1. Standardization supporting smart regulation and growth
Elena SANTIAGO CID
CEN and CENELEC Director General
INNOPROM-2016

2. About CEN and CENELEC

3. 2 organizations

4. 1 network

5. >260 42 61 CEN and CENELEC in a nutshell: some figures >23.000
National members
(33 countries)
>260
European industry and society Partners 61
Standardization Organizations
(4.200 HS)
>23.000
Standards & other documents
Experts
~500
Technical Committees
~2.000
Working Groups

6. Fundamentals – CEN and CENELEC standards are …
Based on the national delegation principle
Representing a consensus among all interested parties, including industry & SMEs and societal stakeholders
Voluntary
Developed by independent organizations clearly distinct from authorities

7. The European standardization model
No standard conflicting with an EN in 33 countries
European Standard (EN)
National standards (XX EN) 1x =
33x
Standards supporting free circulation of goods in the EU and beyond (600 million consumers)

8. Standards for Smart Regulation

9. What is meant by “Smart Regulation” in the EU
Minimum administrative burden on business (especially SMEs!)
Fit for the purpose identified
Submitted to a rigorous impact assessment
Has been subject to a screening for simplification
Is evaluated periodically and amended/withdrawn as required

10. Standards vs. regulation
Mandatory
Imposed
Issued by public authorities
Revised when legislators decide
Sets requirements to protect public interests
Standards
Voluntary
Consensual
Developed by independent organizations
Revised every 5 years (max.)
Provide specifications and test methods (interoperability, safety, quality, etc.)
Standards = a powerful co-regulation tool!

11. Standards can make regulation smarter How?
Regulation to focus on essential mandatory requirements (health & safety)
Standards as market solutions for compliance
Standards help simplify regulation
Broad involvement of stakeholders = broad acceptance and use
Indirect referencing of standards
stable regulation, state-of-the-art compliance solutions
innovation friendly: Manufacturers can use other means to demonstrate compliance, standard easily adapted to tech’l evolution
Standards aligned with international solutions (ISO & IEC)
Openness of the market / global competitiveness
The standardization public-private partnership =
key tool for smarter regulation

12. The EU Smart Regulation success story The “New Approach” & NLF
Standardization request
Harmonized Standard
European Standard (EN)
Presumption of conformity
Standards remain voluntary
~4.200 harmonized standards supporting EU legislation

13. CEN and CENELEC standards support 40 different EU Regulations or Directives

14. Standards supporting the EU New Legislative Framework – broader picture
Legal compliance and/or presumption of conformity through voluntary standards
Accreditation of Conformity Assessment Bodies
Market Surveillance
CE Marking
Free circulation inside the EU

15. Recent EU initiatives to strengthen the standardization public-private partnership
June 2016: EC ‘Standardization package’
Coherent EU approach towards standardization
Standardization in the field of Services
Considers Digitisation policies and ICT priorities
Joint Initiative on Standardisation:
Modernising the Public-Private Partnership
Broad participation demonstrating the added value both for the public & private sectors
Agreement on context, Joint Vision and 15 actions to be delivered before 2020, including:
Timely, open, transparent and inclusive development of standards
Standards supporting Digitisation
Standards in support of Public Procurement
Innovation and standards
Global dimension

16. CEN and CENELEC proposals:
Preparing tomorrow CEN & CENELEC supporting the EU “Better Regulation” Package
Objective: increase efficiency, simplification and burden reduction of EU law
CEN and CENELEC proposals:
Standardisation as a cross-cutting tool to simplify regulations
Alignment of construction products regulation with Regulation on European Standardisation
Promote proper reference to standards to maximise their potential and benefits

17. beyond Europe Standards, a smart tool for market access

18. An evolution of the global trade landscape
Progressive elimination of traditional barriers to trade
Higher interdependence among national & regional economies
An increasing role for standards as trade enablers, creating a level-playing field

19. Standards for market access
Adoption of identical standards = market access opportunity
Only if same technical content
is applied
Modifying content of a standard =
Creating technical barriers to trade
Fragmentation of the market
Lack of coherence and confusion for market operators
Increased costs

20. Beyond Europe Fostering coherence at all levels
European engagement in ISO & IEC
CEN and CENELEC alignment with ISO & IEC, fostering the worldwide adoption of ISO & IEC standards
Partnerships & projects supporting strategic cooperation and technical alignment (through ISO/IEC first)
Dissemination of ‘home-grown’ ENs
(complementary tool for technical alignment)
Involvement in EU regulatory dialogues & trade negotiations (promoting of the model)

21. CEN and CENELEC alignment with ISO/IEC Walking the talk

22. CEN and CENELEC alignment with ISO/IEC Walking the talk

23. CEN, CENELEC and ROSSTANDART Concrete tools for technical alignment
Cooperation Agreement signed in 2013
Objective: To increase cooperation between the European and Russian standardization bodies and promote international standards, in the domain of mutual interests, for the benefit of both industries and the facilitation of trade between the two regions
Activities: exchange of info, bilateral meetings, mutual observership in technical bodies, joint WGs, exchange of standards for adoption
Key results:
Russian observers in several CEN TCs (Gas infrastructure, lifts, aircraft ground support equipment…)
121 ENs provided for review (Eurocodes)
A range of tools supporting bilateral trade and mutual market access

24. Intellectual Property Rights (IPR)
IPR is a key concept when working towards technical harmonization
Patents
Copyright
IPR in standards
IPR of standards

25. Patents in standards Changing business models  increase in: Trends :
patent holders
standard implementers
Use of IPR as strategic asset
Trends :
Standards and Research
complexity of technologies
complexity of standards
new generations of interoperable products
CEN-CENELEC Guide 8
Current focus : essential patents for standards

26. Conclusions

27. Standards = a powerful tool supporting smart regulation (simplification, flexibility, transparency, inclusiveness, boosting competitiveness, fostering innovation…)
Ingredients for a successful use of standards in support of smart regulation:
A strong public-private-partnership
Regulators to focus on essential requirements (health, safety, environment)
Stakeholders to work on state-of-the-art means for compliance
Indirect referencing
Technical alignment preferably at international level (need for a collaborative approach, first in ISO/IEC and bilaterally when needed)
CEN and CENELEC are committed to sharing the benefits of the European experience with their partners

28. Thank you!
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