France Cosmetic Registration QA

Email: par4ww@evershinecpa.com
Manager Zhu, speak in French English and Chinese

HLF-FR-10

What are the categories of cosmetics in France? 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 France, the regulation of the cosmetic market is carried out by the French National Agency for the Safety of Medicines and Health Products (ANSM) and the Directorate-General for Competition Policy, Consumer Affairs and Fraud Control (DGCCRF).

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 cannot be displayed as having properties for the treatment or prevention of human disease, and products intended to be ingested, inhaled, injected or implanted in the body are not classified as cosmetic, even if they claim to be harmful to the skin, teeth, oral mucosa and/or skin appendages (hair, nails) have a special effect. In addition, cosmetic products are monitored by the manufacturer, importer, or those responsible for placing them on the market for claims related to their products.

【參考連結】

file:///C:/Users/B109005/Downloads/20201214-faq-reglementation-cosmetiques.pdf

https://ansm.sante.fr/documents/reference/reglementation-des-produits-cosmetiques

HLF-FR-20

If a foreign company wants to sell cosmetics in France, 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】

file:///C:/Users/B109005/Downloads/20201214-faq-reglementation-cosmetiques.pdf

HLF-FR-25

假如需要辦理，請問法國有專業服務公司可以協助辦理化妝品公司營業許可證？

Evershine RD：

無須申請營業特許證。

No business license is required.

HLF-FR-30

外國公司要到法國銷售化妝品，可以指派法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 cosmetics in France, can it assign an France 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. 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.

Cosmetics do not need marketing authorization before they are put on the market, but the designated person in charge must ensure that the products put on the market are safe for human health under normal or reasonably foreseeable conditions of use, and are obliged to report after the cosmetics are put on the market, such as serious adverse reactions. statement or risk communication, and action to be taken when the product does not meet its safety obligations. France stipulates that when a serious adverse reaction occurs, the responsible person must report to the French ANSM and DGCCRF, a notification of fulfilling the obligation to report risks and take measures,

【參考連結】

https://single-market-economy.ec.europa.eu/sectors/cosmetics/cosmetic-product-notification-portal_en

https://ansm.sante.fr/contact

https://www.economie.gouv.fr/dgccrf/securite/avis-rappels-produits

HLF-FR-35

假如需要辦理指派法國公司擔任營業代理人，請問法國有專業服務公司可以協助？

Evershine RD：

Quatres

http://quatrescosmetics.com/

Passion Cosmetics Paris

https://www.passioncosmeticsparis.com/en/

HLF-FR-40

Do foreign companies need to apply for an approval before importing cosmetics sold to France? 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：

Yes. Applications must be made in the name of a corporate legal person or a natural person within 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

The container and packaging of every cosmetic product offered on the market, whether free or paid, must present the following information in French and in a clear, understandable, indelible form:

1. Name/company name and address of the person in charge: It can be abbreviated, provided that it is easy to identify.

2. Country of Origin

3. Mass or volume content when packaged, except for:

·Packages of product less than 5 grams or less than 5 ml

·Free Sample

·Products in single-dose form

·A prepackaged product containing a set of parts, provided that the quantity of the parts is mentioned on the prepackage, or that the quantity is easily externally determinable, or that the product is usually only sold individually.

4. Minimum Shelf Life: Dates must be mentioned explicitly and consist of month and year (eg: 07/2013) or day, month and year (eg: 06/07/2013) in order. If necessary, conditions of durability can be indicated.

5. Shelf life after opening: Products with a minimum shelf life of more than 30 months are required to label. Indicated by the symbol representing a jar of cream or green, followed by the expiration date (in months and/or years). If the period is expressed in months, it can be expressed with a number followed by the word month or the abbreviation M.

The following shelf life recommendations are published on the ANSM website:

·Minimum period of less than 30 months

·Products without risk of spoilage (e.g. Eau de Parfum)

·Use of these products does not require opening the package (e.g. sprays)

·Intended for one-time use only (eg, a single dose).

6. Special precautions for use, conditions of use and warnings, and instructions for any special precautions for professional use of cosmetic products. In cases where there is insufficient space, the report must be made on flyers, labels, tapes, cards attached to or attached to the product.

7. Manufacture Lot Number or allow to identify manufacture.

8. Function of product (moisturizer, conditioner, etc.).

9. Product ingredient list in descending order by weight (quantity): This list may appear only on the packaging, or on a leaflet, label, or card affixed to the product (may be indicated by an abbreviation or a symbol on the packaging)
Perfume, fragrances and fragrance compositions and their raw materials are denoted by the term perfume or aroma. In addition, in addition to the term perfume or aroma, the substance should be indicated in the ingredient list,

【參考連結】

https://single-market-economy.ec.europa.eu/sectors/cosmetics/cosmetic-product-notification-portal_en

https://ansm.sante.fr/documents/reference/reglementation-des-produits-cosmetiques

HLF-FR-45

請問在法國有哪些專業服務機構，可以協助辦理化妝品產品許可證？

Evershine RD：

Ecomundo

https://www.ecomundo.eu/en

Quatres

http://quatrescosmetics.com/

HLF-FR-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？化妝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 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.

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

The container and packaging of every cosmetic product offered on the market, whether free or paid, must present the following information in French and in a clear, understandable, indelible form:

1. Name/company name and address of the person in charge: It can be abbreviated, provided that it is easy to identify.

2. Country of Origin

3. Mass or volume content when packaged, except for:

·Packages of product less than 5 grams or less than 5 ml

·Free Sample

·Products in single-dose form

·A prepackaged product containing a set of parts, provided that the quantity of the parts is mentioned on the prepackage, or that the quantity is easily externally determinable, or that the product is usually only sold individually.

4. Minimum Shelf Life: Dates must be mentioned explicitly and consist of month and year (eg: 07/2013) or day, month and year (eg: 06/07/2013) in order. If necessary, conditions of durability can be indicated.

5. Shelf life after opening: Products with a minimum shelf life of more than 30 months are required to label. Indicated by the symbol representing a jar of cream or green, followed by the expiration date (in months and/or years). If the period is expressed in months, it can be expressed with a number followed by the word month or the abbreviation M.

The following shelf life recommendations are published on the ANSM website:

·Minimum period of less than 30 months

·Products without risk of spoilage (e.g. Eau de Parfum)

·Use of these products does not require opening the package (e.g. sprays)

·Intended for one-time use only (eg, a single dose).

6. Special precautions for use, conditions of use and warnings, and instructions for any special precautions for professional use of cosmetic products. In cases where there is insufficient space, the report must be made on flyers, labels, tapes, cards attached to or attached to the product.

7. Manufacture Lot Number or allow to identify manufacture.

8. Function of product (moisturizer, conditioner, etc.).

9. Product ingredient list in descending order by weight (quantity): This list may appear only on the packaging, or on a leaflet, label, or card affixed to the product (may be indicated by an abbreviation or a symbol on the packaging) . Perfume, fragrances and fragrance compositions and their raw materials are denoted by the term perfume or aroma. In addition, in addition to the term perfume or aroma, the substance should be indicated in the ingredient list,

【參考連結】

https://single-market-economy.ec.europa.eu/sectors/cosmetics/cosmetic-product-notification-portal_en

https://ansm.sante.fr/documents/reference/reglementation-des-produits-cosmetiques

HLF-FR-55

請問在法國有哪些專業服務機構，可以協助以外國公司名義辦理化妝品產品許可證？

Evershine RD：

Ecomundo

https://www.ecomundo.eu/en

Quatres

http://quatrescosmetics.com/

HLF-FR-60

What documents are required when importing approved cosmetics into France? 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

Registered with French customs to obtain EORI number

Contents of application form:

． Company Name/Name (Natural Person)

． Creation Date/Birthday

． Address, phone, email

． Contact person

． SIRET number

． VAT number

2. Complete the electronic customs declaration on the Delta website, including the declaration form (air or sea manifest), single administrative document (SAD), website: https://reurl.cc/eOQ2pQ.

Contents of declaration form

． Operator’s name and EORI

． Customs Clearance Office Code

． Customs code

． Number of packages

． Sender’s name and address, recipient’s name and address

． Commercial description of the item

． Total mass in kilograms

． Country of origin code

． Invoice value and currency

． Import declaration, etc.

Single Administrative Document (SAD)

． Shipper

． Recipient

． Declarer

． Means of transport, country on departure

． Transit conveyance, country

． Shipping method

． Commercial number

． Payment method

． Destination code

． Terms of Delivery

． Transaction nature

． Container Numbers, Seals and Numbers

． Product code, weight

． Tax calculations

． Arrival date

． Office

． Declarant, etc.

3. Required documents for customs clearance

．Invoice, which should be written in French (or accompanied by a translation)

．Measurement (units must be in metric)

．Shipping Documentation (LTA/AWB, Maritim Connaissement/Bill of Lading, LTM, CMR or LVI)

．Declaration of Origin under CETA Agreement

．Documents proving conformity to EC or French standards

There is no sales license, but before the cosmetics are put on the market, the responsible person needs to ensure the following:

1. Composition of cosmetics: The selection of ingredients contained in cosmetics must comply with cosmetic regulations, including

． Banned Substances

． Restricted Substances

． Substances authorized as

． Colorant

． Preservatives

． UV filter

2. Manufacture: The manufacture of cosmetic products is carried out in accordance with Good Manufacturing Practice (GMP).

3. Preparation of Cosmetic Information File (DIP): A product information file must be prepared for each cosmetic product placed on the market, including soaps, free samples or promotional cosmetic products, etc. The DIP must be at the address of the person in charge that appears on the product label, be available to the competent authority, and be kept by the person in charge for 10 years (from the date of the last batch of cosmetic products placed on the market) in either electronic or paper format, available French or English.

Include the following information:

． Description of the cosmetic:

Include the qualitative, quantitative formula of the product, the exact name of the product, code, logo or formula name for clear identification.

．Product Safety Report

．Declaration of conformity with Good Manufacturing Practice (GMP) (The GMP declaration of conformity can be made by the responsible person or by a third party.)

． Data related to animal testing conducted by the manufacturer, its agents or suppliers, as well as data related to the development or evaluation of cosmetic products or their safety

4. Preparation of the Cosmetic Information File (DIP): A product must be prepared for each cosmetic product placed on the market.

5. Container and packaging labels comply with the rules

6. Complete the Cosmetic Filing Notification Process (CPNP)

【參考連結】

https://www.douane.gouv.fr/professionnels

HLF-FR-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.

【參考連結】

https://ec.europa.eu/growth/sectors/cosmetics/cosmetic-product-notification-portal_en

HLF-FR-75

法國化妝品審核機構，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：

SGS

https://www.sgs.com.tw/

TÜV

https://www.tuv.com/world/en/

HLF-FR-77

請問在法國有哪些化妝品檢驗機構可以提供化妝品檢驗服務？網頁？

Evershine RD：

SGS

https://www.sgsgroup.fr/en

IEC

https://www.iecfrance.com/en/home/

HLF-FR-80

After a foreign subsidiary imports cosmetics and entrusts a distributor in France 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：

No business license is required.

Cosmetics do not need marketing authorization before they are put on the market, but the designated person in charge must ensure that the products put on the market are safe for human health under normal or reasonably foreseeable conditions of use, and are obliged to report after the cosmetics are put on the market, such as serious adverse reactions. statement or risk communication, and action to be taken when the product does not meet its safety obligations. France stipulates that when a serious adverse reaction occurs, the responsible person must report to the French ANSM and DGCCRF, a notification of fulfilling the obligation to report risks and take measures,

【參考連結】

https://ansm.sante.fr/contact

https://www.economie.gouv.fr/dgccrf/securite/avis-rappels-produits

HLF-FR-85

請問在法國有哪些專精於化妝品銷售與消費權益相關法律服務的業者？

Evershine RD：

FIL

https://fil-avocats.com/

Ponthieu Advocates

https://www.ponthieuavocats.com/en/

Legitic

http://www.legitic.com/

Contact Us

Paris Evershine BPO Service Limited Corp.
Email: par4ww@evershinecpa.com
Manager Zhu, speak in English and Chinese

or
For investment structure relevant with multi-national tax planning and Financial & Legal Due Diligence for M&A (Merge and Acquisition), email to HQ4par@evershinecpa.com
Dale Chen, Principal Partner/CPA in Taiwan+China+UK will be accountable to your case.
linkedin address: Dale Chen

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Besides, Evershine is Taiwan local Partner of ADP Streamline ®.
(version: 2024/07)

Please send email to HQ4par@evershinecpa.com

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