European standard setting via CEN TC 437 Global forum on Nicotine 2015 CEN-CENELEC Alberto Simeoni Innovation Dept. GFN 2015 Warsaw, 5 June 2015
EUROPEAN STANDARDIZATION ORGANIZATIONS European Committee for Standardization European Committee for Electrotechnical Standardization Two distinct private international non-profit organizations based in Brussels bringing together the National Standardization Bodies of 33 European countries 2015-06-05 CEN-CENELEC 2015-2
EUROPEAN STANDARDIZATION ORGANIZATIONS Along with the European Telecommunications Standards Institute, CEN and CENELEC are the officially recognized organizations by the European Union and the European Free Trade Association (EU Reg.1025/2012) as being responsible for developing and defining voluntary standards at European level 2015-06-05 CEN-CENELEC 2015-3
CEN & CENELEC WHO WE ARE 33 Members National standardization bodies from EU + EFTA and beyond Affiliates (neighbouring area) 17 for CEN, 14 for CENELEC Partner Standardization Bodies 3 for CEN Partner organizations 8 for CEN, 10 for CENELEC Other liaisons at technical level 100+ organizations Members Affiliates CEN-CENELEC 2015-4
CEN-CENELEC 2015-5
ONE STANDARD FOR 33 COUNTRIES 1 European Standard... replaces 33 different national standards in Europe... creates access to a market of 600 million... 2015-06-05 CEN-CENELEC 2015-6
INTERNATIONAL DIMENSION Vienna Agreement Dresden Agreement ~ 30 % of CEN standards are developed under the Vienna Agreement (depending on the sector) ~ 75 % of CENELEC standards are identical to or based on IEC standards Memorandum of Understading For sectors of telecommunications (ITU-T) and on radio-communication (ITU-R) CEN-CENELEC 2014-7 CEN-CENELEC 2015-7
CEN & CENELEC WORK PROGRAMME CEN-CENELEC 2015-8
WHAT WE STANDARDIZE CEN-CENELEC 2015-9
WHAT IS A STANDARD AND ITS DEVELOPMENT PROCESS CEN-CENELEC 2014-6
WHAT IS A STANDARD 1 Regulation (EU) N.1025/2012 standard means a document that prescribes technical requirements to be fulfilled by a product, process, service or system, adopted by a recognised standardization body, for repeated or continuous application, with which compliance is not compulsory, and which is one of the following: a) international standard means a standard adopted by an international standardisation body; 2015-06-05 CEN-CENELEC 2015-11
WHAT IS A STANDARD 2 (b) European standard means a standard adopted by a European standardisation organisation; (c) harmonised standard means a European standard adopted on the basis of a request made by the Commission for the application of Union harmonisation legislation; (d) national standard means a standard adopted by a national standardisation body; 2015-06-05 CEN-CENELEC 2015-12
WHAT IS A STANDARD standardization is a consensus-driven, open and transparent process where the stakeholders gather together to self-regulate their market. Informal definition Standard is the best technical reference document on which stakeholders can agree 2015-06-05 CEN-CENELEC 2015-13
HELPFUL TOOL FOR BUSINESSES AND SOCIETY - I help companies to self-regulate their business and comply with European and national legislation improve the quality and safety of products and services and their interoperability increase confidence of consumers and social communities in products and services n 2015-06-05 CEN-CENELEC 2015-14
HELPFUL TOOL FOR BUSINESSES AND SOCIETY - II enhance the accessibility of elderly people or people with disabilities improve the safety of workers promote environmental safety and sustainability increase effectiveness and efficiency and allow companies to save money 2015-06-05 CEN-CENELEC 2015-15
PARTICIPATION European associations and partners (e.g. ANEC) European Commission Nominated national delegates CEN/TC Contribute national opinion, discussion with other participants National Mirror Committee National opinion Report back to National Mirror Committee List of CEN members: www.cen.eu/cen/members CEN-CENELEC 2015-16
TECHNICAL BODIES AND WORKING GROUPS National Members send delegates that represent national point of view of all involved parties Technical body Management decisions SBS expert Observers send representatives that participate to the debate (Partner Organization, Liaison Organization, Associated body, European Commission, EFTA) Members send experts Working Group Technical standardization work Observers send experts CEN-CENELEC 2015-17
Standards development process Step by step 1 Proposal - evaluation and decision 2 Drafting and consensus building 3 4 Public enquiry generation of comments Consideration & resolution of comments 5 Approval of the standard 6 Publication CEN-CENELEC 2014-18 CEN-CENELEC 2015-18
CEN/TC 437 - Electronic cigarettes and e-liquids CEN-CENELEC 2014-1
THE NEED FOR STANDARDIZATION FROM LEGISLATOR Dir. 2014/40/EU Tobacco Products Directive Art.20 par.13. The Commission shall, by means of an implementing act, lay down a common format for the notification provided for in par 2 and technical standards for the refill mechanism provided for in par 3(g) COM(2014) 500 Annual Union Work programme for 2015 : 3.2.5. Tobacco Products Under the Tobacco Products Directive the Commission is considering the development of technical standards for electronic cigarettes, in particular their refill mechanism 2015-06-05 CEN-CENELEC 2015-20
CEN/TC 437 ELECTRONIC CIGARETTES AND E-LIQUIDS Approved in January 2015 Scope: Standardization in the field of electronic cigarettes and related e-liquids (consumable), including or not nicotine, for which no other technical committee exists Secretariat: AFNOR (French NSB) 22 June: 1 st kick off meeting Business plan: to be approved Chairperson: to be appointed CEN-CENELEC 2015-21
PROPOSED WORK PROGRAMME (TBC) Electronic cigarettes (mechanical, thermal, electrical and chemical hazards etc) E-liquids (components including nicotine and formaldehyde and their thresholds, black listed components: heavy metals etc.) Emissions and the related analytical methods providing a basis for listing and quantification of all chemical components. 2015-06-05 CEN-CENELEC 2015-22
THE STAKEHOLDERS Vaping industry and companies (suppliers, manufacturers, retailers, importers, exporters etc.), their organisations and trade unions Tobacco companies Users/consumers and their organizations Harm reduction professionals, research institutes and scientists Test laboratories EU institutions, representatives of governmental and public authorities CEN-CENELEC 2015-23
GO TO YOUR NATIONAL STANDARDS BODY!! CEN-CENELEC 2015-24
Alberto Simeoni asimeoni@cencenelec.eu +32 2 5500 813 www.cencenelec.eu CEN-CENELEC 2013-25