The Memorandum On The Law Of Product Safety And Technical Regulations
“The Law of Product Safety and Technical Regulations” (“Law”) No. 7223has been enacted through the Official Gazette numbered 31066 and published on 12 March 2020. The Law will enter in force one year later from the date of publishing, which is 12 March 2021.
The purpose of the relevant Law is to ensure that the products in the market are safe, that they comply with the relevant technical regulations, and to define the principles of market surveillance and inspection, the duties of authorized institutions, and the liabilities of the commercial enterprises and conformity assessment bodies.
Products that are mentioned under the Law and that are deemed to be supplied to the market consists only of (i) the products exported to the member countries of European Union or (ii) targeted to be exported to the member countries of European Union. (“Product”or “Products”). In this context, Products exported or targeted to be exported to the other countries except from the member countries of the European Union are out of scope of this law.
Products that are not made compliant with the technical regulations issued by the public institution (“Authorized Institution”) (the institution which prepares and executes the technical regulations regarding the Products or which inspects such Products) may not be supplied to the market. The technical regulations issued by the Authorized Institution are opened to the opinion of the Ministry of Trade and all other relevant parties, and then finalized accordingly. Technical regulations are accepted in accordance with the public health and safety.
In the event that the Products are supplied to the market without being in compliance with the technical regulation, some compensation liabilities may occur.
Firstly, the compensation for Product liability is regulated under Article 6 of the Law. In this context, if the Product causes damage on any person/good, the manufacturer or the importer of the Product will be responsible for the damage. In order to the manufacturer or the importer may be held responsible, the relation of causality between the damage and non-compliance with the technical regulation shall be proved. Also, in case that there is more than one manufacturer/importer, then joint and several liability of them will arise out. Such liability neither may be eliminated nor may be limited through an agreement between the parties. In this context, any agreement or relevant clauses in this respect will be null and void. The relevant provisions regarding compensation of the Turkish Code of Obligations No. 6098 will be applied for the calculation of the compensation. The compensation shall be demanded within three years as of the date on which the person who suffers the damage becomes aware of the damage subject to the compensation and the liable person for the compensation, and in any case within ten years as of the date on which the damage has occurred.
Regarding the manufacturer’s liabilities regulated under the Article 7 of the Law, it has been regulated that the manufacturer may only supply the Products in accordance with its technical regulation and with the relevant legislation regarding general Product safety. In some cases, the manufacturer shall establish a technical file for the conformity assessment and keep it for the period specified in the technical regulation of the Product and in any case for at least 10 years. The manufacturer shall also take the necessary measures to maintain the appropriate supply of the Product throughout the mass Production. In proportion to the possible risks that the Products carry, the manufacturer shall take samples from the Products available in the market and shall test, examine, take records and make complaints regarding the inappropriate and recalled Products, and inform the distributors about the monitoring activity that he performs. In case that he is or needs to be acquainted with the fact that a Product that has been supplied to the market by him is not proper, he shall take the necessary corrective measures immediately in order to bring the Product to an appropriate state and to stop the supply of the Product to the market or to withdraw or recall the Product if necessary. In addition to this context, he is also liable to follow the instructions of the Authorized Institution.
The manufacturer may appoint an authorized representative by determining clearly and in writing the quality, conditions and limits of the powers and duties of the authorized representative. The authorized representative carries out the instructions of the Authorized Institution regarding the Products and maintains the certificates of conformity for the following 10 years.
Considering the liabilities of the importer, similar to the manufacturer’s liabilities, the importer shall take the necessary precautions for supply of the Products in accordance with the technical regulation and legislation regarding general Product safety in order to prevent the risks that the Product may bear and shall provide the necessary information to the end users to make them avoid such risks. Another important liability regulated hereunder is to make the Product proper for such cases where the importer is acquainted or needs to be acquainted with the fact that a Product that has been supplied to the market is improper, and to take the required corrective measures in order to stop the supply of the Product to the market, withdraw or recall the Product, if necessary.
An important obligation of the distributor, who is either a real person or legal entity other than the manufacturer or importer and who takes part in the market in the supply chain, is to confirm that the manufacturer and importer have fulfilled their obligations before supplying the Product to the market. In the event that the distributor is acquainted or needs to be acquainted with the fact that the Product does not comply with its technical regulation, then the distributor may not keep the Product in the market unless the Product is made proper and in compliance with the Law and he shall immediately inform the manufacturer or importer and the Authorized Institution of any situation in which the Product possesses risk.
Under Article 11 of the Law, the liabilities of other economic operators have been regulated where manufacturer’s liabilities and compensation for the Product liability are applied themselves too. In accordance with this clause, the importers and distributors, that supply the Product to the market under their own name or trademark without making the Product compliant with its technical regulation and the legislation regarding Product safety, shall be considered as manufacturers and shall be subject to the manufacturer’s above mentioned liabilities.
Commercial undertakings that are located at every level of the supply chain are requested to keep regular records of the name, trade name or brand and contact information of the previous and next economic operator in the supply chain in addition to other information that will facilitate the follow-up of the Product for 10 years as of the supply of the Product to the market. They are also responsible for ensuring traceability.
The Products will be subjected to a compliance audit before they are supplied to the market. The Law also includes detailed regulations regarding these compliance auditing bodies and notified bodies. In addition, the general procedures and principles regarding the inspection of the Products have been regulated and there are provisions regarding the detailed duties and powers of the Authorized Institutions.
In the last part of the Law, administrative fines are regulated. In this respect, administrative fines up to TRY 500,000 are imposed to the commercial undertakings which are at the different levels of the supply chain and which act against the above mentioned liabilities. However, if the commercial operators determine that the supplied Product is not proper and if they take the necessary measures in order to eliminate the non-compliance and the risk (by itself without upon a warning of the Authorized Institution) will be exempt from these administrative sanctions.
Additionally, pursuant to this Law, in the event that the manufacturer or importer proves that (i) the Product is not supplied to the market by himself, (ii) the incompatibility arises from the intervention of the distributor or a third party into the Product or from the end-user, or (iii) the incompatibility of the Product arose out because of the Production stage which has been complied in accordance with the technical regulations or other mandatory technical rules; the administrative sanctions will not applied. In that case, if the manufacturer or the importer proves the existence of the foregoing situations, he will not be held liable for the compensation.