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KKDIK Restriction and Annex-17: Prohibited and Conditional Substances
Restriction is the fourth pillar of KKDİK. A substance restricted under Annex 17 must not be manufactured, placed on the market or used contrary to the restriction conditions. Unlike authorisation, restriction does not offer an application route to approval: the specified conditions must be met.
What is Annex-17?
Annex-17 is the list of restricted substances, mixtures and articles of the KKDIK Regulation. Article 57 of the Regulation states: The substance restricted in Annex-17, on its own, in a mixture or in an article, cannot be manufactured, placed on the market or used in violation of the conditions of the restrictions.
There are three things to note:
- It also covers the substance in the article. Just because you do not sell chemicals does not exclude you from the scope — if your product contains a restricted substance, the restriction applies to you as well. See substances in the article.
- There is no tonnage threshold. Registration obligation starts from 1 tonne per year; The restriction is independent of the amount.
- Restriction is not always complete prohibition. For most items, a specific concentration limit applies to a specific use or a specific product group. Therefore, it is not enough to ask whether the substance is in Annex 17; It should be checked whether your own use falls within the condition.
Difference between restriction, permission and registration
| Registration | Permission (Annex-14) | Restriction (Annex-17) What | |
|---|---|---|---|
| does | Prerequisite for placing on the market | Links specific use to permission | Directly limits or prohibits use |
| Is there an application? | Yes, registration file | Yes, permit application | No — compliance mandatory |
| Tonnage threshold | 1 ton per year | None | None |
| Does it cover the goods? | Under certain conditions | Including joining the item | Yes, directly |
| Related article | ARTICLE 6–22 | ARTICLE 45–56 | ARTICLE 57–58 |
Exceptions to restriction
Article 57 recognizes two exceptions:
- Scientific research and development. The restriction condition does not apply to the manufacture, placing on the market or use of the substance within the scope of scientific R&D.
- Product and process focused R&D (PPORD). Whether the restriction will be applied to PPORD and the maximum exempt amount is determined according to Annex-17 — that is, it is looked at item by item, it is not a general exemption.
In addition, the second paragraph of Article 57 introduces a special distinction for uses within the scope of the Cosmetics Regulation in terms of restrictions addressing risks to human health. For banned and restricted substances in cosmetics, also see our prohibited and restricted substances in cosmetics page.
How does the new restriction enter Annex-17?
Article 58 defines the process:
- Unacceptable risk detection. The process begins when an unacceptable risk to human health and the environment occurs as a result of the manufacture, use or placing on the market of the substance.
- Annex-15 restriction proposal file. Relevant institutions can propose the restriction of any substance to the Ministry by preparing the restriction proposal file in Annex-15.
- Risk assessment and socio-economic analysis. During the restriction process, both the risk and the socio-economic impact that the restriction will cause are evaluated. The Ministry may outsource these to third parties or establish expert committees.
- Annex 17 is updated. New restrictions are added and existing restrictions amended, taking into account their socio-economic effects and the availability of alternatives.
According to the second paragraph of Article 58, this process does not apply to the use of the substance as intermediate isolated in situ.
How is the restriction communicated in the supply chain?
Articles 27 and 28 of the Regulation make restriction a mandatory part of the information flow:
- When a restriction is imposed suppliers shall update the safety data sheet without delay (art. 27).
- The updated SDS will be forwarded free of charge to all previous buyers to whom the item was supplied in the previous 12 months.
- Even where an SDS is not required, suppliers must provide recipients with details of any applicable restrictions (Article 28).
Practical conclusion: restriction tracking is not only the job of the production unit, but also the team managing SDSs. See supplier contact.
Practical checklist for companies
- Screen your substance inventory against Annex 17 entries, including substances contained in your products as well as raw materials.
- For each matching item, read the condition: concentration limit, use ban, product group limit?
- Request an Annex-17 declaration of conformity from the supplier for the goods you import. See importer checklist.
- Update the regulatory information in section 15 of your SDS in case of restriction changes.
- If you are relying on the R&D exemption, verify in writing what Annex-17 says to PPORD on that item.
- See the administrative fines page for the sanctions to be applied in case of non-compliance.
ONAY Mühendislik do?
Matches your item and product inventory with Annex-17 items, evaluates whether the condition of each matched item matches your use; If necessary, we carry out the substitution proposal, supplier declaration template and SDS update together. Contact.
Source: Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals, Part Eight (ARTICLE 57–58), Official Gazette 23.06.2017 / 30105 bis. Related pages: KKDIK permit process and Annex-14 · KKDIK Regulation · KKDIK exemptions.