Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals 22 January 2018

Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals 22 January 2018

REGULATION ON REGISTRATION, EVALUATION, AUTHORIZATION AND RESTRICTION OF CHEMICALS

Regulation 1907/2006/EC on Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), regulating the production, import and use principles of the European Union concerning chemical substances entered into force on 1 June 2007.

The REACH Regulation requires companies manufacturing or importing more than 1 ton per year of chemical substances within the EU Member States, to register these manufactured or imported chemical substances with the European Chemicals Agency (ECHA).

REACH Registration of chemicals that are already adapted to Turkey, Regulation on Evaluation, Authorization and Restriction of Chemicals (KKDİK) is published in the Official Gazette on June 23, 2017. Certain substances of the Regulation entered into force on 23 December 2017, six months after the date of publication. Some of articles of the Regulation will enter into force in 2018, 2019, 2021, 2022 and 2023 respectively.

Purpose and Scope

The purpose of this regulation is to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances while enhancing competitiveness and innovation.

This regulation covers manufacturing, placing on the market or use of the substances on their own, in a mixture or in an article and placing the mixtures on the market.

Definitions

Manufacturer: means any natural or legal person, established within Turkey who manufactures a substance in the Republic of Turkey,
Importer: means any natural or legal person, established within Turkey who is responsible for import of a substance,
Manufacturer of a product: Natural or legal persons, established within Turkey who manufacture or assembly the product,
Downstream user: means any natural or legal person established within Turkey, other than the manufacturer or the importer, who uses a substance, either on its own or in a mixture, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user.
Only Representative: A natural or legal person established outside Turkey, who manufactures a substance on its own, in mixtures or in articles, formulates a mixture or produces an article that is imported into the Turkey may by mutual agreement appoint a natural or legal person established in the Turkey to fulfill, as his only representative, the obligations on importers under the scope of this regulation.

Chemical Registration System

The Ministry of Environment and Urbanization is responsible from the Chemical Registry System. You can reach the system via the link below.

https://www.turkiye.gov.tr/csb-kimyasal-kayt-sistemi-bakanlk-2649

Registration

  • Substances on their own, in mixtures or in articles shall not be manufactured or placed in the market unless they are registered in accordance with the relevant provisions of this Part where this is required.
  • All substances manufactured or imported in its own form or in a mixture of 1 ton or more per year before 31/12/2023 shall be registered at the latest by 31.12.2023.
  • Registration process, certain information presented to Turkey for the raw materials market is subject to registration (V. S. test data) which is carried out through the submission of a registration dossier to the Ministry.
  • ll registrants must communicate the substance’s identity and the role of the substance in the supply chain through the Chemical Registration System located on the web page of the Ministry’s preliminary Material Information Exchange Forms by 31/12/2020.
  • Companies that have notified Classification-Inventory will be able to move this information to the pre-Material Information Exchange Forms entry screen.
  • The registration process will commence after the pre-Material Information Exchange Forms period lasting until 31 December 2020 and will be completed on December 31, 2023, whatever the tonnage.
  • Notification for raw materials within the article and registration of over 1 ton / year for the raw materials intended to be released. In addition, supplier of products will be obliged to communicate information on these items in the supply chain if they use certain articles in products.
  • If the amount of the substance in the contaminant is more than one ton per year per manufacturer or importer, and if the concentration of the substance in the contaminant is greater than 0.1% by weight, the Ministry shall be notified through the Chemical Registration System on the web page of the Ministry.

Who should Register?

  • Manufacturers, Importers, Downstream users (Only Representatives, Third-party Representatives)
  • Any producer (only if the substance is intended to be released)

Third-party Representative

Manufacturer / Importer / Downstream user                                                Third-party Representative

 

  • They are fully responsible for complying with their obligations               Co- Registration Application
  • Assign a third-party representative                                                                 Data Sharing
  • Their identity is not disclosed.

Fees

  • The fees that shall be paid in the scope of this Bylaw, is determined annually and published at the website of the Ministry in the circulating capital enterprise unit price list.
  • No fee shall be taken for the substances in the 1-10 tonnage band which have all of the information.

Access to information

Disclosure of the following information shall normally be deemed to undermine the protection of the commercial interests of the concerned person;

  • details of the full composition of a mixture
  • including information about its precise use as an intermediate;
  • the precise tonnage of the substance or mixture manufactured or placed on the market;
  • links between a manufacturer or importer and his distributors or downstream users.

 

  • Where urgent action is essential to protect human health, safety or the environment, such as emergency situations, the Ministry may disclose the information referred to in this paragraph.

Repeals

Following regulations shall be repealed upon the entry into force of this regulation:

  • Regulation on Safety Data Sheets Concerning Hazardous Substances and Mixtures published in the Turkish Official Gazette dated 13/12/ 2014 numbered 29204
  • Regulation on Inventory and Control of Chemicals published in the Turkish Official Gazette dated 26/12/ 2008 numbered27092 (bis)
  • Regulation on Restriction and Ban of Hazardous Substances and Mixtures published in the Official Gazette dated 26/12/ 2008 numbered 27092 (bis)

Effective Date

Of this regulation;

  • Articles 6, 40-56 will enter into force on 31/12/2023,

 

  • Article 57(1);
  • Entries 28, 29, 30, 31, 32, 34, 35, 36, 37, 38, 40, 41, 45, 48,49, 54, 55,57, 58, 60 of Annex 17 will enter into force on 31/12/2018,
  • Entry 62 of Annex 17 will enter into force on 31/12/2019
  • Entries 46a, paragraphs 1 to 4 of 47 and 65 of Annex 17 will enter into force on 31/12/2021
  • Enty 66 of Annex 17 will enter into force on 31/12/2022
  • All other entries of Annex 17 will enter into force 6 months later the date of its publication on the Official Gazette.

 

  • Article 64(1)(a) will enter into force on 31/12/2023, Article 64(1)(b) will enter into force on the published day,
  • All other provisions entered into force on December 23,2017

 

Related Link

http://www.resmigazete.gov.tr/eskiler/2017/06/20170623M1-18.htm

2018-01-22T12:05:04+00:00