Turkish REACH KKDIK

The KKDIK regulation will come into force on 23 Dec 2017. "KKDIK" are the first letters of REACH written in Turkish

TURKREACH KKDIK mirrors EU REACH, but with some differences which are of importance.

That’s why you need a trusted OR in Turkey.

- A single registration deadline for substances in all tonnage bands between 2020 and 2023.

Registration process will begin right after notification deadline 31/12/ 2020.

- Registration process with a short time frame which is quite challenging for industry ( SMEs especially) to face complex tasks such as data sharing & compilation, LoA cost negocation & discussion with Consortia, registration..etc!!

- Inventory Status Does Not Affect Deadlines - Another key differences between EU REACH and TURKREACH KKDIK is Annex 18, which contains qualification requirements for technical experts, requires that notification and registration requirements ( CSR sign off and Safety Data Sheet authoring ) must be fulfilled by certified Chemical Safety Assessors ( certified by the Turk Accreditation Institute).

- SDS regulation will be completely replaced by KKDIK on December 31, 2023.

13 Documents  to be published closely follow Echa's REACH guidance ( on going)

KKDIK will bring various Turkish chemicals legislation under one law. It will replace three existing laws:

• Regulation on the Inventory and Control of Chemicals;
• Regulation on the Preparation and Distribution of Safety Datasheets for Hazardous Materials and Products; and
• Regulation on the Restrictions Relating to the Production, Supply to the Market and Use of Certain Hazardous Materials, Products and Goods.

KKDIK applies to all chemical substances on their own or in preparations as well as in articles. However, the regulation does not cover the following substances and mixtures.

• 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;

Registration and Notification

Upon publication of KKDIK, manufacturers and importers are no longer required to submit notification as required under the Regulation of Inventory and Control of Chemicals. However, starting December 23, 2017, manufacturers and importers need to begin to pre-register substances which are imported in the amount of greater than or equal to 1 metric ton/year, via the Ministry’s Chemical Registration System portal. The Ministry will conduct an evaluation of whether the registration dossiers are complete and follow the requirements; and they will inform the registrant to submit any additional information within 12 months of the Ministry starting the evaluation, for the registrant to meet the compliance requirement.

As in the previous notification system, and like in EU REACH, importers and manufacturers that do not have a legal representative in Turkey can carry out their compliance responsibility under KKDIK through assigning an Only Representative (OR) in Turkey. Annex 18 of KKDIK, which contains qualification requirements for technical experts, requires that notification and registration requirements (and Safety Data Sheet authoring – see below) must be fulfilled by certified Chemical Safety Assessors.

Unlike EU REACH, there are not staggered deadlines for tonnage bands above 1 metric ton/year. The pre-registration deadline is December 31, 2020 and a registration cutoff date of December 31, 2023 is given by the Regulation. This is intended to provide sufficient time for manufacturers and importers to comply with the Regulation.

Safety Data Sheets

On December 31, 2017, the transition period for Safety Data Sheet preparation will begin. During the transition period, an SDS can either be prepared per the Regulation of Safety Data Sheets for Hazardous Substances and Mixtures or per the KKDIK Regulation. The Regulation on Safety Data Sheets for Hazardous Substances and Mixtures will be completely replaced by KKDIK on December 31, 2023.

The requirement for the Safety Data Sheet to be written by a certified Turkish expert still stands under KKDIK. The transition period is intended to provide sufficient time for the Chemical Safety Assessors to acquire the training and certification required for authoring SDSs, as provided in Annex 18 of the KKDIK.

Restriction and Authorization

The Regulation on Restrictions for the Manufacture, Marketing and Use of Certain Dangerous Substances & Preparations, will be repealed by the KKDIK Regulation as of December 23, 2017. Annex 14 & 17 of KKDIK, which closely resemble but are not identical to the EU lists for substances subject to restriction and authorization, will replace this Regulation in regards to restriction and authorization of substances.

Applications for authorization may be submitted through the Ministry’s Chemical Registration System portal, by one or more applicants. The Ministry will perform a Risk Assessment and Socio-economic Analysis of the information and will inform on its decision within 10 months.

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