FDA Thailand 
Factories / OEM
Contract cream manufacturing: what the factory must have
Contract cream manufacturing: how the law sees the relationship
Contract cream manufacturing (OEM) is the route many brand owners choose, because it avoids building a production site. Legally, though, hiring a factory does not move every duty to the factory. Section 14 of the Cosmetic Act B.E. 2558 (2015) requires anyone who manufactures for sale, imports for sale or contract-manufactures cosmetics to notify first, and to start production only after the notification receipt is issued.
Thai FDA documents describe two clear roles: the contract manufacturer, which is the factory, and the hiring party, which is the brand owner. Both appear on the contract manufacturing receipt, and they shape the two questions that matter most: what must the factory have, and whose notification is it?
Before talking to factories, confirm the product is legally a cosmetic. A cream meant to reduce fat, regrow hair or change body function cannot be notified as a cosmetic. Run a first check with the product classification tool.
What a cream factory must have under Thai rules
The Ministry of Public Health notification on criteria, methods and conditions for manufacturing or importing cosmetics B.E. 2561 (2018) requires manufacturers for sale and contract manufacturers to follow Annex A, the minimum every factory must meet. In summary:
Premises
- A sound building with floors, walls and ceilings that are easy to clean.
- At least two separate rooms: production or filling, and storage of raw materials or products.
- Separation from living quarters, and not used as a passageway.
- A permanent sign reading "cosmetic manufacturing site".
People and water
- Production staff trained or self-trained, with records as evidence.
- Health checks at least once a year.
- Process water at least equal to the standard for drinking water in sealed containers.
Documentation and quality
- A master formula that matches the notification.
- Production records for every batch, and a batch numbering system.
- Quality checks and retained samples of finished products.
- Systems for complaints, adverse reaction reporting and recalls.
A brand owner visiting a factory can use this list as questions: ask to see sample batch records, the batch numbering method and the recall procedure. Where the notifier needs proof of the site, the notification on certificates for manufacturing or import sites lets the notifier request a manufacturing site certificate (form SK.2 A), valid for three years.
- ✓A sound, easy-to-clean buildingSeparate from living quarters and not a passageway
- ✓At least two separate roomsProduction or filling, and raw material or product storage
- ✓A permanent "cosmetic manufacturing site" sign
- ✓Trained staff with yearly health checks
- ✓Process water at sealed drinking-water standard
- ✓Master formula matching the notification, records for every batch
- ✓Complaint, adverse reaction and recall systems
Source: MOPH notification on manufacturing or import criteria B.E. 2561 (2018), Annex A
GMP-certified contract manufacturing: what else to ask for
Beyond the minimum, the Thai FDA runs a process for certifying sites against ASEAN Cosmetic GMP for establishments that apply. A factory that markets GMP-standard contract manufacturing should be able to show this certificate.
- Check the list. The Thai FDA publishes a list of GMP-certified cosmetic establishments with factory name, address, certificate number, issue date and valid-until date. Compare it with the certificate the factory shows.
- Check expiry. The Thai FDA audit manual for ASEAN Cosmetic GMP (May 2021) states that certificates are valid for three years.
- Check scope. Make sure the certified scope covers the product format, such as creams, lotions or gels.
The same manual grades defects as critical, major and minor, and classes releasing a product that fails specification as a critical defect; results must be checked and recorded before every release. For a hiring party, that is a reason to ask for batch release or quality results for each lot, not only the certificate on the wall. Background is in what is GMP.
Whose notification is it under contract manufacturing?
The Cosmetic Act defines the "notifier" as the party that receives a receipt for manufacturing for sale, importing for sale or contract manufacturing. Clause 3 of the MOPH notification on cosmetic notification B.E. 2561 (2018) makes the manufacturer, contract manufacturer or importer the applicant on form JK.1 before production or import.
When you hire a factory, the outcome is a contract manufacturing receipt on form JR.1. The template attached to the notification has these fields:
- the contract manufacturer's name, manufacturing site address and storage site address;
- the hiring party's name and business address;
- the trade name, cosmetic name, type, physical form and container.
In short, the factory is the notifier on the receipt and the brand owner is named as the hiring party. The document schedule requires the contract manufacturer to attach the manufacturing contract, and the Thai FDA process chart includes a step for registering details of a new hiring party, so brand owners should have their company details and address in order from the start.
The label must name the real manufacturer
The 2019 labelling notification requires domestically made cosmetics to show the manufacturer's name and address, and section 29 (1) of the Act deems a cosmetic whose label names a manufacturer, importer or source that is not true to be counterfeit. A label design that hides the actual factory is therefore a legal risk, not only a marketing choice.
Source: Cosmetic Act B.E. 2558 · notification on cosmetic notification B.E. 2561 · Thai FDA ASEAN Cosmetic GMP manual
Moving to another factory: limits of the amendment form
A common question after some time in production is whether the existing number can follow the brand to a new factory. The amendment form JK.4 attached to the notification allows two kinds of change:
- the physical form of the container;
- the name or address of the manufacturing, contract manufacturing, import or storage site of the notifier or the hiring party, provided the party remains the same individual or company and no manufacturing site is added.
That condition means JK.4 is not a way to transfer the notifier from one factory to another. The Thai FDA process chart lists cancellation of a receipt or business closure as a separate step. Before moving production, ask the authority how to proceed, and plan the changeover so that nothing is made without a valid receipt.
What the brand owner should hold
The MOPH notification on keeping cosmetic data for inspection B.E. 2560 (2017) lists what manufacturers, importers and contract manufacturers must prepare, including a copy of the receipt, proof of ownership or the manufacturing contract, the formula in INCI names with percentages by weight, the label, the manufacturing process and batch numbering system, and raw material specifications. These are kept at the manufacturing site, so the contract should say which copies the brand owner receives.
What a contract manufacturing agreement should contain
Many factories offer full-service brand creation, from formula to packaging. The broader the service, the clearer the contract needs to be. The section on contract manufacturers and analysts in the Thai FDA audit manual for ASEAN Cosmetic GMP says the contract must include:
- a written form, with authorised representatives of both the hiring party and the contractor;
- the scope of work, such as formula development, evaluation and acceptance of prototypes, safety and performance testing where applicable, packaging development, and sourcing of raw and packaging materials;
- the list of products and the finished product specification;
- pack sizes, container specifications and mandatory legal labelling;
- shipping labels and instructions, and storage conditions.
The manual also sets principles: both parties share responsibility for product quality, the hiring party may inspect the site within the periods agreed, and the contractor must not change the formula or process without the hiring party's permission.
Notification points worth adding
- Who files and renews the notification, and advance notice to the brand before expiry.
- Label proof review before printing, against the receipt.
- Handover of the receipt copy and product information the brand needs.
- What happens to the receipt if the contract ends or production moves.
- Division of duties for complaints and recalls.
What the hiring party is still responsible for
Even with the factory as notifier, the brand owner carries legal risk in several areas, especially decisions the brand makes itself.
- Names and label wording. Clause 3 of the notification on cosmetic notification bars boastful or misleading trade or product names; a receipt obtained with a non-compliant name is deemed unlawful and may be revoked.
- Advertising. Section 41 of the Act prohibits false or exaggerated statements, statements that mislead on material facts, and claims to treat disease or of purposes outside a cosmetic.
- Selling. Section 32 prohibits selling cosmetics that are not notified, unlabelled, wrongly labelled or expired, and applies to every seller, including a brand selling directly.
- Recalls. The MOPH notification on recall, destruction and delivery of cosmetics B.E. 2563 (2020) places recall and destruction costs on the manufacturer, importer, notifier, seller or possessor for sale.
Advertising claims should therefore rest on evidence that the factory and brand both hold. See how to spot exaggerated ads for common problems.
Checklist before signing with a cream factory
- The product meets the cosmetic definition and makes no drug-like claims.
- The factory meets Annex A of the manufacturing criteria, with a "cosmetic manufacturing site" sign.
- If the factory claims GMP, its name and valid-until date appear on the Thai FDA list of certified establishments.
- The formula has been screened against the banned and restricted substance lists.
- It is agreed that the factory notifies on form JR.1 and the hiring party details are correct.
- The contract covers scope, product specification, labelling, no unauthorised formula changes, site inspection rights and recalls.
- Renewal of the receipt and what happens when the contract ends are agreed.
Screen a formula with the formula checker, and see the brand owner's overview in starting your own skincare brand: the legal checklist. For a team that handles development through production, see our product development and OEM service.
Frequently asked questions
Who notifies the cream when I hire a factory?
Under the 2018 notification on cosmetic notification, the contract manufacturer files and receives a contract manufacturing receipt on form JR.1, which names the hiring party and its business address.
Can I keep the same notification number if I change factories?
The JK.4 amendment form only covers name or address changes while the party remains the same individual or company, with no added manufacturing site, so it does not transfer the notifier. Ask the authority before moving production and agree this in the contract in advance.
Must every cosmetics factory be GMP-certified?
The minimum every factory must meet is Annex A of the 2018 notification on manufacturing or import criteria. ASEAN Cosmetic GMP certification is issued by the Thai FDA to establishments that apply; if a factory claims it, check the list the Thai FDA publishes.
Does an OEM cream label need the factory's name?
The 2019 labelling notification requires domestically made cosmetics to show the manufacturer's name and address, and section 29 of the Act deems a label naming an untrue manufacturer to be counterfeit.
Can the factory change the formula itself?
It should not. The Act requires manufacture as notified, and the Thai FDA audit manual for ASEAN Cosmetic GMP says the contractor must not change the formula or process without the hiring party's permission.
Sources
- Cosmetic Act B.E. 2558 (2015) · Open source · Search our archive
- MOPH notification on cosmetic notification, receipts, renewal, amendment and replacement B.E. 2561 (2018) · Open source · Search our archive
- MOPH notification on criteria, methods and conditions for manufacturing or importing cosmetics B.E. 2561 (2018) · Open source · Search our archive
- MOPH notification on applying for and issuing certificates for cosmetic manufacturing or import sites B.E. 2562 (2019) · Open source · Search our archive
- Applying for an ASEAN Cosmetic GMP certificate with audit by the Thai FDA (public guide) · Open source · Search our archive
- List of establishments certified for cosmetic GMP · Open source · Search our archive
- Thai FDA audit manual for ASEAN Cosmetic GMP (May 2021) · Open source · Search our archive
- Cosmetic Committee notification on cosmetic labelling B.E. 2562 (2019) · Open source · Search our archive
- MOPH notification on rules for manufacturers, importers and contract manufacturers to keep cosmetic data for inspection B.E. 2560 (2017) · Open source · Search our archive
- Cosmetic services at central and provincial level (Thai FDA process chart) · Open source · Search our archive
- MOPH notification on recall, destruction and delivery of cosmetics B.E. 2563 (2020) · 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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