China Reach Regulation For Various Sectors

Introduction

The Measures for Environmental Management of New Chemical Substances.

A brief Overview of Chemical management in China:

The regulatory affairs in China is mainly influenced by the US and EU-REACH regulations. The MEP Order 7 - The Measures for Environmental Management of New Chemical Substances, popularly known as CHINA REACH was enforced on October 15, 2010 which makes it mandatory for any trader, manufacturer or importer of chemicals, irrespective of tonnage to be notified to CRC, [Chemical Registration Centre] (CRC-MEP].

Inventory

The Inventory of Existing Chemical Substances in China (IECSC) is the official inventory maintained by MEP, China which lists the substances, which are presently registered under CHINA REACH under various notification types till 2016. Article 3 of the MEP Order 7 defines which substance or material is considered as a NEW Substance. “A new substance is a chemical substance other than those listed on the IECSC”.

“Priority hazardous new chemical substances are hazardous new chemical substances which possess persistent, bio-accumulative properties or are harmful to ecological and human environment. These will be classified as priority hazardous new chemical substances. “The IECSC (2016 revision) currently comprises of 45612 substances among which 8,486 substances do not have CAS numbers. Around 3,300 substances are listed in the confidential part of IECSC. In case a chemical is already listed in the IECSC but has a different use than registered, then it must be registered accordingly.

Polymers are not exempted from Registration.

Exemptions

There are certain chemicals that are exempt from notification, even if they meet the definition of new chemical in China. Any potential notifier should confirm if the substances fall into the range of exemption before starting the registration process.

The following categories are exempted : Finished products covered by other laws and regulations :

E.g.: pharmaceuticals, pesticides, veterinary medicines, cosmetics, foodstuffs, food additives, feed and feed additives, radioactive materials, military products, explosives, tobacco etc.

Naturally occurring substances

E.g. - substances extracted from air by all means, naturally occurring polymers, Living matter like DNA, RNA and various other biological macromolecules, unprocessed substances or substances processed only by physical methods.

Categories of non-commercial or non-intentional production :

E.g. - impurities. Chemical substances produced accidentally like reaction by products, waste products etc.

Other special categories:

E.g. materials like glass, ceramic materials, wires and cables, steel and its products, cement and its various grades etc.

MEE Order 7- New Substance Notification

Receiving and Evaluation Authority:

The New Substance Notification receiving and decision authority rests with the Ministry of Ecological Environment, People’s Republic of China.

Application Conditions: The basic situation of any simple declaration is less than 1 ton. Article 12 of the Measures, highlights the simple declaration of use as an intermediate. Simple declaration of use as an intermediate in an exceptional case or for export only, less than 1 ton; in the case of special application for scientific research purposes, greater than or equal to 0.1 ton, less than 1 ton; For the purpose of process and product research and development, less than 10 tons.

The Applicant conditions are listed as follows in the Article 13 of the Measures: Applicant conditions:

• For production activities, the domestic applicant is the industrial and commercial registration institution of the People's Republic of China that intends to engage in the production of new chemical substances.
• For import activities, the domestic applicant is the industrial and commercial registration institution of the Republic of China that intends to engage in the import of new chemical substances; the overseas applicant is the overseas manufacturer (including the Hong Kong Special Administrative Region) intending to export new chemical substances to the territory of the People's Republic of China, Macao Special Administrative Region and Taiwan region).

If a new chemical substance is not reported for the first time, there shall be no adverse records of administrative punishment for violating the environmental management regulations for new chemical substances in the past three years.

If it meets the following conditions, approval is granted:

• Meet the data requirements;
• Have appropriate risk control measures;
• The technical review recommends registration

Notification Types

The notification types in China REACH are

• Regular Notification
• Simplified Notification - General Conditions
• Simplified Notification - Special Conditions
• Scientific Research Record

Typical notification follows the principle “Higher volume, higher data requirements”. It is compulsory for any registrant to provide corresponding data or materials in accordance with the guidance documents prepared by the MEP. There are 4 levels for typical notification depending on the volume of substance:

• First level : 1~10 t/y;
• Second level : 10~100 t/y; 
• Third level : 100~1000 t/y;
• Fourth level : 1000 t/y+;

Chinese Agent / “OR”

• The appointment of representative agent is similar to that of an Only Representative under EU REACH and may be an external representative agent or a Chinese branch of the foreign manufacturer
• Registrant or its agent shall be a legal entity registered within the territory of China
• Legal entity with a registered capital over CNY 3 million in [Approx. $4,34,400.00]

Preparation and Submission of Notification Dossier

Registrants shall gather all the relevant information and documents required to submit the desired notification type.

List of application materials :

The application materials include the electronic data of the return form filled out by the application soGware, and the pdf file of the complete set of application materials arranged in the following order:

• Notification form;
• Corporate certificate or business license- The institution provides a corporate certificate and the company provides a business
• Agency commission agreement or power of attorney (in case of overseas applicants) - The overseas applicant shall provide a proxy entrustment agreement or power of attorney, and if there is an authorized signature, an authorization letter shall also be
• Chinese Safety Data Sheets;
• Recommended classification and labelling;
• Risk assessment report;
• Test report detailing the substance's physiochemical properties and its toxicity and eco-toxicity properties;
• Certificates for the qualification of laboratories

Address for receiving application :

Le†er receiving unit : Administrative Approval Hall of the Ministry of Ecology and Environment of the People's Republic of China;

Address : No. 115, South Xiaojie, Xizhimen, Xicheng District, Beijing,

Zip code: 100035; Phone: 010-66556048;

Office hours : Morning: 8:30-11:30; afternoon: 13:30-16:30.

Submission of application materials :

Test reports and other documents shall be provided as attachments. All forms and reports must be written in Chinese.

The original paper declaration form and the information required to provide the original paper can be submitted by the applicant through the window, by mail, etc., and the information that needs to be submitted and uploaded online can be transmitted online.

Processing time after submission of notification

The Chemical Research Center shall submit a new chemical substance notification report to the expert committee within 5 working days. The committee will conduct expert review within 60 days and submit expert review opinions. The new chemical substance is registered on the website every 6 months.

Legal Liabilities :

Correctness of the data provided in the notification; Refusing Field Inspection by authorities, processing new chemicals without registration certificates – all amount to heavy fines and severe punishments by MEP.

If the domestic testing agency used for testing of Eco toxicological endpoints falsifies the test data or does not comply with the norms it’s removed from the list of testing agencies and publicized openly.

Post Registration Obligations-  

Post Registration Obligations:

• After notification is completed, a registration certificate containing specific management category will be issued.
• Certificate holder needs to fulfill different post-notification obligations depending on the management category of the substance.
• Chemical substances will be categorized as general new chemical substances or hazardous new chemical substances.
• Like the registration certificate holder and the downstream users have to comply with the other laws and ensure proper risk/hazard management facilities at their site.
• Record of all information related to the substance for 10 years and above Inspection by the Local Environment bodies or Officials from MEP to the manufacturing site.

Registrant's rights and obligations

According to the Administrative Licensing Law, the applicant has the following rights according to law:

• If the applicant meets the statutory conditions and standards, the applicant has the equal right to obtain an administrative license according to law, and the administrative organ may not discriminate.
• A legal person or other organization shall have an administrative license to the administrative organ, and shall have the right to make a statement or a defense; if it has the right to apply for administrative reconsideration or file an administrative lawsuit according to law; if its lawful rights and interests are damaged by the administrative organ's illegal implementation of the administrative license, it shall have the right to demand compensation according to law.

According to the Regulations on the Safety Management of Hazardous Chemicals and the Environmental Management Measures for New Chemical Substances, the applicant shall perform the following obligations according to law:

• It is not allowed to produce, import or process new chemical substances that have not obtained the environmental management registration certificate for new chemical substances. New chemical substances that have not obtained registration certificates or are not filed for filing shall not be used for scientific research;
• When applying for the declaration of new chemical substances, all known information on the hazardous properties and environmental risks of new chemical substances shall be submitted truthfully, and information concerning human health and environmental safety shall not be required to be kept confidential;
• It is forbidden to transfer the environmental management registration certificate for new chemical substances;
• New chemical substances that are permitted to be registered may not be transferred to processing users who are unable to take risk control measures;
• When it is found that a new chemical substance approved for registration has new hazard characteristics, it should immediately submit new information on the hazard characteristics of the new chemical substance;
• The holder of a routinely registered registration certificate shall specify the hazard characteristics of the new chemical substance in the chemical safety data sheet and transmit the following information to the processing user: (1) the risk control measures specified in the registration certificate; (2) Chemistry Product Safety Data sheet; (3) Classification results according to chemical classification, warning labels and warning instructions; (4) other relevant information;
• Submit the corresponding activity report or annual report and conduct activities according to the risk control measures listed in the registration certificate.

Annual Report

Certificate holder of simplified notification shall submit the actual volume of manufacture or import of the new chemical substance for the previous year before 1 Feb of each calendar year.

Certificate holder of hazardous new chemical substances shall report the following information for the previous year before 1 Feb of each calendar year.

• The actual volume of manufacture or import;
• Whether risk management measures have been implemented;
• Environmental exposure and release information;
• The actual impact of the new substance on environment and human health;
• Other information related to environmental risks;

Besides that, certificate holder of priority hazardous new chemical substances shall submit annual plan of the manufacture or import for the current year to CRC along with the status of implementation of risk management measures.

Withdraw Registration

• Certificate holder that has not engaged in manufacturing or importation activities or has stopped manufacturing and importation may withdraw their application of registration certificate, explain it and hand back the registration certificate.
• MEP shall permit the withdrawal and issue a public notice if the above case is confirmed or there is no environmental hazard caused by the new chemical substance.

False Notification

Any registrant who, in violation of this Provision, hides relevant information or provides false application materials in the application for the registration certificates shall be subject to a fine of RMB10,000 at least and RMB30,000 at most, by the MEP. In this case, the MEP is empowered to order the violator to rectify the wrongful acts, record and publicize the fact of violations, and rescind registration certificate if a certificate has been issued.

Punishment Items by MEP

Any registrant who, in violation of this Provision, has one of the following wrong-doings shall be subject to a maximum fine of RMB 10,000 by MEP and rectify the wrongful acts under the order of MEP.

• Having not reported the update about the hazard information of the new chemical substance timely;
• Having not submitted first-activity report or the circulation of new chemical substance as required;
• Having not submitted annual plan as required;
• Having not submitted a report about actual activities as required;

Punishment Items by Local Authorities Part 1

Any registrant who, in violation of this Provision, has one of the following wrongful acts shall be subject to a fine of RMB10,000 at least and RMB30,000 by the local environmental protection authorities. In this case, the local authorities shall report the wrongful acts to MEP which will then record and publicize the fact of violations.

• Refusing field inspections by the competent environmental protection authorities or conducting falsifications when inspected;
• Manufacturing or importing new chemical substances without registration certificate or without meeting the requirements of registration certificates;
• Processing or using new chemical substances that do not have registration certificates;
• Having not implemented risk management measures in accordance with requirements of registration certificates;
• Transferring new chemical substances to downstream users that do not have the capability of implementing risk management measures;

Punishment Items by Local Authorities Part 2

Any registrant who, in violation of this Provision, has one of the following wrongful acts shall be subject to a fine of RMB10,000 at least and RMB30,000 by the local environmental protection authorities. In this case, the local authorities are empowered to order the violator to rectify the wrongful acts.

• Having not communicated risk management information to downstream users;
• Having not kept the application materials for registration certificate, and information related to actual manufacture and import activities;
• Using new chemical substances for scientific research and technological and product research for other purposes

Punishment on Wrongful Act of Expert in Expert Committee

In the event that an expert in expert committee makes falsifications or has negligent actions during the process of review of new chemical notification, which has led to false evaluation result, MEP will rescind the qualification of expert and publicize it.

Punishment of the Wrongful Act of Testing Agency

In the event that a domestic testing agency falsifies test data or has other wrongful acts during the process of generating data for new chemical notification, MEP will remove the testing agency from the list of approved testing agencies and publicize it.

Punishment of Abusing Power

In case of abusing power or neglecting duties, the relevant department and the responsible person(s) involved in the environmental management on new chemical substances shall be subject to administrative punishments in accordance with relevant laws and regulations; in cases of a crime committed, criminal penalties shall be imposed in accordance with relevant laws and regulations.

Registration of Polymers as a New Substance

Details required to register polymer as a new substance in CHINA

1. Exact IUPAC name of the polymer - "Before searching IECSC, it is very important for a company to know the nomenclature rules in China. The Chinese name of a polymer should be named in accordance with . English name shall follow IUPAC or CAS nomenclature rules. Chinese name must match English name precisely."
2. Then, you need to check if all ingredients (including polymers) in the final products are listed on IECSC or not. If not, you might need to submit new chemical substance notification by appointing a local agent.
3. We have to search the inventory to be aware whether the said polymer is already registered by other companies

• Check the IECSC updated pdf for the using the exact IUPAC name of the polymer
• If not available, then we have to check the Confidential section of the IECSC. To search the confidential section of IECSC, we shall submit an enquiry to the Chemical Registration Center (CRC) of MEP in written form. CRC will send a confirmation letter to you regarding whether a substance is listed in the confidential section of the inventory. This whole process takes 3-5 days. 5000 RMB will be charged by Authorities for China IECSC inquiry.

Please note that in China, a polymer must meet the following criteria: 

1. Molecules must be distributed over a range of molecular weights; 
2. The weight percentage of molecules containing three monomer units or above should exceed 50%; 
3. The weight percentage of any molecule of the same molecular weight shall not exceed 50%. 

The preferred method to determine whether a substance falls under the definition of a polymer is Gel Permeation Chromatography (GPC). 

Also, CHINA has also adapted the Polymers of Low Concern[Polymers of Low Concern] rule as per the OECD PLC rule. In China, polymer that meets any one of the following three criteria will be regarded as PLC:

a.  The average molecular weight (MW) of the polymer is between 1,000~10,000 Da. At the same time, the weight percentage of oligomer with MW<500 is less than 10 percent, and the weight percentage of oligomer with MW<1000 is less than 25 percent. Besides, the polymer shall not contain functional groups of high concern (for example, heavy metals) and highly reactive functional groups;

 b, The average molecular weight (MW) of the polymer is greater than 10,000 daltons. At the same time, the weight percentage of oligomer with MW<500 is less than 2 percent, and the weight percentage of oligomer with MW<1000 is less than 5 percent;

 c. Polyester polymer

The following information shall be submitted for the simplified notification of polymers:

• List of monomer (s)/reactants, including the name, CAS number, the content of monomer (s)/reactants as well as whether if monomer (s)/reactants are listed in IECSC;
• Molecular weight and its distribution, including GPC or other testing results to indicate molecular weight and its distribution;
• Description of the mechanism of polymerization process, manufacturing process or flow chart;

For polymers that are not listed on IECSC and not eligible for simplified notification under special conditions, simplified notification under basic conditions shall be submitted if the volume of the polymers is less than or equal to 1 ton per year. If the volume is above 1 ton per year, typical notification shall be submitted.

The following information shall be submitted for the simplified notification under basic conditions for polymer:

• Composition information about the polymer and GPC data;
• Existing physio-chemical data (Melting point, partition coefficient n-octanol/water and water solubility are mandatory);
• 1/3 of the following tests must be carried out in Chinese labs approved by MEP: ready biodegradability, acute toxicity study with Brachydanio rerio, acute toxicity test with earthworms depending on substance properties;