No distribution is allowed without DNV permission CE marking on FPSO DNV BA Korea 0575
Oct 28, 2015
No distribution is allowed without DNV permission
CE marking on FPSO
DNV BA Korea
0575
No distribution is allowed without DNV permission
Basic question
Does FPSO equipment need a CE Marking ?
No distribution is allowed without DNV permission
CE marking
CE mark? CE marking
What is an EU Directive?
Is the product being sold in a country that enforces EU Directives?
Which Directives govern an FPSO?
What must I do to comply?
How do technical standards apply to EU Directives?
What conformity assessment procedures are available ?
What must a technical file contain?
No distribution is allowed without DNV permission
The marking CE, denoting:
“Communautés Européennes”
confirms that a product complies
with all relevant EU Product Directives.
Note: The ship wheel is unique to the Marine Equipment Directive only.
What is CE marking?
No distribution is allowed without DNV permission
What is an EU product Directive?
EU Product Directive:
A law by the EU Council that must be implemented by all EEA
member states. The law (Directive) is binding upon the member state
as to the objective to be achieved, with limited leeway as to how to
achieve it.
Intended to remove technical trade barriers by establishing a
commonly accepted level of safety.
Example: Directive 97/23/EC covering Pressurised Equipment
No distribution is allowed without DNV permission
European Community (EC):
European Economic Area (EEA):
European Union (EU): 27 ea
European Free Trade Association (EFTA): 4 ea
- Norway, Iceland, Liechtenstein,Switzerland
Who cares EU product Directive?
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The Council of Ministers
- Union’s primary decision-making body
The Commission
- “Executive” arm of the EU
The European Parliament
- Acts as an advisory to the Council of Ministers
The European Court of Justice
- Interpret and apply Community law
EU Institutions
No distribution is allowed without DNV permission
‘Notified’ by the National or Competent Authority of an EEA member
state, for a particular Directive
National authorities are not obliged, under Community law, to notify all
bodies who apply.
Must remain third parties
Must remain independent of their clients and other interested parties
Accreditation of Notified Body is not a requirement (certificates
contribute to presumption of conformity through EN 45001)
Notified Body
No distribution is allowed without DNV permission
EU Directives applies on FPSO?
For Ships/MOU’s flagged by EU Countries, Marine Equipment Directive
and EMC Directive apply.
For Offshore Installations (Ships and MOU’s) considered as Mobile
Offshore Units, ATEX, PED, Machinery Directives are excluded.
For Offshore Installations (FOU/FPSOs) considered as “Fixed
Installations” all applicable EU Directives apply (ATEX, PED, Machinery.)
FPSO’s may be considered as ‘fixed installations’ by the governing
authorities, would then be subject to all applicable EU Directives.
The vessel owner/builder should contact the relevant National Authorities
to confirm if the vessel is considered as a Mobile or Fixed installation.
No distribution is allowed without DNV permission
Pressure Equipment Directive
ATEX Directive EMC Directive Low Voltage Directive
EU Directives applied to FPSO
Machinery Directive
No distribution is allowed without DNV permission
Compression packages/systems
Separation modules (process)
Injection modules (water, chemical, etc.)
Electrical generation modules
Water treatment systems
Fuel/Gas glycol VOC systems
Piping
Whole installation
CE marking for typical FPSO equip.
No distribution is allowed without DNV permission
Which EU Directives?
No distribution is allowed without DNV permission
Directives Applied to Fixed Installations
Machinery Directive 98/37/EC 2006/42/EC (from 2010 January)
EMC Directive 89/336/EC 2004/108/EC
Low Voltage Equipment Directive 73/23/EC 2006/95/EC
Pressure Equipment Directive (PED) 97/23/EC
ATEX Directive 94/9/EC
Marine Equipment Directive 96/98/EC & 2001/53/EC
No distribution is allowed without DNV permission
Effective from January 1, 1995 and will change from Dec. 2009
Older “new approach” directive does not use assessment modules
Covers all machines defined as: “ an assembly of linked parts, at least one of which moves, including actuators and control circuits, for the processing , package, moving of a material”
Machine must be powered by external energy source, i.e. electrical, hydraulic, weight, spring, etc.
Applies to fixed offshore installations (and FPSOs)
Machinery Directive 2006/42/EC
No distribution is allowed without DNV permission
Electromagnetic emission and radiation interference
Immunity to electromagnetic exposure
Electrical appliances commercial and household
Domestic radio and television receivers
Industrial manufacturing equipment - Machinery
Mobile radio equipment – R&TTE
Mobile radio and commercial radiotelephone equipment – R&TTE
Medical apparatus – MDD
Electro Magnetic Compatibility 2004/108/EC
No distribution is allowed without DNV permission
All electrical equipment with a voltage rating of between 50 & l000V AC
and 75 to 1500V DC
Electric shock, Fire hazardous during operation, maintenance
Some functional reliabilities (Motors)
Higher than 1000VAC?
Low Voltage Directive 2006/95/EC
No distribution is allowed without DNV permission
Applies to pressure vessels, piping, safety and pressure accessories
with MAWP greater than 0.5 bar.(except as specifically excluded in the
directive)
Mandatory after 29 May 2002
Essential Health and Safety Requirements detail methods for
determining adequate strength, manufacturing procedures, and final
inspection/testing
Utilises conformity assessment modules, CAM
Requires Notified Body involvement in most conformity assessment
procedures
Pressure Equipment Directive 97/23/EC
No distribution is allowed without DNV permission
Equipment and Protective System for use in Explosive Atmospheres
Underground mines
Equipment for use in any explosive atmosphere caused by gases,
vapours, mists or air/dust residues (e.g., above ground mines, offshore
drilling platforms & production facilities, etc.)
Essential Health and Safety Requirements detail methods for
determining adequate safety, manufacturing procedures, and final
inspection/testing
Utilises conformity assessment modules, CAM
Requires Notified Body involvement in most conformity assessment
procedures
ATEX Directive 94/9/EC
No distribution is allowed without DNV permission
Applies to all ships flying the flag of an EEA country
Lifesaving Appliances
Marine Pollution Prevention Equipment
Fire Protection Equipment
Navigation Equipment
Radio Communication Equipment
Conformity Assessment Modules listed in Directive
Marine Equipment Directive 2006/42/EC
No distribution is allowed without DNV permission
What must I do to comply?
Consult the applicable Directive
Must meet applicable Essential Health and Safety Requirements
Manufacturer must complete specified conformity assessment
procedure (modules if applicable)
Issue Manufacturer’s Declaration of conformity
Affix the CE mark (and Notified Body number if applicable)
No distribution is allowed without DNV permission
How do comply?
Perform hazard analysis/identified hazards presented by the equipment
Document how the product meets applicable Essential Health and
Safety Requirements (if not using harmonized standards)
Submit technical documentation to Notified Body (if required by
applicable Directive)
Perform required conformity assessments during fabrication (including
Notified Body where required)
Affix the CE mark (and Notified Body number if applicable)
No distribution is allowed without DNV permission
Standards Hierarchy for Essential Requirements
- Harmonized EN Standards
- International standards
- National Standards
- Third party Standards
- Manufacturers specification
‘Harmonized’ Product Standard: A technical standard, covering a
specific type of family of equipment, reviewed and approved by the European
Commission, which, when used in full, satisfied all Essential Safety
Requirements of relevant EU Product Directives.
‘Harmonized’ Support Standard: A technical standard, reviewed and
approved by the European Commission, which satisfies specific requirements
of EU Product Directives, such as issues related to welding, material
specifications, NDE Operator qualifications. Example: EN-288 series (welding
procedure qualification)
How do standards apply?
No distribution is allowed without DNV permission
Listed in the Official Journal Makes EN Standard official -Harmonized
Organizations illustrated below:
International ISO IEC ITU
European CEN CENELEC ETSI
National DIN/BSI/AFNOR, etc
Third Party DNV/API/ASME, etc
Non -
Electrical Electrical Telecom
Standards
No distribution is allowed without DNV permission
What conformity assessment procedures are available before I can
affix CE marking?
Conformity assessment procedure
No distribution is allowed without DNV permission
Establishes Essential Health and Safety Requirements
Requires Technical Documentation File (TDF)
Extensive number of Harmonized complete standards available
Manufacturer SELF Declaration of Conformity with EHSR
Requires Third Party review or testing when harmonized standards not used or available
Low Voltage Directive 2006/95/EC
No distribution is allowed without DNV permission
Product
Does the product contain radio transmitters ?
Can Harmonized standards be applied in full ?
Standards route (Art. 10.1)
Technical construction file route
(Art. 10.2)
EC type-examination route
(Art. 10.5)
Yes
No
No
Yes
EMC Directive 2004/108/EC
No distribution is allowed without DNV permission
Determine route of compliance
Confirm whether the product is:
- Not listed in annex IV
- Listed in annex IV, does not meet or partly meets EN requirements
- Listed in annex IV, complies with EN requirements
Not listed in annex IV
- Technical File per annex V
- Manufacture self declaration of conformity with essential requirements
- Manufacturer applies CE Mark
Listed in annex IV
- Technical Construction File route
- Quality assurance audit required (2006/42/EC)
- Notified Body involves
Machinery Directive 98/37/EC
No distribution is allowed without DNV permission
Must follow Conformity Assessment Module
Technical Construction File with EHSR
Manufacturer declaration of conformity
Affix CE marking with Notified Body number
- Exclusion on PED category I
- Exclusion on ATEX too per risk hazardous category
For MED affixing CE marking is not needed. Wheel mark is used.
PED, ATEX and MED
No distribution is allowed without DNV permission
Conformity Assessment Modules
Module A: Internal Process Control
Module A1/C1: Module A + Notified Body witness of tests
Module B: Type Examination (by NB)
Module B1: Design Examination (by NB)
Module D/D1: Production Quality Assurance - QS approval by NB
Module E/E1: Product Quality Assurance - QS approval by NB
Module F: Product Verification (by NB)
Module G: Unit Verification (by NB) - Design and Product Verification
Module H/H1: Full Quality Assurance - QS approval by NB
No distribution is allowed without DNV permission
Internal
control of
Production Type Examination
Unit
Verification
Full quality
assurance
EN 29001
Firms:
Maintains
technical
files
Aa
Intervention
of Notified
Body
Firms:
submits
technical file
Notified Body:
Verifies essential
requirements
Firms:
Submits
technical
files
Firms:
Quality
system for
design
Notified Body:
Verifies
conformity
of design ----------------------------------------------------------------------------------------------------------------------------------------------------------
Conformity
to type
Production
quality
assurance
EN 29002
Product
quality
assurance
EN 29003
Product
verification
Firm:
Declares
Conformity
to essential
requirements
Aa
Notified
Body:
-Test product
-Product
checks
Firm:
Declares
conformity
to approved
type
Notified
Body:
-Test product
-Product
checks
Firm:
Quality
system for
production
and testing
Notified
Body:
Surveillance
of quality
system
Firm:
Quality
system for
inspection
and testing
Notified
Body:
Surveillance
of quality
system
Firm:
Declares
conformity
to type or
essential
requirements
Notified
Body:
Verifies
Conformity
Firm:
Submits
product
Notified
Body:
Verifies
essential
requirements
Firm:
Quality
system for
production
and testing
Notified
Body:
Surveillance
of quality
system
P
R
O
D
U
C
T
I
O
N
D
E
S
I
G
N
A
B
G H
C D E F
D
E
S
I
G
N
The Modular Approach to CAM
No distribution is allowed without DNV permission
Impact of PED on Typical FPSO Projects
Requires all pressure equipment of Category I-IV to be CE marked
Requires Notified Body to perform conformity assessment on equipment
of Category II-IV
Requires Notified Body to approve welding procedures and personnel
(through testing)
Requires European approval of NDE personnel for Category III & IV.
Additional requirements related to purchasing of materials
Confusion with overlaps between EU Directive activities and
Classification activities.
No distribution is allowed without DNV permission
Impact of PED on Typical FPSO Projects
Requires special attention to material certificates for pressure materials
Requires special approval of Non-European material specifications by
Notified Body (Particular Material Appraisal)
Requires material manufacturer (mill/foundry, etc.) to have a quality
system certified by a European registrar, or have 3rd party issue material
certifications.
No distribution is allowed without DNV permission
Type Pressure Equipment Category
Module for Conformity Assessmen
t
Conformity Assessment Process per Annex III of the PED
I A Internal Process Control
A1 Internal Process Control with Monitoring
by Notified Body
D1 Production Quality Assurance
Piping II
E1 Product Quality Assurance
Production Quality Assurance B1+D B1+F
EC Design Examination + Product Verification
B+E Production Quality Assurance
B+C1
EC Type Examination + Conformity to Type
III
H Comprehensive Quality Assurance
B+D Production Quality Assurance
B+F
EC Type Examination + Product Verification
G EG Individual Testing
E.g.
Pressure
Vessels,
Pressure
Accessories,
Pressure
Assemblies
Sa
fety
Acce
sso
rie
s
Po
rtab
le E
xtin
gu
ish
ers
a
nd
Bre
ath
ing E
qu
ipm
en
t
IV
H1 Full Quality Assurance with Design Examination and Special Surveillance of the Final Product examination
Impact of PED on Typical FPSO Projects
No distribution is allowed without DNV permission
Impact of ATEX on Typical FPSO Projects
No distribution is allowed without DNV permission
Documentation supporting compliance
Market surveillance purposes
Competent Authority may request
Keep for ten years
Documentation (TDF) vs. Construction (TCF)
Technical File
No distribution is allowed without DNV permission
Required for most manufacturers
Must contain:
Technical File
General description of product
Conceptual design and manufacturing drawings and diagrams of
components, and such
Descriptions and explanations for drawings/diagrams and operation
List of harmonized standards applied in whole or part and description
of solutions adopted to meet essential requirements of Directive where
standards referred to have not been applied
Results of design calculations, examinations carried out, etc.
Test reports
Certificate of NB if required
No distribution is allowed without DNV permission
Some directive (e.g. EMC) Manufacturer’s declaration in any Official
EU Language
Other stated that member states are entitled to require translation into
their own language
Moving toward requiring the documents be submitted in the language
of intended country of use
Official Language
No distribution is allowed without DNV permission
Consult the applicable Directive
Must be visible, legible, and indelible
Place on the product or package
Place on the instruction for use
Place on the sale packaging
If applicable; Accompanied by identification number of Notified Body
Affix CE marking