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KKDIK Aquatic Harmful Substances and Early Registration Obligation

KKDIK's 31 December 2026 full registration threshold does not only cover CMR articles. The wording in the amendment regulation also attributes substances harmful to the aquatic environment to the same date, meeting the relevant thresholds. In the Turkish inventory, this group is more crowded than the CMR group.

Which classification is covered by this?

The decisive factor is category 1 of the hazard classes to the aquatic environment in section 4.1 of Annex 1 of the SEA Regulation:

  • Aquatic Acute 1 — H400: Very toxic to aquatic life
  • Aquatic Chronic 1 — H410: Very toxic to aquatic life with long lasting effects

Categories 2, 3 and 4 (H401, H411, H412, H413) do not fall into this early threshold. For a full list of H statements, see hazard classes and H statements.

How many items are in Türkiye's inventory?

We counted the classifications in our open dataset of 6,212 substances derived from the KKDİK harmonised classification list:

Harmfulness Number of items
Aquatic Acute 1 or Chronic 1 — total (singular item) 1.094
Aquatic Acute 1 (H400) 1.093
Aquatic Chronic 1 (H410) 966
Both CMR 1A/1B and aquatic category 1 216

The aquatic pest group (1.094) is slightly larger than the CMR group (1.072). 216 items are included in both lists. The two combined are 1,950 items, or 31.4% of the inventory — see. Full registration 31 December 2026.

Which sectors are affected?

Aquatic category 1 is not concentrated in a single sector; It spreads over a wide area, covering more than one-sixth of the inventory. In practice, it is most commonly encountered in the following groups:

  • Metals and metal compounds — salts of copper, zinc, lead, cadmium and nickel
  • Biocidal active substances and preservatives — see biocidal product consultancy
  • Dye, pigment and ink components
  • Detergent and surfactant components — see. detergent legislation
  • Plant protection and agricultural chemical intermediates

Do not guess the condition of your own item by product line; Verify based on CAS.

Why is the log file heavy in aquatic harmful matter?

Aquatic category 1 classification means that ecotoxicology data comes to the center. The full log file typically requires:

  • Acute and chronic toxicity data on fish, daphnia and algae
  • Bioaccumulation and biodegradability data — for persistence assessment
  • Environmental PNEC derivation in Chemical safety report
  • Separate exposure scenarios for water, soil and sediment compartments

This data is expensive and time consuming. Consider joint registration in MBDF to avoid bearing the cost alone; Some of the data gaps can be closed with QSAR and read-across.

Connection on restriction and permission side

Aquatic Category 1 classification alone does not place a substance on the Annex 14 authorisation list. Article 47 concerns CMR, PBT, vPvB and equivalent levels of concern. However, Aquatic Category 1 substances are often also examined for persistence and bioaccumulation; a PBT or vPvB finding can bring authorisation into consideration. These properties are also direct prioritisation criteria in substance evaluation.

Checklist

  • Scan your inventory by CAS, separate those carrying H400 and H410.
  • Classify non-harmonized items with your own data — there is no harmonized classification in item 2.273 of the inventory, this means your responsibility, not exemption.
  • Eliminate your ecotoxicology data gaps today; The testing sequence can take months.
  • Contact companies registering the same substance early — see Cost reduction in MBDF.
  • Do not assume classification from EU source; KKDIK annex and EU CLP are not the same in every article.

ONAY Mühendislik do?

We remove aquatic category 1 substances from your inventory, prepare your ecotoxicology data gap map, reduce testing burden with a read-across strategy, and prepare the full log file including PNEC derivation. Contact.

Data source: Open dataset of 6,212 items derived from the KKDIK harmonized classification list (CC BY 4.0). The dataset is published with the permanent address: DOI 10.5281/zenodo.22247796 · kkdik.ai dataset page. Calendar basis: Official Gazette 23.12.2023 / 32408 amendment regulation. Related pages: recording calendar · tonnage band data requirements.

This content was prepared by ONAY experts
Gözde Goetz
Deputy General Manager
Kocaeli Üniversitesi – Chemistry · KDU Certified · 13 years of experience
[email protected] · LinkedIn
Derya İnceli
Operations Manager
Gazi Üniversitesi – Chemistry · KDU Certified · 10 years of experience
[email protected]
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