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- Taiwan special use cosmetics are specified as sunscreen, hair dyes, hair perms, deodorants, teeth whitening and other cosmetics stipulated by TFDA.
- Cosmetics Border inspection mainly focus on products’ category, packaging, labels, etc.
1. Administrative Measures for Special-Use Cosmetics Certificate Issuance
Cosmetic Hygiene Safety Administration Act released on May 2, 2018 re-classified cosmetics as general cosmetics and special-use cosmetics. This Measure specifies the scope of special-use cosmetics as sunscreen, hair dyes, hair perms, deodorants, teeth whitening and other cosmetics stipulated by TFDA. It also stipulates that within a 5-year grace period after the implementation of Cosmetic Hygiene Safety Administration Act, special-use cosmetics must be registered with TFDA prior to importation or manufacture (Click here to see conditions of registration exemption).
Currently, Taiwan cosmetics are classified as general and medicated cosmetics (containing ingredients in Standard List of Maximum Levels of Medical, Poisonous or Potent Drugs in Cosmetics). Licenses of medicated cosmetics obtained before the implementation of the new Act, will not require submission of a new registration application. Instead stakeholders can just apply for an extension of 3 months before the license expires.
Documents necessary for registration of special-use cosmetics manufactured in Taiwan:
| Copy of business registration certificate |
| Copy of pharmacist's practicing license/ resident cosmetic manufacturing supervisors’ certificate of qualifications and employment |
| Samples of product label, instruction and packaging |
| Inspection report (including product characters, main ingredients, testing methods, quantitative methods, ingredients’ limitations, testing results, etc.) Note: inspection report can be replaced by Cosmetic GMP certificate |
| For entrusted manufacturers, copies of applicant’s company/business registration certificate and entrustment contract |
Documents necessary for imported special-use cosmetics registration:
| Copy of company/business registration certificate |
| Samples of product label, instruction and packaging |
| Authorization certificate in the recent 2 years (issued by foreign manufacturers that agree the applicant to import and sale products in Taiwan) |
| Manufacture and sales certificate of country of origin in the recent 2 years |
Ingredient list in the recent 2 years
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| Inspection report (including product characters, main ingredients, testing methods, quantitative methods, ingredients’ limitations, testing results, etc.) |
| For entrusted manufacturers, documents to explain the relationship between the entrusting party and the entrustee |
Note: Special-use cosmetics contain ingredients that are not included in the Standard released by TFDA, shall submit the announcement released by other countries/regions that the ingredients are allowed to be used.
2. Administrative Measures for Cosmetics Border Inspection
Cosmetics with safety risks can only be imported after being sampled and tested by competent authorities. Importers shall apply for sample inspection to the inspection authority at the location of import port 15 days before importation.
1）Documents necessary for border inspection:
| Customs form |
| Other documents stipulated by competent authority |
Note: When the agency applies for inspection, submit power of attorney and documents can prove the agency’s identity or company.
2）Inspection methods
- On-site inspection. Check product categories, packaging, labels, etc.
- Batch-by-batch inspection
- Sampling inspection (sampling inspection rate is 2% to 50%)
3）If the sampling is difficult, or time required for the inspection is more than 5 days, or the product is easily perishable or otherwise unstable, the importer shall make a letter of guarantee in written form and bear the responsibility for storage. Then the competent authority may release the goods.
4）If the imported cosmetics are unqualified, the importer can apply for re-inspection (up to 1 time) within 15 days.
| Unqualified labels | Cosmetics can be imported first, then correct the labels |
| Not the labeling problem | Dispose the unqualified cosmetics according to the Tariff Act |
3. Administrative Measures for Cosmetics Certificate Issuance
Cosmetic manufacturers who complete notification or registration may apply to TFDA for the certificate of production and marketing. Cosmetic manufacturing site approved to comply with cosmetics GMP by TFDA may apply for a GMP certificate.
Currently the GMP certificate is issued by the Ministry of Economic Affairs in accordance with Key Points on the Implementation of Voluntary Cosmetics Good Manufacturing Practices. From January 1, 2021, cosmetics GMP certificate will be issued by "Taiwan Ministry of Health and Welfare".
Documents necessary for applying GMP certificate:
| Copy of company/business registration certificate |
| Copy of factory registration certificate |
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