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Information Details
K-REACH syndication omits data submission considerations
Release time:
2021-11-14 16:39
According to Article 13 of the Implementation Order of the Chemical Substances Registration and Evaluation Law, when filling in the application documents for K-REACH registration, you can apply for submitting omitted data. What are the precautions for these omitted data?
Matters needing attention when filling in
If omitted data are submitted at the time of registration application, clear evidence should be provided to explain the reasons for the omission, and consideration should be given to the particularity, relevance and consistency between the submitted data.
Case Description
01
Case 1, according to Article 13, Items 1-3 of the Law on Evaluation, if the registration application is submitted by omitting some data, but the exposure information of the data such as specific use or risk shows that the substance may be exposed to consumers, it is necessary to confirm that the substance is actually used for the purpose of consumer exposure.
02
Case 2, Registration Evaluation Method for Chemical Substances with Characteristics of Self-Combustibility, Water Reactivity, etc.
According to Article 13, Item 7 of the Law, it is technically impossible to carry out tests, and the registration application omits data submission, but the safe use guidelines should be formulated and submitted in the same way as general liquid substances without special characteristics. The characteristics of the actual material need to be confirmed.
03
Case 3, according to item 7 of article 13 of the law, for test items that are technically impossible to carry out, you can apply to submit omitted data, but you must explain the reasons why the test cannot be carried out, such as the special nature of the substance, the reasons for laboratory equipment, etc.
04
Case 4, according to the notice of the South Korea Academy of Environmental Sciences, for the substance that needs to be tested for repeated administration toxicity (90 days), the test data of repeated dose toxicity (28 days) can be omitted, but the test plan of repeated administration toxicity test (90 days) needs to be submitted, and the basic data are submitted to determine the repeated administration toxicity of the substance.
05
Case 5, according to the notice of the South Korea Academy of Environmental Sciences, "all available tests of toxicity, low toxicity and physiological activity, ignoring human exposure, including no evidence of teratogenicity or second-generation reproductive toxicity tests, can apply for submission of omitted data, but need to submit classification marks harmful to human body in the registration application documents.
In general, substances with low toxicological activity need to meet the criteria in the following table. If the requirements are not met, the test data must not be omitted. If relevant test data is not available, a substitute test plan must be submitted.
※ a: gas, B: vapor, c: dust/mist
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