TREACH (KKDIK) BY-LAW (Part 1, Section 2)
BY-LAW ON REGISTRATION, EVALUATION, AUTHORIZATION AND RESTRICTION OF CHEMICALS
FIRST PART
General Issues
SECOND SECTION
Definitions and General Provision
Definitions
ARTICLE 4 – (1) For the purposes of this Bylaw:
- Alloy: means a metallic material, homogenous on a macroscopic scale, consisting of two or more elements so combined that they cannot be readily separated by mechanical means;
- 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;
- Intermediate: means a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance
- Ministry: means the Ministry of Environment and Urbanization;
- Identified use: means a use of a substance on its own or in a mixture, or a use of a mixture, that is intended by an actor in the supply chain, including his own use, or that is made known to him in writing by a downstream user;
- Scientific research and development: means any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than one tonne per year;
- CAS Number: the number given by the “Chemical Abstract Service”;
- Study summary: means a summary of the objectives, methods, results and conclusions of a full study report providing sufficient information to make an assessment of the relevance of the study;
- Distributor: means any natural or legal person established within Turkey, including a retailer, who only stores and places on the market a substance, on its own or in a mixture , for third parties;
- Substances which occur in nature: means a naturally occurring substance as such, unprocessed or processed only by manual, mechanical or gravitational means, by dissolution in water, by flotation, by extraction with water, by steam distillation or by heating solely to remove water, or which is extracted from air by any means;
- EINECS: European Inventory of Existing Commercial Chemical Substances is the definer of all substances existing in the European Community Market since 18th of September, 1981;
- ELINCS: means all the new substances which are put on European Community Market and have an ELINCS number by sending a notice to European Inventory of Existing Commercial Chemical Substances after 18th of September, 1981;
- Article: means an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition;
- Recipient of an article: means an industrial or professional user, or a distributor, being supplied with an article but does not include consumers;
- Supplier of an article: means any producer or importer of an article, distributor or other actor in the supply chain placing an article on the market;
- Manufacturer of an article: Natural or legal person established in Turkey who manufacture or assembly the article;
- IUPAC name: the name of the substance given by “International Union and Pure Applied Chemistry”;
- Relevant authority: means Ministry of Health for biocidal products, Ministry of Customs and Trade for detergents and surface active agents used in detergents, air aromatizing products, cleaning products with strong acid or base and chemicals used in pool water, Ministry of Food, Agriculture and Livestock for plant protection products, Ministry of Science, Industry and Technology and Ministry of Internal Affairs for explosives and pyrotechnic substances, Ministry of Environment and Urbanization for all other substances and mixtures and for the coordination of all the activities within the framework of this Bylaw; Ministry of Health, Ministry of Customs and Trade, Ministry of Food, Agriculture and Livestock, Ministry of Science, Industry and Technology, Ministry of Economy, Ministry of Work and Social Security, Ministry of Energy and Natural Resources and Ministry of Environment and Urbanization are responsible for inspection and enforcement of restricted and prohibited substances in the scope of Annex 17..
- Manufacturing: means production or extraction of substances in the natural state;
- Manufacturer: means any natural or legal person established within Turkey who manufactures a substance within Turkey;
- Import: means the physical introduction into the customs territory of Turkey;
- Importer: means any natural or legal person established within Turkey who is responsible for import;
- Non-isolated intermediate: means an intermediate that during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes place.
- Robust study summary: means a detailed summary of the objectives, methods, results and conclusions of a full study report providing sufficient information to make an independent assessment of the study minimising the need to consult the full study report;
- Mixture : means a mixture or solution composed of two or more substances;
- Registrant: means the manufacturer or the importer of a substance or the producer or importer of an article submitting a registration for a substance;
- Registrant's own use: means an industrial or professional use by the registrant;
- Restriction: means any condition for or prohibition of the manufacture, use or placing on the market;
- Not chemically modified substance: means a substance whose chemical structure remains unchanged, even if it has undergone a chemical process or treatment, or a physical mineralogical transformation, for instance to remove impurities;
- SME: means small and medium-sized enterprises as defined in Bylaw on Definition, Qualifications and Classification of Small and Medium-sized Enterprises published in the Official Gazette dated 18/11/2005 numbered 25997;
- Use: means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation;
- Use and exposure category: means an exposure scenario covering a wide range of processes or uses, where the processes or uses are communicated, as a minimum, in terms of the brief general description of use;
- Substance: means chemicals elements and their composition which occur naturally or with a production including the additives in order to keep the stability and impurities of production but excluding the dissolvers removed without affecting the stability and the structure;
- Recipient of a substance or a mixture : means a downstream user or a distributor being supplied with a substance or a mixture;
- Supplier of a substance or a mixture: means any manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a mixture , or a mixture;
- Exposure scenario: means the set of conditions, including operational conditions and risk management measures, that describe how the substance is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment. These exposure scenarios may cover one specific process or use or several processes or uses as appropriate;
- Monomer: means a substance which is capable of forming covalent bonds with a sequence of additional like or unlike molecules under the conditions of the relevant polymer-forming reaction used for the particular process;
- Placing on the market: means supplying or making available, whether in return for payment or free of charge, to a third party or import;
- Polymer: means a substance consisting of molecules characterised by the sequence of one or more types of monomer units, distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units and comprises the following:
- A simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant; and
- Less than a simple weight majority of molecules of the same molecular weight.
- Full study report: means a complete and comprehensive description of the activity performed to generate the information. This covers the complete scientific paper as published in the literature describing the study performed or the full report prepared by the test laboratory describing the study performed;
- Transported isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and transported between or supplied to other sites;
- Supplier: means any manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a mixture , or a mixture;
- Actors in the supply chain: means all manufacturers and/or importers and/or downstream users in a supply chain;
- Product and process orientated research and development: means any scientific development related to product development or the further development of a substance, on its own, in mixtures or in articles in the course of which pilot plant or production trials are used to develop the production process and/or to test the fields of application of the substance;
- On-site: means a single location, in which, if there is more than one manufacturer of (a) substance(s), certain infrastructure and facilities are shared;
- On-site isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and where the manufacture of the intermediate and the synthesis of (an)other substance(s) from that intermediate take place on the same site, operated by one or more legal entities; oo) Competent authority: means Ministry of Environment and Urbanization;
- Competent authority: means Ministry of Environment and Urbanization;
- Amount per year: means the average amount of manufacture or import in the previous consecutive three calendar years, for the substances that have been imported or manufactured for at least three consecutive years; the amount of manufacture or import in the year of which the highest quantity is imported or manufactured, for the substances that have not been imported or manufactured for at least three consecutive years;
General provisions
ARTICLE 5 – (1) Any manufacturer, importer and downstream users are responsible with the production, placing on the market or use of the substance without any negative effect to the human health or the environment.
(2) Any manufacturer, importer, or where relevant downstream user, may, whilst retaining full responsibility for complying with his obligations under this Bylaw, appoint a third party representative for all proceedings under Article 12, Article 19, Article 44 and Third Part involving discussions with other manufacturers, importers, or where relevant downstream users. In these cases, the identity of a manufacturer or importer or downstream user who has appointed a representative shall not be disclosed by the Ministry to other manufacturers, importers, or, where relevant, downstream users.
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