Turkey Proposes REACH Regulation

March 3, 20173E Regulatory Research Team

Summary

The Turkish Ministry of Environment and Urbanization has released a new draft of its proposed REACH-like regulation, KKDIK. While the government has not announced an official timeline for final implementation, it is expected to be finalized in the first quarter of 2017.

3E Review

The proposed Turkish regulation is modeled after the European Union's Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). "KKDIK" are the first letters of the REACH acronym when written in Turkish.

Important highlights from the draft legislation include:

Registration: KKDIK requires manufacturers or importers of a substance, either on its own or in one or more mixture(s), in quantities of one ton or more per year, to register with the Ministry of Environment and Urbanization (the Ministry).

Evaluation: The Ministry will perform dossier evaluations to assess testing proposals made by the registrant, or to check that the registration dossiers comply with the requirements. The Ministry may, within 12 months of the start of the compliance check, prepare a draft decision requiring the registrant(s) to submit any information needed to bring the registration(s) into compliance with the relevant information requirements, and may specify adequate time limits for the submission of further information. In regards to the time periods for examination of testing proposals, the Ministry will prepare the draft decisions by 31 December 2025 for the proposals received by 31 December 2022.

Authorization: The KKDIK requires all manufacturers, importers and downstream users applying for authorizations for substances to analyze the availability of alternatives and consider their risks, as well as the technical and economic feasibility of substitution. The Ministry will be responsible for taking decisions on applications for authorization, and will take into account all discharges, emissions and losses, including risks arising from diffuse or dispersive uses which are known at the time of the decision. An application for authorization will be made to the Ministry by using a special system on the webpage of the Ministry, called the Chemical Registration System. Applications for authorization may be made by the manufacturer(s), importer(s) and/or downstream user(s) of the substance, and may be made by one or several persons. Following the receipt of an application, the Ministry will conduct the Risk Assessment and Socio-economic Analysis and will give its draft opinions within ten months of the date of receipt of the application.

Restrictions: Annex 17 of the KKDIK specifies restrictions on the manufacturing, placing on the market and use of certain dangerous substances, mixtures, and articles.

3E Analysis

If passed into law, the KKDIK will repeal:

  • Regulation on Preparation and Dissemination of Safety Data Sheets concerning Dangerous Substances and Preparations (Official Gazette No: 29204, dated 12/13/2014) to be repealed on 31 December 2022;
  • Regulation on Inventory and Control of Chemicals (Official Gazette No. 27092, dated 12/26/2008) to be repealed on the date of publication of the KKDIK; and
  • Regulation on Restrictions and Prohibition of Certain Dangerous Substances (Official Gazette No. 27092, dated 12/26/2008), to be repealed after the six months from the date of publication of the KKDIK.

Some of the deadliness in the latest draft include:

  • All registrants should send the pre-substance information exchange form to the Ministry of Environment and Urbanization through the Chemical Registry System (on the Ministry's webpage) by 31 December 2019.
  • The enforcement dates for several articles of the regulation will begin in 2022.
  • In connection with the sharing of existing data related to registered substances, potential registrants must send the required information to the Ministry of Environment through the Chemical Registration System to inquire about the registration status of the same substance beginning on 31 December 2022.

A comment period was open for two weeks and closed on 31 January 2017. The KKDIK regulation is expected to be finalized in first quarter 2017.