Transcript eurolook template and master

Directive 97/23/EC
on Pressure Equipment (PED):
International aspects and
current developments
Pressure Equipment Workshop, Bratislava April 2005
Scope of presentation
1)
Link to presentation on New Approach
2)
Recapitulation: PED scope, definitions, ESRs,
categories, illustrating progress in understanding
and clarification
3)
Experience and developments: standardisation,
notified bodies, market surveillance
4)
Current topics from Europe and beyond
- all with an International flavour and indication of developments
New Approach
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Technical harmonisation to support the Common Market
19 sectors to date
Define Essential Safety Requirements (ESRs)
Establish hazard categories
List Conformity Assessment Procedures
Self certification / Notified Bodies Assessment
Affix CE-mark
Free movement within EEA
Harmonised Standards provide presumption of conformity
Pressure Equipment Directive (PED)
• Ensures free movement of goods,
• for products which fall within its scope,
• which meet the ESRs,
• having completed Conformity Assessment
• or are Art 3.3 (SEP) equipment.
PED harmonises the previously fragmented
European PE market
Important message for trade
PED 97/23/EC
Recital - 27 “Whereas” clauses set the scene
21 Articles
7 Annexes: ESR, Graphs, Modules, Criteria
for Notified Bodies, Recognised Third Party
Organisations and User Inspectorates, “CE”
Marking, and Declaration of Conformity
Recital
Recital 5 Items and assemblies
Recital 14 Essential Safety Requirements
and Final assessment
Recital 16 CEN, CENELEC
Harmonised Standards
Recital 19 Conformity Assessment
Articles
Article 1 Scope and definitions – next 3 slides
Article 2 Market surveillance – later in my talk
Article 3 Technical Requirements - Annex I
Essential Safety Requirements
Article 8 Safeguard clause
Article 10 Conformity Assessment
Article 15 CE Marking – indicates legal declaration
PED: Scope
Pressure equipment and Assemblies :
- design,
- manufacture,
- conformity assessment
Limited to:
- pressure hazard
- pressure greater than 0.5 bar
- equipment placed on the market OR put into service
- assemblies placed on the market AND put into service
Definitions
1- Vessel
housing for containment of pressurised fluids
2- Piping
pipe or system of pipes mainly for transport of fluids –
includes hoses, expansion joints, fittings
3- Safety accessory
protects against exceeding allowable limits
4- Pressure accessory
operational function e.g. valves, fittings
Assemblies
Several pieces of pressure equipment, provided
1. the result is integrated
2. the result is functional
3. they are a whole
4. they are assembled by one manufacturer
NOTES:
a- the assembly can be built in a workshop or on-site
b- there is no upper limit to an assembly
c- when not placed on the market, assemblies are not covered
Essential Safety Requirements (ESRs)
- General obligations for manufacturer (Prelim and ESR 1)
- e.g. carry out hazard analysis incl. reasonably foreseeable misuse
- to establish technical documentation file
- Design and calculation (ESR 2)
- Manufacturing (ESR 3)
- manufacturers capabilities, manufacturing/joining procedures
- Materials (ESR 4)
- Specific requirements (ESRs 5, 6, 7):
- fired or otherwise heated pressure equipment, - piping, and
- specific quantitative requirements (general rule)
Conformity Assessment
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Categories depend on Hazard Level
Cat I: Self Assessment by Manufacturer
Cats II, III, IV: Notified Body also assesses
12 different CA Modules available
Simplified assessment when using
Harmonised Standards, particularly in design
Criteria for classification
Two fluid groups
- Group 1: Positive list of 7 dangerous fluid types as
defined by Directive 67/548/EEC
- Group 2: Other fluids
Physical state of fluid - gaseous, - liquid
Indication of stored “energy” PS·V or PS·DN (piping etc
Determination of applicable category
Classification
Group 1 fluid
Group 2 fluid
gaseous
Table 1
Table 2
liquid
Table 3
Table 4
gaseous
Table 6
Table 7
liquid
Table 8
Table 9
Pressure
accessories
volume
according to table 1-4
DN
according to table 6-9
Safety
accessories
general
Category IV
specific
Category of respective
equipment
Assemblies
According to highest element (except safety acc.)
vessels
piping
Conformity assessment tables (A)
Vessels for dangerous gases
(Table 1)
Vessels for non-dangerous liquids
(Table 4)
Conformity assessment tables (B)
Piping for dangerous gases
Table 6
Piping for non-dangerous liquids
Table 9
Hazard Categories for PE
Category ESRs
CA Modules
CE mark
I
apply
A
Yes
II
apply
A1, D1, E1
Yes
III
apply
B1 + D, B + E, H
B1 + F, B + C1
Yes
IV
apply
B + D, H1
B + F, G
Yes
(3.3)
SEP
None
NO
Certification for certain manufacturing activities
Capabilities
Qualified personnel
for joining
Qualified joining
procedures
Qualified personnel
for NDT
Certification required
Category
II III IV
X
X
X
X
X
X
X
X
By
notified body
or
recognized third
party organization
recognized third
party organization
Documentation requirements for materials
Materials used for Cat I – IV equipment must be either :
• Harmonised EN Standard (material or product
standard)
• European Approval of Material (EAM)
• Particular Material Appraisal (PMA)
Technical documents must contain:
• Affirmation of compliance with specification by
material manufacturer
• Certificate of specific product control (cat II – IV)
European Approval for Materials (EAM)
- Technical document defining characteristics of materials
- Only for types of materials not covered by Harmonised
Standards
- proposed by a Notified Body
- possible objection by Member States and/or Commission
- If objection raised, Committee 98/34/EC issues opinion
- when published in the Official Journal gives presumption of
conformity
E A Ms
• First four EAMs on Nickel 201 published in OJ 2003/C233/10,
11 other nickel alloys were published in OJ 2005/35/6 - see
http://europa.eu.int/comm/enterprise/pressure_equipment/index.htm
• More EAMs are in the pipeline
• Guiding Principles and standard form downloadable at
http://ped.eurodyn.com/materials/materials.html
• Orgalime support facilitating drafts of EAMs (EU contract):
http://www.orgalime.org/positions/eam.htm
Harmonised Standards (ENs)
• Developed following Commission mandate M/071 to CEN
• Designated by CEN as candidate for harmonisation
• Substantiating the Essential Safety Requirements of the PED
• Use not mandatory but providing presumption of conformity
• Important examples of product standards:
EN 13445 (unfired pressure vessels), EN 13480 (piping),
EN 12952 (water tube boilers), EN 12953 (shell boilers)
Harmonised Standards: Types 1, 2
Type 1:
- Provide a means of fulfilling at least one ESR
-Contain an Annex ZA to provide a reference between the
pertaining section of the EN and the ESRs of the PED
- Give Presumption of Conformity to those ESRs of the PED
which are addressed, when the standard is published in the
OJEC.
Type 2:
- Not fulfilling ESRs by themselves, no publication in OJEC
- usually referenced from type 1 standards
Consolidated list of standards to be published in OJEC soon
Harmonised Standards: Challenges
Some situations are detrimental to European standardisation:
• National standard organisations are obliged to withdraw
documents conflicting with ENs (98/34/EC) and
• Notified Bodies must be free from financial inducements,
related e.g. to standardisation (PED annex IV)
• National regulation must not discriminate certain solutions
Interest of all players, including European industry:
• economically efficient and safe ENs
• ENs competitive with other standards internationally
Notified Bodies & RTPOs: Facts
Individual Member States notify the Commission and other Member
States => Notified Bodies must be subject to laws of a Member State
Member States have to assess integrity, independence and technical
competence of candidates
Involved in conformity assessment of category II, III, IV PE
Heterogeneous manufacturer/user structure => in practice Notified
Bodies/RTPOs often the single most important element ensuring safety
PED annex IV stipulates minimum criteria for Notified Bodies/RTPOs,
Member States may apply additional criteria, but not restricting trade
Notified Bodies & RTPOs: Problems
•Manufacturers:
pay for services - potential for conflict of interest
shop around for cheapest solution –
quality of conformity assessment may deteriorate as a result
•Varying technical performance of notified bodies/RTPOs
•Questions about subsidiaries of notified bodies in third countries include:
technical expertise, training, responsibility, surveillance etc.
So far, most identified problems with the safety of products
also point to related problems with Notified Bodies!
Member States to improve surveillance of notified bodies/RTPOs
Notified Bodies & RTPOs: Problems (ctd)
Attachment to former national legislation and/or
interests in national/ private “standardisation”
may result in discrimination of “alternatives” like ENs
Local incumbents create barriers for “foreign” notified bodies,
e.g. by using tasks under national competence
Notified Bodies Forum (CABF)
Forum of all notified bodies, RTPOs and user inspectorates in the pressure
sector: participation in this forum is strongly encouraged
Purpose: to exchange information and co-ordinate consistent
implementation of PED in Member States in collaboration with WPG/WGP
Rotating chair by notified body representatives, financed by Commission,
attended by various “observers” (Commission, CEN, industry, users,…)
Technical Response Group (TRG) : drafts internal guidance documents on
certain technical/legal questions that may also lead to a WPG/WGP
guideline
Web-based communication platform, contact: [email protected]
Market Surveillance
Member States:
must take measures to ensure market surveillance
verify that ESRs and other requirements are met, when appropriate
ensure that products do not endanger health and safety of persons
and where appropriate domestic animals or property
define additional measures for workers protection, where needed
Market Surveillance
 Important element of the New Approach
 Pressure Sector: awareness needs to be raised but Member States
generally understand their responsibilities and becoming more involved
 Most identified problems are with relatively cheap mass products (simple
pressure vessels, pressure cookers) However, a “small” risk per item may
generate a substantial risk for accidents due to the large number of products
 Sometimes responsibilities (manufacturer, distributor, authorized
representative) difficult to identify, e.g. insufficient labeling, documentation
Market Surveillance: Safeguard Clause
 Detection of product on the market which is not safe to be
used and/or is dangerous
 Clarification between market surveillance and
manufacturer/authorized representative/importer
 If danger persists : withdraw from the market and notify the
Commission and Member States
 Investigation by the Commission
 Commission Decision
Administrative Co-operation
Individual Member States have limited resources but collective strength
• ADCO groups WPA & WGA established in 2004
• Comprise representatives from public administrations only
• Information exchange, co-operation, common concepts and actions for the
surveillance/designation of products and notified bodies
• Chaired by Member States, supported by the Commission
• Regular meetings, web-based communication platforms (Circa, ICSMS)
• Now: “constitution” established => deal with individual cases !
• ADCO approach may be extended with the revision of New Approach
Topic : National vs. EU regulations
Interfaces of national and European competences:
“Placing on the market” vs.
• operation (e.g. attended/unattended operation of boilers)
• initial in-service inspection
• regular in-service inspection
• non-pressure related aspects of PE (e.g. fire extinguishers)
Sometimes clear separation is difficult:
=> Some Member State authorities and “national” competent
bodies tend to impose additional requirements particularly in the
light of experience, which may infringe articles 4, 5 of the PED
Topics : Reports of the Commission
Review of New Approach – mentioned in this talk
SPVD 87/404 and User Inspectorates – PED Article 14:
• Public enquiry via web-based questionnaire July 2004
• Summary of results in November 2004
• Further discussion with Member States and stakeholder groups
• Reports due middle of 2005
Current topics : Liaison on trade
Relations with some trading sectors:
US Department of Commerce, May and Sept 2004
Meeting with Chinese delegation, November 2004
Common themes and outcomes:
to promote understanding of differences in requirements
to facilitate access of European industry to foreign markets, e.g.
(i) solving problems related to implicit technical barriers of
trade
(ii) making foreign legislation more accessible and
transparent
unity of regulation in Europe, replacing fragmented approach
Further information
Commission “eurodyn” and “Europa” web-sites:
http://ped.eurodyn.com
http://europa.eu.int/comm/enterprise/pressure_equipment
Directive text itself
PED WGP Guidelines (hypertext linked to PED)
National Authorities
Euro Info Centers
Industry Associations
Notified Bodies