The Regulation on European Standardisation

1. The Regulation onEuropean Standardisation Enterprise and Industry Directorate-General Standards for Boosting Competitiveness Daniel Bunch BIS 7 November 2012

2. Problems in Europe's Standardisation System (ESS) Commission Communication on the Role of Standardisation (COM(2004) 674) EU Council Conclusions on Competitiveness – December 2004 and December 2006 • Speed of "mandated" Standardisation • Needed to support policies and legislation • Referencing ICT Specifications • Need for speed and elimination of uncertainty • Inclusiveness of the ESS • Integration of users, consumers, SMEs, etc.

3. Preparatory work • Studies: • Specific Policy Needs for ICT Standardisation (2006) • Access to Standardisation (2008) • Standardisation for a competitive and innovative Europe: a vision for 2020, "EXPRESS" (2010) • Future Standardisation Policy: Impact Assessment of Policy Options (2010) • Reports: • EP resolution of 21.10.2010 (The "Kožušník" Report) • Public consultations: • Commission White Paper on “Modernising ICT Standardisation in the EU” (COM(2009) 324) (2009) • Options for reform of the ESS (2010)

4. The Standardisation “Package” of 1 June 2011 • Commission Strategic Communication setting out a Vision for European Standards (COM(2011) 311) • An Impact Assessment accompanying a regulatory proposal (SEC(2011) 671) • A draft Regulation of the European Parliament and of the Council on European Standardisation (COM(2011) 315)

5. Policy context Europe 2020 Flagships • Industrial Policy • Innovation Union • Digital Agenda • Resource Efficiency Single Market Act • 12 levers to boost growth and build confidence Disability Strategy, Trade Objectives, etc.

6. Reg.(EU) No…/2012 Consolidated legal basis for European standardisation • European standardisation as a policy tool for the Union • Sets basic rules for cooperation between standardisation organisations, EC and Member States • ReplacesDecisions 1673/2006/EC and 87/95/EC, and part of Directive 98/34/EC • Amends several Directives (objections to harmonised standards)

7. ESS – What does not change • Voluntary, market-driven approach • Primacy of international standards • Role of the ESOs (and monopoly for making European standards) • National delegation principle and role of the NSBs • Requests for ("Mandated") European Standards, etc.

8. Objectives and achievements • The speedof mandated standardisation • The inclusiveness of standardisation process • Standardisation as a policy tool in service sectors • Review of ICT standardisation policy • The alignment of procedures in harmonisation legislation using "harmonised standards" • A transparent legal basis for financing standardisation

9. 1. Speed of mandated standardisation Planningand transparency of EC mandates to promote earlier availability of mandated standards • Annual Union Work Programme – Art. 8 (strategic priorities, future mandates, international aspects) • Online notification system for stakeholders – Art. 12 (Work programme, mandates, formal objections, ICT specifications, delegated acts) • A deadline for ESOs when accepting mandates – Art. 10(3) • Reporting requirements for ESOs – Art. 24 • Financing conditional on fulfilment of inclusiveness conditions and meeting agreed deadlines – Art. 17(4)

10. 1a. Transparency of Work Programmes • At least once per year all ESOs and NSBs to establish their Work Programme – Art. 3(1) • WP to be published online and notice given in publication of standardisation activities – Art. 3(3) • Notification of WP to other NSBs, ESOs and EC – Art. 3(4) • Notification of draft standards/deliverables on request – Art. 4 • 3 Months to respond to comments • Consult ESOs and EC on comments indicating a negative impact on internal market

11. 2. Inclusiveness of the standardisation process • Representation of SMEs and societal stakeholders in European standardisation including financial support – Art. 5(1) • Participation of research community in European standardisation – Art. 5(2) • Participation of Member States' pubic authorities at national level when developing or revising harmonised standards – Art. 7 • SME access to standards and standardisation at national level – Art. 6

12. 2a. SMEs and Societal Stakeholders • 4 groups of stakeholders under the standardisation legal umbrella – Annex III : • SMEs • Consumers • Environmental interests • Social interests • Representation at the policy development level and key stages in the standardisation process at European level – Art. 5 • Proposal and acceptance of new work items • Technical discussion of proposals • Submission of comments on drafts • Revision of existing standards/deliverables • Information and awareness-building on standards/deliverables

13. 2b. Access of SMEs to NSB work – Art. 6 • Encourage and Facilitate SME access to standards development by for instance – Art. 6(1): • Identifying WP items of interest • Giving access without requiring membership • Free access or special rates for participation • Free access to draft standards • Free abstracts of standards on websites • Reduced rates for standards or bundles of standards • Exchange best practices among NSBs – Art. 6(2) • Annual report to ESOs on above activities and publication on website – Art. 6(3)

14. 3. Standardisation as a policy tool in service sectors • European standardisation is confirmed as a policy tool to support Union legislation and policies on services – Art. 1 • Risk arising from a proliferation national standards (2005-2009: 453 national standards v. 24 European standards adopted) • Clear legal basis for EC mandates on service standards supporting Union legation and policies (Directive 98/34 only mentioned products explicitly) • Transparency of national work programmes including national work items on services – Art. 3

15. 4. Review of ICT standardisation policy • Enabling referencingof existing ICT technical specifications in public procurement – Art. 14 • Proposals for identification from EC and Member States – Art. 13(1) • Criteria for identification – Annex II • ICT multi-stakeholder platform as a consultative entity – Art. 13(3) and Commission Decision of 28.11.11 (OJEU C349/4)

16. 4a. Using existing ICT Specifications • Encourage cooperation between ESOs and Fora and Consortia to develop new ICT standards – Strategic Communication Action 23 • However, many existing globally-adopted ICT specifications were made outside of the ESS (e.g. WiFi, Internet, Web accessibility) • EU will use some existing ICT specifications to ensure interoperability • In delivering EU policies – Strategic Communication Action 20 • eHealth, eAccessibility, Intelligent Transport, eBusiness, Security, etc. • In public procurement – Art. 14 • Avoid lock-in and barriers, promote competition and market access • Provided conditions are met: • Domains where the ESOs are not active (or their standards have no market uptake / obsolete) – Annex II(2) • IP rules at least FRAND (respect competition guidelines on horizontal cooperation agreements) – Annex II (3)(c) • The ICT specification meets all other requirements – Annex II (market uptake, coherence, openness, consensus, transparency…) • ICT Stakeholder Platform will give advice (expert working group with MS, industry, ESOs, Fora & Consortia, SMEs, societal groups)

17. 5. Procedures for "harmonised" standards • Common principles for use of harmonised standards supporting Union harmonisation legislation • Definition – Art. 2(1)(c) • Mandates – Art. 10 • Need to publish reference in the OJEU (if OK!) – Art 10(6) • Formal objections – Art. 11 • Aligning many existing harmonisation directives concerning placing on the market of products • A single procedure for all future harmonisation legislation supported by harmonised standards

18. 6. Legal basis for financing standardisation • Framework for financing ESOs – Arts. 15(1) & 17 • Includes financing of NSBs and other bodies co-operating with ESOs – Art. 15(2) • Framework for financing European stakeholder organisations representing SMEs, consumers, social interests (employees) and environmental stakeholders – Art. 16 • Grants after a call for proposals – Art. 17(1)(c) • Eligibility criteria – Annex III

19. Entry into force 1 January 2013 Implementation – short term • Setting up the new Committee – Art. 22 • Setting up a notification system for all stakeholders – Art. 12 • Adapting mandating and formal objection procedures to incorporate "Comitology" – Arts. 10 & 11 • Preparation of Annual Union Work Programme – Art. 8 • Starting identification ofICT specifications with help of the ICT multi-stakeholder platform – Art. 13 • Publication of the list of NSBs in the OJEU – Art. 27

20. Implementation – medium/longer term • Applying the new financing scheme (ESOs, stakeholder organisations) – Art. 17 • Review of EC website including "vade-mecum" on European standardisation • Building reporting schemes to enable evaluation of implementation (effectiveness and simplification of financing, transparency, inclusiveness, speed and quality of mandated work) – Art. 24(3) • Evaluation of the impact of "comitology" for mandates – Art. 25 • Launching an independent review – Strategic Communication Action 29

21. Thank you for your attention http://ec.europa.eu/enterprise/policies/european-standards/index_en.htm