TÜRKIYE Law and Practice Contributed by: Tansu Akin, Akin Legal
1.4 Obligations to Notify Regulatory Authorities Under the Product Safety Law, the manufacturer (or its authorised representative), the importer and the distributor (collectively referred to as the “Enterprise(s)” ) are obliged to immediately inform the competent market surveillance regu - lator once it is identified that a product poses a risk to health and safety or is not compliant with regulatory standards. This notification require - ment is risk-based, meaning it does not neces - sitate an incident to occur before precautions are taken. The Enterprise is obliged to include in its notifi - cation to the regulator: • the precise identification of the concerned product; • a comprehensive description of the identified risk; • available information pertaining to the trace - ability 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 pre - cautions immediately. Although the definition of “immediate” is not explicitly stated, Enterpris - es 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 initi - ate and track all proceedings through the rel - evant 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 pen - alties due to a breach of product safety obliga - tions. A manufacturer, importer or distributor is subject to administrative fines and penalties if it has breached product safety obligations, unless they can prove they took all necessary precau - tions before regulatory intervention and rectified the failure. Even though there is no provision that clearly addresses 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 neces - sary permissions (TCC 193). Additionally, several criminal allegations have been raised, though without successful out - comes to our knowledge, regarding smuggling and fraud. These allegations are based on the argument that product defects indicate false declarations in product conformity documents, leading to smuggling during customs clearance (for imported goods) and forgery of private docu - ments. It should be noted that such allegations may prompt authorities to take stricter measures during market surveillance activities, including
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