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Does soap need Thai FDA notification? Cosmetic vs herbal soap

9 min read · Updated 9 Nov 2026

Does soap need Thai FDA notification? Most soap is a cosmetic

Whether a Thai FDA soap filing is needed starts with the definition in the Cosmetic Act B.E. 2558 (2015), section 4. A cosmetic is a substance intended to be applied, rubbed, massaged, sprinkled, sprayed or otherwise used on the external parts of the human body, including the teeth and the lining of the mouth, for cleanliness, beauty, changing appearance, controlling body odour or keeping the body in good condition. Bar soap, liquid soap, shower gel, facial foam and hand wash sold to clean the skin fit that definition directly.

Because they are cosmetics, anyone who manufactures for sale, imports for sale or manufactures under contract must notify the product first, and may only produce or import once the notification receipt has been issued (section 14). What people in Thailand call "getting an FDA number for soap" is, legally, cosmetic notification. It is not drug registration.

Not every soap stays under cosmetic law, though. If a soap is positioned to have a health effect, claims to deal with disease, or is meant for animals, the legal route changes. This article explains where that line falls, using only the definitions and guidance in this site's regulation archive, so brand owners can decide before they finalise a formula or print a label.

Is soap a cosmetic? Check where it is used, what it is for and what it claims

The Thai FDA's Criteria for Considering Cosmetic Notification (revised 2021) use a five-point test. Fail any one point and the product is not a cosmetic. Applied to soap, the test becomes a set of simple questions.

1. Formula: no prohibited substances, and restricted substances within the legal limits.
2. Where it is used: on the outside of the body, hair or mouth, not inside the body.
3. Purpose: the main purpose is cleansing, beauty or skin care.
4. Claims: no stated purpose of addressing or preventing disease.
5. Effect on the body: no lasting effect that restores or changes body functions through pharmacological, immunological or metabolic action.

An ordinary cleansing soap passes all five easily. What pushes a soap out of the cosmetic category is rarely the soap base itself; it is the label and the advertising. The same criteria explain that a product claiming to relieve, mitigate or prevent disease, or to change the structure or function of the body, moves into the drug or herbal-product category. The example in the document is an anti-dandruff shampoo containing ketoconazole, which is a drug, not a cosmetic. The same reasoning applies to soap.

If you are not sure which side your product falls on, walk through the questions in the product classification tool before you invest in packaging.

Herbal soap: can a soap with plant extracts still be a cosmetic?

Many brands assume a soap with turmeric, tamarind or other plant extracts must go through the herbal-product route. In fact the answer depends on purpose and claims, not on whether plants are in the formula.

The Herbal Products Act B.E. 2562 (2019), section 4, groups herbal products into medicines from herbs, used to relieve, mitigate or prevent disease, and products made mainly from herbs to improve health or body function. The same definition expressly excludes anything classed as a cosmetic. A soap that contains herbs to clean the skin, and talks about the herbs as ingredients, therefore stays a cosmetic and goes through cosmetic notification.

On the other side, the Ministry of Public Health notification on substances prohibited in herbal products (2023) defines a herbal cosmeceutical as an herbal product used on the external body to produce a health effect. That is the key line. If an herbal soap is designed and marketed for a health effect beyond cleansing or appearance, it moves under herbal-product law; if it claims to address a skin disease, it falls into herbal medicine.

Section 6 of the Herbal Products Act lets the Minister decide by notification which products need formula registration, detailed notification or simple notification. Once a product crosses into the herbal category, you need to check those notifications; a cosmetic notification number cannot stand in for them.

Either way, some plants are restricted. On the cosmetic side, screen the formula against the cosmetic prohibited and restricted lists; on the herbal-cosmeceutical side there is a separate list of prohibited plants and plant parts. You can search names in the ingredient search.

Soap claims that take a product outside cosmetic scope

The Criteria for Considering Cosmetic Notification list products that are not cosmetics, including products for rashes and itching, wounds and corn removal, and products used to reduce weight, break down fat or remove cellulite. A soap that uses similar wording runs the same risk of leaving the cosmetic category.

Product names are checked too. The Thai FDA guideline on words that may not be used in cosmetic trade names and product names (revised 22 August 2025) sorts prohibited words into five groups. The first covers words that imply effects beyond a cosmetic, such as words implying the product can heal disease, words implying an effect on body structure or function, and words implying another product type such as a drug, an herbal product or a disinfectant. Its tables list words that are not allowed, such as CURE, HEAL, MEDICATED and ACNE TREATMENT.

One detail matters for soap: the guideline gives ACNE CONTROL an exception for rinse-off cleansing products. Names are judged by the word and the product type together, so the same word may be acceptable on a face wash but not on a serum. Check the latest version of the guideline before you settle on a name.

Wording that stays within cosmetic scope usually talks about cleansing, skin feel after use, fragrance, moisture and ingredients. Wording that leads outside tends to talk about disease, symptoms, killing germs or changes inside the body. The diagram below sets out examples on each side.

Antibacterial soap and hand wash: claims need test data

A hand wash or shower gel that wants to say antibacterial does not automatically stop being a cosmetic. The Thai FDA issued a guideline on efficacy testing of rinse-off skin cleansing cosmetics (4 October 2022) to support the antibacterial claim on the label.

• Choose an international method, such as EN 1276 (a suspension test against four bacteria), EN 1499 (a test on volunteers' hands) or another accepted international standard.
• Hand wash products may use any of the listed methods; body wash products use method 1.1, EN 1276.
• Tests under methods 1.1 and 1.2 must be done by a government body or an ISO/IEC 17025 accredited laboratory.

In addition, the Thai FDA's citizen manual on notifications that require a label for review lists products with the word Anti-bacterial in the name as a group that must attach every side of the label when filing. Prepare the real label images and the test report together.

Be careful with the difference between reducing bacteria and wording that implies disinfection or infection prevention. The latter sits in the guideline's group of words implying a different product type. If you want that positioning, ask an expert first whether the product can stay a cosmetic.

Intimate cleansing soap: can be notified, with extra conditions

The Thai FDA guideline on notification of products used on intimate areas (revised July 2024) lists rinse-off soap as a type that can be notified as a cosmetic, for the external genital area only. Products used inside the vagina are not cosmetics.

• No names or wording implying relief of symptoms, such as reducing itching or discharge.
• No sexual innuendo and no claims about body structure, such as balancing the internal vaginal environment.
• Attach photos of the actual product, every side of the actual label, and a letter signed by a company director confirming the product will not be described beyond cosmetic scope.
• The formula may not use tranexamic acid or hydrogen peroxide, and officers may ask for irritation test results or pH data if the formula contains potentially irritating substances.

Plan the name, label and attachments for this kind of soap from the start, rather than using a standard soap template and fixing it later.

Pet soap and soap not used on the human body

The cosmetic definition in section 4 refers to the human body only. Pet shampoo and pet soap are therefore outside the cosmetic definition, especially products that claim to control fleas, ticks or other external parasites. The Thai FDA has a separate notification on labelling of external parasite control products for pets in soap or shampoo form, in its hazardous-substances group.

Likewise, laundry soap and dishwashing products are not used on the human body, so they are not cosmetics under the definition. Brands with several product lines should check each product by its real use, and never rely on a cosmetic notification number to cover a product outside the definition.

How to notify soap with the Thai FDA, step by step

Once you have confirmed your soap is a cosmetic, the process is ordinary cosmetic notification.

1. Screen the formula against the prohibited, restricted, preservative and colourant lists, using INCI names. The formula checker gives a first pass.
2. Applicant: a Thai national aged 20 or over, or a company registered in Thailand, under the 2018 notification on cosmetic notification.
3. Production site: it must meet the 2018 notification on cosmetic manufacturing or import criteria, for example separated from living quarters and not used as a walkway, at least two separate rooms, and a permanent sign. Home soap makers should check this first, or use a contract manufacturer whose site complies.
4. File form JK.1 at the Thai FDA, a provincial public health office or online, with the documents listed in the annex.
5. Prepare the Thai label under the Cosmetic Committee notification on cosmetic labelling B.E. 2562 (2019), including all ingredients, directions, manufacturer, batch number and the notification number.

Each step is explained in How to notify cosmetics with the Thai FDA, and the document list is in Documents needed for Thai cosmetic notification. If a factory makes your soap, read who owns the notification when you use a contract manufacturer. Costs and timing depend on the case; our consultants set them out in a quotation.

Checklist before you sell soap in Thailand

• The soap is used on the outside of the human body, for cleansing or appearance.
• The name has no words implying disease, killing germs or effects on the body, checked against the latest guideline.
• For herbal soap, the wording presents herbs as ingredients and does not promise a health effect.
• If the label says antibacterial, you hold test results under the Thai FDA guideline from an eligible laboratory.
• For intimate cleansing soap, label images and the director's letter are ready.
• The formula has been screened, and the production site meets the criteria.
• The notification receipt is issued before manufacture for sale, and the label matches the notification.

If you would like our team to confirm which side your soap falls on and prepare the filing, see our registration and notification service.

Sources

1. (1) พระราชบัญญัติเครื่องสำอาง พ.ศ. 2558 · Open source · Search our archive
2. หลักเกณฑ์การพิจารณาการจดแจ้งเครื่องสำอาง (ฉบับปรับปรุง พ.ศ. 2564) · Open source · Search our archive
3. พระราชบัญญัติผลิตภัณฑ์สมุนไพร พ.ศ.2562 · Open source · Search our archive
4. ประกาศกระทรวงสาธารณสุข เรื่อง ชื่อวัตถุที่ห้ามใช้เป็นสวนผสมในผลิตภัณฑ์สมุนไพร พ.ศ.2566 · Open source · Search our archive
5. แนวทางการพิจารณาคำที่ห้ามนำมาใช้เป็นชื่อหรือส่วนหนึ่งของชื่อการค้าและชื่อเครื่องสำอาง (ฉบับปรับปรุง 22 สิงหาคม 2568) · Open source · Search our archive
6. 27.2 ประกาศสำนักงานคณะกรรมการอาหารและยา เรื่อง แนวทางการทดสอบประสิทธิภาพของเครื่องสำอางทำความสะอาดผิวหนังที่ใช้แล้วล้างออก ลงวันที่ 4 ตุลาคม 2565 · Open source · Search our archive
7. 4.3 การขอจดแจ้งเครื่องสำอาง กรณีต้องส่งฉลากประกอบการพิจารณา (Update 04/09/69) · Open source · Search our archive
8. กองควบคุมเครื่องสำอางและวัตถุอันตราย สำนักงานคณะกรรมการอาหารและยา แนวทางการพิจารณาการจดแจ้งผลิตภัณฑ์ที่ใช้บริเวณจุดซ่อนเร้น (ฉบับปรับปรุง กรกฎาคม 2567) · Open source · Search our archive
9. 12.15เรื่อง-การแสดงฉลากของผลิตภัณฑ์กำจัดตัวเบียนภายนอกของสัตว์เลี้ยง-ชนิดสบู่หรือแชมพูอาบน้ำสัตว์เลี้ยง · Open source · Search our archive
10. 4.1 ประกาศกระทรวงสาธารณสุข เรื่อง การจดแจ้ง การออกใบรับจดแจ้ง การต่ออายุใบรับจดแจ้ง การแก้ไขรายการใบรับจดแจ้ง และการออกใบแทนใบรับจดแจ้งเครื่องสำอาง ลงวันที่ 22 สิงหาคม 2561 · Open source · Search our archive
11. 6.1 ประกาศกระทรวงสาธารณสุข เรื่อง หลักเกณฑ์ วิธีการ และเงื่อนไขในการผลิตหรือนำเข้าเครื่องสำอาง พ.ศ. 2561 ลงวันที่ 4 พฤษภาคม 2561 · Open source · Search our archive
12. 14.1 ประกาศคณะกรรมการเครื่องสําอาง เรื่อง ฉลากของเครื่องสําอาง พ.ศ. 2562 ลงวันที่ 14 มิถุนายน 2562 · Open source · Search our archive

This article is for general information. It is not a Thai FDA ruling or legal advice, and rules change — check the latest notification or ask an expert before filing or producing.

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