CURRENT SITUATION IN JAPAN: REALITY SURROUNDING ANIMAL TESTING FOR COSMETICS
Definition of “Cosmetics”
Under the Japanese law regulating securing quality, effectiveness, and safety assurance of medicines and medical devices, there are four product classifications namely “cosmetics”, “quasi-pharmaceutical products”, “medicines”, and “medical devices”. In the context of CFB’s activities, “cosmetics” includes a part of quasi-pharmaceutical products (quasi-drugs) such as cosmeceutical products, medical tooth paste, solutions for permanent wave or hair color, etc., which are considered as beauty products.
When Animal Testing Required
While cosmetics companies are responsible for the safety assurance of their products, animal testing for cosmetics is not required by law. However, if ingredients of ultraviolet absorbing or scattering agents, tar colors, or preservatives need to be newly included in the positive list (request for revision of the Cosmetics Standards), safety test data is required.
For quasi-drugs, safety test data is required when new ingredients would be added.
Both cases can employ established alternative methods, but for cases without established alternative method, animal testing is inevitable. In addition, it is not prohibited to conduct animal testing for a case which can be conducted by alternative method.
Exceptions Granted by Big Brands
Well-known brands declared to discontinue animal testing grant two exceptions: 1) exports to China where animal testing is a prerequisite and 2) response to user-reported problems. A good example of the latter case is Kanebo whose skin whitening products made thousands of users suffer from leukoderma – a loss of skin pigmentation. In order to clarify the cause, they have to employ animal testing, which is also requested by the government.
Recognition of Alternative Methods
New alternative methods are validated by JaCVAM (Japanese Center for the Validation of Alternative Methods) in Japan. If a cosmetic company has to submit safety test data in response to the government’s request, it is strongly recommended to employ alternative methods with JaCVAM’s guidance document.
Alternative Guidance List
1. LLNA as an alternative to skin sensitization test
2. In vitro 3T3 NRU phototoxicity test as an alternative to phototoxicity text
3. LLNA: DA as an alternative method to skin sensitization test
4. LLNA: BrdU-ELISA as an alternative to skin sensitization test
5. Bovine Corneal Opacity and Permeability assay (BCOP) as an alternative to eye irritation test
6. Isolated Chicken Eye Test (ICE) as an alternative to eye irritation test
7. In vitro skin permeation test (In vitro percutaneous absorption test) (planned)
No Regulations for Animal Testing
In Japan, anyone can establish an animal testing facility freely without permit or registration. Penalties, official investigation systems, and reporting obligation don’t exit. Because of this, we cannot find out how many animals are used for testing.
JAPAN’S CHALLENGES TOWARD BAN ON ANIMAL TESTING FOR COSMETICS
Major cosmetic companies are strongly inclined to discontinue animal testing, awareness of consumers in this issue of this issue is low. According to the survey conducted by Lush Japan in cooperation with CFB member groups in June 2016, people who have heard of animal testing for cosmetics was 28.7% of the total respondents.
However, more than 70% of them answered that they do not want to make animal suffer once they found out that animal testing for cosmetics is conducted.
Do not want to make animals suffer for cosmetics: 70.2%
In Japan, animal testing must be banned by law: 69.6%
Due to low awareness among consumers, the government and trade organizations have little interest in the issue and are not keen to offer necessary support. Naturally, they lack budget allocated to developing alternative methods and adequate manpower. Nevertheless, in this coming November, an international conference named Asian Congress 2016 on Alternatives and Animal Use in the Life Sciences will be held in Karatsu, southern part of Japan backed by enthusiastic people who are concerned about this issue.
Whether Japanese consumers take action, collaborate with scientists and researchers to end animal testing, and influence the government are tasks ahead.
(from CFB panel exhibition at Lush Prize 2016 public event in Seoul, South Korea on 17th November 2016.)