Responsible Person (RP)
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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:
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Product Information File (PIF) |
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Cosmetic product made available on the market shall be safety for human health when used under normal reasonably foreseeable conditions of usePrior 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 relevantinformation 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 of5 years after placing the last batch on the market in Taiwan. |
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Good Manufacturing Practice |
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| Good Manufacturing Practices (GMP) for the production control, storage and
shipment of cosmetic products. The compliance of sampling and analysis of cosmetic products. |
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The compliance of the Cosmetic formula |
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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. |
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TFDA Cosmetics registrations |
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License application Time line |
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Submission> advertisement material Approved
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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 productwas 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 cavitywith a view exclusively or mainly to cleaning them, perfuming them, changing
their appearance, protecting them,keeping them in good condition or correctingbody 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.
