What is a full registration?
A full registration is the submission of a registration dossier to the Ministry that includes all information requirements associated with the relevant tonnage band as specified under the KKDIK Regulation.
Companies That Have Completed Full Registration
Companies listed below are considered to have completed their full registration if they finalise all tonnage-dependent information requirements required for the full registration dossier by the deadlines set out in the provisional Article 2 of the Regulation:
- Lead registrants submitting a joint registration dossier,
- Member companies of joint registration groups whose lead registrant has submitted the full registration dossier,
- Companies that, under Article 12(3) of the Regulation, provide a valid justification for submitting their dossier separately from the joint registration group.
Full Registration Process
The full registration process can be summarised as follows:
- Start of the registration obligation and Pre-SIEF
A manufacturer or importer who manufactures or imports a substance on its own or in a mixture in quantities of one tonne or more per year must submit the required information to the Ministry via the Chemical Registration System (KKS). These information requirements are defined in Article 11 of the Regulation as follows:
- Identity of the manufacturer(s) or importer(s)
- Identity of the substance
- Information on manufacture and uses of the substance, covering all identified uses of the registrant
- Classification and labelling of the substance
- Guidance on safe use of the substance
- Study summaries
- Robust study summaries
- An indication as to which of the information submitted has been reviewed by a chemical assessment expert chosen by the manufacturer or importer
- Testing proposals for standard information requirements
- Exposure information (1-10 tonnes)
- A request as to which of the information should not be made available on the Internet, including a justification as to why publication could be harmful for his or any other concerned party’s commercial interests.
- Chemical Safety Report ( ten tonnes or above)
Every potential registrant manufacturing or importing one tonne or more per year must submit a Pre-SIEF for their substance to the Ministry by 31 October 2025 and must become an SIEF participant. For substances placed on the market for the first time after this date, the Pre-SIEF must be submitted within 30 days following the placing on the market.
- Formation of the Joint Registration Group and Appointment of the Lead Registrant
Registrants must be part of the same registration, unless they have valid grounds as specified in the Regulation. This is referred to as the “One Substance, One Registration Principle” in the Procedures and Principles.
Lead registrants for substances manufactured or imported before publication of the Procedures and Principles must be identified by 31 December 2025 at the latest. For substances manufactured or imported after publication, lead registrants must be identified within six months following the placing on the market.
A lead registrant is confirmed if the candidate is approved by a simple majority of SIEF participants. If a majority is not achieved, the candidate must withdraw and a new selection round begins.
- Submission and Completion of the Full Registration Dossier
For companies submitting a full registration dossier by 31 March 2026, the provisions on temporary registration do not apply. Potential registrants who cannot obtain the required data for the full registration dossier or cannot access such information through publicly available, copyright-free global sources may request an extension.
During the granted extension period, the Ministry may request additional information. These requests must be fulfilled within the timeframe specified by the Ministry. If the requested information cannot be provided within that timeframe, the registrant must request an additional extension with justification.
If the information still cannot be obtained by the end of the extension period, the submitted justifications are reviewed by the Chemical Advisory Group. Following this evaluation, the Ministry will approve or reject the registration for the specific substance.
A Smoother KKDIK Process with Chemleg
Chemleg manages all these complex steps on your behalf. You can rely on the expertise of our team at every stage of the process and stay informed with regular updates.
If you would like to proceed with your KKDIK process together with us, contact us today and benefit from our KKDIK services.