義大利化妝品登記法規問題集

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或
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各國化妝品登記法規問答集

時間：2023/09/18 drafted by Yvonne Chen

HLF-TW-10
請問義大利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 Italy? What is its official name? What is the intensity of management of different categories? What is the governmental authority of cosmetics? Website?
Evershine RD：
在義大利，衛生部 (MOH)是義大利化妝品的監管機構。
化妝品的定義是與人體表面部分接觸的物質或製劑，包含表皮、頭髮、毛髮系統、指甲、嘴唇、生殖器官、牙齒和口腔黏膜，其唯一或主要目的是清潔、添香、幫助改變外觀、保護、保持良好狀態或糾正體味或減輕、預防健康皮膚功能的缺陷或變化。旨在攝入、吸入、注射或植入人體的物質或混合物不被視為化妝品。

1.化妝品的分類必須考慮：配方、產品申請、產品的功能。
2.化妝品包括：
．皮膚霜、乳液、乳液、凝膠和油
．美容面膜、粉底(液、膏、粉)、蜜粉
．用於浴後及身體衛生的滑石粉
．美容皂、除臭皂、香水、花露水和古龍水
．沐浴和淋浴製劑(鹽、泡沫、油、凝膠)
．除毛產品
．除臭劑和止汗劑
．染髮劑、捲髮、拉直和定型製劑、頭髮清潔製劑(乳液、粉末、洗髮精)、保持頭髮形狀的製劑(乳液、乳霜、油)、頭髮定型產品(乳液、髮膠、亮髮劑)
．剃鬚產品(霜、泡沫、乳液)
．化妝品和卸妝產品、塗在嘴唇上的產品
．牙齒和口腔衛生產品
．指甲保養產品和指甲油
．外用私密衛生用品
．防曬產品、曬黑產品
．亮膚產品和抗皺產品

In Italy, the Ministry of Health (MOH) is the regulatory agency for Italian cosmetics.
Cosmetics are defined as substances or preparations that come into contact with surface parts of the human body, including the epidermis, hair, hair system, nails, lips, reproductive organs, teeth and oral mucosa, for the sole or main purpose of cleaning, perfuming, helping to change the appearance, protecting , maintain good condition or correct body odor or reduce or prevent defects or changes in healthy skin function. Substances or mixtures intended for ingestion, inhalation, injection or implantation into the human body are not considered cosmetics.

1. The classification of cosmetics must consider: formula, product application, and product function.
2. Cosmetics include:
   ． Skin creams, lotions, lotions, gels and oils
   ． Beauty masks, foundation (liquid, cream, powder), powder
   ． Talcum powder for after-bath and body hygiene
   ． Beauty soaps, deodorant soaps, perfumes, toilet waters and colognes
   ． Bath and shower preparations (salts, foams, oils, gels)
   ． Hair removal products
   ． Deodorant and antiperspirant
   ． Hair dyes, preparations for curling, straightening and styling hair, preparations for hair cleansing (lotions, powders, shampoos), preparations for maintaining the shape of the hair (lotions, creams, oils), hair styling products (lotions, gels, hair shiners)
   ． Shaving products (cream, foam, lotion)
   ． Cosmetics and makeup removal products, products for application on lips
   ． Teeth and Oral Hygiene Products
   ． Nail care products and nail polish
   ． External personal hygiene products
   ． Sunscreen products, tanning products
   ． Skin lightening and anti-wrinkle products

【參考連結】
https://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=144&area=cosmetici&menu=caratteristiche
https://www.salute.gov.it/portale/home.html

HLF-TW-20
外國公司要到義大利銷售化妝品，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 Italy, 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：
無營業特許證。
No business license.

【參考連結】
https://www.salute.gov.it/portale/temi/p2_4.jsp?lingua=italiano&area=cosmetici

HLF-TW-25

HLF-TW-30
外國公司要到義大利銷售化妝品，可以指派義大利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 Italy, can it assign an Italy 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：
可以
只有在歐盟內被指定為責任人才能投放市場，責任人的主體需由歐盟境內的企業法人或自然人擔任，非歐盟商品進入歐盟與EFTA地區必須要指定歐盟當地法人或自然人擔任公司的責任人，才能將該化妝品投放歐盟市場。一般默認化妝品的責任人為化妝品製造商，進口商，經銷商，如通過書面授權的形式，也可由第三方法人或自然人擔任。
1.責任人須符合其中一項資格：
·歐盟公民(不論居住地)。
·居住在歐盟或是歐洲經濟區會員國的自然人。
·在歐盟或歐洲經濟區內成立的公司（註冊辦事處，中央管理機構或主要機構）。
·在歐盟或歐洲經濟區內建立的組織。
2.完成化妝品備案通報流程
責任人必須在產品上市前經由歐盟統一線上平台進行通報（CPNP，網頁：https://reurl.cc/pM8R7x）方可進入歐盟市場。並且責任人須在產品上市前準備好產品資訊檔案(PIF/DIP)文件，已備官方實地檢查，需檢具：
·產品類別
·產品名稱
·責任人姓名、地址
·上市地區(投放市場的成員國)
·標籤及包裝(合理清晰的照片)
·產品配方
·原產國
·聯繫人
·奈米材料(包括化學名稱、暴露條件)
·CMR類等特殊成分或生殖毒性物質的名稱、化學文摘或EC 編號
·遇到問題時的醫療處理

3. 產品資訊檔案(PIF/DIP)內容包括：
   ·產品描述
   ·產品安全評估報告CPSR
   ·生產工藝描述和良好生產規範(GMP)聲明
   ·動物測試數據聲明
   ·產品功效證明
   4.化妝品安全評估報告(CPSR)所需資料：
   ·產品名和內部編號
   ·詳細配方表
   ·原料品質檢驗報告(CoA)和化學品安全技術書(MSDS)
   ·香精/香料/精油: IFRA文件、過敏原、MSDS, CoA
   ·成品
   ·毒理和臨床研究報告
   ·微生物報告(包括挑戰試驗)
   ·穩定性報告
   ·包裝材料資訊
   ·產品標籤
   ·案例報告
   ·產品的暴露數據
4. 責任人的義務：
   ·承擔產品安全和合規責任
   ·上市前完成CPNP通報
   ·責任人名稱及地址需標註在產品標籤上
   ·責任人需準備完整PIF/DIP文件，應對主管當局的檢查
   ·最後一批產品上市後，責任人須至少保存化妝品安全評估報告十年
   ·根據情況更新CPNP和PIF/DIP
   ·上市後及時上報嚴重不良反應（ SUE）
   ·當有理由認為投放市場的產品不符合法規要求或存在安全問題時，採取必要糾正措施，撤回或召回產品。

產品安全
1.化妝品公司和經銷商有責任實施市場監督。
2.如果出現嚴重不良影響，負責人和/或經銷商應盡快通知發現嚴重不良影響的成員國主管機關：
．所有已知或合理推定已知的嚴重不良影響
．相關化妝品的名稱，以便對其進行具體辨識
．採取的任何糾正措施
3.負責人和/或經銷商必須使用表格（英文）向衛生部通報從義大利消費者收到的 不良反應報告。
4.表格填寫完畢後，可傳真轉寄至號碼 06.59943776、電子郵件地址cosmetovigilance.italy@sanita.it或透過掛號寄至dgfdm@postacert.sanita.it。

Yes.
Only those designated as responsible persons in the EU can be put on the market. The responsible person must be a corporate legal person or natural person in the EU. Non-EU products entering the EU and EFTA areas must designate a local legal person or natural person in the EU as the responsible person of the company. Only then can the cosmetics be placed on the EU market. Generally, the default responsibility for cosmetics is the cosmetics manufacturer, importer, and distributor. If written authorization is provided, it can also be a third-party legal person or natural person.

1. The responsible person must meet one of the following qualifications:
   ·EU citizens (regardless of place of residence).
   ·Natural persons residing in the EU or a member state of the European Economic Area.
   ·Companies established within the EU or EEA (registered office, central authority or principal establishment).
   ·Organizations established within the EU or European Economic Area.
2. Complete the cosmetics registration notification process
   The responsible person must notify the product through the EU unified online platform (CPNP, web page: https://reurl.cc/pM8R7x) before the product can enter the EU market. And the responsible person must prepare the product information file (PIF/DIP) document before the product is put on the market, and prepare official on-site inspection. Inspection tools are required:
   ·Product Category
   ·Product name
   ·Responsible person’s name and address
   ·Region of listing (member state where it is placed on the market)
   ·Labels and packaging (reasonably clear photos)
   ·Product ingredients
   ·Country of origin
   ·Contact
   ·Nano materials (including chemical names, exposure conditions)
   ·The name, chemical abstract or EC number of special ingredients such as CMR or reproductive toxic substances
   ·Medical treatment when encountering problems
3. Product information file (PIF/DIP) content includes:
   ·Product Description
   ·Product Safety Assessment ReportCPSR
   ·Production process description and Good Manufacturing Practice (GMP) statement
   ·Animal Testing Data Statement
   ·Proof of product efficacy
4. Information required for Cosmetic Safety Assessment Report (CPSR):
   ·Product name and internal number
   ·Detailed recipe table
   ·Raw material quality inspection report (CoA) and chemical safety data sheet (MSDS)
   ·Fragrances/Fragrances/Essential Oils: IFRA documents, allergens, MSDS, CoA
   ·Finished product
   ·Toxicological and clinical research reports
   ·Microbiological reporting (including challenge testing)
   ·Stability report
   ·Packaging material information
   ·Product label
   ·Case report
   ·Product exposure data
5. Responsible person’s obligations:
   ·Assume responsibility for product safety and compliance
   ·Complete CPNP notification before listing
   ·The name and address of the responsible person must be marked on the product label
   ·The responsible person needs to prepare complete PIF/DIP documents and respond to inspections by the competent authorities
   ·After the last batch of products are put on the market, the responsible person must keep the cosmetics safety assessment report for at least ten years
   ·Update CPNP and PIF/DIP as appropriate
   ·Promptly report serious adverse reactions (SUE) after marketing
   ·When there is reason to believe that a product put on the market does not meet regulatory requirements or has safety issues, take necessary corrective measures to withdraw or recall the product.

Product Safety

1. Cosmetic companies and distributors have the responsibility to implement market supervision.
2. In the event of serious adverse effects, the responsible person and/or distributor shall notify the competent authority of the Member State where the serious adverse effects are discovered as soon as possible:
   ．All serious adverse effects known or reasonably presumed to be known
   ．The name of the relevant cosmetic product in order to specifically identify it
   ．Any corrective actions taken
3. The person in charge and/or the distributor must notify the Ministry of Health of adverse reaction reports received from Italian consumers using a form (in English).
4. After completing the form, it can be forwarded by fax to the number 06.59943776, the email address cosmetovigilance.italy@sanita.it or by registered mail to dgfdm@postacert.sanita.it.

【參考連結】
https://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=3846&area=cosmetici&menu=vigilanza
https://single-market-economy.ec.europa.eu/sectors/cosmetics/cosmetic-product-notification-portal_en

HLF-TW-35

HLF-TW-40
外國公司銷售到義大利化妝品本身，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？可允許的語文有哪些？網頁？

Do foreign companies need to apply for an approval before importing cosmetics sold to Italy? If yes, which authority is in charge? What documents are required? What is the application process? Do cosmetics packaging and labeling require prior approval? Which languages are allowed? Website?
Evershine RD：
需要辦理產品許可證
只有在歐盟內被指定為責任人才能投放市場，責任人的主體需由歐盟境內的企業法人或自然人擔任，非歐盟商品進入歐盟與EFTA地區必須要指定歐盟當地法人或自然人擔任公司的責任人，才能將該化妝品投放歐盟市場。一般默認化妝品的責任人為化妝品製造商，進口商，經銷商，如通過書面授權的形式，也可由第三方法人或自然人擔任。
1.責任人須符合其中一項資格：
·歐盟公民(不論居住地)。
·居住在歐盟或是歐洲經濟區會員國的自然人。
·在歐盟或歐洲經濟區內成立的公司（註冊辦事處，中央管理機構或主要機構）。
·在歐盟或歐洲經濟區內建立的組織。
2.完成化妝品備案通報流程
責任人必須在產品上市前經由歐盟統一線上平台進行通報（CPNP，網頁：https://reurl.cc/pM8R7x）方可進入歐盟市場。並且責任人須在產品上市前準備好產品資訊檔案(PIF/DIP)文件，已備官方實地檢查，需檢具：
·產品類別
·產品名稱
·責任人姓名、地址
·上市地區(投放市場的成員國)
·標籤及包裝(合理清晰的照片)
·產品配方
·原產國
·聯繫人
·奈米材料(包括化學名稱、暴露條件)
·CMR類等特殊成分或生殖毒性物質的名稱、化學文摘或EC 編號
·遇到問題時的醫療處理

3. 產品資訊檔案(PIF/DIP)內容包括：
   ·產品描述
   ·產品安全評估報告CPSR
   ·生產工藝描述和良好生產規範(GMP)聲明
   ·動物測試數據聲明
   ·產品功效證明
   4.化妝品安全評估報告(CPSR)所需資料：
   ·產品名和內部編號
   ·詳細配方表
   ·原料品質檢驗報告(CoA)和化學品安全技術書(MSDS)
   ·香精/香料/精油: IFRA文件、過敏原、MSDS, CoA
   ·成品
   ·毒理和臨床研究報告
   ·微生物報告(包括挑戰試驗)
   ·穩定性報告
   ·包裝材料資訊
   ·產品標籤
   ·案例報告
   ·產品的暴露數據
4. 責任人的義務：
   ·承擔產品安全和合規責任
   ·上市前完成CPNP通報
   ·責任人名稱及地址需標註在產品標籤上
   ·責任人需準備完整PIF/DIP文件，應對主管當局的檢查
   ·最後一批產品上市後，責任人須至少保存化妝品安全評估報告十年
   ·根據情況更新CPNP和PIF/DIP
   ·上市後及時上報嚴重不良反應（ SUE）
   ·當有理由認為投放市場的產品不符合法規要求或存在安全問題時，採取必要糾正措施，撤回或召回產品。

標籤
1.在義大利市場上銷售的產品，標籤採用義大利語。

2. 可以提供多語言標籤，但至少重要的資訊要以義大利語顯示，並且列印字元大小與其他語言的文字大小相同。
   3.以下資訊必須以義大利語報告
   ．對於在義大利銷售的多語言標籤產品：標稱含量(以重量或體積表示)、化妝品使用日期、特別注意事項、化妝品功能
   ．對於因容器尺寸較小或其他實際原因而在袋子、標籤或紙本上附有說明的產品：使用特別注意事項、成分清單
   ．對於未預先包裝/由賣方應買方要求包裝/為了立即銷售而預先包裝的化妝品：完整標籤
3. 化妝品只有在其容器和包裝上帶有以下不可磨滅、易辨認和可見字符的標籤後才能在市場上銷售
   ．負責人姓名或公司名稱及完整地址；如果有多個地址，則必須將提供給主管機關的地址寫在顯眼位置
   ．以重量或體積表示的標稱含量(義大利語)，對於通常以成套形式銷售的預包裝，可以不標明內容，但包裝上註明件數
   ．最短保存期限或失效日期，即產品在正確儲存的情況下可以使用的日期，或產品保持其特性不變並繼續發揮其初始功能的日期；日期前面帶有符號：用沙漏圖標或單字「最佳使用日期：」。依序由年月或日月年組成。如有必要，也可以透過指定必須遵守的儲存條件來完成有效期限的指示，確保產品的有效性
   ．最短保質期超過30個月的產品，無需在標籤上標明失效日期，但必須標明容器打開後產品的有效期，可以在不對消費者產生有害影響的情況下使用，用打開罐的符號或罐子圖示縮寫詞(PAO)表示，期限以月和/或年表示。
   ．在適當的情況下，必須報告有關的特殊預防措施。如果無法顯示在容器或外包裝，則必須顯示在說明書、袋子或標籤中用縮寫或符號向消費者說明
   ．生產批號或可識別化妝品的參考號碼，如果空間不夠，批號只能顯示在包裝上
   ．非歐盟國家製造產品的原產國
   ．化妝品的功能 (除非從其外觀可以明顯看出)
   ．成分術語表必須使用國際公認的命名法，包括國際化妝品成分命名法 ( INCI )。如果特定成分沒有通用名稱，則應使用普遍認可的命名法。
   防曬用品的標籤
   1.以統一的方式標示紫外線（UVA 、UVB）防護等級資訊。
   2.標示類別之一：低保護、中保護、高保護、非常高保護。
   3.與防護係數的相比，類別的指示更簡單、更相關。因此，類別應與防曬係數一樣清楚地顯示在標籤上。
   4.關於標籤上所報告的防曬係數對應的數字範圍，可以在不限制消費者選擇不同防護措施的能力的情況下減少該數字範圍。
   5.標籤上用於指示保護係數的多個數字無助於提供簡單且相關資訊的目標。從一個數字到下一個數字的保護增加可以忽略不計，特別是在較高的係數範圍內。

Product license required
Only those who are designated as responsible persons in the EU can be placed on the market. The main responsible person must be an enterprise legal person or natural person in the EU. When non-EU goods enter the EU and EFTA regions, a local EU legal person or natural person must be designated as the responsible person of the company. to put the cosmetic product on the EU market. Generally, the responsible person for cosmetics is the manufacturer, importer, and distributor of cosmetics. If authorized in writing, a third legal person or natural person can also be the person responsible.

1. The responsible person shall meet one of the qualifications:
   ·EU citizens (regardless of residence).
   ·A natural person resident in the European Union or a member state of the European Economic Area.
   ·A company established in the European Union or European Economic Area (registered office, central authority or principal body).
   ·Organizations established in the European Union or the European Economic Area.
2. Complete the cosmetic filing notification process
   The responsible person must notify through the EU unified online platform (CPNP, webpage: https://reurl.cc/pM8R7x) before the product is put on the market to enter the EU market. And the responsible person must prepare the product information file (PIF/DIP) document before the product goes on the market.
   ·Product categories
   ·Product Name
   ·Name and address of the person responsible
   ·Listed area (the member country where the market is placed)
   · Label and packaging (reasonable and clear photos)
   ·Product Formulation
   ·Country of origin
   ·Contact
   Nanomaterials (including chemical name, exposure conditions)
   The name, chemical abstract or EC number of special ingredients or reproductive toxic substances such as CMRs
   ·Medical treatment in case of problems
3. Product information file (PIF/DIP) content includes:
   ·Product Description
   ·Product Safety Assessment Report CPSR
   Production process description and Good Manufacturing Practice (GMP) statement
   · Animal Testing Data Statement
   ·Product efficacy certificate
4. Information required for the Cosmetic Safety Assessment Report (CPSR):
   ·Product name and internal number
   ·Detailed formula table
   ·Material Quality Inspection Report (CoA) and Chemical Safety Data Sheet (MSDS)
   ·Fragrance/Fragrance/Essential Oil: IFRA File, Allergens, MSDS, CoA
   ·Finished product
   · Toxicology and clinical research reports Microbiological report (including challenge test)
   ·Stability report
   ·Packaging material information
   ·product label
   ·Case report
   · Exposure data of products
5. Responsibilities of the Responsible Person:
   ·Assume product safety and compliance responsibilities
   ·Complete CPNP notification before listing
   ·The name and address of the responsible person should be marked on the product label
   ·The responsible person needs to prepare a complete PIF/DIP file for inspection by the competent authority
   · After the last batch of products is on the market, the responsible person must keep the cosmetic safety assessment report for at least ten years
   · Update CPNP and PIF/DIP as appropriate
   ·Report serious adverse reactions (SUE) in a timely manner after listing
   · When there is reason to believe that a product placed on the market does not meet regulatory requirements or has a safety issue, take the necessary corrective action to withdraw or recall the product.

Label

1. Products sold in the Italian market have labels in Italian.
2. Multilingual labels can be provided, but at least the important information must be displayed in Italian and the print character size must be the same as the text size in other languages.
3. The following information must be reported in Italian
   ． For multilingual label products sold in Italy: nominal content (expressed by weight or volume), cosmetic use date, special precautions, cosmetic function
   ． For products with instructions on the bag, label, or paper sheet due to small container size or other practical reasons: Special Usage Precautions, Ingredients List
   ． For cosmetics that are not prepackaged/packaged by the seller at the request of the buyer/prepackaged for immediate sale: complete labeling
4. Cosmetics may be sold on the market only if their containers and packages are labeled with the following indelible, legible and visible characters:
   ． The name of the person responsible or the name of the company and the complete address; if there are more than one address, the address provided to the competent authority must be written in a prominent place
   ． Nominal content expressed by weight or volume (Italian), for prepackaged products usually sold in sets, the content does not need to be marked, but the number of pieces is indicated on the package
   ． Minimum shelf life or expiration date, which is the date on which the product can be used if stored correctly, or the date on which the product retains its characteristics and continues to perform its original function; the date is preceded by a symbol: an hourglass icon or the words “Best” Date of use:”. It consists of year, month or day, month and year in sequence. If necessary, expiry date instructions can also be completed by specifying storage conditions that must be observed to ensure the effectiveness of the product.
   ． Products with a minimum shelf life of more than 30 months do not need to indicate an expiry date on the label, but must indicate the expiration date of the product after the container is opened, and can be used without causing harmful effects to consumers, using the symbol of an open can or the abbreviation of the can icon The term (PAO) is expressed in terms of months and/or years.
   ． Where appropriate, relevant special precautions must be reported. If it cannot be displayed on the container or outer packaging, it must be displayed in the instructions, bag or label with an abbreviation or symbol to inform consumers.
   ． Production batch number or reference number that identifies the cosmetic product. If there is insufficient space, the batch number can only be displayed on the packaging.
   ． Country of origin of products manufactured in non-EU countries
   ． The function of the cosmetic (unless obvious from its appearance)
   ． Glossaries of ingredients must use internationally recognized nomenclature, including the International Nomenclature of Cosmetic Ingredients ( INCI ). If there is no common name for a particular ingredient, the generally accepted nomenclature should be used.
   Sunscreen labels
5. Indicate ultraviolet (UVA, UVB) protection level information in a unified manner.
6. Mark one of the categories: low protection, medium protection, high protection, very high protection.
7. Compared with the protection factor, the indication of the category is simpler and more relevant. Therefore, the category should be clearly shown on the label as is the SPF.
8. With regard to the numerical range corresponding to the SPF reported on the label, the numerical range can be reduced without limiting the consumer’s ability to choose different protective measures.
9. Multiple numbers on labels indicating protection factors do not contribute to the goal of providing simple and relevant information. The increase in protection from one number to the next is negligible, especially in the higher coefficient ranges.

【參考連結】
https://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=2899&area=cosmetici&menu=commercializzazione
https://single-market-economy.ec.europa.eu/sectors/cosmetics/cosmetic-product-notification-portal_en
https://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=146&area=cosmetici&menu=presentazione

HLF-TW-45

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？可允許的語文有哪些？？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 cosmetics packaging and labeling require prior approval? Which languages are allowed?? Website?
Evershine RD：
須以歐盟境內的企業法人或自然人名義申請。
只有在歐盟內被指定為責任人才能投放市場，責任人的主體需由歐盟境內的企業法人或自然人擔任，非歐盟商品進入歐盟與EFTA地區必須要指定歐盟當地法人或自然人擔任公司的責任人，才能將該化妝品投放歐盟市場。一般默認化妝品的責任人為化妝品製造商，進口商，經銷商，如通過書面授權的形式，也可由第三方法人或自然人擔任。
1.責任人須符合其中一項資格：
·歐盟公民(不論居住地)。
·居住在歐盟或是歐洲經濟區會員國的自然人。
·在歐盟或歐洲經濟區內成立的公司（註冊辦事處，中央管理機構或主要機構）。
·在歐盟或歐洲經濟區內建立的組織。
2.完成化妝品備案通報流程
責任人必須在產品上市前經由歐盟統一線上平台進行通報（CPNP，網頁：https://reurl.cc/pM8R7x）方可進入歐盟市場。並且責任人須在產品上市前準備好產品資訊檔案(PIF/DIP)文件，已備官方實地檢查，需檢具：
·產品類別
·產品名稱
·責任人姓名、地址
·上市地區(投放市場的成員國)
·標籤及包裝(合理清晰的照片)
·產品配方
·原產國
·聯繫人
·奈米材料(包括化學名稱、暴露條件)
·CMR類等特殊成分或生殖毒性物質的名稱、化學文摘或EC 編號
·遇到問題時的醫療處理

3. 產品資訊檔案(PIF/DIP)內容包括：
   ·產品描述
   ·產品安全評估報告CPSR
   ·生產工藝描述和良好生產規範(GMP)聲明
   ·動物測試數據聲明
   ·產品功效證明
   4.化妝品安全評估報告(CPSR)所需資料：
   ·產品名和內部編號
   ·詳細配方表
   ·原料品質檢驗報告(CoA)和化學品安全技術書(MSDS)
   ·香精/香料/精油: IFRA文件、過敏原、MSDS, CoA
   ·成品
   ·毒理和臨床研究報告
   ·微生物報告(包括挑戰試驗)
   ·穩定性報告
   ·包裝材料資訊
   ·產品標籤
   ·案例報告
   ·產品的暴露數據
4. 責任人的義務：
   ·承擔產品安全和合規責任
   ·上市前完成CPNP通報
   ·責任人名稱及地址需標註在產品標籤上
   ·責任人需準備完整PIF/DIP文件，應對主管當局的檢查
   ·最後一批產品上市後，責任人須至少保存化妝品安全評估報告十年
   ·根據情況更新CPNP和PIF/DIP
   ·上市後及時上報嚴重不良反應（ SUE）
   ·當有理由認為投放市場的產品不符合法規要求或存在安全問題時，採取必要糾正措施，撤回或召回產品。

標籤
1.在義大利市場上銷售的產品，標籤採用義大利語。

2. 可以提供多語言標籤，但至少重要的資訊要以義大利語顯示，並且列印字元大小與其他語言的文字大小相同。
   3.以下資訊必須以義大利語報告
   ．對於在義大利銷售的多語言標籤產品：標稱含量(以重量或體積表示)、化妝品使用日期、特別注意事項、化妝品功能
   ．對於因容器尺寸較小或其他實際原因而在袋子、標籤或紙本上附有說明的產品：使用特別注意事項、成分清單
   ．對於未預先包裝/由賣方應買方要求包裝/為了立即銷售而預先包裝的化妝品：完整標籤
3. 化妝品只有在其容器和包裝上帶有以下不可磨滅、易辨認和可見字符的標籤後才能在市場上銷售
   ．負責人姓名或公司名稱及完整地址；如果有多個地址，則必須將提供給主管機關的地址寫在顯眼位置
   ．以重量或體積表示的標稱含量(義大利語)，對於通常以成套形式銷售的預包裝，可以不標明內容，但包裝上註明件數
   ．最短保存期限或失效日期，即產品在正確儲存的情況下可以使用的日期，或產品保持其特性不變並繼續發揮其初始功能的日期；日期前面帶有符號：用沙漏圖標或單字「最佳使用日期：」。依序由年月或日月年組成。如有必要，也可以透過指定必須遵守的儲存條件來完成有效期限的指示，確保產品的有效性
   ．最短保質期超過30個月的產品，無需在標籤上標明失效日期，但必須標明容器打開後產品的有效期，可以在不對消費者產生有害影響的情況下使用，用打開罐的符號或罐子圖示縮寫詞(PAO)表示，期限以月和/或年表示。
   ．在適當的情況下，必須報告有關的特殊預防措施。如果無法顯示在容器或外包裝，則必須顯示在說明書、袋子或標籤中用縮寫或符號向消費者說明
   ．生產批號或可識別化妝品的參考號碼，如果空間不夠，批號只能顯示在包裝上
   ．非歐盟國家製造產品的原產國
   ．化妝品的功能 (除非從其外觀可以明顯看出)
   ．成分術語表必須使用國際公認的命名法，包括國際化妝品成分命名法 ( INCI )。如果特定成分沒有通用名稱，則應使用普遍認可的命名法。
   防曬用品的標籤
   1.以統一的方式標示紫外線（UVA 、UVB）防護等級資訊。
   2.標示類別之一：低保護、中保護、高保護、非常高保護。
   3.與防護係數的相比，類別的指示更簡單、更相關。因此，類別應與防曬係數一樣清楚地顯示在標籤上。
   4.關於標籤上所報告的防曬係數對應的數字範圍，可以在不限制消費者選擇不同防護措施的能力的情況下減少該數字範圍。
   5.標籤上用於指示保護係數的多個數字無助於提供簡單且相關資訊的目標。從一個數字到下一個數字的保護增加可以忽略不計，特別是在較高的係數範圍內。

Applications must be made in the name of a corporate legal person or a natural person within the EU.
Only those who are designated as responsible persons in the EU can be placed on the market. The main responsible person must be an enterprise legal person or natural person in the EU. When non-EU goods enter the EU and EFTA regions, a local EU legal person or natural person must be designated as the responsible person of the company. to put the cosmetic product on the EU market. Generally, the responsible person for cosmetics is the manufacturer, importer, and distributor of cosmetics. If authorized in writing, a third legal person or natural person can also be the person responsible.

1. The responsible person shall meet one of the qualifications:
   ·EU citizens (regardless of residence).
   ·A natural person resident in the European Union or a member state of the European Economic Area.
   ·A company established in the European Union or European Economic Area (registered office, central authority or principal body).
   ·Organizations established in the European Union or the European Economic Area.
2. Complete the cosmetic filing notification process
   The responsible person must notify through the EU unified online platform (CPNP, webpage: https://reurl.cc/pM8R7x) before the product is put on the market to enter the EU market. And the responsible person must prepare the product information file (PIF/DIP) document before the product goes on the market.
   ·Product categories
   ·Product Name
   ·Name and address of the person responsible
   ·Listed area (the member country where the market is placed)
   · Label and packaging (reasonable and clear photos)
   ·Product Formulation
   ·Country of origin
   ·Contact
   Nanomaterials (including chemical name, exposure conditions)
   The name, chemical abstract or EC number of special ingredients or reproductive toxic substances such as CMRs
   ·Medical treatment in case of problems
3. Product information file (PIF/DIP) content includes:
   ·Product Description
   ·Product Safety Assessment Report CPSR
   Production process description and Good Manufacturing Practice (GMP) statement
   · Animal Testing Data Statement
   ·Product efficacy certificate
4. Information required for the Cosmetic Safety Assessment Report (CPSR):
   ·Product name and internal number
   ·Detailed formula table
   ·Material Quality Inspection Report (CoA) and Chemical Safety Data Sheet (MSDS)
   ·Fragrance/Fragrance/Essential Oil: IFRA File, Allergens, MSDS, CoA
   ·Finished product
   ·Toxicology and clinical research reports Microbiological report (including challenge test)
   ·Stability report
   ·Packaging material information
   ·Product label
   ·Case report
   ·Exposure data of products
5. Responsibilities of the Responsible Person:
   ·Assume product safety and compliance responsibilities
   ·Complete CPNP notification before listing
   ·The name and address of the responsible person should be marked on the product label
   ·The responsible person needs to prepare a complete PIF/DIP file for inspection by the competent authority
   ·After the last batch of products is on the market, the responsible person must keep the cosmetic safety assessment report for at least ten years
   · Update CPNP and PIF/DIP as appropriate
   ·Report serious adverse reactions (SUE) in a timely manner after listing
   ·When there is reason to believe that a product placed on the market does not meet regulatory requirements or has a safety issue, take the necessary corrective action to withdraw or recall the product.

Label

1. Products sold in the Italian market have labels in Italian.
2. Multilingual labels can be provided, but at least the important information must be displayed in Italian and the print character size must be the same as the text size in other languages.
3. The following information must be reported in Italian
   ． For multilingual label products sold in Italy: nominal content (expressed by weight or volume), cosmetic use date, special precautions, cosmetic function
   ． For products with instructions on the bag, label, or paper sheet due to small container size or other practical reasons: Special Usage Precautions, Ingredients List
   ． For cosmetics that are not prepackaged/packaged by the seller at the request of the buyer/prepackaged for immediate sale: complete labeling
4. Cosmetics may be sold on the market only if their containers and packages are labeled with the following indelible, legible and visible characters:
   ． The name of the person responsible or the name of the company and the complete address; if there are more than one address, the address provided to the competent authority must be written in a prominent place
   ． Nominal content expressed by weight or volume (Italian), for prepackaged products usually sold in sets, the content does not need to be marked, but the number of pieces is indicated on the package
   ． Minimum shelf life or expiration date, which is the date on which the product can be used if stored correctly, or the date on which the product retains its characteristics and continues to perform its original function; the date is preceded by a symbol: an hourglass icon or the words “Best” Date of use:”. It consists of year, month or day, month and year in sequence. If necessary, expiry date instructions can also be completed by specifying storage conditions that must be observed to ensure the effectiveness of the product.
   ． Products with a minimum shelf life of more than 30 months do not need to indicate an expiry date on the label, but must indicate the expiration date of the product after the container is opened, and can be used without causing harmful effects to consumers, using the symbol of an open can or the abbreviation of the can icon The term (PAO) is expressed in terms of months and/or years.
   ． Where appropriate, relevant special precautions must be reported. If it cannot be displayed on the container or outer packaging, it must be displayed in the instructions, bag or label with an abbreviation or symbol to inform consumers.
   ． Production batch number or reference number that identifies the cosmetic product. If there is insufficient space, the batch number can only be displayed on the packaging.
   ． Country of origin of products manufactured in non-EU countries
   ． The function of the cosmetic (unless obvious from its appearance)
   ． Glossaries of ingredients must use internationally recognized nomenclature, including the International Nomenclature of Cosmetic Ingredients ( INCI ). If there is no common name for a particular ingredient, the generally accepted nomenclature should be used.
   Sunscreen labels
5. Indicate ultraviolet (UVA, UVB) protection level information in a unified manner.
6. Mark one of the categories: low protection, medium protection, high protection, very high protection.
7. Compared with the protection factor, the indication of the category is simpler and more relevant. Therefore, the category should be clearly shown on the label as is the SPF.
8. With regard to the numerical range corresponding to the SPF reported on the label, the numerical range can be reduced without limiting the consumer’s ability to choose different protective measures.
9. Multiple numbers on labels indicating protection factors do not contribute to the goal of providing simple and relevant information. The increase in protection from one number to the next is negligible, especially in the higher coefficient ranges.

【參考連結】
https://single-market-economy.ec.europa.eu/sectors/cosmetics/cosmetic-product-notification-portal_en
https://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=146&area=cosmetici&menu=presentazione
https://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=2899&area=cosmetici&menu=commercializzazione

HLF-TW-55

HLF-TW-60
經過核准登記的化妝品，進口到義大利要檢附什麼文件？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 documents are required when importing approved cosmetics into Italy? What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
健康許可證
從第三國進口的涉及健康利益的貨物（例如供人類消費的貨物、醫療器材、化妝品等）進入義大利領土國際入境點時必須繳交的文件，必須接受健康許可接受衛生部海事、航空和邊境衛生辦公室（USMAF-SASN 和相關領土單位）的監督。
申請人：進口商或負責人
網頁：https://nsis.sanita.it/ACCN/accessportalnsis/

海關

1. 經濟經營者註冊和識別(EORI)
   向義大利海關總署 ( Agenzia delle Dogane ) 地區辦事處申請取得 EORI 號碼(網頁： www.adm.gov.it/portale/)
   申請書內容
   ．自然人：護照或其他有效身分證件；公司名稱/負責人姓名
   ．創建日期/生日
   ．地址、電話、電子郵件
   ．聯絡人
   ．商業登記證明
   ．如果申請人不是自然人，也不是被授予EORI代碼的法人或團體的法定代表人則必須繳交：經公證的授權書正本、授權書原件
2. 報關
   申報單內容
   ．運營商的名稱和EORI
   ．清關辦事處代碼
   ．報關處代碼
   ．包裹數量
   ．發件人的姓名和地址、收件人的姓名和地址
   ．商品的商業描述
   ．以千克為單位的總質量
   ．原產國代碼
   ．發票價值和貨幣
   ．進口聲明等
   單一行政文件 (SAD)
   ．託運人
   ．收件人
   ．申報人
   ．出發時運輸工具、國家
   ．過境運輸工具、國家
   ．運輸方式
   ．商業編號
   ．付款方式
   ．目的地代碼
   ．交貨條款
   ．交易性質
   ．貨櫃編號、密封貼及編號
   ．商品代碼、重量
   ．稅務計算
   ．抵港日期
   ．辦事處
   ．聲明人等
3. 清關所需文件
   ．發票，應義大利語書寫(或附有翻譯)
   ．計量(單位必須是公制)
   ．健康許可證
   ．原產地聲明

無銷售通知

Health license
Documents that must be submitted when entering the Italian territory at an international point of entry for goods of health interest (such as goods for human consumption, medical equipment, cosmetics, etc.) imported from third countries. A health permit is required. Accepted by the Ministry of Maritime, Aviation and Borders. Supervision by the Office of Health (USMAF-SASN and related territorial units).
Applicant: Importer or person in charge
Web page: https://nsis.sanita.it/ACCN/accessportalnsis/

Customs

1. Economic Operator Registration and Identification (EORI)
   Apply to the regional office of the Italian Customs Administration ( Agenzia delle Dogane ) to obtain an EORI number
   website: www.adm.gov.it/portale/
   Application content
   ． Natural person: passport or other valid identity document; company name/name of person in charge
   ． Creation date/birthday
   ． Address, phone number, email
   ． Contact person
   ． Business registration certificate
   ． If the applicant is not a natural person, nor is he the legal representative of a legal person or group that has been granted an EORI code, he must submit: the original notarized power of attorney, and the original power of attorney.
2. Customs declaration
   Declaration form content
   ． Operator’s name and EORI
   ． Customs clearance office code
   ． Customs declaration office code
   ． Package quantity
   ． Sender’s name and address, Recipient’s name and address
   ． Commercial description of the product
   ． Total mass in kilograms
   ． Country of origin code
   ． Invoice value and currency
   ． Import declaration, etc.
   Single Administrative Document (SAD)
   ． Shipper
   ． Recipient
   ． Notifier
   ． Means of transportation and country at departure
   ． Transit transport, country
   ． Transportation method
   ． Business number
   ． Payment method
   ． Destination code
   ． Terms of Delivery
   ． Nature of transaction
   ． Container number, sealing sticker and serial number
   ． Product code, weight
   ． Tax calculation
   ． Arrival date
   ． Office
   ． Declarant etc.
3. Documents required for customs clearance
   ． Invoice, should be written in Italian (or accompanied by a translation)
   ． Measurement (units must be metric)
   ． Health license
   ． Declaration of origin

No sales notice

【參考連結】
https://www.salute.gov.it/portale/usmafsasn/dettaglioSchedaUsmafSasn.jsp?idMat=SMAF&idAmb=MER&idSrv=NOS&flag=P
https://taxation-customs.ec.europa.eu/system/files/2022-06/EORI%20National%20implementation.pdf
https://www.adm.gov.it/portale/documents/20182/889923/Application+form+for+the+assignment+of+an+EORI+number_+EN.pdf/20443175-1a42-4a72-90b4-3f67d9395492

HLF-TW-70
義大利化妝品審核機構，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 verification? Website?
Evershine RD：
負責人需在歐盟的妝品通知門戶（CPNP）申請，包含以下內容：

1. 化妝品的生產應符合良好生產規範(GMP)
   亦可採用與該標準同等級之其他標準或體系。在歐盟地區是由業者自我管理，企業不需要提供任何 GMP 證書或要求歐盟主管機關核發 GMP 認證。
2. 化妝品安全報告 (CPSR)的產品資訊文件 (PIF)
   ．產品成分之定性及定量組成
   ．化粧品物理性、化學性及安定性
   ．微生物含量
   ．不純物、殘留量及包裝材料資訊
   ．產品標示及警示
   ．化粧品的使用
   ．成分、成分的毒理資料
   ．不良反應和嚴重不良反應
   ．(其他相關)化粧品的資訊等
3. 動物試驗及驗證結果
4. 奈米材料
   ．如有必要，將委託消費者安全科學委員會 (SCCS) 評估奈米材料的安全性。

The responsible person needs to apply in the EU’s Cosmetic Notification Portal (CPNP), including the following:
1.Compliance with Good Manufacturing Practices (GMP)
Other standards or systems of the same level as this standard may also be used. In the EU region, it is self-managed by the industry, and the company does not need to provide any GMP certificate or require the EU competent authority to issue GMP certification.
2.Product Information File (PIF) for Cosmetic Safety Report (CPSR)
． Qualitative and quantitative composition of product ingredients
． Cosmetics physical, chemical and stability
． Microbial content
． Information on Impurities, Residues and Packaging Materials
． Product Labeling and Warnings
． Use of cosmetics
． Toxicological information on ingredients, ingredients
． Adverse Reactions and Serious Adverse Reactions
． (Other related) information on cosmetics, etc.
3.Animal experiments and verification results

4. Nanomaterials
   ．If necessary, the Scientific Committee on Consumer Safety (SCCS) will be commissioned to assess the safety of nanomaterials.

【參考連結】
https://ec.europa.eu/growth/sectors/cosmetics/cosmetic-product-notification-portal_en

HLF-TW-75

HLF-TW-77

HLF-TW-80
外國子公司進口化妝品後，如果委託義大利的經銷商銷售，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 Italy 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：
無營業特許證。

產品安全
1.化妝品公司和經銷商有責任實施市場監督。
2.如果出現嚴重不良影響，負責人和/或經銷商應盡快通知發現嚴重不良影響的成員國主管機關：
．所有已知或合理推定已知的嚴重不良影響
．相關化妝品的名稱，以便對其進行具體辨識
．採取的任何糾正措施
3.負責人和/或經銷商必須使用表格（英文）向衛生部通報從義大利消費者收到的 不良反應報告。
4.表格填寫完畢後，可傳真轉寄至號碼 06.59943776、電子郵件地址cosmetovigilance.italy@sanita.it或透過掛號寄至dgfdm@postacert.sanita.it。

No business license.

Product Safety

1. Cosmetic companies and distributors have the responsibility to implement market supervision.
2. In the event of serious adverse effects, the responsible person and/or distributor shall notify the competent authority of the Member State where the serious adverse effects are discovered as soon as possible:
   ．All serious adverse effects known or reasonably presumed to be known
   ．The name of the relevant cosmetic product in order to specifically identify it
   ．Any corrective actions taken
3. The person in charge and/or the distributor must notify the Ministry of Health of adverse reaction reports received from Italian consumers using a form (in English).
4. After completing the form, it can be forwarded by fax to the number 06.59943776, the email address cosmetovigilance.italy@sanita.it or by registered mail to dgfdm@postacert.sanita.it.

【參考連結】
https://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=3846&area=cosmetici&menu=vigilanza
https://single-market-economy.ec.europa.eu/sectors/cosmetics/cosmetic-product-notification-portal_en
https://www.salute.gov.it/portale/temi/p2_4.jsp?lingua=italiano&area=cosmetici

HLF-TW-85

※備註 (Eevershin內部參考)
網頁：https://nsis.sanita.it/ACCN/accessportalnsis/
此網頁是要有權限才能進去 (沒有特別註明什麼權限)。

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Mobile: +886-933920199 in Taiwan; Mobile: +86-139-1048-6278 in China
TEL: +886-2-27170515 E100 ;
Wechat id:evershiinecpa;
Line Id: evershinecpa
Skype: daleccchen ;
linkedin address:Dale Chen Linkedin

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地址:104臺北市中山區長春路378號6樓
捷運文湖線南京復興站,兄弟大飯店附近
所長 Principal Partner:
陳中成 Dale C.C. Chen;
會計師 in 台灣+中國+英國/企管碩士+企管博士/台灣專利師;
CPA in Taiwan+China+UK/ MBA+DBA/ Patent Attorney in Taiwan;
Mobile: +86-139-1048-6278 in China ;
Mobile:+886-933920199 in Taipei;
Wechat ID: evershiinecpa ;
Line ID:evershinecpa;
Skype:daleccchen ;
Linkedin Address:  Dale Chen Linkedin

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