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KKDIK Excluded Substances: Waste, Intermediate, Polymer, Cosmetics
“Is our product subject to KKDIK?” The answer to the question often lies not in tonnage, but inscope. Article 2 of the Regulation completely excludes some substances and mixtures from the scope; It exempts some of them only from certain parts. Confusing the two is one of the most expensive KKDIK mistakes.
Exclusion is not the same as partial exemption
The Regulation recognizes three different levels:
| Level | Meaning |
|---|---|
| Out of full scope (art. 2/2) | The Regulation does not apply at all |
| Part-based exemption (art. 2/3–2/7) | Some parts do not apply, others do |
| Annex-based exemption (Annex-4, Annex-5) | Substances on the list are exempt from certain parts |
At the second and third level the substance is still within the scope of KKDIK — it is only exempt from some obligations. For example, the safety data sheet obligation may continue.
Those not fully covered (ARTICLE 2/2)
The Regulation does not cover the following substances and mixtures at all:
- Radioactive substances and mixtures — Those covered by the Regulation on the Safe Transport of Radioactive Material
- Substances under customs supervision — provided that they do not undergo any treatment or processing; Substances in transit or in temporary storage, free zones or warehouses for re-export
- Non-isolated intermediates
- Transportation of harmful substances and mixtures — railway, road, inland waterway, sea, air
- Wastes — Those within the scope of the Waste Management Regulation and Radioactive Waste Management Regulation
- Substances and mixtures manufactured or imported for Defense purposes
Warehouse trap: exemption is conditional on “no treatment or processing whatsoever”. The company that changes, mixes or labels the packaging in the warehouse loses this exemption. For compliance on the customs side, see our chemical imports and customs compliance page.
Waste trap: waste is excluded, but recovered material from waste ceases to be waste and is included in the scope. There is a separate partial exemption for recovery (below).
Partial exemption due to product legislation (ARTICLES 2/3 and 2/4)
Second (registration), Fifth (downstream user), Sixth (evaluation) and Seventh (authorization) parts of the regulation do not apply to substances manufactured or imported for use in the following products:
- medical products for human and veterinary use
- Foods — Those covered by the Turkish Food Codex Regulation
- Feeds — Those within the scope of the Regulation on the Placing on the Market and Use of Feeds
In addition, the provisions of Part Four (information in the supply chain, i.e. safety data sheet) do not apply to the following mixtures that reach the end user as a final product: medicinal products, cosmetic products, medical devices that are invasive or come into direct contact with the body, feed and foods.
Cosmetic trap: exemption applies to final cosmetic product and only to Part Four. If you import raw materials to be used in cosmetics, your registration obligation continues. There is also a separate relationship with the Cosmetics Directive in terms of restrictions — see. KKDIK restriction and Annex-17 and prohibited and restricted substances in cosmetics.
Annex-4, Annex-5, re-import and recovery (ARTICLE 2/5)
The Second, Fifth and Sixth parts of the Regulation do not apply to the following articles:
- substances included in Annex 4 — low-risk substances for which sufficient information is considered
- Substances included in Annex 5 — groups of substances exempt from registration
- Reimported substances — Substances registered in Turkey, exported and reimported in the same supply chain; provided that it is proven that the substance is the same and that information is provided in accordance with articles 27/28
- Recovered substances: substances recovered in Türkiye that are the same as a previously registered substance, provided that the information required under Articles 27/28 for the registered substance is available at the recovery establishment.
Recovery exemption is not automatic: the two conditions must be met and documented. For the sameness of the substance, item similarity (sameness) evaluation is required.
Intermediates and polymers (ARTICLES 2/6 and 2/7)
- Intermediates: Except for Articles 9 and 10, the provisions of Part One of Part Two and Part Seven (authorization) do not apply to in situ isolated intermediates and transported isolated intermediates. Detail: intermediate KKDIK registration and controlled conditions.
- Polymers: The provisions of Part Two (registration) and Part Six (evaluation) do not apply to polymers. However, this does not mean that the polymer manufacturer has no obligations — the obligation to register monomer and other substance remains. See KKDIK registration of polymers and road map for polymer manufacturers.
Summary: which exemption removes what?
| Status | Registration | SDS | Permission | Restriction |
|---|---|---|---|---|
| Waste, radioactive, defense, transit | — | — | — | — |
| Substance for medicinal product/food/feed | Exempt | Yes | Exempt | Yes |
| Final cosmetic product (mixture) | — | Exempt | — | Special provision |
| Annex-4 / Annex-5 articles | Exempt | Yes | Yes | Yes |
| Polymer | Exempt | Yes | Yes | Yes |
| In situ isolated intermediate | Partial | Yes | Exempt | Yes |
The most important column in the table is restriction: Annex-17 restrictions are virtually unaffected by any exemptions and do not recognize tonnage thresholds.
ONAY Mühendislik do?
Classifies your product and item portfolio according to the scope criteria in Article 2; We report with reasons which article is out of full scope and which is exempt from only certain parts, and we make your exemption claim defensible in the audit. Contact or see Am I subject to KKDIK?.
Source: Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals ARTICLE 2, Official Gazette 23.06.2017 / 30105 bis. Related pages: KKDIK exemptions · KKDIK Regulation.