Germany Health Food Regulations QA
Email: fra4ww@evershinecpa.com
The Engaging Manager from Headquarter
Ms. Anna Wang, Speak German, English, and Chinese.
skype: burlinna
HLF-TW-1
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:
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】
HLF-TW-20
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：
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-25
假如需要辦理，請問德國有專業服務公司可以協助辦理保健食品公司營業許可證？
Evershine RD：
Gurcan Partners
https://gurcanpartners.com/en/
LawyersGrmany
https://www.lawyersgermany.com/
HLF-TW-30
外國公司要到德國銷售保健食品，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 health food in Germany, can it assign a German 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：
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 to be able to monitor whether appropriate measures have been taken or to request additional measures to reduce or eliminate food safety risks. For dietary supplements, the manufacturer and importer are responsible for the safety of the product.
【參考連結】
HLF-TW-35
假如需要辦理指派德國公司擔任營業代理人，請問德國有專業服務公司可以協助？
Evershine RD：
Hoffmann
https://www.hoffmann-europe.com/en-gb/home
VP
https://www.vitalproducts.de/en/home/
HLF-TW-40
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：
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
請問在德國有哪些專業服務機構，可以協助辦理保健食品產品許可證？
Evershine RD：
HSRC
http://www.hsrc.de/cms/english/homepage/index.html
TAOBE
https://taobe.consulting/services/
HLF-TW-50
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：
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
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保健食品產品許可證？
Evershine RD：
Biorius
https://biorius.com/
HSRC
http://www.hsrc.de/cms/english/homepage/index.html
HLF-TW-60
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：
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
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
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
請問在德國有哪些保健食品檢驗機構可以提供保健食品檢驗服務？網頁？
Evershine RD：
HSRC
http://www.hsrc.de/cms/english/about-us/index.html
TÜV
SGS
HLF-TW-80
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：
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
請問在德國有哪些專精於保健食品銷售與消費權益相關法律服務的業者？
Evershine RD：
Healthlawyer
ZENK
HSRC
http://www.hsrc.de/cms/english/homepage/index.html
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Email: fra4ww@evershinecpa.com
The Engaging Manager from Headquarter
Ms. Anna Wang, Speak German English and Chinese.
skype: burlinna
or
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