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1
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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2
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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3
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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4
Key Elements of KKDİK
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5
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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6
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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7
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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8
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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9
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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10
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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11
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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12
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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13
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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14
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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15
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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16
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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17
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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18
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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19
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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20
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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21
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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22
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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23
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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24
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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25
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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26
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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27
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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28
WHAT IS THE KKDIK ONLY REPRESENTATIVE and WHO CAN APPOINT AN ONLY REPRESENTATIVE?
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29
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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30
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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31
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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32
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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33
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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34
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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35
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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36
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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37
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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38
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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39
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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40
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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41
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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42
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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43
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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44
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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45
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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46
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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47
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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48
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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49
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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50
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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51
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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52
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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53
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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54
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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55
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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56
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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57
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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58
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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59
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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60
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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61
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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62
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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63
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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64
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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65
Gülseren KARABULUT / 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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66
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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67
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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68
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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69
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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70
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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71
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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72
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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73
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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74
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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75
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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76
2022 KKDIK REGISTRATION OFFICIAL FEES ARE PUBLISHED!
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77
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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78
Neslişah ŞAR - Chemical Regulatory Specialist
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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 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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81
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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82
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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83
DETAILS REGARDING THE AMENDMENT TO TURKISH BPR
17-03-2020
Turkish Republic Ministry of Health has published Regulation Amendin
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84
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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85
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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86
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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87
ACTA AND CRAD PRESENT COMPLIMENTARY WEBINAR "TURKEY REACH (KKDIK) ''
31-10-2019
Turkey’s Registration (Kaydı), Evaluation (Değerlendirilmesi), Autho
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88
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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89
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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90
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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91
What are our Compliance Services for the Regulation on Non-Medical Veterinary Health Product?
29-01-2019
• Regulatory compliance support and consultancy
• Preparation of notification file in accordance with the regulation for Non-Medical Veterinary
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92
What is the criteria for a Non-Medical Veterinary Health Product to be Placed on the Turkish Market?
29-01-2019
A notification to the Ministry of Agriculture and Forestry needs to be made with a Technical Dossier that prepared in accordance with the Non-Medical Veterinary Health Product Regulation. When the
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93
SAFETY DATA SHEET COMPATIBLE WITH KKDIK
03-01-2019
Turkcoat Magazine - December - January 20
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94
TURKISH REGULATION ON PERSISTENT ORGANIC POLLUTANTS PUBLISHED
15-11-2018
It had been a while since the draft of the Persistent Organic Pollutants was circulated to the stake holders by the Ministry of Environment and Urbanization. On the date 14 November 2018 the regula
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95
Are Registrations Made for the EU Valid for KKDIK?
08-11-2018
KKDIK is valid for substances manufactured in Turkey or imported into the Turkish customs territory. The REACH regulation applied in the EU is valid for substances manufactured in EU countries or i
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96
What is Extended SDS (e-SDS, eSDS)?
08-11-2018
Extended SDS or e-SDS are Safety Data Sheets that include "Exposure Scenarios" for the usage areas of the harmful substance you have put on the market.
Exposure Scenario
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97
What is KKDIK Compliant Turkish SDS?
08-11-2018
Turkish Safety Data Sheets prepared in accordance with the conditions of KKDİK regulation No. 30105, Annex-2 are KKDİK compliant SDSs. KKDIK compliant Safety Data Sheets can only be prepared by Che
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98
Is the Turkish SDS must be prepare according to which regulation? What is the purpose of this Regulation?
24-05-2018
This regulation covers the procedures and principles about; compilation and distribution of safety data sheets of substances and mixtures that are placed on the market and that are classified as ha
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99
What are the out of scope for Safety Data Sheet?
24-05-2018
According to TC29204, Safety Data Sheet does not apply to substances and mixtures that are listed below and that are intended for the final user in the finished state:
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Irmak TUNÇ KARATAŞ / Chemical Engineer - Senior Chemical Regulatory Specialist / Chemical Assessment Expert
31-01-2018
Irmak TUNÇ was born in İstanbul in 1992. After having her education at Ümraniye High School, she graduated from Chemical Engineer Department at the Cumhuriyet University in 2015.
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