Introduction to Indonesian chemicals management regulations（一）
Odyssey Compliance Incorporation(OCI )has been paying attention to Indonesian chemical regulations for many years. Recently, we will combine practical regulations and operations and use several paragraphs to analyze and launch Indonesian chemical supervision, providing information and observations for China’s cross-border chemical and overseas market compliance.
As Indonesia's industrialization accelerates and ASEAN integration deepens, the specific legal operation and compliance of hazardous and toxic substances (B3) have become a hard threshold for companies to enter the Indonesian market. As the first recommendation article, we sort out Indonesia's B3 regulatory system, substance definition classification and exemption scope, and clear legal and compliance obstacles for Chinese enterprises' cross-border chemical trade.
一、Legal basis
1. Law No. 32 of 2009 "Environmental Protection and Management Law" (National Gazette of the Republic of Indonesia No. 140 in 2009, National Gazette of the Republic of Indonesia Supplement No. 5059);
2. Government Regulation No. 74 of 2001 "Regulations on the Management of Hazardous and Toxic Substances" (National Gazette of the Republic of Indonesia No. 138 of 2001, National Gazette of the Republic of Indonesia Supplement No. 4153) (referred to as B3 Management Regulations);
3. Presidential Decree No. 16 of 2015 "Organic Law of the Ministry of Environment and Forestry" (National Gazette of the Republic of Indonesia No. 17 of 2015);
4. Ministry of Trade's 2022 Order No. 07/M-DAG/PER/5/2022 "On the Distribution and Supervision of Hazardous Substances" (Ministry of Trade's Order No. 44/MDAG/PER/9/2009 in 2009 has been revised several times and has been repealed and replaced in full by Order No. 07 of the Ministry of Trade in 2022);
5. Order No. 03/MDAG/PER/1/2012 of the Ministry of Trade in 2012 "Regulations on the Import of Ozone Depleting Substances";
6. Order No. P.18/Menlhk-II/2015 of the Ministry of Environment and Forestry in 2015 "Organization and Working Rules of the Ministry of Environment and Forestry" (National Announcement No. 713 of the Republic of Indonesia in 2015);
7. "Minister of Trade Regulation No. 7 of 2022 on the Distribution and Management of Hazardous Substances" issued by the Minister of Trade in 2022;
8. Ministry of Environment and Forestry Order No. P.36/MENLHK/SETJEN/KUM.1/6/2017 "Order of the Ministry of Environment and Forestry of the Republic of Indonesia on Registration and Notification Procedures for Hazardous and Toxic Substances";
二、Definition and classification of hazardous and toxic substances
（一）Definition
Dangerous and toxic substances (hereinafter referred to as B3 substances) refer to substances that, due to their nature, concentration and/or quantity, directly or indirectly cause environmental pollution and damage, and/or harm the ecological environment, human health, and the survival of humans and other living things.
（二）Classification
According to Government Regulation No. 74 of 2001 "Measures for the Management of Hazardous and Toxic Substances" (referred to as B3 Management Regulations), namely PP No. 74/2001 (full name: Peraturan Pemerintah No. 74 Tahun 2001 tentang Pengelolaan Bahan Berbahaya dan Beracun), is the Indonesian regulation for the management of hazardous and toxic substances (B3 - Bahan Berbahaya dan Beracun's core regulations divide B3 substances into 3 lists:
（三）Identification of B3 substances (15 hazards)
If the substance is explosive, oxidizing, extremely flammable, highly flammable, flammable, highly toxic, highly toxic, moderately toxic, harmful, corrosive, irritant, harmful to the environment, carcinogenic, teratogenic or mutagenic. [Note: The revised B3 regulations will include more GHS frameworks on specific target organ systemic toxicity, resulting in a broader definition of B3. ]
However, the following chemicals are outside the scope of B3 regulations:
radioactive material,
dynamite,
Extraction and production of oil and natural gas and their processed products,
Food additives for food and beverages,
home medical supplies,
cosmetics,
medicinal ingredients,
Narcotics, psychotropic substances and precursors and other addictive substances,
chemical and biological weapons
Note: Certain hazardous substances are listed in the Annex to the B3 Management Regulation and are subject to various registration and notification requirements.
三、Registration and notification of dangerous and toxic substances (hereinafter referred to as: B3 substance registration and B3 substance notification)
B3 management regulations set up two independent but intertwined compliance paths, and set up dual-track control based on the degree of material risk. Namely B3 Substance Registration and B3 Substance Notification.
（一）Definition
a. B3 substance registration: Any entity that produces B3 substances and/or imports B3 substances into the territory of the Republic of Indonesia is obliged to submit a B3 substance registration application to the Director-General. (Subject: Manufacturer and Importer)
b. B3 substance notification: Any entity that imports B3 substances into or exports B3 substances from the territory of the Republic of Indonesia is obliged to submit a B3 substance notification application to the Director-General. (Subjects: Importers and Exporters). It can be divided into B3 substance import notice and B3 substance export notice.
（二）Scope of controlled substances
1. B3 substance registration
Scope of controlled substances: It has been included in the list of permitted and restricted B3 substances in the annex of Government Regulation No. 74 of 2001 "Measures for the Management of Hazardous and Toxic Substances" (referred to as B3 Management Regulations).
2. B3 Substance Notification
Scope of controlled substances:
a. Restricted B3 substances intended to be imported or exported into the Republic of Indonesia (Table 3 of Annex II);
b. B3 substances intended to be imported into the Republic of Indonesia for the first time (B3 substances not in the annex).
Use a table to illustrate:
B3 registration and notification are the core levels of chemical compliance in Indonesia, which directly determine whether products can be legally produced, imported and circulated. In the next article, we will continue to go in-depth and completely dismantle the full set of application materials, processing procedures, review points and common misunderstandings for B3 registration and notification, helping enterprises to clear customs in one go and implement it efficiently.
Odyssey Compliance Incorporation (OCI) has provided chemical compliance technical services for 19 years and will continue to adhere to its 5A service commitment and wholeheartedly provide technical support to chemical operating companies to answer questions and protect compliance registration and product safety.
Odyssey Compliance Incorporation (OCI) was established in June 2006. It is one of the earliest independent product regulations and compliance technical service providers in China and the Far East. Currently, OCI is a service provider for 125 Fortune 500 companies and has served more than 3,500 global companies in total.
