New Policies on
Chemical Environmental Managementin China

Gao Yingxin
Chemical Registration Center of MEP
September 9, 2010

Table of Contents

Measures on Environmental Management of New
Chemical Substances
Strengthened Management of the Import/ExportRegistration of Toxic Chemicals

•••Overview of Order No.7•
•General

Chapter VI
Supplementary •Provisions

Principles(3 clauses)

Chapter I

Issued by: MEP
Issuance date:
January 19, 2010
Effective as of:October 15, 2010
Form: Ministerial
Order No. 7
Title: Measures on
Environmental
Management of New
Chemical Substances
Structure: 52 clauses
in 6 chapters(8 clauses)
Chapter II

Chapter V Legal
Responsibilities

MinisterialRegulation
No.7

notification
Procedure(7 clauses)(11 clauses)
Chapter III
notification
Management

Chapter IV
Tracking andControl(9 clauses)(14 clauses)

Notification Scope
Red ones are different from the current Order No.17•

Activities––––••

Research
Manufacturing
ImportUsed as process materials

Territories– Chinese territory– Excluding HK, Macao & Taiwan– Including bonded areas and exportoriented processing areas
Substances– Chemical substances not listed in the“Inventory of Existing Chemical
Substances in China”– Raw materials and intermediates for
producing medicines, etc.
– Articles designed to intentionallyrelease the contained new chemical
substances during their regularutilization•Exclusion and exemption categories– Finished products restricted by otherregulations: medicines, pesticides,
veterinary drugs, cosmetics, foods,food additives, feed additives,
radioactive substances, militaryengineering products, fireengineering products and tobaccos– Natural substances: naturalsubstances from physical process andair extraction, natural polymers andlife matters– Non-commercial or unintentional
products: impurities, accidental
reaction products, wastes andbyproducts– Other special substances: materials,alloys, non-isolated intermediates andother articles

Notification Types Higher•

Normal notification

requirements fortesting data
corresponding tohigher level ofnotification

Four levels– Level I: 1t ≤ notified quantity < 10t– Level II: 10t ≤ notified quantity < 100t
– Level III: 100t ≤ notified quantity < 1000t– Level IV: notified quantity ≥ 1000t
Three forms: serial notification, joint notification and repeated notification•Simplified notification– Basic circumstance: notified quantity < 1t
– Specific circumstances• Intermediates or exportation only, notified quantity < 1t
• For scientific research, 0.1t ≤ notified quantity < 1t
• Polymers containing new chemical monomers of 2% or lower, or polymers of lowconcerns• Process and product R&D, notified quantity < 10t (within 2 years)•Record notification– Scientific research, notified quantity < 0.1t
– Imported for conducting eco-toxicity tests of new chemicals within Chinese
territory by using Chinese target organism

Document Requirements
for Normal Notification• New Chemical Substance Normal Notification Form
• Risk Assessment Report• Physical-chemical, toxicological and eco-toxicologicalproperties test report and qualification certificate of the testingagency• Classifications and labels made according to “Safety Rules forClassification, Precautionary Labeling and Precautionary
Statements of Chemicals” (GB20576~20602-2006)• Material Safety Data Sheet (MSDS) of Chemicals
The Eco-toxicological Properties Test Report should contain thedata conducted within Chinese territory by using Chinese targetorganism.

Document Requirements
for Simplified & Record Notification• Simplified Notification– New Chemical Substances Simplified Notification Form
– Basic circumstance: Eco-toxicological properties test
report conducted within Chinese territory by using Chinese
target organism– Specific circumstances: certification documents
corresponding to the circumstance• Record Notification– New Chemical Substances Scientific Research Record FormTechnical Assessment—Normal Notification•

Contents– Name and identification– Hazard properties of physical-chemical, and related to human health andenvironment– Exposure degree and risks to human health and environment– Appropriateness of the control measures of risks to human health andenvironment•

Conclusions– Opinions on the management classifications of new chemical substances
into general and hazardous categories, including the hazardous category
under priority environmental management– Evaluation opinions on human health and environment risks– Evaluation conclusions on the appropriateness of risk control measures– Suggestion on the registration approval

MEP Examination and Approval• For chemical substances with appropriate risk
control measures, registrations shall beapproved, certificates shall be issued.
• For chemical substances without appropriate
risk control measures, notification application
shall be rejected with the written notice of therejection reasons.
The notification contents of new chemical substances
should be annunciated before the decision is made on
approving or rejecting the notification application.

Time Limit for Notification Procedure• Normal notification– Format check: 5 working days
– Expert evaluation: 60 days
– MEP approval: 15 working days

• Simplified notification

The time forsubmitting
supplemental
documents shallnot be included
into the days forexpert evaluation.

– Format check: 5 working days
– Expert evaluation (basic circumstance only): 30 days
– MEP approval: 15 working days

• Record notification– Format check: 5 working days
– Expert evaluation or MEP approval: None

Items of the registration certificate• Title of the applicant or application agent• Name of the new chemical substance• Notified uses
• Notified level and quantity• Management category of the new chemical substance• Risk control measures and administrativerequirements should also be included in theCertificate of Normal Notification

Initial Activity Report• Holder of the Normal registration certificate should submit theNew Chemical Substance Initial Activity Report to CRC-MEPwithin 30 days after the initial production activity, or within 30
days after the initial import and transfer of the new chemical
substances to the user.
• Holder of the registration certificate of hazardous new
chemical substances under priority environmental management
should also submit the information on the flow of the newchemical substances to CRC-MEP within 30 days after eachtransfer of the hazardous new chemical substances underpriority environmental management to different users.

Annual Report••

Holder of a simplified registration certificate should submit a report on the actual
production or import of the new chemical substance approved in the previous year
to CRC-MEP before February 1st each year.
Holder of a registration certificate of hazardous new chemical substances(including the hazardous new chemical substances under priority environmentalmanagement) should submit to CRC-MEP before February 1st each year theinformation on:
–––––

•

Actual production or import;
Implementation of risk control measures;
Environmental exposure and release;
Actual impact on the environment and human health;
Other information related to environmental risks.

Holder of a registration certificate of hazardous new chemical substances underpriority environmental management should also submit to CRC-MEP theproduction or import plan of the new chemical substances notified in the current
year as well as the preparation situation for the implementation of risk control
measures.

Applicant Qualification Requirements• Applicant or application agent for notificationof new chemical substances must be the entity
registered in Chinese territory.
• For applying for notification of new chemical
substances that have been notified before, theapplicant must not bear records ofadministrative punishment for breaking theMeasures on Environmental Management ofNew Chemical Substances.

Testing Agencies• The testing agencies in Chinese territory providing data on thetest of new chemical substances for notification should be thetesting agencies of chemical substances announced by MEP, atthe same time under its supervision and inspection.
• The testing agencies in Chinese territory should abide by theguidelines for chemical test laboratory issued by MEP andconduct eco-toxicity tests on the new chemical substances
according to guidelines for the testing of chemicals or relevant
national standards.
• The testing agencies not located in Chinese territory providing
data based on the eco-toxicity test of the new chemical
substances conducted outside of Chinese territory must pass
the inspection of the authority in charge in the country or meet
GLP guidelines.

Listing in the “Inventory”• Holder of a registration certificate of the general new chemical
substances shall be announced listing into the “Inventory” by
MEP as of five years after the initial production or importactivity.
• Hazardous new chemical substances (including hazardous new
chemical substances under priority environmental management)– Holder of a registration certificate should submit to CRC-MEP thereport on the actual activities six months previous to the end of the fifth
year after the initial production or import activity.
– MEP shall organize the experts of the Evaluation Committee to conduct
retrospective evaluation on the actual activity report, and the newchemical substances shall be listed into the “Inventory” based on theevaluation results.

Strengthened Management of the Registration ofImport/Export of Toxic Chemical Substances• In September 2009, MEP promulgated the “Notification
on Strengthening the Work of Environmental
Management and notification of Toxic ChemicalSubstances” (HuanBan [2009]113).
• In order to facilitate the implementation of theNotification, on January 7, 2010, MEP released the“Notice on Adjusting the registration certificate forEnvironmental Management of the Import/Export ofToxic Chemical Substances and the Application Forms”(HuanBanHan [2010]15).
17

Application Scope
Chemical enterprises listed in the “2010 Listof the Import/Export of Toxic Chemical
Substances Under Strict Restriction by China”(No. 76 Announcement released by MEP &the Customs), as well as the relevant
manufacturers, users and traders of such
substances.

Variations Compared to Former
Registration Requirements
Additional requirements for pre-examination and postsupervision to be conducted by Provincial Environmental
Protection Departments;
Administration is extended to the relevant manufactures andusers in upper and lower streams of the import/export;
Adjustment of requirements for application documents to besubmitted by different types of enterprises as well as theprocedures;
Additional requirement for industry social responsibility.

Time Limit for Registraion Approval
and Effective Period
Time limit for registratrion:– Import registration certificate: within 30 days after the acceptance of theapplication– Import/Export Pass: within 20 days after the acceptance of the application
Effective period:– Import registration certificate: 2 years of validity– Import Clearance Notification: 6 months of validity, not exceeding theeffective date of the registration certificate– Export Clearance Notification: 6 months of validity
Quantity limit for notification– Import Clearance Notification: Not exceeding the quantity limit registered in
the registration certificate, cumulative annual import not exceeding thequantity limit ratified by Provincial Environmental Protection Department– Export Clearance Notification: Cumulative annual export not exceeding thequantity limit ratified by Provincial Environmental Protection Department

Thank you foryour attention!