ce marking on fpso_rev1

No distribution is allowed without DNV permission

CE marking on FPSO

DNV BA Korea

0575


Basic question

Does FPSO equipment need a CE Marking ?


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?


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?


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


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?


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


‘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


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.


Pressure Equipment Directive

ATEX Directive EMC Directive Low Voltage Directive

EU Directives applied to FPSO

Machinery Directive


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.


Which EU Directives?


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

C:/Documents and Settings/JSL/jsl/Local Settings/Temporary Internet Files/OLK3/Machinery Directive.pdf

C:/Documents and Settings/JSL/jsl/Local Settings/Temporary Internet Files/OLK3/2004-0108 New EMC Directive.pdf

C:/Documents and Settings/JSL/jsl/Local Settings/Temporary Internet Files/OLK3/2006-95 LVD (New Directive).pdf

C:/Documents and Settings/JSL/jsl/Local Settings/Temporary Internet Files/OLK3/PED.pdf

C:/Documents and Settings/JSL/jsl/Local Settings/Temporary Internet Files/OLK3/1994-9 ATEX Directive.pdf

C:/Documents and Settings/JSL/jsl/Local Settings/Temporary Internet Files/OLK3/2001_53_EC (MED Amendment II).pdf


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


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


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


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


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


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


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)


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)


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?


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


What conformity assessment procedures are available before I can

affix CE marking?

Conformity assessment procedure


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


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


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


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


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


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


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.



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.


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 ATEX on Typical FPSO Projects


Documentation supporting compliance

Market surveillance purposes

Competent Authority may request

Keep for ten years

Documentation (TDF) vs. Construction (TCF)

Technical File


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


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


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

ce marking on fpso_rev1

Documents

dnv permission eu directives

eu council

law directive

applicable eu directives

eu countries

relevant eu product

european union eu

marine equipment directive