Standardization supporting smart regulation and growth Elena SANTIAGO CID CEN and CENELEC Director General INNOPROM-2016 2016-07-12

About CEN and CENELEC

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>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 200.000 Experts ~500 Technical Committees ~2.000 Working Groups

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

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)

Standards for Smart Regulation

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a rigorous impact assessment Has been subject to a screening for simplification Is evaluated periodically and amended/withdrawn as required

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!

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

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

CEN and CENELEC standards support 40 different EU Regulations or Directives

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

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

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

beyond Europe Standards, a smart tool for market access

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

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

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)

CEN and CENELEC alignment with ISO/IEC Walking the talk

CEN and CENELEC alignment with ISO/IEC Walking the talk

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

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

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

Conclusions

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

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