Home/How to Choose KKDIK Consulting Firm? 10 Criteria Checklist
How to Choose a KKDIK Consulting Firm? 10 Criteria Checklist
When choosing KKDIK consultancy firm, only KKS data entry is not sufficient. Substance identity, tonnage band and company role should be evaluated together. Data ownership, recording strategy and audit evidence files should also be managed from the same hand. ONAY Mühendislik is a chemical regulations consultancy based in Türkiye. He has specialized in KKDIK, REACH, MBDF, sole representation and technical file processes since 2010.
What should be considered when choosing a KKDIK consultancy firm?
The right consultant does not view the process as a single data entry operation. It manages as a holistic compliance process extending from registration of the chemical substance to inspection. The table below summarizes the basic criteria to be sought in a KKDIK consultancy firm and ONAY Mühendislik's response to these criteria.
| Selection Criteria | ONAY Mühendislik |
|---|---|
| Experience | Chemical regulatory consultancy since 2010 |
| Consultancy firm | 2,000+ consultancy companies |
| Item in process | Processing of 14,000+ substances |
| UFI / PCN notification | 4,000+ notifications |
| International process | DEKRA collaboration |
| Area of expertise | KKDIK, REACH, MBDF, GBF, UFI/PCN |
| Technical infrastructure | Data mining, SAR/QSAR and digital file generation |
| Audit approach | GTZ and registration evidence file |
Consultant selection criteria: 10-item checklist
Ask every consultancy you request a quote from the same ten questions below. Comparing their answers helps explain price differences and identify which provider will carry out the required work.
| Criterion | Why it matters | How do you verify |
|---|---|---|
| 1. KDU certificate | Only individuals certified as Chemical Evaluation Specialist may prepare the registration dossier and safety data sheet. | Ask for number and certification numbers of certified experts. Are they permanent or external employees? |
| 2. Leading recording experience | The lead registrant file is technically much more burdensome than the joint registration; It is the party that manages MBDF and establishes the data set. | How many leader files were submitted, in which tonnage band and in what year? |
| 3. Actual presentation in KKS and IUCLID | “We provide consultancy” and “we submitted the file to KKS and it was accepted” are not the same thing. | Ask for the number of files Accepted. If there was rejection, what was the reason? |
| 4. MBDF and LoA negotiation | The largest component of the total cost is often the Letter of Access (LoA) fee. | Request a concrete example of negotiating and lowering the LoA fee. |
| 5. Data gap strategy | Producing scientific justification with QSAR and read-across instead of testing reduces the cost many times. | Is there an example of a file with a read-across reason written and accepted? |
| 6. Exclusive Representation (OR) | The representative established in Türkiye assumes legal responsibilities on behalf of the overseas manufacturer. | Ask how liability is defined in the contract and whether there is guarantee or insurance. |
| 7. SDS / eGBF and exposure scenario | For 10 tons/year and above, Chemical Safety Report and extended SDS with scenario attached become mandatory. | Request an example where the script produces an attached eGBF. Is GBF in Turkish and 16 chapter format? |
| 8. UFI and PCN notification | If you supply a hazardous mixture, this is a separate obligation, independent of substance registration. | How many notifications were made, through which portal and in how long? |
| 9. Privacy and information security | Your formulation and supplier list are your most critical trade secret; The consultant sees all of this. | Request ISO/IEC 27001 certificate and signed confidentiality agreement. |
| 10. Continuity and file transfer | The process continues through 2030. If you change consultants, you should retain your dossier and raw data. | Is there a "file and raw data belongs to the customer" clause in the contract? What is the year of establishment and staff size? |
Practical tip: Send these ten questions in writing and request a written answer. Verbally, every company says “yes, we do”; He/she has to give the number, document number and example in the written answer.
Frequently Asked Questions
How to choose a KKDIK consultancy firm?
When choosing a KKDIK consultant, experience should first be measured: how many years he has been working and how many files he has completed. Then, its suitability for your company role and data ownership management are evaluated. Finally, technical file production capacity and audit evidence file approach are examined.
Is it mandatory to receive KKDIK consultancy?
Not required. However, substance identity, tonnage, data rights and technical file processes require expertise. Expert advice is recommended to reduce the risk of inaccurate recording and auditing. What services does
Official full text of the regulation: KKDIK Regulation - Official Gazette.
ONAY Mühendislik offer?
ONAY Mühendislik provides end-to-end consulting on all phases of chemical regulatory compliance:
- What is KKDIK? KKDIK guide
- KKDIK consultancy services
- Only Representative
- REACH registration services
- Safety Data Sheet (GBF/SDS)
- UFI – PCN file
- MBDF management
Why ONAY Mühendislik?
ONAY Mühendislik, KKDIK offers individual temporary registration, full registration, leader file, MBDF management and sole representative services under one roof. Since 2010, services have been provided to 2,000+ companies in the fields of consultancy, process execution of 14,000+ substances and UFI/PCN notification. This experience combines with technical infrastructure based on data mining and SAR/QSAR. Companies safely complete both their registration obligations and the September 30, 2026 audit preparation.