How to Exempt from Animal Testing in China for Non-special Used Cosmetics?

On January 12, 2021, the Agence Nationale de Sécurité du Médicament (ANSM) unveiled a dedicated online platform which enabled French beauty and personal care products manufacturers to apply for a Good Manufacturing Practices [Bonnes Practiques de Fabrication] certificate. This certificate can be used to prove that manufacturers of non-special used cosmetics have complied with China’s safety requirements.

The certification platform is launched after the promulgation and implementation of China's new version of the "Cosmetic Supervision and Administration Regulations" on January 1, 2021. In order to implement the "Regulations" and the supporting documents, as well as to standardize and guide the registration and filing of cosmetics, the Cosmetics Supervision Department of China National Medical Products Administration commissioned the China Food and Drug Control Institute drafted the "Specification for Cosmetic Registration and Filing Materials (Draft for Comment)", and publicly solicited opinions from the society for the first time on August 28, 2020. On November 5, 2020, the Cosmetics Supervision Department of the NMPA published the "Specification for Cosmetic Registration and Filing Materials (Draft for Comment)”-2nd version, on the NMPA website, seeking public comments again.

The European Union banned animal testing for cosmetics in 2009. But animal testing have always been required for the registration/filing of imported cosmetics in China. In the recent two drafts of Specification for Cosmetic Registration and Filing Materials”(draft for comments), it clearly pointed out that non-special used cosmetics can be exempted from the relevant toxicological test items of the product, as long as special conditions are met.

CIRS is to analyze the requirements for the exemption of toxicological tests for non-special cosmetics under the "Specifications for Cosmetics Registration and Filing Materials" (draft for comments) released on November 5, 2020:

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• Manufacturers of non-special used cosmetics have obtained the relevant qualification certification of the production quality management system issued by the local government department of the country (region) where it is located;

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• Product safety risk assessment results can fully confirm product safety;

Only non-special used cosmetics that meet the above two conditions may be exempted from animal testing. But here are three exceptions:

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• Products claiming to be used by infants and children;

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• Products using new raw materials under safety monitoring;

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• According to the results of quantitative classification scores, filing person, domestic responsible persons, and manufacturer are listed as key supervision targets.

At present, the production quality management system qualification certifications held by most of the cosmetics manufacturers were issued by the cosmetic associations or a third-party. The launch of the online certification platform by the French the ANSM has made France become the first country in the European Union where the government can issue such a certificate. However, it doesn’t mean that, as many reports say, France became the first EU country that can be exempted from animal testing when exporting non-special used cosmetics to China. Actually, either imported non-special used cosmetics or domestic non-special used cosmetics are exempted from related toxicological experiments as long as certain conditions are met.

However, it is not so easy to meet the second condition of the animal testing exemption for non-special used cosmetics, which is, the product safety risk assessment result can fully confirm the product safety". On July 29, 2020, the "Technical Guidelines for Cosmetic Safety Evaluation" (draft for comments) was issued by the National Medical Products Administration. It came up with the most stringent cosmetic safety evaluation requirements in history, and is still not finalized so far.

Cosmetic manufacturers can conduct safety assessments by themselves or by entrusting professional institutions. The personnel engaged in safety assessments should have professional knowledge about cosmetics quality and safety as well as at least 5 years of related experience. Actually, many raw materials which can be used in cosmetics lack historical usage and toxicological data etc.

Regardless of the conditions, the exemption of animal testing for non-special used cosmetics is very important for overseas cosmetics manufacturers that adhere to the concept of animal protection, and will certainly help more cosmetics brands enter the Chinese market.

Finally, there is one more thing: some foreign cosmetics brands previously chose factories in China to produce non-special used cosmetics to avoid animal testing. In the future, the exemption conditions for domestic and imported ordinary cosmetics from animal testing are the same.

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