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Business Introduction
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Business Introduction

Complex certification process?
That’s why we’re here.

SC Holdings offers a comprehensive one-stop solution for K-brands aiming to expand globally. From certifications and regulatory compliance to multilingual label design, we support the entire process for major markets including the United States, Canada, Japan, and the United Arab Emirates.

Launched in January 2025, our FDA (U.S.) and Health Canada (Canada) registration and labeling service has seen explosive growth within just six months. To meet rising demand, SC Holdings will officially establish a dedicated certification team in early 2026—becoming a reliable gateway for more K-brands entering the North American market.

Certification & Labeling Process

  • STEP 1

    Certification Consultation & Document Review

    We guide you through the types of certifications required, necessary documents, timelines, and costs in a clear and friendly manner.

  • STEP 2

    Application & Processing

    We handle the certification procedures on your behalf according to each country’s regulations and provide real-time updates on the progress.

  • STEP 3

    Compliance Label Design

    We design and prepare product labels and layout modifications in compliance with local regulations and language requirements.

  • STEP 4

    Certification Completion

    Once the certification and label design are complete, we deliver the registration numbers, finalized label files, and all related documentation to your brand.

  • U.S. FDA Registration Support

    To sell products in the United States, FDA registration is required based on product type. General moisturizers must undergo Cosmetic Product Listing, while functional products must comply with regulations through OTC (Over-The-Counter Drug) registration.

  • Health Canada Registration Support

    In Canada, product registration via a Responsible Person (RP) is mandatory for selling cosmetics. Depending on the product, either CN (Cosmetic Notification) or NHP (Natural Health Product) registration is required. SC Holdings provides full-service support for both processes.

  • MHLW (Japan) Registration Support

    Functional cosmetics and quasi-drugs sold in Japan must be registered with the MHLW. SC Holdings assists Korean brands in navigating complex Japanese regulations and completing the necessary registration steps.

  • Dubai Municipality (DM) Certification Support

    To distribute cosmetics in the UAE, products must be pre-registered through Dubai Municipality’s Product Registration system. SC Holdings supports brands with document review, preparation, and submission for DM certification.

  • Multilingual Label Sticker Production

    We provide one-stop service for drafting label content in compliance with each country’s legal requirements, translation, design, and printing. Our label stickers meet the specific standards of FDA, Health Canada, DM, and other regulatory agencies.

Certification Cost & Lead Time by Country

Country Regulatory Body Certification Type Label Sticker
Require		 Target Products Cost / Product
(excl. VAT)		 Lead Time Annual
Renewal Required		 Annual
Renewal Fee
United
States		 FDA Cosmetic Product Listing O General moisturizing cosmetics ₩300,000 5–10 business days Recommended ₩200,000
OTC Mineral sunscreen, acne treatment cosmetics ₩700,000 10–20 business days Required ₩500,000
No certification required General food products ₩170,000 5–10 business days Not applicable  
No certification required Functional food, health supplements ₩250,000 5–10 business days Not applicable  
Canada Health
Canada		 Cosmetic Notification O General moisturizing cosmetics ₩400,000 5–90 business days Not applicable  
NHP (Natural Health Product) Mineral sunscreen, acne treatment cosmetics ₩800,000 3–12 months  
No certification required General food products ₩300,000 5–10 business days  
NHP (Natural Health Product) Functional food, health supplements ₩1,000,000 12–18 months  
Japan MLHW (Ministry of Health, Labour and Welfare) Cosmetic Notification O General moisturizing cosmetics ₩750,000 10–20 business days    
Quasi-drug (Functional Cosmetics) SPF sunscreen, medicated whitening cream, acne treatment cosmetics ₩850,000 6–12 months    
Food Import Notification General food products ₩150,000 Required for each export    
Australia AICIS No certification required O General cosmetics ₩100,000 5–10 business days Not applicable  
TGA ARTG Listing Not available Sunscreens, hand sanitizers, acne treatment products Not available 　 　  
FSANZ No certification required O General food, health functional foods ₩300,000 5–10 business days Not applicable  
TGA ARTG Listing Not available Health supplements Not available 　 　  
United
Arab
Emirates		 DM
(Dubai Municipality)		 Product Registration O All cosmetics ₩350,000 6–8 weeks Not applicable  

*After producing the sticker label as a PDF file, mass production support is also available! (Minimum order: 500 units)

 
Country Target Products Notes
United States
(FDA)		 General Food, Functional Food, Health Supplements
Under U.S. FDA regulations, foods do not require pre-approval before sale. However, all products must comply with FDA labeling requirements. Key information such as product name, net contents, nutrition facts, ingredient list, allergen warnings, and manufacturer information must be displayed according to FDA’s format and font guidelines. Failure to comply may result in restrictions on sales within the U.S.

SC Holdings provides labeling design that fully complies with FDA requirements to ensure your products enter the U.S. market without issue.
Canada
(Health Canada)		 General Food, Functional Food, Health Supplements
For general food products in Canada, no pre-approval is required, but bilingual labeling in English and French is mandatory. Labeling must include product name, net contents, Nutrition Facts Table, ingredient list, allergen warnings, and manufacturer information. These must strictly follow the Food and Drug Regulations (FDR), including layout and font size. Non-compliance may prevent product distribution within Canada.

SC Holdings designs bilingual (EN/FR) labels that meet all Health Canada food labeling standards to ensure smooth entry into the Canadian market.

For functional foods and health supplements (NHP), registration of an NPN (Natural Product Number) is required before sales. SC Holdings provides full one-stop support from NHP registration to compliant labeling.
Australia
(FSANZ/TGA)		 General Food, Functional Food, Health Supplements
Exports of general and functional foods to Australia do not require pre-approval as long as they meet the standards of FSANZ (Food Standards Australia New Zealand). However, ingredients must be safe, and products must strictly follow labeling rules, including English Nutrition Information Panel (NIP) and allergen declarations.

Most health supplements are classified as therapeutic goods and require TGA (Therapeutic Goods Administration) registration. Overseas-manufactured products without TGA GMP certification cannot be registered.

SC Holdings provides one-stop support for ingredient review, labeling design, and regulatory guidance to ensure your products meet FSANZ requirements and are safely exported as general or functional foods without needing TGA approval.
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