KKDIK Analytical Analysis Services
Our KKDIK Analytical Analysis Services
Compliant and Reliable Solutions for Substance Identification, Composition and Analytical Information (Annex 6)
Doruksistem manages, end to end, all analytical processes required to verify the identity of substances to be registered under the KKDIK (Turkish REACH) Regulation and to technically demonstrate their sameness criteria (Substance Identity Profile – SIP).
This process is not limited to commissioning laboratory tests; it is handled with an integrated approach covering the definition of the right analytical strategy, the selection of suitable methods, ensuring sample representativeness and evaluating the data in line with the logic of the KKDIK dossier.
Doruksistem carries out its analytical work in cooperation with laboratories accredited to ISO/IEC 17025. As a result, all data generated meet international quality standards in terms of measurement reliability, reproducibility and acceptability by the authorities.
Why Is Analytical Analysis Required under KKDIK?
Analytical Information Requirements under KKDIK Annex 6
Under Annex 6 (Substance Identification) of the KKDIK Regulation, a substance can be registered only if its identity is described in a sufficient, clear and technically reproducible way.
In this context, the basis is not only the trade name or a general description of the substance, but its scientific identity supported by analytical data.
Annex 6 in particular expects the following analytical elements to be provided:
Spectral data (e.g. IR, UV-Vis, NMR, MS)
Chromatographic outputs (GC, HPLC, etc.)
Elemental and compositional analyses
Quantitative data on the main constituent(s), impurities and additives
Clear and reproducible descriptions of the analytical methods used
These data are assessed to demonstrate technically that the substance is the same substance and to show its conformity with the Substance Identity Profile (SIP).
The KKS System and the Role of Analytical Information
With the KKDIK “Procedures and Principles” document published in 2025, the importance of analytical information has been clearly defined even for the interim registration (geçici kayıt) process.
Accordingly, entering data in Section 1.4 – Analytical Information of the KKS (Chemicals Registration System) has become an integral part of the registration process.
Analytical studies provide the essential technical basis in the KKS system, in particular for the following sections:
KKS Section 1.1 – Substance Identification
Description of the chemical structure and characteristic properties of the substance
KKS Section 1.2 – Composition Information
Declaration of the main constituents, impurities and additives together with their concentrations
KKS Section 1.4 – Analytical Information
Submission of the analytical data supporting the above information, together with method descriptions
The analytical information provided in these sections directly affects the technical validity of the registration dossier, consistency within MBDF (SIEF)/joint submission processes and the defensibility of the dossier during evaluation by the Ministry.
Why Are Analytical Studies So Important?
Under KKDIK, the purpose of analytical studies is not simply to fill in a form field but to ensure that the substance can be scientifically identified and compared with other registrations.
If insufficient or inconsistent analytical data are submitted:
Substance sameness may be called into question
Technical disagreements may arise in joint submission processes
The Ministry may request additional information or the dossier may be at risk of rejection
Analytical analyses should therefore be regarded as one of the cornerstones of the KKDIK registration process.
Doruksistem’s Approach
Doruksistem treats the KKDIK Annex 6 and KKS requirements not as separate items but as one integrated technical system.
Analytical studies are carried out with the right choice of methods, a representative sampling strategy and a report format that can be integrated directly into the KKDIK dossier.
This gives client companies a registration basis that is:
Technically robust
Compliant with the legislation
Resilient to inspections and objections
Scope of Our Services
We offer the following services either as a “single package” or on a “modular” basis, depending on your needs:
1) Substance Identification & Characterisation (in line with KKDIK Annex 6)
Spectral identification: UV-Vis, FTIR/IR, NMR, MS (GC-MS / LC-MS/MS), etc.
Chromatographic profile: HPLC, GC (method development/optimisation where necessary)
Reproducibility & methodology description: method, instrument, column, mobile phase, conditions, calibration approach, etc. (as expected for analytical method descriptions under Annex 6)
2) Quantification of Constituents / Impurities / Additives
Quantification of the main constituent(s) and critical impurities by HPLC / GC
Elemental analyses: ICP-OES/ICP-MS, AAS, XRF (depending on the matrix)
Ion analyses: IC
Wet chemistry: titration, etc. (where appropriate)
3) Analytical Report in Line with the KKDIK “Substance Sameness Criteria”
Interpretation of the analytical data set (acceptance criteria/compliance logic)
Report structure suited to the language and format of the dossier
Technical argumentation supporting “sameness” discussions in MBDF/joint submission processes
Note: Analyses are carried out through our solution partners accredited to ISO/IEC 17025; the selection of methods/parameters, the design of sample preparation and KKDIK-compliant reporting are managed by Doruksistem. (For the ISO 17025 approach to laboratory competence, see the TÜRKAK guidance.)
Which Tests Are Needed and When? (Practical Guide)
Analytical Approach by Substance Type
Under KKDIK, there is no single, fixed list of tests that applies to all substances for analytical requirements.
The required analyses are determined according to the substance’s chemical structure, physical properties, composition and registration strategy.
Doruksistem designs the analytical approach specifically for each substance and aims to generate only the data set that is sufficient and technically defensible for KKDIK purposes.
Organic Substances
(Solvents, monomers, intermediates and similar organic chemicals)
For organic substances, the main objective is to clearly establish the structural confirmation, the main constituent and the impurity profile of the substance.
Commonly used analyses include:
GC-FID / GC-MS
Identification of volatile constituents and establishment of the impurity profile
HPLC-UV / RI + LC-MS/MS
Quantitative determination of non-volatile main constituents and trace-level additives
FTIR
Confirmation of functional groups and rapid identification
NMR (where necessary)
Strengthening structural confirmation and clarifying substance identity
Inorganic Substances, UVCBs and Mineral-Based Products
For inorganic substances and UVCBs (substances of Unknown or Variable composition, Complex reaction products or Biological materials), elemental composition and structural characterisation are the priority.
Preferred analyses for these substances include:
XRF / ICP-OES / ICP-MS / AAS
Qualitative and quantitative determination of elemental composition
IC (Ion Chromatography)
Determination of the anion and cation profile
XRD (depending on the product)
Crystal structure and phase analysis
Products Containing Stabilisers, Inhibitors or Additives
For products containing stabilisers or inhibitors, identifying the additives and clearly establishing their concentrations, in addition to the main substance, is critical.
To this end:
Chemical identification of additives and inhibitors
Quantitative analyses in the ppm – % range
Confirmation by HPLC, GC or LC-MS/MS methods
are carried out so that the composition information complies with the requirements of KKDIK Annex 6 and KKS Section 1.2.
Doruksistem’s Strategic Approach
Doruksistem does not apply analytical testing as the same package for every substance.
Instead, an optimum analytical plan is created by assessing together:
The technical nature of the substance
The KKDIK registration scope and tonnage band
The joint submission (MBDF) structure
The risks arising from evaluation by the Ministry
With this approach:
Unnecessary analyses are avoided
The risk of technical non-compliance is reduced
The registration process becomes faster and more predictable
How Does the Analytical Process Work?
Doruksistem carries out analytical processes under KKDIK in pre-planned, transparent and auditable steps.
Each stage is structured taking into account both the KKDIK Annex 6 requirements and the technical expectations of the KKS system.
Preliminary Technical Assessment
In the first step of the analytical process, the technical and regulatory framework of the substance is considered as a whole.
At this stage, the following are reviewed:
Safety Data Sheet (SDS)
Product specification and production process
Uses of the substance
Target market and annual tonnage band
KKDIK registration and joint submission (MBDF) strategy
and the scope of the analytical work required is clarified.
Analytical Planning
Based on the preliminary assessment, an analytical plan suited to the structure of the substance and the registration strategy is drawn up.
The plan defines:
The analytical methods to be used (GC, HPLC, ICP, etc.)
The sample type and its representativeness
Acceptance criteria and the verification approach
The number and scope of analyses required
The aim is to generate a data set that is sufficient and defensible for KKDIK in the most efficient way.
Laboratory Analyses
In line with the analytical plan, tests and analyses are performed in laboratory/laboratories accredited to ISO/IEC 17025.
At this stage:
Sample preparation
Analytical measurements
Calibration and quality controls
are carried out in accordance with international quality standards, and all results are recorded.
Data Verification and Technical Interpretation
Laboratory outputs are assessed in detail by Doruksistem experts from technical and regulatory perspectives.
This assessment covers:
Interpretation of chromatograms and spectra
Verification of impurity and additive profiles
Conformity of the results with the substance sameness criteria
Checks for consistency and reproducibility
KKDIK-Compliant Analytical Reporting
In the final stage, the verified analytical data are reported in line with the KKDIK Annex 6 requirements and the structure of the KKS system.
The report:
Supports KKS Sections 1.1, 1.2 and 1.4
Can be integrated directly into the KKDIK registration dossier
Is ready for evaluation by the Ministry and technical inspections
This provides companies with a robust, consistent and sustainable registration basis.
Deliverables and Reporting
On completion of the analytical work under KKDIK carried out by Doruksistem, complete and compliant technical outputs that can be used directly in the registration process are delivered.
The deliverables are prepared taking into account the KKDIK dossier structure, the KKS system and the Ministry’s evaluation expectations.
Analytical Report (KKDIK-Compliant)
The analytical report prepared in line with the KKDIK Annex 6 requirements presents the identity, composition and analytical verification of the substance in a clear, traceable and defensible way.
Report contents:
Substance identification and characterisation results
Composition, impurity and additive profile
Technical descriptions of the analytical methods
Assessment of the results against the substance sameness criteria
Raw Analytical Data
All raw measurement outputs from the analyses are delivered in line with the principles of transparency and traceability.
These include:
Chromatogram and spectrum outputs
Calibration curves and summary tables
Repeat measurement and verification records, where necessary
Sample and Method Information
To support the technical validity of the analytical work, the following information is integrated into the report:
Sample description and representativeness information
Summary of the analytical methods used
Measurement uncertainty and LOD / LOQ values (where applicable)
Quality control and verification summaries
Supporting Documents for KKS and Submissions to the Ministry
The deliverables are structured so that they can be used for data entry into the KKS system and for responding to requests from the Ministry.
The company receives:
Technical annexes supporting the KKS sections
A list of any additional documents that may need to be submitted
Explanatory notes supporting dossier integrity
Short Checklist
✔ KKDIK-compliant analytical report
✔ Raw analytical outputs (chromatograms / spectra)
✔ Technical description of the analytical methods used
✔ Sample information and quality control summaries
✔ Measurement uncertainty and LOD / LOQ information (if applicable)
✔ Additional documents required for KKS and submissions to the Ministry
The Doruksistem Assurance
All outputs delivered by Doruksistem are:
directly integrable into the KKDIK registration dossier,
technically defensible in joint submission (MBDF) processes,
ready and consistent in response to inspections and requests for further information.
Frequently Asked Questions (FAQ)
Below we answer the most frequently asked questions about KKDIK analytical analysis services.
What exactly does “Analytical Information (KKS Section 1.4)” cover under KKDIK?
Under KKDIK, analytical information must be entered in the KKS system at every stage of the registration process, including interim registration.
This field covers the analytical data set that technically supports the identity of the substance.
Under KKS Section 1.4, the following are generally submitted:
Spectral data (e.g. FTIR, UV-Vis, NMR, MS)
Chromatographic outputs (HPLC, GC)
Elemental analysis results
Clear and reproducible descriptions of the analytical methods used
This information is assessed in line with the KKDIK Annex 6 requirements.
Does KKDIK Annex 6 require the same analyses for all substances?
No. KKDIK Annex 6 does not prescribe a uniform, fixed list of analyses for every substance.
What matters is to submit a data set that describes the chemical structure and composition of the substance in a sufficient and scientifically defensible way.
The required analyses are therefore determined by criteria such as:
The type of substance
Its physical and chemical properties
Its compositional structure
The registration strategy
Are UV-Vis, FTIR or NMR mandatory for every substance?
No.
KKDIK Annex 6 follows a “sufficient and appropriate analytical data” approach.
Where a particular analytical technique is not technically possible or not scientifically meaningful, this can be explained together with a justification.
What matters is that the data set submitted:
Clearly supports the identity of the substance
Is reproducible and defensible
Are NMR or MS always necessary?
No.
NMR or mass spectrometry (MS) is used in particular when needed for structural confirmation.
For some substances, however, FTIR, GC or HPLC data can establish substance identity sufficiently.
The choice of method is made by Doruksistem following a substance-specific technical assessment.
How long does the analytical process take?
The duration of the analytical process varies depending on factors such as:
The type of substance
The number of analyses required
Sample preparation and method complexity
In general, the process follows these steps:
Planning → Laboratory Analyses → Data Evaluation → Reporting
and the exact duration is determined once the analytical plan has been drawn up.
Does Doruksistem perform the analyses itself?
It is not possible for the analyses planned for all substances to be carried out by a single laboratory. Therefore, after test and analysis plans specific to the substance have been prepared, Doruksistem works with its domestic and international partners to manage the coordination of planning, testing, analysis and reporting and ensures that the work is carried out under the most suitable conditions.
Analyses are performed in laboratories accredited to ISO/IEC 17025.
Doruksistem manages the laboratory work, evaluates the analytical data from technical and regulatory perspectives and prepares KKDIK-compliant reporting.
This approach is important for both independence and acceptability by the authorities.
Can the analytical reports be used directly in the KKS system?
Yes.
Analytical reports prepared by Doruksistem are structured to support KKS Sections 1.1, 1.2 and 1.4 and can be integrated directly into the KKDIK registration dossier.
If we already have analyses, do we need new ones?
Not always.
Existing analyses are assessed for:
Currency
Suitability of the methods
Consistency with KKDIK Annex 6 expectations
If they are found suitable, the existing data can be used or the process can be supported with partial complementary analyses.
How do analytical studies affect the joint submission (MBDF) process?
Analytical data play a critical role in substance sameness and joint submission consistency.
A consistent and robust analytical data set:
Reduces the risk of technical objections
Facilitates joint submission discussions
Improves the long-term sustainability of the dossier
As an importer, am I responsible for commissioning analytical analysis?
Under KKDIK, companies importing substances into Türkiye are responsible for the technical accuracy of their registration obligation.
Accordingly, the identity, composition and sameness criteria of the imported substance must be supported by analytical data.
Analytical analyses may be provided by:
The non-Turkish manufacturer,
The Only Representative,
The consortium / Lead Registrant.
However, the analytical data submitted must meet KKDIK Annex 6 and KKS expectations; this does not remove the importer’s responsibility.
Doruksistem, on behalf of importers:
Assesses the suitability of existing analytical data,
Identifies missing or insufficient elements,
Manages the complementary analysis process where necessary.
This allows importers to move forward with confidence, without facing technical non-compliance or registration risks.
As a co-registrant, do I have to submit analytical data?
As a co-registrant, you are not required to submit analytical data in every case, but under certain conditions this obligation arises in practice. KKDIK does not treat this as a simple yes-or-no obligation; it assesses it on the basis of substance sameness and technical adequacy.
Under the basic approach of KKDIK, in a joint submission (MBDF) the substance identity, composition and analytical information are primarily submitted by the Lead Registrant. If the analytical data set in the Lead Registrant’s dossier has been prepared in line with KKDIK Annex 6 and clearly shows that the substance you import or manufacture is the same as the substance described in the Lead dossier, you are not required to submit separate, independent analytical data as a co-registrant. In this case, the joint dossier is considered technically sufficient.
However, this is not an automatic, unconditional exemption. A co-registrant must submit its own analytical data in the following cases:
If your substance differs from the substance described in the Lead dossier because:
– it is produced by a different manufacturing process,
– its impurity profile or additive content differs significantly,
– it contains inhibitors, stabilisers or additional constituents,
– it is a UVCB or has a complex composition,
the analytical data submitted by the Lead may not be considered sufficient to prove substance sameness. In this case, the co-registrant needs to demonstrate with complementary analytical data that its substance conforms to the Substance Identity Profile (SIP) in the Lead dossier.
Furthermore, if the analytical data set in the Lead dossier is weak with respect to Annex 6, if method descriptions are insufficient or if the Ministry requests further information, the consequences affect not only the Lead but also the co-registrants directly. Because technical responsibility under KKDIK is shared, analytical gaps also put the co-registrants’ registrations at risk.
Another common situation in practice is that the co-registrant does not have full technical access to the analytical data in the Lead dossier. If only limited information has been shared under the Letter of Access and you cannot technically assess whether your substance really is the “same substance”, this uncertainty may also require the co-registrant to prepare its own analytical data.
In summary, submitting analytical data as a co-registrant is not mandatory as a rule, but the obligation to submit analytical data arises if:
– substance sameness is unclear,
– the Lead dossier is analytically insufficient,
– there are technical differences specific to your substance.
Doruksistem’s approach here is to avoid unnecessary analysis costs for co-registrants while defining the minimum yet sufficient analytical data set that meets KKDIK Annex 6 and KKS expectations, and to remove technical risks from the registration process.
What information is entered in KKS 1.4 in a co-registration (member registrant) dossier?
As a co-registrant (member registrant) under KKDIK, the information entered in KKS Section 1.4 (Analytical Information) of the co-registration dossier should not be a copy of the Lead Registrant’s (LR) dossier; it should be structured to support the substance composition and substance sameness of your own legal entity.
The first key point is this: under KKDIK, co-registrants are also technically responsible for their own registration dossiers. The analytical information submitted by the Lead Registrant (LR) is the basis, but you need to be able to show that these data cover the same substance as the one you import or manufacture. KKS Section 1.4 is where this technical link is established.
The information entered in KKS 1.4 covers three main elements. First, you must clearly indicate which legal entity composition the analytical information relates to. Every entry made in Section 1.4 must therefore be linked to your own substance composition (1.2 – Composition Information) previously created in KKS. Analytical entries made without this link are not considered technically meaningful by the Ministry.
Second, the purpose and scope of the analytical work must be clearly explained. This explanation should cover points such as verifying the identity of the substance, demonstrating conformity with the Substance Identity Profile (SIP) defined in the Lead dossier and supporting the main constituent and any impurities or additives. The analytical technique used (e.g. GC-MS, HPLC, FTIR, ICP, XRF) is stated at this stage. If a particular analysis has not been performed, the technical justification must also be stated clearly; Section 1.4 in KKS “should not be left empty”.
The third and most critical element is the documentation of the analytical methods and results. As a co-registrant (member registrant), you do not have to upload all of the Lead Registrant’s raw data again; however, a technically defensible analytical report supporting substance sameness must be attached in KKS. This report should include a short description of the method used, a summary of the results and a technical assessment showing why the results are consistent with the SIP in the Lead dossier. Where appropriate, chromatogram or spectrum outputs, a method summary, LOD/LOQ information and quality control notes should also be added.
In summary, the analytical information entered in KKS 1.4 as a co-registrant is not an exact copy of the Lead dossier. The aim is to demonstrate technically that your substance is the same substance as the one defined by the Lead and to meet the requirement for “sufficient and reproducible analytical information” under KKDIK Annex 6. Doruksistem’s approach is precisely to create, for co-registrants, a Section 1.4 content that is minimum yet sufficient, reduces risks and is defensible during evaluation by the Ministry.