Taiwan to Start Animal Testing Application System

Takehome:

TFDA has implemented a new rule: any cosmetic manufacturer that wishes to use animal testing during product/ingredient safety assessment should apply for TFDA approval. This application system will be implemented on Nov.9 2019.

The manufacturer/importer/seller of cosmetics should submit the following documents to TFDA:

1. Hard copy of enterprise/business registered certificate;
2. Hard copy of evidence to prove the legal identity of entrusted company, trade number, professional academy, legal entity, organization or institute;
3. Hard copy of agreement document issued by tested animal caring committee or group and the animal testing conductor should comply with Article 16 of "Animal Protection Law" simultaneously;
4. Evidence and other relevant documents to prove the necessity of conducting animal testing;
5. Evidence and other relevant documents to prove no other alternative testing methods can be applied;
6. Animal testing plan which complies with Article 4 of tested animal caring committee/group management measure and is reviewed and approved by tested animal caring committee /group.

Any omission of the above documents requires further document supplementation submitted by the applicant within a specified time, or TFDA will not accept the application. If the applicant can provide a valid reason, TFDA may grant a one-time extension.

TFDA will invite experts from relevant fields such as cosmetic, toxicology and animal protection to review the animal testing application, and issue the certificate to the applicant once approved.

If either of the following situations occurs, TFDA will revoke the animal testing certificate and will not accept the application of relevant enterprises for two years:

• False information on application documents;
• The actual animal testing differs from the specified animal testing plan.

If the certificate is missing or damaged, enterprise should fill out an application form and submit:

1. In case of missing: acknowledgement of missing the certificate;
2. In case of damaged: the original copy of the certificate.