COMMISSION STAFF WORKING DOCUMENT Accompanying the documents Proposal for a Directive of the European Parliament and of the Council amending Directives 2000/14/EC, 2011/65/EU, 2013/53/EU, 2014/29/EU, 2014/30/EU, 2014/31/EU, 2014/32/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU, 2014/68/EU and 2014/90/EU of the European Parliament and of the Council as regards digitalisation and common specifications and Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) No 765/2008, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2023/1230, (EU) 2023/1542 and (EU) 2024/1781 as regards digitalisation and common specifications
Date: 2025-05-21
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: EC conformity marking, administrative formalities, digitisation, disclosure of information, electronic document, exchange of information, harmonisation of standards, market approval, technical specification, user guide

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 21.5.2025  SWD(2025) 130 final  COMMISSION STAFF WORKING DOCUMENT Accompanying the documents Proposal for a Directive of the European Parliament and of the Council amending Directives 2000/14/EC, 2011/65/EU, 2013/53/EU, 2014/29/EU, 2014/30/EU, 2014/31/EU, 2014/32/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU, 2014/68/EU and 2014/90/EU of the European Parliament and of the Council as regards digitalisation and common specifications      and       Proposal for a Regulation of the European Parliament and of the Council      amending Regulations (EU) No 765/2008, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2023/1230, (EU) 2023/1542 and (EU) 2024/1781 as regards digitalisation and common specifications {COM(2025) 503 final} - {COM(2025) 504 final}  
 
 
CONTENTS 

A. 

Introduction ............................................................................................................................. 2 

B.  Administrative burden associated with obligations to provide paper documentation ............ 4 

C.  Burdens for businesses associated with absence of harmonised standards ............................ 9 

D.  Stakeholder consultations ......................................................................................................11 

1.  Consultations carried out in prior impact assessments and evaluations ............................11 

2.  Consultation of stakeholders  ............................................................................................ 13 

E.  Objectives to be achieved ..................................................................................................... 16 

1.  Reducing administrative burden ....................................................................................... 16 

2.  Supporting the digital transition........................................................................................ 21 

3.  Environmental benefits ..................................................................................................... 21 

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A.  INTRODUCTION 

In  its  Communication  on  ‘Long-term  competitiveness  of  the  EU:  looking  beyond  2030’1,  the 
Commission identified the need of having a regulatory system that achieves objectives at minimal 
costs. It has stipulated the aim to rationalise and simplify reporting requirements for companies 
and administrations and to reduce administrative burdens by 25%, without undermining the related 
policy objectives.  

In her political guidelines, President von der Leyen emphasised that ‘We need to make business 
easier and faster in Europe’. To that end, each Commissioner is tasked with focusing on reducing 
administrative burdens and simplifying implementation and to stress-test the EU acquis. This is 
operationalised in the mission letters to all Members of the College, asking them to ensure that 
existing rules are fit-for-purpose and to focus on reducing administrative burdens and simplifying 
legislation. This includes reducing reporting obligations by at least 25% – and for SMEs at least 
35%.  

Furthermore,  the  Communication  on  “A  simpler  and  faster  Europe”  set  out  a  vision  for  an 
implementation and simplification agenda2. The Commission indicated that it would review and 
adapt the regulatory framework to make it more responsive to the needs of people and businesses. 
Among the simplification initiatives that are mentioned, it includes a series of Omnibus packages 
to tackle priority areas identified with stakeholders over the past years. One of  these initiatives 
relates  to  the  removal  of  inefficient  requests  for  paper  format  in  product  legislation. The  other 
relates  to  faster  unblocking  of  market  access  for  products  for  which  no  standard  exists,  is  not 
available or there is an urgent need.    

Digitalisation  

The EU should leverage the power of digital tools to deliver better and faster solutions. 

The Communication ‘2030 Digital Compass: the European way for the Digital Decade’3 set out a 
vision for the digital transformation of businesses and for the digitalisation of public services. In 
line with this, the Commission promotes the ‘digital by default’ principle in the Better regulation 
toolbox4 to propose policies that are digital, interoperable, future-proof and agile by default. 

The  Digital  Product  Passport  (‘DPP’)  has  been  recognised  as  an  important  tool  for  the  digital 
transition  and  a  key  enabler  for  the  supervision  of  the  e-commerce  landscape  in  the  recently 
published EU Toolbox for Safe and Sustainable E-Commerce5. 

Both the Letta and the Draghi reports underlined the importance of digitalisation for simplification, 
the  first  proposing  to  use  “horizontal  instruments  such  as  ‘simplification  law’  that  reduce  and 

1 COM(2023) 168 final. 
2 COM(2025)47 final, Communication on implementation and simplification.  
3 COM(2021) 118 final. 
4 Better Regulation tool #28 (Digital-ready Policymaking) 
5 COM(2025)37 final, Communication from the Commission to the European Parliament, the Council, the European 
Economic and Social committee and the Committee of the Regions  – A comprehensive EU toolbox for safe and 
sustainable e-commerce. 

2 

 
 
modernise  the  reporting  obligations  and  […]  accelerate  the  digitalisation  of  authorisation  and 
reporting procedures.” and the second indicating “the need to fully digitalise business to authority 
reporting.” 

This  initiative  is  fully  in  line  with  the  above  objectives,  as  well  as  the  objectives  of  the 
Interoperable Europe Act6 and intends to simplify the life of businesses having to comply with one 
or  several  product-specific  Directives  and  Regulations  based  on Article  114 TFEU  and Article 
100(2) TFEU. These contain obligations related to providing, further to a reasoned request, the 
declaration  of  conformity,  information  and  documentation  necessary  to  demonstrate  the 
conformity of the product with the applicable legislations. Moreover, these legislations contain an 
obligation  on  manufacturers  to  provide  instructions  for  use  to  consumers  and  other  users  of 
products  across  most  sectors. Whether  the  obligations  imposed  by  product  legislation  relate  to 
business to government  reporting or instructions for use, they are often interpreted by Member 
State authorities or other authorities as requiring the provision of paper documents. Clarifying that 
businesses are entitled to provide such documents in digital format not only allows them to save 
the costs related to  paper-based processes  but  also encourages  them to  use digital technologies 
when exchanging information with public administrations and business partners.  

Nevertheless,  when  it  comes  to  instructions  for  use,  it  is  necessary  to  safeguard  the  safety  of 
consumers  and  other  users.  As  such,  it  is  important  that  manufacturers  still  provide  safety 
information and other information related to the health and safety of consumers and other non-
professonal users in paper format. Providing instruction of use digitally will also offer users the 
possibility of easier access to information related to the product, including in different languages , 
and make it easier for information to be updated etc. In addition, it will be more inclusive for some 
categories of consumers with the possibility to include audio-visual material.   

Common specifications 

The  EU’s  Single  Market  rests  upon  more  than  3600  harmonised  European  standards,  which 
support the application of numerous EU legal acts. The importance and strategic role of standards 
for EU policy making was underlined in  the Commission’s EU Strategy on Standardisation on 
setting global standards in support of a resilient, green and digital EU Single Market7. 

Harmonised standards have proven to be a well-established tool for manufacturers to benefit from 
a  presumption  of  conformity  with  the  requirements  of  EU  harmonisation  legislation  across  the 
Single  Market  and  at  the  same  time  to  benefit  from  an  easy  way  to  access  the  market,  also  at 
reduced costs.  

The Communication ‘A Competitiveness Compass for the EU’ identified the need to search for 
alternative options to give businesses legal  security on compliance with the EU rules, in situations 

6 Regulation (EU) 2024/903 of the European Parliament and of the Council of 13 March 2024 laying down measures 

for a high level of public sector interoperability across the Union (Interoperable Europe Act) 

7  COM(2022)  31,  Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic and Social committee and the Committee of the Regions  - An EU Strategy on Standardisation Setting 
global standards in support of a resilient, green and digital EU single market . 

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where harmonised standards do not  exist, are not available or there is an urgent need8. Several 
legislative acts already contain an alternative option to provide businesses with legal predictability 
and  ensure  compliance  with  the  EU  acquis  to  cater  for  such  situations. The  present  proposal´s 
objective is to align the alternative option in legislative acts that do not provide for any option to 
harmonised  standards.  The  alternative  option  is  to  be  done  in  a  uniform  manner  as  regards 
definition, legal effect, conditions under which that alternative option may be adopted as well as 
adoption procedure.  

The  initiative  on  common  specifications  is  fully  in  line  with  the  above  referred  objective  and 
intends to simplify the life of businesses having to comply with one or several product-specific 
health  and  safety  requirements,  as  enshrined  in  Directives  and  Regulations  that  make  use  of 
harmonised standards. The alternative option would thus provide legal predictability and certainty 
regarding compliance with the EU rules in situations where no standard exists, is not available or 
there is an urgent need. 

B.  ADMINISTRATIVE  BURDEN  ASSOCIATED  WITH  OBLIGATIONS  TO  PROVIDE  PAPER 

DOCUMENTATION 

Most EU Directives and Regulations under the New Legislative Framework (‘NLF’) do not impose 
any specific format  through which economic operators have to  provide information  to  national 
competent authorities and users. Nevertheless national competent authorities and other economic 
operators  often  require  paper  format.  For  example,  certain  Member  States  accept  digital 
instructions to some extent in certain legislations, e.g. in Directive 2006/42/EC on machinery. This 
Directive will soon be repealed and replaced by Regulation (EU) 2023/1230 which provides for 
the possibility to provide instructions in digital form . However, other legislations, for example,the 
Regulation (EU) 2016/425 on personal protective equipment does not spell this out. 

Because Member States and their various market surveillance authorities have divergent views, 
notified bodies also tend to refuse to certify the conformity of products in case instructions are 
provided in digital format. This means that quite often, manufacturers will prefer to stick to paper 
instructions for use to avoid compliances issues. This can lead to situations where for the same 
obligations, some Member States require the paper format while others accept a digital format. In 
addition, the language used in some EU legal texts may raise doubts about whether a digital format 
is acceptable for exchanging documents. 

Obligations related to providing declaration of conformity 

All  the product legislations aligned with the NLF impose an obligation on the manufacturer to 
draw up an EU declaration of conformity before placing a product on the market.  

8 COM(2025)30 final, Communication from the Commission to the European Parliament, the Council, the European 

Economic and Social committee and the Committee of the Regions - A Competitiveness Compass for the EU 

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Background: Declaration of Conformity 

The  EU  declaration  of  conformity  (DoC)  is  a  mandatory  document  that  a  manufacturer  or 
authorised  representative  needs  to  sign  to  declare  that  the  products  comply  with  the  EU 
requirements.  By  signing  the  DoC  they take  full  responsibility  for  the  product's  compliance 
with the applicable EU law. 

A DoC must contain the following information: 

the product's serial number, model or type identification 

•  name and full business address of manufacturer or of authorised representative 
• 
•  a statement, stating to take full responsibility 
•  means of identification of product allowing traceability – this can include an image 
• 

the details of the notified body which carried out the conformity assessment procedure 
(if applicable) 
the  relevant  legislation  with  which  the  product  complies,  as  well  as  any  harmonised 
standards or other means used to prove compliance 

• 

•  name and signature of the manufacturer 
• 
the date the declaration was issued 
•  supplementary information (if applicable) 

The DoC needs to be translated into the language or languages required by the EU country in 
which the product is sold. 

Besides this obligation, some pieces of product legislation that are covered by this initiative require 
that a copy of the declaration of conformity accompany the product. These include: 

-  Regulation (EU) 2016/424 on cableway installations;  
-  Regulation (EU) 2016/425 on personal protective equipment; 
-  Regulation (EU) 2016/426 on appliances burning gaseous fuels; 
-  Directive 2000/14/EC on the approximation of the laws of the Member States relating to 

the noise emission in the environment by equipment for use outdoors; 

-  Directive 2014/32/EU on the harmonisation of the laws of the Member States relating to 

the making available on the market of measuring instruments; 

-  Directive 2014/33/EU on the harmonisation of the laws of the Member States relating to 

lifts and safety components for lifts;  

-  Directive 2014/34/EU on the harmonisation of the laws of the Member States relating to 
equipment and protective systems intended for use in potentially explosive atmospheres; 
-  Directive 2014/53/EU on the harmonisation of the laws of the Member States relating to 

the making available on the market of radio equipment. 

It would therefore be necessary to introduce the possibility for manufacturers to make the DoC 
available  electronically.  The  DoC  must  be  signed  by  the  manufacturer  and  often  needs  to 

5 

 
 
  
 
 
accompany the product. In some cases, it must be provided to market surveillance authorities upon 
request. Allowing  this  document  to  be  made  available  electronically  eases  the  manufacturer's 
obligations,  eliminating  the  need  for  it  to  accompany  each  product  by  a  paper-based  DoC  and 
enabling the provision of a link to the authorities when requested. 

Where several pieces of Union harmonisation legislation apply to a product, the manufacturer or 
the authorised representative has to  provide a single declaration of conformity  in respect  of all 
such Union acts. However, some recent pieces of EU product legislation, such as Regulation (EU) 
2023/1542 concerning batteries and waste batteries (‘Batteries Regulation’), foresee the use of a 
digital product passport (DPP) and the declaration of conformity for batteries is to be included in 
the digital passport – battery passport. It may happen that a  battery for light means of transport  
is, in addition to the Batteries Regulation also subject to Regulation (EU) 2023/1230 on machinery 
(‘Machinery Regulation’). In such cases, the manufacturer would need to include the declaration 
of conformity in the DPP under the Batteries Regulation, while the Machinery Regulation does 
not yet foresee the DPP.  

This would mean that the manufacturer should create a DPP under the Batteries Regulation  where 
the DoC drawn up according to the Batteries Regulation should be uploaded, as well as ensure 
another  digitally  accessible  storage  location  for  the  DoC  drawn  up  under  the  Machinery 
Regulation. First, this approach would not align with the principle of the single EU declaration of 
conformity,  which  aims  to  simplify  and  streamline  the  demonstration  of  the  compliance  of  the 
product.  Second,  this  would  increase  complexity,  administrative  burden  and  cost  for 
manufacturers. Moreover, the product would need to bear another code or internet address, besides 
the QR code for the DPP, where the machinery-related DoC would be available.  

This would not only increase the burden on manufacturers but also on authorities, who would need 
to verify compliance with multiple DoCs. Overall, this approach would result in  increasing the 
burden  for  both  economic  operators  and  authorities,  leading  to  greater  complexity,  costs,  and 
administrative hurdles.  

To  avoid  inconsistencies  and  an  additional  burden  for  manufacturers  and  to  create  an  overall 
coherence  between  harmonised  product  laws  under  the  NLF,  it  is  necessary  to  introduce  a 
provision  that  allows  for  the  re-use  of  the  DPP  and  its  data  carrier  when  such  a  DPP  is  made 
mandatory by another legal act that covers the same product. 

6 

 
 
 
 
Obligations related to providing technical file/documentation 

On  a  reasoned  request  from  a  competent  national  authority,  businesses  need  to  provide 
documentation that is necessary to demonstrate the conformity of the product9. This documentation 
may include certificates from notified bodies or technical documentation. The different pieces of 
legislation covered by this  initiative either foresee that this documentation can be submitted in 
paper or electronic format, or do not specify any particular format. However, in practice, national 
authorities are not always ready to receive electronic files. 

Regarding  correspondence  between  businesses  and  conformity  assessment  bodies,  there  is  no 
explicit reference to whether this should be electronic or paper-based. However, the language used 
in  the  annexes  to  the  legislative  acts  may  raise  doubts  about  whether  an  electronic  format  is 

9 The  IA  accompanying  the revision  of  the Toys  Safety  Directive,  estimated  the  annual number  of  inspections  by 

MSAs in Europe to be around 25,000 (and may rise to 30,000 in case of implementation of the DPP). 

7 

 
 
 
 
  
 
acceptable for exchanging documents.  Again, some notified bodies request paper format. This is 
due to the fact that the NLF was adopted in 2008 and the terminology used in it, in the spirit of 
that law, has been understood as a paper format. 

It  therefore  seems  necessary  to  introduce  the  obligation  for  such  information  exchange  to  take 
place electronically. Both businesses and notified bodies should be equipped to utilise digital tools. 
This  transition  can  eliminate  paper-based  information,  thereby  reducing  paper  waste  and 
supporting sustainability goals, which are often priorities in professional settings. Digital formats 
also help manage limited space in professional environments by reducing clutter and making it 
easier to organise and store essential safety information. 

Obligations related to instructions  

Under the NLF, manufacturers have the obligation to  ensure that products  are accompanied by 
instructions for use and other information, such as safety information, in a language that can be 
easily  understood  by  consumers  and  other  end-users,  as  determined  by  the  Member  State 
concerned. While the NLF does not impose a particular format for the instructions for use, practice 
has  shown  that    practical  experience  indicates  that  most  market  surveillance  authorities  expect  these 
instructions to be in paper format and consequently enforce this expectation on end users. This stems from 
the  terminology  used  in  the  NLF,  which  has  been  interpreted  within  the  context  of  the  legal 
framework adopted in 2008. For instance, the NLF specifies that products should be accompanied 
by instructions and safety information, which, at the time of adoption, implied a paper format.  

This interpretation cannot be easily altered because safety information still requires a paper format. 
Changing the long-standing interpretation of certain terms might disadvantage end users when a 
paper format is genuinely needed. Therefore, it is essential to explicitly clarify whether a digital 
format for certain documents is permissible or acceptable.  

This  leads  to  products  being  accompanied by paper booklets, which include the instructions in 
multiple languages (based on the Member States where the product is sold), with significant costs 
for manufacturers. While evidence on the actual use of paper instructions by EU consumers is not 
available10, some industry stakeholders consulted for this proposal signalled that this use is limited.  

Considering that in 2024 no less than 94% of EU households had access to the internet11, obliging 
the instructions for use accompanying the products in scope of the proposals to be in paper format 
is outdated and is not aligned with the current technologies, the practice of consumers nor with 
sustainability  objectives.  Consumer  often  report  that  they  frequently  find  paper  instructions 
burdensome, as they can easily be misplaced over time. When these instructions are needed, users 
often resort to searching for them online. Digital instructions provide a more convenient solution, 
as they are easily accessible, can be stored indefinitely without the risk of loss, and allow for quick 
searches  of  specific  information.  Additionally,  digital  formats  can  be  updated  more  readily, 
ensuring users always have access to the most current information. This shift not only enhances 

10 There is general research on the use of manuals by consumers, e.g. a research article from 2014 concluded that most 

people did not read manuals. 

11 Source: Digital economy and society statistics - households and individuals - Statistics Explained 

8 

 
 
 
user experience but also aligns with modern consumer habits and preferences. Yet, consumers who 
prefer having paper-based instruction will still be able to request one, free of charge, at the time of 
purchase, or up to six months after that purchase. 

Consequently, manufacturers should be able to choose a digital format for the instructions for use. 
Where manufacturers choose to provide instructions for use in digital format, the essential safety 
information (including any parts of the instructions for use deemed imperative for safety) should 
still  be  provided  in  paper  format  to  protect  the  safety  of  consumers  or  non-professional  users. 
Moreover, users should be able to obtain a paper copy of the instructions for use upon request – at 
the time of the purchase and for a certain period after their purchase. 

The reason a mandatory paper-based quick user guide has not been foreseen is that it could be an 
additional  burden  and  at  the  same  time  such  an  obligation  could  give  the  impression  that 
instructions for the safe use of the product are not necessarily required to be provided in paper 
form.  It  is  challenging  to  distinctly  separate  safety  information  from  instructions.  Since  safety 
information  should  always  be  provided  in  paper  form  with  consumer  products,  it  inherently 
includes the essential details necessary for safe and efficient use. 

Other obligations related to paper format 

Directive 2014/90/EU on marine equipment has a specific rule that a paper copy of the declaration 
of conformity needs to be kept on board an EU ship until the marine equipment is removed. 

C.  BURDENS FOR BUSINESSES ASSOCIATED WITH ABSENCE OF HARMONISED STANDARDS 

The Commission is committed to a fair and effective functioning of the Single Market. The NLF 
and the inherent role of the European standardisation system play an important part in this. 

This is why in recently revised product harmonisation legislation and Commission proposals; legal 
provisions refer to harmonised European standards that are elaborated in line with Article 10 of 
Regulation (EU) 1025/2012 on European standardisation.  

By  using  harmonised  standards,  businesses  benefit  from  a  presumption  of  conformity  with  the 
essential requirements in a wide range of legislation. Depending on the sectoral legislation, this 
can  enable  simplified  conformity  assessment  procedures,  often  without  third-party  conformity 
assessment (except for certain high-risk products). If harmonised standards are not available (in a 
timely  manner  or  at  all),  businesses  cannot  benefit  from  the  presumption  of  conformity. 
Consequently,  they  are  obliged  to  resort  to  other  methods  to  demonstrate  conformity  and  to 
conduct a third-party conformity assessment, thereby incurring additional costs and complexity. 

 The non-availability or late availability of harmonised standards is common, as demonstrated by 
the  forthcoming  evaluation  of  the  Standardisation  Regulation.  The  evaluation  concludes  that 
current  average  timelines  for  standard-development  do  not  meet  market  and  policy  needs. 
Stakeholders are critical about whether the current timelines (1) allow timely implementation in 

9 

 
  
relevant  industries,  (2)  provide  ample  time  for  clear  communication  and  preparation  for 
implementation, and (3) are reasonable for industry stakeholders12.  

The issue has become increasingly pressing, as there have been situations in recent years when the 
European standardisation organisations (ESOs) did not provide the Commission with the requested 
harmonised standards. This leaves a gap in the application of EU legislation.  

Following  the  recent  European  Court  of  Justice  (ECJ)  ruling  on  access  to  standards,  ISO/IEC 
standards,  which  underpin  the  functioning  of  sectoral  legislation,  have  not  been  offered  to  the 
Commission since March 2024. It is not expected that the situation will improve soon as ISO/IEC 
have  initiated  a  litigation  at  the  ECJ  against  the  Commission.  This  lack  of  standards  is  now 
blocking – and seriously disrupting – the functioning of the Single Market. This situation will only 
exacerbate today there are 117 ISO/IEC harmonised standards that should had been offered to the 
Commission as a draft for referencing in the OJEU in the past 142 months but have not. The role 
of ISO and IEC standards in the EU is significant: 28% of CEN’s harmonised European standards 
are  based  on  ISO  standards  and  67%  of  CENELEC’s  harmonised  standards  are  based  on  IEC 
standards. 

The absence of  ISO/IEC-based standards is  undermining the functioning  of the Single Market. 
Specifically, this means that businesses are facing the burden of having to find alternative methods 
to  demonstrate  conformity  with  EU  regulatory  requirements,  leading  to  more  paperwork, 
significantly  higher  costs,  and  disruptions  to  the  Single  Market's  efficiency.  This  situation  is 
already seriously disrupting the opening of biobanks, market entry of certain medical devices, and 
soon of heat  pumps. Without  these standards, businesses must find alternative ways to  comply 
with EU laws. 

The co-legislators have recognised the need to compensate for the non-availability of harmonised 
standards by introducing a safety net, the so-called fallback option, in various pieces of recently 
adopted EU product legislation (e.g. in respect of fertiliser products, medical devices, machinery 
and  web-accessibility13.  This  fallback  option  enables  the  Commission  to  adopt  common 
specifications  via  implementing  acts  with  a  comitology  procedure).  Depending  on  the  product 
legislation,  this  option  can  be  used  under  specific  conditions,  for  instance  when  there  is  no 
harmonised  standard  available. The  option  was  introduced  only  in  recent  legislation  and  under 
varying conditions, hence it cannot be applied in a comprehensive and coherent manner across 
existing product legislation. This adds to the legal complexity and unpredictability. 

12 Only 26% agreed or strongly agreed that standards are developed in a timeframe that allows timely implementation in relevant industries; only 
35% agreed that the duration of the development process provides ample time for clear communication and preparation for implementation; only 
30% agree that the timelines for standardisation requests are reasonable for industry stakeholders; Evaluation Study of the Regulation (EU) No 
1025/2012 on European standardisation, Section 4.1.1.1 

13 Regulation (EU) 2017/745 (on Medical Devices), Regulation (EU) 2017/746 (on In Vitro Diagnostic Medical Devices), Directive (EU) 2016/1629 
(on technical  requirements  for  inland  waterway vessels),  Directive  (EU)  2016/2102  (Web Accessibility  Directive),  Directive  (EU) 2019/882 
(European  Accessibility  Act),  Regulation  (EU)  2019/1009  (Fertilisers  Regulation),  Regulation  (EU)  2023/1230  (Machinery  Regulation), 
Regulation (EU) 2023/1542 (on batteries and waste batteries), Regulation (EU) 2024/1689 (AI Act), Construction Products Regulation. 

10 

 
 
 
Therefore, the Commission now proposes to introduce the option of common specifications in a 
consistent manner across a wide range of product legislation, building up on the concept already 
available  in  several  legislative  acts.  In  the  absence  of  harmonised  standards,  these  common 
specifications provide legal certainty and simplification to businesses by helping them avoid the 
need  to  find  other  methods  to  demonstrate  conformity,  thus  closing  an  existing  gap  in  the 
application of EU legislation. In such situations, they also help businesses avoid the costs of third-
party  conformity  assessment,  which  is  often  required  by  sectoral  legislation  in  the  absence  of 
harmonised standards. Such costs can vary significantly between sectors and product categories 
(see Section E below). Moreover, in the absence of harmonised standards, common specifications 
can also provide clarity on product safety and thereby preserve consumer trust in products in the 
Single Market.  

D.    STAKEHOLDER CONSULTATIONS  

1.  Consultations carried out in prior impact assessments and evaluations  

The issues related to the digitalisation of the DoC have been consulted with stakeholders in the 
context of past evaluations and impact assessments. This chapter briefly summarises the relevant 
findings contained in those documents. 

(i) 

NLF evaluation and consultations 

In the targeted consultations for the evaluation of the NLF14, 74.5% of the respondents thought 
that the efficiency of the conformity assessment procedure would largely improve (35 responses) 
due to digitalisation of the declaration of conformity / technical product information / technical 
file, without hindering market surveillance activities, while a further 12.8% (six responses) thought 
it would improve to a moderate extent. 

The NLF evaluation also found (on p. 35) that “The burden of printing out product information to 
accompany the product (e.g. safety documentation, instruction manuals, guidance on reasonably 
foreseeable  use  etc.)  was  most  likely  to  be  rated  high  or  very  high  (83%,  39  responses).”.  In 
addition, it found (on p.49) that “Industry respondents were in favour of moving towards digital-
only CE marking, product compliance and user information as soon as possible. This was seen as 
potentially reducing costs, but only if hard copy versions were no longer required. However, none 
of the national competent authorities shared this view.” 

The  NLF  evaluation  further  found  (on  p.  50)  that  “Respondents  that  viewed  digitalisation 
positively argued that it should always be possible to provide and access information, regarding 
whether  a  product  carries  the  CE  mark,  and  in  relation  to  its  declaration  of  conformity  or  the 
technical file, in digital format rather than on paper. Triangulating these findings with the views of 
interviewed stakeholders, a general consensus emerged across all stakeholder groups regarding the 
potential  benefits  of  digitalising  the  obligations  that  require  information  to  be  printed.  Most 
stakeholders believe that digitalisation could facilitate and speed up compliance by simplifying the 

14 SWD(2022)364 final/2, p. 34 

11 

 
 
way  in  which  manufacturers  meet  information  obligations.  Digitalisation  would  serve  two 
objectives: simplification and environmental protection.” 

According  to  the  public  consultation  carried  out  for  the  NLF  evaluation  (p.50),  45,5%  of  the 
stakeholders would appreciate a digital CE marking, 63,2% would appraise positively the digital 
traceability information  (e.g. postal  address  of the manufacturer/importer), while 72% took  the 
view  that  providing  safety  documentation  and  instruction  materials  in  a  digital  form  would  be 
beneficial. Economic operators, industry associations, consumer associations, MSAs and national 
competent  authorities  were  asked  in  the  targeted  consultations  about  the  extent  to  which  the 
digitalisation  of  CE  marking  /  traceability  /  product  information  would  jeopardise  the  right  of 
consumers  to  be  duly  informed.  There  was  some  divergence  in  the  responses  of  the  different 
stakeholder  types.  Industry  associations  (71%,  22  responses)  and  economic  operators  (43.8%, 
seven responses) were most likely to answer that digitalisation would ‘not at all’ jeopardise the 
consumer’s right to be informed. However, none of the national competent authorities shared this 
view. While some acknowledged that they preferred ‘a digital way forward’, it was also accepted 
that not all consumers are digitally adept. Stakeholders explained that providing information in a 
digital  format  of  documents  such  as  the  EU  declaration  of  conformity  or  the  instruction 
accompanying the product, could be an ‘either/or’ option, and not an additional requirement. The 
development of common standards and specification for the content and format of the required 
product information would further facilitate the fulfilment of administrative obligations. 

The  NLF  evaluation  (on  p.  60)  also  touched  upon  a  relevant  Opinion15  of  the  Fit  for  Future 
Platform  (F4F),  which  suggested  that  the  Commission  evaluates  carefully  and  draws  lessons 
relevant to explore whether product information and documentation could be given digitally as a 
default (digital-by-default), except when the product information is mandatory for consumers. The 
F4F recommended that the Commission identifies where and when it could be encouraged that 
information is provided digitally. 

(ii)  Machinery Regulation Impact Assessment 

The Impact Assessment of the Machinery Regulation16 reported on p. 19 that “Manufacturers state 
that  the  requirement  to  provide  printed  versions  increases  costs  and  administrative  burden  for 
economic  operators  and  has  a  negative  impact  on  the  environment.  On  the  other  hand,  some 
authorities  and  users  (workers  and  consumer  associations)  have  concerns  about  ending  this 
requirement  because  of:  (i)  users  that  are  less  digitally  savvy  and  that  may  prefer  paper 
documentation; (ii) a lack of internet access in certain environments; and (iii) changes or updates 
to an online manual that might not match the version of an already purchased product.” 

(iii)  Digital labelling for fertilising products Impact Assessment 

The  Impact  Assessment  of  digital  labelling  for  fertilising  products17  found  (on  p.219)  that 
“Manufacturers are divided on whether digitalisation in general would save them money. 48.4% 

15 Fit for Future Platform Opinion 2021/SBGR1/01 (New Legislative Framework for Products) 
16 SWD(2021) 82 final 
17 SWD(2023) 49 final 

12 

 
 
think  that  it  would  provide  financial  savings  (N=49).  The  majority  of  those  who  thought  that 
digitalisation would save them money were larger enterprises. SMEs were not so supportive of the 
view that digitalisation would save them money (p. 219)” 

(iv) 

Toys Safety Regulation Impact Assessment 

The  2023  Impact Assessment  for  the  Toys  Safety  Regulation  estimates  that  moving  to  digital 
provision  of  compliance  information  could  save  EUR  2.62-3.93  million  per  year  in  that  sector 
only. In addition, it would lower the costs of inspections for companies, as relevant documentation 
would be available online, facilitating document retrieval.   

(v) 

Standardisation Regulation public consultation 

In  the  public  consultation  underpinning  the  forthcoming  evaluation  of  the  Standardisation 
Regulation, most respondents (55%) strongly agreed that the availability of harmonised standards 
facilitates cross-border activities and trade within the Internal Market, with 32% agreeing (sample 
size N=254). A majority of SMEs participating in the public consultation (N=66) strongly agreed 
(37%) or agreed (25%) that harmonised standards facilitate their access to the EU market. In the 
targeted consultation of industry, when asked about the efficiency of the time taken to  develop 
harmonised  standards,  only  a  small  percentage  of  industry  stakeholders  considered  the  current 
process efficient (4% strongly agree, 16% agree)18. Opinions of industry stakeholders were mixed 
regarding the impact of whether the time of the process does not hinder innovation, with 28 % 
agreeing, 14% strongly agreeing, but 24% disagreeing and 12% strongly disagreeing. Individual 
interviews  with  industry  stakeholders  underpinning  the  evaluation  suggested  that  the  speed  of 
development and citation is not in line with market needs, which are evolving at a faster rate than 
harmonised standard development19. 

2.  Consultation of stakeholders  

On 6 February 2025, the Commission organised an outreach event aiming at gathering the opinions 
and feedback of the stakeholders on the simplification exercise.  

During this event, the Commission asked stakeholders whether a gradual approach to ‘digital by 
default’ in product legislation is beneficial or whether there are other aspects that need to be fixed. 
To this question, the stakeholders mainly answered that a gradual ‘digital by default’ initiative is 
indeed beneficial.  

Moreover, when asked what the simplification benefits would from the ‘digital by default’ be and 
in which specific areas, stakeholders answered that they would benefit the most from a ‘digital by 
default’ approach regarding instructions for use and product compliance documentation.  

In parallel, the Commission reached out directly to stakeholders representing sectorial industries 
in order to gather data on potential cost savings that a ‘digital by default’ policy could create.  

18 Targeted Survey Industry Q9: To what extent are you satisfied with the time needed to develop harmonised standards? Sample size: N = 50. 

Results: 4% strongly agree, 16% agree, 30% disagreed, 22% strongly disagreed, 26% neither agreed nor disagreed and 2% doesn’t know. 

19 Evaluation of the Standardisation Regulation (2025, forthcoming), Annex V 

13 

 
 
In  addition,  on  14 April  2025,  the  Commission  consulted  the  members  of  Task  Force  1  of  the 
Industrial Forum and other stakeholders, including representatives of consumer organizations to 
gather their opinions on (i) the digitalisation of the DoC, digital instructions for use and on the 
introduction of the DPP and its use as a tool for making compliance related information accessible 
and (ii) the use of common specifications as a back-up solution where no harmonised standards 
exist. Digitalisation and voluntary digital instructions received broad support from industry at this 
event.  

All members of the Industrial Forum could share their views on this simplification exercise and 
highlight  their  key  expectations  regarding  the  digitalisation  of  the  EU  product  legislation, 
including answering (and disseminating to their members) and EU survey on aligning EU product 
legislation with the digital age. Nearly 100 answers were received to the EU survey by 25 April.  

All stakeholders welcome and support the digitalisation. This reflected as well as in the written 
contributions, during the meeting and in the slido:  

Declaration of Conformity (DoC) 

•  Unanimous  support  in  favour  of  digitalisation.  In  the  slido,  a  majority  considers  it  as  a 

burden reduction  

Instructions for use:  

• 

 Support in favour of digitalisation. Industry would prefer to have the instructions only in 
digital/electronic format. While one consumer association expressed its preference to have 
the  digital  format  in  complement  to  the  paper  format,  another  consumer  association 
supported  the  digital  format  of  the  instructions  following  the  model  of  the  Machinery 
Regulation  in  its  written  answer  to  the  survey  (i.e.  that  essential  safety  information  is 
provided in paper and a paper copy of the instructions for use could be requested by the 
consumer). 

•  During the online consultation, a majority was in favour of voluntary digital instructions 
(i.e. the manufacturer has the choice, but the administration has to accept the digital format) 
and only a minority were in favour of mandatory digital instructions. This was underlined 
by several stakeholders.20 

•  A majority of participants considers the digitalisation of instructions for use as a burden 

reduction. 

Digital Product Passport (DPP) 

•  Most stakeholders expressed their support in favour of the DPP, be it in the survey, in the 

slido or during the meeting.  

20  

During the meeting, some stakeholder asked to include the digitalisation of the instructions for use foreseen 
by the General Product Safety Regulation (this is, however, not foreseen in the scope of acts to be covered 
by the omnibus proposal: only specific product legislation is covered) and a representative from the medical 
device sector advocated a full digitalisation (medical devices are not in the scope of the omnibus proposal).  

14 

 
 
•  Most  stakeholders  were  in  favour  of  using  the  DPP  as  a  tool  to  provide  the  mandatory 

compliance documentation such as the DoC and instructions for use. 

•  The companies shall have the choice of the technical system to generate the DPP file as 

long as it complies with DPP standards. 

Economic impact: costs and savings 

•  The  stakeholders  indicated  that  the  digitalisation  of  the  DoC  and  the  instruction  of  use 

would imply zero costs or would be negligeable.  

•  Several stakeholders underlined the savings that the digitalisation of instructions for use 
could  bring:  paper  costs,  transport  and  related  environmental  benefits.  Figures  were 
provided in the answers to the survey. 

•  Some companies provided estimates on the potential saving in their manufacturing sector 
of around 50 million euros. The field of activities concerned mainly household appliances, 
personal protective equipment or products falling under the radio-equipment directive, the 
ATEX directive or pressure equipment. 

Standardisation 

In response to the EU survey in the remits of the consultations of the Task Force 1 of the Industry 
Forum and additional stakeholders organised by DG GROW in April 2025, stakeholders showed 
concern about the burdens associated with the absence of harmonised standards:  

•  Respondents,  including  both  major  industry  companies  and  SMEs,  as  well  as  industry 
representatives, emphasised the challenges arising from the absence of or delayed publication 
of harmonised standards, namely in terms of costs and administrative burden.  
In  view  of  this,  some  stakeholders  recommended  improving  legal  clarity  and  mutual 
recognition of alternatives to harmonised standards. 

• 

In exchanges with National Standardisation Bodies, the acute problems resulting from the absence 
of harmonised standards and the value of uniform, consistent conditions for the use of common 
specifications were recognised. 

The Evaluation Study of the Regulation (EU) 1025/2012 on European Standardisation, and the 
related public consultation and targeted consultations carried out in 2024, showed that: 

• 

• 

Industry  strongly  relies  on  a  well-functioning  standardisation  system.  Majority  of  industry 
respondents  indicated strong agreement that harmonised standards support EU cross-border 
activities  and  trade.  Without  harmonised  standards,  businesses  are  faced  with  unnecessary 
complexity and costs. 
Industry expressed concern about  the duration of  the standard-development  process,  with  a 
majority of industry stakeholders considering the current process inefficient.  

•  Some industry stakeholders cautioned against reducing the reliance on harmonised standards 
and consider that technical or common specifications should be used only as a last resort in 
case it is not possible to develop a harmonised standard within a reasonable amount of time.  

15 

 
E.  OBJECTIVES TO BE ACHIEVED 

1.  Reducing administrative burden  

The objective of this initiative  is two-fold: (i) to  reduce the burdens related to the provision of 
information in paper format as described above and (ii) to prevent future situations in which legal 
obligations  enter into force without there being  a reliable way to  demonstrate compliance with 
such obligations due to the absence of relevant standards.  

To  achieve  the  digitalisation  objective,  it  is  necessary  to  amend  the  majority  of  directives  and 
regulations under the NLF in order to clarify that the obligations of economic operators to provide 
information  to  national  competent  authorities  (specifically  those  relating  to  the  declarations  of 
conformity) shall be fulfilled through digital means and that instructions for use may be provided 
digitally. 

In order to achieve the burden reduction objective, the following changes are foreseen: 

-  Specifying that the EU declaration of conformity, or a similar document, must be drawn up 
in electronic form and made accessible through an internet address or machine-readable 
code when that declaration needs to accompany a product; 

-  The addition of a “digital contact” as information to be indicated by manufacturers on the 
products  which  are  placed  on  the  market  in  order  to  facilitate  communication  between 
economic operators and national authorities; 

-  Specifying that the instructions accompanying products may be provided in electronic form 
with the exception of the safety information which should be provided in paper for non-
professional  users  while  professional  users  may  request  paper-based  safety  information 
when there is a need for it. Digital safety information is more practical and beneficial for 
professional users, for several reasons. Professionals typically use products regularly and 
are well- versed in their safety requirements, reducing the need for constant reference to 
paper-based  information.  Eliminating  paper-based  information  reduces  paper  waste  and 
supports  sustainability  goals,  which  is  often  a  priority  for  professional  settings. 
Professional  users  also  have  the  skills  and  tools  to  access  digital  formats  of  safety 
information,  which  can  be  more  convenient  and  up-to-date  than  printed  materials.  The 
amendment  of  reporting  obligations  to  national  authorities  that  foresee  a  “paper  or 
electronic format” to “electronic form” only; 

-  The insertion of an obligation for exchanges by electronic means between the economic 

operators and competent authorities; 

-  An obligation to provide the information contained in the EU declaration of conformity 
and  instructions  on  the  digital  product  passport  when  the  product  is  subject  to  another 
Union legislation that requires the use of such digital product passport. 

To achieve the objective of preventing future situations in which legal obligations enter into force 
without  there being  a reliable way to  demonstrate  compliance  with  such obligations  due to the 

16 

 
absence of relevant standards, it is necessary to amend the majority of directives and regulations 
under the NLF in a coherent manner. The following changes are foreseen: 

-  The  introduction  of  provisions  empowering  the  Commission  to  adopt  common 
specifications  as  an  alternative  to  harmonised  standards  where  no  standards  exist,  are 
unavailable or there is an urgency. 

The  use  of  common  specifications  as  a  means  of  establishing  technical  requirements  in  EU 
legislation  is  a  significant  development  that  can  have  far-reaching  implications  for  the 
implementation and enforcement of regulatory measures. The concept of common specifications 
already exists in EU legislation, to cater for situations where harmonised standards are needed but 
unavailable.  Common  specifications  offer  a  flexible  and  efficient  way  to  establish  technical 
requirements,  allowing for quicker adaptation  to  changing  market  conditions and technological 
advancements in situations where harmonised standards´ development is insufficient. The process 
of  developing  common  specifications  is  less  cumbersome  compared  to  harmonized  standards, 
which are often delayed, as evident from the current unavailability of 117 harmonised standards 
based on ISO/IEC for over a year. The high dependency on ISO/IEC standards, with 28% of CEN 
harmonised standards based on ISO and 67% of CENELEC harmonised standards based on IEC, 
underscores the need for alternative solutions. Common specifications, which already exist in over 
10 legislative acts and are proposed to be introduced in 16 further directives and regulations, have 
the same legal effect as harmonized standards, providing a viable alternative.  

When considering the measure to address the legal certainty gap in situations where harmonised 
standards are not available, other measures than common specifications were considered, such as 
soft-law measures. A possible measure could have been guidelines which would provide necessary 
elements  for  economic  operators  to  comply  with  essential  requirements  or  a  non-binding 
Commission communication on transitional methods that could be used temporarily to overcome 
absence of an applicable harmonised standard. However, soft law measures cannot produce any 
binding  legal  effects  in  the  Single  Market.  Therefore,  a  legislative  measure  which  would  put 
common specifications on equal legal footing with harmonised standards was chosen as the most 
appropriate measure. 

A  potential  drawback  of  the  proposed  solution  is  that  the  common  specifications  will  not  be 
developed by European standardisation organisation who according to standing rules laid down in 
Regulation No 1025/2012 retain exclusivity in standards development. However, the measure is 
aimed to precisely address the situation where the exclusive standard developers are not delivering 
harmonised standards which are necessary to support sectoral legislation.  

The  benefits  of  common  specifications,  including  their  ability  to  promote  public  safety, 
environmental protection, and economic growth, outweigh the drawbacks, making them a measure 
that ensures a smooth and effective solution in case of disruptions in availability of harmonised 
standards.  Ultimately,  the  use  of  common  specifications  can  help  mitigate  the  urgent  need  for 
harmonized standards, providing a temporary solution to the current shortage. 

this change does not affect the use and relevance of the traditional procedures for the development 
and delivery of harmonised standards yet creates a single coherent and reliable alternative with 

17 

 
uniform  conditions  of  application  in  the  EU  acquis  in  case  the  three  European  Standardisation 
Organisations are not able to deliver draft harmonised standards in a timely manner. 

This  simplification  measure  is  fully  complementary  with  the  planned  revision  of  the 
Standardisation Regulation (Regulation (EU) 1025/2012), due for adoption in 2026. The revision 
will  involve  a  comprehensive  review  and  adaptation  of  the  EU  standardisation  framework. As 
announced in the 2025 EU Competitiveness Compass, it will aim to accelerate standard-setting 
processes, make them more inclusive and introduce more agility and flexibility in the system.   

The planned revision of the Standardisation Regulation does not remove the need to introduce a 
simpler  and  more  coherent  way  to  obtain  common  specifications  across  all  sectoral/product 
legislation as a fall-back solution. As it concerns a comprehensive revision due in 2026, it also 
does not tackle the urgency related to the regulatory burden on businesses resulting from the refusal 
of certain standardisation organisations to submit draft harmonised standards, hence the need for 
this dedicated simplification measure. 

a)  Burden reduction for businesses 

Digitalisation 

As far as economic operators are concerned, the digitalisation of their obligations would simplify 
and facilitate as well as speed up the transmission of documents to national competent authorities. 
Cost  savings  would  mainly  derive  from  simpler  document  management  (no  handling  of  paper 
copies,  and  no  update  costs  of  existing  documents)  and  paper  and  postage  costs  (replaced  by 
electronic transmission).  

As regards the obligation to provide the certificate of conformity and the technical file upon request 
of  an  authority,  the  related  costs  would  be  reduced  to  a  one-off  cost  of  uploading  the  relevant 
information to a digital storage. No information is available regarding the costs associated today 
to  those  actions,  but  they  can  be  assumed  to  be  relatively  small  at  the  level  of  an  individual 
business. They may be more significant for EU businesses producing or importing a wide range of 
products  falling  under  obligations  related  to  the  provision  of  DoCs  or  technical  files  to  public 
authorities. On the other hand, businesses that are already making use of the possibility to provide 
the relevant information digitally and who only have to deal with public administrations that do 
not request paper documents will not see any savings. It is estimated that there are approximately 
250  000  businesses  active  in  the  manufacturing  sectors  related  to  the  products  in  scope  of  the 
omnibus. At  the  same  time,  this  number  may  include  EU  manufacturing  companies  that  only 
produce  intermediate  goods,  which  do  not  fall  under  the  obligations  related  to  the  DoC  and 
technical  file  and  would  therefore  not  realise  any  savings.  There  is  no  information  about  the 
numbers of products concerned, nor is there any data on how often manufacturers have to provide 
the DoC or technical file to an authority in paper format or what the related costs are. Assuming 
that this might happen on average once per year per company and for one product, and that the 
related cost for paper, printing and postage is about €4, this would mean that the expected annual 
cost savings could be in the magnitude of about €1 million.       

18 

 
The  possibility  to  provide  instructions  for  use  only  in  digital  format  is  likely  to  generate 
considerably larger savings for businesses. These savings relate to the avoided costs of procuring 
the paper, printing and handling costs. The personal protective equipment sector has estimated that 
digital instructions could help save between €100 million and €150 million for their industry per 
year. Similarly, for the home appliances sector, it estimated a potential of €170 million savings, 
noting  that  several  manufacturers  already  have  digital  manuals  available. The  medical  devices 
sector estimated yearly savings for the sector to be at least €13 million, whereas for producers of 
equipment for potentially explosive atmospheres the savings could amount to 2-3 € per device. No 
information is available regarding other sectors. The protective equipment and home appliances 
sectors are likely to cover a large part of the number of products concerned by the omnibus. On 
this basis, a conservative estimate of the savings related to the digital provision of instructions for 
use is that this will save businesses up to €300 million annually (the range of cost savings based 
on the three sectors for which estimates are available is between €283 million and €333 million 
per year). 

Some  industrial  stakeholders  noted  that  a  possible  requirement  to  print  the  instructions  at 
consumer/end-user request might generate significant costs, however these cannot be estimated. 
Other industrial stakeholders did not consider it as a problem.  

Common specifications 

When  harmonised  standards  are  not  available  on  time,  manufacturers  and  businesses  face 
significant uncertainty, leading to increased costs. A part of these costs concerns the need to resort 
to  alternative  methods  to  demonstrate  compliance  and  to  conduct  more  costly  third-party 
conformity assessment. These third-party conformity assessment fees can vary greatly depending 
on  the  sector,  the  type  of  product  and  the  legal  requirements.  According  to  the  2017  impact 
assessment  on  the  New  Legislative  Framework21,  they  are  estimated  to  amount  to  an  average 
annual budget of firms for services of Notified Bodies is in the range of EUR 30 000 – 80 000 and 
around EUR 4 000 for certification of a single product. In the field of toys, in terms of certification 
costs (excluding costs for technical documentation and labelling), the 2023 impact assessment of 
the revision of the Toy Safety Directive reports22 an estimated average of EUR 500 per new toy 
model in case of self-certification and EUR 1 000 in case of third-party conformity assessment 
plus  the  costs  of  the  internal  production  controls23. Third-party  conformity  assessment  fees  for 
more complex products may be significantly higher. For example, the impact assessment of the 
Machinery Regulation (2023/1230) estimated the costs of the conformity assessment to be between 

21 Impact Assessment accompanying the Proposal for a Regulation of the European Parliament and of the Council laying down rules and procedures 

for compliance with and enforcement of Union harmonisation legislation on products, SWD(2017) 466 final 

22 Staff Working Document, Impact assessment report accompanying the document proposal for a Regulation on the safety of toys and repealing 

Directive 2009/48/EC Toy Safety Regulation, SWD(2023) 269 final 

23  Internal  production  controls  are  part  of  Module  C  of  a  conformity  assessment,  as  outlined  in  Decision  768/2008/EC.  In  the  absence  of  a 
presumption  of  conformity  from  a  harmonised  standard,  such  internal  production  controls  must  be  undertaken  in  addition  to  the  third-party 
certification. 

19 

 
 
€105,000 and €275,000. 24 A full quantification is not possible in the absence of comprehensive 
granular data on the third-party assessment fees and products placed on the market but given the 
prevalence  of  self-assessments  based  on  a  presumption  of  conformity  through  the  use  of 
harmonised standards, the total costs can be significant.  

Beyond  these  direct  costs,  the  unpredictability  related  to  the  search  for  alternative  methods  to 
demonstrate compliance, their application and the uncertainty whether these alternative methods 
are  accepted  by  the  third-party  conformity  assessment  can  also  carry  significant  burden.  More 
resources  are  needed  to  identify  and  implement  these  alternative  methods,  although  these  cost 
implications are difficult to quantify. Furthermore, the potential costs of non-compliance, such as 
product recalls, fines and reputational damage can be substantial.  These costs can be a significant 
obstacle for businesses, particularly small and medium-sized enterprises, which may not have the 
resources to absorb them.  

By providing common specifications, the industry can reduce these costs and avoid the financial 
implications of non-compliance. Common specifications can help businesses avoid the costs of 
third-party  conformity  assessment  and  -in  certain  cases-  product  redesign,  retesting,  and 
recertification,  which  can  be  a  significant  expense.  Furthermore,  common  specifications  can 
reduce the costs associated with regulatory uncertainty, such as the costs of consulting with experts, 
conducting risk assessments, and developing contingency plans. By providing a mirror of the legal 
requirements, common specifications can help businesses save resources and allocate their budget 
more efficiently. This, in turn, can lead to increased competitiveness, improved profitability, and 
enhanced innovation, ultimately benefiting both businesses and consumers. The total cost savings 
will  depend  on  the  future  prevalence  of  unavailable  harmonised  standards,  which  cannot  be 
quantified. However, as presented in Section C above, the risk of non-availability of harmonised 
standards  has  significantly  increased  in  light  of  the  non-submission  of  recent  ISO  and  IEC 
standards, which play an important role in the EU Single Market. 

b)  Burden reductions for public administrations  

Abolishing the provision of paper documents in relation to the products covered by this initiative 
would also allow public administrations (e.g. market surveillance authorities) to realise savings 
related  to  paper  handling  (opening  letters,  registering  the  document,  filing/storing  the  physical 
document). On the other hand, the public authorities need to ensure that their staff is trained to 
work  with  electronic  documents/relevant  IT  systems.  In  the  medium-  to  long-term,  paperless 
processes are however likely to increase the efficiency of the relevant public bodies by paving the 
way for the adoption of modern IT tools that will automate relevant tasks. The savings for public 
administrations could not be quantified. 

24 Commission Staff Working Document, Impact Assessment Accompanying the Proposal for a 
Regulation  of  the  European  Parliament  and  of  the  Council  on  machinery  products,  21.4.2021, 
SWD (2021) 82 final 

20 

 
 
 
2.  Supporting the digital transition  

In  2024,  the  vast  majority  (95.36%)  of  EU  enterprises  with  at  least  10  employees  and  self-
employed persons used a fixed broadband connection to access the internet. The share was even 
higher for medium and large enterprises, where almost all enterprises connect to the internet via 
fixed broadband. As far as household are concerned, 94% of EU Households had access to internet 
in 2024 (Source Eurostat). 

The proposed amendments will contribute to reflect in the EU legislation the evolution observed 
among European citizens and economic operators. At the same time, they contribute to the digital 
transition and encourage technological innovation in businesses and public administrations. 

In this context, clarifying that economic operators should only fulfil their obligations via digital 
means will encourage national competent authorities to rethink the ways they process submissions 
or reporting. A digital-by-default approach would create new incentives to invest in data collection 
and processing with eGovernment solutions that could pave the way to a document-free Single 
Market based on interoperable structured data and the once-only principle.  

For  national  competent  authorities,  this  would  also  pave  the  way  for  automation  of  market 
surveillance activities and digital enforcement and their associated benefits in terms of costs and 
efficiency.  

3.  Environmental benefits  

There  are  environmental  costs  associated  with  paper  documentation,  from  sourcing  of  raw 
materials, the paper manufacturing and printing process to disposal. Virgin paper is made from 
wood, which is important for terrestrial carbon-dioxide storage. In addition, paper production is 
an energy-intensive process. It is estimated that roughly one ton of CO2 emissions are associated 
to the production of one ton of paper25, with lower values for recycled paper and higher values for 
virgin  paper.  Using  the  above  estimate  of  approximately  €300  million  savings  related  to  paper 
documentation, and using an assumed 3 cents per page of A4 paper (stakeholder estimate), this 
would translate into 10 billion A4 pages saved per year. At an average paper weight of 5 g per A4 
page,  this  would  translate  into  savings  of  50  000  tons  of  paper  (and  a  similar  amount  of  CO2 
emissions).  CO2  emissions  could  also  be  reduced  due  to  decreased  weight  of  products  being 
transported and shipped, thanks to a possible elimination of paper instruction booklets. 

On the other hand, there are environmental impacts related to the use of digital infrastructure (e.g. 
electricity use) and impacts related to the lifecycle costs of the digital infrastructure (e.g. where 
additional servers and storage need to be put in operation). At the same time, it can be argued that 
there is large technological progress in digital devices, continuously reducing energy use for the 
same functionality, which is unlikely to be the same for the lifecycle costs related to using paper. 
It can therefore be expected that the environmental balance in the medium to long run is favourable 
for replacing paper with digital technology. 

25  https://bioresources.cnr.ncsu.edu/resources/life-cycle-carbon-footprint-analysis-of-pulp-and-paper-grades-in-the-

united-states-using-production-line-based-data-and-integration/ 

21 

 
 
Conclusion on expected savings 

The digitalisation of obligations related the provision of DoCs and the technical file will simplify 
and speed up the transmission of documents to national competent authorities. No significant costs 
are expected for manufacturers due to the foreseen flexibility regarding the digital means. Cost 
savings  for manfucturers of the  concerned products  due to  simpler document management  and 
avoided paper and postage costs are estimated to be of a magnitude of approximately €1 million 
per  year.  The  possibility  to  provide  instructions  for  use  in  digital  format  could  allow  the 
manufacturers to save up to €300 million per year. As this depends on the (voluntary) uptake of 
this possibility by manufacturers, this estimate can only be seen as indicative. The overall savings 
for companies related to digitalisation are thus estimated at around €300 million per year. 
Public authorities may have to invest in training staff to work with digital tools but in the longer 
term, the digitalisation of DoCs and the technical file could allow for increased automation and 
efficiency gains. None of this could, however, be estimated. 

The  common  specifications  will  provide  a  reliable  and  cost  saving  way  for  demontrsting 
conformity with EU requirements, in cases where harmonised standards are missing or insufficient. 
By  mirroring  the  presumption  of  conformity  for  harmonised  standards,  common  specifications 
provide  an  opportunity  for  businesses  to  avoid  other  more  costly  methods  to  demonstrate 
conformity.  A  full  quantification  of  the  overall  savings  is  not  possible  in  the  absence  of 
comprehensive granular data on the third-party assessment fees and the number of products placed 
on the market, but given the prevalence of self-assessments based on a presumption of conformity, 
the total costs can be significant. 

The digitalisation is also expected to lead to environmental benefits related to saving paper. Is is 
expected that this could save approximately 50 000 tons of  CO2 emissions per year. 

Annex: 

Application of the ‘one in, one out’ approach 

One-off 

Recurrent 

Total 

[M€] 

(annualised total net present 
value over the relevant period) 

(nominal values per year) 

Businesses 

New administrative 
burdens (INs) 

Removed administrative 
burdens (OUTs) 

n/a 

n/a 

n/a 

n/a 

An  estimated  EUR  1  million 
savings related to the provision of 
DoCs and technical file digitally 

EUR  300  million  savings  related 
to  provide 
to 
the  possibility 
in  digital 
instructions  for  use 
format 

EUR 301 million 

22 

 
 
Net administrative 
burdens* 

Adjustment costs** 

Citizens 

New administrative 
burdens (INs) 

Removed administrative 
burdens (OUTs) 

Net administrative 
burdens* 

Adjustment costs** 

Total administrative 
burdens*** 

n/a 

EUR -301 million 

EUR -301 million 

Not quantifiable but likely to 
be very limited 

n/a 

n/a 

n/a 

n/a 

n/a 

n/a 

n/a 

n/a 

n/a 

n/a 

n/a 

n/a 

n/a 

EUR -301 million 

EUR -301 million 

(*) Net administrative burdens = INs – OUTs;  
(**)  Adjustment  costs  falling  under  the  scope  of  the  OIOO  approach  are  the  same  as  reported  in  Table  2  above.  Non-
annualised values;  
(***) Total administrative burdens = Net administrative burdens for businesses + net administrative burdens for citizens. 

I. Overview of Benefits (total for standardisation) – Preferred Option 

Description 

Direct benefits 

cost 

Compliance 
reduction 
resulting from the availability of 
common specifications 

Amount 

Comments 

On  average  4  000  EUR  per 
product,  which  would  have 
the 
required  certification 
absence  of  a  harmonised 
standard.  

in 

The figure given is not an aggregated one. It represents the 
amount for a single conformity assessment of one individual 
product (placed on the market) in the absence of harmonised 
standards and when no alternative option exists for using the 
presumption  of  conformity  (i.e.  common  specifications) 
under one of the legislative acts covered by the proposal. On 
top  of  this, the  business would avoid costs related to legal 
uncertainty and finding alternative methods to demonstrate 
compliance, which cannot be quantified. 

23