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[Industry Help Center Notice] Information on providing a checklist for evaluation of developmental toxicity data and evidence of skin sensitization (Jul. 31, 2023)
With the progress of the research project for hazard assessment utilizing non-experimental methods, the National Institute of Environmental Research, part of the Ministry of Environment, plans to classify the checklist for the weight of evidence assessment* of toxicity data for each item and publish it as a serial publication from this year to 2027.
* When evaluating chemical substances using multiple data such as alternatives to animal data, a method for determining which data is more important as evidence by considering test methods, the institution which performed the test, exposure routes, etc.
Following the guide to checking points and checklist for the assessment of weight of evidence of genotoxicity data published in 2022, we have prepared a checklist in the form of a booklet for registration agencies, chemical substance evaluators, etc. to quickly check whether any weight of evidence assessment items are missing while assessing the weight of evidence for skin sensitization and developmental toxicity data, based on the results of the project** undertaken for skin sensitization and developmental toxicity in 2020 and 2022. The booklet will be distributed to interested parties in the industry and evaluators, so please refer to it in the implementation of the system.
** Study on chemical substance hazard assessment using weight of evidence method(2020); and Study on hazard assessment using non-experimental methods(Ⅱ)(2022)
※ Even if the weight of evidence of skin sensitization or developmental toxicity data is evaluated according to this checklist and the registration application documents are prepared by reflecting this, if said data is insufficient to be used as implementation data for the chemical substance-related systems due to quality of referenced data, relevance of assumptions/logic, or details and transparency of the report, it may be necessary to supplement the data or conduct additional animal testing. Additionally, the attached data can be found at the National Chemicals Information System (ncis.nier.go.kr) or the Industry Help Center > Data Center > Guides/Practical Guides tab.
For details, please refer to the attached file.
Source: Industry Help Center > Notices Link
Attached: Checklist for evaluation of developmental toxicity data and evidence of skin sensitization.zip
Jul 31, 2023
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[Industry Help Center Notice] Information on simplification of provided information for chemical substances(not subject to submission of risk data) (Jul. 19, 2023)
Under the active administration system, the method for providing information on chemical substances pursuant to Article 29 of the “Act on Registration, Evaluation, etc. of Chemical Substances (hereinafter referred to as “K-REACH”)” and Article 36 of the Enforcement Rule for the same Act shall be amended and implemented from August 1, 2023 as follows:
a. Changes: When transferring chemical substances (not subject to submission of risk data), the substance’s registration/notification status shall be indicated in the Material Safety Data Sheet (MSDS) instead of its registration/notification number (Enforcement Rule Article 36, Paragraph 1, Item 2)
b. Reason for changes: For the protection of company trade secrets, such as preventing exposure of mixture components
Before amendment
After amendment
Article 36 (Method for providing information on chemical substances, etc.) ① Chemical substance safety information shall be prepared and provided pursuant to the categories in the following items:
(omitted)
When preparing and submitting a Material Safety Data Sheet: Attach chemical substance safety information(risk information) data to Form No. 26 when providing the Material Safety Data Sheet. Notwithstanding the above, in case of the chemical substances under the following categories, only the registration number/notification number of the substances may be additionally provided in the Material Safety Data Sheet.
a. ~ b. (omitted)
Article 36 (Method of providing information on chemical substances, etc.) ① (same as current)
1. (Not changed)
2. -----------------------------
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-----. ----------------, -------
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-----------, only the registration/ notification status ---------------
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a. ~ b. (Not changed)
Source: CHEMNAVI > Notices Link
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