|Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (KKDIK Regulation) was published in the Official Gazette dated June 23, 2011 and numbered 30105. With this Regulation, a new period has started in the management of chemicals in our country.
It is based on the principle that the chemicals are the responsibility of the manufacturers and importers of these chemicals to protect them from the adverse effects of human health or environment.
In other words, the management responsibility for the risks of the substances belongs to those who manufacture, import, market or use these substances within the framework of their professional activities.
A number of obligations have been set out in the Regulation in this context, the most important of which is the registration of chemicals. No more than 1 tonne of substances manufactured or imported in its own form or in the mixture or in articles shall be supplied to the market without obtaining the registration number from our Ministry.
The registration provisions require manufacturers and importers to make data on the substances they manufacture or import; Require them to use these data to assess the risks associated with these substances and to develop and recommend appropriate risk management measures. The registrations of the substances will start on 1 January 2021.Manufacturers and importers of the substances shall make consortiums with other companies which manufacture or import the same substance to create a joint registration file by entering the information on "Substance Information Exchange Forum" through "Chemical Registration System" in MoEU Online System. If the substance is manufactured by more than one manufacturer or imported by more than one importer, some data must be shared and submitted jointly in order to increase the efficiency of the registration system, reduce costs and reduce testing on vertebrate animals. It is aimed to retrieve a single registration dossier for the same substance as the joint registration dossier and to prevent the information contamination.
Within the scope of the regulation, the substances in the articles must also be registered. Manufacturers or importers are obliged to register these substances in the article if they are intended to contain more than one tonne of substance per year and release the substance under normal or foreseeable conditions of use.
A new Chemical Safety Report (CSR) will be prepared in addition to the Safety Data Sheets (SDS) for substances manufactured or imported at 10 tonnes or more of the new applications introduced by the KKDIK/TREACH Directive. In addition, GBF and CSRs will now be prepared by Certified Chemical Assessment Experts.
With the KKDIK Regulation, a total of 60 articles and article groups have been banned and restricted, and implementation will be gradually passed.
Another new application to be initiated together with the KKDIK/TREACH Regulation will be the approval process for substances for which risks can not be controlled and substances for which prohibition and restriction are not enforced, starting from 2024 after the registration is completed.
Industrialists questions related to this regulation via the Question Form located at the Ministry of Chemical Affairs Help Desk https://kimyasallar.csb.gov.tr
The Help Desk also contains guidance manuals on KKDIK/TREACH regulation.
With the publication of the KKDIK/TREACH Regulation, the "Regulation on the Inventory and Control of Chemicals" was lifted on June 23, 2017.
"Regulation on the Restriction and Prohibition of Hazardous Substances and Mixtures" On 23 December 2017,
The "Regulation on Safety Data Sheets for Hazardous Substances and Mixtures" will be lifted from 31 December 2023.