Current status of the chemical management regulations in ASEAN countries

Piyatida (Tung) Pukclai, Ph.D.Chemical Substance Management Meeting 2019 18 – 19 September 2019 | PACIFICO Yokohama

Outline

ThailandUpdates on Hazardous Substance Act and draft of new Chemical Substances Act

MalaysiaCLASS Regulation and current update for Hazardous Chemical Legislation

PhilippinesChemical Management Regulation and the Latest trends in the PICCS and PMPIN Process

Others

2

Business Areas

3

Industrial Chemicals

Crop Protection

Biocides Training

Regulatory Software Solutions

Medical Devices

Veterinary Medicine Cosmetics

Food and Feed

Contact Materials

4

1st issued in B.E. 2535, the 4th revision of Hazardous Substance Act announced on 30th April 2019!!Under the responsibility of the Ministry of Industry (MOI)Diverse characteristics & usages of substances, enforcement is split over 6 authorities:

Department of Agriculture (DOA), Ministry of Agriculture and Cooperatives (MOAC)

Department of Fisheries (DOF), MOAC

Department of Livestock Development (DLD), MOAC

Food and Drug Administration (FDA), Ministry of Public Health (MOPH)

Department of Industrial Works (DIW), MOI

Department of Energy Business (DOEB), Ministry of Energy (ENERGY)

Thailand – Updates on Hazardous Substance ActHazardous Substance Act

5

List of Hazardous Substances Year Link

List of Hazardous Substances No. 1 B.E. 2556 (2013) http://oaep.diw.go.th/haz/wp-content/uploads/2016/12/announce56.pdf

List of Hazardous Substances No. 2 B.E. 2558 (2015) http://oaep.diw.go.th/haz/wp-content/uploads/2016/12/announce58.pdf

List of Hazardous Substances No. 3 B.E. 2559 (2016) http://www.diw.go.th/hawk/news/haz/4-60.pdf

List of Hazardous Substances No. 4 B.E. 2560 (2017) (announced on 11-Jan- 2018)

http://www.diw.go.th/hawk/news/haz/4-61.pdf

List of Hazardous Substances No. 5 B.E. XXXX (XXXX) Draft version: http://www.diw.go.th/hawk/news/haz/law.html

MOI Notifications: List of Hazardous Substances

Draft of List of Hazardous Substances No. 5, B.E. XXXX

Draft Notification: http://www.diw.go.th/hawk/news/haz/Draft_Notification.pdf (in Thai language) Link for comments: http://php.diw.go.th/rubfung/show.php

Proposed changes;

• Decabromodiphenyl ether to be Hazardous substance type 3 (link)

• Short-chain chlorinated paraffins to be Hazardous substance type 3 (link)

• Methoxyacetic acid; MAA to be Hazardous substance type 4* (link)

MAA is a toxic for reproduction category 1B. The MAA which is an unavoidable impurity from the glycolic acid (not include if its concentration is ≤ 0.3% w/v).

• Hexachloro benzene; HCB to be Hazardous substance type 4** (link), unless it is an unavoidable impurity and not exceed 50 ppm (0.005% w/v)

For other substances, please check from here

6

Classification & Hazardous Substance Import Procedure

77

Registration License: valid for 6 years License Permit: valid for 3 years

Type 1 Notify before import (can be done within 1 day) customs procedures(Wo.Ao./Ao.Ko.6 form)

Type 2 Register get registration certificate Type 2 notification submission Notify before import (Wo.Ao./Ao.Ko.1 form) (17 working days) (Wo.Ao./Ao.Ko. 5 form) (Wo.Ao./Ao.Ko.6 form)

Type 3 Register storage inspection get registration cert. submit before import get Permit(Wo.Ao./Ao.Ko.1 & approve & (Wo.Ao./Ao.Ko.6 form)

Wo.Ao.3 or 5 or 7 forms) appeal to Minister in 30 days

Type 4 Prohibited

How to determine hazard type under DIW

8

Apply for 15 digits code for Type 1 (only in sub-list 5.1 and 5.4)Registration for hazardous substance Type 2 and 3Notify the DIW for Type 2 or Apply for license for Type 3Submit “Prior Informed Consent” before proceeding Customs clearance processComply with safety measures in the ministerial notifications (*GHS-SDS and Labeling)

* March 2013 for substance, March 2017 for Mixtures

Online Consultation by importer (submission of 100% composition to DIW)

Type 1 Type 2 Type 3 Type 4

List 5.6Non-Haz

Not under Type 1-4

Proposed inventory inclusion

CBI submission by supplier

Current situation on the Thailand Existing Chemicals Inventory (TECI)

9

Only the DIW “Preliminary of Thailand Existing Chemicals Inventory” is available

Contains information of sub-list No. 5.1, 5.4, and 5.5 only from the year 2012 - 2015

Chemical information data from DIW online consultation results with actual production/ import data

will include in the chemical inventory but the DIW will verify the data before input in the inventory

(criteria is under consideration)

Year Action plan2018: DIW launch the online for the registration of hazardous substance Type 2, 3 and licensing

of Type 3 Hazardous Substance Single Submission (HSSS)

2019: E-licensing

2020:(or later)

Thailand Existing Chemicals Inventory (TECI)

The Hazardous Substance Act (No. 4), B.E. 2562 (2019)(will come into force on October 27th, 2019)

Key points:

Have clear definitions of import, export, transit, re -import, re-export, etc.

For each transit of type 1,2 shall be declared to authority, and type 3 need permission. Not the same process as the import to such a substance

Set up the criteria and rules for the transit

Set the rules to waive for the “re-import”/ “re-export” of hazardous substance

The transit license shall valid not over than 45 days (previously 90 days). The company must be a local entity

The transit shall be sent out from the port within 5 days after the custom inspection.

Regulate activities related to product advertising and sale promotion

Definition of liability and compensation regarding any damages occurring from chemical products

Adjustment of Hazard Substance committee (17 from gov. authorities and 12 max. from external experts) to enhance and streamline requirements in the processing of license and permit, chemical managements, etc.

Link (in Thai): http://www.ratchakitcha.soc.go.th/DATA/PDF/2562/A/056/T_0231.PDF

10

Confidential Business Information (CBI) update!

Link: http://oaep.diw.go.th/haz/wp-content/uploads/2019/06/%E0%B8%9B%E0%B8%A3%E0%B8%B0%E0%B8%81%E0%B8%B2%E0%B8%A8CBI.pdf

Any companies who submitted the CBI from 1st January 2015 - 31st December 2016 and still want to get the evaluation and feedback from HSMD must provide the following information to authority at: cbidiw_59@diw.mail.go.th from now until 30th September 2019.

1. Receiving No.2. The date that supplier sent the CBI to HSMD3. Email of sender

Company can get the old documents within this time. Otherwise, HSMD will reject (or consider as invalid)

11

Draft of new chemical regulation: “Chemical Act”

FDA organized the seminar on 26 April 2019

The 1st draft for public hearing: 26 April 2019 (comments can be submitted until 7th June 2019)

By: Sub-committee on the chemical substances law development, consist of;

16 Government representatives include FDA, DIW, DOA, TISI, Customs, PCD, OAP, etc.

2 Enterprise representatives which are The Federation of Thai Industries (FTI), and Thai Crop Protection Association (TCPA)

2 Civil Society representatives which are Public Health and Development Foundation (PHDF), and Thai Pesticide Alert Network(Thai-PAN)

3 Legal experts

Secretary: DIW and FDA

12

Draft of new Chemical Act

Covers substance, mixture, and article

Chemical management process;

The draft covers the entire chemical life cycle – from produce, import, export, transport, transit, re-import, re-export, having in possession, sales, use, treatment, and disposal of chemical substances and mixtures, as well as to recycling

13

1 • Chemical assessment

2 • Licensing and control

3 • Surveillance and monitoring

Chemical lists under the new Chemical Act

The Chemical Assessment Committee (CAC) will classify chemicals present in the Chemical Inventory according to their risks posed to health and environment, and divide them into 3 lists:

List 1: Enterprises must comply with criteria and conditions impacting produce, import, export, transit, re-import, re-export, having in possession, sales, transport, use, treatment, disposal or recycling issued by competent authority. This includes the current “low-risk chemicals” with regards to health and environment;

List 2: Enterprises must obtain licensing from competent authority. This includes the “high-risk chemicals” with regards to health and environment;

List 3: All activities are prohibited. However, certain chemicals, such as those used for R&D purposes, or chemicals where contamination at use is unavoidable but that are less dangerous may be exempted

Note: currently, only the Prelimianary Thailand Existing Chemical Inventory is available!!

14

Chemical Assessment Flowchart

15

Production, import, export, transit, re-import, re-export, having in possession, sales, transport, use, treatment, disposal, recycling

Chemical Assessment Committee (CAC) set the registration criteria

(HS code & business type)

Thailand Existing Chemical Inventory

Yes

No

New chemical

Chemical Assessment

CAC set the assessment criteria

List 1 List 2 List 3

Control advertisement & label for list 1, 2.1, 2.2, 2.3

2.1 Agriculture

2.2 Public Health

2.3 Industrial and etc.

Chemicals in the list No. 1, 2, 3 are classified by the CAC from the Thailand Existing Chemical Inventory according to their risks posed to health & environment

16

Hazardous Substance Act (and the amendments)

List 1 DOA (1.1, 1.2)

List 2 DOF (2.1, 2.2, 2.3)

List 3 DLD (3.1, 3.2)

List 4 FDA (4.1, 4.2, 4.3)

List 5 DIW (5.1, 5.2, 5.3, 5.4, 5.5, 5.6)For 5.6;ExplosiveFlammable substanceOxidizing agent or PeroxideToxic SubstanceMutagenCorrosiveIrritantCarcinogenToxic substance to reproductive organEnvironmentally hazardous substance

List 6 DOE

Draft of Chemical Act

Thailand Existing Chemical Inventory

List 1 (Low risk)

List 2 (High risk)2.1 Agriculture2.2 Public Health2.3 Industrial and etc.

List 3 Prohibit (Dangerous)

New chemical shall be evaluated/ assessed on the risks posed to health & environment by the CAC prior to commencing any kind of activity related to the substance

Under the 1st draft version of the New Chemical Act

Covers the entire chemical life cycle

Covers substance, mixture, and article

Risk-based

Have the Chemical Assessment Committee (CAC) , Specific Sector of Chemical Management Committee, and National Chemical Agency

License validity: valid according to a period specified in such license but shall not exceed 6 years

Covers surveillance and monitoring

Insurance & compensation for the damages arising from chemicals

Advertisement

New penalty scheme (more strict)

17

Transitional provisions

18

Review of chemicals listed in existing chemical inventory and the classification from current Hazardous Substance Act to this new Act

Transfer the notification/ registration applications under the Hazardous Substance Act to this new Act

The existing permit licenses and registration licenses from the Hazardous Substance Act shall valid until the expiration date

The Hazardous Substance Act and related regulations are being effective until the Chemical Substance Act is approve

Malaysia chemical control management

19

DOA: Pesticide Act 1974

DOSH:Petroleum Act 1984

DOE:Environmental

Quality Act 1974

KPDNKK:Consumer Protection Act 1999

KLN:Chemical Weapons Convention 2005

MOH:Poison Act 1952, Food Act 1983, Dangerous Drug Act 1952

KLN:Ministry of Foreign AffairsKPDNKK: Ministry of Domestic Trade, Co-operatives and Consumerism

Authority: Department of Occupational Safety and Health (DOSH)

Under the Occupational Safety and Health Act 1994 (OSHA)

• CLASS 2013: Classification, Labeling & Safety Data Sheets of Hazardous Chemical Regulations

• USECHH 2000: Use & Standard of Exposure of Chemicals Hazardous to Health Regulations

• CIMAH 1986: Control of Industrial Major Accident Hazards Regulations

• PROHIBITION ORDER 1999: Prohibition of Use of Substances Order

Under the Factories and Machinery Act 1967 (FMA)

• Factories and Machinery (Lead) Regulations 1984

• Factories and Machinery (Asbestos Process) Regulations 1986

• Factories and Machinery (Mineral Dust) Regulations 1989

20

Malaysia – Overview On Current Chemical Legislation

20

CLASS Regulations 2013

21

Link: http://www.dosh.gov.my/index.php/en/chemical-management/class-regulations

Classification, Labelling and Safety Data Sheet of Hazardous Chemicals >> CLASS

Gazetted on 11th October 2013, and on fully enforcement on 17th April 2015

To control classification, packaging, labeling, SDS and inventory of hazardous chemicals

Manufacturer or importer is required to prepare a hazardous chemical inventory, imported or supplied in a quantity of 1 T/Y or above for each calendar year. Such an inventory shall be submitted to the DOSH no later than 31 March in the following year

CLASS regulations also require chemical manufacturers/ importers to classify, label & package chemicals, and compile SDS according to the ICOP

Classification Packaging Labeling SDS Inventory

Manufacturer & importer only21

ICOP 2014Industry Code of Practice (ICOP) on Chemicals Classification and Hazard Communication 2014

The ICOP was adapted from the 3rd revised edition of GHS purple book

Under CLASS Regulation 2013, on 16th April 2014, government gazetted the ICOP CHC 2014

Purpose: detailing requirements specified in CLASS Regulations

ICOP is promulgated as a guidance to help the industry comply with CLASS Regulations. It sets out detailed requirements on chemical classifications, labelling and SDS

Part 1 – List of Classified Chemicals

Part 2 – Chemicals Classification

Part 3 – Hazard Communication : Labeling and SDS

Part 4 – Confidential Business Information (CBI)

2222

Chemicals Information Management System (CIMS)

23

http://cims.dosh.gov.my/

Product identifier

Name of hazardous chemical

Composition of hazardous chemicals

Hazard classification

Total quantity imported or supplied

Note: only hazardous components in mixture have to be reported in the CIMS system

A supplier may omit the name and the composition of a hazardous chemical from SDS and inventory of hazardous chemicals if it constitutes CBI. The information omitted must be replaced with:

Chemicals name - use generic name of the chemicals Concentration of the ingredients - use concentration range

23

Current Update for Hazardous Chemical Legislations Review of CLASS Regulation 2013 (amendment to the CLASS Regulation by end of 2019)

The amendment would add “no CLASS, no entry ” requirement. developing now, subject to get approval from ministry

Seriously looking at compliance to the chemical management within industries

Review of ICOP CHC 2014 (Classification list: Part 1 - Review & addition of chemicals lists)

Review of OSH Order 1999 (Prohibition of Use of Substances)

Additional provision on approval from DOSH to prohibit carcinogenic substances and to include the provision for special handling methods and control measure

Includes specific chemical, CAS No., extent to which use of substance is prohibited and justification

2424

Year 2017 2018 2019Number of classified chemicals 229 3 662

Review of Use & Standard of Exposure of Chemicals Hazardous to Health Regulations (USECHH) 2000

Methodology of Chemical Health Risk Assessment

CHRA SiRAC

Full assessment Simple assessment

Q: When to decide to perform CHRA or SiRAC*? not for foreign supplier

A: Assessor can choose to perform assessment by using CHRA or SiRAC.

However, SiRAC is not applicable to chemical classified as CMR and are only applicable for chemical in solid and liquid form.

*SiRAC: an alternative approach of chemical health risk assessment and may be conducted if the chemicals hazardous to health is listed in the chemical register; and not classified as carcinogenicity cat. 1, mutagenicity cat 1 or 2, or respiratory sensitization cat 1

2525

Current Update for Hazardous Chemical Legislations

Flow Chart on Approach of Assessment of Risk to Health

26USECHH regulations >> CHRA and SiRAC

Current Update for Hazardous Chemical Legislation

Amendment of OSHA 1994 (now is in final stages of amendment). Revocation of regulations in the Factories and Machinery Act 1967

Revision of the Pesticide Act 1974 by the DOA

Revision of the Poison Act 1952 by the MOH

New guideline on control and safe handling of nanomaterials 2018 (Link). Establishment of National Nanotechnology Centre (NNC) for the coordination of R&D and all activities of nanotechnology

2727

Philippines – Overview On Current Chemical Legislation

28

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)

28

29

Is itexempted?

Is it on PICCS?

Exempted!

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

Apply forPICCS

certificate(not

mandatory)

Small quantityimport

certification

Polymer exemptioncertificate

No No No No

Yes Yes Yes Yes

PMPIN

29

Philippine Inventory of Chemicals and Chemical Substances (PICCS)

30

There are 2 types of PICCS:

1) Public PICCS: uploaded in the EMB website https://emb.gov.ph/online-services/ for free access

2) Confidential PICCS: available only to notifier/authorized person for confirmation, request letter required

Updating of the PICCS is done annually, and includes all new chemicals that have been issued non-confidential PMPIN Clearance Certificates

In Mar, 2019, EMB published drafts on additional chemicals in PICCS 33 chemicals are added and amendment to EMB MC 2016-011 to allow the issuance of certification for PICCS

30

Philippine Inventory of Chemicals and Chemical Substances (PICCS)

• Non-chemical substances• Naturally occurring substances• Mixtures• Radioactive substances, pesticides, drugs, foodstuffs, and consumer products that are

regulated by other laws in the Philippines• By-products (Wastes)• Exemption to the PICCS updating: Small-quantity chemicals manufactured or distributed (not

imported) for market test and research and development in quantities less than 1,000 kg/ year

31

Exemption to PICCS

31

Pre-Manufacturing and Pre-Importation Notification (PMPIN)

32

Online-application: Detailed and abbreviated Forms

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

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

Detailed PMPIN Chemicals not listed in any countries 120 – 180 working days(Processing Time)

Abbreviated PMPIN Chemicals listed in any of these countries; USA, Japan, Canada, Australia, EU, Korea

90 working days(Processing Time)

32

PMPIN requirements

1. Submission of complete information of MSDS2. Annual volume of import3. Specific Use of the Chemical4. Complete information in the Abbreviated and Detailed Form should be provided with data focus on:

• Physical and Chemical Properties• Toxicological Effects• Ecotoxicological Effects

5. For Detailed Form, laboratory reports for the above mentioned information are required include: Name of laboratory and location Name and signature of laboratory authorities test reports

6. Interagency Chemical Review Committee assist EMB in the review of Detailed PMPIN Form

Log-on to : http://210.213.80.213

Q: WHO SHALL APPLY?

A: Only local importers, local manufacturers, or the 3rd Party (Ph) applicants on behalf of local importers

3333

PMPIN and the Confidential Business Information (CBI)

• Guideline: EMB-MC-2014-010

• The local counterpart will apply reflecting the information in the PMPIN Form by following the SDS of the products and not the individual chemical

• Supplier will directly disclosed the new chemicals with CBI to the EMB – Central Office or www.emb.gov.ph

• The 3rd party with authorization letter or the supplier may send the information to the EMB-NCR, EMB – Region 4A, and EMB – Region 3

3434

Pending EMB Memorandum Circular on PMPIN Data Requirements

35

Update existing requirements for PMPIN

Proposed data for Physicochemical properties

Proposed data for Toxicological and Environmental/Ecological Properties

Confidential Business Information;

For trade secret declaration of notifier for formulations PMPIN Certificate issued indicate only name of the product to be imported

SDS of the product where new chemical is a component

100% composition of the product to be submitted and CAS of all components

Physicochemical, toxicological and environmental properties of the new chemical to be submitted

For confidentiality of information, submit duly accomplished CBI form to EMB by mail or email at chemicals@emb.gov.ph

35

Small Quantity Importation (SQI)

36

Online-application available

This is an exemption to the PMPIN Process

SQI is required prior to importation of less than 1,000 kg./yr of pure chemical substances or component chemicals in percentage by weight of product, mixtures not listed in the PICCS.

Requirements: Letter of SQI request, notarized application form, and Safety Data Sheet (SDS) of chemicals

Renewed yearly

The 1st SQI application + 4 SQI renewal further, industries shall proceed with the PMPIN

36

37

Applicant can apply for the Polymer exemption if;

Meet the Polymers definitionA substance composed of more than 50% of molecules containing a sequence of at least 3 monomer units covalently bound to at least one other monomer unit or other reactant;Has molecules distributed over a range of MW; andHas no single MW molecule reaching 50% (w/w) of total molecules

Polymer of Low Concern (PLC);Meet the Polymers definitionCationic polymer can be exempted if the FGEW is >5000 Daltons; andMust not be unstable, degradable, decompose, or depolymerize

Polymer Exemption to the PMPIN ProcessImplementation on hold!

Draft Policy for Polymers

37

Priority Chemical List (PCL)

38

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

PCL Compliance Certificate required for importation/manufacture of: New & existing chemicals listed in the PCL or chemicals/mixtures containing PCL chemicals

Exemption: PCL chemical is equal or less than 1%, laboratories using PCL chemicals

Draft of the 3rd revised PCL

DAO 98 – 5828 chemicals

DAO 2005 – 27(Current)

48 chemicals

DAO 20XX – XX (Draft)

92 chemicals

38

Chemical Control Order (CCO)

39

Chemicals under the CCO;

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)

AsbestosPCBsCyanide and cyanide compoundsODSLead and lead compounds

Mercury and mercury compoundsCyanide and Cyanide compoundsChemicals for inclusion in CCO e.g. Cadmium & Cadmium compounds, Arsenic & arsenic compounds, Chromium (VI) & Chromium (VI)

compounds

39

Requirements for CCO Importation Clearance

CCO Registration e.g.

Fully-accomplished Importation Clearance FormEnvironmental permits e.g. ECC, Discharge permit, permit to operate/ exemption, etc.Summary of previous importation/distribution/usageList of customers (for importers)Registration of CCO

40

Plant Geolocation Category of business SEC and Business permits Environmental permits

Management information Preventive and control measures Treatment, storage and disposal information Chemical specific information

40

PHILIPPINES: Current status

Online Permitting and Monitoring System (OPMS): https://210.213.80.213/accounts/login/Development of policy for Polymer Exemption and Polymer of Low Concern (PLC) New approved policy on Clarifications on Permitting Regulations for SQI, PMPIN, PCL, CCOs ( MC 2017-009);

PCL exemption shall only be applied for the mixture if the cumulative percentage of the PCL chemicals in the mixture is ≤1%

For a compound which is a new chemical and regulated under PCL, a PMPIN should be applied first and once PMPIN is approved then the PCL Compliance Certificate shall be applied

Chemicals under CCO which are used in the laboratories are not exempted from CCO

For mixture, if there are 2 or more chemicals controlled under CCO, applicant shall apply CCO only for the chemical with the higher weight percentage

For a mixture with 2 or more chemicals listed in the PCL, one PCL Compliance Certificate shall be applied for the mixture but in the certificate all the PCL chemicals in the mixture will be indicated in the mixture

4141

Thank you very much for your attention

42

Dr. Piyatida (Tung) PukclaiAsia-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 080454Mobile: +66 (0)8 82510303Fax: +66 (0)52 080452E-mail: PPukclai@knoell.comInternet: http://www.thailand.knoell.com/en