About European Standards Aquaculture workshop Brussels, Centre Borschette 2017-04-27 Andrea NAM 1
Actors in standardization
The European Standardization Organizations (ESOs) The Regional Standardization Organizations for EUROPE - recognized by regulation 1025/2012/ EU Deliver as sole parties European Standards (EN) Are Associations based on membership of the National Standardization Bodies of EU/EFTA member states (ETSI also companies). Founded on the WTO principles: coherence, transparency, openness, consensus, voluntary application 2015-3
The European Standardization Organizations (ESOs) CEN... (European Committee for Standardization) CENELEC... (European Committee for Electrotechnical Standardization) ETSI... (European Telecommunications Standards Institute) 2017-4
European Standardization Organizations (ESOs) European Standardization actors Electricity Electrotechnical European Committee for Electrotechnical Standardization Electronic Communications European Telecommunications Standards Institute Chemistry Material European Committee for Standardization Food Energy Services Transport Metrology Healthcare Construction Environment Security & defense Information society Mechanical engineering Heating, cooling, ventilation 2005 CEN all rights reserved 2009 CEN all rights reserved 09.04.2015 4 CEN and CENELEC 2015 5
CEN and CENELEC Members Austria Estonia Hungary Malta Slovakia Belgium Finland Netherlands Slovenia Bulgaria France Iceland Ireland Norway Spain Croatia Cyprus Czech Republic FYROM Germany Italy Latvia Lithuania Poland Portugal Romania United Kingdom Sweden Switzerland Turkey Denmark Greece Luxembourg Serbia
CEN & CENELEC World 34 Members (NSB-NC of 28 EU Members +3 EFTA countries + Turkey, Serbia and FYROM) Affiliates- new Affiliation concept formally recognized as a potential candidate or a candidate country for EU membership (11 CEN, 9 CLC under modification) Companion Standardization Bodies (CSBs) Partner organizations Liaison organizations 2017-7
The NETWORK of CEN & CENELEC More than 200 000 experts are connected - 800 participants from European industry federations and societal stakeholders - 30 000 delegates / experts in CEN and CENELEC - 55 000 delegates / experts in ISO and IEC - 160 000 participants through the national members of CEN and CENELEC
Societal Stakeholders and SMEs (Annex III Organisations) SBS Small Business Standards SME TOOLBOX ETUC - European Trade Union Confederation ANEC - the European consumer voice in standardization ECOS - the European Environmental Citizens Organization for Standardization Societal Stakeholders TOOLBOX
CEN and CENELEC: development of standards 200.000 Experts 486 Technical Committees 1.809 Working Groups 21.596 Standards (nearly 5.000 HS) 479 CWAs 595 Technical Specifications 564 Technical Reports Statistical pack on www.cencenelec.eu
The international dimension Vienna Agreement Frankfurt Agreement National Standardization Bodies and National Committees Principal aim: Identical European and international standards CEN: 31% of portfolio identical to ISO NATIONAL LEVEL CENELEC: 72% of portfolio identical to (+ another 6% based on) IEC standards
Vienna & Frankfurt Agreements: principles» Primacy of International Standards» Avoid duplication of work at International and European levels» Aim at identical worldwide and European standards» Ensure rational use of available resources» Common Drafting Rules 2015-12
About the standards
A European Standard is A document for a common and repeated use Produced by all interested parties through a transparent, open and consensus based process Voluntary in use Reflects market needs A tool to support legislation Highly aligned with ISO/IEC standards
You re living it! CEN and CENELEC 2015 15
Removing trade barriers... 2017-16
The added value of standards Reduces business transaction costs Facilitate access to market Guarantee environmental and consumers protection Increase of products safety Promote technical connectivity, interoperability and sustainability of products and services Facilitate trade by removing trade barriers and enhance competition Help manufacturers comply with legislation & market expectations
Harmonization effect What s special about European Standards? The ESOs 1 European Standard 33 identical national standards All conflicting standards removed Access to a market of 600 Million consumers CEN and CENELEC 2015 18
Uniqueness Commitment of the Members to implement the EN conflicting national standards are automatically withdrawn dow * National standard * Date of withdrawal of national conflicting standards CEN and CENELEC 2015 19
Two production lines 20.000 400 European Standard (EN) Highest level of consensus All relevant stakeholders Mandatory implementation by all Members CWA (Workshop Agreement) Workshop is consortium Agreement of those participating Take it or leave it No implementation Can be basis for a future EN CEN and CENELEC 2015 20
other deliverables 600 500 Technical Specification (TS) Limited level of consensus No immediate need for national implementation All relevant stakeholders No mandatory implementation by Members Can be transformed into a EN Technical Report (TR) Providing information on the technical content of standardization work, data etc. Relevant stakeholders No mandatory implementation CEN and CENELEC 2015 21
Standards and legislation Standards 1. Voluntary 2. Consensual 3. Developed by independent organizations 4. Revised every 5 years 5. Provide specifications and test methods (interoperability, safety, quality, etc.) Legislation 1. Mandatory 2. Imposed by Law 3. Established by public authorities 4. Revised when legislators decide 5. Sets requirements to protect public interests
EU legislation making reference to standards: HOW? Direct reference: mandatory - for specific use NA - Indirect reference legal text refers to publication of standards, standard references are published in the OJEU
Harmonised standards Developed by a recognised ESO and created following a request from the European Commission Harmonised standards cited in the OJEU confer presumption of conformity Manufacturers, other economic operators, or conformity assessment bodies can use harmonised standards to demonstrate that products, services, or processes comply with relevant EU legislation Their use remain voluntary Alternative sources of information DG GROW's European Standards website National information channels (standards bodies, trade organisations...)
New Approach Standardization request Presumption of conformity Harmonized Standard European Standard (EN) 4000+ harmonized standards listed in the OJEU CEN and CENELEC 2015 25
Regulation and the standards Regulation 1025/2012 reconfirms ESO (+ NSB- NC) system in support of European Union policies and strategic objectives CEN & CENELEC support 39 European Directives/Regulations With a total of more than 4000 standards referenced in the OJ (19% of portfolio) CEN and CENELEC 2015 26
Development of standards
Initiation of standard development Output (European Standard) is implemented by all CEN/CLC Members Work is performed with participation of all interested stakeholders (inclusiveness) Evaluation of needs and feasibility with all relevant stakeholders at Technical Board level CEN and CENELEC 2015 28
National delegation principle NSB/NC NSB/NC NSB/NC CEN CENELEC Technical Bodies 2016-29
Technical Committee - main actors Technical Committee officers Chairperson Secretary (NSB/NC) National delegations National position Voting Right Observers European Partners (CEN CENELEC Guide 25) Annex III Organisations Affiliates Representatives of other technical bodies No voting right 2016-30
Standards development process Step by step 1 6 Proposal - evaluation and decision 2 3 4 5 Drafting and consensus building Public enquiry Consideration of comments Approval of the standard Publication 2016-31
Registration NWI TC analyses comments & voting result-8m Publication Development of European Standards New procedure Skip Formal Vote (2m) TC CCMC, NSBs/NCs NSBs/NCs Drafting 8-12 months i Editing, translation & enquiry preparation 3,5 months Enquiry (associated weighted vote) 3 months (12 weeks) Resolution of comments received & Formal Vote (4,5m) i A first working draft should be circulated 4 months after registration of the NWI
Detailed Timeframe - Technical Specifications (TS) Registration of a NWI Start of Vote on TS Definitive text available 12 months* 3.5 12 months weeks 3 months Final draft to CCMC End of Vote on TS Technical work Processing and translation Total max 21,5 months Voting via e-balloting *An extension of 9 months may be requested Andrea NAM 2017-01-17_18 2017 33
Detailed Timeframe - Technical Reports (TR) Registration of a NWI Start of Vote on TR Definitive text available 12 months* 1,5** months 12 weeks 2 months Technical work Final draft to CCMC Editing and finalisation by CCMC since 1 Sept 2016 End of Vote on TR Max total 19 months Vote on TR via e-balloting since 1 Sept 2016 *An extension of 9 months may be requested **TRs are only processed and published in English Andrea NAM 2017-01-17_18 2017 34
Maintenance of a standard Mandatory systematic review (at the latest) every 5 years (Launched by CCMC) Objective: Ensure that standards are still valid and up-to-date Voting Options confirmation withdrawal revision 2015-35
Standards relevant to fish and fish products 2010 36
Standards on fish products CEN workshop agreements WS076001 - CWA 16960:2015 - Batch-based Calculation of Sustainability Impact for Captured Fish Products - To facilitate and prepare the basis for batch based calculations of sustainability impact for wild caught fish products WSFIS001 - CWA 16597:2013 - FishBizz Business Case - For monitoring of quality and sales of fish products WS008002 - CWA 14660:2003 (withdrawn) - Traceability of fishery products - Specification on the information to be recorded in captured fish distribution chains CEN and CENELEC 2016 37
Standards related to fish and fish products Fishing nets Fish-meal - Vocabulary - (ISO 7088:1981) EN ISO 7088:2005 Household and similar electrical appliances - Particular requirements for electric fishing machines Water quality (Determination of the acute lethal toxicity, fish sampling methods) Food processing machinery Chemical disinfectants and antiseptics Foodstuffs analytical standards Animal feeding stuffs CEN and CENELEC 2016 38
http://www.cen.eu http://www.cenelec.eu http://www.cencenelec.eu Contact: anam@cencenelec.eu