In accordance with the Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on Cosmetic Products as well as the European Commission’s Communication on the animal testing and marketing ban in the field of cosmetics, Testing finished cosmetic products and cosmetic ingredients on animals were prohibited after 11 March 2013. As a result, enterprises have to use alternative methods (Please click here for more information about alternative methods).
Cosmetic ingredients are also chemicals. That is to say, they are also under the administration of other chemical regulations. In this article, CIRS sets forth some methods for enterprises to avoid animal test and fulfill relevant requirements under REACH and Provisions on Environmental Administration of New Chemical Substance in China.
In Europe, there are not any specific toxicological requirements for new ingredients. However, new cosmetic ingredients with high risks will be evaluated by SCCS.
In this article, relevant requirements under REACH will be discussed.
Under REACH, for substances in quantities of 1 to 10 tonnes, most of the animal tests are involved with toxicology data, which includes skin irritation/corrosion, eye irritation, skin sensitization and acute oral toxicity.
Now, there’re some mature in vitro testing guidelines concerned skin corrosion/irritation and eye irritation. For example, OECD 439, OECD 430, OECD 431, OECD 435, OECD 437, OECD 438, OECD 460, OECD 491 and OECD 492 are all widely used in the industry and their results are accepted by ECHA. However, in rare cases, in vivo experiments are still required.
In vitro test on skin sensitization is also very popular in recent years. Under the guidance of AOP principle, a number of alternative methods on skin sensitization have been developed and the results are also accepted by ECHA. For example, KeratinoSensTM (OECD 442D), DPRA (OECD 442C) and H-CLAT are the most commonly used in vitro tests on skin sensitization. In order to fulfill the requirements under REACH, enterprises should use combined alternative methods mentioned above.
Although acute oral toxicity test cannot be replaced by in vitro method right now, the results can be predicted by computational models (in silico), in other words, the results obtained through QSAR will be accepted by ECHA.
In conclusion, alternative methods, such as in vitro and QSAR, can be applied directly for substances in quantities of 1 to 10 tonnes under REACH, making it possible to fulfill REACH requirements and avoid animal tests at the same time. However, as substances in quantities of 10 to 100 tonnes should finish 28d repeated dose toxicity test and screening for reproductive/developmental toxicity test, there are no in vitro methods or QSAR to precisely predict the toxicity of the substance. For this reason, substances in quantities of 10 to 100 tonnes or above cannot avoid animal test through in vitro test or QSAR in Europe. However, enterprises may choose read-across to avoid animals testing.
New Cosmetic Ingredient Notification & New Chemical Substance Registration in China
In China, enterprises must submit the following toxicological data when applying for notification of new cosmetic ingredients (substances that have not been listed in INCI):
- Acute oral and acute skin toxicity test;
- Skin and acute eye irritation/corrosion test;
- Skin allergic reaction test;
- Skin phototoxicity and photosensitivity test (required when ingredients absorb ultraviolet);
- Mutagenicity test (it should contain at least one gene mutation test and one chromosomal aberration test)
- Sub-chronic oral and dermal toxicity;
- Teratogenicity test;
- Chronic toxicity/carcinogenicity; and
- Toxicokinetics test.
In China, there is not any alternative methods for them except the skin phototoxicity and photosensitivity test.
Currently, for new chemical substance registration in China, only skin irritation/corrosion test and eye irritation test can be replaced by in vitro test. But enterprises should be aware that China just accepts positive results, which means in vivo tests are still required in case positive results cannot be obtained through in vitro tests. Besides, the use of QSAR is also restricted in China. Enterprises must prove that relevant testing cannot be technically achieved, otherwise, data obtained through QSAR cannot be accepted as core data. For these reasons, data obtained through alternative methods, such as in vitro and QSAR, are not enough for both new cosmetic ingredients notification and new chemical substance registration in China, which makes it not possible to completely avoid animal test.
In one practical case, in order to avoid animal test, CIRS suggests enterprise to do serial registration for one product with two other similar products. The toxicological data comes from an old substance with animal testing data conducted before. Through this method, the enterprise not only fulfills the data requirements but also avoids animal test. However, under current condition, it is impossible to ban animal test and fulfill the data requirements for new cosmetic ingredients in China at the same time.
In Summary, through in vitro tests, QSAR and read-across, animal test can be avoided to some extent. The alternative methods in China are still under development. In accordance with the management requirements of cosmetic new ingredients and new chemical substance, it is still difficult to completely avoid animal test.
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