Pursuant to the recent Presidential Decree dated May 27, 2021, The Regulation on CE Marking (“Regulation”) aiming to establish the rules and procedures regarding CE marking on the products in terms of conformity assessment to ensure consistency of compliance during all stages, from design to production, has entered into force. The Regulation regulates the obligations and procedures to be followed by manufacturers, importers, distributors and authorized representatives of those in a great extent. It also explains how to submit CE marking certification in relation to products, how to issue an EU declaration of conformity, which is also further discussed.
Obligations of Related Actors
With the regulation, the obligations of the manufacturer, authorized representative, importer and distributor are determined, without prejudice to other obligations specified in the relevant technical regulation. First of all, the Regulation defines the “manufacturer” as the natural or legal person who places a product on the market under its own name or trademark. Though, as per the Regulation, importers and distributors who place a product on the market under their own name or trademark or change a product on the market in a way that affects its compliance with the technical regulation or the general product safety legislation published by the Ministry, will be deemed as a manufacturer within the scope of this Regulation and will be obliged to fulfill the obligations assigned for the manufacturer.
Accordingly, manufacturers are obliged to (i) issue the documentation invoked by the relevant technical regulation, (ii) carry out or have the conformity assessment procedures done, (iii) to arrange the EU declaration of conformity, (iv) put the CE mark on the product and (v) keep EU declaration of conformity and technical documentation for ten years and submit those to the related authorities when requested, in an appropriate language.
On the other hand, the authorized representative is obliged to carry out or have the conformity assessment procedures for the product, if the manufacturer assigns the representative in writing. Yet, although the manufacturer has stated in writing, the authorized representative cannot issue the technical documentation.
Furthermore, the Regulation explains that, the importer is obliged to confirm that the manufacturer has fulfilled its’ above stated obligations. It must also confirm that the product bears the CE mark, and that the product is accompanied by the necessary documents. Besides, the obligations of keeping EU declaration of conformity and technical documentation for ten years and submitting those to the related authorities when requested, in an appropriate language, is also shouldered to the importers by the Regulation.
The Regulation stipulates that the distributor shall confirm that the product bears the CE mark and has documents showing its conformity before placing the product on the market. It shall also submit all information and documentation showing the conformity of the products to the authorized institution when requested.
Accordingly, the manufacturer shall be deemed to have declared that the conformity of the product with the relevant technical regulations or product has been subjected to all necessary conformity assessment procedures by putting the CE mark on the product before the product is placed on the market. The CE mark will consist of the letters ‘CE’ in accordance with the form given in the appendix of the Regulation, and the design of the mark cannot be changed except that it is reduced and enlarged in accordance with the proportions in the drawing.
EU Declaration of Conformity
As per the Regulation, in case that the EU declaration of conformity is stipulated under the relevant technical regulation, it will be prepared by the manufacturer or its authorized representative to inform that the product complies with the requirements of the technical regulation. In cases where the product is subject to more than one technical regulation requiring an EU declaration of conformity, the manufacturer demonstrates by issuing a single EU declaration of conformity that these technical regulations fulfill all the rules applicable to the product. Last but not least, if the authorized institution deems appropriate, the EU declaration of conformity may be submitted electronically.
The Regulation is issued based on the Law No. 7223 on Product Safety and Technical Regulations (“Law No. 7223”). This Law No. 7223, repealing the Law No. 4703 The Law on the Preparation and Implementation of the Technical Legislation on Products, was issued in March 2020 however, recently entered into force.
Furthermore, the Regulation has been prepared within the framework of harmonization with the European Union legislation on the basis of the European Parliament and Council’s Regulation numbered 765/2008 on the Determination of the Rules of Accreditation and Market Surveillance and Inspection and Regulation numbered 768/2008.
Ezgi Ceren Aydoğmuş