In January 2022, the Regional Comprehensive Economic Partnership (RCEP) Agreement entered into force, covering 10 ASEAN countries, China, Japan, South Korea, Australia and New Zealand. After RCEP comes into effect, more than 90% of the trade of goods in the region will eventually achieve zero tariffs, which involves the chemical industry with more than 1,000 tariff numbers of RCEP origin rules, benefiting the import and export trade of chemicals. Within the RCEP coverage, most countries, including China, have adopted GHS classification and labelling systems, which requires the Safety Data Sheet (SDS) and labels of chemicals to comply with the GHS-related regulations and standards of each country and region. The CIRS Group makes a summary of the latest management regulations and regulatory requirements on chemicals in RCEP countries to help enterprises enjoy the trade interests brought by the RCEP.
On 29 April 2020, the Ministry of Ecology and Environment released the latest revised version of Measures for Environmental Management Registration of New Chemical Substances (Order No.12 of the Ministry of Ecology and Environment, hereinafter referred to as “Order No.12”), which has entered into force on 1 January 2021. The Measures for Environmental Management of New Chemical Substances (Order No.7 of the Ministry of Environmental Protection) promulgated by the former Ministry of Ecology and Environment on 19 January 2010 shall be abolished simultaneously. The term “new chemical substances” mentioned in the Order No.12 refers to chemical substances that are not listed in the Inventory of Existing Chemical Substances in China (IECSC). The environmental management registration of new chemical substances includes regular registration, simplified registration and record. Producers or importers of new chemical substances shall obtain a regular registration certificate or a simplified registration certificate for environmental management of new chemical substances or handle an environmental management record of new chemical substances before production or import. However, the chemical substances that are specified in the IECSC to be subject to new uses environmental management used for industrial purposes other than the permitted uses, shall be subject to environmental management in accordance with relevant regulations of new chemical substances.
On 17 November 2020, the Announcement of the Guidelines for the Environmental Management and Registration of New Chemical Substances and Instructions for Filling out Related Forms (Ministry of Ecology and Environment Announcement No. 51 of 2020, hereinafter referred to as the Guidelines) was officially announced. The Guidelines provides important guidance for enterprises to carry out the registration and management of new chemical substances, which refines relevant regulations in Order No. 12 and clarifies specific implementation requirements. The Guidelines mainly covers the registration scope, registration type, registration process, requirements for application materials of registration, special provisions on polymers, registration of new uses environmental management, re-registration, change and withdrawal of registration certificate, and tracking management requirements, which specifies the requirements of environmental management registration of new chemical substances and can be used to guide applicants and representatives in registration work. It also fulfills responsibilities and obligations entrusted by the Order No.12.
The K-REACH, known as the Act on Registration and Evaluation of Chemicals, entered into force on 1 January 2015. By adopting registration, assessment, authorization and requirements on registration similar to the EU REACH regulation, this Act covers the management of new chemical substances, the existing chemical substances and downstream products, and proposes requirements for registration of the first batch of 510 substances.
On 28 December 2016, the Ministry of Environment (MOE) in Korea made the decision to revise the current K-REACH regulations and the revised K-REACH was officially implemented on 1 January 2019. As a major amendment, this Act has introduced the model of pre-registration and in-phrase registration by tonnage for existing chemicals, which has a greater impact on the industry. The List of registration for 510 existing chemical substances is not subject to this Act. If the enterprise’s chemical substances are listed on the first batch of 510 designated existing substances without completing the registration process, then the substances cannot be produced in or imported into Korea after 1 July 2018. Only if the registration is completed by the enterprise can the production and import of these substances be operated in Korea.
The entities of registration in K-REACH are native manufacturers, importers in Korea, and non-Korean manufacturers can complete the registration through Only Representative (OR). The registration scope of chemical substances refers to the existing chemical substances that have a production/import volume in the Korean market of over 1 t/a and new chemical substances that have a production/import volume in the Korean market of over 100 kg/a. New chemical substances in volume no more than 100 kg are only required for notification.
There are two chemical regulations in Japan, namely, the Chemical Substance Control Law (CSCL) and the Industrial Safety and Health Law (ISHL).
The Ministry of Economy, Trade and Industry (METI), the Ministry of Health, Labour and Welfare (MHLW), and the Ministry of the Environment (MOE) jointly issued the revised CSCL. The CSCL has come into force in two steps on 1 April 2009 and 1 April 2011 respectively.
The CSCL imposes registration requirements for new chemical substances, and these requirements under CSCL shall be met by the manufacturers and importers in Japan. Their main responsibilities are as follows:
- Make notifications for new chemical substances, including standard notification, low volume confirmation, small amount confirmation and intermediates.
- Submit the annual report.
For chemicals that are not categorized as new chemical substances, they can be divided into existing chemical substances, priority assessment chemical substances (PACs), monitoring chemical substances, Class I specified chemical substances and Class II specified chemical substances. Each of them shall be regulated under various requirements.
Besides the CSCL, manufacturers and importers of new chemical substances shall also meet the requirements of the ISHL issued by the MHLW in 2011. Before the chemical products are manufactured or imported, enterprises shall complete relevant notifications. The qualified entities for notification are manufacturers and importers of new chemical substances in Japan. Types of notifications can be classified as regular notifications and low volume notifications.
There is no exclusive regulation on the management of new chemical substances in Indonesia, and the major chemical regulation in Indonesia is the Government Regulation regarding Hazardous and Toxic Material Management. If chemical substances are listed in the Annex to the Regulation, licenses on production, import, export, transportation, transfer, storage, use and disposal shall be obtained.
The major chemical regulation in Malaysia is the Environmentally Hazardous Substances Notification and Registration Scheme (EHSNR) and there is no exclusive regulation for the management of new chemical substances currently. The EHSNR was promulgated in January 2009 and came into force in 2011, requiring the submission of data related to environmentally hazardous substances (EHS).
According to the EHSNR, an EHS is a substance that is assigned to the hazard category under the GHS classification scheme or a substance that is on the internationally recognized prohibited list. Manufacturers and importers in Malaysia can apply for basic notification (for substances on the EHS reference list only) and detailed notification (for substances not on the EHS reference list).
Rules and regulations for the management of chemicals in Philippines are Toxic Substances and Hazardous and Nuclear Wastes Control Act of 1990 (RA 6969) and Implementing Rules and Regulations of Republic Act 6969 (DAO 29) released by the Department of Environment and Natural Resources (DENR). DAO 29 is the guidance for RA 6969. These regulations cover the importation, manufacture, processing, handling, storage, transportation, sale, distribution, use and disposal of all unregulated chemical substances and mixtures in the Philippines, including those substances for export only after importation. Chemicals that are not listed in the Philippine Inventory of Chemicals and Chemical Substances (PICCS) are new chemical substances, which should be notified under PMPIN before manufacture or import. The notification types of PMPIN cover the abbreviated PMPIN and detailed PMPIN. The former can be used when a new chemical is manufactured, imported or used in other countries without limitation. In addition, sufficient information showing this substance posing no unreasonable risk shall be submitted by the notifier. Detailed PMPIN can be used when the manufacturer or importer cannot adequately demonstrate the safety of the new chemical or when DENR-EMB determines that the information submitted does not contain sufficient documentation to determine the safety of the new chemical. The new chemical substances, of which the import volume is lower than 1000 kg/a, are required to conduct SQI Notification.
On 8 November 2019, the DENR released the Polymers and Polymer of Low Concern (PLC) Exemption from the Pre-Manufacture and Pre-Importation Notification (DAO 2019-18). This administrative order has entered into force and the central office of the Environmental Management Bureau has officially processed the polymer exemption applications on 6 January 2020.
In 2020, Thailand released the Thailand Existing Chemicals Inventory (TECI), containing 11,476 chemical substances. This Inventory is made to assist the implementation of the Hazardous Substance Act and Hazard Classification and Communication System of Hazardous Substances. Thailand is expected to make amendments to provisions on responsibilities and duties in the Hazardous Substance Act in 2022. It is reported that Hazardous Substance Act will introduce a system of registration and labelling of new chemical substances, and establish a national exclusive management agency responsible for the implementation and supervision of regulations.
Chemicals management in Singapore mainly aims at hazardous chemicals that are harmful to human body and the environment, and there are no requirements for new chemical substances. Applications need to be submitted when importation, production, or sale of chemicals that are listed on the list of hazardous substances annexed to the Environmental Protection and Management Act (EPMA).
The notification of the drafted National Chemical Inventory (NCI) was ended on 30 May 2020. After the notification, this Inventory will be considered as the valid version of existing chemicals which has not been officially released yet. Moreover, the Vietnam Chemical Agency (Vinachemia) will make amendments to the Vietnam Chemicals Decree (No.113/2017/ND-CP). Detailed information on chemical substances in Vietnam can be queried through the official database. However, the status of chemical substances on the Inventory can only be acquired through the account applied for by enterprises in Vietnam.
The official database allows enterprises to view the management of chemical substances in Vietnam to determine whether their substances are subject to notification or to be restricted from production and operation.
The Australian Industrial Chemicals Introduction Scheme (AICIS) replaced the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) on 1 July 2020 as the new national regulator of the importation and manufacture of industrial chemicals in Australia. Components used only in cosmetics are prohibited in animal tests on 1 July 2020. Then the Australian Inventory of Chemical Substance (AICS) is replaced by the Australian Inventory of Industrial Chemicals (AIIC) (hereinafter referred to as the Inventory). Enterprises must verify whether the chemicals are listed in the Inventory and whether they meet the use conditions before importing and/or manufacturing the industrial chemicals. Substances that are not listed on the Inventory or whose intended use differs from the conditions of use will be regarded as new industrial chemicals in Australia.. Unless an exemption applies, the new industrial chemical will need to be assessed by the authority for risks to the environment and human health before it can be imported and/or manufactured.
Here are obligations under AICS.
Anyone who imports or manufactures (introduces) industrial chemicals ‑ or products that release industrial chemicals ‑ into Australia for commercial purposes must:
- Register their business and pay a fee (if enterprises are not already registered with NICNAS).
- Categorize each chemical importation or manufacture (introduction) into 1 of 5 categories.
These five introduction categories include: listed chemical introduction, exempted chemical introduction, reported chemical introduction, assessed chemical introduction, and commercial evaluation. Under the category, relevant procedures need to be carried out before the introduction of chemical substances.
Here are reporting and record-keeping requirements:
Regardless of the introduction category, every introducer must submit an annual declaration at the end of every registration year. This is a declaration enterprises make about the industrial chemicals they imported or manufactured in the previous registration year and confirm that their introductions were authorized under Australian laws.
The declaration must be completed by the person/party who introduced the chemical and submitted via AICIS Business Services. A reminder will be sent to enterprises before the due date.
Different from Australian regulations, New Zealand’s Hazardous Substances and New Organisms Act (HSNO Act) is promulgated by the Environment Protection Authority (EPA) to regulate the use of hazardous chemicals in New Zealand.
Under the HSNO Act, all hazardous chemicals produced in or imported to New Zealand shall complete approval procedures rigorously. Producers and importers of hazardous chemicals shall obtain the approvals under the HANO before placing the substances into the market and use the appropriate label, package, and SDS to ensure the products is within the permission range (without prohibited substances).
If the RCEP enters into force, it is conducive to chemical trade in the region. There are significant differences in chemical registration and management in RCEP countries, and enterprises need to know the latest chemical regulatory requirements of the targeted country. If the only representative (OR) is prescribed in the regulation, then OR can be entrusted by enterprises. If the importer is only accepted, the chemical regulation compliance needs to be completed with the assistance of the importer. This article summarizes the latest management regulations and regulatory requirements on chemicals in RCEP countries, which can be used as guidance to help enterprises run the trade smoothly.
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