Frequently Asked Questions (F.A.Q)

For substances manufactured / imported in quantities of 1 tonne or more per year in their own or in the mixture before 31/12/2023, registration must be made between 31/12/2020 and 31/12/2023. Substances after 31/12/2023 must be registered before they are placed on the market.

All registrants shall submit the pre-SIEF to the Ministry of Environment  through the Chemical Registration System on the website of the Ministry by 31/12/2020, containing the following information:

a) The identity of the substance according to Annex-6,
b) Role in the supply chain..

Manufacturers established outside Turkey do not have direct obligations within the scope of Regulation KKDİK. The importers must fulfill their obligations in Turkey under KKDİK Regulation. A natural or legal person established outside Turkey who manufactures a substance on its own, in mixtures or in articles, formulates a mixture or produces an article that is imported into the Turkey may by mutual agreement appoint a natural or legal person established in the Turkey to fulfil, as his only representative, the obligations on importers under the scope of this Bylaw. Only representative shall also comply with all obligations of importers under this Regulation...

A natural or legal person established outside Turkey who manufactures a substance on its own, in mixtures or in articles, formulates a mixture or produces an article that is imported into the Turkey may by mutual agreement appoint a natural or legal person established in the Turkey to fulfil, as his only representative, the obligations on importers under the scope of this Bylaw. Only representative shall also comply with all obligations of importers under this Regulation.

A company resident outside Turkey may appoint a natural or legal person resident in Turkey as its only representative by reaching mutual agreement. The representative shall have a sufficient background in the practical handling of substances and the information related to them and, without prejudice to Article 32, shall keep available and up-to-date information on quantities imported and customers sold to, as well as information on the supply of the latest update of the safety data sheet referred to in Article 27.

In addition to the criteria set out in Article 9(2) of KKDİK regulation,’adequate practical experience and knowledge of the handling of chemical substances ‘is recommended.

The ability to be a single representative depends on the mutual agreement between the manufacturer resident outside Turkey and a natural or legal person resident in Turkey who will be appointed as a single representative. When an only representative submits the registration file (files), it is recommended that he / she also deliver copies of all documents certifying that he / she has been officially assigned. More information about the duties of the only representative is included in the registration guide. If an only representative is appointed, the manufacturer, who is not resident in Turkey according to Article 8(3) of KKDIK, shall notify the importers in the same supply chain. These importers are considered downstream users.

Yes. An only representative may represent one or more companies based outside Turkey that manufacture, formalize, or manufacture substances exported to Turkey, even if they manufacture the same substances. More information about the duties of the only representative is included in the registration guide.

Manufacturers located outside Turkey can start collecting relevant information to assist their only epresentatives and importers under KKDİK. This information includes information about the substance's full name, number (CAS or EINECS/ELINCS/NLP) and composition. This information is given in more detail in the chemical nomenclature guide within the scope of KKDİK. The manufacturer located outside Turkey may also contribute to the internal properties of the substance (see annex 7-11 of KKDİK regulation) by providing the information available at his disposal. However, it should be noted that all obligations under KKDİK for substances exported to Turkey will be fulfilled by an only representative or importer.

Only natural or legal persons resident in Turkey can be ’registrars'. Registration must be made by the person in question in the following cases:

1. If the substance is manufactured in quantities of 1 ton or more per year per manufacturer,
2. If the substance is imported in quantities of 1 ton or more per year per importer,
3. If appointed as the only representative according to Article 9 of KKDİK By Law.

A non-resident company does not have a direct obligation under KKDİK regulation. The companies that are required to fulfill the obligation of KKDIK regulation are the companies that import from abroad. However, the non-resident substance manufacturer or article manufacturer may decide to appoint an ‘only representative’ to alleviate the obligations of importers.

Registration is required regardless of whether they are classified as hazardous for all substances that meet the following conditions:

• Substances complying with the definition in Article 4 of KKDİK regulation;
• Substances imported to Turkey or manufactured in Turkey in quantities of 1 ton and above per year for each registrant;
• Substances which are not exempt from registration or are not considered registered according to the provisions of Articles 2, 10, 16 of the regulation of KKDİK.

Where a group of companies consists of many natural or legal persons, each of them must determine whether they are defined as’registrars ‘according to Article 4(ü) of KKDİK regulation. If the parent company's subsidiaries are a separate legal entity from the parent company, then they may be ‘registrars’ under KKDIK.

The purpose of the SIEFs to facilitate the sharing of information necessary for registration to prevent duplication of studies among potential registrants of the same substance. Another purpose is to agree on the classification and labelling information of the substance. SIEF also serves as the platform for data holders to share their data/work on the item. In addition, if the available information is not sufficient for registration, the SIEF jointly determines the work that needs to be done.

If you buy monomers from companies in Turkey, registration is not your obligation. If you are importing monomers yourself, you must register under KKDIK.

The manufacturer or importer of goods containing the substances nominated to be added to annex-14 according to Article 8 of the code of Conduct shall notify the Ministry through the chemical registration system on the website of the ministry if both of the following conditions apply:

• For each manufacturer or importer, the amount of material in the articles must be more than one ton per annum.
• The concentration of matter in the article is greater than 0.1% by weight.

The Ministry of Environment of Turkey has not imposed any permits or restrictions on the use or non-use of the information in registration files made under REACH. There is no agreement between the Turkish Ministry of Environment and ECHA on this issue.

A third party representative is a natural or legal person resident in Turkey appointed by a Turkish manufacturer, importer or, in relevant cases, downstream user to fulfill their regulatory obligations regarding joint submission of data and sharing of test costs. The only representative is a natural or legal person resident in Turkey, who is a natural or legal person who manufatures a substance outside Turkey, prepares a mixture or produces the goods, and is appointed by mutual agreement to fulfill the importer's obligations under KKDİK.

The provisions of Annex-14 shall enter into force on 31/12/2023. For this reason, Annex-14 will be published after 31/12/2023.

Downstream user: means any natural or legal person established within Turkey, other than the manufacturer or the importer, who uses a substance, either on its own or in a mixture, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user;

Having a participant as coordinator greatly facilitates information sharing within SIEF. This participant may make suggestions on ways to share information about the substance. As defined in Article 12 of KKDIK regulation, SIEF participants may agree on the leader registrant who will undertake the organization of the exchange of information in the first stage and the preparation of the presentation jointly. Of the information to be shared by one or more potential registrants is considered to be commercially confidential (for example, in the production process that may be indicative of the impurity content,) due to the signing of a confidentiality agreement on behalf of the lead registrants or potential registrants may propose the appointment of an independent third party who will deal with confidential information. Any other form of organization is equally possible, as long as all SIEF participants agree on it.

Potential registrars must question whether the registration file has been submitted to the Ministry for the same substance prior to registration for unregistered substances. Article 24 of KKDİK regulation states that studies of existing vertebrate animals must be shared, while other studies may be shared. Potential registrars should therefore refer as much as possible to test Studies previously performed on vertebrate animals in their registration files. It is possible to refer to previously submitted files for information produced by means other than tests on vertebrate animals, but not necessarily. In this respect, it should be kept in mind that SIEFs will continue their operations until 13/12/2025. This allows a new ‘registrant ' who is querying to facilitate data sharing to contact the existing SIEF.

The Only representative (OR) will be appointed as per the legal entities as in the EU REACH. There are no differences in the OR process between KKDIK and REACH. A single Only Representative can be appointed by the multinational company for all legal entities operating in different countries. This can be done for both the purposes of pre-SIEF notification and registration. However, the Only Representative will need to consider submitting pre-SIEF notifications and registrations via his/her KKS account separately based on the volumes of substances of each ‘non- Turkish manufacturer’ that he represents.

The OR of a on Turkish company has the ability to cover its customers with a pre- SIEF done through its Turkish Only Representative that is subject to meeting the requirements of Article 9 of KKDIK. The ‘non-TR manufacturer’ needs to inform all the TR importers in the same supply chain that he has appointed an Only Representative to conduct the registration thus relieving the importers from their registration obligations. A ‘non-Turkish manufacturer’ can only appoint one Only Representative per substance. The Only Representative’s registration should clearly specify which quantity of the imported substance it covers – be it the entire import into Turkey from a given ‘non- TR manufacturer’, or only specified quantities within that total. In cases where an importer is also importing quantities of the same substance from other non-EU sources, then both the Only Representative and the importer must be able to clearly document to enforcement authorities which imports are covered by the registration of the Only Representative; and which are covered by the importer; otherwise, the importer remains responsible for all his imports. In other words, an importer has to submit a registration for the quantity of a substance he imports, but does not have to cover the volume of the substance that is covered by the registration of the Only Representative.

Each document should be prepared by a certified expert in Turkey. There is no need for SDSs to be signed and stamped unless otherwise indicated in the bylaw. MoEU has a separate tool which allows authors to upload them through this particular system. Note: Safety Data Sheets shall be prepared according to the Bylaw on Safety Data Sheets Concerning Hazardous Substances and Mixtures until 31/12/2023. Safety Data Sheets can be prepared according to this Bylaw from the execution date of Article 27 until 31/12/2023.

According to the KKDİK Regulation, there is no requirement to issue any documents by the Only Representative for the importers in Turkey. However, a document showing the imported quantity for pre-SIEF notification and registration in Turkey for the importer is recommended. In that case, it is sufficient to deliver a company letterhead declaration to the customers describing the pre-SIEF notification status of the substances in the mixtures of the non-resident manufacturer. It is foreseen that customs controls will be carried out after the registration deadline ends, which is by the beginning of 2024. Since the importer certificate is not a matter in KKDIK Regulation, it does not have any validity in terms of operations within the scope of KKDIK.