Development, dissemination & promotion of alternatives to animal testing methods act
Law & Regulation
In Effect
August 19, 2025
Summary
South Korea’s National Assembly enacted the Act on the Development, Dissemination, and Promotion of Alternatives to Animal Testing Methods on 19 August 2025, establishing a national statutory framework to promote non-animal testing methods across chemical safety, cosmetics, and broader biomedical research sectors. The act requires the government to formulate a recurring five-year basic plan and creates a coordinating committee under the Prime Minister’s office to direct cross-ministerial policy on alternative testing methods. It defines “animal replacement test methods” as approaches that avoid or reduce animal use through advanced technology and directs relevant ministries to fund, share information on, and promote such methods.
Background Context
South Korea’s Animal Protection Act already required consideration of alternative methods before animal testing is undertaken, and a 2018 revision to the Act on the Registration and Evaluation of Chemical Substances (K-REACH) required prioritization of vertebrate alternative tests and prohibited repeated testing of the same chemicals. The Ministry of Food and Drug Safety separately built out sector-specific guidance, issuing 29 alternative testing method guidelines by October 2023. An initial bill on promoting alternatives was introduced by National Assembly member In-Soon Nam in December 2020 following an expert forum co-hosted with Humane Society International/Korea, and a related bill was introduced by National Assembly member Jeoung Ae Han in December 2022; Humane Society International/Korea submitted a petition with more than 66,000 signatures in January 2023 urging passage. The 2025 act consolidates and extends these sector-specific and bill-stage efforts into a single cross-ministerial statutory framework.
System Impact
System Scale Direction
Neutral / Administrative
Type
Modifies Conditions
Significance
Moderate
The act requires the central government to formulate and periodically update a five-year basic plan for developing, disseminating, and using alternative testing methods, and establishes a coordinating committee under the Prime Minister’s office to review cross-ministerial policy and monitor implementation. Since 19 August 2025, this framework operates alongside existing sector-specific measures: the Ministry of Food and Drug Safety’s 29 alternative testing guidelines issued by October 2023, with additional guidelines for in vitro skin sensitization and ocular irritation testing added in June 2025, and the 2018 K-REACH prioritization of vertebrate alternative tests for chemical hazard assessment. Construction of a national animal-free testing facility at Korea Environment Corporation’s Incheon headquarters began 16 May 2025, with completion scheduled for October 2026, to conduct and support non-animal toxicity testing under the Ministry of Environment. As of mid-2026, the five-year basic plan and Prime Minister-level committee are described in legislative sources as established, but detailed public documentation of their operational decisions or monitoring outputs is limited.
Anticipated Effects
If the five-year basic plan and cross-ministerial committee are implemented as specified, they would be expected to increase funding, information-sharing, and regulatory pathways for alternative testing methods across chemical, cosmetics, and biomedical research sectors.
If the national animal-free testing facility becomes operational as scheduled in October 2026 and the government’s stated goal of replacing over 60% of toxicity testing with alternative methods by 2030 is met, aggregate animal-based toxicity testing would be expected to contract relative to a business-as-usual trajectory; this is a stated policy goal and is not yet documented as a realized outcome in available sources.
Significance Rationale
The act operates nationally and consolidates a cross-ministerial planning structure with associated infrastructure investment, but available sources document institutional and infrastructure establishment rather than a demonstrated system-level change in testing volume or practice at this stage, which supports Moderate significance.
Within The System
Key Actors
National Assembly member In-Soon Nam introduced the initial bill on promoting alternatives to animal testing in December 2020. National Assembly member Jeoung Ae Han introduced a related bill in December 2022. The Ministry of Food and Drug Safety issues and enforces guidelines on alternative testing methods for cosmetics, pharmaceuticals, and other regulated products. The Ministry of Environment, through Korea Environment Corporation, is constructing and will operate the national animal-free testing facility. Humane Society International/Korea co-hosted the 2020 legislative forum and submitted a 2023 petition supporting passage.
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