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KKDIK Permit Process and Annex-14: Substances of High Concern
KKDIK permit process is the third pillar in the name of the regulation: Registration, Evaluation, Permit and Restriction of Chemicals. When a substance of high concern is included in the Annex-14 list, it becomes mandatory to obtain a separate permit from the Ministry for the placing on the market and use of that substance. Being registered does not provide this permission — they are two separate processes.
What is Annex-14, how is it different from registration?
Annex 14 is the KKDİK list of substances subject to authorisation. Under Article 46, a manufacturer, importer or downstream user may not place an Annex 14 substance on the market or use it themselves without authorisation, unless Annex 14 expressly grants an exemption for that use.
| Registration | Permission (Annex-14) | |
|---|---|---|
| Triggered by | Manufacturing/import of 1 ton or more per year | Substance in Annex 14 — no tonnage threshold |
| What does it cover | The item itself | Specific use |
| Who does | Manufacturer, importer, sole representative | Manufacturer, importer and/or downstream user (art. 52/2) |
| Duration | Indefinite (update obligation lasts) | Time-limited — there is a review period (art. 51) |
| Result | Registration number | Permit number — written on the label (art. 55) |
Critical point: permission is given to use, not substance. For the same substance, one use may be permitted while another may be unauthorized.
Which substances are included in Annex-14?
Article 47 of the Regulation lists the criteria for substances of very high concern (SVHC) in six clauses:
- Carcinogenic category 1A or 1B (SEA Regulation Annex 1, section 3.6)
- Germ cell mutagenicity category 1A or 1B (section 3.5)
- Toxic to the reproductive system category 1A or 1B (section 3.7)
- PBT — persistent, bioaccumulative and toxic (KKDIK Annex-13 criteria)
- vPvB — very persistent and very bioaccumulative (Annex-13)
- Equivalent concern — substances identified on a case-by-case basis under Article 49, such as endocrine disruptors
The first three clauses are the group called CMR 1A/1B. This group is also decisive for the 31 December 2026 full registration deadline — meaning a substance can be subject to both early full registration and authorization.
From candidate list to Annex-14: how does the process work?
- Dossier preparation (art. 49). The Ministry or the relevant institution prepares a file in accordance with Annex-15 for the substance that it considers to meet the criteria in Article 47.
- Announcement and opinion. The Ministry announces the preparation of the file on its website and invites the relevant parties to submit their opinions.
- Candidate list. Substances that meet the criteria are included in the list of candidate substances to be included in Annex-14.
- Annex-14 decision (art. 48). The ministerial decision includes the substance identity, the intrinsic properties in Article 47 and transitional regulations: the starting date when the permit will be mandatory and the deadline for application.
Transitional regulations are the most important item for the company: a company that misses the application deadline cannot use the item from the start date.
What is included in the permit application file?
Application is made through Chemical Registration System (KKS). According to the fourth paragraph of Article 52, mandatory content:
- Substance identification (Annex-6, second part) — see substance identification (SID)
- Name and contact information of the applicant(s)
- Request specifying which uses permission is requested
- Chemical safety report (CSR) — if not already submitted as part of the registration
- Analysis of alternatives — including risks of substitution, technical and economic feasibility, R&D carried out
- replacement plan and timeline if analysis indicates suitable alternative
According to the fifth paragraph, optionally socio-economic analysis in accordance with Annex-16 can be added. In practice, this optional document becomes decisive in most cases — here's why.
Two ways of permission: adequate control and socio-economic stability
First route — adequate control (art. 50/2). Permitted if risks arising from use are adequately controlled as documented in the chemical safety report.
This route is not open to everyone. The third paragraph of Article 50 excludes: CMR and substances of equivalent concern for which thresholds cannot be determined, PBT substances, vPvB substances.
The second route is the socio-economic balance (Article 50(4)). Where adequate control cannot be demonstrated or the substance falls within the groups above, authorisation may be granted if the socio-economic benefits outweigh the risks and no suitable alternative substances or technologies are available. This route requires a socio-economic analysis.
The Ministry carries out the risk assessment and socio-economic analysis and delivers its opinion within ten months of receiving the application (Article 54(1)). It may commission third parties or establish expert committees for this work.
Obligations after obtaining permission
- Labeling (art. 55). The authorization holder labels the substance or the mixture containing the substance before placing it on the market for authorized use and includes the authorization number on the label.
- Downstream user notification (art. 56). The downstream user using the authorized substance shall notify the Ministry within 90 days from the first supply of the substance. See subuser obligations.
- Review (art. 51). The permit remains valid provided that a review report is submitted at least 18 months before the end of the review period.
- SDS update (art. 27). When permission is granted or denied, the safety data sheet is updated without delay and forwarded to all recipients in the last 12 months.
Common mistakes
- I have registered, I think the permit is also covered. It is not. Separate application, separate file, separate number.
- Leaving the consent process to the supplier as it is a downstream user. The supplier's consent covers only self-reported uses; If your use is not covered, you must obtain permission.
- Mistaking alternative analysis as a formality. If there is an alternative and there is no replacement plan, the file cannot survive on the socio-economic path.
- Failing to follow transition dates. When the application deadline is missed, production stops after the start date.
- Forgetting the authorization number on the label. Article 55 is a clear obligation; directly visible in the control.
ONAY Mühendislik do?
Scans your portfolio against Annex-14 and candidate list criteria, removes the items that will be subject to permission along with their transition dates; We carry out the application through KKS by preparing a chemical safety report, alternative analysis, substitution plan and, when necessary, Annex-16 socio-economic analysis. Contact or check out our consulting services.
Source: Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals, Seventh Part (ARTICLE 45–56), Official Gazette 23.06.2017 / 30105 bis. Related pages: KKDIK Regulation · KKDIK restriction and Annex-17 · glossary of terms.