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FRIDAY, 26 th DECEMBER 2008 Official Journal No: 27092 (Repeated) Consolidated with the corrigendum on TUESDAY, 10 th November 2009 No: 27402 & SUNDAY, 23 th May 2010 No: 27589 REGULATION ON THE INVENTORY AND CONTROL OF CHEMICALS FIRST SECTION Aim, Scope, Basis and Definitions Aim ARTICLE 1- (1) The purpose of this Regulation is to set out the administrative and technical procedures and principles concerning to the creation and control of inventory in order to provide effective protection aganist adverse effect which the chemicals may cause on human health and the environment. Scope ARTICLE 2- (1) This Regulation includes the below principles of: a) Gathering, presenting and providing accessibility of information on substances. b) Control of possible risks of substances on human health and environment. (2) This Regulation shall not apply to: a) The substances, which are subject to customs supervision in transit, provided that they do not undergo a treatment or processing. b) The substances manufactured or imported for use in military purposes. Basis ARTICLE 3- (1) This Regulation is prepared based upon the Environmental Law No.2872 dated 09/08/1983 and Law No: 4856 dated 01/05/2003 on Organisation and Functions of Ministry of Environment and Forestry. Definitions ARTICLE 4- (1) In enforcement of this Regulation: a) Ministry: means the Ministry of Environment and Forestry responsible for carrying this Regulation into effect.

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DGSA & Chemical Regulations Compliance Services www.crad.com.tr b) CAS Number: means the number provided by "Chemical Abstract Service" c) EC Number: means the number provided by European Commission depending on the structural features of the substance; ç) EINECS: means the European Inventory of Existing Commercial Chemical Substances, which is a descriptive list of all substances available in European Community Market as of 18th September 1981; d)ELINCS: means the European List of Notified Chemical Substances,all new substances which are assigned an ELINCS number provided that it is notified to European Commission and placed on the market of European Community after 18th September 1981; e)Handling: means packing, relocating,transferring from big containers to small ones,repacking, sieving, aerating, mixing and related processes ; renewal or repair of the containers; of the substance or preparation without changing their actual properties f) Safety: means to be away from uncontrolled risks of dangerous substances and preparations; g) IUPAC: means the name of the substance in "International Union of Pure and Applied Chemistry Nomenclature; ) Import: means physical introduction of the substance and/or mixtures into the Customs Territory of Turkey; h) Importer: means any natural or legal person who imports the substance and/or preparation in order to meet the requirements thereof or place on the market; i)Substance: means a chemical element and its compositions in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the production process , but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition; i) Existing substance: means any substance listed in EINECS: J) Preparation: means a mixture or solution composed of two or more substances; k)Risk: means the possibility of the substances and preparations to damage the environment and human health,and seriousness of the damages under the conditions of use of dangerous substances and preparations and/or in case of exposure to dangerous substances and preparations; l) Recommendations for risk reduction: means the recomendations regarding the measures to be taken for reduction of risks of the substance on human health and/or environment, including placing on the market; m) Manufacturer: means any natural and legal person who prepares and/or make someone prepare the chemical substances or preparations with giving their brands or trade name, in any form and with any process, using by chemical elements and/or compounds or mixtures and/or solutions of those, n) Manufacturing: means manufacturing of the substances in solid, liquid or isolated gas state;

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DGSA & Chemical Regulations Compliance Services www.crad.com.tr o) New substance: means any substance listed in ELINCS Dangerous substances and preparations ARTICLE 5- (1) The substances and preparations described below shall be deemed as dangerous for human health and the environment: a) Explosive substances and preparations: solid,liguid,paste- like or gelatinous substances and preparations which may even react exothermically without atmosferic oxygen thereby quickly evolving gases and which, under defined test conditions,detonate,quickly deflagrate or explode upon being self heating when partially confined; b) Oxisiding substances and preparations: substances and preparations which give rise to a highly exorthermic reaction in contact with other substances, and particularly with flammable substances; c) Extremely flammable substances and preparations:. Liquid substances and preparations having an extremely low flash-point and a low boiling-point and gaseous substances and preparations which are flammable in contact with air at ambient temperature and pressure; ç) Highly flamable substances and preparations; 1)Substance and preparations which may become hot and finally catch fire in contact with air at ambient temperature without any application of energy,or; 2) solid substances and preparations which may readily catch fire after brief contact with a source of ignition and which continue to burn or to be consumed after removal of the source of ignition,or; 3) Liquid substances and preparations having a very low flash -point, 4) Substances and preparations which evolve highly flammable gases in dangerous quantities, In case of contact with water or damp air, d) flammable substances and preparations: liquid substances and preparations having a low flash ­point e) Very toxic substances and preparations: substances and preparations which cause death or acute or chronic damage to human health when inhaled,swallowed or absorbed via the skin, in very low quantities. f) Toxic substances and preparations: substances and preparations which cause death or acute or chronic damage to human health when inhaled,swallowed or absorbed via the skin in low quantities. g) Harmful substances and preparations: substances and preparations which cause death or acute or chronic damage to health when inhaled,swallowed or absorbed via the skin, ) Corrosive substances and preparations: substances and preparations which may cause destruction of living tissues in case of contact

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DGSA & Chemical Regulations Compliance Services www.crad.com.tr h) Irritant substances and preparations: substances and preparations which,through immediate,prolonged or repeated contact with the skin or mucous membrane,may cause inflammation, i) Sensitizing substances and preparations: substances and preparations which may cause hypersensitization if they are inhaled or penetrate the skin, and on further exposure to the substance or preparation, characteristic adverse effects are produced. i) Carcinogenic substances and preparations: substances and preparations which,if they are inhaled or ingested or if they penetrate the skin,may induce cancer or increase its incidence, j) Mutagenic substances and preparations: substances and preparations which, if they are inhaled or ingested or if they penetrate the skin, may induce heritable genetic defect or increase their incidence, k) Substances and preparations which are toxic for reproduction: substances and preparations which,if they are inhaled or ingested or if they penetrate the skin,may produce,or increase the incidence of,non-heritable adverse effect in the(unborn child) progeny and/or an impairment of male or female reproductive functions or capacity. l) Substances and preparations which are dangerous for environment: Substances and preparations which present, immediate or delayed danger for one or more components of the environment when they enter environmental media.

SECOND SECTION General Provisions General principles ARTICLE 6- (1) To enable gathering data, prioritization and control of the substance manufactured, or imported in its own or in a preparation shall constitute the basis. (2) To provide adequate protection of human health and environment, by means of reduction of risks posed by dangerous substances to human health and environment, shall constitute the basis.

THIRD SECTION Inventory Creation Providing data on the substances manufactured or imported in high volumes ARTICLE 7- (1) Without prejudice to the application specified in paragraph 1 of Article 10, manufacturers or importers, who have manufactured or imported substances, on their own or in a preparation, in quantities of one thousand tonnes per year or more within the preceding three years from 01/01/2010, shall submit the three years average quantities and the information in the third

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DGSA & Chemical Regulations Compliance Services www.crad.com.tr paragraph of this Article, on which the details are given in Annex II , in accordance with the second paragraph of Article 10, on these substances that they have manufactured or imported, to the Ministry at the latest until the date 31/03/2011. (2) Without prejudice to the application specified in paragraph 1 of Article 10, manufacturers or importers who have manufactured or imported substances on their own or in a preparation for the first time, in quantities of one thousand tonnes per year or more from the date 01/01/2010, shall submit the information in the third paragraph of this Article, on which details are given in Annex-II, in accordance with the second paragraph of article 10, to the Ministry within the consequent three months after one year from the date which the substance was produced or imported for the first time. (3)Information required for substances which are manufactured or imported one thousand tonnes or more per year in its own or in a preparation are: a) Name, EC number, CAS number of the substance; b) Quantity of the substance manufactured or imported c) Classification of the substance including hazard classification, hazard symbol, risk phrases and safety phrases, in accordance with Annex-II of the Regulation on Classification,Packaging and Labelling of Dangeorus Substances and Preparations; ç) Information on foreseeable uses of the substance; d) Data on the physico-chemical properties of the substance; e) Data on movement and behaviour of the substance among environmental media; f) Data on ecotoxicity of the substance; g) Data on acute and sub acute toxicity of the substance; ) Data on effect of substance such as carcinogenic,mutagenic and /or toxic for repruduction; h) Other related information which may be used in risk assessment of the substance

(4) Manufacturers and importers make all reasonable efforts to obtain existing data regarding subclauses (d) to (h) and submit this data to the Ministry. Manufacturers and importers are not obliged to carry out further tests on animals for data or information that are not existing. (5) Ministry will publish a list including substances produced on its own or imported on its own or in a preparation, thousand tonnes or more per year.

The reporting of data on the substances manufactured or imported in small quantities

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DGSA & Chemical Regulations Compliance Services www.crad.com.tr ARTICLE 8- (1) ) Without prejudice to the application specified in paragraph 1 of Article 10, manufacturers or importers who have manufactured or imported substances on their own or in a preparation in quantities of one ton or more but less than one thousand tonnes within the preceding three years from 01/01/2010, shall submit the three years average quantities and the information in the third paragraph of this Article, on which the details are given in Annex III , in accordance with the second paragraph of Article 10, on these substances that they have manufactured or imported, to the Ministry at the latest until the date 31/03/2011. (2) Without prejudice to the application specified in paragraph 1 of Article 10, manufacturers or importers who have manufactured or imported substances on their own or in a preparation for the first time, in quantities of one ton or more but less than one thousand tonnes from the date 1/1/2010, shall submit the information in the third paragraph of this Article, on which details are given in Annex-III, in accordance with the second paragraph of article 10, to the Ministry within consequent three months after one year from the date which the substance was manufactured or imported for the first time. (3)Information required for substances which are manufactured or imported in its own or in a preparation, in quantities of one tonne or more but less one than thousand tonnes per year is: a )Name of the substance,EC number and CAS number; b) Quantity of the substance manufactured or imported c) Classification of the substance including hazard classification, hazard symbol,risk phrases and safety phrases, in accordance with Annex-2 of the Regulation on Classification,Packaging and Labelling of Dangeorus Substances and Preparations; ç) Information on foreseeable uses of the substance; (4) The Ministry may require additional information regarding toxicological and ecotoxicological properties within in the framework of Annex-II concerning the risk assessment of substances from manufacturers or importers which provide data in accordance with the first and second paragraphs.

Exemptions ARTICLE 9- (1) Substances listed in Annex-1 shall be exempted from the conditions of Article 7 and 8 Procedures for the data reporting ARTICLE 10- (1) In case of the substance being manufactured or imported by more than one manufacturer or importer,information in subparagraphs (d),(e),(f),(g),(),(h) of the paragraph 3 of Article 7,and the information requested by paragraph 4 of Article 8, may be submitted by a manufacturer or importer on behalf of them,in case of mutual agreement. However, other manufacturers or importers shall provide the information specified from 1.1 to 1.19 in Annex-II and shall make referance to the manufacturer or importer who applies on behalf of them.

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DGSA & Chemical Regulations Compliance Services www.crad.com.tr (2)Manufacturers or importers shall use the special program package in the website of Ministry in order to provide the information specified in paragraphs (3) of Article 7 and 8. (3)In case of import of substances on their own or in a preparation, the natural or legal persons from whom those substances are imported, may fulfill the obligations of importers under the scope of this regulation, through a representative that are established in Turkey and appointed with an agreement.

Updating the given information ARTICLE 11- (1) The manufacturers and importers who provides information in accordance with Article 7 and 8 shall report the relevant changes to ministry within a month,if: a)A new category of use arises,which changes the type,form, magnitude or duration of exposure of human and the enviroment to the substance, b) New data is obtained related to risk assessment, on physicochemical,toxicological or ecotoxicological properties of the substance; c) A provisional change occurs in the classification of the substance in accordance with the Regulation on Classification, Packaging and Labelling of Dangerous Substance and Preparations; ç) New information is obtained where may be concluded that the substance may pose a serious risk to human health and to the environment; (2) The manufacturer or importer additionally shall submit the information on quantities which is provided in accordance with Article 7 and 8 to the Ministry, every three years, in case of any change in quantities specified in Annexes II and III. (3)In case of changes in terms of address or title of the manufacturer or importer, the manufacturer or importer should communicate the changes to the Ministry not later than a month.

Confidentiality of data ARTICLE 12- (1) If the manufacturer or importer has a thought that the disclosure of information provided in Articles 7.8 and 11 might industrially or commercially harm himself, he shall be able to demand the Ministry in written, not to disclose such information to the third parties.If the manufacturer or the importer disclose the information,which was previously deemed as confidential,they shall notify this to Ministry. (2) Industrial and Commercial Confidentiality shall not apply to: a) The name of the substance

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DGSA & Chemical Regulations Compliance Services www.crad.com.tr b) Data on physicochemical properties and movement and behaviour of the substances among enviromental media. c) The summary of toxicological and ecotoxicological tests and in particular the data on carcinogenic,mutagenic effects and/or toxic effect for reproduction ) ç) Information on substance determination and emergancy intervention methods and measures that must be taken. d) Information on experiments performed on animals or to prevent unnecessary repetition of such experiments. e) In case of release of dangerous substances to the environmental media, analytic methods to enable determination of direct exposure of peopleto those substances, in addition to the determination of such dangerous substances, (3)Ministry shall inform the applicant about the decision, within fifteen (15) days after the confidentiality application, in accordance with paragraph 1, is received. (4) Acceptance of confidentiality application shall be subject to written approval of Ministry. Priority List ARTICLE 13- (1) Ministry shall prepare and publish a priority list of the prioritized substances or the groups of substances which require to pay attention due to their potantial hazards posed to human health and the environment,depending on the information provided by manufacturers and importers in accordance with Article 7 and 8. (2) The following factors shall be taken into consideration for the preparation of priority list: a) Effects of the substance on human health and the environment b) Human and environmental exposure to the substance c) Inadequacy of data on effects of the substance on human health and environment ç) Studies carried out at international organisations and under the international conventions, which Turkey stands as a party. d) Other national legislation on dangerous substances. (3) If the substance has a chronic effect in particular it is carcinogenic, toxic for reproduction and/or mutagenic or it is well known for aggravating these effects or it causes such suspicion, those substances shall be paid special attention.

FOURTH SECTION Assessment of Risks Posed by the Substances to Human Health and the Environment

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DGSA & Chemical Regulations Compliance Services www.crad.com.tr Risk Assessments for the substances appearing on the Priority List ARTICLE 14- (1) Ministry shall perform a risk assessment for the substances in priority list specified in paragraph 1 of Article 13. Depending on this primary risk assessment, the manufacturer or the importer who provided the information on the substance in accordance with Articles 7 and 8, with regard to written request within the scope of the procedure to be specified by Ministry, shall submit the requested information, up on request the additional test results within the period specified by Ministry, after the publication of the list Transitional Provisions Provisional Article 1 (1)The manufacturers or importers which have been completed the data entering process until the date that this regulation has entered into force, are deemed to fulfill their obligations according to the first paragraphs of the Articles 7 and 8 of this regulation. FIFTH SECTION Final Provisions Entry into force ARTICLE 15- (1) This Regulation shall enter into force on the date of publication Enforcement ARTICLE 16- (1) The provisions of this Regulation shall be enforced by the Minister of Environment and Forestry.

ANNEXES

Annex-1 Exemptions from the provisions of Articles 7 and 8. Annex-2 Information referred to in Article 7 Annex-3 Information referred to in Article 8(1) This Regulation was published in the Official Journal Dated 26/12/2008 No 27092 (Repeated)

Amendment to this Regulation was published in the Official Journal Dated 1. 2. 10/11/2009 23/05/2010 No 27402 27589

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