Regulations to Comply with when Placing Chemical Products on the Turkish Market Melih Babayiğit CRAD Regulatory Services www.crad.com.tr 1
Current Regulations Chemical Inventory and Control Regulation (CICR 27092) Regulation on Restrictions for the Manufacture, Marketing and Use of Certain Dangerous Substances & Preparations (27092) SEA Regulation (28848) Turkish CLP implementation SDS Regulation (29204) Product specific registration and/or notification schemes
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Chemical Inventory and Control Regulation No:27092 (Bis) 26th December 2008 Amended on 10th November 2009
Republic of Turkiye MoEU
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Chemical Inventory and Control Regulation Chemicals in the scope; All substances, that are manufactured or imported either on their own or in a mixture that are ≥1mta are to be notified to the Environmental Information System (EIS) of MoEU similar provisions with an old Council Regulation EEC 793/93
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Chemical Inventory and Control Regulation
Chemicals Which Are Out of Scope; The substances, which are subject to customs supervision in transit, provided that they do not undergo a treatment or processing, The substances manufactured or imported for use in military purposes Substances that are < 1mta
All other types of chemical substances are in the scope of the regulation.
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Chemical Inventory and Control Regulation
Annex I Exemptions (like Annex IV&V REACH) Substances that naturally occur in nature, which are not chemically modified, Basic natural chemical substances about which sufficient information is available Chemicals listed in Annex-I Part 3 (Annex IV of REACH) Polymers ( OECD & REACH Polymer definition)
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Chemical Inventory and Control Regulation What are the points to keep an eye on ? • Threshold changes of notified substances. • Changes in the Classification and/or use of notified substances • Changes in the LE details of the importers such as Address or LE name Also ….. • Any substance that is imported to Turkey after 31.12.2010 has to be notified within 12+3 months from the first date of import at the latest… • Will be repealed when Turkish REACH implementation KKDİK is published….
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No:28848 (Bis) 11 December 2013 Republic of Turkiye MoEU
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Turkish SEA Reg. (similarities & differences on legal text) While interpreting and evaluating the scope and principles of SEA regulation after this presentation, please consider that; REACH is not yet adapted in Turkey; so Turkish SEA regulation can not refer to REACH as CLP does, The legal text is texted based on Legal Entities in Turkey. Expert judgement required for interpretations for the imports.
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CLP Implementation Concept & Comparison with EU 27092 SAE Regulation
DSD & DPD
New 28848 SEA Regulation
CLP
28848 SEA Regulation is in force from the date publication (11.12.2013) 27092 SAE Regulation will be fully repealed by the date 1.06.2016
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Turkish SEA is providing an obligation for: manufacturers, importers and downstream users to classify substances and mixtures placed on the market; suppliers to label and package substances and mixtures that are classified as hazardous and placed on the market; manufacturers and importers of substances to notify to the competent authority in order to form a C&L inventory.
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Turkish SEA (Scope) This regulation shall not apply to ….. are all same as EU CLP… with giving references to relevant Turkish regulations to define waste, radioactives etc…
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Turkish SEA Reg. (similarities & differences on legal text) Annexes Annexes
comparison with CLP
I
same
CLASSIFICATION AND LABELLING REQUIREMENTS FOR HAZARDOUS SUBSTANCES AND MIXTURES
II
same
SPECIAL RULES FOR LABELLING AND PACKAGING OF CERTAIN SUBSTANCES AND MIXTURES
III
Same (in Turkish)
LIST OF HAZARD STATEMENTS, SUPPLEMENTAL HAZARD INFORMATION AND SUPPLEMENTAL LABEL ELEMENTS
IV
Same (in Turkish)
LIST OF PRECAUTIONARY STATEMENTS
V
same
VI
few differences
VII
same
Description
HAZARD PICTOGRAMS HARMONIZED CLASSIFICATION AND LABELLING FOR SOME HAZARDOUS SUBSTANCES
TRANSLATION TABLE FROM CLASSIFICATION UNDER 27092 TO CLASSIFICATION UNDER THIS REGULATION
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Turkish SEA Reg. (similarities & differences on legal text) Annexes
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Turkish SEA Reg. (similarities & differences on legal text) details on differences • Annex VI is identical with CLP 3rd ATP but; • There are only differences in entries for Boron compounds for the ones classified as Repr. 2 / Repr. 1B • Signal words are given as ;
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Turkish SEA Reg. (similarities & differences on legal text) details on differences • Also the abbreviations used for Hazard Class and category codes are in Turkish and given as below examples; CLP Hazard Class Acute Tox. 1 - H300 Aerosol 1 - H222, H229 Aquatic Acute 2 - H401 Aquatic Chronic 1 - H410 Asp. Tox. 1 - H304 Carc. 1A - H350 Expl. 1.1 - H201 Eye Dam. 1 - H318 Eye Irrit. 2 - H319 Flam. Gas 1 - H220
SEA Hazard Class Akut Tok. 1- H300 Aerosol 1- H222, H229 Sucul Akut 2- H401 Sucul Kronik 1- H410 Asp. Tok. 1- H304 Kans. 1A- H350 Pat. 1.1- H201 Göz Hsr. 1- H318 Göz Tah. 2- H319 Alev. Gaz 1- H220
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Critical dates of Turkish SEA Regulation • 1st June 2015 - deadline for classification and labelling of substances according to SEA. • 1st June 2016 - deadline for classification and labelling of mixtures to according to SEA. • 1st June 2015 - deadline for notification to C&L inventory for substances placed on the market before 1st June 2015 • 2 years derogation to prevent re-labelling for the products placed on the market respectively dependent on the applicable deadline
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Time table differences for CLP & SEA EU vs Turkey From 1.6.2015 to 1.6.2016 Turkey still requires to communicate dual classification for substances on SDS. ( while EU fully repeals DSD/DPD classification).
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Turkish SEA Regulation C&L notification • Substances placed on the market before 1.6.2015 are to be notified C&L inventory before 1.6.2015 • Substances placed on the market after 1.6.2015 are to be notified to the C&L inventory within one month at the latest after placing on the market for the first time.
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Turkish SEA Regulation C&L notification
Who will notify ? • Notification can be made by Manufacturers or Importers or groups thereof which have a LE in Turkey • For companies that don’t have a LE in Turkey may over take the notification obligation through their Legal representatives that are appointed with a letter of assignment. ( article 41) • As there is no REACH implementation available by now, derogation to notify to C&L inventory for registered substances does not apply as it was in EU.
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Turkish SEA Regulation C&L notification Which substances will be notified for imported substances and mixtures? • Substances which meet the criteria for classification as hazardous and are imported, either on their own or in a mixture above the concentration limits specified in this Regulation (SEA/CLP), where relevant, which results in the classification of the mixture as hazardous. • Please consider that ; Active substances of Biocidal Products Active substances of Plant Protection Products Substances listed in ELINICS as NONS are subject to C&L notification as far as they meet the above mentioned conditions.
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Turkish SEA Regulation C&L notification What will be notified? • Below listed information for each importer of the substance; -Name, Address, phone, fax , e-mail of importer LE, -Contact Person -Place of manufacturing ( if applicable) • Substance identity as stated on Art.39 (1) • Classification of the substance in accordance with Art. 15; • Reasons and justifications if there is lacking or non conclusive data if the substance is not classified for some hazard classes and not being classified due to differences ion of the in accordance with the regulation, • If applicable specific concentration limit values and M- factors; • Labelling data and Hazard statements of the substance.
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Regulation on Safety Data Sheets No:29204 13th December 2014 Republic of Turkiye MoEU
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New Turkish SDS Regulation For which substances & mixtures manufacturers and importers are obliged to provide a compliant SDS? Obligation to provide a compliant SDS criteria are same as EU 453/2010 In general ( Turkish SDS Regulation = EU 453/2010 excluding REACH Registration related parts such as CSA and Registration numbers.) There are still some nuances ……..
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New Turkish SDS Regulation The Language and Content of Safety Data Sheets SDS should be in Turkish, Chemical names should be in Turkish (especially for the substances listed in Annex VI of TR SEA) Hazard classification, H and P phrases as they are given Annex III&VI of TR SEA Reg. Section & subsection order is same with EU 453/2010 except 15.2 25
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New Turkish SDS Regulation The Language and Content of Safety Data Sheets SDS should be in Turkish, Chemical names should be in Turkish (especially for the substances listed in Annex VI of TR SEA) Hazard classification, H and P phrases as they are given Annex III&VI of TR SEA Reg. Section & subsection order is same with EU 453/2010 except 15.2 26
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New Turkish SDS Regulation Other things to consider SDS can be authored by persons who has been certificated by the certification bodies that are accredited by TURKAK in terms of personnel certification scheme (TS EN ISO/IEC 17024) to author SDS. (Article 5 prg 13) Criteria to meet for people to sit the certification exam are given in Annex IV Certification body arranges an examination in accordance with Annex III of the SDS regulation as well as submit a list of certified authors to MoEU Certified author identifies his contact details as well as certificate number in Sec 16 of the SDS
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New Turkish SDS Regulation Article 5 Prg 7 : Information given in Part I of the SDS should appear on each page of the SDS. Below is a sample of Turkish Compliant SDS header (each page) as defined in Annex I Part II of the Turkish SDS regulation
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What is next?
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KKDIK - Turkish REACH • Key message: • substances that are manufactured or imported ≥1 mta neds to be registered between 31.12.2015 – 31.12.2018 (as defined in draft) • We expect this term to be amended as 31.12.201631.12.2020 • Competent Authority: - Turkish Ministry of Environment and Urbanization
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KKDIK - Turkish REACH • Key message: • There will be a pre-registration period for 1 or 2 year. • Possible dates • 31.12.2015 to 31.12.2017 (Pre-registration) • 01.01.2018 - 31.12.2020 (Registration) • Late pre-registration under discussion.
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KKDIK - Turkish REACH • Registration process: - Joint registrations possible - Manufacturers & Exporters of Chemicals who exports substances can appoint Only Representatives (OR) and submit registrations via OR.
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KKDIK - Turkish REACH •Registration process: - But….. Will the EU SIEF’s formed under the scope of REACH agree to use the data created under REACH ????
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• Founded in the year 2007 • Team of 14 consultants and growing… • One stop solution center for all Chemical Compliance issues. • Integrated with global network of consultants • Multi spatial solutions & strategy support
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Fields We Serve • Regulatory Check-Up for compliance to Turkish Regulations • Registration of Biocidal Products in Turkey • Compliance to Turkish SEA (CLP) Regulation • Notification to Turkish C&L Inventory • Notification Services under the scope of Chemical Inventory and Control Regulation (C.I.C.R.) • OR services for global suppliers 35
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Fields We Serve Turkish Chemical Label Compliance Services Notification For Cleaning Products, Containing Strong Acid & Base Notification For Chemicals Used in Pools Notification For Air Aromatizers Turkish Safety Data Sheet Compliance Services Bespoke Consultancy Services Expert Translation Services 36
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Thank you for your attention.
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