Human Society International Report: South Korea Passes Law to Mandate Use of Alternative Tests for Cosmetics

This article is reproduced from Human Society International's publication on 26 November

South Korea has passed a law that from 2018 will mandate the use of non-animal alternative tests for cosmetics where such alternatives have been accepted by the Ministry of Food and Drug Safety. Humane Society International’s #BeCrueltyFree Korea campaign welcomes this as a promising first step, but warns that all OECD-approved alternatives must be adopted swiftly in Korea for the new law to effectively reduce the number of animals suffering in cosmetics testing. The new law falls short of a full ban on cosmetics animal testing and trade, as animal testing is expected to continue wherever non-animal alternative methods are unavailable in Korea or have not yet been developed for certain endpoints.

The #BeCrueltyFree campaign’s ultimate goal remains a full ban on cosmetics animal testing and trade comparable to those implemented across the 28 countries of the European Union, as well as Norway, Israel and India. In the meantime, HSI will focus on work to secure increased funding for alternatives development, as well as accelerate regulatory acceptance of validated alternatives, such as acute toxicity and skin sensitization. HSI campaigning already contributed to the government pledging substantial funds to establish the first Korean Centre for Alternatives.

Claire Mansfield, HSI’s #BeCrueltyFree global campaigns director, said: “Korea’s new law is a promising first step towards ending cosmetics animal testing, but it is by no means the end of the road. Increasing the acceptance of validated alternatives must be a priority if Korea is to embrace the animal welfare, scientific, economic and efficiency benefits of 21st century research methods. So, phase two of our effort here sees us expanding our alliance with South Korean scientists to accelerate the pace of change, and working with members of the General Assembly and relevant ministries to secure increased public funding for alternatives development to fill remaining gaps, not only for cosmetics, but other regulated product sectors as well. Replacing out-dated animal tests with human biology-based approaches is where the future of science is headed, producing more reliable results in a fraction of the time. So we’ll be working hard to ensure that Korea invests in these state-of-the-art technologies.”

The global in vitro testing market is estimated to reach a worth of nearly $9.9billion by 2017, and the EU commanded the largest share of this market in 2013 - growth that is attributed to the support provided by laws such as the cosmetics animal testing ban. A true cosmetics animal testing ban could equally hasten the advancement of 21st century science in Korea. 

Facts: Cosmetics animal testing & alternatives in South Korea

This overview of commonly required tests for cosmetics shows where animal testing is likely to continue despite the new mandatory alternatives law.

• Endpoint: Single dose (acute oral) toxicity (7 rats per test)

Alternative: The validated in vitro 3T3 Neutral Red Uptake cytotoxicity test can screen out substances that would be non-toxic, which could reduce the use of this lethal animal test by nearly 90 per cent, but is not yet accepted by MFDS 

Outcome: Some animal testing for this endpoint is likely to continue

• Endpoint: Skin irritation (1-3 rabbits per test)

Alternative: Human skin model replacement for irritation is accepted by MFDS

Outcome: Full replacement possible, animal testing should stop for this endpoint

• Endpoint: Eye irritation (1-3 rabbits per test)

Alternative: The BCOP and ICE tests are accepted by MFDS, but the fluorescein leakage test is not accepted yet in Korea

Outcome: Full replacement possible, animal testing should stop for this endpoint

• Endpoint: Skin sensitization (32 guinea pigs or 16 mice per test)

Alternative: Only a refinement method (mouse Local Lymph Node Assay), is accepted by MFDS; non-animal testing strategy based on validated in vitro tests is not yet accepted

Outcome: Animal testing for this endpoint is likely to continue

• Endpoint: Photo-toxicity and photo-sensitization (no internationally recognized animal test guideline for either endpoint)

Alternative: The in vitro 3T3 NRU test is accepted for photo-toxicity, but there is currently no internationally accepted replacement for photo-sensitization

Outcome: Animal testing is likely to continue for photo-sensitization

• Endpoint: Repeated dose toxicity (40-80 rats per test)

Alternative: No internationally accepted replacement

Outcome: The MFDS appears not to explicitly require this endpoint for cosmetics, although the law allows regulators could demand data for this or any endpoint, leaving room for animal testing to continue

• Endpoint: Reproductive and developmental toxicity(1,400-2,600 rats per reproductive toxicity test; 660 adult female rabbits and pups or 1,300 adult female rats and pups per developmental toxicity test)

Alternative: No internationally accepted replacement

Outcome: The MFDS appears not to explicitly require this endpoint for cosmetics, although the law allows regulators could demand data for this or any endpoint, leaving room for animal testing to continue.

Reference: Human Society International