Product safety in Türkiye is governed by Product Safety and Technical Regulations Law No. 7223, which applies to every product intended to be placed on the market, placed on the market, made available on the market or put into service (Article 2/1). Two features of that statute decide most files: Article 2/3 makes it residual, so a special law such as the Cosmetics Law displaces it on every point that special law regulates; and Article 5/2 gives a compliant product only a rebuttable presumption of safety, while Article 15/6 confirms that holding conformity documents or markings stops neither an inspection, nor a measure, nor a sanction.
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We act for manufacturers, authorised representatives, importers and distributors across that framework: building the file before an inspection, defending the operator once one is opened, and running withdrawal and recall when a corrective measure becomes unavoidable.
Which Rulebook Actually Applies
The first question is never “is the product safe” but “which instrument sets the standard”. Under Article 5/3 of the Law, where there is no technical regulation for a product, or the technical regulation contains no provisions on human health and safety, safety is assessed under the general product safety legislation. The General Product Safety Regulation (Official Gazette of 11 March 2021, No. 31420) states its own trigger in Article 2/1: it applies where no technical regulation exists, or where one exists but contains no provisions on health and safety or on the risks in issue. It reaches new, used and refurbished products alike, irrespective of the sales technique and including electronic sales.
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That Regulation also carries a presumption worth knowing. Under Article 5/4, and subject to Decision 1/95 of the Türkiye-EU Association Council and the Mutual Recognition Regulation in the non-harmonised field, a product lawfully manufactured or released for free circulation in an EU member state is accepted as safe even if made to different technical rules. Where no technical regulation covers the point, Article 5/5 and 5/6 then measure safety against national standards corresponding to European standards and other listed criteria; and Article 5/7 provides that conformity with those criteria does not prevent the authority from stopping supply, withdrawing or recalling the product, or applying sanctions, where it has sufficient grounds to regard the product as dangerous.
Duties Follow the Role, Not the Contract
Law No. 7223 allocates obligations by statutory role, and a supply agreement cannot reassign them.
| Role | Central duties | Provision |
|---|---|---|
| Manufacturer | Supply only conforming products; draw up the technical file and declaration of conformity and affix the conformity marking; keep the file at least ten years; sample and test proportionately to risk and record complaints and recalls; provide Turkish-language instructions and safety rules; take corrective measures without delay and inform the authority | Art. 7/1 (a)-(i) |
| Authorised representative | Performs the tasks assigned in writing; but even if the mandate is silent, keeps conformity documents at least ten years, supplies them on request in Turkish or another language the authority accepts, and carries out the authority's instructions without delay | Art. 8/1-8/2 |
| Importer | Verify, before the product goes on the market, that it bears the conformity marking, that the required documents accompany it and that the manufacturer has met Art. 7/1 (b), (e) and (f); state its own name and address without obscuring the manufacturer's mandatory information; make a copy of the conformity documents available to the authority on request for at least ten years from import | Art. 9/1 (b), (ç), (h) |
| Distributor | Check the marking, documents and Turkish instructions before making the product available; not obscure mandatory information with its own labels or price tags; confirm the manufacturer or importer has taken corrective measures | Art. 10/1 (a), (ç) |
| Any operator | Keep traceability records identifying the previous and, where applicable, the next operator in the chain for at least ten years; a duty that also binds online sellers, intermediary service providers and media service providers | Art. 12/1-12/2 |
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Two provisions collapse those boxes into one. Article 11/1 deems an importer or distributor to be a manufacturer where it supplies under its own name or trade mark, or alters the product in a way affecting conformity: the own-brand and private-label trap. Article 11/2 does the same where the manufacturer, authorised representative or importer cannot be identified, to a distributor that fails, within ten working days of notification, to name the manufacturer, authorised representative or importer, or failing that the previous operator in the chain. We test these allocations at the supply and distribution contract drafting stage, not after an inspection.
How an Inspection Unfolds
Inspection is not confined to the shop floor. Under Article 16/1 the authority may inspect warehouses, transport vehicles, business premises and production facilities, and demand any document or record. The Framework Regulation on Market Surveillance (Official Gazette of 10 July 2021, No. 31537) adds sharper tools in Article 16/4: unannounced on-site inspection; requests for data including access to embedded software; information on the supply chain, quantities on the market and other models sharing the same technical characteristics; and sampling, including purchases made without disclosing identity, with authority to reverse-engineer the samples.
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The trigger is often documentary rather than physical. Article 16/4 lets the authority presume it has sufficient grounds for a risk assessment where the conformity marking, technical file, label or instructions are absent, incomplete, inadequate or misused, and, independently of the assessment’s outcome, require the defect to be cured, escalating to a ban, withdrawal or recall if it is not. One countervailing rule is worth pleading: Article 16/3 states that the availability of a higher safety level, or the presence of lower-risk products, does not make a product unsafe or seriously risky.
The sequence under the Ministry of Trade’s Regulation is fixed: the regional directorate gives ten working days for the defence (Article 11/1); a risk assessment commission of at least three members evaluates it (Article 10/1); the notified decision allows fifteen working days for a corrective action plan; and once approved, up to six months is set to eliminate the non-conformity, extendable by a further period of up to six months where force majeure is proved (Article 11/3). Where strong indications of serious risk have led to a temporary suspension, Article 21/4 of the Framework Regulation caps that suspension at four days unless testing the product, or supplying the information requested, technically requires longer.
Recall, Withdrawal and Who Pays
Withdrawal and recall are different measures. Withdrawal (Article 3/1(j)) prevents a product in the supply chain from being made available; recall (Article 3/1(d)) brings it back from the end user, and Article 19/1 makes it compulsory only where the other measures taken prove insufficient to remove the risk. The operational rules (the Article 19/3 duty to offer the end user at least one of three options, and the Article 19/4 rule putting every recall cost on the operator and requiring the end user to be able to return the product promptly and easily at no additional cost) are set out in our note on recall obligations under Law No. 7223.
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Two further points shape the commercial outcome. Private-law exposure survives the recall: Article 6 makes the manufacturer or importer liable for damage a product causes to a person or property, voids contract terms excluding or reducing that liability, and sets a limitation period of three years from knowledge and ten years in any event. Why a cap written into a supply or distribution agreement does not survive that provision, and how the statute then splits the burden of proof, is examined in our note on limitation-of-liability clauses under Article 6/4. The chain also has its own settlement mechanism: under Article 21/5, a distributor that returns a withdrawn product may require the manufacturer or importer to cure the problem, and where the product must be destroyed or made unusable, it must be offered either payment of the value at which the product was supplied or replacement with a compliant, safe and equivalent product. Recovering those costs from the party actually responsible is a contractual and litigation exercise running alongside the regulatory file.
Sectoral Regimes: Medical Devices and Cosmetics
Sectoral rules sit on top of, and sometimes displace, the general framework, so the boundary is settled first.
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Medical devices. The Medical Device Regulation (Official Gazette of 2 June 2021, No. 31499 repeated) is made under Article 4 of Law No. 7223 but names the Turkish Medicines and Medical Devices Agency as the competent authority, and layers vigilance duties on top of the general regime. Under Article 85 the manufacturer reports a serious incident as soon as it establishes, or reasonably suspects, a causal link, and in any event within fifteen days of becoming aware, reduced to ten days for a death or an unexpected serious deterioration in health and two days for a serious public health threat; Article 85/7 requires the report even where the manufacturer is unsure the event is reportable. For a non-conformity creating no unacceptable risk, Article 94 requires a reasonable period to end it before restriction, prohibition, withdrawal or recall. Inspection reaches the premises of professional users, and Article 90/7 lets the operator comment before the final inspection report is adopted, which is the point at which health-sector regulatory input is worth most. The registration and authorised-representative steps that come before any of this are set out in our note on placing a medical device on the Turkish market.
Cosmetics. Cosmetics Law No. 5324 is the special law Article 2/3 of Law No. 7223 defers to. Article 3 requires notification to the Ministry of Health before a cosmetic product is placed on the market for the first time and for later changes to the product or the producer, and treats a notification containing incomplete information or documents as not made at all. Article 4 defines “producer” broadly enough to catch a company that merely puts its name, trade mark or distinguishing sign on the product. The enforcement design differs in a way that matters: under Article 6, placing on the market is suspended pending checks, even though its compliance is documented, where there are definite indications that it is unsafe for general health; if the check confirms this, the Ministry, at the producer’s cost, bans placing on the market, has the products withdrawn and, where they cannot be made safe, destroyed in whole or in part, and has the measures announced in two nationally distributed newspapers and on two nationally broadcasting television channels. Who may hold that producer role, and what has to reach the Ministry before the first sale, is set out in our note on the responsible person for cosmetics in Türkiye.
Consumer-Law Duties Run in Parallel
Regulatory compliance does not exhaust the obligations attached to a product. Under Article 56 of Consumer Protection Law No. 6502, producers and importers must issue a warranty certificate for consumer goods, and the warranty period is at least two years from delivery, although the Ministry may fix the terms of particular goods by a different unit of measurement. Where the consumer has used the repair remedy and the goods fail again, or the maximum repair period is exceeded, or repair proves impossible, the seller may not refuse the consumer’s other remedies, and if the request is not met, seller, producer and importer are jointly and severally liable. Article 58 requires maintenance and repair throughout the useful life determined by the Ministry, an approved after-sales service competence certificate for the goods specified by regulation, and current service station data in the Ministry’s system; the two certificates an importer must hold, and the successor-importer rule in Article 58/6, are set out in our note on warranty and after-sales service obligations for importers. These are duties enforced by a different authority on a different timetable, and frequently where a product problem first becomes visible.
Our Approach
We work backwards from the way a file is decided: which rulebook applies, who holds which statutory role, whether the technical and traceability documents exist in the form the authority will demand, and whether the operator can still reach Article 21/1 by acting first. Where an inspection has begun, we prepare the defence within the statutory period, test the risk assessment against Article 16/3, negotiate the corrective action plan and its timetable, and take sanction decisions to the administrative courts under Law No. 2577. Contact us to discuss a product safety or market surveillance matter in Türkiye.
