{"id":228,"date":"2020-04-30T12:01:52","date_gmt":"2020-04-30T12:01:52","guid":{"rendered":"https:\/\/www.kkdikturkey.com\/?p=228"},"modified":"2021-11-18T20:36:39","modified_gmt":"2021-11-18T20:36:39","slug":"kkdik-turkey","status":"publish","type":"post","link":"https:\/\/www.kkdikturkey.com\/index.php\/kkdik-turkey\/","title":{"rendered":"KKDIK TURKEY"},"content":{"rendered":"\n

DRAFT BY-LAW ON REGISTRATION, EVALUATION, AUTHORIZATION AND RESTRICTION OF CHEMICALS<\/a><\/strong><\/h2>\n\n\n\n

FIRST\nPART<\/strong><\/h3>\n\n\n\n

General\nIssues<\/strong><\/p>\n\n\n\n

FIRST SECTION<\/strong><\/p>\n\n\n\n

Aim,\nScope and Basis<\/strong><\/h4>\n\n\n\n

Aim\n<\/strong><\/p>\n\n\n\n

ARTICLE  1 – <\/strong>(1) The purpose of\nthis Bylaw is to ensure a high level of protection of human health and the\nenvironment, including the promotion of alternative methods for assessment of\nhazards of substances while enhancing competitiveness and innovation.<\/p>\n\n\n\n

Scope<\/strong><\/h4>\n\n\n\n

ARTICLE 2 – <\/strong>(1) This Bylaw covers\nmanufacturing, placing on the market or use of the substances on their own, in\na mixture or in an article and placing the mixtures on the market. <\/p>\n\n\n\n

(2) This Bylaw;<\/p>\n\n\n\n

(a) shall\nnot apply to the substances and mixtures below<\/p>\n\n\n\n

1) Radioactive\nsubstances and mixtures within the scope of Bylaw on the Safe Transportation of\nRadioactive Substances published in the Official Gazette dated 08\/07\/2005 and\nnumbered 25869;<\/p>\n\n\n\n

2) Substances,\non their own, in a mixture or in an article, which are subject to customs\nsupervision, provided that they do not undergo any treatment or processing, and\nwhich are in temporary storage, or in a free zone or free warehouse with a view\nto re- exportation, or in transit; <\/p>\n\n\n\n

3) Non-isolated\nintermediates;<\/p>\n\n\n\n

4) The\ncarriage of hazardous substances and hazardous mixtures by rail, road, inland\nwaterway, sea or air;<\/p>\n\n\n\n

5) Wastes\nin the scope of the Bylaw on Waste Management published in the Official Gazette\ndated 02\/04\/2015 and numbered 29314 and Bylaw on Radioactive Waste Management published\nin the Official Gazette dated 09\/03\/2013 and numbered 28882.<\/p>\n\n\n\n

6) Substances and mixtures which are manufactured or imported for the\npurpose of defense<\/p>\n\n\n\n

(3)\nof this Bylaw<\/p>\n\n\n\n

a) The\nprovisions of Second Part, Fifth Part, Sixth and Seventh Part shall not apply to\nthe substances manufactured or imported in order to use in the products below: <\/p>\n\n\n\n

1) Medicinal\nproducts for human or veterinary use within the scope of Bylaw on the Licencing\nof Medicinal Products for Human Use published in the Official Gazette dated 19\/01\/2005\nand numbered  25705, Bylaw on the\nPackaging and Labelling of Medicinal Products for Human Use  published in the Official Gazette dated 12\/08\/2005\nandnumbered 25904 and Bylaw on Veterinary Medicinal Products published in the\nOfficial Gazette dated 24\/12\/2012 and dated and numbered 28152;<\/p>\n\n\n\n

2) Food\nwithin the scope of the Bylaw on Turkish Food Codex published in the Official Gazette\ndated 29\/12\/2011 and numbered 28157; <\/p>\n\n\n\n

3) Feeding\nstuffs within the scope of the Bylaw on Placing on the Market and Use of\nFeeding Stuffs published in the Official Gazette dated 27\/12\/2011 and numbered\n28155;<\/p>\n\n\n\n

(4)\nof this Bylaw:<\/p>\n\n\n\n

(a) The\nprovisions of Fourth Part shall not apply to the extent the following mixtures\nin the finished state, intended for the final user:<\/p>\n\n\n\n

1)\nMedicinal products for human or veterinary use within the scope of Bylaw on the\nLicencing of Medicinal Products for Human Use published in the Official Gazette\ndated 19\/01\/2005 and numbered  25705,\nBylaw on the Packaging and Labelling of Medicinal Products for Human Use and\npublished in the Official Gazette dated 12\/08\/2005 and numbered 25904 and Bylaw\non Veterinary Medicinal Products published in the Official Gazette dated\n24\/12\/2012 and numbered 28152;<\/p>\n\n\n\n

2)\nCosmetic products within the scope of Bylaw on Cosmetics published in the\nOfficial Gazette dated 23\/05\/2005 and numbered 25823;<\/p>\n\n\n\n

3)\nInvasive medical devices or medical devices which can be used in direct physical\ncontact with the human body ;<\/p>\n\n\n\n

4)\nFeeding stuffs within the scope of the Bylaw on Placing on the Market and Use\nof Feeding Stuffs published in the Official Gazette dated 27\/12\/2011 and numbered\n28155.<\/p>\n\n\n\n

5)\nFood within the scope of the Bylaw on Turkish Food Codex published in the\nOfficial Gazette dated 29\/12\/2011 and numbered 28157; <\/p>\n\n\n\n

(5)\nof this Bylaw: <\/p>\n\n\n\n

(a)\nThe following shall be exempted from Second Part, Fifth Part and Sixth Part:<\/p>\n\n\n\n

1) Substances\nincluded in Annex 4, <\/p>\n\n\n\n

2) Substances\nincluded in Annex 5, <\/p>\n\n\n\n

3) Substances\non their own or in mixtures, registered in accordance with Second Part ,\nexported from Turkey by an actor in the supply chain and re-imported into\nTurkey by the same or another actor in the same supply chain who proofs that: <\/p>\n\n\n\n

a) The\nsubstance being re-imported is the same as the exported substance;<\/p>\n\n\n\n

b) He\nhas been provided with the information in accordance with Articles 27 or 28\nrelating to the exported substance.<\/p>\n\n\n\n

4) Substances,\non their own, in mixtures or in articles, which have been registered in\naccordance with Second Part and which are recovered in Turkey if: <\/p>\n\n\n\n

a) The\nsubstance that results from the recovery process is the same as the substance\nthat has been registered in accordance with Second Part; and<\/p>\n\n\n\n

b) The\ninformation required by Articles 27 or 28 relating to the substance that has\nbeen registered in accordance with Second Part is available to the\nestablishment undertaking the recovery.<\/p>\n\n\n\n

(6) of\nthis Bylaw: <\/p>\n\n\n\n

(a) Section 1 of Second\nPart , with the exception of Articles 9 and 10; and Seventh Part  shall not be applied to the on-site isolated\nintermediates and transported isolated intermediates. <\/p>\n\n\n\n

(7) of\nthis Bylaw: <\/p>\n\n\n\n

(a) the\nprovisions of the Second and Sixth Part shall not apply to the polymers. <\/p>\n\n\n\n

Legal\nBasis <\/strong><\/h4>\n\n\n\n

ARTICLE\n3 –<\/strong>\n(1) This By-law is prepared <\/p>\n\n\n\n

  1. Based\non the grounds of 09\/08\/1983 dated 2872 numbered Environmental Law, 04\/07\/2011\ndated 644 numbered Decree Law on Establishment and Duties of Ministry of\nEnvironment and Urbanization, 11\/10\/2011 dated 663 numbered Decree Law on\nEstablishment and Duties of Ministry of Health and Related Authorities,\n24\/04\/1930 dated 1593 numbered General Hygiene Law, 09\/01\/1985 dated 3146\nnumbered Law on Establishment and Duties of Ministry of Labour and Social\nSecurity, 03\/06\/2011 dated 639 numbered Decree Law on Establishment and Duties\nof Ministry of Food,  Agriculture and Livestock,\n11\/06\/2010 dated 5996 numbered Law on Veterinary Services, Plant Health, Food\nand Feeding Stuff, 14\/08\/1987 dated 87\/12028 numbered Regulation Promulgated by\nthe Cabinet of Ministers Decision on Production, Import, Transportation,\nStoring, Warehousing, Sale, Use, Disposing, Control of Explosives, Hunting\nMaterials and Similar Materials  Outside\nthe Scope of the Monopoly and 29\/06\/2001 dated and 4703 numbered Law on\nPreparation and Application of Technical Regulations on Products.<\/li><\/ol>\n\n\n\n

    SECOND\nSECTION<\/strong><\/p>\n\n\n\n

    Definitions\nand General Provision<\/strong><\/p>\n\n\n\n

    Definitions <\/strong><\/h4>\n\n\n\n

    ARTICLE\n4 –<\/strong>\n(1) For the purposes of this Bylaw: <\/p>\n\n\n\n

    a)  Alloy: means a metallic material, homogenous\non a macroscopic scale, consisting of two or more elements so combined that\nthey cannot be readily separated by mechanical means;<\/p>\n\n\n\n

    b)\nDownstream user: means any natural or legal person established within Turkey,\nother than the manufacturer or the importer, who uses a substance, either on\nits own or in a mixture, in the course of his industrial or professional\nactivities. A distributor or a consumer is not a downstream user;<\/p>\n\n\n\n

    c) Intermediate: means a substance that is\nmanufactured for and consumed in or used for chemical processing in order to be\ntransformed into another substance <\/p>\n\n\n\n

    \u00e7)\nMinistry: means the Ministry of Environment and Urbanization; <\/p>\n\n\n\n

    d) Identified\nuse: means a use of a substance on its own or in a mixture, or a use of a mixture,\nthat is intended by an actor in the supply chain, including his own use, or\nthat is made known to him in writing by a downstream user;<\/p>\n\n\n\n

    e) Scientific\nresearch and development: means any scientific experimentation, analysis or\nchemical research carried out under controlled conditions in a volume less than\none tonne per year; <\/p>\n\n\n\n

    f) CAS\nNumber: the number given by the \u201cChemical Abstract Service\u201d;<\/p>\n\n\n\n

    g)\nStudy summary: means a summary of the objectives, methods, results and\nconclusions of a full study report providing sufficient information to make an\nassessment of the relevance of the study; <\/p>\n\n\n\n

    \u011f)\nDistributor: means any natural or legal person established within Turkey,\nincluding a retailer, who only stores and places on the market a substance, on\nits own or in a mixture , for third parties; <\/p>\n\n\n\n

    h)Substances which\noccur in nature: means a naturally occurring substance as such, unprocessed or\nprocessed only by manual, mechanical or gravitational means, by dissolution in\nwater, by flotation, by extraction with water, by steam distillation or by\nheating solely to remove water, or which is extracted from air by any means;<\/p>\n\n\n\n

    \u0131) EINECS: European Inventory of Existing Commercial\nChemical Substances is the definer of all substances existing in the European\nCommunity Market since 18th<\/sup> of September, 1981;<\/p>\n\n\n\n

    i)\nELINCS: means all the new substances which are put on European Community Market\nand have an ELINCS number by sending a notice to European Inventory of Existing\nCommercial Chemical Substances after 18th<\/sup> of September, 1981; <\/p>\n\n\n\n

    j) Article: means an object which during\nproduction is given a special shape, surface or design which determines its\nfunction to a greater degree than does its chemical composition; <\/strong><\/p>\n\n\n\n

    k) Recipient of an article: means an\nindustrial or professional user, or a distributor, being supplied with an\narticle but does not include consumers;<\/p>\n\n\n\n

    l) Supplier of an article: means any producer\nor importer of an article, distributor or other actor in the supply chain\nplacing an article on the market; <\/p>\n\n\n\n

    m) Manufacturer\nof an article: Natural or legal person established in Turkey who manufacture or\nassembly the article;<\/p>\n\n\n\n

     n) IUPAC name: the name of the substance given\nby \u201cInternational Union and Pure Applied Chemistry\u201d;<\/p>\n\n\n\n

    o)\nRelevant authority: means Ministry of Health for biocidal products, Ministry of\nCustoms and Trade for detergents and surface active agents used in detergents, air\naromatizing products, cleaning products with strong acid or base and chemicals\nused in pool water, Ministry of Food, Agriculture and Livestock for plant\nprotection products, Ministry of Science, Industry and Technology and Ministry\nof Internal Affairs for explosives and pyrotechnic substances, Ministry of\nEnvironment and Urbanization for all \nother substances and mixtures and for the coordination of all the\nactivities within the framework of this Bylaw;<\/p>\n\n\n\n

    Ministry\nof Health, Ministry of Customs and Trade, \nMinistry of Food, Agriculture and Livestock, Ministry of Science,\nIndustry and Technology, Ministry of Economy, Ministry of Work and Social\nSecurity, Ministry of Energy and Natural Resources andMinistry of Environment\nand Urbanization are responsible for inspection and enforcement of restricted\nand prohibited substances in the scope of Annex 17..<\/p>\n\n\n\n

    \u00f6) Manufacturing:\nmeans production or extraction of substances in the natural state; <\/p>\n\n\n\n

    p)\nManufacturer: means any natural or legal person established within Turkey who\nmanufactures a substance within Turkey; <\/p>\n\n\n\n

    r)\nImport: means the physical introduction into the customs territory of Turkey; <\/p>\n\n\n\n

    s)\nImporter: means any natural or legal person established within Turkey who is\nresponsible for import; <\/p>\n\n\n\n

    \u015f) Non-isolated\nintermediate: means an intermediate that during synthesis is not intentionally\nremoved (except for sampling) from the equipment in which the synthesis takes\nplace.<\/p>\n\n\n\n

    t) Robust study summary: means a detailed\nsummary of the objectives, methods, results and conclusions of a full study\nreport providing sufficient information to make an independent assessment of\nthe study minimising the need to consult the full study report;<\/p>\n\n\n\n

    u)\nMixture : means a mixture or solution composed of two or more substances; <\/p>\n\n\n\n

    \u00fc)\nRegistrant: means the manufacturer or the importer of a substance or the\nproducer or importer of an article submitting a registration for a substance; <\/p>\n\n\n\n

    v)\nRegistrant’s own use: means an industrial or professional use by the\nregistrant;<\/p>\n\n\n\n

    y) Restriction: means any condition for or\nprohibition of the manufacture, use or placing on the market; <\/p>\n\n\n\n

    z) Not chemically modified substance: means a\nsubstance whose chemical structure remains unchanged, even if it has undergone\na chemical process or treatment, or a physical mineralogical transformation,\nfor instance to remove impurities;<\/p>\n\n\n\n

    aa)\nSME: means small and medium-sized enterprises as defined in Bylaw on\nDefinition, Qualifications and Classification of Small and Medium-sized\nEnterprises published in the Official Gazette dated 18\/11\/2005 numbered 25997; <\/p>\n\n\n\n

    bb)\nUse: means any processing, formulation, consumption, storage, keeping,\ntreatment, filling into containers, transfer from one container to another,\nmixing, production of an article or any other utilisation,<\/p>\n\n\n\n

    1) (Annex:RG-29\/11\/2019-30963) <\/strong>Industrial\nuse: means using a substance or a mixture in industry,<\/p>\n\n\n\n

    2) (Annex: RG-29\/11\/2019-30963) <\/strong>Professional\nuse: means using a substance or a mixture outside industry in areas such as\neducation, health,<\/p>\n\n\n\n

    cc) Use and exposure category: means an\nexposure scenario covering a wide range of processes or uses, where the\nprocesses or uses are communicated, as a minimum, in terms of the brief general\ndescription of use; <\/p>\n\n\n\n

    \u00e7\u00e7) Substance: means chemicals elements and their\ncomposition which occur naturally or with a production including the additives\nin order to keep the stability and impurities of production but excluding the\ndissolvers removed without affecting the stability and the structure;<\/p>\n\n\n\n

    dd) Recipient of a substance or a mixture :\nmeans a downstream user or a distributor being supplied with a substance or a\nmixture; <\/p>\n\n\n\n

    ee) Supplier of a substance or a mixture: means\nany manufacturer, importer, downstream user or distributor placing on the\nmarket a substance, on its own or in a mixture , or a mixture; <\/p>\n\n\n\n

    ff)\nExposure scenario: means the set of conditions, including operational\nconditions and risk management measures, that describe how the substance is\nmanufactured or used during its life-cycle and how the manufacturer or importer\ncontrols, or recommends downstream users to control, exposures of humans and\nthe environment. These exposure scenarios may cover one specific process or use\nor several processes or uses as appropriate; <\/p>\n\n\n\n

    gg) Monomer:\nmeans a substance which is capable of forming covalent bonds with a sequence of\nadditional like or unlike molecules under the conditions of the relevant\npolymer-forming reaction used for the particular process; <\/p>\n\n\n\n

    \u011f\u011f)\nPlacing on the market: means supplying or making available, whether in return\nfor payment or free of charge, to a third party or import; <\/p>\n\n\n\n

    hh) Polymer: means a substance consisting of\nmolecules characterised by the sequence of one or more types of monomer units,distributed\nover a range of molecular weights wherein differences in the molecular weight\nare primarily attributable to differences in the number of monomer units and comprises\nthe following: <\/strong><\/p>\n\n\n\n

    1. A simple weight majority of\nmolecules containing at least three monomer units which are covalently bound to\nat least one other monomer unit or other reactant; and
      1. Less than a simple weight\nmajority of molecules of the same molecular weight. <\/li><\/ol><\/li><\/ol>\n\n\n\n

        \u0131\u0131)\nFull study report: means a complete and comprehensive description of the\nactivity performed to generate the information. This covers the complete\nscientific paper as published in the literature describing the study performed\nor the full report prepared by the test laboratory describing the study\nperformed; <\/p>\n\n\n\n

        ii) Transported isolated intermediate: means\nan intermediate not meeting the criteria of a non-isolated intermediate and\ntransported between or supplied to other sites; <\/p>\n\n\n\n

        jj)\nSupplier: means any manufacturer, importer, downstream user or distributor\nplacing on the market a substance, on its own or in a mixture , or a mixture;<\/p>\n\n\n\n

        kk)\nActors in the supply chain: means all manufacturers and\/or importers and\/or\ndownstream users in a supply chain; <\/p>\n\n\n\n

        ll) Product and process orientated research\nand development: means any scientific development related to product\ndevelopment or the further development of a substance, on its own, in mixtures\nor in articles in the course of which pilot plant or production trials are used\nto develop the production process and\/or to test the fields of application of\nthe substance;<\/p>\n\n\n\n

        mm) On-site:\nmeans a single location, in which, if there is more than one manufacturer of\n(a) substance(s), certain infrastructure and facilities are shared; <\/p>\n\n\n\n

        nn)\nOn-site isolated intermediate: means an intermediate not meeting the criteria\nof a non-isolated intermediate and where the manufacture of the intermediate\nand the synthesis of (an)other substance(s) from that intermediate take place\non the same site, operated by one or more legal entities; <\/p>\n\n\n\n

        oo)\nCompetent authority: means Ministry of Environment and Urbanization; <\/p>\n\n\n\n

        \u00f6\u00f6) Amount\nper year: means the avarege amount of manufacture or import in the previous\nconsecutive three calendar years, for the substances that have been imported or\nmanufactured for at least three consecutive years; the amount of manufacture or\nimport in the year of which the highest quantity is imported or manufactured, for\nthe substances that have not been imported or manufactured for at least three\nconsecutive years;<\/p>\n\n\n\n

        General provisions<\/strong><\/h4>\n\n\n\n

        ARTICLE 5 \u2013<\/strong> (1) Any manufacturer,\nimporter and downstream users are responsible with the production, placing on\nthe market or use of the substance without any negative effect to the human\nhealth or the environment. <\/p>\n\n\n\n

        (2) Any\nmanufacturer, importer, or where relevant downstream user, may, whilst\nretaining full responsibility for complying with his obligations under this\nBylaw, appoint a third party representative for all proceedings under Article\n12, Article 19, Article 44 and Third Part involving discussions with other\nmanufacturers, importers, or where relevant downstream users. In these cases,\nthe identity of a manufacturer or importer or downstream user who has appointed\na representative shall not be disclosed by the Ministry to other manufacturers,\nimporters, or, where relevant, downstream users. <\/p>\n\n\n\n

        SECOND PART<\/strong><\/p>\n\n\n\n

        Registration\nof Substances<\/strong><\/h4>\n\n\n\n

        FIRST SECTION<\/strong><\/strong><\/p>\n\n\n\n

        Information Requirements and General Obligation\nto Register<\/strong><\/p>\n\n\n\n

        Placing of the\nsubstances on the market <\/strong><\/h4>\n\n\n\n

        ARTICLE 6 \u2013<\/strong> (1) Subject\nto Articles 7, 8 and 21, substances on their own, in mixtures or in articles\nshall not be manufactured or placed on the market unless they have been\nregistered in accordance with the relevant provisions of this Part where this\nis required.<\/strong><\/p>\n\n\n\n

        General obligation\nto register substances on their own or in mixtures<\/strong><\/h4>\n\n\n\n

        ARTICLE 7 \u2013<\/strong> (1) Save\nwhere this Regulation provides otherwise, any manufacturer or importer of a\nsubstance, either on its own or in one or more mixture (s), in quantities of\none tons or more per year shall submit a registration to the Ministry through\nChemicals Registration System in the website of Ministry. <\/strong><\/p>\n\n\n\n