In the Official Gazette dated 27 May 2021 and numbered 31493, the “CE” Mark Regulation (“Regulation”) entered into force. In this article, we will try to briefly touch on what is regulated by the Regulation, which covers the products for which the “CE” mark is envisaged, and which determines the procedures and principles regarding the placing and use of this mark.

The CE mark is an abbreviation consisting of the initials of the phrase “Conformité Européenné”.
It indicates that the products carrying this expression comply with the basic requirements known as the product directives of the European Union on health, safety, environment and consumer protection.

Within the scope of the regulation, some obligations are regulated in terms of manufacturers, authorized representatives, importers and distributors.

  • Pursuant to Articles 5 and 6 of the Regulation, certain obligations are imposed on manufacturers and authorized representatives, such as carrying out and/or having conformity assessment procedures done, and putting the “CE” mark on the product.
  • Certain obligations are imposed to the importers, in accordance with Article 7 of the Regulation such as confirming whether the manufacturer fulfills the obligations specified in the Regulation, that the product carries the “CE” mark and that the necessary documents are included with the product, that a copy of the declaration of conformity or the technical file is kept for 10 years and, if requested, to the authorized institution for 10 years.
  • The obligations of the distributor are regulated in Article 8 of the Regulation. Accordingly, the distributor is obliged to show the necessary care while keeping the product on the market, to verify that the product bears the “CE” mark and to have the documents showing conformity before putting the product on the market, and to submit all information and documents showing the conformity of the products to the authorized institution upon the request of the authorized institution.
  • In addition to these, importers and distributors that place a product on the market under their own name or trademark or change a product which is available on the market, in a way that affects its compliance with the technical regulation or the general product safety legislation published by the Ministry of Commerce, shall be liable as the manufacturer.

Another issue mentioned in the regulation is the general principles regarding the CE marking on the product and its use. In this context, it is the manufacturer’s responsibility to confirm whether the “CE” mark complies with all relevant technical regulations and to put and ensure that the “CE” mark is placed on the products. This sign is created in accordance with the shape and size specified in the annex of the Regulation and cannot be changed except by reducing and enlarging in accordance with the proportions in the drawing.

“CE” mark should be placed;

  • In a visible, legible and indelible manner on the product/information plate or, where necessary, on its packaging and the documents accompanying the product stipulated by the relevant technical regulation,
  • Before the product is placed on the market,
  • Only by the manufacturer or his authorized representative,
  • Where required by the relevant technical regulation, the identification registration number of the notified body(s) involved in the production control phase should be included next to the “CE” mark,
  • Without other signs or descriptions to mislead third parties about its meaning and form,
  • In such a way that it can be read by visually impaired people when necessary.

In addition to the ones mentioned above, provisions regarding the EU Declaration of Conformity have been regulated starting from Article 11 of the Regulation. Accordingly, if it is foreseen in the relevant technical regulation, unless otherwise stated, an EU Declaration of Conformity must be issued by the manufacturer or authorized representative, in accordance with the sample in the annex of the Regulation, to declare that the product complies with the requirements of the technical regulation.
If it is issued in another language, the Turkish translation must be attached to the declaration. If the product is subject to more than one technical regulation requiring an EU Declaration of Conformity, the manufacturer will issue a single EU declaration of conformity that fulfills all the rules of these technical regulations applicable to the product. If the relevant technical regulations stipulate that the product will be issued with a declaration of conformity other than the EU declaration of conformity, a declaration of conformity will be issued in accordance with the procedures and principles specified in the technical regulation.

Finally, in case of violation of the provisions of the Regulation, an administrative fine will be applied in accordance with Article 20 of the Product Safety and Technical Regulations Law No. 7223.

Legal Intern, Sıla ATİLLA



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