Notification & Registration of Chemicals

Chemical substances have two sides as both the basic raw material for all economic activities, and as the cause for pollution of the environment. In other words, chemicals utilized as medicine, advanced materials, pesticides, etc. serve to make life convenient, but they also cause serious environmental damage through their persistence and toxicity. Therefore, in order to carry out preventive chemical substance management for the purpose of minimizing effects on health/the environment in the process of chemical use, laws regarding their regulation and certification were enacted and are being enforced.

Notification & Registration of Chemicals

EU
REACH(Registration, Evaluation Authorization and Restriction of Chemicals)

Within the EU, under REACH regulations, all chemical substances which are imported at 1 ton or more annually are obligated to undergo registration(in case of mixtures, each individual constituent substance must be registered).
However, polymers are not subject to this process, and instead polymers require the registration of their monomers. Moreover, if highly dangerous substances are released without intent in the finished product, if said substance exceeds 0.1% in weight per item and exceeds 1 ton annually across all items of the product, it must undergo the notification process.
Businesses outside the EU may register by appointing an OR(Only Representative).

· Support for OR designation process
· Confirmation of SIEF leader and communication
· Confirmation of data owner, communication regarding purchase of data
· Support of SIEF management and consortiums
· Service on registration/notification, permits, performing duties on restrictions
· Providing latest news regarding REACH
· Setting safety test strategies, arranging/monitoring tests


United States
TSCA(Toxic Substances Control Act)

When manufacturing/importing new chemical substances in the US under TSCA, the manufacturer/importer has an obligation to make a PMN(Pre-Manufacture Notice) to the EPA(Environmental Protection Agency) before the act, and report again with a NOC(Notice Of Commencement) once manufacture/import begins.
Various exemption provisions exist regarding the quantity, properties, import purpose, etc. of the substance, with obligations to notify or report to the authorities.

· Application for pre-manufacture exemptions (LVE, TME, LoREX, low-concern polymers, etc.)
· Preparation of PMN dossiers
· Reporting beginning of manufacture/import with NOC
· Notice of manufacture/import activities(NOA Form B)
· Review whether chemical is subject to SNUR
· Setting safety test strategies, arranging/monitoring tests


Japan
化審法(CSCL) 安衛法(ISHL)

When manufacturing/importing new chemical substances in Japan, under the CSCL(Chemical Substance Control Law), the manufacturer/importer must make a notification to the Ministry of Economy, Trade and Industry, the Ministry of Health, Labor and Welfare, and the Ministry of the Environment with hazard information(results from safety tests, etc.) attached, and must also make another separate notification to the Ministry of Health, Labor and Welfare under the ISHL(Industrial Safety and Health Law).
In case the quantity of manufacture/import is small or the substance is a polymer that satisfies certain conditions, the required hazard information in the notification may be reduced or exempted, but in this case an application for confirmation on whether exemption conditions are satisfied is required.

· Determination whether chemical is subject to notification or exemption
· Notification of new chemical substances
· Notification and monitoring of chemical manufacture/import
· Application for registration of new chemical substances with low production quantity
· Application for advance confirmation of low-concern polymers
· Setting safety test strategies, arranging/monitoring tests


China
新化学物质环境管理办法(CHINA REACH)

When manufacturing/importing new chemical substances in China, under CHINA REACH, the manufacturer/importer must notify the authorities and acquire a registration certificate before manufacture/import begins. Moreover, for general notifications, initial activity reports are mandatory, and for simplified notifications, annual reports.
The hazard information submitted in typical notification is applied differentially according to quantity of manufacture/import, and polymers with certain uses or qualifying for certain conditions may use simplified notifications instead.

· Confirmation of registration status in IECSC(Inventory of Existing Chemical Substances in China)
· Review of notification type for chemicals
· Preparation and submission of registration dossiers for new chemical substances(notification of proposal for research funds, simplified notification, general notification)
· Submission of initial activity reports and annual reports
· Setting safety test strategies, arranging/monitoring tests


Taiwan
毒性及懸念化学物質管理法(TCCSCA)  職業安全衛生法(OSHA)

Taiwan’s registration/monitoring system for new chemical systems is governed by the TCCSCA(Toxic and Concerned Chemical Substance Control Act) controlled by the Environmental Protection Administration, and the OSHA(Occupational Safety and Health Act) controlled by the Ministry of Labor. All chemicals that are manufactured/imported in excess of 100kg annually must be notified to the authorities. If the Taiwanese importer designates a TPR(Third-Party Representative) to represent them in the notification process, notification may proceed without revealing the chemical’s information to the importer.

· Confirmation of registration status in TCSI(Taiwan Chemical Substance Inventory)
· Confirmation whether chemical is subject to exemption(R&D, low-concern polymers)
· Preparation and submission of registration dossiers for new chemical substances(low-volume registration, simplified registration, standard registration)
· Setting strategies for, arranging and monitoring tests required in submission(appointment of testing facilities, monitoring of progress)
· Setting safety test strategies, arranging/monitoring tests
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