DETAILS REGARDING THE AMENDMENT TO TURKISH BPR

Content addition date : 17-03-2020

Turkish Republic Ministry of Health has published Regulation Amending the Biocidal Products Regulation in the Official Gazette with No: 31066 on the date 12.03.2020. The amendments came into force on the date of publication.

The Amending Regulation contains important revisions and improvements including but not limited with the below listed subjects;

** The validities of the inventory notification approvals for Product Types 6, 7, 8, 9, 10, 11, 12, 13 and 21 have been extended until 31.12.2023.

** The revisions in the regulations which are published by the Ministry of Environment and Urbanization (such as SEA, SDS Regulations) have been adapted into the Biocidal Products Regulation.

** Some definitions from the EU BPR (528/2012/EU) have been adapted into the Biocidal Products Regulation for the alignment of the regulations and to prevent conflicts and ambiguity. These adaptations include revision of the biocidal product definition and adaptation of the frame formulation concept according to the EU BPR Biocidal Product Family concept.

** The Competent Authority role for Biocidal Products Product Type-1 and Product Type-19 which are in direct contact with the human body has already been transferred from General Directorate of Public Health of MoH to Drugs and Medical Devices Institution of Turkey - Management of Cosmetic Products of MoH with the Presidential Decree published in the Official Gazette on 13.09.2019. This change of Competent Authority role has also been adopted into Biocidal Products Regulation. 

** Product-type descriptions have been adopted according to the EU BPR Product-type descriptions. 

** The provisions related to required analysis in the registration process that are to be performed in the Authorised Turkish Laboratories. With the new amendments, the Authority will decide whether there will be additional analysis requirements after their evaluation on the analysis reports submitted by the companies. This new process will be applicable for Product Types 6, 7, 8, 9, 10, 11, 12, 13 and 21 only.

** Annex-XII of the Biocidal Products Regulation, which is an example Biocidal Product label, has been revised.

    
You can contact with CRAD team for further details.