Amended proposal for a Directive of the European Parliament and of the Council on machinery and amending Directive 95/16/EC (presented by the Commission pursuant to Article 250 (2) of the EC-Treaty)
Date: 2003-02-11
Institutions: European Commission
Subjects: building safety, lift, product safety, proposal (EU)

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 11.2.2003
COM(2003) 48 final

2001/0004 (COD)

Amended proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on machinery and amending Directive 95/16/EC

(presented by the Commission pursuant to Article 250 (2)
of the EC-Treaty)

2001/0004 (COD)

Amended proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on machinery and amending Directive 95/16/EC

(Text with EEA relevance)

1.

BACKGROUND

Transmission  of  the  proposal  to  the  Council  and  the  European
Parliament  [COM(2000) 899  -  2001/0004 (COD)]  in  accordance  with
article 95 of the Treaty

26 January 2001

Opinion of the European Economic and Social Committee

12 September 2001

Opinion of the European Parliament - first reading

4 July 2002.

2.

OBJECTIVE OF THE PROPOSAL

The  aim of the  initial  proposal  was  to  ensure  the  free  movement  of  the  products  within  the
scope by guaranteeing a high level of protection in the areas of health, safety  and consumer
protection.  The  products  within  the  scope  are  essentially  machinery  and  products  used  in
conjunction with such machinery.

In  line  with  the  conclusions  of  the  1994  Molitor  report  the  objective  of  the  initial  proposal
was to provide a better definition of various concepts, to clarify certain aspects and to better
ensure its uniform application. To this end, the explanations of the conformity assessment and
market  surveillance  procedures  were  improved,  avoiding  divergent  interpretations  of  these
procedures.

The  initial  proposal  for  a  revision  to  the  Directive  was  prepared  on  the  basis  of  proposals
drawn up by up a high-level group of independent experts from various backgrounds. It also
took account of  the  experience  gained in the practical application  of  the  amended  Directive
89/392/EEC1.

The main elements of the initial proposal were as follows:

(cid:1)  Better  definition  of  the  scope  of  the  directive,  clarification  of  the  borderline  with  other
directives, in particular the Low Voltage and the Lifts Directives, and a clearer description
of the concept of “Partly Completed Machinery”.

1

Council Directive 89/392/EEC of 14 June 1989 on the approximation of the laws of the Member States
relating to machinery/* Codified version CF 398L0037 */ Official Journal L 183 , 29/06/1989 P. 0009 -
0032  Finnish  special  edition:  Chapter  13  Volume  19  P.  0023  Swedish  special  edition:  Chapter  13
Volume 19 P. 0023 CONSLEG - 89L0392 - 30/08/1993 - 78 P.

2

                                                
(cid:1)  Strengthening  of  the  provisions  relating  to  market  surveillance  and  to  the  notification  of

conformity assessment bodies.

(cid:1)  Introduction of a full quality assurance procedure for certain categories of machinery.

In its amended proposal, the Commission has incorporated many of the suggestions from the
European Parliament, with an aim to further improve the Directive.

Due  to  divergences  between  the  language  versions  of  the  Wieland  report,  a  number  of
amendments have changed in the adopted text compared to the Wieland report, on which the
Commission  based  its  statements  in  the  plenary  session  of  the  European  Parliament.  As  a
result of these divergences amendments 23, 47, 59 and 63 are accepted in part as outlined in
the following chapters.

3.

3.1.

COMMISSION OPINION ON THE AMENDMENTS ADOPTED BY THE PARLIAMENT

Amendments accepted in full by the Commission (2, 3, 16, 18, 42, 66, 69, 72, 74,
75, 76)

The  Commission  can  accept  in  full  amendments  2  and  3,  which  introduce  useful  recitals
clarifying the scope of the Directive.

The  Commission  can  accept  in  full  amendment  16,  on  Article  3  paragraph  2,  proposing  to
delete Article 3 paragraph 2. This paragraph is no longer necessary, since the revised version
of the General Product Safety Directive 2001/95/EC 2, clearly establishes the borderline with
this Directive.

The  Commission  can  accept  in  full  amendment  18,  on  Article  6,  paragraph  1,  which
simplifies the text.

The  Commission  can  accept  in  full  amendment  42,  on  Annex  I,  point  1.1.2,  point  (a),
subparagraph  2,  which  introduces  a  clearer  representation  of  the  different  phases  in  the
lifecycle of a product.

The  Commission  can  accept  in  full  amendment  66,  on  Annex  I,  point  4.3.1,  paragraph  2,
which is an editorial improvement.

The Commission can accept in full amendment 69, on Annex I, point 6.4, which improves the
text.

The Commission can accept in full amendment 72, on Annex I, point 8.2, which improves the
safety level for construction site hoists.

The Commission can accept in full amendment 74, on annex II, Section A, point 1, which is
an improvement to the text.

The Commission can accept in full amendment 75, on Annex  II, Section A, points  4  and  5,
which is an improved drafting compared to the proposal.

2

Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general
product safety (Text with EEA relevance) Official Journal L 011 , 15/01/2002 P. 0004 - 0017

3

                                                
The  Commission  can  accept  in  full  amendment  76,  on  Annex  III,  paragraph  4,  which
simplifies the application of the CE marking.

3.2.

Amendments accepted in principle by the Commission (22, 30, 41, 51, 62, 64)

The Commission can accept in principle amendment 22, on Article 12, paragraph 1, subject to
the following rewording:

"Following  risk  analysis  carried  out  in  the  light  of  the  principles  of  safety
integration  (Annex  I,  point  1.1.2),  the  manufacturer  or  his  authorised
representative  shall  apply  one  of  the  procedures  for  the  assessment  of
conformity described in paragraphs 2 to 5."

The Commission can accept in principle the contents of amendment 30, on Article 17 b (new)
or  rather  Article  14  as  in  the  Commission's  proposal,  which  introduces  substantial
improvements  for  the  designation  of  notified  bodies,  provided  that  the  article  is  kept  in  its
original place as Article 14 and subject to the following rewording:

"Article 14

Notified bodies

1. Member States shall notify the Commission and the other Member States of
the bodies which they have appointed to carry out the assessment of conformity
for placing on the market referred to in Article 12(4) and (5), together with the
specific  tasks  which  these  bodies  have  been  appointed  to  carry  out  and  the
identification  numbers  assigned  to  them  beforehand  by  the  Commission.
Member  States  shall  notify  the  Commission  and  other  Member  States  of  any
subsequent amendment.

2.  The  Member  States  shall  ensure  that  the  notified  bodies  are  monitored
regularly  to  check  that  they  comply  at  all  times  with  the  criteria  set  out  in
Annex XII. The notified body shall provide all relevant information on request,
including budgetary documents, to enable the Member State to ensure that the
requirements of the Annex XII are met.

3. Member States shall apply the criteria referred to in Annex XII in assessing
the bodies to be notified and the bodies already notified.

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

5. Bodies meeting the assessment criteria laid down in the relevant harmonized
standards, the references of which shall be published in the Official Journal of
the  European  Communities  pursuant  to  this  Directive,  shall  be  presumed  to
fulfil the relevant criteria.

6. If a notified body finds that relevant requirements of this Directive have not
been met or are no longer met by the manufacturer or that a certificate should
the  principle  of
not  have  been 
issued  or  place
proportionality,  suspend  or  withdraw 

taking  account  of 
the  certificate 

it  shall, 

issued, 

4

restrictions on it unless  compliance with such requirements is ensured by the
implementation of appropriate corrective measures by the manufacturer. In the
case of suspension or withdrawal of the certificate or of any restriction placed
on  it,  or  in  cases  where  intervention  by  the  competent  authority  may  prove
necessary,  the notified body shall inform the  competent authority  pursuant  to
Article 4 thereof. The Member State shall inform the other Member States and
the Commission without delay.

7.  The  Commission  shall  provide  for  the  organization  of  an  exchange  of
experience  between:  (a) 
for  appointment,
notification and surveillance in the Member States, and (b) the notified bodies,
in order to coordinate the uniform application of this Directive.

the  authorities  responsible 

8.  A  Member  State  which  has  notified  a  body  must  immediately  withdraw  its
notification if it finds:

(a)  that  the  body  no  longer  meets  the  criteria  referred  to  in  Annex  XII,  or
(b) that the body seriously fails to fulfil its responsibilities.

It  shall  immediately  inform  the  Commission  and  the  other  Member  States
accordingly."

Amendment  41,  on  Annex  I,  point  1.1.1,  can  be  accepted  in  principle,  given  the  need  to
introduce 'hazard', by the Commission subject to the following rewording:

"For the purpose of this Annex:

1. 'hazard' means the possible occurrence of an injury to a person or damage
to a person's health;

2. 'risk' means a combination of the probability and the degree of an injury or
damage to health that can arise in a hazardous situation;

3. 'danger zone' means any zone within and/or around machinery in which an
exposed person is subject to a risk to his health or safety;

4. 'hazardous  situation' means a  combination of circumstances specifically in
association with which a risk may materialise;

5. 'exposed person' means any person wholly or partially in a danger zone;

6.  'operator'  means  the  person  or  persons  given  the  task  of  installing,
operating, adjusting, maintaining, cleaning, repairing or moving machinery;

7. 'guard' means a part of a machine used specifically to provide protection by
means of a physical barrier;

8. 'protective device' means a device  (other than a guard) which  eliminates a
potential  danger  or  reduces  the  risk  to  an  acceptable  level,  alone  or  in
conjunction with a guard.

The Commission can accept amendment 51, on Annex I, point 1.6.1, paragraph 2, in principle
subject to the following rewording:

5

"The  safety  requirements  set  out  in  Council  Directive  73/23/EEC  on  the
harmonization  of  the  laws  of  the  Member  States  relating  to  electrical
equipment  (1)  designed  for  use  within  certain  voltage  limits  must  apply  to
machinery.  The  conformity  assessment  of  the  machinery  with  regard  to  the
electrical  hazards  must  be  governed  solely  by  the  provisions  of  the  present
Directive."

(1)  (OJ  L  77,  26.3.1973,  p.29).  Directive  as  last  amended  by  Directive
93/68/EEC (OJ L 220, 30.8.1993, p. 1)

The Commission can accept amendment 62, on Annex I, point 4.1.2.2, paragraphs 6 and 7, in
principle subject to the following rewording:

"The static and dynamic tests may, in the case of series production, be made on
technically comparable machinery representing intended production

In  the  case  of  single  unit  production,  the  static  and  dynamic  tests  must  be
performed on all machinery ready to be put into service.

As a general rule, the tests will be performed at the nominal speeds provided
for.  Should  the  control  circuit  of  the  machinery  allow  for  a  number  of
simultaneous  movements,  the  tests  must  be  carried  out  under  the  least
favorable  conditions,  i.e.  as  a  general  rule,  by  combining  the  movements
concerned."

The  Commission  can  accept  amendment  64,  on  Annex  I,  point  4.2.2,  Introduction,  in
principle subject to the following rewording:

"Machinery with a maximum working load of more than 1 000 kilograms or an
overturning  moment  of  more  than  40  000  Nm  must  be  fitted  with  devices  to
warn the driver and prevent dangerous movements in the event of:"

3.3.

Amendments accepted in part by the Commission (14, 15, 17 and 82, 23, 27, 45
and 36, 47, 49, 56, 57, 59, 61 and 38, 63, 80)

Amendment  14,  on  Article  1,  introduces  numerous  simplifications  and  improvements  to
Article 1 on the scope of the Directive. The Commission can therefore accept amendment 14
in part subject to the following rewording:

“1. This Directive applies to the following products as defined in Article 2:

(a) machinery;
(b) interchangeable equipment;
(c) safety components;
(d) lifting accessories;
(e) removable mechanical transmission devices;
(f) partly completed machinery.

2. The following are excluded from the scope of this Directive:

(a)  components,  including  safety  components,  or  equipment,  including
interchangeable  equipment,  intended  to  be  used  as  spare  parts  to  replace
identical  components  or  equipment  supplied  by  the  manufacturer  of  the

6

original machinery or by a third party in accordance with the manufacturer's
instructions;
(b)  specific  equipment  for  use  in  fairgrounds  and  amusement  parks;
(c)  machinery  specially  designed  or  put  into  service  for  nuclear  purposes
which,  in  the  event  of  failure,  may  result  in  an  emission  of  radioactivity;
(d) firearms;
(e) the following means of transport:
- agricultural and forestry tractor covered by Directive 74/150/EEC (1);
- motor vehicles and their trailers covered by Directive 70/156/EEC(2);
- vehicles covered by Directive 92/61/EEC(3);
- motor vehicles exclusively intended for competition;
and means of transport by air, on water and on rail networks.
Machinery mounted on these means of transport is not excluded.

(1) Official Journal L 084 , 28/03/1974 P. 0010 - 0024 Finnish special edition:
Chapter 13 Volume 3 P. 0227 Greek special edition ....: Chapter 13 Volume 2
P. 0209 Swedish special edition: Chapter 13 Volume 3 P. 0227 Spanish special
edition: Chapter 13 Volume 3 P. 0183 Portuguese special edition Chapter 13
Volume 3 P. 0183.
(2) Official Journal L 042 , 23/02/1970 P. 0001 - 0015 Finnish special edition:
Chapter 13 Volume 1 P. 0120 Danish special edition: Series I Chapter 1970(I)
P. 0082 Swedish special edition: Chapter 13 Volume 1 P. 0120 English special
edition: Series I Chapter 1970(I) P. 0096 Greek special edition ....: Chapter 13
Volume  1  P.  0046  Spanish  special  edition:  Chapter  13  Volume  1  P.  0174
Portuguese special edition Chapter 13 Volume 1 P. 0174
(3) Official Journal L 225 , 10/08/1992 P. 0072 - 0100 Finnish special edition:
Chapter 13 Volume 23 P. 0154 Swedish special edition: Chapter 13 Volume 23
P. 0154

(f) seagoing vessels and mobile offshore units and machinery installed on
board such units;
(g) machines specially designed and constructed for military or police
purposes;
(h) mine winding gear;
(i) machinery intended to move performers during artistic performances;

(j) electrical and electronic products falling into the following areas, in so far
as they are covered by Council Directive 73/23/EEC(1) of 19 February 1973
on the electrical equipment designed for use within certain voltage limits:

household appliances,
audio and video equipment,
information technology equipment,

(i)
(ii)
(iii)
(iv) office machinery and equipment,
(v)

circuit breakers and switches,

(k)the following types of high-voltage electrical equipment:

(i)
(ii)

switch gear and control gear,
transformers;

(l) motors of all types;
(m) industrial sites taken as a whole;
(n) medical devices”

7

(1) Official Journal L 077 , 26/03/1973 P. 0029 - 0033 Finnish special edition:
Chapter 13 Volume 2 P. 0167 Greek special edition ....: Chapter 13 Volume 2
P. 0058 Swedish special edition: Chapter 13 Volume 2 P. 0167 Spanish special
edition: Chapter 13 Volume 2 P. 0182 Portuguese special edition Chapter 13
Volume 2 P. 0182.

The  Commission  can  accept  amendment  15,  on  Article  2,  paragraphs  1  and  2,  introduction
and points (a) to (k), in part subject to the following rewording:

"For the purposes of this Directive, "machinery" means the products defined in
points (a) to (h).

The following definitions shall apply:

(a) "machinery stricto sensu":

(i)

an assembly, fitted with or intended to be fitted with a drive system
other  than  directly  applied  manual  or  animal  effort,  consisting  of
linked parts or components, at least one of which moves, and which
are joined together for a specific application,

(ii) machinery  referred  to  in  (i),  missing  only  the  components  to

connect it on site or to sources of energy and motion,

(iii) machinery  referred  to  in  (i),  ready  to  be  installed  and  able  to
function as it stands only if mounted on a vehicle or installed in a
building or a structure,
lifting  apparatus  whose  only  power  source  is  directly  applied
manual effort;

(iv)

(b)"assembly of machinery" means an assembly of machinery and/or of partly
completed  machinery  which,  in  order  to  achieve  the  same  end,  are  arranged
and controlled so that they function as an integral whole;
(c) "interchangeable equipment" means a device which, after the placing into
service  of  machinery  or  of  a  tractor,  is  assembled  with  that  machinery  or
tractor  by  the  operator  himself  in  order  to  change  its  function  or  attribute  a
new function in so far as this equipment is not a spare part or a tool;
(d) "safety component" means a component included in the list below

- which serves to fulfil a safety function and

- which is independently placed on the market and

-  for which the failure and/or  malfunction  endangers  the  safety  of  persons  in
the danger zone of the machinery and

- which is not necessary in order  for the machinery to  function, or for  which
normal components may be substituted in order for the machinery to function:

(i)
(ii)

(iii)
(iv)
(v)

components referred to in points 19 and 20 of Annex IV,
safety logic units for an emergency stop or movable guard control
circuit,
solenoid valves controlling dangerous movements of machinery,
smoke and dust extraction systems for machinery,
guards  and  protection  devices  and  their  locking  mechanisms  for
machinery,

8

(vi)

control  devices  for  calling  lifting  appliances  and  anti-fall  devices
for hoists,

(vii) devices for preventing lifting appliances from colliding,
(viii) safety belts and seat harnesses,
(ix) non-return valves for installation on hydraulic circuits,
guards for removable mechanical transmission devices;
(x)

(e)  "lifting  accessory"  means  a  component  or  equipment  not  attached  to  the
lifting  machinery,  allowing  the  load  to  be  held,  which  is  placed  between  the
machinery and the load or on the load itself, or which is intended to constitute
an integral part of the load and which is independently placed on the market;
slings and their components are also regarded as lifting accessories;
transmission  device"  means  a  removable
(f)  "removable  mechanical 
component  for  transmitting  power  between  a  self-propelled  machine  or  a
tractor and another machine by joining them at the first fixed bearing. At least
one of these two machines must be mobile;
(g)  "guard  for  a  removable  mechanical  transmission  device"  means  a  device
protecting  persons  exposed  from  the  risk  of  being  dragged  along  by  a
removable transmission mechanical device;
(h) "portable cartridge-operated device" means a portable device intended for
industrial and technical use making use of an explosive charge in the form of a
cartridge,  whereby  energy  is  transmitted  from  the  cartridge  to  the  projectile
via an intermediary component and not by direct action, for the purposes of:

fixing a metal part in a material, or
slaughtering animals, or

(i)
(ii)
(iii) marking an object by cold engraving, or
(iv)

crimping cables;

(i) "partly completed machinery" means an assembly, fitted or intended to  be
fitted with a drive system, of linked parts or mechanical components which are
almost a machine but which cannot themselves perform a specific application.
Partly completed machinery is intended to be incorporated into or assembled
with  one  or  more  machines  or  other  partly  completed  machinery,  thereby
forming a single machine to which this Directive applies;
(j)  "placing  on  the  market"  means  making  available  for  the  first  time  in  the
Community machinery intended for an end user, whether for reward or free of
charge;
(k)  "manufacturer"  means  any  natural  or  legal  person  who  designs  or
manufactures machinery covered by this Directive, with a view to placing it on
the market, under his own name or trademark. The manufacturer may also be:
any  natural  or  legal  person  who  designs  or  manufactures  a
machine  covered  by  this  Directive,  or  who  has  such  a  machine
designed or manufactured, for his own use,
any natural or legal person who, when a machine covered by this
Directive is placed on the market or put into service, is responsible
for its conformity to this Directive;"

(ii)

(i)

The  Commission  can  accept  amendments  17  and  82,  on  Article  5,  in  part  subject  to  the
rewording below:

"1. Before placing a machine on the market and/or putting it into service, the
manufacturer or his authorised representative must:

9

(a) ensure that it satisfies the essential health and safety requirements set out
in Annex I;
(b)  carry  out  the  appropriate  conformity  assessment  procedure  under  Article
12;
(c) draw up the EC declaration of conformity in accordance with Section A of
Annex II and attach it with the machine;
(d) affix the CE marking in accordance with Article 16, and
(e) provide, in particular, the necessary information, such as instructions.

2. Before placing partly completed machinery on the market, the manufacturer
or his authorised representative must ensure that the procedures referred to in
Article 13 have been completed.

3.  For  the  purposes  of  the  procedure  referred  to  in  Article  12,  the
manufacturer  or  his  authorised  representative  must  have,  or  have  access  to,
the necessary means of ensuring that the machine satisfies the essential health
and safety requirements set out in Annex I.

4. Where machinery is also the subject of other Community Directives relating
to  other  aspects  and  providing  for  the  affixing  of  the  CE  marking,  the  latter
shall indicate that the machinery also conforms to the provisions of those other
Directives.

However, where one or more of those Directives allow the manufacturer or his
authorised representative to choose, during a transitional period, the system to
be applied, the CE marking shall indicate conformity only to the provisions of
those Directives applied by the manufacturer or his authorised representative.

Particulars of the Directives applied, as published in the Official Journal of the
European  Communities,  must  be  given  on  the  EC  declaration  of  conformity
which accompanies the machine."

The  suggested  text  originating  from  amendment  82,  regarding  the  responsible  person  for
placing machinery on the market, is not accepted since the definition of manufacturer covers
this.  Furthermore,  Article  5  outlines  the  obligations  of  the  manufacturer  and  not  whom  to
consider to be a manufacturer.

The Commission  can accept in  part amendment  23, on  Article 12  paragraph  4,  introduction
and point (-a) (new), subject to the following rewording:

"4. Where the risk analysis does not enable the conclusion to be drawn that the
Directive has no relevance and the  machinery is referred to  in Annex  IV  and
manufactured  in  accordance  with  the  harmonised  standards  referred  to  in
Article 7(2) and provided that those standards cover  all of  the relevant  risks,
the manufacturer or his authorised representative shall, in order to certify its
conformity  with  the  provisions  of  this  Directive,  apply  one  of  the  following
procedures:

(a)  the  procedure  for  assessment  of  conformity  with  internal  checks  on  the
manufacture provided for in Annex VII;"

10

The Commission can accept amendment 27, on Article 16, paragraph 3, in part subject to the
following rewording:

"3.
The affixing on machinery of markings, signs or inscriptions which are
likely  to  mislead  third  parties  as  to  the  meaning  or  form  of  the  CE  marking
shall be prohibited.

Any other marking may be affixed to the machinery provided that the visibility,
legibility and meaning of the CE marking is not thereby impaired."

The Commission can accept amendments 45 and 36, on Annex I, point 1.2.1, in part subject
to the following rewording:

"Control systems must  be designed and constructed so that they  are safe and
reliable. Above all they must be designed and constructed in such a way that:

- the rigors of normal use and external factors,

- human error during operation, and

- defects and failure of control systems,

do not lead to hazardous situations."

The  part  originating  from  amendment  36,  replacing  "hazardous  situation"  with  "hazard
situation"  throughout  the  Directive  cannot  be  accepted,  since  the  Commission  is  of  the
opinion that the term "hazardous situation" is adequate.

The Commission can accept amendment 47, on Annex I, point  1.3.1 paragraphs 1  and  2, in
part subject to the following rewording:

"Machinery  and  its  components  and  fittings  must  be  so  designed  and
constructed  that  they  are  stable  enough  for  use  without  risk  of  overturning,
falling or unexpected movement.

For  the  purposes  of  this  paragraph,  use  includes  transportation,  assembly,
dismantling, scrapping and any other action involving the machinery."

The Commission can accept amendment 49, on Annex I, point 1.4.2.1, in part subject to the
following rewording:

"They must be fixed by systems that can be opened only with tools. Their fixing
systems must remain attached to the guards or to the machine when removed."

The  Commission  can  accept  amendment  56,  on  Annex  I,  point  1.9,  in  part  subject  to  the
following rewording:

"All  machinery  must  be  marked  legibly  and  indelibly  with  the  following
minimum particulars:

-  the  name  and  address  of  the  manufacturer  and,  where  applicable,  his
authorised representative (1),

11

- where applicable, the name and address of the natural or legal person who
assumes responsibility for its conformity to this Directive,

- designation of the machinery,

- CE marking,

- designation of series or type,

- serial number, if any,

- the year of construction (2).

Furthermore,  machinery  designed  and  constructed  for  use  in  a  potentially
explosive atmosphere must be marked accordingly.

Machinery must also bear full information relevant to its type and essential to
its safe use.

Where a machine  part  must  be handled  during use with lifting  equipment,  its
mass must be indicated legibly, indelibly and unambiguously."

(1)  Business  name  and  full  address;  where  the  marking  is  established  by  the
authorised representative, the business name and address of the manufacturer
must also be shown.
(2) The year of construction is the date with which the end of the manufacturing
process must coincide stricto sensu. The EC declaration of conformity must be
established on that date. It is therefore formally prohibited to pre-date or post-
date the machinery when affixing the CE marking.

The Commission can accept amendment 57, on Annex I, points 1.10 and 1.10.1, points (a) a
nd (b), in part subject to the following rewording:

"1.10. Instructions

Every machine must be accompanied by instructions in the official Community
language(s)  which  may  be  determined  by  the  Member  State  in  which  it  is
placed on the market and/or put into service.

The  instructions  accompanying  the  machine  must  be  either  "Original
instructions" or a "Translation of the original instructions", in which case the
translation must be accompanied by the original instructions.

The  instructions  must  be  drafted  in  accordance  with  the  principles  set  out
below.

1.10.1. General principles on the drafting of instructions

(a) The contents of the instructions must be limited to the machine in question
and cover not only the normal use of the machinery but also uses  which may
reasonably be expected of it.
(b)  The  manufacturer  must  draft  the  instructions  in  an  official  Community
language.  The  words  "Original  instructions"  should  appear  on  the  language
version(s) verified by the manufacturer. If the manufacturer verify versions of

12

the  instructions  in  other official Community  languages,  these  versions  should
also bear the words "Original instructions".

The  Commission  can  accept  in  part  amendment  59,  on  Annex  I,  point  2.2.2,  paragraph  4,
subject to the following rewording:

" If  and in so far as no applicable and  generally recognised rules for  testing
exist,  the  manufacturer  must  state  the  measuring  procedure  used  and  the
conditions under which the measurement was carried out."

The Commission can accept amendment 61 and 38, on Annex I, point 4.1.1, points (b) to (h)
in part subject to the following rewording:

"(b)  'Slinging  device':  an  accessory,  not  forming  part  of  lifting  apparatus,
which  can  be  used  to  make  a  connection,  with  or  without  lifting  devices,
between a load suspension device and a load.
(c) 'Separate lifting accessory': a lifting accessory which helps to make up or
use a slinging device.
(d)  'Guided  load':  load  where  the  total  movement  is  made  along  rigid  or
flexible guides, whose position is determined by fixed points.
(e) 'Working coefficient': the arithmetic ratio between the load guaranteed by
the manufacturer or his authorized representative up to which a piece of lifting
machinery  or  equipment  or  an  accessory  is  able  to  hold  it  and  the  maximum
working  load  marked  on  the  machinery,  equipment  or  accessory  or
respectively.
(f) 'Test coefficient': means the arithmetic ratio between the load used to carry
out the static or dynamic tests on a piece of lifting machinery or equipment or
an  accessory  and  the  maximum  working  load  marked  on  the  piece  of
machinery or equipment or accessory.
(g) 'Static test': the test during which the machinery or the lifting accessory is
first inspected and subjected to a force corresponding to the maximum working
load multiplied by the appropriate static test coefficient and then re-inspected
once the said load has been released to ensure no damage has occurred.
(h) 'Dynamic test': the test during which the machinery or lifting accessory is
operated in all its possible configurations at maximum working load multiplied
by  the  appropriate  dynamic  test  coefficient  with  account  being  taken  of  the
dynamic  behaviour of the  machinery  in  order  to  check  that  the  machinery  or
the lifting accessory is functioning properly.
(i) 'Nominal load': the load on which the design of lifting apparatus for a given
purpose and a given configuration is based;

The part originating from amendment 38, replacing "maximum working load" with "nominal
load"  throughout  the  Directive  cannot  be  accepted,  since  the  Commission  is  of  the  opinion
that  the  term  "maximum  working  load"  is  a  well  established  and  well  understood  concept
already used in the current Machinery Directive.

The  Commission  can  accept  in  part  amendment  63,  on  Annex  I,  point  4.2.1,  subject  to  the
following rewording:

Hold-to-run  control  devices  must  be  used  to  control  the  movements  of  the
machinery  or  its  equipment.  Where  there  is  no  risk  of  the  load  or  the
machinery colliding, the said devices may be replaced by actuators authorising

13

automatic  stops  at  preselected  levels  without  the  operator  holding  a  hold-to-
run control device.

The Commission can accept amendment 80 in part subject to the following rewording:

"(2a)  The  body  must  participate  in  the  coordination  aimed  at  the  uniform
application of this Directive, in accordance with Article 14."

3.5.

Amendments not accepted by the Commission (1, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13,
19, 20, 24, 25, 26, 28, 29, 31, 32, 33 and 37, 34, 35, 40, 44, 48, 50, 55, 58, 60, 65,
67, 70, 71, 73, 77, 78, 79, 83)

The  Commission  cannot  accept  amendment  1,  on  recitals,  which  adds  environmental
performance to the recital, since this is outside the scope of the Machinery Directive.

The  Commission  cannot  accept  amendment  4,  on  recitals,  which  introduces  special
considerations to machinery without or with a very small risk. The Directive aims to provide
free circulation for all kinds of machinery, also for products without risks and with very small
risks. However, according to the proposal lighter requirements apply to these products.

The  Commission  cannot  accept  amendment  5,  on  recitals,  which  urges  the  Commission  to
take measures in the field of equipment used in fairgrounds and amusement parks, since it is
not adequate to have such a consideration in the recitals. The Commission is however aware
of the legislative gap in this area of the Community legislation.

The Commission cannot accept amendments 6, 7, 8 and 11, on the recitals on CE marking and
other  voluntary  marking,  since  this  approach  would  be  too  restrictive.  Furthermore,  the
Commission  is  considering  measures  that  would  address  this  issue  at  a  horizontal  level
ensuring a common application for all New Approach Directives.

The Commission cannot accept amendments 9, 20 and 32, on comitology. Delegation to the
Commission is necessary for the areas that are identified in its original proposal. Furthermore,
they  are  in  contradiction  with  the  Council  Decision  1999/468/EC  of  28  June  19993,  laying
down the procedures for the exercise of implementing powers conferred on the Commission.

The Commission cannot accept amendment 10, on recitals, where  the  Commission  is  called
upon to  investigate if  a separate Directive for high-voltage  equipment  should  be  developed.
Such a consideration is not adequate in the recitals.

The Commission cannot accept amendment 12, introducing a recital on old machinery, since
it is outside the scope of the Directive, which covers machinery placed on the market and/or
put into service for the first time.

The Commission cannot accept amendment 13, on recitals, which urges the European Union
to ensure that codified versions of legal acts are published, since it is outside the scope of the
Machinery  Directive.  Furthermore  the  Commission  often  provides  consolidated  versions  on
its website.

The  Commission  cannot  accept  amendment  19,  on  Article  7,  paragraph  2,  on  harmonised
standards for machinery, since it does not clearly improve the text.

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14

                                                
The Commission cannot accept amendment 24, on Article 12,  paragraph 5,  introduction,  on
conformity assessment, since there is no clear improvement of the text.

The  Commission  cannot  accept  amendment  25,  on  deleting  Article  13  on  procedures  for
partly  completed  machinery.  The  Commission  considers  it  important  to  provide  clarity  by
keeping all dispositions relating to partly completed machinery in a separate article.

The  Commission  cannot  accept  amendment  26,  which  deletes  Article  14  on  notified  bodies
and reinstates it as Article 17b, since moving this Article does not add any value to the text.

The  Commission  cannot  accept  amendments  28  and  29,  on  a  new  Article  17a  on  market
surveillance replacing Article 4, since they deviate from the well-established structure of most
New Approach Directives.

The  Commission  cannot  accept  amendment  31,  on  Article  18,  which  alters  the  Article  on
confidentiality, since there is no clear added value from the changes.

The Commission cannot accept amendments 33 and 37, on Article 24, point 1, on Article 1,
paragraphs  2  and  3  of  the  Lifts  Directive  95/16/EC4,  since  they  do  not  bring  any  clear
improvements to the text.

The  Commission  cannot  accept  amendment  34,  on  Article  26  a  (new),  introducing  a  new
Article  demanding  that  the  Commission  takes  certain  measures  related  to  the  general
evaluation of the New Approach concept. This is clearly outside the scope of the Machinery
Directive as such and has no place in this Directive. However,  the Commission  is currently
preparing  a  Communication  on  the  New  Approach  concept  that  addresses  many  of  the
concerns of the Parliament.

The Commission cannot accept amendment 35, on Article 27, on the entry into force of the
future Directive, since it is not in line with the provisions of the Treaty in this area.

The Commission cannot accept amendment 40, on Annex I, Preliminary Observations, point
3, since it does not add any value to the text.

The Commission cannot accept amendment 44, on Annex I, point 1.1.6, paragraph 2, on the
handling and transportation of machinery, since the proposed drafting does not add any value
and  furthermore  is  against  the  common  drafting  principle  used  in  Annex  I,  whereby
requirements are attributed to the machine and not as a requirement on the manufacturer.

The Commission cannot accept amendment 48, on Annex I, point 1.4.1, indent 5, where the
requirement that guards and protection devices should "be unable to remain in place without
their fixings" is deleted. It is important that this specific requirement applies to all guards and
protection devices.

The Commission cannot accept amendment 50, on Annex I, point 1.5.2, paragraphs 3 and 4,
on the requirements on seats in machinery, since there is no clear added value.

The Commission cannot accept amendment 55, on Annex I, point 1.7.2, paragraph 2, on the
unhindered movement of exposed persons adding the words "where at all possible", since this

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15

                                                
principle is already laid down in general terms in the third preliminary observation of Annex
I.

The Commission cannot accept amendment 58, on Annex I, points 1.10.2, on the content of
the instructions manual, since it does not clearly improve the text.

The Commission cannot accept amendment 60, on annex I, point 3.6.3.1, on the requirements
related to vibrations, since it does not improve the text.

The Commission cannot accept amendment 65, on Annex  I, points 4.2.4,  on lifting,  since it
does not clearly improve the text and aims to correct a linguistic difficulty.

The Commission cannot accept amendment 67, on Annex I, point 6.2, paragraphs 2 and 3, on
the  design  of  controls  for  lifting  or  moving  people,  since  it  does  not  improve  the  text.  It  is
important to require hold-to-run type controls. For the part on design in order to "be easy to
use for disabled users" it is already covered in Annex I, point 7.2.

The  Commission  cannot  accept  amendment  70,  on  Annex  I,  points  7.2  to  7.4,  on  lifting
machinery  intended  for  persons  with  reduced  mobility,  since  there  is  no  good  reason  for
providing a lower safety level for machinery used in domestic environment.

The  Commission  cannot  accept  amendment  71,  on  Annex  I,  point  8.1,  paragraph  1,  and
amendment 73, on annex I, point 8.5, paragraph 1, both on construction site hoists, since they
do  not  improve  the  text  and  do  not  fit  with  the  description  of  construction  site  hoist  as
"intended for lifting persons and persons and goods".

The Commission cannot accept amendment 77, on annex VI, point 2, on the availability of the
technical file, since it is not adding any value to the text.

The  Commission  cannot  accept  amendment  78,  on  Annex  IX,  point  9,  subparagraph  4,  and
amendment  79,  on  Annex  X,  point  9,  subparagraph  4,  on  series  manufacture  of  identical
machines, since they do not clearly improve the text.

The Commission cannot accept amendment 83, on recitals, on the establishment of databases
on the fulfilment of health and safety requirements for machinery, since it is outside the scope
of the Directive.

4.

CONCLUSION

In accordance with Article 250(2) of the EC Treaty, the Commission amends its proposal as
presented above.

16