JCHAS-D-15-00017

Elsevier Editorial System(tm) for Journal of Chemical Health and Safety Manuscript Draft Manuscript Number: JCHAS-D-15-00017 Title: Development and Implementation of Globally Harmonized System (GHS) on Center for Chemical and Packaging, Indonesia Article Type: Feature article Keywords: Globally Harmonized System; Center for Chemical and Packaging; pictogram hazards Corresponding Author: Ms. Eva Oktarina, Corresponding Author's Institution: First Author: Eva Oktarina Order of Authors: Eva Oktarina; Fatma Lestari, Prof; Irma R Lamria, M.Si; Devie F Octaviani, M.Si Abstract: Implementation of GHS as chemical hazards regulation on chemical industry in Indonesia were started to apply since April 12th, 2013 based on No.23/M-IND/PER/4/2013. Center for Chemical and Packaging (CCP) as one of research center under Ministry of Industry Indonesia conduct GHS as hazards communications beneficial on risk judgment for users and environment, help on storage and handling, and facilitate on transportation. Implementation GHS on CCP were pictogram hazards on laboratories and storage chemicals, alert hazard on chemicals management application, and standard operational procedure that obligate safety data sheet from distributor to user.

Journal of Chemical Health & Safety Editor

My name is Eva Oktarina, a researcher from Center for Chemical and Packaging (CCP),

Ministry of Industry, Indonesia. I represent Mrs. Irma R. Lamria, M.Si (CCP, Ministry of Industry),

Prof. Fatma Lestari, PhD (Occupational Health & Safety Department, University of Indonesia),

and Mrs. Devie F. Octaviani.

Center for Chemical and Packaging (CCP) as one of research center under Ministry Of

Indonesia (MOI) that have task force and function as center for chemical cooperate with CRDF

(Civilian Research and Development Foundation). CRDF has Chemical Security Engagement

Programs (CSP), that giving Chemical Security Improvement Grants (CSIG) to CCP in

December 2013 with MoU number CSP-8649-13.

CCP also cooperate with OHS University of Indonesia, that represent by Prof. Fatma Lestari,

PhD and Devie F. Octaviani, M.Si in supervising the safety and security at the CCP's laboratory.

This feature article describe case studies of development and implementation of GHS on CCP,

as the result of CSIG.

Contac authors for this article: Eva Oktarina Staff of Chemical Research Facility Center of Chemical and Packaging Jl. Balai Kimia No.1 Pekayon Pasar Rebo, Jakarta 13069 PO BOX 6916 JATPK Telp : +62218717438 Fax : +62218714928 Ministry of Indonesia [email protected] +6285280666238

Cover Letter

Abstract

Implementation of GHS as chemical hazards regulation on chemical industry in Indonesia were

started to apply since April 12th, 2013 based on No.23/M-IND/PER/4/2013. Center for Chemical

and Packaging as one of research center under Ministry of Industry Indonesia conduct GHS as

hazards communications beneficial on risk judgment for users and environment, help on storage

and handling, and facilitate on transportation. Implementation GHS on CCP were pictogram

hazards on laboratories and storage chemicals, alert hazard on chemicals management

application, and standard operational procedure that obligate safety data sheet from distributor

to user.

Key words: Globally Harmonized System; Center for Chemical and Packaging; pictogram

hazards

Abstract

Introduction

The United Nations Institute for training and Research (UNITAR) deliver innovative

training and conducts research across multiple thematic areas including multilateralism,

economic development and social inclusion, environmental sustainability and green

development, sustainable peace, resilience and humanitarian assistance. UNITAR programs are

including: 1) Chemicals and Waste Management Programme (CWM), 2) Climate Change

Programme, 3) Decentralized Cooperation Programme, 3) Decentralized Cooperation

Programme, 4) Environmental governance Programme, 5) Knowledge Systems innovation, 6)

Multilateral Diplomacy Programme, 7) Peacekeeping Training Programme, 8) Peacemaking and

Conflict Prevention Programme, 9) Public Finance and Trade Programme, and 10)

UNOSAT-UNITAR Operational Satellite Applications Programme1).

UNITAR's Chemicals and Waste Management Programme (CMW) provides support to

governments and stakeholders to strengthen their institutional, technical and legal infrastructure

and capacities for sound chemicals management. To support the implementation of those

programme activities, UNITAR build internationals agreement such as Strategic Approach to

International Chemicals Management (SAICM), the Stockholm-Rotterdam Conventions, and the

Globally Harmonized System of Classification and Labeling of Chemicals (GHS). Those

agreements are aimed at protecting human health and the environment while ensuring

sustainable industrial development.

SAICM is a policy framework to promote chemical safety around the world. SAICM has

as its overall objective the achievement of the sound management of chemicals throughout their

life cycle so that, by 2020, chemicals are produced and used in ways that minimize significant

adverse impacts on human health and the environment 2). SAICM has inter alia with GHS, to

support its aim, implementation of internationally agreed system for classification and

communication of hazards posed by chemicals must be conducted.

*ManuscriptClick here to view linked References

Globally Harmonized System of Classification and Labeling of Chemicals

There are various chemical hazards regulations in this world regards on the country

which has regulatory section to overcome with it. United States reclaim Occupational Safety and

Health Administration that released by Hazard Communication Standards, and Environmental

Protecting Agency that released by Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),

and etc. Each chemical regulation has its own system, with classification criteria, the use of

symbol, signal words and hazards statement like listed on Table 1. The differences often in the

range for specific classification, like variety of definitions of flammability and acute toxicity. Those

differences can be a potential miscommunication, when a chemical is classified as flammable or

toxic in one country but not by another 3). It can be obstacle in chemical industry, chemicals trade,

and can make accident in workplace. Until in 1992, UNCED (United Nations Economics

Commission for Europe) stipulate GHS as Globally Harmonized System for chemical

classifications and communications 4,5). GHS was build to protect human health and the

environment by establishing a single global system to classify chemical hazards, to provide

standard hazard labeling, and to provide uniform Safety Data Sheets. Harmonization would

improve the information base on chemicals and minimize country efforts to maintain an

infrastructure that would manage a national system. The GHS tracks includes hazard

classification criteria for health, environmental and physical hazards 6); classification criteria for

mixtures; and requirements for hazard information and protective measures on labels for

containers of hazardous chemicals, and on substance data sheets for such chemicals,

particularly in the workplace sector. The potential benefits of GHS as a system were appealing to

many countries, as well to stakeholders: 1) Enhance protection of humans and the environment;

2) facilitate international trade in chemicals; 3) reduce need for animal testing and evaluation;

and 4) assist countries and international organizations to ensure the sound management of

chemicals 7).

Table 1. The differences of acute oral toxicity LD50 (mg/kg) between various regulation on some countries

Acute oral toxicity LD50 (mg/kg)

Organization/Country/ Regulation or Standard

High Hazard Low

0 ............ < 50 ............ < 500 ............ < 5000 ............

ANSI/US/A 129.1 < 50 Highly Toxic

> 50 < 500 Toxic

> 500 < 2000 Harmful

OSHA/US/HCS < 50 Highly Toxic

> 50 < 500 Toxic

EPA/US/FIFRA 0 50 Toxicity Category I

> 50 500 Toxicity Category II

> 500 < 5000 Toxic Category III

> 5000 Toxicity Category IV

CPSC/US/FHSA < 50 Highly Toxic

> 50 500 Toxic

GHS 5 > 5 50 > 50 300 > 300 2000 > 2000 5000

DOT/US < 5 Packing Group I

> 5 < 50 Packing Group II

> 50 < 200 (solid) > 50 > 500 (liquid) Packing Group III

NFPA/US 5 Hazard Category 4

> 5 50 Hazard Category 3



> 2000 Hazard Category 0

NPCA/US/HMIS 1 Toxicity Rating 4

> 1 50 Toxicity Rating 3



> 5000 Toxicity Rating 0

EU < 25 Very Toxic

> 25 > 200 Toxic

> 200 < 2000 Harmful

WHMIS/Canada

50 Very Toxic

WHMIS Class D, Division 1, Subdivision A

> 50 500 Toxic

WHMIS Class D, Division 1, Subdivision B

Australia/NOHSC < 25 Very Toxic

> 25 < 200 Toxic

> 200 < 2000 Harmful

Mexico 20 < 50 Highly Toxic

> 50 < 500 Moderately Toxic

> 500 < 5000 Mildly Toxic

Malaysia < 25 Very Toxic

200 to 500 Harmful

Japan < 30 Poisonous

300 to 3000 Powerful

Korea < 25 Very Toxic

> 50 < 200 Toxic

> 200 < 2000 Harmful

Source : A Guide to The Globally Harmonized System of Classification and Labeling of Chemicals (GHS) 8)

Development of GHS in Indonesia

To implemented GHS worldwide, The United Nations Institute for Training and Research

(UNITAR) and the ILO have embarked on a pilot project to assist countries to adopt the GHS.

Indonesia has been cooperating with UNITAR (United Nations for Training and Research) to run

project phase I (2005-2007) granted to The National Agency of drug and Food Control, on

training and capacity building for the implementation of the Globally Harmonized System of

classification and Labeling of chemicals. GHS project phase II (2010-2013) granted to Ministry of

Industry (MOI) with scope project training and capacity building for the implementation GHS of

classification and labeling of chemicals. The GHS project consists updating the National GHS

strategy, which are completion and entry into force GHS implementing legislation. As the results

of project, Ministry of Indonesia covered regulation policy for classification and communication of

Chemicals subsists on Ministry of Indonesia No. 87/M-IND/PER/9/2009 that were published on

September 24, 2009 and effective on March 24, 2010. Ministry of Trade covered regulatory on

Ministry of Trade No. 44/M-DAG/PER/9/2009 that was published on 2009.

Directorate General of Agro and Chemical Industry as one of subordinate Ministry Of

Indonesia that errand on policy drafting, policy implementer, provision of technical assistance,

and administrative implementer in the Agro and Chemical Industry also conceived regulations.

Directorate General of Agro and Chemical Industry published Decree No. 21/IAK/PER/4/2010

concerning "GHS Implementation for Classification and Labeling of Chemicals".

In 2013, regulation No. 87/M-IND/PER/9/2009 changed by No.23/M-IND/PER/4/2013

based on fifth revision of GHS purple book on April 12th, 2013. Regarding to Minister Industry

regulation No. 23/M-IND/PER/4/2013 the chemicals that must obtain GHS were single chemical

from domestic or import production since April 12th 2013. The regulation will void for mix

chemical from domestic or import production on December 31th 2016. This regulation weren't

applicable for pharmaceutical, food additive, cosmetics and pesticide residue on food. All of this

regulations available on http://kemenperin.go.id/ghs 9).

Ministry of Industry has reported GHS Implementation in Indonesia on Regional GHS

Review Conference for South East Asia Countries on May 22, 2013 in Malaysia. GHS Journey in

Indonesia was describing on the Table 2. below:

Table 2. GHS Implementation in Indonesia

Source : Ministry of Industry of Republic of Indonesia 10)

In 2014, Director General on Manufacture Industry Base as one of subordinate Ministry

Of Indonesia that regulate manufacture released Regulatory by Director General on Manufacture

Industry Base No. 04/BIM/PER/1/2014 explained Technical Guidelines and Supervisions

Implementation of Globally Harmonized System Classification and Labeling on Chemical.

Explained in clausal 1 that GHS system is global system from United Nations for criteria

standardizations and harmonized chemical hazards classification system and also communicate

that information on label and Safety Data Sheet (SDS). Indonesia absorb 100% GHS building

block on fifth edition GHS purple books (Table 3), thus resemble on Director General on

Manufacture Industry Base Regulatory No. 04/BIM/PER/1/2014 enclosure 2. The hazards class

is explained on Table 4.

Table 3. Physical, health, and environment hazards stated on Regulatory by Director General on Manufacture Industry Base No. 04/BIM/PER/1/2014 enclosure 2.

Physical hazards Hazard Class Categori/Division/Type a. Explosive Unstable Div 1.1 Div 1.2 Div 1.3 Div 1.4 Div 1.5 Div 1.6 b. Explosive gas (unstable chemical gas) Cat. 1 Cat. 2 c. Aerosol Cat. 1

(Ignitable Aerosol)

Cat. 2 (Ignitable Aerosol)

d. Gas oxidant Cat. 1 e. Gas under pressure - Pressure gas - liquefied gas - Frozen liquid gas on low temperature - diluted gas

Cat. 1

f. Ignitable liquid Cat. 1 Cat. 2 Cat. 3 g. Ignitable solid Cat. 1 Cat. 2 h. Single and mix chemical that can react itself Type A Type B Type G i. Pyrophoric liquid Cat. 1 j. Pyrophoric Solid Cat. 1 k. Single and mix chemical that can ignite heat Cat. 1 Cat. 2 l. Single and mix chemical if contact with water release ignitable gas

Cat. 1 Cat. 2 Cat. 3

m. Oxidant liquid Cat. 1 Cat. 2 Cat. 3 n. Oxidant solid Cat. 1 Cat. 2 Cat. 3 o. Organic peroxidant Type A Type B Type G p. Corrosive on metal Cat. 1 Health hazards Hazard Class Categori/Division/Type a. Acute toxicity - Acute toxicity : Oral - Acute toxicity : Dermal - Acute toxicity : Inhalation

Cat. 1 Cat. 2 Cat. 3 Cat. 4

b. Corrosive/dermal irritation Cat. 1A Cat. 1B Cat. 1C Cat. 2 c. Eyes irritation/eyes damage Cat. 1 Cat. 2A Cat. 2B d. Sensitivity on inhalation system Cat. 1A Cat. 1B e. Sensitivity on dermal Cat. 1A Cat. 1B f. Mutagenic on nutfah cell Cat. 1A Cat. 1B Cat. 2 g. Carcinogenicities Cat. 1A Cat. 1B Cat. 2 h. Toxic to reproduction Cat. 1A Cat. 1B Cat. 2 Addition category

(effect on lactation)

i. Toxic to organ target after single exposure Cat. 1 Cat. 2 Cat. 3 j. Toxic to organ target after repetitive exposure Cat. 1 Cat. 2 k. Aspiration hazard Cat. 1 Environment Hazard Hazard Class Category / Division / Type a. Aquatic hazard or short term Cat. 1 b. Aquatic chronic hazard or long term Cat. 1 Cat. 2 Cat. 3 Cat. 4 c. Hazard for ozone layers Cat. 1

Table 4. Cut-off Value/Concentration Limit for Hazard class Hazard class Cut-off Value/Concentration Limit

Acute toxicity (Category 1-4) 1.0%

Corrosive / dermal irritation 1.0%

Serious eye damage / eyes irritation 1.0%

Aspiration or dermal sensitivity (Category 1A) 0.1% (Aspiration : Solid/gas/liquid & dermal) Aspiration or dermal sensitivity (Category 1B) 1% (Aspiration : Solid/gas/liquid & dermal)

0.2% (Aspiration: Gas) Mutagenesis on nutfah cell (Category 1) 0.1% Mutagenesis on nutfah cell (Category 2) 1% Carcinogenic (Category 1) 0.1% Carcinogenic (Category 2) 1% Toxic to reproduction (Category 1) 0.3% Toxic to reproduction (Category 2) 3% Toxic to reproduction (additional category on lactation)

0.3%

Toxic on specific organ after single exposure (Category 1 - 2)

10%

Toxic on specific organ after single exposure (Category 3)

10%

Toxic on specific organ after repetitive exposure 10% (Category 1 - 2)

Aspiration hazard (Category 1) 10% from composition category 1 and kinetic viscosity 20.5 mm

2/s on 40 C

Aquatic environment hazards 10%

Center for Chemical and Packaging (CCP) as one of research center under Ministry Of

Indonesia (MOI) that have task force and function as center for chemical: intensively interact with

the chemical (chemical as reagent for testing lab, chemical as sample, and chemical for

conducting research), chemical distributor, chemical stakeholder and industry related to

chemical and packaging. For reducing the risk, minimizing miss conception, and assisting the

distribution of chemical, implementation GHS must be applied in CCP.

Implementation of GHS in CCP

Chemical Security Engagement Program (CSP) teams in CCP (Center for Chemical and

Packaging) conduct the Security Hazard and Risk Mapping and associated training, including

GHS introduction, for all analyst, researcher, and regulating authorities. CSP is sponsored by the

U.S. Department of State. CSP works with government, academic, industry and law enforcement

entities in partner countries to: 1) Strengthen the ability to detect and prevent the intentional

misuse of chemical, 2) Promote chemical security culture among chemical scientists and

engineers, 3) Support the implementation of chemical management best practices and increase

physical security of chemicals of concern, and 4) Encourage adoption of, and compliance with,

chemical management standards 11).

CSP also accommodate CCP to build new chemical SOP. CCP conduct GHS

implementation through standard operational procedure (SOP), that valid for all CCP analyst,

researcher, and regulating authorities. The new safety and security chemical handling's SOP

are: Chemicals request SOP, Chemicals procurement SOP; and Chemical Reception and

Storage SOP. On the chemical request SOP, to promote chemical security and prevent the

intentional misuse, CCP made form for chemical request in which the applicants (analysts and

researcher) must fill the GHS labels column (toxic, flammable, corrosive, oxidant, explosive,

carcinogen, and/or skin irritation). So it's very important to all CCP analyst, researcher, and

regulating authorities for understanding GHS.

Standard operational procedure on CCP

Chemical request form with GHS

label from analyst/researcher

Validation from regulator

Procurement division contact the

distributor

Distributor sends the chemicals

include the SDS

The revenue division accept the chemicals include SDS and hand

over it to storage division

Storage division hand over the chemicals include SDS to

analysts/researcher

Storage division stored the chemicals on chemicals storage, classified and stored based on

pictogram hazard labels

Validation from regulator

CPP use chemical labels and Safety Data Sheets (SDS) as the two main tools of

chemical hazard communication regarding general regulations. The requirements for chemicals

labels are 1) product identifier; 2) hazards pictogram; 3) signal words; 4) hazards statement; 5)

precautionary statement; and 6) company identification. Regulatory of Ministry Industry No.

23/M-IND/PER/4/2013 state that labels must be a) easy to reads, b) easy to see, c) proportional

size alphabet and pictogram, d) not easily broken, e) not easily abrading, f) not easy faded by

heat, sun light, water, wind and another disturbance.

Chemical labels were used by CCP analysts on second container for standard dilution.

Analysts make standard dilution from master solution, they use secondary container to keep

standard dilution safe. The second container of standard dilution bottle must be labeling with

informative data, which are product identifier (name, date of making, and concentration), hazards

pictogram, signal words, and analyst identifier. So, other analysts can acknowledge the chemical

based on the chemical labels. The analysts can use and handle chemical (whether it's toxic,

carcinogenic, flammable, poison, or oxidizer), regarding to the labels on the secondary container.

SDS needed to explain for producer-distributor-and buyer (user, analysts and researcher)

concerning hazard information from the chemical product. The requirements for SDS in

Indonesia based on regulation No.23/M-IND/PER/4/2013 are: 1) properties of physical and

chemical, 2) hazards identification; 3) accidental release measure; 4) handling; 5) first-aid

handling; 6) emergency act; and 7) other information.

SDS completeness when distributor gave the chemicals is very important; those were

stated on chemicals SOP. SOP stated that, if in the laboratory the SDS weren't exist (from

previous purchasing or free download from producer website) so the distributor and producer

must complete the SDS.

On chemical warehouse of CCP, CCP team giving hazards pictogram on fume cabinets,

classified them based on pictogram hazards at chemicals label, keep sensitive chemicals on

chillers, using yellow cabinet for indicate flammable chemicals, and blue cabinet for indicate

corrosive chemicals. Classifying definitions of hazardous chemicals and putting them in hazard

classes can be really useful to the users. GHS establishes relative categories that can be a

valuable tool for making judgments about the chemicals classification storage group, the risk of

using a chemical in an operation and the prohibitory taken to annihilate chemicals.

Figure 1. Yellow cabinet for flammable chemicals and blue cabinet for corrosive chemicals

GHS alert also implemented on chemical management for storage as Chemical Inventory

Management System (CIMS) application. The application made SDS base inventory in (C:)

system and "look up" those file name on excel sheet based on its CAS number. The application

translates SDS/CAS number into detectable hazard list for chemicals as hazards alerts on CIMS

column. The printed barcode, regenerate from UN number on SDS, were attached on chemicals

detected by scanner and read in CIMS list. If the chemicals were health hazards or physical

hazards then alerts column will show the hazards class was it on (1-4).

Hazards alerts on CIMS very useful to warn user for handling and storage the chemicals,

it prevents the misuse of chemicals and support the implementation of chemical management

best practices and increase physical security of chemicals of concern.

Figure 2. CIMS showed GHS as alerts for chemical hazards (copyright to Sandia National Laboratory)

Comprehensions and implementation of GHS is important in order to improve safety in

using and handling of chemicals, it must be understood that each chemical has its own potential

hazards. Thus, every chemical must be labeled based on its hazardous properties, and this

hazard information must be adequately communicated to various target such as chemical

transporters, store keepers, distributors, regulating authorities, users (analyst, researcher,

storage officers, cleaning services) and person that come in contact with chemicals12).

Conclusion

The GHS communicate the hazard of chemicals so it's enhancing the protection of human health

and the environment, reducing the risk, clarifying the complexities in chemical classification.

Adoption GHS in Ministry of Industry were stated in regulation No.23/M-IND/PER/4/2013.

Implementation GHS on CCP were include the build of chemical SOP, that obligate safety data

sheet from distributor to users and obligate the applicant (analysts and researcher) to fill the

column hazards on chemical request form; pictogram hazards on laboratories and storage

chemicals; alert hazard on chemicals management application, and alert hazards on chemicals

label.

Acknowledgment

The authors would like to acknowledge the financial support from Chemical Security

Engagement Programs (CSP) with MoU number CSP-8649-13. The authors would like to

express their appreciation to Ministry of Industry Indonesia and Occupational Health & Safety

Department, University of Indonesia for the cooperation in this study.

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JCHAS-D-15-00017