<Important K-REACH Relating Questions and Answers>

Transcription

1 <Important K-REACH Relating Questions and Answers> - Released by National Institute of Environmental Research (NIER) These questions and answers on this paper took place in the public meeting with the Ministry of Environment (MOE) and the relevant industries after the lease of the final version of K-REACH, last December 24, 2014 and this paper is the summary of the most important issues. I. Registration Q1. In order to share the previous registration materials, is it possible to ask the NIER the inquiry about the registration status of the same chemical substance for both of new chemical and existing chemical subject to registration? Q2. Can manufacture or import be allowed just after applying the new chemical registration, even if the completeness check and hazardous assessment have not been done? Q3. When I prepare registration application, how should I do if CAS No., molecular formula or molecular structure are not available? Q4. Is it possible for polymer that is new chemical substance with less than 1 ton/year to be registered as small quantity new chemical registration? Or should I submit the application for polymer with relevant polymer test data depending on tonnage band of less than 1ton? Q5. Test data for physico-chemical properties and hazard can be submitted with full report of test data or robust summary. Then, is any thesis published in international and domestic journals acceptable as replacement of test data? Q6. Is there any non-glp test data that can be submitted for registration? Q7. I purchased sodium hydroxide and diluted it with water and made it a 7% of sodium hydroxide and sold it to domestic clients. Then do I have an obligation of registration as

2 manufacturer under K-REACH? Q8. Can I translate the information on registration application and attachments into English? Q9. For new chemical registration with the quantity less than 1ton but greater than 100kg, submission of test data to the NIER can be exempt, but still some of test data should be submitted to the MOL (Ministry of Labor). In this event, do I have to submit the test data for the MOL to the NIER as well? Or do I need just submit them to the MOL separately? Q11. Under previous TCCA, if the registrant received the result of hazard assessment, he/she can import or manufacture the registered chemical without tonnage limit (except the case of less than 1ton). If the registration is done and the registration number is given under K-REACH, and the manufacturing/importing tonnage band increases after the registration, then is the modified registration (registration update) necessary? Q12. Assume 60 tons/year of the new chemical or existing chemical subject to registration is imported and 60 tons/year of the new chemical or existing chemical subject to registration is manufactured. Then what would it be for total tons of registration? 60 tons or 120 tons? Q13. In the chemical process, gaseous toxic chemical is produced as by-product and it is sold as a mixture form with water. Is this considered as manufacture? And does it have the obligation of registration under K-REACH? Q14. The new chemical or chemical substance subject to registration is imported and its impurities are eliminated, so it becomes so pure form as 99.99% from 99.0%. Then it is sold. In this case, is the registration obligation required for each import and manufacture separately? Q15. Is registration update necessary after year 2020 for importer who registers the new chemical with small quantity (less than 1ton) until 2019 and will import same chemical substance with amount of ton in 2020?

3 Q16. If the same chemical is imported and manufactured, should the registration be done for each import and manufacture separately, or should it be done once? (After checking off both import and manufacture on the application form) Q17. If the amount of manufacture and import of PEC exceeds 1ton after deadline of grace period, until when should the registration be done? Q18. Should new chemical be registered individually, not by joint submission? Is the joint submission necessary for prohibiting repeat of vertebrate animal test? Q19. In the event that the Only representative registers a chemical, if there are several importers, then should importing amount be individual by each importer or should it be the sum of each importer s importing amount? What would be the registration type on the application form? Q20. A new importer is added after the registration was done by Only representative. Then should the OR do registration update even if the total tonnage band remains same and there is no new use information added after the new importer is added? Q21. For chemical intermediate or new chemical registration with small quantity less than 1ton, some data requirements can be omitted but should be submitted if the applicant owns them. What if they are not submitted? Is there any penalty? Q22. Even though the test data is owned for the test item, the registrant does not submit the test data but submitted the test plan report instead. Is this penalized? Q23. CSR is required for above 100 tons in 2015 but it is expanded from When is CSR requirements applied exactly? Is it the point of submission of registration application, or at the point of receiving the result of registration? Q24. Assume the import amount of PEC is 80 tons/year and it is registered in 2016 without CRS and the result of registration is given in From the year of 2017, do I need to do registration

4 update because CRS is required for above 70 tons from the year of 2017? Q25. In case the final PEC list will be announced in the middle of 2015, then the grace period of this registration will be ended by the middle of If I register the PEC in 2018 with the amount above 50 tons, then do I need to submit CSR? Q26. The chemical was registered with non-biocidal use. But later, if new use application to biocide found, the registration update will be made for new use application. Then are additional data required according to Appendix 1 (Subparagraph 7) of Enforcement Rule of the Act? Ⅱ. Registration exemption Q1. Should raw materials and intermediates to be used for manufacture of medical or pharmaceutical products under the pharmaceutical law follow the K-REACH? If it is so, the substance can be exempt from the registration in case the whole amount of the substance will be used only for export? Q2. Regarding to chemical substances which are imported and used for initial test of analytical instruments and are not equipped with machines, if those chemicals are new substances or PECs, are they exempted from registration? Q3. Should new chemical substances imported which are equipped with medical instruments for in vitro diagnoses apply for registration exemption? Q4. Assume an importer received exemption from registration for new chemical which is exempt from registration as Low volume exemption, 100kg/year or as Low concern polymer exemption under previous TCCA. If he imports same chemical substance in 2015, is he considered as receiving registration exemption under K-REACH as well? Q5. In case test sample will be imported for physicochemical properties test or other toxicological test for registration, should it comply with procedures under K-REACH?

5 Q6. Although a consigner received low concern polymer exemption under previous TCCA, the consignee has not manufactured the polymer until After the K-REACH, the consignee can be considered as he received low concern polymer exemption as well by sharing the exemption result from the consigner? Q7. Concerning chemical substance received low volume exemption (<100kg/year) under previous TCCA, should the registration application is required for the first manufacturing or import in 2015 for same substance? Q8. Concerning chemical substance exempt from the registration under previous TCCA, what kind of procedure should be followed under K-REACH for its manufacture or import? Should the exemption application be submitted again after the K-REACH? (For example, R&D substance such as chemical reagent, chemical manufactured or imported up to 10 ton/year solely for export) Q9. Should R&D substance manufactured or imported be reported annually or registered under K-REACH? Q10. In case of new chemical received low volume exemption form the registration under previous TCCA, registration will be required for an increase in manufacturing or importing amount? (For example, when the amount of annual manufacturing or importing increases from 100kg or less to 1 ton or more) Q11. Assume a person who manufactures intermediate used as raw material for synthesizing other chemical and sends the intermediate to another factory manufacturing chemicals with separate manufacturing facilities. Then can this intermediate be exempted from the data requirements needed for registration? Q12. Regarding chemicals for R&D or chemical reagents that got exemption as low volume exemption instead under previous TCCA, it can be effective under K-REACH? If not, what kind of

6 obligation will be given under K-REACH? Q13. Regarding person who shared exemption certification under previous TCCA, what if he does not have actual records of manufacturing or importing? What should he do? Ⅲ. Use Q1. Which category can be determined among Use category for antimicrobial agents, biocides. Q2. What about cases that the use of products containing chemicals is known, but it is difficult to accurately know the use of the component, the ingredient chemical? Q3. Companies may have different standards for preparing `description on specific use written while annual reporting on manufacturing and applying for registration. Are there separate guidelines to be offered? Q4. Are Use advised against written based on results of risk assessment including exposure scenarios? Q5. Regarding the small quantity of new chemicals (below 1 ton), there is no need to submit risk related data including exposure scenarios. In this case, from what ground can `Use advised against be described? Q5. In case of chemicals used as biocides, data requirements with higher tonnage band are applied than actual tonnage band. Then concerning chemicals of 0.1~1 ton manufactured or imported as biocide in 2015, should data requirements corresponding to ones required 1~10 tons be submitted from 2015? Ⅳ. Chemical substances information processing system Q1. From when will reporting on manufacturing and etc. be input through a system?

7 Q2. Please explain about payment method for registration application and registration exemption application. Q3. How to prove mid-sized companies and small-sized companies? Q4. How can industry pay reduced official fee? Ⅴ. Manufacturing of other chemical substances, import reporting Q1. Please make clear the definition of seller and what to be reported as sellers, in case of sales, not manufacturing or importing. Q2. Chemical provider who transfers registered chemicals should provide information about those chemicals to person who receives them under K-REACH. From when should information be provided? What about new chemical substances registered under TCCA? Q3. To keep electronic files (scan and PDF format) is effective in the obligation of record keeping or preservation? Q4. When company A consigns company B to manufacture chemicals, which one has the obligation of registration? Q5. If a foreign manufacturer is reluctant to give chemical information to be imported mentioning it is CBIT. Then what should I do? Q6. When overseas manufacturers or producers appoint Only representative, the OR appointed should notify the appointment to the National Institute of Environmental Research. Can this OR appointed by overseas manufacturers or producers carry out registration before receiving the notification result?

8 Q7. From where can I get English version of K-REACH to explain it to overseas suppliers? Q8. Is there any content limit in determination of impurity? Q9. Will the list of substances of 1 ton or less whose registration was completed under previous TCCA be announced? Q10. Regarding new chemical substances, annual reporting on information about their manufacturing, importing and sales regardless of its quantity. In this case, should we report every year on chemicals that got exemption from registration, including new chemicals that got low volume exemption under previous TCCA? Q11. Why should we do reporting on the small quantity of new chemicals that got exemption under the previous TCCA? It is difficult to identify substances with small quantity and to get its data from manufacturers or producers. This newsletter is provided in Korean, English, and Japanese. Chemtopia has the copy rights for all information contained in this newsletter. Chemtopia s K-REACH corresponding services Sales of translated K-REACH legislation (English, Japanese version are available) Specialized response for foreign exporter, Teleconference available : English, Japanese, Chinese experts available OR Service : Report, registration, communication in supply chain, product notification and all legal obligations on behalf of foreign manufacturer Chemical substance management system in correspond to K-REACH : IT system for quantity management, report, registration, product notification, etc Korea Chemical Substance Regulatory DB provided : Existing chemical, new chemical, toxic chemical, authorization substance, PEC etc. Web-based GHS MSDS authoring system Joint Submission & Data purchase support

9 Inquiries regarding K-REACH: Region Person in charge Contact information Sanghee Park, Ph.D. Jean Cho (Cho, YunJin) English Nick Choi (Choi, GeunBae) Paul Yoo (Yoo, YoungJae) Rachel Lee (Lee, In-Young) Japan China CMS system, Web based GHS MSDS authoring system, Regulatory DB キム ドフン博士 (Ph.D Kim, DoHoon) ジョ ヨンジョン (Cho, YeonJeong) ウォン ソンジャ (Won, SeonJa) リ ミラン (Lee, Milan) 栄永麻里 (Einaga, Mari) 李美兰 (Lee, Milan) - China Local office (located in Tsingtao) 徐贤爱 (Xu, Echo) Korea Main office (Seoul) Kim, HyunJi Kang, SungChan or chemtopia@chemto pia.net