泰国保健食品登记法规问题集

泰国保健食品登记法规问题集

泰国永辉BPO有限公司
1108/31 Sukhumvit Road, Phrakanong, Klongtoey, Bangkok, Thailand 10110
接洽人:
Ploy Lee 泰国籍说中文
Pay Xiao 泰国籍说英文


联络人:苏 玉 燕  副总经理
手机:+886-928-486-835
电话:+886-2-2717-0515 分机:104

Email:bkk4ww@evershinecpa.com

文章目录 点击收合

各国健康食品登记法规问题集

HLF-TH-10
请问泰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 Thailand?
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:

在泰国的食品管理机关是食品药物管理局。其主要职责为进行食品上市前到上市后的管制,包含建立食品标准、管理食品生产和进口、规范食品卫生和标示要求、核发认证(如自由销售证明、卫生证明、优良作业规范认证、HACCP认证等)、食品抽查稽核,以及广告管理等,以确保消费者安全。
在食品法分类中,膳食补充剂属于标准化食品。

膳食补充剂是指除常规食品外,具有营养或其他物质成分可供食用的产品,呈片剂、胶囊剂、粉剂、片剂、液体或其他形式,对于希望促进健康的消费者来说,与传统食品不同。营养物质或其他物质是指:

  1. 从植物或动物中取得的维生素、氨基酸、脂肪酸、矿物质之产品。
  2. 第1项物质的浓缩、代谢、组合或萃取物。
  3. 第1项或第2项物质的人造物质。
  4. 第1、2 或 3 项物质其中一种或多种的混合物。
  5. 食品药品监督管理局规定且经食品委员会批准的其他物质。

The Food and Drug Administration of Thailand under the Ministry of Public Health. Its main responsibilities are to control food from pre-market to post-market, including establishing food standards, managing food production and import, regulating food hygiene and labeling requirements, and issuing certifications (such as free sales certificates, hygiene certificates, GMP certification, HACCP certification, etc.) , food spot inspection and audit, and advertising management, etc., to ensure consumer safety. In the food law classification, dietary supplements are standardized foods.

Food supplement means products taken for consume other than conventional foods which contain nutrients or other substances as ingredients, are in forms of tablets, capsules, powders, flakes, liquids or others ; which are not conventional foods for consumers who expect for benefit of health promotion. Nutrients or other substances mean :

  1. Vitamins, amino acids, fatty acids, minerals and produces obtained from plants or animals.
  2. Concentrates, metabolites composition or extracts of substances of 1.
  3. Artificial substances imitated like substances of 1 or 2.
  4. Mixtures of one or more of substances of 1 ,2 or 3.
  5. Substances or others as to Food and Drug Administration prescribed according to an approval of the Food Committee.

【参考连结】

http://food.fda.moph.go.th/law/TH/pages/product.html

http://food.fda.moph.go.th/law/act.php

HLF-TH-20
外国公司要到泰国销售保健食品,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 Thailand, 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:

需取得营业特许证,资格如下:

  1. 生产者、进口者或生产销售合同者必须具备以下条件:

.自然人:必须具有泰国国籍,最低年龄为二十岁。

.法人:必须在泰国营业登记。

  1. 营业登记须向泰国商务部进行电子登记。

Yes, it is required to obtain an approval.

  1. The producer, importer or production and sales contract must meet the following conditions:

.Natural person: it must have Thai nationality and the minimum age is twenty years old.

.Juridical Person: it must be registered in Thailand.

  1. Business registration is subject to electronic registration with the Ministry of Commerce of Thailand.

【参考连结】

https://www.dbd.go.th/dbdweb_en/index.php#

http://food.fda.moph.go.th/ESub/pages/register.php

HLF-TH-25

HLF-TH-30
外国公司要到泰国销售保健食品,可以指派泰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 Thailand, can it assign a Thailand 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:

可以指派泰国当地公司/人担任营业代理人。

  1. 生产者、进口者或生产销售合同者必须具备以下条件:

.自然人:必须具有泰国国籍,最低年龄为二十岁。

.法人:必须在泰国营业登记。

  1. 营业登记须向泰国商务部进行电子登记。

许可证持有人或公司须负责产品之相关问题,并配合食品药物管理局之相关定期、临时检查。

  1. The producer, importer or production and sales contract must meet the following conditions:

.Natural person: it must have Thai nationality and the minimum age is twenty years old.

.Juridical Person: it must be registered in Thailand.

  1. Business registration is subject to electronic registration with the Ministry of Commerce of Thailand.

The license holder or company shall be responsible for product-related issues and cooperate with relevant periodic and ad hoc inspections by the Food and Drug Administration.

【参考连结】

https://www.dbd.go.th/dbdweb_en/index.php#

http://food.fda.moph.go.th/ESub/pages/register.php

HLF-TH-35

HLF-TH-40
外国公司销售到泰国保健食品本身,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?
可允许的语文除了泰文外,其他哪种语文也可以?网页?

Do foreign companies need to apply for an approval before importing health food sold to Thailand? 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?
In addition to Thailand language, which other languages ​​are allowed? Website?

Evershine RD:

需要。膳食补充剂属标准化食品,需经食品药物管理局审核通过取得製造/进口许可证与优良作业规范认证方可贩售。已获得泰国 FDA 批准的有执照之进口商可以进口各种食品。
指定的仓库或仓库必须经过泰国 FDA 的检查和批准,方可颁发许可证。进口许可证每三年更新一次:

申请进口食品销售许可证者,应提交申请表和规定的文件。

申请表内容。

  1. 申请人姓名、年龄、国籍、身份证号、居住地址、电话。

.户籍影本或照片。

.经认证的註册、目标、授权文件影本或照片。

.申请人指定授权人经营该法人实体的业务证明文件。

.贸易登记或商业登记的影本或照片。

.商务部出具的法人国籍证明文件。

  1. 缴交下列规定文件一式两份:

.用于保持或保存食品质量的必要设备清单(如适用)。

.进口场所、存放场所和场所位置图邻近的建筑。

.内部收容场所的佈局,其比例与其尺寸相对应,并註明以下项目:( 持有房舍的邻近区域、收容处所空间的分隔及通风、必要时安装用于保持或保存食品质量的设备。)

销售给消费者的膳食补充剂产品应以泰文标示,也可以使用外文。需包含以下内容:

  1. 食品名称,「膳食补充剂」应当作为名称的一部分显示,或者附註。
  2. 食品序号。
  3. 生产商或进口商的名称和地址(视情况而定)如下:

.在国内生产的,应标明生产者或者分包商的名称、地址以供销售,也可以标明生产者或者分包商的总公司名称和地址。

.进口商品的进口商名称、地址和生产国。

  1. 膳食补充剂的数量应视情况而定,如下:

.片剂或胶囊形式的膳食补充剂以包为单位标示。

.液体形式的膳食补充剂以体积为标示。

.固体或其他形式的膳食补充剂以淨重标示。

  1. 膳食补充剂的主要成分和声称有用的成分的名称和数量。
  2. 使用防腐剂声明(如有)。
  3. 添加天然颜色或添加人造颜色声明(视情况而定)。
  4. 天然香料、彷天然香料、合成香料的声明(视情况而定)。
  5. 包含任何营养素应通过五类主要食物规范并按适当比例的声明。

10.使用说明。

11.储存说明(如有)。

  1. 视情况应于包装上标示生产、到期日:食用期限或者食品质量合格的日/月/年;膳食补充剂的最低保质期不超过90天的日/月/年;食用期限的月/年;食品质量优良或膳食补充剂标准的最低保质期超过 90 天的月/年。
  2. 膳食补充剂应遵循公告卫生部规范的健康声明和食用警告。

Dietary supplements are standardized foods and need to pass the manufacturing/import license, GMP certification and FDA review before they can be sold. Licensed importers can import a variety of food products, provided they are approved by the Thai FDA. The designated warehouse or warehouse must be inspected and approved by the Thai FDA before a license can be issued. Import licenses are also renewed every three years:

  1. Those who intend to apply for a license of importation of food to sell, An Application Form attached with the regulation shall be submitted together with documents specified in Application.

Application form content

. Applicant’s name, age, nationality, ID number, residential address, telephone

. Family register copy or photo.

. Certified copy or photograph of registration, objective, authorization documents.

. Documents proving that the applicant has appointed an authorized person to operate the legal entity.

. Copy or photograph of trade registration or business registration.

.Legal person nationality certificate issued by the Ministry of Commerce.

  1. The Applicants, according to clause 1, shall attach two copies of the following documents to apply for the license:

.List of equipments used for keeping or preserving of food quality as necessary (if applicable).

.Map of locations of import premises, holding premises and neighboring constructions.

. Layout of inside holding premises which having ratio corresponded to their dimensions and indicates the following items:( Neighboring area of holding premises, Separation of spaces of the holding premises, ventilation including installation of equipments use for keeping or preserving of food quality as necessary.)

Labeling of food supplement products for sale to consumers shall be expressed in Thai language text but foreign language text may also be presented; and shall have texts to express as follows:

  1. Names of food, “food supplements” shall be displayed as a part of the name, or accompanied with.
  2. Food serial number.
  3. Name and address of producers or importers, as the case may be, as follows:

.For food produced within country, name and address of producers or re-packers for sale shall be displayed, or name and address of head office of producers or re-packers may be displayed instead.

.For imported food, name and address of importer and country of producer.

  1. Food supplement quantities shall be expressed as the case may be, as follows:

.Food supplement in form of tablets or capsules expressed as the number per pack.

.Food supplement in form of liquid expressed as net volume.

.Food supplement in form of solid or others expressed as net weight.

  1. Name and quantity of main ingredients of food supplement and constituents which claims for usefulness, on the label of food supplement .
  2. Declaration of “ utilizing preservatives” (if any)
  3. Declaration of “natural colour added” or “artificial colour added” if utilizing, as case may be
  4. Declaration of “natural fragrance”, “imitation natural fragrance”, “synthetic fragrance”, “natural flavour”, or “imitate natural flavour” if any, as case may be.
  5. Clear statement of “Receiving any nutrients should intake by consuming five categories of principal foods and in appropriate proportion.

10.Instruction for use.

  1. Instruction for food storage. (if any)
  2. Date, month, and year of expiration for consumption or date, moth, and year in which food is in good qualities or standards for food supplement with minimum durability of not more than 90 days; or month, and year of expiration for consumption or , moth, and year in which food is in good qualities or standards for food supplement with minimum durability of more than 90 days; and shall incorporated with declarations of “Produce”, “Expire”, or “Consume before” , as the case may be; and date, month, and year shall be respectively expressed. The declarations, according to (12) under the packaging, on the label shall present statement which indicate the position of that declaration.
  3. Warning of food supplement consuming shall be followed the Notification of the Ministry of Public Health, Re : Health claim and Warning of food consuming.

【参考连结】

https://privus.fda.moph.go.th/index.aspx

http://food.fda.moph.go.th/law/TH/pages/product.html

HLF-TH-45

HLF-TH-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?
可允许的语文除了泰文外,其他哪种语文也可以?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?
In addition to the Thailand language, which other languages ​​are allowed? Website?

Evershine RD:

须符合以下资格者方能申请:

  1. 生产者、进口者或生产销售合同者必须具备以下条件:

.自然人:必须具有泰国国籍,最低年龄为二十岁。

.法人:必须在泰国营业登记。

  1. 营业登记须向泰国商务部进行电子登记。

膳食补充剂属标准化食品,需经食品药物管理局审核通过取得製造/进口许可证与优良作业规范认证方可贩售。
已获得泰国 FDA 批准的有执照之进口商可以进口各种食品。
指定的仓库或仓库必须经过泰国 FDA 的检查和批准,方可颁发许可证。进口许可证每三年更新一次:

1.申请进口食品销售许可证者,应提交申请表和规定的文件。

申请表内容

.申请人姓名、年龄、国籍、身份证号、居住地址、电话。

.户籍影本或照片。

.经认证的註册、目标、授权文件影本或照片。

.申请人指定授权人经营该法人实体的业务证明文件。

.贸易登记或商业登记的影本或照片。

.商务部出具的法人国籍证明文件。

2.缴交下列规定文件一式两份:

.用于保持或保存食品质量的必要设备清单(如适用)。

.进口场所、存放场所和场所位置图邻近的建筑。

.内部收容场所的佈局,其比例与其尺寸相对应,并註明以下项目:( 持有房舍的邻近区域、收容处所空间的分隔及通风、必要时安装用于保持或保存食品质量的设备。)

销售给消费者的膳食补充剂产品应以泰文标示,也可以使用外文。需包含以下内容:

  1. 食品名称,「膳食补充剂」应当作为名称的一部分显示,或者附註。
  2. 食品序号。
  3. 生产商或进口商的名称和地址(视情况而定)如下:

.在国内生产的,应标明生产者或者分包商的名称、地址以供销售,也可以标明生产者或者分包商的总公司名称和地址。

.进口商品的进口商名称、地址和生产国。

  1. 膳食补充剂的数量应视情况而定,如下:

.片剂或胶囊形式的膳食补充剂以包为单位标示。

.液体形式的膳食补充剂以体积为标示。

.固体或其他形式的膳食补充剂以淨重标示。

  1. 膳食补充剂的主要成分和声称有用的成分的名称和数量。
  2. 使用防腐剂声明(如有)。
  3. 添加天然颜色或添加人造颜色声明(视情况而定)。
  4. 天然香料、彷天然香料、合成香料的声明(视情况而定)。
  5. 包含任何营养素应通过五类主要食物规范并按适当比例的声明。

10.使用说明。

11.储存说明(如有)。

  1. 视情况应于包装上标示生产、到期日:食用期限或者食品质量合格的日/月/年;膳食补充剂的最低保质期不超过90天的日/月/年;食用期限的月/年;食品质量优良或膳食补充剂标准的最低保质期超过 90 天的月/年。
  2. 膳食补充剂应遵循公告卫生部规范的健康声明和食用警告。

Application of license should meet the following requirements:

  1. The producer, importer or production and sales contract must meet the following conditions:

.Natural person: it must have Thai nationality and the minimum age is twenty years old.

.Juridical Person: it must be registered in Thailand.

  1. Business registration is subject to electronic registration with the Ministry of Commerce of Thailand.

Dietary supplements are standardized foods and need to pass the manufacturing/import license, GMP certification and FDA review before they can be sold.  Licensed importers can import a variety of food products, provided they are approved by the Thai FDA. The designated warehouse or warehouse must be inspected and approved by the Thai FDA before a license can be issued. Import licenses are also renewed every three years:

  1. Those who intend to apply for a license of importation of food to sell, An Application Form attached with the regulation shall be submitted together with documents specified in Application.

Application form content

. Applicant’s name, age, nationality, ID number, residential address, telephone

. Family register copy or photo.

. Certified copy or photograph of registration, objective, authorization documents.

. Documents proving that the applicant has appointed an authorized person to operate the legal entity.

. Copy or photograph of trade registration or business registration.

.Legal person nationality certificate issued by the Ministry of Commerce.

  1. The Applicants, according to clause 1, shall attach two copies of the following documents to apply for the license:

.List of equipments used for keeping or preserving of food quality as necessary (if applicable).

.Map of locations of import premises, holding premises and neighboring constructions.

. Layout of inside holding premises which having ratio corresponded to their dimensions and indicates the following items:( Neighboring area of holding premises, Separation of spaces of the holding premises, ventilation including installation of equipments use for keeping or preserving of food quality as necessary.)

Labeling of food supplement products for sale to consumers shall be expressed in Thai language text but foreign language text may also be presented; and shall have texts to express as follows:

  1. Names of food, “food supplements” shall be displayed as a part of the name, or accompanied with.
  2. Food serial number.
  3. Name and address of producers or importers, as the case may be, as follows:

.For food produced within country, name and address of producers or re-packers for sale shall be displayed, or name and address of head office of producers or re-packers may be displayed instead.

.For imported food, name and address of importer and country of producer.

  1. Food supplement quantities shall be expressed as the case may be, as follows:

.Food supplement in form of tablets or capsules expressed as the number per pack.

.Food supplement in form of liquid expressed as net volume.

.Food supplement in form of solid or others expressed as net weight.

  1. Name and quantity of main ingredients of food supplement and constituents which claims for usefulness, on the label of food supplement .
  2. Declaration of “ utilizing preservatives” (if any)
  3. Declaration of “natural colour added” or “artificial colour added” if utilizing, as case may be
  4. Declaration of “natural fragrance”, “imitation natural fragrance”, “synthetic fragrance”, “natural flavour”, or “imitate natural flavour” if any, as case may be.
  5. Clear statement of “Receiving any nutrients should intake by consuming five categories of principal foods and in appropriate proportion.

10.Instruction for use.

  1. Instruction for food storage. (if any)
  2. Date, month, and year of expiration for consumption or date, moth, and year in which food is in good qualities or standards for food supplement with minimum durability of not more than 90 days; or month, and year of expiration for consumption or , moth, and year in which food is in good qualities or standards for food supplement with minimum durability of more than 90 days; and shall incorporated with declarations of “Produce”, “Expire”, or “Consume before” , as the case may be; and date, month, and year shall be respectively expressed. The declarations, according to (12) under the packaging, on the label shall present statement which indicate the position of that declaration.
  3. Warning of food supplement consuming shall be followed the Notification of the Ministry of Public Health, Re : Health claim and Warning of food consuming.

【参考连结】

https://www.dbd.go.th/dbdweb_en/index.php#

https://privus.fda.moph.go.th/index.aspx

http://food.fda.moph.go.th/law/TH/pages/product.html

HLF-TH-55

HLF-TH-60
经过核准登记的保健食品,进口到泰国要检附什麽文件?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 Thailand?What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?

Evershine RD:

在泰国境内膳食补充剂须遵守食品优良作业规范,泰国食品药物管理局接受的优良作业规范可以是以下任一种形式:

  1. 泰国法律规定的优良生产规范(GMP)。
  2. Codex的GMP。
  3. HACCP。
  4. ISO 9000。
  5. 其他等效或者更高阶的卫生标准(例如ISO 22000,BRC,IFS等)。

泰国法律规定的膳食补充剂优良生产规范(GMP)认证申请资料:

1.申请人、生产基地编号

2.公司名称、膳食补充剂基地位置

3.实验室(有/无)

4.运营商名称、总公司/办事处地址、电话

5.已申请许可/许可的食品种类

6.其他证明文件

.食品生产场所/计划及机器清单

.食物储藏室(如果存储地点与生产现场不在同一地点)

.食物储存位置

.监控系统设备

.法人登记证/商业登记证

.组织结构图

.工作流程图

.工厂平面图

.机器生产现场、周围、各种房间和与生产相关区域的照片

.建筑物的立面图

.员工培训SOP

.健康检查SOP

.员工着装SOP

.机器或设备的马力和员工人数

.SOP 内部审核

.召回化妆品的SOP等

Dietary supplements in Thailand must comply with food GMP regulations, and GMP certificates must also be attached when importing products for sale in Thailand.
GMP accepted by the Thai FDA can be in any of the following forms:

  1. GMP under Thai law.
  2. GMP by Codex.
  3. HACCP.
  4. ISO 9000.
  5. Other equivalent or higher sanitary standards (eg ISO 22000, BRC, IFS, etc.).

Application materials for GMP certification for dietary supplements:

  1. Applicant, production base number
  2. Company name, location of dietary supplement base
  3. Laboratory (with/without)
  4. Operator name, head office/office address, telephone
  5. Types of food for which permit/licensing has been applied
  6. Other documents:

. List of food production sites/plans and machines

. Food pantry (if the storage location is not co-located with the production site)

. food storage location

. Monitoring system equipment

. Legal person registration certificate / business registration certificate

. Organizational chart

. Work flow chart

. Factory floor plan

. Photos of the machine production site, surroundings, various rooms and production-related areas

. Elevation of the building

. Staff training SOP

. Health Check SOP

. Staff Dress SOP

. Machine or equipment horsepower and number of employees

【参考连结】

https://www.fda.moph.go.th/sites/food/SitePages/gmp.aspx

HLF-TH-70
泰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:

向食品药品监督管理局申请食品许可证需提供以下佐证文件

  1. 物理、化学的质量标准,以及原材料的微生素规格(视情况)

.各植物原料的学名和特性。

.每种原料的份数、原材料的独特性、质量控制的检验方法、检验方法的一致性。

.药剂种类及萃取溶液的种类与其浓度、原料量每1克可萃取的活性物质比例。

.原料中该物质的主要成分/物质/标誌物的分析方法。

  1. 製造商提供的原材料详细配方资料及所有成分、数量之细节文件,特别是配方中的必需和非必需成分(以百分比及重量表示)。
  2. 製造商提供的膳食补充剂的实际详细製造过程。
  3. 製造商提供的微生素之物理、化学的产品资料(产品规格)
  4. 膳食补充剂分析结果:必须是国内外政府指定的机构或组织或由该国政府机构认可实验室、机构的分析结果。

The following supporting documents are required to apply for a food license to the Food and Drug Administration

  1. Physical and chemical quality standards, and microbiological specifications of raw materials (as the case may be)

. The scientific name and characteristics of each plant material.

. The number of servings of each raw material, the uniqueness of the raw material, the inspection method for quality control, the consistency of the inspection method.

. The type of drug and the type of extraction solution, its concentration, and the ratio of raw materials to extractable active substances per 1 gram.

. Analysis method of the main component/substance/marker of the substance in the raw material.

  1. The detailed formula information of raw materials and detailed documents of all ingredients and quantities provided by the manufacturer, especially the essential and non-essential ingredients in the formula (expressed in percentage and weight).
  2. The actual detailed manufacturing process of the dietary supplement provided by the manufacturer.
  3. The physical and chemical product information (product specifications) of the micro-organisms provided by the manufacturer
  4. Analysis results of dietary supplements: It must be the analysis results of institutions or organizations designated by domestic and foreign governments or laboratories or institutions recognized by the government agencies of the country.

【参考连结】

http://food.fda.moph.go.th/law/TH/pages/product.html

HLF-TH-75

泰国保健食品审核机构,能够接受海外检验机构的检验资料吗?假如是的话,有些被认可的机构?网页?

Evershine RD:

可以,膳食补充剂分析结果必须是国内外政府指定的机构或组织或由该国政府机构认可实验室、机构的分析结果。

HLF-TH-77

HLF-TH-80
外国子公司进口保健食品后,如果委託泰国的经销商销售,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 Thailand 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:

食品药物管理局对上市食品会进行定期、临时(怀疑/请求)抽查。

上市后控制的目的是确保分配给消费者的食品卫生、质量符合国家食品标准。因此,该措施主要涉及执法活动。
定期对全国所有食品工厂和场所进行检查,同时对食品进行抽样分析和化验,以确保符合法律要求。
如有违规行为,将採取扣押、召回和起诉等措施。一般来说,检查分成两种

  1. 定期检查:有计划的检查,以确保 FDA 年度食品计划的成功实施。

.例行检查:定期检查,特别是对获得许可证的场所进行检查。

.后续检查:为了确认许可证持有人或公司已按照上次检查后的指示採取了某些纠正措施。

.检查点检查:由驻扎在检查站(海关)的食品检查员执行,以确保进入该国的食品安全并符合相关规定。

  1. 怀疑或请求检查:特殊类型的检查,目的是调查和收集必要的证据以採取法律行动。
    包括检查进口国投诉或拒绝的原因,从而解决食品製造商和食品产品的问题。

食品和药物管理局辖下的公共卫生部医学部负责食品分析。

FDA conducts regular, ad hoc (suspect/request) spot checks of marketed foods.
The purpose of post-market control is to ensure that the food distributed to consumers is hygienic and of a quality that conforms to national food standards.
Therefore, the measure mainly concerns law enforcement activities. Regular inspections of all food factories and establishments across the country are carried out, and food samples are analyzed and tested to ensure compliance with legal requirements.
In the event of violations, measures such as seizures, recalls and prosecutions will be taken. In general, inspections are divided into two

  1. Periodic Inspections: Planned inspections to ensure the successful implementation of FDA’s annual food program.

. Routine Inspections: Regular inspections, especially of licensed premises.

. Follow-up Inspections: To confirm that the licensee or company has taken certain corrective actions as indicated after the last inspection.

. Checkpoint Inspections: Performed by food inspectors stationed at checkpoints (customs) to ensure that food entering the country is safe and complies with relevant regulations.

  1. The suspect or request inspection: A special type of inspection for the purpose of investigating and collecting the necessary evidence for legal action. This includes examining the reasons for complaints or refusals by the importing country, thereby addressing issues with food manufacturers and food products.

The Food and Drug Administration’s Division of Public Health Medicine is responsible for food analysis.

URL:http://thaihpvc.fda.moph.go.th/thaihvc/index.jsf

【参考连结】

http://thaihpvc.fda.moph.go.th/thaihvc/index.jsf

https://www.fda.moph.go.th/sites/fda_en/SitePages/Food.aspx?IDitem=LawsAndRegulations

HLF-TH-85

HLF-TH-90
目前维生素C(锭状食品型式)外销至泰国当地的法规规范,如维生素C剂量每日摄取上限会列为药品? 剂量多少列为膳食补充品?

目前维生素C(锭状食品型式)外销至泰国当地的法规规范如下:
• 泰国将食品分为一般食品、特殊食品和新资源食品三大类,其中特殊食品又细分为保健食品、膳食补充品、医疗食品和婴幼儿配方奶粉等。
• 维生素C锭属于膳食补充品,需符合泰国的膳食补充品法规,包括产品註册、成分规范、标示要求、卫生标准等
• 泰国的膳食补充品法规规定,每日摄取量不得超过1000毫克的维生素C才能被列为膳食补充品,否则将被视为药品。
• 泰国的膳食补充品法规也规定,产品标示上必须有以下内容:产品名称、成分表、每日建议摄取量、每份含量、保存方法、注意事项、製造商或进口商名称和地址、有效日期等

各国健康食品登记法规问题集

泰国永辉BPO有限公司
1108/31 Sukhumvit Road, Phrakanong, Klongtoey, Bangkok, Thailand 10110
接洽人:
Ploy Lee 泰国籍说中文
Pay Xiao 泰国籍说英文


联络人:苏 玉 燕  副总经理
手机:+886-928-486-835
电话:+886-2-2717-0515 分机:104

Email:bkk4ww@evershinecpa.com

永辉关係企业: 泰国永辉服务有限公司
Evershine Services (Thailand) Co., Ltd
https://bkk.evershinecpa.com
1108/31 Sukhumvit Road, Phrakanong, Klongtoey, Bangkok, Thailand 10110
Bangkok Manager Paul Xiao, who speaks in both English and Thai.
M: +66-(0)852-222-197

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