Overview on Chemical Control Legislation in Vietnam ... · Definition of hazardous substances will incorporate GHS classification criteria, leading to more B3 substances. A national

May 2018 | Piyatida (Tung) Pukclai, Ph.D.

Overview on Chemical Control Legislation in

Vietnam, Philippines, and Indonesia

1

Overview on Chemical Control Legislation in some ASEAN Countries

Outline

2

Vietnam

Philippines Indonesia

Overview of Chemical Regulations in Vietnam

3

Law on chemical

(No. 06/2007/QH12)

Circular No. 28/2010/TT-BCT









Decree No.

108/2008/ND-CP

Decree No.

26/2011/ND-CP

Decree No.

76/2014/ND-CP

Decree No.

163/2013/NĐ-CP

Decree No.

38/2014/ND-CP







Decree 113/2017/ND-

CP

Circular No.32/2017/TT-

BCT

Law on Chemicals - November 21, 2007

10 Key contents are:

General provisions

Developing the chemical industry

Chemical production & trading

Classification, labelling, packaging & SDS

Chemical use

Accident prevention & mitigation

Declaration, registration & provision of chemical information

Environmental protection & safety for community

State management responsibility & chemical handling

Implementation provisions

4

VIETNAM: Law on Chemicals (No. 06/2007/QH12)

Decree 113/2017/ND-CP replaces Decree No. 108/2008/ND-CP

Regulates requirements for chemical production and trade, classification of chemicals and procedures

for declaration of chemicals.

Chemical importers may complete the declaration of their imported chemicals via the National Single

Window Portal (NSW).

To-be-declared information includes information of declarants and imported chemicals, sale and

purchase invoices, and chemical safety data sheets in Vietnamese.

Declarants will be held responsible for intentionally declared untruthful information under the current

regulations.

Chemical traders to keep confidential names and quantities of produced, imported or traded chemicals,

information about technological and trade secrets.

Note: Important information that can be used for the protection of community health and the environment will not be

considered confidential, including product trade names, names of producers and importers, information in chemical safety

data sheets, cautions for use and direct contact with chemicals and measures to be taken in response to possible

incidents, etc.

5

VIETNAM: Decree 113/2017/ND-CP (guidelines for implementation of certain articles of the Law on Chemicals)

Key points are as follows:

General requirements for safety in chemical production and trade

Requirements for chemicals subject to conditional manufacture or trade

Requirements for industrial precursor chemicals

Requirements for restricted industrial chemicals

Requirements for banned chemicals and toxic chemicals.

Requirements for chemicals requiring chemical incident prevention and response plans

Safety distance of hazardous chemical factories/stores

Classification of chemicals and safety data sheets

Requirements for chemicals subject to declaration

Training courses in chemical safety

6

Decree 113/2017/ND-CP (guidelines for implementation of certain articles of the Law on Chemicals )

The Decree includes 5 lists of regulated chemicals, each with their own prescribed requirements:

List 1: The list of chemicals subject to conditional production or import

List 2: The list of chemicals restricted from production or trade

List 3: The list of banned chemicals

List 4: The list of hazardous chemicals for which chemical incident prevention and response

plans are required

List 5: The list of chemicals subject to compulsory declarations

7

Decree 113/2017/ND-CP (guidelines for implementation of certain articles of the Law on Chemicals )


(providing guidance on the Chemical Law (2007) and Decree No 113/2017/ND-CP)

Key points are as follows:

Guidance on compiling chemical safety data sheet;

19 forms used by business operators and individuals in the chemical-related field issued in

the Annexes;

Setting out plans and measures to prevent and respond to chemical incidents in the

industrial field;

Classification and labeling of chemicals;

Declaration of imported chemicals.

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VIETNAM: Decree 113/2017/ND-CP & Circular No. 32/2017/TT-BCT

Business advice:

Business operators and individuals shall review the Decree 113/2017/ND-CP and the Circular

No. 32/2017/TT-BCT to determine if permits, licenses, or reports will be required to support

chemical activity in Vietnam.

It is important to review the new requirements for SDSs, labels and the revised classification of

chemicals to ensure that their products comply with the various changes and requirements.

9

VIETNAM: Chemical Inventory and Chemical Database

Only industrial chemicals will be listed in the national chemical inventory list.

The list will be frequently updated and new chemical substances can be submitted.

The official issue of first national chemical inventory is expected to be published within 2018.

For reference information, it can be referred to http://vcerc.com/lay-y-kien-cho-ban-du-thao-

danh-muc-hoa-chat-quoc-gia/

10

List of regulated

chemicals under the Law List of current chemicals

based on survey results Build up national

chemical inventory

Existing inventory of other

countries List of current chemicals

based on survey results Build up International

chemical inventory

http://vcerc.com/lay-y-kien-cho-ban-du-thao-danh-muc-hoa-chat-quoc-gia/



























VIETNAM: draft of National Chemical Inventory (rev. as of March 15, 2017)

Consist of 4925 substances

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VIETNAM:

VCERC is considered as a data center for the national chemical inventory draft list (which is

the list of chemicals currently used in Vietnam).

After the National Chemical List is issued, chemicals not on the National Chemical List will be

considered as new chemicals

Registration of new chemicals at competent state agencies before putting them into use or

circulating on the market will be necessary. Procedures not clear yet.

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Overview of Chemical Regulations in Philippines

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Under the responsibility of the Department of Environment and Natural Resources (DENR)

Republic Act 6969 (Toxic Substances and Hazardous and Nuclear Waste Control Act)

Title II of RA 6969 is the regulations for new chemicals, regulated and controlled chemicals,

focused on management and control of industrial chemicals (regulations, restriction,

prohibition).

RA 6969 is a risk-based system

Polymer Exemption

Pre-Manufacturing and Pre-

Importation Notification (PMPIN)

Philippine Inventory of Chemicals

and Chemical Substances (PICCS)

Chemical Control

Order (CCO)

Priority Chemical

List (PCL)

DAO 29 Title II. Toxic Chemical Substances

(Existing Chemicals)

(New Chemicals)

Small Quantity Importation (SQI)

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Is it

exempted?

Is it on

PICCS?

Exempted!

Is it < 1 t/a? Is it a PLC?

Apply for

PICCS

certificate

Small

quantity

import

certification

Polymer

exemption

certificate

No No No No

Yes Yes Yes Yes

PMPIN

Philippine Inventory of Chemicals and Chemical Substances (PICCS)

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PICCS is a list of all existing chemical substances used, sold, distributed, imported, manufactured,

stored, exported, treated or transported in the Philippines.

It serves as a guide for manufacturers and importers of chemicals

A process of evaluation to certifies that the chemical is listed in the PICCS and is not a new chemical

will be evaluated and issued at DENR-EMB Regional offices

Yes No

PICCS certification

submission

Clearance & Permitting Division Record

Case Handler

Chemicals and Hazardous Waste Division Chief

Regional Director

Approved

20 Working Days

Clearance & Permitting Division Record 5 Working Days

Pre-Manufacturing and Pre-Importation Notification (PMPIN)

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Online-application: Detailed and abbreviated Forms

Only local importers/ manufacturers may apply for new chemical substances not yet listed in

PICCS

Detailed PMPIN: chemicals not listed in any countries

Abbreviated PMPIN: chemicals listed in any of these countries; USA, Japan, Canada,

Australia, EU, Korea

Purpose is to screen harmful substances before they enter the Philippine’s commerce

A process where the safety of the chemical to be introduced must be adequately documented

Assessment is based on Hazard identification, Dose-response assessment, Exposure

assessment, Risk characterization

Sufficient information on Physicochemical properties, toxicological & ecological data

Small Quantity Importation (SQI)

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Online-application

The Pre Manufacture for importation of small quantity of new chemicals not over 1000 kg.

The SQI is secured once and valid for 1 year.

The EMB Memorandum Circular No. 11 of 2016 provided that, a maximum of 5 SQI

Clearances may be secured and industries are advised to proceed with the PMPIN process.

Polymer Exemption

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The signatory should be CEO, president, operation manager

Product name/ trade name should be provided

For CBI, the supplier may send the ingredients to EMB Central Office directly

Should meet the Polymers definition

All monomers, other reactants added at quantities less than 2% by weight (proposed)

Must not be unstable, degradable, decompose, or depolymerize

Issuance of 80-90 Polymer Exemption per year

Priority Chemical List (PCL)

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It is a list of existing & new chemicals that DENR has determined to potentially pose

unreasonable risk to public health, workplace & the environment

Users/ Importers/ Manufacturers/ Distributors of chemicals included in the PCL are required to

register their hazardous wastes & chemical substances & submit biennial report (Prescribed

Form)

The following criteria has been established by DENR for PCL based on the selection criteria

used in other industrial nations such as Australia, Japan, Canada and the United States:

Persistence refers to the property of a substance whose half-life in water, sediment, soil, or air

exceeds a duration of 50 days.

Bioaccumulation potential is the measure of a substance’s ability to bioaccumulate in the

food chain.

Toxicity refers to the quality of a substance which meets any of the following criteria:

Acute lethality

Chronic or sub-chronic toxicity

Teratogenicity

Carcinogenicity

Chemical Control Order (CCO)

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Prohibits, limits, or regulates the use, manufacture, import, export, transport, processing,

storage, possession, and wholesale of those priority chemicals that DENR determined to be

regulated, phased-out, or banned due to the serious risks they pose to public health,

workplace & environment

Required to register with DENR, secure Import Clearance and submit annual report

(production & management information)

The Control in a CCO maybe in the form of:

Gradual phase-out plan that may apply to:

Importation/Exportation

Manufacturing & distribution

Industrial use

Limitation of use that may apply to: Product or material/chemical, Premise, Industrial use

Substitution-substituting certain chemical substances that pose less risks to human health and

the environment

Overview of Chemical Regulations in Indonesia

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Government Regulation No. 74/2001 regarding Hazardous & Toxic Material (Bahan

Berbahaya dan Beracun, B3)

Hazardous and toxic materials (B3) are divided into 3 categories and there are different

requirements for each category;

First production/import of hazardous and toxic substance (B3);

The obligation to register a B3 is applicable 1 (one) time for a B3 produced and or imported for

the first time.

Usable hazardous and toxic substances

• Listed in Annex I : Requires registration prior to production/ import for

the first time;

• If not listed but hazard : Requires notification for the first import.

Limited use hazardous substances

• Listed in Annex II Table 1;

• Requires both registration and notification prior to export/ import for the first time.

Banned hazardous substances • Listed in Annex II Table 2;

• Banned for import and use.

Indonesia: Registration and Notification

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Registration: required for hazardous substances listed in Annex I; and the limited use

hazardous substances listed in Annex II Table 1

Notification required for limited use hazardous substances listed in Annex II Table 1 for which

prior informed consent (PIC); and for the first import of non-listed B3 hazardous substances

(applied by importers only)

Registrations shall be submitted to the Ministry of Environment and Forestry via online

registration system “Indonesia National Single Window (INSW)”

The registration of B3 substance is only valid for one time for every production and/or import.

Besides the control of entry of B3 substances, the transportation, storage, and distribution of

B3 substances are also under monitor in Indonesia.

Indonesia: Proposed changes for improving chemical control legislation

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Definition of hazardous substances will incorporate GHS classification criteria, leading to more

B3 substances.

A national database of hazardous substances is going to be formed.

New hazardous substances which are placed on Indonesian market for the first time need to

be evaluated before they can be produced or imported.

The list of chemicals in B3 annexes will be updated.

A technical Hazardous and Toxic Substances (HTS) Committee will be formed to recommend

hazardous substances categorization and evaluate new hazardous substances.

Thank you very much

for your attention

Dr. Piyatida (Tung) Pukclai

Asia-Pacific Business Development & Regulatory Policy Director

Dr. Knoell Consult Thai Co. Ltd.

4th Floor Unit 407 Airport Business Park (B-Building)

92/1 Mahidol Road T. Haiya A. Muang Chiang Mai Thailand 50100

Phone: +66 (0)52 080454

Mobile: +66 (0)8 82510303

Fax: +66 (0)52 080452

E-mail: [email protected]

Internet: http://www.thailand.knoell.com/en

mailto:[email protected]

http://www.thailand.knoell.com/en

Documents

Overview on Chemical Control Legislation in Vietnam ... · Definition of hazardous substances will incorporate GHS classification criteria, leading to more B3 substances. A national