义大利化妆品登记法规问题集

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各国化妆品登记法规问答集

时间：2023/09/18 drafted by Yvonne Chen

HLF-TW-10
请问义大利对于化妆品的归类方式为何？它的正式名称为何？不同归类管理强度有何差异?它的政府管辖机构为何？网页？

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：
在义大利，卫生部 (MOH)是义大利化妆品的监管机构。
化妆品的定义是与人体表面部分接触的物质或製剂，包含表皮、头发、毛发系统、指甲、嘴唇、生殖器官、牙齿和口腔黏膜，其唯一或主要目的是清洁、添香、帮助改变外观、保护、保持良好状态或纠正体味或减轻、预防健康皮肤功能的缺陷或变化。旨在摄入、吸入、注射或植入人体的物质或混合物不被视为化妆品。

1.化妆品的分类必须考虑：配方、产品申请、产品的功能。
2.化妆品包括：
．皮肤霜、乳液、乳液、凝胶和油
．美容面膜、粉底(液、膏、粉)、蜜粉
．用于浴后及身体卫生的滑石粉
．美容皂、除臭皂、香水、花露水和古龙水
．沐浴和淋浴製剂(盐、泡沫、油、凝胶)
．除毛产品
．除臭剂和止汗剂
．染发剂、捲发、拉直和定型製剂、头发清洁製剂(乳液、粉末、洗发精)、保持头发形状的製剂(乳液、乳霜、油)、头发定型产品(乳液、发胶、亮发剂)
．剃鬚产品(霜、泡沫、乳液)
．化妆品和卸妆产品、涂在嘴唇上的产品
．牙齿和口腔卫生产品
．指甲保养产品和指甲油
．外用私密卫生用品
．防晒产品、晒黑产品
．亮肤产品和抗皱产品

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

【参考连结】
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
外国公司要到义大利销售化妆品，无论设100%子公司或分公司，需要在公司登记时取得营业特许证？假如要，其必要条件是什麽？所需文件及申请程序为何？网页？

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：
无营业特许证。
No business license.

【参考连结】
https://www.salute.gov.it/portale/temi/p2_4.jsp?lingua=italiano&area=cosmetici

HLF-TW-25

HLF-TW-30
外国公司要到义大利销售化妆品，可以指派义大利公司担任营业代理人销售吗? 担任营业代理人，其必要条件是什麽？所需文件及申请程序为何？外国公司与营业代理人的产品责任为何?网页？

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
只有在欧盟内被指定为责任人才能投放市场，责任人的主体需由欧盟境内的企业法人或自然人担任，非欧盟商品进入欧盟与EFTA地区必须要指定欧盟当地法人或自然人担任公司的责任人，才能将该化妆品投放欧盟市场。一般默认化妆品的责任人为化妆品製造商，进口商，经销商，如通过书面授权的形式，也可由第三方法人或自然人担任。
1.责任人须符合其中一项资格：
·欧盟公民(不论居住地)。
·居住在欧盟或是欧洲经济区会员国的自然人。
·在欧盟或欧洲经济区内成立的公司（註册办事处，中央管理机构或主要机构）。
·在欧盟或欧洲经济区内建立的组织。
2.完成化妆品备案通报流程
责任人必须在产品上市前经由欧盟统一线上平台进行通报（CPNP，网页：https://reurl.cc/pM8R7x）方可进入欧盟市场。并且责任人须在产品上市前准备好产品资讯档案(PIF/DIP)文件，已备官方实地检查，需检具：
·产品类别
·产品名称
·责任人姓名、地址
·上市地区(投放市场的成员国)
·标籤及包装(合理清晰的照片)
·产品配方
·原产国
·联繫人
·奈米材料(包括化学名称、暴露条件)
·CMR类等特殊成分或生殖毒性物质的名称、化学文摘或EC 编号
·遇到问题时的医疗处理

3. 产品资讯档案(PIF/DIP)内容包括：
   ·产品描述
   ·产品安全评估报告CPSR
   ·生产工艺描述和良好生产规范(GMP)声明
   ·动物测试数据声明
   ·产品功效证明
   4.化妆品安全评估报告(CPSR)所需资料：
   ·产品名和内部编号
   ·详细配方表
   ·原料品质检验报告(CoA)和化学品安全技术书(MSDS)
   ·香精/香料/精油: IFRA文件、过敏原、MSDS, CoA
   ·成品
   ·毒理和临床研究报告
   ·微生物报告(包括挑战试验)
   ·稳定性报告
   ·包装材料资讯
   ·产品标籤
   ·案例报告
   ·产品的暴露数据
4. 责任人的义务：
   ·承担产品安全和合规责任
   ·上市前完成CPNP通报
   ·责任人名称及地址需标註在产品标籤上
   ·责任人需准备完整PIF/DIP文件，应对主管当局的检查
   ·最后一批产品上市后，责任人须至少保存化妆品安全评估报告十年
   ·根据情况更新CPNP和PIF/DIP
   ·上市后及时上报严重不良反应（ SUE）
   ·当有理由认为投放市场的产品不符合法规要求或存在安全问题时，採取必要纠正措施，撤回或召回产品。

产品安全
1.化妆品公司和经销商有责任实施市场监督。
2.如果出现严重不良影响，负责人和/或经销商应尽快通知发现严重不良影响的成员国主管机关：
．所有已知或合理推定已知的严重不良影响
．相关化妆品的名称，以便对其进行具体辨识
．採取的任何纠正措施
3.负责人和/或经销商必须使用表格（英文）向卫生部通报从义大利消费者收到的 不良反应报告。
4.表格填写完毕后，可传真转寄至号码 06.59943776、电子邮件地址cosmetovigilance.italy@sanita.it或透过挂号寄至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.

【参考连结】
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
外国公司销售到义大利化妆品本身，进口前需要办理产品许可吗？如需要，哪个单位在管理？需要什麽文件？申请程序为何？化妆品包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？网页？

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：
需要办理产品许可证
只有在欧盟内被指定为责任人才能投放市场，责任人的主体需由欧盟境内的企业法人或自然人担任，非欧盟商品进入欧盟与EFTA地区必须要指定欧盟当地法人或自然人担任公司的责任人，才能将该化妆品投放欧盟市场。一般默认化妆品的责任人为化妆品製造商，进口商，经销商，如通过书面授权的形式，也可由第三方法人或自然人担任。
1.责任人须符合其中一项资格：
·欧盟公民(不论居住地)。
·居住在欧盟或是欧洲经济区会员国的自然人。
·在欧盟或欧洲经济区内成立的公司（註册办事处，中央管理机构或主要机构）。
·在欧盟或欧洲经济区内建立的组织。
2.完成化妆品备案通报流程
责任人必须在产品上市前经由欧盟统一线上平台进行通报（CPNP，网页：https://reurl.cc/pM8R7x）方可进入欧盟市场。并且责任人须在产品上市前准备好产品资讯档案(PIF/DIP)文件，已备官方实地检查，需检具：
·产品类别
·产品名称
·责任人姓名、地址
·上市地区(投放市场的成员国)
·标籤及包装(合理清晰的照片)
·产品配方
·原产国
·联繫人
·奈米材料(包括化学名称、暴露条件)
·CMR类等特殊成分或生殖毒性物质的名称、化学文摘或EC 编号
·遇到问题时的医疗处理

3. 产品资讯档案(PIF/DIP)内容包括：
   ·产品描述
   ·产品安全评估报告CPSR
   ·生产工艺描述和良好生产规范(GMP)声明
   ·动物测试数据声明
   ·产品功效证明
   4.化妆品安全评估报告(CPSR)所需资料：
   ·产品名和内部编号
   ·详细配方表
   ·原料品质检验报告(CoA)和化学品安全技术书(MSDS)
   ·香精/香料/精油: IFRA文件、过敏原、MSDS, CoA
   ·成品
   ·毒理和临床研究报告
   ·微生物报告(包括挑战试验)
   ·稳定性报告
   ·包装材料资讯
   ·产品标籤
   ·案例报告
   ·产品的暴露数据
4. 责任人的义务：
   ·承担产品安全和合规责任
   ·上市前完成CPNP通报
   ·责任人名称及地址需标註在产品标籤上
   ·责任人需准备完整PIF/DIP文件，应对主管当局的检查
   ·最后一批产品上市后，责任人须至少保存化妆品安全评估报告十年
   ·根据情况更新CPNP和PIF/DIP
   ·上市后及时上报严重不良反应（ SUE）
   ·当有理由认为投放市场的产品不符合法规要求或存在安全问题时，採取必要纠正措施，撤回或召回产品。

标籤
1.在义大利市场上销售的产品，标籤採用义大利语。

2. 可以提供多语言标籤，但至少重要的资讯要以义大利语显示，并且列印字元大小与其他语言的文字大小相同。
   3.以下资讯必须以义大利语报告
   ．对于在义大利销售的多语言标籤产品：标称含量(以重量或体积表示)、化妆品使用日期、特别注意事项、化妆品功能
   ．对于因容器尺寸较小或其他实际原因而在袋子、标籤或纸本上附有说明的产品：使用特别注意事项、成分清单
   ．对于未预先包装/由卖方应买方要求包装/为了立即销售而预先包装的化妆品：完整标籤
3. 化妆品只有在其容器和包装上带有以下不可磨灭、易辨认和可见字符的标籤后才能在市场上销售
   ．负责人姓名或公司名称及完整地址；如果有多个地址，则必须将提供给主管机关的地址写在显眼位置
   ．以重量或体积表示的标称含量(义大利语)，对于通常以成套形式销售的预包装，可以不标明内容，但包装上註明件数
   ．最短保存期限或失效日期，即产品在正确储存的情况下可以使用的日期，或产品保持其特性不变并继续发挥其初始功能的日期；日期前面带有符号：用沙漏图标或单字「最佳使用日期：」。依序由年月或日月年组成。如有必要，也可以透过指定必须遵守的储存条件来完成有效期限的指示，确保产品的有效性
   ．最短保质期超过30个月的产品，无需在标籤上标明失效日期，但必须标明容器打开后产品的有效期，可以在不对消费者产生有害影响的情况下使用，用打开罐的符号或罐子图示缩写词(PAO)表示，期限以月和/或年表示。
   ．在适当的情况下，必须报告有关的特殊预防措施。如果无法显示在容器或外包装，则必须显示在说明书、袋子或标籤中用缩写或符号向消费者说明
   ．生产批号或可识别化妆品的参考号码，如果空间不够，批号只能显示在包装上
   ．非欧盟国家製造产品的原产国
   ．化妆品的功能 (除非从其外观可以明显看出)
   ．成分术语表必须使用国际公认的命名法，包括国际化妆品成分命名法 ( INCI )。如果特定成分没有通用名称，则应使用普遍认可的命名法。
   防晒用品的标籤
   1.以统一的方式标示紫外线（UVA 、UVB）防护等级资讯。
   2.标示类别之一：低保护、中保护、高保护、非常高保护。
   3.与防护係数的相比，类别的指示更简单、更相关。因此，类别应与防晒係数一样清楚地显示在标籤上。
   4.关于标籤上所报告的防晒係数对应的数字范围，可以在不限制消费者选择不同防护措施的能力的情况下减少该数字范围。
   5.标籤上用于指示保护係数的多个数字无助于提供简单且相关资讯的目标。从一个数字到下一个数字的保护增加可以忽略不计，特别是在较高的係数范围内。

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.

【参考连结】
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
外国公司可以用自己名义申请办理产品许可吗？如需要，哪个单位在管理？需要什麽文件？申请程序为何？化妆品包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？？网页？

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：
须以欧盟境内的企业法人或自然人名义申请。
只有在欧盟内被指定为责任人才能投放市场，责任人的主体需由欧盟境内的企业法人或自然人担任，非欧盟商品进入欧盟与EFTA地区必须要指定欧盟当地法人或自然人担任公司的责任人，才能将该化妆品投放欧盟市场。一般默认化妆品的责任人为化妆品製造商，进口商，经销商，如通过书面授权的形式，也可由第三方法人或自然人担任。
1.责任人须符合其中一项资格：
·欧盟公民(不论居住地)。
·居住在欧盟或是欧洲经济区会员国的自然人。
·在欧盟或欧洲经济区内成立的公司（註册办事处，中央管理机构或主要机构）。
·在欧盟或欧洲经济区内建立的组织。
2.完成化妆品备案通报流程
责任人必须在产品上市前经由欧盟统一线上平台进行通报（CPNP，网页：https://reurl.cc/pM8R7x）方可进入欧盟市场。并且责任人须在产品上市前准备好产品资讯档案(PIF/DIP)文件，已备官方实地检查，需检具：
·产品类别
·产品名称
·责任人姓名、地址
·上市地区(投放市场的成员国)
·标籤及包装(合理清晰的照片)
·产品配方
·原产国
·联繫人
·奈米材料(包括化学名称、暴露条件)
·CMR类等特殊成分或生殖毒性物质的名称、化学文摘或EC 编号
·遇到问题时的医疗处理

3. 产品资讯档案(PIF/DIP)内容包括：
   ·产品描述
   ·产品安全评估报告CPSR
   ·生产工艺描述和良好生产规范(GMP)声明
   ·动物测试数据声明
   ·产品功效证明
   4.化妆品安全评估报告(CPSR)所需资料：
   ·产品名和内部编号
   ·详细配方表
   ·原料品质检验报告(CoA)和化学品安全技术书(MSDS)
   ·香精/香料/精油: IFRA文件、过敏原、MSDS, CoA
   ·成品
   ·毒理和临床研究报告
   ·微生物报告(包括挑战试验)
   ·稳定性报告
   ·包装材料资讯
   ·产品标籤
   ·案例报告
   ·产品的暴露数据
4. 责任人的义务：
   ·承担产品安全和合规责任
   ·上市前完成CPNP通报
   ·责任人名称及地址需标註在产品标籤上
   ·责任人需准备完整PIF/DIP文件，应对主管当局的检查
   ·最后一批产品上市后，责任人须至少保存化妆品安全评估报告十年
   ·根据情况更新CPNP和PIF/DIP
   ·上市后及时上报严重不良反应（ SUE）
   ·当有理由认为投放市场的产品不符合法规要求或存在安全问题时，採取必要纠正措施，撤回或召回产品。

标籤
1.在义大利市场上销售的产品，标籤採用义大利语。

2. 可以提供多语言标籤，但至少重要的资讯要以义大利语显示，并且列印字元大小与其他语言的文字大小相同。
   3.以下资讯必须以义大利语报告
   ．对于在义大利销售的多语言标籤产品：标称含量(以重量或体积表示)、化妆品使用日期、特别注意事项、化妆品功能
   ．对于因容器尺寸较小或其他实际原因而在袋子、标籤或纸本上附有说明的产品：使用特别注意事项、成分清单
   ．对于未预先包装/由卖方应买方要求包装/为了立即销售而预先包装的化妆品：完整标籤
3. 化妆品只有在其容器和包装上带有以下不可磨灭、易辨认和可见字符的标籤后才能在市场上销售
   ．负责人姓名或公司名称及完整地址；如果有多个地址，则必须将提供给主管机关的地址写在显眼位置
   ．以重量或体积表示的标称含量(义大利语)，对于通常以成套形式销售的预包装，可以不标明内容，但包装上註明件数
   ．最短保存期限或失效日期，即产品在正确储存的情况下可以使用的日期，或产品保持其特性不变并继续发挥其初始功能的日期；日期前面带有符号：用沙漏图标或单字「最佳使用日期：」。依序由年月或日月年组成。如有必要，也可以透过指定必须遵守的储存条件来完成有效期限的指示，确保产品的有效性
   ．最短保质期超过30个月的产品，无需在标籤上标明失效日期，但必须标明容器打开后产品的有效期，可以在不对消费者产生有害影响的情况下使用，用打开罐的符号或罐子图示缩写词(PAO)表示，期限以月和/或年表示。
   ．在适当的情况下，必须报告有关的特殊预防措施。如果无法显示在容器或外包装，则必须显示在说明书、袋子或标籤中用缩写或符号向消费者说明
   ．生产批号或可识别化妆品的参考号码，如果空间不够，批号只能显示在包装上
   ．非欧盟国家製造产品的原产国
   ．化妆品的功能 (除非从其外观可以明显看出)
   ．成分术语表必须使用国际公认的命名法，包括国际化妆品成分命名法 ( INCI )。如果特定成分没有通用名称，则应使用普遍认可的命名法。
   防晒用品的标籤
   1.以统一的方式标示紫外线（UVA 、UVB）防护等级资讯。
   2.标示类别之一：低保护、中保护、高保护、非常高保护。
   3.与防护係数的相比，类别的指示更简单、更相关。因此，类别应与防晒係数一样清楚地显示在标籤上。
   4.关于标籤上所报告的防晒係数对应的数字范围，可以在不限制消费者选择不同防护措施的能力的情况下减少该数字范围。
   5.标籤上用于指示保护係数的多个数字无助于提供简单且相关资讯的目标。从一个数字到下一个数字的保护增加可以忽略不计，特别是在较高的係数范围内。

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.

【参考连结】
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
经过核准登记的化妆品，进口到义大利要检附什麽文件？经过什麽手续？在销售时要向各地的卫生福利部相关机构事先或事后准备吗？网页？

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：
健康许可证
从第三国进口的涉及健康利益的货物（例如供人类消费的货物、医疗器材、化妆品等）进入义大利领土国际入境点时必须缴交的文件，必须接受健康许可接受卫生部海事、航空和边境卫生办公室（USMAF-SASN 和相关领土单位）的监督。
申请人：进口商或负责人
网页：https://nsis.sanita.it/ACCN/accessportalnsis/

海关

1. 经济经营者註册和识别(EORI)
   向义大利海关总署 ( Agenzia delle Dogane ) 地区办事处申请取得 EORI 号码(网页： www.adm.gov.it/portale/)
   申请书内容
   ．自然人：护照或其他有效身分证件；公司名称/负责人姓名
   ．创建日期/生日
   ．地址、电话、电子邮件
   ．联络人
   ．商业登记证明
   ．如果申请人不是自然人，也不是被授予EORI代码的法人或团体的法定代表人则必须缴交：经公证的授权书正本、授权书原件
2. 报关
   申报单内容
   ．运营商的名称和EORI
   ．清关办事处代码
   ．报关处代码
   ．包裹数量
   ．发件人的姓名和地址、收件人的姓名和地址
   ．商品的商业描述
   ．以千克为单位的总质量
   ．原产国代码
   ．发票价值和货币
   ．进口声明等
   单一行政文件 (SAD)
   ．託运人
   ．收件人
   ．申报人
   ．出发时运输工具、国家
   ．过境运输工具、国家
   ．运输方式
   ．商业编号
   ．付款方式
   ．目的地代码
   ．交货条款
   ．交易性质
   ．货柜编号、密封贴及编号
   ．商品代码、重量
   ．税务计算
   ．抵港日期
   ．办事处
   ．声明人等
3. 清关所需文件
   ．发票，应义大利语书写(或附有翻译)
   ．计量(单位必须是公制)
   ．健康许可证
   ．原产地声明

无销售通知

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

【参考连结】
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
义大利化妆品审核机构，需要附上的实验室检验资料有哪些? 网页？

What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
负责人需在欧盟的妆品通知门户（CPNP）申请，包含以下内容：

1. 化妆品的生产应符合良好生产规范(GMP)
   亦可採用与该标准同等级之其他标准或体系。在欧盟地区是由业者自我管理，企业不需要提供任何 GMP 证书或要求欧盟主管机关核发 GMP 认证。
2. 化妆品安全报告 (CPSR)的产品资讯文件 (PIF)
   ．产品成分之定性及定量组成
   ．化粧品物理性、化学性及安定性
   ．微生物含量
   ．不纯物、残留量及包装材料资讯
   ．产品标示及警示
   ．化粧品的使用
   ．成分、成分的毒理资料
   ．不良反应和严重不良反应
   ．(其他相关)化粧品的资讯等
3. 动物试验及验证结果
4. 奈米材料
   ．如有必要，将委託消费者安全科学委员会 (SCCS) 评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.

【参考连结】
https://ec.europa.eu/growth/sectors/cosmetics/cosmetic-product-notification-portal_en

HLF-TW-75

HLF-TW-77

HLF-TW-80
外国子公司进口化妆品后，如果委託义大利的经销商销售，经销商需要化妆品营业许可证吗？假如化妆品有品质瑕疵的话，外国子公司和经销商各自的责任为何？是连带责任吗？还是可以规范由外国子公司负责？

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：
无营业特许证。

产品安全
1.化妆品公司和经销商有责任实施市场监督。
2.如果出现严重不良影响，负责人和/或经销商应尽快通知发现严重不良影响的成员国主管机关：
．所有已知或合理推定已知的严重不良影响
．相关化妆品的名称，以便对其进行具体辨识
．採取的任何纠正措施
3.负责人和/或经销商必须使用表格（英文）向卫生部通报从义大利消费者收到的 不良反应报告。
4.表格填写完毕后，可传真转寄至号码 06.59943776、电子邮件地址cosmetovigilance.italy@sanita.it或透过挂号寄至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.

【参考连结】
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

※备註 (Eevershin内部参考)
网页：https://nsis.sanita.it/ACCN/accessportalnsis/
此网页是要有权限才能进去 (没有特别註明什麽权限)。

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