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Industry InsightLatest NewsMarketingRegulations24/05/2021How to apply Animal testing exemption during cosmetic filing/notification in China?

From 1st May 2021, the overseas cosmetic brand can apply animal testing exemption during cosmetic filing/notification in China. Because of the implementation of “Provisions for Management of Cosmetic Registration and Notification Dossiers Implemented on May 1, 2021”.

Let’s take a look at the historical background of the animal testing related regulations in China.

Since the promulgation of the “Several Opinions on the Development of Laboratory Animals during the Ninth Five-Year Plan” in 1997, the government has begun to pay attention to animal welfare, ethics, and in vitro method research, requiring ethical review before conducting animal experiments and supporting exploratory research on animal alternative experiments

n 2013, the State Food and Drug Administration (Previously named CFDA) “Notice on Adjusting the Management of Cosmetics Registration and Filing Management”. It put forward the main tasks of developing and promoting cosmetics risk assessment and cosmetic safety evaluation in vitro test technology. Experiment without animals, it can guarantee the safety of using cosmetics. Alternative methods of animal testing, that is, using simple biological systems, in vitro cultured bacteria, cells, 3D reconstructed tissues, organs or non-biological construction systems (such as computer models) to replace experimental animals.

In 2019, the “Administrative Measures for the Recordation of Non-Special Use Cosmetics” (Draft). If the manufacturer of the registered product has obtained the relevant qualification certification of the production quality management system of the regulatory agency, and the product safety risk assessment result can fully confirm the safety of the product, it may be exempted from the relevant toxicological test items of the product. Except in one of the following situations: the product is declared to be used by children or infants; the product uses new materials that have been approved or filed, but the raw materials have not been included in the list of used cosmetics materials; according to the quantitative grading results, the filing person, Domestic responsible persons and actual production enterprises are listed as key supervision objects; filing persons, domestic responsible persons, and actual production enterprises have been filed and investigated for cosmetics quality and safety issues within the past three years.

In 2020, “Technical Guidelines for Cosmetic Safety Assessment” (Draft), It mentioned, “If the conclusion of the cosmetics safety assessment report is not sufficient to rule out the risk of the product to human health, toxicology test methods should be used for product safety evaluation”

Anyway, now China is opening the door to replace the animal testing. Here are the Animal testing exemption conditions:

  • General cosmetics manufacturers have obtained the QMS certification issued by local government
  • The safety assessment can prove product safety
  • NOT intended for infants and children
  • NOT uses new ingredients that are in the safety monitoring period
  • The filing person, Chinese responsible person, or manufacturers do NOT have bad records in China.