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Toxicology Exemptions for Imported Cosmetics in China: A Pathway for Cruelty-Free Products
Publication date:2025-10-14

 Global Cruelty-Free Trend and China's Regulatory Evolution

The cruelty-free movement has been shaping the cosmetics industry worldwide for decades. Regions such as the EU and Canada have fully banned animal testing for cosmetics, while several US states have introduced similar prohibitions. In 2025, Brazil also announced a comprehensive ban, reflecting growing global momentum toward ethical, cruelty-free innovation and rising consumer demand for animal-friendly products.

 

Historically, China required animal testing for imported cosmetics, which deterred many overseas brands from entering its large market. However, China has been actively aligning with international standards. On September 19, 2025, the National Medical Products Administration (NMPA) released the Opinions on Deepening Cosmetics Regulatory Reform and Promoting High-Quality Development of the Industry (Draft for Public Comment). The draft explicitly mentions "Promoting international alignment," "Reducing animal testing," and "Promoting alternatives," reflecting China's ongoing effort to modernize its regulatory framework.

 

Current Regulatory Framework for Toxicological Test Exemptions in China

 For cruelty-free international brands, they can use the toxicological test exemption pathway — a route that lets these cruelty-free products enter the market without undergoing additional animal testing.

 

Under the Provisions for Management of Cosmetic Registration and Notification Dossiers, since May 1, 2021, imported general cosmetics may be exempted from submitting a toxicological test report if all the following criteria are met:

 

  • The manufacturer has obtained a GMP certificate issued by the competent government authority of its home country or region (note: multi-site production requires separate certificates).

  • The product safety risk assessment sufficiently confirms product safety.

  • The product is not subject to the following exclusion criteria:

  1. Intended for infants or children;

  2. Contains new cosmetic ingredients still under three-year safety monitoring period;

  3. The notifier, domestic responsible person, or manufacturer is listed as a key supervision target according to risk grading results.

 

Common Non-Compliance Issues in Practice

Despite these clear rules, regulatory reviews frequently identify non-compliant applications regarding toxicological test exemption. Typical issues include:

 

  • Expired GMP Certificates: Certificates that have passed their validity period are not accepted. For valid exemptions, certificates must be renewed within 90 days of expiration, or the latest version submitted at least every five years.

  • Certificates Not Issued by the Competent Authority: GMP or quality system certificates issued by private or industry associations do not meet regulatory requirements.

  • Missing Manufacturer Name or Address: Certificates must clearly indicate the manufacturer’s legal name and actual production address for traceability.

 

What ZMUni Can Do?

ZMUni Compliance Centre has successfully assisted overseas brands in completing cosmetic notification under the toxicology exemption pathway. Notably, we recently helped a New Zealand cosmetics company obtain exemption from toxicological testing and successfully complete their product notification in China (see our previous post for the full case).

 

With our deep expertise in cosmetic registration, dossier preparation, and regulatory communication, ZMUni provides one-stop support to help international brands enter the Chinese market efficiently and in full compliance.

 

If your brand is exploring entry into the Chinese market and would like expert guidance on compliance, feel free to reach out to us at info@zmuni.com to learn how we can help.

This article is original content from ZMUni Compliance Center. Please contact us for reprinting.
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