荷蘭保健食品登記法規問題集
Email：ams4ww@evershinecpa.com
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荷蘭永輝BPO有限公司
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Anna Wang, 說荷蘭文中文和英文
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聯絡人: 陳中成 總經理 in 台+中+英;專利師;企管碩士+企管博士
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Skype: daleccchen
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linkedin address:Dale Chen Linkedin
HLF-NL-10
請問荷蘭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 the Netherlands? 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：
在荷蘭，食品補充劑的監管由荷蘭食品和消費品安全局 (NVWA)負責。
食品補充劑的定義：來源為一種/多種營養物質或其他具有營養/生理作用的濃縮物質，旨在作為正常飲食的食品補充劑，以預先給藥、少量單位攝入維生素和礦物質方式，採用膠囊，錠劑、片劑、丸劑等形式，液體和粉末以小袋、安剖瓶、滴管等形式銷售，食品補充劑可以包含多種營養素和其他成分。
In the Netherlands, the regulation of dietary supplements is the responsibility of the Netherlands Food and Consumer Product Safety Authority (NVWA).
Definition of Food Supplement: Source of one or more nutrients or other concentrated substances with nutritional/physiological effects, intended as a food supplement to the normal diet, in pre-administered, small unit intake of vitamins and minerals, using Capsules, lozenges, tablets, pills, etc., liquids and powders are sold in sachets, ampoules, droppers, etc., and food supplements can contain a wide variety of nutrients and other ingredients.
【參考連結】
HLF-NL-20
外國公司要到荷蘭銷售保健食品，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 Kingdom of the Netherlands, 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://www.nvwa.nl/onderwerpen/voedingssupplementen-en-kruidenpreparaten
HLF-NL-25
假如需要辦理，請問荷蘭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：
無須申請營業特許證。
HLF-NL-30
外國公司要到荷蘭銷售保健食品，可以指派荷蘭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 Kingdom of the Netherlands, can it assign a Kingdom of the Netherlands 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。
代理商/進口商須與供應商達成明確協議，包括簽訂銷售合同、分銷協議或代理協議，在其中明確說明責任、保證等問題達成的協議，並指明哪個國家/地區的法律將管轄商業關係。如果從歐盟以外進口產品在荷蘭市場上使用並造成損害，需要作為進口商承擔責任，進口商可以安排產品責任保險。
產品責任
當發生不安全事件，在荷蘭銷售、生產、分銷或儲存者皆有義務向NVWA報告，並且必須通知供應商。
1.在以下情況下，產品被視為不安全的人類食品：
．產品不合適(例如：被外來物質或其他物質污染、變質或不符合法律標準)。
．產品有害(例如：含有過多的化學物質或玻璃顆粒) 。
2.報告方式：
．NVWA.nl 網站上的報告表：https://formdesk.minlnv.nl/industrie/GFL-formulier_v5_nl
．NVWA 客戶聯絡中心：0900 – 0388。
3.須提供資料：
．原材料/買家的姓名和地址
．供應商的名稱和地址
．交貨日期和規模
．召回評估表
Yes.
Importer shall make a clear agreement with the supplier. Enter into a sales contract, distribution agreement, or agency agreement that clearly states the agreement reached on issues of liability, warranties, etc., and indicates which country’s law will govern the commercial relationship.
If a product imported from outside the EU is used on the Dutch market and causes damage, it is liable as an importer, who can arrange product liability insurance.
Product responsibility
In the event of an unsafe incident, those selling, producing, distributing or storing in the Netherlands are obliged to report to the NVWA and must inform the supplier.
1. A product is deemed unsafe for human food if:
．The product is unsuitable (eg: contaminated with foreign or other substances, spoiled, or does not meet legal standards).
．The product is hazardous (eg contains excessive chemicals or glass particles).
2. Reporting method:
．Report form on the NVWA.nl website: https://formdesk.minlnv.nl/industrie/GFL-formulier_v5_nl
．NVWA Customer Contact Centre: 0900 – 0388.
3. Information required:
．Raw material/buyer’s name and address
．Supplier’s name and address
．Delivery date and size
．Recall Evaluation Form.
【參考連結】
https://www.nvwa.nl/onderwerpen/melden-onveilige-levensmiddelen
HLF-NL-35
HLF-NL-40
外國公司銷售到荷蘭保健食品本身，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？可允許的語文有哪些？網頁？
Do foreign companies need to apply for an approval before importing health food sold to Kingdom of the Netherlands? 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? Which languages are allowed? Website?
Evershine RD：
無產品許可證。
商品進口荷蘭需要確認以下項目
1.產品受到保護
進口產品應先確定是否受任何商標、設計、專利或版權法的約束。
2.貨物允許
對於來自歐盟以外的貨物，荷蘭海關會檢查是否遵守有關安全、健康、經濟和環境的法規。
3.如果從歐洲經濟區以外進口產品，須徵得生產商許可
如果生產商允許，能從歐洲經濟區(EEA) 以外的國家進口和銷售產品，未經許可的進口稱為平行進口。
4.進口許可證
食品補充劑需要符合歐盟法規才能進口，但無提供許可證。
5.檢查貨物符合商品法
在荷蘭生產、準備或交易食品或其他消費品必須遵守商品法。該法案提供了關於公共衛生、產品安全、貿易公平和適當信息的一般規則。
6. 與供應商達成明確協議
簽訂銷售合同、分銷協議或代理協議，在其中明確說明責任、保證等問題達成的協議，並指明哪個國家/地區的法律將管轄商業關係。
7. 考慮產品責任
如果從歐盟以外進口產品在荷蘭市場上使用並造成損害，需要作為進口商承擔責任，進口商可以安排產品責任保險。
8.對包裝材料的責任
如果在荷蘭製造或進口包裝或包裝產品，有責任管理包裝直到廢物階段（生產者責任）。
9.向海關申報貨物
如果從歐盟以外的國家/地區進口商品，必須向海關申報。也可以讓運輸公司、物流服務提供商或海關代理執行。根據申報，海關將計算進出口關稅。
10.繳納進口稅
將貨物進口到荷蘭時，需要繳納各種稅款（進口稅、增值稅、消費稅等）。進口稅的支付金額取決於產品的種類和原產國。
荷蘭規範食品補充劑標籤需要包含：
1.產品名稱
2.製造商或負責企業的名稱、地址
3.成分，包括添加的水、香氣等
4.淨數量
5.以百分比表示的成分數量
6.營養價值
7.儲存說明和/或使用說明(如有必要)
8.生產代碼或批次代碼
9.最短保質期或最晚消費日期(按日期使用)。
10. 說明產品特徵的營養素或物質類別名稱，或有關這些營養素或物質性質的信息。(例如：複合維生素、omega-3 膠囊、鈣鎂骨配方、multi50+ 女性、輔酶 Q10、維生素 B 複合物、西伯利亞人參) 。
11. 推薦用於日常食用的產品。(例如：多種維生素補充劑-每天 1-3 粒糖衣丸，具體取決於您的飲食；動員用粉末狀肌酸粉-建議成人使用，每天約 2 至 4 克，在用餐期間或用餐後立即用水或果汁搭配服用) 。
12. 超過建議每日份量的警告。(例如：不要超過每天 1-3 粒糖衣丸的推薦用量；不要超過推薦的每日劑量)。
13. 聲明不應使用食品補充劑替代多樣化的飲食，如果在食品補充劑上使用健康聲明，則該強制性聲明必須輔以聲明，強調多樣化、均衡飲食和健康生活方式的重要性。(例如：這種食品補充劑不應用作多樣化飲食的替代品；健康的生活方式和均衡多樣的飲食很重要，食品補充劑不能替代它)。
14. 產品應存放在幼兒接觸不到的地方之警告。(例如：存放在幼兒接觸不到的地方)。
15. 產品中存在的具有營養或生理作用的營養素或物質的量必須以兩種方式在食品補充劑上說明：
．製造商推薦的每日食用維生素、礦物質和其他活性物質的數量。這部分必須在標籤上註明，其單位通常為 mg 或 µg。
．維生素、礦物質的含量佔每日參考攝入量的百分比，也可以用圖形表示。
16. 内容聲明：食品的含量應以體積或質量為單位。(對於通常以單件出售的食品而言，沒有強制標示淨數量，但是，前提是可以清楚地看到件數並且可以很容易從外面算出來，如果不是，則必須在標籤上註明。)
17. 成分表中的維生素和礦物質：按重量降序排列食品的所有成分、配料必須註明具體名稱(可以是合法名稱或通用名稱或描述性名稱) 。
．NVWA 接受維生素或礦物質的化學形式的標籤，並且僅在消費者足夠清楚的情況下才提及維生素或礦物質。
．必須說明食品補充劑中存在的微量營養素或具有營養或生理作用的物質的含量
18. 標籤必須使用荷蘭語，
No product license is required.
Commodities imported into the Netherlands need to confirm the following items:
1. Products are protected
Importing products should first determine if they are subject to any trademark, design, patent or copyright laws.
2. Goods allowed
For shipments from outside the EU, Dutch customs checks compliance with regulations regarding safety, health, economy and environment.
3. If the product is imported from outside the European Economic Area, a manufacturer’s license is required
If the manufacturer allows it to import and sell products from countries outside the European Economic Area (EEA), unauthorised importation is called parallel importation.
4. Import License
Food supplements need to comply with EU regulations to be imported without an import license.
5. Check that the goods comply with the Commodities Act
The production, preparation or trading of food or other consumer products in the Netherlands is subject to commodity law. The Act provides general rules regarding public health, product safety, trade fairness, and appropriate information.
6. Make a clear agreement with the supplier
Enter into a sales contract, distribution agreement, or agency agreement that clearly states the agreement reached on issues of liability, warranties, etc., and indicates which country’s law will govern the commercial relationship.
7. Consider product liability
If a product imported from outside the EU is used on the Dutch market and causes damage, it is liable as an importer, who can arrange product liability insurance.
8. Liability for packaging materials
If packaging or packaging products are manufactured or imported in the Netherlands, there is a responsibility to manage the packaging until the waste stage (producer responsibility).
9. Declaration of goods to customs
If you import goods from a country outside the EU, you must declare it to customs. It can also be performed by transport companies, logistics service providers or customs agents. Customs will calculate import and export duties based on the declaration.
10. Pay import duties
When importing goods into the Netherlands, various taxes (import duty, value added tax, excise duty, etc.) are required to be paid. The amount of import duty paid depends on the type and country of origin of the product.
Dutch regulated food supplement labels are required to contain:
1. Product name
2. The name and address of the manufacturer or responsible enterprise
3. Ingredient, including added water, aroma, etc.
4. Net volume
5. Quantity of ingredients in percent
6. Nutritional value
7. Storage instructions and/or use instructions (if necessary)
8. Production code or batch code
9. Minimum shelf life or latest consumption date (use by date).
10. Names of the nutrient or substance classes that characterize the product, or information about the properties of those nutrients or substances. (Examples: multivitamins, omega-3 capsules, calcium magnesium bone formula, multi50+ women’s, coenzyme Q10, vitamin B complex, Siberian ginseng).
11. Recommended products for daily consumption. (Examples: multivitamin supplements – 1-3 dragees per day, depending on your diet; creatine powder for mobilization – recommended for adults, approximately 2 to 4 grams per day, with water during or immediately after meals Or take it with juice).
12. Warning of exceeding the recommended daily serving size. (Example: Do not exceed the recommended amount of 1-3 dragees per day; do not exceed the recommended daily dose).
13. Statements that dietary supplements should not be used as a substitute for a varied diet, and if health claims are used on dietary supplements, this mandatory statement must be supplemented by a statement that emphasizes the importance of a varied, balanced diet and a healthy lifestyle. (Example: This food supplement should not be used as a substitute for a varied diet; a healthy lifestyle and a balanced and varied diet are important, and food supplements are not a substitute for it).
14. Warnings that the product should be stored out of the reach of young children. (Example: Store out of reach of young children).
15. The amount of nutrients or substances with nutritional or physiological effects that are present in the product must be stated on the food supplement in two ways:
．Manufacturer’s recommended daily intake of vitamins, minerals, and other active substances. This part must be stated on the label and is usually given in mg or µg.
．The content of vitamins and minerals as a percentage of the daily reference intake can also be graphically represented.
16. Declaration of content: The content of food should be measured in volume or mass. (For foods that are usually sold in individual pieces, the net quantity is not mandatory, however, provided the piece count is clearly visible and can be easily counted from the outside, if not it must be stated on the label.)
17. Vitamins and minerals in the ingredient list: All ingredients and ingredients of the food in descending order of weight must be marked with a specific name (which can be a legal name or a generic name or a descriptive name).
．The NVWA accepts the labelling of a vitamin or mineral in its chemical form and only mentions a vitamin or mineral if it is clear enough to the consumer.
．The content of micronutrients or substances with nutritional or physiological effect present in food supplements must be stated
18. Labels must be in Dutch,
【參考連結】
HLF-NL-45
HLF-NL-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？可允許的語文有哪些？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? Which languages are allowed?Website?
Evershine RD：
無產品許可證。
荷蘭規範食品補充劑標籤需要包含：
1.產品名稱
2.製造商或負責企業的名稱、地址
3.成分，包括添加的水、香氣等
4.淨數量
5.以百分比表示的成分數量
6.營養價值
7.儲存說明和/或使用說明(如有必要)
8.生產代碼或批次代碼
9.最短保質期或最晚消費日期(按日期使用)。
10. 說明產品特徵的營養素或物質類別名稱，或有關這些營養素或物質性質的信息。(例如：複合維生素、omega-3 膠囊、鈣鎂骨配方、multi50+ 女性、輔酶 Q10、維生素 B 複合物、西伯利亞人參) 。
11. 推薦用於日常食用的產品。(例如：多種維生素補充劑-每天 1-3 粒糖衣丸，具體取決於您的飲食；動員用粉末狀肌酸粉-建議成人使用，每天約 2 至4 克，在用餐期間或用餐後立即用水或果汁搭配服用) 。
12. 超過建議每日份量的警告。(例如：不要超過每天 1-3 粒糖衣丸的推薦用量；不要超過推薦的每日劑量)。
13. 聲明不應使用食品補充劑替代多樣化的飲食，如果在食品補充劑上使用健康聲明，則該強制性聲明必須輔以聲明，強調多樣化、均衡飲食和健康生活方式的重要性。(例如：這種食品補充劑不應用作多樣化飲食的替代品；健康的生活方式和均衡多樣的飲食很重要，食品補充劑不能替代它)。
14. 產品應存放在幼兒接觸不到的地方之警告。(例如：存放在幼兒接觸不到的地方)。
15. 產品中存在的具有營養或生理作用的營養素或物質的量必須以兩種方式在食品補充劑上說明：
．製造商推薦的每日食用維生素、礦物質和其他活性物質的數量。這部分必須在標籤上註明，其單位通常為 mg 或 µg。
．維生素、礦物質的含量佔每日參考攝入量的百分比，也可以用圖形表示。
16. 内容聲明：食品的含量應以體積或質量為單位。(對於通常以單件出售的食品而言，沒有強制標示淨數量，但是，前提是可以清楚地看到件數並且可以很容易從外面算出來，如果不是，則必須在標籤上註明。)
17. 成分表中的維生素和礦物質：按重量降序排列食品的所有成分、配料必須註明具體名稱(可以是合法名稱或通用名稱或描述性名稱) 。
．NVWA 接受維生素或礦物質的化學形式的標籤，並且僅在消費者足夠清楚的情況下才提及維生素或礦物質。
．必須說明食品補充劑中存在的微量營養素或具有營養或生理作用的物質的含量
18. 標籤必須使用荷蘭語，
No product license is required, and food supplement ingredients and labels must comply with Dutch commodity law.
Dutch regulated food supplement labels are required to contain:
1. Product name
2. The name and address of the manufacturer or responsible enterprise
3. Ingredient, including added water, aroma, etc.
4. Net volume
5. Quantity of ingredients in percent
6. Nutritional value
7. Storage instructions and/or use instructions (if necessary)
8. Production code or batch code
9. Minimum shelf life or latest consumption date (use by date).
10. Names of the nutrient or substance classes that characterize the product, or information about the properties of those nutrients or substances. (Examples: multivitamins, omega-3 capsules, calcium magnesium bone formula, multi50+ women’s, coenzyme Q10, vitamin B complex, Siberian ginseng).
11. Recommended products for daily consumption. (Examples: multivitamin supplements – 1-3 dragees per day, depending on your diet; creatine powder for mobilization – recommended for adults, approximately 2 to 4 grams per day, with water during or immediately after meals Or take it with juice).
12. Warning of exceeding the recommended daily serving size. (Example: Do not exceed the recommended amount of 1-3 dragees per day; do not exceed the recommended daily dose).
13. Statements that dietary supplements should not be used as a substitute for a varied diet, and if health claims are used on dietary supplements, this mandatory statement must be supplemented by a statement that emphasizes the importance of a varied, balanced diet and a healthy lifestyle. (Example: This food supplement should not be used as a substitute for a varied diet; a healthy lifestyle and a balanced and varied diet are important, and food supplements are not a substitute for it).
14. Warnings that the product should be stored out of the reach of young children. (Example: Store out of reach of young children).
15. The amount of nutrients or substances with nutritional or physiological effects that are present in the product must be stated on the food supplement in two ways:
．Manufacturer’s recommended daily intake of vitamins, minerals, and other active substances. This part must be stated on the label and is usually given in mg or µg.
．The content of vitamins and minerals as a percentage of the daily reference intake can also be graphically represented.
16. Declaration of content: The content of food should be measured in volume or mass. (For foods that are usually sold in individual pieces, the net quantity is not mandatory, however, provided the piece count is clearly visible and can be easily counted from the outside, if not it must be stated on the label.)
17. Vitamins and minerals in the ingredient list: All ingredients and ingredients of the food in descending order of weight must be marked with a specific name (which can be a legal name or a generic name or a descriptive name).
．The NVWA accepts the labelling of a vitamin or mineral in its chemical form and only mentions a vitamin or mineral if it is clear enough to the consumer.
．The content of micronutrients or substances with nutritional or physiological effect present in food supplements must be stated
18. Labels must be in Dutch,
【參考連結】
HLF-NL-55
HLF-NL-60
經過核准登記的保健食品，進口到荷蘭要檢附什麼文件？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 Kingdom of the Netherlands? What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
商品進口荷蘭需要確認以下項目
1.產品受到保護
進口產品應先確定是否受任何商標、設計、專利或版權法的約束。
2.貨物允許
對於來自歐盟以外的貨物，荷蘭海關會檢查是否遵守有關安全、健康、經濟和環境的法規。
3.如果從歐洲經濟區以外進口產品，須徵得生產商許可
如果生產商允許，能從歐洲經濟區(EEA) 以外的國家進口和銷售產品，未經許可的進口稱為平行進口。
4.進口許可證
食品補充劑需要符合歐盟法規才能進口，無進口許可證。
5.檢查貨物符合商品法
在荷蘭生產、準備或交易食品或其他消費品必須遵守商品法。該法案提供了關於公共衛生、產品安全、貿易公平和適當信息的一般規則。
6. 與供應商達成明確協議
簽訂銷售合同、分銷協議或代理協議，在其中明確說明責任、保證等問題達成的協議，並指明哪個國家/地區的法律將管轄商業關係。
7. 考慮產品責任
如果從歐盟以外進口產品在荷蘭市場上使用並造成損害，需要作為進口商承擔責任，進口商可以安排產品責任保險。
8.對包裝材料的責任
如果在荷蘭製造或進口包裝或包裝產品，有責任管理包裝直到廢物階段（生產者責任）。
9.向海關申報貨物
如果從歐盟以外的國家/地區進口商品，必須向海關申報。也可以讓運輸公司、物流服務提供商或海關代理執行。根據申報，海關將計算進出口關稅。
10.繳納進口稅
將貨物進口到荷蘭時，需要繳納各種稅款（進口稅、增值稅、消費稅等）。進口稅的支付金額取決於產品的種類和原產國。
海關
1. 經濟經營者註冊和識別
於荷蘭海關註冊取得EORI 編號
申請書內容：
．公司名稱、地址、郵政編碼、城鎮/城市
．RSIN/BSN
．增值稅識別號
．簽名
2. 通過AGS 系統（荷蘭語）進行貨物進出口的電子申報。
網頁：
申報單內容：
．姓名/公司名稱、地址、郵政編碼、城鎮
．商會編號
．EORI 編號或 RSIN
．聯繫人姓名
．海關業務、角色、電話號碼
．聲明
．14 天內的預期船舶數量
．船舶的長度以及相應的關稅
．14 天內到期的總關稅等
無銷售許可證，但在食品補充劑投放市場前，需確保以下幾點：
1.營養聲明符合歐盟規範。
2.食品補充劑的成分符合歐盟規範。
Commodities imported into the Netherlands need to confirm the following items:
1. Products are protected
Importing products should first determine if they are subject to any trademark, design, patent or copyright laws.
2. Goods allowed
For shipments from outside the EU, Dutch customs checks compliance with regulations regarding safety, health, economy and environment.
3. If the product is imported from outside the European Economic Area, a manufacturer’s license is required
If the manufacturer allows it to import and sell products from countries outside the European Economic Area (EEA), unauthorised importation is called parallel importation.
4. Import License
Food supplements need to comply with EU regulations to be imported without an import license.
5. Check that the goods comply with the Commodities Act
The production, preparation or trading of food or other consumer products in the Netherlands is subject to commodity law. The Act provides general rules regarding public health, product safety, trade fairness, and appropriate information.
6. Make a clear agreement with the supplier
Enter into a sales contract, distribution agreement, or agency agreement that clearly states the agreement reached on issues of liability, warranties, etc., and indicates which country’s law will govern the commercial relationship.
7. Consider product liability
If a product imported from outside the EU is used on the Dutch market and causes damage, it is liable as an importer, who can arrange product liability insurance.
8. Liability for packaging materials
If packaging or packaging products are manufactured or imported in the Netherlands, there is a responsibility to manage the packaging until the waste stage (producer responsibility).
9. Declaration of goods to customs
If you import goods from a country outside the EU, you must declare it to customs. It can also be performed by transport companies, logistics service providers or customs agents. Customs will calculate import and export duties based on the declaration.
10. Pay import duties
When importing goods into the Netherlands, various taxes (import duty, value added tax, excise duty, etc.) are required to be paid. The amount of import duty paid depends on the type and country of origin of the product.
Customs
1. Economic Operator Registration and Identification
Registered with Dutch customs to obtain EORI number
Application form content:
．Company Name, Address, Postal Code, Town/City
．RSIN/BSN
．VAT ID
．Sign
2. Electronic declaration of import and export of goods via the AGS system (in Dutch).
Declaration form content:
．Name/Company Name, Address, Postal Code, Town
．Chamber number
．EORI number or RSIN
．Contact name
．Customs operations, roles, phone numbers
．Statement
．Expected number of ships in 14 days
．The length of the vessel and the corresponding tariff
．Total duties due in 14 days etc.
There is no license to sell, but before a food supplement is placed on the market, you need to ensure the following:
1. Nutritional claims are in compliance with EU norms.
2. The ingredients of food supplements comply with EU regulations.
【參考連結】
https://www.belastingdienst.nl/wps/wcm/connect/en/customs/content/how-to-obtain-an-eori-number
HLF-NL-70
荷蘭保健食品審核機構，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：
風險分析系統(HACCP)
製造公司必須擁有基於 HACCP的食品安全體系，HACCP計劃是對整個食品生產過程中涉及的風險以及控制這些風險的程序的分析。
製造公司可以製定自己的HACCP食品安全計劃，該計劃必須遵守歐洲衛生法規，並且考慮HACCP系統的7項基本原則。荷蘭食品和消費品安全局 (NVWA)負責評估計劃並檢查是否按照計畫工作。
1.原則1：進行危害分析。
2.原則2：確定關鍵控制點 (CCP)。
3.原則3：建立關鍵限值。
4.原則4：建立監測程序。
5.原則5：制定糾正措施。
6.原則6：建立驗證程序。
7.原則7：建立記錄保存和文件程序。
Hazard Analysis System (HACCP)
Manufacturing companies must have a food safety system based on HACCP, a HACCP plan is an analysis of the risks involved in the entire food production process and the procedures to control these risks. Manufacturing companies can develop their own HACCP food safety plan, which must comply with European hygiene regulations and take into account the 7 fundamental principles of the HACCP system. The Netherlands Food and Consumer Product Safety Authority (NVWA) is responsible for evaluating the plan and checking whether it is working according to the plan.
1. Principle 1: Perform a hazard analysis.
2. Principle 2: Determine Critical Control Points (CCPs).
3. Principle 3: Establish critical limit values.
4. Principle 4: Establish a monitoring program.
5. Principle 5: Establish corrective actions.
6. Principle 6: Establish verification procedures.
7. Principle 7: Establish procedures for record keeping and documentation.
【參考連結】
https://business.gov.nl/regulation/applying-food-hygiene-haccp-principles/
HLF-NL-75
HLF-NL-77
HLF-NL-80
外國子公司進口保健食品後，如果委託荷蘭的經銷商銷售，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 Kingdom of the Netherlands 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：
無須營業特許證。
產品責任
當發生不安全事件，在荷蘭銷售、生產、分銷或儲存者皆有義務向NVWA報告，並且必須通知供應商。
1.在以下情況下，產品被視為不安全的人類食品：
．產品不合適(例如：被外來物質或其他物質污染、變質或不符合法律標準)。
．產品有害(例如：含有過多的化學物質或玻璃顆粒) 。
2.報告方式：
．NVWA.nl 網站上的報告表：https://formdesk.minlnv.nl/industrie/GFL-formulier_v5_nl
．NVWA 客戶聯絡中心：0900 – 0388。
3.須提供資料：
．原材料/買家的姓名和地址
．供應商的名稱和地址
．交貨日期和規模
．召回評估表
No business license is required.
Product responsibility
In the event of an unsafe incident, those selling, producing, distributing or storing in the Netherlands are obliged to report to the NVWA and must inform the supplier.
1. A product is deemed unsafe for human food if:
．The product is unsuitable (eg: contaminated with foreign or other substances, spoiled, or does not meet legal standards).
．The product is hazardous (eg contains excessive chemicals or glass particles).
2. Reporting method:
．Report form on the NVWA.nl website: https://formdesk.minlnv.nl/industrie/GFL-formulier_v5_nl
．NVWA Customer Contact Centre: 0900 – 0388.
3. Information required:
．Raw material/buyer’s name and address
．Supplier’s name and address
．Delivery date and size
．Recall Evaluation Form.
【參考連結】
https://www.nvwa.nl/onderwerpen/melden-onveilige-levensmiddelen
HLF-NL-85
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Anna Wang, 說荷蘭文中文和英文
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地址:104臺北市中山區長春路378號6樓
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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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