Contract Manufacturing Responsibility: Who Owns the Label, PIF and Notification?

At the heart of the regulatory framework in Türkiye sits a single concept: the responsible person. The regulations define this role clearly — the responsible person may be a natural or legal entity; for products manufactured in the country the responsible person is the manufacturer, and for imported products it is the importer. However, the provision most relevant to contract manufacturing comes in the very next line: if a distributor places a product on the market under its own brand name, or makes a significant modification (other than translation) to a product already on the market, that distributor becomes the responsible person.

In other words, if you are the one placing a fragrance bottled under your own brand on the market, you are the legal party of record — even if the production line belongs to someone else. The parties may also shape this arrangement contractually: the manufacturer and importer may designate another natural or legal person as the responsible person by means of a written agreement; in that case criminal liability rests with that person, and it is that person's company name and address that must appear on the packaging. A subsequent amendment to the Regulation has also explicitly provided that a manufacturer may appoint a responsible person by authorising a natural or legal person resident in Türkiye through a written agreement.

That sentence deserves to be read twice: the name on the label is the address of responsibility. An inspector looks at the packaging and contacts the firm listed there. Saying "the contract manufacturer made it" does not erase the name on the label.

Separate the three roles from the outset, because most crises stem from conflating them:

• Responsible person: The legal party of record. Notification, the product file, labelling and complaint management all rest with this party.
• Manufacturer (contract manufacturer): Responsible for production, hygiene, batch traceability, manufacturing records and Good Manufacturing Practice (GMP).
• Distributor: The party making the product available on the market. Before doing so, the distributor is obliged to verify that labelling information is in place and that language requirements have been met.

There is one further subtlety to bear in mind: leaving the PIF in the contract manufacturer's possession is unworkable in practice. When the file is requested during an inspection, there is no provision for granting firms additional time to prepare it; the file must therefore be complete and accessible before the product is placed on the market. The contract manufacturer may wish to protect the formula as a trade secret; the solution is not to leave the file incomplete, but to arrange a confidentiality agreement plus direct assessor access.

The cost side: do not rely on the phrase "notification is free"

It is commonly stated in the market that "ÜTS registration is subject to an official fee (2026: company registration ~9,117 TRY, product notification per fragrance ~322 TRY)"; the official fee schedule confirms this. According to TİTCK's 2026 fee schedule: the cosmetic product certificate/document fee is 4,186.00 TRY; the cosmetic company registration application fee is 9,117.00 TRY; and the cosmetic product registration application fee is 536.00 TRY per barcode for imported products and 322.00 TRY per barcode for products manufactured in Türkiye. These fees are updated annually in line with the revaluation rate, so revise your budget each year.

• Role definition: Who the responsible person is; which trade name and address will appear on the label.
• Formula ownership: Who owns the formula; can the brand take it if they switch manufacturers, and if not, who finances an equivalent reformulation.
• Document delivery list: GMP declaration, manufacturing method summary, raw material specifications, fragrance oil IFRA compliance certificate and allergen declaration, SDS, batch records — with a maximum delivery deadline for each item.
• Change notification: If the contract manufacturer changes a raw material supplier or a fragrance oil lot, prior written notice is required. A silent substitution means an invalid CPSR.
• Samples and archive: A retained sample from every batch, storage conditions and duration; compliance of records with the ten-year archiving chain.
• Audit rights: The brand owner's right to audit the facility with or without prior notice; the RTE's right of access.
• Recall protocol: Who issues the announcement, who collects the product, who bears the cost, and how many hours before action is taken.
• Complaints flow: If a consumer complaint reaches the contract manufacturer, within how many hours must it be forwarded to the responsible person.
• Regulatory update clause: Cost-sharing for reformulation and label revision when ingredient lists change.
• Recourse and insurance: Administrative fines are levied on the responsible person; where the fault lies with the contract manufacturer, the recourse mechanism and product liability insurance.
• Confidentiality and exclusivity: If you do not want the same formula sold to another brand, state this explicitly; without it, the contract manufacturer is free to do so.

Why the "the manufacturer did it" defence does not hold

Because the regulations attach liability to the party that places the product on the market. The responsible person is obliged to ensure that every cosmetic product placed on the market complies with the provisions of the Regulation. The verb "ensure" cannot be subcontracted to a third party; at most it can be transferred to another resident person by written agreement — and in that case the name on the label changes too. The inspector comes to the address on the label and requests the file there. If the file is in the contract manufacturer's archive, it is at risk of being treated as legally non-existent. The consequences of a deficiency are not trivial: it has been noted that where the product information file is incomplete or absent, an administrative fine applies and withdrawal of the product from the market is mandatory — always verify the current penalty amount from an official source.

The allergen calendar: the most current test of a contract manufacturing relationship

Fragrance allergen labelling is the most critical topic of recent times. The list of fragrance allergens has been expanded to approximately 80 substances. The thresholds remain unchanged: 0.001% for leave-on products and 0.01% for rinse-off products. Products that do not comply with the restrictions may not be placed on the market as of 31 July 2026; from 31 July 2028, products containing these substances that do not meet the specified conditions may not be made available on the market. On 23.06.2026 TİTCK published a guidance document on the labelling of fragrance allergens, covering the declaration of fragrance allergens on labels under Article 22 of the Cosmetics Regulation.

The critical point from a contract manufacturing perspective is that the source is irrelevant: whether an allergen comes from a fragrance mixture, an essential oil, a plant extract, impurities in natural or synthetic components, or contamination from manufacturing or packaging, if the concentration in the finished product exceeds the threshold, it must be declared on the label. For products containing naturally sourced raw materials in particular, it is recommended to re-examine allergen calculations and assess the compliance of existing labels.