Chemical Compliance
Intelligence & Solutions
Registration of New Chemical Substances in China (MEE Order No. 12)
Dec 22, 2020
Nora Wang
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CONTENTS

History

New chemical substances are particularly prioritized in China’s chemical management initiatives, which is largely attributed to the uncertainties, potential risks and regulatory void as a result of their “newness”.

The country’s regulatory endeavors in this regard can be dated back to 2003, when the former State Bureau of Environmental Protection (SBEP) published the Measures on Environmental Management of New Chemical Substances (SBEP Order No. 17 of 2003), the first national-level regulation dedicated to new chemical management. The Measures laid out detailed regulations on the notification, registration and administration of new chemical substances, requiring that a pre-manufacture and pre-importation notification and registration system be put in place.

However, SBEP Order No. 17 did not establish any integrated risk assessment system or risk prevention mechanism, and touched little on follow-up management after the completion of notification procedures, thus failing to effectively supervise the implementation of risk control measures.

In light of these problems as well as the burgeoning chemical industry that called for more profound regulatory changes, the former Ministry of Environmental Protection (MEP) revised the Measures and published it as MEP Order No. 7 in 2010. With its focus shifted from hazard assessment to risk assessment, the Measures optimized management approaches by putting equal emphasis on notification requirements and follow-up management practices, exercised classified measures, and therefore created a more scientific regulatory system for environmental management of new chemical substances.

MEP Order No. 7 has since then been in effect for a decade as an overarching framework for the country’s new chemical management. However, since some of its provisions cannot address the immediate environmental management requirements, an overhaul had been discussed and worked on for years.

In April this year, the Ministry of Ecology and Environment (MEE) published the amendments of MEP Order No. 7. The scheme is thereby renamed as the Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No. 12 of 2020) and set to take effect starting from 1 January 2021. Later in November, the Guidance on Environmental Management Registration of New Chemical Substances, along with tables used in registration of new chemical substances and instructions for filling in the tables, was rolled out.

Substances to be Registered

MEE Order No. 12 requires registration of “new” chemical substances in China. New chemical substances refer to chemical substances that are not listed in the Inventory of Existing Chemical Substances of China (hereinafter referred to as the IECSC).

For chemical substances that have been listed into the IECSC and subject to new usage environmental management, they are subject to environmental management as new chemical substances if they are used for industrial applications other than the permitted uses.

The Measures does not apply to the following two categories:

(1) Pharmaceuticals (including active pharmaceutical ingredients), pesticides (including pesticide technical materials), veterinary drugs (including veterinary drug substances), cosmetics, food, food additives, feed, feed additives, fertilizers, etc.; and

(2) Radioactive materials.

Categories of exemption from registration include:

(1) Naturally occurring substances;

(2) Non-commercial or non-intentionally produced substances;

(3) Other special categories (including materials, alloys, non-isolated intermediates, articles, etc.)

Stakeholders Involved

Applicant: an enterprise or public institution which is registered in the territory of the People’s Republic of China according to law to manufacture or import new chemical substances and able to assume legal liabilities independently; or an overseas manufacturer or trading entity that intends to export new chemical substances to the People’s Republic of China (a representative must be designated in this case)

* Only an applicant can be the holder of registration certificate.

Representative: an enterprise or public institution registered in the territory of the People’s Republic of China according to law and able to assume legal liabilities independently, designated by an overseas applicant to jointly fulfill the obligations regarding the environmental management registration of new chemical substances and the post-registration environmental management; similar to the role of “Only Representative” under EU REACH

Ministry of Ecology and Environment (MEE): policy maker of MEE Order No. 12, in charge of macro regulation on the environmental management of China new chemical substances.

Solid Waste and Chemicals Management Center (SCC): a public institution which is set directly under MEE and in charge of the routine administration of new chemical substance registration in China

Expert Committee: a panel of experts organized by the MEE to conduct scientific review and evaluation of dossiers for new chemical substance registration (mainly for regular registration)

Local authorities: relevant authorities at local levels which are responsible for the supervision of new chemical substance management within their respective jurisdictions

Testing institutes: Both domestic and overseas institutes can produce data which can be provided for new chemical substance registration as long as they meet relevant qualifications

How to Comply

The flowchart below can help a business to identify its obligations and procedures it may need to follow in applying for registration of new chemical substances in China.

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Registration Types and Materials Required

According to MEE Order No. 12, there are three types of registration of new chemical substances, namely regular registration, simplified registration and record notification. It should be noted that there is no long exemption granted to substances manufactured or imported for R&D purpose in quantities of less than 0.1 ton per year. That is to say, no matter how much a new chemical substance is manufactured or imported, it has to be subject to certain registration or notification obligations. Document requirements vary by registration type. See the table below for details.

 

Substance   type

Registration   type

Materials   required

Manufactured/ imported in quantities above 10 tons   per year

 

Regular   registration

1. Regular registration application form

2. Appendixes to the application form:

ü  Legal person certificate or business   license, representation contract or agreement, authorization letter

ü  Testing report or data

ü  Environmental risk assessment report

ü  Socio-economic benefit analysis report   (for highly hazardous new chemicals)

ü  Materials stating the necessity of   information protection (where one wishes to apply for protection of   identification information of chemicals)

ü  Others

Manufactured/ imported in quantities of     1-10 tons per year

 

Simplified   registration

1. Simplified registration application form

2. Appendixes to the application form:

ü  Legal person certificate or business   license, representation contract or agreement, authorization letter

ü  Testing report or data

ü  Conclusions on the persistence,   bioaccumulation and toxicity of new chemicals and the basis for such   conclusions

ü  Materials stating the necessity of   information protection (where one wishes to apply for protection of   identification information of chemicals)

ü  Others

Manufactured/ imported in quantities below   1 ton per year

 

Record   notification

1. Notification form

2. Appendixes to the application form:

ü  Legal person certificate or   business license, representation contract or agreement, authorization letter

ü  Others

Polymers     containing less than 2% of a new chemical monomer/reactant or PLC

1. Notification form

2. Appendixes to the application form

ü  Legal person certificate or   business license, representation contract or agreement, authorization   letter, etc.

ü  List of monomers/reactants, plot of   molecular weight distribution, mechanism of polymerization, materials   illustrating that substances in question are not polymers which are subject   to regular or simplified registration

ü  Others

The Guidance provides two special forms of registration, which are available in both regular and simplified registration. See the table below for details.

Special   form of   registration

Definition

Requirements

Serial registration

Registration of multiple new chemical substances of   similar molecular structure, identical or similar uses, and similar testing   data, which are submitted as a series by the same applicant

1. The quantity registered shall be the sum of   quantities of each substance in a series

2. Number of new chemicals in each series ≤ 6

Joint registration

Registration of the same new chemical substance by   two or more applicants at the same time

1. The quantity registered shall be the sum of   quantities submitted by each applicant

2. The withdrawal of a joint registration   certificate requires the submission of withdrawal application by all joint   applicants

Procedures for Different Registration Types

The procedures for regular registration and simplified registration in comparison to record notification are different. See the pictures below.

Regular and Simplified registration procedure (above)

Record Notification procedure (above)

Notably, there is no approval or public scrutiny for record notification, which means that businesses can start relevant activities immediately after submitting application materials and receiving the receipt sent via the online registration system. The MEE will only conduct spot checks of the materials and release the results on a regular basis. Despite this, businesses still need to carefully prepare materials for record notification so as to avoid any punishment.

The biggest difference in the procedures for regular and simplified registration lies in technical review: for regular registration, the MEE will organize the Solid Waste and Chemicals Management Center (SCC) and the expert committee to carry out technical review, while for simplified registration, the SCC will carry out technical review by itself.

Information Protection Arrangements

Where applicants of simplified or regular registration wishes to apply for identification information protection of chemical substances, they need to submit materials illustrating the necessity of such information protection.

The validity period of identification information protection such as chemical substance names shall not exceed 5 years from the date of first-time registration or record notification. In terms of substances for which registration certificates have been obtained under MEP Order No. 7 and substances which have been included in the Inventory of Existing Chemicals Substances in China (or IECSC) before MEE Order No.12 comes into force and already subject to identification information protection, the validity of information protection shall expire no later than December 31st, 2025.

When a substance registered is listed into IECSC, the identification information of the substance shall be disclosed if it is not subject to information protection or the information protection has expired.

It should be noted that highly hazardous chemical substances, or chemical substances with relatively high potential environmental risk or health risk, and the extension of disclosure may case huge impact on environment and public health.

Post-registration Obligations

Follow-up management after registration will be a priority under the new scheme, with more concrete and stringent requirements laid out in both the Measures and the Guidance, including:

²  Information transferred throughout the supply chain

²  First-time activity report required both for simplified and regular registration

²  Annual report due 04/30 annually required on regular registration, which will be specified on the certificate

²  Disclosure of implementation of environmental risk control measures and environmental management requirements

²  Intensive communication with the authority in case of any new hazards or risk exposure

²  Keep the record of registration for years.

Qualifications of Testing Institutes

The Guidance provides more explicit requirements for both domestic and overseas testing institutes engaged in relevant testing, as shown in the table below.

Institute   type

Testing   type

Qualification   requirements under MEE Order No. 12

Domestic testing   institutes

Testing of physicochemical properties

China Inspection Body and Laboratory Mandatory   Approval (CMA)

Toxicological    testing

1.        CMA

2.        Any   of the following institution:

²  an institution that has passed the accreditation   certification of non-clinical research quality management practices by National   Medical Products Administration (NMPA).

²  a chemical toxicity identification   institution that has passed the quality assessment of the Chinese Center For   Disease Control And Prevention (CDC)

²  a pesticide registration testing entity   announced by the Ministry of Agriculture and Rural Affairs (MARA)

²  an institution that has passed good   laboratory practices evaluation by the Certification and Accreditation Administration   of the People’s Republic of China (CNCA)

Ecotoxicological testing

1.        CMA

2.        Good   laboratory practices (GLP)

3.        Accept   supervision and random inspection of the testing situations and conditions by   the MEE

Overseas testing   institutes

Testing of physicochemical properties

Meet the management requirements of the competent   authority in the country where they are located or the internationally   recognized GLP requirements

Toxicological    testing

GLP

Ecotoxicological testing

GLP

IECSC

The Inventory of Existing Chemical Substances in China (IECSC) contains:

Ø  all existing chemical substances manufactured, processed, sold, used or imported inside mainland China between January 1st, 1992 and October 15th, 2003; and

Ø  new chemical substances that were notified previously and five years have passed since they were first manufactured or imported

IECSC Search

The IECSC serves as the basis to judge whether a substance is identified as new chemical substance subject to registration requirements. Therefore, confirmation of whether the substance in your product falls under IECSC is essential before your entering the Chinese market.

ChemLinked has incorporated the IECSC into the free online ChemLinked Inventory Toolbox, where you can search by inputting the substance CAS number or full English/Chinese name. However, as some confidential substances are not accessible, it does not necessarily mean the substance is a new chemical substance in China if no match is found through the online search. It is recommended to apply for an IECSC comprehensive search (3,000 RMB per substance charged by the authority) to verify the substance of your concern is deemed as new chemical substance to avoid unnecessary notification work.

IECSC Inclusion

Based on MEE Order No. 12, the Guidance sets out requirements and procedures for listing different types of substances into IECSC. It specifies the information which should be made public for any substance registered, including identification, permitted uses (for those subject to new usage environmental management), environmental management requirements, etc. The graph below shows how substances are included into IECSC.

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