Biocidal product regulation the changes to come
|
|
- Anastasia Greer
- 5 years ago
- Views:
Transcription
1 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 its Biocides Stakeholders Day held on 24 September 2014 in Helsinki. All actors (active substance manufacturers and suppliers, biocidal product formulators and providers, importers) are concerned by the recent evolutions particularly impacting the Review Programme, treated articles and IT tools in particular. Margaux Tanguy and Aurélie Lemétais 4 November 2014 Since its entry into force in September 2013 (Regulation No 528/2012), the following amendments have been implemented: - The Review Programme for existing active substances has been postponed until 2024 (Regulation No 736/2013 entered into force on 20/08/2013) - The information required for biocidal product authorisation applications and the notion of technical equivalence have been specified (Regulation No 837/2013 entered into force on 23/09/2013) - The transitional period has been affected (Regulation No 334/2014 entered into force on 25/04/2014) Since 10 October 2014, a new amendment repeals the Review Programme for existing active substances: Commission delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council. New Review Programme Why? The implementation of a new Review Programme for existing active substances was necessary for two reasons: the first was due to the postponing of the Review Programme until 31 December 2024 (Regulation No 736/2013) and the second because of the procedures revision to be in line with the BPR (Regulation No 837/2013 and No 334/2014) EcoMundo Page 1
2 How? Regulation No 1062/2014 establishes a new Review Programme by introducing procedures of inclusion for additional existing active substances; as otherwise, these substances would be on the market illegally. The topics of the new Review Regulation are organized as follows: Articles 3 9: Process and procedures Review Programme Article 10: Joining or replacing participant Articles 11 12: Participants withdrawal This could already be done under the Directive, but now, there is a clear process to first, withdraw a participant and then, replace him. Article 13: Redefinition of active substances (not in the Directive) For example, this was the case of the Margosa extract, which had a definition in the notification dossier and which has been redefined during the evaluation. Article 14 1 : Taking over the role of participant Article 15 2 : Substance/product-type combinations eligible for inclusion in the review programme Article 16 3 : Declaration of interest to notify Article 17 4 : Notification Article 18-20: Follow-up notification process Article 21: Transitional measures including phase-out periods Article 22: Essential use (already in the Directive) Annex I: Information requirements for notifications Annex II: Substance/product-type combinations included in the Review Programme on 4 August Part 1: Active substance/product-type combinations supported on 4 August 2014, which means the substances that are still under evaluation in the review Programme - Part 2: Active substance/product-type combinations not supported on 4 August 2014 Annex III: Time limits by product-types, for submitting the assessment report of the competent authorities (RAC) and for starting the preparation of the Agency s opinion (The Biocidal Product Committee s opinion) Note: Active substances generated in-situ are not included in the new Review Programme. When must you notify? ECHA gives the possibility to: Take over the role of the participant for an active substance/product-type combination (see Annex II, part 2 of regulation No 1062/2014): - when previous participants have withdrawn - when the identity of an active substance has been redefined 1 Article 14 is explained in section When must you notify? 2 Article 15 is explained in section When must you notify? 3 Article 16, relating to article 15, is explained in section When can we apply for this inclusion in the review Programme? 4 Article 17 is explained in section What is a notification? EcoMundo Page 2
3 include an active substance in the new Review Programme when this substance has not been approved or included in the old programme for the PT concerned If you are interested in any of these, then you must act now by submitting a notification to ECHA. The Commission will give its decision of non-approval for any active substance/product-type combination listed in Regulation No 1062/2014 (Annex II, part 2), for which no notification will have been submitted until 30 October 2015 (or if the notification is rejected). Guidance is currently in progress and will be available before the end of the year What is a notification? It is a submission to ECHA, subject to a fee of 10,000 Euros, but reimbursed after submission of the application for the approval of an active substance. Information requirements - very limited and similar to the notification process under the BPD Review Programme - are specified in Annex I: Prepare a dossier in IUCLID and submit it via R4BP Show evidence that it is an existing active substance, i.e. present on the EU market before 14 May 2000 for biocidal purposes Include information on the applicant, the substance s identity and intended use Compliance is verified by ECHA with the possibility of appeal against the decisions rendered, if required. When can we apply for this inclusion in the review Programme? When a biocidal product placed on the market is composed of an existing active substance, which is not approved, or listed in Annex I of the Regulation, or included in the Review Programme for the product-type concerned, the substance can be included in the Review Programme for the producttype concerned for one of the following reasons: The biocidal product placed on the market was initially considered to be outside the scope of the BPD or BPR but this is no longer the case today - for example, flocculants used to remove algae from ponds were, until the BPR, outside the scope of the directive The substance benefited from a derogation for food and feedstuffs (used as attractant or repellent under the old Review Regulation) - a notification must be submitted in order to check if the derogation still applies) Due to the modification of a product-type s scope under the BPR, your active substance is not included in the Review Programme for this new product-type - for example, algaecides, which were used for the preservation of construction materials, moved from product-type 10 to 2 (in this case, the notification has to be submitted to the Commission) Anyone concerned with the above cases mush therefore submit a declaration of interest to notify, then, after ECHA s approval and the publication of the invitation to notify, the notification must be submitted EcoMundo Page 3
4 6 mois 2 ans Submission of a declaration of interest before the Commission or ECHA Acceptance of the declaration by the Commission or ECHA Publication: invitation to send a notification (ECHA) Notification to ECHA Verification of the notofication's compliance by ECHA Submission of a dossier for AS approval or for inclusion in Annex I Process of inclusion in review programme The submission of declaration of interest has to be notified to the Agency (ECHA) for food and feedstuffs derogations or to the Commission for other processes. Therefore, if you have a food and feedstuffs derogation under the old Review Regulation or are affected by the change in scope of a product-type under the BPR, you have to act now by submitting a declaration of interest to notify to either ECHA or the Commission. Indeed, you only have one year to submit your interest to notify otherwise this type of product will be illegal on the market. All the instructions explaining how to submit your declarations of interests (via a web form) or your notifications (via R4BP), will be available on ECHA s website before the end of this year. All other processes described in the Review Regulation - such as withdrawal and taking over the role of the participant - will be done through web forms. Instructions concerning these procedures will soon be available on ECHA s website. IT tools The current versions of the IT tools are R4BP and IUCLID 5.6. R4BP3 Released on 3 December 2014, this tool is important for companies using it to submit their applications. For Member States, it is a communications tool but also a means to collect and store SPCs. This tool facilitates benchmarking on the EU market. Here is a list of some of the new features: Possibility to check your SME status Export the data of your submission onto your local system with the possibility to filter data before the export Printing of the case details Regrouping submissions: for example, before, to apply for Mutual Recognition, you had to do it by member state. In the next version of the R4BP, all you will have to do is select all the member states in which you wish to apply for MR and submit the application in one step. Implementing alerts: you will receive an every time information concerning your ongoing procedures arrives on your account. However, you still have a legal obligation to regularly connect to your account to see if new information has been sent to you. Possibility to nominate consultants in the system Possibility to manually transfer an authorisation from a company A to a company B EcoMundo Page 4
5 SPC editor Summary of Product Characteristics - Release in October 2014 From December, a new SPC will be required for new biocidal product authorisation applications (but not for renewal applications). For the moment, the SPC used is the one available on the ECHA s website (word document). For on-going applications, ECHA will create a new SPC for you. But for new Union authorisation applications, SPC will have a new structure that benefits both ECHA and applicants. Thus, ECHA will provide you with a tool to help you draft your SPC: the SPC editor Launched in October 2014, this new tool helps companies to carry out their duties properly under BPR when submitting their National as well as European authorisation application. The application is available on internet, but the integration of data is via our system in order to guarantee confidentiality. No data will be put online. This tool is entirely compatible with the new 3.2 version of R4BP. Some data entered in the SPC Editor, needed for biocidal product authorisation applications, will be directly integrated in R4BP to avoid entering the same information twice. The SPC Editor drafts SPCs for products alone as well as for families of products. Moreover, it will allow SPC translation into all EU languages including Norwegian. Finally, the SPC can be printed. Be careful, the tool is only available on IE10 + Mozilla Firefox 29+ and Google chrome 35+. If you have already started working on your SPC via word, then you can copy/paste your data into the SPC Editor. IUCLID IUCLID is a mandatory format because it is the best way to communicate data to competent authorities and to the Agency (well structured, possibility to process the data further, no need to print). Technical upgrades are still ongoing: IUCLID 6 will be available for submissions to ECHA from Among the new features: you will be able to install it simply, it opens the possibility to customize your user interface and the help system will be enhanced. Treated articles Concerning restrictions, it has been confirmed that restrictions will be maintained for the use of an active substance in an article if the substance presents an identified danger. According to article 58 (3), labelling is sometimes required, particularly when the active substance has been approved for some uses and not others, or if the substance is of very high concern (for example if it is classified as a skin sensitizer cat.1a/1). In this last case, the company must assess exposures to the substance in order to determine if this specific label is relevant. For complex articles, a mutual agreement was reached. The following example was given: if paint has been treated with a preservative (in-can preservative PT 6) and that this paint is used to paint part of some furniture, then this furniture will not be considered as a treated article because the preservative does not have any expected function on the final article. The next decisions and assessments will be made along this rule. With experience, authorities will decide if it is relevant to come back on this rule or not. Authorities are also reflecting on the sustainable use concept. Some companies are currently consulted to give their opinion on the following questions: EcoMundo Page 5
6 How do you promote products with a better profile for the environment and public health? Answer elements: with a specific labelling or a logo on such products. For example for those that are eligible for the simplified authorisation procedure. How do you follow uses? Answer elements: by annually declaring via R4BP, the quantities of substance or biocidal products placed on the EU market. How do you promote the best practices to inform the final users on the risk and risk management measures? As previously stated, discussions are ongoing. A report will be submitted to the council and Parliament to amend the Regulation. According to M. Choraine (DG Environment, European Commission), the key points and objectives on the short or medium term would be to finish the active substance assessments according to the Review Programme, finish authorising or not all the products for which a Union authorisation application was submitted and finally, think about how to improve the use of biocidal products. The end of this year will be highly eventful, particularly with the implementation of a new Review Programme, the notifications to submit, the launch of the SPC Editor and even of R4BP3.2. However, discussions are still ongoing concerning the notion of treated articles or even families of products. Nevertheless, EcoMundo will be following this closely to always keep you informed on the latest regulation amendments and evolutions that can impact your affairs. By Margaux Tanguy and Aurélie Lemétais Regulatory project leaders at EcoMundo EcoMundo Page 6
7 EcoMundo Page 7
8 References Internet documents ECHA, forthcoming revision of the fee regulation and national fees, relevant policy issues, Pierre Choraine. URL: ECHA, new review programme regulation, Erik Vandeplassche. URL: ECHA, new summary product characteristic (SPC) editor for biocides authorization URL: ECHA, IT tools Biocides stakeholders day, Jan Weber. URL: Health and Safety Executive, Derogation for foodstuff based repellents and attractants. URL: EcoMundo Page 8
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 informationGuidance 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 informationECHA 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 informationASSESSMENT 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 informationProcedure 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 informationCLP 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 information1. 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 informationREACH 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 informationCLP 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 informationGuidance 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 informationCOMMISSION 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 informationEducation, Audiovisual and Culture Executive Agency GRANT DECISION FOR AN ACTION. Decision Nr
Education, Audiovisual and Culture Executive Agency Creative Europe: Culture GRANT DECISION FOR AN ACTION Decision Nr of the Education, Audiovisual and Culture Executive Agency on the award of a grant
More informationImplementation 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 informationIntertek 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 informationHarmonisation 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 informationCHEMICALS (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 informationREACH/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 informationCOMMISSION IMPLEMENTING REGULATION (EU)
L 253/8 Official Journal of the European Union 25.9.2013 COMMISSION IMPLEMENTING REGULATION (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council
More informationAgenda. Workflows and Software Tools for the Process of Registration, Evaluation, Authorisation and Restriction of European Chemicals
Workflows and Software Tools for the Process of Registration, Evaluation, Authorisation and Restriction of European Chemicals Gerlinde Knetsch Federal Environment Agency Unit IV2.1- Information Systems
More informationPractical 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 informationGuidance 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 informationBackground 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 informationCOMMISSION IMPLEMENTING DECISION. of
EUROPEAN COMMISSION Brussels, 16.10.2014 C(2014) 7489 final COMMISSION IMPLEMENTING DECISION of 16.10.2014 laying down rules for the implementation of Decision No 1313/2013/EU of the European Parliament
More informationEUROPEAN 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 information9/10/2013. 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 informationSDS 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 informationUpdate 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 informationREACH 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 informationQuestions 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 informationHealth 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 informationMINIMUM 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 informationNewsletter 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 informationGUIDE FOR APPLICANTS INTERREG VA
GUIDE FOR APPLICANTS INTERREG VA Cross-border Programme for Territorial Co-operation 2014-2020, Northern Ireland, Border Region of Ireland and Western Scotland & PEACE IV EU Programme for Peace and Reconciliation
More information1. INTRODUCTION SNVEL
SNVEL (Syndicat national des vétérinaires d exercice libéral) Response To the COM (2011) 367 final GREEN PAPER on Modernising the Professional Qualifications Directive Dir 2005/36/EC 1. INTRODUCTION SNVEL
More informationCurrent and future standardization issues in the e Health domain: Achieving interoperability. Executive Summary
Report from the CEN/ISSS e Health Standardization Focus Group Current and future standardization issues in the e Health domain: Achieving interoperability Executive Summary Final version 2005 03 01 This
More informationModel Agreement between Lead Partners and partners of an INTERREG IVC project (Partnership Agreement) 1
Model Agreement between Lead Partners and partners of an INTERREG IVC project (Partnership Agreement) 1 Having regard to Council Regulation (EC) No 1080/2006 of 5 July 2006, amended by Regulation (EC)
More informationFORUM 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 informationFAQs on PRIMA Calls PRIMA FAQ. Overview of PRIMA Programme
FAQs on PRIMA Calls These FAQs provide guidance for applicants to PRIMA Calls for Proposals to supplement the information provided in the Call text and Call documents. The FAQs will be updated regularly
More informationCALL FOR PROPOSALS FOR PARTNERSHIP1 COMM/FPA/2016
Directorate-General for Communication CALL FOR PROPOSALS FOR PARTNERSHIP1 COMM/FPA/2016 FOR THE ESTABLISHMENT OF FRAMEWORK PARTNERSHIP AGREEMENTS2 IN THE CATEGORY OF MEDIA PERIOD COVERED: 2018-2019 Application
More informationNovità 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 informationFinal 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 informationEducation, Audiovisual and Culture Executive Agency
Education, Audiovisual and Culture Executive Agency Creative Europe - MEDIA CREATIVE EUROPE MEDIA Sub-programme Established by Regulation N 1295/2013 of the European Parliament and of the Council of 11
More informationGENERAL TENDER CONDITIONS
GENERAL TENDER CONDITIONS F4E_D_27E7D9 v 2.2 Page 1 of 15 TABLE OF CONTENTS 1. Introduction... 3 2. Procurement rules... 3 3. Procurement procedures... 4 4. Compliance with requirements... 5 4.1. Completeness
More informationInternational Cooperation in Horizon 2020 Transport R&I area
No guarantee for accuracy or completeness of the information Your network of Transport National Contact Points International Cooperation in Horizon 2020 Transport R&I area Co-funded by the Horizon 2020
More informationEUROPEAN 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 informationGRANT AGREEMENT FOR AN ACTION ACTION 2 - ERASMUS MUNDUS PARTNERSHIPS Financing exclusively by lump sum contribution(s) and/or unit contribution(s)
Grant Agreement number «NO_REF» MONO BENEFICIARY GRANT AGREEMENT MARCH 2013 Education, Audiovisual and Culture Executive Agency Erasmus Mundus and External Cooperation GRANT AGREEMENT FOR AN ACTION ACTION
More informationBrussels, 19 December 2016 COST 133/14 REV
Brussels, 19 December 2016 COST 133/14 REV CSO DECISION Subject: Amendment of documents COST 133/14: COST Action Proposal Submission, Evaluation, Selection and Approval The COST Action Proposal Submission,
More informationDRAFT OPINION. EN United in diversity EN. European Parliament 2018/0018(COD) of the Committee on Industry, Research and Energy
European Parliament 2014-2019 Committee on Industry, Research and Energy 2018/0018(COD) 13.4.2018 DRAFT OPINION of the Committee on Industry, Research and Energy for the Committee on the Environment, Public
More informationRepublic of Latvia. Cabinet Regulation No. 50 Adopted 19 January 2016
Republic of Latvia Cabinet Regulation No. 50 Adopted 19 January 2016 Regulations Regarding Implementation of Activity 1.1.1.2 Post-doctoral Research Aid of the Specific Aid Objective 1.1.1 To increase
More informationGUIDE FOR ACTION GRANTS 2015
Guide for Action Grants 2015 Version: June 2015 EUROPEAN COMMISSION DIRECTORATE-GENERAL JUSTICE and CONSUMERS Directorate A Unit A4: Programme management GUIDE FOR ACTION GRANTS 2015 *** Justice Programme
More informationCOMMUNICATION STRATEGY
COMMUNICATION STRATEGY Final version Approved by the Monitoring Committee on 30 March 2016 Final version, 30 March 2016 page 2 of 16 INDEX 1 Introduction 4 1.1 Legal background 4 2 Responsibilities of
More informationSPECIFIC CALL FOR PROPOSALS COMM/SUBV/2019/M
Directorate-General for Communication SPECIFIC CALL FOR PROPOSALS COMM/SUBV/2019/M FOR THE ESTABLISHMENT OF SPECIFIC GRANT AGREEMENTS WITH PARTNERS 1 OF THE EUROPEAN PARLIAMENT IN THE MEDIA CATEGORY Implementation
More informationHazard 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 informationEUROPEAN COMMISSION. CALL - EAC/A01/2015 Erasmus+ Vocational Education and Training Mobility Charter
EUROPEAN COMMISSION CALL - EAC/A01/2015 Erasmus+ Vocational Education and Training Mobility Charter 2016-2020 1. Introduction This specific Call is based on Regulation (EU) No 1288/2013 of the European
More informationJoint Operational Programme Romania Republic of Moldova
Joint Operational Programme Romania Republic of Moldova 2014-2020 Procedure for the evaluation and approval of large infrastructure projects selected through direct award Abbreviations CBC Cross Border
More informationMain audit findings on State aid
Main audit findings on State aid Petr JIRMAN Audit Directorate, DG Regional and Urban Policy European Commission Disclaimer: The views expressed are those of the author and cannot be regarded as stating
More informationCall: Graduate school in energy systems
Call: Graduate school in energy systems The Swedish Energy Agency announces grant founding of SEK 45 million within the framework of the five-year research program "Graduate school in energy systems" phase
More informationBASG / Austrian Medicines and Medical Devices Agency Institute Assessment & Analytics Traisengasse 5, A-1200 Vienna
This guidance document is intended to provide applicants with detailed information on the operational procedure of National Scientific Advice (NASA) by the Austrian Federal Office for Safety in Health
More informationGuidance 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 informationREACH 2018 registration deadline Last advice for companies
REACH 2018 registration deadline Last advice for companies Conference & Networking Lunch: REACH&CLP: Implementation and future challenges for companies 14 December 2017 István Mák Dossier Submission and
More informationAnnex. Provisions on auditing notified conformity assessment bodies in the framework of Article 34 3 of the Agency Regulation 1
Making the railway system work better for society. in the framework of Article 34 3 of the Agency Regulation 1 1. Introduction This details the audits performed by the Agency in the framework of the monitoring
More informationThe 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 informationFrequently Asked Questions
Fast Track to Innovation Pilot (2015) Call opening: January 6, 2015 First Cut-off Date: April 29, 2015 Frequently Asked Questions Official European Commission document December 2014 Contents A. Eligibility
More informationHERCULE III PROGRAMME CALL FOR PROPOSALS REF. Hercule III 2014 ANTI-FRAUD TRAINING E PROGRA MME ANTI-FRAU
HERCULE III PROGRAMME 2014-2020 UL CALL FOR PROPOSALS REF. Hercule III 2014 ANTI-FRAUD TRAINING E PROGRA MME 2014-0 Deadline Monday 15 September 2014 Eligibility Period For Activities 13 April 2015 31
More informationApril 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 informationREGISTRATION 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 informationErasmus+ Vocational Education and Training Mobility Charter Specifications for call - EAC/A02/2016
Erasmus+ Vocational Education and Training Mobility Charter 2017-2020 Specifications for call - EAC/A02/2016 EUROPEAN COMMISSION Directorate-General for Education and Culture Directorate B Modernisation
More informationEUROPEAN PARLIAMENT Committee on the Environment, Public Health and Food Safety
EUROPEAN PARLIAMT 2009-2014 Committee on the Environment, Public Health and Food Safety 2012/0266(COD) 12.4.2013 ***I DRAFT REPORT on the proposal for a regulation of the European Parliament and of the
More informationGuideline on good pharmacovigilance practices (GVP)
1 2 26 July 2012 EMA/118465/2012 3 4 Guideline on good pharmacovigilance practices (GVP) Module XV Safety communication 5 Draft finalised by the Agency in collaboration with Member States and submitted
More informationPublic Diplomacy, Policy Research and Outreach Devoted to the European Union and EU-Canada Relations
Public Diplomacy, Policy Research and Outreach Devoted to the European Union and EU-Canada Relations CALL FOR PROPOSALS Application Deadline: 22 September, 2009 This Call for Proposals is designed to pursue
More informationCMDv/BPG/002. BEST PRACTICE GUIDE for Veterinary Decentralised Procedure (DCP)
BEST PRACTICE GUIDE for Veterinary Decentralised Procedure (DCP) Edition number: 05 Edition date: 7 November 2013 Implementation date: 6 February 2006 CMDv Secretariat: 7 Westferry Circus, Canary Wharf,
More informationAustralian/New Zealand Standard
AS/NZS 4501.1:2008 CEN/TR 15321:2006 AS/NZS 4501.1:2008 Australian/New Zealand Standard Occupational protective clothing Part 1: Guidelines on the selection, use, care and maintenance of protective clothing
More information***I DRAFT REPORT. EN United in diversity EN. European Parliament 2018/0018(COD)
European Parliament 2014-2019 Committee on the Environment, Public Health and Food Safety 4.5.2018 2018/0018(COD) ***I DRAFT REPORT on the proposal for a regulation of the European Parliament and of the
More informationREPORTING 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 informationProcesses and Responsibilities. ERA ETCS Conference on Testing and Certification Lille March 29 th 2011
Processes and Responsibilities ERA ETCS Conference on Testing and Certification Lille March 29 th 2011 Overview The principles for authorisation The application of the principles How the CCS TSI supports
More informationCALL FOR PROPOSALS FOR PARTNERSHIP COMM/FPA/2016
Directorate-General for Communication CALL FOR PROPOSALS FOR PARTNERSHIP COMM/FPA/2016 FOR THE ESTABLISHMENT OF FRAMEWORK PARTNERSHIP AGREEMENTS 1 IN THE CATEGORY OF MEDIA PERIOD COVERED: 2016-2019 Application
More informationBrussels, 12 June 2014 COUNCIL OF THE EUROPEAN UNION 10855/14. Interinstitutional File: 2012/0266 (COD) 2012/0267 (COD)
COUNCIL OF THE EUROPEAN UNION Brussels, 12 June 2014 Interinstitutional File: 2012/0266 (COD) 2012/0267 (COD) 10855/14 PHARM 44 SAN 232 MI 492 COMPET 405 CODEC 1471 NOTE from: General Secretariat of the
More informationEUROPEAN COMMISSION. CALL - EAC/A06/2017 Erasmus+ Vocational Education and Training Mobility Charter
Ref. Ares(2017)5680072-21/11/2017 1. EUROPEAN COMMISSION CALL - EAC/A06/2017 Erasmus+ Vocational Education and Training Mobility Charter 1. Introduction This specific Call is based on Regulation (EU) No
More informationUpdate 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 informationSupport 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 informationEurope Direct is a service to help you find answers to your questions about the European Union.
General Report 2015 Disclaimer The views or positions expressed in this Work Programme do not necessarily represent in legal terms the official position of the European Chemicals Agency. The European Chemicals
More informationRecognition of Professional Qualifications
Recognition of Professional Qualifications Modernising Directive 2005/36/EC Marko CURAVIC (DG ENTR/D.1) Towards a more intensive cooperation in the transposition of the Directive 2013/55/EU among Competent
More informationNegotiation Guidance Notes
Negotiation Guidance Notes FP7 Collaborative Projects, Networks of Excellence, Coordination and Support Actions, Research for the benefit of Specific Groups (in particular SMEs) Version 31/7/2007 Disclaimer
More informationPICK-ME Kick-off meeting Political, scientific, contractual and financial aspects
PICK-ME Kick-off meeting Political, scientific, contractual and financial aspects Collegio Carlo Alberto, Torino (Moncalieri) 4 February 2011 Domenico ROSSETTI Commission européenne, DG de la Recherche
More informationREACH-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 informationREACH 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 informationeuropean citizens Initiative
A new right for eu citizens You can set the agenda! guide to the european citizens Initiative European Commission Secretariat-General B-1049 Brussels Manuscript completed in November 2011 Luxembourg: Publications
More informationThe Mineral Products Association
The the aggregates, asphalt, cement, sand industries. MPA members supply around 5bn of essential material to the UK economy; by far the largest single supplier of material to the construction sector. Specific
More informationNHS Fife WORKING WITH THE PHARMACEUTICAL INDUSTRY AND HEALTHCARE EQUIPMENT SUPPLIERS GUIDANCE FOR NHS STAFF
NHS Fife WORKING WITH THE PHARMACEUTICAL INDUSTRY AND HEALTHCARE EQUIPMENT SUPPLIERS GUIDANCE FOR NHS STAFF This guidance relates to all staff employed by NHS Fife (including staff within the Health &
More informationTherefore the provision of medicines is an area for which a Community regulatory framework should be properly supervised to ensure full and
European Association of Pharmaceutical Full-line Wholesalers (GIRP) response to the European Commission Consultation regarding Community action on Health Services Introduction Firstly, GIRP welcomes the
More information( ) 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 informationANNEX. to the COMMISSION DECISION
EUROPEAN COMMISSION Brussels, 15.12.2017 C(2017) 8510 final ANNEX 1 ANNEX to the COMMISSION DECISION on the adoption of a financing decision for 2017 and 2018 for the pilot project "Pilot project - Environmental
More informationICTpsp I C T P O L I C Y S U P P O R T P R O G R A M M E. CIP ICT PSP Pilots A, Pilots B, Thematic Networks, Best Practice Networks, PPI Pilots
DG COMMUNICATIONS NETWORKS, CONTENT & TECHNOLOGY ICT Policy Support Programme Competitiveness and Innovation Framework Programme ICTpsp I C T P O L I C Y S U P P O R T P R O G R A M M E Guidance Notes
More informationGUIDANCE HOW TO IMPLEMENT THE PROJECT VIA THE ELECTRONIC MONITORING SYSTEM (PART II)
Approved by the Head of the Managing Authority Sandis Cakuls on 19.06.2017. GUIDANCE HOW TO IMPLEMENT THE PROJECT VIA THE ELECTRONIC MONITORING SYSTEM (PART II) INTERREG V A LATVIA LITHUANIA PROGRAMME
More informationOpen call for proposals VP/2004/021. Initiatives to promote gender equality between women and men, including activities concerning migrant women
EUROPEAN COMMISSION EMPLOYMENT, SOCIAL AFFAIRS AND EQUAL OPPORTUNITIES DG Horizontal and international issues Equality for Women and Men Open call for proposals VP/2004/021 Initiatives to promote gender
More informationSecond 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 informationAbu Dhabi Occupational Safety and Health System Framework (OSHAD-SF) Mechanisms
Abu Dhabi Occupational Safety and Health System Framework (OSHAD-SF) Mechanisms Mechanism 2.0 OSHAD-SF Administration Version 3.1 March 2017 Table of Contents 1. Introduction... 3 2. Roles and Responsibilities...
More informationVersion September 2014
Guide for Grant Agreement Preparation Version 0.3 25 September 2014 Disclaimer: This document is aimed at assisting applicants and beneficiaries for Horizon 2020 funding. Its purpose is to explain the
More informationCALL FOR PROPOSALS FOR THE CREATION OF UP TO 25 TRANSFER NETWORKS
Terms of reference CALL FOR PROPOSALS FOR THE CREATION OF UP TO 25 TRANSFER NETWORKS Open 15 September 2017 10 January 2018 September 2017 1 TABLE OF CONTENT SECTION 1 - ABOUT URBACT III & TRANSNATIONAL
More informationStandard operating procedure
Standard operating procedure Title: Evaluation procedure for applications and requests for the establishment or review of Maximum Residue Limits (MRLs) Status: PUBLIC Document no.: SOP/V/4150 Lead author
More information