德國化妝品登記法規問題集

德国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

HLF-TW-10
请问德国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 Germany? What is its official name?
What is the intensity of management of different categories?
What is the governmental authority of cosmetics? Website?

Evershine RD：

“化妆品”是指任何物质或混合物，使用于身体表皮、头发及指甲等，或用于清洁牙齿及口腔粘膜者，无论是为改变身体外观、清洁、芳香、或保养目的，皆可被定义为化妆品。

德国是欧洲联盟（European Union）会员国之一，化妆品进口、销售需遵守欧盟协定的化妆品法规，化妆品通过欧盟协定的化妆品法规完成电子登录以及通过德国当地食品、菸草製品化妆品和其它日用品管理法当中针对化妆品要求的有害物质、重金属测试后，使得销售。

‘Cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.

Germany is a member state of the European Union, and the import and sale of cosmetics must comply with the cosmetic regulations of the EU agreement. Cosmetics can be sold after completing the electronic registration through the European Union’s cosmetic regulations and after passing the tests for harmful substances and heavy metals required by cosmetics in the German local laws: Lebensmittel- und Futtermittelgesetzbuches (LFGB).

【参考连结】

https://eur-lex.europa.eu/

https://www.bfr.bund.de/de/start.html

https://www.bvl.bund.de/EN/Home/home_node.html

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02009R1223-20220301

HLF-TW-20
外国公司要到德国销售化妆品，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 Germany, 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：

无须申请营业特许证。

No business license is required.

【参考连结】

https://eur-lex.europa.eu/

HLF-TW-25

HLF-TW-30
外国公司要到德国销售化妆品，可以指派德国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 Germany, can it assign a Germany 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。在欧盟唯有被指定为「指定负责人」的法人或自然人的化妆品才能投放市场，非欧盟商品进入欧盟与EFTA地区，依照法规，必须要指定欧盟当地法人或自然人担任公司的「指定负责人」，才能在欧盟地区销售产品。产品负责人的责任：确保引进欧洲市场的产品之符合性、承担欧盟化粧品法规所规定之各项相关义务、做为与主管机关合作的主要联络人。

指定负责人可以是：

1. 製造商：如果在欧盟内製造。

2. 进口商：如果产品製造商在欧盟以外製造。

3. 经销商：如果是将自己的品牌产品投放市场。

4. 指定人员或公司：由製造商或进口商指定并以书面形式授权。

须符合其中一项资格：

1. 欧盟公民(不论居住地)。

2. 居住在欧盟或是欧洲经济区会员国的自然人。

3. 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）。

4. 在欧盟或欧洲经济区内建立的组织。

负责人之主要义务：

1. 确保该化妆品符合欧盟化妆品规章规定

2. 确保该化妆品对人体健康及安全无害，在化妆品投放市场前，确保化妆品已完成安全性评估并符合标准，且须提供消费者充份资讯。

3. 化妆品上市时，负责人应当保存产品信息档案，自最后一批化妆品上市之日起保存十年。

4. 应准备产品资讯档案向销售地点之各会员国权责机关查阅，需以成员国主管机关易于理解的语言提供。

5. 在将化妆品投放市场之前，负责人应通过电子方式向执委会，执委会亦须将该等资讯再迅速传送各会员国权责机关。

．化妆品的类别及其名称

．产品负责人姓名、地址

．原产国

．将该化妆品投放市场的成员国

．奈米原料(包括化学名称、暴露条件)

．致癌、致突变或生殖毒性物质的名称和化学文摘或 EC 编号

．遇到问题时的医疗处理。

6. 当化妆品投放市场时，负责人应将原始标籤、合理清晰的包装照片通知委员会。

7. 如果对化妆品中含有的任何物质的安全性存在严重疑问，则在市场上销售含有该物质的产品的成员国的主管当局可以通过合理的要求要求负责人提交一份他负责并含有这种物质的所有化妆品清单。清单应标明该物质在化妆品中的浓度。

8. 若产品不符规定，责任人须召回已在欧盟境内销售产品。如果该化妆品已符合规定却仍证实对人体有害，各会员国权责机关可採取必要措施，亦可能要求召回产品。

Yes. Only cosmetic products for which a legal or natural person is designated within the EU as a ‘responsible person’ can be placed on the market. The new cosmetics regulation allows the precise identification of the responsible person is and clearly outlines their obligations. For non-EU goods entering the EU and EFTA regions, according to regulations, a local legal person or natural person in the EU must be designated as the company’s “designated person in charge” Responsible Person (RP) in order to sell products in the EU region. Responsibilities of the person in charge of the product: to ensure the compliance of the products introduced into the European market, to undertake all the relevant obligations stipulated by the EU cosmetics regulations, and to be the main contact person for cooperation with the competent authorities.

The Designated Responsible Person can be:

1. Manufacturer: If manufactured within the EU.

2. Importer: If the product manufacturer manufactures outside the EU.

3. Distributors: if they put their own brand products on the market.

4. Designated person or company: designated by the manufacturer or importer and authorized in writing.

Prerequisites must meet one of the qualifications:

1. EU citizens (regardless of residence).

2. Natural persons resident in the European Union or in a member state of the European Economic Area.

3. A company established in the European Union or the European Economic Area (registered office, central authority or principal body).

4. Organizations established in the EU or the European Economic Area.

Responsible person’s obligations:

1. Ensure that the cosmetic product complies with EU cosmetic regulations

2. Ensure that the cosmetic is harmless to human health and safety. Before the cosmetic is put on the market, ensure that the cosmetic has completed the safety assessment and meets the standards, and must provide sufficient consumer information.

3. When the cosmetics are listed, the person in charge shall keep the product information files for ten years from the date of the last batch of cosmetics.

4. The product information file should be prepared for inspection by the competent authorities of the member states in the place of sale, and it should be provided in a language that the competent authorities of the member states can easily understand.

5. Before selling cosmetics, the person in charge should electronically send the information to the Executive Committee, and the Executive Committee should also promptly transmit the information to the competent authorities of member states.

． Cosmetics category, name

． Name and address of the person in charge of the product

． country of origin

． Member State placing the cosmetic on the market

． Nanomaterials (including chemical name, exposure conditions). Name and Chemical Abstract or EC Number of the carcinogenic, mutagenic or reproductive toxicant

． Medical treatment in case of problems.

6. When cosmetics are sold, the person in charge shall notify the committee of the original label, reasonable and clear packaging photos.

7. In the event of serious doubt as to the safety of any substance contained in cosmetic products, the competent authority of the Member State in which products containing the substance are marketed may, upon reasonable request, require the person in charge to submit a copy of which he is responsible and contains such substance. All cosmetic list of substances. The list should indicate the concentration of the substance in the cosmetic.

8. If the product does not meet the regulations, the responsible person must recall the product that has been sold in the European Union. If the cosmetic product is in compliance with the regulations but it is still proven to be harmful to the human body, the competent authority of each member state may take necessary measures, and may also require the product to be recalled.

【参考连结】

https://eur-lex.europa.eu/

https://www.handelsregister.de/rp_web/welcome.do?language=en&sec_ip=79.114.177.118

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02009R1223-20220301

HLF-TW-35

HLF-TW-40
外国公司销售到德国化妆品本身，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？可允许的语文除了德文外，其他哪种语文也可以？网页？

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

Evershine RD：

需要。欧盟化妆品法规规定企业应于化妆品产品上市前至化妆品登录系统进行电子登录。欧盟委员会将向每个成员国的主管当局和毒害管理中心或相关机构传达登录资讯。

需要文件：

1. 品名及类别

2. 负责人姓名及住址

3. 原产国

4. 化妆品将要上市销售之会员国

5. 必要时应註明实际连络人的详细资讯  

6. 奈米物质

7. CMR 物质的存在

8. 遇到问题时的医疗处理

9. 原始标籤和包装的照片

至德国销售前，需通知联邦各州主管监管机构，以及通过德国规定的有害物质检测后，使得销售该化妆品。

通知内容：

1. 化妆品的製造、成分、材料、预期用途

2. 投放市场

3. 化妆品的评估结果

4. 负责人的信息

5. 化妆品的定量或实质性组成

6. 对人体健康的副作用等

检测项目：

1. 化妆品有害化学成分及重金属测试。

2. 某些成分，如防腐剂、染料或紫外线过滤剂必须获得批准。

产品标籤与包装规定

欧盟化妆品法规定在化妆品容器和包装上要以不可磨灭、易读的字体印有下列信息的化妆品才能在市场上销售：

1. 产品负责人或公司名称及住址

2. 进口化妆品之原产国

3. 包装时之容量(以重量或体积表示) ，但包装少于 5 克或 5 毫升、免费样品和单次应用包装的情况除外。对于通常作为多个出售的预包装，其重量或体积的细节并不重要，只要包装上出现项目的数量，则无需提供内容。

4. 最短保质期：应明确表示，并应按月/年或日/月/年的顺序组成。如有必要，该信息应补充说明为保证规定的耐用性必须满足的条件。对于最低保质期超过 30 个月的化妆品，不应强制标明保质期。对于此类产品，应註明产品在开封后的安全期限，并可在不损害消费者的情况下使用。

5. 使用注意事项：包含列于欧盟化粧品法规专业产品的注意事项。

6. 製造批号或依据，如果由于化妆品太小而由于实际原因无法做到这一点，则此类信息标示在在包装上。

7. 化妆品的产品功能，可以仅在包装上标明，清单前应以“成分”一词开头。

8. 成分列表：若成分含量≥1%则按含量高至低顺序列出；若含量<1%则可以任意顺序列出。成分列表可只在包装上标示。成分是指化妆品在製造过程中有意使用的任何物质或混合物，以下不应被视为成分：

．原材料中的杂质

．混合物中使用但不存在于最终产品中的辅助技术材料

9. 其它注意事项

．香水和芳香组合物及其原料应称为“香水”或“香气” ，除了香精或芳香这两个术语外，还应在成分表中註明

．以奈米材料形式存在的所有成分均应在成分表中明确註明

．用于染发的着色剂以外的着色剂可以以任何顺序列在其他化妆品成分之后。对于以多种色调销售的装饰性化妆品，可以列出除用于染发的着色剂以外的所有着色剂，前提是添加“可能包含”字样或符号“+/-”。(应使用 CI（颜色指数）命名法)

．对于肥皂、浴球和其他小型产品，由于实际原因，所述信息不可能出现在标籤、吊牌、胶带或卡片或随附的传单中，本信息应出现在紧邻化妆品销售容器的通知上。

．德国是欧盟27个会员国之一，化妆品标籤法要求标籤上的某些信息必须使用销售国的官方语言：德语。

The EU cosmetics regulations stipulate that enterprises, before selling cosmetics products, need to complete the electronic registration in the cosmetics registration system. The European Commission will communicate the login information to the competent authorities and poison management centres or relevant bodies of each Member State.

Required documents:

1. Cosmetics name and category

2. Name and address of the responsible person

3. Country of Origin

4. Member States where the cosmetic product will be marketed

5. If necessary, the actual contact details should be indicated

6. Nanomaterials

7. Presence of CMR Substances

8. Medical treatment in case of problems

9. Photos of the original label and packaging

Before selling in Germany, it is necessary to notify the competent regulatory agencies of the federal states, and after passing the inspection of harmful substances stipulated in Germany, the cosmetics can be sold.

Notification content:

1. Manufacture of cosmetic products, ingredients, materials, intended use

2. Placing on the market

3. Cosmetic evaluation results

4. Information of the responsible person

5. Quantitative or substantive composition of cosmetics

6. Side effects to human health, etc.

Test items:

1. Testing of harmful chemical ingredients and heavy metals in cosmetics.

2. Certain ingredients like preservatives, dyes or UV filters must be approved.

Labeling and Packaging

Without prejudice to other provisions in this Article, cosmetic products shall be made available on the market only where the container and packaging of cosmetic products bear the following information in indelible, easily legible and visible lettering:

1. Responsible person or company name and address

2. Origin Country of Imported Cosmetics

3. Capacities (expressed by weight or volume) as packaged, except for packages less than 5g or 5ml, free samples and single-use packages. For prepackages that are usually sold as multiples, the details of their weight or volume are not important, as long as the number of items appears on the package, the content need not be provided.

4. Minimum shelf life: should be clearly stated and should be composed in the order of month/year or day/month/year. If necessary, this information shall be supplemented by a description of the conditions that must be met in order to guarantee the specified durability. For cosmetic products with a minimum shelf life of more than 30 months, the expiration date should not be mandatory. For such products, the safety period of the product after opening should be stated and it can be used without harming the consumer.

5. Precautions for use: Contains the precautions for professional products listed in the EU Cosmetics Regulations.

6. Manufacturing batch number or basis, if this is not possible because the cosmetic is too small or due to practical reasons, such information is indicated on the packaging.

7. The product functions of cosmetics can only be indicated on the package, and the word “ingredients” must be used before the list.

8. List of ingredients: If the content of the ingredients is ≥1%, they are listed in the order of highest content; if the content is less than 1%, they can be listed in any order. The list of ingredients may only be indicated on the packaging. Ingredient means any substance or mixture that is intentionally used in the manufacture of cosmetic products, the following should not be considered as ingredients:

． Impurities in the raw materials

． Auxiliary technology materials used in mixtures but not present in final products

9. Other Notes

． Perfume, fragrance composition and its raw materials shall be called “perfume” or “aroma”, except for the two terms of essence or fragrance, which need to be indicated in the ingredient list

． All ingredients in the form of nanomaterials should be clearly stated in the ingredient list

． Colorants other than colorants used in hair coloring may be listed after other cosmetic ingredients in any order.For decorative cosmetics sold in multiple shades, all colorants except those used for hair coloring may be listed, provided the word “may contain” or the symbol “+/-” is added. (CI (Color Index) nomenclature should be used)

． For soaps, bath balls, and other small products, for practical reasons, the information cannot appear on the label, hang tag, tape or card or accompanying flyer, this information should appear on the notice immediately adjacent to the cosmetic sales container.

．Germany is one of the 27 member states of the EU, and the Cosmetic Labeling Act requires certain information on the label to be in the official language of the country of sale: German.

【参考连结】

https://ec.europa.eu/growth/sectors/cosmetics/cosmetic-product-notification-portal_en

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02009R1223-20220301

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02009R1223-20220301

http://www.gesetze-im-internet.de/

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？可允许的语文除了德文外，其他哪种语文也可以？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?
In addition to German, which other languages are allowed? Website?

Evershine RD：

须以在欧盟会员国地区内有註册的公司或自然人的名义申请。

须符合其中一项资格：

1.欧盟公民(不论居住地)。

2.居住在欧盟或是欧洲经济区会员国的自然人。

3.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）。

4.在欧盟或欧洲经济区内建立的组织。

欧盟化妆品法规规定企业应于化妆品产品上市前至化妆品登录系统进行电子登录。

需要文件：

1. 品名及类别

2. 负责人姓名及住址

3. 原产国

4. 化妆品将要上市销售之会员国

5. 必要时应註明实际连络人的详细资讯  

6. 奈米物质

7. CMR 物质的存在

8. 遇到问题时的医疗处理

9. 原始标籤和包装的照片

产品标籤与包装规定

欧盟化妆品法规定在化妆品容器和包装上要以不可磨灭、易读的字体印有下列信息的化妆品才能在市场上销售：

1. 产品负责人或公司名称及住址

2. 进口化妆品之原产国

3. 包装时之容量(以重量或体积表示) ，但包装少于 5 克或 5 毫升、免费样品和单次应用包装的情况除外。对于通常作为多个出售的预包装，其重量或体积的细节并不重要，只要包装上出现项目的数量，则无需提供内容。

4. 最短保质期：应明确表示，并应按月/年或日/月/年的顺序组成。如有必要，该信息应补充说明为保证规定的耐用性必须满足的条件。对于最低保质期超过 30 个月的化妆品，不应强制标明保质期。对于此类产品，应註明产品在开封后的安全期限，并可在不损害消费者的情况下使用。

5. 使用注意事项：包含列于欧盟化粧品法规专业产品的注意事项。

6. 製造批号或依据，如果由于化妆品太小而由于实际原因无法做到这一点，则此类信息标示在在包装上。

7. 化妆品的产品功能，可以仅在包装上标明，清单前应以“成分”一词开头。

8. 成分列表：若成分含量≥1%则按含量高至低顺序列出；若含量<1%则可以任意顺序列出。成分列表可只在包装上标示。成分是指化妆品在製造过程中有意使用的任何物质或混合物，以下不应被视为成分：

．原材料中的杂质

．混合物中使用但不存在于最终产品中的辅助技术材料

9. 其它注意事项

．香水和芳香组合物及其原料应称为“香水”或“香气” ，除了香精或芳香这两个术语外，还应在成分表中註明

．以奈米材料形式存在的所有成分均应在成分表中明确註明

．用于染发的着色剂以外的着色剂可以以任何顺序列在其他化妆品成分之后。对于以多种色调销售的装饰性化妆品，可以列出除用于染发的着色剂以外的所有着色剂，前提是添加“可能包含”字样或符号“+/-”。(应使用 CI（颜色指数）命名法)

．对于肥皂、浴球和其他小型产品，由于实际原因，所述信息不可能出现在标籤、吊牌、胶带或卡片或随附的传单中，本信息应出现在紧邻化妆品销售容器的通知上。

．德国是欧盟27个会员国之一，化妆品标籤法要求标籤上的某些信息必须使用销售国的官方语言：德语。

Only companies or natural persons registered in the EU member states can apply.

Prerequisites must meet one of the qualifications:

1. EU citizens (regardless of residence).

2. Natural persons resident in the European Union or in a member state of the European Economic Area.

3. A company established in the European Union or the European Economic Area (registered office, central authority or principal body).

4. Organizations established in the EU or the European Economic Area.

The EU cosmetics regulations stipulate that enterprises, before selling cosmetics products, need to complete the electronic registration in the cosmetics registration system.

Required documents:

1. Cosmetics name and category

2. Name and address of the responsible person

3. Country of Origin

4. Member States where the cosmetic product will be marketed

5. If necessary, the actual contact details should be indicated

6. Nanomaterials

7. Presence of CMR Substances

8. Medical treatment in case of problems

9. Photos of the original label and packaging

Labeling and Packaging

Without prejudice to other provisions in this Article, cosmetic products shall be made available on the market only where the container and packaging of cosmetic products bear the following information in indelible, easily legible and visible lettering:

1. Responsible person or company name and address

2. Origin Country of Imported Cosmetics

3. Capacities (expressed by weight or volume) as packaged, except for packages less than 5g or 5ml, free samples and single-use packages. For prepackages that are usually sold as multiples, the details of their weight or volume are not important, as long as the number of items appears on the package, the content need not be provided.

4. Minimum shelf life: should be clearly stated and should be composed in the order of month/year or day/month/year. If necessary, this information shall be supplemented by a description of the conditions that must be met in order to guarantee the specified durability. For cosmetic products with a minimum shelf life of more than 30 months, the expiration date should not be mandatory. For such products, the safety period of the product after opening should be stated and it can be used without harming the consumer.

5. Precautions for use: Contains the precautions for professional products listed in the EU Cosmetics Regulations.

6. Manufacturing batch number or basis, if this is not possible because the cosmetic is too small or due to practical reasons, such information is indicated on the packaging.

7. The product functions of cosmetics can only be indicated on the package, and

8. List of ingredients: If the content of the ingredients is ≥1%, they are listed in the order of highest content; if the content is less than 1%, they can be listed in any order. The list of ingredients may only be indicated on the packaging. Ingredient means any substance or mixture that is intentionally used in the manufacture of cosmetic products, the following should not be considered as ingredients:

． Impurities in the raw materials

． Auxiliary technology materials used in mixtures but not present in final products

9. Other Notes

． Perfume, fragrance composition and its raw materials shall be called “perfume” or “aroma”, except for the two terms of essence or fragrance, which need to be indicated in the ingredient list

． All ingredients in the form of nanomaterials should be clearly stated in the ingredient list

． Colorants other than colorants used in hair coloring may be listed after other cosmetic ingredients in any order.For decorative cosmetics sold in multiple shades, all colorants except those used for hair coloring may be listed, provided the word “may contain” or the symbol “+/-” is added. (CI (Color Index) nomenclature should be used)

． For soaps, bath balls, and other small products, for practical reasons, the information cannot appear on the label, hang tag, tape or card or accompanying flyer, this information should appear on the notice immediately adjacent to the cosmetic sales container.

．Germany is one of the 27 member states of the EU, and the Cosmetic Labeling Act requires certain information on the label to be in the official language of the country of sale: German.

【参考连结】

https://ec.europa.eu/growth/sectors/cosmetics/cosmetic-product-notification-portal_en

https://eur-lex.europa.eu/

HLF-TW-55
请问在德国有哪些专业服务机构，可以协助以外国公司名义办理化妆品产品许可证？