...
1. INTRODUCTION1.0 BackgroundThe purpose of this document is to give suppliers, professional users of hazardous chemicals ...
Regulatory authorities in countries adopting the GHS are thus taking the agreed criteria and provisions and     implementi...
GHS is a logical and comprehensive approach to:       •   Defining health, physical and environmental hazards of chemicals...
1.3 Does GHS cover all substances and mixtures?CLP/GHS Rulebook shall not apply to:     • Radioactive substances and mixtu...
Formatted: Indent: Left: -3,3 cm, Substances or mixtures which are placed on the market in the final form as medical devic...
Food, additives and aromas as well as feedstuff and additive for feedstuffSubstances and mixtures which are in the finishe...
supplier of chemicals shall also update the label in accordance with the provisions provided for in CLP/GHSRulebook.Placin...
Inventory. More information on notification regarding EU GHS and Inventory you may find on            the website ofEurope...
2.1 ManufacturerA manufacturer is any natural or legal person established within the R of Serbia who manufactures a substa...
2.6 Downstream userDownstream user is any natural or legal person established within the R of Serbia, other than the manuf...
If, for the purpose of classification, it is required or decided to generate new data, certain test methods and qualitycon...
Timeline of SDS changing:                                1 Oct 2011         1 Dec 2012          1 Jun 2015         1 Jun 2...
Yes, the use of a harmonised classification from the List of Classified Substances is mandatory formanufacturers, importer...
The Inventory will serve multiple purposes:• It will be a tool for hazard communication and a source of basic information ...
http://webnet3.oecd.org/echemportal/• RTECS (Registry of Toxic Effects of Chemical Substances) available from the NIOSH (U...
On the ECHAs website is also an online tool (“GHS converter”) in German and English language that helps SMEsto familiarise...
classified, i.e. they have to be assessed if they meet the criteria for classification. For this assessment anyavailable h...
DSD/DPD Rulebook                                  CLP/GHS Regulation RulebookDSD/DPD Rulebook terminology, e.g. category o...
NOTE: It is important to make sure that you choose the most appropriate method for your mixture for each hazard class or c...
5.5 Can I translate classification of chemicals (including mixtures) from DSD/DPD system of classificationand labelling to...
classification in accordance with CLP/GHS Rulebook where he does not yet have adequate and reliableinformation.5.6 Where s...
2b) Tested substanceSubstance gave a positive result in the LLNA (Local Lymph Node Assay) with an EC3-value of 10.4%. As t...
Solution:1. Classification according to CLP/GHS Rulebook:Step 1: Check the classification of the mixture as skin corrosive...
The calculation of the sum of quotients (taken from the actual concentration of the substances and theconcentration limit ...
Parathion             0,002        LC50 Fish, Lepomis macrochirus, 96 h = 18 g/L                                   log Kow...
Classification of the mixture: Aquatic Chronic, Category 2, H4116. HOW SHALL I LABEL?See also Guidance on Labelling and Pa...
The product identifier for a mixture shall consist of both:      • The trade name or the designation of the mixture;      ...
Flammable gases (category 1 and 2)                                        √Flammable liquids (category 1 and 2)           ...
Capacity of the package                  Dimensions                                                 (in millimeters)      ...
Derogations:    •      Labelling of outer, inner and single packaging                        Only CLP/GHS or transport    ...
http://echa.europa.eu/reach_enforcement_en.asp   3. An example of label of the small packaging (less than 125ml):         ...
The supplier shall ensure that the label is updated, without undue delay, if the new hazard is more severe. Otherlabelling...
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Manuel CLP-GHS

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  1. 1. GHS (CLP/GHS system) IN PRACTICE1. INTRODUCTION 1.0 Background 1.1 What is GHS? How it is developed and its goal? 1.2.Why are two different Rulebooks on classification, labelling and packaging of hazardous chemicals are needed in Serbia? 1.3 Does GHS cover all substances and mixtures? 1.4 Does GHS cover some articles? 1.5 Must I also classify medical devices, medicinal products, waste food, additives and aromas as well as feedstuff and additive for feedstuff? 1.6 Will plant protection or biocidal products have to be classified and labelled in accordance with CLP/GHS system? 1.7 When do I need to classify and label my chemicals in line with CLP/GHS system? 1.8 What are transitional periods for classification and labelling of chemicals in accordance with CLP/GHS system? 1.9 What are my obligations regarding DSD/DPD system of classification and labelling in the transitional period – do I have to classify and label according to both systems (DSD/DPD and CLP/GHS) in the transitional period?2. WHAT ARE MY OBLIGATIONS REGARDING GHS (=CLP/GHS Rulebook? 2.1 Manufacturer 2.2 Distributor 2.3 Importer 2.4 Re-importer 2.5 Re-filler 2.6 Downstream user 2.7 Supplier3. HOW CAN I BE PREPARED?4. WHERE CAN I TURN FOR INFORMATION ON HAZARDOUS PROPERTIS OF MY CHEMICALS? 4.1 DATA FROM TESTS 4.1.1 Should I test my substance for the purpose of classification? 4.1.2 Should I test my mixture for the purpose of classification? 4.2 DATA FORM SDS 4.2.1 Do Safety Data Sheets need to reflect the GHS elements according to the CLP/GHS Rulebook? 4.3 DATA FROM THE LIST OF CLASSIFIED SUSBTANCES 4.3.1 Am I obligated to use classification of my substances form the List of classified substances? 4.3.2 Where can I find the data needed for classification of substances which are NOT included in the List of classified substances? 4.3.3 Where can I find the data needed for classification of substances which ARE included in the List of classified substances, but are NOT classified for ALL type of hazards (for example hazard classes related to physical hazards)? 4.4 DATA FROM INVENTORY LIST 4. 4.1 What is the Classification & Labelling Inventory and what can it be us for? 4.4.2 What does the Classification & Labelling Inventory contain? 4.5 OTHER SOURCES 4.5.1 EU Guidances on CLP (= EU GHS) 4.5.2 EU Guidance on application of the CLP (= EU GHS) criteria 4.5.3 EU FAQ regarding CLP in EU and useful links 4.5.4 Serbian helpdesk5. HOW SHALL I CLASSIFY? 1
  2. 2. 5.1 What is a classification? And what is a harmonised classification? 5.2 What are the main differences between CLP/GHS and DSD/DPD system of classification and labelling? 5.3. What are the main rules for classification of substances according to CLP/GHS system? 5.4. What are the main rules for classification of mixture according to CLP/GHS system? 5.5 Can I translate classification of chemicals (including mixtures) from DSD/DPD system of classification and labelling to GHS? 5.6 Where shall I found information for classification of chemicals? 5.7 What about the examples of classifying?6. HOW SHALL I LABEL? 6.1 Which information shall be on the label? 6.2 What does mean the term product identifiers? 6.3 Are there any specific labelling and packaging requirements? 6.4 Is it the size of the label important? 6.5 What about the size of the label elements? 6.6 Are there any derogations from labelling requirements? 6.7 What about the examples of labels? 6.8 When should I update my labels? 6.9 Serbian FAQ regarding labelling? Annexes: • Table with all pictograms, H and P • Table on translation • Glossary • GHS pictograms 2
  3. 3. 1. INTRODUCTION1.0 BackgroundThe purpose of this document is to give suppliers, professional users of hazardous chemicals as well as generalpublic basic information on GHS, CLP Regulation and Serbian CLP/GHS. In this manual you will also find theanswers on the FAQ in the filed of chemicals in Serbia.The full official text of the CLP/GHS Rulebook (“Official Gazette of RS” No 64/10) is available on the followingweb link: http://www.ekoplan.gov.rs/shema/1.1 What is GHS? How it is developed and its main goal?Development of GHSThe GHS is an acronym for The Globally Harmonized System of Classification and Labelling of Chemicals. It is asystem for standardizing and harmonizing the classification and labelling of chemicals.The GHS Document, so called "The Purple Book", is not a regulation or a standard but global agreement. Itestablishes agreed hazard classification and communication provisions with explanatory information on how toapply the system. The elements in the GHS supply a mechanism to meet the basic requirement of any hazardcommunication system, which is to decide if the chemical is hazardous and to prepare a label and Safety DataSheet (SDS) as appropriate.Across the world, countries have different rules on classification and labelling. For example, a chemical could beclassified as ‘toxic’ or ‘explosive’ in one country but not in another. Different symbols are also used to indicate thesame hazards. Therefore 20 years ago the need to develop a single, globally harmonized system to addressclassification of chemicals, labels, and SDS was recognized.The most important force that drove the creation of the GHS was the international mandate adopted in the 1992United Nations Conference on Environment and Development (UNCED), "Earth Summit". The harmonization ofclassification and labelling of chemicals all over the world was one of six program areas that were endorsed by theUN General Assembly to strengthen international efforts concerning the environmentally sound management ofchemicals. It was recognized that an internationally harmonized approach to classification and labelling wouldprovide the foundation for all countries to develop comprehensive national programs to ensure the safe use ofchemicals. The main goals of GHS: .1 SUBSTANCE 1 CLASSIFICATION 1 LABEL 1 SAFETY DATA SHEET (SDS) all over the world!The first version of the GHS Document was approved by the Committee of Experts in year 2002 in Geneva. Afterthat GHS has been regularly amended. So GHS is driven and developed at UN level. In order to amend it youmust feed into the UN discussion. The third revised edition of the GHS was published in 2009.The Plan of Implementation of the World Summit on Sustainable Development (WSSD), adopted in Johannesburgin 2002, encourages countries to implement the GHS as soon as possible. Information about the status ofimplementation of the GHS by country is available onhttp://www.unece.org/trans/danger/publi/ghs/implementation_e.html. 3
  4. 4. Regulatory authorities in countries adopting the GHS are thus taking the agreed criteria and provisions and implementing them through their own regulatory process and procedures rather than simply incorporating the text of the GHS into their national requirements. In EU, GHS was introduced by CLP Regulation (1272/2008/EC) (EU GHS) which will run in parallel with the old system, on classification, labelling and packaging until 1 June 2015. All GHS hazard categories have been not introduced in the EU GHS. The scope of the EU GHS has been kept as close as possible to the old, still existing, EU system. Therefore, although the introduces all GHS hazard classes, it does not introduce those hazard categories that are not part of old EU legislation, thus none of the following GHS hazard categories is included in CLP Regulation: • “flammable liquids category 4”, • “acute toxicity category 5”, • “skin corrosion/irritation category 3”, • “aspiration hazard category 2” and • “acute aquatic toxicity category 2 and 3”. Serbia adopted GHS in 2010 by Regulation on classification, packaging, labelling and advertising of chemical and certain product in accordance with globally harmonized system of classification and labelling of the UN. At the same time Serbia as an EU candidate country also introduced DSD/DPD Rulebook (“Official Gazette of RS” No 59/10) which will run in parallel with the CLP/GHS Rulebook until 1 June 2015. Since Serbia has been not yet the member of EU Serbian GHS and EU GHS are not the same! EU GHS also contains some specific EU issues like: different transitional periods, obligation to notify chemicals to the European Chemicals Agency (ECHA), classification and labelling inventory Following schemes show you current situation (before Serbian accession to EU) and future situation (after Serbian accession to EU) regarding the content of the Serbian GHS:Before Serbian accession to EU: “EU GHS” (CLP Regulation) = legal binding text “Purple book” UN GHS Document = international agreement “Serbian GHS” (CLP/GHS Rulebook) = legal binding textAfter Serbian accession to EU: “Purple book” UN GHS Document “Serbian GHS” = international will be substituted by agreement “EU GHS” 4
  5. 5. GHS is a logical and comprehensive approach to: • Defining health, physical and environmental hazards of chemicals; • Creating classification processes that use available data on chemicals for comparison with the defined hazard criteria; • Communicating hazard information, as well as protective measures on labels and Safety Data Sheets (SDS); • Ensure that information on hazards be available in order to enhance the protection of human health and the environment during the handling and use of these chemicals; and • Provide a basis for harmonization of rules and regulations on chemicals at national, regional and worldwide level, and important factor also for trade facilitation.If you are supplying a chemical for professional or industrial use, you must provide a SDS. A SDS has to includethe classification and labelling of the chemical together with other safety information. It is not necessary to supply aSDS to a member of the public who buys a chemical and does not intend to use it for professional or industrialpurposes.In EU SDS is not governed by the CLP Regulation (EU GHS), but it is governed by REACH (Registration,Evaluation and Authorisation of Chemicals) Regulation 1907/2006. Similar situation is in Serbia where SDS isgoverned by Law on Chemicals (“Official Gazette of RS” No 36/09) and Rulebook on SDS (“Official Gazette ofRS” No 81/10) CLP Regulation (EU GHS) do NOT involve provisions on SDS!Benefits of using the GHSIn next years it is anticipated that application of the GHS will: • Enhance the protection of human health and the environment by providing an internationally comprehensible system; • Provide a recognized framework to develop regulations for those countries without existing systems; • Facilitate international trade in chemicals whose hazards have been identified on an international basis; and • Reduce the need for testing and evaluation against multiple classification systems.In countries which will implement GHS:An exporter will be able to use the same description of the hazards on the label in his home country and in thecountry he exports to. This means that, when exporting his product, he can save the costs of re-classification forreasons of compliance with different requirements of the country he is exporting to. Conversely, supplier whowants to import his substances and mixtures will experience the same benefits.In general, a major motivation for the development of the UN GHS was to have a classification system that allowsfor globally uniform physical, environmental, health and safety information on hazardous chemicals. To achievethis aim the criteria for classification and labelling of substances and mixtures were harmonised at UN level.The tangible benefits of using the GHS will be also: • A safer work environment and improved relations with employees; • An increase in efficiency and reduced costs from compliance with hazard communication regulations; • Application of expert systems resulting in maximizing expert resources and minimizing labour and costs; • Facilitation of electronic transmission systems with international scope; and • Reduced costs due to fewer accidents and illnesses.1.2 Why are two different Rulebooks on classification, labelling and packaging of hazardous chemicalsare needed in Serbia?Text will be provided only in Serbian language by colleagues from Chemical Agency! 5
  6. 6. 1.3 Does GHS cover all substances and mixtures?CLP/GHS Rulebook shall not apply to: • Radioactive substances and mixtures; • Substances and mixtures in transit; • Transport of dangerous chemicals; • Non-isolated intermediates; • Substances and mixtures for scientific research and development, which are not placed on the market but are used under controlled conditions where their exposure is reduced; • Waste as defined by the Law on Waste Management (“Official Gazette of RS” No 36/09); and • Substances and mixtures which are subject to customs supervision and placed in the customs warehouse or free zone with the view to reexportation or transit, provided that such chemicals do not undergo the process of working or processing.CLP/GHS Rulebook shall also not apply to substances or mixtures which are placed on the market in the finalform as: • Drugs and medical devices used in human or veterinary medicine; • Cosmetic products; • Food, feeding additives and aromas; and • Feedstuff and additives for feedstuff.However based on CLP/GHS Rulebook hazardous substances or mixtures to be placed on the market, must beclassified before placing them on the market, independently of the actual tonnage manufactured, imported orplaced on the market. Hazardous substances or mixture are those which fulfil the criteria relating to physical hazards, health hazards or environmental hazards, laid down by CLP/GHS Rulebook!1.4 Does GHS cover some articles?No, normally not. However, the obligation to classify and label applies to producers or importers of certainexplosive articles which meet the definition set out in chapter 2.1.1. CLP/GHS Rulebook before placing them onthe market. Other articles are not subject to any classification, labelling and packaging provisions of the CLP/GHSRulebook.1.5 Must I also classify medical devices, medicinal products, waste, food, additives and aromas as well asfeedstuff and additive for feedstuff?Medical devicesSubstances and mixtures which are medical devices as defined in Law on Drugs and medical Devices (“OfficialGazette of RS” No 30/10) and which are invasive or used in direct physical contact with the human body areexempted from the provisions of CLP/GHS Rulebook on the whole if they are in the finished state and intended forthe final user: • Substances and mixtures that are invasive or used in direct physical contact with the human body would include cochlear implants, implantable cardiac pacemakers, implantable defibrillators and implantable nerve stimulators; • Substances and mixtures that are invasive or used in direct physical contact with the human body would include sutures, catheters, stents, balloon catheters and wound dressings and • Substances and mixtures would include reagents for diagnostic of Hepatitis C and HIV, self-diagnosis devices for the measurement of blood sugar and IVD Analysers. 6
  7. 7. Formatted: Indent: Left: -3,3 cm, Substances or mixtures which are placed on the market in the final form as medical devices First line: 3,3 cm do not need to be classified, packaged, labelled regarding CLP/GHS Rulebook! If you export medical devices to EU: • For substances, either on their own or contained in a mixture, the obligation to classify (but not label and package) may still arise from REACH because such substances would have to be registered!WasteWaste as defined in the Law on Waste Management (“Official Gazette of RS” No 36/09) is outside the scope ofCLP/GHS Rulebook. Waste is any substance or object which the waste holder discards, intends or is required todiscard. This may be waste from households (e.g. newspapers or clothes, food, cans or bottles) or fromprofessionals or industry (e.g. tyres, slag, window frames that are discarded).As waste is not considered to be a substance, mixture or article under CLP/GHS Rulebook, waste treatmentoperators are not considered as downstream users. At the same time waste treatment operators will not receiveSafety Data Sheets on how to handle a substance or mixture during the waste phase. Residues from waste treatment operations: 1. As long as they are waste, i.e. they are disposed of (e.g. land-filled), they do not need to be classified, packaged, labelled regarding CLP/GHS Regulation 2. those which are recovered as substances or mixtures do need to be classified, packaged, labelled regarding CLP/GHS RegulationMedicinal productsSubstances and mixtures which are in the finished state and intended for the final user and which are medicinalproducts within the scope of Law on Drugs and Medical Devices (“Official Gazette of RS” No 30/10) medicinalproducts for human use or veterinary medicinal products are on the whole exempted from the provisions of theCLP/GHS Regulation.However, in cases where a manufacturer or importer supplies substances and mixtures, e.g. activepharmaceutical ingredients (APIs) or excipients, that are not yet in the finished state, this manufacturer or importerwill have to classify, package and label these substances and mixtures. Exemption from the provisions of the CLP/GHS Rulebook does not distinguish between active and non-active pharmaceutical ingredients: • It applies to any substance or mixture used in medicinal products, e.g. excipients, which is in the finished state and intended for pharmaceutical use. 7
  8. 8. Food, additives and aromas as well as feedstuff and additive for feedstuffSubstances and mixtures which are in the finished state and intended for the final user as food, additives andaromas as well as feedstuff and additive for feedstuff are on the whole exempted from the provisions of theCLP/GHS Regulation.1.6 Will plant protection or biocidal products have to be classified and labelled in accordance with CLP/GHS system?Active substancesActive substances contained in plant protection or biocidal products will have to be classified and labelled inaccording to the CLP/GHS Rulebook as of 1 October 2011. In contrast to other substances supplied and used inthe industrial supply chain, all hazard classifications of these substances will normally be harmonised. Labells shallinclude any supplemental information required by Law on Plant Protection Products (“Official Gazette of RS” No41/09) or Law on Biocidal Products (“Official Gazette of RS” No 36/09) From 1 October 2011 active substances within the scope of Regulations on plant protection or biocidal products, if placed on the Serbian market ON THEIR OWN, have to be clasified and labelled in accordance with CLP/GHS Rulebook!MixturesA mixture containing one or more active substance in a biocidal or plant protection product, will have to beclassified and labelled in accordance with CLP/GHS Rulebook in line with the transitional provisions. Labelsshall include any supplemental information required by Law on Plant Protection Products (“Official Gazette of RS”No 41/09) or Law on Biocidal Products (“Official Gazette of RS” No 36/09) as appropriate. Such information wouldhave to be placed in the section for supplemental information on the label. Plant protection or biocidal products will have to be be clasified and labelled in accordance with CLP/GHS Rulebook in line with the transitional provisions! Labells shall also contain any additional labelling information required by Regualtions on plant protection or biocidal products !The supplier of a substance or a mixture within the scope of Law on Plant Protection Products or Law on BiocidalProducts shall update the label in accordance with the provisions as provided for in Article 30 of CLP/GHSRulebook. Any update to the classification or labelling of a plant protection or a biocidal product should be performed in accordance with the provisions of the CLP/GHS Regulation (see Article 15 and 30)! DO NOT FORGET: at the same time you should also update SDS!1.7 When do I need to classify and label my chemicals in line with CLP/GHS system?CLP/GHS Rulebook applies to you if you manufacture, import, use or distribute chemical substances or mixtures.You must classify, label and package any substance or mixture, regardless of its annual tonnage, in accordancewith the CLP/GHS Rulebook before you place it on the Serbian market. The timing of the classification andlabelling of chemicals will have to be in line with the transitional provisions set out in CLP/GHS Rulebook. The . 8
  9. 9. supplier of chemicals shall also update the label in accordance with the provisions provided for in CLP/GHSRulebook.Placing on the market of a substance or mixture means making it physically available to third parties, whether inreturn for payment or free of charge. If you manufacture, import, use or distribute chemical substances or mixtures: • You must classify, label and package any substance or mixture in accordance with the CLP/GHS Rulebook before you place it on the Serbian market. Take into account transitional provisions set out in CLP/GHS Rulebook!If you export to EU: • You are required to classify substances that are subject to registration or to notification in line with REACH. This includes e.g. the classification of substances that are used for product and process-orientated research and development! • You must also notify (regarding EU GHS) hazardous substances that you place on the EU market on their own or contained in hazardous mixtures above certain applicable concentration limits, regardless of the annual tonnage imported, as well as substances subject to registration under REACH and that you place on the EU market. However, the duty to notify does not apply in case you have already submitted the information which is relevant for a notification under EU GHS as part of a REACH registration. More information on notification regarding EU GHS and Inventory you may find on the website of European Chemicals Agency. If you export to EU: • You are required to classify substances that are subject to registration or to notification in line with REACH • You are required to classify substances that are subject to notification in line with EU GHS1.8 What are transitional periods for classification and labeling of chemicals in accordance withCLP/GHS system?Transitional provisions are set out in Article 38 of CLP/GHS Rulebook, defining essentially two target dates thataffect the classification, hazard communication and packaging of hazardous substances and mixtures, namely 1October 2011 and 1 June 2015.More detail information shall be added only in Serbian language by colleagues from Chemical Agency!1.9 What are my obligations regarding DSD/DPD system of classification and labelling in thetransitional period – do I have to classify and label according to both systems (DSD/DPD andCLP/GHS) in the transitional period?The main obligation imposed on manufacturers and importers of substances, downstream users, includingformulators of mixtures and re-importers of substances or mixtures is to classify, label and package substancesand mixtures in accordance with the CLP/GHS Rulebook. Distributors (including retailers) of substances andmixtures need to label and package in accordance with CLP/GHS Rulebook.Importers into EU (or groups of importers) who place a hazardous substance on the EU market will also have tonotify certain information, in particular the substance identity and the classification and labelling of that substanceto European Chemicals Agency (ECHA), unless this information has already been submitted as part of aregistration under REACH. ECHA will then include the notified information in the Classification & Labelling 9
  10. 10. Inventory. More information on notification regarding EU GHS and Inventory you may find on the website ofEuropean Chemicals Agency. Attention: you can use only one system at the same time at the label!2. WHAT ARE MY OBLIGATIONS REGARDING GHS (= CLP/GHS Rulebook)?Professional and industrial END USERS have not obligations according the CLP/GHS Regulation. They areconsidered to be end users of the substances and mixtures supplied to them as long as they do not placechemicals on the Serbian market.Examples: • Professional users are cleaning personnel, painters or craftsmen who use e.g. paints, lime or cleaning agents in the context of their professional activity. • Industrial users may use substances or mixtures supplied to them as processing aids which are not consumed by the industrial activity, e.g. surface cleaners prior to electroplating or users of lubricants for chainsaws.Professional and industrial end users are required to respect the information on the label and on the Safety DataSheet supplied to them.Formulators of mixtures are not classed as end users, but rather as downstream users of substances andmixtures.In general obligations of the most important actors of the supply chain are described in following table: Keep info Classify Label Package 10 yrs √ √ √ √Manufacturer √ √ √ √Importer √* √ √ √Downstream User X** √ √ √Distributor*Change composition-classify. If not, use suppliers**Distributor may use classification of another actor If you export chemicals to EU: • You have the obligation to classify substances and mixtures and to notify relevant substance according EU GHS 10
  11. 11. 2.1 ManufacturerA manufacturer is any natural or legal person established within the R of Serbia who manufactures a substancewithin the R of Serbia. His main obligation is to classify, label and package substances and mixtures inaccordance with the CLP/GHS Regulation. Since he knows most data on substance, he plays the most importantrole in the supply chain.2.2 DistributorA distributor is a natural or legal person established within the R of Serbian, including a retailer, who only storesand places on the market a substance, on its own or contained in a mixture, for third parties. Distributors are notobliged to classify themselves. In contrast to other suppliers, a distributor (including a retailer) does not have toclassify substances and mixtures himself, but may take over the classification that was derived in accordance withTitle II of CLP/GHS Rulebook by another actor in the supply chain. Typically, the respective classification is madeavailable on a Safety Data Sheet.The same derogation is also granted to a downstream user as long as he does not change the composition of thesubstance or mixture supplied to him.2.3 ImporterImporter is any natural or legal person established within the R of Serbia who is responsible for import. His mainobligation is to classify, label and package substances and mixtures in accordance with the CLP/GHS Rulebook.2.4 Re-importerA re-importer is considered as a downstream user (see also point 2.6). Re-importers are therefore not obliged toclassify in accordance with Title II CLP/GHS Rulebook, but may also take over the classification derived inaccordance with Title II already by another actor in the supply chain. In any case the re-importer has to ensure thatthe labelling and packaging is in accordance with CLP/GHS Rulebook.For a re-importer to be considered a downstream user certain following conditions have to be fulfilled: • The substance must have been re-imported within the same supply chain. • A re-importer should be able to show that the re-imported substance is the same as the one that was originally exported. • The re-importer should also be able to show that he has been provided with the respective information.When any of the conditions mentioned above is not fulfilled, the re-importer is considered an importer. This meansthat he has the obligation to classify these substances or mixtures.2.5 Re-filler is downstream user (see also point 2.6) of substances or mixtures whose use is limited to transferringsubstances or mixtures supplied to them from one container (or packaging) into another. Re-fillers are thereforenot obliged to classify in accordance with Title II of CLP/GHS Rulebook but may also take over the classificationderived in accordance with Title II already by another actor in the supply chain provided the re-filler does notchange the composition of the substance or mixture that is being refilled. In any case before placing chemical onthe Serbian market the re-filler has to ensure that the labelling and packaging is in accordance with CLP/GHSRulebook. This can mean that the original label must be replaced by another one. For example, when the contentsof a 200 l drum is decanted into 25 ml bottles, the new label should be in line with the small packaging exemptions,unlike the original bigger one which required full labelling. Before placing chemical on the Serbian market re-filler: • Has to ensure that the labelling and packaging is in accordance with CLP/GHS Rulebook. In some cases (when the capacity of the new package is not equal to the original one) this also means that the original label must be replaced by another one! 11
  12. 12. 2.6 Downstream userDownstream user is any natural or legal person established within the R of Serbia, other than the manufacturer orthe importer, who uses a substance, either on its own or in a mixture, for his industrial or professional activities.Downstream user may take over the classification for a substance or mixture derived in accordance with Title II ofCLP/GHS Rulebook by another actor in the supply chain, for example from a Safety Data Sheet, under thecondition that he does not change the composition of this substance or mixture. Before placing chemical on theSerbian market the downstream user has to ensure that the classification, labelling and packaging is inaccordance with CLP/GHS Rulebook. . A distributor or a consumer is NOT a downstream user!2.7SupplierSupplier is any manufacturer, importer, downstream user or distributor placing on the Serbian market a substance,on its own or in a mixture, or a mixture.3.HOW CAN I BE PREPARED?If you supply a chemical, you should: • Make sure you understand what your duties are under the CLP/GHS Rulebook. Youwill have duties if you: import, manufacture, formulate, mix, distribute or sell chemicals. • Make sure you understand the transitional periods to ensure that you re-classify, label and package on time. • Co-operate with others in your supply chain, to make sure the changes are managed smoothly. • Check that your chemicals are correctly classified and that your product labels are accurate.If you use chemicals, you should: • Look out for the changes and check that you are doing what is needed to use the chemical safely. If you are an employer, alert your employees to these changes too. • Speak to your chemical suppliers if you have any questions or if you don’t understand the changes that have been made. • If you are an employer, provide your employees with adequate information, instruction and training. • Follow the advice provided on the new labels and, where appropriate, in Safety Data Sheets.4.WHERE CAN I TURN FOR INFORMATION ON HAZARDOUS PROPERTIS OF MY CHEMICALS?4.1 Data from tests4.1.1 Should I test my substance for the purpose of classification?CLP/GHS Rulebook does not require new testing for the purpose of classification of substances for health orenvironmental hazards; testing for physical hazards is required unless adequate and reliable information is alreadyavailable. However information may also be available from other legislation for which there are specificrequirements for test data to be generated such as Law on Plant Protection Products or Law on Biocidal Productsor from various international programmes.Finally, the supplier may decide to conduct new testing in order to fill data gaps, provided that he has exhausted allother means of generating information. Testing on animals must be avoided wherever possible and alternativemethods (including in vitro testing, the use of (Q)SARs, read-across and/or category approaches) must always beconsidered first provided they provide adequate reliability and quality of data. 12
  13. 13. If, for the purpose of classification, it is required or decided to generate new data, certain test methods and qualityconditions must be met. Studies must be conducted in accordance with the Test Method Regulation (OG No willbe added after publishing.) or other international test methods validated according to international procedures suchas those of the OECD. For physical hazards new tests shall be carried out in compliance with relevant recognisedquality system or by laboratories complying with a relevant recognised standard, and for health and environmentalhazards in compliance with the principles of Good Laboratory Practice (GLP). Animal tests must comply with theLaw on animal welfare ("Offical Gazette of RS" No.41/09) .Tests on non-human primates are prohibited for the purposes of classification. Tests on humans shall not beperformed for the purpose of classification. However, existing data obtained from other sources, such as accidentrecords and epidemiological and clinical studies, can be used.4.1.2 Should I test my mixture for the purpose of classification?For mixtures, classification for physical hazards should normally be based on the results of tests carried out on themixtures themselves.When considering health and environmental hazards, the classification can be based on available information(including test data) on the mixtures themselves, except when classifying for e.g. CMR effects or chronic (long-term) aquatic hazard. In these cases classification of the mixtures is normally based on the information on thesubstances. If no test data are available on the mixtures themselves, such data should not normally be generated;rather, all available information on the ingredients of the mixture should be used to derive a classification. Onlywhen the manufacturer, importer or downstream user has exhausted all other means of generating information,new tests may be performed. Annex I CLP/GHS Rulebook specifies “bridging principles” which enables suppliersto derive health or environmental classifications of their mixtures based on available data on similar testedmixtures and on the ingredient substances. It also provides specific rules for the classification of mixtures basedon the classification of the individual substances in the mixture.4.2 Data from Safety Data Sheets (SDS)4.2.1 Do SDS need to reflect the new classification and labelling elements according to CLP/GHSRulebook?Yes, apart of DSD/DPD information must a supplier also introduce CLP/GHS information into the SDS (Sections 2and 3) relating to CLP/GHS classifications for substances from 1 October 2011 and relating to CLP/GHSclassification for mixtures from 1 June 2015.However, substances already placed on the market before 1 October 2011 and classified, labelled andpackaged according to DSD/DPD Rulebook do not need to be re-labelled or re-packaged according to CLP/GHSsystem until 1 December 2012 and therefore their SDS do not need to be aligned with the CLP/GHS classificationuntil 1 December 2012.A similar transitional arrangement is provided for mixtures. If mixtures have already been placed on the marketbefore 1 June 2015 and classified, labelled and packaged according to DSD/DPD Rulebook do not need to be re-labelled or re-packaged according to CLP/GHS system until 1 June 2017 and therefore their SDS do not need tobe aligned with the CLP/GHS classification until 1 June 2017. 13
  14. 14. Timeline of SDS changing: 1 Oct 2011 1 Dec 2012 1 Jun 2015 1 Jun 2017 SUB Placed on the market : MIX before 1 Oct 2011 Placed on the market : SUB between 1 Oct 2011 and 1 Jun 2015 MIX SUB Placed on the market : from 1 Jun 2015 MIX Placed on the market : from 1 Jun 2017 DSD/DPD system could be used in SDS (unless the substances shall be re-labelled or 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
  15. 15. 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 of Classified Substances, you are not required to gather available information for that specified 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
  16. 16. The Inventory will serve multiple purposes:• It will be a tool for hazard communication and a source of basic information on classified substances for thegeneral and professional public of EU as well as non EU states;• It will reveal disagreement on the classification and labelling of the same substance, thus pointing to thepossibility of considering further discussion, evaluation needs or the need for harmonisation of a particularclassification and labelling of a substance;• It will promote transparency and provides companies with a starting point for agreeing on the self classification of their substances; and• in EU it will be also an important tool for hazard communication and risk management, e.g. when EU MemberState Competent Authorities assess the need for potential authorisations and restrictions of hazardous substancesunder REACH Regulation.4.4.2 What does the Classification & Labelling Inventory contain?The C&L Inventory will contain the identity of the substance, the reason why a classification has not been assignedin cases where a substance has been classified in some but not all hazard classes or differentiations, specificconcentration limits or M-factors (multiplying factors) and the labelling elements for the substance.European Chemicals Agency (ECHA) will also include the following information: • Whether there is a harmonised classification for a particular entry; • Whether an entry is a joint entry between registrants of the same substance; • Whether it is an agreed entry; • Whether the entry differs from another entry on the Inventory for the same substance. The inventory list will be made public on the ECHA’s website end of summer 2011!4.5 OTHER SOURCESInformation on the hazardous properties of substances can be sourced in databases which are accessible on theinternet and in scientific journals. One of the most useful source of information is European Chemicals Agency(ECHA) website:http://echa.europa.eu/classification/clp_guidance_en.aspThere you can find quite a number of major available data bases and databanks (some are free of charge, butothers require payment of a fee). A small selection of mentioned sources is following (note that they may notpresent all sources available; any mention of a data source does not imply endorsement of its content): EU information and data sources:• ESIS (European Chemical Substances Information System) on the website of the JRC Consumer ProductsSafety and Quality Unit website: http://ecb.jrc.it/esis/• EFSA (European Food Safety Authority, for active substances of plant protection products): http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_ScientificOpinionPublicationReport.htm• Each Member State in the European Union has a national helpdesk. Details can be found at:http://echa.europa.eu/help/nationalhelp_en.asp• The European Commission websites:http://ec.europa.eu/enterprise/reach/ghs/index_en.htmhttp://ec.europa.eu/environment/chemicals/ghs/index_en.htm• Joint Research Centrehttp://ecb.jrc.it/REACH/Non-EU sources:• ECHEM Portal from OECD: 16
  17. 17. http://webnet3.oecd.org/echemportal/• RTECS (Registry of Toxic Effects of Chemical Substances) available from the NIOSH (US National Institute ofOccupational Safety and Health) website:http://www.cdc.gov/niosh/rtecs/• USEPA (United States Environmental Protection Agency) website:http://www.epa.gov/• IRIS (Integrated Risk Information System) available from the USEPA website:http://cfpub.epa.gov/ncea/iris/index.cfm• OSHA (US Occupational Safety & Health Administration) website:http://www.osha.gov/• NICNAS (National Industrial Chemicals Notification and Assessment Scheme - Australia) website:http://www.nicnas.gov.au/• TOXNET website which include databases such as Toxline and HSDB:http://toxnet.nlm.nih.gov/• IPCS (International Programme on Chemical Safety) INCHEM website:http://www.inchem.org/• Scientific literature: the PubMed portal from the US National Library of Medicine searches 100’s of relevantjournals, many of which are available free of charge.http://www.ncbi.nlm.nih.gov/entrez/Many of the UN GHS criteria (by hazard class), in particular those relating to physical hazards, are alreadyimplemented through the UN Model Regulations and related legal instruments (ADR, RID, ADN, IMDG Code andICAO regulating the transport of dangerous goods. You can use a transport classification as one of your sourcesof information for the classification and labelling of your substance as far as it is not included in Annex VI toCLP/GHS Regulation. But before you use a transport classification, you should be aware of the following:• transport classifications do not include all of the GHS categories for physical, health and environmentalhazards, so the absence of a transport classification for your substance does not mean that you should not classifyit under CLP/GHS system. In relation to physical hazards, this means that you may have to test in order to providefor the data which are necessary for an unambiguous classification according to CLP/GHS system;• under transport legislation, sometimes special provisions are linked to the entries in the Dangerous GoodsList (ADR, part 3) which have to be met in order to be classified in the respective class for transport. In thesecases the classification for the purposes of supply and use might be different. Further to this, one substance evenmay have two different entries with two different classifications where one of the classifications is linked to one ormore special provisions; and• transport classification may be based on another set of information than is required now by CLP/GHSRegulation.4.5.1 EU Guidances on CLP (= EU GHS)http://guidance.echa.europa.eu/guidance_en.htm4.5.2 EU Guidance on application of the CLP (= EU GHS) criteriaOn the European Chemicals Agency s (ECHA) website,http://guidance.echa.europa.eu/docs/guidance_document/clp_en.pdf , guidance documents are to help industryto comply with the rules of the EU CLP Regulation:• The Introductory Guidance on the CLP Regulation: describes basic obligations and procedures of the EUCLP Regulation• The Guidance on the Application of the CLP Criteria: provides general principles of classification andlabelling under the EU CLP Regulation as well as detailed guidance on the criteria for the classification andlabelling of substances and mixtures.• The Guidance on Labelling and Packaging in accordance with EU CLP Regulation: provides generalprinciples of labelling under the EU CLP Regulation 1272/2008 17
  18. 18. On the ECHAs website is also an online tool (“GHS converter”) in German and English language that helps SMEsto familiarise themselves with GHS/CLP is provided by Berufsgenossenschaft Rohstoffe und chemische Industrie(BG RCI). You can also find the tool on their website: http://www.gischem.de/ghs/index.htm?client_locale=EN.This tool has not been validated at the EU level!4.5.3 EU FAQ regarding CLPOn the ECHAs website http://echa.europa.eu/clp/clp_help_en.asp, are also following useful documents:• Questions and Answers Document: this document contains questions and answers introducing the EU CLP Regulation. The document focuses on background information and on general features and procedures of the CLP Regulation;• Frequently Asked Questions: the frequently asked questions have been agreed by and between the EU national CLP helpdesks, representatives of the European Commission and European Chemicals Agency (ECHA). They are one of the results of the cooperation of the EU national helpdesks in the context of Help Net. The FAQs they try to provide practical and technical advice for the application of the rules of CLP4.5.4 Serbian helpdeskThe text will be provided only in Serbian language by Serbian colleagues!5. HOW SHALL I CLASSIFY?5.1 What is a classification? And what is a harmonised classification?Classification is the starting point for hazard communication. It involves the identification of the intrinsichazardous propertie(s) of a chemical or mixture by assigning a category of hazard/danger using defined criteria.The CLP/GHS Rulebook is designed to be consistent and transparent. It draws a clear distinction between classesand categories in order to allow for "self classification". For many hazards a decision tree approach is provided inthe CLP/GHS Rulebook. For several hazards the GHS criteria are semi-quantitative or qualitative. Expert judgmentmay be required to interpret these data.Chemicals to be placed on the Serbian market have to be classified using one of the following approaches: • Use of harmonised classifications;The List of Classified Substances (“Official Gazette RS” No. 82/10) contains substances which shall normally besubject to harmonised classification and labeling for following hazardous properties: • respiratory sensitisation, category 1, or/and • germ cell mutagenicity, category 1A, 1B or 2 , or/and • carcinogenicity, category 1A, 1B or 2, or/and • reproductive toxicity, category 1A, 1B or 2 .Active substances of plant protection products or biocidal products involved in the List of Classified Substancesshall normally be subject to harmonised classification and labelling for all hazard classes or differentiations.The use of a harmonised classification from the List of Classified Substances is mandatory for manufacturers,importers and downstream users.• Self-classification by application of the criteria:Self-classification is the supplier’s decision on a particular classification. For substances, it must be done for thosehazards where no harmonised classification exists. For mixtures, self-classification has always to be done. Theclassification criteria are set out in Part 2-5 of Annex I to CLP/GHS Rulebook. Mixtures will always have to be self- 18
  19. 19. classified, i.e. they have to be assessed if they meet the criteria for classification. For this assessment anyavailable harmonised classifications of the substances contained in the mixture must be taken into account. Four basic steps to self-classify a substance or mixture: • Collection of available information 1. Collection of available information of the adequacy and reliability of the information • Evaluation • Test data, non-testReview of the informationother the classification criteria • data, human data, against 2. Examination of data • Decision on classification • Expert judgement- assessment of the available data by a qualified, experienced and knowledgeable person as to its relevance, adequacy and reliability 3. Evaluate & review the information • Apply criteria; • Weight of evidence 4. Decision on classification • If substance/mixture meets criteria assign classification • Hazard class and category• Use of translation tables (Annex II to CLP/GHS Rulebook):See also answer 5.5!These tables allow to translate classifications according to DSD/DPD Rulebook to CLP/GHS classifications. Theymay be used in case both of the following conditions are met:- a substance has been classified according to DSD/DPD Regulation before 1 October 2011 or a mixture has beenclassified according to DSD/DPD Regulation before 1 June 2015, and- there are no further data available for the substance or mixture for the hazard class considered.• Use of classification and labelling inventorySee also answers 4.4.1 and 4.4.2!In EU are manufacturers and importers required to notify the European Chemicals Agency (ECHA) of theclassification and labelling of substance(s) placed on the EU market. ECHA shall then include the information in aclassification and labelling inventory in form of a database. Substances placed on the EU market on or after 1December 2010 require notification within one month.The ECHA shall make certain information from the inventory publicly available on its website, including thesubstance name, the classification, labelling and any relevant specific concentration limit or M-factor. It will beindicated if there is a harmonised classification for the entry, or if it is an agreed entry between manufacturers orimporters.While multiple notifications of the same substance may be made by different manufacturers or importers, with thepotential for differences in the classifications notified, over time this should provide the stimulus for EUsuppliers to liaise in order to agree on a single entry.5.2. What are the main differences between CLP/GHS and DSD/DPD systems of classification andlabelling?While the main features of classification and labelling are similar under DSD/DPD Rulebook and CLP/GHSRulebook, there are some differences which are due to the integration of the terminology, classification criteria andlabelling elements of the UN GHS and to procedures taken over by CLP/GHS Rulebook. An overview of the mostimportant differences is included in the table below and further explained in the text following the table: 19
  20. 20. DSD/DPD Rulebook CLP/GHS Regulation RulebookDSD/DPD Rulebook terminology, e.g. category of CLP/GHS Rulebook terminology, i.e. hazard class,danger, risk phrase, safety phrase hazard statement,precautionary statementDSD/DPD Rulebook categories of danger for CLP/GHS Rulebook hazard classes including thosephysical, health and environmental hazards differentiations which best reflect the DSD/DPD Regulation categories of danger; total number of hazard classes higher under CLP/GHS than the total number of categories of danger under DSD/DPD systemDSD/DPD Rulebook calculation rules (“conventional CLP/GHS Rulebook calculation methods (additivity,method”) for the classification of preparations summation) deviating from the DSD/DPD Rulebook calculation rulesTesting, human experience or calculation for mixture Similar to DSD/DPD; in addition bridging principlesclassification that allow the classification of mixtures on the basis of data on similar tested mixtures and information on individual hazardous ingredient substancesDSD/DPD Rulebook categories of danger plus CLP/GHS Rulebook hazard classes plusadditional labelling elements, e.g. R1 (“Explosive supplemental labelling elements taken over fromwhen dry”) DSD/DPD Rulebook e.g. EUH001 (“Explosive when dry”)If harmonised classification then normally for all If harmonised classification then for substancescategories of danger which are carcinogenic, mutagenic, toxic to reproduction or respiratory sensitisers; other effects on a case-by-case basis5.3 What are the main rules for classification of substances according to CLP/GHS system?See also answer 5.1!Classification of substances is assigned by: - Using harmonised classification: • Cca. 8000 substances are listed in the List of Classified Substances • Specific concentration limits must be used - Self-classification: • Apply in absence of harmonised C&L or where harmonised C&L available for some endpoints only - Using Translation Table (If data are not available): • Annex II of CLP/GHS Rulebook5.4 What are the main rules for classification of mixture according to CLP/GHS system?See also answer 5.1!The classification of mixtures involves the same basic steps as the classification of substances. As a general ruleand as with substances, available data on the mixture as a whole should primarily be used to determine theclassification. If this cannot be done, further approaches (see the list of possible methods for classification ofmixtures below) to mixture classification may be applied. You may now apply the so-called bridging principles forsome health and environmental hazards, using data on similar tested mixtures and information on individualhazardous ingredient substances.Application of expert judgement and weight of evidence determination are by CLP/GHS system more explicit in thelegal text when compared to DSD/ DPD system.In case you cannot exploit available test data on the mixture as a whole, the key to its classification will besufficient information on the ingredients of the mixture. 20
  21. 21. NOTE: It is important to make sure that you choose the most appropriate method for your mixture for each hazard class or category!Depending on the information available and on the hazard under consideration you should classify using theapproaches below in the following sequence:1. Using data on the mixture itself1. The mixture as a whole is tested2. The classification criteria are applied as for a substance3. Not applicable for CMR and some environmental hazard classes, but mandatory for physical hazards2. Classification based on the application of bridging principlesBridging principles are used for classifying untested mixtures. When a mixture has not been tested, but there aresufficient data on the components and/or similar tested mixtures, these data can be used in accordance with thefollowing bridging principles: • Diluting: if a mixture is diluted with a diluent that has an equivalent or lower toxicity, then the hazards of the new mixture are assumed to be equivalent to the original • Batching: if a batch of a complex substance is produced under a controlled process, then the hazards of the new batch are assumed to be equivalent to the previous batches • Concentration of highly toxic mixtures: if a mixture is severely hazardous, then a concentrated mixture is also assumed to be severely hazardous • Interpolation within one toxicity category: mixtures having component concentrations within a range where the hazards are known are assumed to have those known hazards • Substantially Similar Mixtures: slight changes in the concentrations of components are not expected to change the hazards of a mixture and substitutions involving toxicologically similar components are not expected to change the hazards of a mixture • Aerosols: an aerosol form of a mixture is assumed to have the same hazards as the tested, non-aerosolized form of the mixture unless the propellant affects the hazards upon spraying.All bridging principles do not apply to every health and environmental endpoint. Consult each endpoint todetermine which bridging principles apply!3. Classification based on the concentration of individual ingredients (using the Tables on genericconcentration limits from CLP/GSH Rulebook)3.1 Additive concentration limits• Skin corrosion/irritation• Serious eye damage/eye irritation• STOT SE, Cat. 3• Hazardous to the aquatic environment3.2 Non- additive concentration limits• Sensitisers (respiratory and skin)• CMR• STOT SE and RE, Cat 1-2• Aspiration hazard• Hazardous to the ozone layer4. Calculation using formulas (acute toxicity)Classification based on concentrations and the acute toxicity (ATE-values) of the ingredients by using the additivityformula. 21
  22. 22. 5.5 Can I translate classification of chemicals (including mixtures) from DSD/DPD system of classificationand labelling to CLP/GHS system?The translation table covers those hazards where there is a reasonable correlation between the DSD/DPD systemand CLP/GHS system. Where there is no corresponding classification under CLP/GHS system, you will need toassess these properties yourself using the criteria in Annex I to CLP/GHS Rulebook. Insufficient correlation isgiven for example in the following situations:• In the case of flammable solids (translation is not possible);• In the case of acute toxicity, the classification bands of the two systems overlap, and until data are available aminimum classification using the translation table may be used. However, you should review this carefully incase you have data which allows the substance or mixture to be classified more accurately.Particular care needs to be taken when using the translation table (Annex II of CLP/GHS Rulebook) for mixtures,as there are a number of limitations to its use. For mixtures originally classified on the basis of test results, thetable may be used as for substances. However, for those mixtures originally classified on the basis of theDSD/DPD concentration limits or the DSD/DPD conventional calculation method, the proposed translationoutcome under CLP/GHS system should carefully be considered, because of the differences in concentrationlimits and calculation methods in CLP/GHS Rulebook or in cases of “no classification” under DSD/DPD system. NOTE: If data are available you MAY NOT use translation table in Annex II of CLP/GHS Rulebook!Example of translation (from DSD system to CLP/GHS):Substance is classified in accordance with the DSD/DPD Rulebook as follows:Carc cat 3 R40T; R23Xi; R41R43N; R50R59Additional data: there are also data on acute toxicity studies available. It is a volatile substance and the inhalationtoxicity has been determined for the vapour with an LC50 of 1.5mg/l/4hr.Solution:You may use the conversion table in Annex II to CLP/GHS Regulation. Whenever data for a hazard class orcategory/differentiation are available the classification shall be done by using the criteria. Therefore you shoulduse the classification criteria for acute toxicity inhalation (vapour) in Annex I (Tab 3.1.1 and Tab 3.1.3) and thetranslation table for the remaining hazards.Carc cat 3 R40 Carc. 2 H351T; R23 Acute Tox. 2 H330Xi; R41 Eye Dam. 1 H318R43 Skin Sens. 1 H317N; R50 Aquatic Acute 1 H400R59 Ozone EUH059Note that in relation to physical hazards, no DSD/DPD classification at all is provided, and consequently noCLP/GHS classification (through translation of the DSD/DPD classification). This means that the supplier has toperform testing in accordance with CLP/GHS Rulebook to verify the presence or absence of a physical hazard 22
  23. 23. classification in accordance with CLP/GHS Rulebook where he does not yet have adequate and reliableinformation.5.6 Where shall I found information for classification of chemicals?See also answers under Chapter 4!First check what kind of information or data are already available "in-house". Apart of the tests data, there areuseful sources of information also: safety data sheet (SDS), List of Substances and in the future the C&L inventoryprovided by European Chemicals Agency (ECHA).5.7 What about the examples of classifying?5.7.1 Classification of SUBSTANCESExample 1: Classification of substance (methanol) for STOT-SEThe following data for substance are known:Animal data:LD50 rat > 5,000 (mg/kg)No specific target organ toxicity (impairment of seeing ability) observed in rats, even in high doses.Human experience:Broad human experience from many case reports about blindness following oral intake. Methanol is known tocause lethal intoxications in humans (mostly via ingestion) in relatively low doses; minimal lethal dose in theabsence of medical treatment is between 300 and 1000 mg/kg” (IPCS).Solution:Use of adequate and reliable human data, where animal data are not appropriate. Independent classification forSTOT-SE and Acute toxicity due to different effects.Using the animal data:The rat is known to be insensitive to the toxicity of methanol and is thus not considered to be a good model forhuman effects (different effect/mode of action). Classification is not possible.Using the data on human experience:The classification criteria for Category 1 are fulfilled: clear human evidence of a specific target organ toxicity effectwhich is not covered by Acute toxicity. Classification: STOT-SE, Category 1Result:Classification of the substance (methanol): STOT-SE, Category 1, H370Note: The standard animal species for single exposure (acute) tests, the rat, is not sensitive, i.e. no appropriatespecies for this specific target organ effect. Methanol is classified independently for acute toxicity, since theimpairment of vision is not causal for the lethality, i. e. there are different effects.Example 2: Classification of substance for skin sensitisation2a) Substance with harmonised classification (Methyl/Chloromethyl-isothiazolinone)Methyl/Chloromethyl-isothiazolinone is an example of an extreme sensitiser. This substance is listed in the List ofClassified Substances (Index-No. 613-167-00-5) with harmonised classification: Skin. sens. 1; H317.Being an extreme sensitiser it has a specific concentration limit with regard to skin sensitisation, and due to thisproperty any mixture containing the substance in a concentration ≥ 0.0015% must be classified with Skin sens. 1;EUH208. 23
  24. 24. 2b) Tested substanceSubstance gave a positive result in the LLNA (Local Lymph Node Assay) with an EC3-value of 10.4%. As thisEC3- value is above the cut-off of 2%, the substance is considered to be a moderate skin sensitiser, and should beclassified as a Skin. sens. 1; H317.The GCL (General Concentration Limits) for classification of mixtures containing this substance is 1%.5.7.2 Classification of MIXTURESExample 1: Classification of mixture for acute toxicityThe following data for mixture are known: Percentage Classification ATE (oral)Substance in mixture according to (mg/kg bw) CLP/GHSSubstance 1 10 Acute tox. 4, H302 500 10 Acute tox. 3, oral, unknownSubstance 2 H301Substance 3 2 Acute tox. 2, H300 50Substance 4 78 No >5000Solution:Use the additivity formula in Annex I (3.1.3.6.1) of CLP/GHS Rulebook.According to table 3.1.2 (Annex I of CLP/GHS Rulebook) substance 2 - which is classified in Cat 3 for acute oraltoxicity - corresponds to an ATE of 100 mg/kg bw.Substance 4 is not included as the ATE is above 2000 mg/kg bw100 / ATEmix = 10 / 500 + 10 / 100 + 2 / 50 = 0.16ATEmix = 100 / 0.16 = 625 mg/kg bwClassification according to CLP/GHS:Result: According to table 3.1.1 and Table 3.1.3 (Annex I of CLP/GHS Rulebook) this results in Acute oral tox. 4,H302Example 2: Classification of mixture for skin corrosion/irritation and eye damage/eye irritationThe following data for mixture are known: Percentage in Classification Classification Specific mixture according to according to Concentration CLP/GHS DSD/DPD Limitsubstance 1 10 Skin irrit. 2 H315. Xi, R38 Nosubstance 2 10 No No No 2 Skin corr. 1B C, R34 Nosubstance 3 H314substance 4 78 No No NoAdditional data:Assumption: additivity applies; no extreme pH-values 24
  25. 25. Solution:1. Classification according to CLP/GHS Rulebook:Step 1: Check the classification of the mixture as skin corrosive according to CLP/GHS Rulebook.Substance 3 is classified as skin corrosive Cat. 1B H314 and is present in the solution in 2%.Using table 3.2.3 (Annex I of CLP/GHS Rulebook) you find:The generic concentration value for skin corrosive ingredients in Cat. 1 is: >5%.The skin corrosive substance is present in 2%, therefore the mixture is not corrosive.Step 2: Check the classification of the mixture for skin irritation according to CLP/GHS Rulebook.Substance 1 is classified as skin irritant Cat. 2, H315 and is present in the solution in 10%.Substance 3 is present in the solution in 2% and will also contribute to this classification.Using table 3.2.3 (Annex I of CLP/GHS Rulebook) you find:All skin corrosive ingredients in Cat. 1 which are present < 5% are to be multiplied by a factor 10 and summed upwith the concentration of all skin irritating ingredients:(2% * 10) + 10% = 30% and 30% is > 10% (limit value), therefore, the mixture is to be classified as: Skin irritant,Cat. 2.In this case, where the concentration of the skin irritant ingredient (substance 1) is already 10%, it is sufficient toderive the classification of the mixture from the concentration of the skin irritant ingredient.The hazard statement is H 315 according to Table 3.2.5 (Annex I of CLP/GHS Rulebook).Step 3: Check the classification of the mixture for serious eye damage or eye irritation according to CLP/GHSRulebook.Using table 3.3.3 (Annex I of CLP/GHS Rulebook) you find:Substance 3 is classified as skin corrosive Cat. 1B H314 and is only present in the solution in 2 %, therefore underthe limit value (≥ 3%) and thus there is no classification for irreversible eye effects. However, as the concentrationof Skin Corr 1 B is within the range ≥ 1% to 3%, the mixture should be classified as: Eye Irritant, Cat 2.The hazard statement is H319 according to table 3.3.5 (Annex I of CLP/GHS Rulebook).Result:Classification of the mixture: Skin irrit, Cat 2, H315 and Eye irrit, Cat 2, H319.2. Classification according to DSD/DPD Rulebook:Substance 1 is classified as Xi; R38 and Substance 3 is classified as C; R34.Using Annex II of CLP/GHS Rulebook the correspondence of the classification according to DSD/DPD Rulebookand CLP/GHS Rulebookn can be cross checked (plausibility check).Step 1: Check the mixture for skin corrosion:For R34 the generic concentration limit according to DSD/DPD Rulebook is ≥ 10 %The concentration of the substance 3 is 2%, thus < 10%.Therefore the mixture has no classification for skin corrosion.Step 2: Check the classification for serious eye damage:For R41 the generic concentration limit according DSD/DPD Rulebook is: ≥ 10 %.The concentration of substance 3 (C; R34) is < 10%.Therefore this mixture is not classified for eye damage.Step 3: Check the mixture for skin irritation:For R38 the generic concentration limit according DSD/DPD Rulebook is: ≥ 20 %For R34 the generic concentration limit according DSD/DPD Rulebook is: ≥ 5 % 25
  26. 26. The calculation of the sum of quotients (taken from the actual concentration of the substances and theconcentration limit for every substance) is: 10/20 + 2/5, which is less than 1.Therefore, the mixture has no classification for skin irritation.Result: Under the DSD/DPD Rulebook this mixture would not have been classified!Example 3: Classification of mixture for several end pointsThe following data for mixture are known: Mixture % STOT-RE. mutagenicity carcinogenicity reprotoxicity substance 9 STOT-RE NC Carc. 2; H351 NC 1 Cat 2; H373 substance 4 STOT-RE NC NC Repr. 2 ; H361f 2 Cat. 2; H373 Substance 0.4 NC Muta. 1B; Carc. 1B ; H350 NC 3 H340 substance 86.6 NC NC NC NC 4NC = No classificationNo additivity applies for the end points indicated.Solution:STOT-REGeneral concentration limit is 10% for STOT-RE Cat. 2 components.None of the substances is present above 10%, therefore no classification of the mixture for STOT-RE (CLP/GHSRulebook, Annex 1, Table 3.9.4).MutagenicityGeneral concentration limit is 0.1%.Substance 3 constitutes 0.4% of the mixture therefore classification of the mixture as Mutagenicity 1B, H340 Table3.9.4, Annex I, Table 3.5.2)CarcinogenicityRelevant concentration limit is 0.1%. (carc. 1B)Substance 3 constitutes 0.4% of the mixture therefore classification of the mixture as Carc. 1B, H350 (Table 3.9.4Annex I, Table 3.6.2)ReprotoxicityGeneral concentration limit is 3%.Substance 2 constitutes 4% of the mixture therefore classification of the mixture as Rep. 2, H361f (Table 3.9.4 ,Annex I, Table 3.7.2)Result:Classification of the mixture: Muta. 1B, H340; Carc. 1B, H350 and Repr.2, H361f.Example 4: Classification of mixtures for environmentThe following data for mixture are known:Substance Konc. Ecotoxicity Data % (w/w) EC50 Daphnia magna, 48 h = 0,37 g/L 26
  27. 27. Parathion 0,002 LC50 Fish, Lepomis macrochirus, 96 h = 18 g/L log Kow= 3,15 BCF = 400 Not rapidly degradable ErC50 Algae (Selenastrum capricornutum), 72 h = 0,2 mg/LButyl benzyl 1 EC50 Daphnia magna, 48 h = 2,2 mg/Lphthalate (BBP) log Kow= 4.7 BCF = 663 – 772 Rapidly degradable EC50 Crustacea, 48 h = 0,0207 mg/LNonylphenol 0,02 LC50 Fish, Lepomis macrochirus, 96 h = 0,128 mg/l log Kow= 4.5 BCF = 1300 Not rapidly degradableSolution:You should first determine the CLP/GHS classification of the substances in the mixture and then the classificationof the mixture using the criteria for environmental hazards in Part 4 of Annex I to CLP/GHS Rulebook.Classification of the substances in the mixtureFirst determine the correct classification and the M-factors of the three substances by using Table 4.1.0 and 4.1.3of (Annex I of CLP/GHS Regulation); this is as follows:Parathion: Category 1 for acute toxicity Category 1 for chronic toxicity M-factor = 1000BBP: Category 1 for acute toxicity Category 1 for chronic toxicity M-factor = 1Nonylphenol: Category 1 for acute toxicity Category 1 for chronic toxicity M-factor = 10Classification of the mixtureDetermine the correct classification of the mixture using the summation method in Tables 4.1.1 and 4.1.2 inAnnex I of CLP/GHS Regulation. Do this separately for the classification of acute and long-term hazards. For thelong-term hazards, begin with the most stringent classification, Chronic category 1. If this does not apply, analysefor classification as Chronic category 2, and so on:Category 1 for acute toxicity: (0,002% x 1000) + (1% x 1) + (0,02% x 10) = 3,2% (< 25%) Conclusion: no classification for acute toxicityCategory 1 for chronic toxicity: (0,002% x 1000) + (1% x 1) + (0,02 x 10) = 3,2 % (< 25%) Conclusion: Chronic category 1 does not apply; continue →Category 2 for chronic toxicity: (0,002% x 1000 x 10) + (1% x 1 x 10) + (0,02% x 10 x 10) = = 32% ( > 25%) →Result: 27
  28. 28. Classification of the mixture: Aquatic Chronic, Category 2, H4116. HOW SHALL I LABEL?See also Guidance on Labelling and Packaging in accordance with EU CLP Regulation on the website ofEuropean Chemicals Agency:http://guidance.echa.europa.eu/docs/guidance_document/clp_labelling_en.htm?time=13033769216.1 Which information shall be on the label?The CLP/GHS Rulebook defines the content of the label and the way the various labelling elements should beorganised. Transitional provisions set out when there is the obligation to label in accordance with the CLP/GHSrules and when the labelling according to DSD/DPD Regulation is still applicable.The information required on the GHS label includes: • Name, address and telephone number of the supplier/s of the substance or mixture; • Nominal quantity of substance or mixture in the packages made available to the general public (unless this quantity is specified elsewhere on the package); • Product identifiers; • Hazard pictograms, signal words, hazard statements, precautionary statements and supplemental information which may consist of information required by other legislation, for example the legislation concerning biocides, pesticides or detergents. As the classification of a substance or mixture can result in duplication or redundancy of labelling elements such as signal words, hazard pictograms and hazard and precautionary statements, precedence rules have been created to limit such duplication or redundancies. General rules for labels: • Labels shall be firmly affixed to one or more surfaces of the packaging • It shall be readable horizontally when the package is set down • Hazard pictogram stands out clearly • It is easy to read • Pictograms must be at least 1/15th of surface of harmonised label; minimum size: 1cm26.2 What dose mean the term product identifiers? The product identifier for a substance shall consist of at least one of the following: • Name & Identification Number from the List of Classified Substances (Official Gazette RS No.82/10) (if the substance is included in the List); • Name & Identification Number from the EU inventory (if the substance is included in the inventory); • CAS number & IUPAC name / another international chemical name; or • IUPAC or another international chemical name. 28
  29. 29. The product identifier for a mixture shall consist of both: • The trade name or the designation of the mixture; • The identity of all substances in the mixture that contribute to the classification of the mixture: - acute toxicity, skin corrosion or serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, respiratory or skin sensitisation, specific target organ toxicity (STOT) or aspiration hazard - a maximum of four chemical names shall suffice, unless more are needed. NOTE: The term used for identification of the substance or mixture shall be the same as that used in the SDS!6.3 Are there any specific labelling and packaging requirements?Yes, there are. If substances or mixtures are supplied to the general public, child-resistant fastenings (CRF)and/or tactile warnings of danger (TW) have to be attached to their packaging in case these substances (seeTable 1) or mixtures display certain hazards or if the packaging contains methanol or dichloromethane (see Table2).Table 1: Overview of hazards that trigger child-resistant fastening or tactile warnings Child-resistant Tactile Hazard Criteria 1 Fastenings WarningsAcute toxicity (category 1 to 3) √ √Acute toxicity (category 4) √STOT single exposure (category 1) √ √STOT single exposure (category 2) √STOT repeated exposure (category 1) √ √STOT repeated exposure (category 2) √Skin corrosion (category 1A, 1B and 1C) √ √Respiratory sensitisation (category 1) √Aspiration hazard (category 1)* √Not aerosols or if in container with sealedspray attachmentAspiration hazard (category 1) √ √Germ cell mutagenicity (category 2) √Carcinogenicity (category 2) √Reproductive toxicity (category 2) √ 29
  30. 30. Flammable gases (category 1 and 2) √Flammable liquids (category 1 and 2) √Flammable solids (category 1 and 2) √Note 1. This provision does not apply to aerosols which are only classified andlabelled as "extremely flammable aerosols" or "flammable aerosols".Table 2: Substances that trigger the CLP/GHS provisions for child-resistant fastenings and/or tactile warningswhen they are contained in other substances or in mixtures at or above the denoted concentration Concentration Child-resistant Tactile Identification of the substance Fastenings limit WarningsMethanol* ≥ 3% √ XDichloromethane ≥ 1% √ X* It should be noted that above a certain concentration, methanol mixtures also need a tactile warning because themixture would then have to be classified as flammable liquid, cat. 2.6.4 Is it the size of the label important?Yes, it is! A minimum size of a label depends on the volume of the packaging. The CLP/GHS Rulebook definesminimum dimensions on the size of the label and some of its elements. They are detailed in Annex I to CLP/GHSRulebook, see also Table on minimum dimensions. Table: Minimum dimensions of labels and pictograms under CLP/GHS 30
  31. 31. Capacity of the package Dimensions (in millimeters) ≤ 3 litres If possible, at least 52 × 74 > 3 litres but ≤ 50 litres At least 74 × 105 > 50 litres but ≤ 500 litres At least 105 × 148 > 500 litres At least 148 × 2106.5 What about the size of the label elements?In general, CLP/GHS system requires that the label elements be of such size and spacing as to be easily read.The exact size of the letters of the signal words, hazard statements, precautionary statements and anysupplemental information is not further defined in the legal text, i.e. it is left to the discretion of the supplier. Thismeans that a stakeholder may decide himself whether he wants to increase the letter size with the overall volumeof the packaging and dimensions of the label, or to fix it more or less for all volumes and labels.Actually some stakeholders recommend to use a minimum letter size of 1,8 mm, in order to warrant the legibility ofthe text. However, this can be understood as recommendation only, but not as legal requirement which is fixed inthe CLP/GHS Rulebook.In relation to the hazard pictograms, CLP links the size of the pictograms to the minimum dimensions of thelabel: each hazard pictogram should cover at least one fifteenth of the surface area of the label dedicated to theinformation required by Article 17 of CLP/GHS Rulebook but the minimum area shall not be less than 1 cm2.However, where a supplier chooses to use a label that is larger than the minimum dimensions for a certaincapacity of the package, it is not necessary for the pictogram to be increased as well, provided it covers onefifteenth of the relevant minimum dimensions, i.e. for a container of a capacity > 50 litres, but ≤ 500 litres, theminimum size of a pictogram must be 32 mm x 32 mm, which is 1/15 of the minimum dimensions (105 mm x148mm) set out in Table 1.3 of Annex I to CLP/GHS Rulebook. Any additional area gained by increasing the sizeof the label can be used for further information which is considered important by the supplier.See also table under question 6.4!6.6 Are there any derogation from labelling requirements?Yes, there are. For substances and mixtures contained in packaging that is small (less than 125ml) or of suchform or shape that it is impossible to meet the requirements is otherwise difficult to label, CLP/GHS Rulebookprovides for exemptions from the regular labelling requirements. These exemptions allow the supplier to omit thehazard and/or precautionary statements or the pictograms from the label elements normally required underCLP/GHS Rulebook in case the substance or mixture is classified for the hazards listed in section 1.5 of Annex I toCLP/GHS Rulebook.CLP/GHS Rulebook sets out new rules for situations where packaging of hazardous substances or mixturesconsists of outer, inner and possibly also intermediate packaging.As a general rule, where the labelling of an outer packaging is in principle subject to both the transport and theCLP/GHS rules, the labelling or marking in accordance with transport legislation is sufficient, and the CLP/GHSlabelling need not appear. Similarly, where a hazard pictogram required by CLP/GHS relates to the same hazardas in the rules for the transport of dangerous goods, the hazard pictogram required by CLP/GHS need not appearon the outer packaging. 31
  32. 32. Derogations: • Labelling of outer, inner and single packaging Only CLP/GHS or transport pictogram may be used ! See Art. 33 of CLP/GHS Rulebook! • Labelling and packaging if packaging: The label information may be reduced! - smaller than 125ml or See Art. 29 and section 1.5.2 of Annex I of CLP/GHS Rulebook! - is otherwise difficult to label See Art. 29 and section 1.5.2 of Annex I of 6.7 What about the examples of the labels?1. An example of the label Pictograms Signal word Identifier Supplier Hazard and precautionary statements identification 2. An example for a label incorporating information required by other legislation (transport): 32
  33. 33. http://echa.europa.eu/reach_enforcement_en.asp 3. An example of label of the small packaging (less than 125ml): Small packaging exemptions: reduced set of hazard and precautionary statements, grouped together on the label by language No omissions, but full range of hazard pictograms6.8 When should I update my labels? 33
  34. 34. The supplier shall ensure that the label is updated, without undue delay, if the new hazard is more severe. Otherlabelling changes shall be updated within 18 months.The supplier of a substance or a mixture within the scope of biocidal and plant protection products shall update thelabel in accordance with those legislation.6.9 Serbian FAQ regarding labelling?Link on this issue will be added by Serbian colleagues .Annexes: • Table with all pictograms, H and P (It shall be added by Serbian colleagues!) • Table on translation (It shall be added by Serbian colleagues!) • Glossary • GHS pictograms 34

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