德国保健食品登记法规问题集

Email：fra4ww@evershinecpa.com
或
德国永辉BPO有限公司
Frankfurt time zone:
Anna Wang, 说德文中文和英文
或
China Time Zone:
联络人: 林幸穗 Anny Lin 协理
手机：+886-937-606-272
skype: annylin8008
wechat: annylin8008
电话：+886-2-2717-0515 分机:110

各国健康食品登记法规问题集

HLF-TW-10
请问德国对于保健食品的归类方式为何？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 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：

保健食品在德国称为食品(膳食)补充剂，隶属在食品规范当中。食品补充剂可能含有多元的营养素或具有特定营养或生理作用的其他物质，旨在补充营养。例如，它们可以是维生素、矿物质、微量元素、氨基酸、脂肪酸、纤维、植物或草药提取物，可以单独或以浓缩形式添加作为组合。食品补充剂用于少量摄入，以剂量形式出售，例如片剂、胶囊剂、包衣片剂、粉末或液体。
与其他食品相比，食品补充剂可能会附带建议摄取量以及其他针对消费者的特定信息，例如应将它们存放在儿童接触不到的地方。根据定义，食品补充剂的成分不会有任何药理作用。如果此类产品具有药理作用，则它属于药品。
在德国，食品补充剂受欧盟的食品法以及德国国食品和饲料法规范，由联邦消费者保护和食品安全办公室负责监测投放市场的食品补充剂和製造公司。

德国将以下四项归为特殊营养食品，需提出申请，获得欧盟授权:
1.婴儿配方奶粉和后续配方奶粉
2.穀类食品和其他辅助食品
3.特殊医学用途食品（均衡饮食）
4.体重控制饮食的每日口粮

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

【参考连结】

https://www.bvl.bund.de/
https://www.bfr.bund.de/

HLF-TW-20
外国公司要到德国销售保健食品，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 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：

欧盟、德国食品法规定，製造、处理、销售食品的公司(食品经营者)必须向各州当地食品管理局註册。食品经营者需要是自然人或法人

註册内容：|
1. 营业场所的名称和地址
．名称
．邮编/城市
．街道

2. 食品经营者的联繫方式
．姓名
．邮编/城市
．街道
．电话传真
．手机/电子邮件

3. 操作模式/活动
．製造商/包装商
．服务公司
．零售商

4. 关于产品的讯息

5.签名

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

【参考连结】

https://www.bvl.bund.de/DE/Arbeitsbereiche/01_Lebensmittel/01_Aufgaben/01_WerMachtWas/01_Landesbehoerden/lm_vet_ueberw_node.html

HLF-TW-35

HLF-TW-40
外国公司销售到德国保健食品本身，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？
保健食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 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。食品补充剂须在联邦消费者保护和食品安全办公室 (BVL) 进行註册(每种膳食补充剂都需要单独註册，以及缴交所用标籤的样本)。无需事先向当局证明有效性或安全性。製造商、进口商要对产品的安全负责，产品只要满足所有食品法要求，就可以投放市场。联邦各州食品监管机构会监控市场上的食品补充剂和製造公司。

註册内容：

1.产品名称、味道

2.註册类型(首次、变更、补充)

3.在德意志联邦共和国首次投放市场的日期：

4.附件

．标籤

．图案档案

．材料

．授权书(若非製造商或分销商申请，需要缴交授权书)

．申请公司资料(国家、地点)

．经销商(如欧盟成员国，需再下拉选单填写、输入国家)

．製造商(如非欧盟成员国，需再下拉选单填写、输入国家)

．进口商/进口商(如非欧盟成员国，需再下拉选单填写、输入国家)

5.膳食补充剂相关内容

．剂型

．消费推荐

．每日最大摄取量

．成分表

．其他

欧盟规定，食品补充剂的标籤应包含以下内容：

1.营养素或物质的产品特徵，以及性质说明

2.推荐用于日常消费的产品部分

3.警告不要超过规定的每日推荐剂量

4.说明不应使用食品补充剂替代多样化饮食的声明

5.说明产品应存放在幼儿接触不到的地方的声明

6. 销售名称应为“食品补充剂”。

7.标籤、展示和广告不得将预防、治疗或治愈人类疾病的特性赋予食品补充剂，或提及此类特性。

8. 标籤、展示和广告不得提及或暗示均衡和多样化的饮食通常不能提供适量的营养。

9. 成员国可要求製造商或将产品投放其境内市场的个人通过向主管当局转发该产品所用标籤的模型，将其投放市场的情况通知主管当局。

德国规定，食品标籤条例规范需要以下标籤信息

1.销售说明：食品名称。

2.成分表

3.添加剂

4.複合成分的成分列表

5.保质期/使用截止日期

6.填充量：包装食品的重量、体积或件数的信息。

7.製造商：製造商、包装商或生产商的名称和地址。

8.批号或批号

9.价格

10.需使用官方语言：德语

营养标示应具有：

1.热量

2.脂肪

3.饱和物

4.碳水化合物

5.糖

6.蛋白质

7.盐

8.营养声明

‧单不饱和

‧多不饱和物

‧多元醇

‧淀粉

‧纤维

‧法律允许的任何维生素或矿物质

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.

【参考连结】

https://apps2.bvl.bund.de/nem/form/main.do

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

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32002L0046

https://www.bvl.bund.de/DE/Arbeitsbereiche/01_Lebensmittel/03_Verbraucher/02_KennzeichnungLM/01_Ueberblick/lm_kennzeichnung_lebensmittel_Ueberblick_node.html

https://www.bmel.de/EN/topics/food-and-nutrition/food-labeling/EU-wide-food-labeling-lmiv-fic.html

https://www.bvl.bund.de/DE/Service/04_FAQ/02_FAQ-Unternehmer/01_Lebensmittel/_functions/faq_table-1-11-nem_unternehmer.html

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？
保健食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 health food packaging and labeling require prior approval? In addition to German, which other languages are allowed? Website?

Evershine RD：

可以。食品补充剂须在联邦消费者保护和食品安全办公室 (BVL) 进行註册(每种膳食补充剂都需要单独註册，以及缴交所用标籤的样本)。

註册内容：

1.产品名称、味道

2.註册类型(首次、变更、补充)

3.在德意志联邦共和国首次投放市场的日期：

4.附件

．标籤

．图案档案

．材料

．授权书(若非製造商或分销商申请，需要缴交授权书)

．申请公司资料(国家、地点)

．经销商(如欧盟成员国，需再下拉选单填写、输入国家)

．製造商(如非欧盟成员国，需再下拉选单填写、输入国家)

．进口商/进口商(如非欧盟成员国，需再下拉选单填写、输入国家)

5.膳食补充剂相关内容

．剂型

．消费推荐

．每日最大摄取量

．成分表

．其他

欧盟规定，食品补充剂的标籤应包含以下内容：

1.营养素或物质的产品特徵，以及性质说明

2.推荐用于日常消费的产品部分

3.警告不要超过规定的每日推荐剂量

4.说明不应使用食品补充剂替代多样化饮食的声明

5.说明产品应存放在幼儿接触不到的地方的声明

6. 销售名称应为“食品补充剂”。

7.标籤、展示和广告不得将预防、治疗或治愈人类疾病的特性赋予食品补充剂，或提及此类特性。

8. 标籤、展示和广告不得提及或暗示均衡和多样化的饮食通常不能提供适量的营养。

9. 成员国可要求製造商或将产品投放其境内市场的个人通过向主管当局转发该产品所用标籤的模型，将其投放市场的情况通知主管当局。

德国规定，食品标籤条例规范需要以下标籤信息

1.销售说明：食品名称。

2.成分表

3.添加剂

4.複合成分的成分列表

5.保质期/使用截止日期

6.填充量：包装食品的重量、体积或件数的信息。

7.製造商：製造商、包装商或生产商的名称和地址。

8.批号或批号

9.价格

10.需使用官方语言：德语

营养标示应具有：

1.热量

2.脂肪

3.饱和物

4.碳水化合物

5.糖

6.蛋白质

7.盐

8.营养声明

‧单不饱和

‧多不饱和物

‧多元醇

‧淀粉

‧纤维

‧法律允许的任何维生素或矿物质

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.

【参考连结】

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32002L0046

https://www.bvl.bund.de/DE/Arbeitsbereiche/01_Lebensmittel/03_Verbraucher/02_KennzeichnungLM/01_Ueberblick/lm_kennzeichnung_lebensmittel_Ueberblick_node.html

https://www.bmel.de/EN/topics/food-and-nutrition/food-labeling/EU-wide-food-labeling-lmiv-fic.html

https://www.bvl.bund.de/DE/Service/04_FAQ/02_FAQ-Unternehmer/01_Lebensmittel/_functions/faq_table-1-11-nem_unternehmer.html

HLF-TW-55

HLF-TW-60
经过核准登记的保健食品，进口到德国要检附什麽文件？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 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：

进口海关需要具备：

进口食品需要先连络各州当地食品检验主管部门，获得批准号的企业可以

1. 海关报单

2.装船通知

3.提单

4.原产地证明

5.保险单等

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.

【参考连结】

https://apps2.bvl.bund.de/nem/form/main.do

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

HLF-TW-70
德国保健食品审核机构，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：

膳食补充剂无需事先向当局证明实验室内容有效性、安全性。製造商、进口商要对产品的安全负责，产品只要满足所有食品法要求，就可以投放市场。联邦各州食品监管机构会监控市场上的食品补充剂和製造公司。

另外，针对膳食补充剂中的维生素和矿物质来源请参考欧洲食品安全局设立的规范标准。网页：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

【参考连结】

https://apps2.bvl.bund.de/nem/form/main.do

HLF-TW-75

德国保健食品审核机构，能够接受海外检验机构的检验资料吗？假如是的话，有些被认可的机构？网页？

Evershine RD：

无需提出实验室检验资料，但需符合欧洲食品安全局设立的规范。

HLF-TW-77

HLF-TW-80
外国子公司进口保健食品后，如果委託德国的经销商销售，经销商需要保健食品营业许可证吗？
假如保健食品有品质瑕疵的话，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 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：

欧盟、德国食品法规定，製造、处理、销售食品的公司(食品经营者)必须向各州当地食品管理局註册。食品经营者需要是自然人或法人

註册内容：

1. 营业场所的名称和地址

．名称

．邮编/城市

．街道

2. 食品经营者的联繫方式

．姓名

．邮编/城市

．街道

．电话传真

．手机/电子邮件

3. 操作模式/活动

．製造商/包装商

．服务公司

．零售商

4. 关于产品的讯息

5.签名

当食品不安全时，食品经营者有义务撤回或召回。他们还有义务通知国家主管当局，以便能够监测是否已採取适当措施或要求採取额外措施以减少或消除食品安全风险。
针对膳食补充剂，製造商、进口商有责任承担商品的安全性。

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.

【参考连结】

URL:https://www.bvl.bund.de/DE/Arbeitsbereiche/01_Lebensmittel/01_Aufgaben/01_WerMachtWas/01_Landesbehoerden/lm_vet_ueberw_node.html

https://www.bvl.bund.de/DE/Arbeitsbereiche/01_Lebensmittel/04_AntragstellerUnternehmen/03_NEM/lm_nahrungsErgMittel_node.html

https://apps2.bvl.bund.de/nem/form/main.do

HLF-TW-85

各国健康食品登记法规问题集

连络我们：
Email：fra4ww@evershinecpa.com
或
德国永辉BPO有限公司
Frankfurt time zone:
Anna Wang, 说德文中文和英文
或
China Time Zone:
联络人: 林幸穗 Anny Lin 协理
手机：+886-937-606-272
skype: annylin8008
wechat: annylin8008
电话：+886-2-2717-0515 分机:110

附加资讯:
台北永辉协同网路服务股份有限公司
永辉启佳联合会计师事务所
地址:104臺北市中山区长春路378号6楼
捷运文湖线南京復兴站,兄弟大饭店附近
所长 Principal Partner:
陈中成 Dale C.C. Chen;
会计师 in 台湾+中国+英国/企管硕士+企管博士/台湾专利师;
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

全球永辉服务据点参考资料:
永辉100%子公司：
永辉总部、台北永辉、厦门永辉、北京永辉、上海那灵、深圳常新、纽约永辉、加州永辉、德州永辉、凤凰城永辉、东京永辉、首尔永辉、河内永辉、越南胡志明、曼谷永辉、新加坡永辉、吉隆玻永辉、雅加达永辉、马尼拉永辉、墨尔本永辉、澳洲雪梨、孟加拉永辉、新德里永辉、印度孟买、杜拜永辉、法兰克福永辉、巴黎永辉、伦敦永辉、荷兰永辉、西班牙永辉、义大利永辉、罗马尼亚永辉、多伦多永辉、墨西哥永辉、捷克永辉。

其他已提供中文化服务城市：
迈阿密、亚特兰大、俄克拉荷马、密歇根、西雅图、特拉华；
柏林; 斯图加特;布拉格；布加勒斯特；班加罗尔；泗水；
高雄、香港、深圳、东关、广州、清远、永康、杭州、苏州、崑山、南京、重庆、许昌、青岛、天津。
永辉潜在可服务城市 (2个月筹备期)：
我们为IAPA会员所,总部在伦敦，全球300个会员所， 员工约1万人。
我们为LEA会员所.总部在 美国芝加哥，全球600个会员所， 员工约2万8千人。
Evershine is local Partner of ADP Streamline® in Taiwan.
(版本:2022/03)

更多城市更多服务 请点击 网站导览