8 clp manual

GHS (CLP/GHS system) IN PRACTICE
1. 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 Supplier

3. 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 helpdesk

5. HOW SHALL I CLASSIFY?
1

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

1. INTRODUCTION

1.0 Background
The purpose of this document is to give suppliers, professional users of hazardous chemicals as well as general
public basic information on GHS, CLP Regulation and Serbian CLP/GHS. In this manual you will also find the
answers 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 following
web link: http://www.ekoplan.gov.rs/shema/

1.1 What is GHS? How it is developed and its main goal?
Development of GHS
The GHS is an acronym for The Globally Harmonized System of Classification and Labelling of Chemicals. It is a
system 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. It
establishes agreed hazard classification and communication provisions with explanatory information on how to
apply the system. The elements in the GHS supply a mechanism to meet the basic requirement of any hazard
communication system, which is to decide if the chemical is hazardous and to prepare a label and Safety Data
Sheet (SDS) as appropriate.

Across the world, countries have different rules on classification and labelling. For example, a chemical could be
classified as ‘toxic’ or ‘explosive’ in one country but not in another. Different symbols are also used to indicate the
same hazards. Therefore 20 years ago the need to develop a single, globally harmonized system to address
classification 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 1992
United Nations Conference on Environment and Development (UNCED), "Earth Summit". The harmonization of
classification and labelling of chemicals all over the world was one of six program areas that were endorsed by the
UN General Assembly to strengthen international efforts concerning the environmentally sound management of
chemicals. It was recognized that an internationally harmonized approach to classification and labelling would
provide the foundation for all countries to develop comprehensive national programs to ensure the safe use of
chemicals.

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. After
that GHS has been regularly amended. So GHS is driven and developed at UN level. In order to amend it you
must 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 Johannesburg
in 2002, encourages countries to implement the GHS as soon as possible. Information about the status of
implementation of the GHS by country is available on
http://www.unece.org/trans/danger/publi/ghs/implementation_e.html.

3

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 text

After Serbian accession to EU:

“Purple book”
UN GHS Document “Serbian GHS”
= international will be substituted by
agreement “EU GHS”

4

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 include
the classification and labelling of the chemical together with other safety information. It is not necessary to supply a
SDS to a member of the public who buys a chemical and does not intend to use it for professional or industrial
purposes.
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 is
governed by Law on Chemicals (“Official Gazette of RS” No 36/09) and Rulebook on SDS (“Official Gazette of
RS” No 81/10)

CLP Regulation (EU GHS) do NOT involve provisions on SDS!

Benefits of using the GHS
In 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 the
country he exports to. This means that, when exporting his product, he can save the costs of re-classification for
reasons of compliance with different requirements of the country he is exporting to. Conversely, supplier who
wants 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 allows
for globally uniform physical, environmental, health and safety information on hazardous chemicals. To achieve
this 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 chemicals
are needed in Serbia?
Text will be provided only in Serbian language by colleagues from Chemical Agency!

5

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 final
form 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 be
classified before placing them on the market, independently of the actual tonnage manufactured, imported or
placed 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 certain
explosive articles which meet the definition set out in chapter 2.1.1. CLP/GHS Rulebook before placing them on
the market. Other articles are not subject to any classification, labelling and packaging provisions of the CLP/GHS
Rulebook.

1.5 Must I also classify medical devices, medicinal products, waste, food, additives and aromas as well as
feedstuff and additive for feedstuff?

Medical devices
Substances and mixtures which are medical devices as defined in Law on Drugs and medical Devices (“Official
Gazette of RS” No 30/10) and which are invasive or used in direct physical contact with the human body are
exempted from the provisions of CLP/GHS Rulebook on the whole if they are in the finished state and intended for
the 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

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!

Waste
Waste as defined in the Law on Waste Management (“Official Gazette of RS” No 36/09) is outside the scope of
CLP/GHS Rulebook. Waste is any substance or object which the waste holder discards, intends or is required to
discard. This may be waste from households (e.g. newspapers or clothes, food, cans or bottles) or from
professionals 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 treatment
operators are not considered as downstream users. At the same time waste treatment operators will not receive
Safety 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 Regulation

Medicinal products
Substances and mixtures which are in the finished state and intended for the final user and which are medicinal
products within the scope of Law on Drugs and Medical Devices (“Official Gazette of RS” No 30/10) medicinal
products for human use or veterinary medicinal products are on the whole exempted from the provisions of the
CLP/GHS Regulation.
However, in cases where a manufacturer or importer supplies substances and mixtures, e.g. active
pharmaceutical ingredients (APIs) or excipients, that are not yet in the finished state, this manufacturer or importer
will 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

Food, additives and aromas as well as feedstuff and additive for feedstuff
Substances and mixtures which are in the finished state and intended for the final user as food, additives and
aromas as well as feedstuff and additive for feedstuff are on the whole exempted from the provisions of the
CLP/GHS Regulation.

1.6 Will plant protection or biocidal products have to be classified and labelled in accordance with CLP/
GHS system?
Active substances
Active substances contained in plant protection or biocidal products will have to be classified and labelled in
according to the CLP/GHS Rulebook as of 1 October 2011. In contrast to other substances supplied and used in
the industrial supply chain, all hazard classifications of these substances will normally be harmonised. Labells shall
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)

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!

Mixtures
A mixture containing one or more active substance in a biocidal or plant protection product, will have to be
classified and labelled in accordance with CLP/GHS Rulebook in line with the transitional provisions. Labels
shall 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 would
have 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 Biocidal
Products shall update the label in accordance with the provisions as provided for in Article 30 of CLP/GHS
Rulebook.

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 accordance
with the CLP/GHS Rulebook before you place it on the Serbian market. The timing of the classification and
labelling of chemicals will have to be in line with the transitional provisions set out in CLP/GHS Rulebook. The
.

8

supplier of chemicals shall also update the label in accordance with the provisions provided for in CLP/GHS
Rulebook.
Placing on the market of a substance or mixture means making it physically available to third parties, whether in
return 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
GHS

1.8 What are transitional periods for classification and labeling of chemicals in accordance with
CLP/GHS system?
Transitional provisions are set out in Article 38 of CLP/GHS Rulebook, defining essentially two target dates that
affect the classification, hazard communication and packaging of hazardous substances and mixtures, namely 1
October 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 the
transitional period – do I have to classify and label according to both systems (DSD/DPD and
CLP/GHS) in the transitional period?
The main obligation imposed on manufacturers and importers of substances, downstream users, including
formulators of mixtures and re-importers of substances or mixtures is to classify, label and package substances
and mixtures in accordance with the CLP/GHS Rulebook. Distributors (including retailers) of substances and
mixtures 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 to
notify certain information, in particular the substance identity and the classification and labelling of that substance
to European Chemicals Agency (ECHA), unless this information has already been submitted as part of a
registration under REACH. ECHA will then include the notified information in the Classification & Labelling

9

Inventory. More information on notification regarding EU GHS and Inventory you may find on the website of
European 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 are
considered to be end users of the substances and mixtures supplied to them as long as they do not place
chemicals 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 Data
Sheet supplied to them.
Formulators of mixtures are not classed as end users, but rather as downstream users of substances and
mixtures.
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

2.1 Manufacturer
A manufacturer is any natural or legal person established within the R of Serbia who manufactures a substance
within the R of Serbia. His main obligation is to classify, label and package substances and mixtures in
accordance with the CLP/GHS Regulation. Since he knows most data on substance, he plays the most important
role in the supply chain.

2.2 Distributor
A distributor is a natural or legal person established within the R of Serbian, including a retailer, who only stores
and places on the market a substance, on its own or contained in a mixture, for third parties. Distributors are not
obliged to classify themselves. In contrast to other suppliers, a distributor (including a retailer) does not have to
classify substances and mixtures himself, but may take over the classification that was derived in accordance with
Title II of CLP/GHS Rulebook by another actor in the supply chain. Typically, the respective classification is made
available 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 the
substance or mixture supplied to him.

2.3 Importer
Importer is any natural or legal person established within the R of Serbia who is responsible for import. His main
obligation is to classify, label and package substances and mixtures in accordance with the CLP/GHS Rulebook.

2.4 Re-importer
A re-importer is considered as a downstream user (see also point 2.6). Re-importers are therefore not obliged to
classify in accordance with Title II CLP/GHS Rulebook, but may also take over the classification derived in
accordance with Title II already by another actor in the supply chain. In any case the re-importer has to ensure that
the 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 means
that 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 transferring
substances or mixtures supplied to them from one container (or packaging) into another. Re-fillers are therefore
not obliged to classify in accordance with Title II of CLP/GHS Rulebook but may also take over the classification
derived in accordance with Title II already by another actor in the supply chain provided the re-filler does not
change the composition of the substance or mixture that is being refilled. In any case before placing chemical on
the Serbian market the re-filler has to ensure that the labelling and packaging is in accordance with CLP/GHS
Rulebook. This can mean that the original label must be replaced by another one. For example, when the contents
of 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

2.6 Downstream user
Downstream user is any natural or legal person established within the R of Serbia, other than the manufacturer or
the 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 of
CLP/GHS Rulebook by another actor in the supply chain, for example from a Safety Data Sheet, under the
condition that he does not change the composition of this substance or mixture. Before placing chemical on the
Serbian market the downstream user has to ensure that the classification, labelling and packaging is in
accordance with CLP/GHS Rulebook. .

A distributor or a consumer is NOT a downstream user!

2.7Supplier
Supplier 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. You
will 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 tests
4.1.1 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 or
environmental hazards; testing for physical hazards is required unless adequate and reliable information is already
available. However information may also be available from other legislation for which there are specific
requirements for test data to be generated such as Law on Plant Protection Products or Law on Biocidal Products
or from various international programmes.
Finally, the supplier may decide to conduct new testing in order to fill data gaps, provided that he has exhausted all
other means of generating information. Testing on animals must be avoided wherever possible and alternative
methods (including in vitro testing, the use of (Q)SARs, read-across and/or category approaches) must always be
considered first provided they provide adequate reliability and quality of data.

12

If, for the purpose of classification, it is required or decided to generate new data, certain test methods and quality
conditions must be met. Studies must be conducted in accordance with the Test Method Regulation (OG No will
be added after publishing.) or other international test methods validated according to international procedures such
as those of the OECD. For physical hazards new tests shall be carried out in compliance with relevant recognised
quality system or by laboratories complying with a relevant recognised standard, and for health and environmental
hazards in compliance with the principles of Good Laboratory Practice (GLP). Animal tests must comply with the
Law 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 be
performed for the purpose of classification. However, existing data obtained from other sources, such as accident
records 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 the
mixtures 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 the
substances. 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. Only
when 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 suppliers
to derive health or environmental classifications of their mixtures based on available data on similar tested
mixtures and on the ingredient substances. It also provides specific rules for the classification of mixtures based
on 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/GHS
Rulebook?
Yes, apart of DSD/DPD information must a supplier also introduce CLP/GHS information into the SDS (Sections 2
and 3) relating to CLP/GHS classifications for substances from 1 October 2011 and relating to CLP/GHS
classification for mixtures from 1 June 2015.
However, substances already placed on the market before 1 October 2011 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 December 2012 and therefore their SDS do not need to be aligned with the CLP/GHS classification
until 1 December 2012.
A similar transitional arrangement is provided for mixtures. If mixtures have already been placed on the market
before 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 to
be aligned with the CLP/GHS classification until 1 June 2017.

13

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

SUB

between 1 Oct 2011 and

1 Jun 2015
MIX

SUB


from 1 Jun 2015

MIX

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 SDS

SUB SDS for substances

MIX SDS for mixtures

4.3 DATA FROM THE LIST OF CLASSIFIED SUBSTANCES

4.3.1 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 for
manufacturers, 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 List
of Classified Substances?
The classification of a substance is based on the relevant information available on its hazardous properties. You
should gather these information to help determine the classification for each of your substances. This information
may 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 or
methods validated according to international procedures. This includes results of testing based on methods or
standards as laid down in the UN Manual of Tests and Criteria and which are referred to in Part 2 of Annex I of
CLP/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 and
occupational 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 the
List of classified substances, but are NOT classified for ALL type of hazards (for example hazard
classes 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. The
physical hazards of substances and mixtures should be determined through testing based on the methods or
standards referred to in Part 2 of Annex I to CLP/GHS Rulebook. These methods can be found for example in the
UN 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 or
databases is already available and where the substance to be classified and the substance described in the
reference 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 source
should be cited and checked by an expert. This should involve the check that there is sufficient documentation to
assess the suitability of the test used, and that the test was carried out using an acceptable level of quality
assurance. Useful data compilations containing physicochemical data are listed in section R.7.1.1.2 of the
Guidance on information requirements and chemical safety assessment on European Chemicals Agency’s
website.

4.4 DATA FROM INVENTORY LIST
4. 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 labelling
information on notified and registered substances. It will also contain the list of harmonised classifications (Annex
VI of EU GHS Regulation). It will be established and maintained by European Chemicals Agency (ECHA).

15

The Inventory will serve multiple purposes:
• It will be a tool for hazard communication and a source of basic information on classified substances for the
general 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 the
possibility of considering further discussion, evaluation needs or the need for harmonisation of a particular
classification 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 Member
State Competent Authorities assess the need for potential authorisations and restrictions of hazardous substances
under 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 assigned
in cases where a substance has been classified in some but not all hazard classes or differentiations, specific
concentration 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 SOURCES
Information on the hazardous properties of substances can be sourced in databases which are accessible on the
internet 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.asp
There you can find quite a number of major available data bases and databanks (some are free of charge, but
others require payment of a fee). A small selection of mentioned sources is following (note that they may not
present 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 Products
Safety 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.htm
http://ec.europa.eu/environment/chemicals/ghs/index_en.htm
• Joint Research Centre
http://ecb.jrc.it/REACH/

Non-EU sources:
• ECHEM Portal from OECD:

16

http://webnet3.oecd.org/echemportal/
• RTECS (Registry of Toxic Effects of Chemical Substances) available from the NIOSH (US National Institute of
Occupational 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 relevant
journals, 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 already
implemented through the UN Model Regulations and related legal instruments (ADR, RID, ADN, IMDG Code and
ICAO regulating the transport of dangerous goods. You can use a transport classification as one of your sources
of information for the classification and labelling of your substance as far as it is not included in Annex VI to
CLP/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 environmental
hazards, so the absence of a transport classification for your substance does not mean that you should not classify
it under CLP/GHS system. In relation to physical hazards, this means that you may have to test in order to provide
for 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 Goods
List (ADR, part 3) which have to be met in order to be classified in the respective class for transport. In these
cases the classification for the purposes of supply and use might be different. Further to this, one substance even
may have two different entries with two different classifications where one of the classifications is linked to one or
more special provisions; and
• transport classification may be based on another set of information than is required now by CLP/GHS
Regulation.

4.5.1 EU Guidances on CLP (= EU GHS)

http://guidance.echa.europa.eu/guidance_en.htm

4.5.2 EU Guidance on application of the CLP (= EU GHS) criteria

On the European Chemicals Agency 's (ECHA) website,
http://guidance.echa.europa.eu/docs/guidance_document/clp_en.pdf , guidance documents are to help industry
to comply with the rules of the EU CLP Regulation:

• The Introductory Guidance on the CLP Regulation: describes basic obligations and procedures of the EU
CLP Regulation
• The Guidance on the Application of the CLP Criteria: provides general principles of classification and
labelling under the EU CLP Regulation as well as detailed guidance on the criteria for the classification and
labelling of substances and mixtures.
• The Guidance on Labelling and Packaging in accordance with EU CLP Regulation: provides general

principles of labelling under the EU CLP Regulation 1272/2008
17

On the ECHA's website is also an online tool (“GHS converter”) in German and English language that helps SMEs
to 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 CLP

On the ECHA's 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 CLP

4.5.4 Serbian helpdesk
The 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 intrinsic
hazardous 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 classes
and categories in order to allow for "self classification". For many hazards a decision tree approach is provided in
the CLP/GHS Rulebook. For several hazards the GHS criteria are semi-quantitative or qualitative. Expert judgment
may 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 be
subject 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 Substances
shall 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 those
hazards where no harmonised classification exists. For mixtures, self-classification has always to be done. The
classification criteria are set out in Part 2-5 of Annex I to CLP/GHS Rulebook. Mixtures will always have to be self-

18

classified, i.e. 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.

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. They
may 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 been
classified 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 inventory
See also answers 4.4.1 and 4.4.2!
In EU are manufacturers and importers required to notify the European Chemicals Agency (ECHA) of the
classification and labelling of substance(s) placed on the EU market. ECHA shall then include the information in a
classification and labelling inventory in form of a database. Substances placed on the EU market on or after 1
December 2010 require notification within one month.
The ECHA shall make certain information from the inventory publicly available on its website, including the
substance name, the classification, labelling and any relevant specific concentration limit or M-factor. It will be
indicated if there is a harmonised classification for the entry, or if it is an agreed entry between manufacturers or
importers.
While multiple notifications of the same substance may be made by different manufacturers or importers, with the
potential for differences in the classifications notified, over time this should provide the stimulus for EU
suppliers 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 and
labelling?
While the main features of classification and labelling are similar under DSD/DPD Rulebook and CLP/GHS
Rulebook, there are some differences which are due to the integration of the terminology, classification criteria and
labelling elements of the UN GHS and to procedures taken over by CLP/GHS Rulebook. An overview of the most
important differences is included in the table below and further explained in the text following the table:

19

DSD/DPD Rulebook CLP/GHS Regulation Rulebook

DSD/DPD Rulebook terminology, e.g. category of CLP/GHS Rulebook terminology, i.e. hazard class,
danger, risk phrase, safety phrase hazard statement,precautionary statement
DSD/DPD Rulebook categories of danger for CLP/GHS Rulebook hazard classes including those
physical, 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
system
DSD/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 rules

Testing, human experience or calculation for mixture Similar to DSD/DPD; in addition bridging principles
classification that allow the classification of mixtures on the basis of
data on similar tested mixtures and information on
individual hazardous ingredient substances
DSD/DPD Rulebook categories of danger plus CLP/GHS Rulebook hazard classes plus
additional labelling elements, e.g. R1 (“Explosive supplemental labelling elements taken over from
when dry”) DSD/DPD Rulebook e.g. EUH001 (“Explosive when
dry”)
If harmonised classification then normally for all If harmonised classification then for substances
categories of danger which are carcinogenic, mutagenic, toxic to
reproduction or respiratory sensitisers; other effects
on a case-by-case basis

5.3 What are the main rules for classification of substances according to CLP/GHS system?
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 Rulebook

5.4 What are the main rules for classification of mixture according to CLP/GHS system?
The classification of mixtures involves the same basic steps as the classification of substances. As a general rule
and as with substances, available data on the mixture as a whole should primarily be used to determine the
classification. If this cannot be done, further approaches (see the list of possible methods for classification of
mixtures below) to mixture classification may be applied. You may now apply the so-called bridging principles for
some health and environmental hazards, using data on similar tested mixtures and information on individual
hazardous ingredient substances.
Application of expert judgement and weight of evidence determination are by CLP/GHS system more explicit in the
legal 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 be
sufficient information on the ingredients of the mixture.

20

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 the
approaches below in the following sequence:

1. Using data on the mixture itself
1. The mixture as a whole is tested
2. The classification criteria are applied as for a substance
3. Not applicable for CMR and some environmental hazard classes, but mandatory for physical hazards

2. Classification based on the application of bridging principles
Bridging principles are used for classifying untested mixtures. When a mixture has not been tested, but there are
sufficient data on the components and/or similar tested mixtures, these data can be used in accordance with the
following 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 to
determine which bridging principles apply!

3. Classification based on the concentration of individual ingredients (using the Tables on generic
concentration 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 environment

3.2 Non- additive concentration limits
• Sensitisers (respiratory and skin)
• CMR
• STOT SE and RE, Cat 1-2
• Aspiration hazard
• Hazardous to the ozone layer

4. Calculation using formulas (acute toxicity)
Classification based on concentrations and the acute toxicity (ATE-values) of the ingredients by using the additivity
formula.

21

5.5 Can I translate classification of chemicals (including mixtures) from DSD/DPD system of classification
and labelling to CLP/GHS system?
The translation table covers those hazards where there is a reasonable correlation between the DSD/DPD system
and CLP/GHS system. Where there is no corresponding classification under CLP/GHS system, you will need to
assess these properties yourself using the criteria in Annex I to CLP/GHS Rulebook. Insufficient correlation is
given 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 a
minimum classification using the translation table may be used. However, you should review this carefully in
case 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, the
table may be used as for substances. However, for those mixtures originally classified on the basis of the
DSD/DPD concentration limits or the DSD/DPD conventional calculation method, the proposed translation
outcome under CLP/GHS system should carefully be considered, because of the differences in concentration
limits 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 R40
T; R23
Xi; R41
R43
N; R50
R59
Additional data: there are also data on acute toxicity studies available. It is a volatile substance and the inhalation
toxicity 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 or
category/differentiation are available the classification shall be done by using the criteria. Therefore you should
use the classification criteria for acute toxicity inhalation (vapour) in Annex I (Tab 3.1.1 and Tab 3.1.3) and the
translation table for the remaining hazards.

Carc cat 3 R40 Carc. 2 H351
T; R23 Acute Tox. 2 H330
Xi; R41 Eye Dam. 1 H318
R43 Skin Sens. 1 H317
N; R50 Aquatic Acute 1 H400
R59 Ozone EUH059

Note that in relation to physical hazards, no DSD/DPD classification at all is provided, and consequently no
CLP/GHS classification (through translation of the DSD/DPD classification). This means that the supplier has to
perform testing in accordance with CLP/GHS Rulebook to verify the presence or absence of a physical hazard

22

classification in accordance with CLP/GHS Rulebook where he does not yet have adequate and reliable
information.

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 are
useful sources of information also: safety data sheet (SDS), List of Substances and in the future the C&L inventory
provided by European Chemicals Agency (ECHA).

5.7 What about the examples of classifying?

5.7.1 Classification of SUBSTANCES

Example 1: Classification of substance (methanol) for STOT-SE
The 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 to
cause lethal intoxications in humans (mostly via ingestion) in relatively low doses; minimal lethal dose in the
absence 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 for
STOT-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 for
human 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 effect
which is not covered by Acute toxicity. Classification: STOT-SE, Category 1

Result:
Classification of the substance (methanol): STOT-SE, Category 1, H370

Note: The standard animal species for single exposure (acute) tests, the rat, is not sensitive, i.e. no appropriate
species for this specific target organ effect. Methanol is classified independently for acute toxicity, since the
impairment of vision is not causal for the lethality, i. e. there are different effects.

Example 2: Classification of substance for skin sensitisation
2a) Substance with harmonised classification (Methyl/Chloromethyl-isothiazolinone)
Methyl/Chloromethyl-isothiazolinone is an example of an extreme sensitiser. This substance is listed in the List of
Classified 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 this
property any mixture containing the substance in a concentration ≥ 0.0015% must be classified with Skin sens. 1;
EUH208.

23

2b) Tested substance
Substance gave a positive result in the LLNA (Local Lymph Node Assay) with an EC3-value of 10.4%. As this
EC3- value is above the cut-off of 2%, the substance is considered to be a moderate skin sensitiser, and should be
classified 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 MIXTURES

Example 1: Classification of mixture for acute toxicity
The following data for mixture are known:
Percentage Classification ATE (oral)
Substance in mixture according to (mg/kg bw)
CLP/GHS
Substance 1 10 Acute tox. 4, H302 500
10 Acute tox. 3, oral, unknown
Substance 2
H301
Substance 3 2 Acute tox. 2, H300 50
Substance 4 78 No >5000

Solution:
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 oral
toxicity - corresponds to an ATE of 100 mg/kg bw.

Substance 4 is not included as the ATE is above 2000 mg/kg bw

100 / ATEmix = 10 / 500 + 10 / 100 + 2 / 50 = 0.16

ATEmix = 100 / 0.16 = 625 mg/kg bw

Classification 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,
H302

Example 2: Classification of mixture for skin corrosion/irritation and eye damage/eye irritation
Percentage in Classification Classification Specific
mixture according to according to Concentration
CLP/GHS DSD/DPD Limit
substance 1 10 Skin irrit. 2 H315. Xi, R38 No
substance 2 10 No No No
2 Skin corr. 1B C, R34 No
substance 3
H314
substance 4 78 No No No

Additional data:
Assumption: additivity applies; no extreme pH-values

24

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.

All skin corrosive ingredients in Cat. 1 which are present < 5% are to be multiplied by a factor 10 and summed up
with 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 to
derive 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/GHS
Rulebook.

Substance 3 is classified as skin corrosive Cat. 1B H314 and is only present in the solution in 2 %, therefore under
the limit value (≥ 3%) and thus there is no classification for irreversible eye effects. However, as the concentration
of 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 Rulebook
and 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

The calculation of the sum of quotients (taken from the actual concentration of the substances and the
concentration 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 points
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
4
NC = No classification
No additivity applies for the end points indicated.

Solution:
STOT-RE
General 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/GHS
Rulebook, Annex 1, Table 3.9.4).

Mutagenicity
General concentration limit is 0.1%.
Substance 3 constitutes 0.4% of the mixture therefore classification of the mixture as Mutagenicity 1B, H340 Table
3.9.4, Annex I, Table 3.5.2)

Carcinogenicity
Relevant 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 3.9.4
Annex I, Table 3.6.2)

Reprotoxicity
General 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 environment
Substance Konc. Ecotoxicity Data
% (w/w)

EC50 Daphnia magna, 48 h = 0,37 g/L

26

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/L
Butyl benzyl 1 EC50 Daphnia magna, 48 h = 2,2 mg/L
phthalate (BBP)
log Kow= 4.7
BCF = 663 – 772
Rapidly degradable
EC50 Crustacea, 48 h = 0,0207 mg/L
Nonylphenol 0,02 LC50 Fish, Lepomis macrochirus, 96 h = 0,128 mg/l

log Kow= 4.5
BCF = 1300
Not rapidly degradable

Solution:
You should first determine the CLP/GHS classification of the substances in the mixture and then the classification
of the mixture using the criteria for environmental hazards in Part 4 of Annex I to CLP/GHS Rulebook.

Classification of the substances in the mixture
First determine the correct classification and the M-factors of the three substances by using Table 4.1.0 and 4.1.3
of (Annex I of CLP/GHS Regulation); this is as follows:

Parathion: Category 1 for acute toxicity
Category 1 for chronic toxicity
M-factor = 1000

BBP: Category 1 for acute toxicity
M-factor = 1

Nonylphenol: Category 1 for acute toxicity
M-factor = 10

Classification of the mixture
Determine the correct classification of the mixture using the summation method in Tables 4.1.1 and 4.1.2 in
Annex I of CLP/GHS Regulation. Do this separately for the classification of acute and long-term hazards. For the
long-term hazards, begin with the most stringent classification, Chronic category 1. If this does not apply, analyse
for 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 toxicity

Category 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

Classification of the mixture: Aquatic Chronic, Category 2, H411

6. HOW SHALL I LABEL?
See also Guidance on Labelling and Packaging in accordance with EU CLP Regulation on the website of
European Chemicals Agency:
http://guidance.echa.europa.eu/docs/guidance_document/clp_labelling_en.htm?time=1303376921

6.1 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 be
organised. Transitional provisions set out when there is the obligation to label in accordance with the CLP/GHS
rules 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: 1cm2

6.2 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

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 (see
Table 1) or mixtures display certain hazards or if the packaging contains methanol or dichloromethane (see Table
2).

Table 1: Overview of hazards that trigger child-resistant fastening or tactile warnings

Child-resistant Tactile
Hazard Criteria 1
Fastenings Warnings

Acute 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 sealed
spray attachment
Aspiration hazard (category 1) √ √
Germ cell mutagenicity (category 2) √
Carcinogenicity (category 2) √
Reproductive toxicity (category 2) √

29

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 and
labelled as "extremely flammable aerosols" or "flammable aerosols".

Table 2: Substances that trigger the CLP/GHS provisions for child-resistant fastenings and/or tactile warnings
when 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 Warnings
Methanol* ≥ 3% √ X
Dichloromethane ≥ 1% √ X

* It should be noted that above a certain concentration, methanol mixtures also need a tactile warning because the
mixture 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 defines
minimum dimensions on the size of the label and some of its elements. They are detailed in Annex I to CLP/GHS
Rulebook, see also Table on minimum dimensions.

Table: Minimum dimensions of labels and pictograms under CLP/GHS

30

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 × 210

6.5 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 any
supplemental information is not further defined in the legal text, i.e. it is left to the discretion of the supplier. This
means that a stakeholder may decide himself whether he wants to increase the letter size with the overall volume
of 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 of
the text. However, this can be understood as recommendation only, but not as legal requirement which is fixed in
the CLP/GHS Rulebook.

In relation to the hazard pictograms, CLP links the size of the pictograms to the minimum dimensions of the
label: each hazard pictogram should cover at least one fifteenth of the surface area of the label dedicated to the
information 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 certain
capacity of the package, it is not necessary for the pictogram to be increased as well, provided it covers one
fifteenth of the relevant minimum dimensions, i.e. for a container of a capacity > 50 litres, but ≤ 500 litres, the
minimum size of a pictogram must be 32 mm x 32 mm, which is 1/15 of the minimum dimensions (105 mm x
148mm) set out in Table 1.3 of Annex I to CLP/GHS Rulebook. Any additional area gained by increasing the size
of 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 such
form or shape that it is impossible to meet the requirements is otherwise difficult to label, CLP/GHS Rulebook
provides for exemptions from the regular labelling requirements. These exemptions allow the supplier to omit the
hazard and/or precautionary statements or the pictograms from the label elements normally required under
CLP/GHS Rulebook in case the substance or mixture is classified for the hazards listed in section 1.5 of Annex I to
CLP/GHS Rulebook.
CLP/GHS Rulebook sets out new rules for situations where packaging of hazardous substances or mixtures
consists 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 the
CLP/GHS rules, the labelling or marking in accordance with transport legislation is sufficient, and the CLP/GHS
labelling need not appear. Similarly, where a hazard pictogram required by CLP/GHS relates to the same hazard
as in the rules for the transport of dangerous goods, the hazard pictogram required by CLP/GHS need not appear
on the outer packaging.

31

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

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 pictograms

6.8 When should I update my labels?

33

The supplier shall ensure that the label is updated, without undue delay, if the new hazard is more severe. Other
labelling 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 the
label 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

Glossary:

ATE: Acute Toxicity Estimate

Carcinogen means a substance or a mixture which induces cancer or increases its incidence

BCF means bioconcentration factor

Bridging principles means deriving health or environmental classifications of mixtures based on available data
on similar tested mixtures and on the ingredient substances

CLP means Classification, Labelling and Packaging of Substances and Mixtures

CLP Regulation (= EU GHS) means EU Regulation (EC) No 1272/2008 on Classification Labelling and Packaging
of Substances and Mixtures

CLP/GHS (= Serbian GHS) means Pravilnik o klasifikaciji, pakovanju, obeležavanju i reklamiranju hemikalije i
određenog proizvoda u skladu sa Globalno harmonizovanim sistemom za klasifikaciju i obeležavanje UN (Sl.
glasnik RS br. 64/10) ⇒ usklađen sa EU Uredbom 1272/2008 (Regulation on Classification, Labelling and
Packaging of substances and mixtures)

DSD/DPD Rulebook means Pravilnik o klasifikaciji, pakovanju, obeležavanju i reklamiranju hemikalije i
određenog proizvoda (Sl. glasnik RS br. 59/10) ⇒ usklađen sa EU Direktivom 67/548/EEZ i 99/45/EZ
(Classification, labelling and packaging of dangerous substances and preparations) – DSD/DPD (Dangerous
Substances Directive/Dangerous Preparations Directive)

CMR means a substance or mixture which is carcinogenic, mutagenic or toxic to reproduction

DPD means the Dangerous Preparations Directive (1999/45/EC)

DSD means the Dangerous Substances Directive (67/548/EEC)

EC50 means half maximal effective concentration

ECHA means European Chemicals Agency

EU means European Union

EU GHS (=CLP Regulation) means EU Regulation (EC) No 1272/2008 on Classification Labelling and Packaging
of Substances and Mixtures

GHS means Globally Harmonised System of Classification and Labelling of Chemicals

Hazard category means the division of criteria within each hazard class, specifying hazard severity

Hazard class means the nature of the physical, health or environmental hazard

Hazard pictogram means a graphical composition that includes a symbol plus other graphic elements, such as a
border, background pattern or colour that is intended to convey specific information

Hazard statement means a phrase assigned to a hazard class and category that describes the nature of the
hazards of a hazardous substance or mixture, including, where appropriate, the degree of hazard

35

8 clp manual

Recommandé

Recommandé

Contenu connexe

Similaire à 8 clp manual

Similaire à 8 clp manual (20)

Dernier

Dernier (20)

8 clp manual