Chemicals Management Laws Continue to Develop in Asia
Countries continue to refine their systems of registration and evaluation of chemicals, requiring industry to evaluate chemical inventories and seek alternatives as necessary.
Countries continue to refine their systems of registration and evaluation of chemicals, requiring industry to evaluate chemical inventories and seek alternatives as necessary. In the EU, member states will evaluate 138 substances over the next two years, according to a recently published community action plan. In the U.S., TSCA reform might bring enhanced requirements for evaluation of certain chemicals. Similarly, countries around the world are enhancing systems of evaluating and eventually phasing out persistent, bio-accumulative and toxic chemicals. China, Japan, South Korea and Taiwan continue to develop chemicals management requirements as described below.
China added 31 “new chemicals” to its list of “existing chemicals” on 8 March 2016, effectively changing regulatory requirements for handling listed chemicals.These 31 substances are now part of China’s inventory of existing chemicals, listing over 45,000 chemicals. Depending on designation and hazard, manufacturers and importers of listed chemicals must comply with pollutant release and reporting requirements, emergency response measures, monitoring and other controls. China’s most strict chemical restrictions apply to chemicals used in petrochemical processing, pharmaceutical manufacturing, chemical fiber manufacturing and manufacturing of bulk industrial chemicals.
Chemicals used in these highly hazardous industries must implement specified chemicals management systems, namely:
- A chemical substances environmental risk evaluation system;
- A hazardous chemicals environmental management registration scheme;
- A release and transport reporting system subject to key environmental management hazardous chemicals; and
- A phase-out list of hazardous chemicals which are highly toxic, non-biodegradable or have high environmental risk.
China aims to have 80% of targeted companies register their hazardous chemicals and report the release and transfer of their characteristic pollutants.
China has also proposed changes to registration requirements for new chemicals. Under China’s current law, a manufacturer or importer must register a chemical not listed on China’s chemical inventory using one of three procedures. The current law establishes a regular notification procedure, a simplified procedure and a research and development registration. Recently proposed changes could alter when registration procedures apply. For example, China proposes to set a lower limit for registration as an R&D chemical. Currently, the law requires R&D registration when a chemical is manufactured or imported in amounts less than 100 kg (0.1 metric tonnes) per year, with no lower limit. The proposal would set eligibility for R&D registration at an import or manufactured amount of at least 10 kg per year, but less than 100 kg per year. A proposed change would also allow companies to use testing results from test methods more than five years old, with approval from a review committee, when registering a chemical. The proposal would also create an exemption to registration for certain chemicals manufactured as reaction by-products that are not hazardous.
In Japan, the Law on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc., or the Chemical Substances Control Law (hereinafter, “CSCL”), regulates manufacture, import and use of chemicals in Japan. The CSCL includes requirements for prior notification, risk assessment, use restriction and reporting of new and existing chemicals, hazard communication and classification of general industrial chemicals. The CSCL is commonly referred to as the Japanese REACH after the amendments in 2009 which transformed the approach of the Japanese chemical management system from hazard-based to risk-based.
On 1 April 2016, administrative agencies designated 21 substances as Priority Assessment Chemicals, bringing the list of Priority Assessment Chemicals to 211 chemicals. The list consists of both chemicals registered as new chemicals and existing chemicals identified for further evaluation by the agencies. Once listed, chemicals are subject to annual reporting requirements. Manufacturers and importers must also provide hazard information to downstream users. Japan generally designates registered chemicals as either Class I or Class II substances. The designation, “Priority Assessment Chemical” is an interim designation for chemicals undergoing further evaluation. Class I chemicals are persistent and highly bio accumulative chemicals with long-term toxicity to humans or animals. Class II chemicals exhibit long-term toxicity to humans, flora or fauna. Regulatory controls vary by class.
In April 2016, South Korea updated hazard communication requirements based on the 4th Revision of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). As of 6 April 2016, chemicals that are used at workplaces have to be classified and labeled, and material safety data sheets for the chemicals have to be prepared, in accordance with the amended Standards on the Classification, Labeling and Material Safety Data Sheets of Chemicals. Amendments added the environmental hazard class “hazardous to the ozone layer.” Other amendments revised hazard statements and precautionary statements to align with the 4th revised edition of the United Nation’s Globally Harmonized System of Classification and Labelling of Chemicals (GHS). The Ministry of Employment and Labor has given a one-year transition period. Suppliers of chemicals and employers who have workplaces where chemicals are handled may continue to use the previous Standards to classify and label hazardous chemicals, and to prepare material safety data sheets for the chemicals, until 5 April 2017.
South Korea is also proceeding with implementation of its Act on the Registration and Evaluation of Chemicals, also known as K-REACH. The act implements an annual reporting requirement for new and existing chemicals. The act also requires registration and risk assessment of a designated set of 540 existing chemicals. In June of 2015, the Ministry designated 540 existing chemicals subject to registration. Registration is due 1 July 2018. This is the first batch of existing chemicals subject to registration. The Ministry of Environment will designate a set of existing chemicals subject to registration every 3 years. Registration deadline for the first set of designated chemicals is July 2018. Manufacturers and importers of designated existing chemicals must also submit risk assessment data if amount manufactured or imported is in amounts greater than or equal to 100 tons or more per year. This threshold will gradually be reduced to 10 tonnes or more per year by 2020.
In January 2016, the Ministry of Labor in Taiwan published a voluntary classification list classifying 6,000 chemical substances. Companies are not required to classify according to the list. The list provides a voluntary reference for companies shipping chemicals to Taiwan. Taiwan implements the 4th Revision of GHS in revised national standard CNS 15030.
Under the Toxic Chemical Substances Control Act, Taiwan is adopting an approach similar to that of the European Union’s Registration, Evaluation, Authorization and Restriction of Chemicals Regulation (EU REACH) to establishing a chemical registration system. Specifically, for existing chemicals, if facilities currently import or manufacture existing chemicals in amounts that exceed 100 kilogram, facilities must register the substance with Taiwan EPA. The registration period for this first group of chemicals ended on 31 March 2016. Existing chemicals are those listed in the Inventory of Existing Chemical Substances. The Inventory contains over 90,000 chemical substances.
Asian regional chemical safety database
Starting 28 April 2016, the ASEAN-Japan Chemical Safety Database (hereinafter, “AJCSD”) was officially launched by AEM-METI Industrial Cooperation Committee – an international cooperative committee between the ASEAN Economic Ministers (AEM) and Japan’s Ministry of Economy, Trade and Industry (METI). The AJCSD allows a singular point of access to the chemicals regulated in 8 ASEAN countries (i.e. Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Thailand, Vietnam) and Japan. Information is in each country’s official language as well as in English. Access is free of charge. AEM-METI designed the database as a way of raising transparency and encouraging compliance with chemicals management requirements. AEM-METI sees the database as a way of promoting gradual harmonization in the region. AEM-METI emphasizes that the database is for reference only, and should not be used as a substitute for regulatory requirements. The ASEAN-Japan Chemical Safety Database is available online.