Philippines Health Food Regulation QA

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HLF-ph-10

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：

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.

【參考連結】

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

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：

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/

【參考連結】

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

HLF-ph-25

假如需要辦理，請問菲律賓有專業服務公司可以協助辦理保健食品公司營業許可證？

Evershine RD：

NDL

https://ndvlaw.com/

YKC

https://www.ykclaw.ph/

HLF-ph-30

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：

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.

【參考連結】

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

HLF-ph-35

假如需要辦理指派菲律賓公司擔任營業代理人，請問菲律賓有專業服務公司可以協助？

Evershine RD：

GoNutrients

https://www.gonutrients.ph/

Bultuhan

https://www.bultuhan.com/

HLF-ph-40

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：

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.

【參考連結】

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

請問在菲律賓有哪些專業服務機構，可以協助辦理保健食品產品許可證？

Evershine RD：

TÜV

https://www.tuvsud.com/en-ph

NDL

https://ndvlaw.com/

HLF-ph-50

Can a foreign company apply for a product license by its own name?
If yes, which authority is in charge? What documents are required? What is the application process?
Do health food packaging and labeling require prior approval? Which languages ​​are allowed?Website?

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.

【參考連結】

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

請問在菲律賓有哪些專業服務機構，可以協助以外國公司名義辦理保健食品產品許可證？

Evershine RD：

TÜV

https://www.tuvsud.com/en-ph

NDL

https://ndvlaw.com/

HLF-ph-60

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：

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).

【參考連結】

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

What are the laboratory inspection materials that need to be attached for verification? Website?

Evershine RD：

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.

【參考連結】

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

HLF-ph-75

菲律賓保健食品審核機構，能夠接受海外檢驗機構的檢驗資料嗎？假如是的話，有些被認可的機構？網頁？

Evershine RD：

SGS

https://www.sgs.com/en-ph

TÜV

https://www.tuvsud.com/en-ph

HLF-ph-77

請問在菲律賓有哪些保健食品檢驗機構可以提供保健食品檢驗服務？網頁？

Evershine RD：

SGS

https://www.sgs.com/en-ph

TÜV

https://www.tuvsud.com/en-ph

HLF-ph-80

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：

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.

【參考連結】

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

請問在菲律賓有哪些專精於保健食品銷售與消費權益相關法律服務的業者？

Evershine RD：

Victoriano Tiu & Aureus

https://victorianotiuaureus.com/

A&T Law

https://www.arceotandoc.com/

Manila Evershine BPO Service Limited Corp.
E-mail: mnl4ww@evershinecpa.com
or
Contact by Viber or Skype in working hours of Philippines time zone.
For Philippines going-out cases, the coordinator window will be:
Manila Branch of Evershine BPO Service Corp. in Taiwan
Project Manager Meiling Wu , who speak in both English and Tagalog.
Viber: +886966173105
Skype: wumeiling25

or
For investment structure relevant to multi-national tax planning and Financial & Legal Due Diligence for M&A (Merge and Acquisition), send an email to HQ4mnl@evershinecpa.com
Dale Chen, Principal Partner/CPA in Taiwan+China+UK will be accountable for your case.
Email address:dalechen@evershinecpa.com
Linkedin address:Dale Chen

Additional Information

Evershine CPAs Firm Headquarters
6th Floor 378 Chang Chun Rd., Taipei City, Taiwan ROC
Partner Kerry Chen, USA Graduate School and a well-English speaker
Tel No.: +886-2-27170515 ext. 105
Mobile: +886-939357000
Email: kerrychen@evershinecpa.com
Skype: oklahomekerry

Evershine has 100% affiliates in the following cities:
Headquarter, Taipei, Xiamen, Beijing, Shanghai, Shanghai,
Shenzhen, New York, San Francisco, Houston, Phoenix Tokyo,
Seoul, Hanoi, Ho Chi Minh, Bangkok, Singapore, Kuala Lumpur,
Manila, Dubai, New Delhi, Mumbai, Dhaka, Jakarta, Frankfurt,
Paris, London, Amsterdam, Milan, Barcelona, Bucharest,
Melbourne, Sydney, Toronto, Mexico

Other cities with existent clients:
Miami, Atlanta, Oklahoma, Michigan, Seattle, Delaware;
Berlin, Stuttgart; Prague; Czech Republic; Bangalore; Surabaya;
Kaohsiung, Hong Kong, Shenzhen, Donguan, Guangzhou, Qingyuan, Yongkang, Hangzhou, Suzhou, Kunshan, Nanjing, Chongqing, Xuchang, Qingdao, Tianjin.

Evershine Potential Serviceable City (2 months preparatory period):
Evershine CPAs Firm is an IAPA member firm headquartered in London, with 300 member offices worldwide and approximately 10,000 employees.
Evershine CPAs Firm is a LEA member headquartered in Chicago, USA, it has 600 member offices worldwide and employs approximately 28,000 people.
Besides, Evershine is Taiwan local Partner of ADP Streamline ®.
(version: 2024/07)
Please send email to HQ4mnl@evershinecpa.com

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