Indonesia Reach Regulation for Various Sectors

In Indonesia the so-called negative list approach is employed for chemicals control. Hazardous and toxic chemicals are regulated by making lists of specified hazardous chemicals to be controlled. Indonesia does not have a risk-based chemical control approach to regulated chemicals based on assessment results of their hazards and exposure as is employed in for example EU-REACH. However, the Indonesia government is working to improve the current method of chemical control. Indonesian government published the Chemical Substance Bill that aims to regulate from import/export, production, transportation, usage to disposal in 2012. As of 2018 the Bill has not been promulgated but is still under consideration.

Currently chemicals are mainly regulated by Government Regulation No. 74/2001 under Law No. 32/2009 but also by specific regulations about distribution and control of hazardous materials. The most important regulations are listed below:

Government Regulation No. 74/2001 on Hazardous and Toxic Substances Management is often called the B3 Management Regulation since hazardous and toxic material is called Bahan Berbahaya dan Beracun (abbreviated as B3) in the Indonesian local language Bahasa. It is a central regulation for chemicals control, and it regulates the entire life cycle of B3 substances, including import, production, transportation, distribution, storage, use, and processing.

Article 3 of Regulation No. 74/2001 lists the management of the following materials as being out of scope of the Regulation. The first six categories on the list are regulated by their own specific regulations and the last two categories are not expected to contain hazardous ingredients according to the Indonesian Food and Drug Authority (FDA).

• Radioactive materials
• Explosive devices/detonators/dynamite
• Mining products, oil, natural gas and their derivatives
• Pharmaceutical prepared materials
• Narcotics, psychotropic, their precursors and other addictive substances
• Chemical weapons and biological weapons
• Food, beverages and food additives
• Household health and cosmetics supplies

Law No. 32/2009 Environmental Protection and Management is a fundamental environment law which regulates the environmental management in Indonesia. The purpose of this Law is to create an environmentally sustainable development through means of an environmental planning policy, as well as the rational exploitation, development, maintenance, restoration, supervision, and control of the environment. Law No. 32/2009 also sets penalties for environmental violations in detail.

Government Regulation No. 36/2017 about Distribution and Control of Hazardous Materials was stipulated by the Minister of Environment and Forestry in 2017 in order to implement the provisions of Article 6 and 10 of Government Regulation 74/2002. Government Regulation 36/2017 requires manufacturers and importers of B3 substances to apply for registration via the PTSP online system. This regulation came into force on 8 June 2017 and the 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 was thereby repealed.

Regulation of the Ministry of Trade No. 07/2022 on the Distribution and Control of Hazardous Materials was enacted in February of 2022. The Regulation governs the distribution of B2 hazardous substances listed in the Appendixes in the Regulation. Businesses distributing B2 substances are required to obtain a business permit or license, label, and issue SDSs for the B2 substances and report distribution results.

In Indonesia, companies involved in hazardous activities, i.e. companies that use or produce hazardous substances are required to conduct waste management and obtain a waste-related license for each waste-related activity (e.g. storage, collection, transportation, utilization, processing, landfilling, and dumping of B3 waste).  Article 1 (22, 23) of Law No. 32/2009 defines B3 waste as any waste containing hazardous and toxic materials and B3 Waste Management as an activity covering the reduction, storage, collection, transportation, utilization, treatment, and/ or filling of B3 waste. Government Regulation No. 22/2021 on Environmental Protection and Management, provides management rules for B3 waste and non-B3 waste. Annex IX of the Regulation sets the list of B3 waste, and Annex X and XI set test parameters to determine B3 waste categories.

Requirements for B3 Waste

Activities related to B3 waste will require a Technical Environmental License referred to as a Technical Approval and/or an Operational Feasibility Letter. The Technical Environmental License is in addition to the environmental assessments that each company is required to obtain. The assessments are as follows:

• Environmental Impact Assessment (EIA - AMDAL in Indonesian)
• Environmental Management and Monitoring Measures
• Statement of Environmental Monitoring and Management

Restrictions or prohibitions on the use of hazardous substances exist for specific products or substances, such as fertilizers, polychlorinated biphenyls (PCBs), and mercury. Both PCBs and mercury are classified as hazardous and toxic substances that must be reduced or eliminated.

The provisions related to PCBs are contained in the Ministry of Environment and Forestry Regulation No. P.29/MENLHK/SETJEN/PLB.3/12/2020 of 2020, Management of Polychlorinated Biphenyls. The Regulation states that PCBs are prohibited for use and that management efforts are required to be made to remove PCBs gradually from transformers, capacitors, and dielectric oil. The presence of PCBs should be eliminated no later than 2028 in accordance with the provisions of the Stockholm Convention.

The provisions for mercury can be found in the Presidential Regulation No. 21 of 2019 on the National Action Plan for Reduction and Abolishment of Mercury Use. The National Action Plan shall be carried out within the period of 2018-2030 and overs strategies, activities, and targets for reducing and eliminating mercury, which is prioritized in the areas of manufacture, energy, small-scale gold mining, and health.

The Ministry of Environment and Forestry (MoEF) has the main authority to operate the current management system guided by the Government Regulation No. 74/2001 on Hazardous Substances Management as well as Government Regulation No. 36/2017 on Procedure about Registration and Notification of Hazardous and Toxic Substances. In order to prevent and mitigate the risks of hazardous and toxic material impacts to the living environment, human health, and other living creatures, the MoEF requires different compliance procedures such as registration and notification of toxic and hazardous (B3) chemicals for various stakeholders. For B2 substances the authority is the Ministry of Trade (MOT).

B2 Substances

The term Hazardous Substance or Bahan Berbahaya (B2) is defined in the Minister of Trade Regulation No. 7/2022 as substances, chemical and biological substances, either in single form or in mixtures which can directly or indirectly endanger health and the environment, which have toxic, carcinogenic, teratogenic, mutagenic, corrosive, and irritation characteristics.

B3 Substances

The term Hazardous and Toxic Substances or Bahan Berbahaya dan Beracun (B3) is defined in Government Regulation No. 74/2001 as substances included in one or more of the following categories: toxic substances, explosive substances, flammable substances, oxidating and reducing substances, explosive and flammable substances, pressured gas, corrosive/irritative substances, radioactive substances, as well as other hazardous and toxic substances.

Importers and producers of B3 substances have compliance obligations that include notification and registration as well as labelling. Distributors of B2 substances must obtain permits and have labelling, SDS, and reporting obligations.

The Ministry of Environment and Forestry (MoEF) Regulation No. 36/2017 on Registration and Notification Procedures for Hazardous and Toxic Substances provides the procedures for the registration and notification of B3 substances. Furthermore, the distribution of B2 substances is regulated by the Ministry of Trade (MOT) Regulation No. 7/2022 on Distribution and Control of Hazardous Materials.

Registration B3 Substances 

Anyone who produces B3 substances and/or imports B3 substances into Indonesia is required to submit an application for B3 Registration to the Director General of the MoEF. The application is made through the PTSP online system with the web address http://ptsp.menlhk.go.id. PTSP is the abbreviation of Pelayanan Terpadu Satu Pintu which translates to the One-Stop Integrated Service. The PTSP is a part of the framework of the Indonesian National Single Window (INSW) electronic registration system. The INSW is an Indonesian national system that provides single submission of data and information, single and synchronous processing of data and information, and single decision making for custom release and clearance of cargoes. The objective of the INSW is to make customs release and clearance of cargos faster and cheaper while preventing illegal trafficking of hazardous substances.

To be able to access the PTSP online system B3 Registration applicants are required to apply for access to PTSP accounts and complete a company registration by uploading the following documents:

• Deed of establishment and/or change of company
• Trade Business Permit (SIUP) / Industrial Business Permit (IUI) / Permanent Business Permit (IUT)
• Company Registration Certificate (TDP)
• Taxpayer Identification Number (NPWP)
• A valid power of attorney for delegating company accounts.

The application for B3 Registration must be uploaded along with the following documents:

• Filled B3 Registration form
• Photo of B3 storage warehouse
• Photo of B3 packaging
• Photo of B3 storage arrangement
• Safety Data Sheet (Lembar Data Keselamatan, LDK)
• Certificate of Analysis (CoA)

Furthermore, every person who is going to import B3 substances into Indonesia, must upload complete documents, which include:

• Import Identification Number (API)
• Goods Import Notification Letter (PIB)
• Notification approval letter from the country of origin
• Other required documents related to B3 Registration (such as a Certificate of B3 Registration and B3 Distribution Permit from the minister who carries out government affairs in the agricultural sector, for B3 types of pesticides)

When the application for B3 Registration has been approved, the Director General of the MoEF issues an electronic B3 Registration Certificate which contains the following information:

• The company name and address
• Code Harmonized System (HS)
• B3 Registration number
• Internationally recognized chemical name
• Trade name
• Country of origin, for B3 imported into Indonesia.

Notification for B3 Substances

Any person who imports B3 substances to Indonesia or exports B3 substances out of Indonesia is required to apply for a B3 Export or Import Notification to the Director General of the MoEF. The B3 notification must be made for:

• B3 substances which are limited to use (listed in Regulation No. 74/2001, Annex II, Table 1), which will be imported into or removed from Indonesia.
• B3 substances which will be entered into Indonesia for the first time.

Import Notification

The B3 Import Notification is submitted by the applicant to the Director General of the MoEF through the authority of the B3 exporting country. The Import Notification should contain the following information:

• Trade name
• Chemical name
• CAS number
• B3 exporter identity
• B3 importer identity
• The intended use
• Safety Data Sheet (LDK)
• The amount of B3 to be included
• B3 import plan

If the application for Import Notification is approved a B3 Import Approval Letter which is valid for 1 year will be issued and will be the basis for issuing B3 Import Permits. The B3 Import Approval Letter contains:

• B3 identity
• Identity of B3 recipient
• B3 exporter identity
• Country of origin B3
• B3 import plan
• B3 use plan

Export Notification

The B3 Export Notification is submitted by the applicant to the authority of the B3 exporting country through the Director General of the MoEF and is carried out if the receiving country’s authority requires a B3 Export Notification. The Export Notification should contain the following information:

• B3 identity
• Identity of the name and address of the B3 exporter company
• B3 exporter Trade Business Permit (SIUP)
• Taxpayer Identification Number (NPWP) of B3 exporters
• B3 importer identity
• Recipient country destination
• Transit country destination
• The intended use
• The amount of B3 to be exported
• Safety Data Sheet
• B3 export notification form

Article 3 of Regulation No. 07/2022 states that distribution of B2 substances only can be conducted by the following three types of business:

• Registered hazardous substances distributors (DT-B2). DT-B2 (Distributor Terdaftar B2) are large scale commercial enterprises handling hazardous substances that possess a business identification number under the Indonesia Standard Industrial Classification No. 46653 for the distribution of hazardous substances.
• Industrial companies handling hazardous substances (P-B2): P-B2 (Perusahaan Industri B2) are persons located in Indonesia that perform activities in the hazardous substances industry sector in accordance with the industrial sector regulations.
• Registered hazardous substances importers (IT-B2): IT-B2 (Importir Terdaftar B2) are state-owned enterprises that possess a business identification number valid as an import identification number and that are engaged in the import and distribution of hazardous substances.

A DT-B2 must have a B2 Business License from the Minister of Trade to be allowed to distribute B2 substances. The application for the Business License shall be made electronically through the Online Single System (OSS: https://www.oss.q.id). The application must be accompanied by documents such as a letter of appointment from a P-B2, a written description of the storage, and a document indicating possession of an emergency response system. The B2 Business License is valid for 3 years. For P-B2 and IT-B2, only a Business Permit in accordance with the law is required.

B2 substances listed in Appendix I of Regulation No. 07/2022 can be distributed directly to businesses that use them as raw substances by P-B2 or IT-B2 or alternatively they can be distributed through an intermediary DT-B2. B2 substances listed in Appendix II cannot be handled by DT-B2 and must therefore be distributed directly from P-B2 or IT-B2 to the business.

When distributing B2 substances it is obligatory to attach a Safety Data Sheet (SDS) and a label on the packaging. The label must include the following information:

• Type of B2
• Name and address of the DT-B2, P-B2, or IT-B2 packing the B2 substances
• Net weight or volume of B2
• Application, hazard pictogram/symbol, signal words, and hazard statement

UKL-UPL

In Indonesia, companies that engage in hazardous activities (including the use or production of hazardous substances) are required to submit a report on environmental management and monitoring measures (UKL-UPL), as a part of the country’s Environmental Impact Assessments (AMDAL in Indonesian) procedure. A UKL-UPL report needs to be submitted by every company every 6 months (depending on the business specification) to the local Department of Environment. The report contains environment quality measurement, management procedures, and evaluation (see Government Regulation No. 22/2021 Article 48-point (6) f.6). To submit a UKL-UPL report, the requirements are as follows:

• Letter of application for environmental recommendation
• Document on Environmental Management Efforts - Environmental Monitoring Efforts (UKL-UPL)
• Spatial suitability letter
• Permission no objection from residents
• Site plan or activity plan
• Environmental management map
• Environmental monitoring map
• Copy of land certificate
• Photocopy of deed of establishment of the company

The requirements and table of contents for the UKL-UPL report may differ from region to region in Indonesia. Applicants can submit their information through the SIPT PDN system (the Domestic Trade Integrated Licensing Information System, an online application platform for permit issuance activities within the Directorate General of Domestic Trade (https://sipt.kemendag.go.id/portal/news). The main function of the SIPT PDN Application include submitting permit applications online by trading companies or individuals, processing permits by officers, and issuing permit recommendations.

Reporting B3 Waste

Article 296 (c) of Regulation No. 22/2021 states that every person who generates hazardous waste and carries out activities for storing hazardous waste must compile and submit reports on the implementation of hazardous waste storage activities to the official issuing the Environmental Approval at least one time in six months since the issuance of the business registration number and/or the Environmental Approval. The report should contain:

• Source, name and amount of hazardous waste
• Category and/or characteristics of the hazardous waste
• Implementation of hazardous waste storage
• Hazardous waste utilization, hazardous waste processing, and/or hazardous waste storage carried out by the producer of the hazardous waste and/or submission of the hazardous waste to hazardous waste collectors, hazardous waste users, hazardous waste processors, and/or hazardous waste landfills.

Reporting for B2 Substances

DT-B2, P-B2, and IT-B2 are required to report the distribution results of B2 online at https://sipt.kemendag.go.id/. DT-B2 are also required to report the amount of B2 obtained from P‑B2 or IT-B2. The reporting shall be done quarterly using the form provided in Appendix III of Regulation No.  7/2022 and within the following deadlines:

• First quarter results: April 5
• Second quarter results: July 5
• Third quarter results: October 5
• Fourth quarter results: January 5 of the following year

Indonesia does not have an approved National Chemical Inventory. However, the Government Regulation No. 74/2001 on Hazardous and Toxic Substances Management regulates hazardous and toxic substances. Since hazardous and toxic material is called Bahan Berbahaya dan Beracun in the Indonesian local language Bahasa, the abbreviation B3 is used for hazardous and toxic substances in Indonesia. Regulation No. 74/2001 contains 2 Annexes that list B3 substances in 3 different categories as listed in the following table:

Number of Substances per B3 category in Indonesia

Article 1 of Regulation No. 74/2001 defines B3 Hazardous and Toxic Substance as substances or materials that by their nature, concentration, and/or quantity, may, either directly or indirectly, contaminate and/or damage the living environment, and/or harm the living environment, health, human survival, and other living creatures. Furthermore, in Article 5 of Regulation No. 74/2001 B3 substances are classified as substances that are explosive, oxidizing, extremely flammable, highly flammable, flammable, extremely toxic, highly toxic, moderately toxic, harmful, corrosive, irritant, dangerous to the environment, carcinogenic, teratogenic, or mutagenic.

Furthermore, the Regulation of the Minister of Trade No. 07/2022, Concerning Distribution and Control of Hazardous Substances, contains 2 lists of B2 hazardous substances. The definition of hazardous substances in Article 1(1) of the Regulation is that hazardous substances (B2: bahan berbahaya) refer to chemical and biological substances and substances in the form of pure substances or mixtures that are toxic, carcinogenic, teratogenic, mutagenic, corrosive, and irritating and that may directly or indirectly endanger human health and the environment, The specific lists of B2 can be found in Appendix I of Regulation No. 07/2022 (Types of Hazardous Materials) with 66 entries and Appendix II (Types of Hazardous Materials Categorized in list of Chemicals) with 96 entries.