Regulation Decision No. 4021 on placing the CE mark and using the mark, which is a sign showing that the products will not harm safety of human life and property, plant and animal existence and the environment if they are used in accordance with their intended purpose, in other words, the product is a safe product, entered into force on 27 May 2021 by being published in the Official Gazette. Within the scope of this newsletter, we will be examining what this Regulation brings about CE marking and its use.

What is the "CE" mark and how is it used?

"CE" is a sign that means that the product which it is attached on meets all the requirements of the relevant Regulation and is a sign that is created in order to ensure the free circulation of goods between the European Union member countries.

The "CE" mark can only be used on products for which technical regulations are required and cannot be used on other products.

"CE" mark,

  • Visible, legible and indelible to the product/data plate/packaging and the documents accompanying the product stipulated by the relevant technical regulation,
  • Before the product is placed on the market,
  • It is placed only by the manufacturer or his/her authorized representative.
  • No other signs and descriptions can be used to mislead third parties about its meaning and form.
  • It is placed in a way that can be read by the visually impaired.

What are the manufacturer's obligations?

The manufacturer, without prejudice to his/her other liabilities, is liable with; (i) issuing the technical file required by the relevant technical regulation, (ii) making and/or having the conformity assessment procedures done, (iii) issuing the EU declaration of conformity or other documents showing its conformity, (iv) placing the "CE" mark on its product, (v) keeping the technical file and the EU declaration of conformity for the period specified in the relevant technical regulation, if the time is not specified, for a period of ten years from the date the product is placed on the market, and submitting it to the authorized institution in Turkish or in a language acceptable to the authorized institution, if requested.

What are the consequences of placing the "CE" mark on the product?

The manufacturer, who puts the "CE" mark on the product or ensures that it is affixed, is deemed to have declared that the product's conformity with the relevant technical regulation or regulations requiring this marking is under its own responsibility and that the product has been subjected to all necessary conformity assessment processes.

What are the obligations of the importer?

The importer is liable with: (i) Confirming that the manufacturer has fulfilled its obligations, (ii) keeping a copy of the EU declaration of conformity for the period specified in the technical regulation, for a period of ten years from the date of placing the product on the market, in Turkish or in a language acceptable to the authorized institution, in case the period is not specified. (iii) If requested by the authorized institution, providing a copy of the technical file to the authorized institution in Turkish or in a language accepted by the authorized institution, for a period of ten years from the date the product is placed on the market, for the period specified in the technical regulation.

What should be the shape of the "CE" mark?

The "CE" mark consists of the letters "CE" and should be used in accordance with the figure and ratio below. Its shape cannot be changed except by minimizing or enlarging it in accordance with the proportions in the drawing specified in the regulation. Unless otherwise specified, it will be a minimum size of 5mm.

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What is the EU Declaration of Conformity?

If it is foreseen in the relevant technical regulation, an EU Declaration of Conformity must be issued by the manufacturer or its authorized representative and it must be declared that the product complies with the requirements of the technical regulation. Unless otherwise stated in the technical regulation, this Declaration is prepared in accordance with the "Example of EU Declaration of Conformity" in the annex of the CE Marking Regulation, and if it is issued in another language, its Turkish translation is also attached.

What are the consequences of issuing an EU declaration of conformity?

By issuing and signing the EU declaration of conformity, the manufacturer assumes responsibility for the conformity of theirselves product with the rules of the relevant technical regulation.

What are the sanctions for violating the provisions of the regulation?

An administrative fine is imposed on those who violate the provisions of this Regulation in accordance with the provisions of Product Safety and Technical Regulations Law No. 7223.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.