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.
Although Turkish BPR has been consolidated in parallel with Regulation 528/2012/EU, there are some crucial differences between them.
SOME DIFFERENCES BETWEEN EU-BPR AND TURKISH BPR
- There isn’t Biocidal Product Family concept with Turkish BPR No.27449. There is Frame Formulation concept within the scope of Turkish BPR such as Biocidal Products Directive 98/8/EC.
- Mutual recognition, that is available in EU counties, is not valid for Biocides that will be on the market in Turkey.
- Registration of a Biocidal Product is not defined according to the Biocidal Product’s Active Substance. Licence Process is available for all Biocidal Product Types.
REQUIREMENTS OF TURKISH BIOCIDAL PRODUCTS REGULATION
Companies, which will market Biocidal Products in Turkey, should licence the Biocidal Products before marketing. Solely Licenced Biocides are allowed to be on Turkish market legally.
The companies carried out the relevant applications of Biocidal Products for being on Turkish market legally, in 2 ways defined as Inventory Notification and Licence Process before 01 January 2018.
The BPR requirements could be summarized such as for some BP types should have been licenced and some BP types should have submitted to the Inventory notification and approved by the Ministry. However, the submission of Inventory Notification expired on 31 December 2017.
As of 01/01/2018 all Biocidal Products, which are proposed to be on the market in Turkey, should have licence before marketing. There are two main Active Substance Lists in Turkey; List A and List 1. List A includes the active substances of which “Approval Status” are “Under review” and List 1 includes the active substances of which “Approval Status” are “Approved” within the scope of EU BPR. Submission of the Licence application doesn’t depend on the active substance being List A or List 1.
BIOCIDAL PRODUCT LICENCE PROCESS IN TURKEY
All the applications are submitted to the Ministry of Health through the online system. The MoH’s online system is called with the Turkish abbreviation as BUT. The companies, which will go Licence Process, should have a company account on the BUT system to be able to submit the relevant files. The companies, that are not located in Turkey, should appointing an Only Representative for Biocidal Products Applications. We can summarize the Licence Process with 5 main steps.
- First Step: Provisional Application: The Licensing Process starts with the Provisional Application. The approval of the Provisional Application means that the Ministry permit the manufacturer to send the product’s samples to Turkey for being analysed.
- Second Step: Looking for an accredited laboratory by the Ministry of Health: All the requested analyses should be performed in an accredited Laboratory in Turkey after approval of the Provisional Application. This purpose, accredited laboratories should be checked for the capacity of performing both analyses methods and efficacy tests.
- Third Step: Sending the Samples to Turkey: The samples should be sealed by the officers at the customs. Only sealed samples are accepted to analyses by the laboratory.
- Fourth Step: Analysing: The routine analyses which are requested by the Ministry are chemical analysis, physical test, short term& long-term and open package stability, efficacy tests. The relevant analyses are launched by the laboratory.
- Fifth Step: Preparation of Biocidal Product’s License File: After completion of the relevant analyses it is started to compilation of the Licence File. After approval of the Licence File by the MoH, the Biocidal Product has its Licence.
AS OF 01 JANUARY 2018, WHAT SHOULD BE DONE FOR BIOCIDAL PRODUCTS IN TURKEY
BIOCIDAL PRODUCTS THAT WILL BE MARKET IN TURKEY FOR THE FIRST TIME:
These Biocides should be licenced before marketing in Turkey.
BIOCIDAL PRODUCTS THAT ARE MARKETED IN TURKEY WITH APPROVAL OF THE INVENTORY NOTIFICATION
The Biocides which are on Turkish market with the approval of the Inventory Notification are Biocidal Product Types 7, 8, 9, 10, 11, 12, 21, 22 or 23. Also these Biocides may be the Products which are Inventory Notifications still under the assessment by the competent authorities at the MoH. But, do not forget that the submission of the inventory notification should have been carried out before 01/01/2018. There are some transition periods for these types of Biocidal Products to be on Turkish market. These Biocidal Products can continue to be on the market in Turkey till 01/01/2020 on condition that carrying out the Provisional Application before 01/01/2019. As it is stated above, Provisional Application is the first step of Licence Process for a Biocidal Product that is on Turkish market.
CHEMLEG SERVICES WITHIN THE SCOPE OF TURKISH BPR
- Acting as Only Representative under Turkish BPR (for non-Turkish companies),
- Compilation of the Provisional Application File,
- 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,
- Conducting the sealing process of the samples
- Analysis follow-up,
- Making correct interventions when necessary during the analysis period,
- Compilation of the Licence File
- Uploading the Provisional Application File & Biocidal Product Licence File to the Biocidal Product Following System (BUTs)
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