TÜRKIYE Law and Practice Contributed by: Tansu Akin, Akin Legal
Manufacturers are required to inform end customers of identified defects, the recall process, and intended corrective measures (replacement, sales contract rescission, or free repair) and submit bi-monthly reports to the Ministry. Informing stakeholders in the supply chain alone is insufficient. The learned intermediary principle is not applicable. If the Ministry identifies potential risks, it will warn the Enterprise to take necessary precautions, including a recall. If the Enterprise fails to take action or initiate a voluntary recall, the Ministry can implement compul - sory recalls and remove the products from the mar - ket. For products marketed under a specific licence or permission from the Ministry, the Ministry may also suspend such licence or permission, effectively ban - ning the product’s marketing. Therefore, a recall can be initiated by the manufac - turer, importer, distributor, or the authority, either auto - matically or upon an individual’s claim. A recall also necessitates that the Enterprise announce the campaign on its website’s front page, directly noti - fy known customers via registered mail, and in some cases, through mandatory advertising. Initiating a recall does not absolve the manufacturer/ importer from liability for damages suffered. They remain liable for compensation, provided the claim - ant proves a causal link between the damage and the defect. Thus, a recall alone does not automatically trigger liability; the existence of damage due to the defect is also required. 1.4 Obligations to Notify Regulatory Authorities Under the Product Safety Law, the manufacturer (or its authorised representative), the importer and the dis - tributor (collectively referred to as the “Enterprise(s)”) are obliged to immediately inform the competent mar - ket surveillance regulator once it has been identified that a product poses a risk to health and safety or is not compliant with regulatory standards. This notifi - cation requirement is risk-based, meaning it does not necessitate an incident to occur before precautions are taken.
The Enterprise is obliged to include in its notification to the regulator: • the precise identification of the concerned product; • a comprehensive description of the identified risk; • available information pertaining to the traceability of the product; and • the measures that are necessary to prevent the occurrence of the identified risks. Under the regulations, the Enterprises are expected to take all necessary actions and precautions imme - diately. Although the definition of “immediate” is not explicitly stated, Enterprises are expected to act in accordance with the severity of the risks, akin to the response of a diligent and prudent businessperson. While there are no formal requirements for reporting to authorities, the government has digitised most of its services. In practice, this necessitates Enterprises and individuals to initiate and track all proceedings through the relevant regulatory bodies’ dedicated websites or databases. These platforms are designed with a step-by-step approach, guiding Enterprises through the notification process. 1.5 Penalties for Breach of Product Safety Obligations The Product Safety Law provides for several types and levels of administrative fines and penalties due to a breach of product safety obligations. A manu - facturer, importer or distributor is subject to adminis - trative fines and penalties if it has breached product safety obligations, unless they can prove they took all necessary precautions before regulatory intervention and rectified the failure. Even though there is no provision that clearly address - es criminal liability due to defective products, the case law refers to a number of criminal offences relating to product liability for specific matters. For instance, defective food and drug products may be interpreted as selling, supplying, or keeping food materials or drugs that endanger human health and life (Turkish Criminal Code (TCC) 186) or producing, providing and selling poisonous products without obtaining necessary permissions (TCC 193).
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