The 'Responsible Person' for Cosmetics in Türkiye: Notification Before Placing on the Market

A cosmetic product may be placed on the Turkish market only if a natural or legal person established in Türkiye has been designated as its responsible person. That rule sits in Article 6/1 of the Cosmetic Products Regulation, published in the Official Gazette of 8 May 2023, No. 32184, repeated issue, and the second paragraph of the same article adds the substance behind the label: the responsible person ensures, for each individual product placed on the market, that the obligations in the Regulation are met.

The concept is newer than most compliance files assume. The 2005 Cosmetics Regulation that this text repealed used no such term — it spoke of the producer’s responsibility, not of a designated person carrying the file. Article 39 brought the new Regulation into force six months after publication, on 8 November 2023, and an amendment published on 5 March 2024 (Official Gazette No. 32480) then moved one of its key rules again. A dossier assembled against the old vocabulary is not merely out of date; it is addressed to a regime that no longer exists.

Who Can Be the Responsible Person for a Cosmetic Product

Article 4/1(h) defines “economic operator” as the manufacturer, the responsible person, the importer and the distributor. The responsible person is listed as a separate category, not as a description of one of the others — which is why the role can be held by a party that neither manufactures nor imports.

The Regulation then allocates it by scenario.

The 2024 amendment is easy to miss because it was drafted as an added sentence rather than a new paragraph. As originally enacted, Article 6/3(a) said flatly that a domestically established manufacturer is the responsible person, with no route out. The sentence added on 5 March 2024 begins with “however” and opens that route: the manufacturer may authorise a person established in Türkiye by written agreement. Imports already had the equivalent option in Article 6/4.

Delegation shifts the work, not the exposure. Article 6/5 provides that where the responsible person is a party appointed by the manufacturer or importer under a written agreement, that person becomes liable on the same legal basis as the manufacturer or importer under Law No. 7223 on Product Safety and Technical Regulations, and Article 35/2 and 35/3 of the Regulation repeat that result on the enforcement side. What the position contains is set out in Article 6 of Law No. 7223: the manufacturer or importer must make good damage the product causes to a person or to property (Art. 6/1), several liable parties answer jointly and severally (Art. 6/3), contract terms that release or reduce that liability are void (Art. 6/4), and the claim is time-barred three years after the injured party learns of the damage and of the person liable, and in any event ten years after the damage arose (Art. 6/6). Anyone accepting the role for a fee is accepting that position, which is why the appointment belongs in a properly negotiated instrument rather than a one-page letter — the allocation of indemnities, information duties and termination consequences here is ordinary commercial contracts work with an unusually direct regulatory consequence.

Notifying a Cosmetic Product Before Placing It on the Market

Article 16/1 requires the responsible person, before a cosmetic product is placed on the market, to notify the Turkish Medicines and Medical Devices Agency through the national electronic database of: the barcode together with the category and name in Annex IX; the name and address of the responsible person where the product information file is held; the country of origin for imported products; contact details for a natural person to reach in case of need; nanomaterials present, with their IUPAC names and reasonably foreseeable exposure conditions; the names and CAS or EC numbers of substances used, including those classified as category 1A or 1B carcinogenic, mutagenic or toxic for reproduction; and a frame formulation giving proportions in ranges, so that emergency medical treatment can be given quickly. Article 16/2 adds the original label, a Turkish label where the original carries none, and an image of the packaging. Under Article 16/3 the Agency forwards this to the National Poison Advice Centre for medical use.

This is a notification, not an approval. The Regulation attaches no examination period to it and issues no decision in response; what conditions market entry is that the notification has been made. That is also the point at which the statute behind the Regulation becomes sharper than the Regulation itself. Article 3 of the Cosmetics Law No. 5324 requires notification before a cosmetic product is placed on the market for the first time, requires subsequent changes to the product or the producer to be notified as well — and then adds, in its own second paragraph, that a notification containing incomplete information or documents is deemed not to have been made. A filing with gaps does not sit somewhere between compliant and non-compliant. In law it is absent, and every unit sold behind it was placed on the market without notification.

Products containing nanomaterials carry a second filing. Article 19/3 requires notification through the same database six months before the product is placed on the market, with the identification and specifications of the nanomaterial, the estimated quantity per year, its toxicological profile, safety data for the product category and reasonably foreseeable exposure conditions. Article 19/4 then removes from that duty nanomaterials meeting the requirements set out in Annex III — an exception that changes the timetable for a launch and is worth checking before the six months are assumed. Article 19/2 draws a further line: unless otherwise stated, the article does not apply to nanomaterials used as colourants, UV filters or preservatives, which are dealt with under Article 17.

The Product Information File Behind the Notification

The notification is short. What stands behind it is not.

Two details in that table are frequently reversed in practice. The file may be kept in Turkish or English — Article 14/4 says so expressly, and Article 8/3 repeats the choice for documents produced on the Agency’s reasoned request — so translating an existing English dossier is not the starting task. But Article 22/5 requires certain label information to be given in Turkish: the nominal content, the minimum durability date, the special warnings and precautions, and the product’s function where it is not obvious from presentation. Where the minimum durability period exceeds thirty months, Article 22/1(c)(3) drops the date requirement — but replaces it with a statement of the period for which the product is safe to use after opening. The ingredient list is not in that list; under Article 22/6 it is written using the common ingredient nomenclature, and Article 22/1(a) requires the responsible person’s name or registered title and address on the pack, with the origin stated for imported products.

Article 7 adds a staffing requirement that has no European analogue and is regularly overlooked: the responsible person employs responsible technical staff, drawn under Article 7/3 from chemists, biochemists, chemical engineers, biomedical engineers, biologists, microbiologists and pharmacists. Article 7/4 lets the responsible person hold that role personally if qualified. Separately, Article 13/4 restricts who may perform the safety assessment to holders of a university qualification in pharmacy, toxicology, medicine or a similar discipline, or an equivalent programme accepted by the Agency — so the technical staff member and the safety assessor are not necessarily the same person.

Where a product is manufactured in Türkiye and a free sale certificate is wanted for export, Article 12/2 routes the application through the responsible person via the electronic database, with the procedure to follow the Agency’s own guidance. That is a common intersection point with the customs and import-export side of a cosmetics business, where classification, origin and documentary compliance at the border are handled under a separate rulebook — the practical sequence at first import is set out in our guide to importing goods into Türkiye.

Cosmetic Product Claims: What the Pack Is Not Allowed to Say

Article 23/1 prohibits, in the labelling, market availability, presentation and advertising of cosmetic products, any text, name, trade mark, registered trade mark, image, figurative or other sign implying that the product has characteristics or functions it does not have. The prohibition reaches the brand name itself, not only the marketing copy around it — a registered trade mark is listed among the vehicles that can carry an impermissible implied claim.

Article 23/2 has the Agency build a national list of common criteria for permissible claims, taking the European Commission’s published common criteria as its reference. Article 23/3 governs the animal-testing claim specifically: it may be made only where the manufacturer or its suppliers have neither carried out nor commissioned animal testing on the finished product, its prototype or any ingredient, and have used no ingredient tested on animals by others for the purpose of developing a new cosmetic product. Article 14/2(ç) then requires evidence for a claimed effect to sit in the product information file where the nature of the claim justifies it, which means claims substantiation is a filing obligation and not only a marketing question.

What Happens When the Agency Finds a Gap?

Article 25 gives the Agency market surveillance through documentary checks on the product information file, physical checks and, where necessary, laboratory testing. Article 28/1 then sets the standard response: for the listed failures — good manufacturing practice, safety assessment, product information file, sampling and analysis, the notifications under Articles 16 and 19, substance restrictions, animal testing, labelling, product claims, public information, the reporting of serious undesirable effects and the information required under Article 27 on the substances a product contains — the Agency requires the responsible person, within a reasonable period it sets in proportion to the risk, to take all appropriate corrective action, including withdrawal from the market or recall.

Three features of that regime matter more than the list itself.

First, compliance is not a complete defence. Article 30/1 empowers the Agency to withdraw, recall or restrict access to a product even though it meets the requirements, where it is established that the product poses a serious risk to human health or there are reasonable grounds to think it may.

Second, there is a hearing before most decisions. Article 31/2 requires that the responsible person be given a reasonable period to state its views before a decision is taken — expressly except where urgent measures are needed because of a serious risk to human health. That exception is the operative half of the sentence: in the cases where the Agency intervenes most urgently, the opportunity to respond comes afterwards.

Third, the costs run to the economic operator. Under Article 31/4 the Agency may prohibit or restrict market availability, withdraw or recall, and order partial or total destruction where the product cannot be made safe, at the operator’s expense, in two situations — urgent action for serious risk, and failure by the responsible person to act within the period set under Article 28/1. Article 31/5 then requires the operator to make a public announcement under Article 18 of Law No. 7223, whose first paragraph fixes the minimum content: identifying marks, an image where possible, the measure taken, a clear description of the problem, the operator’s contact details, and the recommended way to avoid the risk.

Monetary penalties come from the statutes, not from the Regulation, and the order of application is set by Article 2/3 of Law No. 7223: where a special law exists for a product, the provisions of Law No. 7223 apply only in the situations for which the special law makes no provision. For cosmetics the special law is Law No. 5324, whose Article 5 attaches fines to failures to notify, to operating without responsible technical staff, and to placing on the market a product that is not safe under Article 4(d), doubling them on repetition. The figures printed in Article 5 are the nominal amounts set in 2008; under Article 17/7 of the Misdemeanours Law No. 5326 fixed administrative fines are increased each calendar year by the revaluation rate determined under the Tax Procedure Law — the closing sentence of that paragraph excludes proportional fines from the mechanism — so the current level has to be read from the year in which the act occurred rather than from the statute. The bands in Article 20 of Law No. 7223 are revalued through an annual Ministry of Trade communiqué on the same principle.

Two procedural points are worth keeping in view. Article 21/1 of Law No. 7223 provides that no administrative sanction under that Law is applied to an economic operator that identifies the non-conformity itself, takes the necessary measures — including recall — without a request or warning from the authority, and fully remedies the problem. And Article 22/2 sends appeals against administrative sanction decisions under that Law to the administrative courts under Law No. 2577, not to the criminal judgeship of the peace that hears ordinary misdemeanour objections; Article 17/6 of Law No. 5326 separately provides a 25 per cent reduction for payment within the payment period and states that paying does not affect the right to challenge the decision.

Both transitional windows have now closed. Under Provisional Article 1/1, products placed on the market under the repealed 2005 Regulation could remain available for two years from entry into force — until 8 November 2025. Under Provisional Article 1/3, as amended on 5 March 2024, the safety assessment under Article 13/2 and the product information file under Article 14 had to be produced for products notified under the old text within six months of entry into force, which ran out on 8 May 2024. A product still on shelves today is being sold under the current Regulation in full, with no grace period behind it, which is why the responsible person’s file — rather than the notification screen — is where an inspection begins. Where the product also touches clinical or aesthetic services, the overlapping duties sit in health law as much as in product regulation.