This list of Frequently Asked Questions concerning China New Chemical Substance Notification includes 82 queries submitted by Chinese and non-Chinese notifiers to the Chemical Registration Center of Ministry of Environmental Protection in China (CRC-MEP) and REACH24H. Some of them are China REACH regulatory basics that should be known to potential company notifiers and others are specific cases collected based on their China REACH compliance practices. For answers of these 82 questions, please click here to download the full PDF version.
A large part is the feedback updates from CRC-MEP (Chemical Registration Centre of Ministry of Environmental Protection) in China. (View the Chinese version)
Q 1: What is serial notification?
Q 2: What is joint notification?
Q 3. What is repeat notification?
Q 4: When a test is to be carried out in a lab outside of China, does the lab have to follow the chemical test guidelines in China or the local standards?
Q 5: Should I notify for pharmaceutical ingredients that belong to new chemical substances under China REACH before they get registered [with China SFDA]?
Q 6: If a DL- XX acid has been listed on the IECSC, does its L-XX acid or D-XX acid need to complete notification?
Q 7: If the liquid crystal, used in the production of LCD TV panel, PC monitors and mobile phone monitors, belong to new chemical substances, should I notify for them?
Q 8: Must I make sure all additive components(such as antioxidants, heat stabilizers, nucleating transparent agents, slipping agents and anti-block agents, etc.) are listed on IECIC when manufacturing or importing polymers in China?
Q 9: If a substance exists in the form of preparation and the preparation medium contains a new chemical substance under China REACH, how should I deal with the notification of this substance?
Q 10: Could the natural substances extracted by some organic solvents like alcohols be exempted for the obligation of notification?
Q 11: Does enzyme protein fall into the category of living matters under natural substances? Polypeptides (like gramicidin), mucopolysaccharides (like keratin sulfate) and other biological macromolecules can be exempted or not?
Q 12: My company plans to import a cosmetic ingredient listed on the MoH approved IECIC inventory. The substance is identified as a new chemical following IECSC enquiry. Should I notify for this substance then?
Q 13: Suppose catalyst A is the reaction mixture of Substance B (active constituent) and Substance C. Both A and B are new chemical substances. If I’m going to import a product D which is a new chemical on its own and contains substance A. Then which one should I notify?
Q 14: Substance A is a food additive composed of three constituents B, C and D. You might also classify it as a preparation. B, C and D are all food additives, too. Then should I notify for all of them three?
Q 15: A group of substances are identified as by-products in areas outside of China. Their concentration percentage exceeds 10% and they do not meet the criteria of impurities defined in MEP order no 7. Are they exempted?
Q 16: A synthetic new substance P, which generates the impurity Q in percentage of 5% and impurity R in percentage of 20% as a result of side reaction. None of P, Q and R is listed on IECSC. It is technically workable to isolate Q and R from P, but due to economic considerations, the company currently sells this product in the form of a non-isolated mixture, with P at 75%, Q 5% and R 20%. How should the company deal with the notification in this case?
Q 17: During the synthetic process of new chemical substance X, impurities Y and Z are generated in each respective percentage of 12% and 13% as a result of side reaction. None of X, Y and Z is listed on IECSC. It is technically workable to isolate Y and Z from X, but due to economic considerations, the company now sells this product in the form of a non-isolated mixture, with X at 75%, Y 12% and Z 13%. How should the company deal with the notification in this case?
Q 18: Under China REACH, does “the same plant” point to the area owned by different legal entities or the area owned only by my own company?
Q 19: Does on-site transported isolated intermediates need new chemical substance notification?
Q 20: One Chinese company A produced two new chemical substances P1 and P2 and sold them to two Chinese companies B and C. Company B made P1 and P2 react to produce a new chemical substance P3. Company C mixed P1 with other substances to produce a preparation P4. The Companies B and C exported P3 and P4 respectively to customers outside China. Which of the above companies should notify? Which substances from P1 to P4 need to be notified?
Q 21: If one substance is listed in IECSC but its hydrate not, does its hydrates require notification?
Q 22: Polymer P consists of 4 monomers A, B, C and D. Monomers A, B and C are listed in IECSC. Monomer D is not listed IECSC and its concentration in P is lower than 2% w/w in P. One company produced monomer D and then used it directly to produce polymer P. How should the company submit notification for polymer P and monomer D?
Q 23: Suppose we are doing research and our goal is to synthesize D by taking the synthesis route of A-B-C-D. However, we might produce other new chemicals such B’ and C’ during the synthesis process. Question: Should I notify all of B, C, B’ and C’?
Q 24: After registration certificate is issued, if our volume exceeds the allowable limit on the certificate, do we have to submit new notifications or just provide more data?
Q 25: Can we keep molecular formula and molecular structure confidential when we submit notifications?
Q 26: A Chinese company plans to import some new substance X in quantities of less than 1 t/y, which will be used as a monomer to generate polymers by reactions with polymers. As polymer is considered as substance under the MEP Order No.7, can I take this monomer X as a kind of intermediate and apply for a special condition under simplified notification for X in the form of “intermediate manufactured or imported in quantities of less than 1 t/y”?
Q 27: For the sole purpose of scientific research and development (R&D), my company uses a new substance (not listed on IECSC) as raw material (ingredient) to generate an existing substance, which is the result of our R&D. Does our generated product meets the following condition: “The produced substance in R&D activities are allowed to be put on the market but can only be used for the purpose of R&D other than any other uses after it is sold unless it is registered” (described in page 11 of China REACH Guidance).
Q 28: A company is a Chinese importer of complete cars. If A imports a complete car of which the engine contains oil, and A guarantees that the oil contained in the car engine is sealed up and will not overflow nor release, should A notify for a new substance added into the engine oil contained in his imported car?
Q 29: My question is about the definition of manufacturers based in and outside of China. In the following supply chain, new pigment substance manufacturer à pigment formulation producer who produces printing ink à printing ink repacking/outfit supplier à business trader à Chinese importer, which one is the manufacturer? The repacking/outfit supplier?
Q 30: When I search on the IECSC, I can only find out if a substance is listed on it but no further information about the substance. Can I ask will IECSC consider adding more information for the non-confidential substances, like physic-chemical properties?
Q 31: What qualifications do China REACH have for notifiers?
Q 32: Can a Chinese branch of my controlling company be the representative agent for our Can a Chinese branch of my controlling company be the representative agent for our new chemical substance notification?
Q 33: Are companies in the free trade zones and export processing zones considered as Chinese notifiers or non-Chinese notifiers?
Q 34: When a non-Chinese notifier obtains the registration certificate of China new chemical substance notification through his representative agent, can I take it that his representative agent thereby is granted the green light to import the registered new substance simultaneously?
Q 35: After a non-Chinese notifier completes his notification and obtains a registration certificate, several Chinese importers plan to import directly from the non-Chinese exporter, but here do these Chinese importers need to notifier the imported substances separately?
Q 36: In the case that a non-Chinese notifier obtains the certificate of a special simplified notification, when the non-Chinese notifier changes his company information, say company name, but the certificate holder remains the same, now does he need to update his registration certificate? If yes, what documents shall be submitted to CRC-MEP?
Q 37: Can a non-Chinese notifier ask his Chinese-based branch to submit his notification documentation?
Q 38: Is signature stamp accepted for non-Chinese notifiers in the area of legal representative stamp? My company stamp has slight difference from my company full name, for instance “Limited” shortened as “Ltd”. Is this kind of difference acceptable in application documents?
Q 39: Non-Chinese notifier A obtains a registration certificate through his Chinese-based representative agent B. However B goes bankrupt or no long engages in the China REACH agency services or does not exist. Should A change for a new representative agent or take some other measures?
Q 40: A trade company purchases some new substance on the Chinese market. The substance is place in a Chinese free trade zone before it is exported to other countries. Does this trade company need to notify for the new substance?
Q 41: A company imports some new chemical substance to a warehouse inside a Chinese free trade zone and then keeps the substance from any processing before exporting it to other countries. In this case, does A need to notify for the substance?
Q 42: Does China new chemical substance notification have any administrative fees?
Q 43: Two companies plan to carry out a joint notification for some new substance. Company A will notify in quantities of 5 t/a and Company B 4 t/a, which makes the notified quantity sum to 9 t/a, under the category of Band 1 (1-10 t/a) of Regular (Typical) Notification. Two years later, Company B increases the production to 6 t/a and the sum of A and B adds up to 11 t/a, which reaches Band 2 (10-100 t/a). B plans to conduct an independent notification under Band 2 and B undertakes the data part. Hereby, is Company A allowed to correspondingly expand his limit of production, under 100 t/a?
Q 44: Company A manufactures a new substance X at tonnage level of 9 t/a and carries out the Regular Notification under Band 1 (1-10 t/a). Another Company B also manufactures the same substance and in the same quantities. Could B combine A’s tonnage and provide data required of Band 2 [in the case of the “repeat notification”]?
Q 45: After my company completes the Band 1 (1-10 t/a) of Regular Notification, my production increases rapidly to Band 3 (100-1000 t/a). So in the case of change of registered tonnage band, do I need to provide two ecological toxicological tests or one?
Q 46: In Regular Notification, will the information on potential uses of a registered new substance appear in its registration certificate?
Q 47: Am I obliged to fill up the longitude and latitude coordinates of my company in application of Regular Notification?
Q 48: In applying for Regular Notification, if certain substance is classified as “substance liable to self combustion”, do I only need to submit the density test data?
Q 49: In applying for Regular Notification, can I borrow relevant data or information of other test reports as my data sources. For example, can I use the water solubility data in acute toxicity test for aquatic organism as my data source?
Q 50: In Regular Notification, the following substances can be exempted from submission of ecotox data: “substances which in contact with water emit flammable gases” and “substances which in contact with water/light decompose and from whose reaction the produced substances are all listed on IECSC”. Then do I have exemptions for general cases of Simplified Notification?
Q 51: In the application of Band 1 under Regular Notification, if I have got acute toxicity data for aquatic organism, can I choose prolonged acute toxicity fish 14-day test or daphnia magna reproductive test for the aquatic organism toxicity data obliged to be conducted inside China?
Q 52: I have the test data of certain new substance issued by a non-Chinese lab. In its notification, can I complete its risk assessment report meanwhile its compulsory test is carried out in the Chinese-based lab?
Q 53: If the change of activities of my registered substance demands for a change of my registration certificate. When do you define the beginning of a first activity report?
Q 54: If the laboratory committed to undertake my testing is not qualified of GLP until after my test is finished. Can I say my test data originate from a GLP lab?
Q 55: Notifiers need to supply test reports attached with laboratory qualification at the Regular Notification application. As for eco toxicity testing, the MEP has published a list of accredited labs based inside China. So do I still need to provide a similar lab qualification document?
Q 56: Accredited Chinese laboratory list concerning the physic-chemical test and toxicity test has not been made public yet. Then what kind of lab qualifications should I submit for this part?
Q 57: If the laboratory (Chinese) provides test reports with Chinese measurement authentication marks, can I be exempted from submitting lab qualification documents? And non-Chinese labs usually have a statement about their qualification in their test reports. Is this kind of self-statement valid as their qualification? Do I still need other lab qualification documents?
Q 58: Do you have any requirements on animal test?
Q 59: If I come across one test item that the Guidance for the Testing of Chemicals (HJ/T 153) does not specify. Two different testing methods, Chinese and non-Chinese, are available now for the item. Which method should I apply to?
Q 60: For the 201 alga growth inhibition test, there are several different indicators, such as EC50, EbC50, ErC50, etc. Which one should I choose in the test report?
Q 61: In a general case of Simplified Notification, must data on water solubility and partition coefficient n-octanol/water be issued by an accredited lab? Do you accept data acquired by the notifier’s own lab (not GLP), estimated by analog software or sourced from authority literature on record?
Q 62: In the simplified notification for polymers, if feed ratios of all the monomers of a polymer vary and this produces several polymers with distinct molecular weight yet of the same chemical name. Can I view all these polymers as one and notify for the produced new chemical substance?
Q 63: My company did a special Simplified notification for a substance used for product research & process technology with annual tonnage below 10 t/a and manufactured/ imported for less than 2 years. Two years later, can I still carry out a special simplified notification for the same substance in the same reason?
Q 64: One Chinese domestic company W produces and also imports certain polymer formed by substance A and B, C and D. The non-Chinese exporter Y uses A, B, C and D as initial reactants in his production (all four substances are added into the reaction container). Due to reasons of process confidentiality, Company Y exports the polymer AB formed by A and B to Company W who further adds C and D in the polymer production (three substances are added to the reaction container). So when W applies for the special simplified notification, which monomers should he fill up, four substances (A, B, C and D) or three substances (AB, C and D)?
Q 65: One Chinese domestic company X produces certain polymer and mixes it with other materials and solvents in the mixers of his factory so that a preparation is produced for barrel sales. Then in the application of a special simplified notification, can X consider himself as the processing/using party in the item 2.5 of the application form?
Q 66: My company produces a preparation made from polymer, solvent and rosin resin. Can I put in only the solvent name in the column of “preparation media” on the application form for simplified notification? If not, how should I fill up in that area?
Q 67: In the notification of polymers, companies are required to provide the information of additives. Then how detailed the information on additives should be? Does it include CAS number, substance name, concentration, feed ratio and information of whether listed on IECSC, etc.?
Q 68: Must the power of attorney be signed by the same representative person?
Q 69: My company obtains the simplified notification certificate for certain new substance. If its actual uses change in later activities, do I need to re-notify for the substance?
Q 70: For the purpose of scientific research, new substances manufactured or imported at annual tonnage below 0.1 t/a should be notified under Scientific Research Record. Does Scientific Research Record set up any minimum tonnage limit?
Q 71: What’s the difference between the purpose of “scientific research” and that of “product research and process technology”?
Q 72: After my company submits all required application documents for Scientific Research Record notification, when shall I begin the scientific research activities?
Q 73: If the recorded substance in Scientific Research Record Notification will be studied by more than one scientific institute, how shall I deal with this?
Q 74: If there is any change occurring to the scientific institute that carries out the research of my recorded substance, should I re-do the Scientific Research Record Notification?
Q 75: If certain substance has two forms of existence, say a preparation form and a pure substance form, do I need to write down both forms in the application form?
Q 76: Must I describe the use of substances contained within the preparation media?
Q 77: Shall I submit a GPC (Gel Permeation Chromatography) report for polymer Simplified Notification?
Q 78: Must I fill up for the “industry category” for my notified substance on the application form?
Q 79: The storage of relevant notification materials concerns the user information. Can I only record my direct downstream users, because it’s difficult to provide further downstream users’ information?
Q 80: How will a new substance be included into the IECSC under MEP Order No 7?
Q 81: How should I dispose of the waste of a general new substance?
Q 82: My company acquired the registration certificate before 15 October 2010 but we have never submitted the first-time activity report for record up to now. Do I still need to submit this first-time activity report? Can I wait till the fifth year after I got the certificate to submit the report and then my registered substance would be automatically included in IECSC?
