德國化妝品登記法規問題集

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各國化妝品登記法規問答集

HLF-TW-10
請問德國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 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：

“化妝品”是指任何物質或混合物，使用於身體表皮、頭髮及指甲等，或用於清潔牙齒及口腔粘膜者，無論是為改變身體外觀、清潔、芳香、或保養目的，皆可被定義為化妝品。

德國是歐洲聯盟（European Union）會員國之一，化妝品進口、銷售需遵守歐盟協定的化妝品法規，化妝品通過歐盟協定的化妝品法規完成電子登錄以及通過德國當地食品、菸草製品化妝品和其它日用品管理法當中針對化妝品要求的有害物質、重金屬測試後，使得銷售。

‘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).

【參考連結】

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
外國公司要到德國銷售化妝品，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 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：

無須申請營業特許證。

No business license is required.

【參考連結】

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

HLF-TW-25

HLF-TW-30
外國公司要到德國銷售化妝品，可以指派德國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 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。在歐盟唯有被指定為「指定負責人」的法人或自然人的化妝品才能投放市場，非歐盟商品進入歐盟與EFTA地區，依照法規，必須要指定歐盟當地法人或自然人擔任公司的「指定負責人」，才能在歐盟地區銷售產品。產品負責人的責任：確保引進歐洲市場的產品之符合性、承擔歐盟化粧品法規所規定之各項相關義務、做為與主管機關合作的主要聯絡人。

指定負責人可以是：

1. 製造商：如果在歐盟內製造。

2. 進口商：如果產品製造商在歐盟以外製造。

3. 經銷商：如果是將自己的品牌產品投放市場。

4. 指定人員或公司：由製造商或進口商指定並以書面形式授權。

須符合其中一項資格：

1. 歐盟公民(不論居住地)。

2. 居住在歐盟或是歐洲經濟區會員國的自然人。

3. 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）。

4. 在歐盟或歐洲經濟區內建立的組織。

負責人之主要義務：

1. 確保該化妝品符合歐盟化妝品規章規定

2. 確保該化妝品對人體健康及安全無害，在化妝品投放市場前，確保化妝品已完成安全性評估並符合標準，且須提供消費者充份資訊。

3. 化妝品上市時，負責人應當保存產品信息檔案，自最後一批化妝品上市之日起保存十年。

4. 應準備產品資訊檔案向銷售地點之各會員國權責機關查閱，需以成員國主管機關易於理解的語言提供。

5. 在將化妝品投放市場之前，負責人應通過電子方式向執委會，執委會亦須將該等資訊再迅速傳送各會員國權責機關。

．化妝品的類別及其名稱

．產品負責人姓名、地址

．原產國

．將該化妝品投放市場的成員國

．奈米原料(包括化學名稱、暴露條件)

．致癌、致突變或生殖毒性物質的名稱和化學文摘或 EC 編號

．遇到問題時的醫療處理。

6. 當化妝品投放市場時，負責人應將原始標籤、合理清晰的包裝照片通知委員會。

7. 如果對化妝品中含有的任何物質的安全性存在嚴重疑問，則在市場上銷售含有該物質的產品的成員國的主管當局可以通過合理的要求要求負責人提交一份他負責並含有這種物質的所有化妝品清單。清單應標明該物質在化妝品中的濃度。

8. 若產品不符規定，責任人須召回已在歐盟境內銷售產品。如果該化妝品已符合規定卻仍證實對人體有害，各會員國權責機關可採取必要措施，亦可能要求召回產品。

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.

【參考連結】

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
外國公司銷售到德國化妝品本身，進口前需要辦理產品許可嗎
？如需要，哪個單位在管理？需要什麼文件？申請程序為何？
化妝品包裝內容及各種標示，需要事先核准嗎？可允許的語文除了德文外，其他哪種語文也可以？網頁？

Do foreign companies need to apply for an approval before importing cosmetics sold to 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。歐盟化妝品法規規定企業應於化妝品產品上市前至化妝品登錄系統進行電子登錄。歐盟委員會將向每個成員國的主管當局和毒害管理中心或相關機構傳達登錄資訊。

需要文件：

1. 品名及類別

2. 負責人姓名及住址

3. 原產國

4. 化妝品將要上市銷售之會員國

5. 必要時應註明實際連絡人的詳細資訊  

6. 奈米物質

7. CMR 物質的存在

8. 遇到問題時的醫療處理

9. 原始標籤和包裝的照片

至德國銷售前，需通知聯邦各州主管監管機構，以及通過德國規定的有害物質檢測後，使得銷售該化妝品。

通知內容：

1. 化妝品的製造、成分、材料、預期用途

2. 投放市場

3. 化妝品的評估結果

4. 負責人的信息

5. 化妝品的定量或實質性組成

6. 對人體健康的副作用等

檢測項目：

1. 化妝品有害化學成分及重金屬測試。

2. 某些成分，如防腐劑、染料或紫外線過濾劑必須獲得批准。

產品標籤與包裝規定

歐盟化妝品法規定在化妝品容器和包裝上要以不可磨滅、易讀的字體印有下列信息的化妝品才能在市場上銷售：

1. 產品負責人或公司名稱及住址

2. 進口化妝品之原產國

3. 包裝時之容量(以重量或體積表示) ，但包裝少於 5 克或 5 毫升、免費樣品和單次應用包裝的情況除外。對於通常作為多個出售的預包裝，其重量或體積的細節並不重要，只要包裝上出現項目的數量，則無需提供內容。

4. 最短保質期：應明確表示，並應按月/年或日/月/年的順序組成。如有必要，該信息應補充說明為保證規定的耐用性必須滿足的條件。對於最低保質期超過 30 個月的化妝品，不應強制標明保質期。對於此類產品，應註明產品在開封後的安全期限，並可在不損害消費者的情況下使用。

5. 使用注意事項：包含列於歐盟化粧品法規專業產品的注意事項。

6. 製造批號或依據，如果由於化妝品太小而由於實際原因無法做到這一點，則此類信息標示在在包裝上。

7. 化妝品的產品功能，可以僅在包裝上標明，清單前應以“成分”一詞開頭。

8. 成分列表：若成分含量≥1%則按含量高至低順序列出；若含量<1%則可以任意順序列出。成分列表可只在包裝上標示。成分是指化妝品在製造過程中有意使用的任何物質或混合物，以下不應被視為成分：

．原材料中的雜質

．混合物中使用但不存在於最終產品中的輔助技術材料

9. 其它注意事項

．香水和芳香組合物及其原料應稱為“香水”或“香氣” ，除了香精或芳香這兩個術語外，還應在成分表中註明

．以奈米材料形式存在的所有成分均應在成分表中明確註明

．用於染髮的著色劑以外的著色劑可以以任何順序列在其他化妝品成分之後。對於以多種色調銷售的裝飾性化妝品，可以列出除用於染髮的著色劑以外的所有著色劑，前提是添加“可能包含”字樣或符號“+/-”。(應使用 CI（顏色指數）命名法)

．對於肥皂、浴球和其他小型產品，由於實際原因，所述信息不可能出現在標籤、吊牌、膠帶或卡片或隨附的傳單中，本信息應出現在緊鄰化妝品銷售容器的通知上。

．德國是歐盟27個會員國之一，化妝品標籤法要求標籤上的某些信息必須使用銷售國的官方語言：德語。

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.

【參考連結】

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

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

Evershine RD：

須以在歐盟會員國地區內有註冊的公司或自然人的名義申請。

須符合其中一項資格：

1.歐盟公民(不論居住地)。

2.居住在歐盟或是歐洲經濟區會員國的自然人。

3.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）。

4.在歐盟或歐洲經濟區內建立的組織。

歐盟化妝品法規規定企業應於化妝品產品上市前至化妝品登錄系統進行電子登錄。

需要文件：

1. 品名及類別

2. 負責人姓名及住址

3. 原產國

4. 化妝品將要上市銷售之會員國

5. 必要時應註明實際連絡人的詳細資訊  

6. 奈米物質

7. CMR 物質的存在

8. 遇到問題時的醫療處理

9. 原始標籤和包裝的照片

產品標籤與包裝規定

歐盟化妝品法規定在化妝品容器和包裝上要以不可磨滅、易讀的字體印有下列信息的化妝品才能在市場上銷售：

1. 產品負責人或公司名稱及住址

2. 進口化妝品之原產國

3. 包裝時之容量(以重量或體積表示) ，但包裝少於 5 克或 5 毫升、免費樣品和單次應用包裝的情況除外。對於通常作為多個出售的預包裝，其重量或體積的細節並不重要，只要包裝上出現項目的數量，則無需提供內容。

4. 最短保質期：應明確表示，並應按月/年或日/月/年的順序組成。如有必要，該信息應補充說明為保證規定的耐用性必須滿足的條件。對於最低保質期超過 30 個月的化妝品，不應強制標明保質期。對於此類產品，應註明產品在開封後的安全期限，並可在不損害消費者的情況下使用。

5. 使用注意事項：包含列於歐盟化粧品法規專業產品的注意事項。

6. 製造批號或依據，如果由於化妝品太小而由於實際原因無法做到這一點，則此類信息標示在在包裝上。

7. 化妝品的產品功能，可以僅在包裝上標明，清單前應以“成分”一詞開頭。

8. 成分列表：若成分含量≥1%則按含量高至低順序列出；若含量<1%則可以任意順序列出。成分列表可只在包裝上標示。成分是指化妝品在製造過程中有意使用的任何物質或混合物，以下不應被視為成分：

．原材料中的雜質

．混合物中使用但不存在於最終產品中的輔助技術材料

9. 其它注意事項

．香水和芳香組合物及其原料應稱為“香水”或“香氣” ，除了香精或芳香這兩個術語外，還應在成分表中註明

．以奈米材料形式存在的所有成分均應在成分表中明確註明

．用於染髮的著色劑以外的著色劑可以以任何順序列在其他化妝品成分之後。對於以多種色調銷售的裝飾性化妝品，可以列出除用於染髮的著色劑以外的所有著色劑，前提是添加“可能包含”字樣或符號“+/-”。(應使用 CI（顏色指數）命名法)

．對於肥皂、浴球和其他小型產品，由於實際原因，所述信息不可能出現在標籤、吊牌、膠帶或卡片或隨附的傳單中，本信息應出現在緊鄰化妝品銷售容器的通知上。

．德國是歐盟27個會員國之一，化妝品標籤法要求標籤上的某些信息必須使用銷售國的官方語言：德語。

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.

【參考連結】

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

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

HLF-TW-55
請問在德國有哪些專業服務機構，可以協助以外國公司名義辦理化妝品產品許可證？