COMMON POSITION (EC) No 1/1999 adopted by the Council on 30 November 1998 with a view to adopting Council Directive 1999/.../EC of ... on transportable pressure equipment
Date: 1998-11-30
Institutions: Council of the European Union
Subjects: EC conformity marking, dangerous substance, free movement of goods, pressure equipment, safety standard

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I

(Information)

COUNCIL

COMMON  POSITION  (EC)  No  1/1999

adopted  by  the  Council  on  30  November  1998

with  a  view  to  adopting  Council  Directive  1999/. . ./EC  of  . . .  on  transportable  pressure
equipment

(1999/C  18/01)

THE  COUNCIL  OF  THE  EUROPEAN  UNION,

Having  regard  to  the  Treaty  establishing  the  European
Community,  and  in  particular  Article  75(1)(c)  thereof,

Having  regard  to  the  proposal  from  the  Commission (1),

Having regard to the opinion of the Economic and Social
Committee (2),

Acting  in  accordance  with  the  procedure  laid  down  in
Article  189c  of  the  Treaty (3),

(1)  Whereas  within  the  framework  of  the  common
transport  policy  further  measures  must  be  adopted
to  ensure  transport  safety;

(2)  Whereas  each  Member  State  currently  requires  all
transportable equipment to be used on its territory
to  undergo  certification  and  inspection,  including

(1)  OJ  C  95,  24.3.1997,  p.  2,  and  OJ  C  186,  16.6.1998,

p.  11.

(2)  OJ  C  296,  29.9.1997,  p.  6.
(3)  Opinion  of  the  European  Parliament  of  19  February  1998
(OJ  C  80,  16.3.1998,  p.  217),  Council  common  position  of
30 November 1998 and Decision of the European Parliament
of  . . .  (not  yet  published  in  the  Official  Journal).

inspections,  by 

periodic 
its  designated  bodies;
whereas  this  practice,  requiring  multiple  approvals
if  equipment  is  to  be  used  in  more  than  one  State
in  the  course  of  a  transport  operation,  constitutes
an  obstacle  to  the  provision  of  transport  services
within  the  Community;  whereas  action  by  the
Community  to  harmonise  approval  procedures  is
justified 
the  use  of
transportable  pressure  equipment  on  the  territory
of  another  Member  State  in  the  context  of  a
transport  operation;

in  order 

facilitate 

to 

(3)  Whereas  measures  should  be  adopted  for  the
progressive  establishment  of  a  single  market  in
transport  and,  in  particular,  for  free  movement  of
transportable  pressure  equipment;

(4)  Whereas  action  at  Community  level  is  the  only
possible  way  of  achieving  such  harmonisation,
since  Member  States  acting 
independently  or
through  international  agreements  cannot  establish
the same degree of harmonisation in the approvals
for such equipment; whereas, currently, recognition
of  approvals  given  in  different  Member  States  is
not  satisfactory  because  of 
the  element  of
discretion;

(5)  Whereas  a  Council  Directive  is  the  appropriate
legal  instrument  to  enhance  the  safety  of  this

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equipment, as it provides a framework for uniform
and  compulsory  application  of 
the  approval
procedures  by  Member  States;

(6)  Whereas  Council  Directives  94/55/EC (1)  and
96/49/EC (2)  have  extended  the  application  of  the
provisions  of  the  ADR (3)  and  RID (4)  to  cover
national  traffic  in  order  to  harmonise  across  the
Community  the  conditions  under  which  dangerous
goods  are  transported  by  road  and  by  rail;

(7)  Whereas  Directives  94/55/EC  and  96/49/EC
provide  for  the  option  of  applying  conformity
in
assessment  procedures  based  on  modules 
accordance  with  Decision  93/465/EEC (5) 
to
certain  new  transportable  pressure  equipment;
whereas  this  option  should  be  replaced  by  an
obligation  extended  to  cover  all  new  transportable
pressure  equipment  used  for  the  transport  of
dangerous  goods  and  falling  within  the  scope  of
Directives  94/55/EC  and  96/49/EC;

(8)  Whereas  Directive  97/23/EC (6)  lays  down  the
general  requirements  for  the  free  movement  and
safety  of  pressure  equipment;

(9)  Whereas  aerosol  dispensers  and  gas  cylinders  for
breathing  appliances  should  be  excluded  from  the
scope  of  this  Directive  as  their  free  movement  and

(1)  Council  Directive  94/55/EC  of  21  November  1994  on  the
approximation of the laws of the Member States with regard
to  the  transport  of  dangerous  goods  by  road  (OJ  L  319,
12.12.1994,  p.  7).

(2)  Council  Directive  94/49/EC  of  23  July  1996  on  the
approximation of the laws of the Member States with regard
to  the  transport  of  dangerous  goods  by  rail  (OJ  L  235,
17.9.1996,  p.  25).

(3)  ADR:  European  Agreement  concerning  the  International

Carriage  of  Dangerous  Goods  by  Road.

(4)  RID:  Regulations  concerning  the  International  Carriage  of
Dangerous Goods by Rail as set out in Annex I to Appendix
B  of  the  amended  version  of  the  Convention  concerning  the
international  carriage  of  goods  by  rail  (COTIF).

(5)  Council  Decision  93/465/EEC  of  22  July  1993  concerning
the  modules  for  the  various  phases  of  the  conformity
assessment  procedures  and  the  rules  for  the  affixing  and  use
of  the  CE  conformity  marking,  which  are  intended  to  be
used  in  the  technical  harmonisation  directives  (OJ  L  220,
30.8.1993,  p.  23).

(6)  Directive  97/23/EC  of  the  European  Parliament  and  of  the
Council  of  29  May  1997  on  the  approximation  of  the  laws
of  the  Member  States  concerning  pressure  equipment  (OJ  L
181,  9.7.1997,  p.  1).

safety 
already 
75/324/EEC (7)  and  Directive  97/23/EC;

covered 

are 

by  Directive

the  periodic 

(10)  Whereas  recognition  of  the  approval  certificates
issued  by  the  inspection  bodies  designated  by  the
Member  States’  competent  authorities,  of  the
conformity  assessment  or  reassessment  procedures
inspection  procedures
and  of 
contributes towards removing obstacles to freedom
to  provide  transport  services;  whereas  such  an
objective  cannot  be  achieved  satisfactorily  at
another  level  by  the  Member  States;  whereas,  to
eliminate  the  element  of  discretion,  it  is  necessary
to  establish  clearly  which  procedures  should  be
followed;

establishing 

(11)  Whereas it is necessary to lay down common rules
for 
recognition  of  designation
inspection  bodies  which  ensure  compliance  with
Directives  94/55/EC  and  96/49/EC;  whereas  these
common  rules  will  have  the  effect  of  eliminating
unnecessary  costs  and  administrative  procedures
related  to  the  approval  of  the  equipment  and  of
eliminating  technical  barriers  to  trade;

(12)  Whereas, 

to  hinder 

in  order  not 

transport
operations  between  a  Member  State  and  a  third
country,  this  Directive  should  not  be  applied  to
transportable  pressure  equipment  exclusively  used
for 
transport  operations  of  dangerous  goods
between  the  territory  of  the  Community  and  that
of  third  countries;

(13)  Whereas  Member  States  have 

to  designate
inspection  bodies 
the
entitled 
conformity  assessment  or  reassessment  procedures
and  periodic  inspections;  whereas  they  must  also
ensure 
sufficiently
independent,  efficient  and  professionally  able  to
carry  out  their  appointed  tasks;

to  perform 

bodies 

such 

that 

are 

(14)  Whereas  specific  procedures  should  be  introduced
for  evaluating  the  conformity  of  new  valves  and
other  accessories  used  for  transport;

(15)  Whereas provisions should be introduced regarding
the  reassessment  of  existing  equipment,  as  defined
in  Annex  IV,  Part  II;  so  as  to  enable  this  Directive
to  be  applied  to  such  equipment;

(7)  Council  Directive  75/324/EEC  of  20  May  1975  on  the
approximation  of  the  laws  of  the  Member  States  relating  to
aerosol  dispensers  (OJ  L  147,  9.6.1975,  p.  40).  Directive  as
amended  by  Directive  94/1/EC  (OJ  L  23,  28.1.1994,  p.  28).

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the  Annexes 

(16)  Whereas  compliance  with  the  technical  provisions
of 
to  Directives  94/55/EC  and
96/49/EC  for  new  equipment  must  be  shown  by
means of the conformity assessment procedures set
I;  whereas  periodic
out 
inspections  of  existing  equipment  will  be  carried
out  according  to  the  procedures  set  out  in  Annex
IV,  Part  III;

in  Annex 

IV,  Part 

for  by  this  Directive;  whereas  a  single  procedure
should be established for all transportable pressure
equipment;

(23)  Whereas a periodic inspection procedure should be
established  for  existing  gas  cylinders  which  are  in
accordance 
84/525/EEC,
84/526/EEC  and  84/527/EEC,

Directives 

with 

(17)  Whereas  equipment  referred  to  in  this  Directive
should bear a mark to indicate its compliance with
the 
requirements  of  Directive  94/55/EC  or
96/49/EC  and  this  Directive  in  order  to  be  placed
on 
in
accordance  with  its  intended  purpose;

filled,  used  and  refilled 

the  market, 

(18)  Whereas  Member  States  must  allow  transportable
pressure equipment bearing the mark referred to in
Annex  VII  to  move  freely  on  their  territory,  to  be
placed  on  the  market,  to  be  used  in  the  course  of
in
any 
accordance  with  its  intended  purpose,  without
undergoing further assessment or having to comply
with  further  technical  requirements;

transport  operation  or 

to  be  used 

(19)  Whereas  it  is  appropriate  that  a  Member  State,
provided  it  informs  the  Commission,  should  be
able  to  take  measures  to  limit  or  prohibit  the
placing  on  the  market  and  use  of  equipment  in
cases  where  it  presents  a  particular  risk  to  safety;

(20)  Whereas  a  committee  procedure 

should  be
followed  for  amendment  of  the  Annexes  to  this
Directive and for postponing the date the Directive
is  brought  into  effect  for  certain  transportable
pressure  equipment;

(21)  Whereas provision should be made for transitional
arrangements 
to  enable  pressure  equipment,
manufactured in accordance with the national rules
in force before this Directive is brought into effect,
to  be  placed  on  the  market  and  put  into  service;

(22)  Whereas Directives 84/525/EEC (1), 84/526/EEC (2)
and  84/527/EEC (3)  on  gas  cylinders  provide  for  a
conformity  procedure  different  from  that  provided

(1)  Council  Directive  84/525/EEC  of  17  September  1984  on  the
approximation  of  the  laws  of  the  Member  States  relating  to
seamless,  steel  gas  cylinders  (OJ  L  300,  19.11.1984,  p.  1).
(2)  Council  Directive  84/526/EEC  of  17  September  1984  on  the
approximation  of  the  laws  of  the  Member  States  relating  to
seamless,  unalloyed  aluminium  and  aluminium  alloy  gas
cylinders  (OJ  L  300,  19.11.1984,  p.  20).

(3)  Council  Directive  84/527/EEC  of  17  September  1984  on  the
approximation  of  the  laws  of  the  Member  States  relating  to
welded  unalloyed  steel  gas  cylinders  (OJ  L  300,  19.11.1984,
p.  48).

HAS  ADOPTED  THIS  DIRECTIVE:

Article  1

Scope

1. The  purpose  of  this  Directive  shall  be  to  enhance
safety  with  regard  to  transportable  pressure  equipment
approved for the inland transport of dangerous goods by
road and by rail and to ensure the free movement of such
equipment  within  the  Community,  including  the  placing
on  the  market  and  repeated  putting  into  service  and
repeated  use  aspects.

2. This  Directive  shall  apply:

(a)  for  the  purpose  of  placing  on  the  market:  to  new
transportable pressure equipment as defined in Article
2;

(b) for  the  purpose  of  reassessment  of  conformity:  to
existing  transportable  pressure  equipment  as  defined
in  Article  2  which  meets  the  technical  requirements
laid  down  in  Directives  94/55/EC  and  96/49/EC;

(c)  for  repeated  use  and  periodic  inspections:

—  to  the  transportable  pressure  equipment  referred

to  in  (a)  and  (b),

—  to  existing  gas  cylinders  bearing  the  conformity
marking  laid  down  in  Directives  84/525/EEC,
84/526/EEC  and  84/527/EEC.

3. Transportable  pressure  equipment  which  was  placed
on the market before . . . (4) or, in the case of Article 18,
within  two  years  of  that  date  and  which  has  not  been
reassessed  as  to  its  conformity  with  the  requirements  of
Directives  94/55/EC  and  96/49/EC,  shall  be  outside  the
scope  of  this  Directive.

the 

4. Transportable  pressure  equipment  used  exclusively
for 
transport  of  dangerous  goods  between
Community  territory  and  third-country  territory,  carried
out  in  accordance  with  Article  6(1)  and  Article  7  of
Directive  94/55/EC  or  Article  6(1)  and  Article  7(1)  and
(2)  of  Directive  96/49/EC,  shall  be  outside  the  scope  of
this  Directive.

(4)  Date  laid  down  in  Article  17(1).

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Article  2

Definitions

For  the  purposes  of  this  Directive:

1.  ‘transportable  pressure  equipment’  means:

—  all  receptacles  (cylinders,  tubes,  pressure  drums,
cryogenic  receptacles,  bundles  of  cylinders  as
defined  in  Annex  A  to  Directive  94/55/EC),

—  all  tanks, 

including  demountable  tanks,  tank
containers  (mobile  tanks),  tanks  of  tank  wagons,
tanks  or  receptacles  of  battery  vehicles  or  battery
wagons,  tanks  of  tank  vehicles,

the  Annexes 

used  for  the  transport  of  Class  2  gases  in  accordance
with 
to  Directives  94/55/EC  and
96/49/EC  and  for  the  transport  of  certain  dangerous
substances  of  other  classes  indicated  in  Annex  VI  to
this  Directive, 
including  their  valves  and  other
accessories  used  for  transport.

This  definition  excludes  equipment  subject  to  the
general  exemption  principles  applicable  to  small
quantities and to the special cases provided for in the
Annex  to  Directive  94/55/EC  and  the  Annex  to
Directive  96/49/EC  as  well  as  aerosol  dispensers  (UN
number  1950)  and  gas  cylinders  for  breathing
appliances;

2.  ‘mark’  means  the  symbol  referred  to  in  Article  10;

3.  ‘conformity  assessment  procedures’  means 

those

procedures  set  out  in  Annex  IV,  Part  I;

4.  ‘reassessment  of  conformity’  means  the  procedure  for
subsequent assessment, at the request of the owner or
his  authorised  representative  established 
the
Community  or  of  the  holder,  of  the  conformity  of
transportable 
already
manufactured and put into service before . . . (1) or, in
the  case  of  Article  18,  within  two  years  of  that  date;

equipment 

pressure 

in 

5.  ‘notified  body’  means  an  inspection  body  designated
by  the  national  competent  authority  of  a  Member
State  in  accordance  with  Article  8  and  meeting  the
criteria  of  Annexes  I  and  II;

6.  ‘approved body’ means an inspection body designated
by  the  national  competent  authority  of  a  Member
State  in  accordance  with  Article  9  and  meeting  the
criteria  of  Annexes  I  and  III.

Article  3

Conformity  assessment  or  the  placing  on  the
Community  market  of  new  transportable  pressure
equipment

1. New  receptacles  and  new  tanks  shall  meet  the
relevant  provisions  of  Directive  94/55/EC  and  96/49/EC.
The compliance of such transportable pressure equipment
with  these  provisions  shall  be  established  by  a  notified
body  exclusively  in  accordance  with  the  conformity
assessment  procedures  set  out  in  Annex  IV,  Part  I,  and
specified  in  Annex  V.

2. New  valves  and  other  accessories  used  for  transport
shall  meet  the  relevant  provisions  of  the  Annexes  to
Directives  94/55/EC  and  96/49/EC.

in 

transportable  pressure  equipment, 

3. Valves  and  other  accessories  having  a  direct  safety
in
function 
particular  safety  valves,  valves  for  filling  and  emptying
and  cylinder  valves,  shall  be  subject  to  a  conformity
assessment  procedure  at 
least  a  stringent  as  that
undergone  by  the  receptacle  or  tank  to  which  they  are
fitted.

Such valves and other accessories used for transport may
be subject to a different conformity assessment procedure
separate  from  that  used  for  the  receptacle  or  tank.

4. Should Directive 94/55/EC and 96/49/EC not contain
any  detailed  technical  provisions  for  the  valves  and
accessories  referred  to  in  paragraph  3,  such  valves  and
accessories  must  meet  the  requirements  of  Directive
97/23/EC and, pursuant to that Directive, be subject to a
category II, III or IV conformity assessment procedure as
laid  down  in  Article  10  of  Directive  97/23/EC  according
to whether the receptacle or tank belongs to category 1, 2
or  3  as  laid  down  in  Annex  V  to  this  Directive.

5. No  Member  State  shall  prohibit,  restrict  or  impede
the  placing  on  the  market  or  putting  into  service  on  its
territory  of  transportable  pressure  equipment  referred  to
in  Article  1(2)(a)  which  complies  with  this  Directive  and
bears the relevant mark provided for in Article 10(1) and
(2).

Article  4

Conformity  assessment  for  the  placing  on  the  national
market  of  new  transportable  pressure  equipment

(1)  Date  laid  down  in  Article  17(1).

1. By  way  of  derogation  from  Article  3,  Member  States
may  authorise  on  their  territory  the  placing  on  the

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market, transport and putting into service by users, of the
receptacles — including their valves and other accessories
used  for  transport  —  covered  by  Article  1(2)(a),  the
conformity  of  which  has  been  assessed  by  an  approved
body.

2. Transportable  pressure  equipment  the  conformity  of
which  has  been  assessed  by  an  approved  body  may  not
bear  the  market  described  in  Article  10(1).

3. The  approved  body  shall  work  exclusively  for  the
group  of  which  it  is  a  member.

4. The  procedures  applicable  to  conformity  assessment
by approved bodies shall be modules A1, C1, F and G, as
described  in  Annex  IV,  Part  I.

5. The  effects  of  this  Article  shall  be  monitored  by  the
Commission  and  evaluated  as  from  . . . (1).  To  this  end,
Member  States  shall  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  this  Directive.

Article  5

Reassessment  of  conformity  for  existing  transportable
pressure  equipment

the 

1. The  conformity  of 
transportable  pressure
equipment referred to in Article 1(2)(b) with the relevant
provisions  of  the  Annexes  to  Directives  94/55/EC  and
96/49/EC  shall  be  established  by  a  notified  body  in
accordance  with  the  conformity  reassessment  procedure
set  out  in  Annex  IV,  Part  II,  to  this  Directive.

Where  such  equipment  was  manufactured  in  series,
Member  States  may  authorise  the  reassessment  of
conformity  with  regard  to  receptacles,  including  their
valves  and  other  accessories  used  for  transport,  to  be
carried  out  by  an  approved  body  provided 
that
conformity  of  the  type  is  reassessed  by  a  notified  body.

2. No  Member  States  shall  prohibit,  restrict  or  impede
the  placing  on  the  market  or  putting  into  service  on  its
territory  of  transportable  pressure  equipment  referred  to
in  Article  1(2)(b)  which  complies  with  this  Directive  and
bears  the  relevant  mark  provided  for  in  Article  10(1).

Article  6

Periodic  inspection  and  repeated  use

1. Periodic inspections of the receptacles, including their
valves  and  accessories  used  for  transport,  referred  to  in

Article  1(2)(c)  shall  be  arranged  by  a  notified  or
approved  body  in  accordance  with  the  procedure  set  out
in  Annex  IV,  Part  III.  Periodic  inspections  of  tanks,
including  their  valves  and  other  accessories  used  for
transport,  shall  be  arranged  by  a  notified  body  in
accordance  with  the  procedure  laid  down  in  Annex  IV,
Part  III,  module  1.

However, Member States may permit periodic inspections
of  tanks  carried  out  on  their  territory  also  to  be
performed  by  the  approved  bodies  which  have  been
recognised  for  carrying  out  periodic  inspections  of  tanks
and  which  act  under  the  supervision  of  a  body  notified
under  the  procedure  provided  for  in  Annex  IV,  Part  III,
Module 2 concerning periodic inspection through quality
assurance.

2. The  transportable  pressure  equipment  referred  to  in
Article  1(2)  may  be  subjected  to  periodic  inspection  in
any  Member  State.

3. No  Member  State  may,  on  grounds  concerning
transportable  pressure  equipment  as  such,  prohibit,
restrict  or  impede  the  use  (including  filling,  storing,
emptying  and  refilling)  on  its  territory  of  the  following
transportable  pressure  equipment:

—  the  equipment  referred  to  in  Article  1(2)(a)  and  (b)
and  the  first  indent  of  Article  1(2)(c),  which  satisfies
the  provisions  of  this  Directive  and  bears  the
corresponding  mark,

—  existing  gas  cylinders  bearing  the  conformity  mark
provided  for  in  Directives  84/525/EEC,  84/526/EEC
and  84/527/EEC  and  the  mark  and  identification
number  referred  to  in  Article  10(3)  of  this  Directive
indicating  that  it  has  undergone  periodic  inspection.

the  storage  or  use  of 

4. Member  States  may  establish  national  requirements
for 
transportable  pressure
equipment,  but  not  for  transportable  pressure  equipment
itself  or  for  the  accessories  needed  during  transport.
Member  States  may,  however,  pursuant  to  Article  7,
retain  national  requirements  for  connecting  devices,
colour  codes  and  reference  temperatures.

Article  7

National provisions

1. A  Member  State  may  retain  its  national  provisions
concerning  devices  intended  for  connection  with  other
equipment  and  colour  codes  applicable  to  transportable
pressure  equipment  until  such 
time  as  European
standards  for  use  are  added  to  the  Annexes  to  Directives
94/55/EC  and  96/49/EC.

(1)  Three  years  after  the  date  laid  down  in  Article  17(1).

However,  where  safety  problems  arise  with  the  transport
or  use  of  certain  types  of  gas,  a  short  transitional  period

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may  be  allowed,  in  accordance  with  the  procedure  laid
down  in  Article  15,  in  order  to  enable  Member  States  to
retain  their  national  provisions  even  after  the  European
standards  have  been  added  to  the  Annexes  to  Directives
94/55/EC  and  96/49/EC.

2. A Member State in which the ambient temperature is
regularly lower than − 20 °C may impose more stringent
standards  as  regards  the  operating  temperature  of
material  intended  for  use  in  the  national  transport  of
dangerous  goods  within  its  territory  until  provisions  on
the  appropriate  reference  temperatures  for  given  climatic
zones  are  incorporated  in  the  Annexes  to  Directives
94/55/EC  and  96/49/EC.

Article  8

Notified  bodies

1. Member States shall communicate to the Commission
and  the  other  Member  States  the  list  of  notified  bodies
established  within  the  Community  which  they  have
designated  to  carry  out  the  new  transportable  pressure
equipment conformity assessment procedures pursuant to
Annex  IV,  Part  I,  to  reassess  the  conformity  of  existing
types or equipment with the requirements of the Annexes
to  Directives  94/55/EC  and  96/49/EC  pursuant  to  Annex
IV,  Part  II,  and/or  to  perform  the  task  of  periodic
inspections  pursuant  to  Annex  IV,  Part  III,  module  1
and/or  to  perform  the  task  of  surveillance  pursuant  to
III,  module  2.  They  shall  also
Annex 
communicate the identification numbers assigned to them
beforehand  by  the  Commission.

IV,  Part 

The  Commission  shall  publish  in  the  Official  Journal  of
the  European  Communities  a  list  of  the  notified  bodies,
with their identification numbers and the tasks for which
they  have  been  notified.  The  Commission  shall  ensure
that  this  list  is  kept  up  to  date.

2. Member  States  shall  apply  the  criteria  set  out  in
Annexes  I  and  II  for  the  designation  of  notified  bodies.
Each  body  shall  submit  to  the  Member  State  which
intends  to  designate  it  complete  information  concerning,
and  evidence  of,  compliance  with  the  criteria  in  Annexes
I  and  II.

3. A  Member  State  which  has  notified  a  body  shall
withdraw  such  notification  if  it  finds  that  the  body  no
longer  meets  the  criteria  referred  to  in  paragraph  2.

It  shall  forthwith  inform  the  Commission  and  the  other
Member  States  of  any  such  withdrawal  of  notification.

Article  9

Approved  bodies

1. Member States shall communicate to the Commission
and  the  other  Member  States  the  list  of  approved  bodies

in 

the  Community,  which 

established 
they  have
recognised in accordance with the criteria of paragraph 2,
for  the  purpose  of  carrying  out  periodic  inspections  of
receptacles — including their valves and other accessories
used  for  transport  —  referred  to  in  Article  2(1),  first
indent, or conformity reassessment of existing receptacles
—  including  their  valves  and  other  accessories  used  for
transport  —  which  conform  to  a  type  reassessed  by  a
notified  body,  to  ensure  continued  compliance  with  the
relevant  provisions  of  Directives  94/55/EC  and  96/49/EC
in  accordance  with  the  procedures  laid  down  in  Annex
IV,  Part  III,  module  1.  They  shall  also  communicate  the
identification  numbers  assigned  to  them  beforehand  by
the  Commission.

Member  States  using  the  option  provided  for  in  Article
6(1), second subparagraph, shall also communicate to the
Commission  and  the  other  Member  States  the  list  of
approved  bodies  established  in  the  Community,  which
they  have  recognised  for  the  purpose  of  carrying  out
periodic  inspections  of  tanks.

The  Commission  shall  publish  in  the  Official  Journal  of
the  European  Communities  a  list  of  the  approved  bodies
recognised,  with  their  identification  numbers  and  the
tasks 
they  have  been  recognised.  The
Commission  shall  ensure  that  this  list  is  kept  up  to
date.

for  which 

2. Member  States  shall  apply  the  criteria  set  out  in
Annexes I and III for the recognition of approved bodies.
Each  body  shall  submit  to  the  Member  State  which
intends  to  recognise  it  complete  information  concerning,
and  evidence  of,  compliance  with  the  criteria  in  those
Annexes.

3. A  Member  State  which  has  recognised  a  body  shall
withdraw the approval if it finds that the body no longer
meets  the  criteria  referred  to  in  paragraph  2.

It  shall  forthwith  inform  the  Commission  and  the  other
Member  States  of  any  such  withdrawal  of  approval.

Article  10

Marking

1. Without  prejudice  to  the  requirements  for  the
marking of receptacles and tanks laid down in Directives
94/55/EC  and  96/49/EC,  receptacles  and  tanks  satisfying
the provisions of Article 3(1) and Article 5(1) shall have a
mark affixed to them in accordance with Annex IV, Part
I.  The  form  of  the  mark  to  be  used  is  set  out  in  Annex
VII.  This  mark  shall  be  visibly  and  immovably  affixed
and shall be accompanied by the identification number of
the  notified  body  which  has  performed  the  conformity
assessment procedure on the receptacles and tanks. In the
event of reassessment, this mark shall be accompanied by
the  identification  number  of  the  notified  or  approved
body.

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For  transportable  pressure  equipment  complying  with
Article  7(2),  the  identification  number  of  the  notified  or
approved  body  shall  be  followed  by  ‘−  40  °C’.

2. New  valves  and  other  accessories  having  a  direct
safety function shall bear either the mark provided for in
Annex  VII  hereto  or  that  provided  for  in  Annex  VI  to
Such  marks  need  not  be
Directive  97/23/EC. 
accompanied by the identification number of the notified
body which carried out the conformity assessment on the
valves  and  other  accessories  used  for  transport.

The  other  valves  and  accessories  shall  not  be  subject  to
any  special  marking  requirements.

3. Without  prejudice  to  the  requirements  for  the
marking of receptacles and tanks laid down in Directives
94/55/EC  and  96/49/EC,  for  the  purposes  of  periodic
inspections, all transportable pressure equipment referred
to  in  Article  6(1)  shall  bear  the  identification  number  of
the  body  which  performed  the  periodic  inspection  of  the
equipment  to  indicate  that  it  may  continue  to  be  used.

With  regard  to  gas  cylinders  covered  by  Directives
84/525/EEC,  84/526/EEC  and  84/527/EEC,  when  the
first periodic inspection is carried out in accordance with
this  Directive,  the  aforementioned  identification  number
shall  be  preceded  by  the  mark  described  in  Annex  VII.

4. For both conformity assessment and reassessment and
for  periodic  inspections,  the  identification  number  of  the
notified or approved body shall be visibly and immovably
affixed under its responsibility either by the body itself or
by  the  manufacturer,  or  his  authorised  representative
established  within  the  Community,  or  by  the  owner  or
his 
the
Community,  or  by  the  holder.

representative 

established 

authorised 

in 

5. The  affixing  of  markings  on  transportable  pressure
equipment  which  are  likely  to  mislead  third  parties  with
regard  to  the  meaning  or  the  graphics  of  the  mark
referred to in this Directive shall be prohibited. Any other
marking  may  be  affixed  to  equipment  provided  that  the
visibility and legibility of the marking in Annex VII is not
thereby  reduced.

Article  11

Safeguard clause

restrict  or  prohibit  the  placing  on  the  market,  transport
or use of the equipment in question or have it withdrawn
from  the  market  or  from  circulation.  It  shall  forthwith
inform  the  Commission  of  any  such  measure,  indicating
the  reasons  for  its  decision.

2. The  Commission  shall  enter  into  consultation  with
the  parties  concerned  without  delay.  Where 
the
Commission  considers,  after  this  consultation,  that  the
measure  is  justified,  it  shall  immediately  so  inform  the
Member  State  which  took  the  initiative  and  the  other
Member  States.

Where the Commission considers, after this consultation,
that  the  measure  is  unjustified,  it  shall  immediately  so
inform  the  Member  State  which  took  the  initiative  and
the  owner  or  his  authorised  representative  established  in
the Community or the holder, or the manufacturer or his
authorised 
the
Community.

established  within 

representative 

3. Where  transportable  pressure  equipment  which  does
not comply bears the marking provided for in Article 10,
the  competent  Member  State  shall  take  appropriate
action against the person(s) who affixed the marking and
shall  so  inform  the  Commission  and  the  other  Member
States.

4. The Commission shall ensure that the Member States
are  kept  informed  of  the  progress  and  outcome  of  this
procedure.

Article  12

Undue  marking

Without  prejudice  to  Article  11,  where  a  Member  State
establishes  that  the  marking  described  in  Annex  VII  has
been  affixed  unduly,  the  owner  or  his  authorised
representative  established  in  the  Community  or  the
holder,  or 
the  manufacturer  or  his  authorised
representative established within the Community, shall be
obliged  to  make  the  transportable  pressure  equipment
the
conform  as  regards 
marking  and 
the
to  end 
conditions  imposed  by  the  Member  State.

the  provisions  concerning 
infringement  under 

the 

Should  non-conformity  persist,  the  Member  State  shall
take  all  appropriate  measures  to  restrict  or  prohibit  the
placing on the market, transport or use of the equipment
on  question  or  to  ensure  that  it  is  withdrawn  from  the
market  or  from  circulation  in  accordance  with  the
procedure  laid  down  in  Article  11.

1. Where  a  Member  State  finds  that  transportable
pressure  equipment,  when  correctly  maintained  and  used
for  its  intended  purpose,  is  liable  to  endanger  the  health
and/or  safety  of  persons  and,  where  appropriate,
domestic  animals  or  property,  during  transport  and/or
use, notwithstanding the fact that it bears a mark, it may

Article  13

Decisions  leading  to  refusal  or  restriction

Any  decision  taken  pursuant  to  this  Directive  which  has
the  effect  of  restricting  the  placing  on  the  market,

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transport  or  use  or  requires  the  withdrawal  from  the
market  or  from  circulation  of  transportable  pressure
equipment  shall  state  the  exact  grounds  on  which  it  is
based.  Such  Decision  shall  not  notified  forthwith  to  the
party concerned, who shall at the same time be informed
of  the  legal  remedies  available  to  him  under  the  laws  in
the  Member  State  concerned  and  of  the  time  limits  to
which  such  remedies  are  subject.

Article  14

Committee

Article  16

Adoption  and  publication

1. Member  States  shall  adopt  and  publish  the  laws,
regulations  and  administrative  provisions  necessary  to
comply  with  this  Directive  no  later  than  . . . (1).  They
shall  forthwith  inform  the  Commission  thereof.

When  Member  States  adopt  those  measures  they  shall
contain  a  reference  to  this  Directive  or  shall  be
accompanied  by  such  reference  on  the  occasion  of  their
official  publication.  The  methods  of  making  such
reference  shall  be  laid  down  by  the  Member  States.

The  amendments  necessary  for  adapting  the  Annexes  to
this  Directive  shall  be  adopted  in  accordance  with  the
procedure  laid  down  in  Article  15.

2. Member States shall communicate to the Commission
the  texts  of  the  main  provisions  of  national  law  which
they  adopt  in  the  field  governed  by  this  Directive.

Article  15

Article  17

Implementation

1. Where  reference  is  made  to  the  procedure  provided
for  in  this  Article,  the  Commission  shall  be  assisted  by
the  Committee  on  the  transport  of  dangerous  goods  set
up  under  Article  9  of  Directive  94/55/EC,  hereinafter
referred 
composed  of
representatives  of  the  Member  States  and  chaired  by  a
representative  of  the  Commission.

‘the  Committee’, 

as 

to 

2. The representative of the Commission shall submit to
the  Committee  a  draft  of  the  measures  to  be  taken.  The
Committee  shall  deliver  its  opinion  on  the  draft  within  a
time  limit  which  the  chairman  may  lay  down  according
to  the  urgency  of  the  matter.  The  opinion  shall  be
delivered  by  the  majority  laid  down  in  Article  148(2)  of
the  Treaty  in  the  case  of  decisions  which  the  Council  is
required  to  adopt  on  a  proposal  from  the  Commission.
The  votes  of  the  representatives  of  the  Member  States
within the Committee shall be weighted in the manner set
out  in  that  Article.  The  chairman  shall  not  vote.

3. The  Commission  shall  adopt  the  measures  envisaged
if  they  are  in  accordance  with  the  opinion  of  the
Committee.

If  the  measures  envisaged  are  not  in  accordance  with  the
opinion  of  the  Committee,  or  if  no  opinion  is  delivered,
the  Commission  shall,  without  delay,  submit  to  the
Council  a  proposal  relating  to  the  measures  to  be  taken.
The  Council  shall  act  by  a  qualified  majority.

If  within  three  months  of  the  date  of  referral  to  the
Council  the  Council  has  not  acted,  the  proposed
measures  shall  be  adopted  by  the  Commission.

1. Member  States  shall  adopt  no  later  than  . . . (2)  the
provisions  which  they  have  adopted  to  comply  with  this
Directive  to  transportable  pressure  equipment.

2. The  date  referred  to  in  paragraph  1  shall  be  deferred
for  certain  transportable  pressure  equipment  for  which
there are no detailed technical specifications or for which
adequate  reference  to  the  relevant  European  standards
has  not  been  added  to  the  Annexes  to  Directives
94/55/EC  and  96/49/EC.

The  equipment  concerned  by  any  such  deferral  and  the
date  on  which  this  Directive  becomes  applicable  to  it
shall be determined in accordance with the procedure laid
down  in  Article  15.

Article  18

Transitional arrangements

into  service  of 

Member  States  shall  authorise  the  placing  on  the  market
and  putting 
transportable  pressure
equipment  which  complies  with  the  regulations  in  force
within their territory before . . . (3)  until  24  months  from
that  date  and  shall  authorise  the  subsequent  putting  into
service  of  such  equipment  placed  on  the  market  prior  to
that  date.

(1)  18  months  from  the  date  of  entry  into  force  of  this

Directive.

(2)  Two  years  as  from  the  date  of  entry  into  force  of  this
Directive,  or,  1  July  2001,  if  the  latter  date  falls  later  than
the  former.

(3)  Date  as  laid  down  in  Article  17(1).

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Article  19

Penalties

Member  States  shall  lay  down  a  system  of  penalties  for
breaches  of  the  national  provisions  adopted  pursuant  to
this Directive and shall take all the measures necessary to
ensure that those penalties are applied. The penalties thus
for  shall  be  effective,  proportionate  and
provided 
dissuasive.

Member  States  shall  notify  the  relevant  provisions  to  the
Commission  not  later  than  . . . (1)  and  shall  inform  it  of
any  subsequent  changes  as  soon  as  possible.

The  provisions  of  Directive  76/767/EEC (3)  shall  no
longer  apply  from  . . . (4)  or,  in  the  case  of  Article  18,
within  two  years  of  that  date,  for  transportable  pressure
equipment  falling  within  the  scope  of  this  Directive.

However, EEC pattern approval certificates for cylinders,
issued  pursuant  to  Directives  84/525/EEC,  84/526/EEC
and  84/527/EEC  shall  be  recognised  as  equivalent  to  the
EC  type-examination  certificates  provided  for  in  this
Directive.

Article  21

This  Directive  shall  enter  into  fore  on  the  day  of  its
publication  on  the  Official  Journal  of  the  European
Communities.

Article  20

Article  22

Applicability  of  provisions  of  other  Directives

This  Directive  is  addressed  to  the  Member  States.

As  from  . . . (2)  or,  in  the  case  of  Article  18,  within  two
years  of  the  date,  the  only  provisions  of  Directives
84/525/EEC,  84/526/EEC  and  84/527/EEC  to  remain
applicable shall be those of Article 1 and those of Annex
I,  Parts  1  to  3,  of  each  of  those  Directives.

Done  at  . . .

For  the  Council

The  President

(1)  18  months  from  the  date  of  entry  into  force  of  this

Directive.

(2)  Date  as  laid  down  in  Article  17(1).

(3)  Council  Framework  Directive  76/767/EEC  of  27  July  1976
on  the  approximation  of  the  laws  of  the  Member  States
relating  to  common  provisions  for  pressure  vessels  and
methods  of  inspecting  them  (OJ  L  262,  27.9.1976,  p.  153).
Directive  as  last  amended  by  the  1994  Act  of  Accession.

(4)  Date  laid  down  in  Article  17(1).

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ANNEX  I

MINIMUM  CRITERIA  TO  BE  MET  BY  NOTIFIED  OR  APPROVED  BODIES,  AS  REFERRED  TO  IN
ARTICLES  8  AND  9

1.  A  notified  inspection  body  or  an  approved  inspection  body  that  is  part  of  an  organisation  involved  in

functions  other  than  inspection  must  be  identifiable  within  that  organisation.

2.  The  inspection  body  and  its  staff  must  not  engage  in  any  activities  that  may  conflict  with  their
independence of judgment and integrity in relation to their inspection activities. In particular the staff of
the inspection body must be free from any commercial, financial and other pressures which might affect
their  judgment,  particularly  from  persons  or  organisations  external  to  the  inspection  body  with  an
interest in the results of inspections carried out. the impartiality of the inspection staff of the body must
be  guaranteed.

3.  The  inspection  body  must  have  at  its  disposal  the  necessary  staff  and  possess  the  necessary  facilities  to
enable it to perform the technical and administrative tasks connected with the inspection and verification
operations  properly.  It  must  also  have  access  to  the  equipment  required  to  perform  special
verifications.

4.  The staff of the inspection body who are responsible for inspection must have appropriate qualifications,
sound  technical  and  vocational  training  and  a  satisfactory  knowledge  of  the  requirements  of  the
inspections  to  be  carried  out  and  adequate  experience  of  such  operations.  In  order  to  guarantee  a  high
level  of  safety  the  inspection  body  must  be  in  a  position  to  provide  expertise  in  the  field  of  safety  of
transportable pressure equipment. The staff must have the ability to make professional judgments as to
conformity  with  general  requirements  using  examination  results  and  to  report  thereon.  They  must  also
have  the  ability  required  to  draw  up  the  certificates,  records  and  reports  to  demonstrate  that  the
inspections  have  been  carried  out.

5.  They  must  also  have  relevant  knowledge  of  the  technology  used  for  the  manufacturing  of  the
transportable  pressure  equipment,  including  accessories,  which  they  inspect,  of  the  way  in  which  the
equipment submitted to their inspections is used or is intended to be used, and of the defects which may
occur  during  use  or  in  service.

6.  The  inspection  body  and  its  staff  must  carry  out  the  assessments  and  verifications  with  the  highest
degree  of  professional  integrity  and  technical  competence.  The  inspection  body  must  ensure  the
confidentiality  of  information  obtained  in  the  course  of  its  inspection  activities.  Proprietary  rights  must
be  protected.

7.  The remuneration of persons engaged in inspection activities must not directly depend on the number of

inspections  carried  out  and  in  no  case  on  the  results  of  such  inspections.

8.  The inspection body must have adequate liability insurance unless its liability is assumed by the State in

accordance  with  national  laws  or  by  the  organisation  of  which  it  forms  a  part.

9.  The inspection body must itself normally perform the inspections which it contracts to undertake. When
a  inspection  body  sub-contracts  any  part  of  the  inspection,  it  must  ensure  and  be  able  to  demonstrate
that  its  sub-contractor  is  competent  to  perform  the  service  in  question  and  must  take  full  responsibility
for  that  sub-contracting.

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ANNEX  II

SUPPLEMENTARY  CRITERIA  TO  BE  MET  BY  THE  NOTIFIED  BODIES  REFERRED  TO  IN
ARTICLE  8

1.  A  notified  body  must  be  independent  of  the  parties  involved  and  therefore  provide  ‘third  party’

inspection services.

The  notified  body  and  its  staff  responsible  for  carrying  out  the  inspection  must  not  be  the  designer,
manufacturer,  supplier,  purchaser,  owner,  holder,  user  or  maintainer  of  the  transportable  pressure
equipment,  including  accessories,  which  that  body  inspects,  nor  the  authorised  representative  of  any  of
these parties. They must not be directly involved in the design, manufacture, marketing or maintenance
of the transportable pressure equipment, including accessories, nor represent the parties engaged in these
activities.  This  does  not  preclude  the  possibility  of  exchanges  of  technical  information  between  the
manufacturer  of  transportable  pressure  equipment  and  the  inspection  body.

2.  All  interested  parties  must  have  access  to  the  services  of  the  inspection  body.  There  must  be  no  undue
financial or other conditions. The procedures under which the body operates must be administered in a
non-discriminatory manner.

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ANNEX  III

SUPPLEMENTARY  CRITERIA  TO  BE  MET  BY  THE  APPROVED  BODIES  REFERRED  TO  IN
ARTICLE  9

1.  The approved body must form a separate and identifiable part of an organisation involved in the design,

manufacture,  supply,  use  or  maintenance  of  the  items  it  inspects.

2.  The approved body must not become directly involved in the design, manufacture, supply or use of the

transportable  pressure  equipment,  including  accessories  inspected,  or  similar  competitive  items.

3.  There  must  be  a  clear  separation  of  the  responsibilities  of  the  inspection  staff  from  those  of  the  staff
employed  in  the  other  functions,  which  must  be  established  by  organisational  identification  and  the
reporting  methods  of  the  inspection  body  within  the  parent  organisation.

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ANNEX  IV

PART  I

CONFORMITY  ASSESSMENT  PROCEDURES

Module  A  (internal  production  control)

1.  This  module  describes  the  procedure  whereby  the  manufacturer,  or  his  authorised  representative
established  within  the  Community  who  carries  out  the  obligations  laid  down  in  point  2,  ensures  and
declares that transportable pressure equipment satisfies the requirements of the Directive which apply to
it. The manufacturer, or his authorised representative established within the Community, must affix the
Π  marking  to  all  transportable  pressure  equipment  and  draw  up  a  written  declaration  of  conformity.

2.  The  manufacturer  must  draw  up  the  technical  documentation  described  in  point  3  and  either  the
manufacturer  or  his  authorised  representative  established  within  the  Community  must  keep  it  at  the
disposal  of  the  relevant  national  authorities  for  inspection  purposes  for  a  period  of  10  years  after  the
last  of  the  transportable  pressure  equipment  has  been  manufactured.  Where  neither  the  manufacturer
nor  his  authorised  representative  is  established  within  the  Community,  the  obligation  to  keep  the
technical  documentation  available  is  the  responsibility  of  the  person  who  places  the  transportable
pressure  equipment  on  the  Community  market.

3.  The  technical  documentation  must  enable  an  assessment  to  be  made  of  the  conformity  of  the
transportable  pressure  equipment  with  the  requirements  of  the  Directive  which  apply  to  it.  It  must,  as
far as is relevant for such assessment, cover the design, manufacture and operation of the transportable
pressure  equipment  and  contain:

—  a  general  description  of  the  transportable  pressure  equipment,

—  conceptual  design  and  manufacturing  drawings  and  diagrams  of  components,  sub-assemblies,

circuits, etc.,

—  descriptions and explanations necessary for an understanding of the said drawings and diagrams and

the  operation  of  the  transportable  pressure  equipment,

—  a  description  of  the  solutions  adopted  to  meet  the  requirements  of  the  Directive,

—  results  of  the  design  calculations,  examinations  carried  out,  etc.,

—  test  reports.

4.  The manufacturer, or his authorised representative established within the Community, must keep a copy

of  the  declaration  of  conformity  with  the  technical  documentation.

5.  The  manufacturer  must  take  all  measures  necessary  to  ensure  that  the  manufacturing  process  requires
the manufactured transportable pressure equipment to comply with the technical documentation referred
to  in  point  2  and  with  the  requirements  of  the  Directive  which  apply  to  it.

Module  A1  (internal  manufacturing  checks  with  monitoring  of  the  final  assessment)

In  addition  to  the  requirements  of  module  A,  the  following  applies.

Final assessment must be performed by the manufacturer and monitored by means of unexpected visits by a
notified  body  chosen  by  the  manufacturer.

During  such  visits,  the  notified  body  must:

—  ensure  that  the  manufacturer  actually  performs  final  assessment,

—  take  samples  of  transportable  pressure  equipment  at  the  manufacturing  or  storage  premises  in  order  to
conduct checks. The notified body assesses the number of items of equipment to sample and whether it
is  necessary  to  perform,  or  have  performed,  all  or  part  of  the  final  assessment  of  the  equipment
samples.

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Should one or more of the items of transportable pressure equipment not conform, the notified body must
take  appropriate  measures.

On the responsibility of the notified body, the manufacturer must affix that body’s identification number to
each  item  of  transportable  pressure  equipment.

Module  B  (EC  type-examination)

1.  This  module  describes  the  part  of  the  procedure  by  which  a  notified  body  ascertains  and  attests  that  a
representative example of the production envisaged meets the provisions of the Directive which apply to
it.

2.  The  application  for  EC  type-examination  must  be  lodged  by  the  manufacturer  or  by  his  authorised

representative  established  within  the  Community  with  a  single  notified  body  of  his  choice.

The  application  include:

—  the  name  and  address  of  the  manufacturer  and,  if  the  application  is  lodged  by  the  authorised

representative  established  within  the  Community,  his  name  and  address  as  well,

—  a  written  declaration  that  the  same  application  has  not  been  lodged  with  any  other  notified  body,

—  the  technical  documentation  described  in  point  3.

The applicant must place at the disposal of the notified body a representative example of the production
envisaged,  hereinafter  called  ‘type’.  The  notified  body  may  request  further  examples  should  the  test
programme  so  require.

A  type  may  cover  several  versions  of  transportable  pressure  equipment  provided  that  the  differences
between  the  versions  do  not  affect  the  level  of  safety.

3.  The  technical  documentation  must  enable  an  assessment  to  be  made  of  the  conformity  of  the
transportable  pressure  equipment  with  the  requirements  of  the  Directive  which  apply  to  it.  It  must,  as
far as is relevant for such assessment, cover the design, manufacture and operation of the transportable
pressure  equipment  and  contain:

—  a  general  description  of  the  type,

—  conceptual  design  and  manufacturing  drawings  and  diagrams  of  components,  sub-assemblies,

circuits, etc.,

—  descriptions and explanations necessary for an understanding of the said drawings and diagrams and

the  operation  of  the  transportable  pressure  equipment,

—  a  description  of  the  solutions  adopted  to  meet  the  essential  requirements  of  the  Directive,

—  results  of  the  design  calculations  made,  examinations  carried  out,  etc.,

—  test  reports,

—  information  concerning  the  tests  provided  for  in  manufacture,

—  information  concerning  the  qualifications  or  approvals.

4.  The  notified  body  must:

4.1.  examine  the  technical  documentation,  verify  that  the  type  has  been  manufactured  in  conformity
with  it  and  identify  the  components  designed  in  accordance  with  the  relevant  provisions  of  the
Directive.

In  particular,  the  notified  body  must:

—  examine  the  technical  documentation  with  respect  to  the  design  and  the  manufacturing

procedures,

—  assess the materials used where these are not in conformity with the relevant provisions of the

Directive  and  check  the  certificate  issued  by  the  materials  manufacturer,

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—  approve  the  procedures  for  the  permanent  joining  of  pressure  equipment  parts  or  check  that

they  have  been  previously  approved,

—  verify  that  the  staff  undertaking  the  permanent  joining  of  pressure  equipment  parts  and  the

non-destructive  tests  are  qualified  or  approved,

4.2.  perform or have performed the appropriate examinations and necessary tests to establish whether

the  solutions  adopted  by  the  manufacturer  meet  the  requirements  of  the  Directive;

4.3.  perform or have performed the appropriate examinations and necessary tests to establish whether

the  relevant  provisions  of  the  Directive  have  been  applied;

4.4.  agree with the applicant the location where the examinations and necessary tests are to be carried

out.

5.  Where the type satisfies the provisions of the Directive which apply to it, the notified body must issue an
EC type-examination certificate to the applicant. The certificate, which should be valid for 10 years and
be  renewable,  must  contain  the  name  and  address  of  the  manufacturer,  the  conclusions  of  the
examination  and  the  necessary  data  for  identification  of  the  approved  type.

A list of the relevant parts of the technical documentation must be annexed to the certificate and a copy
kept  by  the  notified  body.

If  the  notified  body  refuses  to  issue  an  EC  type-examination  certificate  to  the  manufacturer  or  to  his
authorised representative established within the Community, that body must provide detailed reasons for
such  refusal.  Provision  must  be  made  for  an  appeals  procedure.

6.  The applicant must inform the notified body that holds the technical documentation concerning the EC
type-examination certificate of all modifications to the approved transportable pressure equipment; these
are  subject  to  additional  approval  where  they  may  affect  conformity  with  the  requirements  of  the
Directive or the prescribed conditions for use of the equipment. This additional approval must be given
in  the  form  of  an  addition  to  the  original  EC  type-examination  certificate.

7.  Each  notified  body  must  communicate  to  the  Member  States  the  relevant  information  concerning  EC

type-examination  certificates  which  it  has  withdrawn,  and,  on  request,  those  it  has  issued.

Each  notified  body  must  also  communicate  to  the  other  notified  bodies  the  relevant  information
concerning  the  EC  type-examination  certificates  it  has  withdrawn  or  refused.

8.  The  other  notified  bodies  may  receive  copies  of  the  EC  type-examination  certificates  and/or  their
additions.  The  annexes  to  the  certificates  must  be  held  at  the  disposal  of  the  other  notified  bodies.

9.  The  manufacturer,  or  his  authorised  representative  established  within  the  Community,  must  keep  with
the technical documentation copies of EC type-examination certificates and their additions for a period
of  10  years  after  the  last  of  the  transportable  pressure  equipment  has  been  manufactured.

Where  neither  the  manufacturer  nor  his  authorised  representative  is  established  within  the  Community,
the  obligation  to  keep  the  technical  documentation  available  is  the  responsibility  of  the  person  who
places  the  product  on  the  community  market.

Module  B1  (EC  design  examination)

1.  This module describes the part of the procedure whereby a notified body ascertains and attests that the
design of an item of transportable pressure equipment meets the provisions of the Directive which apply
to  it.

2.  The  manufacturer,  or  his  authorised  representative  established  within  the  Community,  must  lodge  an

application  for  EC  design  examination  with  a  single  notified  body.

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The  application  must  include:

—  the  name  and  address  of  the  manufacturer  and,  if  the  application  is  lodged  by  the  authorised

representative  established  within  the  Community,  his  name  and  address  as  well,

—  a  written  declaration  that  the  same  application  has  not  been  lodged  with  any  other  notified  body,

—  the  technical  documentation  described  in  point  3.

The  application  may  cover  several  versions  of  the  transportable  pressure  equipment  provided  that  the
differences  between  the  versions  do  not  affect  the  level  of  safety.

3.  The  technical  documentation  must  enable  an  assessment  to  be  made  of  the  conformity  of  the
transportable  pressure  equipment  with  the  requirements  of  the  Directive  which  apply  to  it.  It  must,  as
far as is relevant for such assessment, cover the design, manufacture and operation of the transportable
pressure  equipment  and  contain:

—  a  general  description  of  the  equipment  in  question,

—  conceptual  design  and  manufacturing  drawings  and  diagrams  of  components,  sub-assemblies,

circuits, etc.,

—  descriptions and explanations necessary for an understanding of the said drawings and diagrams and

the  operation  of  the  equipment,

—  a  description  of  the  solutions  adopted  to  meet  the  requirements  of  the  Directive,

—  the  necessary  supporting  evidence  for  the  adequacy  of  the  design  solution;  this  supporting  evidence
must include the results of tests carried out by the appropriate laboratory of the manufacturer or on
his  behalf,

—  results  of  the  design  calculations  made,  examinations  carried  out,  etc.;

—  information  regarding  qualifications  or  approvals.

4.  The  notified  body  must:

4.1.  examine  the  technical  documentation  and  identify  the  components  which  have  been  designed  in

accordance  with  the  relevant  provisions  of  the  Directive.

In  particular,  the  notified  body  must:

—  assess the materials used where these are not in conformity with the relevant provisions of the

Directive,

—  approve  the  procedures  for  the  permanent  joining  of  pressure  equipment  parts  or  check  that

they  have  been  previously  approved,

—  verify  that  the  staff  undertaking  the  permanent  joining  of  pressure  equipment  parts  and  the

non-destructive  tests  are  qualified  or  approved;

4.2.  perform  the  necessary  examination  to  establish  whether  the  relevant  provisions  of  the  Directive

have  actually  been  applied.

4.3.  perform  the  necessary  examinations  to  establish  whether  the  relevant  provisions  of  the  Directive

have  actually  been  applied.

5.  Where the design meets the provisions of the Directive which apply to it, the notified body must issue an
EC  type-examination  certificate  to  the  applicant.  The  certificate  must  contain  the  name  and  address  of
the  applicant,  the  conclusions  of  the  examination,  conditions  for  its  validity  and  the  necessary  data  for
identification  of  the  approved  design.

A list of the relevant parts of the technical documentation must be annexed to the certificate and a copy
kept  by  the  notified  body.

If  the  notified  body  refuses  to  issue  an  EC  type-examination  certificate  to  the  manufacturer  or  to  his
authorised representative established within the Community, that body must provide detailed reasons for
such  refusal.  Provision  must  be  made  for  an  appeals  procedure.

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6.  The applicant must inform the notified body that holds the technical documentation concerning the EC
type-examination  certificate  of  all  modifications  to  the  approved  design;  these  are  subject  to  additional
approval  where  they  may  affect  conformity  with  the  requirements  of  the  Directive  or  the  prescribed
conditions for use of the equipment. This additional approval must be given in the form of an addition
to  the  original  EC  type-examination  certificate.

7.  Each  notified  body  must  communicate  to  the  Member  States  the  relevant  information  concerning  EC

design-examination  certificates  which  it  has  withdrawn,  and,  on  request,  those  it  has  issued.

Each  notified  body  must  also  communicate  to  the  other  notified  bodies  the  relevant  information
concerning  the  EC  type-examination  certificates  it  has  withdrawn  or  refused.

8.  The  other  notified  bodies  may  on  request  obtain  the  relevant  information  concerning:

—  the  EC  design-examination  certificates  and  additions  granted,

—  the  EC  design-examination  certificates  and  additions  withdrawn.

9.  The  manufacturer,  or  his  authorised  representative  established  within  the  Community,  must  keep  with
the technical documentation referred to in point 3 copies of EC design-examination certificates and their
additions  for  a  period  of  10  years  after  the  last  of  the  transportable  pressure  equipment  has  been
manufactured.

Where  neither  the  manufacturer  nor  his  authorised  representative  is  established  within  the  Community,
the  obligation  to  keep  the  technical  documentation  available  is  the  responsibility  of  the  person  who
places  the  product  on  the  community  market.

Module  C1  (conformity  to  type)

1.  This  module  describes  that  part  of  the  procedure  whereby  the  manufacturer,  or  his  authorised
representative  established  within  the  Community,  ensures  and  declares  that  transportable  pressure
equipment  is  in  conformity  with  the  type  as  described  in  the  EC  type-examination  certificate  and
satisfies  the  requirements  of  the  Directive  which  apply  to  it.  The  manufacturer,  or  his  authorised
representative established within the Community, must affix the Π marking to all transportable pressure
equipment  and  draw  up  a  written  declaration  of  conformity.

2.  The  manufacturer  must  take  all  measures  necessary  to  ensure  that  the  manufacturing  process  requires
the  manufactured  transportable  pressure  equipment  to  comply  with  the  type  as  described  in  the  EC
type-examination  certificate  and  with  the  requirements  of  the  Directive  which  apply  to  it.

3.  The manufacturer, or his authorised representative established within the Community, must keep a copy
of  the  declaration  of  conformity  for  a  period  of  10  years  after  the  last  of  the  transportable  pressure
equipment  has  been  manufactured.

Where  neither  the  manufacturer  nor  his  authorised  representative  is  established  within  the  Community,
the obligation to keep the technical documentation available is the responsibility of the person places the
transportable  pressure  equipment  on  the  Community  market.

4.  Final  assessment  must  be  subject  to  monitoring  in  the  form  of  unexpected  visits  by  a  notified  body

chosen  by  the  manufacturer.

During  such  visits,  the  notified  body  must:

—  ensure  that  the  manufacturer  actually  performs  final  assessment,

—  take samples of transportable pressure equipment at the manufacturing or storage premises in order
to  conduct  checks.  The  notified  body  assesses  the  number  of  items  of  equipment  to  sample  and
whether  it  is  necessary  to  perform,  or  have  performed,  or  have  performed,  all  or  part  of  final
assessment  of  the  equipment  samples.

Should  one  or  more  of  the  items  of  transportable  pressure  equipment  not  conform,  the  notified  body
must  take  appropriate  measures.

On  the  responsibility  of  the  notified  body,  the  manufacturer  must  affix  that  body’s  identification
number  to  each  item  of  transportable  pressure  equipment.

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Module  D  (production  quality  assurance)

1.  This module describes the procedure whereby the manufacturer who satisfies the obligations of point 2
ensures and declares that the transportable pressure equipment concerned is in conformity with the type
described  in  the  EC  type-examination  certificate  and  satisfies  the  requirements  of  the  Directive  which
apply to it. The manufacturer, or his authorised representative established within the Community, must
affix  the  Π  marking  to  all  transportable  pressure  equipment  and  draw  up  a  written  declaration  of
conformity.  The  Π  marking  must  be  accompanied  by  the  identification  number  of  the  notified  body
responsible  for  Community  surveillance  as  specified  in  point  4.

2.  The manufacturer must operate an approved quality system for production, final inspection and testing

as  specified  in  point  3  and  be  subject  to  surveillance  as  specified  in  point  4.

3.  Quality system

3.1.  The  manufacturer  must  lodge  an  application  for  assessment  of  his  quality  system  with  a  notified

body  of  his  choice.

The  application  must  include:

—  all  relevant  information  on  the  transportable  pressure  equipment  concerned,

—  the  documentation  concerning  the  quality  system,

—  the  technical  documentation  for  the  approved  type  and  a  copy  of  the  EC  type-examination

certificate.

3.2.  The quality system must ensure compliance of the transportable pressure equipment with the type
described in the EC type-examination certificate and with the requirements of the Directive which
apply  to  it.

All  the  elements,  requirements  and  provisions  adopted  by  the  manufacturer  must  be  documented
in  a  systematic  and  orderly  manner  in  the  form  of  written  policies,  procedures  and  instructions.
The  quality  system  documentation  must  permit  a  consistent  interpretation  of  the  quality
programmes,  plans,  manuals  and  records.

It  must  contain  in  particular  an  adequate  description  of:

—  the  quality  objectives  and  the  organisational  structure,  responsibilities  and  powers  of  the

management  with  regard  to  the  quality  of  the  transportable  pressure  equipment,

—  the  manufacturing,  quality  control  and  quality  assurance  techniques,  processes  and  systematic

measures  that  will  be  used,  particularly  the  procedures  used,

—  the  examinations  and  tests  that  will  be  carried  out  before,  during  and  after  manufacture,  and

the  frequency  with  which  they  will  be  carried  out,

—  the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data,  reports

concerning  the  qualifications  or  approvals  of  the  personnel  concerned,

—  the means of monitoring the achievement of the required quality and the effective operation of

the  quality  system.

3.3.  The notified body must assess the quality system to determine whether it satisfies the requirements

referred  to  in  3.2.

The  auditing  team  must  have  at  least  one  member  with  experience  of  assessing  the  transportable
pressure  equipment  concerned.  The  assessment  procedure  must  include  an  inspection  visit  to  the
manufacturer’s  premises.

The decision must be notified to the manufacturer. The notification must contain the conclusions
of the examination and the reasoned assessment decision. Provision must be made for an appeals
procedure.

3.4.  The  manufacturer  must  undertake  to  fulfil  the  obligations  arising  out  of  the  quality  system  as

approved  and  to  ensure  that  it  remains  satisfactory  and  efficient.

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The  manufacturer,  or  his  authorised  representative  established  within  the  Community,  must
inform  the  notified  body  that  has  approved  the  quality  system  of  any  intended  adjustment  t  the
quality system.

The  notified  body  must  assess  the  proposed  changes  and  decide  whether  the  amended  quality
system  will  still  satisfy  the  requirements  referred  to  in  3.2  or  whether  a  reassessment  is
required.

It  must  notify  its  decision  to  the  manufacturer.  The  notification  must  contain  the  conclusions  of
the  examination  and  the  reasoned  assessment  decision.

4.  Surveillance  under  the  responsibility  of  the  notified  body

4.1.  The  purpose  of  surveillance  is  to  make  sure  that  the  manufacturer  duly  fulfils  the  obligations

arising  out  of  the  approved  quality  system.

4.2.  The manufacturer must allow the notified body access for inspection purposes to the locations of
manufacture,  inspection,  testing  and  storage  and  provide  it  with  all  necessary  information,  in
particular:

—  the  quality  system  documentation,

—  the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data,  reports

concerning  the  qualifications  of  the  personnel  concerned,  etc.

4.3.  The  notified  body  must  carry  out  periodic  audits  to  make  sure  that  the  manufacturer  maintains
and applies the quality system and provide the manufacturer with an audit report. The frequency
of  periodic  audits  must  be  such  that  a  full  reassessment  is  carried  out  every  three  years.

4.4. 

In  addition,  the  notified  body  may  pay  unexpected  visits  to  the  manufacturer.  The  need  for  such
additional  visits,  and  the  frequency  thereof,  will  be  determined  on  the  basis  of  a  visit  control
system  operated  by  the  notified  body.  In  particular,  the  following  factors  must  be  considered  in
the  visit  control  system:

—  the  category  of  the  equipment,

—  the  results  of  previous  surveillance  visits,

—  the  need  to  follow  up  corrective  action,

—  where  applicable,  special  conditions  linked  to  the  approval  of  the  system,

—  significant  changes  in  manufacturing  organisation,  policy  or  techniques.

During such visits the notified body may, if necessary, carry out tests, or have them carried out, to
verify  that  the  quality  system  is  functioning  correctly.  The  notified  body  must  provide  the
manufacturer  with  a  visit  report  and,  if  a  test  has  taken  place,  with  a  test  report.

5.  The  manufacturer  must,  for  a  period  of  10  years  after  the  last  of  the  transportable  pressure  equipment

has  been  manufactured,  hold  at  the  disposal  of  the  national  authorities:

—  the  documentation  referred  to  in  the  second  indent  of  3.1,

—  the  adjustments  referred  to  in  the  second  paragraph  of  3.4,

—  the  decisions  and  reports  from  the  notified  body  which  are  referred  to  in  the  last  paragraph  of  3.3,

in  the  last  paragraph  of  3.4,  and  in  4.3  and  4.4.

6.  Each  notified  body  must  communicate  to  the  Member  States  the  relevant  information  concerning  the

quality  system  approvals  which  it  has  withdrawn,  and,  on  request,  those  it  has  issued.

Each  notified  body  must  also  communicate  to  the  other  notified  bodies  the  relevant  information
concerning  the  quality  system  approvals  it  has  withdrawn  or  refused.

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Module  D1  (production  quality  assurance)

1.  This module describes the procedure whereby the manufacturer who satisfies the obligations of point 3
ensures and declares that the items transportable pressure equipment concerned satisfy the requirements
of  the  Directive  which  apply  to  them.  The  manufacturer,  or  his  authorised  representative  established
within the Community, must affix the Π  marking to all transportable pressure equipment and draw up
a written declaration of conformity. The Π marking must be accompanied by the identification number
of  the  notified  body  responsible  for  Community  surveillance  as  specified  in  point  5.

2.  The  manufacturer  must  draw  up  the  technical  documentation  described  below.

The  technical  documentation  must  enable  an  assessment  to  be  made  of  the  conformity  of  the
transportable  pressure  equipment  with  the  requirements  of  the  Directive  which  apply  to  it.  It  must,  as
far as is relevant for such assessment, cover the design, manufacture and operation of the transportable
pressure  equipment  and  contain:

—  a  general  description  of  the  equipment  in  question,

—  conceptual  design  and  manufacturing  drawings  and  diagrams  of  components,  sub-assemblies,

circuits, etc.,

—  descriptions and explanations necessary for an understanding of the said drawings and diagrams and

the  operation  of  the  equipment,

—  a  description  of  the  solutions  adopted  to  meet  the  requirements  of  the  Directive,

—  results  of  the  design  calculations  made,  examinations  carried  out,  etc.;

—  test  reports.

3.  The manufacturer must operate an approved quality system for production, final inspection and testing

as  specified  in  point  4  and  be  subject  to  surveillance  as  specified  in  point  5.

4.  Quality system

4.1.  The  manufacturer  must  lodge  an  application  for  assessment  of  his  quality  system  with  a  notified

body  of  his  choice.

The  application  must  include:

—  all  relevant  information  on  the  transportable  pressure  equipment  concerned,

—  the  documentation  concerning  the  quality  system.

4.2.  The  quality  system  must  ensure  compliance  of  the  transportable  pressure  equipment  with

requirements  of  the  Directive  which  apply  to  it.

All  the  elements,  requirements  and  provisions  adopted  by  the  manufacturer  must  be  documented
in  a  systematic  and  orderly  manner  in  the  form  of  written  policies,  procedures  and  instructions.
The  quality  system  documentation  must  permit  a  consistent  interpretation  of  the  quality
programmes,  plans,  manuals  and  records.

It  must  contain  in  particular  an  adequate  description  of:

—  the  quality  objectives  and  the  organisational  structure,  responsibilities  and  powers  of  the

management  with  regard  to  the  quality  of  the  transportable  pressure  equipment,

—  the  manufacturing,  quality  control  and  quality  assurance  techniques,  processes  and  systematic

measures  that  will  be  used,

—  the  examinations  and  tests  that  will  be  carried  out  before,  during  and  after  manufacture,  and

the  frequency  with  which  they  will  be  carried  out,

—  the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data,  reports

concerning  the  qualifications  or  approvals  of  the  personnel  concerned,

—  the means of monitoring the achievement of the required quality and the effective operation of

the  quality  system.

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4.3.  The notified body must assess the quality system to determine whether it satisfies the requirements

referred  to  in  4.2.

The  auditing  team  must  have  at  least  one  member  with  experience  of  assessing  the  transportable
pressure  equipment  concerned.  The  assessment  procedure  must  include  an  inspection  visit  to  the
manufacturer’s  premises.

The decision must be notified to the manufacturer. The notification must contain the conclusions
of the examination and the reasoned assessment decision. Provision must be made for an appeals
procedure.

4.4.  The  manufacturer  must  undertake  to  fulfil  the  obligations  arising  out  of  the  quality  system  as

approved  and  to  ensure  that  it  remains  satisfactory  and  efficient.

The  manufacturer,  or  his  authorised  representative  established  within  the  Community,  must
inform  the  notified  body  that  has  approved  the  quality  system  of  any  intended  adjustment  to  the
quality system.

The  notified  body  must  assess  the  proposed  changes  and  decide  whether  the  amended  quality
system  will  still  satisfy  the  requirements  referred  to  in  4.2  or  whether  a  reassessment  is
required.

It  must  notify  its  decision  to  the  manufacturer.  The  notification  must  contain  the  conclusions  of
the  examination  and  the  reasoned  assessment  decision.

5.  Surveillance  under  the  responsibility  of  the  notified  body

5.1.  The  purpose  of  surveillance  is  to  make  sure  that  the  manufacturer  duly  fulfils  the  obligations

arising  out  of  the  approved  quality  system.

5.2.  The manufacturer must allow the notified body access for inspection purposes to the locations of
manufacture,  inspection,  testing  and  storage  and  provide  it  with  all  necessary  information,  in
particular:

—  the  quality  system  documentation,

—  the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data,  reports

concerning  the  qualifications  of  the  personnel  concerned,  etc.

5.3.  The  notified  body  must  carry  out  periodic  audits  to  make  sure  that  the  manufacturer  maintains
and applies the quality system and provide the manufacturer with an audit report. The frequency
of  periodic  audits  must  be  such  that  a  full  reassessment  is  carried  out  every  three  years.

5.4. 

In  addition,  the  notified  body  may  pay  unexpected  visits  to  the  manufacturer.  The  need  for  such
additional  visits,  and  the  frequency  thereof,  will  be  determined  on  the  basis  of  a  visit  control
system  operated  by  the  notified  body.  In  particular,  the  following  factors  must  be  considered  in
the  visit  control  system:

—  the  category  of  the  equipment,

—  the  results  of  previous  surveillance  visits,

—  the  need  to  follow  up  corrective  action,

—  where  applicable,  special  conditions  linked  to  the  approval  of  the  system,

—  significant  changes  in  manufacturing  organisation,  policy  or  techniques.

During such visits the notified body may, if necessary, carry out tests, or have them carried out, to
verify  that  the  quality  system  is  functioning  correctly.  The  notified  body  must  provide  the
manufacturer  with  a  visit  report  and,  if  a  test  has  taken  place,  with  a  test  report.

6.  The  manufacturer  must,  for  a  period  of  10  years  after  the  last  of  the  transportable  pressure  equipment

has  been  manufactured,  hold  at  the  disposal  of  the  national  authorities:

—  the  documentation  referred  to  in  point  2,

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—  the  documentation  referred  to  in  the  second  indent  of  4.1,

—  the  adjustments  referred  to  in  the  second  paragraph  of  4.4,

—  the  decisions  and  reports  from  the  notified  body  which  are  referred  to  in  the  last  paragraph  of  4.3,

in  the  last  paragraph  of  4.4,  and  in  5.3  and  5.4.

7.  Each  notified  body  must  communicate  to  the  Member  States  the  relevant  information  concerning  the

quality  system  approvals  which  it  has  withdrawn,  and,  on  request,  those  it  has  issued.

Each  notified  body  must  communicate  to  the  other  notified  bodies  the  relevant  information  concerning
the  quality  system  approvals  it  has  withdrawn  or  refused.

Module  E  (product  quality  assurance)

1.  This module describes the procedure whereby the manufacturer who satisfies the obligations of point 2
ensures  and  declares  that  the  items  transportable  pressure  equipment  is  in  conformity  with  the  type  as
described  in  the  EC  type-examination  certificate  and  satisfies  the  requirements  of  the  Directive  which
apply to it. The manufacturer, or his authorised representative established within the Community, must
affix the Π  marking to each product and draw up a written declaration of conformity. The Π  marking
must  be  accompanied  by  the  identification  number  of  the  notified  body  responsible  for  Community
surveillance  as  specified  in  point  4.

2.  The manufacturer must operate an approved quality system for production, final inspection and testing

as  specified  in  point  3  and  be  subject  to  surveillance  as  specified  in  point  4.

3.  Quality system

3.1.  The  manufacturer  must  lodge  an  application  for  assessment  of  his  quality  system  with  a  notified

body  of  his  choice.

The  application  must  include:

—  all  relevant  information  on  the  transportable  pressure  equipment  concerned,

—  the  documentation  concerning  the  quality  system,

—  the  technical  documentation  for  the  approved  type  and  a  copy  of  the  EC  type-examination

certificate.

3.2.  Under  the  quality  system,  each  item  of  transportable  pressure  equipment  must  be  examined  and
appropriate  tests  must  be  carried  out  in  order  to  ensure  its  conformity  with  the  requirements  of
the  Directive  which  apply  to  it.  All  the  elements,  requirements  and  provisions  adopted  by  the
manufacturer  must  be  documented  in  a  systematic  and  orderly  manner  in  the  form  of  written
policies,  procedures  and  instructions.  The  quality  system  documentation  must  permit  a  consistent
interpretation  of  the  quality  programmes,  plans,  manuals  and  records.

It  must  contain  in  particular  an  adequate  description  of:

—  the  quality  objectives  and  the  organisational  structure,  responsibilities  and  powers  of  the

management  with  regard  to  the  quality  of  the  transportable  pressure  equipment,

—  the  examinations  and  tests  to  be  carried  out  after  manufacture,

—  the  means  of  monitoring  the  effective  operation  of  the  quality  system,

—  the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data,  reports

concerning  the  qualifications  or  approvals  of  the  personnel  concerned.

3.3.  The notified body must assess the quality system to determine whether it satisfies the requirements

referred  to  in  3.2.

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The  auditing  team  must  have  at  least  one  member  with  experience  of  assessing  the  transportable
pressure  equipment  concerned.  The  assessment  procedure  must  include  an  inspection  visit  to  the
manufacturer’s  premises.

The decision must be notified to the manufacturer. The notification must contain the conclusions
of the examination and the reasoned assessment decision. Provision must be made for an appeals
procedure.

3.4.  The  manufacturer  must  undertake  to  fulfil  the  obligations  arising  out  of  the  quality  system  as

approved  and  to  ensure  that  it  remains  satisfactory  and  efficient.

The  manufacturer,  or  his  authorised  representative  established  within  the  Community,  must
inform  the  notified  body  that  has  approved  the  quality  system  of  any  intended  adjustment  to  the
quality system.

The  notified  body  must  assess  the  proposed  changes  and  decide  whether  the  amended  quality
system  will  still  satisfy  the  requirements  referred  to  in  3.2  or  whether  a  reassessment  is
required.

It  must  notify  its  decision  to  the  manufacturer.  The  notification  must  contain  the  conclusions  of
the  examination  and  the  reasoned  assessment  decision.

4.  Surveillance  under  the  responsibility  of  the  notified  body

4.1.  The  purpose  of  surveillance  is  to  make  sure  that  the  manufacturer  duly  fulfils  the  obligations

arising  out  of  the  approved  quality  system.

4.2.  The manufacturer must allow the notified body access for inspection purposes to the locations of
manufacture,  inspection,  testing  and  storage  and  provide  it  with  all  necessary  information,  in
particular:

—  the  quality  system  documentation,

—  the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data,  reports

concerning  the  qualifications  of  the  personnel  concerned,  etc.

4.3.  The  notified  body  must  carry  out  periodic  audits  to  make  sure  that  the  manufacturer  maintains
and applies the quality system and provide the manufacturer with an audit report. The frequency
of  periodic  audits  must  be  such  that  a  full  reassessment  is  carried  out  every  three  years.

4.4. 

In  addition,  the  notified  body  may  pay  unexpected  visits  to  the  manufacturer.  The  need  for  such
additional  visits,  and  the  frequency  thereof,  will  be  determined  on  the  basis  of  a  visit  control
system  operated  by  the  notified  body.  In  particular,  the  following  factors  must  be  considered  in
the  visit  control  system:

—  the  category  of  the  equipment,

—  the  results  of  previous  surveillance  visits,

—  the  need  to  follow  up  corrective  action,

—  where  applicable,  special  conditions  linked  to  the  approval  of  the  system,

—  significant  changes  in  manufacturing  organisation,  policy  or  techniques.

During such visits the notified body may, if necessary, carry out tests, or have them carried out, to
verify  that  the  quality  system  is  functioning  correctly.  The  notified  body  must  provide  the
manufacturer  with  a  visit  report  and,  if  a  test  has  taken  place,  with  a  test  report.

5.  The  manufacturer  must,  for  a  period  of  10  years  after  the  last  of  the  transportable  pressure  equipment

has  been  manufactured,  hold  at  the  disposal  of  the  national  authorities:

—  the  documentation  referred  to  in  the  second  indent  of  3.1,

—  the  adjustments  referred  to  in  the  second  paragraph  of  3.4,

—  the  decisions  and  reports  from  the  notified  body  which  are  referred  to  in  the  last  paragraph  of  3.3,

in  the  last  paragraph  of  3.4,  and  in  4.3  and  4.4.

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6.  Each  notified  body  must  communicate  to  the  Member  States  the  relevant  information  concerning  the

quality  system  approvals  which  it  has  withdrawn,  and,  on  request,  those  it  has  issued.

Each  notified  body  must  also  communicate  to  the  other  notified  bodies  the  relevant  information
concerning  the  quality  system  approvals  it  has  withdrawn  or  refused.

Module  E1  (production  quality  assurance)

1.  This module describes the procedure whereby the manufacturer who satisfies the obligations of point 3
ensures and declares that the transportable pressure equipment satisfies the requirements of the Directive
which apply to it. The manufacturer, or his authorised representative established within the Community,
must  affix  the  Π  marking  to  each  item  of  transportable  pressure  equipment  and  draw  up  a  written
declaration  of  conformity.  The  Π  marking  must  be  accompanied  by  the  identification  number  of  the
notified  body  responsible  for  surveillance  as  specified  in  point  5.

2.  The  manufacturer  must  draw  up  the  technical  documentation  described  below.

The  technical  documentation  must  enable  an  assessment  to  be  made  of  the  conformity  of  the
transportable  pressure  equipment  with  the  requirements  of  the  Directive  which  apply  to  it.  It  must,  as
far as is relevant for such assessment, cover the design, manufacture and operation of the transportable
pressure  equipment  and  contain:

—  a  general  description  of  the  equipment  in  question,

—  conceptual  design  and  manufacturing  drawings  and  diagrams  of  components,  sub-assemblies,

circuits, etc.,

—  descriptions and explanations necessary for an understanding of the said drawings and diagrams and

the  operation  of  the  equipment,

—  a  description  of  the  solutions  adopted  to  meet  the  requirements  of  the  Directive,

—  results  of  the  design  calculations  made,  examinations  carried  out,  etc.;

—  test  reports.

3.  The  manufacturer  must  operate  an  approved  quality  system  for  the  final  transportable  pressure
equipment  inspection  and  testing  as  specified  in  point  4  and  be  subject  to  surveillance  as  specified  in
point  5.

4.  Quality system

4.1.  The  manufacturer  must  lodge  an  application  for  assessment  of  his  quality  system  with  a  notified

body  of  his  choice.

The  application  must  include:

—  all  relevant  information  on  the  transportable  pressure  equipment  concerned,

—  the  documentation  concerning  the  quality  system.

4.2.  Under  the  quality  system,  each  item  of  transportable  pressure  equipment  must  be  examined  and
appropriate  tests  must  be  carried  out  in  order  to  ensure  its  conformity  with  the  requirements  of
the  Directive  which  apply  to  it.  All  the  elements,  requirements  and  provisions  adopted  by  the
manufacturer  must  be  documented  in  a  systematic  and  orderly  manner  in  the  form  of  written
policies,  procedures  and  instructions.  The  quality  system  documentation  must  permit  a  consistent
interpretation  of  the  quality  programmes,  plans,  manuals  and  records.

It  must  contain  in  particular  an  adequate  description  of:

—  the  quality  objectives  and  the  organisational  structure,  responsibilities  and  powers  of  the

management  with  regard  to  the  quality  of  the  transportable  pressure  equipment,

—  the  procedures  used  for  the  joining  of  parts,

—  the  examinations  and  tests  to  be  carried  out  after  manufacture,

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—  the  means  of  monitoring  the  effective  operation  of  the  quality  system,

—  the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data,  reports

concerning  the  qualifications  or  approvals  of  the  staff  concerned.

4.3.  The notified body must assess the quality system to determine whether it satisfies the requirements

referred  to  in  4.2.

The  auditing  team  must  have  at  least  one  member  with  experience  of  assessing  the  transportable
pressure  equipment  concerned.  The  assessment  procedure  must  include  an  inspection  visit  to  the
manufacturer’s  premises.

The decision must be notified to the manufacturer. The notification must contain the conclusions
of the examination and the reasoned assessment decision. Provision must be made for an appeals
procedure.

4.4.  The  manufacturer  must  undertake  to  discharge  the  obligations  arising  from  the  quality  system  as

approved  and  to  ensure  that  it  remains  satisfactory  and  efficient.

The  manufacturer,  or  his  authorised  representative  established  within  the  Community,  must
inform the notified body which has approved the quality system of any intended adjustment to the
quality system.

The  notified  body  must  assess  the  proposed  changes  and  decide  whether  the  modified  quality
system  will  still  satisfy  the  requirements  referred  to  in  4.2  or  whether  a  reassessment  is
required.

It  must  notify  its  decision  to  the  manufacturer.  The  notification  must  contain  the  conclusions  of
the  examination  and  the  reasoned  assessment  decision.

5.  Surveillance  under  the  responsibility  of  the  notified  body

5.1.  The  purpose  of  surveillance  is  to  make  sure  that  the  manufacturer  duly  fulfils  the  obligations

arising  out  of  the  approved  quality  system.

5.2.  The manufacturer must allow the notified body access for inspection purposes to the locations of
manufacture,  inspection,  testing  and  storage  and  provide  it  with  all  necessary  information,  in
particular:

—  the  quality  system  documentation,

—  the  technical  documentation,

—  the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data,  reports

concerning  the  qualifications  of  the  personnel  concerned,  etc.

5.3.  The  notified  body  must  carry  out  periodic  audits  to  make  sure  that  the  manufacturer  maintains
and applies the quality system and provide the manufacturer with an audit report. The frequency
of  periodic  audits  must  be  such  that  a  full  reassessment  is  carried  out  every  three  years.

5.4. 

In  addition,  the  notified  body  may  pay  unexpected  visits  to  the  manufacturer.  The  need  for  such
additional  visits,  and  the  frequency  thereof,  will  be  determined  on  the  basis  of  a  visit  control
system  operated  by  the  notified  body.  In  particular,  the  following  factors  must  be  considered  in
the  visit  control  system:

—  the  category  of  the  equipment,

—  the  results  of  previous  surveillance  visits,

—  the  need  to  follow  up  corrective  action,

—  where  applicable,  special  conditions  linked  to  the  approval  of  the  system,

—  significant  changes  in  manufacturing  organisation,  policy  or  techniques.

During such visits the notified body may, if necessary, carry out tests, or have them carried out, to
verify  that  the  quality  system  is  functioning  correctly.  The  notified  body  must  provide  the
manufacturer  with  a  visit  report  and,  if  a  test  has  taken  place,  with  a  test  report.

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6.  The  manufacturer  must,  for  a  period  of  10  years  after  the  last  of  the  transportable  pressure  equipment

has  been  manufactured,  hold  at  the  disposal  of  the  national  authorities:

—  the  documentation  referred  to  in  section  2,

—  the  documentation  referred  to  in  the  third  indent  of  4.1,

—  the  adjustments  referred  to  in  the  second  paragraph  of  4.4,

—  the  decisions  and  reports  from  the  notified  body  which  are  referred  to  in  the  last  paragraph  of  4.3,

in  the  last  paragraph  of  4.4,  and  in  5.3  and  5.4.

7.  Each  notified  body  must  communicate  to  the  Member  States  the  relevant  information  concerning  the

quality  system  approvals  which  it  has  withdrawn,  and,  on  request,  those  it  has  issued.

Each  notified  body  must  communicate  to  the  other  notified  bodies  the  relevant  information  concerning
the  quality  system  approvals  it  has  withdrawn  or  refused.

Module  F  (product  verification)

1.  This  module  describes  the  procedure  whereby  a  manufacturer,  or  his  authorised  representative
established  within  the  Community,  ensures  and  declares  that  the  transportable  pressure  equipment
subject  to  the  provisions  of  point  3  is  in  conformity  with  the  type  described:

—  in  the  EC  type-examination  certificate,  or

—  in  the  EC  design-examination  certificate,

and  satisfies  the  requirements  of  the  Directive  which  apply  to  it.

2.  The  manufacturer  must  take  all  measures  necessary  to  ensure  that  the  manufacturing  process  requires

the  transportable  pressure  equipment  to  comply  with  the  type  described:

—  in  the  EC  type-examination  certificate,  or

—  in  the  EC  design-examination  certificate,

and  with  the  requirements  of  the  Directive  which  apply  to  it.

The manufacturer, or his authorised representative established within the Community, must affix the Π
marking  to  all  transportable  pressure  equipment  and  draw  up  a  declaration  of  conformity.

3.  The  notified  body  must  perform  the  appropriate  examinations  and  tests  in  order  to  check  the
conformity  of  the  transportable  pressure  equipment  with  the  relevant  requirements  of  the  Directive  by
examining  and  testing  every  product  in  accordance  with  point  4.

The manufacturer, or his authorised representative established within the Community, must keep a copy
of  the  declaration  of  conformity  for  a  period  of  10  years  after  the  last  of  the  transportable  pressure
equipment  has  been  manufactured.

4.  Verification  by  examination  and  testing  of  each  item  of  transportable  pressure  equipment

4.1.  Each  item  of  transportable  pressure  equipment  must  be  individually  examined  and  must  undergo
appropriate  examinations  and  tests  in  order  to  verify  that  it  conforms  to  the  type  and  the
requirements  of  the  Directive  which  apply  to  it.

In  particular,  the  notified  body  must:

—  verify  that  the  personnel  undertaking  the  permanent  joining  of  parts  and  the  non-destructive

tests  are  qualified  or  approved,

—  check  the  certificate  issued  by  the  materials  manufacturer,

—  carry out the final inspection and proof test or have them carried out and, where appropriate,

examine  the  safety  devices.

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4.2.  The  notified  body  must  affix  its  identification  number  or  have  it  affixed  to  each  item  of
transportable  pressure  equipment  and  draw  up  a  written  certificate  of  conformity  relating  to  the
tests  carried  out.

4.3.  The manufacturer, or his authorised representative established within the Community, must ensure
that  the  certificates  of  conformity  issued  by  the  notified  body  can  be  made  available  on  request.

Module  G  (EC  unit  verification)

1.  This  module  describes  the  procedure  whereby  the  manufacturer  ensures  and  declares  that  transportable
pressure  equipment  which  has  been  issued  with  the  certificate  referred  to  in  point  4.1  satisfies  the
requirements  of  the  Directive  which  apply  to  it.  The  manufacturer,  or  his  authorised  representative
established  within  the  Community,  must  affix  the  Π  marking  to  the  equipment  and  draw  up  a
declaration  of  conformity.

2.  The manufacturer must apply to a notified body of his choice for unit verification. The application must

contain::

—  the  name  and  address  of  the  manufacturer  and  the  location  of  the  transportable  pressure

equipment,

—  a  written  declaration  to  the  effect  that  application  has  not  been  lodged  with  another  notified

body,

—  technical  documentation.

3.  The  technical  documentation  must  enable  the  conformity  of  the  transportable  pressure  equipment  with
the  requirements  of  the  Directive  which  apply  to  it  to  be  assessed  and  the  design,  manufacture  and
operation  of  the  transportable  pressure  equipment  to  be  understood.

The  technical  documentation  must  contain:

—  a  general  description  of  the  equipment  in  question,

—  conceptual  design  and  manufacturing  drawings  and  diagrams  of  components,  sub-assemblies,

circuits, etc.,

—  descriptions and explanations necessary for an understanding of the said drawings and diagrams and

the  operation  of  the  equipment,

—  results  of  design  calculations  made,  examinations  carried  out,  etc.,

—  test  reports,

—  appropriate  details  relating  to  the  approval  of  the  manufacturing  and  test  procedures  and  of  the

qualifications  or  approvals  of  the  staff  concerned.

4.  The  notified  body  must  examine  the  design  and  construction  of  each  item  of  transportable  pressure
equipment  and  during  manufacture  perform  appropriate  tests  to  ensure  its  conformity  with  the
requirements  of  the  Directive  which  apply  to  it.

4.1.  The  notified  body  must  affix  its  identification  number  or  have  it  affixed  to  the  transportable
pressure  equipment  and  draw  up  a  certificate  of  conformity  for  the  tests  carried  out.  This
certificate  must  be  kept  for  a  period  of  10  years.

4.2.  The manufacturer, or his authorised representative established within the Community, must ensure
that the declaration of conformity and certificate of conformity issued by the notified body can be
made  available  on  request.

In  particular,  the  notified  body  must:

—  examine  the  technical  documentation  with  respect  to  the  design  and  the  manufacturing

procedures,

—  assess the materials used where these are not in conformity with the relevant provisions of the

Directive  and  check  the  certificate  issued  by  the  materials  manufacturer,

—  approve  the  procedures  for  the  permanent  joining  of  pressure  equipment  parts,

—  verify  the  qualifications  or  approvals  required,

—  perform  the  final  inspection,  perform  the  proof  test  or  have  it  performed  and  examine  the

safety  devices  if  applicable.

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Module  H  (full  quality  assurance)

1.  This module describes the procedure whereby the manufacturer who satisfies the obligations of point 2
ensures  and  declares  that  the  transportable  pressure  equipment  in  question  satisfies  the  requirements  of
the Directive which apply to it. The manufacturer, or his authorised representative established within the
Community, must affix the Π marking to each item of transportable pressure equipment and draw up a
written declaration of conformity. The Π marking must be accompanied by the identification number of
the  notified  body  responsible  for  the  surveillance  referred  to  in  point  4.

2.  The manufacturer must implement an approved quality system for design, manufacture, final inspection

and  testing  as  specified  in  point  3  and  be  subject  to  surveillance  as  specified  in  point  4.

3.  Quality system

3.1.  The  manufacturer  must  lodge  an  application  for  assessment  of  his  quality  system  with  a  notified

body  of  his  choice.

The  application  must  include:

—  all  relevant  information  concerning  the  transportable  pressure  equipment  in  question,

—  the  documentation  concerning  the  quality  system.

3.2.  The  quality  system  must  ensure  compliance  of  the  transportable  pressure  equipment  with  the

requirements  of  the  Directive  which  apply  to  it.

All  the  elements,  requirements  and  provisions  adopted  by  the  manufacturer  must  be  documented
in  a  systematic  and  orderly  manner  in  the  form  of  written  policies,  procedures  and  instructions.
The  quality  system  documentation  must  permit  a  consistent  interpretation  of  the  procedural  and
quality  measures  such  as  programmes,  plans,  manuals  and  records.

It  must  contain  in  particular  an  adequate  description  of:

—  the  quality  objectives  and  the  organisational  structure,  responsibilities  and  powers  of  the

management  with  regard  to  the  quality  of  the  design  and  to  product  quality,

—  the  technical  design  specifications,  including  standards,  that  will  be  applied,

—  the  design  control  and  design  verification  techniques,  processes  and  systematic  measures  that

will  be  used  when  designing  the  transportable  pressure  equipment,

—  the  corresponding  manufacturing,  quality  control  and  quality  assurance  techniques,  processes

and  systematic  measures  that  will  be  used,

—  the  examinations  and  tests  to  be  carried  out  before,  during  and  after  manufacture,  and  the

frequency  with  which  they  will  be  carried  out,

—  the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data,  reports

concerning  the  qualifications  or  approvals  of  the  personnel  concerned,

—  the  means  of  monitoring  the  achievement  of  the  required  transportable  pressure  equipment

design  and  quality  and  the  effective  operation  of  the  quality  system.

3.3.  The notified body must assess the quality system to determine whether it satisfies the requirements

referred  to  in  3.2.

The  auditing  team  must  have  at  least  one  member  with  experience  of  assessing  the  transportable
pressure  equipment  concerned.  The  assessment  procedure  must  include  an  inspection  visit  to  the
manufacturer’s  premises.

The decision must be notified to the manufacturer. The notification must contain the conclusions
of the examination and the reasoned assessment decision. Provision must be made for an appeals
procedure.

3.4.  The  manufacturer  must  undertake  to  fulfil  the  obligations  arising  out  of  the  quality  system  as

approved  and  to  ensure  that  it  remains  satisfactory  and  efficient.

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The  manufacturer,  or  his  authorised  representative  established  within  the  Community,  must
inform  the  notified  body  that  has  approved  the  quality  system  of  any  intended  adjustment  to  the
quality system.

The  notified  body  must  assess  the  proposed  changes  and  decide  whether  the  modified  quality
system  will  still  satisfy  the  requirements  referred  to  in  3.2  or  whether  a  reassessment  is
required.

It  must  notify  its  decision  to  the  manufacturer.  The  notification  must  contain  the  conclusions  of
the  examination  and  the  reasoned  assessment  decision.

4.  Surveillance  under  the  responsibility  of  the  notified  body

4.1.  The purpose of this surveillance is to make sure that the manufacturer duly fulfils the obligations

arising  out  of  the  approved  quality  system.

4.2.  The manufacturer must allow the notified body access for inspection purposes to the locations of
design, manufacture, inspection, testing and storage and provide it with all necessary information,
in particular:

—  the  quality  system  documentation,

—  the  quality  records  provided  for  in  the  design  part  of  the  quality  system,  such  as  results  of

analyses,  calculations,  tests,  etc.,

—  the  quality  records  provided  for  in  the  manufacturing  part  of  the  quality  system,  such  as
inspection  reports  and  test  data,  calibration  data,  reports  concerning  the  qualifications  of  the
staff  concerned,  etc.

4.3.  The  notified  body  must  carry  out  periodic  audits  to  make  sure  that  the  manufacturer  maintains
and applies the quality system and provide the manufacturer with an audit report. The frequency
of  periodic  audits  must  be  such  that  a  full  reassessment  is  carried  out  every  three  years.

4.4. 

In  addition,  the  notified  body  may  pay  unexpected  visits  to  the  manufacturer.  The  need  for  such
additional  visits,  and  the  frequency  thereof,  will  be  determined  on  the  basis  of  a  visit  control
system  operated  by  the  notified  body.  In  particular,  the  following  factors  must  be  considered  in
the  visit  control  system:

—  the  category  of  the  equipment,

—  the  results  of  previous  surveillance  visits,

—  the  need  to  follow  up  corrective  action,

—  where  applicable,  special  conditions  linked  to  the  approval  of  the  system,

—  significant  changes  in  manufacturing  organisation,  policy  or  techniques.

During such visits the notified body may, if necessary, carry out tests, or have them carried out, to
verify  that  the  quality  system  is  functioning  correctly.  The  notified  body  must  provide  the
manufacturer  with  a  visit  report  and,  if  a  test  has  taken  place,  with  a  test  report.

5.  The  manufacturer  must,  for  a  period  of  10  years  after  the  last  of  the  transportable  pressure  equipment

has  been  manufactured,  keep  at  the  disposal  of  the  national  authorities:

—  the  documentation  referred  to  in  the  second  indent  of  the  second  paragraph  of  3.1,

—  the  adjustments  referred  to  in  the  second  paragraph  of  3.4,

—  the  decisions  and  reports  from  the  notified  body  which  are  referred  to  in  the  last  paragraph  of  3.3,

in  the  last  paragraph  of  3.4,  and  in  4.3  and  4.4.

6.  Each  notified  body  must  communicate  to  the  Member  States  the  relevant  information  concerning  the

quality  system  approvals  which  it  has  withdrawn,  and,  on  request,  those  it  has  issued.

Each  notified  body  must  also  communicate  to  the  other  notified  bodies  the  relevant  information
concerning  the  quality  system  approvals  it  has  withdrawn  or  refused.

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Module  H1  (full  quality  assurance  with  design  examination  and  special  surveillance  of  the  final  test)

1.  In  addition  to  the  requirements  of  module  H,  the  following  apply:

(a)  the  manufacturer  must  lodge  an  application  for  examination  of  the  design  with  the  notified  body;

(b) the  application  must  enable  the  design,  manufacture  and  operation  of  the  transportable  pressure
equipment  to  be  understood,  and  enable  conformity  with  the  relevant  requirements  of  the  Directive
to  be  assessed.

It  must  include:

—  the  technical  design  specifications,  including  standards,  which  have  been  applied,

—  the necessary supporting evidence for their adequacy. This supporting evidence must include the
results  of  tests  carried  out  by  the  appropriate  laboratory  of  the  manufacturer  or  on  his  behalf;

(c)  the  notified  body  must  examine  the  application  and  where  the  design  meets  the  provisions  of  the
Directive  which  apply  to  it  issue  an  EC  design-examination  certificate  to  the  applicant.  The
certificate  must  contain  the  conclusions  of  the  examination,  the  conditions  for  its  validity,  the
necessary  data  for  identification  of  the  approved  design  and,  if  relevant,  a  description  of  the
functioning  of  the  transportable  pressure  equipment;

(d) the applicant must inform the notified body that has issued the EC design-examination certificate of
all  modifications  to  the  approved  design.  Modifications  to  the  approved  design  must  receive
additional  approval  from  the  notified  body  that  issued  the  EC  design-examination  certificate  where
they  may  affect  conformity  with  the  requirements  of  the  Directive  or  the  prescribed  conditions  for
use  of  the  transportable  pressure  equipment.  This  additional  approval  must  be  given  in  the  form  of
an  addition  to  the  original  EC  design-examination  certificate;

(e)  each  notified  body  must  also  communicate  to  the  other  notified  bodies  the  relevant  information

concerning  the  EC  design-examination  certificates  it  has  withdrawn  or  refused.

2.  Final  assessment  is  subject  to  increased  surveillance  in  the  form  of  unexpected  visits  by  the  notified
body.  In  the  course  of  such  visits,  the  notified  body  must  conduct  examinations  on  the  transportable
pressure  equipment.

PART  II

CONFORMITY  REASSESSMENT  PROCEDURE

1.  This  procedure  describes  the  method  for  ensuring  that  transportable  pressure  equipment  placed  on  the
market  as  defined  in  Article  1(2)(b)  complies  with  the  relevant  requirements  of  Directive  94/55/EC  and
96/49/EC.

2.  The  user  must  make  available  to  a  notified  body  information  regarding  transportable  pressure
equipment  placed  on  the  market  which  enables  that  body  to  identify  the  equipment  precisely  (origin,
design  rules  and,  for  acetylene  cylinders,  also  details  of  the  porous  mass).  The  user  must,  where
appropriate,  notify  any  prescribed  restrictions  on  use,  and  forward  any  notes  on  possible  damage  or
repairs  which  have  been  carried  out.

The  notified  body  must  also  check  that  valves  and  other  accessories  having  a  direct  safety  function
ensure  a  level  of  safety  in  line  with  that  defined  pursuant  to  Article  3  of  this  Directive.

3.  The  notified  body  must  check  whether  transportable  pressure  equipment  which  has  been  placed  on  the
market affords at least the same degree of safety as the transportable pressure equipment referred to in
Directive 94/55/EC and 96/49/EC. The check must be carried out on the basis of documents produced in
accordance  with  point  2  and,  where  appropriate,  of  further  inspections.

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4.  If the results of the above checks are satisfactory, the transportable pressure equipment must be subject

to  the  periodic  inspection  provided  for  in  Annex  IV,  Part  III.

5.  For  receptacles  manufactured  in  series,  including  their  valves  and  other  accessories  used  for  transport,
the  relevant  conformity  reassessment  operations  relating  to  individual  inspections  of  equipment,  as
indicated  in  points  3  and  4  above,  may  be  carried  out  by  an  approved  body  provided  that  a  notified
body  has  previously  carried  out  the  relevant  conformity  reassessment  operations  indicated  in  point  3.

PART  III

PROCEDURES  FOR  PERIODIC  INSPECTION

Module  1  (periodic  inspection  of  products)

1.  This  module  describes  the  procedure  whereby  an  owner  or  his  authorised  representative  established
within the Community or the holder ensures that the transportable pressure equipment subject to point
3  continues  to  meet  the  requirements  of  this  Directive.

2.  To meet the requirements referred to in point 1 the owner or his authorised representative established in
the Community or the holder must take all measures necessary to ensure that the conditions of use and
of  maintenance  ensure  the  continued  conformity  of  the  transportable  pressure  equipment  to  the
requirements  of  this  Directive,  in  particular  so  that:

—  the  transportable  pressure  equipment  is  used  as  intended,

—  it  is  filled  in  appropriate  filling  centres,

—  any  maintenance  work  or  repairs  are  carried  out,

—  the  periodic  inspections  necessary  are  carried  out.

The  measures  carried  out  must  be  recorded  in  documents  and  held  at  the  disposal  of  the  national
authorities  by  the  owner  or  his  authorised  representative  established  in  the  Community  or  the  holder.

3.  The  inspection  body  must  perform  the  appropriate  examinations  and  tests  in  order  to  check  the
conformity  of  the  transportable  pressure  equipment  with  the  relevant  requirements  of  the  Directive  by
examining  and  testing  every  product.

3.1.  All  transportable  pressure  equipment  must  be  examined  individually  and  appropriate  tests,  as  set
out  in  the  Annexes  to  Directives  94/55/EC  and  96/49/EC,  must  be  carried  out  in  order  to  check
that  it  meets  the  requirements  of  those  Directives.

3.2.  The inspection body must affix its identification number or have it affixed to each product being
periodically  inspected  immediately  after  the  date  of  periodic  inspection  and  draw  up  a  written
periodic-inspection  certificate.  That  certificate  may  cover  a  number  of  items  of  equipment  (group
certificate).

3.3.  The owner or his authorised representative established in the Community or the holder must keep
the  periodic-inspection  certificate  required  under  section  3.2,  and  the  documents  required  under
point  2  at  least  until  the  next  periodic  inspection.

Module  2  (periodic  inspection  through  quality  assurance)

1.  This  module  describes  the  following  procedures:

—  the  procedure  whereby  the  owner  or  his  authorised  representative  established  in  the  Community  or
the  holder,  who  satisfies  the  obligations  of  point  2,  ensures  and  declares  that  the  transportable
pressure equipment continues to meet the requirements of the Directive. The owner or his authorised
representative  established  in  the  community  or  the  holder  must  affix  the  date  of  periodic  inspection
to  all  transportable  pressure  equipment  and  draw  up  a  written  declaration  of  conformity.  The  date
of  periodic  inspection  must  be  accompanied  by  the  identification  number  of  the  notified  body
responsible  for  surveillance  as  specified  in  point  4,

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—  the procedure whereby, in the case of periodic inspection of tanks performed by the approved body
in  accordance  with  the  second  paragraph  of  Article  6(1),  the  approved  body  which  satisfies  the
obligations  of  the  last  paragraph  of  point  2,  certifies  that  the  transportable  pressure  equipment
continues  to  meet  the  requirements  of  this  Directive.  The  approved  body  must  affix  the  date  of
periodic  inspection  to  all  transportable  pressure  equipment  and  draw  up  a  periodic  inspection
certificate. The date of periodic inspection must be accompanied by the identification number of the
approved  body.

2.  The  owner  or  his  authorised  representative  established  in  the  Community  or  the  holder  must  take  all
steps  necessary  to  ensure  that  the  conditions  of  use  and  of  maintenance  are  such  as  to  enable  the
transportable pressure equipment to comply permanently with the requirements of this Directive and in
particular  that:

—  the  transportable  pressure  equipment  is  used  as  intended,

—  it  is  filled  in  appropriate  filling  centres,

—  any  maintenance  work  or  repairs  are  carried  out,

—  the  periodic  inspections  necessary  are  carried  out.

The  measures  carried  out  must  be  recorded  in  documents  and  held  by  the  owner  or  his  authorised
representative  established  in  the  Community  or  the  holder  at  the  disposal  of  the  national  authorities.

The owner or his authorised representative established within the Community or the holder must ensure
that the qualified staff and necessary facilities within the meaning of Annex I, points 3 to 6, are available
for  the  purpose  of  the  periodic  inspections.

The owner or his authorised representative established in the Community or the holder or the approved
body must operate an approved quality system for the periodic inspection and tests of the equipment as
specified  in  point  3,  and  be  subject  to  surveillance  as  specified  in  point  4.

3.  Quality system

3.1.  The  owner  or  his  authorised  representative  established  in  the  Community  or  the  holder  or  the
approved  body  must  lodge  an  application  for  assessment  of  his  quality  system  for  the
transportable  pressure  equipment  with  a  notified  body  of  his  choice.

The  application  must  include:

—  all  relevant  information  on  the  transportable  pressure  equipment  being  submitted  for  periodic

inspection,

—  the  documentation  regarding  the  quality  system.

3.2.  Under  the  quality  system,  each  item  of  transportable  pressure  equipment  must  be  examined  and
appropriate  tests  must  be  carried  out  in  order  to  ensure  its  conformity  with  the  requirements  set
out  in  the  Annexes  to  Directives  94/55/EC  and  96/49/EC.  All  the  elements,  requirements  and
provisions adopted by the manufacturer must be documented in a systematic and orderly manner
in  the  form  of  written  policies,  procedures  and  instructions.  This  quality  system  documentation
must  permit  a  consistent  interpretation  of  the  quality  programmes,  plans,  manuals  and  records.

It  must  contain  in  particular  an  adequate  description  of:

—  the  quality  objectives  and  the  organisational  structure,  responsibilities  and  powers  of  the

management  with  regard  to  the  quality  of  the  transportable  pressure  equipment,

—  the  examinations  and  tests  to  be  carried  out  for  the  periodic  inspection,

—  the  means  of  monitoring  the  effective  operation  of  the  quality  system,

—  the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data,  reports

concerning  the  qualifications  or  approvals  of  the  staff  concerned.

3.3.  The notified body must assess the quality system to determine whether it satisfies the requirements

referred  to  in  3.2.

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The  auditing  team  must  have  at  least  one  member  with  experience  of  assessing  the  transportable
pressure  equipment  concerned.  The  assessment  procedure  must  include  an  inspection  visit  to  the
premises of the owner or of his authorised representative established in the Community or of the
holder  or  of  the  approved  body.

The  decision  must  be  notified  to  the  owner  or  his  authorised  representative  established  in  the
Community or to the holder or the approved body. The notification must contain the conclusions
of  the  examination  and  the  reasoned  assessment  decision.

3.4.  The  owner  or  of  his  authorised  representative  established  in  the  Community  or  the  holder  or  the
approved  body  must  undertake  to  discharge  the  obligations  arising  from  the  quality  system  as
approved  and  to  ensure  that  it  remains  satisfactory  and  efficient.

The  owner  or  of  his  authorised  representative  established  in  the  Community  or  the  holder  or  the
approved  body  must  inform  the  notified  body  which  has  approved  the  quality  system  of  any
intended  adjustment  to  the  quality  system.

The  notified  body  must  assess  the  proposed  changes  and  decide  whether  the  modified  quality
system  will  still  satisfy  the  requirements  referred  to  in  3.2  or  whether  a  reassessment  is
required.

It  must  notify  its  decision  to  the  owner  or  his  authorised  representative  established  in  the
Community or to the holder or the approved body. The notification must contain the conclusions
of  the  examination  and  the  reasoned  assessment  decision.

4.  Surveillance  under  the  responsibility  of  the  notified  body

4.1.  The  purpose  of  surveillance  is  to  make  sure  that  the  owner  or  his  authorised  representative
established  in  the  Community  or  the  holder  or  the  approved  body  duly  fulfils  the  obligations
arising  out  of  the  approved  quality  system.

4.2.  The  owner  or  his  authorised  representative  established  in  the  Community  or  the  holder  or  the
approved  body  must  allow  the  notified  body  access  for  inspection  purposes  to  the  locations  of
inspection,  testing  and  storage  and  provide  it  with  all  necessary  information,  in  particular:

—  the  quality  system  documentation,

—  the  technical  documentation,

—  the  quality  records,  such  as  inspection  reports  and  test  data,  reports  concerning  the

qualifications  of  the  personnel  concerned,  etc.

4.3.  The  notified  body  must  carry  out  periodic  audits  to  make  sure  that  the  owner  or  his  authorised
representative  established  in  the  Community  or  the  holder  or  the  approved  body  maintains  and
applies  the  quality  system  and  provide  the  owner  or  his  authorised  representative  established  in
the  Community  or  the  holder  or  the  approved  body  with  an  audit  report.

4.4. 

In  addition,  the  notified  body  may  pay  unannounced  visits  to  the  owner  or  his  authorised
representative  established  in  the  Community  or  the  holder  or  the  approved  body.  During  such
visits,  the  notified  body  may  if  necessary  perform  tests  or  have  tests  performed  to  verify  if
necessary  that  the  quality  system  is  functioning  correctly.  The  notified  body  must  provide  the
owner  or  his  authorised  representative  established  in  the  Community  or  the  holder  or  the
approved  body  with  a  visit  report  and,  if  a  test  has  taken  place,  with  a  test  report.

5.  The owner or his authorised representative established in the community or the holder or the approved
body  must,  for  a  period  of  10  years  from  the  date  of  the  last  periodic  inspection  of  the  transportable
pressure  equipment,  hold  at  the  disposal  of  the  national  authorities:

—  the  documentation  referred  to  in  the  second  indent  of  the  second  paragraph  of  3.1,

—  the  adjustments  referred  to  in  the  second  paragraph  of  3.4,

—  the  decisions  and  reports  from  the  notified  body  which  are  referred  to  in  the  last  paragraph  of  3.3,

in  the  last  paragraph  of  3.4  and  in  4.3  and  4.4.

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ANNEX  V

MODULES  TO  BE  FOLLOWED  FOR  CONFORMITY  ASSESSMENT

The following table indicates which conformity assessment modules as described in Annex IV, Part I, are to
be  followed  for  the  transportable  pressure  equipment  defined  in  Article  2(1).

Category  of  transportable  pressure  equipment

Modules

1.  Receptacles for which the product of the test pressure and
the capacity is no more than 100 MPa × litre (1 000 bar ×
litre)

2.  Receptacles for which the product of the test pressure and
the capacity is more than 100 and no more than 300 MPa
×  litre  (1 000  and  3 000  bar  ×  litre  respectively)

3.  Receptacles for which the product of the test pressure and
the  capacity  exceeds  300  MPa  ×  litre  (3 000  bar  ×  litre),
and  tanks

A1,  or  B  in  combination  with  C1

H,  or  B  in  combination  with  E,  or  B  in
combination  with  C1

G,  or  H1,  or  B  in  combination  with  D,
or  B  in  combination  with  F

1.  Transportable  pressure  equipment  must  be  subject,  at  the  choice  of  the  manufacturer,  to  one  of  the
conformity  assessment  procedures  laid  down  for  the  category  in  which  it  is  classified.  In  the  case  of
receptacles or their valves or other accessories used for transport, the manufacturer may also choose to
apply  one  of  the  set  procedures  for  the  higher  categories.

2.  As  part  of  the  quality  assurance  procedures,  the  notified  body  must,  when  making  unannounced  visits,
take a sample of the equipment at the manufacturing or storage premises for the purpose of carrying out
a  check,  or  having  a  check  carried  out,  in  conformity  to  the  requirements  of  this  Directive.  For  this
purpose  the  manufacturer  must  inform  the  notified  body  of  the  production  programme  planned.  The
notified  body  must  make  at  least  two  visits  during  the  first  year  of  manufacture.  The  frequency  of
subsequent visits will be determined by the notified body on the basis of the criteria set out in point 4.4
of  the  relevant  modules  in  Annex  IV,  Part  I.

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ANNEX  VI

LIST  OF  DANGEROUS  SUBSTANCES  OTHER  THAN  THOSE  IN  CLASS  2  REFERRED  TO  IN
ARTICLE  2

UN  number

Class

ADR/RID  figures

Dangerous  substances

1051

1052

1790

6.1

8

8

1

6

6

Stabilised  hydrogen  cyanide

Anhydrous  hydrogen  fluoride

Hydrofluoric  acid

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ANNEX  VII

MARK  OF  CONFORMITY

The  conformity  mark  shall  take  the  following  form:

If  the  mark  is  reduced  or  enlarged,  the  proportions  of  the  above  drawing  must  be  respected.

The various components of the mark must have substantially the same vertical dimensions, which may not
be  less  than  5  mm.

This  minimum  dimension  may  be  waived  for  small  devices.

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STATEMENT  OF  THE  COUNCIL’S  REASONS

I. 

INTRODUCTION

The  Commission  submitted  a  proposal  for  a  Council  Directive  on  transportable  pressure
equipment  to  the  Council  on  10  January  1997 (1).

The  proposal  is  based  on  Article  75(1)(c)  of  the  EC  Treaty.

The  European  Parliament  delivered  its  opinion  on  the  Commission  proposal  on  19
February  1998 (2),  and  the  Economic  and  Social  Committee  delivered  its  opinion  on  10
July  1997 (3).

In  the  light  of  the  European  Parliament’s  opinion,  the  Commission  submitted  an  amended
proposal (4)  to  the  Council  on  14  May  1998.

On  30  November  1998,  the  Council  adopted  its  common  position,  in  accordance  with
Article  189c  of  the  EC  Treaty.

II.  AIMS  OF  THE  PROPOSAL

1.  It  will  be  remembered  that  Directive  97/23/EC (5),  which  concerned  the  placing  on  the
market of pressure equipment, excluded transportable pressure equipment (abbreviated
to ‘TPE’ throughout this document) from its scope, stating that such equipment would
be  dealt  with  as  soon  as  possible  by  forthcoming  Community  Directives  in  that  they
were  covered  by  the  provisions  of  the  ADR (6)  and  RID (7),  as  transposed  into
Community  law  in  Directives  94/55/EC (8)  and  96/49/EC (9).

Directives 94/55/EC and 96/49/EC established the technical requirements with regard to
safety  in  the  transport  of  dangerous  goods,  including  the  requirements  applicable  to
TPE.

The purpose of the present proposal is to establish a legal framework for enhancing the
safety  of  TPE  by  means  of  the  uniform  and  compulsory  application  of  the  technical
provisions  applying  to  such  equipment  as  laid  down  in  the  Annexes  to  Directives
94/55/EC and 96/49/EC. Indeed, under those Directive, Member States are not obliged
to give mutual recognition to approvals granted for TPE, in respect of both placing on
the  market  and  periodic  inspections.

(1)  OJ  C  95,  24.3.1997,  p.  2.
(2)  OJ  C  80,  16.3.1998,  p.  212.
(3)  OJ  C  296,  29.9.1997,  p.  6.
(4)  OJ  C  186,  16.6.1998,  p.  11.
(5)  Directive  97/23/EC  of  the  European  Parliament  and  of  the  Council  of  29  May  1997,  on  the
approximation of the laws of the Member States concerning pressure equipment (OJ L 181, 9.7.1997, p.
1).

(6)  ADR:  European  Agreement  concerning  the  International  Carriage  of  Dangerous  Goods  by  Road.
(7)  RID: Regulations concerning the International Carriage of Dangerous Goods by Rail as set out in Annex
I  to  Appendix  B  of  the  amended  version  of  the  Convention  concerning  the  international  carriage  of
goods  by  rail  (COTIF).

(8)  Council  Directive  94/55/EC  of  21  November  1994  on  the  approximation  of  the  laws  of  the  Member
States  with  regard  to  the  transport  of  dangerous  goods  by  road  (OJ  L  319,  12.12.1994,  p.  7),  as
amended by Commission Directive 96/86/EC (OJ L 335, 24.12.1996, p. 43). For the latest amendments
to  the  Annexes,  see  OJ  L  251,  15.9.1997,  p.  1.

(9)  Council  Directive  96/49/EC  of  23  July  1996  on  the  approximation  of  the  laws  of  the  Member  States
with  regard  to  the  transport  of  dangerous  goods  by  rail  (OJ  L  235,  17.9.1996,  p.  25),  as  amended  by
Commission  Directive  96/87/EC  (OJ  L  335,  24.12.1996,  p.  45).

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Currently,  Member  States  may,  regarding  a  transport  operation,  require  equipment
already  approved  in  another  Member  State  to  be  subject  to  further  approval  when
placed  on  the  market  or  used  on  their  territory.

2.  The  proposal  is  not  only  aimed  at  ensuring  the  safety  of  transport  operations  but  also

seeks  to  achieve  freedom  of  movement  for  TPE  throughout  the  Community.

(a) As  regards  freedom  of  movement  for  TPE,  including  its  placing  on  the  market,

transport  and  use,  the  proposal  provides  for:

—  the mutual recognition of approvals granted by inspection bodies which have had
to  meet  common  quality  criteria  before  being  appointed  by  the  competent
national  authorities;  such  bodies  may  be  part  of  the  organisation  which  they
inspect  (type  B  or  type  C  bodies)  or  may  be  completely  separate  from  and
independent  of  the  organisation  (type  A  bodies),

—  the  introduction  of  a  Community  mark  of  conformity,  in  the  form  shown  in
Annex  VII  to  the  proposal,  enabling  approved  TPE  to  be  easily  identified  and
constituting  a  guarantee  of  a  high  safety  level.

Manufacturers will, therefore, no longer have to obtain approval for their TPE from
the national administration of each Member State in which they wish to place their
equipment  on  the  market.  Once  a  Member  State  has  granted  approval  and  a  mark
of  conformity,  they  may  proceed  to  market,  transport  or  use  the  equipment
throughout  the  Community.

The advantage of this new procedure is that the costs and administrative procedures
arising  from  having  to  obtain  approval  for  the  equipment  in  all  the  Member  States
concerned  are  eliminated.

(b) As  regards  the  safety  of  transport  operations,  the  Commission  proposal  provides

for:

—  the  application  of  harmonised  procedures  for  the  the  periodic  inspection  of

existing  TPE.

The approval certificate testifying that the TPE has passed the periodic inspection
will be recognised in all Member States. If the inspection has been carried out by
a  notified  inspection  body  under  the  conditions  laid  down  in  the  proposal,  TPE
complying  with  the  relevant  provisions  of  the  Annexes  to  Directives  94/55/EC
and  96/49/EC  will  be  permitted  to  bear  the  new  Community  mark  given  in
Annex  VII,

—  the  application  of  harmonised  conformity  assessment  procedures,  using  the
module  approach  laid  down  for  all  technical  harmonisation  directives,  for  all
new  TPE  falling  within  the  scope  of  the  Directive  other  than  gas  cylinders
manufactured  in  accordance  with  the  gas  cylinder  Directives  84/525/EEC (1),
84/526/EEC (2)  and  84/527/EEC (3).  Where  approval  for  such  TPE  has  been
granted  by  a  recognised  body,  provision  is  also  made  for  the  equipment  to  bear
the  Community  mark  given  in  Annex  VII.

(1)  OJ  L  300,  19.11.1984,  p.  1.
(2)  OJ  L  300,  19.11.1984,  p.  20.
(3)  OJ  L  300,  19.11.1984,  p.  48.

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Thus:

—  new  TPE,  complying  with  the  relevant  provisions  of  Directives  94/55/EC  and
96/49/EC  and  bearing  the  new  mark  given  in  Annex  VII,  will  be  permitted  to
move  freely  throughout  Community  territory,

—  existing  TPE  complying  with  the  relevant  provisions  of  Directives  94/55/EC  and
96/49/EC  and  on  which  the  mark  given  in  Annex  VII  has  been  affixed  after
passing  the  periodic  inspection,  will  be  permitted  to  be  used  throughout  the
Community.

III.  ANALYSIS  OF  THE  COUNCIL’S  COMMON  POSITION

The  Council’s  common  position  is  essentially  the  same  as  the  Commission  proposal.
However,  it  does  contain  a  number  of  amendments  and  the  main  ones  are  outlined
below.

(a)  Reassessment  of  conformity  for  existing  TPE

The  draft  Directive  common  position  provides  for  the  introduction  of  a  procedure  for
subsequent assessment, at the request of the owner or holder, of the conformity of TPE
already  manufactured  and  put  into  service  before  the  implementation  date  of  this
Directive  with  the  relevant  provisions  of  the  Annexes  to  Directives  94/55/EC  and
96/49/EC. The aim of this procedure is to make the Directive valid for such equipment
(Articles  2  and  5  and  Annex  IV,  Part  II).

A  specific  provision  has  been  included  for  the  reassessment  of  valves  and  other
accessories  used  for  transport  (Annex  IV,  Part  II,  point  2).

If  the  results  of  the  reassessment  are  satisfactory,  the  TPE  must  undergo  the  periodic
inspection  (Annex  IV,  Part  II,  point  4).

(b) TPE  outside  the  scope  of  the  Directive

Unlike  the  Commission  proposal,  the  common  position  specifically  excludes  aerosol
dispensers  and  gas  cylinders  for  breathing  appliances  from  the  scope  of  the  Directive
(Article  2,  definition  of  TPE  and  corresponding  recital  9).

Equipment  used  exclusively  for  transport  with  third  countries  (Article  1(4))  is  also
excluded  from  the  scope  of  the  common  position.

(c)  Notified  bodies  and  approved  bodies

—  Structure

The  common  position  does  away  with  the  type  C  bodies  provided  for  in  the
Commission  proposal  and  establishes  two  types  of  body,  a  notified  body
(corresponding  to  type  A)  and  an  approved  body  (corresponding  to  type  B).

The  notified  body  is  independent  of  the  organisation  which  it  inspects  and  for
which it monitors and provides ‘third party’ inspection services (Articles 2, 3 and 8;
Annexes  I  and  II).

An approved body, on the other hand, is a separate entity and must be identifiable
within  the  organisation  which  it  inspects  (Articles  2,  4  and  9;  Annexes  I  and  III).

Member  States  are,  however,  obliged  to  ensure  that  both  types  of  body  are
sufficiently  independent,

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—  Tasks

A notified body carries out conformity assessment on new TPE intended for placing
on  the  Community  market  with  the  mark  provided  for  in  Annex  VII  to  the  draft
Directive  (Article  3  and  Annex  IV,  Part  I).

The notified body performs reassessment of the conformity of existing types or TPE
(Annex  IV,  Part  II).

It  also  carries  out  periodic  inspections  (Annex  IV,  Part  III,  module  1)  and/or
monitoring  (Annex  IV,  Part  III,  module  2).

The approved body carries out the periodic inspection of receptacles, including their
valves  and  other  accessories  (Annex  IV,  Part  III,  module  1).

Member  States  may  authorise  an  approved  body  to:

—  assess the conformity of receptacles, including their valves and other accessories,
which  are  intended  to  be  placed  on  the  national  market  and  hence  do  not  bear
the  Community  mark  (Article  4),

—  carry  out  the  reassessment  of  the  conformity  of  receptacles,  including  their
valves and other accessories, manufactured in series, provided that conformity of
the  type  is  reassessed  by  a  notified  body  (Article  5(1)),

—  carry  out  periodic  inspections  of  tanks,  acting  under  the  supervision  of  a  body
notified  under  the  procedure  provided  for  in  Annex  IV,  Part  III,  module  2
(Article  6(1)).

(d) Provisions  concerning  valves  and  other  accessories  used  for  transport

The common position provides for a number of provisions on ensuring safety in the use
of  valves  and  other  accessories  to  be  included:

—  in  the  requirements  which  must  be  met  in  the  conformity  assessment  of  new  TPE

intended  to  be  placed  on  the  Community  market  (Article  3(2)  and  (3)),

—  as  part  of  the  reassessment  of  conformity  (Annex  IV,  Part  II,  point  2).

Provisions  relating  to  the  marking  of  new  valves  and  other  accessories  following
conformity  assessment  are  also  included  (Article  10(2)).

(e)  National provisions

The  common  position  stipulates  that  Member  States  may  retain  their  national
requirements  for  devices  intended  for  connection  with  other  equipment,  for  colour
coding  and  for  the  reference  temperature  (Article  7).

(f)  Comittee  procedure

The  common  position  provides  for  the  type  III(a)  Committee  procedure  instead  of  the
type  I  procedure  in  the  Commission  proposal  (Article  15).

(g)  Implementation  of  the  Directive

Since the date of entry into force of the Directive does not tally with the Commission’s
proposed  dates  for  its  transposition,  the  latter  have  been  changed  (Article  16  and
Article  17(1)).

In  addition,  provision  is  made  for  deferral  of  the  Directive’s  implementing  date  for
certain  TPE  (Article  17(2)).

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(h) Transitional  arrangement

The  common  position  provides  for  the  introduction  of  a  transitional  provision
authorising the placing on the market and putting into service of TPE manufactured in
accordance  with  the  regulations  in  force  nationally  before  the  implementation  of  this
Directive  (Article  18).

(i)  Gas cylinders

The  common  position  specifies  which  procedures  are  applicable  to  gas  cylinders:  a
single  conformity  assessment  procedure  for  all  new  TPE,  including  the  gas  cylinders
provided  for  in  Directives  84/525/EEC,  84/526/EEC  and  84/527/EEC  and  also  a
periodic inspection procedure as in the aforementioned three Directives for existing gas
cylinders  (Article  20).

IV.  EUROPEAN  PARLIAMENT  AMENDMENTS

1.  European  Parliament  amendments  accepted  by  the  Commission  and  adopted  by  the

Council

The Council followed the amended Commission proposal and incorporated the content,
if  not  the  wording,  of  the  following  European  Parliament  amendments:

—  in  recital  13,  the  common  position  incorporates  amendment  4,  specifying  that  the

inspection  bodies  must  be  sufficiently  independent,

—  in Article 1(3), Article 16(1) and Article 17(1), the common position takes account
of  amendments  6,  10,  19  and  20,  second  part,  deferring  the  implementing  date  of
the  Directive,  although  the  date  specified  in  the  common  position  is  later,

—  in  Article  2,  point  1,  the  common  position  incorporates  amendment  7,  extending

the  scope  of  the  Directive  to  non-refillable  TPE,

—  In Article 5(1), the common position takes account of amendment 11, providing for
the  introduction  of  a  conformity  reassessment  procedure  for  existing  TPE,  carried
out  by  type  A  bodies  (called  ‘notified  bodies’  in  the  common  position),

—  in  Article  6(2),  the  common  position  takes  account  of  amendment  12,  providing

that  periodic  inspections  may  be  carried  out  in  any  Member  State.

The  council  also  incorporated  amendments  9,  15  and  23,  deleting  the  provisions
concerning  type  C  inspection  bodies,  namely  the  definition  in  Article  2,  and  Article  7
and  Annex  IV,  which  formed  part  of  the  Commission  proposal.

In  line  with  the  Commission’s  amended  proposal,  the  common  position  also  deletes
Annex  III(4),  with  a  view  to  extending  the  powers  of  type  B  bodies  (called  ‘approved
bodies’  in  the  common  position.

2.  European Parliament amendments not accepted by the Council and not included by the

Commission

In  accordance  with  the  Commission’s  amended  proposal,  the  Council  did  not  accept:

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—  amendment  1,  which  would  introduce  into  the  fifth  recital  other  aims  than  the
Directive  should  pursue.  The  Council  thought  it  preferable  for  this  recital  to  refer
only  to  the  main  aim  of  the  Directive,  namely  the  safety  of  the  transport  of  TPE,

—  amendments  2  and  3,  which  would  introduce  drafting  and  other  changes  into  the
sixth  and  tenth  (ninth  in  the  amended  proposal)  recitals.  The  Council  felt  that  the
text  of  the  amended  proposal  was  more  precise,

—  amendment  14,  which  would  amend  Article  9  of  the  common  position,  limiting
application of that Article to existing approved bodies alone. The Council felt that a
provision  of  this  kind  would  be  too  restrictive  and  that  access  to  the  marked  by
new  approved  bodies  should  not  be  prevented,

—  amendment  16,  which  would  add  to  Article  9  a  paragraph  laying  down  that
approved  bodies  should  be  subject  to  inspection  at  least  once  a  year,  and
amendment  20,  first  part,  which  would  introduce  into  Article  19  a  provision  to
ensure that the penalties adopted by Member States did not diverge too widely. The
Council  felt  that  the  frequency  of  inspections  and  the  detail  of  the  penalties  fell
directly  within  the  competence  of  the  Member  States,

—  amendment  22,  which  would  amend  Annex  III(2)  in  the  sense  that,  where  the
approved  body  has  carried  out  maintenance  of  the  TPE,  it  could  not  longer  carry
out the periodic inspection of the equipment. The Council felt that such a provision
would  be  too  restrictive.