外國公司來台灣投資: 公司登記、會計、稅務及薪資處理服務

台灣化妝品登記法規問題集

永輝提供公司註冊、薪酬、會計、稅務、盡職調查、法定審計等服務,服務對象爲臺灣外商企業(WFOE),其母公司來自世界各國。
我們與海外同仁使用雲端系統協同為客戶服務

聯絡人: 朱鍵彰 協理
電話 : +886-2-2717-0515 E103
手機 : +886-939-357-735
電郵:sales.taiwan@evershinecpa.com

HLF-TW-10

請問台灣對於化妝品的歸類方式為何?它的正式名稱為何?
不同歸類管理強度有何差異?它的政府管轄機構為何?網頁?

What are the categories of cosmetics in Taiwan? What is its official name? What is the intensity of management of different categories? What is the governmental authority of cosmetics? Website?

Evershine RD:

化粧品分為二種,一為特定用途化粧品,一為一般化粧品。一般化粧品無須申請備查,惟其外包裝標示仍應依規定標示。
特定用途化粧品須向衛生福利部食品藥物管理署辦理查驗登記,經核准並發給許可證後,始得製造或輸入。

特定用途化粧品,指由中央主管機關依化粧品衛生安全管理法第五條第一項公告,具有防曬、染髮、燙髮、止汗制臭、牙齒美白或其他用途之化粧品。除衛生福利部另有規定之外,其含有特定用途成分應符合「特定用途化粧品成分名稱及使用限制表」之規定。

【參考連結】https://www.fda.gov.tw/TC/site.aspx?sid=294&r=500300219

Cosmetics are categorized as general cosmetics and specific purpose cosmetics. Specific purpose cosmetics refers to the List of Specific Purpose Ingredients in Cosmetic Products regarding the use for sunscreen, hair-dyeing, permanent waving, antiperspirant, deodorant, tooth-whitening, or other purposes.

If categorized as specific purpose cosmetics, an application for approval license shall be submitted to TFDA for registration before import.

If categorized as general cosmetics, the ingredients of the product shall comply with the regulations regarding cosmetic ingredients in Taiwan (R.O.C), ensuring safety and stability, and complete cosmetic notification and required labelling items before the products go to the market. Also, cosmetic notification shall be completed. Moreover, product information file shall be established, according to the announced schedule, and the Cosmetics Good Manufacturing Practice Regulations shall be enforced at the manufacturing premises.

【參考連結】

https://www.fda.gov.tw/ENG/law.aspx?cid=5062&cr=422615320

HLF-TW-20

外國公司要到台灣銷售化妝品,無論設100%子公司或分公司,需要在公司登記時取得營業特許證?
假如要,其必要條件是什麼?所需文件及申請程序為何?網頁?

If a foreign company wants to sell cosmetics in Taiwan, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration? If so, what are the requests? What are the required documents and application procedures? Website?

Evershine RD:

在經濟部營業項目代碼表中的代碼尾數為0代表不需辦理特許證,1代表需要辦理特許證。

化粧品批發業F108040、化粧品零售業 F208040

In the code table of the business of the Ministry of Economic Affairs, the last digit of the code is 0, which means no preliminary approval is required, and 1 means that preliminary approval is required.

Cosmetics wholesale F108040;Cosmetics retail F208040

【參考連結】https://gcis.nat.gov.tw/cod/browseAction.do?method=browse&layer=1&code=F

HLF-TW-25

假如需要辦理,請問台灣有專業服務公司可以協助辦理化妝品公司營業許可證?

Evershine RD:

一般會計師/記帳士事務所皆可代理辦理

HLF-TW-30

外國公司要到台灣銷售化妝品,可以指派台灣公司擔任營業代理人銷售嗎? 擔任營業代理人,其必要條件是什麼?所需文件及申請程序為何?外國公司與營業代理人的產品責任為何?網頁?

If a foreign company wants to sell cosmetics in Taiwan, can it assign a Taiwanese company to act as a business agent? What are the requests for acting as a business agent?
What are the required documents and application procedures?
What is the product liability of foreign companies and the business agents? Website?

Evershine RD:

在「特定用途化粧品許可證核發辦法」第五條中規定,輸入特定用途化粧品許可證者,應提出公司登記或商業登記證明文件影本,意謂可提出公司登記或商業登記文件之代理人即具備申請條件。

It is stated in Article 5 of the “Measures for the Issuance of Licenses for Special-purpose Cosmetics” that those who import the special-purpose cosmetics should submit a copy of the company registration or business registration certificate, which means that the agent who can provide the company registration or business registration document has the right to application.

【參考連結】https://www.fda.gov.tw/TC/site.aspx?sid=294&r=500300219

HLF-TW-35

假如需要辦理指派台灣公司擔任營業代理人,請問台灣有專業服務公司可以協助?

Evershine RD:

無此機制, 須以台灣當地公司名義代理。

HLF-TW-40

外國公司銷售到台灣化妝品本身,進口前需要辦理產品許可嗎?
如需要,哪個單位在管理?需要什麼文件?申請程序為何?

化妝品包裝內容及各種標示,需要事先核准嗎?
可允許的語文除了中文外,其他哪種語文也可以?網頁?

Do foreign companies need to apply for an approval before importing cosmetics sold to Taiwan? If yes, which authority is in charge? What documents are required? What is the application process? Do cosmetic packaging and labeling require prior approval? In addition to Chinese, which other languages ​​are allowed? Website?

Evershine RD:

特定用途化粧品進口或上市前,須向食品藥物管理署辦理「特定用途化粧品查驗登記」,取得許可證後方可輸入或製造。

化粧品之中文標示應依「化粧品衛生管理條例」及「化粧品之標籤仿單包裝之標示規定」,產品標示項目需刊載製造廠名、地址、品名、許可證字號、全成分、用途、用法、重量或容量、批號或出廠日期、保存方法及保存期限等,自國外輸入之化粧品,尚需載明輸入廠商之名稱、地址。

依「化粧品外包裝、容器、標籤或仿單之標示規定」之規定,化粧品具外包裝及容器者,除於外包裝明顯處標示中文品 名外,容器應至少標示中文或外文品名。全成分名稱以中文或英文標示。

Specific purpose cosmetics, an application for approval license shall be submitted to TFDA for registration before import.

The ingredients of the product shall comply with the regulations regarding cosmetic ingredients in Taiwan, ensuring safety and stability, and complete cosmetic notification and required labeling items before the products go to the market. Also, cosmetic notification shall be completed. Moreover, product information file shall be established, according to the announced schedule, and the Cosmetics Good Manufacturing Practice Regulations shall be enforced at the manufacturing premises. The product labeling items need to include the manufacturer’s name, address, product name, license number, full ingredients, use, usage, weight or volume, batch number or date of manufacture, storage method and storage period, etc. Cosmetics imported from abroad need to list the name and address of the manufacturer.

For cosmetic products with outer packaging and containers, in addition to the Chinese name marked on the outer packaging, the container should at least display the name in Chinese or other languages. All ingredient names are marked in Chinese or English.

【參考連結】https://www.fda.gov.tw/TC/site.aspx?sid=294&r=500300219

【參考連結】https://www.fda.gov.tw/TC/siteListContent.aspx?sid=1152&id=5194

【參考連結】特定用途成分名稱及使用限制表https://www.fda.gov.tw/TC/siteList.aspx?sid=1152

【參考連結】https://www.fda.gov.tw/TC/newsContent.aspx?cid=3&id=25259

HLF-TW-45

請問在台灣有哪些專業服務機構,可以協助辦理化妝品產品許可證?

Evershine RD:

台美檢驗https://www.superlab.com.tw/registration/

HLF-TW-50

外國公司可以用自己名義申請辦理產品許可嗎?如需要,哪個單位在管理?需要什麼文件?
申請程序為何?化妝品包裝內容及各種標示,需要事先核准嗎?
可允許的語文除了中文外,其他哪種語文也可以?網頁?

Can a foreign company apply for a product license by its own name? If yes, which authority is in charge? What documents are required? What is the application process?
Do cosmetic packaging and labeling require prior approval?
In addition to Chinese, which other languages ​​are allowed? Website?

Evershine RD:

依「特定用途化粧品許可證核發辦法」第五條規定,申請輸入特定用途化粧品許可證者,應提出公司登記或商業登記證明文件影本,意即須提出台灣當地公司登記或商業登記文件之業者才具備申請條件。

化粧品之中文標示應依「化粧品衛生管理條例」及「化粧品之標籤仿單包裝之標示規定」,產品標示項目需刊載製造廠名、地址、品名、許可證字號、全成分、用途、用法、重量或容量、批號或出廠日期、保存方法及保存期限等,自國外輸入之化粧品,尚需載明輸入廠商之名稱、地址。

依化粧品外包裝或容器之規定,具外包裝及容器者,除於外包裝明顯處標示中文品 名外,容器應至少標示中文或外文品名。全成分名稱以中文或英文標示。

It is stated in Article 5 of the “Measures for the Issuance of Licenses for Special-purpose Cosmetics” that those who import the special-purpose cosmetics should submit a copy of the company registration or business registration certificate, which means that only the agent who can provide the local (Taiwan) company registration or business registration document has the right to application.

The ingredients of the product shall comply with the regulations regarding cosmetic ingredients in Taiwan, ensuring safety and stability, and complete cosmetic notification and required labeling items before the products go to the market. Also, cosmetic notification shall be completed. Moreover, product information file shall be established, according to the announced schedule, and the Cosmetics Good Manufacturing Practice Regulations shall be enforced at the manufacturing premises. The product labeling items need to include the manufacturer’s name, address, product name, license number, full ingredients, use, usage, weight or volume, batch number or date of manufacture, storage method and storage period, etc. Cosmetics imported from abroad need to list the name and address of the manufacturer.

For cosmetic products with outer packaging and containers, in addition to the Chinese name marked on the outer packaging, the container should at least display the name in Chinese or other languages. All ingredient names are marked in Chinese or English.

【參考連結】https://www.fda.gov.tw/TC/site.aspx?sid=294&r=500300219

【參考連結】

https://www.fda.gov.tw/TC/siteListContent.aspx?sid=1152&id=5194

【參考連結】「特定用途成分名稱及使用限制表」https://www.fda.gov.tw/TC/siteList.aspx?sid=1152

【參考連結】「化粧品外包裝、容器、標籤或仿單之標示規定」https://www.fda.gov.tw/TC/newsContent.aspx?cid=3&id=25259

HLF-TW-55

請問在台灣有哪些專業服務機構,可以協助以外國公司名義辦理化妝品產品許可證?

Evershine RD:

台美檢驗https://www.superlab.com.tw/registration/

HLF-TW-60

經過核准登記的化妝品,進口到台灣要檢附什麼文件?經過什麼手續?
在銷售時要向各地的衛生福利部相關機構事先或事後準備嗎?網頁?

What are the required documents for the application of importing cosmetics registration?
What is the application process? Website?

Evershine RD:

依「特定用途化粧品許可證核發辦法」第五條規定,申請查驗登記發給輸入特定用途化粧 品許可證者,應填具申請書,檢附下列文件、資料,並繳納費用, 向衛生福利部食品藥物管理署提出:

  一、公司登記或商業登記證明文件影本。

  二、產品標籤、仿單及包裝設計稿樣。

  三、最近二年內出具之授權書。

  四、最近二年內出具之出產國許可製售證明。

  五、最近二年內出具之成分表。

  六、檢驗成績書。

  七、委託製造者,載明委託者及受託製造廠雙方關係之證明文件。

According to Paragraph 1, Article 5 of Regulations for Issuance of License of Specific Purpose Cosmetics, an applicant applies for the registration of the license for importing specific purpose cosmetics shall submit an application with following documents, information, and pay the fee to the TFDA:

  1. A copy of company registration or business registration certificate.
  2. Drafts of product labels, leaflets, and packaging.
  3. The authorization letter issued within the past two years.
  4. The MFSC issued within the past two years.
  5. An ingredient list issued within the past two years.
  6. The certificate of analysis.
  7. For the contract manufacturer, a certificate identifies the relationship between the hiring firm and the contract manufacturer.

【參考連結】https://www.fda.gov.tw/TC/site.aspx?sid=294&r=1685384889

HLF-TW-70

台灣化妝品審核機構,需要附上的實驗室檢驗資料有哪些? 網頁?

What are the laboratory inspection materials that need to be attached for TFDA verification?

Evershine RD:

依「特定用途化粧品許可證核發辦法」第9條規定,檢驗成績書應記載下列事項:

  一、性狀:產品之外觀、顏色、形狀、劑型。

  二、主成分:產品中含有特定用途之成分。

  三、主成分之鑑別方法。

  四、主成分之定量方法。

  五、主成分之含量合格範圍,且該範圍應介於添加含量之百分

    之九十至百分之一百十間。

  六、檢驗結果。

  七、其他測定資料。

According to Article 9 of Regulations for Issuance of License of Specific Purpose Cosmetics, the certificate of analysis shall include:

1. Properties: Appearance, color, shape and dosage form of the product.

2. Main ingredient: The product contains ingredients for specific purposes.

3. Identification method of main ingredient.

4. Quantitative methods of main ingredient.

5. The content of the main ingredient is within the qualified range, and the range should be within the percentage of the added content 90% to 100%.

6. Test results.

7. Other measurement data.

【參考連結】https://www.fda.gov.tw/TC/site.aspx?sid=294&r=1685384889

HLF-TW-75

台灣化妝品審核構,能夠接受海外檢驗機構的檢驗資料嗎?假如是的話,有些被認可的機構?網頁?

Evershine RD:

可接受海外機構出具的檢驗資料,須依照「特定用途化粧品許可證核發辦法」第9條規定,檢驗成績書應記載下列事項:

  一、性狀:產品之外觀、顏色、形狀、劑型。

  二、主成分:產品中含有特定用途之成分。

  三、主成分之鑑別方法。

  四、主成分之定量方法。

  五、主成分之含量合格範圍,且該範圍應介於添加含量之百分

    之九十至百分之一百十間。

  六、檢驗結果。

  七、其他測定資料。

SGS: https://www.sgs.com

TUV Rheinland: http://vip.asia-learning.com/tuvtw/aboutus

HLF-TW-77

請問在台灣有哪些化妝品檢驗機構可以提供化妝品檢驗服務?網頁?

Evershine RD:

台美檢驗https://www.superlab.com.tw/registration/

台灣檢驗科技股份有限公司https://www.sgs.com.tw/

安諾生物科技股份有限公司https://www.biotechts.com/

HLF-TW-80

外國子公司進口化妝品後,如果委託台灣的經銷商銷售,經銷商需要化妝品營業許可證嗎?
假如化妝品有品質瑕疵的話,外國子公司和經銷商各自的責任為何?
是連帶責任嗎?還是可以規範由外國子公司負責?

After a foreign subsidiary imports cosmetics and entrusts a distributor in Taiwan to sell it, does the distributor need a cosmetics business license?
What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects? Is it joint liability?
Or can the responsibility of the foreign subsidiary be regulated?

Evershine RD:

特定用途化粧品進口或上市前,須向食品藥物管理署辦理「特定用途化粧品查驗登記」,取得許可證後方可輸入或製造。

若因產品瑕疵而造成的消費者損害,台灣之輸入業者(經銷商/代理商/進口商)有責任對於消費者之損害做出賠償。
然,台灣輸入業者與國外原廠公司之合約中可明確規範相關條例;再者,亦可針對產品投保產品責任險。

For specific purposes of cosmetics, an application for approval license shall be submitted to TFDA for registration before import.

In case of consumer damage caused by product defects, Taiwanese importers (distributors/agents) are responsible for making compensation for consumer damages. The relevant regulations can be clearly specified in the contracts between Taiwanese importers and foreign original companies; moreover, product liability insurance can also be purchased for products.

【參考連結】https://www.fda.gov.tw/TC/site.aspx?sid=294&r=500300219

HLF-TW-85

請問在台灣有哪些專精於化妝品銷售與消費權益相關法律服務的業者?

Evershine RD:

較大型律師事務所應具有專精FDA業務之律師負責相關業務。

聯絡我們:

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聯絡人: 朱鍵彰 協理
電話 : +886-2-2717-0515 E103
手機 : +886-939-357-735
電郵:sales.taiwan@evershinecpa.com

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