Singapore Health Food Regulation QA

Email: sin4ww@evershinecpa.com

Singapore CPA Lau Wei-Koon, speak in both English and Chinese
215 Henderson Road #03-03 Henderson Industrial Park Singapore 159554

HLF-SG-10

What are the categories of health food in Singapore? 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 Singapore, Health Sciences Authority (HAS) under the Ministry of Health is the national regulatory body for the regulation of supplements, and the Internal Health Products Section is responsible for overseeing supplements.

A nutraceutical is a product used to supplement the diet, support (maintain), enhance and improve the health functions of the human body.
It cannot be injectable or preparations that require sterility, such as injections and eye drops.
It cannot be part of a meal or diet. The supplement must also contain one or more, or a combination of the following ingredients:

1. Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics and other biologically active substances.

2. Substances derived from natural sources, including extracts, isolates, concentrates of animal, mineral and plant materials.

3. Synthetic sources of ingredients mentioned in (1) and (2).

Health supplements must be administered in small unit dosage forms such as: capsules, soft gels, lozenges, liquids, syrups.

【參考連結】

https://www.hsa.gov.sg/health-supplements/overview

HLF-SG-20

If a foreign company wants to sell health food in Singapore, 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：

Import, manufacture and sale of supplements without HSA approval and permission.
Supplements do not require pre-market approval, but supplements must comply with the guidelines for supplements, and the HSA prohibits the addition of medicinal ingredients such as steroids to supplements.

【參考連結】

https://www.hsa.gov.sg/health-supplements/overview

HLF-SG-25

假如需要辦理，請問新加坡有專業服務公司可以協助辦理保健食品公司營業許可證？

Evershine RD：

無須申請營業許可證

HLF-SG-30

If a foreign company wants to sell health food in Singapore, can it assign a Singapore 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：

Import, manufacture and sale of supplements without HSA approval and permission
Supplements do not require pre-market approval, but supplements must comply with the guidelines for supplements, and the HSA prohibits the addition of medicinal ingredients such as steroids to supplements.

Distributors are responsible for the safety and quality of their health supplements, and distributors must ensure that the products meet the safety and quality standards set forth by the HSA.
If any safety or quality issues with locally sold supplements are detected, the HSA will take necessary action and the public will be warned about the harmful product.

URL:

【參考連結】

https://www.hsa.gov.sg/health-supplements/overview

HLF-SG-35

假如需要辦理指派新加坡公司擔任營業代理人，請問新加坡有專業服務公司可以協助？

Evershine RD：

F&B

https://www.wholesomefoodpeople.com/

Nature’s Glory

https://www.natures-glory.com/

HLF-SG-40

Do foreign companies need to apply for an approval before importing health food sold to Singapore?
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：

No product licensing is required, and packaging and labelling do not require prior approval, but they need to comply with the specifications.
Import, manufacture and sale of supplements without HSA approval and permission
Supplements do not require pre-market approval, but supplements must comply with the guidelines for supplements, and the HSA prohibits the addition of medicinal ingredients such as steroids to supplements.

Packaging & Labeling

1.Product labels should be prominent and conspicuous. All product labels must be in English. If there is information in other languages, it should be consistent with the English text.

2.The information should be sufficient and authentic, and the labels should be printed or presented in a clear and indelible way.

3.Product name (including brand name, if applicable)

A brand name usually refers to a company or manufacturer’s name for a product or line of products (it may not). A product name is the name given to a particular product to distinguish it from other similar products on the market.

4.Dosage Form

Refers to the final physical form of the product that contains the active ingredient, ready to be used by consumers, such as tablets, capsules, soft gels, liquids, etc.

5.Active ingredient name and quantity

． Active ingredients are those that contribute to the intended function of the product. (Internationally recognized nomenclature is recommended for ingredient names.)

． The name and quantity of the plant/animal from which the active ingredient was extracted and the plant or animal part that constitutes the active ingredient, as well as the type of preparation to which it applies, shall be declared by the scientific name.

． Use of common or local names of plants or animals is optional.

． For vitamins and minerals, use the generic or chemical name.

． For mineral supplements in salt form, the strength of the element should be stated.

． The number of active ingredients refers to the amount or recommended dose of each active ingredient in each dosage form.

6.Product Indications/Intended Use

． Intended purpose means a statement relating to the indication, benefit or action of the product.

． Statements of intended use or intent should be made in accordance with the guidelines.

7.Dosage and Instructions for Use

Information on the route of administration, dose, frequency and, if applicable, duration of use of the product for which the product is intended.

8.Lot No.

A name (numbers or letters or a combination of both) that identifies a product batch and allows traceability of the complete history of a particular product batch, including all stages of production, controls, distribution, and raw materials used.
The batch number should be preceded by a title such as the batch number or BN.

9.Expiry Date

Refers to the date assigned to each individual batch by which the batch still meets the required specification.
Expiration dates should be declared in month and year (e.g. Jan/2022, 01/2022), with headings such as due date or EXP before the title to avoid ambiguity and confusion.

10. Manufacturer Name and Country: Full name and country.

11. Name and Address of Local Importer: Full name and address of importer.

12. Contraindications (if applicable)

13. WARNINGS: Include side effects, contraindications and appropriate precautions.

． Inactive substances with sensitizing effects should be declared: benzoic acid, sodium benzoate, tartrazine

14. Others (if applicable)

15. Storage Conditions: Declare the conditions under which the product should be properly stored to maintain product quality.

16. Package size/net content

Refers to the quantity of product in a package or container and can be expressed in absolute quantities (for solid dosage forms), such as 30 capsules/container, or net content (for liquid, powder, or semi-solid dosage forms), such as 500mL/vial.

【參考連結】

https://www.hsa.gov.sg/health-supplements/overview

https://www.hsa.gov.sg/docs/default-source/hprg-tmhs/chpb-tmhs/tmhs_labelling_guidelines.pdf

HLF-SG-45

請問在新加坡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：

無須申請產品許可證

HLF-SG-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?

Evershine RD：

No product licensing is required, and packaging and labelling do not require prior approval, but they need to comply with the specifications.

Import, manufacture and sale of supplements without HSA approval and permission

Supplements do not require pre-market approval, but supplements must comply with the guidelines for supplements, and the HSA prohibits the addition of medicinal ingredients such as steroids to supplements.

Packaging & Labeling

1.Product labels should be prominent and conspicuous. All product labels must be in English. If there is information in other languages, it should be consistent with the English text.

2.The information should be sufficient and authentic, and the labels should be printed or presented in a clear and indelible way.

3.Product name (including brand name, if applicable)

A brand name usually refers to a company or manufacturer’s name for a product or line of products (it may not). A product name is the name given to a particular product to distinguish it from other similar products on the market.

4.Dosage Form

Refers to the final physical form of the product that contains the active ingredient, ready to be used by consumers, such as tablets, capsules, soft gels, liquids, etc.

5.Active ingredient name and quantity

． Active ingredients are those that contribute to the intended function of the product. (Internationally recognized nomenclature is recommended for ingredient names.)

． The name and quantity of the plant/animal from which the active ingredient was extracted and the plant or animal part that constitutes the active ingredient, as well as the type of preparation to which it applies, shall be declared by the scientific name.

． Use of common or local names of plants or animals is optional.

． For vitamins and minerals, use the generic or chemical name.

． For mineral supplements in salt form, the strength of the element should be stated.

． The number of active ingredients refers to the amount or recommended dose of each active ingredient in each dosage form.

6.Product Indications/Intended Use

． Intended purpose means a statement relating to the indication, benefit or action of the product.

． Statements of intended use or intent should be made in accordance with the guidelines.

7.Dosage and Instructions for Use

Information on the route of administration, dose, frequency and, if applicable, duration of use of the product for which the product is intended.

8.Lot No.

A name (numbers or letters or a combination of both) that identifies a product batch and allows traceability of the complete history of a particular product batch, including all stages of production, controls, distribution, and raw materials used. The batch number should be preceded by a title such as the batch number or BN.

9.Expiry Date

Refers to the date assigned to each individual batch by which the batch still meets the required specification. Expiration dates should be declared in month and year (e.g. Jan/2022, 01/2022), with headings such as due date or EXP before the title to avoid ambiguity and confusion.

10. Manufacturer Name and Country: Full name and country.

11. Name and Address of Local Importer: Full name and address of importer.

12. Contraindications (if applicable)

13. WARNINGS: Include side effects, contraindications and appropriate precautions.

． Inactive substances with sensitizing effects should be declared: benzoic acid, sodium benzoate, tartrazine

14. Others (if applicable)

15. Storage Conditions: Declare the conditions under which the product should be properly stored to maintain product quality.

16. Package size/net content

Refers to the quantity of product in a package or container and can be expressed in absolute quantities (for solid dosage forms), such as 30 capsules/container, or net content (for liquid, powder, or semi-solid dosage forms), such as 500mL/vial.

【參考連結】

https://www.hsa.gov.sg/health-supplements/overview

https://www.hsa.gov.sg/docs/default-source/hprg-tmhs/chpb-tmhs/tmhs_labelling_guidelines.pdf

HLF-SG-55

請問在新加坡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：

無須申請產品許可證

HLF-SG-60

What documents are required when importing approved health food into Singapore? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?

Evershine RD：

Import of health food requires a customs import license, and no prior reporting is required before sales.

Customs Import Permit:

1. Register an account with the portal:

https://www.tradenet.gov.sg/TN41EFORM/tds/sp/splogin.do?action=init_acct

2. Designated customs broker (Singapore Logistics Association/Singapore Air Freight Forwarders Association) or self-declaration.

．Must be tied to Singapore Customs Responsible Bank GIRO (IBG) for payment of duties, taxes, fees, fines and other charges for services provided by Singapore Customs directly from your bank account to Singapore Customs.

． If the IBG is not held at Singapore Customs, customs duties and GST will be deducted from the IBG of your reporting agent.

3. Provide security

．Guarantee is required for transactions involving dutiable goods, temporary importation of goods for approved purposes, and the operation of franchise premises such as licensed warehouses and excise factories.

． The guarantee provided shall be in the form of bank guarantee, financial company guarantee or security deposit.

4. Obtain customs import license

．Applications must be submitted through TradeNet (TradeNet software, government applications)

．The application fee for each license is usually S$2.88, excluding customs brokerage service fees.

Document content

．Application company (customs declaration must be made in the name of the company, if it is an individual, you can entrust an agency company to apply), zip code, address, telephone, fax, industry

．Contact, Contact, Phone, Fax, Email

．Billing administrator (usually supervisor or financial officer) name, ID/passport number, contact details, email

．Payment method

．Signature

5. Prepare cargo clearance documents

．Provide supporting documents including invoice, packing list and bill of lading/air waybill

．Documents Required for Containerized Cargo

Importing containerized cargo by sea eliminates the need to present printed copies of customs permits and supporting documents to checkpoint personnel at the port of entry.

To import containerized cargo by air or land, you need to present a customs permit and supporting documents such as invoice, packing list and bill of lading/airway bill to verify with the checkpoint officer.

． Documents Required for Regular Cargo

For conventional goods, please submit the goods, printed copies of customs passes, invoices, packing lists, bills of lading/airway bills and other supporting documents to the inspection personnel for verification when the goods are cleared.

． Keep trade documents

Relevant supporting documents related to the purchase, import, sale or export of goods are retained for 5 years from the date of approval of the license application.

【參考連結】

https://www.customs.gov.sg/businesses/importing-goods/overview

https://www.customs.gov.sg/businesses/importing-goods/import-procedures/apply-customs-import-permit

HLF-SG-70

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

Evershine RD：

Health supplement distributors must ensure that your products meet safety and quality standards.

1. Substances not allowed

Imported or sold health products must not contain the following

． Ingredients from human body parts

． poison

． Ingredients that may affect human health

． ingredients that can cause zoonotic diseases

2. Toxic Heavy Metal Limits

． Arsenic: 5 parts per million (ppm)

． Cadmium: 0.3ppm

． Lead: 10ppm

． Mercury: 0.5ppm

3. Microbial limit

Supplements should not exceed the following microbial limits

． Total number of aerobic bacteria: not more than 10 5

． Yeast and mold: no more than 5 x 10 2

． E. coli, Salmonella and Staphylococcus aureus: Not allowed

． Distributors and sellers are obligated to ensure that the microbial content and heavy metals of the product are appropriate and safe for use in accordance with the recommended conditions of use and intended users.

4. Vitamin and Mineral Limits

Limits of vitamins in general adult health products. (Daily maximum)

． Biotin: 0.9 mg

． Folic acid: 0.9 mg

． Niacinamide: 450 mg

． Niacin: 15 mg

． Vitamin A (retinol): 1.5 mg (5000 IU)

． Vitamin B1: 100 mg

． Vitamin B2: 40 mg

． Vitamin B5 (pantothenic acid): 200 mg

． Vitamin B6: 100 mg

． Vitamin B12: 0.6 mg

． Vitamin C: 1000 mg

． Vitamin D: 0.025 mg (1000 IU)

． Vitamin E: 536 mg (800 IU)

． Vitamin K1/K2: 0.12 mg

Limits of minerals in general adult health products. (Daily maximum)

． Boron: 6.4 mg

． Calcium: 1200 mg

． Chromium: 0.5 mg

． Copper: 2 mg

． Iodine: 0.15 mg

． Iron: 15 mg*

． Magnesium: 350 mg

． Manganese: 3.5 mg

． Molybdenum: 0.36 mg

． Phosphorus: 800 mg

． Selenium: 0.2 mg

． Zinc: 15 mg

． For multivitamin and mineral supplements for pregnant women, consider increasing the iron limit to 30 mg/day.

Quality Standard

1. Physical test parameters based on dosage form

．Hardness and brittleness measure a product’s mechanical integrity and ability to withstand mechanical stress and resistance to chipping or surface wear during manufacture, handling and shipping.

．The degree of disintegration determines whether the product contents will disintegrate within a specified period of time when placed in a liquid medium under specified test conditions.

．Dissolution assesses how quickly and to what extent a product dissolves to form a leachable.

．Viscosity measures the amount of friction and drag within a liquid’s contents.

．Uniformity of dosage unit is a measure of how uniformly the active substance is distributed in a product, and can also be demonstrated by content uniformity or mass variation.

2. Test Requirements

．The test report should contain at least the following information:

1 report date

2 Brand name (if applicable) and product name

3 batch numbers

4 Name of the test substance

5 Refer to relevant specifications and test procedures

6 Test results if necessary

7 test dates

8 Analyst name and signature

．Finished products should be tested for heavy metals, microorganisms, poisons and adulterants.
Product specification sheets or certificates of analysis for raw materials or intermediates are not intended to replace finished product testing.

．Test results should be reported quantitatively (eg, Arsenic 0.05ppm).
For test results reported as Not Detected or ND, the detection limit must be stated on the test report.

3. Manufacturing standard

Acceptable manufacturing standards

．Pharmaceutical Inspection Cooperative Program (PIC/S) Good Manufacturing Practice for Pharmaceutical Products

．World Health Organization (WHO) Good Manufacturing Practice (GMP)

．ASEAN Good Manufacturing Practice (GMP) Guidelines for Traditional Medicines

．ASEAN Good Manufacturing Practice (GMP) Guidelines for Nutraceuticals

．US Food and Drug Administration (US FDA) Current Good Manufacturing Practices (cGMP) for Dietary Supplements

．International Organization for Standardization (ISO) – Food Safety Management (ISO 22000)*

．Food Safety System Certification (FSSC) 22000*

．Hazard Analysis Critical Control Point (HACCP) System*

*These are certification standards for food safety management systems and are considered applicable if the product is regulated by the food laws of the country of manufacture.
For manufacturers certified to HACCP standards, distributors should ensure that these manufacturers have procedures in place to manage feedback and recall activities.

【參考連結】

https://www.hsa.gov.sg/health-supplements/overview

HLF-SG-75

新加坡保健食品審核機構，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：

Signatory Search

ILAC中列出的相應國家認可機構，請參考網站

HLF-SG-77

請問在新加坡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：

新加坡認可的分析測試實驗室可以在 SACSINGLAS 的網站上找到https://www.sac-accreditation.gov.sg/

ALS Technichem (S) Pte Ltd

https://www.alsglobal.com/

HLF-SG-80

After a foreign subsidiary imports health food and entrusts a distributor in Singapore 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：

No business license required.

Distributors are responsible for the safety and quality of their health supplements, and distributors must ensure that the products meet the safety and quality standards set forth by the HSA.
If any safety or quality issues with locally sold supplements are detected, the HSA will take necessary action and the public will be warned about the harmful product.

【參考連結】

https://www.hsa.gov.sg/health-supplements/overview

https://www.hsa.gov.sg/consumer-safety/articles/how-health-supplements-are-regulated-by-hsa

HLF-SG-85

請問在新加坡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？

Gravitas Law LLC

https://www.gravitaslaw.com.sg/

Rajah & Tann

https://www.rajahtannasia.com/one-team/partners/hoon-chi-tern

Contact Us

Singapore Evershine BPO Service Limited Corp.
E-mail: sin4ww@evershinecpa.com
Singapore CPA Lau Wei-Koon, speak in both English and Chinese
215 Henderson Road #03-03 Henderson Industrial Park Singapore 159554

or
For investment structure relevant with multi-national tax planning and Financial & Legal Due Diligence for M&A (Merge and Acquisition), email to HQ4sin@evershinecpa.com
Dale Chen, Principal Partner/CPA in Taiwan+China+UK will be accountable to your case.
Email address:dalechen@evershinecpa.com
linkedin address: Dale Chen

Additional Information

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 HQ4sin@evershinecpa.com

More Cities and More Services please click  Sitemap