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Regulation8 min read

Which documents are required to manufacture a cosmetic product?

Responsible technical person, ministry notification, product tracking registration, safety report and SDS: what is needed and when.

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Short answer

To place a cosmetic product on the market in Türkiye you need: company registration with the Ministry of Health, an appointed responsible technical person, notification of the product to the Product Tracking System, and a prepared product information file with a safety assessment. Trademark registration protects the brand, and barcode registration is needed for retail sale.

Do cosmetics require a licence?

Unlike medicines, cosmetics are subject to notification rather than prior approval. You do not wait for a permit before placing a product on the market; you notify it in the prescribed way and keep the required technical file available. That does not make the process easy — responsibility rests entirely with the manufacturer and the party placing it on the market.

Inspection happens after notification. That is why a complete, defensible file matters more than the notification itself.

Responsible technical person

Every company manufacturing or placing cosmetics on the market must appoint a responsible technical person meeting the qualifications set out in regulation. This person is technically accountable for the product's regulatory conformity.

For brands using contract manufacturing this is usually provided as a service by the manufacturer. What matters is that scope is explicit in the contract: does the function stay with the manufacturer, or will the brand appoint its own?

Ministry registration

The company must be registered with the Ministry for cosmetic activity. The manufacturing site, responsible technical person and scope of activity appear in that registration. In contract manufacturing the site is the manufacturer's facility, while the brand registers in its capacity as the party placing the product on the market.

Product Tracking System notification

Every cosmetic product is notified to the Product Tracking System before being placed on the market. The notification covers product name, category, ingredient information, packaging details and the responsible company.

Notification is not a one-off: the record must be updated whenever the formula, packaging or product name changes. This is an obligation most brands overlook.

Product information file and safety assessment

The product information file covers the formula, method of manufacture, quality control data, stability results, packaging information and the safety assessment. It is the first document requested in an inspection.

The safety assessment is a technical study demonstrating the product is safe for human health under foreseeable conditions of use. Without it the product cannot legally be placed on the market.

Safety data sheet (SDS)

An SDS covers transport, storage and emergency handling information. It is commonly requested in export and bulk shipping. While not mandatory for every cosmetic product, logistics processes frequently require it.

Trademark and barcode registration

Trademark registration is not a legal requirement but it is the only way to protect your brand. If someone else registers an unregistered name, you can lose the right to use it. Applying at the start of product development is best, because registration takes months.

Barcode registration is required for the product to be sold through retail channels. Chain retailers and e-commerce platforms will not accept products without one.

Why sequence matters

Some of this work runs in parallel, but parts are dependent. Product tracking notification requires the final formula and packaging information, so it cannot be completed before packaging is settled. Label design cannot be finished before the ingredient list is final.

Getting the order wrong is most costly at label design: when a formula is revised the ingredient list changes, and printed labels become unusable.

Who does what

  • Formula and production: the manufacturer
  • Stability and microbiology testing: the manufacturer or an accredited laboratory
  • Safety assessment and product information file: the manufacturer or a qualified assessor
  • Responsible technical person: manufacturer or brand owner, per contract
  • Product tracking notification: the party placing the product on the market
  • Trademark and barcode registration: the brand owner (a manufacturer may provide this as a service)

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