AMENDMENT OF THE REGULATION ON THE “CE” MARK WHICH INDICATES THE SAFETY OF THE PRODUCT
The Regulation on the “CE” Mark (in Turkish, “CE İşareti Yönetmeliği”) (hereinafter referred to as the “Regulation”), which was prepared based on the Article 24 of the Law on Product Safety and Technical Regulations numbered 7223 (hereinafter referred to as the “Law”), has been accepted with presidential decision dated 26 May 2021 and numbered 4021, published in the Official Gazette numbered 31493 on 27 May 2021 and entered into force on the date of publication.
This Regulation has been prepared in accordance with the European Union legislation and on the basis of the Regulation (EC) numbered 765/2008 and dated 9 July 2008 of the European Parliament and of the Council Regarding the Requirements for Accreditation and Market Surveillance and the Decision numbered 768/2008/EC and dated 9 July 2008 of the European Parliament and of the Council on a Common Framework for the Marketing of Products.
The purpose of the Regulation is to determine:
- the procedures and principles regarding the placement of the “CE” mark on the product and
- the use of the same.
The Regulation comprises the products for which it is stipulated to be required the affixing of “CE” mark as per the relevant technical regulation.
The “CE” mark signifies that the products that are included in the scope of 23 New Approach Directives which is prepared within the scope of the New Approach Policy adopted by the European Union in 1985 in accordance with the technical legislation, are in compliance with aforementioned directives and have passed the necessary conformity assessments. The CE mark is a sign that indicates that the product is safe that it will not harm human life and property, the existence of plants and animals and the environment in case of intended proper use.
- Obligations of Manufacturers, Authorized Representatives, Importers and Distributors
- Issuing the technical file required by the relevant technical regulation;
- carrying out and/or to having conformity assessment procedures done;
- Issuing the EU declaration of conformity or other documents showing conformity;
- Affixing the “CE” mark on the product;
- Keeping the technical file and the EU declaration of conformity for the period specified in the relevant technical regulation, or for ten (10) years as from the date the product is placed on the market in case the period is not specified, and providing the same to the competent authority in Turkish or a language acceptable to the competent authority, upon request.
The obligations of the authorized representative (in Turkish, “Yetkili Temsilci”), who is defined as the natural or legal person residing in Turkey who is assigned in writing by the manufacturer to fulfill some of the obligations of the manufacturer on its behalf within the scope of the Law and other relevant legislation, have been determined under the Article 6 of the Regulation.
The obligations of the importers are regulated under Article 7 of the Regulation and without prejudice to other obligations specified in the relevant technical regulation, are as follows:
- Confirming that the manufacturer has fulfilled its obligations specified in Article 5;
- Confirming that the product bears the “CE” mark and that the necessary documents accompany the product;
- Keeping a copy of the EU declaration of conformity to be submitted to the authorized institution for the period specified in the technical regulation, or for a period of ten (10) years as from the date the product is placed on the market in case the period is not specified, in Turkish or in a language acceptable to the competent authority;
- Upon request of the competent authority, providing a copy of the technical file to the competent authority for the period specified in the technical regulation, or for ten (10) years as from the date the product is placed on the market in case the period is not specified, in Turkish or in a language acceptable to the competent authority.
Pursuant to Article 8 of the Regulation, the distributor shall take the necessary care while keeping the product on the market. The distributor, without prejudice to other obligations specified in the relevant technical regulation, shall verify that the product bears the “CE” mark and the necessary documents showing conformity accompany the product, before placing the product on the market. Upon the request of the competent authority, it shall submit all information and documents showing the conformity of the products.
Article 9 of the Regulation regulates the cases where the manufacturer’s obligations apply to importers and distributors, setting forth that importers and distributors who place a product on the market under their own name or trademark or change a product in the market in a way that affects its compliance with the technical regulation or the general product safety legislation issued by the Ministry are deemed as manufacturers and are obliged to fulfill the obligations of the manufacturer.
- Affixing the “CE” Mark on the Product, Usage of the “CE” Mark and EU Declaration of Conformity
- By placing or having the “CE” mark placed on the product, the manufacturer shall deemed to have declared that the conformity of the product with the relevant technical regulations stipulating the affixing of the mark is under its responsibility and that the product is subjected to all necessary conformity assessment procedures.
- Some of the main requirements as for the “CE” mark are as follows:
- Consists of the letters “CE” in accordance with the shape specified in the annex of the Regulation, and the design of the sign cannot be changed except that it is reduced and/or enlarged in accordance with the proportions in the drawing;
- Shall be at least 5 mm in size, unless otherwise specified in the relevant technical regulation;
- Shall be affixed visibly, legibly and indelibly to the product or the informative sheet, if not possible due to the structure of the product or its permanence cannot be guaranteed, to the packaging and the accompanying documents stipulated by the relevant technical regulation;
- Shall be affixed before the product is placed on the market;
- Shall be affixed solely by the manufacturer or its authorized representative.
- “CE” mark shall only be used on products if technical regulations require the affixing. It is forbidden to affix the CE marking to products for which technical regulations do not exist or do not require the affixing of CE marking.
EU declaration of conformity shall be issued by the manufacturer or its authorized representative to inform that the product is in compliance with the requirements of the technical regulation.
Authorized representatives residing in EU member states are considered equivalent to authorized representatives residing in Turkey on the basis of reciprocity.
With the entry into force of this Regulation which has been adopted in conformity with the EU legislation has abolished CE Mark Regulation which came into force by the council of ministers’ decision numbered 2011/2588 and dated 16 December 2011.
Please kindly note that the administrative fines envisaged under Article 20 of the Law shall be applied to those acting contrary to the provisions of the Regulation.
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