Business reports & registrations

Hygiene Products Manufacturing Business Report: Procedure and Facility Standards — Item Manufacturing Report and Self-Quality Inspection

Under the Cleansing and Hygiene Products Control Act, anyone who intends to manufacture, process or subdivide hygiene products for sale or for use in business must meet the facility standards set by Ordinance of the Prime Minister and file a business report for hygiene products manufacturing with the competent city, county or district (si/gun/gu) office. Even for the same hygiene products, an import business reports to the regional office of food and drug safety, so identify the business type first. After the report, the item manufacturing report for designated items, sanitation education and self-quality inspection follow.

Procedure

  1. 1. Check whether the product is a hygiene product

    Hygiene products include detergents, rinse aids, oral care products such as toothbrushes, dental floss and tongue cleaners, tattoo dyes, disposable cups, spoons, chopsticks and straws, and toilet paper and paper napkins. First check whether the product you intend to make falls within this scope or is classified as a cosmetic or a quasi-drug.

  2. 2. Set up the workplace facilities

    The workplace must be separated from spaces used for other purposes and built so that it can be kept clean. Provide separate storage space for raw materials, supplies and finished products, and check before signing a lease whether the building use is suitable for manufacturing work.

  3. 3. Submit the business report

    After the facilities are in place, submit the business report form and attachments to the city, county or district (si/gun/gu) office having jurisdiction over the location of the place of business. The reporting person must not fall under any ground for disqualification, and a report of change is also filed when any of the prescribed reported matters is changed.

  4. 4. Item manufacturing report and sanitation education

    For products designated as items that need special control to protect public health, report the product name, ingredients and other matters to the competent city, county or district (si/gun/gu) office before manufacturing. The business operator also completes the prescribed sanitation education.

  5. 5. Operate self-quality inspection

    Check whether the manufactured hygiene products meet the standards and specifications, either by inspecting them yourself or by entrusting the inspection to a hygiene products testing and inspection agency. Check the inspection items and frequency for each item and set up a pre-shipment inspection system.

Required documents

  • Business report form for hygiene products manufacturing
  • Floor plan of the workplace and facility layout materials
  • Evidence of the right to use the business premises, such as the building register and lease contract
  • Certificate of completion of sanitation education
  • Item manufacturing report (for items subject to reporting)
  • Business registration certificate or certificate of all registered matters of the corporation

Fees

In the industry, preparing and filing the business report and item manufacturing report documents is generally priced at several hundred thousand won, and the fee varies with the number of items and whether the facilities need to be supplemented. We review the product list and workplace materials and advise you on the fee after a consultation.

Legal basis and review date

  • Cleansing and Hygiene Products Control Act, Article 2
  • Cleansing and Hygiene Products Control Act, Article 3
  • Cleansing and Hygiene Products Control Act, Article 9
  • Cleansing and Hygiene Products Control Act, Article 11
  • Cleansing and Hygiene Products Control Act, Article 13
  • Cleansing and Hygiene Products Control Act, Article 16

Checked against the statutes on

Statutes and public notices change, so each case needs to be checked individually. Statute titles are given in English for reference. The Korean statutes are the authoritative text.

Check these first

  • Before signing a lease, first check whether the building use and the partitioning of the workplace meet the facility standards.
  • Hygiene products without labeling that meets the labeling standards may not be sold or displayed.

Frequently asked questions

Is hygiene products manufacturing subject to a permit or a report?
A report. After meeting the facility standards, file a business report with the city, county or district (si/gun/gu) office having jurisdiction over the location of the place of business. An import business is different because its reporting authority is the regional office of food and drug safety.
Do I need a manufacturing business report if I buy finished products and sell them divided into smaller packages?
Yes. Subdivision, which means repackaging finished products in order to distribute them in divided quantities, is also included in hygiene products manufacturing. The same facility standards are applied to a subdivision workplace.
Is making toothbrushes or dental floss also hygiene products manufacturing?
Yes. Oral care products such as toothbrushes, dental floss and tongue cleaners are hygiene products under the Cleansing and Hygiene Products Control Act. Product labeling standards and self-quality inspection also follow this Act.
Must an item manufacturing report be filed for every product?
No. Only products designated as items that need special control, for example because people may be exposed to chemical substances, are subject to reporting. Check before the business report whether the product you will make falls under this.
What happens to products manufactured without a report?
They may be seized or destroyed. Hygiene products manufactured, processed or subdivided without a business report may be seized by the relevant public official, or the official may have them destroyed.
Can an administrative agent handle the hygiene products manufacturing business report for me?
Yes. Hwang Yunsang Administrative Office reviews the items and business type, checks the facility standards, prepares the business report form and item manufacturing report, submits them to the competent city, county or district (si/gun/gu) office on your behalf, and responds to requests for supplementation.

Contact us

Hwang Yunsang Administrative Office in Songdo, Incheon prepares and submits administrative documents and explains the procedure. If your situation is similar, send us a message.

📍 2697, 26F POSCO Tower-Songdo, 165 Convensia-daero, Yeonsu-gu, Incheon, Republic of Korea · 📞 010-3374-2687 · 🌐 hwangadmin.com

This guide is general information based on public sources. Requirements, documents and deadlines differ by case and by the competent agency, so please confirm them before you proceed.