Preparing for Market Surveillance: What Documents Does an Inspector Require?

In cosmetics there is no prior authorisation — only notification. Nobody stamps your paperwork with "approved to manufacture"; you make a declaration, and the state follows up to verify its accuracy through market surveillance and control (PGD). In this system, the burden rests entirely on your shoulders. If your file is ready, an inspection is a conversation. If it is not, it becomes a written report.

The logic of the legislation is clear: the prior-authorisation model has been abolished and, in alignment with European Union legislation, the system has moved to notification and market surveillance. The powers available to the inspector are correspondingly broad — the Authority carries out checks on cosmetic products and economic operators through physical inspections of the product information file at an appropriate scale and, where possible, on suitable samples, along with laboratory testing where necessary.

The figures speak to how serious this is. TITCK's Q2 2026 data identified a significant number of products that were non-compliant with technical regulations or posed a risk, with total administrative fines for non-conformities announced at TRY 11,754,478. In Q1 2026 that figure stood at TRY 33,521,611. Inspection is therefore not a theoretical possibility — it is a fixed reality in the industry's calendar.

Where the file must be kept is equally non-negotiable. The responsible person holds the product information file at the address stated on the label, in electronic or other format, ready to be presented upon request by the Authority. The practice long established in the industry is that this information must be available at the address stated on the label within three working days. A single address may be designated as the location of the file; it need not be the manufacturing address, but if multiple addresses appear on the label, the one where the file is held should be clearly indicated — for example, by underlining it.

The retention period is lengthy: the responsible person retains the product information file for ten years following the date on which the last batch of the cosmetic product was placed on the market. When you discontinue a fragrance, do not delete the file. That file stays with you for ten years.

An inspection is fundamentally a document-reading exercise. The inspector checks the paperwork, not the scent. The table below shows the core documentation required of a fragrance/cosmetics business — its regulatory basis, who prepares it, and where it must be kept.

The content of the PIF is not left to guesswork — it is prescribed item by item. The file must contain the product name and code name, the qualitative and quantitative composition of the product; where a fragrance oil or fragrance compound is used, the compound code and the identity of the supplier must be stated; ingredients must be listed by their INCI names and functions. The file must also include the physico-chemical (colour, scent, density, viscosity, pH, etc.) and microbiological specifications for both the raw materials and the finished product, a description of the manufacturing method in accordance with GMP and the corresponding declaration of conformity, training and work records demonstrating the manufacturer's competence, and the Cosmetic Product Safety Report. The PIF may be prepared in Turkish or English.

A critical detail for perfumers: If you are using a ready-made fragrance oil, you are not expected to know every molecule it contains — you declare the compound code and the supplier's identity. However, you are required to provide the IFRA compliance statement, the allergen declaration, and the MSDS for that fragrance oil. If your supplier cannot furnish these three documents, the formula you build around that fragrance oil will never have a defensible file.

The most common stumbling block in inspections is not the formula — it is the label. The label is the first thing the inspector reads the moment they pick up a product. It is the only surface that can trigger a fine before a laboratory is visited or a file is opened.

The regulatory requirement is unambiguous: cosmetic products may only be placed on the market if the information on their inner and outer packaging is indelible, easily legible and clearly visible. In practice, the headings an inspector examines are: product name and function, nominal content, name and address of the responsible person, batch/lot number, usage warnings, expiry date or period after opening (PAO), and the full INCI list.

A frequent mistake on dates: for cosmetic products with a minimum durability exceeding thirty months, stating a date is not mandatory; however, such products must indicate the period during which the product remains safe after opening. In other words, for a fragrance you do not leave the date field blank — you use the PAO symbol correctly.

The most significant recent change for fragrance manufacturers concerns fragrance allergens. EU Regulation 2023/1545 has increased the number of fragrance allergens that must be individually named on the label from twenty-six to over eighty; substances exceeding the thresholds must be declared. The thresholds themselves are unchanged: 0.001% (10 ppm) in leave-on products and 0.01% (100 ppm) in rinse-off products. The timeline is two-phased: from 31 July 2026, products newly placed on the market must comply with the new labelling rules; by 31 July 2028, all products on the market — including those already in circulation — must be compliant.

The core of the task is a calculation: obtain a full allergen declaration from your supplier for every fragrance oil; multiply the proportion of each allergen within the fragrance oil by the dosage of that fragrance oil in your formula; compare the result against the leave-on/rinse-off threshold; and add anything that exceeds the threshold to the ingredient list under its correct INCI name. Without performing this multiplication, no INCI list can be considered reliable.

When an inspector asks "which fragrance oil did you use for this batch, which lot, and how many grams?" the answer cannot be verbal. A production record must be kept for every batch: raw material name, supplier, lot number, weighed quantity, production date, and the signature of the person responsible.

Grams or millilitres? Always record your formula in grams (g) — a balance never lies. However, because filling is volumetric, do not overlook the density difference: citrus oils are around ~0.84 g/ml, while heavy resins and some synthetics can exceed 1.10 g/ml. If you assume "100 g = 100 ml" without accounting for density, you will end up with either overflow or underfill in a 100 ml bottle. Record both the gram weight and the calculated volume in your record; also note the density value used for the conversion.

Half of the documentation is produced in the laboratory; the other half is produced at the desk. The desk side is this: the product must have been notified to the TITCK Product Tracking System (UTS). This is the prerequisite for legally selling and issuing invoices via Trendyol, Hepsiburada or your own website. Without notification, the product is considered "unregistered" on the market — and that is the most serious heading in an inspection.

First, let us clarify the distinction between process and responsibility, because this is where the most confusion arises in the industry:

• Process: Brand application → GS1 barcode → UTS company registration → product (fragrance) notification. This is an administrative workflow that can be completed within a week.
• Responsibility: Having completed the notification does not demonstrate that the product is safe and compliant. The obligations to maintain a ready file, construct a correct label and report complaints remain with the responsible person/manufacturer — registration does not transfer this burden. To complete a cosmetic product registration, the company must also appoint a qualified responsible technical person.

The items below are official fees payable to the relevant authorities; they are separate from any consultancy or responsible-manager fees. Amounts change every year — always verify the current figures directly on the relevant authority's website before proceeding.

An internal audit is a rehearsal for the real inspection. Pick three products at random from your shelf, put them on the table and act as your own inspector: Is there a notification number? Does the address on the label match the address where the file is held? Is the most recent batch record available? Is the IFRA compliance statement for the fragrance oil in the file? Has the allergen calculation been updated against the 2026 thresholds?

Work with a clear understanding of the penalty scale as well. The amounts in the Cosmetics Act are updated through revaluation; the administrative fine of TRY 20,000 for failure to notify currently stands at TRY 611,938.00 in practice; the TRY 10,000 fine for failing to employ a qualified responsible technical person stands at TRY 305,969.00; the fine for substances that must not appear in the formula at all is TRY 611,938.00; for products containing substances above permitted limits it is TRY 458,953.00; and the fine for a product that is harmful to health rises from TRY 50,000 to TRY 1,529,844.00. Furthermore, where a penalty-triggering offence is repeated, fines are applied at double the rate, and the imposition of an administrative fine does not preclude the application of other administrative measures and sanctions. In practice these measures take the form of administrative fines, corrective action, market withdrawal and destruction. These amounts are updated annually by the revaluation rate; verify the current figures with TITCK before making any decisions.

When your file is ready, an inspection is not a threat — it is a confirmation. Documents in order, label correct, records traceable: the rest is your signature.