The Ministry of Environment and Urbanization (MoEU) in Turkey has implemented and enforced its own REACH-like regulation as of December 23, 2017. In this article KKDIK will be referred to as T-REACH (per English translation of KKDIK).
T-REACH regulation is similar to the EU REACH regulation in that companies are required to register all chemical substances (on their own, in mixtures or in articles with an intended release) manufactured in Turkey, or imported into Turkey, with volumes greater than 1t/y before certain agreed upon deadlines. See below:
|Notification/Pre-Registration||December 31, 2020|
|Registration||December 31, 2023|
|Authorization||Date/Substance in Annex XIV|
|Restriction||Dates in Art. 66|
Those who have registered (Manufacturers, Importers, Formulators, Only Representatives) their chemical substances are also required to notify. Notification (Pre-registration) involves revealing the substances identity as well as indicating its role in the supply chain. This is all done through the Ministry's Chemical Registration System Portal. However, at this point in time, links to helplines in the government are available in Turkish. Companies already set up with the Classification - Inventory Notification (SEA) are able to transfer the data to the MoEU notification portal.
As with EU REACH, the registration process includes the submission of a substance dossier to the MoEU only after the notification deadline of December 31, 2020 and before the registration deadline of December 31, 2023. In other words, if a substance has not been pre-registered by December 31, 2020, then only less than 1 tonne of that substance per year can be manufactured, or imported into Turkey until a full registration has been completed.
The data requirement and risk assessment reports are similar to EU-REACH data requirements with their chemical dossier. There are reduced registration requirements for substances for product and process-oriented research and isolated intermediates. For polymers, the monomers within the polymer are registered if the volume of the monomer exceeds 1t/y. Joint submissions are mandatory.
Companies not located within Turkey must appoint an Only Representative (OR) in Turkey for both the notification and registration of all substances imported into Turkey. Even if another manufacturer or importer has pre-registered a substance, all other manufacturers and/or importers of that substance must also pre-register it. Since the registration window is highly compressed, it is not clear how the Turkish agency or the participants will handle this process. It seems likely that many registrants will attempt to purchase LoAs from EU - REACH registrations and create duplicate submissions to gain market access.
Substances on T-REACH Annex 14, which is similar to EU - Substances of Very High Concern Candidate List (SVHC) cannot be manufactured, imported or used unless authorization first. Application for authorization can be submitted via the portal and will be assessed by the MoEU. A decision to authorize will be made within 10 months of submission. The list of substances to be added to Annex XIV will be determined by the MoEU, in accordance with the REACH regulation and published on the Ministry's website.
Companies are required to comply with all Restrictions in Annex 17 (Article 66 of KKDIK regulation), which is virtually identical to REACH Annex XVII Restricted Substances List.
The following are exempt from T-REACH1:
- Radioactive substances and mixtures;
- Goods, mixtures or articles in transit and goods in free-zone for re-export
- Non-isolated intermediates;
- Transport of dangerous substances and mixtures by various modes;
- Substances manufactured or imported for defense purpose;
- Medicinal products;
- Veterinary products;
- Medical devices;
- Cosmetic products;
- Food and feeds;
In short, the one main difference between EU-REACH and T-REACH (KKDIK) is that the latter allows only authorized and fully trained experts to sign off the submitted dossiers. Compliance with T-REACH requires:
- Pre-register/register applicable substances equal to or greater than 1t/year before set deadline. (if company is outside of Turkey, there is the need to set up a local only representative)
- Create compliant Safety Data Sheets (i.e. in Turkish, 16-sections) and;
- Monitor T-REACH Annex 14 and Annex 17 to ensure substances imported or manufactured are not subject to authorization or are restricted in any way.
Trinity Consultants is fully capable of helping with both the notification and registration of chemicals entering Turkey as well as setting up an Only Representative in Turkey. If any company has any needs for this service please let them know that Trinity Consultants is available and proficient with these regulatory responsibilities as their consultants, previously with The Redstone Group, have helped many companies with EU-REACH evaluation, pre-registration, registration, authorization of a plethora of chemical substances.
- KKDIK regulation - English translation
- KKDIK regulation annex 17 - English translation
- KKDIK regulation annex 18 - English translation
1 Active substances and co-formulants which are only manufactured or imported for use in plant protection products are considered registered under T- REACH. Active substances in approved biocidal products are also considered registered. However, plant protection products and biocidal products are not fully exempt under KKDIK regulation. For example, GHS safety data sheet and labelling are still required.
NOTE: There is the need for an Only Representative (OR) in accordance with Article 9 of KKDIK for companies that do not have a Legal Entity in Turkey. One of the initial actions for the global chemical industry should be to find a reliable OR that has a Legal Entity in Turkey. The companies who already have an appointed Only Representative in Turkey, for example to comply with SEA and/or CICR regulations can ask their OR to manage their responsibilities under KKDIK. The other global manufacturers who have not yet appointed an OR would be advised to start seeking one.