The Regulation on CE Sign (“CE Regulation“), the Regulation on Adequacy Assessment Establishments and Approved Establishments (“Establishment Regulation“) and the Regulation concerning the Adequacy Assessment Methods (“Assessment Regulation“) drafted pursuant to Article 24(2)(a) and (b) of Law on Product Safety and Technical Requirements (“Law“) No. 7223 were published and came into force on the Official Gazette No. 31493 on 27 May 2021. Subject regulations set forth crucial changes in terms of manufacturer’s liabilities and the adequacy assessment establishments and approved establishment’s obligations. The CE Regulation is available here (in Turkish). The Establishment Regulation is available here (in Turkish). The Assessment Regulation is available here (in Turkish).
The Regulation on CE Sign
In addition to the obligations of the manufacturers, the authorized representatives and the importers; the obligations of the distributors are regulated under the new CE Regulation. Accordingly, a distributor must provide the necessary care to a product that they place on the market. Additionally, prior to put a product on the market, the distributor must ensure that that the product bears “CE” sign and has documents proving the adequacy. The distributor may have to submit the adequacy documents to the authorized establishments (i.e. the public institution that draft technical regulations concerning the product safety) if the relevant authorized establishment requests to do so. A failure to comply with new obligations may cause the manufacturers to receive a monetary sanction pursuant to Article 20 of the Law.
The Regulation on Adequacy Assessment Establishments and Approved Establishments
According to Establishment Regulation, the adequacy assessment establishments and foreign approved establishments that open a branch or agency in Turkey are obliged to notify the authorized establishments concerning their field of practice. An adequacy assessment establishments that initialize their practice for the first time must make the subject notification within one month. Existing adequacy assessment establishments must notify the authorized establishments concerning their field of practice within two months as of the publishing date of the Establishment Regulation. Therefore, the deadline for notification is 27 July 2021. In the event of incompliance with the above mentioned obligations, the monetary sanctions regulated under Article 20 of the Law will be applied.
The Regulation concerning the Adequacy Assessment Methods
The Assessment Regulation contains guidance concerning general principles to follow during adequacy assessment. A list of modules is provided as annex to the subject regulation. Each module provide methods to follow during adequacy assessment depending on the risk that a type of product bears. Additionally, the Regulation clarifies that the decision of adequacy assessment given by approved establishments are remediable.
The subject regulations set forth some essential changes in terms of product safety legislation. Companies working in this field as well as adequacy assessment establishments and approved establishments should carefully examine the changes and take appropriate measures to comply with their new obligations.