Provisions Concerning the Exemption of Toxicological Testing

Product testing reports for registration or notification must be issued by a designated cosmetic testing agency and comply with the Safety and Technical Standards for Cosmetics, the Work Specifications for Cosmetic Registration and Notification Testing, and other relevant regulations. Product testing reports include toxicological test reports. The Safety and Technical Standards for Cosmetics is gradually incorporating alternative non-animal testing methods.

I. General Exemption for General Cosmetics

Manufacturing enterprises of General Cosmetics may be exempted from submitting toxicological test reports for a product if they meet the following two conditions:

  1. The enterprise has obtained Quality Management System (QMS) certification issued by the relevant government authority of its home country (or region).
  2. The product’s Safety Risk Assessment results can fully confirm the safety of the product.

II. Exceptions (Exemption Does Not Apply)

The exemption from toxicological testing does not apply if any of the following conditions exist:

  1. The product is claimed for use by infants or children.
  2. The product uses a New Cosmetic Ingredient that is still under safety monitoring.
  3. Based on quantitative credit rating results, the notifier, domestic responsible person, or manufacturer is listed as a target for prioritized supervision (high-risk monitoring).

III. Requirements for Multiple Manufacturers

In cases where a product is produced by multiple manufacturing enterprises, the exemption from toxicological testing is only applicable if all participating manufacturers have obtained QMS certifications issued by their respective local government authorities.

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