Asean Oshnet Report Final

DEPARTMENT OF OCCUPATIONAL SAFETY AND HEALTH MINISTRY OF HUMAN RESOURCES

MALAYSIA

ASEAN-OSHNET/UNITAR-ILO REGIONAL WORKSHOP ON THE DRAFT ASEAN GUIDELINES ON CLASSIFICATION,

LABELING AND PACKAGING (CLP) OF CHEMICALS REPORT

With the financial support of the Government of Switzerland and the European Union.

6-8 March 2006 Grand Seasons Hotel

Kuala Lumpur Malaysia

ASEAN OSHNET Workshop i

No. Content Page

1.0 Background 1

2.0 Objective 1

3.0 Workshop Organisation 2

4.0 Launching Ceremony 3

5.0 Workshop Session 3

6.0 Closing Ceremony 7

7.0 Resolutions on the Draft Asean Guidelines on the Classification,

Labelling & Safety Data Sheet

8

8.0 Workshop Conclusion 9

9.0 Workshop Recommendation 9

10.0 Acknowledgment 9

11.0 ASEAN OSHNET Workshop Report prepared 10

12.0 Appendix 1 : Opening Speech by Deputy Secretary of Ministry of

Human Resources, Malaysia

11

13.0 Appendix 2 : Speech by Director General of DOSH 16

14.0 Appendix 3 : Speech by Executive Director ASEAN OSHNET

Secretariat Malaysia

19

15.0 Appendix 4 : Summary of presentation papers 26

Presentation 1 : Introduction to GHS 26

Presentation 2 : Physical Hazard Classification 28

Presentation 3 : Classification of health hazards 31

Presentation 4 : Classification of Environment Aquatic Hazards 31

Presentation 5 : Classification of Mixture 34

Presentation 6 : Data Sources for Classification Purposes 35

Presentation 7 : GHS Implementation and Tools for it in Japan 38

Presentation 8 : GHS Labelling 41

Presentation 9 : Hazard communication – Safety Data Sheets 43

Presentation 10 : New Zealand Experience GHS 44

16.0 Appendix 5 : Program for ASEAN OSHNET Workshop 47

ASEAN OSHNET Workshop ii

No. Content Page

17.0 Appendix 6 : Question and answer 50

18.0 Appendix 7: List of Speaker/Chairman/Facilitator 55

19.0 Appendix 8: List of Participant of ASEAN OSHNET Workshop on

6-8 March 2006

56

20.0 Appendix 9: List of Secretariat of the ASEAN OSHNET

Workshop

57

21.0 Appendix 10: Curriculum Vitae of the Presenter From

UNITAR/ILO (Burkhard Wagner)

58

22.0 Appendix 11 : Curriculum Vitae of the Presenter From

UNITAR/ILO (Wayne Creaser)

59

21.0 Appendix 12 : Curriculum Vitae of the Presenter From Japan

(Hiroshi Jonai)

60

22.0 Appendix 13 : Curriculum Vitae of the Presenter From New

Zealand (Barry Dyer)

61

23.0 Appendix 14 : Exercise 1 (Classification of a Substance ) 62

24.0 Appendix 15 : Exercise 2 (Classification of a Mixture) 64

23.0 Appendix 16 : Assignment on Classification 68

24.0 Appendix 17 : Assignment on Labelling 71

25.0 Appendix 18 : Assignment on Safety Data Sheet 75

26.0 Appendix 19 : Draft ASEAN Guidelines on Chemical

Classification, Labelling & Safety Data Sheet 2006

77

ASEAN OSHNET Workshop 1

1.0 Background

The globally Harmonised System (GHS) is the vehicle being promoted by both

the United Nations (UN) and the Asia Pacific Economic Conference (APEC) for

worldwide harmonisation of rules regarding classification and labelling of chemicals.

The GHS is common approach for definition and classification of hazards and a

system to ensure consistent worldwide hazard communication, through uniform

hazard information on labels and safety data sheet. It provides the underlying

infrastructure for establishment of national comprehensive chemical safety programs.

In ASEAN, there are ten nations with different classification & hazard communication,

systems in place. The result is increased cost of doing business between ASEAN

nations from reclassification & rebelling to meet each national requirements.

Therefore, there is urgent need to discuss among government authorities in ASEAN

the need to harmonise the different systems through the adoption of an ASEAN

guideline on chemical classification, labelling and safety data sheet based on the

international accepted Globally Harmonised System for hazard classification and

labelling, in short the GHS.

2.0 Objective The main goal of the workshop is to bring together key representatives from

governments of the ASEAN to discuss strategies and capacities in implementing the

GHS at the regional level. The objectives of the workshop are as follow:

1. To provide the awareness & insight on the GHS to workshop participants from

the 10 ASEAN countries;

2. To acquire knowledge in understanding the GHS;

3. To share experiences in implementing the GHS in the ASEAN countries;

4. To deliberate and discuss on the principles and the content and formulating of

the proposed ASEAN Guidelines on Chemical Classification, Labelling and

Safety Data Sheet.


3.0 Workshop Organisation

This three (3) days workshop was organised under the ASEAN OSHNET as a

project under programme area of Standards [Malaysia] where it located in Agenda

Item number seven (7) naming by Status Report on the Implementation of the

Activities under the ASEAN OSHNET Plan of Action. This project has been decided

on 6th ASEAN OSHNET Coordinating Board Meeting on 17-18 March 2005 at Ha

Long, Quang Ninh, Vietnam. The workshop was served for the Asean Country. The

countries that participated this workshop are Brunei, Cambodia, Indonesia, Laos,

Myanmar, Singapore, Thailand, Vietnam and Malaysia as a host country. The

Philippines did not participated in this workshop.

There four (4) resource persons on GHS that contributed to this workshop,

were Dr. Burkhard Wagner from Germany, and Mr. Wayne Creaser from Australia as

a representative of UNITAR-ILO. Prof. Dr. Hiroshi Jonai from Japan represented the

experience of implementation GHS on Japan. Mr. Barry Dyer from New Zealand

represented the experience of implementation GHS. Please refer to Appendix 10, 11,

12 and 13 on their curriculum vitae.

The list of ASEAN OSHENET Workshop participants is shown in Appendix 8.

List of speakers, chairman of session and facilitators is given in Appendix 7 and the

list of workshop’s secretariat is in Appendix 9.

The UNITAR and ILO supported this workshop by sending two (2) experts and

allocating a financial contribution of USD10,000 (RM37,000) to financially support the

main bulk of the workshop expenses of USD13,650 (RM50,500). The difference was

paid for the Malaysian Government.


4.0 Launching Ceremony The launching ceremony of ASEAN OSHNET Workshop was officiated by Mr.

Adzmi Mohd Sani, Deputy Secretary of Ministry of Human Resources Malaysia. This

ceremony was also attended by Ir. Abu Bakar Che’ Man, Director General of the

Department of Occupational Safety and Health (DOSH) and Ir. Dr. Johari Basri,

Executive Director of ASEAN OSHNET Secretariat. Please refer to Appendix 1, 2 and

for their welcoming and opening speeches. About 70 persons attended the opening

ceremony including 22 participants from ASEAN and 11 Senior Officers from DOSH.

5.0 Workshop Session The workshop programme is given in Appendix 5. The summary of the

presentation are shown below. There are two (2) exercises held in day two (2). Please

refer Appendix 14 and 15. Group assignments are located in Appendix 16, 17 and 18.

These assignment based on the draft of Asean Guidelines on Chemical Classification,

Labelling and Safety Data Sheet 2006. Refer to Appendix 19.

PRESENTATION 1 INTRODUCTION TO GHS

By Wayne Creaser Mr Wayne Creaser talked about the introduction of GHS which include the

history, scope and application of GHS. He also touched about the key elements and

GHS implementation in Australia.

PRESENTATION 2

HYSICAL HAZARD CLASSIFICATION By Burkhard Wagner

Mr Burkhard Wagner, expert from UNITAR and originally from Germany talked

about the Physical Hazard Classification. In his speech, he explained the definitions of

gas, solid and liquid. He also explained about the definitions of explosives substances,

flammable gases, flammable aerosols, oxidizing gases, flammable liquids, flammable

solids, oxidizing liquids, oxidizing solids, organics peroxides and corrosive to metal.


PRESENTATION 3 CLASSIFICATION OF HEALTH HAZARDS

By Wayne Creaser In the third presentation, Mr Wayne Creaser briefly talked about the

Classification of Health Hazards. In this presentation, he explained that health hazards

can be can be categorized into various hazard categories, i.e. acute toxicity, skin

corrosion or irritation, serious eye damage or eye irritation, respiratory or skin

sensitization, germ cell mutagenicity, carcinogenicity, reproductive toxicity, specific

target organ systemic toxicity (single exposure), specific target organ systemic toxicity

(repeated exposure) and aspiration hazard.

PRESENTATION 4 CLASSIFICATION OF ENVIRONMENTAL AQUATIC HAZARDS

By Burkhard Wagner Mr Burkhard Wagner talked about the Classification of Environmental Aquatic

Hazards. In his presentation, he explained the Data Elements for Classification such

as acute aquatic toxicity, bioaccumulation potential, rapid degradability and chronic

toxicity, and also provides the definitions of these terminologies.

PRESENTATION 5 CLASSIFICATION OF MIXTURES

By Wayne Creaser Mr Wayne Creaser explained the classification criteria for mixtures based on

the classification criteria for substances, taking into consideration any impurities,

additives or individual constituents of a substance that exceed the cut-off

value/concentration limit for a given hazard class. He explained that if the data are not

available for the mixture itself, bridging principles such as dilution, batching,

concentration of mixtures of the highest category within one hazard class, interpolation

within one toxicity category, substantially similar mixtures and aerosolized mixtures

should be applied.


PRESENTATION 6 DATA SOURCES FOR CLASSIFICATION PURPOSES

By Burkhard Wagner The data sources for classification purposes are the tools to classify the

chemical from any sources. In this presentation, Dr Wagner explained data quality and

good laboratory practices. He also discussed about the weight of and data quality

scoring guide. Data are categorized into six (6) categories.

PRESENTATION 7 GHS IMPLEMENTATION AND TOOLS FOR IT IN JAPAN

By Hiroshi JONAI Prof. Hiroshi Jonai is a GHS expert from Japan who had willingly participated in

this workshop to share Japan’s experiences in implementing the GHS. He briefly

explained the current regulations for chemical control and hazard communication in

Japan. He also touched about the issues in the GHS implementation such as big

coverage of substances and mixtures under GHS, collection of hazard data of

chemicals, not regulated by laws or regulations, independent hazard communication

system not related to risk management and clearance of duplication of label elements.

In Japan, GHS implementation includes GHS committee consisted of every Ministry

concerned (MHLW, METI, MoE, MIC, MAFF, MLIT and MOFA) established 2001,

translation of GHS Text into Japanese: First revised version is available from the web-

site of METI, MoE and MHLW), seminars on GHS (>2,000 participants) and

pamphlets for raising awareness.

PRESENTATION 8 GHS LABELLING

By Wayne Creaser Mr Wayne Creaser talked about the importance of labelling in which the

comprehensibility of hazard communication elements is the key elements to inform the

public about chemical hazards. The guiding principles are (a) information should be

conveyed in more than one way, (b) comprehensibility should take account of existing

information (literature, studies and data), (c) phrases indicating degree of hazard

should be consistent across different hazard types, (d) words and phrases should

retain comprehensibility when translated into other languages, (e) format and colour of


the label elements, and (f) SDS format should be standardized. Information required

on a GHS label are pictograms, signal words, hazard statements, precautionary

statements and pictograms, product identifier and supplier information.

PRESENTATION 9

HAZARD COMMUNICATION – SAFETY DATA SHEETS By Wayne Creaser

Mr. Wayne Creaser emphasized the role of safety data sheets in providing

comprehensive information of a substance/mixture for use in workplace, the

information provided enables the employer to develop worker protection measures

specific to the workplace and to consider measures to protect the environment. SDS

also should be provided for all substances/mixtures meeting GHS harmonized criteria

for physical, health and environmental hazards, in the concentration exceeding cut-off

values. The 16-section format of SDS are identification, hazard(s) identification,

composition/information on ingredients, first-aid measures, fire-fighting measures,

accidental release measures, handling and storage, exposure controls/personal

protection, physical and chemical properties, stability and reactivity, toxicological

information, ecological information, disposal considerations, transport information,

regulatory information and other information.

PRESENTATION 10 NEW ZEALAND EXPERIENCE IN GHS

By Barry Dyer Mr. Barry Dyer, from New Zealand shared the New Zealand industry experience in

implementing GHS. He talked about the basic requirements that are reflected in New

Zealand’s international obligations, industry best practice, performance based and the

commonality with Australia. He also talked about New Zealand’s national performance

standards, professional qualifications for enforcement officers, test certifiers and

approved handlers, quality assurance accreditation for test certifiers and trainers, and

training courses using reference material and training aids. Finally, he talked about the

compliance tools used in New Zealand.


6.0 Closing Ceremony Ir. Zainuddin Abdullah, Deputy Director General of DOSH officiated the closing

ceremony of ASEAN OSHNET Workshop. He also handed over certificates of

attendance to all the participants. The Deputy Director General in his closing remarks

thanked the organizing committee for their successful organization of the workshop.

He thanked the UNITAR/ILO for their support & contributions. He also thanked all the

experts that have contributed to the success of the workshop.


7.0 Resolutions on the Draft Asean Guidelines on the Classification, Labelling & Safety Data Sheet 7.0.1 General

1. Consumer chemicals will not be excluded if it is to be used at the place of

work rather than for domestic purposes.

2. Hazardous chemicals to be defined in the guidelines

3. To clarify & refined on the definition of ‘articles’

4. To include provision on training.

5. Technical guidance required for certain issues such as classification.

6. Promotion of guidelines by ASEAN-OSHNET and member countries.

7. Purpose of guidelines to be clarified.

8. Schedule 1 to be consistent with GHS

7.0.2 Classification 1. Classification duty only on the manufacturer, formulator & the importer.

2. Classification to be reviewed periodically or when there is new and

significant information

3. The definition and/or registration of the competent classifier to be left to the

legal requirements of each country

7.0.3 Labelling 1. Precedence of symbols for physical hazards to be deleted

2. Labelling sizes not to be included in this guidelines unless it has been

determined by the UN expert sub-committee.

3. Sample labels to be included

4. Format and positioning of label elements to be addressed in guidelines.

5. Selection of precautionary statements to be included.

6. Cut-off limits for labelling to be consistent with SDS

7.0.4 Safety Data Sheet 1. To delete chapter on SDS except where countries have options.

2. Confidential Business Information, CBI to be excluded, for countries to define.

3. Translation to be done by competent person


8.0 Workshop Conclusion The workshop was successfully run as planned according to the programme and

concludes with the resolutions on the draft Asean Guidelines on the Classifications,

Labelling & Safety Data Sheet.

9.0 Workshop Recommendation The draft guideline will be finalized and submitted to the ASEAN Coordinating

Board Meeting for their deliberation and endorsement.

10.0 Acknowledgment The organizing committee would like to thank all of the following countries,

organizations and individuals that have contributed in a way or the other toward the

success of this workshop:

a) UNITAR/ILO and donor countries

b) ASEAN OSHNET Secretariat

i) Government of Brunei Darussalam

ii) Government of Cambodia

iii) Republic of Indonesia

iv) Democratic Republic of Laos

v) Republic of Myanmar

vi) Republic of Singapore

vii) Thailand

viii) Vietnam

c) UNITAR experts – Dr. Burkhard Wagner and Mr. Wayne Creaser

d) Prof. Dr. Hiroshi Jonai from Japan

e) Mr. Barry Dyer from New Zealand Chemical Industrial Council

f) Grand Season Hotel, Kuala Lumpur

g) Prime Ministers Department

h) Ministry of Human Resources Malaysia

i) Ministry of Agriculture & Agro based Product

j) MTUC

k) CICM

l) Department of Occupational Safety and Health Malaysia (DOSH)

m) National Institute of Occupational Safety and Health Malaysia (NIOSH)


11.0 ASEAN OSHNET Workshop Report prepared by:

(KASMAN NASIR) (AZMIR ISMAIL)

Assistant Director Assistant Director DOSH, DOSH, Malaysia Malaysia Reviewed by: (HAJI ANUAR MOHD MOKHTAR)

Director Chemical Management Division, Department of Occupational Safety and Health, Malaysia Approved by: (IR ZAINUDDIN ABDULLAH)

Deputy Director General (Operation) Chemical Management Division, Department of Occupational Safety and Health, Malaysia


Appendix 1

OPENING SPEECH Datuk Abdul Rahman Bakar

Deputy Minister of Human Resource, Malaysia

Read by Mr. Adzmi Mohd Sani

Deputy Secretary of Ministry of Human Resources, Malaysia

ASEAN OSHNET Workshop on the Draft ASEAN Guidelines on Classification,

Labeling and Packaging (CLP) Chemical

6th March 2006 ( Monday), 9.00 am

Grand Seasons Hotel, Kuala Lumpur

Good morning and welcome to Kuala Lumpur, Malaysia,

First and foremost, I wish to express my gratitude and heartiest thanks to the

organizing committee for inviting me to give a few words and officially open the

ASEAN OSHNET Workshop on the Draft ASEAN Guidelines on Classification,

Labelling and Packaging (CLP) Chemical. I hope that all ASEAN delegations will take

this opportunity not only to exchange ideas and opinions but also to visit the beautiful

of Kuala Lumpur, the heart of Malaysia.

Ladies and gentlemen,

Chemicals have become a part of our life, sustaining many our activities, preventing

and controlling disease and increase productivity. However, sometimes these

chemicals can turn dangerous, becoming hazardous to human health and safety,

properties and the environment when handled improperly. In order to safely use

chemical and mitigate the incidences of injury or poisoning or diseases arising from

the use of chemicals, the information concerning their hazards should be effectively

communicated to workers and public.


Many existing national and regional chemical hazards communication systems are

similar in intent (they are designing to protect people from experiencing adverse

effect), there are significant differences in their specific provisions with regard to the

criteria used to classify chemicals, the warning phrases and symbols or other hazard

communication components used to convey the information. The result is a patchwork

of sometimes conflicting and diverse national and international requirements.


The Globally Harmonised System of Classification and Labelling of Chemicals, in

short GHS is a common and coherent approach to defining and classifying hazards

and a system to ensure consistent worldwide communication through uniform hazard

information on labels and safety data sheet. It provides the underlying infrastructure

for establishment of national, comprehensive chemical safety programs. There will be

4 key sectors affected by the GHS Implementation at the National level, i.e. the

industrial workplace; the agricultural sector; the transport sector and consumer

products.

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.


I was informed that the GHS was developed as a result of Agenda 21, agreed in 1992

at the United Nation Conference on the Environment & Development (UNCED) held in

Rio de Janeiro, Brazil. From this conference, six programme areas were established

to strengthen national and international effort related to environmentally sound

management of chemicals. Agreements in this conference were endorsed by the

United Nations General Assembly.


I believe, an important driving factor for creation of the GHS is the similarity in the

hazards communication systems with regards to the criteria used to classify the

chemicals, the warning phrases and symbols or other hazard communication

components used to convey the information. Failing to standardised lead to

conflicting and diverse national and international requirements.

These are due to the variations in classification criteria where the same chemical may

be classified as having different degrees of hazard, and thus require different warning

statements. It all depends on the classification system being applied in a given

situation. Inevitably, symbols and terminology also vary from system to system. For

example, a chemical in one country may be classified as being flammable for purpose

of transport, but not for workplace use. Or it may be considered carcinogenic in one

country, but not in another.


I glad to note that most of the ASEAN countries indicated their intent to implement the

GHS. This is based on survey report prepared by UNITAR/Ministry of environment

Japan ASIA-Pacific Regional GHS that was initiated in 2004. Nine out of the 10

ASEAN countries already have chemical classification systems in at least one sector

out of the 4 covered under GHS. A few countries like Malaysia, Indonesia and

Thailand are in the stage of preparing for establishing new legislation or administrative

procedures.

Through the ASEAN OSHNET Coordinating Board Meeting in 2002, Malaysia was

entrusted to develop as ASEAN guidelines on Classification, Labelling & Packaging.

This guideline was initially to be based on the Malaysian Occupational Safety & Health

(Classification, Packaging & Labelling of Hazardous Chemicals) Regulations 1997 and

its guidelines. Later on, a workshop held to discuss the guideline was held in Malaysia

in 2002 concluded that the guidelines should be based on the GHS as the

implementation of the GHS worldwide was inevitable in the future.

The proposal of the workshop to adopt GHS as the basis for these guidelines was

endorsed by ASEAN-OSHNET Coordinating Board in 2003. Before the details of the


guidelines could be discussed, the workshop participants will be trained on the

essentials of GHS and UNITAR was invited to give technical inputs on the GHS. I

would like to thank the UNITAR for its willingness to collaborate with ASEAN-OSHNET

on GHS training for officials from ASEAN in this workshop.


As for the government of Malaysia, the system on hazard classification and

communication has been introduced to Malaysia by our Ministry of International Trade

and Industries (MITI) who had attended 2002 APEC Ministers meeting which all APEX

members ought to work towards GHS implementation by 2006. MITI has taken the

step to coordinate steps toward National GHS implementation by forming The National

Coordinating Committee for GHS Implementation early of this year. This inter-agency

Coordinating Committee comprises representatives from relevant government

agencies and is chaired by a senior official from the Ministry of International Trade and

Industry. This should pave the way for inter-agency cooperation and harmonization of

chemical hazard communication systems in Malaysia with the GHS.

Under the Ministry of Human Resource, the Department of Occupational Safety and

Health committed to adopt the GHS as the basis in the existing legislations. The

existing regulatory mechanism can be utilized to accommodate the GHS by amending

the existing relevant legislations such as Occupational Safety and Health

(Classification, Packaging and Labelling of hazardous Chemicals) Regulations 1997.


On behalf on the government of Malaysia, I am obliged with the participating ASEAN

countries towards the development of ASEAN guidelines on Classification, Labelling

and Packaging Chemical to adopt GHS as basis. I hope that the workshop will come

to the consensual decision from ASEAN participants on the proposed draft whether to

adopt full GHS Classification and/or for individual nation to determine building block

to be adopted in your respective legislation.

Ladies and Gentlemen,


To conclude, I would like to express my heartiest appreciation to all of you for your

support and experiences shared in this workshop. Special thanks to United Nation,

Institute for Training and Research, (UNITAR)/International Labor Organization (ILO)

and ASEAN OSHNET Secretariat.

With that, I officially declared the ASEAN OSHNET Workshop on the Draft ASEAN

Guidelines on Classification, Labelling and Packaging (CLP) Chemical open.

Thank you.


Appendix 2 Speech by Ir Haji Abu Bakar Che Man

Director General

Department of Occupational Safety and Health Malaysia

ASEAN OSHNET Workshop on the Draft ASEAN Guidelines on Classification, Labelling and Packaging (CLP) Chemical

6th March 2006 ( Monday), 9.00 am

Grand Seasons Hotel, Kuala Lumpur

Yg. Bhg En Adzmi Mohd Sani

Deputy Secretary General, Ministry of Human Resources, Malaysia,

Yg. Bhg. Dato’ Dr Ir. Johari Basri

Executive Director ASEAN OSHNET Secretariat,

Mr. Wayne Creaser

Senior Special Fellow, Department of Employment and Workplace Relation,

Distinguished Speakers:

Distinguished guests,

Participants from ASEAN countries,


On behalf of the organizing committee, I wish to express my appreciation to Yang

Bhg. En Adzmi Mohd Sani, Deputy Secretary General of Ministry Of Human

Resources, for his consent to deliver an opening address for this ASEAN OSHNET


Workshop on the Draft ASEAN Guidelines on Classification, Labeling and

Packaging (CLP) of Chemicals.

I would also like to welcome all participants from ASEAN member countries for your

presence in this workshop. The organizing committee hopes that your presence will

contribute in realizing our aim to streamline the ASEAN member countries legislation

and guidelines on classification, labeling and packing of chemicals with the Globally

Harmonized System.


The Globally Harmonized System or the GHS implementation and chemical hazard

communication has emerged as one of the top priority of chemical management in the

ASEAN region. Majority of the ASEAN member countries reported that one of the

causes of occupational and environmental health illnesses is due to the lack of

comprehensive hazard communication elements in the legislative system of the

countries.

I am happy to note that the World Summit for Sustainable Development has initiated

the WSSD Global Partnership for capacity Building to implement the Globally

Harmonized System (GHS). UNITAR/ILO was the focal point for this capacity building

programme, which are funded by the European Commission and the Government of

Switzerland. This particular workshop is one of the regional capacity-building activities

focused for ASEAN member countries. Before this workshop, there were three other

country-based pilot projects that have been organized in Indonesia, Thailand, and The

Philippines.

The Department of Occupational Safety and Health (DOSH), Ministry of Human

Resources Malaysia is honored to have been given the opportunity to organize this

workshop, supported by the ASEAN OSHNET Secretariat and the United Nation

Institute of Training and Research (UNITAR).

The objectives of the workshop are:

to acquire knowledge and further understanding on the Globally Harmonized System;


to share experiences in implementing the GHS in the respective ASEAN member

countries ; and

to discuss the proposed draft on ASEAN Guidelines on the Classification, Labelling

and Packaging of chemicals based on the GHS.


This 3-days workshop will consist of presentation by experts from UNITAR, Australia

and Japan on subjects related to GHS. There will also be a presentation and

discussion on the proposed draft of ASEAN Guidelines on Classification, Labeling and

packing of chemicals by Department of Occupational Safety and Health, Malaysia.

The organizing committee is grateful and honored to have Mr. Buckhard Wagner from

UNITAR, Mr. Wayne Creaser from Australia, Mr. Hiroshi Jonai from Japan and Mr.

Barry Dyer from New Zealand as expert speakers for this workshop. All of us truly

appreciate your presence and contribution to the workshop.


To conclude, on behalf of the organizing committee I would like to express my

heartiest appreciation to the UNITAR/ILO for their financial support and most

importantly coordinating the presence of fellow experts on GHS for this workshop. I

would also wish to thank the ASEAN OSHNET Secretariat for their valuable support in

coordinating participation of delegates from ASEAN member countries. I hope this

workshop, in our own way, will contribute towards the ultimate goal of ensuring that

chemical hazards information is made in a harmonized and comprehensible format in

and to countries around the world.

Thank you.


Appendix 3 Speech by Dato’ Ir. Dr. Johari Basri

ASEAN OSHNET Secretariat Malaysia

ASEAN-OSHNET Secretariat

ASEAN-OSHNET/UNITAR-ILO Workshop on ASEAN Guidelines for

Classification, Labelling and Packaging of Chemicals Welcome Address

Dato’ Ir Dr. Johari Basri

Executive Director, ASEAN-OSHNET Secretariat, Malaysia

Executive Director, National Institute of Occupational Safety and Health (NIOSH),

Malaysia

Yang Berusaha Encik Azmi Mohd. Sani, Deputy Secretary General, Ministry of Human

Resources, Malaysia;

Yang Berusaha Ir Hj. Abu Bakar Che Man, Director General, Department of

Occupational Safety and Health, Malaysia;

Technical Experts from The United Nations Institute and Research (UNITAR)

Our Dear Friends from ASEAN-OSHNET Member Countries;

Colleagues from the Ministry of Human Resources;

Guests; and

Ladies and Gentlemen;

First of all, on behalf of ASEAN-OSHNET Secretariat, I would like to congratulate the

Department of Department of Occupational Safety and Health, Malaysia, especially


the Workshop Organising Committee, for having worked very hard in order to

successfully organise and host this ASEAN-OSHNET/UNITAR-ILO Workshop on

ASEAN Guidelines for Classification, Labelling and Packaging of Chemicals, which

has brought us all together with our friends from all over South East Asia today. I am

convinced that the organisation of this Workshop has taken not a little amount of

effort, energy, commitment and sacrifice, and I am sure all of us in the whole ASEAN-

OSHNET organisation can be proud of you all for that. I would also like to convey our

gratitude to the United Nations Institute for Training and Research (UNITAR) for: (1)

having provided a generous amount of funding to support this Workshop; and (2)

having provided expert technical support in the form of subject specialists speaking

and teaching on UNITAR’s behalf. Last but not least, I would like also to commend all

ASEAN-OSHNET Member Countries for having made the effort to participate in this

Workshop. We regret though that Laos and Philippines are unable to be with us today.


South East Asia has always been a region of harmony and cooperation. In this region,

community interests almost always prevail over those of the individual. Rugged

unilateral individualism, especially one that tends to be at odds with the interests of the

wider community, is a rarity, very much the exception rather than the norm.

Everywhere ― in the corporate boardrooms, in the city streets, in the rural paddy

fields ― people are always helping one another make something new, something

good and something useful that will make a positive difference in their lives. They

continually support one another in their toil, in both fair and foul weather, in their

struggle for existence and survival.

When it is time to plant the paddy seedlings, for example, you only have to tell one

neighbour and the whole village will come running to help out. Time for the harvest?

Just pass the message on to the next village. A death in the family? The folks around

you will come bringing plenty of aid and comfort ― without you having to call them. A

wedding in the area? The womenfolk will just team up, pooling materials, resources

and expertise and cooking in concert to prepare food for the feast.


In the coastal areas, fishermen that have cast a large net into the sea just have to yell

for helping hands from everybody nearby. There is always an exuberant mustering of

a force strong enough to pull in the main ropes and haul the catch ashore. Alongside

the big brawny men of the sea, old folks, women and even children pitch in to heave

and tug to a man’s counting. When the catch is huge and spirited, the effort to land it

grows in the same proportion. Passers by are invited to join in and often they happily

do.

Different forms of collaboration thus occur out of the natural penchant for cooperation

and harmony among South East Asians. They have taken place throughout all of

South East Asia under various names. They are called “gotong royong” in Malay-

speaking Nusantara (the Malay Archipelago, i.e. Indonesia, Malaysia and Brunei),

“samakhee” in Laos and Thailand, “la lahn dum la rach” in Vietnam, “phyi khaing phyu”

in Myanmar, “saburosthor” in Cambodia, “bayanihan” in the Philippines and “chai sam

hup chop” among South East Asians of Cantonese descent. It is this common spirit

that has been, still is and should always be the driving force for ASEAN regional

cooperation and integration, and it is what we in ASEAN-OSHNET should harness

and exploit for the good of workers all over South East Asia.


The word ‘harmony’ too, for instance, has an interesting development. It comes from

the Greek ‘harmos’, meaning joint. Thus, when many different things are joined

together in perfect fit, or many different people or groups of people work together in

perfect coordination, they are both said to be ‘in harmony’. Thus, for any collaborative

venture to work best, harmony must first exist. In the musical sense, for example,

when good harmony is present in a concert, beautiful music is produced.

Harmony exists in nature in various forms and to various degrees. However, civilised

societies cannot leave it to nature ― including human nature ― the responsibility for

building and maintaining harmony between people, between nations or even between

regions, or we run the risk of having whatever harmony existing reduced to the lowest

level, i.e. the law of the jungle, as has occurred many times in the past.


Harmony, therefore, has been a very important principle in ASEAN, and will always

remain so. In the political and trade realms, harmonisation of standards and rules

among member countries has been instrumental in bringing ASEAN collectively to

where it is today. In the face of globalisation and its attendant challenges,

harmonisation efforts are taking on a level of commitment and urgency such as has

never been seen before.

In relation to this, the field of OSH is not spared too, and the need for harmonisation

has reached new levels of importance and must therefore be properly and duly

addressed. ASEAN-OSHNET, therefore, as the main platform for ASEAN cooperation

in OSH, thus has its own special role to play with regard to harmonisation. In the

aspect of chemical safety, for example, this ASEAN-OSHNET/UNITAR-ILO Workshop

on ASEAN Guidelines for Classification, Labelling and Packaging of Chemicals, as I

understand it, is intended to produce a set of regional Guidelines consistent with the

UN-advocated Globally Harmonised System for Classification, Labelling and

Packaging of Chemicals (GHS) for use throughout the entire ASEAN region. These

Guidelines, when finalised and completed, will then be used by all ASEAN countries to

guide them in drawing up their own national regulations on classification, labelling and

packaging of hazardous chemicals. The Guidelines are expected to cover not only

workplace chemical-related safety and health, but also be comprehensive enough to

address the same concerns in the agriculture, transport and consumer sectors, for

which another Workshop is being held at national level later this week.


ASEAN has now become a major player in international trade, and trading in the

international marketplace has its own challenges. Trade barriers of different forms can

arise due to factors such as regulatory restrictions, conformity assessment

requirements and also due to differences in product standards. Individual nations

impose technical regulations and associated product standards based on their own

domestic social and economic considerations. When domestic conditions between

different nations differ, their regulations and standards will often tend to differ too.

Manufacturers, suppliers, importers and exporters of regulated products who are

engaged in international trade then have to comply with these different regulations and

standards.


In situations where difficulties are encountered in complying or demonstrating

compliance through conformity assessment systems, regulations and associated

product standards can inadvertently give rise to technical barriers to free trade. Very

often when these occur, they are due the differences in regulations and standards

between nations. Many experts envisage that barriers can be significantly reduced, if

not eliminated altogether, by adopting a common set of internationally aligned or

harmonised regulations or standards. It is to fulfil this very important function that

universal standards organisations such as the International Organisation for

Standardisation (ISO) and the International Electrotechnical Commission (IEC) have

been established.

International Standards are widely adopted at the national or regional level and

applied by multinational manufacturers, service providers, trade organisations,

purchasers, consumers, government agencies, testing laboratories and other

interested parties. Since these standards generally reflect the best experiences of

industry, researchers, consumers and regulators worldwide, and cover common needs

in a wide range of countries, they constitute one of the important bases for the

removal of technical barriers to international trade.


The national use of voluntary international standards has not progressed to the same

level in all sectors. For instance, OSH standards, although often adopted by

developing countries from those of leading developed countries, have generally been

substantially modified and altered to suit domestic conditions. Only in relatively recent

years has there been significant activity in the development of international standards

in the OSH sector. One important result of such activity is the Occupational Safety and

Health Management System (OSH-MS) initiated and developed by the ILO, which has

now been adopted and adapted by several countries. In Malaysia, for instance, it has

been modified and made into a Malaysian National Standard titled Occupational

Safety and Health Management System Guidelines, i.e. MS 1722: 2003.

Among the likely future priorities of ASEAN-OSHNET that we all should consider,

therefore, is to secure a strong commitment towards integration and harmonisation of


OSH standards, including regulations, codes and guidelines, and OSH-related

standards for products and services. This would both help move OSH among ASEAN

countries to a higher plane as well as remove OSH-related technical barriers to

international trade. It could also possibly help facilitate increased regional trade and

cooperation in OSH products, expertise and services, which can only work in favour of

OSH capacity and capability enhancement in the region.

In this respect, therefore, the proposed “ASEAN Guidelines on Classification,

Labelling and Packaging and of Chemicals” ― one of several current ASEAN-

OSHNET projects ― which are expected to incorporate the principles contained in the

Globally Harmonised System for Classification, Labelling and Packaging of Chemicals

(GHS), is a most excellent example of this new thinking.


On ASEAN-OSHNET in general, I would like to convey my concern about the

commitment of some ASEAN-OSHNET Member Countries to ASEAN-OSHNET

activities, such as ASEAN-OSHNET Workshops. I would like to remind Member

Countries that they may need to revitalise their commitment to these ASEAN-

OSHNET activities, in order to sustain the growth, development and even relevance of

ASEAN-OSHNET. Not all Host Countries have easy access to funding, and even the

ASEAN-OSHNET Secretariat itself has not been that successful in sourcing for funds,

although we believe and hope we are getting better at it.

The point is, it’s not that easy to make people part with their money. In that sense,

therefore, we all have to take our hats off to UNITAR. In relation to that, with due

respect and while acknowledging the problems that may be faced by some Member

Countries, I would like to urge all Member Countries in general to make a special effort

to renew their pledge to the principle of cost sharing that has previously been agreed

by all. Nevertheless, having said that, any Member Country wishing to host any

ASEAN-OSHNET activity is still most welcome to seek the assistance of ASEAN-

OSHNET Secretariat to facilitate the sourcing of funding, giving ample, very ample

advance notice, and ASEAN-OSHNET Secretariat will still collaborate with Host

Countries to try our best together to support Member Countries facing difficulty

attending.



This ASEAN-OSHNET/UNITAR-ILO Workshop on ASEAN Guidelines for

Classification, Labelling and Packaging of Chemicals, I am sure, is most timely and

will I hope eventually provide us all with the right strategy to align and harmonise our

currently vastly diverse national rules on classification, labelling and packaging of

chemicals in ASEAN. This I hope will minimise the adverse effects of such diversity on

international trade while also addressing their implications on work safety and health.

At the same time, this Workshop would also provide all participants as well as some

others among us the opportunity to engage in mutually enriching social, educational

and cultural exchange among themselves.

I hope all participants will devote all their attention to the matters being discussed and

deliberated on over the next three days, so that at the end of the Workshop they can

go back home all the richer and all the better-equipped in information, knowledge and

wisdom, which they can then apply for the improvement of workplace safety and

health in their respective countries. On the other hand, like the man said, “All work and

no play makes Jack a dull boy”. So, needless to say, besides the academic stuff, I

hope all of you will spend the other parts of your time here mixing around, getting to

know one another, making friends, building networks etc., all for the sake of ASEAN

cooperation and integration, especially in the field of Occupational Safety and Health.

Speaking of play, making friends and building networks, ASEAN-OSHNET

Secretariat/NIOSH Malaysia are jointly organising an ASEAN-OSHNET Friendship

Dinner, at NIOSH Malaysia premises, at 7.30 p.m. on Thursday, 9th March 2006, just

a day after this Workshop ends. Therefore, I would like to use this opportunity to

welcome and invite you all to attend this Dinner. We have also planned a special post-

workshop programme for Workshop Participants, comprising a NIOSH Malaysia

Corporate Visit, Priority Training Needs Discussion and “Cruise Tasik” (Putrajaya Lake

Cruise). I understand some participants have already made arrangements to return

home on Wednesday, 8th March 2006. However, I hope they will make an effort to

extend their stay by one more day if possible, for us all to gather together, talk, work

and play, all for the sake of ASEAN cooperation and integration. With that, I would like

to end. Thank you.


Appendix 4 Summary of presentation papers. Presentation 1 : Introduction to GHS

By Wayne Creaser Introduction to GHS was the first presentation at the ASEAN OSHNET

Workshop. It touch about the history, scope and application of the Globally

Harmonized System of Classification and Labelling of Chemicals (GHS), key

elements of GHS and GHS implementation in Australia

History 1992 UNCED Agreement, endorsed by the UN General Assembly:

A globally-harmonised hazard classification and compatible labelling

system, including material safety data sheets and easily understandable

symbols, should be available, if feasible, by the year 2000

Scope The Globally Harmonized System of Classification and Labelling of Chemicals:

• Is a comprehensive tool that harmonises chemical classification and hazard

communication

• Covers all hazardous chemical substances, dilute solutions and mixtures

• Classification based on the hazard properties of the chemical

Principles of Harmonisation • The level of protection should not be reduced as a result of harmonisation.

• The scope includes both hazard classification criteria and hazard

communication tools (labels, MSDS).

• Changes in all existing systems will be required.

• The GHS does not include requirements for testing.

• Target audiences include consumers, workers, transport workers and

emergency responders.

• In relation to chemical hazard communication, Confidential Business

Information (CBI) should be protected.


The Benefits of Harmonization Countries, international organisations, chemical producers and users of chemicals

all benefit to :

• Enhanced protection of humans and environment

• Facilitate international trade in chemicals

• Reduce need for testing and evaluation

• Assist countries and international organisations in the sound

management of chemicals

Key Elements of the GHS • THE GHS ELEMENTS INCLUDE:

• CLASSIFICATION CRITERIA

• Physicochemical

• Health (acute and chronic)

• Environmental

• Mixtures

• HAZARD COMMUNICATION

• Labels

• Safety Data Sheets

• Education & Training

International Implementation • Implementation internationally aimed for 2008

• New version of the GHS released in August 2005

• SDS guidance (new Appendix)

• New precautionary statements

• Some new and revised classification criteria

• Editorial amendments

Australian Implementation • Working to be in a position to implement by 2008

• Development of a single regulatory framework for the control of

workplace chemicals

• Amalgamate current frameworks

• Achieve consistency across jurisdictions

• Implement the GHS

• New SDS and labelling codes of practice


• Implementation of the GHS important for mutual recognition of chemicals with

New Zealand

• Alignment and its timing with key chemical trading partners important

Implementation Issues • Need to manage transition to new framework

• Common legislative requirements and timing

• Education (label elements)

• Phase in period when current and new requirements will be accepted

• Allow recognition of GHS prior to formal commencement

Presentation 2 : Physical Hazard Classification

By Burkhard Wagner Definitions

• Gas: Vapour pressure at 50°C >300 kPa or completely gaseous at 20°C

and 101.3kPa

• Liquid: Not a gas, but initial melting point ≤20°C

• Solid: All others

Same criteria applied to Substances & Preparations

Explosives Substances and preparations capable by chemical reaction of producing gas at

such a temperature, pressure and speed as to cause damage to people and

surroundings including:

• Articles containing such substance and preparations

• Pyrotechnic substances/articles

Guidance Screening procedure:

• presence of specific chemical groups

• oxygen balance

• exothermic decomposition energy and onset

• concentration of inorganic oxidizing substances

Flammable Gases Definition:


• Gases having a flammable range with air at 20°C and 101.3 kPa

Category 1: Extremely flammable gases

• Gases ignitable when in mixture of ≤ 13% in air or having a flammable

range with air of ≥12 %.

Category 2: flammable gases

• Gases other then those of category 1 (but with a flammable range with air at

20°C and 101.3 kPa)

Flammable Aerosols To classify aerosols as flammable, the following characteristics/results of

testing need to be considered:

• Concentration of flammable components

(all liquids, gases, solids according to GHS criteria)

• Heat of combustion *

• Ignition distance test **

• Enclosed space ignition test *

• Foam test (for foam aerosols) ** *mainly transport/storage

** mainly worker/consumer Aerosols are:

• Non flammable, if concentration of flammable components ≤ 1% and heat of

combustion is < 20 kJ/g.

• Extremely flammable, if concentration of flammable components >85% and

heat of combustion is ≥ 30 kJ/g to avoid excessive testing.

All other flammable aerosols are assigned on the basis of the test results to:

• Category 1: Extremely flammable aerosols

• Category 2: Flammable aerosols

There is a clear sequence of testing provided. Note: If product is not tested, classify it in Category 1.

Oxidizing Gases Definition: Gases which may, generally by providing oxygen, cause or

contribute to the combustion of other material more than air does

Gases Under Pressure

• Gases contained in a receptacle at a pressure ≥ 280 kPa at 20°C or as a

refrigerated liquid


• This definition covers four types of gases or gas mixtures to cope with

effects of pressure or freezing which may lead to serious dammage to

people/surroundings or death of people independently from other hazards

gases may posess Flammable Liquids

Liquids with a flash point ≤ 93°C

Flammable liquids are classified in one of 4 Categories according to:

• Flash point

• Initial boiling point

Flammable Solids Definition: Solids which are readily combustible (can be easily ignited by brief

contact with ignition source and flame spreads rapidly) and may

cause or contribute to fire through friction.

• To be classified in one of 2 Categories according to Test Method N° 1 as

described in the Manual of Tests and Criteria.

• To be tested: burning time, burning rate and behaviour of fire in a wetted

zone of the test sample.

Oxidizing Liquids Definition: Substances and preparations, which cause or contribute to the

combustion of other material (generally by yielding oxygen, but also

fluor e.g. Iodinepentafluoride).

Oxidizing Solids Definition: Substances which cause or contribute to the combustion of other

material generally by yielding oxygen.

Organic Peroxides Liquids or Solids containing the bivalent -O-O- structure, thermaly unstable and

exothermic self-accelerating decomposition.

• Such substances and preparations may

• be liable to explosive decomposition

• burn rapidly

• be sensitive to impact or friction

• react dangerously with other substances


Corrosive to Metals Definition: Substances and mixtures which by chemical reaction cause damage

or destroy metals.

Corrosion rate >6.25 mm/year at 55°C

Protection purpose:

• not material compatibility between container/tank and product

• but protection of equipment or installations in case of leakage (e.g.

plane, ship, tank)

Presentation 3 : Classification of health hazards

By Wayne Creaser Health hazards includes:

• Acute toxicity (Chapter 3.1)

• Skin corrosion/irritation (Chapter 3.2)

• Serious eye damage/eye irritation (Chapter 3.3)

• Respiratory or skin sensitization (Chapter 3.4)

• Germ cell mutagenicity (Chapter 3.5)

• Carcinogenicity (Chapter 3.6)

• Reproductive toxicity (Chapter 3.7)

• Specific target organ systemic toxicity- single exposure (Chapter 3.8)

• Specific target organ systemic toxicity- repeated exposure (Chapter 3.9)

• Aspiration hazard (Chapter 3.10)

Presentation 4 : Classification of Environmental Aquatic Hazards

By Burkhard Wagner Data Elements for Classification

• Acute aquatic toxicity – representative species e.g.

– fish 96 h LC50; crustacea 48 h EC50; algae 72 or 96 h ErC50

• Bioaccumulation potential

– Log Kow or Bioconcentration Factor (BCF)

• Rapid degradability

– Ready biodegradability; BOD5/COD; other evidence for rapid

degradation

• Chronic toxicity – relevant species e.g.


– Fish Early Life Stage; Daphnia reproduction; Algal Growth Inhibition

Classification Criteria I

• The GHS consists of

– three acute classification categories, and

– four chronic classification categories.

• The acute and the chronic classification categories are applied independently.

• The criteria for classification of a substance in acute categories 1 to 3 are

defined on the basis of the acute toxicity data only.

Classification Criteria II

• The criteria for classification of a substance into chronic categories combine

two types of information, i.e. acute toxicity data and environmental fate data

(degradability and bioaccumulation).

• For assignment of mixtures to chronic categories, degradation and

bioaccumulation properties are derived from tests on components.

Definitions I

• Aquatic acute toxicity means the intrinsic property of a substance to be

injurious to an organism in a short term exposure to that substance

• Aquatic chronic toxicity means potential or actual properties of a substance

to cause adverse effects to aquatic organisms during exposure which are

determined in relation to the life-cycle of the organism.

Definitions II

• Degradation means the decomposition of organic molecules to smaller

molecules and eventually to carbon dioxide, water and salts. (It contains

biodegradation and hydrolysis.)

• Bioaccumulation means net result of uptake, transformation, and elimination

of the substance in an organism due to all routes of exposure (i.e. air, water,

sediment/soil, and food).

Aquatic Toxicity

• LC50 = lethal concentration, at which 50% of test animals (fish) in a laboratory

experiment die.

• ErC50 = effect concentration, at which 50% of growth rate of algae in

laboratory experiment shows no growth.


• EC50 = effect concentration, at which 50% of test animals (crustacea) in a

laboratory experiment show effect.

• NOEC = No effect concentration, at which test animals show no effect (used in

chronic tests).

Aquatic Toxicity Testing

• Aquatic toxicity is an important element in identifying potential hazards to the

aquatic environment

• Fish, crustacea and algae/aquatic plants are considered representative of

aquatic flora & fauna

• Classification utilises data from tests at these three trophic levels

Intrinsic Properties

• Toxicity is an intrinsic property of a substance and relates to the potential of the

substance to cause effects

• Generally exposure to increasing concentrations of substance causes

increasingly severe effects, or effects on a greater proportion of an exposed

population

• By convention toxicity is expressed relative to parameters of this

concentration/response relationship.

Chronic Data

• Chronic toxicity is toxicity over an ‘extended’ period, defined with respect to the

life-time of the test organism

• In classification, chronic toxicity is normally inferred from acute toxicity + lack of

(bio)degradation and/or potential to bioaccumulate

• In some circumstances such inference of chronic toxicity can be avoided using

real data.

Degradation Testing

• Degradability is an important intrinsic property of substances that determines

their likely persistence in the environment

• Degradation processes can be facilitated by micro-organisms (biotic) or follow

abiotic pathways (eg hydrolysis or photolysis)

• Degradation is the decomposition of (organic) molecules to smaller molecules (primary degradation) and eventually to carbon dioxide, water and

salts (ultimate degradation) Incomplete Data Sets


Toxicity

• Incomplete toxicity data-sets, e.g., where data are not available on all three

trophic levels.

• Classification considered as ’provisional’ and subject to further information

becoming available.

• In general, all the data available will need to be considered prior to assigning a

classification.

Degradation

• Default assumption in case of incomplete data-set: not (bio)degradable

Bioconcentration

• Default assumption in case log Kow is not applicable (few cases): no

bioconcentration in fish (BCF < 500)

Presentation 5 : Classification of MIXTURES

By Wayne Creaser Classification criteria for mixtures

• Based on the classification criteria for substances;

• Consider the classification of any impurities, additives or individual constituents

of a substance which have been identified, if they exceed the cut-off

value/concentration limit for a given hazard class.

Normally,

the harmonized cut-off value/concentration limit is to be applied in all

jurisdictions and for all sectors.

• If there is evidence that the hazard of an ingredient is present below the cut-

off/concentration limit, or

• If there is conclusive data that the hazard of an ingredient will not be present at

a level above the harmonized cut-off/concentration limit,

• Data are available for the complete mixture.

• Data are not available for the mixture itself: Apply bridging principles:

i. Dilution;

ii. Batching;

iii. Concentration of mixtures of the highest category within one hazard

class;


iv. Interpolation within one toxicity category;

v. Substantially similar mixtures;

vi. Aerosolized mixtures;

• Classification based on ingredients: Apply additivity formula

i. Data available for all ingredients;

ii. Data available only for some ingredients;

Germ cell mutagenicity

• Classification of mixtures will be based on the available test data for the individual

ingredients of the mixture, using cut-off values/concentration limits for those

ingredients.

• The classification may be modified on a case-by-case basis based on the available

test data for the mixture as a whole or based on bridging principles.

Carcinogenicity



ingredients.



Reproductive toxicity



ingredients.



Presentation 6 : Data Sources for Classification Purposes

By Burkhard Wagner Data Quality I

Test data determine hazardous properties

• GHS classifications are test data independent

• Data from international standard tests, e.g. OECD Test Guidelines, ISO

Guidelines

• Data produced with OECD GLP

• Data estimated by QSAR


• Test data for physical hazards are generally more clear cut than test data for

health and environmental hazards

Data Quality II (MAD Agreement)

• MAD = Mutual Acceptance of Data

• OECD Decision 1981 (legally binding) • Experimental Data produced in one country with OECD Test Guidelines and

GLP must be accepted in the other country.

• Most recent countries that acceded to MAD were South Africa and Israel.

Data Quality III

• Test data already generated should be accepted for classification, therefore

avoiding duplicative testing.

• It may be difficult to determine the quality of test data. In such cases, expert

judgment will be necessary.

• Generally, data of good quality and reliability in humans will have precedence

over other data.

Data Quality IV

• Positive effects seen in either humans and animals will normally justify

classifications. (Chapter 3.4.2.2.2.2)

• The word “quality” is found 14 times in Chapter 3 “Health Hazards”, indicating

that particularly the animal and human toxicity data are especially critical for

health classification.

Weight of Evidence

• Both positive and negative results are assembled together in the weight of

evidence determination. However, a single positive study performed according to

good scientific principles and with statistically and biologically significant positive

results may justify classification

Weight of Evidence (Environment)

• More than one acceptable test available for the same taxonomic group

– The most sensitive (the one with the lowest L(E)C50 or NOEC) is

generally used for classification.

• Larger data sets (4 or more values) available for the same species

– The geometric mean of toxicity values may be used as the

representative toxicity value for that species.


– It is not advisable to combine tests of different species within a

taxonomic group or in different life stages or tested under different

conditions or duration.

Data Quality Scoring Guide I

• Objective: – To assist in the process of deciding on the best available data in case no

data according to standard test guidelines and GLP are available

• Category 1: – Data derived from official data sources validated by regulatory

authorities

– Examples: EU Water Quality Monographs, USEPA Water Quality

Criteria.

– These data can be considered as valid for classification purposes.

– No assumption should be made that these are the only data available

• Due regard should be given to the date of the relevant report.

Newly available data may not have been considered.

• Category 2: – Data derived from recognised international guidelines (e.g., OECD

Guidelines) or national guidelines of equivalent quality (but not under

GLP)

– Subject to the data interpretation issues these data can be used for

classification.

• Category 3: – Data derived from testing which, while not strictly according to a

guideline detailed above, follows accepted scientific principles and

procedures and/or has been peer reviewed prior to publication.

– Where all the experimental detail is not recorded, some judgement may

be required to determine validity.

– Normally, such data may be used within the classification scheme.

• Category 4: – Data derived from testing procedures which deviate significantly from

standard guidelines and are considered as unreliable, should not be

used in classification.


• Category 5: – QSAR data

– Can be relied upon to provide predictions of acute toxicity for fish,

daphnia, and algae for non-electrolyte, non-electrophilic, and otherwise

non-reactive substances.

– Reliable QSARs have been derived for chemicals acting by a basic

narcosis mechanism.

• Nonelectrolytes of low reactivity such as hydrocarbons, alcohols,

ketones and certain aliphatic chlorinated hydrocarbons which

produce their biological effects as a function of their partition

coefficients.

– Problems remain for substances which operate by means of special

mechanisms

• functional groups which interact with biological receptors, or which

can form sulfhydryl bonds with cellular proteins.

– Data derived from quality QSARs can be used for classification

• Category 6: – Data derived from secondary sources such as handbooks, reviews,

citation, etc where the data quality cannot be directly evaluated.

– Such data should be examined where data from quality 1,2 and 3 are not

available, to determine whether they can be used.

– Such data should have sufficient detail to allow quality to be assessed.

– In determining the acceptability of these data for the purposes of

classification due regard should be given to the difficulties in testing that

may have affected data quality and the significance of the reported result

in terms of the level of hazard identified.

Presentation 7 : GHS Implementation and Tools for it in Japan By Hiroshi JONAI

• Manufacturer or Supplier: To classify chemicals and make labels and SDS, to

educate workers

• Government: To harmonize the domestic regulations in order to implement GHS

• Employer: To give a chance of education and training for workers on GHS

• Worker: To understand the meaning of contents of a label or SDS


• Consumer: To understand the meaning of contents of a label

• Institute, Agency, Academic society etc. : To do hazard assessment,

information dissemination, education program etc.

Current Regulations for chemical control in Japan

• Laws and regulations were followed by accidents and occupational diseases.

• Chemicals or jobs to be controlled were listed up in the regulations . Hazard Communication in Japan

• Hazard Communication and Risk Management are combined. (No Hazard

Communication Std.)

• There is no pictogram but KANJI in a label (regulations).

• Hazard information is little but precautionary statements are many in a label.

Hazard Classification

• Physical hazards; Air or Sea transport – same as UNTDG

Other sectors – their own categories

• Acute toxicity; Two categories with criteria (e.g. Oral - 50 mg/kg, 300mg/kg)

• Other health hazards; List of substances according to a hazard concerned (e.g.

Cancer)

• Environmental hazards; List of substances according to a hazard concerned

Current SDS

• Format of SDS is the same as ISO’s.

– Revised according to GHS (2005)

• SDS should be produced for about 1,300 substances under the regulations.

• For the other chemicals, SDSs are made voluntarily.

Issues to be cleared for GHS Implementation

• Big coverage of substances and mixtures under GHS

• Collection of hazard data of chemicals, not regulated by laws or regulations

• Independent hazard communication system not related to risk management

• Clearance of duplication of label elements

GHS Implementation in Japan

• GHS committee consisted of every Ministry concerned （MHLW, METI, MoE,

MIC, MAFF, MLIT and MOFA) established 2001

• Translation of GHS Text into Japanese: First revised version is available from the

web-site of METI, MoE and MHLW)


• Seminars on GHS (>2,000 participants)

• Pamphlets for raising awareness

• Revision of Industrial Safety and Health Law for better hazard communication

Enforcement from December 1, 2006

• Guidelines for classification of chemicals

• Classifying 1,500 regulated substances according to GHS criteria and the results

are available on the web of NITE (National Institute of Technology and Evaluation).

Having done 98 substances (Feb. 2006)

New JIS based on GHS (JIS: Japanese Industrial Standard)

• JIS-SDS based on GHS was issued in Dec. 2005.

• JIS-labelling system based on GHS will be issued in 2006.

Educational Tools for GHS

Pamphlet

• For the public (Ministry of Environment, 2003)

• For industries (Ministry of Health, Labour and Welfare, 2006)

• For workers (Ministry of Health, Labour and Welfare, 2006)

Seminars or Lectures

• For the staff concerned with chemical control from enterprises, institutes and

agencies

• For researchers studying chemical hazards

Workshop

• To classify chemicals according to GHS criteria (JISHA : Japan Industrial Health

and Safety Association)

• To make labels and SDSs under GHS requirements

Guidelines issued • For dealers how to comply with Poisonous and Deleterious Control Law

• For classifiers how to classify the regulated 1,500 substances

• For suppliers how to make SDS for mixtures


Presentation 8 : GHS Labelling By Wayne Creaser

Target audiences: needs

• Factors considered:

• Potential use of products;

• Availability of information other than label;

• Availability of specific training.

• Needs:

• Workplace: labels, SDS, specific training;

• Consumers: labels

• Emergency responders: labels, specific training;

• Transport: labels, transport documents, specific training.

Comprehensibility of hazard communication elements

Guiding principles:

• Information should be conveyed in more than one way

• Comprehensibility should take account of existing information (literature,

studies and data)

• Phrases indicating degree of hazard should be consistent across different

hazard types

• Words and phrases should retain comprehensibility when translated into other

languages

• Format and colour of the label elements, and SDS format should be

standardized

Labelling according to GHS

Information required on a GHS label:

• Pictograms : Graphical composition that includes a symbol and other graphic

elements, such as a border, background pattern or colour that is intended to

convey specific information.

• Signal words : word used to indicate the relative level of severity of hazard and

alert the reader to a potential hazard on the label.

• Hazard statements : phrase assigned to a hazard class and category that

describes the nature of the hazards of a hazardous product, including, where

appropriate, the degree of hazard.


• Precautionary statements and pictograms : phrases (and/or pictograms) that

describe recommended measures that should be taken to minimise or prevent

adverse effects resulting from exposure to a hazardous product, or improper

storage or handling of a hazardous product.

• Product identifier : Chemical identity of the substance.

• Supplier information : Name, address and telephone number of the

manufacturer or supplier of the substance/mixture

Labelling according to GHS: Precedence of hazard information

Symbols for physical hazards:

• Substances/mixtures covered by UN Model Regulations:

as specified by the Model Regulations;

• Workplace: as specified by competent authority;

Symbols for health hazards:

Exclamation mark should not appear if:

• if skull and crossbones applies; or

• if used for skin sensitization or skin/eye irritation:

• if corrosive symbol applies;

• if the health hazard symbol appears for respiratory sensitization;

• Signal words: If “Danger” applies, “warning” should not appear

• Hazard statements: All applicable hazard statements should appear on the

label, in the order specified by the competent authority.

Australian perspective on labelling

• Australian chemical regulatory system is complex

• Different regulatory agencies covering different sectors, for example:

– Agricultural and Veterinary Chemicals

– Scheduled poisons (eg domestic chemicals, pharmaceuticals)

– Workplace chemicals

• Hazard classification and communication using a combination of hazard and

risk based approaches

• For successful implementation of GHS in Australia, labelling must be able to

accommodate both approaches

• Workplace chemicals driving GHS implementation in Australia

• Development of a GHS based labelling code

• Work to develop a hierarchy or precedence of:


– hazard classes and categories,

– hazard statements and

– precautionary statements

to accommodate risk-based approaches to labelling

• Additional precedence rules (than currently in GHS) for some situations (eg

small containers)

Presentation 9 : Hazard communication – Safety Data Sheets By Wayne Creaser

• Australia was the lead country in the UN Correspondence Group on Safety

Data Sheets

• The guidance material was endorsed at the December 2004 GHS meeting

• The current Annex 4 of the GHS (Revision 1) is based on the Australian

National Code of Practice for the Preparation of MSDS

• The SDS requirements are based on a 16-header format

Role of Safety Data Sheets

• Provide comprehensive information of a substance/mixture for use in workplace

• Are product related

• The information provided enables the employer:

• To develop worker protection measures specific to the workplace

• To consider measures to protect the environment

Safety Data Sheets

• SDS should be provided for:

• all substances/mixtures meeting GHS harmonized criteria for physical,

health and environmental hazards;

• mixtures containing substances meeting criteria for carcinogenicity,

toxicity for reproduction or specific target organ systemic toxicity, in

concentration exceeding cut-off values.

• other substances/mixtures not meeting the criteria for classification as

hazardous but containing hazardous substances in certain

concentrations, if required by the competent authority

Safety Data Sheets: Format

Information should be presented as follows:

1. Identification


2. Hazard(s) identification

3. Composition/information on ingredients

4. First-aid measures

5. Fire-fighting measures

6. Accidental release measures

7. Handling and storage

8. Exposure controls/personal protection

9. Physical and chemical properties

10. Stability and reactivity

11. Toxicological information

12. Ecological information

13. Disposal considerations

14. Transport information

15. Regulatory information

16. Other information.

Updating information

• Labels and Safety Data Sheets should be updated when new and significant

information is available for a chemical.

(“New and significant information” means any information that changes GHS

classification and leads to a change in the information to be provided in the label or in

the SDS.)

Presentation 10 : New Zealand Experience in GHS By Barry Dyer

The New Zealand Experience

Hazardous Substances and New Organisms (HSNO) Act

• Act Drafted 1989 - 1995

• Enacted 1996

Background

• Replace Obsolete Regulations

• Environmental 1991

• Workplace Health & Safety 1992

• Building 1992

Basic Requirements


• Reflect New Zealand’s International Obligations

• Industry Best Practice

• Performance Based

• Commonality with Australia

Hazardous Substances Regulations

• Reflects GHS and UN Transport Model

• Involves 9 Government Agencies

• Created Environmental Risk Management Agency (ERMA)

• Support of NZ Chemical Industry Council (NZCIC)

• Provoked opposition from Employers

Hazardous Substances and New Organisms (HSNO) Act

Hazardous Substances Regulations (13) 2001

• Phased Implementation 2001 –

• Five Year Transitional Period July 06

Basic Infrastructure

• National Performance Standards

Approved Codes of Practice

Standards

• Professional Qualifications

Enforcement Officers

Test Certifiers

Approved Handlers

• Quality Assurance Accreditation

Test Certifiers

Trainers

• Training – Model Courses

Reference Material

Training Aids

Progress to date

• Regulatory Timetable – Complete Transition Phase (July 06) On Target

• Updating Regulations Uncertain

• Compliance Objectives Incomplete

• Infrastructure Incomplete

• Enforcement Deferred


• Update Regulations Uncertain

• Provide Performance Standards Behind Schedule

• Introduce Major Improvements e.g. Group Standards On Target

• Training Slow Progress

• Compliance Behind Schedule

• Enforcement Delayed

Compliance Tools

• Codes of Practice

Signage©

SDS©

Labelling©

Emergency

Management

• Industry Guides

DG Wheel/Charts

• ChemCall©24/7 ERS

Regulatory Requirement

(GHS/TPT)

• Site Assessments

PRINCE©

Accreditation


Appendix 5 Program for ASEAN OSHNET Workshop

ASEAN OSHNET Workshop on The Draft ASEAN Guidelines on Classification,

Labeling and Packaging (CLP) of Chemicals

(in collaboration with UNITAR-ILO) Grand Seasons Hotel, Kuala Lumpur, Malaysia

6 – 8 March 2006

DAY 0 ( 05th MARCH 2006 ) Time Activity

1400-1800 Arrival of ASEAN Delegates 1830-2230 Dinner at (hotel)

End of Day 0


0700-0800 Breakfast at (hotel)

0800-0845 Registration/Arrival of Guests

0845-0900 Arrival of Yang Berhormat Datuk Abdul Rahman Bakar, Deputy Minister of Human Resources, Malaysia

0905-0910 Welcoming Address by Ir Hj Abu Bakar Che’ Man, Director General of Department of Occupational Safety and Health, Malaysia

0910-0915 Welcoming Address by Y. Bhg Dato’ Ir Dr Johari Basri, Executive Director of ASEAN OSHNET Secretariat

0915-0920 Welcoming Address by UNITAR

0920-0935 Opening Address by Yang Berhormat Datuk Abdul Rahman Bakar, Deputy Minister of Human Resources, Malaysia

0930-1000 Tea Break

1000-1100 Presentation 1 by Mr. Wayne Creaser, Australia: Introduction to the GHS

1100-1200 Presentation 2 by Mr. Burkhard Wagner, UNITAR: Classification of Physical Hazards

1200-1230 Presentation 3 by Mr. Wayne Creaser, Australia: Classification of Health Hazards

1230-1400 Lunch

1400-1500 Presentation 4 by Mr. Burkhard Wagner, UNITAR: Classification of Environmental Hazards

1500-1600 Presentation 5 by Mr. Wayne Creaser, Australia: Classification of Mixtures

1600-1615 Tea break

1615-1715 Presentation 6 by Mr. Burkhard Wagner, UNITAR: Data sources for classification purposes



2000-2230 Welcoming Dinner at (hotel). Host by DOSH, Malaysia End of Day 1

DAY 2 ( 07th MARCH 2006 ) 0700-0800 Breakfast at (hotel)

0900-0930 Presentation 7 by Mr Hiroshi Jonai, Japan: The Experience of Japan with GHS Implementation

0930-1015 Presentation 8 by Mr. Wayne Creaser, Australia: GHS Labelling

1015-1030 Tea break

1030-1115 Presentation 9 by Mr. Wayne Creaser, Australia: GHS Safety Data Sheet (SDS)

1115-1135 Presentation 10 by Mr. Barry Dyer, New Zealand: New Zealand Experience in implementing GHS

1135-1245 Exercise 1: Worked example on classification & labelling of a pure chemical

1245-1415 Lunch 1415-1530 Exercise 2: Worked example on classification & labelling of a mixture 1530-1545 Tea break

1545-1645 Presentation of a Draft ASEAN CLP Guidelines by Hj Anuar Mohd Mokhtar, DOSH Malaysia

2000-2230 Dinner at (hotel)

End of Day 2

DAY 3 ( 08th MARCH 2006 ) 0700-0800 Breakfast at (hotel)

0900-0915 Briefying on the group discussion 0915-1000 Break-up session: Discussion on criteria used for the guidelines 1000-1015 Tea break 1015-1230 Discussion continue 1230-1400 Lunch 1400-1420 Group #1 presentation 1420-1440 Group #2 presentation 1440-1500 Group #3 presentation 1500-1600 Resolutions on Draft ASEAN CLP Guidelines 1600-1615 Tea break 1615-1630 Closing

2000-2230 Dinner at (hotel)

End of Day 3



0700-0800 Breakfast at (hotel) 0830-0900 Room check-out 0900-2230 Departure/Program with NIOSH Malaysia

End of Day 4


Appendix 6 Question and answer

Presentation 1 : By Mr. Wayne Creaser, Australia: Introduction to the GHS Question : I’m always wonder why, United Nation put it as a model regulation for

the transport dangerous goods, might be incredibly help the country

wishing to follow that particular regime. How far are we confidence with

some model regulation on GHS?

(Mr. Barry Dyer)

Answer : I think that we did five ways after a long why way thing. The transport

dangerous goods covered by a things commended by relationship

advise product.

Presentation 2 : By Mr. Burkhard Wagner, UNITAR-ILO

Classification of Physical Hazard Question : I wonder if you say that it is corrosive to metal and your definition of

substance and mixture which by chemical reaction cause damage but

the criteria said that it will be caution red more than 6.25mm/year at

550C. If there is a time consuming for this testing, so in the testing

method will be compared or will be doing in some term instead to do a

year?

(Participant from Thailand)

Answer : Sorry, I’m not sure in the testing method.

Presentation 3 : By Mr. Wayne Creaser, Australia Classification of Health Hazard

Question : Can we state precise concentration that should be applied.

(Participant from Brunei)

Answer : The answer probably no because some compounds even you dilute to

some extremely level it still be extremely toxic where others compounds


you can use cut-off 0.1% because each compounds have a different cut-

off value. GHS always consider if you can substituting the chemical for

other that have less hazard for long term benefits.

Question : In doing testing, there is bound to be different interpretation of the testing

result especially on health hazards. Do we have mechanism to resolve

this differences.

(Participant from Malaysia)

Answer : This need to have to start developing a database of classified

substances a baseline where you do have general agreement from the

toxicological community to say yes that this is the reasonable finding you

have. At this stage there is no agreement or process to set-up something

internationally to look at the work that was done between USCPI in

Germany is being reviewed or up for discussion the next GHS meeting

and we hope it will be debated in the next meeting.

Presentation 4 : By Mr. Burkhard Wagner, UNITAR-ILO

Classification of Environmental Hazard Question : Do you have any institute that implement of this standard where it can be

as a reference organisation lately? It can be a government.

(Participant from Thailand)

Answer: All the test data more or less produce by industries and in Germany

when we received the data, we check the industries if they follow the

guidelines and have produce a documentation or good laboratory

practices we formally accept it. The MITI have done the test for more

than 10,000 chemical and this can be reliable, and I considered this data

as a reference data. But in Purple Book, there is no re-testing necessary.

(Mr. Wagner Creaser)


Presentation 5 : By Mr. Wayne Creaser, Australia Classification of Mixture

No Question

Presentation 6 : By Mr. Burkhard Wagner, UNITAR-ILO Data sources for classification purposes

Question : You mentioning about the quality of the data it have 6 categories right,

its that right that category 1 is more reliable than category 2.


Answer : It’s a hierarchy, its preceding way from simple to complex. I think its

starts from quality data to the less quality data.

Presentation 7 : By Mr. Hiroshi Jonai, Japan The Experience of Japan with GHS Implementation

No Question

Presentation 8 : By Mr. Wayne Creaser, Australia GHS Labelling

Question : Is Australia adopting a new requirement about the minimum information

that need to put on the labels of small container.

Answer : There were a discussion in the GHS Committee at UN about the

minimum information on small container that you must enclosed the SDS

if you packages small container generally small container come in boxes

and SDS is an extra information.

Question : What about the label itself, do we restrict the number of pictograms that

is supposed to put in the labels?

Answer : You must made a decision what is the most important information you

need to put in the labels because if you put all the information it become

smaller and unreadable.


Question : Is there any reference regarding the size of the labels?

Answer : As an example, the minimum size of label is depends on the size of the

container just like a 200 litres drum you should put all the information in

the labels so that everybody can read it.

Question : Do we need to labels fixed structures like tank or moving container in the

workplace?

Answer : In Australia, a placard is needed because the potential we exposed to

the chemical is high. Without a placard displayed in the tank or the

moving container, the information about the chemical will not be known

by the public.

Presentation 9 : By Mr. Wayne Creaser, Australia GHS Safety Data Sheet (SDS)

Question : Under what situation that the suppliers did not need applying SDS?

Answer : The situation where the products is not classified as hazardous

chemical.

Question : If the mixtures is below the cut-off point, do we need the SDS?

Answer : That will be correct if the product is not classified as the hazardous

products to the consumer. A lot of companies developed SDS because it

involved the consumer.

Presentation 10 : By Mr. Wayne Creaser, Australia New Zealand Experience in GHS

Question : Do you have a training courses for the classifiers to do the

classifications?



Answer : No, but I’m sure ERMA will provide the training if u ask them but there

will be someone would like to share the experience if you really want it, I

think Peter Dawson is the right person.

Question : Could you tell me the main reason why government really want to

implement GHS?

Answer : The reason was we had a forty years old legislation and we sat down

and discuss in 1998 and decide we must change all the requirements

using the chemicals.


Appendix 7 List of Speaker/Chairman/Facilitator

No. Name Agency/Country Remark

1. Haji Anuar Mohd Moktar DOSH Speaker/Moderator/Chairman

2. Wayne Creaser Australia Speaker/Moderator

3. Dr. Burkhard Wagner Germany Speaker

4. Prof. Dr. Hiroshi Jonai Japan Speaker/Moderator

5. Barry Dyer New Zealand Speaker/Moderator

6. Ir. Mohtar Musri DOSH Chairman

7. Ibrahim Abdul Rahman NIOSH Chairman


Appendix 8 List of Participant of ASEAN OSHNET Workshop on 6-8 March 2006

No. Name Country

1. Haji Rambli Trokie Brunei

2. Shahriman Haji Besar Brunei

3. Dr. Leng Tong Cambodia

4. Dr. Pok Vanthat Cambodia

5. Roland Hutapea Indonesia

6. Tumbur Saut Parulian Indonesia

7. Dr. Bounma Sitthisom Laos

8. Khamphat Onlasy Laos

9. Buhairah Ismail Malaysia

10. Fadzil Osman Malaysia

11. Habibah Supoh Malaysia

12. Mohd Fadhil Haji Abu Yazid Malaysia

13. Prema Arasan Malaysia

14. Sukati Sakka Malaysia

15. Soa Win Sein Myanmar

16. U Thein Win Myanmar

17. Chow Li Yee Singapore

18. Dan Liu Singapore

19. Chana Charnmongkol Sumalee Thailand

20. Suksuntichai Kanokkarn Thailand

21. Dang Chan Thong Vietnam

22. Ngo Ke Nghiep Vietnam


Appendix 9 List of Secretariat of the ASEAN OSHNET Workshop

No. Name Agency Position

Tuan Hj Anuar Mohd Mokhtar DOSH Director

Pn Zaiton Sharif DOSH Deputy Director

En Ramesh Zakir DOSH Deputy Director

Pn Habibah Supoh DOSH Assistant Director

Cik Zamrudah Yeop DOSH Assistant Director

Roselan Mohamed DOSH Assistant Director

Hamidi Saidin DOSH Assistant Director

Mokhtar Sabtu DOSH Assistant Director

Kasman Nasir DOSH Assistant Director

Noraita Tahir DOSH Assistant Director

Noor Azurah Abd. Rahman DOSH Assistant Director

Azmir Ismail DOSH Assistant Director

Ikhwani Ismail DOSH Assistant Director

Nichalos a/l Maria Soosay Thas DOSH Assistant Director

Ibrahim Abd Rahman NIOSH OSHNET Secretariat

Ayob NIOSH

Khamsiah Mohamad MOHR International Division

Roslindawati Mohamed DOSH Admin

Zuhairi Zakeri DOSH OSH Officer

Christina Shak Sang DOSH OSH Officer

Sofia Hasan DOSH Sister

Noraini Ismail DOSH Sister

Sulaiman R Rahman DOSH OSH Officer

Mohd Poad Abdullah DOSH OSH Officer

Nordin Saian DOSH OSH Officer

Nor Azli Muhamad DOSH OSH Officer

Norazilah Ayuni Muhamad DOSH Admin

Suhairi Abdul Kadir DOSH OSH Officer

Mohd Fairuz Malek DOSH Admin

Yuzriman Jamil DOSH OSH Officer


Appendix 10 Curriculum Vitae of the Presenter from UNITAR-ILO

BURKHARD WAGNER PhD

Chemist

1969 - PhD of University of Heidelkeof in Germany

1970-1971 - Post doc at California, Institute of

Technology in Pasadena/USA

1974-2005 - Employed by the German Environment Protection Agency in

Berlin

2005 - Retired in April

1979-1981 - Worked at OECD in Paris on Good Laboratory Practice.

1991-1996 - Worked at UNEP Chemicals in Geneva/Switzerland.

1999-2006 - Worked in environmental risk assessment of chemicals,

biocides, pesticides, specialist on environmental exposure

assessment.

United Nation Institute for Training and Research (UNITAR) of Experts on GHS


Appendix 11 Curriculum Vitae of the Presenter from UNITAR-ILO

WAYNE CREASER Assistant Secretary

Standards and Research Branch

Office of the Australian Safety and Compensation Council

Department of Employment and Workplace Relations

Wayne has recently been promoted into a position with management and leadership

responsibility for development of national standards relating to plant and occupational

licensing, research on OHS policy issues and reviewing national OHS framework

implementation issues.

Prior to this, Wayne has been responsible for managing the review of the Australian

workplace chemicals framework, developing a new national standard and code of

practice utilising the GHS as the basis for classification and hazard communication. In

this position, Wayne has been head of the Australian delegation to the GHS for the

past two years (2004).

Wayne’s background is in chemistry supplemented with graduate diplomas in

occupational health and safety and management.

Prior to joining the Office of the Australian Safety and Compensation Council, Wayne

worked for the Australian Capital Territory and Northern Territory government’s OHS

regulatory authorities, managing the OHS inspectorates. He has also worked as an

occupational hygienist and environmental chemist.

Wayne lives in Canberra with his wife and two children and is involved in playing and

coaching hockey and is currently undertaking a course in fine woodworking.


Appendix 12 Curriculum Vitae of the Presenter from Japan

HIROSHI JONAI email:[email protected] MD, MSc. Chem. Eng., PhD

1978 Graduated at Waseda University

Master Degree of Chemical Engineering

1985 Graduated at Akita University

School of Medicine (Got Physician’s License)

1985 – 2002 March

Worked for National Institute of Industrial Health

2002 April Working for Nihon-University as a Professor

Japan Delegates for UNSCEGHS

United Nations Sub-Committee of Experts on GHS


Appendix 13 Curriculum Vitae of the Presenter from New Zealand

BARRY DYER New Zealand

Chemical Industry Council

The New Zealand Chemical Industry Council is a not-for-profit industry association

representing 90% of Chemical manufacturing and importers. The council aim is to

achieve excellence in safety, health and environmental performance, particularly the

safe management of hazardous substances and dangerous goods through the global

chemical industry’s responsible care initiative.

Following a distinguished military career, Barry was appointed to revitalize the

organization and help the industry prepare for the new GHS based chemical control

legislation.

Under Barry’s leadership, the council is playing a leading role in implementing this

complex and confusing system. The council provides

Technical advice to government, industry and the community

Specialist training for government and industry

A comprehensive range of ‘compliance tools’

A 24/7 emergency response advisory service

Advice and support to APEC countries

Barry is a board member of the international council of chemical associations (ICCA)

comprising 52 countries who are working to implement the GHS by 2010

Barry’s member also included major chemical users, such as hospitals, local

environmental agencies, government agencies, transport operators and the armed

forces.


Appendix 14

ASEAN OSHNET Workshop on the Draft ASEAN Guidelines on Classification, Labelling and Packaging (CLP) of Chemicals Kuala Lumpur, Malaysia 6-8 March 2006 Exercise 1: Classification of a Substance Using the following hazard information for 37% aqueous formaldehyde solution (formalin): • Determine hazard classification using GHS criteria. • Using the hazard classification, determine which label elements (symbols, signal

words and hazard statements) would be needed on a label. Property Results Flammability Flash point 83-85 C

BP 96 C Acute toxicity Oral LD50

Dermal LD50 Inhalation LC50 (4 h)

Rat: 800 mg/kg bw Guinea pig: 260 mg/kg bw Rabbit: 270 mg/kg bw Rat: 480 ppm (0.578 mg/L) Mouse: 414 ppm (0.511 mg/L)

Corrosion/Irritation Eye test Instilling 10 �l of 37% formalin solution into the eye resulted in irritation of the iris and conjunctiva 3 hours post instillation and permanent damage to cornea after 1 day.

Sensitisation Skin Inhalation

Known skin sensitiser (patch testing) from human and animal trials. Some evidence that formaldehyde may cause sensitisation in sensitive population, however results are inconclusive.

Carcinogenicity Meets criteria for classification as a carcinogen category 1

Chronic toxicity Does not meet criteria for classification as systemically toxic.

Mutagenicity Does not meet criteria for classification as a mutagenic substance.

Reproductive, developmental effects

Does not meet criteria for reproductive or developmental toxicity.

Environmental toxicity Acute Most sensitive aquatic organism was Daphnia pulex, with the lowest reported median effective concentration (EC50) of 5.8 mg/L.


Answers As a result of the above test results, the substance may be assigned to the following GHS hazard classes. Health

hazards Classification Symbol Signal

word Hazard statement

Health hazards – acute toxicity

Oral Category 3 skull and cross bones

Danger Toxic if swallowed

Dermal Category 3 skull and cross bones

Danger Toxic in contact with skin

Inhalation Category 2 skull and cross bones

Danger Fatal if inhaled

Corrosion/irritation Eye Category 1 Corrosion Danger Causes serious eye damage

Sensitisation Skin Category 1 Exclamation mark

Warning May cause an allergic skin reaction

Carcinogenicity Category 1 Health hazard

Danger May cause cancer by inhalation

Environmental hazard

Acute toxicity

Category 2 - - Toxic to aquatic life

Flammable liquid Category 4 - Warning Combustible liquid


Appendix 15 ASEAN OSHNET Workshop on the Draft ASEAN Guidelines on Classification, Labelling and Packaging (CLP) of Chemicals Kuala Lumpur, Malaysia 6-8 March 2006 Exercise 2: Classification of a Mixture 1. Determine the GHS hazard classification of a hypothetical mixture

containing 10% pesticide X and 90% aromatic hydrocarbon solvent. No data are available for the mixture therefore hazard classification must be determined using the following hazard information for the two ingredients in the mixture.

2. Using the hazard classification derived, determine which label elements

(symbols, signal words and hazard statements) would be needed on a label. Data for pesticide X (10%) Acute toxicity – oral LD50 = 20 mg/kg bw Acute toxicity – dermal LD50 = 100 mg/kg bw Acute toxicity – inhalation LD50 = 0.1 mg/L Acute toxicity – aquatic Freshwater cladoceran (Daphnia magna) Estuarine mysid (Neomysis mercedis)

Mean 48h EC50 = 0.15 mg/L Mean 96h LC50 = 0.20 mg/L

Flash point 120 C Vapour pressure 0.00004 mm Hg Water solubility 0.002 g/100 mL Octanol/water partition coefficient

Log Kow = 3.8

Data for aromatic hydrocarbon (90%) Acute toxicity – oral LD50 = 650 mg/kg bw Acute toxicity – inhalation LD50 = 12.5 mg/L Flash point 4 C Vapour pressure 21 mm Hg Boiling point 111 C Viscosity 0.590 mPa.s = 0.6806

mm2/s Density 0.8669 g/cm3


Answers Calculation for acute toxicity of the mixture Using equation in section 3.1.3.6.1, page 115

∑=n ATEiCi

ATEmix100 =

ATEnCn

ATEC

ATEC .....

2

2

1

1 ++

Where :

ATEmix = acute toxicity estimate for the mixture ATEi = acute toxicity of ingredient i Ci = concentration of the ingredient i

Rearrange equation to determine ATEmix as follows:

1001 ∑

= n ATEiCi

ATEmix therefore

∑=

n ATEiCi

ATEmix 100 =

ATEnCn

ATEC

ATEC

.....

100

2

2

1

1 ++

inhalation toxicity,

ATEmix

5.1290

1.010

100

+=

2.7100100+

= = 0.93 mg/L

(acute tox (inhalation) cat 2) Dermal toxicity (mixture) Only 1 ingredient has dermal toxicity therefore calculation of dermal toxicity of the mixture is simply a dilution: = 100/(10/100) = 100/0.1 = 1000 mg/kg bw therefore classification as acute toxicity (dermal) category 3 Oral toxicity (mixture)

ATEmix

65090

2010

100

+=

138.05.0100+

= = 156 mg/L

Therefore classification is acute toxicity (oral) category 3


Flammability Using logic in section 2.6.4.1, page 70 Part 2.6.4.2.2 applies because pesticide x is non-volatile (v.p.=0.00004 mm Hg compared to 21 mm Hg for aromatic hydrocarbon solvent) therefore flash point of mixture is based on flash point of solvent. That is, mixture has flash point of 4 C. Flammability classification is category 2 (flash point <23 C and BP >35 C). Environmental toxicity classification Lowest acute aquatic tox is 0.15 mg/L for pesticide x making the ingredient aquatic acute I category. Aromatic hydrocarbon solvent has no aquatic toxicity and therefore is not considered further. Use decision flow chart in figure 4.1.2 which should lead to classification using summation method. Go to section 4.1.3.5.5.3 – classification of acute categories I, II and III. See also summation method, referred to in Table 4.1.2 on page 231. Step 1: Acute I x M >25% means mixture classed as acute I. [M derived from LC50 value range as shown in Table 4.1.4 on page 231]. Component with acute tox I is less than 25% therefore go to step 2 (3.10.3.5.5.3.2). Step 2: 10 times Acute I ingredient = 100 , ie >25% therefore classify mixture as Acute II. This step completes the classification of aquatic toxicity. Aspiration toxicity The mixture meets the criteria for classification into category 1 because it is contains 90% aromatic hydrocarbon solvent with kinematic viscosity of <20.5 mm2/s. Overall classification of mixture: acute toxicity (dermal) category 3 acute toxicity (oral) category 3 acute toxicity (inhalation) category 2 Flammable liquid category 2 Aquatic - Acute toxicity category II. Aspiration toxicity category 1 Label elements Health

hazards Classification Symbol Signal

word Hazard statement

Health hazards – acute toxicity

Oral Category 3 skull and cross bones

Danger Toxic if swallowed

Dermal Category 3 skull and cross bones

Danger Toxic in contact with skin

Inhalation Category 2 skull and cross bones

Danger Fatal if inhaled

Environmental hazard

Acute toxicity

Category 2 - - Toxic to aquatic life

Flammable Category 2 Flame Danger Highly


Health hazards

Classification Symbol Signal word

Hazard statement

liquid flammable liquid and vapour

Aspiration hazard

Category 1 Health hazard

Danger May be fatal if swallowed and enters airways


Appendix 16 Group 1: Assignment on classification No Chapter/Header Comment

(fully agree) Comment (Partially agree)

Reason and recommendation

1 Chapter 1

1.1 Scope x To be added in ”Definition” 1. Use at work: use means chemicals involved in

production, processing, handling, storage, transportation, disposal and treatment.

2. Hazardous chemicals : any substances or mixtures which possess any of the properties categories in schedule 1

3. Item to remove from definition : supplier 1.2 Coverage x 1.3 Exclusions x Para 3: Pharmaceutical products, consumer products, food

additives, cosmetics, and pesticide residues in food are not covered if use for intentional intake. Para 4: to refer to planner to redefined definition of “articles” and clarify on including explosive articles.

Additional : Training Planner to discuss 2 Chapter 2

2.1 Duty to classify x Para 5 : should read as It is the duty of formulator, manufacturer and importer of chemical for use at work………until schedule I

2.2 Classification process

x Para 6 ; all agreed except b) Subsequent review of those data and quality to ascertain……. Para 7 : b and c To write Purple Book

2.3 Use available data x Para 8 : add : Classification should be reviewed in periodic time frame or when new data become available.


No Chapter/Header Comment (fully agree)

Comment (Partially agree)

Reason and recommendation

2.4 Use of cut-off x Para 9 : However, if the supplier if information that the hazard…..

2.5 Classification summary

x Para 10 : Schedule II to be removed and replaced with Annex II Purple Book…….

2.6 Competent Classifier x Para 11 : Planner to consider on: 1. Industry to organize 2. Government should train own personnel 3. Government can support industry in training 4. Industry should have own competent classifier 5. Government should certify competent classifier


Appendix 17 GROUP 2 : Assignment on Labelling

SUKSUNTICHAI KANOKKARN (THA) -Chairman SUKATI SAKKA (MAS) ROLAND HUTAPEA (INA) HAJI RAMBLI TROKIE (BRU) DR. LENG TONG (CAM) DR BOUNMA SITTHISOM (LOA) MOHD FADHIL HJ ABU YAZID (MAS)-Rappateur FACILITATOR EXPERT : HIROSHI JONAI CO-FACILITATOR: ANUAR MOHD. MOKHTAR

TOPIC : LABELLING DRAFT CHAPTER 3: LABELLING 3.1 Information on a Label 12. A supplier should ensure that every packaging is labelled clearly and indelibly with the following information - (a) the name of the chemical product and component; (b) pictograms or symbols depicting the danger as stipulated in Schedule II; (c) signal word ‘danger’ or ‘warning’ (d) hazard statements associated with the use of the chemicals as stipulated in

Schedule II; and (e) precautionary statements as stipulated in Schedule III; (f) name, address and telephone number of the principal supplier; 13. The hazard pictograms signal word and hazard statements should be located together on the label. 14. Indications such as "non-toxic", "non-harmful" or any other similar indications must not appear on the label or packaging of chemicals even though the chemical has been classified into hazard categories other than toxic or harmful, or has not been classified into any of the hazard category. 3.2 Precedence Principles 15. The precedence of symbols for physical hazards should follow the rules of the UN Model Regulations on the Transportation of Dangerous Goods. (Delete) 16. For health hazards the following principles of precedence applies:

a) if the skull and crossbones applies, the exclamation mark should not appear;

b) if the corrosive symbol applies, the exclamation mark should not appear when it is used for skin or eye irritation;


c) if the hazard symbol appears for respiratory sensitization, the exclamation mark should not appear where it is used for skin or eye irritation;

d) if the signal word “danger” applies, the signal word “warning” should not appear;

e) all assigned hazard statements should appear on the label , with the hazard statements corresponding to the “danger” signal word to appear before the hazard statements corresponding to the “warning” signal word.

3.3 Dimension of a Label 17. The area covered by the hazard pictogram, signal word and hazard statements

as required under paragraph 13 should be as stipulated in Schedule IV. 3.4 Affixing of label 18. The label should be firmly affixed to one or more surfaces of the packaging

so that the label can be read horizontally when the package is set down normally.

19. Where labelling on the container surface is not possible due to its size or unevenness, the containers should be tagged. 3.5 Review of labels 20. Labels should be reviewed every 5 years or earlier if there are ‘new and significant’ information about a chemical hazard. New and significant information is any information that changes the classification of the substance or mixture and leads to a resulting change in the information provided on the label or any information concerning the chemical and appropriate measures that may affect the safety data sheet. Schedule II: CLASSIFICATION AND LABELLING SUMMARY Please refer to Annex 2 of the purple book. Schedule III: PRECAUTIONARY STATEMENTS Please refer to Annex 3 of the purple book.


Schedule IV: LABELLING SIZES Capacity of the package Area occupied by the three label

elements prescribed under paragraph 13.

Not more than 3 litre Greater than 3 litre but not exceeding 10 litres Greater than 10 litres but not exceeding 50 litres Greater than 50 litres but not exceeding 500 litres Greater than 500 litres

To cover at least 50% of total label area At least 52 mm x 74 mm or 3848 square millimetres At least 74 mm x 105 mm or 7770 square millimetres At least 105 mm x 148 mm or 15540 square millimetres At least 148 mm x 210 mm or 31080 square millimetres

Label Example

1. Chemical Name 2. Signal word 3. Pictogram (Symbol) 4. Hazard statement 5. Precautionary statement 6. Supplier Points to pick up

1. Order of 1 to 6 2. Location of 1 to 6 3. Label size 4. Selection of precautionary statement 5. Frame color

Chemical name:…… Cas No:………. Signal word

1

1

1

Hazard statement

• ……….. • ………..

Precautionary statement • ……….. • ………..

Company name: Tel:

1

2

3

4

5

6


Questions

1) Are the labeling precedence principles acceptable?

All precedence principles are acceptable except no 15 because of not

consistent with GHS.

2) Are the labeling sizes required to be stipulated? If yes, any comments or

suggestions?

Leave decision to the UN expert sub committee.

3) What are the specific technical materials to be developed to support the

guidelines?

Technical Guidance must be informed for the whole GHS. Apart from

the code of practice in specific issue eg. the terminology, the sample of

GHS labelling, the quality of SDS etc.

4) Can the Small Medium Industries (SMEs) implement this guidelines?

Use the strengh of association to devolop or sharing the resources.

5) How to implement guidelines in ASEAN Region?, (Road shows, training and

timing)

Sharing the resources as well as allocate some or manpower budget

information system because the major point is to communicate hazard

with understanding label to the users.

6) Other points for improving draft?

Put some appropiate sample label to the draft by comparing the old and

new GHS label should be. Conclusion We must emphasize that standard of GHS should be one and harmonize all standards across the continents even though they have their own standards. This leads to add -on value in practical GHS standard in the real world.


Appendix 18 GROUP 3 : Assignment on Safety Data Sheet

1. Stock taking in Asean countries remarks Existing: detailed CPL guidelines compared to Asean guidelines Malaysia Exisiting: Pesticides law but no guidelines Myanmar Checklist Cambodia Regulations on chem. used in factory consists 1,500 chem Factory to submit SDS to gov

Thailand

Drafting standard according to GHS Singapore 2. Definitions Definitions in GHS need not be redefined Article requires refinement See Australian standard Flash point to follow GHS Change purple book to GHS current revision – as a reference doc for this guidelines

Definition of suppliers too broad and not consistant to scope….?

3. SDS Refer to GHS Annex 4 for SDS and table 152

Meanings: shall = mandatory Maybe = optional

Optional for countries to define: Imported SDS may be translated to national language for countries

Option for countries to define: Review of Safety Data Sheet Safety data sheet should be reviewed every 5 years or earlier if there are ‘new and significant’ information about a chemical hazard. New and significant information is any information that changes the classification of the substance or mixture and leads to a resulting change in the information provided on the label or any information concerning the chemical and appropriate measures that may affect the safety data sheet.

Refer to CBI to refer to GHS section1.4.8

Option for countries to define: The following proportion ranges maybe indicated as: > 60 %; (30% -60%); (10 % - 30%); < 10%

Option for countries to define Criteria for CBI full ingredient and full name disclosure refer to EEC council directive 67/548/EEC on generic names.


Criteria for full disclosure: cat 1 health hazards or country PEL?? to discuss… Chapter 6: Hazards Communication. Optional for countries to define: The information to be used on labels and safety datasheets maybe written in the respective national language.

Optional for countries to define: The translation of the label elements and safety data sheets maybe done by competent (as defined by competent authority) translators.

Classification of Confidential Business Information (CBI) chemicals: formulator may use the highest range for formulation.

ASEAN-OSHNET/UNITAR-ILO Workshop 2006 82


DEFINITIONS “aerosols” means any non-refillable receptacles made of metal, glass or plastics and containing a gas compressed, liquefied or dissolved under pressure, with or without a liquid, paste or powder, and fitted with a release device allowing the contents to be ejected as solid or liquid particles in suspension in a gas, as a foam, paste or powder or in a liquid state or in a gaseous state. Aerosol includes aerosol dispensers; “alloy” means a metallic material, homogenous on a macroscopic scale, consisting of two or more elements so combined that they cannot be readily separated by mechanical means. Alloys are considered to be mixtures for the purpose of classification under this guideline; “article” means a particular item or separate thing such as a lead acid battery, a dry cell battery or a cigarette lighter, that are not normally considered as a chemical substance per se; "boiling point" means the temperature of a liquid at which the vapour pressure ( i.e the pressure characteristic at any given temperature in oC of a vapour in equilibrium with its liquid form) is equal to or slightly greater than ambient atmospheric pressure;

"carcinogen" means a chemical substance or a mixture of chemical substances which induce cancer or increase its incidence; “chemical identity” means a name that will uniquely identify a chemical. This can be a name that is in accordance with the nomenclature systems of the International Union of Pure and Applied Chemistry (IUPAC) or the Chemical Abstracts Service (CAS), or a technical name; "exothermic reaction" means a chemical reaction which resulted in the production of heat energy; "flash point", in relation to extremely flammable, highly flammable and flammable chemicals, means the lowest temperature in degrees Celsius at which the liquid will produce enough vapour to ignite; "foodstuff" means food or drink intended for consumption; “hazard category” means the division of criteria within each hazard class, e.g. oral acute toxicity includes five hazard categories and flammable liquids includes four hazard categories. These categories compare hazard severity within a hazard class and should not be taken as a comparison of hazard categories more generally;


“hazard class” means the nature of the physical, health or environmental hazard, e.g. flammable solid, carcinogen, oral acute toxicity; "LC50" means the concentration of a chemical in air or of a chemical in water which causes death of 50% of a group of test animals;

"LD50" means the amount of a chemical, given all at once, which causes death of 50% of a group of test animals; “mixture” means mixtures or solutions composed of two or more substances in which they do not react; "mutagen" means an agent giving rise to an increased occurrence of mutations in population of cells and/or organisms; “mutation” means a permanent change in the amount or structure of the genetic material in a cell; “precautionary statement” means a phrase (and/or pictogram) that describes recommended measures that should be taken to minimize or prevent adverse effects resulting from exposure to a hazardous product, or improper storage or handling of a hazardous product; “product identifier” means the name or number used for a hazardous product on a label or in the safety data sheet. It provides a unique means by which the product user can identify the substance or mixture within the particular use setting e.g. transport, consumer or workplace; “purple book” means the First Revised Edition of the Globally Harmonized System of Classification and Labelling (GHS) documentation published in 2005 by the United Nations; “signal word” means a word used to indicate the relative level of severity of hazard and alert the reader to a potential hazard on the label. ‘Danger’ and ‘Warning’ are used as signal words with ‘danger’ being of higher severity than ‘warning’. “substance” means chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the product and any impurities deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition; "supplier" means a person who supplies chemicals and include a formulator, a manufacturer, an importer, a retailer or a distributor;


CHAPTER 1: INTRODUCTION 1.1 Scope 1. This guideline is applicable to all persons who formulate, manufacture, import, retail, supply, and distribute hazardous chemicals for use at work. 1.2 Coverage 2. Chemicals covered by this guideline are industrial chemicals and pesticides. Chemicals refer to pure chemical substances, their dilute solutions or to mixtures of chemical substances. 1.3 Exclusions 3. Pharmaceutical products, consumer products, food additives, cosmetics, and pesticide residues in food are not covered for intentional intake. 4. Articles are outside the scope of this guideline.


CHAPTER 2: CLASSIFICATION 2.1 Duty to classify 5. It is the duty of any persons who supplies chemicals for use at work to classify them according to the specific hazard class as laid down in Schedule I. 2.2 Classification process 6. Hazard classification incorporates 3 steps, i.e.:

a) Identification of relevant data regarding the hazards of a substance or mixture; b) subsequent review of those data to ascertain the hazards associated with the

substance or mixture; and c) a decision on whether the substance or mixture will be classified as a hazardous

substance or mixture and the degree of hazard, where appropriate, by comparison of the data with agreed hazard classification criteria.

7. The recommended process of classification of mixtures is based on the following sequence:

a) where test data are available for the complete mixture, the classification of the mixture will always be based on that data;

b) where test data are not available for the mixture itself, then bridging principles

included and explained in each specific chapter of the purple book should be considered to see whether they permit classification of the mixture;

In addition, for the health and environmental classes,

c) If (i) test data are not available for the mixture itself, and (ii) the available information is not sufficient to allow application of the above mentioned bridging principles, then the agreed method(s) described in each chapter of the purple book for estimating the hazards based on information known will be applied to classify the mixture.

2.3 Use of available data 8. Test data already generated for the classification of chemicals under previous systems should be accepted when classifying these chemicals under this system. 2.4 Use of cut-off/concentration limits 9. Normally, the generic cut-off values/concentration limits adopted in the GHS should be applied uniformly in all jurisdictions and for all sectors. However, if the supplier has information that the hazard of an ingredient will be evident below the generic cut-off values/concentration limits, the mixture containing that ingredient should be classified accordingly.


2.5 Classification summary 10. Summary of classification criteria and hazard communication elements can be found in Schedule II. For details on the classification criteria please refer to the references given under the Criteria column. 2.6 Competent Classifier 11. The classification of products should be done by a competent classifier.


CHAPTER 3: LABELLING

3.1 Information on a Label 12. A supplier should ensure that every packaging is labelled clearly and indelibly with the following information - (a) the name of the chemical product and component;

(b) pictograms or symbols depicting the danger as stipulated in Schedule II;

(c) signal word ‘danger’ or ‘warning’ (d) hazard statements associated with the use of the chemicals as stipulated in Schedule

II; and (e) precautionary statements as stipulated in Schedule III; (f) name, address and telephone number of the principal supplier; 13. The hazard pictograms signal word and hazard statements should be located together on the label. 14. Indications such as "non-toxic", "non-harmful" or any other similar indications must not appear on the label or packaging of chemicals even though the chemical has been classified into hazard categories other than toxic or harmful, or has not been classified into any of the hazard category.

3.2 Precedence Principles 15. The precedence of symbols for physical hazards should follow the rules of the UN Model Regulations on the Transportation of Dangerous Goods. 16. For health hazards the following principles of precedence applies:

a) if the skull and crossbones applies, the exclamation mark should not appear; b) if the corrosive symbol applies, the exclamation mark should not appear when

it is used for skin or eye irritation; c) if the hazard symbol appears for respiratory sensitization, the exclamation

mark should not appear where it is used for skin or eye irritation; d) if the signal word “danger” applies, the signal word “warning” should not

appear; e) all assigned hazard statements should appear on the label , with the hazard

statements corresponding to the “danger” signal word to appear before the hazard statements corresponding to the “warning” signal word.

3.3 Dimension of a Label 17. The area covered by the hazard pictogram, signal word and hazard statements as

required under paragraph 13 should be as stipulated in Schedule IV. 3.4 Affixing of label 18. The label should be firmly affixed to one or more surfaces of the packaging so that the label can be read horizontally when the package is set down normally.


19. Where labelling on the container surface is not possible due to its size or unevenness, the containers should be tagged.

3.5 Review of labels

20. Labels should be reviewed every 5 years or earlier if there are ‘new and significant’ information about a chemical hazard. New and significant information is any information that changes the classification of the substance or mixture and leads to a resulting change in the information provided on the label or any information concerning the chemical and appropriate measures that may affect the safety data sheet.


CHAPTER 4: SAFETY DATA SHEET 4.1 Duty to Furnish Safety Data Sheet

21. A supplier should furnish the current Safety Data Sheet for each hazardous chemical supplied to any person for use at work based on the generic cut-off values/concentration limits indicated in Table I:

Table I:

Cut-off values/concentration limits for health & environmental hazard class.

Hazard Class Cut-off Value/

Concentration Limit

Acute Toxicity ≥ 1.0%

Skin Corrosion/Irritation ≥ 1.0%

Serious Damage to Eyes/Eye Irritation ≥ 1.0%

Respiratory/Skin Sensitization ≥ 1.0%

Mutagenicity: Category 1 ≥ 0.1%

Mutagenicity: Category 2 ≥ 1.0%

Carcinogenicity ≥ 0.1%

Reproductive Toxicity ≥ 0.1%

Target Organ Systemic Toxicity (Single

Exposure)

≥ 1.0%

Target Organ Systemic Toxicity (Repeated

Exposure)

≥ 1.0%

Hazardous to the Aquatic Environment ≥ 1.0%

4.2 Review of Safety Data Sheet

22. Safety data sheet should be reviewed every 5 years or earlier if there are ‘new and significant’ information about a chemical hazard. New and significant information is any information that changes the classification of the substance or mixture and leads to a resulting change in the information provided on the label or any information concerning the chemical and appropriate measures that may affect the safety data sheet.


4.3 Format of SDS 23. The Safety Data Sheet should contain the following information in the following order:– Section 1: Identification of the chemical and of the supplier Section 2: Hazards identification Section 3: Composition/information on ingredients Section 4: First aid measures Section 5: Fire fighting measures Section 6: Accidental release measures Section 7: Handling and storage Section 8: Exposure controls/personal protection Section 9: Physical and chemical properties Section 10: Stability and reactivity Section 11: Toxicological information Section 12: Ecological information Section 13: Disposal considerations Section 14: Transport information Section 15: Regulatory information Section 16: Other information 4.4 Content of SDS 24. Section 1 should contain the following information: Product Details i. Product Identifier

The product identifier used should be the same as used in the label. Where a substance or a mixture is covered by the UN Model Regulations on the Transport of Dangerous Goods, the UN proper shipping name should also be used on the package.

ii.Other means of identification

This includes the trade name, the chemical name, and/or the chemical formula. For substances, the chemical family could also be stated. The manufacturer’s code could also be included.

iii.Recommended Use

This sub-section should state the common uses of the product and it should be given in descending order of importance. The method of application should also be included. For example, ‘Use: A spray on paint stripper’. Restrictions on use should also be stated.


Supplier’s Identification i. Supplier’s Name: This subsection should state

a) the names of overseas or local manufacturers and b) the names of local supplier (formulator or importer or distributor).

ii. Supplier’s Telephone Number:

This subsection should state the supplier (local supplier) company’s telephone number, including the area code, where advice on the hazardous chemical can be obtained. The information given should not be a general switchboard number, but should direct a caller to someone who can clarify information or provide further information and/or a bibliography. The titles of a position or department should be inserted. This contact point refers to the local supplier company.

iii. Emergency phone number:

State the emergency telephone number where advice on an emergency could be given 24 hours.

25. Section 2 on hazard identification is important for emergency overview purpose. The supplier should state the classification of the substance or mixture. The label elements, including precautionary statement should be stated. Hazard symbols may be provided as a graphical reproduction of the symbols in black and white or the name of the symbol e.g. flame, skull and crossbones. Other hazards which do not result in classification (e.g. dust explosion) or are not covered by the GHS could be stated as well. 26. Section 3 on the composition information on ingredient should describe the actual composition of the hazardous chemical. It should be completed both for pure entities and for mixtures. The information should allow users to identify clearly the risks associated with a particular chemical so that they may conduct a risk assessment. Ingredient details should be listed in a column format under the following headings, i.e: chemical identity; common name, synonyms, etc.; and the CAS number. The description of information required under section 3 should be as follows:- i . Chemical identity

The substance or each ingredient present in a mixture, including impurities and stabilizing additives that are themselves classified and which contribute to the classification of the substance itself, should be listed by its chemical name according to the IUPAC naming system. For mixtures, the proportion of all ingredients that are present above their cut-off levels should be stated. Ingredients should be listed with the ingredient representing the highest proportion first and so on in descending order. Solvents (including water) should be listed last. It is not possible to set a lower limit of chemicals included in this list as an entity at 0.01 % may be more than 10 times more toxic than one at 0.1%. (Please note that only the composition of the hazardous ingredient(s), need to be stated)


ii. Common name, synonym The common name for the substance or mixture should be given as well as synonyms.

iii. CAS No.

The substance or in the case of mixture, each ingredient should be listed with its Chemical Abstract Service (CAS) Number.

27. Section 4 on first aid measures should describe the necessary measures according to the different routes of exposure, i.e. inhalation, skin and eye contact and ingestion. This section should also describe the most important symptoms or effects whether acute or delayed. Immediate medical attention and special treatment needed, if necessary, should also be indicated. Examples of suitable instructions are (if appropriate for the chemical):

• Give water or milk to drink and induce vomiting; • Irrigate with very generous quantities of water for 15 minutes; • Urgently seek medical assistance; • Seek medical advice. Show this CSDS to a medical practitioner; or • Transport to a hospital or medical centre.

Advice to Doctor: Specific antidotes should be indicated where they are available. Where no specific antidote is available, the doctor should be advised to contact a poison information centre. This should also, if possible, indicate whether delayed effects can be expected after exposure. 28. Section 5 on fire-fighting measures should indicate the suitable (and unsuitable) extinguishing media. Specific hazards arising from the chemical should be indicated (Fire hazards in presence of various chemical, explosion hazards in presence of various chemical & any dangerous decomposition products). This section should specify the special protective equipment and precautions for fire-fighters. 29. Section 6 on accidental release measures is to provide information on the actions to be taken in the event of an accidental release (including leaks and spills) of a chemical. This section should address personal precautions, protective equipment and emergency procedures in the event of accidental release of chemicals into the environment. Indicate also the methods and materials for containment and cleaning of spills or leakages. This section should also include environmental precautions to prevent or minimise environmental pollution.


30. Section 7 on handling and storage to describe the precautions for safe handling and the conditions for safe storage, including any incompatibilities. This section should include all data required for the safe handling and storage requirements of the chemical, including, where appropriate:

• Location/siting of store; • Fire separation distances; • Ventilation; • Temperature conditions; • Protection from weather, sun light, etc; • Type of container; • Types of products near which the material should not be stored; • Type of flooring; • Bunding; • Security; • Emergency facilities, e.g. showers, eye washes.

31. Section 8 on exposure controls/personal protection should focus on the exposure limit relevant to the product or any or all of its ingredients and the requirements for engineering measures and/or protective equipment. Control parameters such as the occupational exposure limit values or the biological limit values should be included where applicable. Emphasis in the safety data sheet should be on engineering methods of minimising and controlling exposure rather than on the need for protective equipment. This section should recommend appropriate engineering measures and indicate whether special ventilation requirements are necessary and specify which type to be used, e.g. use in a well-ventilated area, ensure ventilation is adequate to maintain air concentrations below the occupational exposure limits, local exhaust ventilation required etc. Information on personal protection should be specific both about when protection is required and the type required. This information may not be relevant for emergency services. The specific types of respirators etc. should be defined e.g. ‘approved face mask’ will not be sufficient information whereas ‘approved half-face cartridge respirator suitable for organic vapours’ could be sufficient. Special requirements may exist for gloves or other protective clothing to prevent skin exposure, so that specifics of material are needed; that is ‘impervious gloves’ is not sufficient whereas ‘PVC gloves’ or ‘nitrile gloves’ could be used. Similarly, eye protection if required should be described as ‘general use industrial safety glasses’ or other specific requirements. 32. Data provided under section 9 on physical and chemical properties should apply to the product. If the product is a mixture, the data should describe the mixture. The information is useful for estimating exposure potential; handling leaks and spills; designing ventilation system; and aiding in design, development and checking of safety controls and procedures. The data provide should include, where appropriate, the following:


i. Appearance : should be described in terms of colour and form (e.g. brown liquid, grey powder)

ii. Odour : should be mentioned whether the odour of the product is detectable or no. Include its odour threshold where applicable.

iii. pH : give the pH of the product iv. Melting /freezing point : melting or freezing point at 760 mm Hg to be

indicated in degrees Celsius (°C) v. Boiling point : initial boiling point and boiling range at 760 mm

Hg should be indicated in degrees Celsius (°C) vi. Flash Point : flash point should be expressed in °C. It should

indicate the method that the data is established, either by closed or open cup methods.

vii. Evaporation Rate : should state the reference liquid the ratio refers to. viii.Flammability : whether the solid and gas are flammable,

combustible or inert. The upper/lower flammability/ explosive limits should be expressed where applicable.

ix. Vapour Pressure : vapour pressure should be expressed in mm Hg at 25 °C

x. Vapour Density : the density of the vapour compared to the density of air

xi. Specific Gravity : the density of the product compared to water with density of water being equal to one g/cm3

xii. Solubility : when describing solids or powders, solubility in water in grams per litre or parts per million parts of water may be included

xiii.Partition coefficient : log n-octanol/water partition coefficient (log Kow) xiv.Autoignition Temperature : the minimum temperature required to start or

cause self sustained combustion in any substance. xv. Decomposition temperature: in °C xvi.Other Information : other information such as volatility, penetration,

percent volatiles, viscosity @ 40 0C could be inserted

33. Section 10 on stability and reactivity should provide information on chemical stability. This section should also state the possibility of hazardous reactions under certain conditions and indicate incompatible materials or conditions to be avoided such as static discharge, shock or vibration. Examples: ‘Avoid physical conditions e.g. temperature, pressure, light, shock, and contact with moisture or air’ or ‘Avoid proximity to other chemicals e.g. acids, bases, oxidising agents or any other specific substance that may cause a dangerous reaction’. Where hazardous decomposition products are given off, these should be specified along with the necessary precautions.


34. Section 11 should provide toxicological information on the substance or mixture. Concise but complete and comprehensible description of the various toxicological (health) effects and the available data used to identify those effects should be given. These include

a) information on the likely routes of exposure (inhalation, ingestion, skin and eye contact);

b) symptoms related to the physical, chemical and toxicological characteristics; c) delayed and immediate effects and also chronic effects from short- and long-term

exposure; and d) numerical measures of toxicity (such as acute toxicity estimates).

Reference should be made for overexposure effects both acute and chronic. Reference should also be made to health hazards as a result of possible reaction with other chemicals including any known interactions, for example, resulting from the use of medication, tobacco and alcohol. 35. Section 12 should provide ecological information that includes ecotoxicity (aquatic and terrestrial, where available); persistence and degradability; bioaccumulative potential; and mobility in soil. Other adverse effects should also be included, e.g. effects on water treatment works. 36. Section 13 on disposal considerations should describe the waste residues and information on their safe handling and methods of disposal, including the disposal of any contaminated packaging. This section should contain specific recommendation on: • Disposal containers; • Disposal method; • The need to check local statutory requirements; • Special precautions for incineration or landfill. Recommendations on disposal methods are considered essential. Disposal into sewerage systems should be discouraged. Recommendation for small- and large- scale disposals should be distinguished from each other. 37. Section 14 should provide transport information that includes the UN number; UN proper shipping name; transport hazard class(es); and packing group (if applicable). This section should indicate whether the chemical is a marine pollutant or not. Special precautions which a user needs to be aware of or needs to comply with in connection with transport or conveyance either within or outside their premises should be mentioned, e.g. ‘precautions on hazard such as shock sensitivity’.


38. Section 15 should provide information on safety, health and environmental regulations specific for the product in question. 39. Section 16 to provide any information not specified in other sections which the manufacturer could provide. Information on preparation and revision of the SDS should be included in this section. References could also be listed in this section.


CHAPTER 5: CONFIDENTIAL BUSINESS INFORMATION 40. Where the name of the chemical constitute confidential information, the name of the chemical may be omitted from the label or SDS but the actual chemical name must be disclosed upon written request to a medical practitioner or to any person who uses or handles the chemical provided that the information is to be used only for the protection of the safety and health of employees. The name of the chemical may be omitted and replaced by its generic name if the chemical is either

a. Classified as harmful or irritant; or b. Below the relevant concentration limit/cut-off level. (refer Table I)

41. If the exact amount of ingredient in the formulation cannot be specified, then the proportion ranges of each ingredient contained in the product should be indicated so as to provide as much information as possible about the potential hazards of a formulation. The following proportion ranges should be indicated as: Very High > 60 %; High (30% -60%); Medium (10 % - 30%); Low < 10%

42. The following three examples below show how ingredients should be presented taking into consideration the concern on confidentiality of information. Example 1: Full disclosure of ingredients and composition of mixture. xylene [1330-20-7] 67 % trichloroethylene [79-01-6] 23% ethanol [64-17-5] 8% benzene [71-43-2] 0.9 % other impurities

Example 2: If the exact composition of the mixture is confidential. xylene [1330-20-7] very high trichloroethylene [79-01-6] medium ethanol [64-17-5] low benzene [71-43-2] low other impurities

Example 3 : If the identity of trichloroethylene is commercially confidential. xylene [1330-20-7] 67% chlorinated alkyl hydrocarbon 23% ethanol [64-17-5] 8% benzene [71-43-2] 0.9% other impurities


CHAPTER 6: HAZARD COMMUNICATION 43. The information to be used on labels and safety datasheets should be written in the respective National Language and English. 44. The translation of the label elements and safety data sheets should be done by competent translators with relevant technical background. 45. Workers should be trained to read and understand labels, safety data sheets and any other specific communication systems used in a workplace.


Schedule 1: HAZARD CLASSES AND HAZARD CATEGORIES

HAZARD TYPES HAZARD CLASSES HAZARD CATEGORIES 1. Explosives Division 1.1 to 1.6 2. Flammable gases Categories 1 and 2 3. Flammable aerosols Categories 1 and 2 4. Oxidizing gases Category 1 5. Gases under pressure Compressed gas; liquefied gas;

refrigerated liquefied gas; dissolved gas

6. Flammable liquids Categories 1 to 3 7. Flammable solids Categories 1 and 2 8. Self-reactive substances Types A to F 9. Pyrophoric liquids Category 1 10. Pyrophoric solids Category 1 11. Self-heating substances Categories 1 and 2 12. Substances, which on contact with water, emit flammable gases

Categories 1 to 3

13. Oxidizing liquids Categories 1 to 3 14. Oxidizing solids Categories 1 to 3 15. Organic peroxides Types A to F

PHYSICAL HAZARD

16. Corrosive to metals Category 1 17. Acute toxicity (oral, dermal and inhalation)

Categories 1 to 4

18. Skin corrosion/irritation Categories 1A, 1B, 1C and 2 19. Serious eye damage/ eye irritation

Categories 1 and 2A

20. Respiratory sensitizer Category 1 21. Skin sensitizer Category 1 22. Mutagenicity Categories 1A, 1B and 2 23. Carcinogenicity Categories 1A, 1B and 2 24. Toxic to reproduction Categories 1A, 1B and 2 25. Target organ systemic toxicity following single exposure

Categories 1 and 2

26. Target organ systemic toxicity following repeat exposure

Categories 1 and 2

HEALTH HAZARD

27. Aspiration hazard Categories 1 and 2 28. Acute hazards to the aquatic environment

Category 1 ENVIRONMENTAL HAZARD 29. Chronic hazards to the aquatic

environment Categories 1 and 2


Schedule II: CLASSIFICATION AND LABELLING SUMMARY Please refer to Annex 2 of the purple book. Schedule III: PRECAUTIONARY STATEMENTS Please refer to Annex 3 of the purple book. Schedule IV: LABELLING SIZES Capacity of the package Area occupied by the three label elements

prescribed under paragraph 13.

Not more than 3 litre

Greater than 3 litre but not exceeding 10 litres

Greater than 10 litres but not exceeding 50 litres

Greater than 50 litres but not exceeding 500 litres

Greater than 500 litres

To cover at least 50% of total label area

At least 52 mm x 74 mm or 3848 square millimetres




Asean Oshnet Report Final

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Transcript of Asean Oshnet Report Final