KKDIK (Turkish-REACH) Regulation Overview
The KKDIK Regulation (Registration, Evaluation, Authorization, and Restriction of Chemicals), also known as Turkish REACH, was:
- Published on 23 June 2017 by the Ministry of Environment and Urbanization (MoEU) of the Republic of Turkey.
- Came into effect on 23 December 2017.
This regulation mirrors the EU REACH Regulation (EC No. 1907/2006) in structure, intent, and process, ensuring that manufacturers, importers, and suppliers manage chemical safety effectively within Turkey.
Scope of KKDIK (Turkish-REACH) Registration
The KKDIK regulation applies to:
Substances
- Any chemical substance manufactured in or imported into Turkey in quantities of 1 ton or more per year.
Substances in Mixtures
- Substances that are part of a mixture, where the total quantity manufactured or imported reaches 1 ton or more per year.
Substances in Articles
- Substances contained in articles manufactured or imported into Turkey with intentional release during normal or reasonably foreseeable use.
- The total annual quantity of the released substance must be 1 ton or more per year.
Note:
The intentional release from articles refers to scenarios like fragrances from air fresheners, inks from printer cartridges, or chemicals in cleaning wipes.
Who Must Complete KKDIK Registration?
1. Turkey-Based Manufacturers and Importers
- Manufacturers and importers of substances, mixtures, or articles located in Turkey are obligated to comply with the KKDIK registration requirements.
2. Non-Turkey Manufacturers
- Non-Turkey manufacturers exporting substances, mixtures, or articles to Turkey must:
- Appoint a KKDIK Only Representative (OR) based in Turkey.
- The OR will take responsibility for fulfilling the registration and communication obligations under KKDIK.
- This helps non-Turkey companies continue business in Turkey without burdening their local customers with registration obligations.
Key Point:
The Only Representative (OR) acts on behalf of non-Turkey manufacturers to ensure compliance and serve as the point of contact for regulatory bodies.
KKDIK (Turkish-REACH) Registration Process and Timelines
The KKDIK registration is divided into two main phases:
Step 1: Pre-Registration (Deadline Passed)
- The pre-registration phase (similar to the EU REACH pre-SIEF process) allowed companies to:
- Submit basic information about substances.
- Participate in Substance Information Exchange Forums (SIEFs) to avoid duplicate testing and share data with other registrants.
- Prepare for the formal registration phase.
Pre-registration Deadline:
Companies had until 31 December 2020 to submit pre-registration information.
Step 2: Registration
Following pre-registration, companies must submit full registration dossiers by the regulatory deadline.
Registration Requirements:
For substances that meet the 1 ton/year threshold, the registration dossier must include:
Identification of the Substance:
- Chemical identity, structure, composition, and impurities.
Hazard Classification and Labeling:
- GHS-compliant classification and labeling details.
Physicochemical Properties:
- Physical and chemical characteristics such as melting point, boiling point, solubility, etc.
Toxicological and Ecotoxicological Data:
- Health and environmental impact studies to assess risks.
Exposure Scenarios and Risk Management Measures:
- Information on how the substance is used and controlled during its lifecycle.
Chemical Safety Report (CSR):
- Mandatory for substances ≥10 tons/year. It includes detailed exposure and risk assessment for workers, consumers, and the environment.
Registration Deadline:
- The final registration deadline under KKDIK is 31 December 2023.
- Companies must ensure that all substances manufactured or imported at 1 ton/year or more are fully registered before this date.
Data Sharing and Consortia
KKDIK encourages data sharing to reduce costs and unnecessary testing on animals.
- Joint Submission: Companies manufacturing or importing the same substance are required to share relevant test data and submit a joint registration dossier.
- Lead Registrant: One company (often a major stakeholder) acts as the Lead Registrant to compile and submit the dossier on behalf of other co-registrants.
- SIEF (Substance Information Exchange Forum): Registrants collaborate in SIEFs to share information and testing costs.
Benefits of Joint Registration:
- Cost-effective approach.
- Avoids duplication of efforts and testing.
Role of Only Representatives (OR)
Non-Turkey manufacturers rely on Only Representatives (OR) to fulfill KKDIK obligations.
- Responsibilities of ORs:
- Register substances on behalf of the non-Turkey entity.
- Maintain communication with the Turkish Ministry of Environment and Urbanization.
- Support local importers by ensuring compliance with KKDIK.
Consequences of Non-Compliance
Failure to comply with KKDIK requirements can result in:
- Import/Manufacturing Bans: Substances not registered cannot be legally imported or manufactured in Turkey.
- Fines and Penalties: Regulatory authorities may impose financial penalties.
- Loss of Market Access: Companies risk losing access to the Turkish market.
Next Steps for Companies
Review Substances:
- Identify substances manufactured, imported, or included in articles that meet the 1 ton/year threshold.
Appoint an OR (if needed):
- Non-Turkey companies must appoint a KKDIK OR to manage registration.
Participate in Joint Registration:
- Collaborate with other registrants to share costs and data.
Prepare and Submit Dossiers:
- Develop comprehensive registration dossiers in line with KKDIK requirements.