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2.classification and Labelling Systems For Chemicals

This document discusses classification and labelling systems for chemicals. It outlines that there are a small number of significant systems at national, regional, and international levels that classify chemicals based on their intrinsic health and physical hazards. The criteria and definitions used in these systems vary in areas like the number of hazard scales, specific terminology, test methods, and how mixtures are classified. Establishing an international structure could help harmonize approaches and better protect workers, the public, and the environment. The document then provides details on some major international systems like those from the United Nations for transport and others focused on exposure levels and environmental impacts.

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100% found this document useful (1 vote)
1K views6 pages

2.classification and Labelling Systems For Chemicals

This document discusses classification and labelling systems for chemicals. It outlines that there are a small number of significant systems at national, regional, and international levels that classify chemicals based on their intrinsic health and physical hazards. The criteria and definitions used in these systems vary in areas like the number of hazard scales, specific terminology, test methods, and how mixtures are classified. Establishing an international structure could help harmonize approaches and better protect workers, the public, and the environment. The document then provides details on some major international systems like those from the United Nations for transport and others focused on exposure levels and environmental impacts.

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CLASSIFICATION AND LABELLING SYSTEMS FOR CHEMICALS

Konstantin K. Sidorov, Igor V. Sanotskiy


___________________________________________________________________

Classification systems
3.1. General
3.1.1. The competent authority, or a body approved or recognised by the competent authority, should establish systems and specific criteria
for classifying a chemical as hazardous and should progressively extend these systems and their application. Existing criteria for
classification established by other competent authorities or by international agreement may be followed, if they are consistent with the
criteria and methods outllined in this code, and this is encouraged where it may assist uniformity of approach. The results of the work of the
UNEP/ILO/WHO International Programme on Chemical Safety (IPCS) coordinating group for the harmonisation of classification of
chemicals should be considered when appropriate. The responsibilities and role of competent authorities concerning classification systems
are set out in paragraphs 2.1.8 (criteria and requirements), 2.1.9 (consolidated list) and 2.1.10 (assessment of new chemicals).
3.1.2. Suppliers should ensure that chemicals they supplied have been classified or that they have been identified and their properties
assessed (see paragraphs 2.4.3 (assessment) and 2.4.4 (classification)).
3.1.3. Manufacturers or importers, unless exempted, should give to the competent authority information about chemical elements and
compounds not yet included in the consolidated classification list compiled by the competent authority, prior to their use at work (see
paragraph 2.1.10 (assessment of new chemicals)).
3.1.4. The limited quantities of a new chemical required for research and development purposes may be produced by, handled in, and
transported between laboratories and pilot plant before all hazards of this chemical are known in accordance with national laws and
regulations. All available information found in literature or known to the employer from his or her experience with similar chemicals and
applications should be fully taken into account, and adequate protection measures should be applied, as if the chemical were hazardous.
The workers involved must be informed about the actual hazard information as it becomes known.
3.2. Criteria for classification
3.2.1. The criteria for the classification of chemicals should be based upon their intrinsic health and physical hazards, including:
(a) toxic properties, including both acute and chronic health effects in all parts of the body;
(b) chemical or physical characteristics, including flammable, explosive, oxidising and dangerously reactive properties;
(c) corrosive and irritant properties;
(d) allergenic and sensitising effects;
(e) carcinogenic effects;
(f) teratogenic and mutagenic effects;
(g) effects on the reproductive system.
3.3. Method of classification
3.3.1. The classification of chemicals should be based on available sources of information, e.g.:
(a) test data;
(b) information provided by the manufacturer or importer, including information on research work done;
(c) information available as a result of international transport rules, e.g., the United Nations Recommendations on the Transport of
Dangerous Goods, which should be taken into account for the classification of chemicals in the case of transport, and the UNEP Basel
Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal (1989), which should be taken into
account in respect of hazardous wastes;
(d) reference books or literature;
(e) practical experience;
(f) in the case of mixtures, either on the test of the mixture or on the known hazards of their components;
(g) information provided as a result of the risk evaluation work performed by the International Agency for Reseach on Cancer (IARC), the
UNEP/ILO/WHO International Programme on Chemical Safety (IPCS), the European Communities and various national and international
institutions, as well as information available through systems such as the UNEP International Register of Potentially Toxic Chemicals
(IRPTC).
3.3.2. Certain classification systems in use may be limited to particular classes of chemicals only. An example is the WHO Recommended
classification of pesticides by hazard and guidelines to classification, which classifies pesticides by degree of toxicity only and principally by
acute risks to health. Employers and workers should understand the limitations of any such system. Such systems can be useful to
complement a more generally applicable system.

3.3.3. Mixtures of chemicals should be classified based on the hazards exhibited by the mixtures themselves. Only if mixtures have not
been tested as a whole should they be classified on the basis of intrinsic hazards of their component chemicals.
Source: ILO 1993, Chapter 3.
_______________________________________________________________________________

Hazard classification and labelling systems are included in legislation covering the safe production, transport, use and disposal of
chemicals. These classifications are designed to provide a systematic and comprehensible transfer of health information. Only a small
number of significant classification and labelling systems exist at the national, regional and international levels. Classification criteria and
their definitions used in these systems vary in the number and degree of hazard scales, specific terminology and test methods, and the
methodology for classifying mixtures of chemicals. The establishment of an international structure for harmonizing classification and
labelling systems for chemicals would have a beneficial impact on chemical trade, on the exchange of information related to chemicals, on
the cost of risk assessment and management of chemicals, and ultimately on the protection of workers, the general public and the
environment.
The major basis for classification of chemicals is the assessment of exposure levels and environmental impact (water, air and soil). About
half of the international systems contain criteria related to a chemicals production volume or the effects of pollutant emissions. The most
widespread criteria used in chemical classification are values of median lethal dose (

) and median lethal concentration (

). These

values are evaluated in laboratory animals via three main pathways-oral, dermal and inhalation-with a one-time exposure. Values of
and
are evaluated in the same animal species and with the same exposure routes. The Republic of Korea considers
with
intravenous and intracutaneous administration as well. In Switzerland and Yugoslavia chemical management legislation requires
quantitative criteria for
with oral administration and adds a provision which specifies the possibility of different hazard classifications
based on the route of exposure.
In addition, differences in the definitions of comparable hazard levels exist. While the European Community (EC) system utilizes a threelevel acute toxicity scale (very toxic, toxic and harmful), the US Occupational Safety and Health Administration (OSHA) Hazard
Communication Standard applies two acute toxicity levels (highly toxic and toxic). Most classifications apply either three categories
(United Nations (UN), World Bank, International Maritime Organization (IMO), EC and others) or four (the former Council for Mutual
Economic Assistance (CMEA), the Russian Federation, China, Mexico and Yugoslavia).
International Systems
The following discussion of existing chemical classification and labelling systems focuses primarily on major systems with long application
experience. Hazard assessments of pesticides are not covered in general chemical classifications, but are included in the Food and
Agricultural Organization/World Health Organization (FAO/WHO) classification as well as in various national legislation (e.g., Bangladesh,
Bulgaria, China, the Republic of Korea, Poland, the Russian Federation, Sri Lanka, Venezuela and Zimbabwe).
Transport-oriented classifications
Transport classifications, which are broadly applied, serve as a basis for regulations governing labelling, packaging and transport of
dangerous cargoes. Among these classifications are the UN Recommendations on the Transport of Dangerous Goods (UNRTDG), the
International Maritime Dangerous Goods Code developed within the IMO, the classification established by the Group of Experts on the
Scientific Aspects of Marine Pollution (GESAMP) for hazardous chemicals carried by ship, as well as national transport classifications.
National classifications as a rule comply with UN, IMO and other classifications within international agreements on transportation of
dangerous goods by air, rail, road and inland navigation, harmonized with the UN system.
The United Nations Recommendations on the Transport of Dangerous Goods and related transport modal authorities
The UNRTDG create a widely accepted global system which provides a framework for intermodal, international and regional transport
regulations. These Recommendations are increasingly being adopted as the basis of national regulations for domestic transport. The
UNRTDG is rather general on issues such as notification, identification and hazard communication. The scope has been restricted to the
transport of hazardous substances in packaged form; the Recommendations do not apply to exposed hazardous chemicals or to transport
in bulk. Originally the objective was to prevent dangerous goods from causing acute injury to workers or the general public, or damage to
other goods or the means of transport employed (aircraft, vessel, railcar or road vehicle). The system has now been extended to include
asbestos and substances hazardous to the environment.
The UNRTDG focus primarily on hazard communication based on labels which include a combination of graphic symbols, colours, warning
words and classification codes. They also provide key data for emergency response teams. The UNRTDG are relevant for the protection of
such transport workers as aircrew, mariners and the crews of trains and road vehicles. In many countries the Recommendations have been
incorporated in legislation for the protection of dock workers. Parts of the system, such as the Recommendations on explosives, have been
adapted to regional and national regulations for the workplace, generally including manufacturing and storage. Other UN organizations
concerned with transport have adopted the UNRTDG. The transport classification systems of dangerous goods of Australia, Canada, India,
Jordan, Kuwait, Malaysia and United Kingdom basically comply with the major principles of these Recommendations, for example.
The UN classification subdivides chemicals into nine classes of hazards:
1st class-explosive substances

2nd class-compressed, liquefied, dissolved under pressure or deeply condensed gases


3rd class-easily inflammable liquids
4th class-easily inflammable solid substances
5th class-oxidizing substances, organic peroxides
6th class-poisonous (toxic) and infectious substances
7th class-radioactive substances
8th class-corrosive agents
9th class-other dangerous substances.
The packaging of goods for the purpose of transport, an area specified by the UNRTDG, is not covered as comprehensively by other
systems. In support of the Recommendations, organizations such as IMO and International Civil Aviation Organization (ICAO) carry out
very significant programmes aimed at training dock workers and airport personnel in the recognition of label information and packaging
standards.
The International Maritime Organization
The IMO, with a mandate from the 1960 Conference on Safety of Life at Sea (SOLAS 1960), has developed the International Maritime
Dangerous Goods (IMDG) Code. This code supplements the mandatory requirements of chapter VII (Carriage of Dangerous Goods) of
SOLAS 74 and those of Annex III of the Maritime Pollution Convention (MARPOL 73/78). The IMDG Code has been developed and kept up
to date for more than 30 years in close cooperation with the UN Committee of Experts on Transport of Dangerous Goods (CETG) and has
been implemented by 50 IMO members representing 85% of the worlds merchant tonnage.
Harmonization of the IMDG Code with the UNRTDG ensures compatibility with the national and international rules applicable to the
transport of dangerous goods by other modes, in so far as these other modal rules are also based on the recommendations of the
UNCETG-that is, ICAO Technical Instructions for the Safe Transport of Dangerous Goods by Air and the European Regulations concerning
the international carriage of dangerous goods by road (ADR) and by rail (RID).
In 1991 the 17th IMO Assembly adopted a Resolution on the Coordination of Work in Matters Relating to Dangerous Goods and Hazardous
Substances, urging, inter alia, UN bodies and governments to coordinate their work in order to ensure the compatibility of any legislation on
chemicals, dangerous goods and hazardous substances with established international transport rules.
Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal, 1989
The Conventions Annexes define 47 categories of wastes, including domestic wastes. Although the hazard classification parallels that of
the UNRTDG, a significant difference includes the addition of three categories reflecting more specifically the nature of toxic wastes:
chronic toxicity, liberation of toxic gases from interaction of wastes with air or water, and capacity of wastes to yield secondary toxic material
after disposal.
Pesticides
National classification systems related to the hazard assessment of pesticides tend to be quite comprehensive because of the wide use of
these chemicals and the potential long-term damage to the environment. These systems may identify from two to five hazard
classifications. The criteria are based on median lethal doses with different routes of exposure. While Venezuela and Poland recognize only
one route of exposure, ingestion, the WHO and various other countries identify both ingestion and skin application.
The criteria for hazard assessment of pesticides in East European countries, Cyprus, Zimbabwe, China and others are based on median
lethal doses via inhalation. Bulgarias criteria, however, include skin and eye irritation, sensitization, accumulation ability, persistence in
environmental media, blastogenic and teratogenic effects, embryotoxicity, acute toxicity and medical treatment. Many classifications of
pesticides also include separate criteria based on median lethal doses with different aggregative states. For example, criteria for liquid
pesticides are usually more severe than those for solid ones.
WHO Recommended Classification of Pesticides by Hazard
This Classification was first issued in 1975 by the WHO and updated subsequently on a regular basis by the United Nations Environment
Programme, the ILO and the WHO (UNEP/ILO/WHO) International Programme on Chemical Safety (IPCS) with input from the Food and
Agriculture Organization (FAO). It consists of one hazard category or classification criterion, acute toxicity, divided in four classification
levels based on
(rat, oral and dermal values for liquid and solid forms) and ranging from extremely to slightly hazardous. Apart from
general considerations, no specific labelling rules are provided. The 1996-97 update contains a guide to classification which includes a list
of classified pesticides and comprehensive safety procedures. (See the chapter Minerals and agricultural chemicals.)
FAO International Code of Conduct on the Distribution and Use of Pesticides
The WHO Classification is supported by another document, the FAO International Code of Conduct on the Distribution and Use of
Pesticides. Although it is only a recommendation, this classification is applied most widely in developing countries, where it is often included
into pertinent national legislation. With regard to labelling, the FAO has published Guidelines on Good Labelling Practice for Pesticidesas
an addendum to these guidelines.
Regional Systems (EC, EFTA, CMEA)
The EC Council Directive 67/548/EEC has been in application for over two decades and has harmonized the pertinent legislation of 12
countries. It has evolved into a comprehensive system which includes an inventory of existing chemicals, a notification procedure for new
chemicals prior to marketing, a set of hazard categories, classification criteria for each category, testing methods, and a hazard
communication system including labelling with codified risk and safety phrases and hazard symbols. Chemical preparations (mixtures of

chemicals) are regulated by Council Directive 88/379/EEC. The definition of the chemical safety data sheet data elements is practically
identical to that defined in ILO Recommendation No. 177, as discussed earlier in this chapter. A set of classification criteria and a label for
chemicals that are dangerous to the environment have been produced. The Directives regulate chemicals placed on the market, with the
goal of protecting human health and the environment. Fourteen categories are divided into two groups related respectively to physicochemical properties (explosive, oxidizing, extremely flammable, highly flammable, flammable) and toxicological properties (very toxic, toxic,
harmful, corrosive, irritant, carcinogenic, mutagenic, toxic to reproduction, properties dangerous to health or the environment).
The Commission of European Communities (CEC) has an extension to the system specifically addressed to the workplace. In addition,
these measures on chemicals should be considered within the overall framework of the protection of the health and safety of workers
provided for under Directive 89/391/EEC and its individual Directives.
With the exception of Switzerland, the countries in EFTA follow the EC system to a large degree.
Former Council for Mutual Economic Assistance (CMEA)
This system was elaborated under the umbrella of the Standing Commission for Cooperation in Public Health of the CMEA, which included
Poland, Hungary, Bulgaria, the former USSR, Mongolia, Cuba, Romania, Vietnam and Czechoslovakia. China still uses a system which is
similar in concept. It consists of two classification categories, namely toxicity and hazard, using a four-level ranking scale. Another element
of the CMEA system is its requirement for the preparation of a toxicological passport of new chemical compounds subjected to introduction
in the economy and domestic life. Criteria for irritancy, allergic effects, sensitization, carcinogenicity, mutagenicity, teratogenicity, antifertility
and ecological hazards are defined. However, the scientific basis and the testing methodology related to the classification criteria are
significantly different from those used by the other systems.
Provisions for workplace labelling and hazard symbols are also different. The UNRTDG system is used for labelling goods for transport, but
there does not seem to be any linkage between the two systems. There are no specific recommendations for chemical safety data sheets.
The system is described in detail in the UNEP International Register of Potentially Toxic Chemicals (IRPTC) International Survey of
Classification Systems. While the CMEA system contains most of the basic elements of the other classification systems, it differs
significantly in the area of hazard assessment methodology, and uses exposure standards as one of the hazard classification criteria.
Examples of National Systems
Australia
Australia has enacted legislation for the notification and assessment of industrial chemicals, the Industrial Chemicals Notification and
Assessment Act of 1989, with similar legislation enacted in 1992 for agricultural and veterinary chemicals. The Australian system is similar
to that of the EC. The differences are mainly due to its utilization of the UNRTDG classification (i.e., the inclusion of the categories
compressed gas, radioactive and miscellaneous).
Canada
The Workplace Hazardous Materials Information System (WHMIS) was implemented in 1988 by a combination of federal and provincial
legislation designed to enforce the transfer of information about hazardous materials from producers, suppliers and importers to employers
and in turn to workers. It applies to all industries and workplaces in Canada. WHMIS is a communication system aimed primarily at
industrial chemicals and composed of three interrelated hazard communication elements: labels, chemical safety data sheets and worker
education programmes. A valuable support to this system was the earlier creation and commercial distribution worldwide of a computerized
database, now available on compact disc, containing over 70,000 chemical safety data sheets voluntarily submitted to the Canadian Centre
for Occupational Health and Safety by manufacturers and suppliers.
Japan
In Japan, the control of chemicals is covered mainly by two laws. First, the Chemical Substances Control Law, as amended in 1987, is
aimed at preventing environmental contamination by chemical substances that are low in biodegradability and harmful to human health.
The law defines a premarket notification procedure and three hazard classes:
Class 1-specified chemical substances (low biodegradation, high bioaccumulation, risk to human health)
Class 2-specified chemical substances (low biodegradation and bioaccumulation, risk to human health and of contamination of the
environment in vast areas)
Class 3-designated substances (low biodegradation and bioaccumulation, suspicion of risk to human health)
Control measures are defined, and a list of existing chemicals is provided.
The second regulation, the Industrial Safety and Health Law, is a parallel system with its own list of Specified chemical substances which
require labelling. Chemicals are classified into four groups (lead, tetraalkyl lead, organic solvents, specified chemical substances). The
classification criteria are (1) possible occurrence of serious health impairment, (2) possible frequent occurrence of health impairment and
(3) actual health impairment. Other laws dealing with the control of hazardous chemicals include the Explosives Control Law; the High
Pressure Gas Control Law; the Fire Prevention Law; the Food Sanitation Law; and the Drugs, Cosmetics and Medical Instruments Law.
United States
The Hazard Communication Standard (HCS), a mandatory standard promulgated by OSHA, is a workplace-oriented binding regulation
which refers to other existing laws. Its goal is to ensure that all chemicals produced or imported are evaluated, and that information related
to their hazards is transmitted to employers and to workers through a comprehensive hazard communication programme. The programme

includes labelling and other forms of warning, chemical safety data sheets and training. Label and data sheet minimum contents are
defined, but the use of hazard symbols is not mandatory.
Under the Toxic Substances Control Act (TSCA), administered by the Environmental Protection Agency (EPA), an inventory listing
approximately 70,000 existing chemicals is maintained. The EPA is developing regulations to complement the OSHA HCS which would
have similar hazard evaluation and worker communication requirements for the environmental hazards of chemicals on the inventory.
Under TSCA, prior to manufacture or import of chemicals which are not on the inventory, the manufacturer must submit a premanufacture
notice. The EPA may impose testing or other requirements based on the premanufacture notice review. As new chemicals are introduced
into commerce, they are added to the inventory.
Labelling
Labels on containers of hazardous chemicals provide the first alert that a chemical is hazardous, and should provide basic information
about safe handling procedures, protective measures, emergency first aid and the chemicals hazards. The label should also include the
identity of the hazardous chemical(s) and the name and address of the chemical manufacturer.
Labelling consists of phrases as well as graphic and colour symbols applied directly on the product, package, label or tag. The marking
should be clear, easily comprehensible and able to withstand adverse climatic conditions. The labelling should be placed against a
background that contrasts with the products accompanying data or package colour. The MSDS provides more detailed information on the
nature of the chemical products hazards and the appropriate safety instructions.
While presently there are no globally harmonized labelling requirements, there are established international, national and regional
regulations for labelling hazardous substances. Requirements for labelling are incorporated into the Law on Chemicals (Finland), the Act on
Dangerous Products (Canada) and EC Directive N 67/548. Minimum label content requirements of the European Union, United States and
Canadian systems are relatively similar.
Several international organizations have established labelling content requirements for handling chemicals at the workplace and in
transport. The labels, hazard symbols, risk and safety phrases, and emergency codes of the International Organization for Standardization
(ISO), the UNRTDG, the ILO and EU are discussed below.
The section on labelling in the ISO/IEC guide 51, Guidelines for Inclusion of Safety Aspects in Standards, includes commonly recognized
pictograms (drawing, colour, sign). In addition, short and plain warning phrases alert the user to potential hazards and provide information
on preventive safety and health measures.
The guidelines recommend the use of the following signal words to alert the user:
DANGER-high danger
HANDLE WITH CARE-intermediate danger
BEWARE-potential danger.
The UNRTDG establish five main pictograms for easy visible recognition of dangerous goods and significant hazard identification:
bomb-explosive
flame-flammable
skull and cross-bones-toxic
trefoil-radioactive
liquid pouring out of two test-tubes on a hand and a piece of metal-corrosive.
These symbols are supplemented by other representations such as:
oxidizing substances-flame above a circle
non-flammable gases-a gas bottle
infectious substances-three crescent signs superimposed on a circle
harmful substances which should be stowed away-St. Andrews cross posed on a wheat-ear.
The Chemicals Convention, 1990 (No. 170), and Recommendation, 1990 (No. 177), were adopted at the 77th Session of the International
Labour Conference (ILC). They establish requirements for the labelling of chemicals to ensure the communication of basic hazard
information. The Convention states that label information should be easily understandable and should convey the potential risks and
appropriate precautionary measures to the user. Regarding the transport of dangerous goods, the Convention refers to the UNRTDG.
The Recommendation outlines labelling requirements in accordance with existing national and international systems, and establishes
criteria for classification of chemicals including chemical and physical properties; toxicity; necrotic and irritating properties; and allergic,
teratogenic, mutagenic and reproductive effects.
The EC Council Directive N 67/548 stipulates the form of label information: graphic hazard symbols and pictograms including risk and
safety phrases. Hazards are coded by the Latin letter R accompanied with combinations of Arabic numerals from 1 to 59. For example, R10
corresponds with flammable, R23 with toxic by inhalation. The hazard code is given with a safety code consisting of the Latin letter S
and combinations of numerals from 1 to 60. For example, S39 means Wear eye/face protection. The EC labelling requirements serve as a
reference for chemical and pharmaceutical companies throughout the world.

Despite significant efforts in chemical hazard data acquisition, evaluation and organization by different international and regional
organizations, there is still a lack of coordination of these efforts, particularly in the standardization of assessment protocols and methods
and interpretation of data. The ILO, the Organization for Economic Cooperation and Development (OECD), the IPCS and other concerned
bodies have initiated a number of international activities aimed toward establishing a global harmonization of chemical classification and
labelling systems. The establishment of an international structure to monitor chemical hazard assessment activities would greatly benefit
workers, the general public and the environment. An ideal harmonization process would reconcile the transport, marketing and workplace
classification and labelling of hazardous substances, and address consumer, worker and environmental concerns.

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