德國保健食品登記法規問題集
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Anna Wang, 說德文中文和英文
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HLF-TW-10
請問德國對於保健食品的歸類方式為何？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 health food in Germany? What is its official name? What is the intensity of management of different categories? What is the governmental authority of health food? Website?
Evershine RD：
保健食品在德國稱為食品(膳食)補充劑，隸屬在食品規範當中。食品補充劑可能含有多元的營養素或具有特定營養或生理作用的其他物質，旨在補充營養。例如，它們可以是維生素、礦物質、微量元素、氨基酸、脂肪酸、纖維、植物或草藥提取物，可以單獨或以濃縮形式添加作為組合。食品補充劑用於少量攝入，以劑量形式出售，例如片劑、膠囊劑、包衣片劑、粉末或液體。
與其他食品相比，食品補充劑可能會附帶建議攝取量以及其他針對消費者的特定信息，例如應將它們存放在兒童接觸不到的地方。根據定義，食品補充劑的成分不會有任何藥理作用。如果此類產品具有藥理作用，則它屬於藥品。
在德國，食品補充劑受歐盟的食品法以及德國國食品和飼料法規範，由聯邦消費者保護和食品安全辦公室負責監測投放市場的食品補充劑和製造公司。
德國將以下四項歸為特殊營養食品，需提出申請，獲得歐盟授權:
1.嬰兒配方奶粉和後續配方奶粉
2.穀類食品和其他輔助食品
3.特殊醫學用途食品（均衡飲食）
4.體重控制飲食的每日口糧
Health foods are called food (dietary) supplements in Germany and are subject to food regulations. Food supplements may contain multiple nutrients or other substances with specific nutritional or physiological effects and are intended to supplement nutrition.
For example, they contain vitamins, minerals, trace elements, amino acids, fatty acids, fibers, plant or herbal extracts, which can be added individually or in concentrated form as a combination. Food supplements are intended for small intake and are sold in dosage forms such as tablets, capsules, coated tablets, powders or liquids.
Compared to other foods, dietary supplements may come with recommended intakes and other consumer-specific information, such as keeping them out of the reach of children. By definition, the ingredients of a food supplement do not have any pharmacological effect.If such a product has a pharmacological effect, it is a pharmaceutical product.
In Germany, food supplements are regulated by EU food law and LFGB. Federal Office of Consumer Protection and Food Safety (BVL) monitors food supplements and manufacturing companies that are placed on the market.
Germany classifies the following items as special nutritional foods an application is required, and an EU authorization is required:
1. Infant formula and follow-on formula
2. Cereals and other complementary foods
3. Foods for special medical purposes (balanced diet)
4. Daily rations for weight control diets
【參考連結】
https://www.bvl.bund.de/
https://www.bfr.bund.de/
HLF-TW-20
外國公司要到德國銷售保健食品，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 health food 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：
歐盟、德國食品法規定，製造、處理、銷售食品的公司(食品經營者)必須向各州當地食品管理局註冊。食品經營者需要是自然人或法人
註冊內容：|
1. 營業場所的名稱和地址
．名稱
．郵編/城市
．街道
2. 食品經營者的聯繫方式
．姓名
．郵編/城市
．街道
．電話傳真
．手機/電子郵件
3. 操作模式/活動
．製造商/包裝商
．服務公司
．零售商
4. 關於產品的訊息
5.簽名
EU and German food laws stipulate that companies (food operators) that manufacture, process, and sell food must register with the local food administrations of each state. Food operators need to be natural or legal persons
Register content:
1. Name and address of business premises
．Name
．Zip/City
．Street
2. Contact information of food operators
．Name
．Zip/City
．Street
．Telephone / Fax
．Cell Phone/Email
3. Operating Mode/Activity
．Manufacturer/packager
．Service company
．Retailer
4. Information about products
5. Sign
【參考連結】
HLF-TW-35
HLF-TW-40
外國公司銷售到德國保健食品本身，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？
保健食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 health food sold to Germany? If yes, which authority is in charge? What documents are required? What is the application process? Do health food packaging and labeling require prior approval? In addition to German, which other languages are allowed? Website?
Evershine RD：
需要。食品補充劑須在聯邦消費者保護和食品安全辦公室 (BVL) 進行註冊(每種膳食補充劑都需要單獨註冊，以及繳交所用標籤的樣本)。無需事先向當局證明有效性或安全性。製造商、進口商要對產品的安全負責，產品只要滿足所有食品法要求，就可以投放市場。聯邦各州食品監管機構會監控市場上的食品補充劑和製造公司。
註冊內容：
1.產品名稱、味道
2.註冊類型(首次、變更、補充)
3.在德意志聯邦共和國首次投放市場的日期：
4.附件
．標籤
．圖案檔案
．材料
．授權書(若非製造商或分銷商申請，需要繳交授權書)
．申請公司資料(國家、地點)
．經銷商(如歐盟成員國，需再下拉選單填寫、輸入國家)
．製造商(如非歐盟成員國，需再下拉選單填寫、輸入國家)
．進口商/進口商(如非歐盟成員國，需再下拉選單填寫、輸入國家)
5.膳食補充劑相關內容
．劑型
．消費推薦
．每日最大攝取量
．成分表
．其他
歐盟規定，食品補充劑的標籤應包含以下內容：
1.營養素或物質的產品特徵，以及性質說明
2.推薦用於日常消費的產品部分
3.警告不要超過規定的每日推薦劑量
4.說明不應使用食品補充劑替代多樣化飲食的聲明
5.說明產品應存放在幼兒接觸不到的地方的聲明
6. 銷售名稱應為“食品補充劑”。
7.標籤、展示和廣告不得將預防、治療或治愈人類疾病的特性賦予食品補充劑，或提及此類特性。
8. 標籤、展示和廣告不得提及或暗示均衡和多樣化的飲食通常不能提供適量的營養。
9. 成員國可要求製造商或將產品投放其境內市場的個人通過向主管當局轉發該產品所用標籤的模型，將其投放市場的情況通知主管當局。
德國規定，食品標籤條例規範需要以下標籤信息
1.銷售說明：食品名稱。
2.成分表
3.添加劑
4.複合成分的成分列表
5.保質期/使用截止日期
6.填充量：包裝食品的重量、體積或件數的信息。
7.製造商：製造商、包裝商或生產商的名稱和地址。
8.批號或批號
9.價格
10.需使用官方語言：德語
營養標示應具有：
1.熱量
2.脂肪
3.飽和物
4.碳水化合物
5.糖
6.蛋白質
7.鹽
8.營養聲明
‧單不飽和
‧多不飽和物
‧多元醇
‧澱粉
‧纖維
‧法律允許的任何維生素或礦物質
Food supplements need to be registered with the Federal Office of Consumer Protection and Food Safety (BVL) (each dietary supplement needs to be registered individually, along with a sample of the label used). There is no need to prove efficacy or safety to the authorities in advance. Manufacturers and importers are responsible for the safety of the product, which can be placed on the market as long as it meets all food law requirements. Federal and state food regulators monitor food supplements and manufacturing companies on the market.
Registration content:
1. Product name, taste
2. Type of registration (initial, change, supplement)
3. Date of first placing on the market in the Federal Republic of Germany:
4. Accessories
．Label
．pattern file
．Material
．Power of Attorney (if not applied by the manufacturer or distributor, the Power of Attorney is required)
．Application company information (country, location)
．Distributor (if non-EU member states, you need to fill in the drop-down menu and enter the country)
．Manufacturer (if not a member of the EU, you need to fill in the drop-down menu and enter the country)
．Importer/Importer (if not a member of the EU, you need to fill in the drop-down menu and enter the country)
5. Contents related to dietary supplements
．Dosage form
．Consumer recommendation
．Maximum daily intake
．Ingredient list
．Other
The EU stipulates that the labeling of food supplements should contain the following:
1. Product characteristics of nutrients or substances, and description of properties
2. Products recommended for daily consumption
3. Warning not to exceed the stated daily recommended dose
4. Statement stating that dietary supplements should not be used as a substitute for a varied diet
5. A statement stating that the product should be stored out of the reach of young children
6. The marketing name shall be “Food Supplements”.
7. Labels, displays and advertisements must not confer the properties of preventing, treating or curing human diseases to food supplements, or refer to such properties.
8. Labels, displays and advertisements must not refer to or imply that a balanced and varied diet generally does not provide adequate nutrition.
9. Member States may require a manufacturer or an individual placing a product on the market within its territory to notify the competent authority of the placing on the market by forwarding to the competent authority a model of the label used for the product.
Germany stipulates that the following label information is required by the Food Labeling Regulations
1. Sales description: food name.
2. Ingredient list
3. Additives
4. Ingredient list of compound ingredients
5. Shelf life/use by date
6. Filling quantity: Information on the weight, volume or number of pieces of the packaged food.
7. Manufacturer: The name and address of the manufacturer, packer or producer.
8. Lot number or lot number
9. Price
10. Official language required: German
Nutrition labels should have:
1. Heat
2. Fat
3. Saturates
4. Carbohydrates
5. Sugar
6. Protein
7. Salt
8. Nutrition Claims
‧Monounsaturated
‧Polyunsaturated
‧Polyol
‧starch
‧fiber
‧Any vitamin or mineral permitted.
【參考連結】
https://apps2.bvl.bund.de/nem/form/main.do
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32002L0046
https://www.bmel.de/EN/topics/food-and-nutrition/food-labeling/EU-wide-food-labeling-lmiv-fic.html
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？
保健食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 health food packaging and labeling require prior approval? In addition to German, which other languages are allowed? Website?
Evershine RD：
可以。食品補充劑須在聯邦消費者保護和食品安全辦公室 (BVL) 進行註冊(每種膳食補充劑都需要單獨註冊，以及繳交所用標籤的樣本)。
註冊內容：
1.產品名稱、味道
2.註冊類型(首次、變更、補充)
3.在德意志聯邦共和國首次投放市場的日期：
4.附件
．標籤
．圖案檔案
．材料
．授權書(若非製造商或分銷商申請，需要繳交授權書)
．申請公司資料(國家、地點)
．經銷商(如歐盟成員國，需再下拉選單填寫、輸入國家)
．製造商(如非歐盟成員國，需再下拉選單填寫、輸入國家)
．進口商/進口商(如非歐盟成員國，需再下拉選單填寫、輸入國家)
5.膳食補充劑相關內容
．劑型
．消費推薦
．每日最大攝取量
．成分表
．其他
歐盟規定，食品補充劑的標籤應包含以下內容：
1.營養素或物質的產品特徵，以及性質說明
2.推薦用於日常消費的產品部分
3.警告不要超過規定的每日推薦劑量
4.說明不應使用食品補充劑替代多樣化飲食的聲明
5.說明產品應存放在幼兒接觸不到的地方的聲明
6. 銷售名稱應為“食品補充劑”。
7.標籤、展示和廣告不得將預防、治療或治愈人類疾病的特性賦予食品補充劑，或提及此類特性。
8. 標籤、展示和廣告不得提及或暗示均衡和多樣化的飲食通常不能提供適量的營養。
9. 成員國可要求製造商或將產品投放其境內市場的個人通過向主管當局轉發該產品所用標籤的模型，將其投放市場的情況通知主管當局。
德國規定，食品標籤條例規範需要以下標籤信息
1.銷售說明：食品名稱。
2.成分表
3.添加劑
4.複合成分的成分列表
5.保質期/使用截止日期
6.填充量：包裝食品的重量、體積或件數的信息。
7.製造商：製造商、包裝商或生產商的名稱和地址。
8.批號或批號
9.價格
10.需使用官方語言：德語
營養標示應具有：
1.熱量
2.脂肪
3.飽和物
4.碳水化合物
5.糖
6.蛋白質
7.鹽
8.營養聲明
‧單不飽和
‧多不飽和物
‧多元醇
‧澱粉
‧纖維
‧法律允許的任何維生素或礦物質
Food supplements need to be registered with the Federal Office of Consumer Protection and Food Safety (BVL) (each dietary supplement needs to be registered individually, along with a sample of the label used).
Registration content:
1. Product name, taste
2. Type of registration (initial, change, supplement)
3. Date of first placing on the market in the Federal Republic of Germany:
4. Accessories
．Label
．pattern file
．Material
．Power of Attorney (if not applied by the manufacturer or distributor, the Power of Attorney is required)
．Application company information (country, location)
．Distributor (if non-EU member states, you need to fill in the drop-down menu and enter the country)
．Manufacturer (if not a member of the EU, you need to fill in the drop-down menu and enter the country)
．Importer/Importer (if not a member of the EU, you need to fill in the drop-down menu and enter the country)
5. Contents related to dietary supplements
．Dosage form
．Consumer recommendation
．Maximum daily intake
．Ingredient list
．Other
The EU stipulates that the labeling of food supplements should contain the following:
1. Product characteristics of nutrients or substances, and description of properties
2. Products recommended for daily consumption
3. Warning not to exceed the stated daily recommended dose
4. Statement stating that dietary supplements should not be used as a substitute for a varied diet
5. A statement stating that the product should be stored out of the reach of young children
6. The marketing name shall be “Food Supplements”.
7. Labels, displays and advertisements must not confer the properties of preventing, treating or curing human diseases to food supplements, or refer to such properties.
8. Labels, displays and advertisements must not refer to or imply that a balanced and varied diet generally does not provide adequate nutrition.
9. Member States may require a manufacturer or an individual placing a product on the market within its territory to notify the competent authority of the placing on the market by forwarding to the competent authority a model of the label used for the product.
Germany stipulates that the following label information is required by the Food Labeling Regulations
1. Sales description: food name.
2. Ingredient list
3. Additives
4. Ingredient list of compound ingredients
5. Shelf life/use by date
6. Filling quantity: Information on the weight, volume or number of pieces of the packaged food.
7. Manufacturer: The name and address of the manufacturer, packer or producer.
8. Lot number or lot number
9. Price
10. Official language required: German
Nutrition labels should have:
1. Heat
2. Fat
3. Saturates
4. Carbohydrates
5. Sugar
6. Protein
7. Salt
8. Nutrition Claims
‧Monounsaturated
‧Polyunsaturated
‧Polyol
‧starch
‧fiber
‧Any vitamin or mineral permitted.
【參考連結】
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32002L0046
https://www.bmel.de/EN/topics/food-and-nutrition/food-labeling/EU-wide-food-labeling-lmiv-fic.html
HLF-TW-55
HLF-TW-60
經過核准登記的保健食品，進口到德國要檢附什麼文件？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 health food into Germany? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
進口海關需要具備：
進口食品需要先連絡各州當地食品檢驗主管部門，獲得批准號的企業可以
1. 海關報單
2.裝船通知
3.提單
4.原產地證明
5.保險單等
Import customs:
To import food, you need to contact the local food inspection department in each state first, and companies that have obtained an approval number can start importing.
1. Customs declaration
2. Shipping Notice
3. Bill of Lading
4. Certificate of Origin
5. Insurance policy, etc.
【參考連結】
https://apps2.bvl.bund.de/nem/form/main.do
https://www.bvl.bund.de/EN/Home/home_node.html
HLF-TW-70
德國保健食品審核機構，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：
膳食補充劑無需事先向當局證明實驗室內容有效性、安全性。製造商、進口商要對產品的安全負責，產品只要滿足所有食品法要求，就可以投放市場。聯邦各州食品監管機構會監控市場上的食品補充劑和製造公司。
另外，針對膳食補充劑中的維生素和礦物質來源請參考歐洲食品安全局設立的規範標準。網頁：https://www.efsa.europa.eu/en
For dietary supplements, there is no need to prove the validity and safety of the laboratory content to the authorities in advance. Manufacturers and importers are responsible for the safety of the product. As long as the product meets all the requirements of the food law, it can be placed on the market. Federal and state food regulators monitor the market for food supplements and manufacturing companies.
European Food Safety Authority: An agency set up by the European Union to conduct comprehensive assessments of the sources of vitamins and minerals in dietary supplements. URL:https://www.efsa.europa.eu/en
【參考連結】
https://apps2.bvl.bund.de/nem/form/main.do
HLF-TW-75
德國保健食品審核機構，能夠接受海外檢驗機構的檢驗資料嗎？假如是的話，有些被認可的機構？網頁？
Evershine RD：
無需提出實驗室檢驗資料，但需符合歐洲食品安全局設立的規範。
HLF-TW-77
HLF-TW-80
外國子公司進口保健食品後，如果委託德國的經銷商銷售，經銷商需要保健食品營業許可證嗎？
假如保健食品有品質瑕疵的話，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 health food and entrusts a distributor in Germany to sell it, does the distributor need a health food 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：
歐盟、德國食品法規定，製造、處理、銷售食品的公司(食品經營者)必須向各州當地食品管理局註冊。食品經營者需要是自然人或法人
註冊內容：
1. 營業場所的名稱和地址
．名稱
．郵編/城市
．街道
2. 食品經營者的聯繫方式
．姓名
．郵編/城市
．街道
．電話傳真
．手機/電子郵件
3. 操作模式/活動
．製造商/包裝商
．服務公司
．零售商
4. 關於產品的訊息
5.簽名
當食品不安全時，食品經營者有義務撤回或召回。他們還有義務通知國家主管當局，以便能夠監測是否已採取適當措施或要求採取額外措施以減少或消除食品安全風險。
針對膳食補充劑，製造商、進口商有責任承擔商品的安全性。
EU and German food laws stipulate that companies (food operators) that manufacture, process, and sell food must register with the local food administrations of each state. Food operators need to be natural or legal persons
Register content:
1. Name and address of business premises
．Name
．Zip/City
．Street
2. Contact information of food operators
．Name
．Zip/City
．Street
．Telephone / Fax
．Cell Phone/Email
3. Operating Mode/Activity
．Manufacturer/packager
．Service company
．Retailer
4. Information about products
5. Sign
Food operators are obliged to withdraw or recall when food is unsafe. They are also obliged to notify national competent authorities so that they can monitor whether appropriate measures have been taken or require additional measures to reduce or eliminate food safety risks. For dietary supplements, manufacturers and importers are responsible for the safety of the products.
【參考連結】
https://apps2.bvl.bund.de/nem/form/main.do
HLF-TW-85
連絡我們：
Email：fra4ww@evershinecpa.com
或
德國永輝BPO有限公司
Frankfurt time zone:
Anna Wang, 說德文中文和英文
或
China Time Zone:
聯絡人: 陳中成 總經理 in 台+中+英;專利師;企管碩士+企管博士
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
附加資訊:
台北永輝協同網路服務股份有限公司
永輝啟佳聯合會計師事務所
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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永輝100%子公司：
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我們為IAPA會員所,總部在倫敦，全球300個會員所， 員工約1萬人。
我們為LEA會員所.總部在 美國芝加哥，全球600個會員所， 員工約2萬8千人。
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(版本:2022/03)
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