From affirmation of new chemical substances through submission to the Chinese Authority
From January 1, 2021, "Measures for the Environmental Management Registration of New Chemical Substances" (Order No. 12 of the Ministry of Ecology and Environment of the P. R. China) replaced "Measures for Environmental Management of New Chemical Substances" (Order No. 7 of Ministry of Environmental Protection, date of enforcement: October 15, 2010) . As a consequence thereof, where exporters of new chemical substances out of China who wish to import new chemical substances into China, they shall execute a Registration Procedure via importers within China, or via an agent.
We, Sumika Chemical Analysis Service, Ltd. (SCAS) provide an integrated service (one-stop service), including the affirmation of new chemical substance, the arrangement of required studies, the applications of documents to the authorities, and a local agent service by our subsidiary, Sumika Analysis & Evaluation Service (Shanghai) Co., Ltd. (SAES) or our partner in China.
Regulation
"Measures for the Environmental Management Registration of New Chemical Substances" (Order No. 12 of the Ministry of Ecology and Environment of the P. R. China)
Date of enforcement:
January 1, 2021
Responsible authority:
the Ministry of Ecology and Environment of the P. R. China (Contact: The Solid Waste and Chemicals Management Center of the Ministry of Ecology and Environment of the P. R. China )
Former regulation:
"Measures for Environmental Management of New Chemical Substances" (Order No. 17 of state Ministry of Environmental Protection Administration) (Date of enforcement: September 12, 2003)
"Measures for Environmental Management of New Chemical Substances" (Order No. 7 of Ministry of Environmental Protection) (Date of enforcement: October 15, 2010)
Overview
Object substance
·Chemical substances which are not listed in the Inventory of Existing Chemical Substances in China (IECSC).
·Chemical substances which have been listed in the IECSC and subject to new usage environmental management, and are used for industrial applications other than the permitted uses.
Notifier
·The domestic legal entities registered within the territory of People’s Republic of China who are planning to be engaged in new chemical substance importation/manufacture.
·The oversea legal entities who are planning to be engaged in new chemical substance importation into China. (The oversea notifier must designate enterprises and institutions (Locl agent) registered in accordance with the law in the P. R. China that are able to bear legal responsibility independently as agents to jointly perform the registration of environmental management of new chemical substances and post-registration environmental management obligations, and to assume responsibility in accordance with the law.)
Obtaining a registration certificate
Obtain a new chemical environmental management registration certificate or implement a new chemical environmental management notification before manufacture or importation.
Local agent
Local agent shall be able to bear legal responsibility to jointly perform the registration of environmental management of new chemical substances and post-registration environmental management obligations with the the oversea notifier, and to assume responsibility in accordance with the law.
Type of notification ("Measures for the Environmental Management Registration of New Chemical Substances" Articale 11 - 14)
| General Registration |
Annual Manufacture / Importation Volume ≥ 10 t/a (After registration, the substance can be listed in IECSC in five years.) |
| Simplified Registration |
1 t/a ≤ Annual Manufacture / Importation Volume < 10 t/a (After registration, the substance will not be listed in IECSC) |
| Record Notification |
New chemical substances manufactured or imported with an annual volume of less than 1 ton or Polymers containing less than 2% monomers or reactants which are new chemical substances, or polymers of low concern (No registration certificate issued, activity possible after submission of application to authorities) |
Our services
Preliminary survey before Registration
Inventory of Existing Chemical Substances in China monitoring
Planning of a registration strategy based on your existing data (physico-chemical property, toxicity, eco-toxicity data, exposure status, classification, and labeling), considering your business situation
Services related to Registration
Specifying the data gap, planning the studies strategy for filling in the data gap
Arrangements in affiliated testing institutions in China or overseas, studies progress monitoring, etc.
Dossier preparation, submission and corresponding of authorities’ requirement
Local agent services provided by our local subsidiary, Sumika Analysis & Evaluation Service (Shanghai) Co., Ltd. (SAES) or our partner in China
Other consulting services
Preparation of SDS and Label based on the requirements in China
Coordination and negotiations with Chinese authorities
Regulatory survey and report etc
Contact Us for Services
For inquiries and requests concerning services of analysis, measurements, products and consulting , please feel free to contact us via inquiry form or telephone/fax .
- Telephone
- +81-3-5689-1219
- FAX
- +81-3-5689-1222