Insights series 1 on the Guideline of MEE MEE Order No.12

Scope of new chemical substances

Notified substances:

1. Substances not listed into IECSC

2. Raw materials or intermediates used for the production of medicines and pesticides

3. New substance contained in intermediate products or finished products such as surfactants that have specific functions

4. Chemical substances and polymers that have no unique structure and indeterminate molecular structure

Substances’ addition:  

1. Chemical substances subject to new-use environmental management

2. Chemical substances, intermetallic compounds and polymers whose molecular structures can’t be determined

3. Medicines (including API), pesticides (including technical pesticides), and veterinary drugs that are intended to be changed to other industrial uses, and raw materials or intermediates intended to be used to produce the above products

Inapplicable categories addition:

1.Pharmaceutical (including Active Pharmaceutical Ingredient), pesticide (including pesticide technical drug), veterinary drug (including Active Pharmaceutical Ingredient), cosmetics, food, food additive, feed, feed additive, fertilizer and other products;

2. Radioactive substance.

Exemption category extension:

1.Chemicals produced as a consequence of chemical reaction for achieving specific functions by products or preparations that are not produced, imported or sold artificially

2.Mixture resulting from physical mixing of existing substances and containing no new substance

3.Chemical substances in anhydrous form or their hydrates, either of them is included in IECSC

Applicants and agents

Domestic notifier: holder of the registration certificate

Overseas notifier: the OR is the holder of the registration certificate

1.Applicant is the holder of the registration certificate.

2.Processing user can also be an applicant under a particular situation.

3.Simplified requirements on "OR” qualifications

Scientific   research Record

1.For scientific research, with an annual production or import tonnage level less   than 0.1t

2.Ecotoxicology tests performed within China

Record

1.Annual production or import tonnage level is less than 1t/y

2.Polymers whose new chemical substance monomer or reactant content is no more than 2% or low concern polymers (Simplified or General registration shall be applied if they don't meet polymer record conditions or are excluded for record)

Simplified   notification

1.Intermediates or for export only, less than 1t/year;

2.For scientific research purposes, 0.1~1t/year;

3.2% polymer or LCP

4.Basic situation (less than 1t/year)

General notification  

Level 1: 1~10t/y

Simplified registration

Annual production or import tonnage level is more than 1t (inclusive) and less than 10t

Level 2: 10~100t/y

Level 3: 100~1,000t/y

Level 4: more than 1000t/y

General   registration

Annual production or import quantity is more than 10t (inclusive) ; no level division

Special   cases of General notification

Series notification, joint notification (same OR or respective ORs can be commissioned), joint series notification, repeated notification, repeated notification for increasing the registration tonnage level, and repeated notification for changing registered purpose

Special cases of General and Simplified   registration

Series registration and joint registration

Guideline under MEP Order No. 7

Guideline under MEE Order No.12

Not approved

New chemical substances inconsistent with the requirements will not to be approved

1.Practice fraud

2.Incorrect name or identification information

3.Test reports or data are unqualified

4.Failure to supplement and submit corrections within 6 months

Besides cases described above, those that are unqualified for risk evaluation and have potential of unreasonable risks will not be allowed to be registered for General registration; Substances with PBT potential or cumulative environmental risks will not be allowed for Simplified registration.

publicity   

Name (generic name), notifier, type of notification & management category of new chemical substance , etc.

Registration certificate number, name (class name), applicant and OR, activity type, new-use management requirements, etc.

2. Record

Guideline under MEP Order No. 7

Guideline under MEE Order No.12

Application

Review within 5 working days after receiving application dossiers, which will be submitted to MEE monthly and the results will be publicized in batches

1.Online registration system will automatically send the record receipt;

2.Carry out compliance checks for record materials and send correction notices;

3.Which is inconsistent with recordation requirements will be cancelled, and punishment will be carried out as if no registration certificate has been obtained if activities have been conducted.

Publicity

Acceptance number, acceptance time, notifier, number of new chemical substances recorded, etc.

Name (generic name), applicant and OR, record conditions, record number, etc.

1.Application form for record

2.Materials indicating compliance with record requirements

3.Materials stating necessity of information protection

4.Other existing information related to health hazard characteristics and environmental risks

1.Application form of simplified   registration

2.Test report (physicochemical, persistence, bioaccumulation and aquatic environment toxicology)

3.Letter of commitment to implement or disseminate environmental risk control measures and environmental management requirements

4.Identification conclusion and basis for persistence, bioaccumulation and toxicity identification of the substance applied

5.Materials stating necessity of information protection

6.Qualification Certificates of test agency

7.Other existing information related to health hazard characteristics and environmental risks

1.Application form of General notification

2.Test report (physicochemical, health toxicology, ecological toxicology)

3.Letter of commitment to implement or disseminate environmental risk control measures and environmental management requirements

4.Materials stating necessity of information protection

5.Qualification Certificates of test agencies

6.Environmental risk assessment report

7.Social and economic benefit analysis

8.Other existing information related to health hazard characteristics and environmental risks

Test agencies

Domestic

Ecotoxicology: Test agencies announced by MEE

Physicochemical: CMA, CNAS, MOA’s GLP

Health toxicology: under SFDA Good Laboratory Practices (GLP)& comply with NHC chemical toxicity identification agency chemical toxicity identification laboratory conditions and working guidelines, and CNAS-GLP

Ecological toxicology: compliant with GLP and MEE’s chemical test agency management requirements

Health toxicology: chemical toxicity identification agencies that under SFDA GLP certification management and have passed quality inspection of CDC, pilot pesticide registration units announced by MOA, and CNAS-GLP

Overseas

Pass inspection of competent authority of countries concerned or measure up with requirements of eligible laboratories

Physicochemical: ISO17025 or GLP

Health toxicology or ecotoxicology: GLP

Test methods

Addition:

Carry out tests in reference to OECD latest chemical test guidelines where OECD chemical test guidelines have updated but domestic test methods or relevant national standards are not updated in time.

Test samples

Physicochemical test samples shall come from   pure substances, while toxicology and ecotoxicology ones shall come from pure or mixed products

Physicochemical, toxicological and eco-toxicological test data shall come from pure products

Re-registration

General notification:

1.Increase tonnage level registered

2.Change registered use of hazardous new chemical substances requiring key environmental management

General registration:

1.Intended production or import tonnage level exceeds the registered tonnage level

2.Type of activity turns from import to production; 

3.Change of purpose applied;

4.Change of environmental risk control measures

5.Other situations leading to increased environmental risks

Changes in registration certificates

1.Change of identification information 

2.Change of name of registration certificate holder

3.Change in tonnage level within the scope of the registered tonnage level

General registration:

1.Name change of applicant/OR

2.Replacement of OR

3.Type of activity turns from production to import or increase import tonnage level

4.Change of identification information

Simplified registration:

1.Name change of applicant/OR

2.Replacement of OR

3.Change of identification information

4.Change of quantity registered

5.Change of activity type

6.Change of purpose applied

7.Change of risk control measures

Revocation

Self-application for cancellation

1.Withdrawn by MEE:

2.Revocation:

a. Self-application for revocation (to be proposed jointly by the registration certificate holder and OR);

Substance of registration certificate revocation by self-application will be listed in IECSC  still when it is full for five years of registration. Holder of the original registration certificate whose certificate has been revoked is not allowed to register the same new chemical substance again within five years.

b. Obtain the registration certificate by improper means

c. Registration certificate issued by the competent authority by abuse of power and negligence of duty

Information   dissemination

1.Risk control measures specified in the registration certificate;

2.MSDS；

3.Classification results as per chemical classification, warning label and warning safety regulations;

4.Other related information

1.Registration certificate number or record receipt number;

2.Purpose applied:

3.Environmental and health hazard characteristics and risk control measures of new chemical substances;

4.Environmental management requirements on new chemical substances

Data   storage

Relevant dossiers are to be kept for more than ten years

1.Relevant dossiers related to General and simplified registration are to be kept for at least ten years;

2.Record-related dossiers are to be kept for at least three years

Publicity   of risk control measures

No requirement in this regard

Producers and processing users performing General registration shall make known on their official websites of the environmental risk control measures and environmental management requirements implemented

First   activity report

Registration certificate holder of General notification shall submit report of the first activity within 30 days of the first production event or first import and transfer of substances to processing users;

Registration certificate holder shall submit the first activity report within 60 days of the first production event or the first import and transfer of substances to the processing user;

Each   activity report

Registration certificate holder of hazardous new chemical substances with key environmental management shall submit each activity report within 30 days from the date of each transfer of such substances to different processing users

Each activity report has been canceled

Annual   report

Registration certificate holders of simplified notification, General notification of hazardous substance and hazardous substance with key environmental management shall submit annual report before February 1 each year

Registration certificate holder shall submit annual report before Apr. 30 each year from the year following if environmental management requirements on the General registration certificate require to do so

Listed   into IECSC

General category: to be listed by MEE within five years from the date of the first production or import activity;

Hazardous category (including hazardous categories with key environmental management): Submit an application six months before a five-year period of the first production or import

1.Chemical substances produced, sold, processed, used or imported within the territory of People's Republic of China before Oct. 15, 2003 will be listed into IECSC on a regular basis;

2.New substances that have obtained General registration certificates will be listed into the IECSC by competent ecological environment department under the State Council five years from the date of first registration and publicize accordingly to IECSC

3.New chemical substances obtained registration certificates under MEP Order No. 7 will be listed into IECSC within five years from the date of the first activity if actual activities are carried out and will be listed into IECSC within five years after MEE Order No. 12 was implemented if no actual activities are carried out;

4.New chemical substances that have obtained registration certificates under Order No. 17 will be listed into IECSC from the date when the Measure has been implemented for six months.

Identification information protection

The applicant shall notify the registration center in writing when contents to be kept confidential are to be disclosed

Protection period of identification information shall not exceed five years from the date of first record or registration;

Identification information protection period extension application for substances listed in IECSC:

An application for extension of identification information protection is granted except for the following circumstances:

1.Failing to submit the application on time;

2.The necessity of extension is not sufficient

3.High hazardous chemicals

Note:

It is applicable to MEP Order No. 7, but not to Order No. 17;

The extension period shall not exceed 5 years.