France Health Food Registration QA
Email: par4ww@evershinecpa.com
Manager Zhu, speak in English and Chinese
HLF-FR-10
What are the categories of health food in France? 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 France, food supplements, regulated by the Directorate-General for Competition, Consumption and Combating Fraud (DGCCRF), are intended to supplement the normal diet and consist of a concentrated source of nutrients or other substances with nutritional or physiological effects, alone or in combination is sold in dosage forms in such form as capsules, lozenges, tablets, pills and other similar forms, as well as powder sachets, liquid ampoules, dropper-filled bottles and other similar forms of liquid or powdered preparations, Take in small units.
【參考連結】
https://www.economie.gouv.fr/dgccrf
https://www.legifrance.gouv.fr/loda/id/JORFTEXT000000638341/2022-09-19/
HLF-FR-20
If a foreign company wants to sell health food 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】
https://www.economie.gouv.fr/dgccrf/Securite/Produits-alimentaires/Compl%C3%A9ments-alimentaires
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保健食品公司營業許可證？
Evershine RD：
無須申請營業特許證。
HLF-FR-30
If a foreign company wants to sell health food 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：
No business license.
Adverse reactions related to the consumption of food supplements require notification of a nutritional alert to the French National Agency for Food Safety, Environment and Labour (ANSES).
1. Notifier:
．Health professionals (doctors, pharmacists, nutritionists, etc.).
．Manufacturer or distributor.
．Anyone who has experienced adverse reactions. However, it is advisable to contact a health professional so that he can declare.
2. URL: https://www.nutrivigilance-anses.fr/nutri#!
3. Content:
．Name (reporter), email, zip code, address, phone
．Adverse event occurred, age or year of birth, gender, pregnancy, weight, height, occupation, consumer history, description of factors, adverse effects
．Product, trade name, reason for consumption, consumption dose, place of purchase, start date of use, whether the product is discontinued, end date of consumption, whether the effect disappears after discontinuation, and whether to resume product consumption
．Time of onset, description of symptoms, medical outcome statement, other information, etc.
4. ANSES will assess adverse events and associated liability.
【參考連結】
https://www.economie.gouv.fr/dgccrf/Securite/Produits-alimentaires/Compl%C3%A9ments-alimentaires
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：
Bariatrix Europe
https://www.bariatrixeurope.com/
Actives & Co
HLF-FR-40
Do foreign companies need to apply for an approval before importing health food sold to France? 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：
Food supplements must be declared as companies in France or EU member states.
Before a food supplement can be placed on the market, the DGCCRF (Directorate General of Competition, Consumption and Combating Fraud) must be notified of the food supplement, the specific labelling, the positive list of plants and other substances that can be used in dietary supplements, and the maximum daily intake of nutrients .
1. Declaration agency: DGCCRF online declaration
URL: https://teleicare.dgccrf.finances.gouv.fr
2. Applicants: Those who put food supplements on the market can be manufacturers, importers, distributors, etc., but must be a company in France or an EU member state.
3. Application content:
． Personal information (title, professional phone number, email), etc.
． Label
． User promise
． Product Declaration
． SIRET number
． Ingredient, other active ingredients, ingredient type
． Microorganism
． Describe
． Proof that the product is legally authorized in other EU member states (if any)
． Attachment: Statement (PDF/JPEG/GIF/PNG) etc.
Label
As with all foods, dietary supplements must provide consumers with a range of mandatory information, which must be presented in an easily accessible manner, i.e. on the packaging or on the label affixed to the dietary supplement, stating:
1. Denomination.
2. Ingredient list.
3. Major allergens.
4. Composition and Quantity.
5. Net quantity of food.
6. The date or expiration date of the minimum shelf life.
7. Special conditions of storage and/or use.
8. The operator’s name or company name and address.
9. Country of Origin or Country of Origin.
10. Instructions for use.
11. For beverages containing more than 1.2% alcohol by volume, the actual alcohol concentration by volume.
12. Nutritional Claims: The amounts of nutrients or substances with nutritional or physiological effects present in the Recommended Daily Serving.
13. Category names of nutrients or substances in the product or a statement relating to the properties of these nutrients or substances.
14. The recommended daily dose.
15. Warning not to exceed the indicated daily dose.
16. Statement preventing the use of food supplements as a substitute for a varied diet.
17. Warning that the product should be kept out of the reach of young children.
Notice
1. Labels must be readily visible, legible and, where applicable, indelible. It may not be hidden, obscured, truncated or separated by other indications or images or any other distracting elements.
2. It is prohibited to deceive consumers with false or misleading claims, or to use nutritional or health claims that are not expressly authorized.
3. All products shipped to France must have French labels, and multilingual labels are accepted.
4. French must be used on labels and in documents, packaging and merchandise. The use of foreign names in place of an existing equivalent French term is prohibited; however, when no French equivalent exists, foreign names are authorized.
【參考連結】
https://www.economie.gouv.fr/dgccrf/complements-alimentaires-quel-etiquetage
HLF-FR-45
請問在法國有哪些專業服務機構，可以協助辦理保健食品產品許可證？
Evershine RD：
AxeRegel
Azierta
HLF-FR-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：
Food supplements must be declared as companies in France or EU member states.
Before a food supplement can be placed on the market, the DGCCRF (Directorate General of Competition, Consumption and Combating Fraud) must be notified of the food supplement, the specific labelling, the positive list of plants and other substances that can be used in dietary supplements, and the maximum daily intake of nutrients .
1. Declaration agency: DGCCRF online declaration
URL: https://teleicare.dgccrf.finances.gouv.fr
2. Applicants: Those who put food supplements on the market can be manufacturers, importers, distributors, etc., but must be a company in France or an EU member state.
3. Application content:
． Personal information (title, professional phone number, email), etc.
． Label
． User promise
． Product Declaration
． SIRET number
． Ingredient, other active ingredients, ingredient type
． Microorganism
． Describe
． Proof that the product is legally authorized in other EU member states (if any)
． Attachment: Statement (PDF/JPEG/GIF/PNG) etc.
Label
As with all foods, dietary supplements must provide consumers with a range of mandatory information, which must be presented in an easily accessible manner, i.e. on the packaging or on the label affixed to the dietary supplement, stating:
1. Denomination.
2. Ingredient list.
3. Major allergens.
4. Composition and Quantity.
5. Net quantity of food.
6. The date or expiration date of the minimum shelf life.
7. Special conditions of storage and/or use.
8. The operator’s name or company name and address.
9. Country of Origin or Country of Origin.
10. Instructions for use.
11. For beverages containing more than 1.2% alcohol by volume, the actual alcohol concentration by volume.
12. Nutritional Claims: The amounts of nutrients or substances with nutritional or physiological effects present in the Recommended Daily Serving.
13. Category names of nutrients or substances in the product or a statement relating to the properties of these nutrients or substances.
14. The recommended daily dose.
15. Warning not to exceed the indicated daily dose.
16. Statement preventing the use of food supplements as a substitute for a varied diet.
17. Warning that the product should be kept out of the reach of young children.
Notice
1. Labels must be readily visible, legible and, where applicable, indelible. It may not be hidden, obscured, truncated or separated by other indications or images or any other distracting elements.
2. It is prohibited to deceive consumers with false or misleading claims, or to use nutritional or health claims that are not expressly authorized.
3. All products shipped to France must have French labels, and multilingual labels are accepted.
4. French must be used on labels and in documents, packaging and merchandise. The use of foreign names in place of an existing equivalent French term is prohibited; however, when no French equivalent exists, foreign names are authorized.
【參考連結】
https://www.economie.gouv.fr/dgccrf/complements-alimentaires-quel-etiquetage
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保健食品產品許可證？
Evershine RD：
AxeRegel
Azierta
HLF-FR-60
What documents are required when importing approved health food 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：
Without an import license, food supplements can be imported only if they meet the French requirements and complete the food supplement declaration (= product license) at the competent authority (DGCCRF).
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 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.douane.gouv.fr/professionnels
https://www.douane.gouv.fr/demarche/enregistrer-votre-entreprise-aupres-de-la-douane-numero-eori
https://food.ec.europa.eu/safety/labelling-and-nutrition/food-supplements_en
HLF-FR-70
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
Hazard Analysis System (HACCP)
Food supplements are required to comply with HACCP, a mandatory regulation for food hygiene, and manufacturers need to thoroughly analyze the product for each phase of the associated hazard, severity and frequency of occurrence up to their delivery. As well as appropriate preventive controls, critical controls, to guarantee the safety and quality of the product, manufacturers must demonstrate to France that they comply with the HACCP principles.
Documentation includes:
1. Procedures (PrP, HACCP, QC, etc.).
2. Quality policy implementation plan (review, training, etc.).
3. Instructions for formulation, manufacturing process, packaging, etc.
4. Record and track the lifecycle of each batch of products.
5. Specification sheets related to raw materials and components, semi-finished and finished products, and packaged items.
6. Reasons and proofs supporting production.
【參考連結】
https://www.economie.gouv.fr/dgccrf/complements-alimentaires-regles-dhygiene
HLF-FR-75
法國保健食品審核機構，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：
HQTS
TUV
https://www.tuv.com/france/fr/
HLF-FR-77
請問在法國有哪些保健食品檢驗機構可以提供保健食品檢驗服務？網頁？
Evershine RD：
Lustrel
FL
https://www.thefrenchlab.fr/en/
HLF-FR-80
After a foreign subsidiary imports health food and entrusts a distributor in France 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. Food supplements can be imported only if they meet the French requirements and complete the food supplement declaration.
Adverse reactions related to the consumption of food supplements require notification of a nutritional alert to the French National Agency for Food Safety, Environment and Labour (ANSES).
1. Notifier:
．Health professionals (doctors, pharmacists, nutritionists, etc.).
．Manufacturer or distributor.
．Anyone who has experienced adverse reactions. However, it is advisable to contact a health professional so that he can declare.
2. URL: https://www.nutrivigilance-anses.fr/nutri#
3. Content:
．Name (reporter), email, zip code, address, phone
．Adverse event occurred, age or year of birth, gender, pregnancy, weight, height, occupation, consumer history, description of factors, adverse effects
．Product, trade name, reason for consumption, consumption dose, place of purchase, start date of use, whether the product is discontinued, end date of consumption, whether the effect disappears after discontinuation, and whether to resume product consumption
．Time of onset, description of symptoms, medical outcome statement, other information, etc.
4. ANSES will assess adverse events and associated liability.
【參考連結】
https://www.economie.gouv.fr/dgccrf/Securite/Produits-alimentaires/Compl%C3%A9ments-alimentaires
HLF-FR-85
請問在法國有哪些專精於保健食品銷售與消費權益相關法律服務的業者？
Evershine RD：
Delcade
Avibitton
https://www. avibitton.com/en/
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Manager Zhu, speak in English and Chinese
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Email: par4ww@evershinecpa.com
Manager Zhu, speak in French English and Chinese
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Email: par4ww@evershinecpa.com
Manager Zhu, speak in French English and Chinese
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