The European Pressure Equipment

Directive (PED)
97/23/EC

ABMA 15th January 2010

Presented by: Michel Margat

• Intent of the PED
• PED development since 1999
• New Legislative framework

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 Intent of PED

• The PED is one of a series of EC directives

adopted by Member States.
• PED basis:
– Remove barriers to allow free movement of the goods
across EU
• Applies to new pressure equipment
• Single items and assemblies MAWP > 0.5 bar
• In 27 EU Member States plus 2 candidates, 3 EEA countries
and 1 associate country

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 Intent of PED

• PED dates :
– Until November 29th 1999 every EU state had different
rules and inspection organisations
Germany – TUV
France – DRIRE
Italy – ISPSEL …
• From 1999 to May 2002 transition period
• May 2002 Mandatory

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 Intent of PED

• Harmonise rules for consistent application:

– Design, manufacture, testing and conformity assessment

• Does not mandate a design standard however,

– Must use selected standard in it’s entirety
• Supplement as required by PED
• No cherry picking between codes
– Promotes the use of Harmonised Standards as these give
a presumption of conformity
• A series of EN standards written for Directives by CEN
• The user and location of installation may influence their use

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 Intent of PED

• Harmonised standards for manufacturing a PE:

– EN 13445: Unfired Pressure vessel 2002 oldest + add
(8 parts)
– EN 12952: Water tube boiler 2001 (16 parts)
– EN 12953: fire tube boiler ed 2002 (12 parts)
– EN 13480: industrial piping & pipeline 2002 + Add
– EN 12516: industrial valves 2004
– And more …

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 Intent of PED

• Hazard based philosophy

– Eliminate or reduce hazards
– Protect against hazards which cannot be eliminated
– Inform users of residual hazards and indicate any special
measures
– Designed to prevent danger from misuse or give
warnings
• Mandatory Essential Safety Requirements (ESR’s)
– Manufacturer analyses hazards
• Manufacturer addresses hazards that exist in through design and
construction
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 Intent of PED

• Design
– To ensure equipment will be safe throughout its
intended life
• Manufacturing
– The manufacturer must ensure the competent
execution by applying the appropriate techniques and
procedures
• Including preparation of components, permanent joints, NDE,
heat treatment, and traceability

• Materials
– Must be suitable for such application during the
scheduled lifetime
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• PED development since 1999

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 PED development

• Since 1999 PED develops thru

– Conformity Assessment Body Forum
CABF national level
CABF European level (Brussels)
– Return from Experience
– Market surveillance of Member state
– country joining EC recently

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 PED development

• Role of the NoBo in PED development

– Bring real case example to discuss with EU commision
– Facing problem of applying PED
– country joining EC recently
• NoBo can initiate
– Guideline
– PED clarification CABF-R
– Return from experience
• thru Manufacturer, end user, national regulation

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 PED development

• Since 2002
226 guidelines printed
– Scope and exclusion (54)
– Classification and category (38)
– Assemblies (17)
– Evaluation assessment (13)
– Interpretation of ESR for design (7)
– Interpretation of ESR for Manufacturing (16)
– Interpretation of ESR for Material (29)
– Interpretation of other ESR (19)
– Miscellaneous (24)
– Horizontal issues (9)
all guideline available on PED web site:
http://ec.europa.eu/enterprise/sectors/pressure-and-gas/documents/ped/guidelines/index_en.htm

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 PED development

• CABF Recommendation:
– 18 CABF-R available for Notified Bodies
– Clarifications to a question/situation by CABF in
Brussels
• Technical position
• Define same approach for all Notified Bodies
• Enforce consistency of NoBo applying the PED
• Ensure Mfr of the Nobo position/interpretation
– CABF-R not elected as a guideline
CABF-R 12.pdf

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 PED development

• Material and PED: Three options for compliance

1.Harmonized standards (option 1)

• EN Harmonized standards only
plate, forging, fitting, pipe, bolting …
• Direct PED presumption of conformity

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 PED development

• Material and PED: Option 2

2. European Approval for Materials (EAM)
• Guiding principle to make EAM, published on PED web site
define scope and methodology to make EAM :
document N° PE01-01 rev 6
• Approved by specific NoBo and EC
• Not applicable for material already define in an harmonized
standard
(not applicable for ASME, ASTM, DIN, BS, JIS materials etc)
• So far only nickel based alloys
http://ec.europa.eu/enterprise/sectors/pressure-and-
gas/documents/ped/materials/index_en.htm

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 PED development

• Material and PED: option 3

3. Particular Material Appraisal (PMA)

• Prepared by manufacturer
• Lowest degree of presumption of conformity
• Applicable for all material that is not harmonized such as :
ASME, DIN, BS, NF, JIS materials etc…

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 PED development

• Guiding principle to make PMA

− EC request CABF to work on this guide to provide :
− Consistency on Material evaluation PMA
− Have clear instruction to make it
− Define process to assess Material for PED ESR
− Guiding principal for PMA printed in Nov 2006
Document PE-03-28 rev 5, available on PED web site

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 PED development
Material
Properties Specified properties
Same properties
in weld and HAZ Sufficiently
Ductile

Compatible
(galvanic) Sufficiently
Tough

Suitable for
intended processing Resistant to Aging

Chemically resistant
Selection 18
 PED development

• Summary of what is a PMA

Ø PMA is a process (not only a document) applied to materials

not covered by an Harmonized std
Ø PE Manufacturer must be able to demonstrate compliance
with ESRs for Material
Ø PMA therefore is a « decription of the solutions adopted to
meet the ESRs » for materials
Ø Where to found the guide:
http://ec.europa.eu/enterprise/sectors/pressure-and-gas/files/pe-03-28-
guiding-principles-for-the-content-of-pma_en.pdf

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 PED development

• Guiding principle for Assemblies

– Work started at CABF on EU commission request

– Two drafts to be presented
– After completion will go to EC for acceptance
– Covers modules A1, B, C1, F, G (inspection)
– Need to be completed by Quality assurance modules
(D,E, H & H1)

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 PED Development

• Guiding principle for Assemblies

– Objective:
Ø Establish consistency in application of global conformity
assessment procedure by Notified Bodies
Ø Give guidance to main step for the conformity assessment of
assemblies
Ø Explain and clarify some guidelines
Ø To be a public document available to all involved parties
Ø Target end 2010

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PED New text to be applied and future
development

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 PED New text

• Two Regulations
– Regulation EC 1272/2008
call also the CLP regulation
– Regulation EC 765/2008
new legal frame work

• One decision
– Decision EC 768/2008 (july 08)
(Basis for the future legislation)

How these texts will impact the PED ?

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 Regulation EC 1272/2008

• New Regulation « CLP » EC 1272/2008

CLP: Classification,labelling and packaging of substance and mixtures
– New classification for fluids
– Direct impact on PED, repeal directive 67/548 EEC
listed in article 9 of the PED
– Entered in force 20 Jan 09, with transition periods for:
• Substances till 1 dec 2010
• Mixture till first June 2015
• By 2015 the PED article 9 should be modified to refer to CLP

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 Regulation EC 1272/2008

• Action proposed by EU Commission to implement

CLP regulation

– Immediate
new PED guideline 2/39 proposed
– Short term
Review existing guideline 2/7 & 2/20
(show difference and impact of the CLP regulation)
– Medium term
Modify PED to include CLP Regulation

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 Regulation EC 765/2008

• Also called « New Legal Framework » (NLF)

(applicable 1st January 2010)

• Objective of the NLF

– Improve transparency in the control of the NoBo
– Reinforce Market Surveillance (EU Level)
– Reinforce the CE marking

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 Regulation EC 765/2008

• set requirement for Accreditation / Appointment:

– Accreditation of Notified Bodies

• Transparent accreditation to ensure level of confidence in CoC
• One accreditation Body per country
• Accreditation preferred means of demonstrating technical competence
of the NoBo
– NoBo’s appointed by National Authority.
• Evaluation of the NoBo is done by a National Authorities.
• National Authorities shall:
– Supply to the EC and the other Member states the necessary documentary
evidence demonstrating compliance of the NoBo to the relevant regulatory
requirement.

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 Regulation EC 765/2008

• set requirement for (cont’d):

– Market surveillance
• Internal
• Imported product
• Sharing information / resources between Member States
• Safeguard close

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 Regulation EC 765/2008

• Set requirement for (cont’d):

– CE Marking general Principle
• CE Marking affix only by the Mfr or his authorised representative
• By CE marking Mfr take full responsibility for the conformity of the product
• The CE Marking attest the conformity to the relevant community
harmonisation legislation
• Forbiden to affix other making that can mislead
• Official CE marking sign

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 Decision EC 768/2008

• Objective :
• Coherent and robust regulatory frame work for free movement
of the goods
• Strengthens key elements
obligation of economic operators, notification and operation of
NoBo’s

Reinforced provision need to be integrated into existing

legislation.

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 Decision EC 768/2008

• Main topics:
• Give clear definitions
manufacturer:
– legal person who manufacture a product or has a product designed
or manufactured and marked that product under his name or
trademark
placing on market:
– first making available of product on the community market
And more such as:
– Importer, CE marking, Withdrawal, …
• Obligations of economic operators
– Manufacturer, authorised representative, importer, distributors

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 Decision EC 768/2008

• Main topics:
• Conformity assessment Procedure:
– New organisation of modules : A1/A2, C1/C2, B1/B2
• CE Marking:
– Rules for affixing it:
» Before the product is placed on market
» Followed by NoBo identification number
» MS take appropriate action in the event of improper use of CE marking

– Additional rules to the Regulation 765/2008

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 Decision EC 768/2008

• Main topics (Cont’d ):

• Notifying authorities :
– Criteria for notifying authorities:
» No conflict of interest with NoBo
» Objectivity and impartiality of its activities
» No conformity assessment or consultency services
» Confidentiality …
• Notification process:
– with accreditation certificate by Notified Authority
– without accreditation : appointment by National authorities (MS)

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 Decision EC 768/2008

• Main topics (Cont’d ):

• Notified Body:
– Control of the NoBo’s through Member state & EU commission
(de- notification possible)

– Subcontracting
NoBo take full responsibility for the task perfomed

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 Decision EC 768/2008

• Main topics (Cont’d ):

• Safeguard Mechanism:
– Ensure coherent EU action against non compliant products
» Notification of measure - time for objection
» No Objection – all MS take relevant action
» Objection: matter decide at EU level - European Commission decision
– Compliant product posing risk
» Economic operator inform the commission and the other MS, of the
action taken: take necessary action, or withdrawn or recall
» European Commission decide if measure is justified and in case not
propose appropriate measure.

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 PED new text

• Possibility of revising the PED

– All ESR will remain in place ( Annex 1 of the PED)

– No Technical modification
– Commission working on impact (implementation of the
decision and the new regulations)
– Target date probably 2015 (no date fixed)

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 PED new text

Questions?

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