South Korea to Update Rules for Using Non-testing Methods (Updated on Sep 30, 2022)

Updates:

On September 30, 2022, by NIER Announcement No. 2022-62, South Korea's NIER announced the adoption of the proposed revision. It took effect immediately.

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South Korea’s National Institute of Environment Research (NIER) recently opened a public consultation on the draft revision to the Regulation on Registration Application Dossier Preparation, Hazard Evaluation Methods, etc., which specifies non-testing methods for chemical registration under K-REACH and adds new exemption criteria for testing items. The public consultation ended on September 14, 2022.

K-REACH allows the use of non-testing methods to fill data gaps for chemical registration. However, the authority has been held a conservative stance in accepting non-test data. The proposed revision reflects a shift in the authority’s attitude in this regard in view of the global trend of using non-testing methods to minimize the use of vertebrate testing.

Proposed updates

1. Adding the definitions of in vivo, non-testing data, read across and weight of evidence (WoE). E.g., non-testing data refers to data generated based on the hazard evaluation results from the QSAR model, read-across approach or WoE, as well as data generated from other animal testing alternatives.

2. Specifying non-testing methods to generate data required for registration dossiers, i.e., QSAR, read-across, WoE, and adding requirements for the non-testing data generated via each of the foregoing methods (see table below).

Non-testing Data	Consider the followings
QSAR Data	Whether the results are generated from a scientifically validated and validated QSAR model. Whether the evaluated substances are within the applicable range of the QSAR model. Whether appropriate results are presented for classification, labeling, and hazard evaluation.
Read-across Data	Similarities in the structure of the evaluated substances and reference substances, including similarities between the substances they convert in living organisms. Similarities in absorption, distribution, metabolism, etc. between evaluated substances and reference substances. Whether reliable and suitable data is generated for classification, labeling, and hazard evaluation.
WoE Data	Whether the individual datasets apply to the relevant testing items for the hazard evaluation. Whether the total evidence presented is enough for the classification, labeling and hazard evaluation. *Note: If the individual dataset is QSAR data or read-across data, the corresponding requirements above shall be taken into account.

3. Adding new exemption criteria for testing items, such as:

Testing item	Newly added exemption criteria
Skin and eye irritation/corrosiveness test	Substances that are classified as strong acid (pH < 2.0) or strong alkali (pH > 11.5).
Reproduction/developmental toxicity screening test	Substances that have the extended one-generation reproductive toxicity study data.
Two-generation reproduction toxicity study
Carcinogenicity test	Substances that are classified as carcinogenetic based on the carcinogenicity evaluation report of international specialized organizations such as the International Agency for Research on Cancer (IARC).

More newly added exemption criteria can be accessed in Appendix 2 (marked in blue) of the draft revision to the Regulation on Registration Application Dossier Preparation, Hazard Evaluation Methods, etc.

4. Adding rules for registrants to submit feedback on hazard evaluation results. Registrants can raise an objection and submit materials (e.g., hazard classifications or assessment results issued by overseas authorities) to NIER supporting the grounds of the objection within 30 days from the release date of the results.

As proposed, the new rules for raising an objection will take effect on October 15, 2022. For the other three proposed updates, once adopted and made public, they will come into force immediately.