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Information Details

New chemical substances listed detailed (II) regular registration

Release time:

2022-09-13 10:18

Except for the previously introduced new chemical substances that have been legally produced or imported in China before October 15, 2003, which can be included in the "List" by means of supplements, other substances can only be included in the "List" by means of regular registration. According to the requirements of the "New Chemical Substances Environmental Management Registration Measures" (Order No. 12 of the Ministry of Ecology and Environment) and its registration guidelines, in addition to the substances that have obtained regular registration under the current Order No. 12, the previous "New Chemical Substances Environmental Management Measures" (Ministry of Environmental Protection Order No. 7) regular registered and the "New Chemical Substances Environmental Management Measures" (Order No. 17 of the State Environmental Protection Administration) can also be included in the "List.

Among them, for the new chemical substances that have obtained registration certificates in accordance with Decree No. 7, the competent authority has included the last 255 substances that meet the requirements in the "List" on June 17, 2021. The above 255 registered substances are all listed in an open way. The public information includes Chinese name, English name, molecular formula, CAS number or serial number (CAS number is unknown). There is no use restriction and no new use environmental management registration is involved.

Order 12 and Order 7 regular the inclusion of registered substances in the list

General requirements

12 order to obtain the regular registration certificate of the new chemical substances from the date of the first registration of five years to be listed in the "list".

New chemical substances that have not yet been listed under Order 7 and have obtained regular registration certificates shall be announced and entered into the "List" at the corresponding time according to whether there are actual production or import activities as of January 1, 2021.

Time of inclusion in the Directory

1. The new chemical substances that have obtained the regular registration certificate in Order No. 12 shall be listed in the "List" after five years from the date of first registration.

2. As of January 1, 2021, the registered substances regular in Order 7 that have actually produced or imported new chemical substances but have been less than five years old shall be announced by the competent department of ecological environment of the State Council after five years from the date of the first production or import activities Included in the "List"; there are no registered substances regular Order 7 that have actually produced or imported new chemical substances, five years from the date of implementation of the "Measures, the announcement of the competent department of ecological environment under the State Council is included in the list.

Scope of substance

(I) substances for inclusion in the List

1. New chemical substances that have been registered for 5 years regular Order 12;

2. Decree No. 7 regular the registration of new chemical substances that have been in actual activity for five years;

3. After five years from the date of implementation of Decree No. 12, other Decree No. 7 not included in the "List" regular register new chemical substances.

Substances not (II) for inclusion in the List

1, simple registration of new chemical substances;

(2) new chemical substances for the record;

3. Registration of new chemical substances that have been withdrawn or revoked in accordance with the provisions of Articles 34 and 35 of the regular.

Application for Extension of Disclosure of Chemical Substance Identification Information

Applicants who approve the confidentiality of chemical substance identification at the time of registration may apply for extension of disclosure of substance identification information.

Circumstances in which the (I) cannot apply:

(1) Chemical substances for which information protection was not implemented at the time of application for registration of substances;

2. Chemical substances whose information protection has expired.

(II) Application Material Requirements

If an application is made for the extension of the disclosure of the labeling information of chemical substances, the holder of the registration certificate shall submit the necessary explanatory materials to the competent department of ecological environment under the State Council six months before the expiration of the validity period of the information protection (the content shall be the latest information up to the time of submission of the application materials), including but not limited:

1, apply for extension of the disclosure of chemical substances specific identification information column and the corresponding period;

2. An explanation of whether the chemical substance labeling information applied for extension of disclosure is known to the public. Including but not limited:

1) Whether the chemical substance identification information applied for extension of disclosure appears in relevant public materials or media such as advertisements/publicity materials, public publications, public patents/documents, databases, Internet, etc., and is related to the applicant's enterprise information, which can be known to the public or competitors;

2) Whether the labeling information of the chemical substance applied for extension of disclosure has been published or made public by the competent department of ecological environment or other competent authorities at home and abroad. If so, the competent authority to provide disclosure of this information, details of the disclosure;

3) A description of whether the chemical substance labeling information applied for extension of disclosure still has commercial value, including whether there is evidence or reasonable expectation that the chemical substance labeling information applied for extension of disclosure, if disclosed, will cause material damage to the applicant's market competition position, and the causal relationship between information disclosure and material damage;

4) Whether the applicant has taken and will continue to implement relevant measures to prevent the disclosure of the chemical substance identification information applied for extension from being leaked, and provide the specific contents of relevant measures.

(III) review decision

The competent department of ecological environment of the State Council shall organize the examination of the application for extension of disclosure of chemical substance labeling information, and make a decision according to the following circumstances:

1. All holders of registration certificates for chemical substances to be applied for extension shall submit the application for extension on time. The necessity of extension shall be fully and reasonably explained, and the extension shall not be granted if the potential environmental or health risks are high, and the extension may have a significant impact on the public interests of the environment and health;

2, the existence of one of the following circumstances, not to approve the extension of the disclosure of chemical substance labeling information:

1) One or more than one registration certificate holder of the chemical substance that intends to apply for extension fails to submit the extension application on time;

2) The explanation of the necessity of the extension is not sufficient;

3) It is a highly hazardous chemical substance, or has a large potential environmental or health risk, and delayed disclosure may have a significant impact on the public interest of the environment and health.

(IV) information protection period

Among them, the longest protection period for the identification information of the substances registered in Decree No. 7 is December 31, 2025.

information disclosure

When listed in the Directory, the Chinese and English names or class names (confidential substances), molecular formulas, CAS numbers or serial numbers (unknown or confidential substances with CAS numbers), permitted uses, environmental management requirements, etc. of chemical substances shall be disclosed.

New Use Environmental Management

The chemical substances in the "List" for the implementation of environmental management for new uses are listed in the "List" for permitted uses. If the corresponding substances are used for other industrial uses other than permitted uses, new chemical substances still need to be registered.

After the approval of the new use environmental management registration, if it does not belong to the high-hazard chemical substance, the registered permitted new use shall be added to the "List"; if it belongs to the high-hazard chemical substance, the new use environmental management of the substance in the "List" The scope remains unchanged.

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