Responsible Person (RP)
A responsible person is essential to market your cosmetics in Taiwan. We could be your responsible Person on behalf.
The responsible peron has responsibilities and obligations for regluation compliance:
- ensure the safety of the cosmetics made available on the market
- ensure the quality of the cosmetics made available on the market
- ensure that immediately notify the authority if a serious undesirable effect occurred.
Product Information File(PIF)
Cosmetic product made available on the market shall be safety for human health when used under normal reasonably foreseeable conditions of use Prior to placing a cosmetic product on the market, the RP should ensure that the cosmetic product has under gone a safety assessment on the basis of the relevant
information and that a cosmetic product safety report is set up according to regulation and guidance.
The Responsible person guarantees that any product placed on the market is linked to a relevant and complete PIF and keep the product information file for a period of 5 years after placing the last batch on the market in Taiwan.
Good Manufacturing Practice
Good Manufacturing Practices (GMP) for the production control, storage and shipment of cosmetic products.
The compliance of sampling and analysis of cosmetic products.
The compliance of the Cosmetic formula
it is essential to have a safety officer qualified for safety assessment. Prohibited ingredients and CMR substances: carcinogenic, mutagenic or toxic to reproduction are listed and prohibited Restricted substances for ingredients: substances that can be used in cosmetics products only under the conditions described such as product type, purity criteria, percentage of maximal use. etc.Allowed substance: Three functions of ingredients are listed by the regulation: coloring agents, preservatives and UV filters.The specific case of nanomaterial: it is necessary to notify the present of the nanomaterial at least 6 months before the cosmetic product is placed on the market.
TFDA Cosmetics registrations
- Regulation consulting
- Responsible person in Taiwan on behalf
- Formula review
- Claim review
- Cosmetic Labeling Requirements
- PIF establishment
- Safety Assessment including SPF
- Postmarket reporting
License application Time line
- It takes around 3-4 months to get approval after submission.
- Formula Preview > PIF Preparation > TFDA submission, communication> Approval
Advertisement Preview
- It is necessary to apply permit for putting advertisement material in public for cosmetic according Taiwan regulation.
- It takes around 21 working days to get advertisement permit.
- Submission Package Preparation > Preview > Submission> advertisement material Approved
歐盟法規:Directive 76/768/EEC, Directive 93/35/EEC, Directive 2003/15/EC
When a cosmetic product is placed on the market, the responsible person shall keep a product information file (PIF) for it. The product information file shall be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market.
The ultimate responsibility for ensuring compliance with these legal requirements lies with responsible persons operating within the EU market.
Cosmetic product: any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, mails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them,keeping them in good condition or correcting body odors.
Compliance with the good manufacturing practice shall be presumed where the manufacture is in accordance with the relevant harmonized standards, the references of which have been published in the Official Journal of the European Union.
A brief overview of the method of manufacture including bulk storage and filling for the manufacturing site(s) concerned is expected.
The Cosmetics Regulation does not require external certification to be obtained; only compliance is expected.