Communication from the Commission to the Council and the European Parliament - Evaluation of the use of User Inspectorates under the Pressure Equipment Directive (97/23/EC)
Date: 2006-03-10
Institutions: European Commission
Subjects: EU Member State, pressure equipment, qualitative analysis, roadworthiness tests, safety standard

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 10.3.2006 
COM(2006) 109 final 

COMMUNICATION FROM THE COMMISSION TO THE COUNCIL AND THE 
EUROPEAN PARLIAMENT 

Evaluation of the use of User Inspectorates under the Pressure Equipment Directive 
(97/23/EC) 

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TABLE OF CONTENTS 

SUMMARY ............................................................................................................................... 3 

1. 

INTRODUCTION........................................................................................................ 3 

Background ................................................................................................................................ 3 

Review method........................................................................................................................... 4 

2. 

THE FUTURE OF THE USER INSPECTORATES................................................... 4 

General remarks ......................................................................................................................... 4 

Safety Concerns related to conflict of interest ........................................................................... 5 

Marking for equipment assessed by User Inspectorates ............................................................ 6 

Transposition of provisions on User Inspectorates to become mandatory................................. 6 

Extension of the scope of tasks to be performed by User Inspectorates .................................... 7 

3. 

CONCLUSIONS.......................................................................................................... 9 

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COMMUNICATION FROM THE COMMISSION TO THE COUNCIL AND THE 
EUROPEAN PARLIAMENT 

Evaluation of the use of User Inspectorates under the Pressure Equipment Directive 
(97/23/EC) 

SUMMARY 

The current Communication is a follow-up to the invitation contained in Directive 97/23/EC 
on Pressure Equipment to present a report evaluating the functioning of User Inspectorates. 

The  evaluation  of  the  use  of  User  Inspectorates  shows  that  no  safety  issues  could  be 
identified. The concept of User Inspectorates is functioning well and in the intended manner, 
i.e.  in  accordance  with  the  underlying  concept  of  User  Inspectorates  originally  intended  to 
allow  the  user  groups  to  take  advantage  of  their  technical  expertise  for  limited  internal 
applications. The Directive’s provisions could on certain points be optimised, but the benefits 
would not be expected to be significant. 

The Commission therefore concludes there is no sufficient reason to forward to the Council 
and  the  Parliament  a  proposal  for  amendment  of  the  Pressure  Equipment  Directive  with 
regard to User Inspectorates. 

1. 

INTRODUCTION 

Background 

The  Pressure  Equipment  Directive  contains  an  invitation  to  the  Commission  (article  14)  to 
present  a  report  on  user  inspectorates.  Whilst  in  New  Approach  Directives  third  party 
intervention  in  conformity  assessment  is  exclusively  implemented  through  organisations 
notified  thereto  by  Member  States  (Notified  Bodies),  the  Pressure  Equipment  Directive 
presents a particularity in that Member States can authorize in their territory the placing on the 
market  and  the  putting  into  service  of  pressure  equipment  or  assemblies  the  conformity  of 
which has been assessed by “User Inspectorates”, i.e. part of the group of the company using 
the equipment (user). 

User  Inspectorates  being  a  new  element,  reflecting  practices  at  the  time  of  adoption  of  the 
Pressure  Equipment  Directive  only  in  certain  Member  States,  the  Directive  requires  the 
Commission  to  monitor  the  effects  of  the  use  of  User  Inspectorates  and  to  present  an 
evaluation  three  years  after  implementation  of  the  Directive  at  national  level.  To  this  end, 
Member  States  are  requested  to  forward  to  the  Commission  any  useful  information  on  the 
implementation of this Article. If necessary the evaluation shall be accompanied by a proposal 
for amendment of the Pressure Equipment Directive. 

The current Communication implements this request. 

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Review method 

This  Communication  is  based  on  a  series  of  consultations  of  national  authorities  and 
stakeholders that can be summarized as follows: 

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The main platform for consultation with national authorities and stakeholders was the 
Working  Group  Pressure  organised  by  the  Commission  services,  dealing  with  both 
issues since 2003. 

In  order  to  collect  an  as  broad  view  as  possible,  the  Commission  organised  an 
internet  consultation  to  collect  stakeholder  views  and  proposals  from  the  European 
pressure  sector  in  order  to  gather  experiences  on  the  User  Inspectorates  and  to 
examine  whether  the  provisions  of  the  PED  should  be  modified  or  maintained  in 
their  present  form.  This  consultation  was  announced  through  various  channels  and 
was  available  on  internet  from  the  beginning  of  October  2004  until  the  end  of 
January 2005. A significant number of comments were received1. 

A summary and detailed analysis of the responses in relation the User Inspectorates 
identified  by  the  public  enquiries,  together  with  preliminary  conclusions,  were 
examined by the Working Group Pressure in April 2005. 

National  authorities  were  invited  to  consider  the  identified  issues  until  the  end  of 
May  2005  in  order  to  ensure  that  they  could  comment  on  any  aspects  to  be  still 
reviewed. 

2. 

THE FUTURE OF THE USER INSPECTORATES 

General remarks 

Worldwide,  users  of  engineering  equipment  have  had  departments  ensuring  periodic  in-
service  inspections  as  part  of  their  overall  organization.  In  particular  the  major  user 
companies  have  found  such  arrangements  to  be  an  important  element  in  assuming  their 
responsibilities for the safe, reliable and efficient operation of their plants. These inspection 
departments  are  normally  professionally  skilled  and  knowledgeable  and  -  through  intimate 
daily contact with the plants for which their owners are ultimately responsible - have a unique 
understanding of the service conditions to which the equipment will be exposed. 

Even  though  not  all  Member  States  had  experience  with  user  inspectorates  for  regulatory 
purposes,  a  provision  was  introduced  in  the  Pressure  Equipment  Directive,  article  14, 
allowing  some  of  these  inspection  departments  becoming  responsible  for  part  of  the 
conformity assessment of new equipment, thereby replacing and complementing the tasks of 
notified  bodies.  However,  as  various  Member  States  considered  that  the  concept  of  User 
Inspectorates was not fully compatible with the New Approach requiring the intervention of 
“independent  third  parties”,  Member  States  were  given  the  option  not  to  implement  the 
Directive as regards the provisions on user inspectorates into their national legislation. 

1 

A summary of comments is given on 
http://europa.eu.int/comm/enterprise/pressure_equipment/index_en.htm 

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In  contrast  to  Notified  Bodies,  which  “may  not  become  directly  involved  in  the  design, 
manufacture,  supply,  installation,  operation  or  maintenance  of  the  pressure  equipment  or 
assemblies”,  User  Inspectorates2  may  in  principle  be  involved  in  the  “design,  manufacture, 
supply,  installation,  operation  or  maintenance”  of  pressure  equipment,  but  they  must  not  be 
responsible for these tasks. 

Each  User  Inspectorate  “must  be  organisationally  identifiable  and  have  reporting  methods 
within  the  group  of  which  it  is  part  which  ensure  and  demonstrate  its  impartiality”  so  that 
“their independence of judgement and integrity in relation to their inspection activities” is not 
affected. Member States are responsible for the monitoring of User Inspectorates and have to 
make sure that these requirements are properly implemented. 

User  inspectorates  being  a  new  element  in  the  New  Approach,  the  Directive  requires  the 
Commission to monitor the effects of the use of use inspectorates and to present an evaluation 
three years after implementation of the Directive at national level. To this end, Member States 
are requested to forward to the Commission any useful information on the implementation of 
this article. If necessary the evaluation shall be accompanied by a proposal for amendment of 
the Pressure Equipment Directive. 

The various options that were examined with national authorities and stakeholders with regard 
to the future of the User Inspectorates were (i) to abandon the concept of User Inspectorates, 
(ii) to limit the scope of their tasks, (iii) to maintain them or (iv) to extend them. 

Safety Concerns related to conflict of interest 

At the time the Pressure Equipment Directive was developed there were some concerns that 
pressure  equipment  assessed  by  a  User  Inspectorate  may  present  higher  risk  potential 
compared  to  cases  where  a  Notified  Bodies  is  involved  in  the  conformity  assessment.  Also 
some responses received during the internet consultation suggested that the concept of User 
Inspectorates  should  be  abandoned.  However,  only  some  general  safety  concerns  were 
mentioned but not any further specified. 

Safety concerns expressed in the course of consultation process seemed to be related mainly 
to a perceived lack of independence of User Inspectorates, as they are part of the group of the 
user  of  pressure  equipment  and  can  in  principle  be  involved  in  the  design,  manufacture, 
supply, installation, operation or maintenance of pressure equipment. However, involvement 
of User Inspectorates in these tasks typically leads to higher specific competences as well. 

Both  the  public  enquiry  and  consultations  with  Member  States  showed  that  the  concept  of 
User  Inspectorates  has  been  functioning  well  and  neither  problems  nor  misbehaviour  have 
been identified. 

The  Commission  concludes  that  there  are  no  particular  safety  concerns  with  regard  to  the 
work performed by the User Inspectorates. 

2 

By way of derogation from the provisions relating to the tasks carried out by the Notified Bodies, Article 14 of the 
Pressure equipment Directive allows Member States to authorize in their territory the placing on the market, and 
the  putting  into  service  by  users,  of  pressure  equipment  or  assemblies  of  which  conformity  with  the  essential 
requirements has been assessed by a User Inspectorate. 

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Marking for equipment assessed by User Inspectorates 

In the course of the consultation process, it was proposed that User Inspectorates should, like 
Notified Bodies receive an identification number by the Commission upon notification by a 
Member  State.  Equipment  assessed  by  a  User  Inspectorates  would  then  bear  a  specific 
marking, e.g. “UI”, as opposed to the CE marking, combined with the identification number 
of the assessing User Inspectorate. Such procedure would facilitate market surveillance tasks 
of Member States and lead to more transparency. It would then be consequent to include such 
marked  equipment  in  the  scope  of  the  safeguard  clause,  Article  8,  and  unduly  affixed  CE 
marking Article 16 too. 

During the consultation process, national authorities were specifically invited to provide their 
position on this suggestion, and to communicate whether any problems linked to the absence 
of such marking had been identified. 

A  number  of  national  authorities  drew  attention  to  the  fact  that  when  pressure  equipment 
assessed by a User Inspectorate is placed on the market and put into service, it is sufficient for 
authorities to have technical data available in the documentation, without a need for a general 
marking.  Similarly,  for  second  hand  pressure  equipment  the  documentation  following  the 
product should be sufficient for assessment. Some authorities require from User Inspectorates 
notified by them to use internal specific marks to facilitate checking whether the conformity 
assessment has already taken place. 

Other authorities expressed their concerns about a possible loophole where products approved 
by a User Inspectorate, i.e. intended to be used within a particular company, would be sold to 
other  users,  a  risk  in  their  view  aggravated  if  products  were  marked.  This  argument  does 
however  not  seem  convincing,  the  more  as  marking  would  facilitate  market  surveillance  in 
verifying whether products in a given installation have been assessed by the competent User 
Inspectorate. 

Considering  all  elements,  the  Commission  concludes  that  pressure  equipment  assessed  by  a 
User  Inspectorate  is  intended  only  for  a  specific  operator  and  cannot  therefore  be  used  by 
other operators. Consequently, no specific marking is needed. This position is supported also 
by the Commission’s Working Group Pressure. 

Transposition of provisions on User Inspectorates to become mandatory 

Currently, if a Member State has not transposed Article 14 or has transposed but not notified a 
User Inspectorate, it is not obliged to accept on its territory conformity assessment performed 
by User Inspectorates notified by other Member States. 

Many respondents, mainly users and User Inspectorates, therefore suggested that all Member 
States should be obliged to transpose Article 14 on User Inspectorates and accept conformity 
assessment of all User Inspectorates, regardless of whether they have themselves designated 
User Inspectorates. In their view, large industrial user groups, often multi-national companies, 
operating across the EU can only fully benefit from their User Inspectorates and implement a 
common  safety  policy,  if  they  can  follow  the  same  conformity  assessment  procedures 
everywhere. The non-acceptance of conformity assessments carried out by User Inspectorates 
for  equipment  installed  on  the  territory  of  just  a  few  Member  States  would  be 
disproportionately  detrimental  to  the  interests  of  such  user  groups  and  their  safety  policy, 

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hindering  efficient  work  and  maintenance  of  uniform  safety  and  integrity  management 
systems. 

On the other hand, Member States that had not transposed Article 14 explained in the course 
of the consultation process that this was not done because of lack of any previous experience 
on the concept, but because it was neither considered necessary nor specific advantages were 
seen. However, even those Member States declared their readiness to revise their legislation 
in the light of experience in other Member States and requests from industry. 

The  Commission  concludes  that  it  would  be  beneficial  to  implement  the  Directive’s 
provisions on User Inspectorates in all Member States. However, making the transposition of 
the Directive’s provisions on User Inspectorates mandatory is not considered relevant enough 
so  as  to  justify  a  Commission  proposal  and  a  regulatory  procedure  involving  Council  and 
Parliament for an amendment of the Pressure Equipment Directive. 

Extension of the scope of tasks to be performed by User Inspectorates 

Originally the concept of User Inspectorates was intended only for the user groups’ internal 
purposes in order to allow the operators of technically highly complex pressure equipment to 
use the accumulated expertise within the group in the conformity assessment. Therefore, the 
conformity assessment modules available for User Inspectorates were limited. 

This  is  perceived  as  too  restrictive,  especially  by  the  User  Inspectorates.  One  third  of  the 
respondents  of  the  public  consultation  suggested  that  the  tasks  to  be  performed  by  User 
Inspectorates should be extended. 

In  the  course  of  the  consultation  process,  the  following  options  for  extending  the  scope  of 
tasks have been identified: 

Assessment of type and design 

The  conformity  assessment  procedures  that  can  be  implemented  by  User  Inspectorates  are 
modules  A1  (internal  production  control),  C1  (conformity  to  type),  F  (product  verification) 
and G (EC unit verification). The User Inspectorates act exclusively for the group of which 
they are part. 

At  first  glance  it  may  seem  illogical  that  conformity  assessment  according  to  the  design 
modules B (EC type-examination) and B1 (EC design-examination) can not be performed by 
a User Inspectorate, given that the latter may perform conformity assessment according to the 
module  G,  which  comprises  design  and  manufacture.  It  is  also  claimed  that  specialised 
knowledge  on  the  production  process  by  the  user  would  be  better  integrated  already  in  the 
design  phase  of  pressure  equipment  if  User  Inspectorates  could  do  the  related  conformity 
assessment. 

It is true that in certain cases of very complex systems, User Inspectorates could be the most 
competent  bodies  for  conformity  assessment.  However,  it  should  be  noted  that  in  practice 
conformity assessments of non-serial products with combinations of modules like B1 + F, B + 
F and B + C1 done by a (single) User Inspectorate are quite similar to conformity assessment 
with  module  G.  Therefore  there  would  be  little  added  value  of  giving  User  Inspectorates 
access to modules B and B1, if they can not carry out assessment of manufacturers’ quality 
systems at the same time as it is at present the case. 

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Moreover, modules B and B1 are mainly relevant for serially manufactured products. But the 
latter are rarely intended to be put into service by only one user group. Therefore assessment 
by a User Inspectorate is of little economic interest in this respect. 

Assessment of manufacturers’ quality systems 

In  case  of  serial  production,  manufacturers  tend  to  use  quality  systems.  Since  customer 
specific serial equipment is stated to become increasingly important for big users, is has been 
proposed that User Inspectorates could assess manufacturers’ quality systems according to the 
relevant modules (D, D1, E, E1, H and H1) of the Pressure Equipment Directive. 

As  such,  no  safety  reason  why  User  Inspectorates  could  not  be  competent  for  this  task  has 
been presented. 

However,  Member  States  considered  that  there  is  no  need  for  this  extension,  because 
manufacturers  have  normally  established  quality  systems.  Additional  assessment  by  User 
Inspectorates  would  be  duplication  of  assessments,  sometimes  possibly  only  due  to  certain 
pressure from big user groups on smaller manufacturers, without any added value. 

Approval of permanent joining procedures and qualifications of permanent joining and non-
destructive testing (NTD) personnel 

Some  respondents  of  the  web  consultation  asked  for  extension  of  the  scope  of  tasks  to  be 
performed  by  User  Inspectorates  to  cover  approval  of  permanent  joining  procedures  and 
qualifications of permanent joining and NTD personnel, claiming that User Inspectorates have 
well-established expertise concerning permanent joining (welding) and NDT. They also claim 
that  it  is  illogical  if  User  Inspectorates  are  excluded  from  approval  of  these  manufacture 
related procedures and qualifications, while they can be in charge of conformity assessment 
related  to  the  manufacture  phase;  these  restrictions  would  be  impractical  and  undermine 
efficiency. Finally, the requirement to use Notified Bodies on these aspects would not add any 
value to safety. 

The feedback from Member States’ authorities, however, clearly indicated that that there is no 
need for extension towards this direction. Most relevant personnel of manufacturers would be 
approved  by  a  third-party,  i.e.  by  a  Notified  Body  or  recognised  third  party  organisation 
anyway since manufacturers need such general approval for other customers too. Moreover; 
the  question  arises  whether  an  NDT/welding  approval  by  a  User  Inspectorate  in  the  future 
would be generally valid and could also be used for the manufacture of pressure equipment 
the conformity of which is not assessed by a User Inspectorate. 

Like for the previous points, it should be born in mind that the concept of User Inspectorates 
was introduced as a derogation for very specific purposes from the principle that conformity 
assessment, outside the internal production control module (A), are verified by third parties, 
i.e.  Notified  Bodies.  In  order  to  safeguard  this  principle,  a  clear  distinction  should  be  kept 
between User Inspectorates and Notified Bodies. Only in case of clear evidence, tasks of User 
Inspectorates would need to be widened. 

For  these  reasons,  the  Commission  concludes  that  scope  of  tasks  to  be  performed  by  User 
Inspectorates should remain confined to specific purposes of a user group and not be extended 
to cover conformity assessment for other purposes. 

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3. 

CONCLUSIONS 

The Commission notes that according to national authorities and stakeholders the concept of 
User  Inspectorates  is  functioning  well  and  in  the  intended  manner.  No  evidence  supporting 
safety concerns could be identified. It is accepted that in the light of first experiences on User 
Inspectorates  the  Directive’s  provisions  could  be  optimised  in  some  minor  points,  i.e.  by 
making  the  transposition  of  Pressure  Equipment  Directive  Article  14  mandatory.  However, 
the related benefit is not expected to be significant enough, given the administrative costs of 
an  amendment  of  the  Pressure  Equipment  Directive  on  both  national  and  EU  level  and  the 
possibility  for  Member  States  to  implement  the  provisions  on  User  Inspectorates  on  a 
voluntary basis. Hereby, the limited resources of national administrations and the Commission 
and  the  prevalence  of  other  imminent  tasks,  like  market  surveillance,  have  to  be  taken  into 
account. 

An  extension  of  the  scope  of  the  tasks  to  be  performed  by  the  User  Inspectorates  coming 
closer to the field of activities of the Notified Bodies could mix the roles of User Inspectorates 
and Notified Bodies and confuse the manufacturers e.g. in case of need for a general approval 
for products intended for all customers and for an additional assessment and approval for the 
same  type  of  product  manufactured  for  the  user  group,  which  would  present  duplication  of 
assessments. 

Furthermore,  an  extension  of  the  tasks  to  be  performed  by  the  User  Inspectorates  would 
conflict  with  the  underlying  concept  of  User  Inspectorates  originally  intended  to  allow  the 
user groups to take advantage of their technical expertise for limited internal applications, as 
opposed to external purposes or trading. Following this principle, the conformity assessment 
tasks carried out by User Inspectorates should remain limited to technically complex and in 
most  cases  individually  manufactured  products.  For  this  purpose  the  current  provisions  on 
User Inspectorates are adequate. 

Consequently,  the  Commission  considers  that  the  current  concept  of  User  Inspectorates 
corresponds  well  to  the  intended  purpose  of  these  inspection  bodies  being  part  of  the  user 
group  and  does  not  find  it  necessary  to  forward  a  proposal  for  amendment  of  the  Pressure 
Equipment Directive in connection to Article 14 of the Pressure Equipment Directive. 

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