Introduction to Chemical Regulations in Indonesia

Indonesia

Introduction to Chemical Regulations in Indonesia

Little Pro on 2016-11-14

As Indonesia is close to finalizing their revised chemicals regulation, we would like to give you a brief introduction to how industrial chemicals are currently regulated in Indonesia and what expected changes are to be included in revised government regulation for hazardous and toxic substances (B3).

List of Main Chemical Regulations in Indonesia

There are a number of chemical regulations governing industrial chemicals in Indonesia. The most important regulation is Government Regulation Number 74 year 2001 regarding Hazardous and Toxic Material Management. Since hazardous and toxic material is called Bahan Berbahaya dan Beracun (abbreviated as B3) in Indonesian local language Bahasa, the government regulation number 74 is often called B3 management regulation. The revised B3 regulation is still being revised and has not been published yet [Update: Oct 2017].

Other related chemical regulations include:

Law of the Republic of Indonesia Number 32 year 2009 regarding Environmental Protection and Management;
Government Regulation of the Republic of Indonesia Number 74 year 2001 regarding Hazardous and Toxic Material Management (B3);
Ministry of Environment and Forestry (MoEF) Regulation 36/2017 on Registration and Notification Procedures for Hazardous and Toxic Substances
Decree of Environment Minister Number 3 year 2008 regarding hazardous and toxic material symbol and labelling.

Definition of Hazardous Substances and Scope

Indonesia's chemical management focuses on the management of hazardous chemical substances only. Hazardous substance (B3) is substance/material which its nature or and its amount and or its concentration, either directly or indirectly, can pollute or damage the environment, and or may endanger the environment, human health, and survival of human beings as well as other life.

To be more specific, a substance may be regarded as B3 if it is explosive, oxidizing, extremely flammable, highly flammable, flammable, extremely toxic, highly toxic, moderately toxic, harmful, corrosive, irritant, dangerous to the environment, carcinogenic, teratogenic, or mutagenic. [Note: More GHS building blocks such as specific target organ toxicity will be included when B3 regulation is revised, leading to broader B3 definition.]

However, the following chemicals are out of scope of B3 management regulation.

Radioactive materials,
Explosives,
Mining and production of oil and gas and their processed products,
Food and beverages and other food additives,
Household medical supplies,
Cosmetics,
Pharmaceutical ingredients,
Narcotics, psychotropic substances and precursors as well as other addictive substances,
Chemical weapons and biological weapons

Certain hazardous substances are listed in annexes to B3 management regulation and subject to various registration and notification requirements.

Hazardous and Toxic Material (B3) Management

Hazardous and toxic materials (B3) are divided into 3 categories and there are different requirements for each category.

Category	Requirements
Usable hazardous and toxic substances	Listed in Annex I (209 chemicals): Requires registration prior to production/import for the first time; Non-listed B3 hazardous substances: Requires notification for the first import.
Limited use hazardous substances	Listed in Annex II table 1(10 chemicals); Requires both registration and notification prior to export/import for the first time.
Banned hazardous substances	Listed in Annex II table 2 (45 chemicals); Banned for import and use.

Registration and Notification

The differences between registration and notification are listed as follows:

Type	Target	Who
Registration	Required for hazardous substances listed in Annex I (209 chemicals); and Limited use hazardous substances listed in Annex II table 1(10 chemicals)	Producer, importer
Notification	Required for limited use hazardous substances listed in Annex II table 1 (10 chemicals) for which prior informed consent (PIC) procedure is followed; and For the first import of non-listed B3 hazardous substances (applied by importers only)	Exporter, importer

Registrations shall be submitted to the Ministry of Environment and Forestry via an electronic registration system. So far, only limited info such as substance identity, business license, tax identification info, MSDSs, certificate of analysis, and photo of warehouses are required.

More info about registration and notification procedure and info requirement is set out in the Ministry of Environment and Forestry (MoEF) Regulation 36/2017 on Registration and Notification Procedures for Hazardous and Toxic Substances. This regulation replaces MoEF Regulation 2/2010 on the Utilization of Electronic Registration Systems for Hazardous and Toxic Substances under the Framework of the Indonesian National Single Window at the Ministry of the Environment and comes into force on 8 June 2017.

GHS Implementation in Indonesia

Indonesia has adopted GHS for both industrial chemicals and pesticides since 2010. SDSs and labels for hazardous and toxic materials need to be GHS compliant. More info about GHS in Indonesia can be found here.

Proposed Changes in New B3 Management Regulation

The definition of hazardous substances will incorporate GHS building blocks and 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.

References

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