TREACH (KKDIK) BY-LAW (Part 1, Section 1)
REGULATION ON THE INVENTORY AND CONTROL OF CHEMICALS
FIRST PART
General Issues
FIRST SECTION
Aim, Scope and Basis
Aim
ARTICLE 1 – (1) The purpose of this Bylaw is to regulate the administrative and technical procedures and principles regarding the registration, evaluation, authorization and restriction of chemicals, 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.
Scope
ARTICLE 2 – (1) This Bylaw 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.
(2) This Bylaw shall not apply to the substances and mixtures below:
- Radioactive substances and mixtures within the scope of Bylaw on the Safe Transportation of Radioactive Substances published in the Official Gazette dated 08/07/2005 and numbered 25869,
- 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 in the scope of the Bylaw on Waste Management published in the Official Gazette dated 02/04/2015 and numbered 29314 and Bylaw on Radioactive Waste Management published in the Official Gazette dated 09/03/2013 and numbered 28582.
- Substances and mixtures which are manufactured or imported for the purpose of defense
(3) The provisions of Second Part, Fifth Part, Sixth and Seventh Part shall not apply to the substances manufactured or imported in order to use in the products below:
- Medicinal products for human or veterinary use within the scope of Bylaw on the Licencing of Medicinal Products for Human Use published in the Official Gazette dated 19/01/2005 and numbered 25705, Bylaw on the Packaging and Labelling of Medicinal Products for Human Use published in the Official Gazette dated 25/04/2017 and numbered 30048 and Bylaw on Veterinary Medicinal Products published in the Official Gazette dated 24/12/2011 and dated and numbered 28152;
- Food within the scope of the Bylaw on Turkish Food Codex published in the Official Gazette dated 29/12/2011 and numbered 28157;
- Feeding stuffs within the scope of the Bylaw on Placing on the Market and Use of Feeding Stuffs published in the Official Gazette dated 27/12/2011 and numbered 28155;
(4) The provisions of Fourth Part shall not apply to the extent the following mixtures in the finished state, intended for the final user:
- Medicinal products for human or veterinary use within the scope of Bylaw on the Licencing of Medicinal Products for Human Use, Bylaw on the Packaging and Labelling of Medicinal Products for Human Use and Bylaw on Veterinary Medicinal Products,
- Cosmetic products within the scope of Bylaw on Cosmetics published in the Official Gazette dated 23/05/2005 and numbered 25823,
- Invasive medical devices or medical devices which can be used in direct physical contact with the human body,
- Feeding stuffs within the scope of the Bylaw on Placing on the Market and Use of Feeding Stuffs,
- Food within the scope of the Bylaw on Turkish Food Codex,
(5) The following shall be exempted from Second Part, Fifth Part and Sixth Part:
- substances included in Annex 4,
- substances included in Annex 5,
- substances on their own or in mixtures, registered in accordance with Second Part, exported from Turkey by an actor in the supply chain and re-imported into Turkey by the same or another actor in the same supply chain who proofs that:
- the substance being re-imported is the same as the exported substance;
- he has been provided with the information in accordance with Articles 27 or 28 relating to the exported substance.
- Substances, on their own, in mixtures or in articles, which have been registered in accordance with Second Part and which are recovered in Turkey if:
- the substance that results from the recovery process is the same as the substance that has been registered in accordance with Second Part; and
- the information required by Articles 27 or 28 relating to the substance that has been registered in accordance with Second Part is available to the establishment undertaking the recovery.
(6) Section 1 of Second Part , with the exception of Articles 9 and 10; and Seventh Part shall not be applied to the on-site isolated intermediates and transported isolated intermediates.
(7) The provisions of the Second and Sixth Part shall not apply to the polymers.
Legal Basis
ARTICLE 3 – (1) This By-law is prepared based on the grounds of 09/08/1983 dated and 2872 numbered Environmental Law, 29/06/2011 dated and 644 numbered Decree Law on Establishment and Duties of Ministry of Environment and Urbanization, 11/10/2011 dated and 663 numbered Decree Law on Establishment and Duties of Ministry of Health and Related Authorities, 24/04/1930 and dated 1593 numbered General Hygiene Law, 09/01/1985 dated and 3146 numbered Law on Establishment and Duties of Ministry of Labour and Social Security, 03/06/2011 dated and 639 numbered Decree Law on Establishment and Duties of Ministry of Food, Agriculture and Livestock, 11/06/2010 dated and 5996 numbered Law on Veterinary Services, Plant Health, Food and Feeding Stuff, 29/06/2001 dated and 4703 numbered Law on Preparation and Application of Technical Regulations on Products and 14/08/1987 dated and 87/12028 numbered Regulation Promulgated by the Cabinet of Ministers Decision on Production, Import, Transportation, Storing, Warehousing, Sale, Use, Disposing, Control of Explosives, Hunting Materials and Similar Materials Outside the Scope of the Monopoly.
TURKREACH (KKDIK) BY-LAW
- FIRST PART - General Issues
- SECOND PART - Registration of Substances
- FIRST SECTION - Information Requirements and General Obligation to Register
- SECOND SECTION - Substances Regarded as Being Registered Substances
- THIRD SECTION - Obligation to Register and Information Requirements for Certain Types of Isolated Intermediates
- FOURTH SECTION - Common Provisions for All Registrations
- THIRD PART - Data Sharing and Avoidance of Unnecessary Testing
- SIXTH PART - Evaluation
- SEVENTH PART - Authorization
- EIGHTH PART - Restrictions on the Manufacturing, Placing on the Market and Use Of Certain Dangerous Substances, Mixtures and Articles