Deadline for Pre-registration (Pre-SIEF Notification) for KKDIK (Turkey REACH) is 31st Dec. 2020. There is no late-pre-registration possible and susbtance that are not pre-registered by the deadline will not be allowed to be placed in the Turkish market until their registration is complete

Frequently Asked Questions

As per the Official Guideline on Registration Heading 2.5.1 in KKDIK, the ingredients in the finished cosmetic products also need to be registered, as cosmetic products can be defined under the term "mixture" and ingredients of a mixture must be registered according to KKDIK.

 

Although cosmetics are covered by the Bylaw on Cosmetics (separate regulation on cosmetics in Turkey), they are not exempted from registration i.e., the ingredients of the finished products also need to be registered even if it's a finished product intended for the end-user. 


However under KKDIK, cosmetic products that are delivered to the end-user as a final product are exempt from Safety Data Sheet requirements (KKDIK Article 2(4)(b)) and if a Chemical Safety Report is needed to be prepared for the product, the report does not have to have a "human health" section as it must be already covered by the aforementioned Bylaw on Cosmetics. 

 

In principle the exporter of the finished cosmetics product has a compliance liability for both these regulations in Turkey (KKDIK and Bylaws on Cometic regulations).

The main chemical regulation in Turkey is KKDIK, which is an acronym in the Turkish language for Registration, Evaluation, Authorization and Restriction of Chemicals. KKDIK is also known as Turkey-REACH.

  • Kimyasalların  (Chemicals)
  • Kaydı (Registration)
  • Değerlendirilmesi (Evaluation)
  • İzni (Authorization)
  • Kısıtlanması(Restriction)

Turkey-REACH Regulation came into force to improve and arrange previous legal regulation related to chemicals. The Ministry of Environment and Urbanization (MoEU) manages registration, evaluation, authorization and restriction processes of the chemicals to provide to be adapted to Turkey-REACH Regulation.

  • Turkey-REACH Regulation and the other related regulation can be found in helpdesk of the MoEU.https://kimyasallar.csb.gov.tr(In Turkish)
  • Guide documents of the can be found at https://kimyasallar.csb.gov.tr/rehber-dokumanlar/18

Under Turkey-REACH, chemicals can be registered with following tonnage bands:

  • 1-10 tons/ year
  • 10-100 tons/ year
  • 100-1000 tons/ year
  • 1000+ tons/ year

In case the substance qualifies as an intermediate, the applicable tonnage bands for registration as a transported isolated intermediate (TII) are: 

  • <1000 tons/ year 
  • >1000 tons/ year

Turkey REACH (KKDIK) regulates manufacturing, placing on the market or use of chemicals and chemicals in a mixture or in an article.

Enterprises have the obligation to comply with the KKDIK regulation via pre-registration and registration.

  • The pre-registration and registration are applicable to all substances (regardless of the phase-in and non-phase-in status in the Turkey inventory.)
  • Substances registered within EU-REACH need to be registered again under KKDIK.

The following substances are exempted from Turkey REACH: 

  • Radioactive substances and mixtures
  • Substances, on their own, in a mixture or in an article, which are subject to customs supervision, provided that they do not undergo any treatment or processing, and which are in temporary storage, or in a free zone or free warehouse with a view to re- exportation, or in transit;
  • Non-isolated intermediates;
  • The carriage of hazardous substances and hazardous mixtures by rail, road, inland waterway, sea or air;
  • Wastes
  • Substances and mixtures which are manufactured or imported for the purpose of defense

 

Further information on substances and exemptions (v) are listed below: 

Substance information  Registration Authorization Evaluation Supply Chain Information Downstream users

Medicinal products for human and veterinary use 

Food 

Feeding products 

Cosmetic products 

 

 

 

 

Invasive medical devices or medical devices which can be used in direct physical contact with the 

human body 

 

 

 

 

On-site isolated intermediates and transported intermediates 

 

 

 

Polymers  

 

 

 

Biocidal Products 

 

 

 

 

Plant Protection Products 

 

 

 

 

Product and Process Oriented Research and Development (PRORD) 

v (can be exempted for 5 years once notification is submitted to the Ministry) 

 

 

 

  • The deadline for Pre-registration under the KKDIK is 31 December 2020. Substance registration will start from 1 January 2021 and end in 31 December 2023. Companies that submit the pre-registration before 31 December 2020 can continue to manufacture or export while registration is in process. Tonnage band will not affect the registration deadlines.  

    However, companies that fail to pre-register can manufacture or export the substances only after the registration is completed.  

  • Turkish Manufacturers
  • Turkish Importers
  • Non-Turkish manufacturers can appoint an “Only Representative (OR)” to register on behalf of them, also taking over the registration responsibility from the importer.

Companies can pre-register the substances by filling the pre-SIEF. 

Documents  

1 – 10 t/y 

10-100 t/y 

100-1000 t/y 

1000 + t/y 

Technical Dossier including main information as registrant’s identification, Substance ID, guidance on safe use, classification and labeling 

 ✓

Exposure Assessment 

 

 

 

Exposure Scenario 

 

Chemical Safety Report and Chemical Safety Assessment 

 

✓ 

Safety Data Sheet 

(if the substance is under harmful criteria) 

Physicochemical Properties

✓  

✓  

✓ 

✓ 

Toxicological Information 

✓* 

✓ 

✓ 

✓ 

Ecotoxicological Information. 

✓*

✓ 

✓ 

✓ 

*: If the substance is hazardous 

Registrants can submit pre-registration and registration via MoEU Chemical Registration System (KKS): https://ecbs.cevre.gov.tr/ 


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