EuropeAid /114385/D/SV/CY Project

Assessment and administration capacity building

for the harmonisation with the New Approach directives

SEMINAR on New Approach Directives

February 16+17, 2004 in Nicosia

ATEX Directive
PED
Pressure Equipment
directive
97/23/EEC

The views expressed in this publication do not necessarily reflect the views of the European Commission.
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Assessment and administration capacity building for the harmonisation with
the New Approach Directives

Contents

• EC-Directives according to § 95EEC

– Aim of EC-Directives
• Pressure Equipment Directive
(97/23/EG)
– Aim of Directives according to § 95 EEC
– Free movement
– Transition period
– Conformity assessment
• Guidelines on the Pressure Equipment Directive
– Grouping of Guidelines
– Examples
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Assessment and administration capacity building for the harmonisation with
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• Problematic points in the application of the PED

– The term Manufacturer

– Sound engineering practice
– Risk analysis
– Materials for Pressure Equipment
– European approval of materials
– Harmonised European Standards
– Operating instructions
– Transitional period for PED application
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Assessment and administration capacity building for the harmonisation with
the New Approach Directives
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Assessment and administration capacity building for the harmonisation with
the New Approach Directives
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Assessment and administration capacity building for the harmonisation with
the New Approach Directives

Aim of Directives according to § 95 EEC

• Directives according to § 95 EEC (former §100a EEC) are to

– ensure free movement of goods in the Common European Market.
– remove barriers to free trade in the internal market by harmonization
of national legislation in the EU Member states.
• Pressure Equipment is placed on the common market by the
manufacturer or his authorized representative established within
the Community.
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Assessment and administration capacity building for the harmonisation with
the New Approach Directives
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Assessment and administration capacity building for the harmonisation with
the New Approach Directives
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Assessment and administration capacity building for the harmonisation with
the New Approach Directives
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Assessment and administration capacity building for the harmonisation with
the New Approach Directives

Free Movement
(Article 4 PED)

Member States shall not, on ground of the hazards due to

pressure, prohibit, restrict or impede the placing on the market
or putting into service under the conditions specified by the
manufacturer of pressure equipment or assemblies referred to in
Article 1 which comply with the Directive and bear the CE
marking indicating that they have undergone conformity
assessment in accordance with Article 10.
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Assessment and administration capacity building for the harmonisation with
the New Approach Directives

Transitional provisions
(Article 20 PED)

• Clause (1):
Member States shall apply such provisions as from 29
November 1999.

• Clause (3) :
Member States must permit the placing on the market of
pressure equipment and assemblies which comply with the
regulations in force in their territory at the date of application of
the Directive until 29 May 2002, and permit such equipment to
put into service beyond that date.
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the New Approach Directives

Transitional period for the application of the PED

¾ In the transitional period (from 29 May 1997 to 29 May 2002) the

manufacturer of a pressure equipment or an assembly is free to
chose between the application of the “new law” and the “old law”
(Article 20).
¾ In case of choosing the “old law” the manufacturer should
mention it in the user instructions.
¾ After the transition period pressure equipment manufactured
according to the “old law” the item needs to be reassessed to
comply with the requirements of the PED may not placed on the
market in the European Economic Area (EEA) and Switzerland.
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Assessment and administration capacity building for the harmonisation with
the New Approach Directives
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Assessment and administration capacity building for the harmonisation with
the New Approach Directives

Conformity assessment
(Article 10 PED)
• Before placing on the market, the manufacturer shall subject
each item of equipment to one of the conformity assessment
procedures described in Annex III, according to the conditions
given in this Article.
• The conformity assessment procedures to be applied to an item
of pressure equipment with a view to affixing the CE marking
shall be determined by the category, as defined in Article 9, in
which the equipment is classified.
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the New Approach Directives

Categories for unfired pressure vessels for liquids of fluid Group 2

(PED Annex II Diagram 4)
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Assessment and administration capacity building for the harmonisation with
the New Approach Directives
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Assessment and administration capacity building for the harmonisation with
the New Approach Directives
 EuropeAid/114385/D/SV/CY
Assessment and administration capacity building for the harmonisation with
the New Approach Directives
 EuropeAid/114385/D/SV/CY
Assessment and administration capacity building for the harmonisation with
the New Approach Directives
 EuropeAid/114385/D/SV/CY
Assessment and administration capacity building for the harmonisation with
the New Approach Directives
 EuropeAid/114385/D/SV/CY
Assessment and administration capacity building for the harmonisation with
the New Approach Directives
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Assessment and administration capacity building for the harmonisation with
the New Approach Directives
 EuropeAid/114385/D/SV/CY
Assessment and administration capacity building for the harmonisation with
the New Approach Directives
 EuropeAid/114385/D/SV/CY
Assessment and administration capacity building for the harmonisation with
the New Approach Directives
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Assessment and administration capacity building for the harmonisation with
the New Approach Directives

Guidelines on the PED

• The Commission’s Working Group Pressure (WGP) comprise

– representatives of the EU-Member States and
– representatives of European Organisations, e.g. ORGALIME,
CEOC; CEFIC, CECT, EBA.
• The guidelines are the consensus of WGP on the correct
interpretation of the PED text;
• There is no legal binding effect of the guidelines;
• The guidelines are published by the EU Member states and the
European Organisations involved.

NOTE: Guidelines are available from www.http://ped.eurodyn.com

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the New Approach Directives

Grouping of Guidelines on the PED

1. Scope and exclusions

2. Classification and categories
3. Assemblies
4. Conformity assessment procedures
5. Interpretation of essential safety requirements on design
6. Interpretation of essential safety requirements on fabrication
7. Interpretation of essential safety requirements on materials
8. Interpretation of other essential safety requirements
9. Miscellaneous
10. Horizontal questions
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the New Approach Directives

WPG 1/3 as an example Guideline related to: Article 1

Question: Are replacements, repairs or modifications of pressure
equipment in use covered by the directive?
Answer:
1. Entire change: the complete replacement of an item of pressure
equipment by an new one is covered by the PED.
2. Repairs are not covered by the PED but are covered by national
regulations (if any).
3. Pressure equipment which have been subject to important
modifications that change its original characteristics , purpose and/or
type after it has been put into service has to be considered as a new
product covered by the directive. This has to be assessed by a case
by case basis.
Reason: The directive applies only to the first placing on the market and
putting into service. See “blue guide” chapter 2.1.
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the New Approach Directives

WPG 3/2 as an example

Guideline related to: Article 1.2 and 3. 2
Question: Are joining operations on site covered by the PED?
Answer: For the joining on site of components or equipment, two cases
have to be considered:
1. Joining of component parts: joining of component parts to comprise
an item of pressure equipment is subject to the requirements of the
Directive. The manufacturer -even he is the user- has the
responsibility that the resulting item of pressure equipment is in
compliance with the Directive.
2. Joining of items of pressure equipment: The joining is not covered by
the PED if it is carried out to constitute an installation under the
responsibility of the user but remain covered by national rules.
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the New Approach Directives

WPG 3/2 as an example (concluded)

If the joining is carried out under the responsibility of a manufacturer
to constitute an assembly covered by the definition given in Article
1.2.1.5, this assembly must fulfil the requirements of the Directive.
Reason: The fifth recital in the Directive says: “This Directive does not
cover the assembly of pressure equipment on the site and under the
responsibility of the user, as in the case of industrial installations”.

NOTES:
1. The definition of assembly in Article 1.2.1.5 is limited to those assemblies
assembled by a manufacturer. When items of pressure equipment or
assemblies are being put together by a user, to avoid confusion, the term
“installation” is used.
2. See also guideline 3/8
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The term “Manufacturer

• EN 764-3
Manufacturer: Individual or organisation that is responsible for the
design, fabrication, testing, inspection and installation of pressure
equipment and assemblies where relevant:
NOTE 1: The manufacturer may subcontract one or more of the above
mentioned tasks under his responsibility.
NOTE 2: In EU Member states the manufacturer is responsible for compliance
with the Pressure Equipment Directive 97/23/EC. For those manufacturers
outside the EU their authorized representative inside the EU assumes this
responsibility.
• Commission’s Working Group

Pressure 1-1999:
Manufacturer can be each, who is “capable and willing” to overtake this task.
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the New Approach Directives

Sound engineering practice

Pressure equipment and/or assemblies ... designed and
manufactured in accordance with the sound engineering
practice of a Member State in order to ensure save use (Article
3.3).
Guideline 9/1:
„Sound engineering practice” means, ... that such equipment is
designed taking in account all relevant factors influencing its
safety. Furthermore, such equipment is manufactured, verified
and delivered with instructions for use in order to ensure its
safety during its intended life, when used in foreseeable or
reasonably foreseeable conditions. The manufacturer is
responsible for the application of sound engineering practice.
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the New Approach Directives

General risk analysis

The manufacturer is under an obligation to analyse the hazards in order

to identify those which apply to his equipment and to meet the
requirements of all relevant directives:
e.g. risk in account of:
¾ pressure
• Pressure Equipment Directive
¾ moving elements
• Machinery Directive
¾ electrical current
• Low Voltage Directive
¾ electromagnetic influences
• Electromagnet Compatibility Directive
¾ potentially explosive atmospheres
• Explosion Protection Directive
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the New Approach Directives

Risk analysis for pressure equipment

• The manufacturer is under an obligation to analyse the hazards in
order to identify those which apply to his equipment in account
of pressure; he must then design and construct it taking account
of his analysis

(Annex 1, Preliminary observations number 3).

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the New Approach Directives

Risk analysis for pressure equipment (conclusion)

• In choosing the most appropriate solutions, the manufacturer
must apply the principles set out below in the following order:
¾ eliminate or reduce hazards as far as reasonable practical,
¾ apply appropriate protection measures against hazards which
cannot be eliminated,
¾ where appropriate, inform user of residual hazards and indicate
whether it is necessary to take appropriate special measures to
reduce the risk at the time of installation and/or use (Annex 1,
number 1.2)-
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Materials for Pressure Equipment

The manufacturer must provide in his technical documentation

elements relating to compliance with the material specifications
of the Directive in one of the following forms:
Ö by using materials which comply with harmonized standards ,
Ö by using materials covered by a European approval of pressure
equipment materials in accordance with Article 11.
Ö by using a particular material appraisal.
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the New Approach Directives

Materials for Pressure Equipment (concluded)

¾ The equipment manufacturer must take appropriate measures to

ensure that the material used conforms with the required
specifications.
¾ For the main pressure-bearing parts of equipment in categories
II, III and IV, this must take the form of a certificate of specific
product control.
¾ Where a material manufacturer has a appropriate quality-
assurance system, ... the manufacturer are presumed to certify
conformity with the relevant requirements of this section.
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the New Approach Directives

European approvals for materials (Article 1, 2.9)

”European approval for materials” means a technical document

defining characteristics of materials intended for repeated use in
the manufacture of pressure equipment which are not covered
by any harmonized standard.
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the New Approach Directives

Harmonized European Standards

Ö Harmonized European Standards are prepared under a

mandate given to CEN by the European Commission and the
European Free Trade Association. After formal adoption by the
European Commission they are published in the Official Journal
of the Commission.
Ö The mandate is mentioned in the foreword of a harmonized
standard.
Ö The user of a harmonized European Standard may presume
conformity with the Essential Safety Requirements of the
Pressure Equipment Directive (presumption of conformity).
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the New Approach Directives

Operating instructions (Annex I, Number 3.4)

• When pressure equipment is placed on the market, it must be

accompanied, as far as relevant, with instructions for the user,
containing all the necessary information for:
– mounting including assembling of different pieces of pressure
equipment
– putting into service
– use
– maintenance including checks by the user
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Assessment and administration capacity building for the harmonisation with
the New Approach Directives
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Assessment and administration capacity building for the harmonisation with
the New Approach Directives
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Assessment and administration capacity building for the harmonisation with
the New Approach Directives
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Assessment and administration capacity building for the harmonisation with
the New Approach Directives
 EuropeAid/114385/D/SV/CY
Assessment and administration capacity building for the harmonisation with
the New Approach Directives
 EuropeAid/114385/D/SV/CY
Assessment and administration capacity building for the harmonisation with
the New Approach Directives
 EuropeAid/114385/D/SV/CY
Assessment and administration capacity building for the harmonisation with
the New Approach Directives
 EuropeAid/114385/D/SV/CY
Assessment and administration capacity building for the harmonisation with
the New Approach Directives
 EuropeAid/114385/D/SV/CY
Assessment and administration capacity building for the harmonisation with
the New Approach Directives
 EuropeAid/114385/D/SV/CY
Assessment and administration capacity building for the harmonisation with
the New Approach Directives
 EuropeAid/114385/D/SV/CY
Assessment and administration capacity building for the harmonisation with
the New Approach Directives
 EuropeAid/114385/D/SV/CY
Assessment and administration capacity building for the harmonisation with
the New Approach Directives