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Information Details

Analysis of the main points of simple declaration of new chemical substances and scientific research filing

Release time:

2019-12-11 11:18

Basis of 1. regulations

REGULATIONS AND REGULATIONS

1. Regulations on the Safety Management of Hazardous Chemicals (Order No. 591 of the State Council)

2. Measures for Environmental Management of New Chemical Substances (Order No.7 of the former Ministry of Environmental Protection)

Policy Documents

1. Notice on Linkage Matters Related to Environmental Management Registration of New Chemical Substances (HB [2010] No. 123)

2. Six supporting documents of the Measures, including the Guidelines for Declaration and Registration of New Chemical Substances (HB [2010] No. 124)

3. Measures for the Administration of Experts on Environmental Management of Chemical Substances (HB [2011] No. 59)

4. Measures for the Administration of Qualified Laboratories for Chemical Testing (HB [2012] No. 7)

Technical Documents

1. List of Existing Chemical Substances in China (Announcement No. 1, 2013 of the former Ministry of Environmental Protection)

2. Guidelines for Risk Assessment of Chemical Substances (Draft for Comments, HB [2011] No. 1147)

3. Guidelines for Hazard Identification of New Chemical Substances (Draft for Comments, HB [2011] No. 1147)

4. Testing Methods of Chemicals (China Environmental Science Press, 2004/2013)

5. Information Technical Requirements for Registration and Identification of New Chemical Substances (for Trial Implementation)

6. Guidelines for Compilation of Declarations of New Chemical Substance (HJ/T 420-2008)

Regulatory requirements

Article 12 [Basic Situation of Simple Declaration] Article 13 [Special Situation of Simple Declaration]]

Basic situation of simple declaration: annual production or import volume is less than 1 ton;

Simple declaration of special circumstances:

-Used as an intermediate or for export only, with an annual production or import volume of less than 1 ton;

-For the purpose of scientific research, the annual production or import volume is more than 0.1 tons but less than 1 ton;

-Polymers with less than 2% monomer content of new chemicals or low-interest polymers;

-For the purpose of process and product research and development, annual production or import volume is not satisfied

10 tons, and not more than two years.

Article 14 [Requirements for Filing and Reporting]]

(I) for the purpose of scientific research, the annual production or import of new chemical substances is not

0.1 tons;

(II) In order to use Chinese test organisms in China for the ecology of new chemical substances

Toxicology testing while importing test samples of new chemical substances.

2. material requirements

The summary declaration materials shall be arranged in the following order:

1) Simple declaration form for new chemical substances;

2) Attachments to the simple declaration form (attachment numbers are arranged according to the order in which they appear in the declaration form)

A copy of the legal person certificate or business license;

Agency Entrustment Agreement;

Legal person power of attorney;

Proof of compliance with the corresponding summary declaration;

List of third party information;

Statement of Confidentiality of Chemical Name;

Test report;

Description of production process;

Description of exposure and use;

List of attachments.

The filing materials of scientific research shall be arranged in the following order:

1) New chemical substance scientific research filing declaration form;

2) Annexes to the application form for filing scientific research of new chemical substances (the attachment numbers are arranged according to the order of appearance in the application form)

Copy of legal person certificate or business license;

agency entrustment agreement;

Letter of Authorization of Legal Person;

Third party information, etc.

Key points of 3. filling

Part I: Information of the declarant

Information of declarant and agent in item 1.1 and item 1.2

Domestic filers and agents only accept simplified Chinese names, while overseas filers only accept English names (Hong Kong, Macao and Taiwan companies can accept simplified Chinese names); It is recommended that the contact person be filled in as the direct contact person for this declaration, so as to facilitate future contact with relevant declaration matters.

1.4 Declaration

After the software is completed, the application form must be printed first, and then handwritten and signed and stamped with the official seal. The domestic declarant (legal person or authorized signatory) shall sign and affix the official seal (not the name seal of the person) at the legal representative on the left side of the application form. Note: If the seal is deemed invalid at the agent's seal in the lower right corner of the application form!

Part II: Basic information of summary declaration

2.1 reasons for declaration

Compare the information in the annex to select the appropriate reasons for the declaration to avoid wrong choices, such as the basic situation but the reason for the special situation, the low concern polymer but the choice of 2% polymer, etc.

Intermediates and instructions for export only need to be signed and sealed.

2.2 reporting activities and reporting volume

(If it is an integer tonnage, it does not need to be accurate to decimal places)

2.3 declared purposes

It is recommended to directly state the actual use of the declared substance, the description should be concise, not too complex or too broad, it is recommended to combine into one sentence. If you fill in multiple purposes, use a pause to separate the middle and no punctuation marks at the end.

Part III: Information on Declared Substances

Simple declaration

Name of 3.1 declared substance

Chemical Name:

-- Chinese name:

The symbol shall conform to the Chinese naming standard (corresponding to the name of the CA index in the United States). No spaces are allowed. All numbers, English letters, brackets, hyphens and other symbols shall be in half-width format. At the same time, attention shall be paid to the format of upper and lower labels.

-- English name:

Should be named in accordance with the current IUPAC naming convention, or use the US CA index name

For chemical substances that do not have a CAS number but whose written English name conforms to the CAS nomenclature, the "English name" shall be the "CAS name"

Note that special formatting is removed; Chinese and English names should correspond.

In addition to the proper name, element symbol and writing specification requires the use of capital format, only the first letter of the first word, special characters pay attention to italics (such as "β", "ω", etc.):

For mixtures or reaction products with a clear structure of each component, the "substance category" should be checked with "no unique, definite molecular structure"

Class name:

If the chemical name is confidential, the class name must be filled in subsequently; the Chinese class name shall be prepared by referring to the Guidelines for the Compilation of Class Names for the Declaration of New Chemical Substances (HJ/T 420-2008); the English class name shall be translated and compiled according to the Chinese class name; the Chinese and English class names shall correspond

Other names:

Fill in the commodity name, common name, common name and industry name, etc.

polymer declared substance name requirements:

Basic principle: chemical names and class names in both Chinese and English should correspond to each other.

1. Chinese name:

(1) with a unique, determine the molecular structure of the polymer naming documents based on:

Nomenclature Principles of Inorganic Chemistry (1980 Edition)

Principles of Organic Chemistry Nomenclature (1980 Edition)

Nomenclature of Polymer Chemistry (2005 edition)

National Standard General Rules for the Nomenclature of Chemicals (GBT23955)

Current IUPAC Naming Specification Document

(2) there is no unique, determine the molecular structure of the polymer name:

Substances with CAS number

Refer to CA Index Name to name the Chinese name, which should conform to the Chinese naming standard.

Substance without CAS number

Refer to the Nomenclature Principles of Polymer Chemistry.

For known repeating structural units, the structural basis nomenclature is used;

For example: polyethylene, polystyrene, siloxane, polysiloxane.

For unknown repeating structural units, the source-based nomenclature is used. The basic naming of the source is generally expressed in the following form:

Polymers of Monomer 1 with Monomer 2 (Monomer 3,... and the last monomer)

If necessary, insert modifications describing the structure, morphology or process, such as random, alternating, block, graft, etc., before "polymer. If the polymer has an end-capping group not derived from a monomer of the polymer, the expression "α-end-capping 1-ω-end-capping 2" is also inserted.

Polymers for multi-step polymerization should be described hierarchically, and different levels should be separated by brackets.

3.2 structure information

Molecular formula: pay attention to the foot mark, and remove the special format.

Structural formula: need to use professional drawing software (e. g. Chemdraw, ChemWindow)

CAS No.: If the name of the substance is not confidential, the CAS No. shall not be confidential; if there is no CAS No., it may not be provided. Fill in: None/Undetermined

3.3 forms of existence

Preparation: Provide the name of the medium and the concentration of the declared substance in the product: XX%

Article: The weight percentage to be filled in the article: XX%

3.4 nature of the declared substance

-Special cases (MSDS substitution)

-- Basic situation

Data such as water solubility and n-octanol/water partition coefficient are required (except for those eligible for exemption), and test data and estimated data are accepted.

Domestic ecotoxicity test results: the test species in the ecotoxicology test report should be extracted and filled in the corresponding position, and the test results should be filled in the name of the laboratory, the purity of the sample and the test method used.

Scientific Research Record

The filling specification and simplicity of the information of the applicant and the identification information of the declared substance and the corresponding part in the regular declaration.

Consistent requirements

Note:

a) Information of 1.3 units carrying out scientific research:

-- The scientific research unit can be the applicant itself or a number of scientific research units.

-- It is required that the scientific research unit must be a domestic company and be consistent with the business license information provided in the annex.

B) 2.9 scientific research projects:

-as far as possible to provide specific research project objectives and plans

-- The situation of scientific research projects shall be consistent with the reasons for declaration.

-- Simple declaration of project proposals with words such as "process research and product development" appearing in the filing, and scientific research filing is a basic research for the purpose of scientific research.

This issue will be introduced here, and the next issue will introduce the regular declaration. Please look forward to it.

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