REPORT FROM THE COMMISSION on the implementation of Article 4 of Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011
Date: 2025-03-03
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: electronic commerce, import (EU), market approval, market supervision, marketing standard, product quality, product safety, quality standard, single market, surveillance concerning imports

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 3.3.2025  COM(2025) 63 final  REPORT FROM THE COMMISSION on the implementation of Article 4 of Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011  
 
 
1.  CONTEXT 

1.1. 

Implementation report 

This  report  provides  an  overview  of  the  implementation  of  Article  4  of  Regulation  (EU) 
2019/1020  of  the  European  Parliament  and  of  the  Council  of  20  June  2019  on  market 
surveillance and compliance of products and amending Directive 2004/42/EC and Regulations 
(EC) No 765/2008 and (EU) No 305/2011 (hereinafter: Regulation (EU) 2019/1020). Such a 
report is required according to Article 42(3)1 of Regulation (EU) 2019/1020. The report should 
in particular evaluate the scope of that Article, its effects and its costs and benefits. 

1.2.  The Market Surveillance Regulation (EU) 2019/1020 

The  framework  for  EU  market  surveillance  of  products  covered  by  certain  Union 
harmonisation  legislation  is  provided  for  in  Regulation  (EU)  2019/1020.  That  Regulation 
became applicable on 16 July 2021. Member States’ market surveillance authorities (MSAs) 
are required to ensure that the legislation is fully complied with. 

Regulation (EU) 2019/1020 covers products that are subject to Union harmonisation legislation 
concerning manufactured products other than food, feed, medicinal products for human and 
veterinary use, living plants and animals, products of human origin and products of plants and 
animals  relating  directly  to  their  future  reproduction.  Regulation  (EU)  2019/1020  is  also 
strongly  linked  to  the  General  Product  Safety  Regulation  (GPSR)2,  since  some  GPSR 
provisions will apply to the products covered by Regulation (EU) 2019/1020, and vice versa. 
The GPSR will become applicable on 13 December 2024. 

1.3.  Article 4 of Regulation (EU) 2019/1020 

To  ensure  the  compliance  of  products  on  the  Union  market,  Article  4  of  Regulation  (EU) 
2019/1020, requires that, for some products, there must be an economic operator established 
in the Union responsible for certain specific tasks as defined in Article 4(3) of the Regulation. 
In  this  report,  the  term  “responsible  economic  operator”  refers  to  the  economic  operator 
responsible for the tasks defined in Article 4. 

Four types of operators can act as the economic operator referred to in Article 4: a manufacturer 
established in the EU, an importer (where the manufacturer is not established in the EU), an 
authorised representative who has a written mandate from the manufacturer designating the 
authorised  representative  to  perform  the  tasks  set  out  in  Article  4(3)  on  the  manufacturer's 
behalf, or a fulfilment service provider3 established in the EU, where there is no manufacturer, 

1 As provided for in that Article, this report was due by 16 July 2023. Due to data limitations and the fact that 
that publication at that date would have meant to work with findings covering only one year, it was considered 
appropriate to publish the report at this point in time. 
2 Regulation (EU) 2023/988 of the European parliament and of the Council of 10 May 2023 on general product 
safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council and Directive 
(EU) 2020/1828 of the European Parliament and the Council, and repealing Directive 2001/95/EC of the European 
Parliament and of the Council and Council Directive 87/357/EEC, OJ L.135 of 23.5.2023, p.1-51. 
3 Defined in Article 3(11) of the Regulation as ‘any natural or legal person offering, in the course of commercial 
activity,  at  least  two  of  the  following  services:  warehousing,  packaging,  addressing  and  dispatching,  without 
having ownership of the products involved, excluding postal services as defined in point 1 of Article 2 of Directive 
97/67/EC of the European Parliament and of the Council, parcel delivery services as defined in point 2 of Article 
2 of Regulation (EU) 2018/644 of the European Parliament and of the Council, and any other postal services or 
freight transport services’. 

1 

 
 
 
importer or authorised representative established in the EU. In this way MSAs have someone 
to  whom  they  can  address  requests,  including  requests  for  information  regarding  products’ 
compliance  with  Union  harmonisation  legislation,  and  who  can  co-operate  with  MSAs  in 
making sure that immediate corrective action is taken to remedy instances of non-compliance. 
Article  4  is  applicable  since  16  July  2021.  On  23  March  2021,  the  Commission  published 
Guidance on its practical application for responsible economic operators and MSAs.4  

The  initial  Commission proposal5  regarding  the  scope  of  Article  4  included  all  harmonised 
products envisaged in Annex 1, and only excluded cosmetic products, medical devices, and 
energy-related products6, as the requirement for a responsible person in the EU already existed 
for these categories of product. As discussions developed with the co-legislators, changes were 
made so that Article 4 only covers 18 of the Regulations and Directives7 to which Regulation 
(EU) 2019/1020 applies. That limitation followed a risk-based analysis of where the need for 
a responsible economic operator acting as a liaison point with the MSAs could be identified.8 
It  considered  the  potential  risks,  number  of  cases  of  non-compliance,  as  well  as  whether 
products are mainly traded through physical (rather than online) supply chains. 9 

1.4.  Methodology and sources of information for this report 

In accordance with Article 42(3) of Regulation (EU) 2019/1020, this report has a specific focus 
on the application of Article 4. It is not a full evaluation. 10 It is based on data and information 
for the years 2021 (since 16 July 2021, when Regulation (EU) 2019/1020 became applicable), 
2022  and  2023,  thus  gathered  only  2  or  3  years  after  Regulation  (EU)  2019/1020  became 
applicable.  

This report is based mainly on information from an Evaluation Study on the implementation of 
Article 4 of Regulation (EU) 2019/1020 on Market Surveillance and compliance of products, 
compiled by Deloitte Consulting for the European Commission from August 2023 to July 2024. 
In addition to desk research, that study presented findings from targeted consultations in the 
form of surveys and interviews. Unless otherwise stated, when this report makes reference to 
survey results or results from “the consultant/the study”, it should be read as references to that 
study. The surveys were undertaken on the EU Survey platform targeting MSAs11 and customs 
authorities, as well as manufacturers, importers, authorised representatives, fulfilment service 
providers, and consumer representatives. With the exception of MSAs, the consultant could 
only reach a low response rate among the stakeholders: 

4 OJ C 100 23.3.2021, p. 1-15. eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52021XC0323(01) 
5 COM 2017(795) 
6  The  respective  Regulations  (Reg.  (EU)  1223/2009  (Art.  4),  Reg.  (EU)  2017/745  (Art.  15,  16),  Reg.  (EU) 
2017/746 (Art. 15, 16) and Reg. (EU) 2017/1369 (Art. 6)) already provided for a responsible person in the EU for 
these product categories. 
7 Please see Annex for a list of the relevant pieces of legislation. 
8 Recital 21 of Reg. 2019/1020. 
9 Recital 22 of Reg.2019/1020. 
10  A  full  evaluation  in  the  meaning  of  the  Better  Regulation  Guidelines  of  the  European  Commission: 
https://commission.europa.eu/law/law-making-process/planning-and-proposing-law/better-regulation/better-
regulation-guidelines-and-toolbox_en 
11 In total, there are around 1000 MSAs in the EU. 

2 

 
 
 
 
 
Target group 

Number of responses to the survey 

MSAs 

Customs authorities 

Manufacturers 

Importers 

Authorised representatives 

Fulfilment service providers 

Consumer representatives 

11812 

10 

60 

2 

0 

1 

1 

The  consultant  also  undertook  interviews  to  address  the  data  gaps  identified  and  to  gather 
information for case studies: 

Target group 

Economic operators 

MSAs 

Customs authorities 

Experts 

Consumer representative 
organisations 

Number of interviews 
conducted 

3 

10 

2 

1 

3 

At  least  one  MSA  responded  from  each  Member  State,  but  the  distribution  of  responses  is 
uneven. Germany accounted for 25 out of 118 responses. Other notable respondents included 
Spain  with  11  MSAs  responding  and  Finland  with  9.  In  contrast,  several  Member  States, 
including France, Poland, Belgium, and Malta, only had one response. It should be noted that 
the  number  of  MSAs  varies  significantly  between  Member  States,  as  it  depends  on  their 
domestic organisation and administrative structure. 

Due to the very low response rate from economic operators, the consultant contracted IPSOS13 
to  collect  survey responses from  manufacturers producing  products  covered by Article 4 in 

12 10 of these MSAs focus on products not covered by Article 4 and have not checked products covered by Article 
4. Consequently, they could not share their experiences regarding the implementation of Article 4. 
13 IPSOS is a multinational market research firm, based in France. 

3 

 
 
 
 
 
Germany  and  France  respectively.  IPSOS  provided  25  responses  from  German  and  25 
responses from French manufacturers respectively, which are included in the first table above. 

Regarding customs authorities, responses were received from 10 Member States: Belgium, 
Cyprus, Denmark, Finland, France, Ireland, Latvia, Romania, Slovakia, and Sweden. Among 
these, 2 authorities (Ireland and Sweden) agreed to participate in an interview. 

In addition to the study mentioned above, this report also takes into account findings gathered 
in two separate projects: 

a)  A joint action initiated by a Working Group in the EUPCN14, which gathered evidence 
from  MSAs  to  assess  the  compliance  of  products  sold  online  with  the  formal 
requirements of Article 4(1). 

b)  A joint action JAHARP2021-1015 focusing on the role of fulfilment service providers 

in Article 4 ("Support on Article 4 of Regulation (EU) 2019/1020"). 

As follows from the information above, there are some limitations to the input used for the 
analysis  in  this  report.  Considering  that  the  report  comes  relatively  soon  after  Regulation 
(EU) 2019/1020 became applicable and that it takes time for MSAs and other stakeholders to 
adapt to the new provisions, there is only limited data and practical experience. Most concrete 
data gathered by the consultant is from 2022. In addition, whereas the consultant, as explained 
above,  aimed  at  covering  several  categories  of  stakeholders,  the  response  rate  could  be 
considered satisfactory only for MSAs. 

14 EU Product Compliance Network, established under Reg. 2019/1020 in order to structure the co-ordination and 
co-operation between EU MSAs. 
15  JAHARP  -  Joint  Market  Surveillance  Action  on  HARmonised  Products  2021  Omnibus  -  is  a  portfolio  of 
projects co-funded by the EU. The projects aim at supporting the  application of the new Market Surveillance 
Regulation (EU) 2019/1020 through the development of common approaches and good practices.  

4 

 
 
 
 
2. 

IMPLEMENTATION OF ARTICLE 4 

2.1. 

Implementation measures 

2.1.1.  Have MSAs carried out checks on implementation of Article 4? 

The  MSAs  have  undertaken  checks  of  Article  4  compliance  (normally  checking  that 
responsible  economic  operator  is  indicated  on  the  product),  either  as  separate  measures  or, 
more  often,  in  connection  with  checks  of  compliance  with  other  provisions  of  Union 
harmonisation legislation. According to the study, 85% (92 out of 108) of the MSAs have 
conducted  compliance  checks  for  Article  4  since  Regulation  (EU)  2019/1020  became 
applicable16. Within these 85%, 20% (18 out of 92) indicated that they had done checks with a 
primary focus on assessing compliance with Article 4.17 

In case of products entering the EU from third countries, Article 4 information is not directly 
provided or made available to customs authorities in customs declarations or in any other 
manner (please also see section 3 on customs reform proposal). To verify compliance with 
Article  4,  customs  authorities  and  other  authorities  designated  for  the  controls  on  products 
entering the EU market18 have therefore no other choice than undertaking a physical control of 
the  product,  either  randomly  or  as  part  of  other  controls.  Due  to  this  lack  of  information, 
customs have no relevant risk information for risk management and are thus not able to identify 
risks of non-compliance with Article 4. This is a significant impediment of the current Article 
4, which basically prevents any effective enforcement at EU external borders whereas this was 
clearly a core objective thereof. Still, most customs authorities (7 out of 10) report performing 
controls on Article 4 compliance.19 Since most customs authorities that answered the survey 
have not taken specific steps to ensure Article 4 controls20, it would seem that, as for MSA 
checks, Article 4 customs controls are mostly done in connection with other controls. 

2.1.2.  Has Article 4 been complied with? 

Article  4  checks  by  MSAs  are  often  done  in  connection  with  other  checks.  During  the 
specific Article 4 checks21, the responsible economic operator was not indicated in 7% of the 
cases. In 5% of the checks, the contact details of a responsible economic operator established 
in the EU were given but when MSAs contacted that economic operator, it turned out that the 
information  was  not  correct  (the  economic  operator  was  not  reachable  or  declined 
responsibility).22 

Based  on  the  responses  of  MSAs,  responsible  economic  operators  usually  provide  postal 
addresses (84% of MSAs reported this) and electronic addresses (69%) or telephone numbers 
(40%).23 More than half of the MSAs stated that non-compliance with Article 4 was higher 
regarding  products  sold  online  than  offline  (significantly  higher  35%,  or  somewhat  higher 
16%). 

16 Deloitte 5.1.2.A.1, p. 55. 
17 Deloitte 5.1.2.A.1, p. 55. 
18 Art. 25(1) Regulation (EU) 2019/1020 
19 Deloitte 5.1.2.A.2, p. 59. 
20 Deloitte 5.1.3.A.2 p. 66. 
21 The MSAs who participated in the survey reported 29 745 such checks in 2022. 
22 Deloitte 5.1.2.A.1, p. 56. 
23 Deloitte 5.1.2.A.1, p. 56. 

5 

 
 
 
Implementation facts gathered in an MSA joint action under EUPCN 

Concrete  experience  of  Article  4  compliance  has  been  gathered  through  a  joint  action 
initiated by a Working Group in the EUPCN. The objective of this joint action was to assess 
the compliance of products sold online with the formal requirements of Article 4(1) (i.e. 
presence  of  responsible  economic  operator  in  the  EU).  To  achieve  this,  it  aimed  at  the 
broadest  view  possible  of  products  offered  online  to  Union  consumers  by  economic 
operators  from  third  countries.  MSAs  from  11  Member  States  participated.  They  were 
recommended to inspect the online offers for approximately 10 different products. The action 
took place from July to December 2023. In total, 215 online offers were analysed. It covered 
37% of the product sectors relevant for Article 4. 

As a first step, a request for information on the manufacturer and the responsible economic 
operator in the Union referred to in Article 4(1) of Regulation (EU) 2019/1020 was sent out 
to  the  economic  operators  (normally  the  manufacturer)  not  established  in  the  Union.  An 
answer with indication of a responsible economic operator in the EU was received in 
43% of the cases. As a second step, a request for information was sent out to the responsible 
economic  operators  indicated,  in  order  to  verify  if  that  entity  actually  existed  and 
acknowledged  his  responsibility.  The  responsible  economic  operator  was  confirmed  in 
only  34%  of  the  requests  sent  out  in  the  second  step,  so  around  two  thirds  of  the 
indications of economic operators turned out to be incorrect or could not be verified as they 
did not reply. This means that the joint action showed a low level of compliance with Article 
4(1) for products sold online compared with the result indicated earlier in this section, which 
covers other sales channels. Overall, only 14% (31 out of 215) of the online offers from third 
countries could be considered compliant with Article 4. 

In  conclusion, while there has been some level  of compliance with  Article 4, there are still 
significant challenges, particularly in the realm of e-commerce (which to a large extent is the 
supply channel that Article 4 aims at addressing) and for the identification and verification of 
responsible economic operators. When Article 4 checks are done in connection with checks of 
other compliance issues, the picture seems quite different than when checks focused on Article 
4 are done for products offered online from third countries. 

2.1.3.  Has Article 4 had effects on overall compliance? 

As concerns the effects of Article 4 on overall compliance (i.e. compliance with harmonisation 
legislation), there are no clear such effects over the short time period in which Article 4 has 
been in application. Half of the responding MSAs (50%, 54 out of 108) did not experience 
any change in the overall levels of compliance and safety among the products subject to 
Article  4  compared  to  other  products.  Another  37%  (40  out  of  108)  of  the  MSAs  had  no 
opinion, which may indicate that no major change has been noted.24  

24 Deloitte 5.2.A.1, p. 88. 

6 

 
 
 
 
Fig 1: Change in compliance and safety among products covered by Article 4 

On average, the MSAs that responded to the consultant’s survey found non-compliant products 
(general non-compliance) in around 10% of their checks (11% in 2019 and 9% in 2022). The 
highest incidence of non-compliant products was related to products covered by Article 4 (12% 
in 2019 and in 2022 as well)25, reinforcing the picture that Article 4 does not seem to have an 
immediate effect on general compliance.  

As to products sold online, most of the MSAs (38%, 41 MSAs) that could express an opinion 
have not experienced any change after 2021 in the frequency of general non-compliance for 
products  covered  by  Article  4.  15%  of  the  MSAs  responded  that  the  frequency  of  non-
compliance for products  covered by Article 4  and sold  online changed:  6% said  that it had 
decreased  somewhat,  but  6%  indicated  that  it  is  significantly  higher  and  4%  said  that  it  is 
somewhat higher.  

The experience of MSAs seems  to  show that  when they  reach out  to  responsible  economic 
operators  in  cases  where  the  relevant  products  show  a  possible  non-compliance,  those 
economic operators responded in most cases or always (72% of the responding MSAs reported 
this). In case of a response, they responded within the time requested by the MSA in 75% of 
the cases and they also collaborated with the MSAs in 73% of cases.26 In general, nearly half 
(47%)  of  the  responding  MSAs  could  not  state whether  the  application  of  Article  4  had  an 
impact on cooperation with economic operators. 28% of the MSAs stated that the cooperation 
with economic operators has not improved, while 21% indicated that it slightly improved. Only 
4%  of  the  MSAs  experienced  significant  improvement  in  cooperation  with  economic 
operators.27 

2.1.4.  Practical issues in Article 4 implementation 

Almost half (44%, 48 MSAs) of the respondent MSAs did not find the interpretation of their 
tasks regarding Article 4 difficult, while 21% experienced difficulties (only 2% found the 
interpretation very difficult).28 Among customs authorities, 4 out of 10 of the respondents did 
not  find  that  interpreting  their  tasks  concerning  Article  4  had  been  challenging,  while  30% 

25 Deloitte 5.1.2.A.1, Table 6, p. 58. 
26 5.1.2.A.1, p. 56. 
27 Deloitte 5.1.3.A.1, p. 64. 
28 Deloitte 5.1.4.A.1, p. 71. 

7 

 
 
 
 
found it somewhat challenging.29 Furthermore, only 3%30 of all respondent MSAs had sought 
assistance from the EU Commission services regarding Article 4. 

When asked to identify the type of responsible economic operator for which compliance with 
Article 4 poses a particular challenge, 37% of MSAs identified importers, 35% of MSAs cited 
fulfilment  service  providers,  17%  mentioned  authorised  representatives,  and  11%  noted 
manufacturers.31. However, as concerns legal interpretation issues, many MSAs indicated that 
they experienced some challenges regarding the fulfilment service provider and their tasks, 
in interpreting terms as 'addressing' and 'dispatching'.32 The consultation of MSAs and others 
revealed  some  further  practical  issues,  such  as  where  the  responsible  economic  operator’s 
contact details should be indicated. 

2.2.  Costs and benefits 

2.2.1.  Benefits 

The expected benefits of Article 4 include not only the facilitation of corrective actions and 
enforceability of MSA decisions, but  also  a more level  playing  field  between EU and third 
country producers through deterrence in the form of increased risks and consequences for third 
country producers bringing non-compliant products to the EU market. As indicated in section 
2.1.3,  Article  4  does  not  yet  seem  to  have  had  a  deterrent  effect  in  terms  of  decreased 
occurrence  of  non-compliant  products.  According  to  multiple  MSAs,  responsible  economic 
operators, especially fulfilment service providers, are very difficult to identify when they are 
not mentioned on or with the product, and even when they are identified, it is challenging to 
contact them. In most cases, extra efforts made by MSAs to identify and contact responsible 
economic operators do not bring any result. In the survey, 4 out of the 10 customs authorities 
who replied  saw no changes regarding the number of non-compliant products  at  the  border 
since the introduction of Article 4. Another 40% of customs authorities do not know whether 
there has been any change, with the remaining 20% saying there has actually been an increased 
non-compliance in the relevant products since the implementation of Article 4.33 

2.2.2.  Costs 

While  checking  contact  details  of  responsible  economic  operators  can  require  some  time34, 
65% (70 out of 108) of MSAs did not, according to the consultant’s survey, experience 
any changes in the cost of market surveillance since Article 4 became applicable. Around 
10%  (11  out  of  108)  stated  that  their  costs  of  market  surveillance  increased  slightly  since 
Article 4 became applicable. For another 3% (3 out of 108) these costs increased significantly. 
In the few MSAs that reported cost increases due to incorporating the requirements of Article 
4 into the regular checks, the reasons were related to the use of new technical tools or to the 
hiring of additional staff. It was very rare that MSAs made additional budget available in order 
to  ensure  compliance  with  Article  4.35  Among  customs  authorities,  any  costs  related  to 
Article 4 seem to be limited, with 4 out of the 10 who replied indicating that verification of 

29 Deloitte 5.1.4.A.2, p. 74. 
30 Deloitte 5.1.4.A.1, p. 71. 
31 Deloitte 5.1.5.A.1, p. 80. 
32 Deloitte 5.1.4.A.1, p. 72. 
33 Deloitte, 5.2.A.2, p. 93. 
34 The average time needed to perform a check on harmonised products currently covered by Article 4 increased 
between 2019 and 2022, with Article 4 compliance checks incorporated into the general checks. 
35 1 MSA reported doing this in the Deloitte study (section 5.2.A.1, p. 90).  

8 

 
 
 
the contact details of responsible economic operators had not brought additional costs (while 
20% responded that it had brought some costs).36 For economic operators, the nature of the 
Article 4 tasks mean that for compliant products the costs (mainly indication of responsible 
economic operator) of Article 4 compliance are marginal, though the very few survey responses 
received show that some economic operators (manufacturers) estimate Article 4 costs at levels 
around 1-1.5%37 of the overall costs of being compliant with EU regulations38. The consultant 
points out that such interpretation issues can lead to overestimation of Article 4 costs.39 

2.3. 

Scope of Article 4 

The scope of Article 4 is limited in terms of product categories, range of responsible economic 
operators and tasks. A notable share (up to 53 %; different from one type of scope to another) 
of  the  surveyed  stakeholder  respondents  chose  to  answer  "don't  know"  when  assessing  the 
scope  of  Article  4,  possibly  indicating  a  certain  lack  of  engagement  concerning  the 
appropriateness  of  the  scope  of  Article  4  regarding  product  categories  covered,  type  of 
responsible economic operators and the tasks of responsible economic operators.  

2.3.1.  Scope of Article 4 - product categories 

As explained in section 1.3, the scope of Article 4 is limited in terms of product categories.  

More  than  half  (53%,  57  out  of  108)  of  MSA  respondents  stated  that  they  did  not  know 
whether the scope of products covered is appropriate. The vast majority of the MSAs that 
responded “Don’t know” actually have experience in checking compliance with Article 4, but 
they  are  unsure  about  the  effects  of  expanding  its  scope.  22%  of  MSAs  (24  out  of  108) 
responded that the scope of Article 4 was appropriate in terms of the products covered. While 
concrete experience brought forward by MSAs does not seem to indicate that this limited scope 
poses problems for market surveillance, 25% of MSAs (27 out of 108) indicated that the scope 
of products should be extended.40With respect to concrete possibilities for extension of the 
scope, the options brought forward (by at most 5-10% of MSAs for each option) ranged from 
suggesting that individual product categories be added to suggesting that the scope be widened 
to all products.  

While the current scope of Article 4 does not present significant obstacles according to customs 
authorities, there is recognition of potential efficiency gains through its extension to cover all 
harmonised products. Extending Article 4 to all harmonised products would simplify customs 
controls  and  enhance  the  efficiency  and  effectiveness  of  customs  risk  profiling  and  risk 
analysis. 41 It would also align with the approach of the GPSR. 

Both  economic  operators  and  consumer  representative  organisations  expressed  mixed 
views on the product categories covered by Article 4. They did not offer suggestions regarding 
the inclusion of new product categories.  

36 Deloitte 5.2.A.4, p. 101.  
37 Deloitte 5.2.A.3, p. 96. 
38  The  costs  related  to  making  sure  the  product  is  compliant  and  accompanied  by  documentation  such  as 
declaration of conformity should normally not be seen as Article 4 costs. 
39 Deloitte 5.2.B, p. 104. 
40  Deloitte  5.3.A.1,  p.108.  The  suggestions  for  additions  usually  seem  to  reflect  the  sectors  covered  by  the 
responding MSAs. 
41 Deloitte 5.3.A.2, p. 113. 

9 

 
 
 
2.3.2.  Scope of Article 4 - types of responsible economic operators 

As outlined in section 1.3, there are four types of actors that can function as the responsible 
economic operator referred to in Article 4. MSAs have mixed views about this aspect of the 
scope of Article 4. The largest group (38%, 41 out of 108) of MSA respondents expressed 
uncertainty  about  whether  additional  actors,  beyond  the  four  categories  of  responsible 
economic  operators  listed  in  Article  4(2),  should  be  added.42  An  important  share  (37%)  of 
MSAs stated that the current scope of responsible economic operators was appropriate and that 
no additional actors should be considered. Still, 25% of MSA respondents indicated that the 
scope of Article 4 should be expanded to encompass more types of economic operators.43 13% 
of the MSAs (14 out of 108) highlighted the particular role of providers of online marketplaces. 
They are not economic operators, but some MSAs expressed a wish for them to have a role in 
the market surveillance process. Of 25 MSAs who made concrete suggestions on a role for 
more  actors  under  Article  4,  14  (56%  of  respondents)  highlighted  providers  of  online 
marketplaces.44  In  this  context,  several  MSA  respondents  emphasized  the  possibility  for 
providers of online marketplaces to verify the responsible economic operators before listing 
products and publishing offers.45 As concerns other stakeholders than MSAs, the majority of 
economic operators, and all consumer organisations that participated in the consultation, agreed 
with this approach on expansion of tasks (e.g. verifying that products are marked in accordance 
with Art. 4) to providers of online marketplaces.  

2.3.3.  Scope  of  Article  4  -  tasks  to  be  performed  by  the  responsible  economic 

operators 

The  existing  tasks  of  the  responsible  economic  operator  outlined  in  Article  4  include:  i) 
verifying and keeping the documentation of products, ii) co-operating with MSAs by providing 
information and documentation during compliance checks, and iii) co-operating with MSAs in 
case  of  product  recall.  Half  of  the  MSA  respondents  found  that  these  tasks  contribute  to 
improving the effectiveness of their market surveillance.  

29% of MSAs (31 out of 108) indicated that the scope of Article 4 was appropriate and that no 
additional  tasks  and  responsibilities  were  necessary.  Meanwhile,  54%  of  MSA  respondents 
stated they were uncertain whether additional tasks and responsibilities should be assumed by 
responsible economic operators under Article 4.46 

Of  the  MSAs  who  could  express  an  opinion,  38%  find  that  additional  tasks  should  be 
introduced for responsible economic operators. Suggestions included e.g. holding responsible 
economic operators accountable for product compliance; empowering responsible economic 
operators to take corrective actions such as publishing safety warnings, withdrawing products 
from  the  market,  and  recalling  products  from  end-users  and  verifying  the  accuracy  of 
compliance  information  (rather  than  merely  confirming  its  presence).  One  out  of  the  three 
consumer representative organisations interviewed, also stated that product safety should be a 
task of responsible economic operators. 47  

42 Deloitte 5.3.A.1, p. 109. 
43 Deloitte 5.3.A.1, p. 109. 
44 Deloitte 5.3.A.1, p. 110 
45 Please also see section 3 of this report. 
46 Deloitte 5.3.A.1 p. 111. 
47 Deloitte 5.3.A.4, p. 113. 

10 

 
 
 
3.  RELATED POLICY DEVELOPMENT 

The GPSR will have effects on Article 4 in at least three ways:  

a)  Economic operators making products covered by Article 4, or by the GPSR, available 
on the market in distance sales, including online will have to indicate the responsible 
economic operator when the GPSR becomes applicable on 13 December 2024 (Article 
2(1)  of  the  GPSR  together  with  Article  19(a)  and  (b)  of  the  GPSR).  In  addition, 
providers of online marketplaces will be required to design and organise their online 
interface in a way that enables these traders to provide and display the details of the 
responsible economic operator (Article 22(9)(a) and (b) of the GPSR) and ensure that 
the information is displayed or otherwise made easily accessible by consumers on the 
product listing. 

b)  Article 16 of the GPSR will extend the application of Article 4(2) and (3) of Regulation 

(EU) 2019/1020 to all products not covered by harmonisation legislation. 

c)  Article 16 of the GPSR will also add additional regular compliance check tasks for the 
responsible  economic  operators  concerned  in  relation  to  these  non-harmonised 
products. These checks  will also  include safety  checks  (checks against the technical 
documentation). 

The Digital Services Act (DSA)48 provisions on providers of online platforms can contribute 
to address the issue of non-compliance of products sold on online platforms allowing traders 
to conclude distance contracts with consumers (i.e. online marketplaces), as it adds specific 
tasks on them that play a key role in market surveillance. According to Article 30 of the DSA, 
providers  of  online  platforms  may  only  allow  products  to  be  offered  to  consumers  on  their 
platforms if the trader has provided specific information to the platform, including its name, 
contact  details,  identification  number,  payment  account  details,  the  trade  register  and  its 
registration number or equivalent means of identification (where the trader is registered in a 
trade register or similar public register) as well as a self-certification committing to only offer 
products or services that comply with the applicable rules of EU law.49 Both the trader’s details 
and the self-certification of compliance must be made available to the recipients of the service 
by the provider of the online platform50, who also needs to make best efforts to assess whether 
the information provided is reliable and complete. 

Furthermore, Article 31 DSA imposes an obligation on marketplaces to design their service in 
a way that allows traders to comply with their existing obligations under for instance consumer 
protection  or  market  surveillance  law,  such  as  identifying  the  responsible  person  or  the 
economic operator for each listing. This provision will allow consumers to understand who is 
responsible for each product they buy. 

48 Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single 
Market for Digital Services and amending Directive 2000/31/EC (OJ L 277 of 27.10.2022). The DSA became 
applicable on 17 February 2024, which means that it could not have effect on the results presented in this report.  
49 Article 30(1) DSA. 
50 Article 30(7) DSA 

11 

 
 
 
To support MSAs in a context of booming e-commerce51, the Commission has launched the 
eSurveillance  WebCrawler,  an  application  to  facilitate  the  enforcement  work  of  Market 
Surveillance on products sold online. It  identifies product offers of goods notified in Safety 
Gate, the EU rapid alert system for dangerous non-food products, that are still available online. 
The system enables automatic detection and generation of automatic takedown requests by the 
enforcement authorities. 

Furthermore, the Commission is developing another WebCrawler to detect non-compliant or 
dangerous  products  sold  online.  This  tool  crawls  product  descriptions  and  customers’ 
reviews to detect specific keywords that could indicate non-compliance of products sold on 
commercial web pages. The pilot phase took place in 2023 and was successful. The second 
development  phase  is  taking  place  in  2024  and  involves  the  development  of  new  AI 
functionalities. The WebCrawler is planned to be in full use in 2025 and will be shared with 
all interested MSAs. 

Finally, to address the lack of relevant information available to customs authorities with respect 
to  product  compliance,  the  Commission  included  in  its  customs  reform  proposal52  an 
obligation to provide or make available to customs authorities certain data relevant for product 
compliance  controls  at  EU  external  borders,  as  a  new  condition  for  the  release  for  free 
circulation.  The  additional  data  will  include  the  importer,  the  manufacturer,  the  product 
supplier where this is different from the manufacturer, ‘the responsible economic operator in 
the Union pursuant to Article 4 of Regulation (EU) 2019/1020 and Article 16 of Regulation 
(EU) 2023/988’, and the legislation applicable to the product. If the new requirement is kept 
after  co-legislators  adopt  the  proposal,  this  new  information  obligation  will  enable  risk 
management and risk-based controls on the compliance with Article 4, including in the case of 
e-commerce. 

4.  CONCLUSIONS 

The findings presented in this report indicate that MSAs and customs authorities implement 
Article  4,  though  with  some  challenges  and  non-compliance  issues  as  described  above. 
Implementation of Article 4 seems to have brought only marginal cost increases for authorities 
or  economic  operators.  There  are,  however,  no  concrete  signs  yet  that  its  introduction  has 
contributed to improving the overall compliance. It may be argued though that Article 4 non-
compliance is likely to signal a risk of general non-compliance, since a product that does not 
comply with a clear formal rule (such as an information or marking obligation), might also be 
at risk of more substantial non-compliance53. 

With view to e-commerce, results of the report furthermore indicate that non-compliance with 
Article  4  was  higher  regarding  products  sold  online  than  offline.  A  significant  share  of 
responding MSA pointed particularly at the role of providers of online marketplaces. Those are 

51 According to the data  available to the  Commission (DG  TAXUD), in 2023, a total of 2.3 billion items not 
exceeding  EUR  150  were  imported  into  the  EU,  which  is  a  clear  increase  compared  with  previous  years. 
Consumers’ behaviour is likely to lead to further dramatic increases of distance sales, also of products that are 
directly shipped from third countries. These are expected to reach around 4 billion of consignments in 2024, while 
commercial traditional imports (i.e. sold in brick-and-mortar shops) are approximately 300 million per year. 
52 Article 88(3)(a) of the Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE 
COUNCIL  establishing  the  Union  Customs  Code  and  the  European  Union  Customs  Authority,  and  repealing 
Regulation (EU) No 952/2013 (COM/2023/258 final). 
53 For example, if a product covered by the Toy Safety Directive does not have a responsible economic operator, 
as required by Art.  4, it may be justified to check if that product does not also fail to comply with the safety 
requirements of that Directive. 

12 

 
 
 
not economic operators, but some respondents suggested that those should be more considered 
in the market surveillance process (e.g. it was proposed that providers of online marketplaces 
could potentially be involved in verifying the indications of responsible economic operators 
when products are made available on the platform). 

It should be noted that Article 4 has only been applied for a relatively short period, and the 
information gathered to support this report was limited. As more experience is gathered among 
stakeholders,  routines  and  procedures  will  be  developed  which  could  lead  to  improved 
implementation  and  enforcement.  Furthermore,  since  its  adoption,  new  legislation  has  been 
proposed or adopted and entered into application, which – combined with Article 4 – should 
produce positive results to improve the situation: 

-  The  obligations  on  providers  of  online  marketplaces  under  the  GPSR  and  the  DSA 
(mandatory  indication  of  responsible  economic  operator  in  online  offers)  may  help 
address  the  issue  of  non-compliance  of  products  sold  on  online  platforms,  once  the 
GPSR enters into application, and the DSA shows positive results in terms of online 
indication of responsible economic operators. On the other hand, the GPSR may make 
compliance more challenging for economic operators, as it extends the scope of Article 
4 and introduces new tasks for the responsible economic operators.  

-  The customs reform proposes a new obligation to provide or make available to customs 
certain data, notably the responsible economic operator in the EU pursuant to Article 
4. This should improve risk management and product compliance, as the reform enables 
risk-based controls at EU external borders on products entering the EU market subject 
to Article 4. Prior to the proposed reform, such information is not provided to customs 
authorities. 

According to Article 42(1) of Regulation (EU) 2019/1020, the Commission shall carry out a 
full evaluation of Regulation (EU) 2019/1020 by 31 December 2026. That evaluation will also 
cover Article 4, using more data and practical  implementation  experience, which should be 
available by then. The 2026 evaluation will therefore build upon this report, taking into account 
the application of the GPSR, e-commerce development (in terms of e.g. higher quantities and 
new business  models) etc. Moreover, the Commission  is  committed to build on the various 
available tools with a holistic approach to tackle challenges with e-commerce platforms.54 

54 See Political Guidelines of the President for 2024-29, which state that the Commission will tackle "challenges 
with e-commerce platforms to ensure consumers and businesses benefit from a level playing field based on 
effective customs, tax and safety controls and sustainability standards. 
https://commission.europa.eu/document/download/e6cd4328-673c-4e7a-8683-
f63ffb2cf648_en?filename=Political%20Guidelines%202024-2029_EN.pdf 

13 

 
 
 
 
 
 
 
 
Article 4 only applies in relation to products that are subject to: 

Annex 

-  Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 
2011 laying down harmonised conditions for the marketing of construction products and 
repealing Council Directive 89/106/EEC (OJ L 88, 4.4.2011, p. 5). 

-  Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 
on personal protective equipment and repealing Council Directive 89/686/EEC (OJ L 81, 
31.3.2016, p. 51). 

-  Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 
on  appliances  burning  gaseous  fuels  and  repealing  Directive  2009/142/EC  (OJ  L  81, 
31.3.2016, p. 99). 

-  Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the 
approximation  of  the  laws  of  the  Member  States  relating  to  the  noise  emission  in  the 
environment by equipment for use outdoors (OJ L 162, 3.7.2000, p. 1). 

-  Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on 

machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24). 

-  Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on 

the safety of toys (OJ L 170, 30.6.2009, p. 1). 

-  Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009 
establishing  a  framework  for  the  setting  of  ecodesign  requirements  for  energy-related 
products (OJ L 285, 31.10.2009, p. 10). 

-  Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on 
the  restriction  of  the  use  of  certain  hazardous  substances  in  electrical  and  electronic 
equipment (OJ L 174, 1.7.2011, p. 88). 

-  Directive 2013/29/EU of the European Parliament and of the Council of 12 June 2013 on 
the harmonisation of the laws of the Member States relating to the making available on the 
market of pyrotechnic articles (OJ L 178, 28.6.2013, p. 27). 

-  Directive 2013/53/EU of the European Parliament and of the Council of 20 November 2013 
on recreational craft and personal watercraft and repealing Directive 94/25/EC (OJ L 354, 
28.12.2013, p. 90). 

-  Directive 2014/29/EU of the European Parliament and of the Council of 26 February 2014 
on the harmonisation of the laws of the Member States relating to the making available on 
the market of simple pressure vessels (OJ L 96, 29.3.2014, p. 45). 

-  Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 
on  the  harmonisation  of  the  laws  of  the  Member  States  relating  to  electromagnetic 
compatibility (OJ L 96, 29.3.2014, p. 79). 

14 

 
 
- 

 Directive 2014/31/EU of the European Parliament and of the Council of 26 February 2014 
on the harmonisation of the laws of the Member States relating to the making available on 
the market of non-automatic weighing instruments (OJ L 96, 29.3.2014, p. 107). 

-  Directive 2014/32/EU of the European Parliament and of the Council of 26 February 2014 
on the harmonisation of the laws of the Member States relating to the making available on 
the market of measuring instruments (OJ L 96, 29.3.2014, p. 149). 

-  Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 
on the harmonisation of the laws of the Member States relating to equipment and protective 
systems intended for use in potentially explosive atmospheres (OJ L 96, 29.3.2014, p. 309). 

-  Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 
on the harmonisation of the laws of the Member States relating to the making available on 
the market of electrical equipment designed for use within certain voltage limits (OJ L 96, 
29.3.2014, p. 357). 

-  Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on 
the harmonisation of the laws of the Member States relating to the making available on the 
market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62). 

-  Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on 
the harmonisation of the laws of the Member States relating to the making available on the 
market of pressure equipment (OJ L 189, 27.6.2014, p. 164). 

Additions to this list have been made after adoption of Reg. 2019/1020. Article 4 also applies 
to the following regulations:  

-  Commission Delegated Regulation (EU) 2019/945 of 12 March 2019 on unmanned aircraft 
systems and on third-country operators of unmanned aircraft systems (OJ L152, 11.6.2019, 
p. 1);  

-  Regulation (EU) 2023/1542 of the European Parliament and of the Council of 12 July 2023 
concerning batteries and waste batteries, amending Directive 2008/98/EC and Regulation 
(EU) 2019/1020 and repealing Directive 2006/66/EC (OJ L 191, 28.7.2023, p. 1–117);  

-  Regulation  (EU)  2024/1252  of  the  European  Parliament  and  of  the  Council  of  11  April 
2024 establishing a framework for ensuring a secure and sustainable supply of critical raw 
materials and amending Regulations (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1724 
and (EU) 2019/1020 (O.J. L 2024/1252, 3.05.2024). 

- 

In  addition,  the  following  Commission  proposal  includes  provisions  which,  if  adopted, 
would  make  Article  4  of  Regulation  2019/1020  applicable  to  the  products  concerned: 
Commission  Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council 
laying down harmonised conditions for the marketing of construction products, amending 
Regulation (EU) 2019/1020 and repealing Regulation (EU) 305/2011 – COM(2022)144. 

15