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Project SESEI, European Standards
& Certification FIEO: 17th Feb 2014 Dinesh Chand Sharma
Director – Standardization, Policy and Regulation
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Outline
Project SESEI
European Standards
CE Marking
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Project SESEI
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Seconded European Standardization Expert in India local representative and a connect-between standardizers’ communities
in EU/EFTA and India
EU-India dialogue and cooperation on standards, R&D, Innovation, and policy/regulation around standardization
Project Owners EU Standards Organizations (ETSI, CENELEC and CEN),
European Commission and EFTA - European Free Trade Association
Priority Sector for this phase of the project (3 Year) ICT , Electrical Appliances including Consumer Electronics, Machinery
and Automotive
INDIA EUROPE Harmonized Standards
ISO, IEC, ITU, 3GPP, EN
Project SESEI
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EUROPEAN STANDARDS
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What is a standard?
It is a document that define
technical or quality requirements
with which current or future
products, production processes,
services or methods may comply
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Always voluntary
Consensus based
Established by all interested parties
Driven mainly by business
Drafted by technical experts
Approved by a recognized, independent standardization body
Standard are :
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Enhance safety of products
Promote common understanding
Facilitate trade by reducing TBs
Promote interoperability of products and services
Benefits of economies of scale
Support environmental sustainability
Facilitate the uptake of innovation and reflect the outcome of research and development
Why standards are important?
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Who makes European standards?
CEN..............................
(European Committee for
Standardization)
CENELEC .......................
(European Committee for
Electrotechnical Standardization)
ETSI .............................
(European Telecommunications
Standards Institute)
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Officially created as an international non-profit association based in Brussels on 30 Oct 1975
Responsible for planning, drafting and adoption of European Standards in all areas of economic activity with the exception of electrotechnology (CENELEC) and telecommunication (ETSI).
33 National Members work together to develop voluntary European Standards (ENs)
— These standards have a unique status as they becomes national standards in Member countries and conflicting standards are withdrawn
Vienna Agreement − signed by CEN in 1991 with ISO (International Organization for Standardization),
— 30% of CEN standards identical to ISO standards
1. Austria 2. Belgium 3. Bulgaria 4. Croatia 5. Cyprus 6. Czech Republic 7. Denmark 8. Estonia 9. Finland 10. France 11. Germany 12. Greece 13. Hungary 14. Iceland 15. Ireland 16. Italy 17. Latvia 18. Lithuania 19. Luxembourg 20. Malta 21. The Netherlands 22. Norway 23. Poland 24. Portugal 25. Romania 26. Slovakia 27. Slovenia 28. Spain 29. Sweden 30. Switzerland 31. The Former Yugoslav
Republic of Macedonia 32. Turkey 33. United Kingdom
EU Standards Organization - CEN
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European Committee for Electrotechnical Standardization responsible for standardization in electrotechnical engineering field
non-profit technical organization set up under Belgian law, created in 1973 as a result of the merger of two previous European organizations: CENELCOM and CENEL.
33 National Members work together to develop voluntary European Standards (ENs)
— These standards have a unique status as they becomes national standards in Member countries and conflicting standards are withdrawn
Dresden Agreement – signed by CENELEC with IEC (International Electrotechnical Commission)
75% of CENELEC standards identical to IEC standards
EU Standards Organization - CENELEC
1. Austria 2. Belgium 3. Bulgaria 4. Croatia 5. Cyprus 6. Czech Republic 7. Denmark 8. Estonia 9. Finland 10. France 11. Germany 12. Greece 13. Hungary 14. Iceland 15. Ireland 16. Italy 17. Latvia 18. Lithuania 19. Luxembourg 20. Malta 21. The Netherlands 22. Norway 23. Poland 24. Portugal 25. Romania 26. Slovakia 27. Slovenia 28. Spain 29. Sweden 30. Switzerland 31. The Former Yugoslav
Republic of Macedonia 32. Turkey 33. United Kingdom
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Recognized, Independent, not-for-profit organization, created in 1988
Active in all areas of ICT & Setting globally-applicable standards for
— telecommunications
— radiocommunications
— broadcasting
— related topics
Offer direct participation
750+ Member companies and organizations
Over 30 000 publications - freely available!
EU Standards Organization - ETSI
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European Commission & Standards
Coordinates the standardisation policy and cooperate with the different stakeholders
Promotes the use of European standards to support EU legislation and policies to enhance the competitiveness of European industry
Coordinates the standardisation mandates (requests) to CEN/CENELEC/ETSI
Funds CEN/CENELEC/ETSI (operating and action grants)
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Interestingly, standardisation is financed primarily by industry
followed by:
National Governments
European Commission/EFTA
93-95%
3-5%
2%
Who is paying for standardisation?
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Abbreviations
ESOs = European Standardisation Organisations (CEN/CENELEC/ETSI)
OJEU = The Official Journal Of the EU
EC = European Commission
EN = European Standard
NA = New Approach
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Standards vs Législation
Standards :
1. Voluntary
2. Consensual
3. Developed by independent organisations
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. Gives requirements to protect public interests
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EU legislation & Standards
EU legislation makes reference to Standards
Direct reference: mandatory – mandatory for specific use
Indirect reference « New Approach »
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The New Approach
Facilitate free movement of goods
in the Internal Market whilst ensuring a
high level of protection for consumers
Elimination of barriers to trade through technical harmonisation
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New Approach
4) risk-based conformity assessment
2) use standards to translate essential requirements into technical products specifications or alternatives
3) standard(s) confer presumption of conformity
1) focus on essential health & safety requirements of product groups (danger/hazard) & harmonise through EU legislation
Through standards to leaner & more effective legislation
5) safe products = manufacturer’s responsibility
6) market surveillance by Member States = ex-post check if the products on the market are indeed safe
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Legislative and normative processes
Directive
Mandate
Standards
Publication in the Official Journal
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What is a mandate?
Given by the Commission to get standards that support EU legislation or policies
A non-binding invitation to the ESOs to develop standards
A reference framework for standardisation
Indispensable for harmonised standards supporting New Approach and NLF legislation
A means for Member States to give political and technical acceptance to standardisation work
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What is in a Mandate? (content)
Reference to Legislation
Scope – Task – Objectives
Work programme
Standards to be
developed Time plan
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There are 3 types of mandates
1 2 3
Study mandate
Programming mandate
Standardisation mandate
1+2 2+3
Examine feasibility of standardisation
Prepare programme for standardisation
Develop standards
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Harmonised standards
The lists of harmonised standards are published in the Official Journal of the EU (OJEU)
The lists are continuously updated but not on regular intervals
Alternative sources of information:
DG Enterprise “European Standards web-site” (original source >> RSS Feeds are available)
National information channels (standards bodies, trade organisations ...)
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Integration of Standards
“Vienna Agreement” with
“Dresden Agreement” with
MoU with
Towards integration of regional and global standardization
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CE MARKING
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EU Council Directives
There are 40+ enacted Directives, and several more in-draft
The EU Directives are intended to: — Protect all EU Citizens from harm — Improve Citizens’ well-being — Provide essential Safety in Workplace, Home Life, and Leisure Activities. — Now also to address Environmental Protection
Eg. and Senior of the Directives: The Low Voltage Directive 73/23/EEC (LVD) Created in 1973 to assure a degree of Electrical Safety.
— Home and Business’ have 230 Volts, 50 Hz, 1Ǿ. — Heavy Industry uses 400 Volts, 50 Hz, 3Ǿ — Objective: To prevent Electric Shock, Burns, Injuries, Fires and Property Damage — There are several Product Specific Test and Evaluation Standards covering every type of electrically
powered product.
— Latest version is designated 2006/95/EC
Two Directives were enacted to provide Environmental Protection:
— RoHS- Restrictions of Hazardous Substances used in manufacture Controls Levels of Lead, Mercury, Cadmium, Hexavalent Chromium etc, used in products in
order to minimize seepage in land fills
— WEEE - Electronic Waste Disposal is being controlled.
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CE MARK Concept
The CE Mark with a Declaration of Conformity is analogous to a passport for products exported to the EU. Its intent is to IDENTIFY Compliant Products so they are not delayed or held in Customs.
The CE MARK protocol is essentially an honor system accepted by EU member countries. Manufacturers can Self-Declare Compliance by adding CE MARKS and signing a Declaration of Conformity. It is also required that a Technical File be created.
The Technical File is the backup document for the CE MARK and Declaration of Conformity. The Technical File is NOT typically included with the product shipment. The Technical File is intended to:
— Identify the Importer or Purchaser who is resident within the EU
— Describe the Product
— List Safety and Compliance Critical Parts
— Cite the applicable EU Directives
— List all Safety, EMC and Other Tests performed to Validate Compliance
— List Tests related to I.D. Number of each Test Standard used
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CE MARK Deliverables Detailed Findings Report is the first document generated. It is generated after the 1st safety review of the product. It is specific to the Clients Product. It includes viable suggestions for Corrections
The Findings Report notes any discrepancy in the product’s construction and offers suggestions
for making corrections. When appropriate we even suggest sources for key components and
alternatives.
The Declaration of Conformity provided as a draft
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CE Compliant Products Technical Report
EMC Test Report : EMC = ElectroMagnetic Compatibility
The “Technical File” or CE Mark Test Report
1. Includes a Declaration of Conformity (D.o.C). A separate D.o.C is also provided as a Certificate to accompany the shipping documents to an EU Port-of-Entry. Only one D.o.C. is required per shipment. This is regardless of the number of units in a single shipment.
2. The CE Mark Report is provided in pdf format and is known as a Technical File (TF). It is a detailed Report describing the product in detail and all of its testing. It bears the written opinion of a Competent and Independent 3rd Test Lab that the CE Marked Product has been evaluated and tested. It cites all of the Directives and Test Standards used in making the decision. The TF is used to set aside any challenges that a manufacturer may get as to the validity of the CE Mark.
4. If a customs official or a customer questions the validity of the CE Mark, a review of the TF should quickly
set aside any concerns. Typically, one hard copy is kept at the main office and one sent to each Importer/Agent.
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All About CE Marking, NANDO, MRA & Market Surveillance
All About CE Marking NANDO
— Nando (New Approach Notified and Designated Organisations)
MRA
— Mutual recognition agreements
MS
— Market surveillance
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1. Identify Applicable Directive
2. Verify Requirements
3. Need for notified body?
4. Check Conformity
5. Technical Document [ report ]
6. Affix CE Marking
6 Steps Summary for Manufacturer
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Contact Details:
Dinesh Chand Sharma (Seconded European Standardization Expert in India)
Director – Standardization, Policy and Regulation
European Business Technology Centre, DLTA Complex, South Block, 1st Floor, 1, Africa Avenue, New Delhi
110029
Mobile: +91 9810079461, Tel: +91 11 3352 1500, [email protected]
Thank you!