A BRIEF ABOUT HISTORY OF TURKISH BPR
Biocidal Products Regulation was published in 2009 in Turkey. The Turkish BPR was prepared in accordance with EU Biocidal Products Directive 98/8/EC. In later years, “Consolidated Regulation on Biocidal Products No.28939” was published in 2013 in parallel with the Directive 98/8/EC of the European Union and Regulation 528/2012/EU.
SOME DIFFERENCES BETWEEN EU-BPR AND TURKISH BPR
Although Turkey’s BPR has been prepared and consolidated in parallel with the European Regulation 528/2012/EU, there are some significant differences between them, some of which are outlined below:
- There isn’t Biocidal Product Family concept within the Turkish BPR No.27449. Within the Turkish BPR, there is a concept known as Frame Formulation, which is in line with the Biocidal Products Directive 98/8/EC.
- Biocides that will be marketed in Turkey are not covered by the mutual recognition principle that is applicable in EU countries.
REQUIREMENTS OF TURKISH BIOCIDAL PRODUCTS REGULATION
The marketing of a biocidal product in Turkey requires authorization from the competent authorities according to the “Biocidal Products Regulation” (No. 27449/4) dated 31 December 2009, and the active substances in the product must be approved in advance. The licence and registration of a biocidal product shall be granted to natural or legal entities resident in Turkey or having their head office, branch office or representative in Turkey.
There are two main Active Substance Lists in Turkey; List A and List 1. List A contains active substances undergoing review, while List 1 contains approved active substances under EU BPR.
In accordance with ECHA, List A and List 1 undergo regular updates. The active substances contained in biocidal products intended for sale in Turkey must be categorized as either “Under Review” or “Approved”. Any active substance rejected under the EU BPR will be taken off the Biocidal Products Active Substance Lists.
Following these steps in the licensing process is necessary to authorize a Biocidal Product in Turkey.
LICENCE PROCESS FOR BIOCIDAL PRODUCT LICENCE IN TURKEY
Biocidal products covered by the Turkey BPR Regulation are grouped into 4 main groups:
–Main group 1: Disinfectants (PT 1 – PT 5)
–Main group 2: Preservatives (PT 6 – PT 13)
–Main group 3: Pest control (PT 14 – PT 20)
–Main group 4: Other biocidal products (PT 21 – PT 22)
In order to be sold in Turkey, all biocidal products must go through a notification or registration process. The licence application for any product considered within the scope of the biocidal claim can be made by companies located within the borders of Turkey. In the event that international companies do not meet this condition, they can fulfill the required procedures by means of a Turkish Legal Entity.
Biocidal product licensing process can be summarised in 3 basic steps.
- STEP 1: Necessary analyses of the biocidal product
- The Biocidal Product Licence dossier should include the below analysis results of the biocidal products:
- Physicochemical tests,
- Long-term and short-term (accelerated) stability tests,
- Stability test of the opened package of the product (according to product type),
- Efficacy tests.
- If these tests are not available, they must be carried out in authorized laboratories in Turkey.
- The Ministry of Health can accept the results of tests conducted abroad for applications of imported product registration, provided that these tests meet certain conditions laid out in the Regulation.
- STEP 2: Dossier study of biocidal product
- Searching laboratory in Turkey to perform the analysis requested by the Ministry (if tests are not available, upon company request)
- Preparation and controlling studies of the documents received
- Preparation of the Safety Data Sheet (SDS) of the Biocidal Product
- Preparation of Biocidal Product Label under Annex-XII
- Preparation of the Formulation and Specification documents of the Biocidal Product
- Preparation of Biocidal Products Dossier in accordance with Annex-IIB
- Preparation of Active Substance Dossier in accordance with Annex-IIA
- Preparation of toxicological and ecotoxicological Risk Assessment Report of the product under Annex-VI
- STEP 3: Submission of the Biocidal Product Licence File and awaiting Ministry evaluation
- Submission of the hard copies of the Biocidal Product Licence File to the Ministry of Health
- Following up the application regularly
- Meeting the Ministry’s request for additional information or documents promptly and accurately
- Evaluation of the authority and licensing of Biocidal Product
CHEMLEG SERVICES UNDER THE SCOPE OF TURKISH BPR
The licensing of biocidal products requires expertise due to its thorough procedure. We provide a wide range of services that align with the Biocidal Product Regulation to meet the needs of our customers.
Our services include:
- Acting as Only Representative under Turkish BPR (for non-Turkish companies),
- Researching of the analysis and efficacy test methods’ compliance with the obligatory methods by the MoH,
- Researching an accredited laboratory which will perform the chemical analysis, physical and efficacy tests that are requested by the MoH,
- Analysis follow-up,
- Making correct interventions when necessary, during the analysis period,
- Compilation of the Licence File
For further information or support, please contact our expert team.
You can send your questions to our e-mail: info@chemleg.com