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1

What Is a Biocidal Product License?

27-08-2025
A biocidal product license is an official authorization that certifies a product’s effectiveness and safety in controlling harmful organisms. In Türkiye, this license is granted accordin
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2

How to Obtain a Biocidal Product License in Türkiye?

27-08-2025
Obtaining a biocidal product license involves a structured process and preparation of specific documentation. In Türkiye, this procedure is overseen by the Ministry of Health, and the responsi
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3

What is Biocide-Treated Article?

26-08-2025
Biocide-Treated Articles are defined as articles that have been treated with one or more biocide active substances or that intentionally contain these active substances. Such artic
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4

BIOCIDAL PRODUCTS IN OUR LIVES

26-08-2025
A biocidal product is any chemical or biological substance containing active ingredients designed to destroy, repel, render harmless, or control harmful organisms such as bacteria,
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5

BIOCIDAL PRODUCT LICENSING IN TURKIYE

26-08-2025
In Turkey, biocidal products must be licensed by the Ministry of Health before they can be placed on the market. This process ensures that the product is both safe and effective. A
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6

WHAT IS a BIOCIDAL PRODUCT?

26-08-2025
What Is a Biocidal Product? According to the regulation, a biocidal product is defined as any substance or mixture containing one or more active ingredients
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7

Who is Required to Comply with the KKDİK Regulation?

14-08-2025
► Turkish manufacturers, manufacturer of an article and importers of substances ► Non-Turkish companies exporting chemicals to Turke
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8

KKDİK Regulation & EU REACH Regulation

14-08-2025

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9

Key Elements of KKDİK

14-08-2025

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10

IMPORTANT - KKDİK NEWS UPDATE- PRINCIPLES AND PROVISIONS ARE PUBLISHED!

13-08-2025
We wish to inform you that after a long period of silence since Jan 2024 Ministry of Environment, Urbanization and Climate Change of Republic of Turkiye who is the enforcing Competent Authority for
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11

WHAT SHOULD THE TESTING STRATEGY BE WHEN PREPARING A KKDIK REGISTRATION DOSSIER?

07-08-2025
KKDIK Regulation - Turkish REACH Regulation (Registration, Evaluation, Authorization of Chemicals) requires that the test strategy applied in preparing the registration dossier be
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12

KKDIK EXEMPTION: NATURALLY OCCURRING AND CHEMICALLY UNMODIFIED SUBSTANCES

07-08-2025
Under the KKDIK Regulation (Turkish REACH Regulation), certain substances may be exempt from the registration requirement. One such exemption applies to substances that occur natur
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13

What is the KKDİK Regulation Annex 14: List Of Substances Subject To Authorization?

07-08-2025
The KKDIK Regulation (Registration, Evaluation, Authorization, and Restriction of Chemicals), which aims to manage chemicals in Turkey without harming human health and the environm
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14

Should KKDIK Registration be done for Biocidal Products?

07-08-2025
Active substances manufactured or imported for use in biocidal products are considered to be registered under the Biocidal Products Regulation if the following conditions are met. 
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15

Should KKDIK Registration be done for Cosmetic Products?

07-08-2025
Companies operating in the cosmetics industry must comply with numerous regulations, not only in terms of product safety and consumer health, but also in terms of legal obligations. One of the most
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16

HOW TO LABEL DETERGENT PRODUCTS?

21-07-2025
Detergent products are chemical products that are widely used in high quantities by both professionals and end consumers. Since these products can have negative effects on human health and the envi
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17

TO BE ABLE TO READ AND UNDERSTAND THE SAFETY DATA SHEET

21-07-2025
Safety Data Sheets (SDS) are the most important of the basic tools of chemical management. First of all, it is a very serious requirement that SDSs are prepared correctly and in co
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18

SAFETY DATA SHEET - WHY IS SDS IMPORTANT?

21-07-2025
Safety in workplaces where chemicals are used, stored or transported is very important for both employees and the workplace environment and is a legal obligation. One of the most effective ways to
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19

BENEFITS OF THE KKDİK (TURK REACH) PROCESS FOR TURKEY

19-06-2025
The foundations of the KKDİK process were laid in 2007 with the European Union's REACH Regulation. REACH is considered one of the world’s most comprehensive chemical regu
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20

ARE STRICTLY CONTROLLED CONDITIONS TRULY ENSURED? HOW CAN THEY BE VERIFIED?

19-06-2025
The KKDİK (Turkish REACH) Regulation not only requires the implementation of “Strictly Controlled Conditions” during the registration of intermediates
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21

Nazım ERDOĞAN / Environmental Engineer - Chemical Regulatory Specialist

19-06-2025
Born in Istanbul in 1988, Nazım ERDOĞAN completed his high school education at Ertuğrul Gazi High School and graduated from Dokuz Eylül University - Environmental Engineering Department in 201
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22

WHAT ARE THE STRICTLY CONTROLLED CONDITIONS THROUGHOUT THE LIFE CYCLE OF A SUBSTANCE?

13-06-2025
The KKDİK Regulation and the "Intermediates Guide" define strictly controlled conditions as “a set of technical measures supported by operating pro
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23

WHAT ARE STRICTLY CONTROLLED CONDITIONS UNDER KKDİK REGULATION AND WHAT DO THEY REQUIRE?

13-06-2025
According to Articles 17 and 18 of the KKDİK Regulation (Turkish REACH), the registration of substances as on-site isolated intermediates or transported isolated intermediates requ
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24

ENGLISH VERSION OF THE KKDİK REGULATION NO. 30105

13-06-2025
The KKDİK Regulation No. 30105, which was enacted regarding the Registration, Evaluation, Authorization, and Restriction of Chemicals in Turkey, serves as a significant refe
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25

STEPS TO ACCESS THE CHEMICAL REGISTRATION SYSTEM (KKS)

13-06-2025
Integrated Environmental Information System (EÇBS) is an application integrated with e-government and affiliated to the Ministry of Environment, Urbanization and Clim
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26

WHAT IS OBLIGATIONS OF TOLL MANUFACTURERS UNDER THE KKDIK REGULATION?

13-06-2025
The KKDIK (Registration, Evaluation, Authorization, and Restriction of Chemicals) Regulation, which was implemented in Turkey for the safe use and control of chemicals, imposes reg
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27

KKDIK REGISTRATION OBLIGATION FOR POLYMERS AND THE STATUS OF MONOMERS

13-06-2025
The KKDİK (Registration, Evaluation, Authorization, and Restriction of Chemicals) Regulation has introduced comprehensive regulations to ensure the safe use of chemicals. However, there is a specia
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28

WHAT IS THE STATUS OF SUBSTANCES STORED IN FREE ZONES UNDER THE SCOPE OF KKDİK?

13-06-2025
The KKDİK (Registration, Evaluation, Authorization, and Restriction of Chemicals) Regulation, which sets out the regulations regarding the production, import, and use of chemicals in Turkey, exclud
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29

CHEMICAL SAFETY ASSESSMENT (CSA)

30-05-2025
The purpose of the KKDİK Regulation is to protect humans, other living beings and the environment from chemicals, to encourage alternative methods for assessing the hazards of subs
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30

CHEMICAL SAFETY REPORT (CSR)

30-05-2025
The Chemical Safety Report (CSR) is a document that compiles and presents the information required for the safe use of a chemical substance. In other words, the CSR is a report tha
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31

CAN THERE BE MULTIPLE REGISTRANT ROLES IN KKDIK REGISTRATION?

29-05-2025
Example Scenario: Under the KKDİK Regulation, should a company that holds both the importer and Only Representative (OR) roles for the same substance in the same supply chain submit two sep
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32

MONOMER REGISTRATION AND SPECTRAL DATA FOR SUBSTANCES USED IN POLYMER MANUFACTURING UNDER KKDİK

29-05-2025
Under the KKDİK Regulation, the registration of polymers and monomers requires particular attention to the following aspects: ► Spectral Data and Chromatogra
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33

KKDIK REGISTRATION FOR CHEMICALS PRODUCED DOMESTICALLY AND EXPORTED ABROAD

29-05-2025
According to Article 7 of the KKDIK Regulation, there is a registration obligation for substances produced in quantities of 1 ton or more
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34

INTERMEDIATE SUBSTANCE REGISTRATION UNDER THE KKDIK REGULATION

29-05-2025
Intermediate substances are chemical substances that are typically used in the production of final products, processed, or combined with other substances, but are not presented as standalone produc
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35

WHAT IS A POISON CENTRE NOTIFICATION (PCN) AND WHY IS IT IMPORTANT FOR COMPANIES TO COMPLY?

28-05-2025
Poison Centre Notifications (PCN) are prepared to reduce the health risks of people exposed to certain harmful chemicals and to ensure that they receive the right emergency health
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36

Is there an English version of the KKDIK Regulation No. 30105?

23-05-2025
Yes, there is an English version of the KKDIK Regulation. You can download the KKDIK Regulation and its annexes below.
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37

Should Polymers be Registered under KKDIK?

23-05-2025
Polymers are exempt from KKDİK registration, but their monomers are subject to KKDİK registration if they meet the following conditions. Any manufacturer or importer of a
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38

Are the Materials I Store in The Free Zone Exempt From KKDIK Registration?

23-05-2025
The KKDİK Regulation shall not apply to the substances and mixtures below: Substances, on their own, in a mixture or in an article, which are subject to customs supervision, provided
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39

ESSENTIAL ELEMENTS ON THE LABEL OF DETERGENT PRODUCTS

16-05-2025
As a basic rule, product labels must comply with the current legislation of the country in which the product is marketed. Therefore, the labels are expected to be up-to-date and accurate in terms o
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40

COMPLIANCE WITH REGULATION AND INSPECTIONS ON DETERGENT PRODUCTS

16-05-2025
The preparation of a label that complies with the legislation on detergent products is of great importance for both consumer safety and the marketability of the product. Labels provide critical inf
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41

WHY IS EXPOSURE SCENARIO IMPORTANT?

16-05-2025
Exposure Scenarios (ESS) are critical to ensuring the safe use of chemical substances. Here are a few points that highlight the importance of exposure scenarios:
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42

DO NOT DELAY IN MAKING YOUR PCN-POISON CENTER NOTIFICATIONS!

16-05-2025
Why is PCN-Poison Center Notification so important? Various chemical products offered to the EU market, even if handled properly, can pose undesirable health risk
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43

KKDİK REGISTRATION RESPONSIBILITY FOR SUBSTANCES PURCHASED FROM THE TURKISH DOMESTIC MARKET

14-05-2025
The Registration, Evaluation, Authorization, and Restriction of Chemicals (KKDİK) Regulation was enacted in Turkey to control the impact of chemical substances on human health and
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44

PREPARATION OF THE REGISTRATION DOSSIER IN THE KKDIK REGISTRATION PROCESS

14-05-2025
Under the KKDİK Regulation (Registration, Evaluation, Authorization, and Restriction of Chemicals), individuals and companies who are required to register chemical substances are a
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45

WHAT IS THE KKDIK ONLY REPRESENTATIVE and WHO CAN APPOINT AN ONLY REPRESENTATIVE?

07-01-2025

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46

REACH COMPLIANT SDS (SAFETY DATA SHEET)

07-01-2025
Regulation (EC) No 1907/2006 (REACH) is a legal EU regulation that provides information on the determination, indication, precautions against the hazards of chemicals and the creat
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47

KKDIK Regulation Only Representative Service

06-01-2025
Only Representative refers to an established or legal entity resident in Turkey who is appointed by a manufacturer, formulator or article producer resident outside of Turkey to ful
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48

KKDIK Regulation Only Representative Service

06-01-2025
Only Representative refers to an established or legal entity resident in Turkey who is appointed by a manufacturer, formulator or article producer resident outside of Turkey to ful
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49

What does the Only Representative Mean?

06-01-2025
Only Representative is a real or legal person resident in Turkey appointed by a real or legal person who manufactures a substance, prepares a mixture or produces an article
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50

What is the Difference Between a Only Representative and a Third Party Representative?

06-01-2025
Only Representative is a real or legal person resident in Turkey appointed by a real or legal entity who manufactures a substance, prepares a mixture or produces an article ou
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51

What are the Obligations of the Only Representative?

06-01-2025
The real or legal entity resident outside Turkey that manufactures the substance, formulates the mixture or produces the article must appoint a sole representative to carry out the necessary regist
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52

2025 BIOCIDAL PRICE TARIFF AND ANALYSIS INFORMATION GUIDE IS PUBLISHED!

06-01-2025
A guide to current price tariffs including all fees requested by the Ministry dur
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53

KKDIK OFFICIAL FEES FOR 2025 ARE PUBLISHED!

03-01-2025
The updated KKDIK official fee list for 2025, prepared by the Autho
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54

THE UPDATE OF THE CLP REGULATION PUBLISHED!

03-12-2024
The update to the Chemical Classification, Labelling and Packaging (CLP) Regulation was published on 20 November 2024 under Regulation (EU) 2024/2865. The update i
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55

How Should Biocidal Product Active Substance Dossiers be Submitted?

14-08-2024
The Ministry of Health does not accept copies of dossiers pertaining to the active substance within the biocidal product license dossier. Documents pertaining to the biocidal active substance (CoA,
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56

Confidentiality Principles in the Biocidal Product Authorization Dossier

14-08-2024
The Annex II-A active substance data set contains comprehensive information and data on the active substance. Most of this information is classified as confidential. Your active substance supplier
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57

How Should Dossiers be Prepared for a Biocide Product License Application?

14-08-2024
Dossiers for Biocidal Product License Applications must be prepared in accordance with the Checklist and submitted to the Ministry. All dossiers must be prepared with wet signatures. Since the Dire
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58

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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59

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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60

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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61

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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62

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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63

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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64

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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65

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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66

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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67

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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68

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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69

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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70

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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71

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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72

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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73

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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74

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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75

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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76

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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77

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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78

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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79

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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80

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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81

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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82

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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83

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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84

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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85

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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86

Is My Product a Processed Article or a Biocidal Product?

15-03-2024
This should be assessed on a product-by-product basis. The product's claims, composition, and intended use are important factors. To ensure a correct assessment, you can contact our biocidal te
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87

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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88

How Long does the Biocide Product Licensing Process Take?

15-03-2024
No clear and definite timeframe can be given for this. The duration of the licensing process for a biocide product varies depending on many parameters. These include:
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89

What Services Does CRAD Provide Under the Biocidal Products Regulation?

15-03-2024
CRAD has been carrying out product licensing procedures since 2010. With an experienced and knowledgeable team, it provides support and services to companies seeking to obtain licenses. &nbs
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90

Which Products Are Considered Biocidal Products?

15-03-2024
If you are placing your product on the domestic market with a claim that it is a biocidal product, or intend to do so, and it contains at least one or more active substances (excluding biocidal pro
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91

How is Biocidal Product Licensing Done?

15-03-2024
For the biocidal product licensing process to be completed, the steps outlined in the Biocidal Products Regulation must be followed in full, the license application must be submitted to the ministr
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92

What is a Biocidal Product?

15-03-2024
Biocidal products are defined in the Biocidal Products Regulation as ready-to-use mixtures containing one or more active substances that exert a controlling effect on any harmful organism from a ch
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93

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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94

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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95

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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96

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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97

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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98

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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99

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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100

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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