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1

Is it Acceptable to Submit Copies of Documents Related to the Active Substance?

14-08-2024

Unfortunately, the Authority does not consider copies of documents acceptable. Documents related to the active substance (CoA, report, certificate, etc.) must be obtained from the supplier with a w
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2

Our Active Substance Supplier does not want to share the Annex II-A File Requirements due to Confidentiality Reasons, what should we do?

14-08-2024

The Annex II-A active substance data set contains comprehensive information and data about the active substance. The majority of this information is classified as confidential information.
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3

How should the Documents be Prepared According to the Biocidal Product License Application Checklist?

14-08-2024

The file must be prepared in accordance with the Checklist and submitted to the Authority. All documents must be prepared with wet signatures. Since the Environmental Health Department does not hav
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4

INFORMATION ON THE LEAD REGISTRATION DOSSIER WITHIN THE SCOPE OF KKDIK REGULATION

07-08-2024

What is Lead Registration Dossier?  "Lead Registration Dossier" refers to the dossier including the information of the people who undertake respo
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5

CHEMICAL SAFETY ASSESSMENT AND CHEMICAL SAFETY REPORT

22-07-2024

KKDIK is based on the principle that the industry should ensure the production, import, use or release of substances to the market without harming human health and the environment. C
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6

KKDIK EXPOSURE SCENARIO

22-07-2024

What is an Exposure Scenario? Exposure scenario (ES) can be defined as the measures determined to control and, if possible, minimise the negative effects on the environment
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7

INFORMATION ON THE REGISTRATION PROCESS WITHIN THE SCOPE OF THE KKDIK REGULATION

22-07-2024

What is KKDIK? KKDIK (Registration, Evaluation, Authorization and Restriction of Chemicals) Regulation was enforced by Republic of Türkiye, Ministry of Environment, Urb
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8

INFORMATION ON THE CO-REGISTRATION DOSSIER WITHIN THE SCOPE OF KKDIK REGULATION

22-07-2024

What is a Co-Registration Dossier? A co-registration dossier is a dossier prepared by a group of chemical substance manufacturers or importers in order to register the sa
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9

How Should the Registration Tonnage be Calculated within the Scope of KKDIK Regulation?

11-07-2024

The annual tonnage amount must be calculated for the registration dossier.  According to Article 4 (öö) of the KKDIK Regulation, annual quantity: It r
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10

Labelling of Chemicals and Safety Data Sheet (SDS-SDS-MSDS) Compliance Services

05-06-2024

Companies which are in compliance with country specific regulatory requirements are ahead of the game with regard to competition environment of international business. The most substantial hazard c
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11

REACH (1907/2006 EC) Regulation Compliance Services

05-06-2024

Manufacturers and distributors of different sizes are increasingly facing substantial challenges resulting from globalization and newest international regulatory issues. With regard to companies ha
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12

Use of EU Poison Center Notification (PCN) and UFI Code

04-06-2024

In accordance with Article 45 and Annex VIII of the Regulation (EC) No. 1272/2008 (CLP) and, chemical mixtures that are classified as hazardous to human health * and/or having physicochemical **&nb
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13

Global Regulation Compliance and Representation Services

04-06-2024

As CRAD, we provide many different services to companies exporting to the EU to meet legal requirements such as REACH Only Representative, pre-registration, registration, label, SDS, notification,
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14

Use of EU Poison Center Notification (PCN) and UFI Code

04-06-2024

In accordance with Article 45 and Annex VIII of the Regulation (EC) No. 1272/2008 (CLP) and, chemical mixtures that are classified as hazardous to human health *and/or having physicochemical **haza
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15

Who is Responsible for Notification of SDS to ECBS?

26-04-2024

The safety data sheet of substances or mixtures placed on the market the market, shall be uploaded to the specific IT tool in ECBS which is designed for the safety data sheet and provided on the we
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16

Who should get the UFI Code?

22-04-2024

Importers and/or downstream users of EU area are required to obtain a UFI Code for their hazardous mixtures.
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17

How to get UFI Code?

22-04-2024

A format for the Unique Formula Identifier has been defined and a software application has been developed that allows the creation of UFIs by ECHA's website. To generate a UFI
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18

What is UFI?

22-04-2024

UFI stands for "Unique Formula Identifier" and is a code that must be included on the labels of hazardous mixtures. The Unique Formula Identifier (UFI)
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19

Is it Prohibited to use SVHC Substances?

22-04-2024

Suppliers operating in European Union countries are obliged to provide this SVHC information at all stages of the supply chain if their products contain more than 0.1% (w/w) SVHC substances (high r
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20

What is an SVHC Substance?

22-04-2024

SVHC stands for "Substance of Very High Concern" in English and means high risk substances. According to the REACH regulation, SVHC substances, which can be found in vari
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21

What are PFAs?

22-04-2024

Containing more than 4,700 chemicals, perfluorinated and polyfluorinated alkyl substances (PFAS) are a group of commonly used man-made chemicals that accumulate in the human body and the environmen
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22

Who does the PCN Notifications?

22-04-2024

PCN notifications must be submitted by importers and downstream users placing mixtures classified for human health or physical hazards on the market. Notifications can also be made by a third-party
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23

How to Prepare a PCN Notification (Poison Centre Notification) File?

22-04-2024

A PCN notification (Poison Centre Notification) file can be prepared in 3 ways. Online via ECHA Submission portal Via IUCLID with system-to-system serv
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24

What is a Poison Centre Notification (PCN)?

22-04-2024

According to Article 45 of the CLP Regulation, companies placing dangerous mixtures on the market are obliged to provide information on certain dangerous mixtures to the relevant national authoriti
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25

What are the Implementation dates for the UFI Code?

22-04-2024

The obligation to write a UFI code on the label has been implemented for all product types. For mixtures for consumer use : from 1 January 2021 For mixtures for profess
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26

How to Prepare a PCN File?

22-04-2024

Notification dossiers are available through the ECHA submission portal for many countries. However, for some member states, notification files are sent to the institution they determine.
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27

What will be required for UFI Code and PC Notification (Poison Center Notification)?

22-04-2024

EU resident tax number of the company that will receive the UFI code An internal formulation number Information to which EU countries the product will be delivered
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28

What is a PCN-Poison Centre Notification File?

22-04-2024

With the UFI code on the label, the product composition and hazards will be identified to the relevant poison centre, which will ensure faster emergency response.
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29

Where is the UFI Code Used?

22-04-2024

The first step when creating a UFI code is determine whether it is subject to this obligation. The obligation to obtain a UFI code within the scope of Article 45 of the CLP regula
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30

What is the UFI Code?

22-04-2024

The 16-character code, called the Unique Formula Identifier (UFI code), is a mandatory label element and importers and downstream users will be required to file with specific produ
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31

Is Active Substance Registration done in Turkey?

15-03-2024

No, active substance registration is not made within the scope of TR-BPR. Instead, the Annex II-A active substance file, which is the TR-BPR annex, is submitted to the Authority. This file contains
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32

Treated Articles or Biocidal Products?

15-03-2024

In this regard, an evaluation should be made on a product basis. The product's claims, content and intended use are important. In order for a correct evaluation to be made, you can contact our
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33

In which Laboratory are Biocidal Product Analyzes Performed?

15-03-2024

With the Regulation on Amendments to the Biocidal Products Regulation published in the Official Gazette dated 30/12/2021 and numbered 31705, the definition of authorized laboratory is only valid fo
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34

How long does the Biocidal Product Licensing Process take?

15-03-2024

There is no clear time for this. The data provided by manufacturers/applicants and the scope of this data better determine the process. In addition, since the process progresses in line with the de
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35

What are our services within the scope of the Biocidal Products Regulation?

15-03-2024

•    Regulatory compliance support and consultancy •    Acting as representative/registrant •    Label compliance in accord
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36

What should be done for products falling within the scope of the Biocidal Product Regulation?

15-03-2024

If you offer or want to offer your product to the domestic market with a claim stating that it is a biocidal product, a license application must be made within the scope of TR-BPR. O
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37

What Regulations are Followed in the Biocidal Product Registration Process?

15-03-2024

Biocidal Products Regulation (Official Gazette No. 27449 and Dated 31 December 2009) Regulation on Classification, Labelling and Packaging of the Substances and Mixtures (dated 1
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38

What is Biocidal Product?

15-03-2024

These are active substances and preparations that contain one or more active substances, are offered for sale in ready-to-use form and have a controlling effect on any harmful organism chemically o
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39

Neslihan HORUZ / Accounting

20-02-2024

Neslihan Horuz was born in 1995. After having her education at Dilek Sabancı Anatolian Vocational High School in the Department of Accounting, she graduated from Balıkesir University Faculty of Eco
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40

Zeynep AKBOSTANCI / Bioengineer

20-02-2024

Zeynep AKBOSTANCI  was born in Kocaeli in 2000. After having her education at Kocaeli Anatolian High School, she graduated from Department of Bioengineering Yıldız Technical University in 2023
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41

2024 BIOCIDAL PRICE TARIFF AND ANALYSIS INFORMATION GUIDE IS PUBLISHED!

01-02-2024

A guide to current price tariffs including all fees requested by the Ministry dur
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42

KKDIK OFFICIAL FEES FOR 2024 ARE PUBLISHED!

03-01-2024

Please find the details regarding the official fees for KKDİK registration dossier
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43

REVISION OF KKDIK REGULATION REGARDING THE EXTENSION OF REGISTRATION DEADLINES PUBLISHED ON OFFICIAL GAZETTE!

25-12-2023

The long-waited Revision of KKDİK Regulation Regarding the Extension of Registration Deadlines published on Official Gazette on the date 23 December 2023 and No: 32408.
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44

DRAFT ADDENDUM FOR KKDIK IS OPEN FOR CONSULTATION!

14-11-2023

On 13th November 2023 Ministry of Environment, Urbanization and Climate Change ( MoEUCC) had circulated a draft amendment to the KKDİK Regulation for consultation and to obtain proposals & opin
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45

NEW DRAFT ADDENDUM TO KKDIK AS DECLARED AT AN AUTHORITY MEETING HELD WITH INDUSTRY STAKE HOLDER ASSOCIATIONS!

23-10-2023

We wish to inform you that; On October 19, 2023, a meeting with the title of "KKDIK Evaluation Meeting" was held at the Ministry of Environment and Urbanization chaired b
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46

REASONS AND COMMENTS REGARDING THE NEED FOR DEADLINE EXTENSION FOR KKDIK REGISTRATIONS

17-10-2023

Author: Melih Babayigit / CAE- Principal Regulatory Consultant                           The lack of
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47

DECISION ON NON-APPROVAL OF ACTIVE SUBSTANCES HAS BEEN PUBLISHED!

11-09-2023

It has been decided that the relevant substances will not be approved for use as biocidal product active ingredients in the specified product types based on COMMISSION IMPLEMENTING DECISION (EU) 20
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48

ATTENTION BIOCIDAL PRODUCT MANUFACTURERS AND IMPORTERS!

04-08-2023

In the first paragraph of Article 11 of the Biocidal Products Regulation, “…. The Ministry may request the content of the file in a physical and/or electronic carrier environment.&rdqu
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49

Melek Şebnem TEMEL / Environmental Engineer (M.Sc)

04-08-2023

Melek Şebnem TEMEL was born in 1991 in Kadıköy, Istanbul. After completing her high school education at E.C.A. Elginkan Anatolian High School, she graduated from Yıldız Technical University, E
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50

Öykü KARAMANLIOĞLU / Chemical Engineer

03-08-2023

Öykü KARAMANLIOĞLU, born in 1995 in Aydın/Nazilli, graduated from Yeditepe University Chemical Engineering Department in 2021 after completing her high school education at Nazilli Mehmet
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51

UPDATE OF REGULATION ON EU CLP IS PUBLISHED!

12-07-2023

Regulation (EU) 2023/1434 has been published in the EU Official Gazette. In accordance with this regulation; New NOTES have been added to section 1.1.3 of Annex VI with the aim of adapting to techn
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52

NEW DATA SHARING PROVISIONS FOR KKDIK

13-06-2023

Ministry of Environment, Urbanization and Climate Change (MoEUCC) had published a set of provisions and rules to be followed for the Joint Submission & Data sharing principles under the scope o
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53

KKDIK DEADLINE APPROACHING- NEW PROVISIONS HAVE BEEN ANNOUNCED!

07-02-2023

KKDİK Deadline approaching- new provisions have been announced by the Competent Authority to support the stakeholders achieve timely submission:  As the time is moving fast to t
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54

2023 PRICE TARIFF AND ANALYSIS INFORMATION GUIDE IS PUBLISHED!

02-02-2023

A guide to current price tariffs including all fees requested by the Ministry during the licensing process of biocidal products has been published. Please you can access the guide vi
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55

Buse KAYA / Translator

30-01-2023

Born in Izmir in 1998, Buse Kaya graduated from Yeditepe University Translation Studies Department in 2022, after completing her high school education at the private Sezin High School. After comple
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56

Gülseren SARİKAYA / Chemical Engineer - Chemical Regulatory Specialist / Chemical Assessment Expert

30-01-2023

Gülseren SARIKAYA was born in Istanbul-Kadıköy in 1994, she completed her high school education at Istanbul Anatolian High School. Then, she graduated from Ankara University, Department o
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57

KKDIK OFFICIAL FEES FOR 2023 ARE PUBLISHED!

02-01-2023

Please find the details regarding the official fees for KKDİK registration dossier
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58

ELİF MATYAŞ DURAN / Chemist - Chemical Regulatory Specialist / Chemical Assessment Expert

26-11-2022

 Elif MATYAŞ DURAN born 1991 in Istanbul, started her high school education at Orhan Cemal Fersoy High School, and in graduated from Gazi University, Faculty of Science, Department of Chemistr
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59

11 October 2022 LR & OR Event by MoEUCC Regarding Data Sharing and Progress of KKDIK

13-10-2022

An event organised by Turkey’s Ministry
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60

Esra BAL / Biologist - Chemical Regulatory Specialist / Chemical Assessment Expert

20-07-2022

Esra BAL, was born in Singapore in1996, graduated from Marmara University Department of Biology in 2019. She completed her internship in Istanbul University Capa Medical Faculty Clinical Bioch
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61

Selenay AVCI/ Chemical Engineer - Chemical Regulatory Specialist / Chemical Assessment Expert

18-07-2022

Selenay AVCI was born in İstanbul in 1994. After having her education at Antalya Anatolian High School, she graduated from Department of Chemical Engineering at Izmir Institute of Technology in 201
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62

Sude ORUÇ / Chemical Engineer -Chemical Regulatory Specialist / Chemical Assessment Expert

18-07-2022

Sude ORUÇ was born in İstanbul in 1999. After having her education at İstanbul Kadıköy High School, she graduated from Chemical Engineer Department at the Ondokuz Mayıs University in 20
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63

OFFICIAL LETTER ON LICENSING BUSINESS AND TRANSACTIONS AND USE OF AUXILIARY ACTIVE SUBSTANCES HAS BEEN PUBLISHED!

22-03-2022

The Environmental Health Department has issued the Official Letter dated 10/03/2022 and numbered E-19020089-819-1014, in which it specifies the details of the Biocidal Product licensing work and pr
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64

2022 PRICE TARIFF AND ANALYSIS INFORMATION GUIDE IS PUBLISHED!

07-03-2022

A guide to current price tariffs including all fees requested by the Ministry during the licensing process of biocidal products has been published.
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65

IN-SITU GENERATION SYSTEMS INSTRUCTION HAS BEEN PUBLISHED!

02-02-2022

The Turkish Competent Authority has prepared and published the “In
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66

THE REGULATION ON THE AMENDMENT OF THE BIOCIDAL PRODUCTS REGULATION HAS BEEN COME INTO FORCED!

30-12-2021

The Ministry of Health of the Turkish Republic has published the r
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67

USAGE OF UTS BIOCIDAL MODULE AND EXTENSION OF LICENSE VALIDITY FOR BIOCIDAL PRODUCTS IN DIRECT CONTACT WITH THE HUMAN BODY (PRODUCT TYPE-1 AND PRODUCT TYPE-19)

01-12-2021

With the announcement published by Turkish Medicines and Medical Devices Agency (TİTCK), It has been stated that as of 09.12.2021, registration applications for product type-1 and product type-19 b
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68

ACTIVE SUBSTANCE REGISTRATION SCIENTIFIC COMMITTEE FIRST MEETING HELD

01-12-2021

The Scientific Committee on Active Substance Registration, appointed by the General Directorate of Public Health (HSGM) with the official letter dated 24.11.2021 and numbered E-19020089-020-4826, h
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69

ABOUT CESSATION OF USE OF CERTAIN ACTIVE SUBSTANCES

19-10-2021

The European Commission Implementation Decree dated 02/08/2021 and numbered 2021/1283/EU, published in the Official Journal of the European Union dated 03/08/2021 and numbered L279, entered into fo
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70

THE INSTRUCTIONS ON BIOCIDAL PRODUCT ANALYSIS AND AUTHORIZED LABORATORIES HAVE BEEN UPDATED!

24-09-2021

The Instructions on Biocidal Product Analysis and Authorized Laboratories which were published by the General Directorate of Public Health dated 16/08/2021 and numbered E-19020089-020-3305 have bee
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71

THE INSTRUCTIONS ON BIOCIDAL PRODUCT ANALYSIS AND AUTHORIZED LABORATORIES HAVE BEEN UPDATED!

17-08-2021

The Instructions on Biocidal Product Analysis and Authorized Laboratories which were published by the General Directorate of Public Health dated 29/01/2021 and numbered E-19020089-105.99-99-4 have
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72

THE DRAFT REGULATION ON THE AMENDMENT OF THE BIOCIDAL PRODUCTS REGULATION HAS BEEN ANNOUNCED!

17-08-2021

The Ministry of Health of the Turkish Republic has announced the draft regulation on the Amending of the Biocidal Products Regulation aiming to bring the current Biocidal Products Regulation and it
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73

THE USE OF ESBIOTHRIN AS AN ACTIVE SUBSTANCE IN BIOCIDAL PRODUCTS HAS BEEN SUSPENDED.

16-08-2021

The Commission Implementing Decision (EU) 2021/98 published in the Official Journal of the European Union dated 29/01/2021 and numbered L31, not approving esbiothrin as an existing active substance
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74

2022 KKDIK REGISTRATION OFFICIAL FEES ARE PUBLISHED!

04-01-2022

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75

BIOCIDAL PRODUCT LICENSE VALIDITY PERIODS HAVE BEEN UPDATED!

02-06-2021

As known, the license validity periods of all biocidal product licenses issued following the provisions of the Biocidal Product Regulation dated 31 December 2009 and 27449 (4th bis.) will expire on
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76

LABORATORY INSTRUCTION ON PT-1 AND PT-19 BIOCIDAL PRODUCT ANALYSES HAS BEEN PUBLISHED!

10-03-2021

Product Type-1 and Product Type-19 biocidal products whose duties and responsibilities were transferred to the Turkish Medicines and Medical Devices Agency (TİTCK) has published the laboratory inst
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77

Neslişah ŞAR - Chemical Regulatory Specialist

10-03-2021

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78

BRIEF UPDATE ON KKDIK REGISTRATION PROCESS AND ASSIGNMENT OF LEAD REGISTRANT (LR)

04-02-2021

Recently MoEU had published an announcement giving some details and guidance on the LR assignment with in the KKDİK SIEF Structures and conditions on individual submission. 
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79

THE INSTRUCTIONS ON BIOCIDAL PRODUCT ANALYSIS AND AUTHORISED LABORATORIES HAS BEEN UPDATED!

04-02-2021

Instructions on Biocidal Product Analysis and Authorised Laboratories wh
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80

TURKISH BIOCIDAL PRODUCT REGISTRATION OFFICIAL FEES UPDATED!

26-01-2021

Turkish Biocidal Product Registration official fees were updated in the Guide Bo
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81

VIRTUAL CONFERENCE ANNOUNCEMENT

05-01-2021

Melih Babayigit, General Manager at CRAD will be present
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82

NEW ERA OF KKDIK - REGISTRATION PHASE AND ACTIONS TO TAKE

05-01-2021

As you well know the KKDİK (In other words Turkish REACH) had entered a new era as of 1.1.2021. There had been a 3-year period for pre-registration of the substances placed on the market by way of
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83

TURKISH KKDIK OFFICIAL FEES FOR 2021 OFFICIALLY PUBLISHED

04-01-2021

As our clients & followers would recall we had circulated the news
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84

SEA REGULATION OF TURKISH REPUBLIC (TURKISH CLP) IS UPDATED

14-12-2020

The long waited Turkish SEA update is published on the date 10th Dece
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85

PRE-REGISTRATION (IN OTHER WORDS LATE PRE-REGISTRATION) FOR KKDIK WILL BE POSSIBLE AFTER 31.12.2020

05-10-2020

Our clients many times consulted us the possibility of a Late pre-registration under the scope of KKDİK after the initial deadline for pre-registration which is 31.12.2020.  We
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86

TURKISH KKDIK OFFICIAL FEES ANNOUNCED AS A DRAFT

05-10-2020

Some certain activities are subject to official fees under the scope of KKDİK. These can be listed as:
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87

Bilge Nur KAKŞİ / Chemical Engineer - Chemical Regulatory Specialist

12-09-2020

Bilge Nur KAKŞİ, born in 1996 in Istanbul, graduated from Kocaeli University Chemical Engineering Department in 2020 after completing her high school education at Halide Edip Adıvar Anatoli
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88

DETAILS REGARDING THE AMENDMENT TO TURKISH BPR

17-03-2020

Turkish Republic Ministry of Health has published Regulation Amendin
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89

REGULATION AMENDING THE TURKISH BIOCIDAL PRODUCTS REGULATION IS PUBLISHED!

17-03-2020

Turkish Republic Ministry of Health has published Regulation Amendin
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90

What Should Those Who Have Not Registered Within The Registration Period In The KKDIK Regulation Or Those Who Will Manufacture and/or Import or Place a New Substance On The Market After The Registration Period Do?

07-02-2020

Depending on the KKDIK registration tonnage; with the end of the registration period, as of 31/12/2026, 31/12/2028 and 31/12/2030, unregistered substances on their own or in mixtur
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91

DRAFT OF THE REGULATION AMENDING THE TURKISH BIOCIDAL PRODUCTS REGULATION IS PUBLISHED

30-12-2019

Ministry of Health of Turkish Republic published the Draft of the Regulatio
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92

CHANGE OF THE COMPETENT AUTHORITY FOR BIOCIDAL PRODUCTS IN DIRECT CONTACT WITH THE HUMAN BODY (PRODUCT TYPE-1 AND PRODUCT TYPE-19)

13-12-2019

For Biocidal Products which are in direct contact with the human body (eg.Product Type-1 and Product Type-19); the Competent Authority role under the scope of Turkish Biocidal Prod
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93

CONFIDENTIALITY OF CHEMICAL SUBSTANCE ON LABEL OR SAFETY DATA SHEET (USE OF ALTERNATIVE CHEMICAL NAME)

10-12-2019

Many companies do not prefer the disclose their formulation of products to secure their CBI. Because of this concern, they aim to hide some substances in their composition, on the label or on the S
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94

ADOPTION ON CYANIDE COMPOUNDS TO THE KKDİK REGULATION ANNEX 17 HAS BEEN PUBLISHED ON OFFICIAL GAZETTE

02-12-2019

On 29 November 2019, Regulation on the Amendment of the
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95

ACTA AND CRAD PRESENT COMPLIMENTARY WEBINAR "TURKEY REACH (KKDIK) ''

31-10-2019

Turkey’s Registration (Kaydı), Evaluation (Değerlendirilmesi), Autho
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96

RECAST OF THE REGULATION ON PREVENTING AND REDUCING THE EFFECTS OF MAJOR INDUSTRIAL ACCIDENTS IS PUBLISHED!

05-03-2019

The Regulation on Preventing and Reducing the Effects of Major Industrial Accidents No:30702 published on the date March 2, 2019 by the cooperation of Ministry of Family, Labour and Social Services
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97

What is the Ingredient Data Sheet for Detergents Regulation?

20-02-2019

Manufacturers placing on the market the preparations covered by Detergents Regulation shall, upon request, make available without delay and free of charge, to any medical personnel, an ingredient d
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98

How The Packages Should Be Labelled Which Is Not Exceeding 125 Ml?

20-02-2019

If the contents of the packaging do not exceed 125 ml, and the substance can be classified as one or more of some hazard categories, it may be subject to exceptions. In some cases, hazard statement
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99

Is the Certificate Expire Safety Data Sheets (SDS) should Be Updated?

20-02-2019

According to the 9th paragraph of the 27th article of the KKDİK Regulation No. 30105; Suppliers update their Turkish safety data sheets without losing time in the following cases regarding their su
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100

MINISTRY OF HEALTH HAS PUBLISHED THE INSTRUCTIONS ON BIOCIDAL PRODUCT ANALYSIS AND AUTHORISED LABORATORIES.

20-02-2019

Working Procedures and Principles of Biocidal Product Analysis Laboratories
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