Netherlands Health Food Regulation QA

Netherlands Health Food Regulation QA

HLF-NL-10

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:

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.

【Reference link】

https://www.nvwa.nl/

https://www.nvwa.nl/onderwerpen/voedingssupplementen-en-kruidenpreparaten/documenten/consument/eten-drinken-roken/supplementen-en-preparaten/publicaties/nvwa-handboek-voedingssupplementen-verrijkte-levensmiddelen-en-kruidenpreparaten

HLF-NL-20

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:

No business license is required.

【Reference link】

https://www.nvwa.nl/onderwerpen/voedingssupplementen-en-kruidenpreparaten

HLF-NL-30

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:

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.

【Reference link】

https://www.nvwa.nl/onderwerpen/melden-onveilige-levensmiddelen

HLF-NL-40

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:

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,

【Reference link】

https://reurl.cc/m3OnYM

https://www.nvwa.nl/onderwerpen/voedingssupplementen-en-kruidenpreparaten/documenten/consument/eten-drinken-roken/supplementen-en-preparaten/publicaties/nvwa-handboek-voedingssupplementen-verrijkte-levensmiddelen-en-kruidenpreparaten

HLF-NL-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? Which languages ​​are allowed?? Website?

Evershine RD:

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,

【Reference link】

https://reurl.cc/m3OnYM

https://www.nvwa.nl/onderwerpen/voedingssupplementen-en-kruidenpreparaten/documenten/consument/eten-drinken-roken/supplementen-en-preparaten/publicaties/nvwa-handboek-voedingssupplementen-verrijkte-levensmiddelen-en-kruidenpreparaten

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 Netherlands? What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?

Evershine RD:

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.

【Refernce link】

https://www.belastingdienst.nl/wps/wcm/connect/en/customs/content/how-to-obtain-an-eori-number

https://www.belastingdienst.nl/wps/wcm/connect/bldcontenten/belastingdienst/customs/customs-processes/import/forms-explanations-brochures/import-forms-explanations-brochures

https://business.gov.nl/running-your-business/international-business/import/checklist-dutch-regulations-for-importing-products/

HLF-NL-70

What are the laboratory inspection materials that need to be attached for verification? Website?

Evershine RD:

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/

https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines#defs

HLF-NL-80

After a foreign subsidiary imports health food and entrusts a distributor in 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:

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.

【Reference link】

https://www.nvwa.nl/onderwerpen/melden-onveilige-levensmiddelen

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