1. Legal Framework
Currently, there is no in-force specific regulation that directly governs product safety matters under Turkish law, but the Law numbered 7223 on the Product Safety and Technical Regulations (“The New Law”) which regulates product liability and safety matters and technical regulations of products in Turkey is published on Official Gazette on 12 March 2020 to be effective as of 12 March 2021. Although the New Law will be considered as the main legal basis for the product safety matters, it also declares that in case the technical regulations do not include any provision regarding human health and safety, the assessment of the product safety is made according to the general product safety regulations. There are some provisions regarding product safety contained within various pieces of legislation which is currently applied in Turkish law. Furthermore, legislation regarding product safety prepared by international organizations such as the World Trade Organization, the Food & Drug Administration, the European Organization for Quality, and the Food and Agriculture Organization is recognized by Turkish legislation. For instance, Turkey's food legislation relating to product safety is largely in line with European Union food legislation.
Regulations regarding product safety matters, until 12 March 2021, in Turkey include the following:
• the Law on the Preparation and Implementation of Technical Legislation on Products numbered 4703 (this law will be annulled by the Law numbered 7223 on the Product Safety and Technical Regulations on 12 March 2021);
• the Code of Obligations;
• the Law on Protection of the Consumer;
• the Regulation on Surveillance and Supervision of Products in the Market;
• the Regulation on Control of Food Safety and Quality; and
• the Turkish Food Codex Regulation.
The Law numbered 4703 is considered to be a general source of product safety rules until the New Law will come into force in 12 March 2021, then it will be abrogated. It forms the basis of all technical legislation regarding different kinds of products. Also, it mainly specifies that producers must release only safe products to the market; any products that comply with the technical regulations are considered to be safe. However, where the technical regulation is not available, the safety of the product shall be evaluated according to the national or international standards; if such standards do not exist, it shall be evaluated considering the good practice code in the sector, or the level of science and technology, or the reasonable expectations of the consumer. These standards are facultative for products regulated by a specific technical regulation.
2. Regulatory Authorities
Under Turkish law, currently, there is no statute that directly governs product safety or constitutes an agency that is mainly interested in product safety, although there are key government agencies for each sector that are competent to regulate product safety, including the following:
• the Ministry of Agriculture and Forestry is responsible for the regulation, surveillance, and supervision of foods;
• the Turkish Pharmaceuticals and Medical Devices Agency of the Ministry of Health is responsible for the regulation, surveillance, and supervision of pharmaceutical and medical devices products; and
• the Ministry of Commerce is responsible for the regulation, surveillance, and supervision of imported products.
In addition, the Ministry of Health, the Ministry of Industry and Technology, the Energy Market Regulatory Authority, and the Ministry of Environment and Urban Planning monitor the market from their respective viewpoints. These government agencies have the authorization to make regulations regarding the technical features of products, and to create safety standards that are specific to each sector; they are also entitled to impose required measures, such as product recall, announcements to the public, etc.
According to the New Law, after the date 12 March 2021, the competent authorities will be constituted with certain authorized to conduct market surveillance and supervision. The competent authorities are authorized to (i) conduct inspections to the storages, transportation vehicles, manufacturing site or any other workplace, (ii) make tests on the samples of the products, (iii) request any information and document from the audited entity. After the inspection, the competent authority shall decide whether there is sufficient reason to conduct risk evaluation or not.
3. Corrective Actions
Certain public authorities are entitled to order corrective actions for products that do not comply with technical legislation or that violate public health, environmental health, consumer protection, or energy efficiency, based on public interest. The current law contains no specific criteria for market surveillance and the inspection of the product, but the relevant public authority is authorized to regulate specific measures. For instance, if the relevant public authority detects upon market surveillance and inspection that the product is unsafe, it may ban the supply of the product to the market or recall the product that has already been supplied to the market under the Law numbered 4703. If the producer fails to announce the information about the risk of the product and corrective actions, the Law numbered 4703 ensures that the relevant public authority shall notify the persons at risk through an announcement to
be published in at least two newspapers distributed throughout the country and on two TV channels broadcasting throughout the country. Additionally, the Turkish Pharmaceuticals and Medical Devices Agency of the Ministry of Health is entitled to investigate the products that are suspected of being inaccurate in terms of the health and safety of the consumer, and to recall them from the market in accordance with the Withdrawal Regulation numbered 29537. Also, if the demand for the recall of pharmaceuticals and medical devices is not fulfilled by the responsible person, the marketing authorization of the device may be suspended by the relevant authority.
As of 12 March 2021, the competent authority will have the authority to conduct market surveillance and supervision. Accordingly, the business enterprises shall take effective and corrective actions in line with their above-mentioned responsibilities, otherwise, the competent authority may impose administrative sanctions and/or give the business enterprise time to take corrective actions. Some of the essential corrective actions provided under the Law are presented below:
Informing the competent authority with the risks constituted by the products, already taken corrective actions and their results,
Taking necessary precautions to ensure the conformity,
Suspension of the release of the products that have symptoms referring that it may pose serious risks,
Ceasing the release to the market and recalling the products from the market,
In case the business enterprises do not take the necessary precautions in time or such precautions are regarded as insufficient by the competent authority, the competent authority shall ex-officio take the necessary precautions.
4. Notification to Regulatory Authorities
The notification procedure in respect of product safety matters can differ according to the subject of the issues. As a general rule, the assumption of risk is enough to commence the notification process. Accordingly, the relevant company or authority may start the examination process for market surveillance and inspection of the product. For instance, in the case of pharmaceuticals and medical devices that are suspected to be unsafe and defective, the notifications may be made by the persons, institutions and organizations to the relevant authority, provincial health directorates or the company responsible. On the other hand, regulatory authorities are competent to determine the obligation for notification of the products before they are supplied to the market. Obligations to notify the regulatory agencies regarding products would be different according to the technical legislation applicable to each kind of product. For instance, cosmetic products can only be released to the market after final certain laboratory research on the cosmetic product is notified to the Turkish Pharmaceuticals and Medical Devices Agency of the Ministry of Health.
5. Breach of Obligations
The penalty rules for breaching product safety obligations would vary according to the technical regulations for every kind of product. In addition, there are differences between government agencies regarding the strictness of applying sanctions. As per Art. 12 of the Law numbered 4703, an administrative fine ranging from TRY 3.471,00 to 434.036,00 (in the New Law the range is from TRY 10.000,00 to 500.000,00) shall be applied to the producer for the year 2020, distributor, and other related person for breaching certain product safety rules determined under Art. 5, which provides that the producer must only supply safe products to the market, and Art. 9 of the Law numbered 4703. On the other hand, if the responsible firms, pharmaceutical warehouses, and businesses like pharmacies do not cease selling the defective pharmaceuticals and medical devices after the recall announcement, the penalty provisions of the Law on Pharmaceuticals and Medicinal Products numbered 1262, the Turkish Criminal Code numbered 5237 and the Law on Misdemeanours numbered 5326 shall be applied to them.
For instance, a recent Supreme Court decision involved a stationery manufacturer and importer company being penalized TRY 99,227 for not complying with the product safety legislation, according to Art. 5/3 of the Law numbered 4703 since the product safety test on the imported erasers resulted in a negative outcome, which was examined by an authorized chemical laboratory pursuant to the Communiqué on Market Surveillance and Supervision on Hazardous Chemical Ingredients of Some Consumer Products. Accordingly, all unsafe products were recalled from the market by the Ministry of Commerce.
Another example involves another stationery manufacturer and importer firm, which was fined due to the fact that it released the imported erasers to the market without applying product safety regulations. Even though the erasers were produced abroad and complied with the product safety rules of the foreign country, the products that are released to the market in Turkey must comply with the local legislation and be safe according to Art. 5/3 of the Law numbered 4703. In conclusion, the company was fined to TRY 12,327 and all the released erasers were recalled from the market by the Ministry of Commerce.
You may reach the detailed explanations on the New Product Liability and Safety Code in here.
The previous version of the article has been published on Chambers under the Chambers Product Liability & Safety 2019 Guide.