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South Korea’s National Institute of Environmental Research (NIER) published on 4 May 2017 guidelines for acceptance of alternative data that can be used instead of test reports generated by a GLP laboratory for chemical registration under K-REACH, including:
1. Literature, such as
Academic papers containing data and test results of specific chemicals
Well recognized science handbooks for test results
Toxicity databases, including the US National Library of Medicine's Hazardous Substances Data Bank (HSDB), IUCLID or the US EPA's Integrated Risk Information System (IRIS), etc.
2. Data from assessment reports, such as
Chemical substances assessment reports from OECD, WHO, etc., including OECD’s screening information dataset (SIDS), International Agency for Research on Cancer (IARC) Monographs, etc.
Chemical management report from advanced countries (EU, US, etc.), e.g. EU risk assessment reports (RARs), US Registration Eligibility Decisions (RED) for pesticides, etc.
For using data from literature, the below criteria should be applied:
the test result (test methods, result value and conclusion) indicating the hazards of the tested substance is presented in detail and obtained by internationally recognized test methods;
the test result is used as core data for hazard or risk assessment as well as for GHS classification;
the test result is included in a universal science handbook (Merck Index, Pesticides Manual published by British Crop Production Council, HSDB, etc.)
The flexibility to use alternatives to test reports will help to accelerate chemical registration. The registrants should pay attention to issues concerning ownership and intellectual property. To be able to use the data for registration, companies should have permission.
