1. Definition

KKDIK (Kimyasalların Kaydı, Değerlendirilmesi, İzni ve Kısıtlanması Hakkında Yönetmelik) is a Turkish regulation on the registration, evaluation, authorization and restriction of chemical substances. This regulation is based on the EU REACH Regulation, which was officially published by the Turkish Ministry of Environment and Urban Planning (MoEUCC) on June 23, 2017, and came into force throughout the country on December 23 of the same year. According to the Turkish KKDIK regulations, enterprises must register with the Turkish Ministry of Environment and Urban Planning for the production or import of >= 1 t/a of chemical substances in Turkey, otherwise enterprises are not allowed to produce, import or sell the chemical substances in Turkey. The KKDIK regulations are implemented to ensure the safe management of chemical substances, protect human health and the environment, and promote sustainable development. The regulation applies to chemical substances produced, imported, exported, circulated and used in Turkey.

1.1 Subjects of KKDIK Regulation

1. Producers and importers of substances in Turkey;
2. Producers and importers of goods in Turkey;
3. Manufacturers of substances, mixtures and articles outside Turkey: the registration obligation must be fulfilled through the OR (Only Representative) in Turkey.

Note: KKDIK's procedure for specifying OR is the same as that of EU REACH. Businesses and OR companies outside Turkey must have an agreement signed by both parties, OR must be able to prove who he represents. This agreement needs to be submitted to the Turkish Ministry of Environment and Urban Planning upon request.

1.2 Objects of registration

1. Substances produced or imported in Turkey in a tonnage >= 1 t/a;
2. Substances in mixtures produced or imported in Turkey in a tonnage >= 1 t/a;
3. Chemical substances intended to be released in articles produced or imported in Turkey in a tonnage >= 1 t/a.

2. Registration of Substances Themselves or in Mixtures

1. Unless otherwise provided for in this Regulation, the producer or importer of any substance, whether in a single substance or in a mixture of one or more substances in a tonnage >= 1 t/a, shall submit a registration application through the Chemical Registration System (KKS System) on the website of the Ministry of Urban and Environmental Planning.
2. For monomers used as on-site separation intermediates or transferable separation intermediates, the provisions of articles 17 and 18 do not apply.
3. Any manufacturer or importer of polymers shall submit a registration application to the Ministry of Urban and Environmental Planning for monomeric substances or any other substances that have not been registered by a supply chain actor if the following two conditions are met:

•  if the mass fraction of such monomeric substances or other substances in the form of monomeric units and chemically bonded substances in such polymers is >= 2%;
•  if the total amount of such monomeric substances or other substances is >= 1 t/a.

3. Registration and Notification of Substances in Articles

(1) In accordance with Article 8 of the KKDIK Regulation, any producer or importer of an article must submit to the Ministry of Environment and Urban Planning (MEU) the registration of any substance contained in the article if the following two conditions are met:

•  the total amount of the substance in the article exceeds 1t/a/per producer or importer;
•  the substance is intended to be released under normal and reasonably foreseeable conditions of use.

(2) If a substance meets the criteria set out in Article 47 and the criteria set out in Article 49 and if the following two conditions are met, any producer or importer of an article shall notify MEU via the Chemical Registration System (KKS System) in accordance with Paragraph 4 of this Article:

•  the total amount of the substance in the article exceeds 1 t/a/per producer or importer;
•  the total amount of the substance in the article exceeds 0.1% in mass fraction (w/w);

(3) Paragraph 2 does not apply if the producer or importer can exclude exposure to humans or the environment under normal or reasonably foreseeable conditions of use (including disposal). In this case, the producer or importer shall provide appropriate instructions to the recipient of the article.

(4) The information to be notified shall include the following:

• the identity and contact details of the producer or importer as specified in section 1 of Annex 6, except for its own site of use;
• the registration number (if any) as described in article 20(1);
• the characteristics of the substance as specified in sections 2.1 to 2.3.4 of Annex 6;
• the classification of the substance as specified in sections 4.1 and 4.2 of Annex 6;
• a brief description of the use of the substance in the article and the use of the article as specified in section 3.5 of Annex 6;
• the tonnage range of the substance (e.g. 1-10 t/a;10-100 t/a;100-1000 t/a and over 1000 t/a);

(5) The Ministry of Urban and Environmental Planning may require the producer or importer of an article to submit a registration for any substance in the article if all of the following conditions are met:

• the producer or importer of an article in which the total amount of the substance present in the article exceeds 1 t/a;
• the substance is released from the article;
• the substance poses a risk to human health or the environment when released from the article;
• the substance is not subject to paragraph 1.

4. Exemption

KKDIK applies to all chemical substances and their articles (single substances and mixtures), except for the following substances and their mixtures:

5. Implementation Process

According to KKDIK regulations, companies that produce, import and export tonnage >= 1 t/a per year must complete the registration process for the relevant substances by December 31, 2023. On October 19, 2023, the initial planning for KKDIK was launched at an evaluation meeting organized by the General Council of the Department of Environmental Management Chemicals Management of the Ministry of Environment, Urbanization and Climate Change. According to the draft submitted to Non-governmental organizations on November 14, 2023, the deadline for the KKDIK regulations will be gradually extended based on tonnage and classification.

The official announcement of the Amendment to the Regulations on the Registration, Evaluation, Authorization and Restriction of Chemicals on December 23, 2023 means that an update of the KKDIK regulations, which delays the registration deadline for substances produced in Turkey or imported into Turkey, has come into effect as follows:

1. Amend the start date in Section 24 (Inquiry) and the closing date in Section 25 (SIEF formation) of the Regulations by extending them from "December 31, 2023" to "December 31, 2030".
2. Extend the termination date of SIEF from the original 31 December 2025 to 31 December 2032.
3. The deadline for pre-registration is removed by changing the words "until 31 December 2020" in provisional Article 1 of the Regulation to "the period set out in the procedures and principles to be published by the Ministry".
4. Modify the registration deadline as follows:

(a) The deadline for registration is 31 December 2026 for substances that:

• Substances whose annual production or import volume is >=1000 tpa;
• Substances whose annual production or import volume is >=100 tpa, and substances whose hazard classification includes aquatic acute 1 and/or aquatic chronic 1 (H400, H410);
• Substances whose annual production or import volume is >=1 tpa, and substances that are carcinogenic, mutagenic and/or toxic to the reproductive system that are classified as a Class 1A or Class 1B hazard under the Regulations on Classification, Labelling and Packaging of Substances and Mixtures.

(b) Without prejudice to the period specified in subparagraph (a) of this paragraph, for substances produced or produced in quantities >=100 tpa per year, the deadline for registration shall be 31 December 2028.
(c) Substances which, without prejudice to the period specified in subparagraphs (a) and (b) of this paragraph, produce or import >=1 tpa per year, with a registration deadline of 31 December 2030.

6. Information Required for Registration

(1) Substance identification information (such as substance name, EC number, CAS number, structural formula, etc.)

(2) Enterprise information, and indicate the identity of the enterprise (such as Only Representative, importer, producer)

(3) Registration data requirements of KKDIK regulations:

7. Pre-registration Process

1. Information filling: accurately fill in the substance identification information (such as substance name, EC number, CAS number, structural formula, etc.), enterprise information (OR, importer, manufacturer)
2. Information review: review the accuracy of information
3. Information submission: Submit information in the KKS system to obtain the pre-registration number (18 digits: 05-XXXXXX-XX-0000)
4. Pre-registration completion: Make pre-registration certificate and complete pre-registration

8. Official Registration

For substances with annual production, import and export tonnage >= 1 t/a, depending on the tonnage, enterprises can choose to complete the formal registration before different dates, the formal registration tonnage and data requirements are basically consistent with EU REACH, and the data of EU REACH can be fully applied to KKDIK registration. However, it is important to note that data under the EU requires data rights to be used for KKIDK registration.

8.1 Official Registration Process

Note: When preparing data, ensure that the data nodes in Annex 7,8,9,10 are consistent with EU reach. When the data is submitted to the authorities, it needs to be shown that the relevant data has been reviewed by a chemical assessment expert, and the CSR must also be reviewed by a chemical assessment expert.

8.2 Submission of Official Registration

8.2.1 Joint submission

If a substance is produced by more than one manufacturer or imported by more than one importer, it can be registered through a joint submission. First, the lead registrant is selected, and the lead registrant will submit the registration, and then the other registrants will submit the registration.

8.2.2 Separate Submission

Registrants may elect to submit separately if they believe that the cost of a joint submission is unreasonable or that a joint submission would result in the disclosure of information that they consider to be commercially sensitive and likely to cause significant commercial harm to them, or if they disagree with the lead registrant's choice of information.

Like EU REACH, KKDIK advocates "joint submission", which requires the lead registrant to submit the registration dossier first, and then the other registrants to submit it jointly. Registrants of the same substance will form a Substance Information Exchange Forum (Sief) to share core data on the substance, and eventually lead registrants will jointly submit an application document. After the leader's registration dossier has been approved, the joint registrant can prepare and submit the relevant registration documents. To join a joint registration, the registrant must obtain all necessary core data access rights, pay the associated lead registration program fees, and obtain a Letter of Authorization (LoA).

9. Registration Administration Fee

Table 1, Regular Registration Administrative Fees (TRY) (Updated in 2024.01.12)

Table 2, Intermediate Registration Administrative Fees (TRY) (Updated in 2024.01.12)

As with EU REACH, the official KKDIK registration dossier is subject to an administrative fee. The amount of the administrative fee is related to the tonnage of the registered substance and the size of the enterprise. From the beginning of 2024, officials increased administrative fees. Compared with the previous administrative fees, the increase has been more than 50%.

10. Obligations Beyond KKDIK Registration

10.1 Assessment

The assessment is carried out by the Ministry of Environment and Urban Planning (MoEU) of Turkey and consists mainly of a dossier assessment and a substance assessment, the main content of which is to review the integrity of the registered data to determine whether the chemical poses a hazard to human health or the environment and to decide whether to require further testing and assessment. The assessment may include a review of substance properties, exposure routes and toxicological data, and high-risk substances may be included in the authorization or restriction list.

10.2 Authorization

Authorization list: Annex XIV

Authorization Candidate List: SVHC list

Although Annex XIV of KKDIK entered into force on the date of implementation of the regulation, no substances were published in the list. Turkish officials plan to take substances from the EU REACH authorization list as a candidate list in 2020 and collect all comments (especially on the use subject to exemption from the authorization requirements) to determine the authorization list under KKDIK. Once a substance is listed in Annex XIV, it needs to submit an authorization application before it can be used or placed on the Turkish market, and the authorization list will be published after December 31, 2023.

10.3 Restrictions

List of restrictions: Annex XVII

Annex XVII in KKDIK came into effect on December 23, 2017 and replaces the original Regulation on the Restriction of Production, Sale and Use of Certain Hazardous Substances, Products and Goods. Once a substance is listed in Annex XVII of the Restriction List, its use in Turkey is restricted or prohibited.