菲律宾保健食品登记法规问题集

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各国健康食品登记法规问题集

HLF-ph-10
请问菲律宾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 Philippines? 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：

菲律宾食品/膳食补充剂主管机关为食品药物管理局(FDA)，辖下的食品监管和研究中心 (CFRR) 负责监管製造、进口、出口、分销、销售、邀约销售、转让、促销、广告、贊助和/或在适当情况下的使用和食品和食品/膳食补充剂的测试，以及负责对食品的安全性、功效和质量进行研究，并製定与食品安全和质量相关的标准。

食品/膳食补充剂是指补充膳食的加工食品，其含有以下一种或多种膳食成分：维生素、矿物质、氨基酸、草本植物、其他植物、动物、人工或天然植物的膳食物质增加每日总摄入量，以符合菲律宾最新的能量和营养摄入量或国际商定的最低每日需求量。
通常以胶囊、片剂、液体、凝胶、粉末或丸剂的形式出现，不代表用作常规食品或作为膳食或饮食的唯一项目或替代药物和药物。

In Philippines, the food/dietary supplements competent authority is the Food and Drug Administration (FDA), and the Food Regulatory and Research Center (CFRR) under it is responsible for supervising the manufacture, import, export, distribution, sale, invitation to sell, and transfer , promotion, advertising, sponsorship and/or use, where appropriate, and testing of foods and food/dietary supplements, and responsible for conducting research into the safety, efficacy and quality of food and setting standards related to food safety and quality .

Foods/dietary supplements are processed foods that supplement the diet and contain one or more of the following dietary components: vitamins, minerals, amino acids, herbal, other plant, animal, artificial or natural plant dietary substances to increase the total daily intake to comply with the latest energy and nutrient intakes in the Philippines or internationally agreed minimum daily requirements. Usually in the form of capsules, tablets, liquids, gels, powders or pills and is not intended to be used as a regular food or as the sole item of a meal or diet or as an alternative to medicines and medications.

【参考连结】

https://www.fda.gov.ph/wp-content/uploads/2022/06/The-Rules-and-Regulations-Implementing-Republic-Act-No.-9711-%C2%AD-The-Food-and-Drug-Administration-Act-of-2009.pdf

HLF-ph-20
外国公司要到菲律宾销售保健食品，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 Philippines, 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：

需要，在菲律宾从事的食品/膳食补充剂进出口、贸易、零售和分销的企业需要从菲律宾食品药物管理局(FDA)获得经营许可证(LTO)及完成产品註册。

1.申请人：在菲律宾从事食品/膳食补充剂的进出口、贸易、零售和分销的当地企业。

2.申请网页：https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login

经营许可证(LTO)

申请文件

1. 申请表(一式两份)

．申请人/製造商名称

．营业地址

．电话号码

．传真号码

．电子邮件

．厂址

．产品名称

．品牌名称

．使用的强化剂名称、化学形式、资源

．包装类型和标誌包装类型和标誌

2.附件

．FDA LTO/其他机构的 LTO 或许可、有效性。

．FDA认可实验室的主食中强化剂分析证书。

．建议使用 DSPS 的标籤。

．申请费/品牌。

．申请人/授权代表姓名、职位、签名。

．营业执照：当营业或设立地址与商业名称註册地址不同时，申请人应提交营业执照副本(例如：市长许可证)。

．收入证明，例如最近经审计的财务报表和资产负债表(pdf)。

．大中型食品製造商、贸易商和分销商(进口商、出口商和/或批发商)需要缴交风险管理计划(RMP)。

．现场主文件(SMF)，申请LTO为大中型食品製造商(CFRR)的申请人需要缴交。

．位置图等。

Yes. Businesses engaged in the import, export, trade, retail and distribution of food/dietary supplements in the Philippines need to obtain a license to operate (LTO) from the Philippine Food and Drug Administration (FDA) and complete product registration.

1. Applicant: Local businesses engaged in import, export, trade, retail and distribution of food/dietary supplements in the Philippines.

2. URL: https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login

License to operate (LTO)

Application documents

1. Application form (in duplicate)

．Applicant/Manufacturer Name

．Business address

．Phone number

．Fax number

．E-mail

．Factory site

．Product

．Brand

．Enhancer name, chemical form, resource used

．Types of packaging and markings Types of packaging and markings

2. Attachment

．FDA LTO/Other Agency LTO or License, Validity.

．Certificate of Analysis for Fortifiers in Staple Foods from an FDA-recognized laboratory.

．The DSPS label is recommended.

．Application fee/brand.

．Applicant/authorized representative name, title, signature.

．Business License: When the business or establishment address is different from the registered address of the business name, the applicant should submit a copy of the business license (eg: Mayor’s Permit).

．Proof of income, such as the most recent audited financial statements and balance sheet (pdf).

．Medium and large food manufacturers, traders and distributors (importers, exporters and/or wholesalers) are required to submit a Risk Management Plan (RMP).

．Site Master File (SMF), which is required for applicants applying for LTO as a medium to large food manufacturer (CFRR).

．Location map etc.

URL:https://www.fda.gov.ph/downloadables/

【参考连结】

https://www.fda.gov.ph/wp-content/uploads/2021/03/Requirements-for-Initial-Application-License-to-Operate-for-Food-Establishments.pdf

HLF-ph-25

HLF-ph-30
外国公司要到菲律宾销售保健食品，可以指派菲律宾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 Philippines, can it assign a Philippines 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，营业代理人须为菲律宾当地企业，并取得经营许可证(LTO)。

1.申请人：在菲律宾从事食品/膳食补充剂的进出口、贸易、零售和分销的当地企业。

2.申请网页：https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login

经营许可证(LTO)

申请文件

1. 申请表(一式两份)

．申请人/製造商名称

．营业地址

．电话号码

．传真号码

．电子邮件

．厂址

．产品名称

．品牌名称

．使用的强化剂名称、化学形式、资源

．包装类型和标誌包装类型和标誌

2.附件

．FDA LTO/其他机构的 LTO 或许可、有效性。

．FDA认可实验室的主食中强化剂分析证书。

．建议使用 DSPS 的标籤。

．申请费/品牌。

．申请人/授权代表姓名、职位、签名。

．营业执照：当营业或设立地址与商业名称註册地址不同时，申请人应提交营业执照副本(例如：市长许可证)。

．收入证明，例如最近经审计的财务报表和资产负债表(pdf)。

．大中型食品製造商、贸易商和分销商(进口商、出口商和/或批发商)需要缴交风险管理计划(RMP)。

．现场主文件(SMF)，申请LTO为大中型食品製造商(CFRR)的申请人需要缴交。

．位置图等。

产品责任

1.负责将食品/膳食补充剂投放市场的公司是不良事件召回的主要责任方。

2.如果食品/膳食补充剂在原产地因健康和安全原因受到抨击或撤回，进口商应立即採取必要措施，禁止向公众出售、分销或捐赠，或立即欉市场上召回、撤回或扣押。

3.经FDA 声明为有害、不安全或有危险的保健产品的企业，应立即召回、撤回、扣押该产品，或禁止其向公众销售、分销或捐赠。

4.召回的处理包含：

．食品/膳食补充剂的质量/投诉处理

．不良事件监测和基于事件的监测反应报告

．卫生产品的抽样、测试和验证

．许可后检查、监测和调查

．确认通知的后评估

．广告和宣传材料监控

．与其他监管机构和国际合作伙伴的协调

．其他 MAH 的上市后监督活动的结果

5.一旦触发事件发生，产品召回委员会应审查和评估健康危害。在做出召回特定食品/膳食补充剂的决定时，应考虑以下因素：

．已因使用保健产品而发生疾病、伤害、疾病或中毒。

．可能导致人群接触的任何现有状况。

．对预期接触此类卫生产品的不同人群的危害。

．面临风险的人群可能面临的危害的严重程度。

．人群可能面临的暴露风险发生的可能性。

．健康影响的短期和长期后果。

．对公众造成严重欺骗的风险。

．不符合 FDA 标准。

．误报有害物质含量。

．汙染产品的材料，无论是意外的还是有意的。

．参加情况可能需要的其他因素。

6.分类：

．I 类召回：可能危及生命或可能导致严重健康风险、健康损害或影响(例如对健康造成永久性损害或死亡)的产品缺陷/状况。

．II 类召回：可能导致中毒或暂时/医学上可逆的不利健康问题或虐待的产品缺陷/状况。

．III 级召回：可能不会对健康造成重大危害的产品缺陷/状况，但可能因其他原因而开始撤回。

Yes. The business agent must be a local company in the Philippines and have obtained a license to operate (LTO).

License to operate (LTO)

Application documents

1. Application form (in duplicate)

．Applicant/Manufacturer Name

．Business address

．Phone number

．Fax number

．E-mail

．Factory site

．Product

．Brand

．Enhancer name, chemical form, resource used

．Types of packaging and markings Types of packaging and markings

2. Attachment

．FDA LTO/Other Agency LTO or License, Validity.

．Certificate of Analysis for Fortifiers in Staple Foods from an FDA-recognized laboratory.

．The DSPS label is recommended.

．Application fee/brand.

．Applicant/authorized representative name, title, signature.

．Business License: When the business or establishment address is different from the registered address of the business name, the applicant should submit a copy of the business license (eg: Mayor’s Permit).

．Proof of income, such as the most recent audited financial statements and balance sheet (pdf).

．Medium and large food manufacturers, traders and distributors (importers, exporters and/or wholesalers) are required to submit a Risk Management Plan (RMP).

．Site Master File (SMF), which is required for applicants applying for LTO as a medium to large food manufacturer (CFRR).

．Location map etc.

Product Liability

1. The company responsible for placing the food/dietary supplement on the market is the primary responsible party for the adverse event recall.

2. If the food/dietary supplement is criticized or withdrawn for health and safety reasons in the country of origin, the importer shall immediately take the necessary measures to prohibit the sale, distribution or donation to the public, or to immediately recall, withdraw or seize the market.

3. Businesses that have been declared by the FDA to be harmful, unsafe, or dangerous health care products should immediately recall, withdraw, seize, or prohibit their sale, distribution, or donation to the public.

4. The processing of recall includes:

．Food/Dietary Supplement Quality/Complaint Handling

．Adverse Event Monitoring and Event-Based Surveillance Response Reporting

．Sampling, testing and verification of hygiene products

．Post-licensing inspections, monitoring and investigations

．Post-evaluation of confirmation notices

．Monitoring of advertising and promotional materials

．Coordination with other regulatory agencies and international partners

．Results of post-market surveillance activities of other MAHs

5. Once a triggering event occurs, the Product Recall Committee shall review and evaluate the health hazards. The following factors should be considered when making a decision to recall a specific food/dietary supplement:

．Sickness, injury, illness, or poisoning has occurred as a result of the use of a health product.

．Any existing conditions that could lead to population exposure.

．Hazards to different populations expected to be exposed to such hygiene products.

．The severity of the hazard that the at-risk population may be exposed to.

．The likelihood of occurrence of exposure risks that the population may face.

．Short-term and long-term consequences of health effects.

．Risk of serious deception to the public.

．Not FDA compliant.

．Misreporting the content of hazardous substances.

．Materials that contaminate a product, either accidentally or intentionally.

．Other factors that may be required for participation.

6. Classification:

．Class I Recalls: Product defects/conditions that may be life-threatening or may cause serious health risks, health damage, or effects (such as permanent damage to health or death).

．Class II Recalls: Product defects/conditions that may cause poisoning or temporary/medically reversible adverse health problems or abuse.

．Class III Recalls: Product defects/conditions that may not pose a significant health hazard, but may have begun to be withdrawn for other reasons.

【参考连结】

https://www.fda.gov.ph/downloadables/

HLF-ph-35

HLF-ph-40
外国公司销售到菲律宾保健食品本身，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 Philippines? 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：

在菲律宾从事的食品/膳食补充剂进出口、贸易、零售和分销的企业需要从菲律宾食品药物管理局(FDA)获得经营许可证(LTO)及完成产品註册。

1.申请人：在菲律宾从事食品/膳食补充剂的进出口、贸易、零售和分销的当地企业。

2.申请网页：https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login

经营许可证(LTO)

申请文件

1. 申请表(一式两份)

．申请人/製造商名称

．营业地址

．电话号码

．传真号码

．电子邮件

．厂址

．产品名称

．品牌名称

．使用的强化剂名称、化学形式、资源

．包装类型和标誌包装类型和标誌

2.附件

．FDA LTO/其他机构的 LTO 或许可、有效性。

．FDA认可实验室的主食中强化剂分析证书。

．建议使用 DSPS 的标籤。

．申请费/品牌。

．申请人/授权代表姓名、职位、签名。

．营业执照：当营业或设立地址与商业名称註册地址不同时，申请人应提交营业执照副本(例如：市长许可证)。

．收入证明，例如最近经审计的财务报表和资产负债表(pdf)。

．大中型食品製造商、贸易商和分销商(进口商、出口商和/或批发商)需要缴交风险管理计划(RMP)。

．现场主文件(SMF)，申请LTO为大中型食品製造商(CFRR)的申请人需要缴交。

．位置图等。

食品/膳食补充剂产品註册

1.申请人：在菲律宾从事食品/膳食补充剂的进出口、贸易、零售和分销的当地企业。

2.申请网页：

https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login

3.要求

．有效经营许可证

．所有清晰及完整的标籤或产品的扫描副本(如果适用)，包含产品和/或包装和二次包装(纸盒或纸板盒)

．外国代理协议(副本)

．分销证明书(副本)

．合约(副本)

．发票(副本)

．製造商的协议备忘录(副本)

．符合GMP的製造商註册证书(副本)

．有效的植物检疫证书/健康证书

．有效的ISO22000认证

．原产国签发的HACCP证书

．获认可规管机构证明的免费贩售证明书

．稳定性研究

．成品分析证书 (COA)

．适用的安全数据(例如 LD-50 毒性测试)

．授权书

．承诺宣誓

2.其他文件(如果适用)

．技术或营养健康研究或报告

．市场调查研究

．分析、定量分析及计算证书

．在同行评审的科学期刊上发表的科学报告或研究

标籤

1. 食品标识

．产品名称/食品名称

．使用品牌名称和/或商标

．完整的成分清单

．淨含量和脱水重量

．製造商、再包装商、包装商、进口商、贸易商和分销商的名称和地址

．批次识别

．储存情况

．到期或失效日期/使用截止日期/消费前日期(建议的最后消费日期)

．食物过敏原信息

．营养成分/营养信息/营养价值

2.成分标籤

．除单一成分食品外，应在标籤上註明完整的成分清单。

．配料表应以适当的标题开头或前面，标题应包含或包括配料一词

．完整清单应按比例递减顺序在主显示面板或信息面板上公佈。

．添加的水应在配料表中声明，除非水构成配料的一部分，例如復合食品中使用的盐水、糖浆或肉汤，并在配料表中声明。在製造过程中蒸发的水或其他挥发性成分无需声明。

．如果一种成分本身是两种或多种成分的产物，则可以在成分表中声明该複合成分，但必须立即附有括号中按比例降序排列的成分表。

．複合成分佔食品5%以下的，除在成品中具有工艺功能的食品添加剂外，无需声明该成分。

．除非通用类别名称提供更多信息且与现有法规/标准不冲突，否则应为成分使用特定名称，而不是集体(通用)名称。

．应声明香精和调味物质。

．使用的任何焦木酸或其他人工烟味香精，应声明为人工香精或人工烟味香精。

．着色物质应使用它们的通用名称或食用色素或颜色(对于源自植物材料或与其相同的物质)进行声明，对于煤焦油染料或其他合成化合物。

．食品添加剂应当标註通用名称和功能类别。

．所有食品补充剂的标籤都应标明未批准的治疗性声明，以告知消费者食品/膳食补充剂没有批准的疗效。

3. 食品添加剂声明

．食品添加剂必须在成分表中声明其通用名或类别名，表明其功能类别。

．含量低于实现技术功能所需的水平，无需在成分清单中声明。

4. 有效期/有效期

．应按以下顺序清晰、醒目、清晰地印在所有产品标籤(酒精饮料除外)上：日、月、年。

．日期和年份的声明是数字，而月份的声明必须是文字以避免混淆(例如：到期日期：2012年1月1日或12年1月1日)。

5. 消费者投诉服务台地址

6. 营养信息

．营养成分应以表格形式，标示蛋白质、碳水化合物(包括膳食纤维和糖)、脂肪(包括饱和脂肪、反式脂肪和胆固醇)、钠、能量的声明价值或卡路里。

．所有营养成分的含量均应以切片、片或指定的重量或体积表示，与平均或一般食用量有关。

． 营养素的声明也可以以每份的单位或推荐的能量和营养素摄入量百分比(RENI)或两者来表示，前提是所有供本地消费的本地生产的食品也应标明实际价值的相应 RENI百分比以整数表示。

．碳水化合物、蛋白质、脂肪(胆固醇以毫克(mg)表示)、糖和膳食纤维应以最接近的克(g)表示。能量值应以卡路里(kcal)表示。钠应以毫克表示。

．维生素和矿物质应以毫克或微克(mcg 或 <μg)表示。维生素 A、D 和 E 应使用国际单位 (IU)。

7.语言和易读性要求

．食品标籤上所有信息所使用的语言必须是英语或菲律宾语或其组合。进口食品的标註为外文信息的，应附有相应的英文译文。

．如果 FDA 允许用完现有标籤，则只能允许使用临时不干胶标籤进行英文或菲律宾语翻译，最长期限为六个月。所有信息都应准确、清晰，并且必须包含在一个标籤中。贴纸必须耐用，即不能轻易从标籤或包装上取下。

．如果食品包装的标籤太小以至于无法使用规定尺寸的字母，或者涉及次要或可选信息，则可以使用按比例缩小的字母，前提是规定的细节清晰可见，并且指定的标籤空间与包装的大小成正比。对于其他无法容纳标籤信息的小包装，可以仅标明品牌名称和产品名称。但这些产品不得单独出售，也不得用于零售。

8. 原产国标籤

．进口到菲律宾的每件外国原产物品都应使用菲律宾的任何官方语言(菲律宾语或英语)进行标记。原产国应在物品(或容器)的性质允许的情况下，在显眼的地方以清晰、不可磨灭和永久的方式标明。

．食品的製造商、再包装商、包装商、进口商、贸易商或分销商的名称和地址应在本地製造产品的标籤上註明。

．进口产品，还应申报进口商的完整名称、地址以及原产国。

．对于带有外国品牌或由外国公司许可生产的产品，如果声明外国公司的名称和/或地址，其字体大小应不大于当地公司使用的字体。

．当食品在改变其性质的第二个国家进行加工时，进行加工的第二个国家应被视为标籤的原产国。

．如果製造商在许多城市和/或城镇都有工厂，只要每个食品包装都有代码/标记来识别生产它的加工厂，地址标示公司总部。

Businesses engaged in the import, export, trade, retail and distribution of food/dietary supplements in the Philippines need to obtain a license to operate (LTO) from the Philippine Food and Drug Administration (FDA) and complete product registration.

1. Applicant: Local businesses engaged in import, export, trade, retail and distribution of food/dietary supplements in the Philippines.

2. URL: https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login

License to operate (LTO)

Application documents

1. Application form (in duplicate)

．Applicant/Manufacturer Name

．Business address

．Phone number

．Fax number

．E-mail

．Factory site

．Product

．Brand

．Enhancer name, chemical form, resource used

．Types of packaging and markings Types of packaging and markings

2. Attachment

．FDA LTO/Other Agency LTO or License, Validity.

．Certificate of Analysis for Fortifiers in Staple Foods from an FDA-recognized laboratory.

．The DSPS label is recommended.

．Application fee/brand.

．Applicant/authorized representative name, title, signature.

．Business License: When the business or establishment address is different from the registered address of the business name, the applicant should submit a copy of the business license (eg: Mayor’s Permit).

．Proof of income, such as the most recent audited financial statements and balance sheet (pdf).

．Medium and large food manufacturers, traders and distributors (importers, exporters and/or wholesalers) are required to submit a Risk Management Plan (RMP).

．Site Master File (SMF), which is required for applicants applying for LTO as a medium to large food manufacturer (CFRR).

．Location map etc.

Food/Dietary Supplement Product Registration

1. Applicant: Local businesses engaged in import, export, trade, retail and distribution of food/dietary supplements in the Philippines.

2. Application webpage:

https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login

3. Request

．Valid business license

．All clear and complete labels or scanned copies of products (if applicable) including product and/or packaging and secondary packaging (carton or cardboard)

．Foreign Agency Agreement (copy)

．Distribution certificate (copy)

．Contract (Copy)

．Invoice (copy)

．Manufacturer’s Memorandum of Agreement (copy)

．GMP compliant manufacturer registration certificate (copy)

．Valid phytosanitary certificate/health certificate

．Valid ISO22000 certification

．HACCP certificate issued by the country of origin

．Free selling certificate certified by a recognized regulatory body

．Stability study

．Finished Product Certificate of Analysis (COA)

．Applicable safety data (e.g. LD-50 toxicity test)

．Power of attorney

．Pledge oath

2. Additional documents (if applicable)

．Technical or Nutritional Health Research or Report

．Market research research

．Certificate in Analysis, Quantitative Analysis and Computing

．Scientific reports or research published in peer-reviewed scientific journals

Label

1. Food Labeling

．Product name/Food name

．Use of brand names and/or trademarks

．Complete Ingredient List

．Net content and dehydrated weight

．Name and address of manufacturer, repacker, packer, importer, trader and distributor

．Batch identification

．Storage situation

．Expiration or expiry date/use-by date/pre-consumption date (recommended last-consumption date)

．Food Allergen Information

．Nutrition Facts/Nutrition Information/Nutritional Value

2. Ingredient labels

．Except for single-ingredient foods, the full list of ingredients should be stated on the label.

．The ingredient list should begin or precede the appropriate title, which should contain or include the word ingredient

．The full list shall be published on the main display panel or information panel in descending order of scale.

．Added water should be declared in the ingredient list unless water forms part of an ingredient, such as brine, syrup or broth used in compound foods, and declared in the ingredient list. No declaration is required for water or other volatile components that evaporate during the manufacturing process.

．If an ingredient is itself the product of two or more ingredients, the compounded ingredient may be declared in the ingredient list, but must be immediately accompanied by a list of ingredients in descending proportional order in parentheses.

．If the compound ingredient accounts for less than 5% of the food, except for the food additive with technological function in the finished product, there is no need to declare the ingredient.

．Unless the generic category name provides more information and does not conflict with existing regulations/standards, specific names should be used for ingredients rather than collective (generic) names.

．Flavor and flavoring substances should be declared.

．Any pyrolignoic acid or other artificial tobacco flavors used should be declared as artificial flavors or artificial tobacco flavors.

．Coloring substances should be declared using their common name or food coloring or color (for substances derived from or identical to plant material), for coal tar dyes or other synthetic compounds.

．Food additives shall be marked with their generic names and functional categories.

．All food supplement labels should carry an unapproved therapeutic claim to inform consumers that the food/dietary supplement does not have an approved therapeutic effect.

3. Declaration of Food Additives

．Food additives must declare their common name or category name in the ingredient list, indicating their functional category.

．Levels below the level required to achieve technical function do not need to be declared in the ingredient list.

4. Validity Period / Validity Period

．Should be legible, prominent, and legible on all product labels (except alcoholic beverages) in the following order: day, month, year.

．Date and year declarations are numbers, while month declarations must be literals to avoid confusion (eg: due date: 1/1/2012 or 1/1/12).

5. Address of the Consumer Complaint Service Desk

6. Nutrition information

．Nutrition facts should be in tabular form with the declared value of protein, carbohydrates (including dietary fiber and sugars), fats (including saturated fat, trans fat, and cholesterol), sodium, energy, or calories.

．All nutrient content should be expressed in slices, slices, or specified weight or volume relative to average or typical serving size.

．Nutrient claims may also be expressed in units per serving or in percent of recommended energy and nutrient intake (RENI) or both, provided that all locally produced food products for local consumption are also stated with the corresponding RENI percent of actual value in Integer representation.

．Carbohydrates, proteins, fats (cholesterol expressed in milligrams (mg)), sugars and dietary fiber should be expressed to the nearest gram (g). Energy values should be expressed in calories (kcal). Sodium should be expressed in milligrams.

．Vitamins and minerals should be reported in milligrams or micrograms (mcg or <µg). International units (IU) should be used for vitamins A, D, and E.

7. Language and legibility requirements

．All information on food labels must be in English or Filipino or a combination thereof. If the imported food is marked with information in a foreign language, the corresponding English translation shall be attached.

．If the FDA allows existing labels to be used up, only temporary stickers for English or Filipino translations will be allowed for a maximum period of six months. All information should be accurate, clear, and must be included on a single label. The sticker must be durable, i.e. not easily removed from the label or packaging.

．If the label of a food package is too small to use the prescribed size letters, or involves secondary or optional information, scaled letters may be used, provided that the prescribed details are clearly visible and that the designated label space is consistent with the packaging proportional to the size. For other small packages that cannot accommodate label information, only the brand name and product name may be indicated. These products, however, may not be sold individually or for retail sale.

8. Country of Origin Label

．Every foreign origin item imported into the Philippines should be marked in any of the official languages ​​of the Philippines (Filipino or English). The country of origin shall be clearly, indelibly and permanently marked in a conspicuous place where the nature of the article (or container) permits.

．The name and address of the manufacturer, repacker, packer, importer, trader or distributor of the food should be indicated on the label of the locally manufactured product.

．For imported products, the full name, address and country of origin of the importer should also be declared.

．For products bearing a foreign brand or licensed by a foreign company, the name and/or address of the foreign company should be declared in a font size no larger than that used by the local company.

．When the food is processed in a second country that changes its nature, the second country where the processing takes place shall be considered the country of origin of the label.

．If the manufacturer has factories in many cities and/or towns, as long as each food package has a code/mark to identify the processing plant that produced it, the address indicates the company headquarters.

【参考连结】

https://www.fda.gov.ph/wp-content/uploads/2021/03/Requirements-for-Initial-Application-License-to-Operate-for-Food-Establishments.pdf

https://www.fda.gov.ph/wp-content/uploads/2021/03/Food-Registration-Requirements-to-secure-Certificate-of-Product-Registration.pdf

HLF-ph-45

HLF-ph-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?

在菲律宾从事的食品/膳食补充剂进出口、贸易、零售和分销的企业，需以当地企业名义从菲律宾食品药物管理局(FDA)获得经营许可证(LTO)及完成产品註册。

1.申请人：在菲律宾从事食品/膳食补充剂的进出口、贸易、零售和分销的当地企业。

2.申请网页：https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login

经营许可证(LTO)

申请文件

1. 申请表(一式两份)

．申请人/製造商名称

．营业地址

．电话号码

．传真号码

．电子邮件

．厂址

．产品名称

．品牌名称

．使用的强化剂名称、化学形式、资源

．包装类型和标誌包装类型和标誌

2.附件

．FDA LTO/其他机构的 LTO 或许可、有效性。

．FDA认可实验室的主食中强化剂分析证书。

．建议使用 DSPS 的标籤。

．申请费/品牌。

．申请人/授权代表姓名、职位、签名。

．营业执照：当营业或设立地址与商业名称註册地址不同时，申请人应提交营业执照副本(例如：市长许可证)。

．收入证明，例如最近经审计的财务报表和资产负债表(pdf)。

．大中型食品製造商、贸易商和分销商(进口商、出口商和/或批发商)需要缴交风险管理计划(RMP)。

．现场主文件(SMF)，申请LTO为大中型食品製造商(CFRR)的申请人需要缴交。

．位置图等。

食品/膳食补充剂产品註册

1.申请人：在菲律宾从事食品/膳食补充剂的进出口、贸易、零售和分销的当地企业。

2.申请网页：

https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login

3.要求

．有效经营许可证

．所有清晰及完整的标籤或产品的扫描副本(如果适用)，包含产品和/或包装和二次包装(纸盒或纸板盒)

．外国代理协议(副本)

．分销证明书(副本)

．合约(副本)

．发票(副本)

．製造商的协议备忘录(副本)

．符合GMP的製造商註册证书(副本)

．有效的植物检疫证书/健康证书

．有效的ISO22000认证

．原产国签发的HACCP证书

．获认可规管机构证明的免费贩售证明书

．稳定性研究

．成品分析证书 (COA)

．适用的安全数据(例如 LD-50 毒性测试)

．授权书

．承诺宣誓

2.其他文件(如果适用)

．技术或营养健康研究或报告

．市场调查研究

．分析、定量分析及计算证书

．在同行评审的科学期刊上发表的科学报告或研究

标籤

1. 食品标识

．产品名称/食品名称

．使用品牌名称和/或商标

．完整的成分清单

．淨含量和脱水重量

．製造商、再包装商、包装商、进口商、贸易商和分销商的名称和地址

．批次识别

．储存情况

．到期或失效日期/使用截止日期/消费前日期(建议的最后消费日期)

．食物过敏原信息

．营养成分/营养信息/营养价值

2.成分标籤

．除单一成分食品外，应在标籤上註明完整的成分清单。

．配料表应以适当的标题开头或前面，标题应包含或包括配料一词

．完整清单应按比例递减顺序在主显示面板或信息面板上公佈。

．添加的水应在配料表中声明，除非水构成配料的一部分，例如復合食品中使用的盐水、糖浆或肉汤，并在配料表中声明。在製造过程中蒸发的水或其他挥发性成分无需声明。

．如果一种成分本身是两种或多种成分的产物，则可以在成分表中声明该複合成分，但必须立即附有括号中按比例降序排列的成分表。

．複合成分佔食品5%以下的，除在成品中具有工艺功能的食品添加剂外，无需声明该成分。

．除非通用类别名称提供更多信息且与现有法规/标准不冲突，否则应为成分使用特定名称，而不是集体(通用)名称。

．应声明香精和调味物质。

．使用的任何焦木酸或其他人工烟味香精，应声明为人工香精或人工烟味香精。

．着色物质应使用它们的通用名称或食用色素或颜色(对于源自植物材料或与其相同的物质)进行声明，对于煤焦油染料或其他合成化合物。

．食品添加剂应当标註通用名称和功能类别。

．所有食品补充剂的标籤都应标明未批准的治疗性声明，以告知消费者食品/膳食补充剂没有批准的疗效。

3. 食品添加剂声明

．食品添加剂必须在成分表中声明其通用名或类别名，表明其功能类别。

．含量低于实现技术功能所需的水平，无需在成分清单中声明。

4. 有效期/有效期

．应按以下顺序清晰、醒目、清晰地印在所有产品标籤(酒精饮料除外)上：日、月、年。

．日期和年份的声明是数字，而月份的声明必须是文字以避免混淆(例如：到期日期：2012年1月1日或12年1月1日)。

5. 消费者投诉服务台地址

6. 营养信息

．营养成分应以表格形式，标示蛋白质、碳水化合物(包括膳食纤维和糖)、脂肪(包括饱和脂肪、反式脂肪和胆固醇)、钠、能量的声明价值或卡路里。

．所有营养成分的含量均应以切片、片或指定的重量或体积表示，与平均或一般食用量有关。

． 营养素的声明也可以以每份的单位或推荐的能量和营养素摄入量百分比(RENI)或两者来表示，前提是所有供本地消费的本地生产的食品也应标明实际价值的相应 RENI百分比以整数表示。

．碳水化合物、蛋白质、脂肪(胆固醇以毫克(mg)表示)、糖和膳食纤维应以最接近的克(g)表示。能量值应以卡路里(kcal)表示。钠应以毫克表示。

．维生素和矿物质应以毫克或微克(mcg 或 <μg)表示。维生素 A、D 和 E 应使用国际单位 (IU)。

7.语言和易读性要求

．食品标籤上所有信息所使用的语言必须是英语或菲律宾语或其组合。进口食品的标註为外文信息的，应附有相应的英文译文。

．如果 FDA 允许用完现有标籤，则只能允许使用临时不干胶标籤进行英文或菲律宾语翻译，最长期限为六个月。所有信息都应准确、清晰，并且必须包含在一个标籤中。贴纸必须耐用，即不能轻易从标籤或包装上取下。

．如果食品包装的标籤太小以至于无法使用规定尺寸的字母，或者涉及次要或可选信息，则可以使用按比例缩小的字母，前提是规定的细节清晰可见，并且指定的标籤空间与包装的大小成正比。对于其他无法容纳标籤信息的小包装，可以仅标明品牌名称和产品名称。但这些产品不得单独出售，也不得用于零售。

8. 原产国标籤

．进口到菲律宾的每件外国原产物品都应使用菲律宾的任何官方语言(菲律宾语或英语)进行标记。原产国应在物品(或容器)的性质允许的情况下，在显眼的地方以清晰、不可磨灭和永久的方式标明。

．食品的製造商、再包装商、包装商、进口商、贸易商或分销商的名称和地址应在本地製造产品的标籤上註明。

．进口产品，还应申报进口商的完整名称、地址以及原产国。

．对于带有外国品牌或由外国公司许可生产的产品，如果声明外国公司的名称和/或地址，其字体大小应不大于当地公司使用的字体。

．当食品在改变其性质的第二个国家进行加工时，进行加工的第二个国家应被视为标籤的原产国。

．如果製造商在许多城市和/或城镇都有工厂，只要每个食品包装都有代码/标记来识别生产它的加工厂，地址标示公司总部。

Enterprises engaged in the import, export, trade, retail and distribution of food/dietary supplements in the Philippines are required to obtain a license to operate (LTO) and complete product registration from the Philippine Food and Drug Administration (FDA) in the name of the local enterprise.

1. Applicant: Local businesses engaged in import, export, trade, retail and distribution of food/dietary supplements in the Philippines.

2. URL: https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login

License to operate (LTO)

Application documents

1. Application form (in duplicate)

．Applicant/Manufacturer Name

．Business address

．Phone number

．Fax number

．E-mail

．Factory site

．Product

．Brand

．Enhancer name, chemical form, resource used

．Types of packaging and markings Types of packaging and markings

2. Attachment

．FDA LTO/Other Agency LTO or License, Validity.

．Certificate of Analysis for Fortifiers in Staple Foods from an FDA-recognized laboratory.

．The DSPS label is recommended.

．Application fee/brand.

．Applicant/authorized representative name, title, signature.

．Business License: When the business or establishment address is different from the registered address of the business name, the applicant should submit a copy of the business license (eg: Mayor’s Permit).

．Proof of income, such as the most recent audited financial statements and balance sheet (pdf).

．Medium and large food manufacturers, traders and distributors (importers, exporters and/or wholesalers) are required to submit a Risk Management Plan (RMP).

．Site Master File (SMF), which is required for applicants applying for LTO as a medium to large food manufacturer (CFRR).

．Location map etc.

Food/Dietary Supplement Product Registration

1. Applicant: Local businesses engaged in import, export, trade, retail and distribution of food/dietary supplements in the Philippines.

2. Application webpage:

https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login

3. Request

．Valid business license

．All clear and complete labels or scanned copies of products (if applicable) including product and/or packaging and secondary packaging (carton or cardboard)

．Foreign Agency Agreement (copy)

．Distribution certificate (copy)

．Contract (Copy)

．Invoice (copy)

．Manufacturer’s Memorandum of Agreement (copy)

．GMP compliant manufacturer registration certificate (copy)

．Valid phytosanitary certificate/health certificate

．Valid ISO22000 certification

．HACCP certificate issued by the country of origin

．Free selling certificate certified by a recognized regulatory body

．Stability study

．Finished Product Certificate of Analysis (COA)

．Applicable safety data (e.g. LD-50 toxicity test)

．Power of attorney

．Pledge oath

2. Additional documents (if applicable)

．Technical or Nutritional Health Research or Report

．Market research research

．Certificate in Analysis, Quantitative Analysis and Computing

．Scientific reports or research published in peer-reviewed scientific journals

Label

1. Food Labeling

．Product name/Food name

．Use of brand names and/or trademarks

．Complete Ingredient List

．Net content and dehydrated weight

．Name and address of manufacturer, repacker, packer, importer, trader and distributor

．Batch identification

．Storage situation

．Expiration or expiry date/use-by date/pre-consumption date (recommended last-consumption date)

．Food Allergen Information

．Nutrition Facts/Nutrition Information/Nutritional Value

2. Ingredient labels

．Except for single-ingredient foods, the full list of ingredients should be stated on the label.

．The ingredient list should begin or precede the appropriate title, which should contain or include the word ingredient

．The full list shall be published on the main display panel or information panel in descending order of scale.

．Added water should be declared in the ingredient list unless water forms part of an ingredient, such as brine, syrup or broth used in compound foods, and declared in the ingredient list. No declaration is required for water or other volatile components that evaporate during the manufacturing process.

．If an ingredient is itself the product of two or more ingredients, the compounded ingredient may be declared in the ingredient list, but must be immediately accompanied by a list of ingredients in descending proportional order in parentheses.

．If the compound ingredient accounts for less than 5% of the food, except for the food additive with technological function in the finished product, there is no need to declare the ingredient.

．Unless the generic category name provides more information and does not conflict with existing regulations/standards, specific names should be used for ingredients rather than collective (generic) names.

．Flavor and flavoring substances should be declared.

．Any pyrolignoic acid or other artificial tobacco flavors used should be declared as artificial flavors or artificial tobacco flavors.

．Coloring substances should be declared using their common name or food coloring or color (for substances derived from or identical to plant material), for coal tar dyes or other synthetic compounds.

．Food additives shall be marked with their generic names and functional categories.

．All food supplement labels should carry an unapproved therapeutic claim to inform consumers that the food/dietary supplement does not have an approved therapeutic effect.

3. Declaration of Food Additives

．Food additives must declare their common name or category name in the ingredient list, indicating their functional category.

．Levels below the level required to achieve technical function do not need to be declared in the ingredient list.

4. Validity Period / Validity Period

．Should be legible, prominent, and legible on all product labels (except alcoholic beverages) in the following order: day, month, year.

．Date and year declarations are numbers, while month declarations must be literals to avoid confusion (eg: due date: 1/1/2012 or 1/1/12).

5. Address of the Consumer Complaint Service Desk

6. Nutrition information

．Nutrition facts should be in tabular form with the declared value of protein, carbohydrates (including dietary fiber and sugars), fats (including saturated fat, trans fat, and cholesterol), sodium, energy, or calories.

．All nutrient content should be expressed in slices, slices, or specified weight or volume relative to average or typical serving size.

．Nutrient claims may also be expressed in units per serving or in percent of recommended energy and nutrient intake (RENI) or both, provided that all locally produced food products for local consumption are also stated with the corresponding RENI percent of actual value in Integer representation.

．Carbohydrates, proteins, fats (cholesterol expressed in milligrams (mg)), sugars and dietary fiber should be expressed to the nearest gram (g). Energy values should be expressed in calories (kcal). Sodium should be expressed in milligrams.

．Vitamins and minerals should be reported in milligrams or micrograms (mcg or <µg). International units (IU) should be used for vitamins A, D, and E.

7. Language and legibility requirements

．All information on food labels must be in English or Filipino or a combination thereof. If the imported food is marked with information in a foreign language, the corresponding English translation shall be attached.

．If the FDA allows existing labels to be used up, only temporary stickers for English or Filipino translations will be allowed for a maximum period of six months. All information should be accurate, clear, and must be included on a single label. The sticker must be durable, i.e. not easily removed from the label or packaging.

．If the label of a food package is too small to use the prescribed size letters, or involves secondary or optional information, scaled letters may be used, provided that the prescribed details are clearly visible and that the designated label space is consistent with the packaging proportional to the size. For other small packages that cannot accommodate label information, only the brand name and product name may be indicated. These products, however, may not be sold individually or for retail sale.

8. Country of Origin Label

．Every foreign origin item imported into the Philippines should be marked in any of the official languages ​​of the Philippines (Filipino or English). The country of origin shall be clearly, indelibly and permanently marked in a conspicuous place where the nature of the article (or container) permits.

．The name and address of the manufacturer, repacker, packer, importer, trader or distributor of the food should be indicated on the label of the locally manufactured product.

．For imported products, the full name, address and country of origin of the importer should also be declared.

．For products bearing a foreign brand or licensed by a foreign company, the name and/or address of the foreign company should be declared in a font size no larger than that used by the local company.

．When the food is processed in a second country that changes its nature, the second country where the processing takes place shall be considered the country of origin of the label.

．If the manufacturer has factories in many cities and/or towns, as long as each food package has a code/mark to identify the processing plant that produced it, the address indicates the company headquarters.

【参考连结】

https://www.fda.gov.ph/wp-content/uploads/2021/03/Requirements-for-Initial-Application-License-to-Operate-for-Food-Establishments.pdf

https://www.fda.gov.ph/wp-content/uploads/2021/03/Food-Registration-Requirements-to-secure-Certificate-of-Product-Registration.pdf

HLF-ph-55

HLF-ph-60
经过核准登记的保健食品，进口到菲律宾要检附什麽文件？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 Philippines? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?

Evershine RD：

海关

1.进口商企业首先需要取得国税局的进口清关证书，然后进口商在海关局 (BOC) 註册，并在客户资料註册系统 (CPRS) 上开设一个帐户。网页：https://aeo.customs.gov.ph/

2.进口清关证书有效期为三年，而海关客户资料认证必须每年更新。CPRS 认证费用为 P1000(20 美元)，通常需要 15 个工作日来处理。

3. 菲律宾海关对进口商品徵收 12% 的增值税 (VAT)，对价值低于 P10,000(200 美元)的商品不徵收关税或税款。

4.进口到菲律宾的企业在货物到达时必须提供以下文件：

．打包清单。

．发票。

．提货单。

．海关进口申报。

．原产地证书。

．食品和药物管理局的产品註册证书。

．经正式公证的估价补充声明 (SDV) 。

．自由贸易协定 (FTA) 的原产地证明。

．货物报关单。

．税收抵免证书 (TCC) 或税收借记通知单 (TDM)(如果适用) 。

．经营许可证 (LTO)

．产品註册证书 (CPR)

．FDA 认证/通知/许可(对于那些不需要 LTO 和/或 CPR 的人)

．分析证书(如适用)

5. 进口文件

．提单/空运提单，或船舶或飞机的承运人或代理人的证明。

．商业发票、信用证或任何其他可证明付款的商业文件。

．表明货物商业价值的商业文件。

6. 对于信用证 (L/C) 交易，需要正式完成的信用证，包括形式发票和预先海关进口关税的单一行政文件 (SAD)。
非信用证交易需要形式发票，例如承兑汇票 (D/A)、付款单据 D/P)、开立账户 (OA) 或自筹资金文件。

7.文件必须连同报关人和报关行(如有)签署并公证的 SAD 打印件一起提交给海关正式入境处 (FED) 或其同等办公室或单位。

Customs

1. The importer business first needs to obtain the import clearance certificate from the Internal Revenue Service, and then the importer registers with the Bureau of Customs (BOC) and opens an account on the Customer Data Registration System (CPRS). Website: https://aeo.customs.gov.ph/

2. The import customs clearance certificate is valid for three years, and the customs customer data certification must be updated every year. CPRS certification costs P1000 ($20) and usually takes 15 business days to process.

3. Philippine Customs imposes a 12% Value Added Tax (VAT) on imported goods and no duties or taxes are levied on goods valued below P10,000 (US$200).

4. Enterprises importing into the Philippines must provide the following documents upon arrival of the goods:

．Packing list.

．Invoices.

．Bill of lading.

．Customs import declaration.

．Certificate of Origin.

．Product Registration Certificate from the Food and Drug Administration.

．Duly notarized Supplemental Statement of Valuation (SDV).

．Free Trade Agreement (FTA) certificate of origin.

．Goods declaration.

．Tax Credit Certificate (TCC) or Tax Debit Memo (TDM) (if applicable).

．License to operate (LTO)

．Certificate of Product Registration (CPR)

．FDA clearance/notification/license (for those who do not need LTO and/or CPR)

．Certificate of Analysis (if applicable)

5. Import Documentation

．Bill of lading/air waybill, or proof of the carrier or agent of the ship or aircraft.

．Commercial Invoice, Letter of Credit or any other commercial document to prove payment.

．A commercial document showing the commercial value of the goods.

6. For Letter of Credit (L/C) transactions, a duly completed letter of credit including pro forma invoice and Single Administrative Document (SAD) with pre-customs import duties is required. Proforma invoices are required for non-LC transactions, such as drafts of acceptance (D/A), payment documents (D/P), opening of accounts (OA), or self-funding documents.

7. The documents must be submitted to the Customs Official Entry Division (FED) or its equivalent office or unit together with a signed and notarized SAD printout of the customs broker and the customs broker (if any).

【参考连结】

https://www.fda.gov.ph/downloadables/

https://customs.gov.ph/wp-content/uploads/2016/09/Import-Transaction-Overview-Infographic_v1.0.pdf

HLF-ph-70
菲律宾保健食品审核机构，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：

1.食品成分分析/食品营养检测

．食品添加剂分析

．草药製剂和膳食补充剂评估

．营养标籤和声称

．食品包装检测

．食品汙染测试和残留物测定

．食品、水和环境的微生物分析

．稳定性研究

．成品分析证书 (COA)

．适用的安全数据(例如 LD-50 毒性测试)

2. HACCP

．危害分析：从原料採收处理开始，经由加工、包装、流通乃至最终产品提供消费者为止，进行一科学化及系统化之评估分析整个过程，以了解各种潜在性危害发生之可能性及其危害程度。

．重要管制点：对可能造成显着危害之製程中某一点、步骤或程序，以有效监控方法(措施与条件)以预防、去除或降低食品危害至最低可以接受之程度。

．建立管制界限

．执行管制监测

．建立矫正措施

．建立记录系统

．实施Codex HACCP (危害分析及重要管制点)食品卫生系统等

2. GMP

．建立和维护质量管理体系，以控制生产和分销过程，确保该企业生产的所有产品均符合公佈的标准并可供人类安全食用，直至到期日。

．足够数量的人员，具备与其分配的工作岗位相适应的专业资格，并接受过基本的GMP知识、食品安全和相关专业知识的培训。生产负责人和质量控制负责人必须是该机构的全职员工，并且相互独立。机构专业负责人必须具有医学、药学、营养学、食品安全、食品技术等专业之一的大学本科以上学历，并具有3年以上相关专业领域的工作经验。

．车间、设备及附属设施系统按照使用目的设计、建造和安装，单向原则，易于清洁，防止和最大程度减少错误风险，避免汙垢堆积、汙染等对产品产生不利影响的因素，并保持日常清洁活动。

．实施和维护有关生产、质量控制、流通和分销的完整记录和文件，以检索每个产品批次的历史记录并记录执行的所有其他活动。

．所有生产操作必须遵循流程和说明。在生产过程中採取检查和监督措施，防止和避免混淆、汙染和交叉汙染的风险。执行操作后立即记录结果或在记录中完成生产阶段后立即记录结果。

．设有质量控制部门，以确保产品在适当的条件和工艺下製造并符合既定标准；已进行必要的测试；产品质量不合格不准销售；必须监测产品的稳定性。

．检测或委託生产的受委託方必须有足够的厂房、设备和人员，以满足转让方的要求，并符合主管管理机构对检测或生产食品/膳食补充剂条件的规定。

．有规定投诉处理、产品召回和自检流程；遵循程序并记录并保留这些活动的充分记录等。

1. Food ingredient analysis/food nutrition testing

． Food Additive Analysis

． Evaluation of herbal preparations and dietary supplements

． Nutrition Labels and Claims

． Food packaging inspection

． Food Contamination Testing and Residue Determination

． Microbiological Analysis of Food, Water and the Environment

． Stability Studies

． Finished Product Certificate of Analysis (COA)

． Applicable safety data (such as LD-50 toxicity test)

2. HACCP

．Hazard analysis: From raw material harvesting and processing, through processing, packaging, distribution, and final product delivery to consumers, a scientific and systematic evaluation and analysis of the entire process is carried out to understand the possibility of various potential hazards and their hazards degree.

． Important control point: For a point, step or procedure in the process that may cause significant harm, effective monitoring methods (measures and conditions) are used to prevent, remove or reduce food hazards to the lowest acceptable level.

．Establish regulatory boundaries

．Executive Regulatory Monitoring

．Establish corrective measures

．Establish a system of record

．Implementation of Codex HACCP (Hazard Analysis and Critical Control Point) food hygiene system, etc.

2. GMP

．Establish and maintain a quality management system to control the production and distribution process to ensure that all products produced by this business meet published standards and are safe for human consumption until the expiration date.

．A sufficient number of personnel with professional qualifications appropriate to their assigned jobs and trained in basic GMP knowledge, food safety and related professional knowledge. The Head of Production and Head of Quality Control must be full-time employees of the facility and be independent of each other. The person in charge of the institution must have a bachelor’s degree or above in one of the majors in medicine, pharmacy, nutrition, food safety, food technology, etc., and have more than 3 years of work experience in related professional fields.

．Workshops, equipment and ancillary facilities systems are designed, constructed and installed in accordance with the purpose of use, one-way principle, easy to clean, prevent and minimize the risk of errors, avoid factors such as dirt accumulation, contamination that adversely affect the product, and maintain daily cleaning activities .

．Implement and maintain complete records and documentation regarding production, quality control, circulation and distribution to retrieve the history of each product batch and record all other activities performed.

．All production operations must follow processes and instructions. Inspection and supervision measures are taken during the production process to prevent and avoid the risk of mix-ups, contamination and cross-contamination. The result is recorded immediately after the action is performed or after the production stage is completed in the record.

．There is a quality control department to ensure that products are manufactured under proper conditions and processes and meet established standards; necessary tests have been carried out; products are not of acceptable quality for sale; product stability must be monitored.

．The entrusted party for testing or entrusted production must have sufficient plant, equipment and personnel to meet the requirements of the transferor and comply with the regulations of the competent management agency on the conditions for testing or producing health food.

．Procedures for complaint handling, product recalls and self-inspection are in place; procedures are followed and adequate records of these activities are recorded and maintained, etc.

【参考连结】

https://www.fda.gov.ph/downloadables/

HLF-ph-75

HLF-ph-77

HLF-ph-80
外国子公司进口保健食品后，如果委託菲律宾的经销商销售，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 Philippines 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：

在菲律宾从事的食品/膳食补充剂进出口、贸易、零售和分销的企业需要从菲律宾食品药物管理局(FDA)获得经营许可证(LTO)及完成产品註册。

产品责任

1.负责将食品/膳食补充剂投放市场的公司是不良事件召回的主要责任方。

2.如果食品/膳食补充剂在原产地因健康和安全原因受到抨击或撤回，进口商应立即採取必要措施，禁止向公众出售、分销或捐赠，或立即欉市场上召回、撤回或扣押。

3.经FDA 声明为有害、不安全或有危险的保健产品的企业，应立即召回、撤回、扣押该产品，或禁止其向公众销售、分销或捐赠。

4.召回的处理包含：

．食品/膳食补充剂的质量/投诉处理

．不良事件监测和基于事件的监测反应报告

．卫生产品的抽样、测试和验证

．许可后检查、监测和调查

．确认通知的后评估

．广告和宣传材料监控

．与其他监管机构和国际合作伙伴的协调

．其他 MAH 的上市后监督活动的结果

5.一旦触发事件发生，产品召回委员会应审查和评估健康危害。
在做出召回特定食品/膳食补充剂的决定时，应考虑以下因素：

．已因使用保健产品而发生疾病、伤害、疾病或中毒。

．可能导致人群接触的任何现有状况。

．对预期接触此类卫生产品的不同人群的危害。

．面临风险的人群可能面临的危害的严重程度。

．人群可能面临的暴露风险发生的可能性。

．健康影响的短期和长期后果。

．对公众造成严重欺骗的风险。

．不符合 FDA 标准。

．误报有害物质含量。

．汙染产品的材料，无论是意外的还是有意的。

．参加情况可能需要的其他因素。

6.分类：

．I 类召回：可能危及生命或可能导致严重健康风险、健康损害或影响(例如对健康造成永久性损害或死亡)的产品缺陷/状况。

．II 类召回：可能导致中毒或暂时/医学上可逆的不利健康问题或虐待的产品缺陷/状况。

．III 级召回：可能不会对健康造成重大危害的产品缺陷/状况，但可能因其他原因而开始撤回。

Businesses engaged in the import, export, trade, retail and distribution of food/dietary supplements in the Philippines need to obtain a license to operate (LTO) from the Philippine Food and Drug Administration (FDA) and complete product registration.

Product Liability

1. The company responsible for placing the food/dietary supplement on the market is the primary responsible party for the adverse event recall.

2. If the food/dietary supplement is criticized or withdrawn for health and safety reasons in the country of origin, the importer shall immediately take the necessary measures to prohibit the sale, distribution or donation to the public, or to immediately recall, withdraw or seize the market.

3. Businesses that have been declared by the FDA to be harmful, unsafe, or dangerous health care products should immediately recall, withdraw, seize, or prohibit their sale, distribution, or donation to the public.

4. The processing of recall includes:

．Food/Dietary Supplement Quality/Complaint Handling

．Adverse Event Monitoring and Event-Based Surveillance Response Reporting

．Sampling, testing and verification of hygiene products

．Post-licensing inspections, monitoring and investigations

．Post-evaluation of confirmation notices

．Monitoring of advertising and promotional materials

．Coordination with other regulatory agencies and international partners

．Results of post-market surveillance activities of other MAHs

5. Once a triggering event occurs, the Product Recall Committee shall review and evaluate the health hazards.
The following factors should be considered when making a decision to recall a specific food/dietary supplement:

．Sickness, injury, illness, or poisoning has occurred as a result of the use of a health product.

．Any existing conditions that could lead to population exposure.

．Hazards to different populations expected to be exposed to such hygiene products.

．The severity of the hazard that the at-risk population may be exposed to.

．The likelihood of occurrence of exposure risks that the population may face.

．Short-term and long-term consequences of health effects.

．Risk of serious deception to the public.

．Not FDA compliant.

．Misreporting the content of hazardous substances.

．Materials that contaminate a product, either accidentally or intentionally.

．Other factors that may be required for participation.

6. Classification:

．Class I Recalls: Product defects/conditions that may be life-threatening or may cause serious health risks, health damage, or effects (such as permanent damage to health or death).

．Class II Recalls: Product defects/conditions that may cause poisoning or temporary/medically reversible adverse health problems or abuse.

．Class III Recalls: Product defects/conditions that may not pose a significant health hazard, but may have begun to be withdrawn for other reasons.

【参考连结】

https://www.fda.gov.ph/downloadables/

https://www.fda.gov.ph/wp-content/uploads/2021/03/Requirements-for-Initial-Application-License-to-Operate-for-Food-Establishments.pdf

HLF-ph-85

各国健康食品登记法规问题集

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电话：+886-2-2717-0515 分机:104

全球永辉服务据点参考资料:
永辉100%关係企业
永辉总部、台北永辉、厦门永辉、北京永辉、上海那灵、深圳常新、纽约永辉、加州永辉、德州永辉、凤凰城永辉、东京永辉、首尔永辉、河内永辉、越南胡志明、曼谷永辉、新加坡永辉、吉隆玻永辉、雅加达永辉、马尼拉永辉、墨尔本永辉、澳洲雪梨、孟加拉永辉、新德里永辉、印度孟买、杜拜永辉、法兰克福永辉、巴黎永辉、伦敦永辉、荷兰永辉、西班牙永辉、义大利永辉、罗马尼亚永辉、多伦多永辉、墨西哥永辉、捷克永辉。
其他已提供中文化服务城市：
迈阿密、亚特兰大、俄克拉荷马、密歇根、西雅图、特拉华；
柏林; 斯图加特;布拉格；布加勒斯特；班加罗尔；泗水；
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永辉潜在可服务城市 (2个月筹备期)：
我们为IAPA会员所,总部在伦敦，全球300个会员所，员工约1万人。
我们为LEA会员所,总部在美国芝加哥，全球600个会员所，员工约2万8千人。
Evershine is local Partner of ADP Streamline® in Taiwan.
(版本:2022/03)
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