Turkey is one of the candidate countries of the EU and is continuously in the process of transposing EU legislation into national law. On 23 June 2017, the Ministry of Environment and Urban Planning (MoEU) issued Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (KKDIK - the acronym corresponds to REACH in Turkish).
The Regulation is modelled on the Regulation (EC) 1907/2006 on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) known as EU REACH. According to Article 1 of KKDIK, the purpose of this Regulation is to regulate the administrative and technical procedures and principles regarding registration, evaluation, authorization and restriction of chemicals to ensure a high level of protection of human health and environment, as well as the promotion of alternative methods for assessment of hazards of substances.
KKDIK replaces the following laws:
- Regulation on the Inventory and Control of Chemicals, No. 27092 (replaced on 23 June 2017),
- Regulation on the Restrictions Relating to the Production, Supply to the Market and Use of Certain Hazardous Materials, Products and Goods, No. 27092 (replaced on 23 December 2017),
- Regulation on the Preparation and Distribution of Safety Datasheets for Hazardous Materials and Products, No. 29204 (will be replaced on 31 December 2023).
Since the responsibility for fulfilling the processes mentioned in KKDIK belongs to the manufacturer, importer, downstream user or their only representative, these bodies are obliged to ensure that the substances which are manufactured and used are not harming human health and the environment.
With this aim, KKDIK introduces a registration obligation. There are some exemptions to the registration obligation:
- Substances that are not within the scope of KKDIK: Since the substances in this group are not within the scope of KKDIK, they do not have pre-registration or registration obligations. These are: radioactive substances, substances subject to customs supervision, substances for use in national defense, wastes, non-isolated intermediates, carriage of hazardous substances by rail, road, inland waterway, sea or air.
- Substances exempt from registration within the scope of KKDIK: Although the substances in this group are within the scope of KKDIK, they are exempt from pre-registration or registration obligations. These are: foods or feeding stuffs, medicinal products, substances included in Annex IV, substances included in Annex V, registered substances from the recovery process, registered substances being re-imported, polymers (monomers and other reactants need to be registered), PPORD substances (PPORD notification).
- Substances accepted as registered: Active ingredients of the product groups listed here are considered to be registered under KKDIK. Therefore, they do not need to be registered again. These are: active substances for use in biocidal products, active substances for use in plant protection products.
KKDIK imposes registration obligations on any manufacturer or importer of a substance who is operating within Turkey and producing or importing of chemical substances (either on its own or in one or more mixture(s)) in quantities equal to or more than 1 tonne a year, that they must register the chemical substances which they produce or import within the scope of KKDIK. The registration obligation divides into 2 phases: pre-registration and registration.
- 23 December 2017 – 31 December 2020: pre-registration / pre-SIEF (pre-Substance Information Exchange Forum) phase
- 01 January 2021 – 31 December 2023: registration phase
Unlike the EU REACH, KKDIK does not have a “late pre-registration” phase between pre-registration and registration phases.
Pre-SIEF Phase: This phase is similar to pre-registration in REACH-IT. According to Article 25(1) of KKDIK: “All potential registrants, downstream users and third parties of substance who have submitted pre-substance information exchange forum (pre-SIEF) to the Ministry, or registrants who have submitted a registration for that substance before 31/12/2023 shall be participants in a substance information exchange forum (SIEF).”
All pre-registrations should be submitted before 31 December 2020 along with the information on substances identity according to Annex VI and registrants role in the supply chain through the online Chemicals Registration System (KKS – Kimyasal Kayıt Sistemi) in the website of the Ministry of Environment and Urbanization (MoEU).
Registration Phase: Pre-registered substances may be manufactured, imported or placed on the market within the country in this phase. Non-pre-registered substances may only be manufactured or imported or placed on the market within the country after the registration process is completed. The substances for which pre-registration procedures have been completed must be submitted along with a compile dossier to the Ministry by the certified Chemical Assessment Expert described in KKDIK Annex XVIII for each substance between 1 January 2021 and 31 December 2023.
After the completion of the registration phase on 1 January 2024, substances which have not been previously registered may only be manufactured or imported or placed on the market within the country after registration has been completed. In other words, as of 2024, companies which do not have a registration number from the MoEU will not be able to supply their products to the market.
Additionally, recently MoEU announced a draft list of fees payable as regards certain obligations under KKDIK and it will be finalized by the end of 2020.
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