Turkey’s KKDIK Regulation: Transposing EU REACH into National Law
Turkey is one of the candidate countries of the EU and is continuously in the process of transposing EU legislation into national law.
Introduction To KKDIK
On 23 June 2017, the Ministry of Environment and Urban Planning (MoEU) issued Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (KKDIK – the acronym corresponds to REACH in Turkish).
The Regulation is modelled on the Regulation (EC) 1907/2006 on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) known as EU REACH. According to Article 1 of KKDIK, the purpose of this Regulation is to regulate the administrative and technical procedures and principles regarding registration, evaluation, authorization and restriction of chemicals to ensure a high level of protection of human health and environment, as well as the promotion of alternative methods for assessment of hazards of substances.
KKDIK replaces the following laws:
- Regulation on the Inventory and Control of Chemicals, No. 27092 (replaced on 23 June 2017),
- Regulation on the Restrictions Relating to the Production, Supply to the Market and Use of Certain Hazardous Materials, Products and Goods, No. 27092 (replaced on 23 December 2017),
- Regulation on the Preparation and Distribution of Safety Datasheets for Hazardous Materials and Products, No. 29204 (will be replaced on 31 December 2023).
Since the responsibility for fulfilling the processes mentioned in KKDIK belongs to the manufacturer, importer, downstream user or their only representative, these bodies are obliged to ensure that the substances which are manufactured and used are not harming human health and the environment.
With this aim, KKDIK introduces a registration obligation. There are some exemptions to the registration obligation:
- Substances that are not within the scope of KKDIK: Since the substances in this group are not within the scope of KKDIK, they do not have pre-registration or registration obligations. These are: radioactive substances, substances subject to customs supervision, substances for use in national defense, wastes, non-isolated intermediates, carriage of hazardous substances by rail, road, inland waterway, sea or air.
- Substances exempt from registration within the scope of KKDIK: Although the substances in this group are within the scope of KKDIK, they are exempt from pre-registration or registration obligations. These are: foods or feeding stuffs, medicinal products, substances included in Annex IV, substances included in Annex V, registered substances from the recovery process, registered substances being re-imported, polymers (monomers and other reactants need to be registered), PPORD substances (PPORD notification).
- Substances accepted as registered: Active ingredients of the product groups listed here are considered to be registered under KKDIK. Therefore, they do not need to be registered again. These are: active substances for use in biocidal products, active substances for use in plant protection products.
Phases Of Registration Obligation
KKDIK imposes registration obligations on any manufacturer or importer of a substance who is operating within Turkey and producing or importing of chemical substances (either on its own or in one or more mixture(s)) in quantities equal to or more than 1 tonne a year, that they must register the chemical substances which they produce or import within the scope of KKDIK.
The registration obligation divides into 2 phases: pre-registration and registration.
- 23 December 2017 – 31 December 2020: pre-registration / pre-SIEF (pre-Substance Information Exchange Forum) phase
- 01 January 2021 – 31 December 2023: registration phase
Unlike the EU REACH, KKDIK does not have a “late pre-registration” phase between pre-registration and registration phases.
This phase is similar to pre-registration in REACH-IT. According to Article 25(1) of KKDIK: “All potential registrants, downstream users and third parties of substance who have submitted pre-substance information exchange forum (pre-SIEF) to the Ministry, or registrants who have submitted a registration for that substance before 31/12/2023 shall be participants in a substance information exchange forum (SIEF).”
All pre-registrations should be submitted before 31 December 2020 along with the information on substances identity according to Annex VI and registrants role in the supply chain through the online Chemicals Registration System (KKS – Kimyasal Kayıt Sistemi) in the website of the Ministry of Environment and Urbanization (MoEU).
Pre-registered substances may be manufactured, imported or placed on the market within the country in this phase. Non-pre-registered substances may only be manufactured or imported or placed on the market within the country after the registration process is completed. The substances for which pre-registration procedures have been completed must be submitted along with a compile dossier to the Ministry by the certified Chemical Assessment Expert described in KKDIK Annex XVIII for each substance between 1 January 2021 and 31 December 2023.
After the completion of the registration phase on 1 January 2024, substances which have not been previously registered may only be manufactured or imported or placed on the market within the country after registration has been completed. In other words, as of 2024, companies which do not have a registration number from the MoEU will not be able to supply their products to the market.
Fees and Obligations
Additionally, On 30 December 2022, the Revolving Fund Management of the Turkish Ministry of Environment and Urbanization (MoEU) announced the list of fees payable as regards certain obligations under the country’s Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals (KKDİK).
In accordance with Article 59(1) of KKDİK, fees shall be charged for the following activities underlined in Articles 7(1); 8(5); 10(2); 17(2); 18(2); 19; 22(1); 51; 52 and 61(2):
- Chemical registration
- Chemical registration update
- Request for not making information available to the public
- Product and process-oriented R&D notification
- Authorisation application and
- Authorisation review
The list provides a cost advantage for joint-registration applicants and reduced fees for SMEs. For micro-enterprises registration of substances in 1-10 tonnage band, they shall pay 110 TL, while large registrants with a single application for a substance over 1000 tons will have to pay 33.300 TL.
Considering the application of authorisation-related measures shall apply later from 31 December 2023, the list does not contain fees related to authorisation application or review. The announcement indicates that, such fees will be determined in future.
In accordance with Article 59(2) of the Regulation, the Announcement also specifies that substances in the 1-10 tonnage band which have all of the information according to Annex 7 in their registration dossier are exempt from fee.
This excel file contains all types of fees related to the activities of MoEU. KKDİK related fees start from row 383. It will apply to all 2023 activities and will be subject to annual review.
Guidelines For Chemical Registration System
Moreover, On 19 March 2021, the Turkish Ministry of Environment and Urbanization, Chemicals Management Department published a Guideline on Chemical Registration System (CRS) Updated Interface and Usage.
This document contains information on the utilization innovations of the renewed Chemical Registration System (CRS) (KKS – Kimyasal Kayıt Sistemi). There is no change in the scope and workflow of the application. Flowcharts about Only Representative procedures and substance management are also given in this document.
On 30 November 2021, Department published an updated version of the Guideline on Chemical Registration System (CRS).
Articles 4.10 and 4.11 are added in the updated version 2.3 which are about “Error / Change Notification Module” and “Chemical Safety Report and KGDRS (Chemical Safety Assessment and Reporting System)” respectively. (In the Index Part, these Articles are numbered as 4.8 and 4.9 mistakenly.)
On 4 January 2022, Department published an updated version of the Guideline on Chemical Registration System (CRS).
Article 4.11 and sub-articles 4.11.1, 4.11.2 and 4.11.3 are deleted in the updated version 2.4. These provisions concerned the following headings: “Chemical Safety Report and KGDRS (Chemical Safety Assessment and Reporting System)”, “Exposure Assessment”, “Risk Characterization”, and “KGDRS Tool” respectively. (In the Index Part, these Articles are numbered as 4.9, 4.9.1, 4.9.2 and 4.9.3 mistakenly.)
On 30 March 2022, Department published an updated version of the Guideline on Chemical Registration System (CRS). These changes are very minor.
Guidance Document For Substance Registrations
Lastly, the Turkish Ministry of Environment and Urbanisation has published a Guidance Document to help industry prepare for substance registrations under the Turkish REACH Regulation which was published on 23 June 2017 and enters into force on 23 December 2017. Like the EU REACH regulation, the Turkish regulation requires companies to register all substances manufactured in Turkey or imported into Turkey with volume above 1t/y.
The purpose of the guide is to assist companies and Chemical Assessment Specialists in preparing Chemical registration files, Chemical Safety Reports, and safety data sheets. It is recommended to use the translations in the terminology table.
Stay Ahead Of Regulatory Changes
Accelerate your ability to achieve, maintain & expand market access for all products in global markets with C2P – Your key to unlocking market access, trusted by more than 300 of the world’s leading brands.
C2P is an enterprise SaaS platform providing everything you need in one place to achieve your business objectives by proving compliance in over 195 countries.
C2P is purpose-built to be tailored to your specific needs with comprehensive capabilities that enable enterprise-wide management of regulations, standards, requirements and evidence.
Add-on packages help accelerate market access through use-case-specific solutions, global regulatory content, a global team of subject matter experts and professional services.
- Accelerate time-to-market for products
- Reduce non-compliance risks that impact your ability to meet business goals and cause reputational damage
- Enable business continuity by digitizing your compliance process and building corporate memory
- Improve efficiency and enable your team to focus on business critical initiatives rather than manual tasks
- Save time with access to Compliance & Risks’ extensive Knowledge Partner network
Unlock Market Access – See C2P In Action
Join us for a bite-sized high-level products compliance solution demo to witness the true power behind C2P.