各国健康食品登记法规问答集
Email:par4ww@evershinecpa.com
或
法国永辉BPO有限公司
Paris time zone:
Manager Zhu, 法国永居卡居民 说法文中文和英文
或
China Time Zone:
联络人: 林幸穗 Anny Lin 协理
手机:+886-937-606-272
skype: annylin8008
wechat: annylin8008
电话:+886-2-2717-0515 分机:110
HLF-FR-10
请问法国对于保健食品的归类方式为何?它的正式名称为何?不同归类管理强度有何差异?它的政府管辖机构为何?网页?
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:
在法国,食品补充剂由「竞争、消费和打击欺诈总局」 (Directorate-General for Competition, Consumption and Combating Fraud, DGCCRF)监管,食品补充剂旨在补充正常饮食的食品,由营养物质或其他具有营养或生理作用的浓缩物质构成,单独或组合的方式以剂量形式销售,其呈现形式例如胶囊、锭剂、片剂、丸剂和其他类似形式,以及粉袋、液体安剖、装有滴管的瓶子和其他类似形式的液体或粉状製剂,小计量单位服用。
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.
【参考连结】
https://www.economie.gouv.fr/dgccrf
https://www.legifrance.gouv.fr/loda/id/JORFTEXT000000638341/2022-09-19/
HLF-FR-20
外国公司要到法国销售保健食品,无论设100%子公司或分公司,需要在公司登记时取得营业特许证?
假如要,其必要条件是什麽?所需文件及申请程序为何?网页?
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:
无须申请营业特许证。
No business license is required.
【参考连结】
https://www.economie.gouv.fr/dgccrf/Securite/Produits-alimentaires/Compl%C3%A9ments-alimentaires
HLF-FR-25
假如需要办理,请问法国有专业服务公司可以协助办理保健食品公司营业许可证?
Evershine RD:
无须申请营业特许证。
HLF-FR-30
外国公司要到法国销售保健食品,可以指派法国公司担任营业代理人销售吗?
担任营业代理人,其必要条件是什麽?所需文件及申请程序为何?外国公司与营业代理人的产品责任为何?网页?
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,以法国当地或欧盟成员国之公司身分登记食品补充剂产品申报。
申报机构:DGCCRF线上申报(https://teleicare.dgccrf.finances.gouv.fr)
申请者资格:将食品补充剂投放市场者,可以是製造商、进口商、经销商等,但需为法国或欧盟成员国之公司身分。
食用食品补充剂有关的不良反应需向法国国家食品安全、环境及劳动局(ANSES) 通报营养警戒。
1.通报者:
.卫生专业人员 (医生、药剂师、营养师等)。
.製造商或分销商。
.任何经历过不良反应的人。但是建议联繫健康专业人士,以便进行申报。
2.网页:https://www.nutrivigilance-anses.fr/nutri#!
3.通报内容:
.姓名(申报人)、电子邮件、邮政编码、地址、电话
.发生不良事件者、年龄或出生年份、性别、是否怀孕中、体重、身高、职业、消费者历史、因素描述、不良影响
.产品、商品名称、消费原因、消耗剂量、购买地点、开始使用日期、产品是否停产、消费结束日期、停药后是否影响消失、是否恢復产品消费
.发病时间、症状描述、医疗结果声明、其他信息等
4. ANSES将评估不良事件及相关责任。
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.
【参考连结】
https://www.economie.gouv.fr/dgccrf/Securite/Produits-alimentaires/Compl%C3%A9ments-alimentaires
HLF-FR-35
HLF-FR-40
外国公司销售到法国保健食品本身,进口前需要办理产品许可吗?如需要,哪个单位在管理?需要什麽文件?
申请程序为何?保健食品包装内容及各种标示,需要事先核准吗?可允许的语文有哪些?网页?
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,须以法国或欧盟成员国之公司身分登记食品补充剂产品申报。
在食品补充剂投放市场之前,必须向DGCCRF(竞争、消费和打击欺诈总局)通报食品补充剂、特定标籤、可用于膳食补充剂的植物和其他物质的正面清单以及营养素的最大每日摄入量。
1.申报机构:DGCCRF线上申报
网页:https://teleicare.dgccrf.finances.gouv.fr
2.申请者:将食品补充剂投放市场者,可以是製造商、进口商、经销商等,但需为法国或欧盟成员国之公司身分。
3.申请内容:
.个人信息(职位、专业电话号码、电子邮件)等。
.标籤
.用户承诺书
.产品声明
.SIRET 编号
.成分、其他活性成分、成分类型
.微生物
.描述
.产品在欧盟其他成员国合法授权之证明(如果有)
.附件:声明书(PDF/JPEG/GIF/ PNG)等
标籤
与所有食品一样,食品补充剂必须向消费者提供一系列强制性信息,必须以易于取用的方式呈现,即在包装上或附在食品补充剂上的标籤上标示:
1.面额。
2.成分清单。
3.主要过敏原。
4.成分和数量。
5.食品的淨数量。
6.最低保质期的日期或到期日。
7.特殊的储存和/或使用条件。
8.经营者的名称或公司名称和地址。
9.原产国或原产地。
10.使用说明。
11.对于酒精含量超过 1.2%(按体积计)的饮料,按体积计的实际酒精浓度。
12.营养声明:推荐的每日份量中存在的营养物质或具有营养或生理作用的物质的量。
13.产品的营养素或物质的类别名称或与这些营养素或物质的性质有关的说明。
14.推荐每日剂量。
15.警告不要超过指示的每日剂量。
16.防止将食品补充剂用作多样化饮食的替代品的声明。
17.产品应存放在幼儿接触不到的地方的警告。
注意
1. 标籤必须容易看到、清晰易读,并且在适用的情况下,不可磨灭。
不可以被其他指示或图像或任何其他干扰元素隐藏、遮蔽、截断或分隔。
2. 禁止以虚假或误导性的说法欺骗消费者,禁止使用未经明确授权的营养或健康声明。
3. 所有运往法国的产品必须有法语标籤,可以接受多语言标籤。
4.在标籤以及文件、包装和商品中必须使用法语。
禁止使用外国名称代替现有的等效法语术语; 但是当不存在法语等效名称时,外国名称是被授权的。
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.
【参考连结】
https://www.economie.gouv.fr/dgccrf/complements-alimentaires-quel-etiquetage
HLF-FR-45
HLF-FR-50
外国公司可以用自己名义申请办理产品许可吗?如需要,哪个单位在管理?需要什麽文件?申请程序为何?
保健食品包装内容及各种标示,需要事先核准吗?可允许的语文有哪些?网页?
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:
须以法国或欧盟成员国之公司身分登记食品补充剂产品申报。
在食品补充剂投放市场之前,必须向DGCCRF(竞争、消费和打击欺诈总局)通报食品补充剂、特定标籤、可用于膳食补充剂的植物和其他物质的正面清单以及营养素的最大每日摄入量。
1.申报机构:DGCCRF线上申报
网页:https://teleicare.dgccrf.finances.gouv.fr
2.申请者:将食品补充剂投放市场者,可以是製造商、进口商、经销商等,但需为法国或欧盟成员国之公司身分。
3.申请内容:
.个人信息(职位、专业电话号码、电子邮件)等。
.标籤
.用户承诺书
.产品声明
.SIRET 编号
.成分、其他活性成分、成分类型
.微生物
.描述
.产品在欧盟其他成员国合法授权之证明(如果有)
.附件:声明书(PDF/JPEG/GIF/ PNG)等
标籤
与所有食品一样,食品补充剂必须向消费者提供一系列强制性信息,必须以易于取用的方式呈现,即在包装上或附在食品补充剂上的标籤上标示:
1.面额。
2.成分清单。
3.主要过敏原。
4.成分和数量。
5.食品的淨数量。
6.最低保质期的日期或到期日。
7.特殊的储存和/或使用条件。
8.经营者的名称或公司名称和地址。
9.原产国或原产地。
10.使用说明。
11.对于酒精含量超过 1.2%(按体积计)的饮料,按体积计的实际酒精浓度。
12.营养声明:推荐的每日份量中存在的营养物质或具有营养或生理作用的物质的量。
13.产品的营养素或物质的类别名称或与这些营养素或物质的性质有关的说明。
14.推荐每日剂量。
15.警告不要超过指示的每日剂量。
16.防止将食品补充剂用作多样化饮食的替代品的声明。
17.产品应存放在幼儿接触不到的地方的警告。
注意
1. 标籤必须容易看到、清晰易读,并且在适用的情况下,不可磨灭。
不可以被其他指示或图像或任何其他干扰元素隐藏、遮蔽、截断或分隔。
2. 禁止以虚假或误导性的说法欺骗消费者,禁止使用未经明确授权的营养或健康声明。
3. 所有运往法国的产品必须有法语标籤,可以接受多语言标籤。
4.在标籤以及文件、包装和商品中必须使用法语。禁止使用外国名称代替现有的等效法语术语; 但是当不存在法语等效名称时,外国名称是被授权的。
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.
【参考连结】
https://www.economie.gouv.fr/dgccrf/complements-alimentaires-quel-etiquetage
HLF-FR-55
HLF-FR-60
经过核准登记的保健食品,进口到法国要检附什麽文件?经过什麽手续?
在销售时要向各地的卫生福利部相关机构事先或事后准备吗?网页?
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:
食品补充剂必须符合法国的要求并在主管部门 (DGCCRF )完成食品补充剂申报即可进口。
海关
1. 经济经营者註册和识别
于法国海关註册取得EORI 编号
申请书内容:
.公司名称/姓名(自然人)
.创建日期/生日
.地址、电话、电子邮件
.联络人
.SIRET号码
.增值税号码
2. 于Delta网站完成电子报关,包含申报单(空运或海运舱单)、单一行政文件 (SAD),网页:https://reurl.cc/eOQ2pQ。
申报单内容
.运营商的名称和EORI
.清关办事处代码
.报关处代码
.包裹数量
.发件人的姓名和地址、收件人的姓名和地址
.商品的商业描述
.以千克为单位的总质量
.原产国代码
.发票价值和货币
.进口声明等
单一行政文件 (SAD)
.託运人
.收件人
.申报人
.出发时运输工具、国家
.过境运输工具、国家
.运输方式
.商业编号
.付款方式
.目的地代码
.交货条款
.交易性质
.货柜编号、密封贴及编号
.商品代码、重量
.税务计算
.抵港日期
.办事处
.声明人等
3. 清关所需文件
.发票,应以法语书写(或附有翻译)
.计量(单位必须是公制)
.运输文件(LTA/AWB、Maritim Connaissement/Bill of Lading、LTM、CMR 或 LVI)
.根据 CETA 协议的原产地声明
.证明符合 EC 或法国标准的文件
无销售许可证,但在食品补充剂投放市场前,需确保以下几点:
1.营养声明符合欧盟规范。
2.食品补充剂的成分符合欧盟规范。
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.
【参考连结】
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
法国保健食品审核机构,需要附上的实验室检验资料有哪些? 网页?
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD:
风险分析系统(HACCP)
食品补充剂需要符合HACCP,为食品卫生的强制性规定,製造商需要对每个阶段相关的危害、严重性和发生频率的详尽分析产品直到他们的交付产品。以及适当的预防性控制措施、关键控制措施,用以保证产品的安全和质量,製造商必须向法国证明他们遵HACCP 原则。
文件包括:
1.程序(PrP、HACCP、质量控制等)。
2.质量政策实施计划(审核、培训等)。
3.配方、製造工艺、包装等的说明。
4.记录跟追踪每批产品的生命週期。
5.原材料和成分、半成品和成品以及包装物品有关的规格表。
6.支持生产的理由、证明。
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.
【参考连结】
https://www.economie.gouv.fr/dgccrf/complements-alimentaires-regles-dhygiene
HLF-FR-75
HLF-FR-77
HLF-FR-80
外国子公司进口保健食品后,如果委託法国的经销商销售,经销商需要保健食品营业许可证吗?
假如保健食品有品质瑕疵的话,外国子公司和经销商各自的责任为何?是连带责任吗?还是可以规范由外国子公司负责?
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,完成食品补充剂产品申报即可进口。
食用食品补充剂有关的不良反应需向法国国家食品安全、环境及劳动局(ANSES) 通报营养警戒。
1.通报者:
.卫生专业人员 (医生、药剂师、营养师等)。
.製造商或分销商。
.任何经历过不良反应的人。但是建议联繫健康专业人士,以便进行申报。
2.网页:https://www.nutrivigilance-anses.fr/nutri#!
3.通报内容:
.姓名(申报人)、电子邮件、邮政编码、地址、电话
.发生不良事件者、年龄或出生年份、性别、是否怀孕中、体重、身高、职业、消费者历史、因素描述、不良影响
.产品、商品名称、消费原因、消耗剂量、购买地点、开始使用日期、产品是否停产、消费结束日期、停药后是否影响消失、是否恢復产品消费
.发病时间、症状描述、医疗结果声明、其他信息等
4. ANSES将评估不良事件及相关责任。
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.
【参考连结】
https://www.economie.gouv.fr/dgccrf/Securite/Produits-alimentaires/Compl%C3%A9ments-alimentaires
HLF-FR-85
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