Country Sheet. Global Emerging Regulations Issue Team. Turkey

Size: px
Start display at page:

Download "Country Sheet. Global Emerging Regulations Issue Team. Turkey"

Transcription

1 Country Sheet Global Emerging Regulations Issue Team Turkey Date: August nd Revision: June 2012 Disclaimer This document is prepared by the Cefic Global Emerging Regulations Issue Team for Cefic members only and should not be distributed further. The information contained in this paper has been based on the currently available information, and provided in good faith. No warranties are made to its completeness or accuracy and use of the information is at users own risk. General: The Ministry of Environment and City Planning 1) is responsible for the control of industrial chemicals since the elections in June Environmental Law No issued in 1983 (most recent amendment made by Law No. 5491, 2006) and Dangerous Chemicals Regulation 1993 (published in Official Gazette issue , last amendment in 2001) set forth the principles for the management of hazardous substances. Turkey is an official candidate country to access the EU and makes efforts to implement EU legislation. The Turkish Dangerous Chemicals Regulation has been amended several times for the purpose of transposing, either partially or fully, European Directives such as 67/548/EEC; 76/769/EEC; 99/45/EC, and 91/155/EEC. According to UNITAR reports, Turkey has shown interest in the GHS Capacity Development and has requested GHS Capacity Building Assistance. The implementation of GHS will happen through adoption and enforcement of the EU CLP Regulation based on its 2 nd ATP. This is likely to happen in The Regulation on the Inventory and Control of Chemicals (December 26, 2008), amended twice (final amendment on 23/05/2010) includes some of the principles of the EU REACH Regulation. CEFIC GER group was involved in advocacy work on this regulation. Turkey signed the Chemical Weapons Convention in 1993 followed by ratification in Turkey also ratified the Montreal Protocol on ozone depleting substances in 1990 and adopted its subsequent

2 amendments.

3 1. Restrictions on Marketing & Use Regulation on the Inventory and Control of Chemicals defines the substances for which the registration is required before they are placed on the market. Regulation on restrictions on the manufacturing, placing on the market and use of certain dangerous substances, preparations and articles has been issued ((76/769/EEC - REACH Annex XVII) (TeACH,26/12/2008) 2) and updated on 26 April 2011 (only available in Turkish) 2). 2. Hazard Communication 2.1. Safety Data Sheet Turkey s requirements for Safety Data Sheets (Communiqué on the Procedure for the Preparation of the Safety Data Sheets published in Official Gazette issue ) transposed EU Directive 91/155/EEC and its amendment 2001/58/EC. The 16-section Safety Data Sheet should be written in Turkish language. By-law on Preparation and distribution of safety sheets compliant with Annex II of REACH. (TeACH,26/12/2008) 2) - Important requirements: 1) SDS in Turkish language 2) Electronic copy to be provided to Ministry of Environment A person certified against the requirements of the Turkish standard Institute is responsible for the correctness of the Turkish SDS. contact: Türk Standartları Enstitüsü Personel Belgelendirme Merkezi (TSE = Turkish Standard Institute) Adress: Necatibey Caddesi No:112 Ankara - Türkiye Tel: Fax: pbm@tse.org.tr For the time being importers must use SDS according to the SDS By-Law (as 2001/58/EC). Classification must be made according to Turkish Classification and Labeling By-Law (67/548/EEC and 99/45/EC). It seems that that SDS conforming REACH Annex II can be used including Turkish CLP By-Law classification, but not EU CLP classification Classification & Labelling The EU Directives on Dangerous Substances and Preparations (DSD 67/548/EEC, DPD 99/45/EC) have been transposed into the Turkish legislation in the By-Law on Classification, Packaging and Labelling of Dangerous Substances and Preparations (TeACH,26/12/2008) 2) An EU project supported the preparations to transpose and implement the EU CLP Regulation in Turkey. As of 1 June 2011, the Technical Assistance Project of the European Union for the Harmonization of Regulation 1272/2008/EC on the Classification, Labeling, and Packaging of Substances and Mixtures (the CLP Regulation) in Turkey was completed. The implementation of GHS is likely to be delayed to sometime in A draft CLP By-Law is expected by end of At present the foreseen implementation date is 1 January 2014 for substances and 1 June 2015 for mixtures. Mandatory labeling requirements for Lubricants issued by EPDK (Energy Market Regulatory Authority) on 12 Feb 2011 should include for all mineral oil based products produced in Turkey by 30 June 2011 the licensed number of the producer given by EPDK for mineral oil based production, custom tariff number (GTIP) of the product, trade mark registration number which is announced to EPDK by manufacturer, production date of the product, typical characteristics of the product (such as : TBN, viscosity Index, pour point, density, flashpoint), ingredients of the product, TSE (Turkish Standards Institution) conformity

4 approval certificate number, net and gross weight of the product. 3. Product Registration There are no chemical product registration requirements as known from the EU countries. However, the Turkish legislation requires obtaining a certificate from the Ministry of Environment and Forestry (MoEF) 1) to be able to import and manufacture hazardous chemicals in Turkey. 4. Inventory In order to have an inventory before implementing REACH, the Turkish regulators had issued a regulation on the Inventory and Control of Chemicals, often referred to as the By-law, which updates the 1983 Environmental Law (Law Number 2872) and the 2003 Law on Establishment and Duties of Ministry of Environment and Forestry (Law Number 4856). It was first published on 26 th December 2008, and officially enforced. An amendment was published on 10/11/2009 and the second amendment has been formally published on 23/05/2010. Translations of the latest amendment and a consolidated version of the overall By-law are available via Cefic. The Notification and Registration process is for individual substances (not polymers, which are exempt) and substances in mixtures manufactured within or imported into Turkey in quantities of >1 t in the 3 years prior to 1 January The deadline of this activity was 31 st March For substances imported for the first time after 1 January 2010, the reporting has to be completed within 15 months. Annex I refers to a list of exemptions. Polymers have been added to the list of Annex 1 listed substances. Polymers are not defined in the law, however as there are references to EINECS and ELINCS it may be reasonable to assume that only OECD conforming polymers are formally exempt. The information requirements are tonnage dependant and are specified in Annexes 2 (>1000 t) & Annex 3 (>1-<1000 t) of the By-law. Any substance produced/imported for the first time by a company from 1/01/2010 onwards should be registered within a 12+3 month period from the start date of first production/import. The main page address is By clicking on "Kimyasallar Veri Bankası" the inventory page will be opened. The notification needs to be done by manufacturers/importers based in Turkey. Non-Turkish companies may use an third party to notify (same concept as OR in REACH) There is guidance on the HEDSET and a more practical guidance issued by the MoEF1) translated and re-worked by Cefic. Important to mention that the volume trigger is not the 3-year average, if the the limit of 1000 t/year has been exceeded once within the 3 years, reporting has to follow the requirements for the higher tonnage band. Guidance HEDSET EN.docx Guidance MoE&F re-worked by Cefic Ja Existing notifications require an update within 3 months for the following changes: classification; use; volume threshold; changes to contact details. The inventory for the lower volume banded substances is undergoing correction and will be published in due course.

5 A list of HPV chemicals (>1000 t/a) after the initial reporting under this By-Law has been published in Q2/2011: Within this page, click on the link titled "tiklayiniz"; a spreadsheet with EC#, Turkish chemical name and English name opens. The Turkish government has published a list of chemicals manufactured and imported in the country above 1t/y for which notifications were received before 31 March The list contains 2,887 substances, with the substance names in both Turkish and English. Microsoft Office Excel Worksheet 5. New Substance Notification There is no scheme for notification of new substances as Turkey intends to implement REACH (timing currently unknown) 6. Contact Information Nathalie Allard Cefic nal@cefic.be 1) MoEF Ministry of Environment and Forestry is divided into two new ministries as Ministry of Environment and City Planning and Ministry of Water and Forestry as a consequence of establishing a new Government after the elections in June The authority on Chemical Management had moved to Ministry of Environment and City Planning and that may cause a postponement in the expected term of the prioritization of chemicals as a result of the Chemical Inventory Notifications (source: CRAD 15 Aug 2011) 2) Reference documents can be requested via Cefic (see 6. Contact information)

Intertek Health, Environmental & Regulatory Services

Intertek Health, Environmental & Regulatory Services 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

More information

Background to CLP. Presentation Overview. Why Introduce GHS? Basic CLP requirements 8/30/2011

Background to CLP. Presentation Overview. Why Introduce GHS? Basic CLP requirements 8/30/2011 About the Speaker Classifications, Labeling & Packaging (CLP) Regulatory Compliance AHMP National Conference August 29, 2011 Isaac Powell Product Manager - Technical Services 3E Company Carlsbad, CA Isaac

More information

REACH Pre-registration Questions and Answers

REACH Pre-registration Questions and Answers REACH Pre-registration Questions and Answers (RELEASE 5) You may continue to manufacture, import or use a chemical only if it is pre-registered and registered in time! Reference: ECHA-08-QA-01.5-EN Date:

More information

CLP Regulation Recent implementation and issues. Workshop "Product Stewardship and PROCESS SAFETY 30/11/2017 Dr. Blanca Serrano

CLP Regulation Recent implementation and issues. Workshop Product Stewardship and PROCESS SAFETY 30/11/2017 Dr. Blanca Serrano CLP Regulation Recent implementation and issues Workshop "Product Stewardship and PROCESS SAFETY 30/11/2017 Dr. Blanca Serrano CLP Regulation Introduction Introduction Regulation (EC) No 1272/2008 on classification,

More information

CHEMICALS (Classification, Labelling, Packaging of substances and mixtures -CLP) Screening Meeting EU Serbia June 2013

CHEMICALS (Classification, Labelling, Packaging of substances and mixtures -CLP) Screening Meeting EU Serbia June 2013 CHEMICALS (Classification, Labelling, Packaging of substances and mixtures -CLP) Screening Meeting EU Serbia June 2013 Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances

More information

Changes to Chemical Labels and SDS - Speaker s notes

Changes to Chemical Labels and SDS - Speaker s notes Slide 1 Changes to Chemical Labels and SDS Title slide. Slide 2 Changes to labels and SDS This presentation is intended to help those who need to give information about changes to the way that chemical

More information

CLP the implementation of GHS in the EU Facts and practical advice

CLP the implementation of GHS in the EU Facts and practical advice CLP the implementation of GHS in the EU Facts and practical advice Seminar on the latest trend regarding revised CSCL, REACH and CLP 30 March 2010, Tokyo Gabriele Schöning ECHA Classification Unit Content

More information

Bilateral screening: Chapter 27 PRESENTATION OF THE REPUBLIC OF SERBIA Classification, labelling and packaging of substances and mixtures - CLP

Bilateral screening: Chapter 27 PRESENTATION OF THE REPUBLIC OF SERBIA Classification, labelling and packaging of substances and mixtures - CLP REPUBLIC OF SERBIA Negotiating Group for the Chapter 27 Environment and Climate Change Bilateral screening: Chapter 27 PRESENTATION OF THE REPUBLIC OF SERBIA Classification, labelling and packaging of

More information

REACH Evaluation. Graham Lloyd Regulatory/Technical. REACH in Practice Conference 1 June, Steptoe & Johnson LLP & Regulatory Compliance Ltd

REACH Evaluation. Graham Lloyd Regulatory/Technical. REACH in Practice Conference 1 June, Steptoe & Johnson LLP & Regulatory Compliance Ltd REACH Evaluation Graham Lloyd Regulatory/Technical REACH in Practice Conference 1 June, 2007 REACH Evaluation What is to be evaluated Compliance check Substance evaluation Evaluation process and decisions

More information

SDS and what is new under REACH and EU GHS? PRISM2 Workshop Promoting Resposibility in SME s 08 April Slovakia. L. Heezen

SDS and what is new under REACH and EU GHS? PRISM2 Workshop Promoting Resposibility in SME s 08 April Slovakia. L. Heezen SDS and what is new under REACH and EU GHS? PRISM2 Workshop Promoting Resposibility in SME s 08 April Slovakia L. Heezen Why do we need GHS? Substance - oral toxicity LD 50 = 257 mg/kg GHS Transport EU

More information

Hazard Communication. Hazard Communication

Hazard Communication. Hazard Communication Safety Data Sheets Hazard Communication Hazard Communication Overview Introduction Regulatory Requirements Suppliers Duties SDS and CLP Annex II changes (453/2010) Recipients Duties Summary and Guidance

More information

REPUBLIC OF SERBIA Bilateral screening: Chapter 1 Free Movement of Goods. C L P Classification, Labeling and Packaging of substances and mixtures

REPUBLIC OF SERBIA Bilateral screening: Chapter 1 Free Movement of Goods. C L P Classification, Labeling and Packaging of substances and mixtures REPUBLIC OF SERBIA Bilateral screening: C L P Classification, Labeling and Packaging of substances and mixtures C O N T E N T STATE OF PLAY LEGISLATIVE FRAMEWORK COMPETENT AUTHORITY (CA) ADMINISTRATIVE

More information

LISAM SYSTEMS REACH Compliant SDSs: What s Changed and What s Coming

LISAM SYSTEMS REACH Compliant SDSs: What s Changed and What s Coming REACH Compliant SDSs: What s Changed and What s Coming Simon Bradshaw, June 2016 REACH Compliant SDSs: Structure, Content and Requirements Simon Bradshaw, June 2016 REACH... Regulation 1907/2006 Amendment

More information

REACH/CLP Update. Roseleen Murphy IMFI 12 th May 2011

REACH/CLP Update. Roseleen Murphy IMFI 12 th May 2011 REACH/CLP Update Roseleen Murphy IMFI 12 th May 2011 Overview Update on REACH Registration Duties for Article producers and Importers Substances of Very High Concern and the Candidate List Authorisation

More information

Practical guide 7: How to notify substances in the Classification and Labelling Inventory

Practical guide 7: How to notify substances in the Classification and Labelling Inventory Practical guide 7: How to notify substances in the Classification and Labelling Inventory LEGAL NOTICE This document contains guidance on the CLP Regulation explaining the CLP obligations and how to fulfil

More information

Implementation of REACH & CLP: common challenges of national authorities and ECHA

Implementation of REACH & CLP: common challenges of national authorities and ECHA Implementation of REACH & CLP: common challenges of national authorities and ECHA Finnish Safety and Chemicals Agency (Tukes); Opening Seminar 9 February 2011, Tampere Geert Dancet Executive Director Content

More information

The Classification and Labelling Inventory. Cefic s viewpoint

The Classification and Labelling Inventory. Cefic s viewpoint The Classification and Labelling Inventory Cefic s viewpoint Marie-Pierre Rabaud RIEF III Brussels 24 June 2014 The C&L Inventory Improvement of the C&L Inventory is a need Industry to consider ways to

More information

Guidance on the preparation of dossiers for harmonised classification and labelling (CLH) under Regulation (EC) No.

Guidance on the preparation of dossiers for harmonised classification and labelling (CLH) under Regulation (EC) No. Guidance on the preparation of dossiers for harmonised classification and labelling (CLH) under Regulation (EC) No. 1272/2008 DRAFT LEGAL NOTICE This document contains guidance to the preparation of dossiers

More information

Update from ECHA. REACH Implementation Workshop X. 13 December Laurence Hoffstadt ECHA Substance Identification & Data Sharing

Update from ECHA. REACH Implementation Workshop X. 13 December Laurence Hoffstadt ECHA Substance Identification & Data Sharing Update from ECHA REACH Implementation Workshop X 13 December 2011 Laurence Hoffstadt ECHA Substance Identification & Data Sharing Overview Update registrations/ dissemination Summary Analysis 2010- substances

More information

Introduction UN GHS. CLP outline. Requirement for SDS. Measures needed GHS CLP SDS. Transition from DSD/DPD to CLP DSD/DPD CLP

Introduction UN GHS. CLP outline. Requirement for SDS. Measures needed GHS CLP SDS. Transition from DSD/DPD to CLP DSD/DPD CLP Introduction UN GHS GHS CLP outline CLP Transition from DSD/DPD to CLP DSD/DPD CLP EU own Hazard Statements Classification & Harmonized classification & Requirement for SDS SDS Measures needed P23 Example

More information

Guidance on Scientific Research and Development (SR&D) and Product and Process Orientated Research and Development (PPORD)

Guidance on Scientific Research and Development (SR&D) and Product and Process Orientated Research and Development (PPORD) G U I D A N C E Guidance on Scientific Research and Development (SR&D) and Product and Process Orientated Research and Development (PPORD) Version 2.1 October 2017 2 Guidance on Scientific Research and

More information

FORUM FOR EXCHANGE OF INFORMATION ON ENFORCEMENT. Disclaimer:

FORUM FOR EXCHANGE OF INFORMATION ON ENFORCEMENT. Disclaimer: FORUM FOR EXCHANGE OF INFORMATION ON ENFORCEMENT Adopted at the 9 th meeting of the Forum on 1-3 March 2011 Strategies for enforcement of Regulation (EC) no. 1907/2006 concerning the Registration, Evaluation,

More information

ECHA and the implementation of REACH,CLP and other tasks

ECHA and the implementation of REACH,CLP and other tasks ECHA and the implementation of REACH,CLP and other tasks Eva Sandberg International Unit www.kemi.se ECHA, its tasks and organisation European Chemicals Agency ECHA REACH Regulation entered into force

More information

Final Draft Agenda Sixteenth meeting of the Forum for Exchange of Information on Enforcement (Forum-16) October 2013

Final Draft Agenda Sixteenth meeting of the Forum for Exchange of Information on Enforcement (Forum-16) October 2013 18 October 2013 ECHA/Forum-16/2013/A/final Final Draft Agenda Sixteenth meeting of the Forum for Exchange of Information on Enforcement (Forum-16) 28-31 October 2013 European Chemicals Agency Helsinki,

More information

5.1 EXAMPLES ON HOW TO LABEL

5.1 EXAMPLES ON HOW TO LABEL 5 PART 5: LABELLING Note: The label sizes in the examples in Section 5.1.3 are not illustrated in the actual size but are only examples of possible lay-outs. The print quality is also not the same as when

More information

IFCS Indicators of Progress. Priorities for Action beyond 2000 and Forum Recommendations

IFCS Indicators of Progress. Priorities for Action beyond 2000 and Forum Recommendations IFCS Indicators of Progress Priorities for Action beyond 2000 and Forum Recommendations QUESTIONNAIRE Please provide the information described on the following pages concerning your country, giving the

More information

ASSESSMENT OF THE CONSOLIDATED ANNUAL ACTIVITY REPORT OF THE AUTHORISING OFFICER FOR THE YEAR 2014

ASSESSMENT OF THE CONSOLIDATED ANNUAL ACTIVITY REPORT OF THE AUTHORISING OFFICER FOR THE YEAR 2014 Management Board Decision 07/2015 1(5) ASSESSMENT OF THE CONSOLIDATED ANNUAL ACTIVITY REPORT OF THE AUTHORISING OFFICER FOR THE YEAR 2014 THE MANAGEMENT BOARD, Having regard to Regulation (EC) No 1907/2006

More information

Update of the Work plan on international activities 2012

Update of the Work plan on international activities 2012 Helsinki, 15 December 2011 Doc.: MB/57/2011 final Update of the Work plan on international activities 2012 (Document endorsed by the Management Board) WORK PLAN FOR INTERNATIONAL ACTIVITIES OF ECHA 2012

More information

REACH and CLP an industrial perspective on registrations and notifications

REACH and CLP an industrial perspective on registrations and notifications REACH and CLP an industrial perspective on registrations and notifications Leendert van Dijk On behalf of EASTMAN REACH Team Agenda Introduction of Eastman Chemical Our REACH footprint REACH: what is new?

More information

VLARIP Netwerkevent. 24 januari 2013

VLARIP Netwerkevent. 24 januari 2013 VLARIP Netwerkevent 24 januari 2013 Omgaan met (uitgebreide) veiligheidsinformatiebladen Raf Leyman Regulatory Affairs Manager EMEA Agenda REACH@Buckman history Buckman REACH Safety Data Sheets (e)sds

More information

Harmonisation of Information for Poison Centres

Harmonisation of Information for Poison Centres EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Chemicals, metals, mechanical, electrical and construction industries; Raw materials Chemicals - Classification & Labelling, Specific Products,

More information

The CLP Regulation: origin, scope and evolution

The CLP Regulation: origin, scope and evolution 126 Ann Ist Super Sanità 2011 Vol. 47, No. 2: 126-131 DOI: 10.4415/ANN_11_02_02 The CLP Regulation: origin, scope and evolution Paola Di Prospero Fanghella and Tiziana Catone Centro Nazionale Sostanze

More information

April 21 st, 2016 Webinar. registrations What is next for the industry?

April 21 st, 2016 Webinar. registrations What is next for the industry? April 21 st, 2016 Webinar A look beyond REACH 2018 registrations What is next for the industry? Some Notes It is assumed that attendees have basic knowledge about REACH. Let us make this webinar interactive,

More information

EU harmonization of the information for emergency health response (Art. 45 Regulation 1272/2008 )

EU harmonization of the information for emergency health response (Art. 45 Regulation 1272/2008 ) EU harmonization of the information for emergency health response (Art. 45 Regulation 1272/2008 ) 6th BfR-Nutzerkonferenz Produktmeldungen 10 November 2015, Berlin-Marienfelde Roberto Scazzola DG Internal

More information

( ) Page: 1/24. Committee on Subsidies and Countervailing Measures SUBSIDIES

( ) Page: 1/24. Committee on Subsidies and Countervailing Measures SUBSIDIES 14 July 2017 (17-3798) Page: 1/24 Committee on Subsidies and Countervailing Measures Original: English SUBSIDIES NEW AND FULL NOTIFICATION PURSUANT TO ARTICLE XVI:1 OF THE GATT 1994 AND ARTICLE 25 OF THE

More information

ITMA 2015 Textile Colourant & Chemical Leaders Forum. Updates on REACH Regulation. Dr Maurizio Colombo, REACH and CPL Coordinator, Federchimica

ITMA 2015 Textile Colourant & Chemical Leaders Forum. Updates on REACH Regulation. Dr Maurizio Colombo, REACH and CPL Coordinator, Federchimica ITMA 2015 Textile Colourant & Chemical Leaders Forum Updates on REACH Regulation Dr Maurizio Colombo, REACH and CPL Coordinator, Federchimica Milano, 14 th November 2015 Federchimica Organisation More

More information

MINIMUM CRITERIA FOR REACH AND CLP INSPECTIONS 1

MINIMUM CRITERIA FOR REACH AND CLP INSPECTIONS 1 FORUM FOR EXCHANGE OF INFORMATION ON ENFORCEMENT Adopted at the 9 th meeting of the Forum on 1-3 March 2011 MINIMUM CRITERIA FOR REACH AND CLP INSPECTIONS 1 MARCH 2011 1 First edition adopted at the 6

More information

Strategies for REACH Compliance. Chicago 23 March 2012

Strategies for REACH Compliance. Chicago 23 March 2012 Strategies for REACH Compliance Chicago 23 March 2012 Content Context of the proposal presentation Table of contents I. INTRODUCTION Who is EcoMundo? Why REACH affects U.S. companies? The basics to understand

More information

REACH-IT Industry User Manual

REACH-IT Industry User Manual REACH-IT Industry User Manual Part 16 - How to create and submit a C&L notification using the REACH-IT online Version (1.0) Page 1 of 68 Document History Version Changes 1.0 First release Reference: ECHA-10-B-31-EN

More information

REACH Forum, Compliance Control of REACH and CLP Regulations

REACH Forum, Compliance Control of REACH and CLP Regulations REACH Forum, Compliance Control of REACH and CLP Regulations Szilvia Deim Vice-Chair of the Forum Forum for Exchange of Information on Enforcement 4 September 2018, Bratislava 1 Forum as a unique body

More information

EU Poison Centres Webinar. 27 May 2014, 9:00am BST

EU Poison Centres Webinar. 27 May 2014, 9:00am BST EU Poison Centres Webinar 27 May 2014, 9:00am BST Today s webinar aims v To hear about the current state of play on the changes that are likely to be proposed on the reporting of information to EU poison

More information

A look into the PCN format, UFI generator and EU PCS

A look into the PCN format, UFI generator and EU PCS A look into the PCN format, UFI generator and EU PCS Dijana Spasojevic, Principal consultant, and Philippe Boveroux, Project manager 7 th BfR User conference 15 November, 2015 Who we are Dijana Spasojevic

More information

Health and Safety Authority. Function and Scope of REACH and CLP Helpdesks

Health and Safety Authority. Function and Scope of REACH and CLP Helpdesks Rev 1. June 2009 Health and Safety Authority Function and Scope of REACH and CLP Helpdesks Introduction The EU Regulation for Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

More information

IVDD revision changes to the European regulation of in-vitro diagnostic (IVD) Medical Devices. Med-Info. TÜV SÜD Product Service GmbH

IVDD revision changes to the European regulation of in-vitro diagnostic (IVD) Medical Devices. Med-Info. TÜV SÜD Product Service GmbH Med-Info International expert information for the Medical Device industry IVDD revision changes to the European regulation of in-vitro diagnostic (IVD) Medical Devices The current regulatory framework

More information

EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL. Safety of the food chain Chemicals, contaminants, pesticides

EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL. Safety of the food chain Chemicals, contaminants, pesticides 1 EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL Safety of the food chain Chemicals, contaminants, pesticides SANCO/12545/2014 rev. 2 March 2016 GUIDANCE DOCUMENT FOR APPLICANTS ON

More information

Chemical Legislation European Enforcement Network.

Chemical Legislation European Enforcement Network. 1 Chemical Legislation European Enforcement Network www.cleen-europe.eu 2 fundamental principle The member states are responsible for the enforcement of chemicals legislation. It is their task to undertake

More information

Multi-Annual Work Programme

Multi-Annual Work Programme Multi-Annual Work Programme 2009-2012 Европейска агенция по химикали Evropská agentura pro chemické látky Det Europæiske Kemikalieagentur Europäische Chemikalienagentur European Chemicals Agency Ευρωπαϊκός

More information

Biocidal product regulation the changes to come

Biocidal product regulation the changes to come Biocidal product regulation the changes to come The Biocidal Product Regulation, which came into force on 1 September 2013 is still changing. ECHA announced the evolutions of this changing regulation during

More information

Amendments to Part II of the Canada Labour Code. October 24, 2014

Amendments to Part II of the Canada Labour Code. October 24, 2014 Amendments to Part II of the Canada Labour Code October 24, 2014 Background Amendments were made to Part II of the Canada Labour Code under the Economic Action Plan 2013 Act, No. 2. Royal Assent was received

More information

Classification of consumer products under the EU CLP Regulation: what to consider when caring for contact dermatitis patients

Classification of consumer products under the EU CLP Regulation: what to consider when caring for contact dermatitis patients Contact Dermatitis Review Article COD Contact Dermatitis Classification of consumer products under the EU CLP Regulation: what to consider when caring for contact dermatitis patients Peter Elsner Department

More information

FEMA Mission Statement and Critical Objectives MISSION STATEMENT: CRITICAL OBJECTIVES: Science. Advocacy. Communication

FEMA Mission Statement and Critical Objectives MISSION STATEMENT: CRITICAL OBJECTIVES: Science. Advocacy. Communication FEMA 2017-2018 Mission Statement and Critical Objectives MISSION STATEMENT: The Flavor and Extract Manufacturers Association furthers the business interests of its members through a sound scientific program

More information

Contents A. INTRODUCTION... 2 A1. Purpose, scope and other addressees of the report... 2 A2. Significant organisational changes affecting the NSA...

Contents A. INTRODUCTION... 2 A1. Purpose, scope and other addressees of the report... 2 A2. Significant organisational changes affecting the NSA... Contents A. INTRODUCTION... 2 A1. Purpose, scope and other addressees of the report... 2 A2. Significant organisational changes affecting the NSA... 2 B. OVERALL SAFETY PERFORMANCE AND STRATEGY... 3 B.1

More information

ENERGY SECTOR UNBUNDLING IN TURKEY. Selim Dündar Attorney-at-Law, LL.M. Alper Utaş Attorney-at-Law, LL.M.

ENERGY SECTOR UNBUNDLING IN TURKEY. Selim Dündar Attorney-at-Law, LL.M. Alper Utaş Attorney-at-Law, LL.M. ENERGY SECTOR UNBUNDLING IN TURKEY Selim Dündar Attorney-at-Law, LL.M. Alper Utaş Attorney-at-Law, LL.M. 1 The notion expressing restructuring of the enterprises that include the relevant network infrastructure

More information

Review Date: Scope: All CHL Employees and Contractors Originated: 5/15/2017 References: OSHA Revisions:

Review Date: Scope: All CHL Employees and Contractors Originated: 5/15/2017 References: OSHA Revisions: Community Healthlink Policy and Procedure Manual Section: 11 Facilities and Equipment Policy Number: 11-14 Effective Date: 5/15/17 Title: Hazard Communication Program Review Date: Scope: All CHL Employees

More information

Guideline for Complying with Regulations of Substances Control (CRSC)

Guideline for Complying with Regulations of Substances Control (CRSC) 50-05 Classification Number 50-05 Guideline for Complying with Regulations of Substances Control (CRSC) October, 2016 Quality Assurance Department Editor Engineering Administration Group Mitsubishi Heavy

More information

NOTE BY THE TECHNICAL SECRETARIAT

NOTE BY THE TECHNICAL SECRETARIAT OPCW Technical Secretariat International Cooperation and Assistance Division S/551/2006 27 February 2006 Original: ENGLISH Introduction NOTE BY THE TECHNICAL SECRETARIAT INVITATION TO NATIONAL AUTHORITIES

More information

Guidance for applicants requesting scientific advice

Guidance for applicants requesting scientific advice 7 December 2017 EMEA/CVMP/SAWP/172329/2004 Rev. 5 Veterinary Medicines Division Introduction The Scientific Advice Working Party (SAWP-V) of the Committee for Medicinal Products for Veterinary Use (CVMP)

More information

Procedure for handling applications for authorisation and review reports under REACH

Procedure for handling applications for authorisation and review reports under REACH Procedure for handling applications for authorisation and review reports under REACH 1. Purpose This procedure describes how to handle applications for authorisation (AfA) as established by the REACH Regulation

More information

Transposition of Aviation Directive. Aviation in EU ETS Workshop 30 June 2009

Transposition of Aviation Directive. Aviation in EU ETS Workshop 30 June 2009 Transposition of Aviation Directive Aviation in EU ETS Workshop 30 June 2009 Presentation Consultation Process and Papers circulated Brief Overview of Aviation Directive Approach to Transposition Phase

More information

TURKEY. Maximum benefit from off set agreements in enhancing technological capacity.

TURKEY. Maximum benefit from off set agreements in enhancing technological capacity. TURKEY 1. General Policy Framework Documents entitled Science and Technology Policy of Turkey Summary and Policy Making Bodies in Science and Technology have been provided to the OECD Secretariat. The

More information

Guidance on the Biocidal Products Regulation

Guidance on the Biocidal Products Regulation G U I D A N C E Guidance on the Biocidal Products Regulation Volume V, Guidance on active substances and suppliers (Article list) Draft Version.0 September 0 DRAFT Volume V: Guidance on active substances

More information

REPORTING OF REACH IMPLEMENTATION

REPORTING OF REACH IMPLEMENTATION National Supervisory Authority for Welfare and Health Finnish Environment Institute Ref. Ares(2011)183072-18/02/2011 REPORTING OF REACH IMPLEMENTATION 2007 2009 FINLAND 28 MAY2010 MS REACH Reporting Questionnaire

More information

Questions and answers on the procedure of PIP compliance verification at EMA, and on paediatric rewards

Questions and answers on the procedure of PIP compliance verification at EMA, and on paediatric rewards 15 December 2014 EMA/PDCO/179892/2011 Rev. 2 Product Development Scientific Support Paediatric Medicines Questions and answers on the procedure of PIP compliance verification at EMA, and on paediatric

More information

Strategic Approch to Occupational Safety and Health

Strategic Approch to Occupational Safety and Health 5th China International Forum on Work Safety Beijing, 31 August 2 September 2010 Strategic Approch to Occupational Safety and Health Seiji MACHIDA SafeWork, ILO Geneva 1 Global Challenges on OSH Estimated

More information

To: Prefectural Governors From: Director General, Pharmaceutical and Food Affairs Bureau, Ministry of Health, Labour and Welfare

To: Prefectural Governors From: Director General, Pharmaceutical and Food Affairs Bureau, Ministry of Health, Labour and Welfare This draft English translation of notification on GLP has been made by JSQA. JSQA translated them with particular care to accuracy, but does not guarantee that there are no differences in the delicate

More information

REGISTRATION OF MEDICINES IN THE EURASIAN ECONOMIC UNION

REGISTRATION OF MEDICINES IN THE EURASIAN ECONOMIC UNION REGISTRATION OF MEDICINES IN THE EURASIAN ECONOMIC UNION www.gratanet.com At the Pharmaceutical Forum of the EAEU and CIS countries held in Moscow in late February 2018, the Director of the Department

More information

essenscia SME projects to improve REACH & CLP implementation: VLARIP & WALRIP

essenscia SME projects to improve REACH & CLP implementation: VLARIP & WALRIP essenscia SME projects to improve REACH & CLP implementation: VLARIP & WALRIP Ir. Tine Cattoor Advisor Product Policy VLARIP projectleader tcattoor@essenscia.be 7/10/2014 content essenscia & members REACH

More information

Convention on Nuclear Safety

Convention on Nuclear Safety Convention on Nuclear Safety National Report by Malta for the 7 th Review Meeting Made in connection with Article 5 of the Convention on Nuclear Safety List of Acronyms and Abbreviations... 2 Introduction....

More information

MEDICINES CONTROL COUNCIL

MEDICINES CONTROL COUNCIL MEDICINES CONTROL COUNCIL QUESTIONS & ANSWERS: LICENSING OF MEDICAL DEVICE ESTABLISHMENTS This document is intended to provide clarity on guidelines and applications for the licensing of medical device

More information

SFHPHARM11 - SQA Unit Code FA2X 04 Prepare extemporaneous medicines for individual use

SFHPHARM11 - SQA Unit Code FA2X 04 Prepare extemporaneous medicines for individual use Prepare extemporaneous medicines for individual use Overview This standard covers your role in preparing extemporaneous medicines for individual use. This involves accurately calculating the quantities

More information

ICH Topic Q4B Annex 6 Uniformity of Dosage Units General Chapter. Step 3

ICH Topic Q4B Annex 6 Uniformity of Dosage Units General Chapter. Step 3 European Medicines Agency December 2008 EMEA/CHMP/ICH/645408/2008 ICH Topic Q4B Annex 6 Uniformity of Dosage Units General Chapter Step 3 ANNEX 6 TO NOTE FOR EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL

More information

Newsletter September 2017

Newsletter September 2017 Newsletter September 2017 Newsletter Summary Reach 2018 Reach & CLP Updates Restriction Regulation Updates Regulation Updates about products and Regulations EU Supply Chain Comunication Calls for Information

More information

REGULATORY IMPACT ANALYSIS (RIA) SAFETY, HEALTH AND WELFARE AT WORK

REGULATORY IMPACT ANALYSIS (RIA) SAFETY, HEALTH AND WELFARE AT WORK REGULATORY IMPACT ANALYSIS (RIA) SAFETY, HEALTH AND WELFARE AT WORK (Prevention of sharps injuries in the hospital and healthcare sector) REGULATIONS 2012 (S.I. No. of 2012) 11 th January 2012 RIA Prevention

More information

CHEMICAL WATCH GLOBAL ENFORCEMENT SUMMIT 2015

CHEMICAL WATCH GLOBAL ENFORCEMENT SUMMIT 2015 CHEMICAL WATCH GLOBAL ENFORCEMENT SUMMIT 2015 NEW FOR 2015 LE CHATELAIN BOUTIQUE HOTEL, BRUSSELS A unique opportunity to join our panels: twenty-one+ experts including EU and Member State officials, regulatory

More information

1. Address by Dr. Chris SAID, Parliamentary Secretary for Consumers, Fair Competition and Public Dialogue

1. Address by Dr. Chris SAID, Parliamentary Secretary for Consumers, Fair Competition and Public Dialogue PUBLIC Helsinki, 4 st October 2011 PRELIMINARY CONCLUSIONS OF THE 23 RD MANAGEMENT BOARD MEETING ON 29.-30.9.2011 1. Address by Dr. Chris SAID, Parliamentary Secretary for Consumers, Fair Competition and

More information

TEXAS HAZARD COMMUNICATION ACT AND RULES. Sec : EMPLOYEE EDUCATION PROGRAM

TEXAS HAZARD COMMUNICATION ACT AND RULES. Sec : EMPLOYEE EDUCATION PROGRAM TEXAS HAZARD COMMUNICATION ACT AND RULES Sec. 502.010: EMPLOYEE EDUCATION PROGRAM (a) An employer shall provide at least once a year, an education and training program for employees. INTRODUCTION The Texas

More information

OCCUPATIONAL AND ENVIRONMENTAL SAFETY & HEALTH OPERATIONAL PROCEDURE

OCCUPATIONAL AND ENVIRONMENTAL SAFETY & HEALTH OPERATIONAL PROCEDURE OCCUPATIONAL AND ENVIRONMENTAL SAFETY & HEALTH OPERATIONAL PROCEDURE Subject: Emergency Eyewash Stations Effective Date: January 2016 version 2 Supersedes: May 2009 Review Date: 3 years or legislation

More information

EUROPEAN COMMISSION DIRECTORATE-GENERAL JUSTICE

EUROPEAN COMMISSION DIRECTORATE-GENERAL JUSTICE EUROPEAN COMMISSION DIRECTORATE-GENERAL JUSTICE SPECIFIC PROGRAMME "ISEC" (2007-2013) PREVENTION OF AND FIGHT AGAINST CRIME CALL FOR PROPOSALS JUST/2013/ISEC/DRUGS/AG Action grants Targeted call on cross

More information

EFTA SURVEILLANCE AUTHORITY DECISION OF 5 JULY 2006 ON AN AID SCHEME FOR RESEARCH, DEVELOPMENT AND INNOVATION IN THE MARITIME INDUSTRY (NORWAY)

EFTA SURVEILLANCE AUTHORITY DECISION OF 5 JULY 2006 ON AN AID SCHEME FOR RESEARCH, DEVELOPMENT AND INNOVATION IN THE MARITIME INDUSTRY (NORWAY) Event No: 363351 Case No: 59434 Decision No: 216/06/COL EFTA SURVEILLANCE AUTHORITY DECISION OF 5 JULY 2006 ON AN AID SCHEME FOR RESEARCH, DEVELOPMENT AND INNOVATION IN THE MARITIME INDUSTRY (NORWAY) THE

More information

REPUBLIC OF LITHUANIA LAW ON SAFETY AND HEALTH AT WORK. 1 July 2003 No IX-1672 Vilnius (As last amended on 2 December 2010 No.

REPUBLIC OF LITHUANIA LAW ON SAFETY AND HEALTH AT WORK. 1 July 2003 No IX-1672 Vilnius (As last amended on 2 December 2010 No. REPUBLIC OF LITHUANIA LAW ON SAFETY AND HEALTH AT WORK 1 July 2003 No IX-1672 Vilnius (As last amended on 2 December 2010 No. XI-1202) PART I GENERAL PROVISIONS CHAPTER I SCOPE, BASIC CONCEPTS AND APPLICATION

More information

III-V Materials, KETs and CLP/REACH Procedures

III-V Materials, KETs and CLP/REACH Procedures Soitec is member of III-V Materials, KETs and CLP/REACH Procedures Entreprise Policy Group Reach Sub Group Meeting November 30th 2012 Summary 1. From III-V Materials to Key Enabling Technologies (KETs)

More information

EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS

EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL

More information

Novità in materia di CLP : impatto sui biocidi. Maristella Rubbiani CSC/ISS

Novità in materia di CLP : impatto sui biocidi. Maristella Rubbiani CSC/ISS Novità in materia di CLP : impatto sui biocidi Maristella Rubbiani CSC/ISS REGULATION 1272/2008 - CLP - (REPLACED 67/548/EU DIRECTIVE) (REPLACING 99/45/EU DIRECTIVE) Professional/ non professional products

More information

IH Regulatory Agenda. Gary Hatcher American Electric Power

IH Regulatory Agenda. Gary Hatcher American Electric Power IH Regulatory Agenda Gary Hatcher American Electric Power Summary Confined Spaces in Construction (OSHA) Beryllium (OSHA) Injury/Illness Prevention Program (I2P2) (OSHA) Infectious Disease (OSHA) Blood

More information

NHS Lanarkshire Policy for the Availability of Unlicensed Medicines

NHS Lanarkshire Policy for the Availability of Unlicensed Medicines NHS Lanarkshire Policy for the Availability of Unlicensed Medicines Prepared by: NHS Lanarkshire Chief Pharmacist Endorsed by: Area Drug & Therapeutic Committee Previous Version/Date: Primary Policy Date:

More information

Support for Applied Research in Smart Specialisation Growth Areas. Chapter 1 General Provisions

Support for Applied Research in Smart Specialisation Growth Areas. Chapter 1 General Provisions Issuer: Minister of Education and Research Type of act: regulation Type of text: original text, consolidated text In force from: 29.08.2015 In force until: Currently in force Publication citation: RT I,

More information

Future road of REACH. Checking out the map. Fulvia Raffaelli Unit G.1 : Chemicals, REACH. European Commission Enterprise and Industry

Future road of REACH. Checking out the map. Fulvia Raffaelli Unit G.1 : Chemicals, REACH. European Commission Enterprise and Industry Future road of REACH Checking out the map Fulvia Raffaelli Unit G.1 : Chemicals, REACH 1 A future in REACH A future of REACH 2 A future in REACH: We have passed first registration (4 000 substances 25

More information

9/10/2013. Contributions of ECHA to the achievement of the REACH goals. Content of Discussion

9/10/2013. Contributions of ECHA to the achievement of the REACH goals. Content of Discussion Contributions of ECHA to the achievement of the REACH goals 5 Jahre REACH und weitere Beitrage zur Nachhaltigen Chemie Darmstadt, Germany 4 September 2013 Geert Dancet Executive Director Content of Discussion

More information

New documents from version 22 to 22.1

New documents from version 22 to 22.1 1 New documents from version 22 to 22.1 Contents 1. Assembly resolutions 2. MSC circulars 3. MEPC circulars 4. MSC-MEPC circulars 5. Other circulars 6. Codes, Procedures 7. Manuals 1. Assembly resolutions

More information

The Role and Responsibilities of the Medical Physicist in MRI in Europe

The Role and Responsibilities of the Medical Physicist in MRI in Europe Stelios Christofides EFOMP Immediate Past President cstelios@cytanet.com.cy OUTLINE The Legal Framework The Problem The MRI Alliance Status of Play Reference Websites The EFOMP Activities 2 The Legal Framework

More information

Australia s National Guidelines and Procedures for Approving Participation in Joint Implementation Projects

Australia s National Guidelines and Procedures for Approving Participation in Joint Implementation Projects Australia s National Guidelines and Procedures for Approving Participation in Joint Implementation Projects March 2010 Version 1.2 Contacting the National Authority for the CDM and JI For information about

More information

Guidance on the Biocidal Products Regulation

Guidance on the Biocidal Products Regulation G U I D A N C E Guidance on the Biocidal Products Regulation Volume V, Guidance on active substances and suppliers (Article 95 list) Version 2.1 March 2017 2 Guidance on BPR: Volume V Version 2.1 March

More information

EIA process in India. Sujit Kumar Singh Programme Manager Centre for Science and Environment New Delhi, India

EIA process in India. Sujit Kumar Singh Programme Manager Centre for Science and Environment New Delhi, India EIA process in India Sujit Kumar Singh Programme Manager Centre for Science and Environment New Delhi, India EIA history - India After Bhopal Gas tragedy Environmental Protection Act was enacted (1986)

More information

REPORTING FORMS COVER PAGE

REPORTING FORMS COVER PAGE REPORTING FORMS pursuant to the Decision of the Third CCW Review Conference on the establishment of a Compliance mechanism applicable to the Convention, as contained in its Final Declaration, Annex II,

More information

Second REACH registration deadline a success. 3 Nearly more substances registered by industry. 10 Setting scientific. 14 Promoting substitution

Second REACH registration deadline a success. 3 Nearly more substances registered by industry. 10 Setting scientific. 14 Promoting substitution 1 3 June 2013 3 Nearly 3 000 more substances registered by industry By the second REACH registration deadline of 31 May, 3 215 companies submitted 9 084 registration dossiers for 2 923 substances to ECHA.

More information

Nuclear material security in Thailand

Nuclear material security in Thailand Nuclear material security in Thailand Ms. Jarunee Kraikaew (Nuclear Chemist, Senior level) Nuclear non-proliferation center (NPC) Bureau of Technical Support for Safety Regulation (BTSR) Office of Atoms

More information

Department of Defense INSTRUCTION

Department of Defense INSTRUCTION Department of Defense INSTRUCTION SUBJECT: DoD Hazard Communication (HAZCOM) Program NUMBER 6050.05 August 15, 2006 Incorporating Change 1, August 25, 2008 USD(AT&L) References: (a) DoD Instruction 6050.5,

More information

COMMISSION DIRECTIVE 2011/18/EU

COMMISSION DIRECTIVE 2011/18/EU 2.3.2011 Official Journal of the European Union L 57/21 DIRECTIVES COMMISSION DIRECTIVE 2011/18/EU of 1 March 2011 amending Annexes II, V and VI to Directive 2008/57/EC of the European Parliament and of

More information

From pre-registration to joint submission Hendrik Abma Director General European Association of Chemical Distributors (FECC)

From pre-registration to joint submission Hendrik Abma Director General European Association of Chemical Distributors (FECC) From pre-registration to joint submission Hendrik Abma Director General European Association of Chemical Distributors (FECC) Commission REACH Workshop 14 April 2008 AGENDA FECC Pre-registration - Pre-SIEF

More information

Local Emergency Planning Committee Responsibilities

Local Emergency Planning Committee Responsibilities Local Emergency Planning Committee Responsibilities A. AUTHORITY FOR LOCAL EMERGENCY PLANNING COMMITTEES 42 U.S.C. 11001-11050 The Emergency Planning and Community-Right-to-Know Act require the establishment

More information