法國保健食品登記法規問題集
Email:par4ww@evershinecpa.com
或
法國永輝BPO有限公司
Paris time zone:
Manager Zhu, 法國永居卡居民 說法文中文和英文
或
China Time Zone:
聯絡人: 陳中成 總經理 in 台+中+英;專利師;企管碩士+企管博士
Mobile: +886-933920199
in Taiwan; Mobile: +86-139-1048-6278
in China
TEL: +886-2-27170515 E100
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Wechat id:evershiinecpa;
Line Id: evershinecpa
Skype: daleccchen
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linkedin address:Dale Chen Linkedin
HLF-FR-10
請問法國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 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:
在法國,食品補充劑由「競爭、消費和打擊欺詐總局」 (Directorate-General for Competition, Consumption and Combating Fraud, DGCCRF)監管,食品補充劑旨在補充正常飲食的食品,由營養物質或其他具有營養或生理作用的濃縮物質構成,單獨或組合的方式以劑量形式銷售,其呈現形式例如膠囊、錠劑、片劑、丸劑和其他類似形式,以及粉袋、液體安剖、裝有滴管的瓶子和其他類似形式的液體或粉狀製劑,小計量單位服用。
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
外國公司要到法國銷售保健食品,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 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
外國公司要到法國銷售保健食品,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 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:
可以,以法國當地或歐盟成員國之公司身分登記食品補充劑產品申報。
申報機構:DGCCRF線上申報(https://teleicare.dgccrf.finances.gouv.fr)
申請者資格:將食品補充劑投放市場者,可以是製造商、進口商、經銷商等,但需為法國或歐盟成員國之公司身分。
食用食品補充劑有關的不良反應需向法國國家食品安全、環境及勞動局(ANSES) 通報營養警戒。
1.通報者:
.衛生專業人員 (醫生、藥劑師、營養師等)。
.製造商或分銷商。
.任何經歷過不良反應的人。但是建議聯繫健康專業人士,以便進行申報。
2.網頁:https://www.nutrivigilance-anses.fr/nutri#!
3.通報內容:
.姓名(申報人)、電子郵件、郵政編碼、地址、電話
.發生不良事件者、年齡或出生年份、性別、是否懷孕中、體重、身高、職業、消費者歷史、因素描述、不良影響
.產品、商品名稱、消費原因、消耗劑量、購買地點、開始使用日期、產品是否停產、消費結束日期、停藥後是否影響消失、是否恢復產品消費
.發病時間、症狀描述、醫療結果聲明、其他信息等
4. ANSES將評估不良事件及相關責任。
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
HLF-FR-40
外國公司銷售到法國保健食品本身,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 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:
需要,須以法國或歐盟成員國之公司身分登記食品補充劑產品申報。
在食品補充劑投放市場之前,必須向DGCCRF(競爭、消費和打擊欺詐總局)通報食品補充劑、特定標籤、可用於膳食補充劑的植物和其他物質的正面清單以及營養素的最大每日攝入量。
1.申報機構:DGCCRF線上申報
網頁:https://teleicare.dgccrf.finances.gouv.fr
2.申請者:將食品補充劑投放市場者,可以是製造商、進口商、經銷商等,但需為法國或歐盟成員國之公司身分。
3.申請內容:
.個人信息(職位、專業電話號碼、電子郵件)等。
.標籤
.用戶承諾書
.產品聲明
.SIRET 編號
.成分、其他活性成分、成分類型
.微生物
.描述
.產品在歐盟其他成員國合法授權之證明(如果有)
.附件:聲明書(PDF/JPEG/GIF/ PNG)等
標籤
與所有食品一樣,食品補充劑必須向消費者提供一系列強制性信息,必須以易於取用的方式呈現,即在包裝上或附在食品補充劑上的標籤上標示:
1.面額。
2.成分清單。
3.主要過敏原。
4.成分和數量。
5.食品的淨數量。
6.最低保質期的日期或到期日。
7.特殊的儲存和/或使用條件。
8.經營者的名稱或公司名稱和地址。
9.原產國或原產地。
10.使用說明。
11.對於酒精含量超過 1.2%(按體積計)的飲料,按體積計的實際酒精濃度。
12.營養聲明:推薦的每日份量中存在的營養物質或具有營養或生理作用的物質的量。
13.產品的營養素或物質的類別名稱或與這些營養素或物質的性質有關的說明。
14.推薦每日劑量。
15.警告不要超過指示的每日劑量。
16.防止將食品補充劑用作多樣化飲食的替代品的聲明。
17.產品應存放在幼兒接觸不到的地方的警告。
注意
1. 標籤必須容易看到、清晰易讀,並且在適用的情況下,不可磨滅。
不可以被其他指示或圖像或任何其他干擾元素隱藏、遮蔽、截斷或分隔。
2. 禁止以虛假或誤導性的說法欺騙消費者,禁止使用未經明確授權的營養或健康聲明。
3. 所有運往法國的產品必須有法語標籤,可以接受多語言標籤。
4.在標籤以及文件、包裝和商品中必須使用法語。
禁止使用外國名稱代替現有的等效法語術語; 但是當不存在法語等效名稱時,外國名稱是被授權的。
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
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?
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:
須以法國或歐盟成員國之公司身分登記食品補充劑產品申報。
在食品補充劑投放市場之前,必須向DGCCRF(競爭、消費和打擊欺詐總局)通報食品補充劑、特定標籤、可用於膳食補充劑的植物和其他物質的正面清單以及營養素的最大每日攝入量。
1.申報機構:DGCCRF線上申報
網頁:https://teleicare.dgccrf.finances.gouv.fr
2.申請者:將食品補充劑投放市場者,可以是製造商、進口商、經銷商等,但需為法國或歐盟成員國之公司身分。
3.申請內容:
.個人信息(職位、專業電話號碼、電子郵件)等。
.標籤
.用戶承諾書
.產品聲明
.SIRET 編號
.成分、其他活性成分、成分類型
.微生物
.描述
.產品在歐盟其他成員國合法授權之證明(如果有)
.附件:聲明書(PDF/JPEG/GIF/ PNG)等
標籤
與所有食品一樣,食品補充劑必須向消費者提供一系列強制性信息,必須以易於取用的方式呈現,即在包裝上或附在食品補充劑上的標籤上標示:
1.面額。
2.成分清單。
3.主要過敏原。
4.成分和數量。
5.食品的淨數量。
6.最低保質期的日期或到期日。
7.特殊的儲存和/或使用條件。
8.經營者的名稱或公司名稱和地址。
9.原產國或原產地。
10.使用說明。
11.對於酒精含量超過 1.2%(按體積計)的飲料,按體積計的實際酒精濃度。
12.營養聲明:推薦的每日份量中存在的營養物質或具有營養或生理作用的物質的量。
13.產品的營養素或物質的類別名稱或與這些營養素或物質的性質有關的說明。
14.推薦每日劑量。
15.警告不要超過指示的每日劑量。
16.防止將食品補充劑用作多樣化飲食的替代品的聲明。
17.產品應存放在幼兒接觸不到的地方的警告。
注意
1. 標籤必須容易看到、清晰易讀,並且在適用的情況下,不可磨滅。
不可以被其他指示或圖像或任何其他干擾元素隱藏、遮蔽、截斷或分隔。
2. 禁止以虛假或誤導性的說法欺騙消費者,禁止使用未經明確授權的營養或健康聲明。
3. 所有運往法國的產品必須有法語標籤,可以接受多語言標籤。
4.在標籤以及文件、包裝和商品中必須使用法語。禁止使用外國名稱代替現有的等效法語術語; 但是當不存在法語等效名稱時,外國名稱是被授權的。
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
HLF-FR-60
經過核准登記的保健食品,進口到法國要檢附什麼文件?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 France? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD:
食品補充劑必須符合法國的要求並在主管部門 (DGCCRF )完成食品補充劑申報即可進口。
海關
1. 經濟經營者註冊和識別
於法國海關註冊取得EORI 編號
申請書內容:
.公司名稱/姓名(自然人)
.創建日期/生日
.地址、電話、電子郵件
.聯絡人
.SIRET號碼
.增值稅號碼
2. 於Delta網站完成電子報關,包含申報單(空運或海運艙單)、單一行政文件 (SAD),網頁:https://reurl.cc/eOQ2pQ。
申報單內容
.運營商的名稱和EORI
.清關辦事處代碼
.報關處代碼
.包裹數量
.發件人的姓名和地址、收件人的姓名和地址
.商品的商業描述
.以千克為單位的總質量
.原產國代碼
.發票價值和貨幣
.進口聲明等
單一行政文件 (SAD)
.託運人
.收件人
.申報人
.出發時運輸工具、國家
.過境運輸工具、國家
.運輸方式
.商業編號
.付款方式
.目的地代碼
.交貨條款
.交易性質
.貨櫃編號、密封貼及編號
.商品代碼、重量
.稅務計算
.抵港日期
.辦事處
.聲明人等
3. 清關所需文件
.發票,應以法語書寫(或附有翻譯)
.計量(單位必須是公制)
.運輸文件(LTA/AWB、Maritim Connaissement/Bill of Lading、LTM、CMR 或 LVI)
.根據 CETA 協議的原產地聲明
.證明符合 EC 或法國標準的文件
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。
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
法國保健食品審核機構,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)
食品補充劑需要符合HACCP,為食品衛生的強制性規定,製造商需要對每個階段相關的危害、嚴重性和發生頻率的詳盡分析產品直到他們的交付產品。以及適當的預防性控制措施、關鍵控制措施,用以保證產品的安全和質量,製造商必須向法國證明他們遵HACCP 原則。
文件包括:
1.程序(PrP、HACCP、質量控制等)。
2.質量政策實施計劃(審核、培訓等)。
3.配方、製造工藝、包裝等的說明。
4.記錄跟追蹤每批產品的生命週期。
5.原材料和成分、半成品和成品以及包裝物品有關的規格表。
6.支持生產的理由、證明。
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
HLF-FR-77
HLF-FR-80
外國子公司進口保健食品後,如果委託法國的經銷商銷售,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 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:
不需要,完成食品補充劑產品申報即可進口。
食用食品補充劑有關的不良反應需向法國國家食品安全、環境及勞動局(ANSES) 通報營養警戒。
1.通報者:
.衛生專業人員 (醫生、藥劑師、營養師等)。
.製造商或分銷商。
.任何經歷過不良反應的人。但是建議聯繫健康專業人士,以便進行申報。
2.網頁:https://www.nutrivigilance-anses.fr/nutri#!
3.通報內容:
.姓名(申報人)、電子郵件、郵政編碼、地址、電話
.發生不良事件者、年齡或出生年份、性別、是否懷孕中、體重、身高、職業、消費者歷史、因素描述、不良影響
.產品、商品名稱、消費原因、消耗劑量、購買地點、開始使用日期、產品是否停產、消費結束日期、停藥後是否影響消失、是否恢復產品消費
.發病時間、症狀描述、醫療結果聲明、其他信息等
4. ANSES將評估不良事件及相關責任。
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
連繫人:
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