Professional Documents
Culture Documents
August 2015
Compared to 97/23/EC, the 2014/68/EU has grown in size by almost 60% to 96 pages, it now has seven
Chapters containing 52 Articles and a further six Annexes. Although there are extensive additions, a
number of deletions and changes to the document, the impact on manufacturers is less than might be
imagined. The majority of the additions concern the Notification of Conformity Assessment Bodies and
EU legal aspects. This document will assist manufacturers in identifying the areas that need to be
addressed for future compliance. There were several editorial changes made between the two directives
that will not be covered within this document, but all significant changes applicable for the manufacturer
will be addressed.
2014/68/EU will be implemented in two parts. The first part became mandatory on June 1, 2015, and is
in relation to Article 13, Classification of pressure equipment. The second part, the replacement of the
97/23/EC becomes effective July 19, 2016. This implementation is discussed in detail below.
Article 10, NLF PED contains important information for importers and distributers. It states when they
place the equipment on the market under their own name or trademark that they shall be considered as
a manufacturer (and thus bear the associated responsibilities of the manufacturer, as described in the
Directive). This requirement is not intended to apply to such organizations who place the equipment on
the market under the original manufacturers name, for example valve stockists who hold catalogues of
valves where the manufacturer is clearly identified.
Article 10 also details firm rules when an importer or distributer modifies the equipment in such a way
that compliance with the Directive may be affected. If they make such modifications before placing on
the market then they are to be considered a manufacturer.
Generally the responsibilities of the manufacturer, or authorized representatives, remain the same in
2014/68/EU.
The CLP re-classifies certain substances from the Dangerous Substances Directive. The European
Commission conducted an assessment regarding the effects of the re-classifications and concluded that
only a small number of substances/mixtures would be affected and that the impact on manufacturers
would be minimal.
Article 9 of 97/23/EC outlines the provisions for dangerous fluids (substances) and classifies them in
Group 1, all other fluids not referenced were placed in Group 2. Article 13 of 2014/68/EU classifies
substances and mixtures as hazardous and places them in Group 1, all other substances and mixtures
fall into Group 2. The hazardous substances and mixtures are now broken down into 17 different
physical and health classes in accordance with Parts 2 and 3 of Annex I in the CLP Regulation.
Hartford Steam Boiler UK Limited
Crosby Court 28 George Street Birmingham, B3 1QG United Kingdom
Notified Body Number 2561
Registered Address: Baker Tilly Marlborough House Victoria Road South Chelmsford Essex CM1 1LN England Registration Number: 02708264
The labels associated with the substances and mixtures have also been changed to coincide with the
CLP, manufacturers are also encouraged to review these.
Whilst a hazard analysis considers such common and less common factors as overpressure, fatigue,
brittle fracture, wind, earthquake, fire, explosion and so on, its implied that a risk analysis would take this
a step further, most likely considering the probability and the magnitude of a failure. Its understandable
that this presents a problem for the majority of manufacturers, such finite details regarding the location
and nature of the installation is usually unknown and often the final user will not readily release such
information.
Our Design Check List template (DCL, form QP10.3-F.002) has always addressed risk evaluation at a
fundamental level and was compiled following the results of discussions at the EU Conformity
Assessment Body Forum in Brussels at the onset of the 97/23/EC. We know from these discussions that
Hartford Steam Boiler UK Limited
Crosby Court 28 George Street Birmingham, B3 1QG United Kingdom
Notified Body Number 2561
Registered Address: Baker Tilly Marlborough House Victoria Road South Chelmsford Essex CM1 1LN England Registration Number: 02708264
Category II
Module A1
Module D1
Module E1
Module A2
Module D1
Module E1
Category III
Modules B1 + D
Modules B1 + F
Modules B + E
Modules B1 + C1
Module H
Category IV
Modules B + D
Modules B + F
Module G
Module H1
Category I
Module A
Module A2
Module B
(production)
Module B
(design)
EC Type examination
C2
D1
E1
Product verification
EC unit verification
H1
Annex III still addresses the conformity assessment procedures. Although there are changes in some of
the layout and text descriptions, the module requirements remain the same in principal. Generally the
text has been expanded in each module description for clarification, and revised in its layout and
formatting. It has also removed many of the cross references between modules that is present in
97/23/EC, 2014/68/EU now lists each modules responsibilities and requirements in full under each
module heading. There is guidance provided within each module description for CE marking and EU
Hartford Steam Boiler UK Limited
Crosby Court 28 George Street Birmingham, B3 1QG United Kingdom
Notified Body Number 2561
Registered Address: Baker Tilly Marlborough House Victoria Road South Chelmsford Essex CM1 1LN England Registration Number: 02708264
Article 48
Although there no transition period as described above, there is a paragraph written into Article 48 that
will greatly assist manufacturers, and Notified Bodies, to cope with this immediate transition.
Article 48 states that certificates and decisions issued by conformity assessment bodies under Directive
97/23/EC shall be valid under this directive.
What this means is that all certificates issued under 97/23/EC, and this includes Quality System
Certificates, EC-Type and EC-Examination certificates, remain valid without need for revision following
the implementation of 2014/68/EU on July 19 2016.
For example:
A valid module B1 certificate issued referencing 97/23/EC, remains valid as an EU-Type
examination certificate for Module B (Design).
A valid Quality System Certificate for Module H1, including associated design certificates, remain
valid without revision under 2014/68/EU.
In addition to certificates, the Article also states that decisions under 97/23/EC remain valid. What
this means is for equipment that is applied under module G for example, if the design part of the
conformity assessment is completed and accepted by the Notified Body, before July 19, 2016,
then the decision to accept the design remains valid once 2014/68/EU becomes effective.
HSB GS will provide more information in due course with details about how certificates may be
revised to reference 2014/68/EU if requested by the manufacturer, or when certificates are
renewed.
There is essentially no transition phase between the withdrawal of the 97/23/EC and the full
implementation of 2014/68/EU. The key stage for manufacturers to consider is the signing date of
the declaration of conformity for the equipment. This is the day that the manufacturer declares it
complies with the applicable regulation.
On the date of July 18 2016, the declaration of conformity needs to be signed with reference to
97/23/EC.
On the next day, July 19 2016, the declaration of conformity needs to be signed with reference to
2014/68/EU
Although there are no technical changes to the essential safety requirements (other than adding
risk), manufacturers need to bear these dates in mind for future pressure equipment construction,
taking into account the expected date of signing the declaration of conformity.
Guidelines
There is an ongoing effort to transfer all of the applicable old guidelines to 2014/68/EU. As there are no
real technical changes to the PED, the work is in changing the references to text and paragraphs that
appear in all the guidelines. This task has proved more time consuming then first expected, and there is
expected to be a significant delay in the completion of this guideline transfer. However, as there is no
real technical change in the guidelines, they can continue to be used once 2014/68/EU comes into
effect, provided consideration is given for the paragraph references.
2014/68/EU will also have new guidelines. At the time of this publication, two of new guidelines have just
been published along with two transposed guidelines from 97/23/EC. These new guidelines will also be
numbered differently with a prefix A-01, A-02, B-01, etc depending on their classification grouping.
Further information on this grouping will appear on 2014/68/EU website in due course:
(http://ec.europa.eu/growth/sectors/pressure-gas/index_en.htm).
Chapter 1
Chapter 2
Chapter 3
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Chapter 4
Chapter 5
Directive 2014/68/EU
~~~
~~~
Article 1(1)
Chapter 6
Chapter 7
Article 1(1)
Article 1(2)
Article 1(3)
~~~
Article 2
Article 1(2)
Article 2(15) to (32)
Article 3
Article 3
Article 4(1)
Article 4
Article 5(1)
Article 4(2)
~~~
Article 5(3)
Article 6
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Article 7
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Article 8
Article 9
Article 10
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Article 11
Article 5
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Comments
General provisions, Articles 1 to 5
Obligations of economic operators, Articles 6 to 11
Conformity and classification of pressure equipment and
assemblies, Articles 12 to 19
Notification of conformity assessment bodies, Articles 20 to 38
Union market surveillance, control of pressure equipment and
assemblies entering the Union market, and Union safeguard
procedure, Articles 39 to 43
Committee procedure and delegated acts, Articles 43 to 46
Transition and final provisions, Articles 46 to 52
Definitions have been moved to Article 2. The Article has been
revised editorially, but there is no technical change in the scope of
the new PED.
Includes all the definitions from the old PED, and expands this list
significantly. New definitions are in sections (17) through (32) and
include definitions for putting into service, economic operators
etc
See Article 1 above
See Article 2 above
Title changed from Market Surveillance to Making Available on the
Market and Putting Into Service. Editorially revised also.
Numbering and editorial revision only.
Added a paragraph on free movement for equipment assessed by
user inspectorate.
See Article 5 above.
New Article. It correlates several major responsibilities of the
manufacturer that were previously found scattered throughout the
old PED, and lists these obligations in one article.
New Article. Gives the responsibilities of authorized
representatives, when one is appointed by a manufacturer.
New Article. Gives the responsibilities for importers.
New Article. Gives the responsibilities for distributers.
New Article. Important Article highlighting that when importers or
distributers place equipment on the market under their own name
or trademark, or modify equipment already on the market, that
they shall be considered as a manufacturer for the purpose of the
Directive.
New Article. Economic operators responsibilities regarding
requests from Market Surveillance Authorities
Deleted, included in Article 12, see below
~~~
Article 12(1)
Article 7(1)
Article 45
Article 7(2)
Article 44(1)
Article 7(3)
Article 7(4)
~~~
Article 44(5), second
subparagraph
~~~
Article 8
Article 9(1)
Article 9(2) point
1
~~~
Article 9(2) point
2
Article 9(3)
Article 10
Article 13(1)(a)
Article 13(1)(b)
Article 13(2)
Article 14
Identical
Editorial changes, deletion of paragraph 1.1, text references the
module changes
Identical
Editorial changes only
Editorial changes only
Identical
New paragraph, Commission shall publish approval of EAM that
meet Annex in the OJ
Identical
New paragraph, withdrawal of EAM from the OJ
Revised and included under Article 24
Revised and included under Article 24
Identical
Editorial changes only
Editorial changes only
Article 11(1)
Article 11(2)
Article 11(3)
Article 11(4)
~~~
Article 15(1)
Article 15(2)
Article 15(3)
Article 12(2)
Article 15(4)
Article 11(5)
~~~
Article 12
Article 13
Article 14(1)
Article 14(2)
Article 14(3) to
(8)
Article 14(9) and
(10)
~~~
Article 15(5)
Article 15(6)
~~~
~~~
Article 16(1)
Article 5(2)
Article 16(2) to (7)
Article 17
~~~
Article 15(1)
Article 15(2)
Article 15(3)
Article 15(4) and
(5)
~~~
Article 18
~~~
Article 19(1)
Article 19(2)
~~~
~~~
Article 20
Article 21
Article 22
Article 23
Article 24
Article 25
Article 26
Article 27
Article 28
Article 29
Article 30
Article 31
Article 32
Article 33
Article 34
Article 35
Article 36
Article 37
Article 38
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Article 39
Article 40
Article 41
Article 42
Article 43
Article 44(2) to (4)
Article 44(5), first
subparagraph
Article 46
~~~
Article 47
Article 19
Article 20(1) to
(2)
Article 20(3)
~~~
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~~~
~~~
Article 48(1)
Article 48(2) and (3)
Article 49
Article 50
~~~
Article 51
Article 21
Annex I
Article 52
Annex I
Annex II
Annex II
Annex III,
introductory
wording
Annex III, point 1,
Module A
Part of Chapter 7
New Article, Repeal. Deletion of Article 9 from 97/23/EC from 1
June 2015, repeal of 97/23/EC from 19 July 2016
Part of Chapter 7
New Article, Entry into force and application of 2014/68/EU from
19 July 2016
Editorial changes only
Essential Safety Requirements. Generally minor editorial changes
only. Preliminary observation 3 was revised to add in the word
risk, when describing the manufacturers responsibilities with
regards to performing a hazard and risk analysis.
Changes to the Module names. A1 is now A2, C1 is now C2, B1 is
now B (design type). The conformity assessment tables
themselves remain unchanged.
Identical
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Annex IV
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Annex V
Annex VI
For more information pertaining to the new Directive please see the following links:
Technical Manager
gavin_edley@hsbct.com
Lee Moffatt
Quality Manager
lee_moffatt@hsbct.com