CHEMICAL REGULATIONS IN TURKEY<br />CRAD REGULATORY COMPLIANCE CONSULTING<br />Melih BABAYİĞİT<br />June28, 2011<br />
2<br />CHEMICAL REGULATIONS IN TURKEY <br />Current Situation in TurkeyfromtheRegulatoryscope<br />Turkey  aims to fulfill...
To be in compliance with global modalregulations such as GHS,  UN ADR etc.& EU Regulationsin order to maintain its economi...
To improve local chemical industry to the global standards
Tocoversteps in accessionprocesstofullmembershipto EU.</li></li></ul><li>3<br />CHEMICAL REGULATIONS IN TURKEY<br />Curren...
ChemicalInventoryand Control Regulation C.I.C.R.
Regulation on Authoring and Distribution of Safety Data Sheets for Hazardous Substances and Preparations
Regulation on Classification, Labelling and Packaging of DangerousSubstances and Preparations
Regulation on Restrictions for the Manufacture, Marketing and Use of Some Chemicals
Otherindustry-specificregulations ( detailstofollow )</li></li></ul><li>CHEMICAL REGULATIONS IN TURKEY<br />ChemicalInvent...
Purpose<br /><ul><li>To set up an inventoryforthechemicals
Settle the administrative and technical principles and procedures fordeveloping controlagainst the  potential adverse effe...
Tobuild a baseforfutureregulations</li></ul>CHEMICAL REGULATIONS IN TURKEY <br />ChemicalInventoryandControlRegulation<br />
CHEMICAL REGULATIONS IN TURKEY <br />Regulation on Inventory andControl of Chemicals<br />General Provisions <br />To enab...
CHEMICAL REGULATIONS IN TURKEY <br />Regulation on Inventory and Control of Chemicals<br />Chemicals Which Are Out of Scop...
The substances manufactured or imported for use in military purposes
Substancesthatare < 1mta </li></ul>All other types of chemical substances are underthe scope of theregulation.<br />
CHEMICAL REGULATIONS IN TURKEY <br />Regulation on Inventory andControl of Chemicals<br />Exemptions (Annex I)<br /><ul><l...
Polymers ( OECD & REACH Polymerdefinition) </li></li></ul><li>CHEMICAL REGULATIONS IN TURKEY <br />Regulation on Inventory...
CHEMICAL REGULATIONS IN TURKEY <br />Regulation Inventory and Control of Chemicals<br />Difficulties aboutthe Implementati...
CHEMICAL REGULATIONS IN TURKEY <br />Regulation Inventory and Control of Chemicals<br />BEST  PRACTICE FOR SOLUTION<br />A...
Better interpretation of regulations and obligations,
Ensuring full compliance on behalf of Turkish clients,
Protection of clients from ramifications,
Follow up of upcoming regulations,</li></li></ul><li>CHEMICAL REGULATIONS IN TURKEY <br />Authoringand Distribution of Saf...
CHEMICAL REGULATIONS IN TURKEY <br />Authoring and Distribution of SDS for Hazardous Substances and Preparations Regulatio...
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Crad Turkish Chemical Regulations or Turkish REACH

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A brief introduction of Turkish Chemical regulations from the lead regulatory consultant CRAD Melih Babayigit.

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Crad Turkish Chemical Regulations or Turkish REACH

  1. 1. CHEMICAL REGULATIONS IN TURKEY<br />CRAD REGULATORY COMPLIANCE CONSULTING<br />Melih BABAYİĞİT<br />June28, 2011<br />
  2. 2. 2<br />CHEMICAL REGULATIONS IN TURKEY <br />Current Situation in TurkeyfromtheRegulatoryscope<br />Turkey aims to fulfill its own process with similar regulations to EU regulations, on chemicals:<br /><ul><li>To protect the human health and the environment
  3. 3. To be in compliance with global modalregulations such as GHS, UN ADR etc.& EU Regulationsin order to maintain its economic growthandposition.
  4. 4. To improve local chemical industry to the global standards
  5. 5. Tocoversteps in accessionprocesstofullmembershipto EU.</li></li></ul><li>3<br />CHEMICAL REGULATIONS IN TURKEY<br />Current RegulatorySituation in TurkeyaboutChemicals<br /><ul><li>Legislations Which Have Been RecentlyPublished And Came IntoForce ( 26 December 2008 No: 27092 )
  6. 6. ChemicalInventoryand Control Regulation C.I.C.R.
  7. 7. Regulation on Authoring and Distribution of Safety Data Sheets for Hazardous Substances and Preparations
  8. 8. Regulation on Classification, Labelling and Packaging of DangerousSubstances and Preparations
  9. 9. Regulation on Restrictions for the Manufacture, Marketing and Use of Some Chemicals
  10. 10. Otherindustry-specificregulations ( detailstofollow )</li></li></ul><li>CHEMICAL REGULATIONS IN TURKEY<br />ChemicalInventoryandControlRegulation<br />No: 27092 (Repeated) <br />26 TH DECEMBER 2008 and Consolidated with the corrigendum on 10 TH November 2009 <br />MoEF<br />No: 27092 (Bis) <br />26 TH DECEMBER 2008 and Consolidated with the corrigendum on 10 TH November 2009 <br />Republic of TurkeyMoEF<br />
  11. 11. Purpose<br /><ul><li>To set up an inventoryforthechemicals
  12. 12. Settle the administrative and technical principles and procedures fordeveloping controlagainst the potential adverse effects of chemicals on human health & environment
  13. 13. Tobuild a baseforfutureregulations</li></ul>CHEMICAL REGULATIONS IN TURKEY <br />ChemicalInventoryandControlRegulation<br />
  14. 14. CHEMICAL REGULATIONS IN TURKEY <br />Regulation on Inventory andControl of Chemicals<br />General Provisions <br />To enable gathering data, prioritization and control of the substance manufactured or imported on its own or in a preparation shall constitute the basis.<br />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.<br />
  15. 15. CHEMICAL REGULATIONS IN TURKEY <br />Regulation on Inventory and Control of Chemicals<br />Chemicals Which Are Out of Scope;<br /><ul><li>The substances, which are subject to customs supervision in transit, provided that they do not undergo a treatment or processing,
  16. 16. The substances manufactured or imported for use in military purposes
  17. 17. Substancesthatare < 1mta </li></ul>All other types of chemical substances are underthe scope of theregulation.<br />
  18. 18. CHEMICAL REGULATIONS IN TURKEY <br />Regulation on Inventory andControl of Chemicals<br />Exemptions (Annex I)<br /><ul><li>Substances that naturally occur in nature, which are not chemically modified</li></ul>Coal, petroleumgas<br /><ul><li>Basic natural chemical substances about which sufficient information is available </li></ul>Hydrogen, noble gases<br /><ul><li>Chemicals listed in Annex-I Part 3
  19. 19. Polymers ( OECD & REACH Polymerdefinition) </li></li></ul><li>CHEMICAL REGULATIONS IN TURKEY <br />Regulation on Inventory and Control of Chemicals<br />Determination of Obligations and Deadlines<br />
  20. 20. CHEMICAL REGULATIONS IN TURKEY <br />Regulation Inventory and Control of Chemicals<br />Difficulties aboutthe Implementation<br />Ingredient information of mixtures are mainly not known by importers.<br />Supplying information on ingredients is hard as most exporters with righteous causes keep it as CBI.<br />Information required for substances are too much and complex for most of the importers<br /> Lack of skilled staff for the literature search and data submission <br />Lack of regulatory compliance background at importers.<br />
  21. 21. CHEMICAL REGULATIONS IN TURKEY <br />Regulation Inventory and Control of Chemicals<br />BEST PRACTICE FOR SOLUTION<br />Appointing a contracted representative <br /><ul><li>Keep CBI safe,
  22. 22. Better interpretation of regulations and obligations,
  23. 23. Ensuring full compliance on behalf of Turkish clients,
  24. 24. Protection of clients from ramifications,
  25. 25. Follow up of upcoming regulations,</li></li></ul><li>CHEMICAL REGULATIONS IN TURKEY <br />Authoringand Distribution of Safety Data Sheets for Hazardous Substances and PreparationsRegulation<br />No: 27092 (Repeated) <br /> 26 TH DECEMBER 2008 <br />Republic of TurkeyMoEF<br />
  26. 26. CHEMICAL REGULATIONS IN TURKEY <br />Authoring and Distribution of SDS for Hazardous Substances and Preparations Regulation <br />Purpose<br />To settle the administrative and technical principles and procedures in terms of preparing and distributing safety data sheets in order to provide <br /><ul><li>effective control
  27. 27. efficient surveillance </li></ul>against the potential adverse effects of hazardous chemicals and preparations<br />
  28. 28. CHEMICAL REGULATIONS IN TURKEY <br />Authoring and Distribution of SDS for Hazardous Substances and Preparations Regulation<br />Chemicals & Preparations which a SDS is required;<br />Substances and preparations:<br /><ul><li>classified as hazardous according to Regulation No: 27092
  29. 29. which are not classified as hazardous but which may create hazard to human health and to the environment within the specified concentrations,
  30. 30. Preparations containing a substance which has OEL,</li></ul> A safety data sheet should be prepared and suppliedtotheprofessionaluser.<br />
  31. 31. CHEMICAL REGULATIONS IN TURKEY <br />Authoring and Distribution of SDS for Hazardous Substances and Preparations Regulation<br />Out of Scope<br />The substances and preparations supplied to end users as a final product<br /><ul><li>Medical products which are used with the purpose of human health or veterinary medicine,
  32. 32. Medical devices which are invasive or used with direct physical contact to human body and about which there are data providing and protective provisions in the other regulations at the same level as this,
  33. 33. Cosmeticenduser products,
  34. 34. Mixtures of substances which are described as waste ,
  35. 35. Food products,
  36. 36. Radioactive substances and preparations containing such substances,</li></li></ul><li>CHEMICAL REGULATIONS IN TURKEY <br />Authoring and Distribution of SDS for Hazardous Substances and Preparations Regulation<br />Out of Scope <br /><ul><li>Animal feed
  37. 37. Transport of dangerous goods by railways, motorways, seaways, inland waterways and airways,
  38. 38. Substances and mixtures 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
  39. 39. Explosives, military supplies and products placed on the markets that has a pyrotechnic effect about which there are data providing and protective provisions covered by other regulations,</li></li></ul><li>CHEMICAL REGULATIONS IN TURKEY <br />Authoring and Distribution of SDS for Hazardous Substances and Preparations Regulation<br /><ul><li>Who may prepare?</li></ul>It should be prepared by persons who has been certificated by the institutions that are accredited in terms of personnel certification scheme to author SDS. <br /> *SDS provisionsforimports of requiresthesamequalifications as above.<br />
  40. 40. Authoring and Distribution of SDS for Hazardous Substances and Preparations Regulation<br /><ul><li>Submitting to authorities
  41. 41. Both in written and electronically at the first submission and each revision
  42. 42. An e- copy should be submitted to MoEF.</li></ul>18<br />CHEMICAL REGULATIONS IN TURKEY <br />
  43. 43. CHEMICAL REGULATIONS IN TURKEY <br />Authoring and Distribution of SDS for Hazardous Substances and Preparations Regulation<br />The Language and Content of Safety Data Sheets<br /><ul><li>SDS should be in Turkish.
  44. 44. Chemical names should be in Turkish.( as in Annex II of Clas.Reg. )
  45. 45. R and S phrases should be as they are on Annex V&VI of Clas.Reg.
  46. 46. Section order is same with Annex II of REACH except: </li></ul> the inversion of Section 2 & 3<br />2.Composition/information on ingredients,<br /> 3.Hazards identification,<br />(MoEF is planning an amendment on that inversion & order of sections under REACH Annex II is considered to be compatible ) <br />
  47. 47. CHEMICAL REGULATIONS IN TURKEY <br />Authoring and Distribution of SDS for Hazardous Substances and Preparations Regulation<br />Difficulties on the Implementation of Regulation<br /><ul><li>Insufficient number of certificated staff,
  48. 48. Lack of information and personnelparticularlyfortheimporters,
  49. 49. Companies havepoorcapabilities on following up related regulations,
  50. 50. Classification calculation is a hard and experience requiring process,
  51. 51. Continious updates of informations and regulationsabout classification of chemicals.</li></li></ul><li>CHEMICAL REGULATIONS IN TURKEY <br />CurrentRegulation on Classification, Labelling and Packaging of Substances and Preparations<br />No 27092 (Repeated) 26 TH Dec 2008 <br />Republic of TurkeyMoEF<br />
  52. 52. CHEMICAL REGULATIONS IN TURKEY <br />Regulation on Classification, Labelling and Packaging of Substances and Preparations<br /><ul><li>Identicalrequirementswithformer EU requirements
  53. 53. 29th ATP
  54. 54. Issuesandconcerns</li></ul>What’snext<br />
  55. 55. 23<br />CHEMICAL REGULATIONS IN TURKEY <br />Regulation on Classification, Labelling and Packaging of Substances and Preparations<br /><ul><li>EU CLP 1272/2008 will be harmonized
  56. 56. Regulationdrafting
  57. 57. Forecastedimplementation & transitionperiod</li></li></ul><li>CHEMICAL REGULATIONS IN TURKEY <br />Regulation on Restrictions for the Manufacture, Marketing and Use of Some Chemicals<br />Group of SubstancesSubjecttoRestrictionsare:<br />Asbestosfibres<br />Polychlorinatedterphenyls (PCT) <br />polychlorinatedbiphenyls (PCB)<br />Polybromobiphenyls (PBB)<br />AzocolourantsandAzodyes<br />Someotherchemicalspresented in theannexI of theReg.<br />
  58. 58. CHEMICAL REGULATIONS IN TURKEY <br /><ul><li>OtherProductandIndustrySpecificRegulationsand SEVESO II implementationforsites in Turkey</li></ul>BiocidalProductsRegulation (27449) MoH<br />Regulation on Classification, LabellingandPackagingof Plant Protect Products (27885)MoAgriculture<br />Declarationon Detergents & surfactantsused in Detergents (27794) MoH<br />Regulation on Controlofthe Major Industrial Accidents-SEVESO II (27676)MoEF<br />25<br />
  59. 59. 26<br />CHEMICAL REGULATIONS IN TURKEY <br />Industry-specificregulations<br />BiocidalProductsRegulation<br />(MoH)<br />No: 27449 <br />(Bis) <br /> 31th Dec. 2009 <br />Regulation on Cosmetics<br />(MoH)<br />Regulationon Plant ProtectionProducts<br />(M.of Agriculture and Rural Affairs)<br /> No: 27885<br />25th March 2011<br /> No: 25823<br />23rd May2005<br />Declaration on Detergents & surfactantsused in Detergents<br /> No: 27794 23rdDec.2010 (MoH) <br />

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