overview on chemical control legislation in vietnam ... · definition of hazardous substances will...
TRANSCRIPT
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
Circular No. 40/2011/TT-BCT
Circular No. 04/2012/TT-BCT
Circular No. 42/2013/TT-BCT
Circular No. 20/2013/TT-BCT
Circular No. 18/2011/TT-BCT
Circular No. 07/2013/TT-BCT
Circular No. 44/2012/TT-BCT
Circular No. 36/2014/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
Circular No. 43/2009/TT-BCT
Circular No. 50/2012/TT-BCT
Circular No. 29/2014/TT-BCT
Circular No. 52/2014/TT-BCT
Circular No. 61/2014/TT-BCT
Circular No. 06/2015/TT-BCT
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 )
Circular No. 32/2017/TT-BCT
(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.
8
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
VIETNAM: draft of National Chemical Inventory (rev. as of March 15, 2017)
Consist of 4925 substances
11
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.
12
Overview of Chemical Regulations in Philippines
13
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)
14
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)
15
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)
16
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)
17
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
18
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)
19
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)
20
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
21
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
22
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
23
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