Answers to Frequently Asked Questions about the Environmental Management Measures for New Chemical Substances (Order No.7)

1. If the bulk drug before obtaining the approval is a new chemical substance, does it need to be declared?
Answer: A declaration is required.

2. A mixed spin ×× acid has been listed in the List of Existing Chemical Substances in China. Do left-handed ×× acid and right-handed ×× acid still need to be declared?
A: If left-handed ×× acid or right-handed ×× acid is not listed in the List of Existing Chemical Substances in China, it needs to be declared separately.

3. If the liquid crystal used in the production of LCD TV panels, computer displays and mobile phone displays is a new chemical substance, does it need to be declared?
A: need to declare, should be declared by the LCD manufacturers or importers.

4, the production or import of polymers contained in the various additives (antioxidants, heat stabilizers, transparent nucleating agents, gliding agents, opening agents, etc.) must be included in the "China's existing chemical substances list", in order to be used in polymers?
Answer: If the chemical substances contained in the additives are not included in the "List of Existing Chemical Substances in China" and are new chemical substances, they should be declared in accordance with the "Environmental Management Measures for New Chemical Substances" (Order No. 7).

5. If a substance exists in the form of a preparation, and its preparation medium contains a new substance (undeclared substance), will it affect the declaration of this substance?
A: Any new chemical in the formulation needs to be declared.

6. Are natural substances extracted with organic solvents such as alcohols exempt?
Answer: According to the "New Chemical Substance Declaration and Registration Guidelines" on page 8, only natural substances extracted from water can be exempted.

7. Does enzyme protein belong to the category of living substances in naturally occurring substances? Do biological macromolecules such as polypeptides (such as gramicidin) or mucopolysaccharides (such as keratan sulfate) also belong to the category of substances exempted from declaration?
A: According to page 8 of the Guidelines for the Registration of New Chemical Substances, life substances in naturally occurring substances are exempt, but products produced through industrialization need to be declared.

8. A domestic company plans to import some cosmetic raw materials that have been listed in the cosmetics catalogue approved by the Ministry of Health. After checking, it is confirmed to be a new chemical substance. Does the company still need to declare new chemical substances?
Answer: A declaration is required. According to Article 2 of Order No. 7 and page 7 of the Guidelines for the Declaration and Registration of New Chemical Substances, the Environmental Management Measures for New Chemical Substances (Order No. 7) shall apply to the environmental management of activities related to new chemical substances used as raw materials or intermediates for cosmetics.

9. Catalyst A is a reaction mixture of B (active ingredient) and C. Both A and B are new chemical substances. If you plan to import product D containing A (D is also a new chemical substance), which one should you declare?
A: All new chemicals in the product should be declared.

10. Substance A is a food additive prepared from three components B, C and D, I .e. a preparation, and three components B, C and D also belong to food additives. At this time, do the three components B, C and D need to declare new chemical substances?
Answer: According to page 7 of the "Guidelines for the Declaration and Registration of New Chemical Substances", food additives themselves do not need to be declared, but the raw materials or intermediates for the production of food additives that belong to new chemical substances need to be declared. If the three components B, C and D of the production of food additive A are confirmed to be food additives, whether or not they are new chemical substances, they belong to the exemption category and do not need to be declared.

11. There is a class of substances that are determined to be by-products abroad, and the content exceeds 10%, which does not meet the definition of impurities in Decree No. 7. Can they be exempted?
A: The declaration shall be made in accordance with the requirements of Decree No. 7 and the Guidelines for the Declaration and Registration of New Chemical Substances.

12. Synthesis of new chemical substance P produces 5% impure Q and 20% impure R due to side reactions. P, Q, and R are all new chemical substances that are not included in the existing chemical substance list. It is technically possible to separate Q and R from P, but in view of cost, the product is sold in the state of an unseparated mixture (P, Q, and R account for 75%, 5%, and 20%, respectively). In this case, how should a new chemical substance declaration be made?
A: According to page 8 of the Guidelines for the Registration of New Chemical Substances, P and R are not exempt and need to be declared. Q can be exempted from declaration as an impurity with a content of less than 10%.

13. When synthesizing the new chemical substance X, 12% impure Y and 13% impure Z are produced due to side reactions. X, Y, and Z are all new chemicals that are not included in the existing list of chemical substances. It is technically possible to separate Y, Z from X, but in terms of cost, the product is sold in the state of a mixture of X(75%), Y(12%), Z(13%) without separation. In this case, do X, Y and Z need to be declared as 3 new chemical substances respectively?
A: According to page 8 of the Guidelines for Declaration and Registration of New Chemical Substances, X, Y and Z are not exempt and need to be declared separately.

14. In the environmental management of new chemical substances, does the same factory area refer to several legal entities or one legal entity?
Answer: It refers to the same factory area of the same legal entity.

15. Is it necessary to declare new chemical substances for on-site transferable isolated intermediates?
Answer: It is up to the declarant to judge whether "on-site transferable isolated intermediates" are non-isolated intermediates. Intermediates other than non-isolated intermediates are subject to this "Environmental Management Measures for New Chemical Substances" (Decree No. 7). See page 9 of the Guidelines for the Registration of New Chemical Substances.

16, a domestic enterprise intends to import less than 1 tons of a new chemical substance from abroad, used as a monomer in the country through the polymerization of synthetic polymers, synthetic polymers are the only use of the substance. Since the polymer itself is classified as a substance in Decree 7, can this monomer be understood as an intermediate, and a simple declaration of special circumstances can be made on the grounds of "intermediate, and the annual production or import volume is less than 1 ton?
Answer: According to page 9 of the "Guidelines for the Registration of New Chemical Substances", "intermediates refer to chemical substances that are chemically reacted in one step in the entire chemical reaction and are consumed in the next chemical reaction process to produce other chemical substances or products. Intermediates should not be present in manufactured chemicals or products, except as impurities. "The substance to be imported mentioned in the question is not the substance reacted in the previous step in the whole reaction, so it cannot be used as an intermediate.

17. If the raw materials for research and development are new chemical substances and the products for research and development are existing substances, then whether the products for research and development can be sold through market behavior, but after sales, they can only continue to be used for research and cannot be used for activities other than research, unless the new chemical substance has been registered "(described on page 11 of the" New Chemical Substance Declaration and Registration Guidelines ")?
Answer: In this case, new chemical substances used as raw materials need to be declared in accordance with Order 7. As existing chemical substances, products are managed according to existing chemical substances and do not apply to Order 7.

18. A is the importer of the whole car. Add organic oil to the engine of the imported vehicle. After the oil is added, it will stay in the engine and seal it, and will not flow out of the engine or release it. If a new chemical substance is added to this oil, does A need to declare it?
Answer: No need. Because it is not an article that intentionally releases new chemicals when used in regular, it does not need to be declared.

19, on the "definition of domestic and foreign manufacturers". The situation is as follows: new chemical substance pigment producer → ink producer of pigment formula → ink distributor/distributor → trader → Chinese importer. May I know which one the manufacturer refers to? Is it an ink distributor/changer?
A: The manufacturers referred to in the Guidelines for the Declaration and Registration of New Chemical Substances refer to manufacturers or traders that export or produce new chemical substances in China. Foreign manufacturers who sell new chemical substances directly into the territory of China are required to make a declaration.

20. When querying through the List of Existing Chemical Substances in China, it can only be known that the substance is not in the list and there is no other information. When inquiring about some foreign directories, for unclassified substances, you can see its physical and chemical properties. In order to regulate the management of chemicals in China, can some information be added to the List of Existing Chemical Substances in China for unclassified substances?
Answer: In the environmental management of new chemical substances, the role of the "China Existing Chemical Substances List" is to define whether a substance is a new chemical substance. When conditions are available, the registration center will consider adding other functions to the List of Existing Chemical Substances in China.

21. What are the requirements for the qualifications of the applicant?
A: See Article 16 of the Measures for Environmental Management of New Chemical Substances.

22. Can a domestic branch act as an agent for an overseas head office?
A: Domestic branches can act as agents if they meet the qualification requirements of agents in the Guidelines for the Registration of New Chemical Substances.

23. Is the declarant in the bonded area and the export processing area a domestic or overseas declarant?
Answer: It belongs to the domestic declarer.

24. After the foreign declarant obtains the new chemical substance registration certificate through the agent, does the agent also obtain the permission to import the new chemical substance?
A: No. After obtaining a new chemical substance registration certificate, only the declarant is granted an import license for the new chemical substance.

25. The foreign declarant made the declaration through an agent and obtained a registration certificate for a new chemical substance. When multiple domestic companies import the new chemical directly from the company, do these domestic companies need to make a separate declaration?
A: Since the foreign declarant has obtained the registration certificate of the substance, as long as it carries out the import of new chemical substances in accordance with the scope and requirements of the registration certificate, the domestic company in the above situation does not need to declare the substance.

26. The foreign declarant made the declaration through an agent and obtained a simple declaration registration certificate for special circumstances. If the name of the company of the overseas applicant changes and the holder of the registration certificate remains unchanged, is it necessary to do the registration certificate change procedure? If so, what information should be submitted?
Answer: The registration certificate needs to be changed. The original applicant of the registration certificate shall submit a written application for change to the registration center, stating the specific changes such as company name change, company merger or asset acquisition, merger and acquisition, etc., and submit supporting materials, and submit the original of the new agency agreement to the registration center. After verification, the registration center shall put forward suggestions on whether to change or not, and report to the Ministry of Environmental Protection. The decision on whether to grant the change is made by the Ministry of Environmental Protection. If the change is approved, the original registration certificate shall be returned, a new registration certificate shall be issued, the name of the applicant of the original registration certificate shall be canceled, and the corresponding information shall be changed in the new chemical substance management file.

27. Can the declaration materials of overseas applicants be submitted by domestic branches?
A: There are no restrictions on the way the applicant's declaration materials are submitted.

28. Is it acceptable for the legal representative of the overseas declarant to affix the name seal? The name of the unit is not completely consistent with the official seal. If "Limited" is replaced by "Ltd", is the difference acceptable?
Answer: If the name seal of the host country has legal effect, it can be accepted. The name of the unit must be consistent with the official seal.

29. Foreign enterprise A obtains a new chemical substance registration certificate through agent B. Should Company A change its agent or take other measures at this time due to the failure of Company B or other reasons that it no longer engages in this business or Agent B no longer exists?
A: Overseas Enterprise A should change its agent. The original holder of the registration certificate shall submit a written application for change to the registration center, stating the specific changes such as company name change, company merger or asset acquisition, merger and acquisition, etc., and submit supporting materials, and submit the original of the new agency agreement and the qualification certification documents of the new agent to the registration center.
After verification, the registration center shall put forward suggestions on whether to change or not, and report to the Ministry of Environmental Protection. The decision on whether to grant the change is made by the Ministry of Environmental Protection. If the change is approved, the original registration certificate shall be returned, a new registration certificate shall be issued, the name of the holder of the original registration certificate shall be canceled, and the corresponding information shall be changed in the new chemical substance management file. The new registration certificate shall indicate the new registration certificate number and registration time according to the registration certificate, and the changes shall be noted.
After the name of the holder of the registration certificate is changed, the new holder of the registration certificate shall bear the responsibility of the holder of the original registration certificate.

30. A trading company buys a new chemical substance from China and puts it directly in the bonded area, then resells it to other countries. Does the trading company need to declare the new chemical substance?
Answer: When the trading company purchases the new chemical substance, it shall require the supplier of the new chemical substance to provide the registration certificate of the new chemical substance, and shall not purchase the new chemical substance that is not registered.

31. A company imports a new chemical substance into a warehouse in a bonded area in China without any processing before exporting it. Is it necessary to declare a new chemical substance in this case?
Answer: According to page 10 of the "Guidelines for the Declaration and Registration of New Chemical Substances", "The Measures are not applicable to those that are temporarily stored in the bonded area after import and are exported without any processing (including changing packaging, selecting, sorting, etc.)."

32. Do I need to pay a fee to the Chemical Registration Center of the Ministry of Environmental Protection for the declaration of new chemical substances?
A: Currently, there is no fee for new chemical substance declarations.

33, related to the joint declaration of incremental issues.
The two companies make a joint declaration of a new chemical substance, of which company a declares 5 t/a and company B declares 4 t/a, totaling 9 t/a, which belongs to level 1. Two years later, Company B's production increased to 6t/a (sum = 11t/a) and made a level 2 independent declaration. Company B provided the data. In this case, is the production limit of company a automatically expanded to the sum of company B, I .e. <100t/a?
A: A shall be produced or imported in accordance with the registration quantity stated in the original registration certificate.

34. Company A produces new chemical substance X,9 t/a, which is regular declared according to Grade 1.
After that, Company B also produced new chemical substance X,9 t/a, which was regular declared at Level 1. Company A and Company B are completely different companies. In this case, is Company B required to provide the data required for Level 1 reporting? Is it possible to be required to provide the data required for Level 2 reporting?
Answer: In case of repeated declaration in Article 4 on page 47 of the Guidelines for Declaration and Registration of New Chemical Substances, the required data shall be submitted according to the sum of the declared quantities.

35. If the regular declaration goes directly from level 1 to level 3, is it necessary to choose two ecotoxicology tests or one?
Answer: Test data should be provided in accordance with Level 3 data requirements.

36. Will the potential use of the new chemical substance declared by the regular appear on the registration certificate?
A: No, the registration certificate shows the declared purpose approved by the Ministry of Environmental Protection.

37. Is it necessary to fill in the "longitude and latitude coordinates of the factory gate" in the regular declaration form?
Answer: According to the "New Chemical Substance Declaration and Registration Guidelines" and the requirements of the declaration form.

38. When making a regular declaration, if a substance is a "spontaneous combustion substance", is it only necessary to submit density test data?
A: According to page 34 of the Guidelines for the Registration of New Chemical Substances, only density test data can be submitted for regular declarations belonging to "spontaneous combustion substances", and explanatory or evidential information with corresponding attributes should also be submitted.

39. When making regular declaration, can some data quote relevant data or contents in other test reports as data sources (e. g. quote the water solubility data appearing in the aquatic organism toxicity test report and use the report as the data source of water solubility data)?
A: According to page 31 of the Guidelines for the Registration of New Chemical Substances, "the declaration data for regular declaration can be derived from test reports, published authoritative literature, authoritative databases, or data generated by QSAR, cross-reference, expert statements, etc., of which data derived from test reports should be submitted first".
The relevant parameters of the test substance extracted from the test report cannot be used as a data source.

40. In the regular declaration, "chemical substances that emit flammable gases when exposed to water" and "products that decompose or react with water/light are all chemical substances in the List" can be exempted from submitting ecotoxicological data, so can the same be exempted in the simple declaration of basic situations?
A: Yes. As with the regular declaration requirements, descriptive or supporting information with corresponding attributes should be submitted at the same time.

41, in the first level of regular declaration, if there are foreign aquatic organisms acute toxicity data, then must be carried out in the domestic aquatic organisms toxicity test can choose fish 14 days extended toxicity test or Daphnia magna breeding test?
A: Yes. According to the requirements of page 36 of the "New Chemical Substance Declaration and Registration Guidelines" for ecotoxicology tests completed in China. Submission of at least one item of aquatic toxicity data (recommend preferred fish) at level 1.

(Note: Ministry of Environmental Protection Announcement No. 42 of 2017 has deleted the data requirement for the 14-day extended toxicity test of fish.)

42, a declared substance, there are foreign test data. Can the risk assessment report be completed at the same time as the in-country test?
Answer: No. The risk assessment of the declared substance should be based on all known information at the time of the declaration.

43. If the registration certificate is changed due to the increase of the activity of new chemical substances, how to define the first activity time of new chemical substances?
Answer: The first time provided in the first activity report form shall prevail.

44. Is it possible to obtain GLP only after the laboratory does not have GLP qualification when conducting tests?
A: Laboratory qualification is subject to the date of issuance of the test report.

45. The laboratory qualification certificate shall be provided in the test report declared by the regular. Regarding ecotoxicology testing, since the Ministry of Environmental Protection has published the domestic test list, is it no longer necessary to provide the qualification certificates of the laboratories included in the list?
A: The testing agency announced by the Ministry of Environmental Protection does not need to provide qualification certificates.

(Note: Announcement No. 85 of 2016 of the Ministry of Environmental Protection has canceled the review and announcement system of chemical testing institutions.)

46. With regard to physicochemical and toxicological testing, the list of testing institutions has not yet been published. What kind of laboratory qualification documents should be provided?
A: For physicochemical and toxicological testing, the testing agency should provide a copy of the qualification certificate obtained. See page 28 of the guide.

47. If a domestic testing institution provides an experimental test report with a measurement certification mark, is it not necessary to provide a separate laboratory qualification certificate? The experimental report provided by an overseas testing institution generally has a declaration of laboratory qualification at the front of the report, is such a declaration valid and is it necessary to provide an additional qualification certificate?
Answer: If the domestic testing institution provides the experimental test report with the measurement certification mark, it should also provide a copy of the qualification certificate obtained. Overseas testing institutions, if they have inspection by the competent authorities of the country where they are located or proof of compliance with the specifications of qualified laboratories, shall provide copies.

48. Are there any requirements for experimental animals?
Answer: It should be in accordance with the relevant national regulations on experimental animals.

49. For an indicator not included in the Guidelines for Chemical Testing (HJ/T 153), there are foreign methods and national standards in China. Which method should be used for testing?
A: According to the provisions on page 28 of the Guidelines for the Declaration and Registration of New Chemical Substances, China's standards should be selected.

50. For the 201 Alga Growth Inhibition Test (Alga Growth Test), there are several expressions of results, such as EC50, EbC50, ErC50, etc. Which should be submitted?
A: First of all, the test method should meet the requirements of the "New Chemical Substance Declaration and Registration Guidelines"; secondly, because Order 7 requires the environmental hazard classification of the declared new chemical substances, the algae endpoint specified in the GB20602-2006 is 72h-ErC50. Therefore, for this test, namely "201 Alga Growth Inhibition Test (Alga Growth Test), the result expression should give priority to the ErC50 value of 24h ~ 72h, especially the 72h-ErC50 value.

51. In the simple declaration of the basic situation, must the data of water solubility and partition coefficient be issued by a qualified laboratory? Is the data obtained by the laboratory of the applicant company (without GLP qualification), the data estimated by the simulation software or the data cited in the published literature acceptable?
Answer: In the simple declaration of the basic situation, the data source of water solubility and partition coefficient is not required.

52. In the simple declaration of polymers, if the feed ratio of each monomer is different, several polymers with different molecular weights are produced, but the polymers have the same chemical name. Are these polymers declared as the same new chemical substance?
A: Yes.

53, to "process and product research and development, annual production or import volume of less than 10 tons, and not more than two years" reason for the simple declaration of special circumstances to obtain the registration certificate, after two years after the expiration of this reason again for the simple declaration of special circumstances?
Answer: No.

54. A domestic company W produces and imports a polymer formed from A and B, C and D. When foreign exporters Y produce, A, B, C and D are used as initial reactants (A, B, C and D are added to the reactor); Due to some process secrets involved, foreign exporter Y exports polymers of A and B to domestic company W, and W adds C and D for production polymerization (domestic suppliers add C, D and AB primary polymers to the reactor). May I ask, when company w makes a simple declaration for special circumstances, does the monomer fill in a, B, c and d, or does it fill in the initial polymer of c, d and AB?
A: The initial polymers of C, D and AB should be filled in.

55. After a domestic company X produces a polymer, it is mixed with other materials and solvents in the mixer in its factory to form a formulation, which is then sold in barrels. So, when making a simple declaration under special circumstances, is Company X itself counted as the processing user when filling in the processing user information in item 2.5 of the declaration form?
A: If the company only sells the formulation of the polymer, the process of mixing the polymer with other materials and solvents is part of its entire production process and is not counted as a processing user; if it not only sells the formulation but also sells the polymer separately, the company should be counted as a processing user.

56. The products of Company A are all formulations composed of polymer, solvent and rosin resin. Is it OK to fill only the solvent name in the column of "preparation medium" in the existing form of Item 3.3 of the simple declaration form? If not, how should it be filled in?
Answer: No, the name of solvent and rosin resin should be filled in truthfully.

In the declaration of the polymer, the additive information should be reflected. To what extent does the additive information need to be detailed? Do you need CAS number, CAS name, content, feed ratio and whether it is in the List of Existing Chemical Substances in China?
Answer: The declarant should provide the above information in the list of monomers and reactants.

58. Does the power of attorney of the legal representative need to be permanently authorized to the same person?
A: No, but the original power of attorney should be resubmitted when replacing the authorized person.

59, a new chemical substance after a simple declaration to obtain a registration certificate, such as later in the actual use of the process of use changes, whether it is necessary to re-declare?
Answer: The name, registration quantity, registration purpose, declaration reason and change of activity type of new chemical substances that have obtained the simple declaration registration certificate need to be re-declared. The name change of the declarant and the holder of the registration certificate does not need to be re-declared, but the change can be applied.

60. For the purpose of scientific research, if the annual production or import volume of new chemical substances is less than 0.1 tons, scientific research filing can be carried out. Is there a lower limit for scientific research filing?
A: There is no lower limit on the number of scientific research filings.

61. What is the conceptual difference between scientific research and process development?
A: according to page 11 of the guidelines for the registration of new chemical substances, "research refers to the exploratory activities of understanding and applying new chemical substances, involving scientific research, technology and product development research. Scientific research refers to the process of exploring new knowledge, new theories and new principles, which can be divided into basic research and applied research; process and product development research refers to the research on the basis of scientific research and the application of scientific research results to market development and production practice ".

62. After submitting all the materials for scientific research filing and declaration, when can scientific research activities be carried out?
A: According to page 23 of the Guidelines for the Registration of New Chemical Substances, "the applicant for scientific research filing can carry out activities related to the new chemical substances after submitting the application materials for scientific research filing of new chemical substances. If the relevant activities have been carried out but the registration center has received a request for correction, the correction shall be made in accordance with the prescribed requirements ".
The applicant for scientific research filing shall carry out relevant activities in accordance with Article 34 of the measures for the Environmental Management of New Chemical substances (order No. 7) and accept the supervision and inspection of the environmental protection department.

63. How should we deal with the materials in the filing and declaration of scientific research, when many scientific research institutions carry out scientific research at the same time?
Answer: Relevant information should be provided in the form of attachments in items 1.3, 2.7~2.11 of the new chemical substance scientific research filing declaration form.

64. For the materials that have been filed, if the scientific research unit changes, does the applicant need to re-file them?
A: A description of the change is required.

65. If a substance exists in two forms, such as preparations and pure substances, should it be filled in on the declaration form.
Answer: Everything needs to be filled.

66. Do the substances in the preparation medium have to be explained?
Answer: The "New Chemical Substance Declaration and Registration Guidelines" and the declaration form are not required to fill in.

67. Is it necessary to submit GPC report for simple declaration of polymer?
Answer: For the simple declaration of polymers, it is necessary to submit a molecular weight distribution map, including gel permeation chromatogram (GPC,Gel Permeation Chromatography) or other results that characterize the molecular weight of the polymer and its distribution, such as weight average molecular weight, number average molecular weight, molecular weight distribution, etc.

68. Does the industry classification of the declared substance have to be filled in?
A: According to the "Requirements for Filling in regular Declarations", "Requirements for Filling in Simple Declarations" and "Requirements for Filling in Scientific Research Filing Declarations", "Industry Classification" must be filled in.

69, data preservation includes user information, do you only need to record your next level of users? Because you can't provide further downstream user information.
A: Yes.

70. Under Decree No. 7, how can new chemical substances be included in the List of Existing Chemical Substances in China?
Answer: Only new chemical substances approved for registration through regular declaration can be included in the "List of Existing Chemical Substances in China" (hereinafter referred to as the "List"). New chemical substances that are simply declared for registration and scientific research are not included in the Directory.
According to Article 41 of Chapter IV of the Measures for the Environmental Management of New Chemical Substances (Order No. 7), general new chemical substances shall be listed in the "List" by the Ministry of Environmental Protection after five years from the date of the first production or import activities of the holder of the registration certificate. The holder of the registration certificate of hazardous new chemical substances (including key environmental management hazardous new chemical substances) shall submit a report on the actual activities to the registration center six months before the expiration of five years from the date of the first production or import activities. The Ministry of Environmental Protection organizes experts from the review committee to conduct a retrospective evaluation of the actual activity report, and according to the evaluation results, the announcement of hazardous new chemical substances (including key environmental management hazardous new chemical substances) is included in the "List".

71. How should the waste of new chemical substances in general be disposed?
A: It should be disposed of as hazardous waste.

72, has been registered before October 15, 2010, has not submitted the first record form before, do you still need to submit it? Only after 5 years to report, can you enter the directory after the report?
Answer: The registration certificate obtained under Order 17 shall be submitted to the first import flow record form in accordance with the relevant provisions of Order 17. If it is not submitted, it shall be handled in accordance with the provisions of Document 123.

73. Foreign enterprises import samples to China for physical and chemical, toxicological and ecotoxicological tests. When filing scientific research for declaration, the declaration reason in the declaration form is to choose "to import new chemical substance test samples for ecotoxicological characteristics test of new chemical substances with Chinese test organisms in China? If so, is it necessary to fill in the relevant laboratory data of chemistry, toxicology and ecotoxicology in the 1.3 scientific research units? 2.7,2.8, do 2.9 items need to be filled in separately?
A: Yes. 1.3,2.7,2.8 and 2.9 items need to fill in the relevant information of the implementation of scientific research units.

74, the domestic physical and chemical test report requires that must be stamped with the national measurement certification seal?
Answer: It is not necessary,. However, certification materials showing that the testing organization meets the qualification requirements of the Guide shall be attached.

75. There are multiple declared substances in the series of declarations. Do you need to submit a risk assessment report, or do you need to submit several risk assessment reports for several substances?
Answer: Only one risk assessment report needs to be submitted, but the specific substances corresponding to the specific values should be indicated in the report.

76, left-handed body and right-handed body have been listed in the list of existing chemical substances in China, so can mixed-handed body be managed as an existing chemical substance?
Answer: If the mixed spin body is not listed in the "List of Existing Chemical Substances in China", when the applicant needs to produce or import the mixed spin body, he/she also needs to register and manage the new chemical substance.

77. A company produces a new chemical substance in Factory A in China as a raw material for export to Factory B abroad. Factory B processes the raw material (only mixed) and then exports it to Factory A in China for labeling. In this case, if Factory A already has the production registration certificate of the new chemical substance, is it still necessary to apply for the import registration certificate of the new chemical substance?
A: Factory A or Factory B is required to handle the registration certificate of the import activity of the new chemical substance.

78. A product consists of four isomers with similar structures, iso A, iso B, iso C and iso D. These four isomers are not listed in the List of Existing Chemical Substances in China. How to declare new chemical substances for the product?
Answer: If the four isomers in the product function as a whole and cannot be separated during production and use, the product can be declared as a new chemical substance as a whole. If the product is composed of an artificial mixture of the four isomers, the four isomers shall be declared as new chemical substances respectively; or, when the four isomers meet the series declaration conditions, a series declaration can be made.

79. A new chemical substance is an additive for food packaging materials that has been approved by the Ministry of Health. If the import of the new chemical substance is limited to additives in food packaging materials, is it necessary to declare the new chemical substance?
Answer: It is needed. According to the first chapter of the "Guide", "the scope of application of new chemical substances", the management of other laws and regulations is limited to manufactured products composed of new chemical substances, and new chemical substances contained in products need to be declared.

80. A new chemical substance is a kind of micro-spherical particles after being processed and formed. The imported form is that the new chemical substance is physically mixed with other resin particles in proportion. New chemicals are not released during use. Does the substance fall into the category of an exempt article and do not require a declaration of a new chemical substance?
A: According to page 9 of the Guide, articles should meet three requirements at the same time. The substance does not meet the requirements of the Guidelines and requires a new chemical substance declaration.

81, a film product, mainly used in the production of LED light-emitting diodes, its role is to bond certain materials in the LED tube. Its adhesion mechanism is: with the help of the physical properties of the film, the chemical reaction of the adhesion promoter in the film completes its function. Is this film an article exempt from declaration?
A: According to page 9 of the Guide, articles should meet three requirements at the same time. This film product does not meet the requirements of the Guide and new chemicals in the film need to be declared.

82. During the period of data correction, it is confirmed that the declared substances have been included in the list. How to deal with them?
A: When the applicant notifies the Chemical Registration Center in writing or the registration center finds confirmation, the Chemical Registration Center will terminate the declaration.

83, the applicant to carry out a new chemical substance of scientific research filing declaration, supply a number of units to carry out scientific research. Can you fill in multiple scientific research units on the same declaration form? If there are many other scientific research units that need the substance afterwards, how to declare and how to count the declaration amount?
Answer: It is allowed to fill in multiple scientific research units on one application form and provide relevant information of scientific research units and projects in the form of attachments. If additional scientific research units are needed after that, change instructions and application materials with additional scientific research units and project information shall be provided. The same applicant, the same substance, corresponding to the situation of multiple scientific research units, the cumulative total of new chemical substances conducted by all scientific research units shall not exceed 100kg/year.

84. The declarant has filed a scientific research on the type of production activities for a new chemical substance. The declared quantity is 90kg/year, which has been accepted. Can the substance be filed on the type of import activities, with the declared quantity being 90kg/year?
Answer: If the activity type is changed to "Import", yes, but a change description should be submitted at the same time. Otherwise, you can't. Because for scientific research filing, the cumulative production and import volume shall not exceed 100kg/year.

Does it need to be put on record for scientific research for substances that have been registered under Decree No. 85 and 17?
A: For the same applicant, there is no need for scientific research filing in this case.

After a new chemical substance has obtained a simple declaration registration certificate, it is proposed to apply for a regular declaration. After obtaining the regular declaration registration certificate, can the annual production of the two registration certificates be superimposed? (Updated on March 25, 2015)
Answer: After obtaining the regular declaration registration certificate, the simple declaration registration certificate will automatically become invalid and should be returned to the solid management center. The annual production volume of the substance should be the regular declaration registration approval volume.

87. A, as the agent of Company B, makes a scientific research filing declaration with a declaration quantity of 99Kg. A Can the applicant declare the scientific research of the same substance for the record, with the declared quantity of 99Kg?
A: Yes.

88. The four units jointly declared a new chemical substance, each with a declaration volume of 2 tons/year (all for production activities) and a total volume of 8 tons/year, so they declared and provided data at the level 1 level. After approval, the registration volume of each registration certificate is 2 tons/year. If one of the units plans to expand the production capacity to 5 tons/year in the future, how will it be changed? Will the data be provided according to the second level? Will the data be provided by the one unit or the four units that expand the production capacity together? (Revised on October 15, 2013)
A: If one or more units intend to increase production so that the total amount of the joint declaration exceeds the original registration level, the unit that intends to increase production shall submit supplementary materials in accordance with the regular declaration procedures and re-apply for the declaration of the increased total level. After approval, it is only valid for units participating in the re-declaration of increased production.

89, a product is plant water distillation extract, the production process is water vapor distillation extraction, that is, hot water into natural plants, collection of water vapor, cooling after the product. Can products obtained through the above process be exempted from the declaration of new chemical substances?
A: The product is processed by water distillation extraction and does not fall into the exemption category specified in the Guidelines for the Registration of New Chemical Substances.

90. A substance A is not included in the List of Existing Chemical Substances in China after investigation. The substance is a functional component in the product, and the declared amount is <1 ton/year, and a simple declaration of basic conditions should be made. Although the substance is not in the "List", some substances of the same family as the substance, such as the potassium salt and ammonium salt of its cation, are already in the "List", and the performance of the substance is mainly determined by its cation part. If the substance is subject to a simple declaration of basic conditions in China, I wonder if the data of potassium salt of its cation can be used directly without the need to test substance A again?
Answer: No. The test shall be carried out on the actual declared substance.

91. Companies A, B and C are all foreign filers. If they apply for joint declaration in regular declaration, must the three filers appoint the same agent? Are the registration certificates issued separately or the same registration certificate?
Answer: The same agent is not required. Once the joint declaration is approved for registration, each declarant will receive a separate registration certificate.

92. Does the series of regular declarations require the submission of a full set of data for at least one substance??
A: The Guidelines stipulate that "a series of declarations may consist of test data of one or more new chemical substances in the series of declarations to form the minimum test data requirements at that level", ecotoxicology and toxicology data are not required to be test data of the same substance, allowing combination of data. Physico-chemical characterization data must contain all data for all substances in the series declaration.

93. Can the data in the series declaration use the data of substances other than the series declaration?
Answer: No.

94. What is the difference between repeated declaration and data provided by a third party for declaration?
Answer: Repeated declaration is to have before and after the declaration of the main body, and respectively obtain the registration certificate. The third party in the declaration refers to the party who assists in submitting the information and is not the subject of the declaration and will not obtain the registration certificate. If a third party assists in submitting a test report that has been used before in the regular declaration, that is, the same test report is used in the declaration, it will be processed according to the cumulative magnitude.

95. Company A first declared a new chemical substance with a declaration amount of 900 tons. Company B later declared 900 tons of the same substance. Does Company B need to add up the magnitude to declare?
A: If any test report already used by Company A is used in Company B's declaration, the magnitude will be accumulated. If the same test report is not used, it is regarded as an independent declaration, not affected by other declarations, and does not add up the magnitude.

Under Decree No. 96 and Decree No. 17, a declarant has already declared and obtained the registration certificate of substance A. Under Decree No. 7, another declarant has declared substance A. Does the declared magnitude add up?
Answer: No accumulation.

97, a company intends to import a natural wood extract, the extraction process uses an organic solvent (butylene glycol). The content of new chemicals in the extract is less than 1% (the organic solvent is removed from it, and heat denaturation may occur). May I ask (1) Can the declarant declare with the extracted mixture (1% chemical substance + 99% solvent)?(2) Is the substance name "XXX tree extract" or "substance extracted from XXX wood with water and butylene glycol (1:1)" more appropriate?(3) Because the content of the new chemical substance is too small (the content is 1%), is it acceptable to conduct ecotoxicology tests with the extracted mixture?
Answer: You can declare according to the extracted mixture. Substance designation shall be "Substance extracted from XXX wood with water and butanediol (1:1)". Reports of ecotoxicological tests carried out on the extracted mixture can be accepted.

98. In the secondary regular declaration, the declarant submitted the domestic fish 14-day extended toxicity test, can the fish acute toxicity test be exempted? If so, must one of the algae growth inhibition toxicity test and the Daphnia acute toxicity test be done in China?
Answer: No. Test reports shall be provided in accordance with the data requirements specified in the Guidelines.

(Note: Ministry of Environmental Protection Announcement No. 42 of 2017 has deleted the data requirement for the 14-day extended toxicity test of fish.)

99. The domestic declarant has registered the new chemical substance A, which is imported into the country and sold to another company, which simply mixes and processes the substance A without chemical reaction to produce new substances. Do processed products need to be declared and registered when exported abroad?
Answer: No need.

100, A and B are all overseas companies, and A has already applied for the registration certificate of the new chemical substance P. A sells substance p to company B and B sells it to company c in China. does c need to apply for a registration certificate?
A: B or C requires a registration certificate for the type of import activity.

101. The declarant has obtained the registration certificate of the new chemical substance A. If the declarant has actual activities in the first year and no actual activities in the following two years, should the registration certificate be canceled?
Answer: The holder of the registration certificate can choose whether to cancel or not. The holder of the original registration certificate after cancellation shall not declare the same new chemical substance again within five years.

102. Company A made a declaration for the filing of scientific research on new chemical substances and gave the products to Company B for scientific research activities, but Company B sold the new chemical substances on the market. Who will be responsible in this case?
Answer: The "Guidelines" stipulate that new chemical substances produced by research can be sold through market activities, but after sales, they can only continue to be used in research and cannot be used in activities other than research, unless the new chemical substance has been registered. When Company A fulfills the relevant provisions of the Measures, it shall not be liable; when Company A fails to fulfill the relevant provisions of the Measures, both A and B shall be liable.

103. A company has declared a simple declaration of the polymer situation of substance A and has not yet obtained a registration certificate. This declaration is applied for by the company's coatings department and is used as a paint dispersant. Now the company's other business unit, the electronic materials department, also has to declare the substance, but the use/form of existence/downstream processing user/packaging/use of products containing the declared substance is different in the way of exposure and use. Will this problem be solved by incremental declaration (note where the declaration information has changed) or by reapplying for an unrelated declaration (the declarant and the declared substance are the same)?
A: When the registration certificate has not been obtained, the applicant should withdraw the original declaration and apply for a new declaration, including all uses/forms of existence/downstream processing users/packaging/use of products containing the declared substance. If the registration certificate has been obtained, it should be re-declared and returned to the registration certificate.

104. What are the applicable objects of the Annual Report Form for New Chemical Substances (Trial)?
Answer: holders of registration certificates for simple declaration and regular declaration of hazardous new chemical substances (including hazardous new chemical substances for key environmental management) shall fill in the Annual Report Form for New Chemical substances (for trial implementation) and report the annual activities of all registration certificates obtained in accordance with the Environmental Management measures for New Chemical substances (Decree No. 7 of the Ministry of Environmental Protection). For example, the registration certificate reported in 2013 includes not only the valid registration certificate approved in 2012, but also the valid registration certificate approved in 2011.

105. If the registration certificate is changed, how to submit the Annual Report Form for New Chemical Substances (Trial)?
Answer: If there is any change in the registration certificate, the changed registration certificate number shall prevail, and a "New Chemical Substance Annual Report Form (Trial)" containing the activities of the new chemical substance for the whole year before and after the change shall be submitted.

106, how to define the amount of new chemical activity?
Answer: The amount of new chemical substances involved in the Annual Report Form of New Chemical Substances is the pure amount of new chemical substances. If it is an article or preparation, it shall be filled in after the content percentage or concentration in the article or preparation is converted into the pure amount.

107. How to determine the submission time of the Annual Report Form for New Chemical Substances (Trial)?
Answer: According to the "New Chemical Substances Environmental Management Measures" (Order No. 7 of the Ministry of Environmental Protection), it should be submitted to the registration center before February 1 each year.

108. Can the holder of the registration certificate submit the Annual Report Form for New Chemical Substances (Trial) multiple times?
Answer: Yes, the holder of the registration certificate can modify the submitted information. However, it is necessary to resubmit the revised full set of information. The previously submitted information will be automatically invalidated, and the registration center will be subject to the electronic data and PDF files finally included in the system.

109. Does an invalid registration certificate need to submit an annual report?
Answer: In the year when the registration certificate expires, it is still necessary to report the actual activities before the expiration, and it will not be reported from the year following the expiration.

110. If multiple products include the same new chemical substance, how to fill in the commodity code when importing?
A: If multiple products include the same new chemical substance and these products are imported, when filling in the import situation in Table 2, select the commodity code corresponding to the product with the highest content of the new chemical substance to fill in, but the total import amount should include the amount of all products converted into pure products of the new chemical substance. When filling in the import activity record in Form III, the import status of each product, including the corresponding commodity code of each product, shall be filled in, and the import volume shall be converted into the quantity of pure new chemical substance in the product.

111. Do new chemical substances registered under the original Order 17 need to submit annual reports?
Answer: No need.

112. Is it necessary to submit an annual report for new chemical substances in the management category of "general?
Answer: No need.

113, table 3 "3 exposure and release", imported need to fill in?
Answer: No need. Fill in this section only when the new chemical activity type is Production.

114. During the reporting year of new chemical substances, there was neither import nor production, but the products in stock in the past were transferred. Is this situation filled in as no activity or activity?
Answer: Fill in according to the situation of activities.

115. How to fill in the registration certificate summary column on the first page of the annual report?
Answer: No need to fill in, it is automatically generated by the software according to the filling situation of Table 2 and Table 3 in Table 1.

116. What is included in the full set of information in the annual report?
A: The full set of information in the annual report consists of three parts: first, all the registration certificate information held by the holder of the registration certificate. If the data are corrected, the complete information of all registration certificates held by other registration certificate holders shall be submitted at the same time in addition to the corrected information. The second is the annual report electronic data submitted through the "New Chemical Substance Annual Report Online Filling System"; The third is the signed and sealed PDF format annual report electronic copy printed and uploaded through the "New Chemical Substance Annual Report Online Filling System.

117, in order to make the silica better fusion in the coating, the surface of the silica is grafted with a small amount of polysiloxane, that is, on the surface of the silica, the siloxane grafted silica is obtained. The grafting process is that the hydroxyl group in the polysiloxane and the oxygen in the silica are connected by hydrogen bonds and then dehydrated, so that the silicon in the siloxane and the silicon in the silica are covalently connected by oxygen atoms. Does siloxane grafted silica need to be declared?
Answer: The declarant should check the novelty with the actual substance. If it is confirmed to be a new chemical substance, it should be declared.

118. Enzymes obtained by fermentation, such as amylase or protease added to washing powder. Do these substances fall into the exemption category of "naturally occurring substances" in the Guide and do not require a new chemical substance declaration?
A: Enzymes produced by industrial fermentation do not fall into the exempt category of "naturally occurring substances.

119. A company A imports a registered new chemical substance from abroad and sells it directly to a domestic customer P after importing it into China. The domestic customer P exports the substance directly to the customs and imports it into the customs after processing and preparation. At this time, because the subject of import and export has changed, it is necessary to reapply for an import registration certificate. So can the domestic customer P use the test data of the former declarant A when applying for the import registration certificate without adding up the magnitude?
A: According to Article 5 of Chapter IV of the Guide, magnitudes are not cumulative.

120. A company has made a scientific research filing declaration for a new chemical substance for a certain component in an imported product. The company will give the product to Company A for scientific research and testing. Company A will prepare the product into a primer for automobiles and give it to Company B, which produces automobiles. Company B will eventually apply the primer to automobiles. Can Company B market the cars coated with this batch of primer?
Answer: No. According to Article 3 of Chapter 1 of the Guide, new chemical substances produced by research can be sold through market activities, but after sale, they can only continue to be used for research and cannot be used for activities other than research, unless the new chemical substance has been registered.

121. A declared substance decomposes when exposed to water. After verification, the hydrolysate contains a new chemical substance, but the content is less than 10%. Is the ecotoxicological data of the new chemical substance still needed?
A: According to Article 3 of Chapter IV of the Guidelines, "if there are new chemical substances (single substance content> 10%) in the products of water/light decomposition or reaction", if the single content of new chemical substances is less than 10%, the submission of ecotoxicological data can be exempted.

122. A chemical substance has been declared abroad, and the data results of the experiment are listed on the official website. May I ask: Is it possible to directly use the data results on the website to declare regular in China without submitting a test report?
A: If the complete test report is published on foreign official websites, it is acceptable. If it is only a summary of the test report or test results, it is only used as reference material.

123. With regard to the change of registered use, Article 2 of Chapter 6 of the Guide stipulates that key environmental management hazardous new chemical substances that have obtained a registration certificate shall be re-declared when they change their use. For general and hazardous new chemical substances, is it necessary to re-declare the change of use after obtaining the registration certificate? If the registration certificate has not been obtained, but the applicant has to change the use of the new chemical substance during the data review process (Q & A 103), does the regular declaration have to cancel the original declaration before applying for a new declaration?
Answer: For new chemical substances of general and hazardous categories, if they change their use after obtaining the registration certificate, they only need to apply for a change of use and do not need to re-declare. If the registration certificate has not been obtained, but the applicant has to change the use of the new chemical substance during the data review process, the simple and regular declaration must first cancel the original declaration and then apply for a new declaration.

124. The provisions of the Guidelines for the Application and Registration of New Chemical Substances on the qualifications of domestic testing institutions "In terms of physical and chemical characteristics (including identification data such as spectral data and chromatographic data, but excluding gel permeation chromatogram of polymers), the Ministry of Environmental Protection shall, before publishing the list, be a testing institution with one of the following qualifications: laboratory accreditation of China National Accreditation Committee for Conformity Assessment, national metrological accreditation, and pesticide good laboratory (GLP) assessment of the Ministry of the Ministry of the Ministry of the Ministry of the Ministry of Agriculture, however, it can only provide data on test items or indicators that its qualification allows. "In January 2013, the Ministry of Agriculture announced No. 1891 in the People's Republic of China. According to the relevant provisions such as the Measures for the Administration of Full Component Analysis and Test Units for Pesticide Registered Original Drugs (Ministry of Agriculture Announcement No. 525) and the Measures for the Administration of Assessment of Good Pesticide Laboratories (Ministry of Agriculture Announcement No. 739), 10 units were approved as full component analysis and test units for pesticide registered original drugs and met the requirements of Good Laboratory Practice (GLP). Can these 10 units produce physical and chemical property data of new chemical substances?
A: These 10 units can issue physical and chemical property data of new chemical substances within the scope of GLP-compliant projects or indicators approved by the Ministry of Agriculture.

125. Company A is preparing to declare a new chemical substance B (silicate of a magnesium sodium fluoride), because substance B is insoluble in water and is inorganic, and water often contains sodium, magnesium and fluorine plasma, and the concentration of ions in water may be higher than the solubility of substance B in water, thus affecting the accuracy of solubility detection in water. May I ask whether it is possible to submit the "Earthworm Acute Toxicity Test" and apply for exemption from the "Fish Acute Toxicity Test"?
A: First of all, the applicant needs to provide proof that the ion concentration in the water is indeed higher than the solubility of the substance in water. The staff of the registration center will transfer the material to the experts of the ecological toxicology professional group for judgment to determine whether the test can be replaced.

126, metal oxide a and metal oxide B (a and B are all substances in the list of existing chemical substances in China), at high temperature (>500 ℃), the constituent atoms of a and B penetrate through mutual atomic gaps, and form homogeneous reaction product c after cooling. No new chemical bonds are formed between the metal oxide A and the metal oxide B, and the reaction product C does not belong to the intermetallic compound/well-defined intermetallic compound. May I ask: Does reaction product C need to be declared?
A: C does not need to be declared in the "List" and does not need to be declared in the "List.

127. A mixture Z has been listed in the List of Existing Chemical Substances in China, but a component A of Z has not been separately listed in the List of Existing Chemical Substances in China. May I ask whether component A can be managed as an existing chemical substance without the need to register a new chemical substance?
A: Component A should be subject to a new chemical declaration.

128. Does an existing chemical substance need to be declared as a new chemical substance after being isotope labeled?
Answer: The isotope-labeled compound does not need to be declared when there is no obvious difference in biological activity between the original substance and the original substance, otherwise a new chemical substance declaration is required; if the labeled substance produces radioactive rays, it is also applicable to the national regulations on radioactive substances.

129. A substance A has been listed in IECIC (List of Names of Approved Cosmetic Raw Materials) but not in IECSC (List of Existing Chemical Substances in China), that is, the substance A is not a new cosmetic raw material but a new chemical substance in China. At this time, A does not need to register as a new cosmetic raw material, so does A need to declare a new chemical substance?
A: A new chemical declaration is required.

130. A substance B is not listed in IECIC and is not listed in IECSC, that is, B is not only a new raw material for cosmetics, but also a new chemical substance in China. At this time, the substance B needs to be registered as a new raw material for cosmetics. So does B still need to register new chemical substances in China?
A: A new chemical declaration is required.

131. An enterprise produces new chemical substance A to produce raw materials for various pesticide products of different formulations. According to the Regulations on Pesticide Administration, the company should register A as a "new pesticide". Does the company still need to declare A as a "new chemical substance"?
Answer: Substance A is a raw material or intermediate for the production of pesticides and needs to be declared.

132. An enterprise produces a new chemical substance B that is only used as a standard substance for the active ingredient of pesticides. According to the Regulations on Pesticide Administration, the company does not need to register B as a "new pesticide". Does the company need to declare B as a "new chemical substance"?
Answer: Substance B is a raw material for the production of pesticides and needs to be declared.

133. Does the approved API need to be declared as a new chemical substance in China?
A: After obtaining the approval, the API needs to be declared as a new chemical substance in China. API should belong to the scope of raw materials and intermediates, so regardless of whether there are other laws and regulations, all need to declare.

134. The powdered new chemical substance A is mixed with other substances coated on aluminum foil and imported into China for battery manufacturing. This kind of aluminum foil is used as the electrode of the battery. In the process of manufacturing the battery, no chemical reaction occurs and no new chemical substances are released. In the final use, the new chemical substance A on the aluminum foil realizes the function of storing and discharging electricity through the change of its own ion price. May I ask: In this case, does the new chemical substance A belong to the category of exempted articles and no new chemical substance declaration is required?
Answer: Does not meet the definition of Article 3 in the article, does not belong to the article, cannot be exempted.

135. A company is preparing to import a new chemical substance A, which is an extract extracted from the aqueous suspension culture solution of rose leaf plant cells and is used as a cosmetic raw material to enhance skin activity. The whole process mainly involved in physical injury induced callus formation, cell culture in aqueous medium and physical crushing package process, without any chemical reaction involved. According to this, can the new chemical substance A be defined as a "naturally occurring substance" to meet the exemption conditions?
Answer: If the process does not involve any chemical solvents, the new chemical substance A does not need to be declared if the production process meets the "naturally occurring substance" in the exemption conditions of the "Guide.

136. Substance Z is the reaction product of A, B, C, comprising five components, D (about 60%),E (about 20%),F (about 10%),G (about 6%),H (about 4%). Among them, A,B and C are all in the list, but Z (not polymer) is not in IECSC, where D is listed in the list, and the remaining components are by-products and are not in the list. The five products are technically inseparable and are not separated when used, and can all be used as raw materials for the production of another product. May I ask (1) Is there still an exemption for cases where the content of such by-products exceeds about 40%?(2) If there is no exemption, should the new chemical substance be declared as a whole (reaction product Z of A, B and C), or should E and F be declared separately (so that the total amount of remaining by-products is less than 20% and less than 10% separately)?
Answer:(1) There is no exemption. (2) The overall Z should be declared.

137. A degradable fiber A is used in oil field operations to increase oil production, mixed with fracturing proppants and other completion fluids at the surface and pumped downhole. The fibers did not undergo any chemical changes during the process of ground mixing and pumping. However, when A is sent to a predetermined location downhole and shut in the well, it can rapidly degrade and dissolve in the downhole temperature, forming a kind of acidic non-hazardous liquid. This acidic liquid can react with the calcareous minerals in the surrounding rock to form a nearly neutral calcium and magnesium rich liquid. When the well resumes production, this liquid will also return to the surface. May I ask: Can this degradable fiber A be interpreted as an article and exempted from declaration during the use described?
Answer: A has undergone chemical changes during final use, so it does not fall within the scope of exemption. If A is not in the "List of Existing Chemical Substances in China", a new chemical substance should be declared.

138. Stabilizer and chelating agent need to be added to a product A. Stabilizer/chelating agent itself is not a new substance, but stabilizer and chelating agent will react with product A to produce a new chemical substance B when used. Does the new chemical substance B produced in this case meet the requirements of "chemical substances, mixtures or articles not produced by design reaction during final use" in the exemption conditions of the guide without declaration?
A: If New Chemical B is necessary to achieve the performance of Product A, you need to declare New Chemical B. Otherwise there is no need to declare.

139. Does the second declarant in the repeated declaration need to wait for the first declarant to obtain registration before making the declaration, or can it be repeated only after the first declarant submits the data?
A: After the former declarant submits the declaration information, the latter declarant may make a repeated declaration.

140. Chapter VI, Section VII of the Guidelines for the Declaration and Registration of New Chemical Substances stipulates that "the holder of the original registration certificate after cancellation shall not re-declare the same new chemical substance within five years". For a foreign declarant, where the holder of the registration certificate is a domestic agent, can A declare the same new chemical substance again through another agent within five years after the cancellation of a registration certificate declared by foreign declarant A?
Answer: No. The holder of the original registration certificate after cancellation shall not re-declare the same new chemical substance within five years. For overseas declarants, they shall not re-declare the same new chemical substance through another agent.

141. Bonded Area Registered Company A purchases a new chemical substance product Z from domestic manufacturer B. Company B has obtained Z's new chemical substance production registration certificate. Now Company A will sell part of the product Z to mainland customer C from the bonded area warehouse without changing packaging. May I ask: Does the process from the bonded area to the mainland require import registration?
Answer: No declaration is required.

142. Processing company A in the bonded area imports raw materials (raw materials contain new chemical substances) for the production of medicines from overseas manufacturer B. After simple processing (no chemical reaction), all the raw materials are exported abroad. In this case, does processing company A or overseas manufacturer B in the bonded area need to declare new chemical substances?
A: A new chemical import declaration is required.

143. If the anhydrous compound A is already in the IECSC, but the hydrate of A is not in the IECSC. Is it necessary to declare a new chemical substance for a hydrate? If a hydrate of A is already in IECSC, but other hydrates of A or itself are not in IECSC. Is it necessary to declare a new chemical substance for A and its hydrate? (March 9, 2015 update)
Answer: A and its hydrate (any number of crystal water) in the above two cases do not need to be declared.

144. Copper Clad Laminate (CCL) is a product made of wood pulp paper or glass fiber cloth as reinforcing materials, impregnated with resin, coated with copper foil on one or both sides, and made by hot pressing. Prepreg is a resin matrix impregnated with continuous fibers or fabrics under strictly controlled conditions to make a composition of resin matrix and reinforcement, which is an intermediate material in the manufacture of composite materials, both of which are used in electronic substrates. Are prepregs and copper clad laminates used in the processing of electronic substrates exempt from the declaration of new chemical substances?
Answer: It is necessary to confirm whether new substances are released during the regular use of prepregs and copper clad laminates. If new substances are released, new substances need to be declared.

145. Can test reports (such as algae growth inhibition toxicity, Daphnia acute toxicity, fish acute toxicity, activated sludge respiratory inhibition toxicity) made in ecological laboratories with only regular first-class qualification be used for declaration of second-class or above?
A: Can be used for higher level declarations.

(Note: Announcement No. 85 of 2016 of the Ministry of Environmental Protection has canceled the review and announcement system of chemical testing institutions.)

146. Before the "Environmental Management Measures for New Chemical Substances (03 Edition)" came into effect, an enterprise had been legally importing a new chemical substance A, which was used as an emetic, which was widely used in the production and synthesis of agrochemical products. In view of Article 42 of the Measures for the Environmental Management of New Chemical Substances issued by Order No. 7 of the Ministry of Environmental Protection, it is stipulated that "the Ministry of Environmental Protection shall organize an investigation of new chemical substances every five years. For chemical substances that have been legally produced or imported in the People's Republic of China before October 15, 2003, the Ministry of Environmental Protection shall be included in the" List of Existing Chemical Substances in China ". May I ask:(1) Can the new chemical substance A be included in the List of Existing Chemical Substances in China after the Ministry of Environmental Protection carries out the new chemical substance screening?(2) Can the enterprise continue to import A before being included in the list?(3) If the substance needs to be declared as a new substance, can the enterprise import the substance at the same time as the secondary regular declaration?
Answer:(1) Follow the relevant regulations during the investigation. (2) The enterprise needs to apply for the registration certificate of the type of import activity, and the import activity can only be carried out after obtaining the registration certificate. (3) No, import activities can only be carried out after obtaining a registration certificate.

147. The registered capital of a subsidiary B of an overseas company A in China is about 2 million yuan, which does not meet the minimum registered capital requirement of an agent. However, based on the economic strength and experience of Company A, Company A believes that Company B is capable of undertaking the corresponding responsibilities and obligations of an agent. May I ask: Can Company B declare new chemical substances as an agent of Company A?
A: Company B cannot act as an agent for Company A to declare new chemical substances.

148. For mixtures, is the Chinese name mixture or mixture?
Answer: The unified specification is "mixture" and "mixture" is no longer accepted ".

149. How to check "English name" for chemical substances that do not have CAS number but whose written English name conforms to CAS naming specification?
Answer: Check "CAS Name".

150. For mixtures or reaction products with a clear structure of each component, how to check the "substance category?
Answer: Check "No unique, determine molecular structure".

151. What are the requirements for writing class names?
Answer: The Chinese category name should be compiled according to the Guidelines for Compilation of New Chemical Substance Declaration Category Name (HJ/T 420-2008); English category names are compiled according to the translation of Chinese category names.

152. What are the special requirements for the preparation of molecular formulas for substances with special substituents (e. g. position, uncertain number, etc.)?
Answer: It can be written according to the requirements of the regular molecular formula, or the molecular formula of the special substituent can be attached to the molecular formula of the main structure, with brackets and no spacers. If there are more than one, brackets can be added separately.

153. Can words appear in molecular formulas?
Answer: Text is not allowed.

154. What are the requirements for the submission of atlas data?
Answer: For organic matter, at least 2 kinds of atlas in infrared, nuclear magnetic resonance and mass spectrometry should be provided. For chiral substances, information on optical rotation should be provided as much as possible. The test condition information shall be included in the submission of the atlas data.

155. For monitoring methods in environmental media, which environmental media monitoring method is submitted?
Answer: Environmental media include water, atmosphere, soil, and others. According to the physical characteristics and final destination of the declared substance, the detection method of the declared substance in the corresponding environmental medium shall be provided.

156. For some special new chemical substances, such as substances that can only exist in acid solution, pyrophorous substances, etc., can they be declared without submitting physical and chemical data? Or submit data estimated by QSAR method instead of test data?
Answer: First of all, the properties of the new chemical substance itself and its storage conditions, the properties of the chemical products containing the new chemical substance and its storage conditions, and the content of the new chemical substance should be explained in detail; secondly, it should be in accordance with the ''New Chemical Substances According to the requirements of the Guidelines for Declaration and Registration, physical and chemical test data should be submitted as much as possible. For items that cannot be tested under normal temperature and pressure or normal experimental conditions, the test should be carried out as much as possible by changing the experimental conditions to obtain the test data. For example, for pyrophorous substances, the density test can be carried out under the condition of isolating air. For projects that cannot be tested even if the experimental conditions are changed, the data estimated by QSAR method, the cross-reference data of analogs or the statement issued by experts and laboratories that the test cannot be carried out can be submitted for review and confirmation by the expert review committee.

157. Should a decomposition temperature be provided for new chemicals that decompose before melting?
A: The decomposition temperature should be provided.

158. Hazardous classifications such as "explosives", "self-reactive substances and mixtures", "oxidizing liquids", "oxidizing solids" and "organic peroxides" can be judged on the basis of the molecular structure of the chemical substance. May I ask the declarant to make his own judgment? Or must it be an expert statement?
Answer: the applicant can judge by himself or by entrusting experts according to the molecular structure of the chemical substance, and the appropriateness of the judgment result shall be determined by the expert evaluation committee.

159. Can the 90-day repeated toxicity data replace the 28-day repeated toxicity data?
Answer: For the same exposure route, 90-day repeated exposure toxicity data are submitted, and 28-day repeated exposure toxicity data may not be submitted.

160. For substances with a capacity of more than 100 tons, if there is no toxicity data for repeated exposure for 28 days and 90 days, can it be directly used for repeated exposure for 90 days and then exempted from repeated exposure for 28 days?
Answer: For substances with a declared quantity of more than 100 tons/year, if there is no repeated toxicity data for 28 days and 90 days, the repeated toxicity test report for 90 days may not be submitted.

161. The Ministry of Environmental Protection announced that the "Table 4 Toxicological Data Exemption Conditions" in the "Guidelines for the Application and Registration of New Chemical Substances" P38 "Requirements for Application Materials for 4. New Chemical Substances" in Annex 4 of the "Announcement No. 42 of 2017" stipulates that the inhalable part of the particle size distribution of the substance is less than 1% (particles with particle size <10μm) (weight percentage), in addition, the aerosol, particle or droplet MMAD>100 μm "can be used to exempt acute inhalation toxicity. Q:(1) How to understand "respirable fraction"?(12) What kind of material should be provided for "respirable fraction <1%"?(23) What is meant by "MMAD"?(34) What kind of material should be provided for "aerosols, particles or droplets produced during use, MMAD>100 μm?
Answer:(1)"inhalable part" refers to particles with particle size <100μm;(12)"inhalable part <1%" shall provide particle size test report;(23)"MMAD" is all called "aerodynamic mass average diameter";(34)"MMAD of aerosols, particles or droplets generated during use> 100 μm" involves the actual situation of substances used by enterprises, it shall be up to the declarant to provide the supporting materials.

(Note: Ministry of Environmental Protection Announcement No. 42 of 2017, page 8, has made it clear that "inhalable part" refers to particles with a particle size of <10μm.)

162. Are substances with skin corrosivity exempt from the submission of acute and 28-day recurrent dermal toxicity data?
A: Substances that are caustic to the skin are exempt from submitting acute transdermal toxicity data and 28-day repeated transdermal toxicity data.

163. Note 4) of "Table 1 Toxicology Minimum Data Requirements" in P33 "Requirements for 4. New Chemical Substance Declaration and Registration Guidelines" stipulates "Level 2, when the 28-day repeated toxicity test result shows serious irreversible damage or no observable effect level is very low, 90-day repeated toxicity data shall be provided. Q: What do you mean by "severe irreversible injury" and "no observable effect at a very low level?
Answer: "irreversible injury" refers to the injury that cannot be recovered during the recovery period of the test; "Severe irreversible injury" needs to be judged by experts; "No observable effect level is very low" refers to the lowest observable effect level (oral)<100 mg/kg,(transdermal)<200 mg/kg,(inhalation, gas)<0.25mL/L,(inhalation, vapor)<1mg/L,(inhalation, dust/smoke/fog)<0.2mg/L.

(Note: Announcement No. 42 of 2017 of the Ministry of Environmental Protection has deleted this expression involved in the note. At the same time, page 10 of the exemption conditions for regular declaration of toxicological data in Annex 4 has clearly defined the criteria for judging that there is no observable harmful effect level is very low.)

164. "Table 4 Toxicological Data Exemption Conditions" in "4. New Chemical Substance Declaration and Registration Guidelines" P38 "Requirements for New Chemical Substance Declaration and Registration" stipulates that chronic toxicity can be exempted when "no observable effect level of repeated toxicity is very high. Q:(1) Does "repeated toxicity" mean "90-day repeated toxicity" or "28-day repeated toxicity"?(2) How to understand "high level of no observable effect"?
Answer:(1)"Repeated toxicity" refers to "90-day repeated toxicity", not "28-day repeated toxicity";(2) For "no observable effect level is very high", there is no clear value, which needs to be determined by expert review.

(Note: Ministry of Environmental Protection Announcement No. 42 of 2017 is clearly explained in Note 2 on page 10.)

165. For reproductive or developmental toxicity, ask:(1) Can prenatal developmental toxicity data (OECD TG 414) be used instead of reproductive/developmental screening test data (OECD TG 421) if potential reproductive or developmental toxicity is not known in the secondary declaration?(2) Can teratogenic test data (OECD TG 414) be used instead of reproductive/developmental screening test data (OECD TG 421) for secondary declaration?
Answer: The prenatal developmental toxicity data and teratogenicity test data refer to the same test (OECD TG 414). If there is prenatal developmental toxicity data (teratogenicity test data)(OECD TG 414) in secondary declaration, reproductive/developmental screening test data (OECD TG 421) can be exempted.

(Note: Ministry of Environmental Protection Announcement No. 42 of 2017 is explained in Note 5 on page 4).)

166. Is it possible to replace reproductive/developmental screening test data (OECD TG 415) with first-generation reproductive toxicity test data (OECD TG 421) for secondary reporting?
A: If there is only one generation of reproductive toxicity test data (OECD TG 415), the reproductive/developmental screening test data (OECD TG 421) should also be submitted in accordance with the Guidelines for the Registration of New Chemical Substances.

(Note: Ministry of Environmental Protection Announcement No. 42 of 2017 is explained in Note 5 on page 4).)

167. For toxicokinetics, ask:(1) How to understand the "absorption kinetics related information" should be submitted in the secondary declaration?(2) How to understand the "complete toxicokinetics related information" should be submitted in the tertiary declaration? (Updated on December 07, 2015)
Answer:(1) In the secondary declaration, the relevant information of absorption kinetics should be submitted (not the absorption kinetics report based on the acute and chronic toxicity test data), including the following information:
1) Absorption kinetic test data of the declared substance, or;
2) Relevant absorption kinetics literature or research data of the declared substance, or;
3) Homologue test data or literature (research) data that can explain the absorption kinetics of the relevant characteristics of the declared substance, or;
4) Based on the scientific and reasonable structure-activity relationship model, the prediction report of the absorption dynamics of the declared substances is reported.
(2) The test report on the toxicokinetics of the declared substance shall be submitted at the third level of declaration.

(Note: Ministry of Environmental Protection Announcement No. 42 of 2017 is explained in Note 6 on page 4).)

168. "When there is data indicating that the declared substance has obvious target organ toxicity, corresponding toxicity data shall be submitted, such as neurotoxicity data for organophosphorus substances, as stated in" Table 1 Toxicology Minimum Data Requirements "Note 108) in P33" Requirements for 4. New Chemical Substance Declaration and Registration Guidelines. Q: Is "target organ toxicity" only for the nervous system?
Answer: "Target organ toxicity" is not only for the nervous system. The need to supplement the corresponding toxicity data should be determined by the expert review, in general, will not be required to submit, but for special categories of substances, such as toxicity through acute toxicity test and other regular tests can not be observed or with special toxicity of substances, will be required to submit the corresponding toxicity data.

(Note: Announcement No. 42 of 2017 of the Ministry of Environmental Protection, the adjustment number of this note is Note 10).)

169. if the pH of the declared substance is <2 or pH>11.5, ask: can acute transdermal toxicity, acute inhalation toxicity, 28-day exposure, 90-day exposure, AMES test, reproductive and developmental toxicity, carcinogenicity, etc. be exempted?
A: In principle, special substances should also be tested as much as possible. If it is really impossible to carry out the test, the expert or laboratory's instructions should be provided.

170. Is there a trade-off between test methods? Do results from non-screening test methods take precedence over results from screening test methods?
Answer: The results obtained by the confirmatory test method/non-screening test method take precedence over the results obtained by the screening test method; The results obtained by the national standard recommend test method take precedence over the results obtained by the non-national standard recommend test method. The results obtained by the in vivo test method take precedence over the results obtained by the in vitro test method. However, multiple in vitro test results cannot be denied by only one in vivo test result.

171. Can the local lymph node test (OECD TG 429) be used instead of the skin sensitization test (OECD TG 406)?
A: Yes.

172. Can the in vitro skin irritation test (OECD TG 439) be used instead of the acute skin irritation/corrosion test (OECD TG 404)?
Answer: If the in vitro skin irritation test (OECD TG 439) test result is positive, the acute skin irritation/corrosivity test report (OECD TG 404) may not be submitted. The positive result shall be adopted in the classification of skin irritation/corrosivity hazards. If the test result is negative, the acute skin irritation/corrosivity test report (OECD TG 404) shall also be submitted.

173. Can the bovine corneal opacity and penetration test (OECD TG 437) or the isolated chicken eye test (OECD TG 438) be used as an alternative to the eye irritation/corrosion test (OECD TG 405)?
Answer: If the bovine corneal opacity and penetration test (OECD TG 437) and/or the isolated chicken eye test (OECD TG 438) are positive, the eye irritation/corrosion test report (OECD TG 405) may not be submitted, and this positive result shall be adopted in the classification of eye irritation/corrosion hazards. If the test result is negative, the eye irritation/corrosion test report (OECD TG 405) shall also be submitted.

174. Is it possible to use the combined chronic toxicity and carcinogenicity test (OECD TG 453) to replace both the carcinogenic test (OECD TG 451) and the chronic toxicity test (OECD TG 452 )?
A: Yes.

175. Can the in vitro mammalian cell micronucleus test (OECD TG 487) be used as an alternative to the in vitro chromosome aberration test (OECD TG 473)?
A: Yes.

176. For the same test method, the health toxicity test is performed by different laboratories or at different test times. Q:(1) How to deal with different qualitative (negative, positive) test results?(2) How to deal with different quantitative test results?
A: For valid test results, in accordance with the principle of strict treatment,(1) hazard classification gives priority to positive results;(2) hazard classification gives priority to values with lower levels of toxic effects.

177. How do I calculate LD50 and other indicators for mixtures?
Answer: The mixture is tested as a whole to obtain the overall LD50 value.

178. How to classify the hazards of mixtures?
Answer: The hazard classification of the mixture shall be carried out in accordance with the relevant provisions of the national standard. The overall test data of the mixture is preferred for classification. If there is no test data of the whole mixture, the classification is carried out by bridging principle or adding data of mixture components.

179. regular level 4 declaration, acute toxicity of fish has been done abroad and chronic toxicity of fish has been done at home. Is it not necessary to do acute toxicity test of fish at home?
A: Fish acute toxicity tests should be carried out in China in accordance with the requirements of the guidelines, and ecotoxicology tests carried out in China should be increased step by step. Level II declaration needs to submit a 14-day extended toxicity test for fish; Level III and Level IV may not submit a 14-day fish toxicity test.

(Note: Announcement No. 42 of 2017 of the Ministry of Environmental Protection has deleted the data requirement for the 14-day extended toxicity test of fish.)

180. Can the fish chronic toxicity test report replace the fish acute toxicity test report or the 14-day extended toxicity test report?
Answer: 1) For Class I and Class II regular declarations and simple declarations, if the fish chronic toxicity test is completed in China and includes reliable acute test or 14-day extended test endpoint information of the same fish, the fish chronic toxicity test report can replace the fish acute toxicity test report or 14-day extended toxicity test report; 2) For Class III and Class IV regular declarations, the fish acute toxicity test report and chronic toxicity test report shall be submitted at the same time.

(Note: Announcement No. 42 of 2017 of the Ministry of Environmental Protection has deleted the data requirement for the 14-day extended toxicity test of fish.)

181. Adsorption/desorption test in which method?
A: The data of adsorption/desorption test (OECD TG 106) should be based on the data of high-performance liquid chromatography to estimate the adsorption coefficient of soil and sludge (OECD TG 121) as a supplement. When the adsorption/desorption test method is not applicable, the high performance liquid chromatography method can be used, and the reason is explained.

182. Are the information requirements for exposure different from those for domestic production when the declared substance is not produced domestically but is imported for domestic use?
A: If the applicant is a foreign supply distributor and the downstream user has not yet been identified, provide brief information on the process of use. If the declarant is a domestic processing user and is directly used to produce other substances after importing the declared substances, a clear production and use process flow chart, process description and chemical reaction formula shall be provided. The flow chart shall indicate the location of the "three wastes" generation node; Explain the quantity of "three wastes", the concentration or content of the declared substances in the "three wastes" and the material balance data.

183. What are the special requirements for the submission of information on exposure when the declared substance is both produced and used in the country?
Answer: For production and use, clear production process flow chart, process description and chemical reaction formula should be submitted respectively. The flow chart shall indicate the location of the node where the "three wastes" are generated. Explain the quantity of "three wastes", the concentration or content of declared substances in "three wastes" and the material balance data.

184. What are the requirements for filling in the "Environmental Friendly Statement" column?
Answer: Fill in the improvement of the declared substance compared with the existing substance. If the declared substance is a new chemical substance in the hazardous category of key environmental management, the necessity of producing or using the declared substance, whether there are other alternative substances or technologies, and the feasibility of replacing it shall be clearly stated.

185. What are the requirements for spectrogram reports for new chemical substance declarations?
Answer: The spectrogram test report should be issued by a testing organization that meets the qualification requirements of the guidelines, and the original spectrogram should be attached, and the correlation of data, spectrogram, test conditions, instrument model and other information should be clear and clear.

186. By what criteria should the ecotoxicological data of the declared substance be classified as hazardous?
A: The classification of ecotoxicological hazards should be carried out in accordance with the Code for the Classification and Labelling of Chemicals (GB30000.28-2013) and the Guidelines for the Identification of Hazards of New Chemical Substances (Draft for Comment).

187. How does the Center respond to the applicant's inquiry about whether the substance has been registered as a new chemical substance?
Answer: In order to protect the applicant's commercial and technical secrets, if the substance to be inquired has been registered and the applicant obtains its registration information after the former applicant agrees, the center may reply; in other cases, the center does not reply to the specific registration information.

188. To declare a new chemical regular level 4, how many aquatic toxicity tests should be completed in China? Which ones are included?
A: According to the requirements of the Guidelines, four aquatic biological toxicity tests should be completed in China to declare the regular level 4 of new chemical substances.; Three of the test items are the same as the regular level 3 declaration, and the other test can be selected from the aquatic organism toxicity test required by the level 1, level 2 and level 3 regular declaration minimum data.

(Note: Ministry of Environmental Protection Announcement No. 42 of 2017, Note 4 on page 5) It has been explained that the minimum ecotoxicology data requirements for Level 3 and Level 4 have been distinguished. For fish chronic toxicity tests, Level 4 should be submitted to fish larval growth tests. At the same time, according to the requirements of the Guidelines for ecotoxicology tests completed in China, "at least one item (recommend the preferred fish) shall be submitted at the first level; From the beginning of the second level, at least one of the newly added data requirements shall be selected step by step for each additional order of magnitude.)

189. According to the requirements of the Guidelines for completing aquatic biological toxicity tests in China, at least one of the new data requirements shall be selected for each additional order of magnitude from the second level onwards. The new data requirements include fish bioaccumulation tests?
A: Includes fish bioaccumulation tests.

190. After the registration of hazardous new chemical substances (including key environmental management hazardous new chemical substances), if changes in risk control measures are involved, how should they be handled?
Answer: If the risk control measures are changed after the registration of hazardous new chemical substances (including key environmental management hazardous new chemical substances), such as "processing in a closed system" is changed to "semi-closed or non-closed system", an application shall be submitted according to the registration certificate change procedure, the changed information such as risk assessment report shall be resubmitted, and a list of changed items shall be listed, technical review by the Solid Management Center, technical review by the Review Committee and approval by the Environmental Protection Department.

191. How should the quantity of a substance in the series declaration be changed?
Answer: If the sum of the total amount of series of substances declared is still within the original magnitude after the change of the declared quantity of a single substance, the change procedures and material requirements are the same as those of the ordinary application for quantity change within the magnitude. If the sum of the total amount of series of substances declared exceeds the original magnitude after the change of the declared quantity of a single substance, the substance shall be re-declared with the changed magnitude, and the newly added test report subject shall be the substance.

192. According to the Guide, the reporting data "should provide information on the expert's profile if it is derived from the expert's statement". For the English version of the expert profile, is a Chinese translation required?
A: The English version of the expert's brief introduction should be accompanied by a Chinese translation.

193. According to the Guidelines, "if the products of water/light decomposition or reaction are all chemical substances in the List, the submission of ecotoxicological data is exempted". Is it necessary to submit supporting materials for the inclusion of all products in the List?
Answer: It is necessary to submit the certification materials that all products are included in the directory.

194. Should the name of the foreign declarant be in English? Is there a case requirement?
Answer: The name of the overseas applicant (except Taiwan, Hong Kong and Macau) should be in English, both upper and lower case, and should be consistent with the official seal, agency agreement or entrustment contract.

195. Is the environmental management of activities related to new chemical substances in the free trade zone applicable to the Environmental Management Approach for New Chemical Substances (Decree No. 7)?
A: The requirements for the declaration and registration of new chemical substances in the free trade zone are the same as those in the bonded zone.

196. A chemical substance has been listed in the List of Hazardous Chemicals, but is not listed in the List of Existing Chemical Substances in China. Is it necessary to declare a new chemical substance?
Answer: It is needed.