COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT REPORT Accompanying the Proposal for a Regulation of the European Parliament and of the Council on machinery products
Date: 2021-04-21
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: EC conformity marking, European standard, machinery, market approval, product design, product safety, safety standard, technical standard

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 21.4.2021  SWD(2021) 83 final  COMMISSION STAFF WORKING DOCUMENT  EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT REPORT  Accompanying the Proposal for a Regulation of the European Parliament and of the Council on machinery products {COM(2021) 202 final} - {SEC(2021) 165 final} - {SWD(2021) 82 final}  
 
 
Executive Summary Sheet 

Impact assessment on a proposal for a regulation of the European Parliament and of the Council on machinery. 

A. Need for action 

Why? What is the problem being addressed?  
As  part  of  the  Commission  Work  Programme  2020  under  the  priority  ‘A  Europe  fit  for  the  Digital  Age’,  the 
Commission  plans  to  revise  the  Machinery  Directive  (‘the  MD’,  Directive  2006/42/EC).  This  revision 
contributes  to  both  the  digital  transition  and  to  the  strengthening  of  the  single  market.  In  February  2020,  the 
Commission published a white paper on artificial intelligence accompanied by a report, Report on the safety and 
liability  implications  of  Artificial  Intelligence,  the  Internet  of  Things  and  robotics.  The  report  concluded  that  the 
EU’s  current  product-safety  legislation  –  in  particular  the  MD  –  contains  a  number  of  gaps  that  need  to  be 
addressed.  
The general objectives of the MD are to: (i) ensure free movement of machinery within the single market; and (ii) 
ensure a high level of protection for machinery users and other exposed persons. The REFIT evaluation of the 
MD  (SWD  (2018)160)  concluded  that  the  Directive  is  generally  relevant,  effective,  efficient  and  coherent.  The 
evaluation  also  concluded  that  the  MD  has  EU  added  value,  but  it  argued  that  the  MD  needed  specific 
improvements and simplification. The evaluation stated that the MD enables technological developments in the 
digital era, given that the MD is underpinned by the  ‘new  approach’ principles (the ‘new approach’ means that 
legislation  sets  mandatory  basic  requirements,  leaving  standardisers  organisations  to  set  the  technical  details 
needed to meet those requirements). However, the evaluation argued that further analysis of the MD is needed 
to assess its effectiveness and fitness for purpose in the future. This further analysis should cover developments 
in digitalisation, such as the internet of things, artificial intelligence (AI), and the new generation of autonomous 
robots. 
In particular, the revision of the MD intends to address the following issues: (i) the MD does not sufficiently cover 
new risks originating from emerging technologies; (ii) legal uncertainty due to a lack of clarity on the scope and 
definitions; and possible safety gaps in traditional technologies; (iii) insufficient provisions for high risk machines; 
(iv)  monetary  and  environmental  costs  due  to  extensive  paper-based  documentation;  (v)  inconsistencies  with 
other pieces of Union product-safety legislation; and (vi) divergences in interpretation due to transposition. 

What is this initiative expected to achieve?  
The  MD  is  a  piece  of  product-safety  legislation  that  aims  to  ensure  a  high  level  of  protection  for  workers, 
consumers  and  other  exposed  persons  by  focusing  on  the  safety  of  machinery  itself,  and  thus  imposing 
obligations  on  machinery  manufacturers  to  design  and  construct  inherently  safe  machinery  (safety  by  design). 
This initiative intends to revise the MD so that it can continue fullfilling its objectives by: (i) ensuring a high level 
of safety and protection for users of machinery and other people exposed to it; and (ii) establishing a high level 
of  trust  in  digital  innovative  technologies  for  consumers  and  users,  thus  ensuring  a  level  playing  field  for 
economic operators and preserving the competitiveness of the machinery sector in global digital markets.  
These  general  objectives  translate  into  the  following  six  specific  objetives:  (i)  cover  new  risks related  to  digital 
emerging  technologies;  (ii)  ensure  coherent  interpretation  of  the  scope  and  definitions  and  improve  safety  for 
traditional  technologies;  (iii)  reassess  machines  considered  as  high  risk  and  reassess  related  conformity 
procedures;  (iv)  reduce  paper-based  requirements  for  documentation;  (v)  ensure  coherence  with  other  NLF 
legislation; and (vi) reduce possible divergences in interpretation derived from transposition. 

What is the value added of action at the EU level?  
The machinery sector is a highly relevant part of the engineering industry and one of the industrial drivers of the 
EU economy. In 2017, the machinery sector recorded turnover of EUR 663 billion, production of EUR 609 billion, 
and  a value added of EUR 191  billion. The total  EU  machinery  and equipment exports amounted to EUR  503 
billion,  of  which  49%  were  exported  to  EU  Member States  (i.e.  intra-EU  exports),  while  51%  were  exported  to 
countries outside the EU (extra-EU exports). 
The MD is a key driver of safety for machinery users in the EU. As already mentioned, the main objectives of the 
MD are to ensure a high level of health and safety protection for these users, and to allow the free circulation of 
machinery in the EU. In particular, the MD helps reduce social costs by preventing accidents that may be caused 
by the use of machinery. A key rationale for an EU-level machinery directive is to provide harmonisation across 
Member States based on Article 114 TFEU. Any changes to the MD’s scope or requirements must be made at 
EU level to avoid distorting the market, creating barriers to the free movement of products and undermining the 
protection of human health and well-being. 

B. Solutions 

What  legislative  and  non-legislative  policy  options  have  been  considered?  Is  there  a  preferred 

1 

 
choice or not? Why?  
There are four policy options. These are set out in the bullet points below. 

  Option  0  –  No  change:  The  baseline  scenario  is  ‘no  action’.  This  option  would  leave  the  existing 
standardisation process to develop as usual, without particular focus on risks stemming from emerging 
technologies, and with no particular focus on areas for improvement related to traditional technologies. 
This baseline  option  would also  include revision  of the  Guide to application of  the  Machinery Directive 
(‘the Guide’) following the normal process (discussions among stakeholders and decision taken only by 
consensus). 

  Option  1  –  Self-regulation  by  industry  and  changes  to  the  Guide:  This  option  would  make  no 
changes  to  the  current  MD.  Instead  it  would  introduce  clarifications  to  the  Guide  with  a  push  for:  (i) 
consensus  on  scope  and  definitions;  (ii)  reduction  of  paper-based  documentation;  (iii)  clarifications  on 
existing  high-risk  machinery;  (iv)  better  coherence  with  other  NLF  product-safety  legislation;  and  (v) 
fewer divergences in interpretations in the various Member States. On this last point, this option would 
also  involve  dedicated  sessions  of  the  Machinery  Expert  Group.  New  risks  stemming  from  emerging 
technologies  (as  well  as  certain  risks  from  traditional  technologies)  would  be  addressed  through  the 
issuance of a new Commission standardisation request, within the boundaries of the current legal text.  

  Option  2  –  Burden  minimisation:  This  option  would  focus  on  clarifying  the  legal  text  and  scope  and 
achieving simplification. To this end, this option would change the current MD to increase legal clarity in 
scope and definitions. It would also make changes to achieve simplification by: (i) introducing to the legal 
text permission for instruction manuals to be issued in digital format; (ii) aligning the MD to the NLF; and 
(iii) avoiding divergences in interpretation by converting the MD into a regulation. Changes to the current 
act would also include an empowerment to the Commission for reviewing in the future the list of high-risk 
machines under certain criteria. However, all these changes would be made without adaptations to the 
safety requirements for products. There would therefore be no changes in the manufacturers’ obligations 
for designing and manufacturing the machinery. This would be complemented by the issuance of a new 
Commission  standardisation  request,  within  the  boundaries  of  the  current  safety  requirements  in  legal 
text. 

  Option 3 – Burden minimisation and enhanced safety: This option is the most ambitious, striving for 
a better safety while taking advantage of all burden reduction possibilities. To this end, this option would 
change the current act to increase legal clarity in scope and definitions. It would also make changes to 
achieve  simplification  by:  (i)  allowing  digital  documentation;  (ii)  aligning  the  MD  to  the  NLF;  and  (iii) 
avoiding  divergences  in  interpretation  by  converting  the  MD  into  a  regulation.  This  option  would  also 
include an empowerment to the Commission for reviewing the current list of machines presenting high 
risks  to  new  market  developments  in  this  area,  remove  the  internal  check  option  for  the  conformity 
assessment of the high risk machines, and make a first adaptation of the list of high risk machines. In 
addition, it would also adapt the safety requirements of Annex I with which manufacturers must comply 
when designing and manufacturing machinery, to address risks stemming from emerging technologies, 
as well as specific risks from traditional technologies. This would be complemented by the issuance of a 
new  Commission  standardisation  request,  taking  into  account  any  new  and/or  revised  safety 
requirements in the legal text. 

The  preferred  policy  option  is  option  3.  This  policy  option  addresses  all  identified  problems  in  the  most 
effective and efficient way, proposing a revised MD that is not only fit for purpose now, but also in the years to 
come.  It  also  ensures  coherence  with  existing  product-safety  legislation,  with  the  future  regulation  on  artificial 
intelligence and with the Cybersecurity Act.  
The preferred option adds new requirements and clarifies existing ones: (i) in a targeted and proportional way; 
and (ii) only when necessary. These new requirements and clarifications are often applicable to certain types of 
machinery  only.  The  preferred  option  will  add  legal  clarity  to  the  current  MD  in  its  scope,  definitions  and 
requirements, including those requirements to cover risks stemming from emerging technologies. The preferred 
option  will  also  be  instrumental  in  properly  driving  the  standardisation  activities  in  a  way  that  enhances  safety 
and ensures a higher level of trust and industry competitiveness in the market (including the digital market). In 
addition,  the  preferred  option:  (i)  empowers  the  Commission  to  adapt  the  current  list  of machines  that  present 
high risks to take account of new market developments in this area; (ii) removes the internal-check option for the 
conformity  assessment  of  high-risk  machines;  and  (iii)  reviews  the  list  of  high-risk  machines  in  full  coherence 
with the new regulation on Artificial Intelligence. It proposes a burden-reduction measure highly requested by the 
industry and in line with the Commission digital policy, by allowing digital documentation (while at the same time 
granting  end-users  the  possibility  to  request  a  printed  version  of  the  instruction  manual  free  of  charge  at  the 
moment of purchase). Finally, the revised MD will gain in coherence and legal certainty by being aligned to the 
NLF  and  becoming  a  regulation.  To  ensure  proportionality,  this  policy  option  is  complemented  by:  (i)  a  new 
standardisation request to be issued by the Commission; and (ii) a Guide for detailed clarifications. 

2 

 
 
Who supports which option?  
Member  State  authorities,  notified  bodies,  consumer  associations,  and  workers’  asociations  mostly  support 
option 3. 
Manufacturers  agree  with  the  need  to  act,  although  they  would  rather  take  action  via  the  standardisation 
process, without changes to the health and safety requirements of the MD (with some exceptions, such as the 
standalone  software  that  fulfils  a  safety  function,  on  which  they  agree  it  should  be  considered  as  a  safety 
component). Manufacturers would also mostly prefer that the list of high-risk machinery remains unchanged, and 
that  the  obligation  of  third-party  involvement  in  the  conformity  assesment  remains  non-mandatory.  However, 
option  3  allows  digital  formats  for  the  manual  of  instructions  and  the  declaration  of  conformity,  both  widely 
requested by industry.  
All stakeholder groups support the alignment to the NLF and the conversion of the MD into a regulation. 

C. Impacts of the preferred option 

What are the benefits of the preferred option (if any, otherwise main ones)?  
For manufacturers: Savings of EUR 5 000 - EUR 10 000 per instance for clarifications of differences in 
interpretation between Member States; a reduction in printing costs of up to EUR 16.6 billion (EUR 201 000 per 
company) for digital documentation; simplification thanks to the MD coming under the same NLF framework as 
other pieces of product-safety legislation; cost savings thanks to fewer clarification procedures due to no 
transposition amounting to EUR 100 - EUR 500 per instance; better functioning of the single market; a more 
level playing field thanks to better legal certainty; and increased competitiveness. 
For users (workers and consumers): Less non-compliant machinery on the market; increased safety thanks to 
clarifications; increased safety for workers and consumers; better protection of user’s health and safety following 
the removal of internal checks for the conformity asessment of high-risk machinery; increased readability of non-
paper instructions which will be better adapted for the blind and partially sighted; and access to ICSMS (the 
communication system used by Member States to assist in pan-European market surveillance). 
For Member States: Greater legal clarity; access to ICSMS; saving on transposition costs. 
For notified bodies: Decreased storage costs for manuals; benefits through equal interpretation across Member 
States. 
For European standardisation organisations: Benefits expected from the equal interpretation of the 
regulation. 
For society: Reduced social costs for sick leave and occupational injuries (e.g. savings for vibration-related 
sick-leave of EUR 15 million a year). 

What are the costs of the preferred option (if any, otherwise main ones)?  
For manufacturers: One-off costs for compliance and adaptation to changes on requirements; costs for third 
party involvement for the conformity assessment of high-risk machines EUR 202 million one-off overall; costs for 
purchasing, setting up and maintaining a server to allow the management of digital instruction and and 
declaration of conformity: one-off cost of EUR 29 million (EUR 1 000 per company), annual costs of EUR 48 
million (EUR 3 000 per company).  
For users (workers and consumers): Costs of changes to manufacturers could be pushed down the value 
chain to consumers; EUR 0.4 printing costs per manual in average if user decides to print the digital manual in 
one language after the purchase of the machinery. 
For Member States: Costs of adapting to changes; one-off costs for adaptation to changes expected.  
For notified bodies: An increase in turnover of EUR 202 million for the product portfolio of 10% of machinery 
under Annex IV currently assessed through internal checks; one-off costs for adaptation to changes expected. 
For European standardisation organisations: Drafting and revision of new harmonised standards to provide 
presumption of conformity to the new and revised requirements. 

How will businesses, SMEs and micro-enterprises be affected?  
In the machinery sector, 98% of companies are SMEs. Legal certainty will particularly favour SMEs since they 
have  fewer  resources  to  assess  and  interpret  the  legal  text.  In  addition,  legal  certainty  on  the  safety 
requirements  will  result  in  clearer  harmonised  standards,  which  will  also  be  beneficial  for  SMEs  that  rely  on 
harmonised  standards  to  comply  with  the  safety  requirements.  Standardisation  on  emerging  technologies 
happens  in  alignment  with  –  and  with  reciprocal  feedback  from  –  the  ISO/IEC  (International  Organization  for 
Standardization /International Electrotechnical Commission) so that competitiveness within the EU and globally 
is  maximised  and  exports  are  facilitated  (key  area  for  the  EU  machinery  sector,  which  exports  51%  of  its 
production to countries outside the EU, and exports are also critically important for SMEs). 
Manufacturers of Annex IV high-risk machines are often SMEs. However, it is not expected they face high costs 
increases because they often use third party involvement already for several reasons: (i) a lack of means (e.g. 
they do not have laboratories/expertise); (ii) as a guarantee of quality; and (iii) to improve brand recognition.  

3 

 
The following burden-reduction measures will favour SMEs: 
- cost savings for manufacturers by allowing digital instructions and digital declarations of conformity; 
- alignment to the NLF means a better functioning of the legislation and its enforcement, but also less burden for 
manufacturers dealing with several product-safety acts applying to their products; 
-  complementarity  between  legal  texts  on  AI  and  machinery,  by  which  the  AI  regulation,  for  those  AI  systems 
covered by the MD, foresees that the conformity assessment is done only once, under the MD. 

Will there be significant impacts on national budgets and administrations?  
Member States will face some adaptation costs to make these changes. However, they will largely benefit from 
better legal clarity and alignment to the NLF, which will facilitate their market-surveillance tasks. Greater safety 
and less non-compliant machinery will reduce the need for intervention in the market. EU countries will benefit 
from reduced social costs for sick leave and occupational injuries. 

Will there be other significant impacts?  
A  significant  evironmental  benefit  for  society  will  come  from  reduced  use  of  paper  to  print  instruction  manuals 
and a corresponding decrease in carbon footprint. 

D. Follow-up 

When will the policy be reviewed?  
By  three  years  after  the  regulation  becomes  applicable  and  every  four  years  thereafter,  the  Commission  will 
submit a report on the evaluation and review of this Regulation to the European Parliament and to the Council.  

4