KKDIK (Registration, Evaluation Authorization and Restriction of Chemicals) Regulation:

TR Ministry of Environment and Urbanization (MoEU), KKDIK Regulation Official Gazette on 23 June 2017. Issue: 30105 (Repeating) has been published. KKDIK entered into force 6 months later on 23 December 2017.

KKDIK Regulation aims to protect human health and the environment from the negative effects of chemicals at the highest level.

The Ministry of Environment and Urbanization will manage the registration, evaluation, permit and restriction processes of chemical substances in accordance with the provisions of KKDIK Regulation.

KKDİK regulations require that companies  register all the materials produced in Turkey or imported to Turkey in the amount of 1 tonne or more per year  before 31 December 2023.

 

Main Objectives of KKDIK Regulation:

• To protect human health and the environment at a high level from the damages of chemicals.

• To hold those who place chemicals on the market (manufacturer or importer) responsible for the safe use of chemicals.

• Ensure competition and innovation in the chemical industry increased in Turkey

• To reduce animal experiments used in the assessment of harmful properties of substances and to encourage alternative methods eg. QSAR and read across.

 

Scope of KKDIK Regulation:

KKDIK includes all chemical substances placed on the market in mixture, article or on their own and contains provisions related to these.

However, the regulation does not cover the following substances, articles and mixtures:

• Radioactive substances and mixtures

• Goods to be transported, mixtures or articles and goods in the free zone for re-export

• Non-isolated intermediates

• Transport of dangerous substances and mixtures in various modes

• Substances produced or imported for military defense purposes

• Medicinal products

• Veterinary products

• Medical devices

• Cosmetics

• Food 

Note: Active substances produced or imported for use only in plant protection products are considered to be registered under KKDIK. Active substances in approved biocidal products are also considered registered. However, plant protection products and biocidal products cannot be exempted from the scope of KKDIK regulation. For example, labeling is still required for SDS preparation and SEA regulations.

 

Critical Points Regarding the Obligations of the Sector Under KKDIK:

 

Registration:

• The registrant can be: Manufacturer, Importer or Only Representative

• Scope: All substances manufactured or imported, including substances intended to emit> = 1t / year.

• Deadline for pre-registration: 31 Dec 2020

• Deadline for registration: 31 Dec 2023

• Four different tonnage bands: 1-10t / year, 10-100t / year, 100-1000t / year, 1000t / year

• Data requirement and risk assessment report similar to EU REACH

• Reduced registration requirements for substances used for product and process oriented research and isolated intermediates

• Monomer, Oligomer and Polymers: If the volume of monomer is over 1 ton per year and if it is => 2% in polymer, monomers will be recorded.

• Joint submission is required.

• Safety Data Sheet: GHS Safety Data Sheet including 16 articles in Turkish and approved by a certified person.

 

Evaluation :

It specifies the test activities to determine the hazard and precautionary statements of chemical substances.

 

Permission:

• Substances in Annex 14 may not be manufactured, imported or used unless permitted.

• Similar to the EU SVHC candidate list, there will be candidate substances to be included in Annex 14.

• Annex 14 is designed similarly to the REACH Annex XIV Permit List and will be published after the registration process is complete.

 

Restriction:

• The restriction conditions specified in Annex 17 must be observed.

• Annex 17 is designed similarly to the REACH Annex XVII Restricted Substances List.

• Includes restrictions planned to take effect on certain dates.

 

KKDİK differences between Turkey and the EU REACH:

One of the main differences between REACH and KKDIK is that registrations are only allowed by experts with a Chemical Assessment Expert (KDU) certification.

Similar obligations are also present in the SDS Regulation. Safety Data Sheets should be prepared in Turkish by a certified person.

In addition, information about the authorized expert, the necessary criteria and the authorities for certification in order to prepare a Chemical Safety report is included in Annex-18 of  KKDIK Regulation.

 

SEA Directive has entered into force before KKDIK in Turkey. Thus the situation in Turkey and in the EU process and schedule leads to different degrees of progress. Another difference is that tonnage bands do not affect the deadline for final registrations.

 

Things to be done to comply with KKDIK regulations:

• Registration and notification procedures for the covered substances must be completed before the deadline.

• Companies not having an office in Turkey,  may  appoint a local representative (OR).

• Make sure your Safety Data Sheets are compliant.

• Follow the list of substances subject to authorization in Annex 14 and the list of restricted substances in Annex 17.

 

Our Services Under KKDIK:

• Determining your covered items

• Determination of your roles and responsibilities within the scope of KKDIK

• Managing the entire process

• Pre-Registration / Registration of Substances

• Follow-up of participant activities in Pre-Registration and Registration stages

• Follow-up of consortium activities

• Preparation, compilation and uploading of registration files by Chemical Assessment Experts to KKS

• Creating a substance inventory within the scope of ANNEX-17 (Restricted Substances List)

• Creating a substance inventory within the scope of ANNEX-14 (List of Authorized Substances)

• Preparation of REACH and KKDIK Compliance Certificate