Turkey REACH Regulatory Compliance

Freyr offers expert guidance and support for Turkey REACH Regulatory compliance. Our services cover KKDIK compliance strategy, dossier preparation, data management, toxicological assessments, and SDS preparation.

Turkey REACH Regulatory Compliance – Overview

Many countries like Turkey incorporate complex Regulatory processes for chemicals used in consumer products. The Ministry of Environment, Urbanization, and Climate Change in Turkey is responsible for regulating chemical products.

The Turkey REACH regulation is similar to the European Union (EU) REACH regulation with respect to its provisions. “KKDIK” is the acronym for “Registration, Evaluation, Authorization, and Restriction of Chemicals” in Turkish.

Chemical manufacturers and the associated supply chain must comply with the KKDIK registration requirements to support their business continuity. Regulatory actions should be taken as per the involved deadlines.

KKDIK registration, or the Turkey REACH registration, has replaced the following regulations:

  • The Inventory and Control of Chemical Regulation.
  • Regulation on Restrictions for the Manufacture, Marketing, and Use of Certain Dangerous Substances and Preparations.
  • Regulation on Safety Data Sheets for Hazardous Substances and Mixtures.

Regulatory Obligations

  • Pre-registration (Pre-SIEF) with the Turkish MoEU: the deadline was December 31, 2020.
  • KKDIK registration with the Turkish MoEU via the Ministry’s Chemical Registration System (CRS), an online system tool: the deadline was December 31, 2023.
  • C&L inventory notification.
  • Safety Data Sheet (SDS) preparation and distribution.

Exemptions

  • Radioactive substances and mixtures
  • Substances, on their own, in a mixture, or in an article, which are subject to customs supervision if they do not undergo any treatment or processing, and which are in temporary storage, or a free zone or free warehouse with a view to re-exportation, or transit.
  • Non-isolated intermediates
  • Carriage of hazardous substances and mixtures by rail, road, inland waterway, sea, or air
  • Waste products
  • Substances and mixtures that are manufactured or imported for defense
  • Medicinal products for human or veterinary use
  • Food products
  • Animal feed
  • Active substances for use in biocidal products (these substances are regarded as already registered as biocidal products, and their active ingredients are covered by the Biocidal Products Regulation (BPR)).
  • Active substances for use in Plant Protection Products (PPPs), as they are regarded as registered.

Relevant KKDIK Annexes

Annex IGeneral provisions for assessing substances and preparing chemical safety reports.
Annex IIRequirements for preparing Safety Data Sheets (SDS).
Annex IVExemptions from the obligation to register in accordance with article 2(5)(a).
Annex VExemptions from the obligation to register in accordance with article 2(5)(b).
Annex XIIICriteria for the identification of PBT substances and vPvB substances.
Annex XIVList of substances subject to authorization.
Annex XVIIRestrictions on the manufacture, placing on the market, and the use of certain dangerous substances, mixtures, and articles.

Turkey REACH Regulatory Compliance - Expertise

  • KKDIK Regulatory compliance and strategy.
  • Provide advice on supply chain-related KKDIK compliance approach.
  • Dossier preparation and submission through the chemical registration tool.
  • Data management and data gap analysis.
  • Conduct toxicological assessments.
  • Compilation of exposure scenario.
  • Late pre-registration activity.
  • Preparation and management of SDS according to KKDIK Annex II and the SEA (Turkish CLP) Regulation.