Intertek Health, Environmental & Regulatory Services Vai dove Ti porta la Chimica Go where the markets for Chemicals are! Workshop Centro REACH - 3 rd December 2014 Turkey - a country moving towards Europe with its regulations (KKDIK and GHS) Silvia Faraoni, Intertek Life Sciences, Italy 1
Agenda Registration of substances Safety Data Sheets Classification and Labelling C&L Inventory 2
Turkish legislation moving towards Europe Classification and labelling inventory to be set up GHS implemented, although C&L notification system not yet applicable Turkish- KKDIK (Reach Regulation) just available as a draft, final version expected by end 2014 Safety Data Sheet Regulation, expected by the end 2014 3
Agenda Registration of substances Safety Data Sheets Classification and Labelling CLP Inventory 4
Regulation on Inventory and Control of Chemicals (MoEF) Current Regulation: The Inventory Regulation No. 27092 was published on 26th December 2008 and entered into force on 1st January 2009. Amendments: The Inventory Regulation was amended on 10th November 2009 (No 27402) A further amendment was published 23rd May 2010, Regulation No. 27589. Objectives: Controlling risks re: new and existing substances manufactured in or imported into Turkey. Setting out the administrative procedures and principles concerning the creation and maintenance of a national chemicals inventory. Develop a priority list of notified substances and conduct risk assessments on priority substances. 5
Regulation on Inventory and Control of Chemicals (MoEF) Deadlines Substances already on the market in amount of > 1 tpa before 01/01/2010: Submission Deadline was 31st March 2011 Substances on the market for the first time in amount of > 1 tpa after 01/01/2010: Submission deadline is three months after the anniversary of first import or manufacture How to submit Submission of substance data must be made via a web based tool HEDSET maintained on the MoEF website. The Notifiers needs to create an account by applying to MOEF in order to obtain a login and password. Note: only Turkish legal entities can create an account. HEDSET Login page: http://www.kimyasallar.cevreorman.gov.tr 6
Regulation on Inventory and Control of Chemicals (MoEF) Obligations: Obligation to notify only applies to Turkish based operators, either manufactures or importers. Non-Turkish operators importing into Turkey: Information submitted through an affiliate, or Information submitted through Turkish customers (importers), or Information submitted through a Turkish Representative (Trustee). The Turkish representative helps non-turkish manufacturers to preserve confidentiality and not to be linked to a certain importer/client. 7
Regulation on Inventory and Control of Chemicals (MoEF) Data requirements : Name of substance with EC and CAS Number Quantity of substance manufactured or imported 1-1000 tpa Classification and labelling Information on uses Physico-chemical properties Data on pathways and environmental fate Eco-toxicity properties Data on acute and sub-acute toxicity Data on carcinogenicity, mutagenicity and/or toxicity for reproduction Any other information relevant to the risk evaluation of the substance > 1000 tpa 8
Turkish version of REACH KKDIK KKDIK As a candidate for EU membership, Turkey started the process of introducing REACH into its own legislation in 2011. The implementation project ended in 2013 with a draft Regulation. A draft of the Regulation in Turkish has been published by the Ministry of Environment (MoE) for public consultation; Registrations according to the Turkish version of Reach known in the country as KKDIK are scheduled between 31 December 2015 and 31 December 2018; Entry into force foreseen for second quarter of 2015; According to the current draft, there is no separation of deadlines. Companies exporting chemicals or articles containing certain chemicals to Turkey can appoint an only representative (OR), like in the EU, to submit the KKDIK registration on their behalf. The exporters clients in Turkey will then have a downstream user status. 9
Turkish version of REACH KKDIK KKDIK: Consist of a main text Regulation on Chemical Registration, Evaluation, Authorisation and Restriction, 66 articles 18 Annexes The content is very similar to REACH, since it includes: CSA and reporting (CSR) DNELs & PNECs calculation Requirements depending on the tonnage band Exemptions PBT, vpvb assessment Substances obliged to authorization list Use restrictions SDS preparation (16 section) 10
Turkish version of REACH KKDIK WHAT is new? The MoE has inserted Annex XVIII to KKDIK, that states the criteria for training and certification of a risk assessor in Turkey Probably data submitted for EU REACH will be used for KKDIK registrations, however companies will need a certified Turkish risk assessor, who will ensure translation into Turkish and who compiles risk assessment reports for the registrants and prepare SDS There is no different deadlines depending on tonnage band. In Turkey, manufacturers can register their substances at any time between the end of 2015 and the end of 2018. 11
Turkish version of REACH KKDIK Annex XVIII Annex XVIII states in detail the: Education Qualification Exam, Certification Bodies and Chemical Evaluation Certificate of Competency Education and training to get the Certificate of competency the training (period can not than 64 hours, number of participants in training does not exceed 25 people...) Proficiency requested in the examination Certificate of Competency as a result of the examination conducted by the certification body shall be entitled to receive a qualification certificate Chemical Assessment of Competence Certificate validity period of five years, those who want to refresh the document, without any requirement to re-enter education exam; CRITERIA To be able to take the examination (at least 64 hours of being involved in education, faculty of pharmacy, science chemistry, biology, production of the chemical, laboratory, quality control in the field have worked at least 5 years 12
Agenda Registration of substances Safety Data Sheets Classification and Labelling C&L Inventory 13
Regulation on the Preparation and Distribution of Safety Data Sheets (MoEF, MoH, MARA) Current Regulation: Published on 26th December 2008 and came into force 26th December 2009, Regulation 20792. Harmonizes with Safety Data Sheet Directive 91/155/EEC / REACH (old European format) Hazard ingredients under Composition and Information on Ingredients SDS section should be in Turkish especially the ones listed in Annex II Those writing safety data sheets are in principle required to have been certified by an official accreditation body. This Regulation will be repealed by implementation of the REACH Regulation in Turkey, expected end of the year 2014. 14
Agenda Registration of substances Safety Data Sheets Classification and Labelling C&L Inventory 15
C&L: GHS implementation SEA Regulation: Regulation on Classification, Labeling and Packaging of Substances and Mixtures No. 28848, published December 2013 Known by Turkish abbreviation: SEA Regulation Repeals and replaces Regulation on Classification, Packaging and Labeling of Hazardous Substances and Preparations ( SAE Regulation - No. 27092, 28 December 2008) Adopts UN GHS 27092 SAE Regulation DSD & DPD 28848 SEA Regulation GHS New 28848 SEA Regulation is in force by the date 11.12.2013 27092 SAE Regulation will be repealed by the date 1 June 2016 16
Turkish SEA Obligations: Manufacturers, importers and downstream users have to classify substances and mixtures placed on the Turkish market according to SEA Regulation; Suppliers have to label and package substances and mixtures placed on the Turkish market according to SEA Regulation Manufacturers and importers of substances have to notify classification and labelling to the competent Turkish Authority in order to form the C&L inventory. 17
Turkish SEA SEA critical dates for C&L Substances until June 1, 2015 and Mixtures until June 1, 2016, can be classified, labeled and packaged as per the SAE Regulation. Substances until June 1, 2015 and Mixtures until June 1, 2016, can also be classified, labeled and packaged as per SEA Regulation (optional). Substances regulated starting from June 1, 2015 until June 1, 2016 will be classified as per the SAE Regulation (mandatory) and also in accordance with the provisions of SEA Regulation (both classifications to be reported on SDS). In this case the substances are Packaged and labeled just in accordance with SEA Regulation. Substances which are classified, labeled and packaged in accordance with the SAE Regulation and supplied to market place prior to June 1, 2015, the substances do not need to be labeled and packaged until January 1, 2017 as per the requirements of SEA Regulation. The mixtures which are classified, labeled and packaged in accordance with SAE and are supplied to market place prior to June 1, 2016, need not be labeled and packaged until June 1, 2018 as per the requirements of SEA Regulation. 18
SEA vs CLP EU has given the industry for implementation a transition term of 2 years for the substances 6,5 years for mixtures from the date of publication of CLP TR has given the industry for implementation a transition term of 1,5 years for the substances 2,5 years for mixtures from the date of publication of SEA 19
SEA vs CLP SEA REGULATION Section 1: Purpose, Scope, Definitions Section 2: General Provisions on CLP of Hazardous Substances and Mixtures Hazardous Substances and Mixtures Section 3: Hazard Classification Section 4: Labeling and Hazard Communication Section 5: Packaging Section 6: Harmonization of C&L of Substances and C&L Inventory Section 7: Cooperation and Helpdesk Section 8: Common and Final Provisions Annex I: Requirements for C&L of Hazardous Substances and Mixtures Annex II: Special Rules for L&P of Certain Substances and Mixtures Annex III: List of Hazard Statements, Supplemental Hazard Information, and Supplemental Label Elements Annex IV: List of Precautionary Statements Annex V: Hazard Pictograms Annex VI: Harmonized C&L for Certain Hazardous Substances Annex VII: Translation Table from SAE (EU DSD) Annex VIII: Conditions for Substance Classification and Notification Annex IX: General Rules for Adaptation of Standard Testing Regimes Annex X: Information to Be Submitted for Public Access Annex XI: Application Format for Hazard Assessments and Harmonized Classification CLP REGULATION TITLE I: General Issues No equivalent No equivalent TITLE II: Hazard Classification TITLE III: Hazard Communication in the form of labelling TITLE IV: Packaging TITLE V: Harmonization of C&L of substances and the C&L inventory TITLE VI: Competent Authorities and Enforcement TITLE VII: Common and Final Provisions Same Same Same Same Same Same Same No equivalent No equivalent No equivalent No equivalent 20
Agenda Registration of substances Safety Data Sheets Classification and Labelling C&L Inventory 21
Turkish SEA Who has to notify? Notification has to be submitted by Manufacturers or Importers which have a LE in Turkey 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). How to submit? C&L notifications will be submitted via KKS tool of Environmental Information System (EIS), that will be probably similar to REACH-IT The notification tool is mostly ready but still needs modifications for group notifications, therefore it is not possible to submit the C&L notification at the moment. 22
Turkish SEA Which substances will be notified? Substances which meet the criteria for classification as hazardous and are imported, either on their own or in a mixture above the concentration limits as set in the Regulation (SEA) which results in the classification of the mixture as hazardous. Please note: Active substances of Biocidal Products Active substances of Plant Protection Products Are subject to notification as far as they meet the above mentioned conditions. Turkish SEA will effect notifications submitted under the scope of 27092 C.I.C. Regulation (current registration system), but the notification tool is not ready to update the classification and labelling data according to SEA/C&L. 23
Turkish SEA What will be notified? Information for each Manufacturer/ Importer/ Turkish Representative of the substance as follows: Name, address, phone, fax, e-mail Contact Person Place of manufacturing (if applicable) Information of the substance as stated on Art.39; 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; If applicable specific concentration limit values and M-factors; Labelling data and Hazard statements of the substance. 24
Turkish SEA SEA critical dates for Inventory Substances placed on the market before 1.6.2015 to be notified in a period from 1.6.2014 to 1.6.2015 * Substances placed on the market after 1.6.2015 be notified within one month at the latest after placing on the Turkish market for the first time. *term depending on KKS tool availability 25
Turkish legislation moving towards Europe Will Turkey manage to keep it up with Europe? We will see what happens by the end of the year 26
Thank you! silvia.faraoni@intertek.com 27