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

1. CHEMICAL REGULATIONS IN TURKEY CRAD REGULATORY COMPLIANCE CONSULTING Melih BABAYİĞİT June28, 2011

3. To be in compliance with global modalregulations such as GHS, UN ADR etc.& EU Regulationsin order to maintain its economic growthandposition.

4. To improve local chemical industry to the global standards

6. ChemicalInventoryand Control Regulation C.I.C.R.

7. Regulation on Authoring and Distribution of Safety Data Sheets for Hazardous Substances and Preparations

8. Regulation on Classification, Labelling and Packaging of DangerousSubstances and Preparations

9. Regulation on Restrictions for the Manufacture, Marketing and Use of Some Chemicals

12. Settle the administrative and technical principles and procedures fordeveloping controlagainst the potential adverse effects of chemicals on human health & environment

13. Tobuild a baseforfutureregulationsCHEMICAL REGULATIONS IN TURKEY ChemicalInventoryandControlRegulation

14. CHEMICAL REGULATIONS IN TURKEY Regulation on Inventory andControl of Chemicals General Provisions To enable gathering data, prioritization and control of the substance manufactured or imported on its own or in a preparation shall constitute the basis. 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.

16. The substances manufactured or imported for use in military purposes

17. Substancesthatare < 1mta All other types of chemical substances are underthe scope of theregulation.

20. CHEMICAL REGULATIONS IN TURKEY Regulation Inventory and Control of Chemicals Difficulties aboutthe Implementation Ingredient information of mixtures are mainly not known by importers. Supplying information on ingredients is hard as most exporters with righteous causes keep it as CBI. Information required for substances are too much and complex for most of the importers Lack of skilled staff for the literature search and data submission Lack of regulatory compliance background at importers.

22. Better interpretation of regulations and obligations,

23. Ensuring full compliance on behalf of Turkish clients,

24. Protection of clients from ramifications,

27. efficient surveillance against the potential adverse effects of hazardous chemicals and preparations

29. which are not classified as hazardous but which may create hazard to human health and to the environment within the specified concentrations,

30. Preparations containing a substance which has OEL, A safety data sheet should be prepared and suppliedtotheprofessionaluser.

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. Cosmeticenduser products,

34. Mixtures of substances which are described as waste ,

35. Food products,

37. Transport of dangerous goods by railways, motorways, seaways, inland waterways and airways,

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

41. Both in written and electronically at the first submission and each revision

42. An e- copy should be submitted to MoEF.18 CHEMICAL REGULATIONS IN TURKEY

44. Chemical names should be in Turkish.( as in Annex II of Clas.Reg. )

45. R and S phrases should be as they are on Annex V&VI of Clas.Reg.

46. Section order is same with Annex II of REACH except: the inversion of Section 2 & 3 2.Composition/information on ingredients, 3.Hazards identification, (MoEF is planning an amendment on that inversion & order of sections under REACH Annex II is considered to be compatible )

48. Lack of information and personnelparticularlyfortheimporters,

49. Companies havepoorcapabilities on following up related regulations,

50. Classification calculation is a hard and experience requiring process,

53. 29th ATP

54. IssuesandconcernsWhat’snext

56. Regulationdrafting

59. 26 CHEMICAL REGULATIONS IN TURKEY Industry-specificregulations BiocidalProductsRegulation (MoH) No: 27449 (Bis) 31th Dec. 2009 Regulation on Cosmetics (MoH) Regulationon Plant ProtectionProducts (M.of Agriculture and Rural Affairs) No: 27885 25th March 2011 No: 25823 23rd May2005 Declaration on Detergents & surfactantsused in Detergents No: 27794 23rdDec.2010 (MoH)