Regulatory Blog

On 12 August 2025, the Ministry of Environment, Urbanisation and Climate Change of the Republic of Türkiye published the Procedures and Principles Regarding the Implementation of the KKDIK Regulation. With the publication of these Procedures and Principles, important updates have been introduced to the KKDIK compliance process. These are summarised below: 1 – Pre-Registration Deadlines Have Been Revised. According to the new provisions, the final deadline for pre-registration is 31 October 2025. Pre-registrations must be submitted to the Ministry via the Chemical Registration System (KKS) and companies must become SIEF participants by this manner. For substances manufactured or imported after 31 October 2025, pre-registration must be completed within 30 days following the placing on the market. 2 – Deadline Set for Determining the Lead Registrant. If a substance was placed on the market before the publication of the Procedures and Principles, the lead registrant must be determined by 31 December 2025 at the latest. For substances placed on the market for the first time after the publication, the lead registrant must be determined within 6 months. 3 – Temporary Registration Process Planned. If the lead registrant is unable to fulfil the obligations regarding full registration, a temporary registration must be submitted by 31 March 2026. The following information must be provided for temporary registration:

The regulation titled “Regulation Amending the Regulation on the Registration, Evaluation, Authorization, and Restriction of Chemicals (KKDIK)” was published in the Official Gazette dated 23/12/2023 and numbered 32408. As you know, in November 2023, the Ministry published the “Draft Regulation Amending the Regulation on the Registration, Evaluation, Authorization, and Restriction of Chemicals (KKDIK).” With this draft, registration deadlines were extended, and it was stated that matters related to the pre-registration deadline and the joint registration process would be determined within the framework of the Procedures and Principles to be published by the Ministry. With the publication of the “Regulation Amending the Regulation on the Registration, Evaluation, Authorization, and Restriction of Chemicals (KKDIK)” on December 23, 2023, the updates made to the KKDIK Regulation have become official, eliminating any uncertainties for the relevant parties.

This new regulation significantly updates Regulation (EC) No 1272/2008 (CLP – Classification, Labelling, and Packaging Regulation), tightening the management of chemical substances and mixtures. The main changes introduced are: Strengthening Implementation for Online Sales Classification of Multi-Component Substances and Plant Extracts Endocrine Disruptors, PBTs, and Other Hazard Classifications New Criteria for the Classification of Mixtures Major Changes in Labelling and Packaging Requirements Repackaging of Hazardous Substances and Refill Stations New Obligations for Emergency Health Response Information New Regulations for Advertising and Online Sales Changes in the Classification of Industrial Products Transition Processes and Implementation Schedule These amendments aim to strengthen the management of chemical substances to protect both human health and the environment. Notably, significant innovations have been introduced regarding online sales, endocrine disruptors, and digital labelling. 1.Strengthening Implementation for Online Sales It has become mandatory for an EU-based supplier to be involved in online sales from non-EU suppliers. As a result, non-EU companies selling online must comply with regulations through an EU-based supplier. Previously, Regulation (EC) No 1272/2008 assumed that all economic operators were established within the EU. However, non-EU firms could sell hazardous chemicals directly to EU consumers, making regulatory oversight difficult. Solution:By requiring an EU-based supplier, all market placements, including online sales, will be aligned with regulations. This amendment aligns with: (EU) 2019/1020 Market Surveillance and Compliance Regulation (EU) 2022/2065 Digital Services Act (DSA) (EU) 2023/988 General Product Safety Regulation (GPSR) As a result, non-EU firms will be prevented from selling hazardous chemicals directly to EU consumers, online sales platforms will be responsible for monitoring sellers, and authorities will be able to enforce legal actions through EU-based suppliers. 2.Classification of Multi-Component Substances and Plant Extracts Multi-component substances are not fundamentally different from mixtures in terms of hazard classification. According to Article 13 of the EU REACH Regulation, to minimize animal testing, data on multi-component substances should be generated under the same conditions as for other substances. However, individual component data should only be collected if those components are independently registered substances. Special case for plant extracts:Components that may be hazardous in isolation may not pose risks in the full extract. A temporary exception has been introduced to allow scientific evaluation of whether these substances should be classified as mixtures. The European Commission will reassess this issue within five years. 3.Endocrine Disruptors, PBTs, and Other Hazard Classifications New classifications have been introduced for: Endocrine Disruptors (Hormonal System Disruptors) Persistent, Bioaccumulative, and Toxic (PBT) Substances and Very Persistent and Very Bioaccumulative (vPvB) Substances Persistent, Mobile, and Toxic (PMT) Substances and Very Persistent and Very Mobile (vPvM) Substances Specific timelines have been established for the classification and labelling for substances and mixtures.