Netherlands Cosmetics Regulation QA
HLF-NL-10
What are the categories of cosmetics in the Netherlands? What is its official name?
What is the intensity of management of different categories? What is the governmental authority of cosmetics? Website?
Evershine RD：
In the Netherlands, the regulation of cosmetic products is the responsibility of the Netherlands Food and Consumer Product Safety Authority (NVWA). Cosmetics are any substances or mixtures that come into contact with the surface layers of the human body (the epidermis, hair and capillaries, nails, lips, and external genitalia), or the teeth and the mucous membranes of the mouth.
Substances and preparations whose main purpose is to cleanse, scent, improve appearance, improve body odor, or protect the body in good condition. Cosmetics are personal care products. For example: cosmetics, deodorants, perfumes, face creams, soaps, shampoos, body washes, toothpaste, shaving cream and sunscreen.
【參考連結】
https://www.nvwa.nl/onderwerpen/cosmetica
HLF-NL-20
If a foreign company wants to sell cosmetics 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.
【參考連結】
https://www.nvwa.nl/onderwerpen/cosmetica
HLF-NL-30
If a foreign company wants to sell cosmetics 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：
Only those who are designated as responsible persons in the EU can be placed on the market. The main responsible person must be an enterprise legal person or natural person in the EU. When non-EU goods enter the EU and EFTA regions, a local EU legal person or natural person must be designated as the responsible person of the company. to put the cosmetic product on the EU market. Generally, the responsible person for cosmetics is the manufacturer, importer, and distributor of cosmetics. If authorized in writing, a third legal person or natural person can also be the person responsible.
1. The responsible person shall meet one of the qualifications:
·EU citizens (regardless of residence).
·A natural person resident in the European Union or a member state of the European Economic Area.
·A company established in the European Union or European Economic Area (registered office, central authority or principal body).
·Organizations established in the European Union or the European Economic Area.
2. Complete the cosmetic filing notification process
The responsible person must notify through the EU unified online platform (CPNP, webpage: https://reurl.cc/pM8R7x) before the product is put on the market to enter the EU market. And the responsible person must prepare the product information file (PIF/DIP) document before the product goes on the market.
·Product categories
·Product Name
·Name and address of the person responsible
·Listed area (the member country where the market is placed)
· Label and packaging (reasonable and clear photos)
·Product Formulation
·Country of origin
·Contact
Nanomaterials (including chemical name, exposure conditions)
The name, chemical abstract or EC number of special ingredients or reproductive toxic substances such as CMRs
·Medical treatment in case of problems
3. Product information file (PIF/DIP) content includes:
·Product Description
·Product Safety Assessment Report CPSR
Production process description and Good Manufacturing Practice (GMP) statement
· Animal Testing Data Statement
·Product efficacy certificate
4. Information required for the Cosmetic Safety Assessment Report (CPSR):
·Product name and internal number
·Detailed formula table
·Material Quality Inspection Report (CoA) and Chemical Safety Data Sheet (MSDS)
·Fragrance/Fragrance/Essential Oil: IFRA File, Allergens, MSDS, CoA
·Finished product
· Toxicology and clinical research reportsMicrobiological report (including challenge test)
·Stability report
·Packaging material information
·Product label
·Case report
· Exposure data of products
5. Responsibilities of the Responsible Person:
·Assume product safety and compliance responsibilities
·Complete CPNP notification before listing
·The name and address of the responsible person should be marked on the product label
·The responsible person needs to prepare a complete PIF/DIP file for inspection by the competent authority
· After the last batch of products is on the market, the responsible person must keep the cosmetic safety assessment report for at least ten years
· Update CPNP and PIF/DIP as appropriate
·Report serious adverse reactions (SUE) in a timely manner after listing
· When there is reason to believe that a product placed on the market does not meet regulatory requirements or has a safety issue, take the necessary corrective action to withdraw or recall the product.
Product Liability
1. Manufacturers, authorized representatives, first importers within the EU are considered as producers and the main tasks are risk assessment, further investigation and corrective action.
2. Distributors must collect, provide and transmit information.
3. Retailers must immediately pass on information about unsafe products, such as consumer complaints, to their suppliers.
4. If the product does not meet the safety requirements, the manufacturer and distributor must report the risk involved and what has been done to eliminate the hazard by reporting to the NVWA online through the business gateway.
【參考連結】
HLF-NL-40
Do foreign companies need to apply for an approval before importing cosmetics sold to Kingdom of the Netherlands? If yes, which authority is in charge? What documents are required? What is the application process? Do cosmetics packaging and labeling require prior approval? Which languages are allowed? Website?
Evershine RD：
Applications must be made in the name of a corporate legal person or a natural person within the EU.
Only those who are designated as responsible persons in the EU can be placed on the market. The main responsible person must be an enterprise legal person or natural person in the EU. When non-EU goods enter the EU and EFTA regions, a local EU legal person or natural person must be designated as the responsible person of the company. to put the cosmetic product on the EU market.
Generally, the responsible person for cosmetics is the manufacturer, importer, and distributor of cosmetics.
If authorized in writing, a third legal person or natural person can also be the person responsible.
1. The responsible person shall meet one of the qualifications:
·EU citizens (regardless of residence).
·A natural person resident in the European Union or a member state of the European Economic Area.
·A company established in the European Union or European Economic Area (registered office, central authority or principal body).
·Organizations established in the European Union or the European Economic Area.
2. Complete the cosmetic filing notification process
The responsible person must notify through the EU unified online platform (CPNP, webpage: https://reurl.cc/pM8R7x) before the product is put on the market to enter the EU market. And the responsible person must prepare the product information file (PIF/DIP) document before the product goes on the market.
·Product categories
·Product Name
·Name and address of the person responsible
·Listed area (the member country where the market is placed)
·Label and packaging (reasonable and clear photos)
·Product Formulation
·Country of origin
·Contact
Nanomaterials (including chemical name, exposure conditions)
The name, chemical abstract or EC number of special ingredients or reproductive toxic substances such as CMRs
·Medical treatment in case of problems
3. Product information file (PIF/DIP) content includes:
·Product Description
·Product Safety Assessment Report CPSR
Production process description and Good Manufacturing Practice (GMP) statement
· Animal Testing Data Statement
·Product efficacy certificate
4. Information required for the Cosmetic Safety Assessment Report (CPSR):
·Product name and internal number
·Detailed formula table
·Material Quality Inspection Report (CoA) and Chemical Safety Data Sheet (MSDS)
·Fragrance/Fragrance/Essential Oil: IFRA File, Allergens, MSDS, CoA
·Finished product
·Toxicology and clinical research reports Microbiological report (including challenge test)
·Stability report
·Packaging material information
·Product label
·Case report
·Exposure data of products
5. Responsibilities of the Responsible Person:
·Assume product safety and compliance responsibilities
·Complete CPNP notification before listing
·The name and address of the responsible person should be marked on the product label
·The responsible person needs to prepare a complete PIF/DIP file for inspection by the competent authority
·After the last batch of products is on the market, the responsible person must keep the cosmetic safety assessment report for at least ten years
·Update CPNP and PIF/DIP as appropriate
·Report serious adverse reactions (SUE) in a timely manner after listing
·When there is reason to believe that a product placed on the market does not meet regulatory requirements or has a safety issue, take the necessary corrective action to withdraw or recall the product.
Label
1. Manufacturer/Importer’s Name, Address: Name and address of the person responsible for placing the product on the market. There are often multiple addresses on the label, and the address where the product information file is located must be highlighted. (such as underscore the address)
2. Country of Origin: When the product is produced outside the EU, it must be indicated on the product or packaging.
3. Quantity: The content in packaging, expressed by weight or volume.
4. Shelf life: There are two different systems included in cosmetic regulations to indicate shelf life. Which system should be used depends on the shelf life after production.
．If the unopened product has a shelf life of thirty months or more, the expiry date must be indicated. (indicated by an open jar symbol)
．If the product has a shelf life of less than thirty months from production, it must be preceded by a best before end or hourglass symbol before the expiration date.
．In some cases, the expiration date does not need to be stated if the concept of shelf life after opening is not affected.
5. Special Precautions for Use: Instructions for use on how to best use this product. At a minimum, the warnings and special precautions for the cosmetic product must be stated.
6. Lot number or code: This is the unique number of the product, if you have any doubts about the quality of the product, you can check if this applies to the whole lot.
7. Product function: Product description, such as body wash, lip balm, after-sun or shaving foam. The function of the cosmetic must be stated on the packaging unless this is clearly evident from the packaging or product name.
8. Ingredient Declaration: All ingredients used in the production must be declared on the packaging. (represented by the INCI international name cosmetic ingredients)
．Ingredients are listed in order of decreasing weight.
．Ingredients that are less than 1% in a product can be listed at the end of the ingredient list in any order.
．Some products consist of a range of colors, and in order to avoid having to make a separate label for each new shade, all of the colors can be listed in one ingredient statement.
．Dyes should be listed using CI nomenclature (color index) where applicable.
9. Some products come in packages that are so small that there is no room for ingredient descriptions, directions for use and warnings. In this case, hand open book symbol or text can refer to this information. The ingredients, directions for use and warnings can then be printed on a separate card or leaflet with the product.
10. Product labels must be marked in Dutch, and products with instructions for use or warnings must be translated into Dutch.
【參考連結】
https://wetten.overheid.nl/BWBR0029746/2014-03-01#Opschrift
https://single-market-economy.ec.europa.eu/sectors/cosmetics/cosmetic-product-notification-portal_en
https://www.nvwa.nl/onderwerpen/cosmetica/checklist-etiketteringsverplichtingen-cosmetica
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 cosmetics packaging and labeling require prior approval? Which languages are allowed?Website?
Evershine RD：
Applications must be made in the name of a corporate legal person or a natural person within the EU.
Only those who are designated as responsible persons in the EU can be placed on the market. The main responsible person must be an enterprise legal person or natural person in the EU. When non-EU goods enter the EU and EFTA regions, a local EU legal person or natural person must be designated as the responsible person of the company. to put the cosmetic product on the EU market. Generally, the responsible person for cosmetics is the manufacturer, importer, and distributor of cosmetics. If authorized in writing, a third legal person or natural person can also be the person responsible.
1. The responsible person shall meet one of the qualifications:
·EU citizens (regardless of residence).
·A natural person resident in the European Union or a member state of the European Economic Area.
·A company established in the European Union or European Economic Area (registered office, central authority or principal body).
·Organizations established in the European Union or the European Economic Area.
2. Complete the cosmetic filing notification process
The responsible person must notify through the EU unified online platform (CPNP, webpage: https://reurl.cc/pM8R7x) before the product is put on the market to enter the EU market. And the responsible person must prepare the product information file (PIF/DIP) document before the product goes on the market.
·Product categories
·Product Name
·Name and address of the person responsible
·Listed area (the member country where the market is placed)
· Label and packaging (reasonable and clear photos)
·Product Formulation
·Country of origin
·Contact
Nanomaterials (including chemical name, exposure conditions)
The name, chemical abstract or EC number of special ingredients or reproductive toxic substances such as CMRs
·Medical treatment in case of problems
3. Product information file (PIF/DIP) content includes:
·Product Description
·Product Safety Assessment Report CPSR
Production process description and Good Manufacturing Practice (GMP) statement
·Animal Testing Data Statement
·Product efficacy certificate
4. Information required for the Cosmetic Safety Assessment Report (CPSR):
·Product name and internal number
·Detailed formula table
·Material Quality Inspection Report (CoA) and Chemical Safety Data Sheet (MSDS)
·Fragrance/Fragrance/Essential Oil: IFRA File, Allergens, MSDS, CoA
·Finished product
·Toxicology and clinical research reports Microbiological report (including challenge test)
·Stability report
·Packaging material information
·Product label
·Case report
·Exposure data of products
5. Responsibilities of the Responsible Person:
·Assume product safety and compliance responsibilities
·Complete CPNP notification before listing
·The name and address of the responsible person should be marked on the product label
·The responsible person needs to prepare a complete PIF/DIP file for inspection by the competent authority
·After the last batch of products is on the market, the responsible person must keep the cosmetic safety assessment report for at least ten years
· Update CPNP and PIF/DIP as appropriate
·Report serious adverse reactions (SUE) in a timely manner after listing
·When there is reason to believe that a product placed on the market does not meet regulatory requirements or has a safety issue, take the necessary corrective action to withdraw or recall the product.
Label
1. Manufacturer/Importer’s Name, Address: Name and address of the person responsible for placing the product on the market. There are often multiple addresses on the label, and the address where the product information file is located must be highlighted. (such as underscore the address)
2. Country of Origin: When the product is produced outside the EU, it must be indicated on the product or packaging.
3. Quantity: The content in packaging, expressed by weight or volume.
4. Shelf life: There are two different systems included in cosmetic regulations to indicate shelf life. Which system should be used depends on the shelf life after production.
．If the unopened product has a shelf life of thirty months or more, the expiry date must be indicated. (indicated by an open jar symbol)
．If the product has a shelf life of less than thirty months from production, it must be preceded by a best before end or hourglass symbol before the expiration date.
．In some cases, the expiration date does not need to be stated if the concept of shelf life after opening is not affected.
5. Special Precautions for Use: Instructions for use on how to best use this product. At a minimum, the warnings and special precautions for the cosmetic product must be stated.
6. Lot number or code: This is the unique number of the product, if you have any doubts about the quality of the product, you can check if this applies to the whole lot.
7. Product function: Product description, such as body wash, lip balm, after-sun or shaving foam. The function of the cosmetic must be stated on the packaging unless this is clearly evident from the packaging or product name.
8. Ingredient Declaration: All ingredients used in the production must be declared on the packaging. (represented by the INCI international name cosmetic ingredients)
．Ingredients are listed in order of decreasing weight.
．Ingredients that are less than 1% in a product can be listed at the end of the ingredient list in any order.
．Some products consist of a range of colors, and in order to avoid having to make a separate label for each new shade, all of the colors can be listed in one ingredient statement.
．Dyes should be listed using CI nomenclature (color index) where applicable.
9. Some products come in packages that are so small that there is no room for ingredient descriptions, directions for use and warnings. In this case, hand open book symbol or text can refer to this information. The ingredients, directions for use and warnings can then be printed on a separate card or leaflet with the product.
10. Product labels must be marked in Dutch, and products with instructions for use or warnings must be translated into Dutch.
【參考連結】
https://wetten.overheid.nl/BWBR0029746/2014-03-01#Opschrift
https://www.nvwa.nl/onderwerpen/cosmetica/checklist-etiketteringsverplichtingen-cosmetica
HLF-NL-60
What documents are required when importing approved cosmetics 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：
The responsible person must notify through the EU unified online platform (CPNP, URL: https://reurl.cc/pM8R7x) before the product is put on the market to enter the EU market.
Customs
1. Registration and identification of economic operators: obtain EORI number from Dutch customs registration
Contents of application form:
．Company name, address, zip code, town/city, RSIN/BSN
．VAT ID
．Sign
2. Register with the Dutch customs system
．Applicant’s name or company name, address, zip code and town, chamber of commerce number, EORI number or RSIN, contact name, role, phone number, statement of documents.
．Licenses, software and communication connections
．Expected number of vessels within 14 days
．Total tariffs due within 14 days
．Additional authorization
．Sign (name, role, place, date, signature)
3. Customs declaration
．Company Details: Name, Address, Zip Code, City, Phone Number, Fax Number, EORI Number/RSIN
．Notification details: arrival/entry, departure/result, exceptions
．Registration or container number
．Data claims or documentary evidence
．A brief description of the product, alcohol percentage
．Commodity Code, Quantity, Weight, Origin, Destination, Currency, Value
．Sign (name, role, place, date, signature)
【參考連結】
https://www.belastingdienst.nl/wps/wcm/connect/en/customs/customs
HLF-NL-70
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
The responsible person needs to apply in the EU’s Cosmetic Notification Portal (CPNP), including the following:
1.Compliance with Good Manufacturing Practices (GMP)
Other standards or systems of the same level as this standard may also be used. In the EU region, it is self-managed by the industry, and the company does not need to provide any GMP certificate or require the EU competent authority to issue GMP certification.
2.Product Information File (PIF) for Cosmetic Safety Report (CPSR)
． Qualitative and quantitative composition of product ingredients
． Cosmetics physical, chemical and stability
． Microbial content
． Information on Impurities, Residues and Packaging Materials
． Product Labeling and Warnings
． Use of cosmetics
． Toxicological information on ingredients, ingredients
． Adverse Reactions and Serious Adverse Reactions
． (Other related) information on cosmetics, etc.
3.Animal experiments and verification results
4. Nanomaterials
．If necessary, the Scientific Committee on Consumer Safety (SCCS) will be commissioned to assess the safety of nanomaterials.
The Netherlands Food and Consumer Product Safety Authority (NVWA) may request specific product information from the person in charge, which the manufacturer or supplier must provide within 3 working days (in Dutch).
【參考連結】
https://ec.europa.eu/growth/sectors/cosmetics/cosmetic-product-notification-portal_en
https://www.rvo.nl/onderwerpen/eu-wetgeving/specifieke-producteisen/cosmetica
HLF-NL-80
After a foreign subsidiary imports cosmetics and entrusts a distributor in Kingdom of the Netherlands to sell it, does the distributor need a cosmetics 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：
Product Liability
1. Manufacturers, authorized representatives, first importers within the EU are considered as producers and the main tasks are risk assessment, further investigation and corrective action.
2. Distributors must collect, provide and transmit information.
3. Retailers must immediately pass on information about unsafe products, such as consumer complaints, to their suppliers.
4. If the product does not meet the safety requirements, the manufacturer and distributor must report the risk involved and what has been done to eliminate the hazard by reporting to the NVWA online through the business gateway.
【參考連結】
Contact Us
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