The 3rd Summit Meeting on Chemical Regulations in Asia Pacific Q&A Summary

Hazardous Chemicals

1. Q: I have a question about the JT 617. I know that 80% of the contents in JT 617 borrow from ADR. However, as the ADR currently implemented in Europe is updated. Will the JT 617 to be released align with the latest ADR?

A: It is true that most part of JT 617 borrows from ADR. In the future, we will discuss whether to align JT617 with the latest ADR.

2. Q: Is it true that any substance listed into the Catalogue of Hazardous Chemicals 2015 is classified as hazardous chemicals? Or is it just substances compliance with the building blocks are classified as hazardous chemicals?

A: In accordance with the requirements of the Catalogue of Hazardous Chemicals, all substances that are listed in the Catalogue are classified as hazardous chemicals.

3. Q: I am from a trade company which mainly deals with boric acid. You know that the boric acid is classified as a hazardous chemical, yet it shall not be classified as dangerous goods. Can you please tell me if the standard for the storage of boric acid will be different from that for the storage of other hazardous chemicals after the revision of the standard?

A：All the substances listed in the Catalogue of Hazardous Chemicals 2015 shall fulfill the requirements of GB 15603. However, national standards do not involve the storage of canned goods, bulk goods as well as goods stored in container yards.

4. Q: It is quite difficult for us to apply for a hazardous chemicals warehouse for boric acid. Besides, the storage capacity of the warehouse seems too small for us considering the large volume of boric acid. As a result, our marketing activities are seriously affected. How can we solve this problem?

A: You can rent a hazardous chemical warehouse is Shanghai, yet the rent is quite high. In China, the supply of hazardous chemical warehouses falls short of the demand. China may set out to discuss whether to exempt some chemicals in terms of storage in the future. But I do not know when that might happen.

5. Q: Can you please give me some information about regulations on the storage of boric acid and other relevant chemicals in the European Union or the US?

A: China Association of Warehouses and Distribution has tried to communicate with relevant institutions in EU, the US and Japan since last year. As far as I know, regulations in EU, US and Japan do not require enterprises to store their chemicals in specific warehouses. Usually, overseas enterprises will adopt B2B trading.

6. Q: In some regions of China, boric acid is mistakenly classified as dangerous goods during transport, which seriously affected the transport of boric acid. Will it be eliminated in the future?

A: You shall not blame the traffic police for this. This real problem is that regulations concerning the management of hazardous chemicals have some defects. The regulations will be revised soon.

7. Q: During the process of multi-ministerial law enforcement, standards adopted by the Ministry of Transport, Ministry of Environmental Protection, the Fire Department and State Administration of Work Safety are different. Is there any possibility that all departments can work together and conduct cooperative management? Will there be any additional exemptions in the future?

A: There is not any exemption right now. Besides, the State Administration of Work Safety does not supervise consumer goods. It just supervises chemicals. Take perfume as an example. Perfume is classified as a hazardous chemical, yet its quantity is quite small. Two years ago, we started to discuss the specific exemption amount for perfume, but we could not reach an agreement. Other countries are also in a similar situation. All we can do is to improve our regulations in practical cases.

Japanese Chemical Regulations

8. Q: After CSCL is amended, how can enterprises find the emission factor to judge the distributed volume of the current year?

A.: The emission factor will be adopted in the future. We are still under discussion on how to use the emission factor. Besides, we are also discussing whether to apply the emission factor on existing chemicals and how to make relevant rules. We hope that the emission of chemical substances can be stabilized by adopting the emission factor. Relevant amendments to the CSCL will be released on the official website of Ministry of Environment.

9. Q: Is the emission factor relevant to the properties of the substances, such as the degradability, or is it just relevant to the use of the substance?

A.: Degradable substances, such as pesticides, can be migrated into the environment. However, articles, like battery, are quite difficult to migrate into the environment. As a result, the emission factor will be determined by taking into consideration of both the properties of substances and the usage.

10. Q: In accordance with the requirements of the CSCL, new substance notification must be submitted by Japanese manufacturers or importers. As a Chinese importer, how can I comply with CSCL?

A.: CSCL does not require an only representative. All the Japanese manufacturers and importers must carry out new chemical substance notification.

11. Q: When will the environment emission be calculated, from the chemical substances enter sewage treatment plant or the chemical substances enter the environment?

A.: The environment emission will be calculated when contamination in terms of the pollution discharged to the environment or water. However, calculation methods will be different based on the different source of environment emission, such as the emission occurred during manufacturing or application. As a result, it is difficult for me to explain how to calculate the environment emission right now.

K-REACH

12. Q: Are there any requirements in Europe, China or the US similar to the potassium hydroxide waive under K-REACH? If there is, then are the strategies and reasons for waiving the same as those in Korea? Does the waiving in Korea align with that in other countries?

A.: Substances similar to potassium hydroxide shall also get registered in China, Europe and the US. The registration requirements under K-REACH align with that under EU-REACH. The other question is about the reason for waiving, I am very sorry but I cannot answer the question in details here.

13. Q: If you decide whether to waive the data of some substances based on their effect on humans or the environment, then the standard of judgment should be similar globally.

A.: Considering the geographical area of Korea is small, some requirements in Korea are different from that in other countries.

14. Q: Are the registration fee for passive member and active member the same? Will the cost sharing be affected?

A: The consortium will elect the lead registrant. All the consortium members will negotiate how to register the substance. Relevant expenses shall be shared by all members. After all the materials are submitted and approved, all members may start to discuss how to allocate the expenses.

15. Q:Are Phenol and Potassium hydroxide in your presentation successfully registered?

A: The two substances are still in the registration process. KTR just submitted the application for registration and materials of the two substances are now checked by NIER.

16. Q: If the ready biodegradability report is submitted, is the hydrolysis report still needed?

A.: If results show that the substance could be readily biodegraded, then the hydrolysis report is not needed.

17. Q: I have a question about joint submission. The lead registrant of one substance was elected. Then, the lead registrant changed its mind and was not willing to register the substances any more. As a result, other enterprises have to elect another lead registrant instead. As a result, registration will be delayed and registrants may miss the registration deadline. Have you ever considered pushing back the registration deadline? Will you take measures to punish the lead registrants failing to undertake their responsibilities?

A.: In accordance with the requirements of relevant departments, registration must be completed prior to 30 June 2018. However, similar cases occur from time to time. We are also very concerned about whether the registration can be completed on time if there are large numbers of applications for registration. However, the consortium shall negotiate to settle this problem and we are not able to give you a definite answer on whether the registration deadline will be postponed.

18. Q: If the classified components exceed the threshold, does it have to be shown in the SDS in Australia?

A.: Yes, classified components exceeding the threshold must be shown in the SDS.

REACH and Australian Chemical Regulations

19. Q: I am from a manufacturing company in New Zealand. Can you please tell me which 24h emergency contact information I shall provide, the New Zealand contact or the Australian contact?

A: You cannot use the New Zealand address in your SDS. You have two options if it is quite difficult for you to provide Australian contact information: 1. You can use the 24h emergency contact provided by poison center; 2. You can also search for an Australian service provider which can provide 24h emergency contact to enterprises.

20. Q: Can you please tell me how long it will take to complete REACH registration for SMEs?

A：It depends. If one SME knows the substance quite well, for instance, the company has relevant data of the substance and knows the exposure scenarios quite well, the registration might be finished in a few months. Besides, registration can be submitted online. Actually, it takes much longer for enterprises to reach a consensus on data sharing.

21. Q: Are there any requirements for substance bioaccumulation under REACH? How to evaluate the accumulation of substances?

A: The ecological environmental data is also required. We have already taken actions to solve the problems concerning bioaccumulation. Currently, REACH only requires enterprises to collect standard data on accumulation. Besides, after enterprises submitted relevant data to ECHA, ECHA will also further analyze the selected substances and relevant information, for instance, some substances will be listed in the Corap. ECHA will pay particular attention to some substances if risks of these substances are high. ECHA will also require extra data if the substances are specific hazardous chemicals.

22. Q: The SVHC list becomes longer year after year. Do we have to provide test reports annually or do we just need to make an announcement?

A: The SVHC list will be updated each year. In accordance with the requirements under REACH, enterprises must provide the latest test reports once the SVHC list is updated. For this reason, relevant enterprises must pay sustained attention to the update status of the SVHC list.

23. Q.: You mentioned in your presentation that it is estimated that about 25000 substances will get registered before the 2018 deadline. Do the 25000 substances include non phase-in substances?

A: I need to check with my colleagues concerning whether the estimates include non phase-in substances. But it is certain that registration will reach a peak before the 2018 registration deadline. I hope enterprises can get prepared in advance.

24. Q: Is it reasonable that ECHA requires importers of ink or ink box to provide SDS?

A.: Ink will migrate to the environment during use and humans might be exposed to it. As a result, it is reasonable to require importers of ink or ink box to provide SDS.

Chemical Regulations in China

25. Q: Will you refer to the lists of restricted substances in foreign countries when preparing the list of chemical substance subject to priority control, such as the authorization list, restricted list and SVHC list?

A: We began to screen substances even before the release of Action Plan for Preventing and Treatment of Water Pollution. As we are required to ascertain this list before the end of this year, we will borrow some substances contained in the lists of restricted substances in foreign countries.

26. Q: After the list of chemicals subject to priority control is released, who should carry out the risk assessment, the Ministry of Environmental Protection or enterprises themselves?

A: It is probably that the Ministry of Environmental Protection will require relevant enterprises to provide safe use report. Then by taking into consideration of all the safe use report submitted by relevant enterprises, the Ministry of Environmental Protection will make a final decision.

27. Q.: Do you have a comparison list between the testing fee before and after the amendments

A: Charges and cycle of experiments vary from testing institution to testing institution. As a result, I cannot tell you the exact cost. However, there is no doubt that the testing fees for enterprises applying for registration will be largely reduced.

28. Q: Does the Division of Chemical Management have to manage all chemicals, no matter those substances are hazardous or not? Maybe you should focus on supervising hazardous chemicals, what do you think?

A: We do not manage all the chemical substances. Actually, we only manage chemicals with hazards, toxicity and uncontrollable risks; or chemicals that can be replaced by less hazardous chemicals.

29. Q: I heard that the amended MEP Order 7 might be released at end of 2017. Can you please tell me when it will be released exactly?

A: The amended MEP Order 7 will not be released for the time being. It is possible that the draft of the revised documents can be submitted to the Ministry of Environmental Protection at the end of this year.

GHS and chemical regulations in Southeast Asia

30. Q:I am from a company which involves in developing SDS preparation software. We found that some H&P statements have multiple expressions and some of them even conflict with each other. Besides, GB 32374 was implemented earlier this year. In this national standard, the H&P statements are also different from that in GB 30000 or other relevant national standards. So which one shall I use?

A: The Chinese version of the GHS 4threvised edition can only be used as a reference when preparing Chinese SDS. Problems concerning the inconformity of H&P statements have already been reported to the State Administration of Work Safety and they will be updated when the national standards are revised. In fact, all the expressions are available if they are stated in a national standard.

31. Q.:Our products are appropriately labeled. However, when we are clearing customs, the customs in different regions have different requirements. For instance, one customs requires us to magnify some particular expressions on our label. Is that right?

A: Customs in different places may have different requirements. In practical cases, enterprises shall subject to the local requirements in case their products are detained.

32. Q.: What kind information shall I provide if I need to apply for CBI in Thailand? What are the charges?

A. Substance notification in Thailand shall be completed by domestic manufacturers or importers. If suppliers do not wish to provide all the information, such as the components and cas, they can apply for CBI for free.