EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, 30.6.2021  
COM(2021) 346 final  
2021/0170 (COD)  
 
Proposal for a  
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  
on general product safety, amending Regulation (EU) No 1025/2012 of the European 
Parliament and of the Council, and repealing Council Directive 87/357/EEC and 
Directive 2001/95/EC of the European Parliament and of the Council  
 
 
 
(Text with EEA relevance)  
{SEC(2021)  280 final}  - {SWD(2021)  168 final}  - {SWD(2021)  169 final}   EN 1  EN TABLE OF CONTENTS  
EXPLANATORY MEMORANDUM  ................................ ................................ .......................  3 
1. CONTEXT OF THE PROPOSAL  ................................ ................................ .........................  3 
• Reasons for and objectives of the proposal  ................................ ................................ .. 3 
• Consistency with other EU policies  ................................ ................................ .............  5 
2. LEGAL BAS IS, SUBSIDIARITY AND PROPORTIONALITY  ...............................  6 
• Legal basis  ................................ ................................ ................................ ....................  6 
• Subsidiarity (for non -exclusive competence)  ................................ ...............................  7 
• Proportionality ................................ ................................ ................................ ..............  8 
• Choice of the instrument  ................................ ................................ ..............................  8 
3. RESULTS OF EX POST EVALUATIONS, STAKEHOLDER CONSULTAT IONS 
AND IMPACT ASSESSMENTS  ................................ ................................ ................  8 
• Ex post evaluations/fitness checks of existing legislation  ................................ ...........  8 
• Stakeholder consultations ................................ ................................ .............................  9 
• Collection and use of expertise  ................................ ................................ ..................  11 
• Impact assessment  ................................ ................................ ................................ ...... 11 
• Regulatory fitness and simplification ................................ ................................ .........  13 
• Fundamental rights  ................................ ................................ ................................ ..... 14 
4. BUDGETARY IMPLICATIONS  ................................ ................................ ..............  15 
5. OTHER ELEMENTS ................................ ................................ ................................ . 15 
• Implementation plans and monitoring, evaluation and reporting arrangements  ........  15 
• Detailed explanation of the specific provisions of the proposal  ................................  15 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on general 
product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of 
the Council, and repealing Council Directive 87/357/EEC an d Directive 2001/95/EC of the 
European Parliament and of the Council  ................................ ................................ ......................   
CHAPTER I  ................................ ................................ ................................ .............................  32 
General provisions  ................................ ................................ ................................ ....................  32 
CHAPTER II  ................................ ................................ ................................ ............................  35 
Safety requirements  ................................ ................................ ................................ ..................  35 
CHAPTER III  ................................ ................................ ................................ ...........................  37 
Obligations of economic operators  ................................ ................................ ..........................  37 
Section 1  ................................ ................................ ................................ ................................ ... 37 
Section 2  ................................ ................................ ................................ ................................ ... 43 EN 2  EN CHAPTER IV  ................................ ................................ ................................ ..........................  44 
Online marketplaces  ................................ ................................ ................................ .................  44 
CHAPTER V  ................................ ................................ ................................ ............................  46 
Market surveillance and implementation  ................................ ................................ .................  46 
CHAPTER VI  ................................ ................................ ................................ ..........................  47 
Safety Gate rapid alert system  ................................ ................................ ................................ .. 47 
CHAPTER VII  ................................ ................................ ................................ .........................  48 
Commission role and enforcement coordination  ................................ ................................ ..... 48 
CHAPTER VIII  ................................ ................................ ................................ ........................  51 
Right to information and remedy  ................................ ................................ .............................  51 
CHAPTER IX  ................................ ................................ ................................ ..........................  53 
International cooperation  ................................ ................................ ................................ ..........  53 
CHAPTER X  ................................ ................................ ................................ ............................  54 
Financial provisions  ................................ ................................ ................................ .................  54 
CHAPTER XI  ................................ ................................ ................................ ..........................  57 
Final provisions  ................................ ................................ ................................ ........................  57 
LEGISLATIVE FINANCIAL STATEMENT  ................................ ................................ .........  62 EN 3  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  PROPOSAL   
• Reasons for and objectives of the proposal  
This proposal for a Regulati on on consumer product safety is in line with the New Consumer 
Agenda of 20201 aiming to: (i) update and modernise the general framework for the safety of 
non-food consumer products; (ii) preserve its role as a safety net for consumers; (iii) adapt the 
provisions to challenges posed by new technologies and online selling; and (iv) ensure a level 
playing field for businesses. While the proposal will replace the Directive 2001/95/EC on 
general product safety2 (‘GPSD’), it will continue applying to manufactured non -food 
consumer products. The proposed Regulation will also provide continuity with the GPSD by: 
(i) requiring that consumer products be ‘safe’; (ii) setting certain obligations for economic 
operators;  and (iii) containing provisions for the development of standards in support of the 
general safety requirement. It also aligns the market surveillance rules for products falling 
outside the scope of the EU harmonisation legislation (‘non -harmonised product s’) with those 
applying to products falling under the scope of the EU harmonisation legislation (‘harmonised 
products’) as set out in Regulation (EU) 2019/1020. The proposed Regulation aims therefore 
both to update the rules currently set out in Directive 2001/95/EC to ensure a safety net for all 
products, and, at the same time, to ensure that the regime provides greater consistency 
between harmonised and non -harmonised products.  
Already in 2011, the Single Market Act3 identified the revision of the GPSD an d of 
Regulation (EC) No 765/20084 as key actions ‘to improve the safety of products circulating in 
the EU through better coherence and enforcement of product safety and market surveillance 
rules’. Such revision was proposed in 2013 in a package including t he revision of both legal 
instruments, the purpose being to introduce a single legislative framework for harmonised and 
non-harmonised products. It was considered that overlaps in market surveillance rules and 
obligations of economic operators laid down in  various pieces of EU legislation (GPSD, 
Regulation (EC) No 765/2008 and sector -specific EU harmonisation legislation) have led to 
confusion among economic operators and national authorities and have hampered the 
effectiveness of market surveillance activi ty in the EU. The proposed package stalled in 
negotiations for its adoption and was withdrawn. In the meantime, in 2017, following up on 
the 2015 Communication Upgrading the Single Market: more opportunities for people and 
business5, the Commission adopted  a proposal to revise Regulation (EC) 765/2008 to 
strengthen product compliance and enforcement of EU harmonisation legislation on products, 
                                                 
1 Communication from the Commission to the European Parliament and the Council, New Consumer 
Agenda – Strengthening consumer resilience for sustainable recovery , COM(2020) 696 final.  
2 Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general 
product safety (Text with EEA relevance),) OJ L 11, 15.1.2002, p. 4 . 
3 Communication from the Commission to the European Parliament and the Council, the European 
Economic and Social Committee and the Committee of the Regions, Single Market Act – Twelve levers 
to boost growth and strengthen confidence – Working together to cre ate new growth/* COM/2011/0206 
final.  
4 Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out 
the requirements for accreditation and market surveillance relating to the marketing of products and 
repealing Regu lation (EEC) No 339/93 (Text with EEA relevance), )OJ L 218, 13.8.2008, p. 30.  
5 Communication from the Commission to the European Parliament and the Council, the European 
Economic and Social Committee and the Committee of the Regions, Upgrading the Single  Market: 
more opportunities for people and business, COM/2015/0550 final.  EN 4  EN as part of the ‘goods package’, e.g. a package of initiatives to ensure a better functioning of 
the single market f or goods. This led to the adoption, in 2019 , of Regulation (EU) 2019/10206. 
 • Consistency with existing policy provisions in the policy area  
Regulation (EU) 2019/10207 
Regulation (EU) 2019/1020 lays down rules and procedures for compliance with, and 
enfor cement of, EU harmonisation legislation on products. The proposal seeks to enable 
better cooperation among national market surveillance authorities. To that end, it aims to 
clarify the procedures for the mutual assistance mechanism between them, and, for s ome 
product categories, it will require non -EU manufacturers to designate a natural or legal person 
responsible for compliance information. The proposal covers market surveillance of non -food 
products (‘industrial products’) whose placement on the single m arket is subject to EU 
harmonising acts. It is applicable, except for Chapter VII, to harmonised products only.  
To ensure coherence and consistency between the regimes for harmonised and non -
harmonised products, this proposal takes up and adapts a number of provisions of Regulation 
2019/1020, such as Chapters IV, V and VI on market surveillance and Article 4.  
Decis ion 768/2008/EC8 
Decision 768/2008/EC sets out common principles and procedures that EU legislation must 
follow when harmonising conditions for marketing products in the EU and the EEA. It 
includes reference requirements to be incorporated whenever product  legislation is revised. 
As such, it is a template for future product harmonisation legislation.  
To ensure consistency between the legislation for harmonised and non -harmonised products, 
this proposal takes up some of the provisions of Decision 768/2008/E C, such as those on 
traceability requirements and the obligations of economic operators.  
Regulation (EU) 1025/20129 
Regulation (EU) 1025/2012 provides a legal basis to use European standards for products and 
services, identify ICT technical specifications,  and finance the European standardisation 
process. It also sets an obligation for European standardisation organisations  (CEN, 
CENELEC, ETSI) and national standardisation bodies on transparency and participation.  
                                                 
6 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 Regu lations (EC) No 
765/2008 and (EU) No 305/2011, OJ L 169, 25.6.2019, p. 1.  
7 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 Regu lations (EC) No 
765/2008 and (EU) No 305/2011, OJ L 169, 25.6.2019, p. 1.  
8 Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common 
framework for the marketing of products, and repealing Council Decision 93/465/EEC (Text with EEA 
relevance),) OJ L 218, 13.8.2008, p. 82.  
9 Regulation (EU) No  1025/2012 of the European Parliament and of the Council of 25  October 2012 on 
European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 
94/9/EC , 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 
2009/105/EC of the European Parliament and of the Council and repealing Council Decision 
87/95/EEC and Decision No  1673/2006/EC of the European Parliament and of the Council , L 316, 
14.11.2012, p. 12 . EN 5  EN To ensure consistency with the general regi me for standardisation as provided for by 
Regulation (EU) 1025/2012, this proposal provides for a number of amendments to 
Regulation (EU) 1025/2012 to adapt it to the specific characteristics of the proposed 
regulation, in particular to the fact that this Regulation requires the adoption of specific safety 
requirements and to the fact that the standards adopted under this regulation cannot be 
assimilated to harmonised standards and are indicated therefore as “European standards”.  
Directive (EU) 2019/77110 
Directive 2019/771 introduces rules on the conformity of goods, remedies in the event of a 
lack of conformity and how to make use of those remedies.  
The proposal provides remedies specifically for dangerous products that have been recalled 
from the market. This particular situation justifies having a set of rules that are partially 
different and easier to activate, in particular because the consumer does not need to 
demonstrate the non -conformity of the product. These rules are applicable only if products ar e 
recalled. Therefore they do not amend Directive 2019/771 but only add additional protection 
in the case of recall.  
Regulation (EU) 2019/88111 
The Cybersecurity Act introduces an EU -wide cybersecurity certification framework for ICT 
products, services and processes. However, it does not include minimum cybersecurity legal 
requirements for ICT products. This proposal clarifies that cybersecurity risks that have an 
impact on the safety of consumers are covered by the concept of safety under the proposed 
Regul ation.  
• Consistency with other EU policies  
The following ongoing or planned initiatives at EU level play an important role for product 
safety:  
The Digital Services Act  (DSA), adopted by the Commission on 15 December 202012, aims 
to regulate the responsibil ities of providers of intermediary services online, including online 
platforms such as social media and online marketplaces, with regard to illegal content, goods 
or services offered by their users. That proposal sets out a number of due diligence obligati ons 
for online platforms relevant for the proposed regulation, including the introduction of the 
‘traceability of traders’ principle and the obligation to take into consideration product safety 
law in structuring the interface (Article 22). The DSA covers all types of illegal content, as 
defined by national or EU law, including the sale of dangerous products online. As the DSA is 
a legislative instrument of general application, it does not include specific provisions 
addressing such type of content. The DSA  also sets out the framework for the notice and 
                                                 
10 Directive (EU) 2019/771 of the European Parliament and of the Council of 20 May 2019 on certain 
aspects concerning contracts for the sale of goods, amending Regulation (EU) 2017/2394 and Directive 
2009/22/EC, and repealing Direc tive 1999/44/EC (Text with EEA relevance),.) OJ L 136, 22.5.2019, p. 
28. 
11 Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA 
(the European Union Agency for Cybersecurity) and on information and communications technology 
cybersecurity certification and repealing Regulation (EU) No 526/2013 (Cybersecurity Act),  OJ L 151, 
7.6.2019, p. 15.   
12 Proposal for a regulation of the European Parliament and of the Council on a Single Market For Digital 
Services (Digital Ser vices Act) and amending Directive 2000/31/EC, COM/2020/825 final.  EN 6  EN action procedure (Article 14). The proposed regulation specifies certain obligations for online 
marketplaces in the product safety field.  
The legislative proposal on artificial intelligence (AI)  lays down har monised rules for the 
placing on the market, putting into service and use of artificial intelligence systems in the EU. 
The rules need to ensure a high level of protection of the public interests, in particular on 
health and safety, and people’s fundamenta l rights and freedoms. It lays down specific 
requirements with which high -risk AI systems must comply and imposes obligations on 
providers and users of such systems.  
This proposal takes into consideration these provisions and provides a safety net for products 
and risks to health and safety of consumers that do not enter into the scope of application of 
the AI proposal.  
The chemicals strategy adopted in October 202013 points to the fact that the already 
widespread use of chemicals will increase, including in consumer products, and that it is 
necessary to ban the most harmful chemicals in consumer products to ensure their safety. The 
REACH Regulation14 has introduced obli gations for the industry to assess and manage the 
risks posed by chemicals and provide appropriate safety information for their users. It also 
provides for restrictions to protect human health and the environment from unacceptable risks 
posed by chemicals.  This proposal maintains a safety net for chemical risks in products not 
covered by specific legislation.  
The Circular economy action plan adopted in March 202015 aims to reduce waste through 
reuse, repair, remanufacturing and high -quality recycling - in particular concerning secondary 
raw materials where dangerous substances can persist - and states that the safety of products 
must be taken into consideration as a primary objective. This proposal acknowledges that, 
when economic operators or authorities fa ce a choice of corrective actions, the most 
sustainable action (i.e. the one with the lowest environmental impact) should be preferred, 
provided that it does not result in a lower level of safety.”  
2. LEGAL  BASIS,  SUBSIDIARITY  AND  PROPORTIONALITY  
• Legal  basis 
The legal basis for the proposed Regulation is Article 114 TFEU, with due regard to Article 
16916. Its objective is to ensure product safety and improve the functioning of the internal 
market. At the same time, it aims to ensure a high level of consumer protection, by 
                                                 
13 Communication from the Commission to the European Parliament and the Council, the European 
Economic and Social Committee and the Committee of the Regions, Chemicals Strategy for 
Sustainabi lity – Towards a Toxic -Free Environment, COM/2020/667 final.  
14 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), 
estab lishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council 
Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council 
Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC  and 
2000/21/EC, OJ L 396, 30.12.2006, p.1.  
15 Communication from the Commission to the European Parliament and the Council, the European 
Economic and Social Committee and the Committee of the Regions A new Circular Economy Action 
Plan For a cleaner and mor e competitive Europe COM/2020/98 final.  
16 Article 169 makes reference to Article 114 to achieve its objectives.  EN 7  EN contributing to protect the health and safety of European consumers and promoting their right 
to information17.  
• Subsidiarity  (for non-exclusive  competence)   
The proposal harmonises the general product safety requirement in the EU.  Ensuring the 
safety of products in the single market cannot be achieved sufficiently by Member States 
acting alone for the following reasons:  
– Products circulate freely across the single market. When a dangerous product is 
identified in a certain country i t is very likely that the same product could be 
found in other Member States too, not least because of the exponential growth of 
online selling.  
– Different rules on product safety at national level can create uneven costs for 
businesses to comply with prod uct safety legislation, and therefore can cause 
distortions in the level playing field on the internal market.  
– To ensure a high level of consumer protection, the EU must contribute to 
protecting the health and safety of consumers. If different countries ha ve different 
rules, consumers will not be protected against dangerous products in the same way 
across the EU.  
– To be effective, market surveillance must be uniform across the EU. If market 
surveillance is ‘softer’ in some parts of the EU, weak spots are cr eated. These 
threaten the public interest, create unfair trading conditions and encourage ‘forum 
shopping’18. 
EU-level action on product safety for non -harmonised products has the following added 
value:  
– Common rules and standards for product safety at EU le vel mean that businesses 
no longer have to comply with heterogeneous sets of national rules. This generates 
benefits in terms of costs savings, a lower administrative burden and a less 
complex legal regime for businesses. This also enables free circulation  of goods in 
the EU and allows for closer cooperation between Member States.  
– Common EU rules allow economies of scale in market surveillance, particularly 
important with the exponential development of online selling, which intensifies 
cross -border sales an d direct imports from outside the EU. The costs of market 
surveillance are also shared through joint market surveillance actions and the 
exchange of information among EU countries.  
– The functioning of the single market will be improved by EU -level action. 
Common product safety and market surveillance rules across the EU will ensure a 
more even treatment of businesses, and therefore will be less likely to distort the 
level playing field on the EU single market.  
– EU action allows for faster and more efficient c irculation of information, in 
particular via the Safety Gate/RAPEX system, thus ensuring fast action against 
dangerous products across the EU and a level playing field.  
                                                 
17 Also, product safety is part of the high level of consumer protection ensured by EU policies (see Article 
38 of the Charter of Fundamental Rig hts of the European Union) and is therefore one of the pillars of 
EU consumer protection policy.  
18 Traders trying different entry points to the EU.  EN 8  EN – At international level, the common set of provisions established under the GPSD 
has al so enabled the EU to be stronger in promoting a high level of safety both 
bilaterally and multilaterally, thus tackling the increasing circulation of goods 
from third countries via online selling.  
• Proportionality  
This proposal strikes a careful balance between, on the one hand, EU countries’ regulatory 
autonomy in setting the level of consumer protection and market surveillance they consider 
necessary, and, on the other hand, the need to address product safety issues that have to be 
tackled centrally. As  underlined in Chapter 7 of the impact assessment, the challenges remain 
considerable, with a high presence of unsafe consumer products on the EU market. The costs 
and regulatory burdens associated with this proposal have been kept as limited as possible. 
Total costs for businesses in the EU27 in the first year of implementation of this Regulation is 
estimated at  0.02% of turnover of EU companies  for manufacturing, wholesale and retail of 
non-harmonised  products. The measures included in this proposal do no t extend beyond what 
is necessary to solve the identified problems and to achieve the objectives set. The foreseen 
costs for the Commission and Member States are considered as acceptable, and will be 
compensated by the savings incurred by businesses, and b enefits for businesses, consumers 
and Member States alike.  
• Choice  of the instrument  
A regulation is the only suitable instrument to achieve the objective of improving enforcement 
of, and compliance with EU legislation on product safety ensuring coherenc e in the 
implementation of its legal framework. A directive would not sufficiently achieve the 
objectives, as jurisdictional boundaries and potential jurisdictional conflicts would persist 
following its transposition. The choice of Regulation instead of Di rective also allows to better 
deliver on the objective to ensure coherence with the market surveillance legislative 
framework for harmonised products, where the applicable legal instrument is also a 
Regulation (Regulation (EU) 2019/1020).  Finally, such a c hoice will further reduce the 
regulatory burden through a consistent application of product safety rules across the EU.  
3. RESULTS  OF EX POST  EVALUATIONS,  STAKEHOLDER  
CONSULTATIONS  AND  IMPACT  ASSESSMENTS   
• Ex post evaluations/fitness  checks  of existing  legislation   
This proposal for a regulation builds on the evaluation of the General Product Safety 
Directive, conducted as a ‘back -to-back’ evaluation with the impact assessment 
accompanying the proposal. The GPSD ha s a twofold objective. It pursues the aim of 
improving the functioning of the single market , by introducing a common legislative 
framework to avoid disparities between Member States that could have emerged in the 
absence of EU law. At the same time, the GP SD intends to achieve a high level of consumer 
protection  by introducing a general product safety requirement and other measures. Both 
aims are interrelated: the harmonised safety requirement for consumer products envisaged by 
the GPSD prevents disparities  that would lead to the creation of barriers to trade and 
distortion of the level playing field within the single market.  
The evaluation concluded that the role of the GPSD as a cornerstone of consumer safety and 
the functioning of the single market is unc ontested. Its objectives remain fully relevant, and 
its EU added value cannot be denied. The GPSD’s role as a ‘safety net’ remains essential for 
consumer protection, as it provides a legal basis aimed to ensure that no dangerous products 
end up in consumer s’ hands. The establishment of the rapid alert system for dangerous non -EN 9  EN food products under the GPSD has proven to be a success. However, the evaluation has 
exposed a number of factors that question how far some provisions of the GPSD still 
contribute to t he proper achievement of its goals.  
In the first place, the growth of e-commerce  has decreased the effectiveness of the GPSD. 
The GPSD applies to all consumer products, regardless of whether they are sold in bricks -
and-mortar shops or online. However, the lack of explicit provisions in the GPSD to address 
the specificities of online selling, in particular the appearance of new actors in the online 
supply chain, has negatively affected the safety of EU consumers and the level playing field 
for compliant EU b usinesses.  
The rapid development of new technologies  also raises questions about the scope of some of 
the key concepts of the GPSD. The appearance of some new risks linked to connectivity, the 
applicability of the Directive to software updates and downloa ds as well as the evolving 
functionalities of AI -powered products raise the question whether the GPSD is clear enough 
to provide legal certainty for businesses and protection to consumers.  
The evaluation has also identified a lack of internal coherence in the EU legal framework, 
with the existence of two different sets of rules on market surveillance  for harmonised and 
non-harmonised products.  
Finally, it is apparent from the evaluation tha t it would be necessary to fine -tune some of the 
provisions to improve the effectiveness of the GPSD. In particular, legislative changes or 
further actions are needed to improve the effectiveness of product recalls . There is also a 
need for a mechanism to arbitrate disputes between Member States regarding risk 
assessments. The traceability system  under the Directive and the resources constraints of 
market surveillance authorities  make it difficult to effectively control the safety of products, 
and consequen tly need to be tackled to ensure the proper protection of consumers and 
functioning of the Single market. Also, the Food -Imitating Products Directive (FIPD)  is 
currently not enforced in a harmonised manner among Member States, so a solution to 
address this  issue is needed.  
• Stakeholder  consultations  
In preparing this proposal, the Commission consulted stakeholders via a public consultation 
on the inception impact assessment and roadmap, an open public consultation (OPC), 
stakeholder workshops, as well as a d hoc contributions and targeted consultations with 
Member States and other stakeholders. The results from the consultation activities have been 
incorporated throughout the impact assessment and are reflected in this proposal. The main 
points raised during  the consultations are the following:  
Preserving the safety net : The overall feedback among all stakeholder groups was that the 
GPSD is a useful piece of legislation and its safety net principle should be preserved. 
However, a large majority of respondent s stated that current EU safety rules for non -food 
consumer products covered by the GPSD could be improved in specific areas so that they 
better protect consumers (71% of answers in the OPC).  
Tackling the challenges posed by new technologies : While all st akeholders acknowledged 
that new technologies raise many challenges, they put forward divergent approaches to tackle 
them. In the consultations, consumer representatives and several Member State authorities 
expressed support for expanding the definition of  ‘safety’ to include (cyber)security aspects 
that have an impact on safety. However, in the consultation on the roadmap/inception impact 
assessment, technology -oriented businesses were more reluctant to include new technologies 
and new risks related to the m in the GPSD. They would prefer the GPSD to remain 
technology -neutral, with risks linked to new technologies covered in other, more specific EN 10  EN pieces of legislation. Nevertheless, the proposal for a regulation includes such aspects to make 
sure that risks p osed by new technologies are in the scope of the safety net, in case they are 
not covered by more specific pieces of EU legislation19.  
Addressing safety issues associated with products sold online : The issue of products 
coming directly or via online platforms from outside the EU was a recurrent issue mentioned 
in the consultations. Businesses and business representatives stressed the importance of 
having a level playing field and pointed out that c urrently many EU retailers suffer as a result 
of unfair competition from operators based in third countries. Member State authorities 
stressed that it was difficult to control products coming from third countries and to take 
enforcement action against econ omic operators outside the EU. Views diverged between 
stakeholders regarding the obligations of online marketplace s: 
– Online marketplaces providing their feedback on the roadmap indicated that they 
would accept some of the obligations under the current volu ntary Product Safety 
Pledge being binding, but would not be in favour of further obligations.20 
Retailers argued that online marketplaces play a key role in the supply chain, and 
therefore they should have corresponding responsibilities.  
– Consumer represent atives and Member States authorities were in favour of 
strengthening responsibilities across the supply chain.  
Improving market surveillance rules and enforcement:  As regards market surveillance and 
enforcement, stakeholders from all categories were in fav our of an alignment of market 
surveillance rules between harmonised and non -harmonised products. This is included in the 
proposal. Regarding the introduction of a ‘responsible person’ in the revised GPSD, a large 
majority of respondents in the OPC consider ed that products covered by the GPSD should 
only be placed on the EU market if there is an economic operator established in the EU 
responsible for product safety purposes (70% of respondents in favour).  
Revision of the standardisation process: A majority of stakeholders was in favour of 
simplifying the standardisation process for developing new standards under the GPSD and 
now under this Regulation. This is provided for in this proposal.  
Including food -imitating products in the scope of the revised GPSD : Most stakeholders 
were in favour of incorporating the food -imitating legislation into the revised GPSD. A large 
majority of respondents to the OPC stated that products which resemble foodstuff should be 
incorporated into the general product safety legal in strument (69% of respondents in favour). 
In the consultation on the inception impact assessment, respondents favoured including this 
element in the product safety risk assessment. This approach is reflected in the proposal. No 
support was expressed for a f ull ban of food -imitating products.  
Improving the framework for product recalls : Stakeholders repeatedly stressed the crucial 
importance of contacting affected consumers directly in the case of recalls whenever possible, 
for instance because the product w as registered, bought online, or bought with the use of 
loyalty card. Several stakeholders mentioned that consumers should be able to choose to 
receive safety notifications only (when registering a product or subscribing to a loyalty 
scheme). There was a b road agreement that some key elements and ground rules, applicable 
to all recall notices, should be standardised and made compulsory, which is the case in the 
                                                 
19 Please see the o pinion of the Sub -group on Artificial Intelligence (AI), connected products and other 
new challenges in product safety to the Consumer Safety Network of December 2020.  
20 Feedbacks received on the roadmap : General Product Safety Directive – review (europa.eu)  EN 11  EN proposed regulation. Several stakeholders mentioned the need to make recall participation less 
burdensome and more attractive to consumers.  
Improving traceability along the supply chain : A large majority of stakeholders agreed that 
the system of product traceability should be strengthened in the GPSD (82% in favour in the 
OPC). Moreover, the role of online marketplaces in improving product traceability was also 
stressed, with respondents notably arguing that marketplaces should check that traceability 
information is available before listing a product.  
Addressing counterfeit products: Brand owner orga nisations stressed that the GPSD should 
be amended to tackle counterfeit unsafe products. This issue was duly taken into 
consideration but not included in this proposal, as counterfeit products are already addressed 
by EU legislation, and unsafe products a re covered in the GPSD and in this proposal 
regardless of their authenticity. Even though counterfeit products can pose safety risks, the 
safety of a given product has to be analysed based on a risk assessment.  
• Collection  and use of expertise   
The prepa ratory steps for this proposal rest on expert advice and a number of studies. This 
includes studies with a focus on the GPSD’s implementation, to support the evaluation and 
impact assessment, as well as on the effectiveness of product recalls.  
The Commiss ion also gathered expertise and views through targeted consultations and 
engagement activities, including a series of workshops, conferences, interviews with experts 
and authorities, and the opinion of the Sub -group of the Consumer Safety Network on 
artifi cial intelligence, connected products and other new challenges on product safety. The 
Commission held numerous bilateral meetings and carried out an analysis of ad -hoc position 
papers from consumer organisations, industry representatives and academia.  
• Impact  assessment   
This proposal is supported by an impact assessment report (SWD (2021) 169, SWD (2021) 
168). The impact assessment report has been scrutinised by the Regulatory Scrutiny Board 
and received a positive opinion (SEC 280 (avis du RSB)  
In the c ontext of this initiative, the Commission examined several policy alternatives as 
presented in the impact assessment report. The range of policy alternatives analysed included 
both non -legislative and legislative actions to address the different specific o bjectives as 
presented in the report: (i) ensure the EU legal framework provides general safety rules for all 
consumer products and risks, including products and risks linked to new technologies; (ii) 
address product safety challenges in the online sales c hannels; (iii) make product recalls more 
effective and efficient to keep unsafe products away from consumers; (iv) enhance market 
surveillance and ensure better alignment of rules for harmonised and non -harmonised 
consumer products; and finally (v) address  safety issues related to food -imitating products.  
A number of options were assessed. First, the Commission considered how it could respond to 
the specific objectives without revising the GPSD (Option 1). Several non -legislative 
measures have been considered, in particular: (i) issuing guidance documents o n the 
applicability of the GPSD to new technologies and on recalls and; (ii) exploring expansion of 
the voluntary measures under the Product Safety Pledge for online sales. However, the 
different consultations showed that such non -legally binding measures would not tackle the 
identified shortcomings.  EN 12  EN The Commission considered several legislative options to tackle the specific objectives: a 
targeted legislative revision of the GPSD (Option 2) focusing on a limited number of changes 
and a full revision of th e GPSD proposing a comprehensive action on all objectives (Option 
3). The impact assessment shows that Option 3, which is more ambitious than Option 2, also 
better addresses the identified shortcomings and better meets the specific objectives to be 
address ed, while keeping the economic impacts still limited. Option 4 considered a full 
integration of market surveillance instruments, as proposed in the 2013 product safety and 
market surveillance package, to analyse whether this option would still be valid aft er the 
recent adoption of Regulation (EU) 2019/1020. The impact assessment showed that Option 4, 
although similar on substance to Option 3, might generate higher costs for EU businesses. 
Therefore, the Commission chose Option 3 (full revision of the GPSD i ncluding change to a 
regulation) as the best policy choice for the current proposal since it addresses best the policy 
objectives while limiting the costs for businesses and market surveillance authorities.  
Different options have also been considered regar ding the safety of food -imitating products. 
These were: (i) to maintain a separate regime for these products under a separate directive 
(revising Directive 87/357/EEC); (ii) to integrate the specific provisions of the current 
Directive 87/357/EEC into the new GPSD with a specific legal regime; (iii) to abandon 
targeted provisions on food -imitating products and use the general provisions to ensure safety 
of such products based on the case -by-case risk assessment instead. For the first two options, 
the Commis sion also considered developing guidance to overcome the issue of different 
interpretation by Member States; however, consulting the Member States showed that the 
divergences in interpretation of the Food -Imitating Products Directive were so great that a 
legal revision of the rules was necessary to ensure its even application. The Commission 
chose as the best policy option discontinuing the specific regime for food -imitating products 
and assessing their safety according to the same risk assessment principle s as for the other 
non-harmonised consumer products (the food -imitating aspect will be taken into account in 
the risk assessment of the given product).  
The preferred option, which includes: a) clarification on how this legislation would  apply to 
risks pose d by new technologies and online selling, b) provisions enhancing the effectiveness 
of product recalls, c) alignment with harmonised market surveillance rules and ensuring better 
responsibilities related to products safety of economic operators and online marketplaces, d) 
simplification of standardisation procedures and e) integration of the provisions of the Food 
Imitating Products Directive,  is expected to have the following impacts:  
On economic impacts, the preferred option is expected to lead to major b enefits for consumers 
and society. The estimated consumer detriment should decrease by approximately EUR 1.0 
billion in the first year of implementation of the preferred option and by approximately EUR 
5.5 billion over the next decade. This option should a lso reduce consumer detriment related to 
ineffective recalls by more than EUR 400 million per year. Moreover, by reducing the number 
of unsafe products, the proposed measures should also reduce the current detriment suffered 
by EU consumers and society due  to preventable product -related accidents (estimated today at 
EUR 11.5 billion per year) and the current cost of healthcare for product -related injuries 
(current estimate EUR 6.7 billion per year). The precise impact could not been quantified due 
to lack o f injury data to estimate trends. Estimated cost savings caused by reducing the 
differences in national implementation and legal fragmentation are estimated at EUR 59 
million annually for businesses and EUR 0.7 million per year for market surveillance 
authorities.  
Total costs for businesses in the EU (active in manufacturing, wholesale and retail of non -
harmonised products) are estimated at EUR 196.6 million, equivalent to 0.02% of their EN 13  EN turnover in the first year of implementation. In the following years,  the recurrent costs would 
amount to EUR 177.8 million for EU businesses. These costs are linked to the increased 
obligations for businesses mainly for online sales, sales of new technology products and 
recalls of unsafe products, and to the alignment of m arket surveillance rules with those for 
harmonised products. Market surveillance authorities in Member States would face total 
additional recurrent costs under this proposal of approximatively EUR 6.7 million annually 
due to their increased powers in the m arket surveillance of unsafe products, and only 
relatively moderate one -off adaptation and implementation costs.  
• Regulatory  fitness  and simplification   
This proposal envisages revising two existing legislative instruments: the General Product 
Safety Dir ective and the Food -Imitating Product Directive. To simplify the legislation, the 
Commission proposes to repeal the Food -Imitating Product Directive and assess the safety of 
food-imitating products under the current proposal for a new general product safet y 
regulation.  
The Commission also identified several areas where the administrative burden and related 
costs could be reduced.  
First, this proposal would reduce regulatory costs and burdens for businesses, since the legally 
binding clarifications and the choice of a regulation as instrument will reduce regulatory 
uncertainty and ensure more even implementation of the product safety legislation compared 
to today under the GPSD. Also, aligning the general market surveillance and safety 
requirements for harmo nised and non -harmonised products will reduce implementation 
differences and improve the traceability of the supply chain. Cost reductions will occur for all 
businesses, and in particular for the 42% of businesses who reported additional costs related 
to the uneven implementation of the GPSD. Cost savings for businesses through more 
harmonised implementation are estimated at around EUR 59 million annually (EUR 34 
million saved by EU SMEs and EUR  26 million saved by EU large businesses respectively).  
Second, this proposal will bring efficiency gains in market surveillance and enforcement to 
Member States. This is due to aligning market surveillance provisions between harmonised 
and non -harmonised products, more aligned enforcement powers, increased det errent effect 
and a new arbitration mechanism. Therefore, this proposal brings cost reductions for all 
market surveillance authorities in Member States, and in particular for the 16% of them who 
reported related additional costs due to the different legal frameworks between harmonised 
and non -harmonised products. These cost savings for Member States are estimated at 
EUR  0.7 million per year across the EU.  
Finally, the proposed simplification of the standardisation process will reduce the 
administrative bur den for Member States and the Commission. Such streamlining of the 
standardisation EU process will accelerate standardisation work and thus increase legal 
certainty and help companies to comply with the general product safety requirement.  
This proposal does not exempt micro -enterprises and SMEs from any of the obligations. EU 
product safety legislation does not allow for ‘lighter’ regimes for SMEs since any consumer 
product must be safe whatever the characteristics of its supply chain in or der to meet the 
general objective of product safety and consumer protection. The Commission estimates the 
total compliance costs of this proposal for EU SMEs at EUR 111.1 million (one -off and 
recurrent costs) in the first year of implementation. In the sub sequent years, the recurrent 
costs would amount to around EUR 100 million for EU SMEs. Estimated savings caused by 
reduced differences in national implementation and legal fragmentation would amount to 
EUR 34 million for EU SMEs.  EN 14  EN This proposal will have p ractical implications both on the economic operators handling 
products covered by the GPSD and on market surveillance authorities in the Member States.  
Businesses will have to comply with additional requirements regarding traceability and 
transparency. Ad ditional requirements on recalls will apply for businesses that have actually 
brought unsafe products onto the market. Online marketplaces will also have to make sure 
they set up internal mechanisms to comply with their new obligations relating to product 
safety. In addition, companies selling in the single market from outside the EU will have to 
set up arrangements to ensure that the products sold in the EU have a responsible economic 
operator.  
Member States’ market surveillance authorities might require a dditional resources to cope 
with the broadening of market surveillance responsibilities and the new competences they 
would be given. For example, the new tools for market surveillance online broaden the 
possibilities for national authorities and may requir e additional resources and skills. However, 
with these new powers being largely aligned with the existing market surveillance provisions 
applicable to harmonised products under Regulation (EU) 2019/1020, market surveillance 
authorities are often familiar w ith them, in particular in those Member States where the same 
national market surveillance authorities handle already both harmonised and non -harmonised 
products. The practical implications for Member States are therefore rather better synergies 
and better  use of existing structures and resources than new additional needs. The extended 
coverage of risks from new technologies (e.g. cybersecurity risks that have an impact on 
safety) would be expected to increase the need for professional staff and external ex pertise in 
Member States to check the safety of new technology products.  
The most affected business sectors would be online sales and producers in some new 
technology sectors. However, thanks to harmonised EU requirements this should not have a 
major impac t on their competitiveness.  
This proposal operates effectively in both the digital and physical worlds and takes into 
account digital developments, in particular the development of online sales and new 
technology products. Addressing the digital challenge s for product safety is one of the main 
objectives of this proposal. It improves market surveillance rules for online sales and sets 
product safety obligations for online marketplaces and online retailers to improve the safety of 
products sold online. This  proposal also addresses new safety risks brought by new 
technologies and clarifies the application of product safety rules to software. This proposal is 
fully consistent with the EU’s digital policies in place and in particular with the proposal for 
the D igital Services Act and with the legislative work on artificial intelligence and the internet 
of things. This initiative is supported by existing ICT solutions, namely the EU Rapid Alert 
System for dangerous non -food products (‘Safety Gate’) and the relate d Business Gateway.  
• Fundamental  rights   
This proposal aims to strengthen the protection of European consumers’ health and safety and 
promote their right to information. Thanks to clearer obligations and better product safety 
enforcement, this proposal is  expected to have a positive impact on, and ensure a higher level 
of, consumer protection and environmental protection, in line with Articles 37 and 38 of the 
Charter of Fundamental Rights of the European Union.  
The proposal imposes additional requirement s on businesses that are necessary to pursue the 
general EU interest of increasing consumer protection. The resulting compliance costs are 
estimated to be comparatively low compared to businesses’ turnover. As such, these 
requirements do not affect the fun damental freedom to conduct a business and its 
proportionality under Article 52 of the Charter.  EN 15  EN 4. BUDGETARY  IMPLICATIONS   
The proposed regulation requires the Commission to support and facilitate the cooperation of 
market surveillance enforcement authori ties, including coordinated market surveillance 
activities, the new arbitration mechanism and peer reviews. Furthermore, this proposal allows 
for enhanced cooperation and exchange of information with EU international partners in the 
product safety field. F inally, this proposal provides for the adoption of implementing acts and 
delegated acts (related to traceability and recalls) and possible higher standardisation activity 
through a simplified standardisation procedure. This will trigger additional workload  for the 
Commission, estimated at four extra full -time officials (three administrators and one 
assistant). These resources will be obtained through the redistribution and refocusing of the 
existing personnel’s tasks.  
The Commission will also finance electr onic interfaces, namely the Safety Gate webpage, the 
Safety Gate portal (which provides notifications of dangerous products) and the Safety 
Business Gateway collecting notifications from economic operators to market surveillance 
authorities.  
Additional co sts for these coordination activities and electronic interfaces can be covered by 
the single market programme under the current multiannual financial framework 2021 -2027. 
Similar financing possibilities may also be included under the successor programmes u nder 
future multiannual financial frameworks. The details are set out in the financial statement 
attached to this proposal.  
5. OTHER  ELEMENTS  
• Implementation  plans  and monitoring,  evaluation  and reporting  arrangements   
The implementation of the proposal will be accompanied by monitoring based on predefined 
core enforcement indicators. The Commission is carrying out a study to define a common set 
of feasible and relevant enforcement indicators in the product safety field,  to be agreed with 
Member States.  
In addition to the regular monitoring and reporting, an evaluation of the effectiveness, 
efficiency, relevance, coherence and EU added value of this legislative intervention is 
proposed after 5 years of implementation by Member States.  
The Commission will support the implementation of the proposal by coordination actions, 
both in the context of the Consumer Safety Network (follow -up of implementation, exchange 
of best practices between Member States, etc.) and the market surveillance coordinated 
activities (CASPs).  
• Detailed  explanation  of the specific  provisions  of the proposal   
The proposed regulation consists of 11 chapters comprising 47 articles.  
Chapter I – General provisions  
This chapter sets out the scope and th e main terms used in the proposed regulation. It provides 
a ‘safety net’ for all products falling under its scope of application establishing requirements 
to ensure the safety of consumer products and therefore the safety of consumers. It provides 
rules on  the application of this Regulation to the non -harmonised legislation. It updates the 
definitions used in Directive 2001/95/EC, in particular to take into account the different scope 
of the definition of product, and introduces a specific definition of ‘on line marketplace’  
Chapter II – Safety requirements  EN 16  EN It introduces the general safety requirement, confirms the importance of standards published 
in the EU Official Journal as providing presumption of safety and updates aspects for 
assessing the safety of p roducts to take into consideration food -imitating products in the risk 
evaluation, following the repeal of Directive 87/357/EEC. New aspects for assessing product 
safety also include the possible risks related to products based on new technologies.  
Chapter  III – Obligations of economic operators  
Section 1  
This Section set outs the obligations of the economic operators except those economic 
operators which fall under the scope of application of Regulation (EU) 2019/1020. This is to 
avoid that obligations co ntained in this Chapter could conflict with similar obligations 
contained in the harmonised legislation. Apart of the more general obligations of economic 
operators to ensure the safety of products, it introduces the concept of substantial 
modification, in  which case responsibility for the safety of the product shifts to the person 
making the modification. Furthermore, it extends the concept of person responsible contained 
in Article 4 of Regulation (EU) 2019/1020 to non -harmonised products. This is a neces sary 
condition for making the products available on the market to tackle the issues of direct 
imports from third countries. This chapter also contains the basic provisions on traceability, 
mostly taken from Decision 768/2008/EC, and the possibility, in the  case of products 
susceptible to pose a serious risk to people’s health and safety, to adopt a more stringent 
system of traceability, to be adopted by a delegated act.  
Section 2  
This Section contains the obligations of economic operators which are applicable also to 
economic operators falling under the scope of Regulation (EU) 2019/1020. These are 
obligations which do not have correspondence in the harmonised sectors and therefore their 
applicability also to this sector would not create conflict. It  concerned the obligation of 
economic operators in case of distance sales and in case of accidents with a product.  
Chapter IV – Online marketplaces  
This Chapter examines the role played by online marketplaces and lays down specific 
obligations applicable t o them.  
Chapter V – Market surveillance and implementation  
This chapter takes up and adapts the entire Chapters IV, V and VI of Regulation (EU) 
2019/1020 on market surveillance. The aim is to create, as far as possible, a single regime for 
both harmonised and non -harmonised products.  
Chapter VI – Safety Gate rapid alert system  
This chapter lays down the principle for exchanging information in the case of a dangerous 
product and changes the name of the RAPEX system to Safety Gate, while maintaining the 
same characteristics of the system. The proposal adds more specific deadlines. The relation 
between Safety Gate and the Information and Communication System on Market Surveillance 
(ICSMS) is made clearer; the chapter also clarifies that Member State authorities  can decide 
to entrust the task of single liaison officer to the Safety Gate National contact point.  
Chapter VII – Commission role and enforcement coordination  
This chapter provides the possibility for the Commission to adopt measures, through 
implementin g acts, in case of a serious risk which cannot be contained satisfactorily by means 
of measures taken by the Member State(s) concerned or by any other procedure under EU 
legislation. This possibility already exists in the GPSD: the proposed regulation make s its EN 17  EN scope of application more precise. Chapter V also introduces a voluntary arbitration 
mechanism where Member States can submit to the Commission questions concerning the 
identification or the level of a risk linked to a product in case of diverging ri sk assessments. 
This will make it possible to take more uniform action at EU level against dangerous 
products.  
Chapter VIII – Right to information and remedy   
This chapter provides provisions on information for consumers. It confirms the obligation for 
the Commission and Member States to make available to consumers information relating to 
risks to health and safety posed by products. It also sets the obligation for Member States to 
give consumers the opportunity to submit complaints to the competent nationa l authorities.  It 
confirms and further enhances the scope of the Safety Gate web portal, which already exists, 
adding a new section where consumers can consult warnings and recalls issued directly by 
economic operators. On recalls, the new provisions try t o improve their effectiveness, thus 
ensuring a more complete and widespread provision of information for consumers, as well as 
an enhanced system of remedies available to consumers.  
Chapter IX – International cooperation   
This Chapter provides the legal bas is for the Commission to establish forms of cooperation to 
improve product safety. These include common enforcement actions, technical support, 
exchange of officials, and the exchange of information on dangerous products and in 
particular information conta ined in the Safety Gate. In this respect, the provision allows either 
fully fledged participation in Safety Gate or an exchange of selected information.  
Chapter X – Financial provisions  
The proposed Regulation provides for the financing by the Commission o f activities in all 
matters falling under its scope of application.  
The proposed Regulation includes general clauses on protecting the financial interests of the 
EU. 
Chapter XI - Final provisions  
This chapter provides in particular for a system of penalti es: while recognising that 
establishing penalties is a national competence, it sets out guiding principle for penalties, in 
particular criteria for setting penalties, the types of infringements to be penalised, criteria on 
maximum ceilings, as well as the possibility to impose periodic penalty payments.  EN 18  EN 2021/0170 (COD)  
Proposal for a  
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  
on general product safety, amending Regulation (EU) No 1025/2012 of the European 
Parliament and of the Council, and repealing Council Directive 87/357/EEC and 
Directive 2001/95/EC of the European Parliament and of the Council  
 
 
 
(Text with EEA relevance)  
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,  
Having regard to the Treaty on the  Functioning of the European Union, and in particular 
Article 114 thereof,  
Having regard to the proposal from the European Commission,  
After transmission of the draft legislative act to the national parliaments,  
Having regard to the opinion of the European  Economic and Social Committee21,  
Acting in accordance with the ordinary legislative procedure,  
Whereas:  
(1) Directive 2001/95/EC of the European Parliament and of the Council22 lays down the 
requirement that consumer products must be safe and that Member States' market 
surveillance authorities must take action against dangerous products as well as 
exchange information to that effect through the “Union rapid information exchange 
system”, RAPEX.  
(2) Directive 2001/95/EC needs to be revised and updated in light of the developments 
related to new technologies and online selling, to ensure consistency with 
developments in the Union harmonisation legislation and in the standardisation  
legislation, to ensure a better functioning of the product recalls as well as to ensure a 
clearer framework for food -imitating products so far regulated by Council Directive 
87/357/EEC23. In the interest of clarity, Directive 2001/95/EC, as well as Directi ve 
87/357/EEC, should be repealed and replaced by this Regulation.  
(3) A Regulation is the appropriate legal instrument as it imposes clear and detailed rules 
which do not give room for divergent transposition by Member States. The choice of 
                                                 
21 .OJ C , , p. .  
22 Directive 2001/95/EC of the European Parliament and of the Council on general product safety (OJ L 
11, 15.1.2002, p. 4).  
23 Council Directive 87/357/EEC of 25 June on the approximation of the laws of the Member States 
concerning products which, appearing to be other than they are, endanger the health or safety of 
consumers (OJ L 192, 11.7. 1987, p. 49).  EN 19  EN Regulation ins tead of Directive also allows to better deliver on the objective to ensure 
coherence with the market surveillance legislative framework for products  falling 
under the scope of Union harmonisation legislation as set out in Regulation (EU) 
2019/1020, where t he applicable legal instrument is also of the same type, namely 
Regulation (EU) 2019/1020  of the European Parliament and of the Council24. Finally, 
such a choice will further reduce the regulatory burden through a consistent 
application of product safety ru les across the Union.  
(4) The aim of this instrument is to contribute to the attainment of the objectives referred 
to in Article 169 of the Treaty. In particular, it should aim at ensuring health and safety 
of consumers and the functioning of the internal market as regards products intended 
for consumers.  
(5) This Regulation should aim at protecting consumers and their safety as one of the 
fundamental principle of the EU legal framework, enshrined in the EU Charter of 
fundamental rights. Dangerous products can have very negative consequences on 
consumers and citizens. All consumers, including the most vulnerable, such as 
children, older persons or persons with disabilities, have the right to safe products. 
Consumers should have at their disposal sufficient m eans to enforce such rights, and 
Member States adequate instruments and measures at their disposal to enforce this 
Regulation.  
(6) Despite the development of sector -specific Union harmonisation legislation that 
addresses safety aspects of specific product s or categories of products, it is practically 
impossible to adopt Union legislation for all consumer products that exist or may be 
developed. There is therefore still a need for a legislative framework of a horizontal 
nature to fill gaps and ensure consum er protection not otherwise ensured, in particular 
with a view to achieving a high level of protection of safety and health of consumers, 
as required by Article 114 and Article 169 of the Treaty.  
(7) At the same time, in respect of products subject to sect or-specific Union 
harmonisation legislation, the scope of application of the different parts of this 
Regulation should be clearly set out to avoid overlapping provisions and an unclear 
legal framework.  
(8) Whilst some of the provisions such as those conce rning most of the obligations of 
economic operators should not apply to products covered by Union harmonisation 
legislation since already covered in such legislation , a certain number of other 
provisions should apply in order to complement Union harmonisat ion legislation. In 
particular the general product safety requirement and related provisions should be 
applicable to consumer products covered by Union harmonisation legislation when 
certain types of risks are not covered by that legislation. The provision s of this 
Regulation concerning the obligations of online marketplaces, the obligations of 
economic operators in case of accidents, the right of information for consumers as well 
as the recalls of consumer products should apply to products covered by Union  
harmonisation legislation when there are not specific provisions with the same 
objective in such legislation. Likewise RAPEX is already used for the purposes of 
Union harmonisation legislation, as referred to in Article 20 of Regulation (EU) 
                                                 
24 Regulation (EU) 2019/1020 of the European Parliament and of th e 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 (OJ L 169, 25.6.2019, p. 1 ).  EN 20  EN 2019/1020 of the European Parliament and of the Council25, therefore the provisions 
regulating the Safety Gate and its functioning contained in this Regulation should be 
applicable to Union harmonisation legislation.  
(9) The provisions of Chapter VII of Regulation (EU) 2019/1020, setting up the rules of 
controls on products entering the Union market, are already directly applicable to 
products covered by this Regulation and it is not the intention of this Regulation to 
modify such provisions. The stability of the former is particularly important taking 
into account the fact that the authorities in charge of these controls (which in almost 
all Member States are the customs authorities) shall perform them on the basis of risk 
analysis as referred to in Articles 46 and 47 of  Regulation (EU) No 952/2013 (the 
Union Customs Code), the implementing legislation and corresponding guidance. This 
risk-based approach is pivotal to customs controls given the substantial volumes of 
goods coming into and leaving the customs territory and  results in application of 
concrete control measures depending on identified priorities. The fact that the 
Regulation does not modify in any way Chapter VII of Regulation 2019/1020, directly 
referring to the risk based approach laid down in the customs leg islation, means in 
practice that the authorities in charge of controls on products entering the Union 
market (including customs authorities) should limit their controls to the most risky 
products, depending on the likelihood and impact of the risk, thereby  ensuring 
effectiveness and efficiency of their activities as well as protection of their capacity to 
perform such controls.  
(10) The precautionary principle is a fundamental principle for ensuring the safety of 
products and consumers and should therefore be taken into due account by all relevant 
actors when applying this Regulation.  
(11) Considering also the broad scope given to the concept of health26, the environmental 
risk posed by a product should be taken into consideration in the application of this 
Regulation inasmuch as it can also ultimately result in a risk to the health and safety of 
consumers.  
(12) Products which are designed exclusively for professional use but which have 
subsequently migrated to the consumer market should be subject to this Re gulation 
because they could pose risks to the health and safety of consumers when used under 
reasonably foreseeable conditions.  
(13) Union legislation on food, feed and related areas sets up a specific system ensuring the 
safety of the products covered by it. Therefore, food and feed should be excluded from 
the scope of this Regulation with the exception of materials and articles intended to 
come into contact with food insofar as risks are concerned that are not covered by 
Regulation (EC) No 1935/2004 of th e European Parliament and of the Council27 or by 
other food specific legislation which only covers chemical and biological food -related 
risks.  
                                                 
25 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 (OJ L 169, 25.6.2019, p. 1 ).  
26 European Environment Agency,  ‘Healthy environment, healthy  lives: how the environment influences 
health and well -being in Europe’, EEA report No 21/2019, 8 September 2020.  
27 Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on 
materials and articles on materials and ar ticles intended to come into contact with food and repealing 
Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4).  EN 21  EN (14) Medicinal products are subject to a pre -market assessment that includes a specific risk -
benefit analysis. The y should therefore be excluded from the scope of this Regulation.  
(15) Aircraft referred to in Article 2(3) point (d) of Regulation (EU) 2018/113928 are 
subject to the regulatory control of the Member States, in light of their limited risk to 
civil aviation  safety. They should therefore be excluded from the scope of this 
Regulation.  
(16) The requirements laid down in this Regulation should apply to second hand products 
or products that are repaired, refurbished  or recycled that re -enter the supply chain in 
the course of a commercial activity, except for those products for which the consumer 
cannot reasonably expect that they fulfil state -of-the art safety standards, such as 
antiques or products which are presented as to be repaired or to be refurbished.  
(17) Directive 87/357/EEC on consumer products which, although not foodstuff, resemble 
foodstuff and are likely to be confused with foodstuff in a way that consumers, 
especially children, may place them in their mouths, suck or ingest them and which 
might caus e, for example, suffocation, poisoning, the perforation or obstruction of the 
digestive tract, has given rise to controversial interpretation. Furthermore it has been 
adopted at a time where the legal framework for consumer product safety was very 
limited in scope. For these reasons, Directive 87/357/EEC should be repealed.  
(18) Services should not be covered by this Regulation. However, in order to secure the 
attainment of the protection of health and safety of consumers, products that are 
supplied or made available to consumers in the context of the provision of services, 
includ ing products to which consumers are directly exposed during a service 
provision, should fall within the scope of this Regulation. Equipment on which 
consumers ride or travel which is operated by a service provider should be excluded 
from the scope of this Regulation since it has to be dealt with in conjunction with the 
safety of the service provided.  
(19) Items which connect to other items or non -embedded items which influence the way 
another item works can present a risk for the safety of the product. That aspect should 
be taken into due consideration as a potential risk. The connections and interrelation 
that an item might have with external items should not jeopardise its safety.  
(20) New technologies also cause new risks to consumers’ health and safe ty or change the 
way the existing risks could materialise, such as an external intervention hacking the 
product or changing its characteristics.  
(21) The World Health Organisation defines ‘health’ as a state of complete physical, 
mental and social well -being and not merely the absence of disease or infirmity. This 
definition supports the fact that the development of new technologies might bring new 
health risks to consumers, such as psychological risk, development risks, in particular 
for children, mental risks, depression, loss of sleep, or altered brain function.  
(22) Specific cybersecurity risks affecting the safety of consumers as well as protocols and 
certifications can be dealt with by sectorial legislation. However, it should be ensured, 
                                                 
28 Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common 
rules in the field of civil a viation and establishing a European Union Aviation Safety Agency, and 
amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 
and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and 
repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the 
Council and Council Regulation (EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1 –122).  EN 22  EN in case of gaps in the sectorial legislation, that the relevant economic operators and 
national authorities take into consideration risks linked to new technologies, 
respectively when designing the products and assessing them, in order to ensure that 
changes introduc ed in the product do not jeopardise its safety.  
(23) The safety of products should be assessed taking into account all the relevant aspects, 
notably their characteristics and presentation as well as the specific needs and risks for 
categories of consumers who are likely to use the products, in particular children, 
older persons and persons with disabilities. Therefore, if specific information is 
necessary to make products safe toward a given category of persons, the assessment of 
the safety of the products should take into consideration also the presence of this 
information and its accessibility. The safety of products should be assessed taking into 
consideration the need for the product to be safe over its entire lifespan.  
(24) Economic operators should hav e obligations concerning the safety of products, in 
relation to their respective roles in the supply chain, so as to ensure a high level of 
protection of the health and safety of consumers. All economic operators intervening 
in the supply and distribution chain should take appropriate measures to ensure that 
they only make available on the market products, which are safe and in conformity 
with this Regulation. It is necessary to provide for a clear and proportionate 
distribution of obligations corresponding  to the role of each operator in the supply and 
distribution process.  
(25) Distance  selling, including online selling, should also fall within the scope of this 
Regulation. Online selling has grown consistently and steadily, creating new business 
models an d new actors in the market such as the online marketplaces.  
(26) Online marketplaces play a crucial role in the supply chain - allowing economic 
operators to reach an indefinite number of consumers - and therefore also in the 
product safety system.  
(27) Given the important role played by online marketplaces when intermediating the sale 
of products between traders and consumers, such actors should have more 
responsibilities in tackling the sale of dangerous products online. Directive 
2000/31/EC of the Europ ean Parliament and of the Council29 provides the general 
framework for e -commerce and lays down certain obligations for online platforms. 
Regulation […/…] on a Single Market for Digital Services (Digital Services Act) and 
amending Directive 2000/31/EC30 regulates the responsibility and accountability of 
providers of intermediary services online with regard to illegal contents, including 
unsafe products. That Regulation applies without prejudice to the rules laid down by 
Union law on consumer protection and pr oduct safety. Accordingly, building on the 
horizontal legal framework provided by that Regulation, specific requirements 
essential to effectively tackle the sale of dangerous products online should be 
introduced, in line with Article [1(5), point (h)] of t hat Regulation.  
(28) The Product Safety Pledge, signed in 2018 and joined by a number of marketplaces 
since then, provides for a number of voluntary commitments on product safety. The 
Product Safety Pledge has proved its rationale in enhancing the protecti on of 
                                                 
29 Directive 2000/31/EC of the European Parliament and of the Council of 8 Jun e 2000 on certain legal 
aspects of information society services, in particular electronic commerce, in the Internal Market 
('Directive on electronic commerce') - OJ L 178, 17.7.2000, p. 1 –16. 
30 Regulation […/…] on a Single Market for Digital Services (Digi tal Services Act) and amending 
Directive 2000/31/EC.  EN 23  EN consumers against dangerous products sold online. Nonetheless, its voluntary nature 
and the voluntary participation by a limited number of online marketplaces reduces its 
effectiveness and cannot ensure a level -playing field.  
(29) Online marketplace s should act with due care in relation to the content hosted on their 
online interfaces that concerns safety of products, in accordance with the specific 
obligations laid down in this Regulation. Accordingly, due diligence obligations for all 
online market places should be established in relation to the content hosted on their 
online interfaces that concerns safety of products.  
(30) Moreover, for the purposes of effective market surveillance, online marketplaces 
should register in the Safety Gate portal and  indicate, in the same portal, the 
information concerning their single contact points for the facilitation of 
communication of information on product safety issues. The single point of contact 
under this Regulation might be the same as the point of contact  under [Article 10] of 
Regulation (EU) …/…[ the Digital Services Act ], without endangering the objective of 
treating issues linked to product safety in a swift and specific manner.  
(31) In order to be able to comply with their obligations under this Regulat ion, in particular 
in respect of timely and effective compliance with the orders of public authorities, 
processing of notices of other third parties and cooperating with market surveillance 
authorities in the context of corrective measures upon request, on line marketplaces 
should have in place an internal mechanism for handling product safety -related issues.  
(32) The obligations imposed by this Regulation on online marketplaces should neither 
amount to a general obligation to monitor the information which they transmit or store, 
nor to actively seek facts or circumstances indicating illegal activity, such as the sale 
of dangerous products online. Online marketplaces should, nonetheless, expeditiously 
remove content referring to dangerous products from their  online interfaces, upon 
obtaining actual knowledge or, in the case of claims for damages, awareness of the 
illegal content, in particular in cases where the online marketplace has been made 
aware of facts or circumstances on the basis of which a diligent economic operator 
should have identified the illegality in question, in order to benefit from the exemption 
from liability for hosting services under the 'Directive on electronic commerce' and the 
[Digital Services Act]. Online marketplaces should process notices concerning content 
referring to unsafe products, received in accordance with [Article 14] of Regulation 
(EU) …/…[ the Digital Services Act ], within the additional timeframes established by 
this Regulation.  
(33) Article 14(4) of Regulation (EU) 2019/ 1020 provides market surveillance authorities 
with the power, where no other effective means are available to eliminate a serious 
risk, to require the removal of content referring to the related products from an online 
interface or to require the explicit display of a warning to end users when they access 
an online interface. The powers entrusted to market surveillance authorities by Article 
14(4) of Regulation (EU) 2019/1020 should also apply to this Regulation. For 
effective market surveillance under this  Regulation and to avoid dangerous products 
being present on the Union market, this power should apply in all necessary and 
proportionate cases and also for products presenting a less than serious risk. It is 
essential that online marketplaces comply with such orders as a matter of urgency. 
Therefore, this Regulation introduces binding time limits in this respect, without 
prejudice to the possibility for a shorter time limit to be laid down in the order itself. 
This power should be exercised in accordance w ith [Article 8] of the Digital Services 
Act. EN 24  EN (34) Even where the information from the Safety Gate does not contain an exact uniform 
resource locator (URL) and, where necessary, additional information enabling the 
identification of the illegal content conce rned, online marketplaces should nevertheless 
take into account the transmitted information, such as product identifiers, when 
available, and other traceability information, in the context of any measures adopted 
by online marketplaces on their own initiat ive aiming at detecting, identifying, 
removing or disabling access to dangerous products offered on their marketplace, 
where applicable.  
(35) For the purposes of [Article 19] of Regulation (EU) …/…[ the Digital Services Act ], 
and concerning the safety of pr oducts sold online, the Digital Services Coordinator 
should consider in particular consumer organisations and associations representing 
consumers’ interest, upon their request, as trusted flaggers, provided that the 
conditions set out in that article have been met.  
(36) Product traceability is fundamental for effective market surveillance of dangerous 
products and corrective measures. Consumers should also be protected against 
dangerous products in the same way in the offline and online sales channels, inc luding 
when purchasing products on online marketplaces. Building on the provisions of 
Regulation (EU) …/…[ the Digital Services Act ]concerning the traceability of traders, 
online marketplaces should not allow listings on their platforms unless the trader 
provided all information related to product safety and traceability as detailed in this 
Regulation. Such information should be displayed together with the product listing so 
that consumers can benefit from the same information made available online and 
offline. However, the online marketplace should not be responsible for verifying the 
completeness, correctness and the accuracy of the information itself, as the obligation 
to ensure the traceability of products remains with the trader.  
(37) It is also importan t that online marketplaces closely cooperate with the market 
surveillance authorities, law enforcement authorities and with relevant economic 
operators on the safety of products. An obligation of cooperation with market 
surveillance authorities is imposed on information society service providers under 
Article 7(2) of Regulation (EU) 2019/1020 in relation to products covered by that 
Regulation and should therefore be extended to all consumer products. For instance, 
market surveillance authorities are constan tly improving the technological tools they 
use for the online market surveillance to identify dangerous products sold online. For 
these tools to be operational, online marketplaces should grant access to their 
interfaces. Moreover, for the purpose of produ ct safety, market surveillance authorities 
may also need to scrape data from the online marketplaces.  
(38) Direct selling by economic operators established outside the Union through online 
channels hinders the work of market surveillance authorities when t ackling dangerous 
products in the Union, as in many instances economic operators may not be 
established nor have a legal representative in the Union. It is therefore necessary to 
ensure that market surveillance authorities have adequate powers and means to  
effectively tackle the sale of dangerous products online. In order to ensure an effective 
enforcement of this Regulation, the obligation set out in Article 4(1), (2) and (3) of 
Regulation 2019/1020 should be extended also to products falling outside the s cope of 
the Union harmonisation legislation to ensure that there is a responsible economic 
operator established in the Union, which is entrusted with tasks regarding such 
products, providing market surveillance authorities with an interlocutor and 
performi ng specific tasks in a timely manner.   EN 25  EN (39) Contact information of the economic operator, established in the Union and 
responsible for products falling under the scope of application of this Regulation 
should be indicated with the product in order to facilitate checks throughout the supply 
chain.  
(40) Where economic operators or market surveillance authorities face a choice of various 
corrective measures, the most sustainable action resulting in the lowest environmental 
impact, such as the repair of th e product, should be preferred, provided that it does not 
result in a lesser level of safety.  
(41) Any economic operator that either places a product on the market under their own 
name or trademark or modifies a product in such a way that conformity with t he 
requirements of this Regulation may be affected, should be considered to be the 
manufacturer and should assume the obligations of the manufacturer.  
(42) Internal conformity procedures through which economic operators ensure, internally, 
the effective an d swift performance of their obligation as well as the conditions to 
react timely in case of a dangerous product, should be put in place by the economic 
operators themselves.  
(43) When making products available on the market, economic operators should prov ide 
minimum information on product safety and traceability as part of the relevant offer. 
This should be without prejudice to the information requirements laid down by 
Directive 2011/83/EU of the European Parliament and of the Council31, such as on the 
main  characteristics of the goods, to the extent appropriate to the medium and to the 
goods.  
(44) Ensuring product identification and the traceability of products throughout the entire 
supply chain helps to identify economic operators and to take effective cor rective 
measures against dangerous products, such as targeted recalls. Product identification 
and traceability thus ensures that consumers and economic operators obtain accurate 
information regarding dangerous products which enhances confidence in the mark et 
and avoids unnecessary disruption of trade. Products should therefore bear information 
allowing their identification and the identification of the manufacturer and, if 
applicable, of the importer. Such traceability requirements could be made stricter fo r 
certain kinds of products. Manufacturers should also establish technical 
documentations regarding their products, which should contain the necessary 
information to prove that their product is safe.  
(45) The legal framework for market surveillance of pro ducts covered by Union 
harmonisation legislation and set out in Regulation (EU) 2019/1020 and the legal 
framework for market surveillance of products covered by this Regulation should be 
as coherent as possible. It is therefore necessary, as far as market surveillance 
activities, obligations, powers, measures, and cooperation among market surveillance 
authorities are concerned, to close the gap between the two sets of provisions. For that 
purpose Articles 10 to 16, Articles 18 and 19 and Articles 21 to 24 o f Regulation (EU) 
2019/1020 should be applicable also to products covered by this Regulation.  
                                                 
31 Directive 2011/83/EU of the European Parliament and of the Council of 25  October 2011 on consumer 
rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament 
and of  the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European 
Parliament and of the Council (OJ L 304, 22.11.2011, p. 64).  EN 26  EN (46) To preserve the coherence of the market surveillance legal framework and, at the same 
time, ensure an effective cooperation between the European network of t he Member 
States’ authorities competent for product safety (‘Consumer Safety Network’) 
provided for by this Regulation and the Union Product Compliance Network aimed at 
structured coordination and cooperation between Member States’ enforcement 
authorities and the Commission provided for by Regulation (EU) 2019/1020, it is 
necessary to associate the Consumer Safety Network to the Union Product 
Compliance Network in the activities referred to in Articles 11, 12, 13 and 21 of 
Regulation (EU) 2019/1020.  
(47) National authorities  should be enabled to complement the traditional market 
surveillance activities focused on safety of products with market surveillance activities 
focusing on the internal conformity procedures  set up by economic operators to ensure 
product safety. Market surveillance authorities should be able to require the 
manufacturer to indicate which other products - produced with the same procedure, or 
containing the same components considered to present a risk or that are part of the 
same producti on batch - are affected by the same risk.  
(48) An exchange of information between Member States and the Commission concerning 
the implementation of this Regulation should be established on the basis of output 
indicators which would allow measuring and comp aring Member States’ effectiveness 
in implementing Union product safety legislation.  
(49) There should be effective, speedy and accurate exchange of information concerning 
dangerous products.  
(50) The Union rapid information system (RAPEX) has proved its effectiveness and 
efficiency. It enables corrective measures to be taken across the Union in relation to 
products that present a risk beyond the territory of a single Member State. It is 
opportune, though, to change the used abbreviated name from RAPEX to Safety Gate 
for greater clarity and better outreach to consumers. Safety Gate comprises a rapid 
alert system on dangerous non -food products whereby national authorities and the 
Commission can exchange information on such products, a web portal to inform th e 
public (Safety Gate portal) and an interface to enable businesses to comply with their 
obligation to inform authorities and consumers of dangerous products (Safety Business 
Gateway).  
(51) Member States should notify in the Safety Gate both compulsory and  voluntary 
corrective measures that prevent, restrict or impose specific conditions on the possible 
marketing of a product because of a serious risk to the health and safety of consumers 
or, in case of products covered by Regulation (EU) No 2019/1020, also  to other 
relevant public interests of the end -users.  
(52) Under Article 34 of Regulation (EU) No 2019/1020,  Member States authorities are to 
notify measures adopted against products covered by that Regulation, presenting a less 
than serious risk, through  the information and communication system referred to in the 
same article, while corrective measures adopted against products covered by this 
Regulation presenting a less than serious risk should be notified in the Safety Gate. 
Member States and the Commis sion should make available to the public information 
relating to risks to the health and safety of consumers posed by products.  It is 
opportune for consumers and businesses that all information on corrective measures 
adopted against products posing a risk are contained in the Safety Gate, allowing 
relevant information on dangerous products to be made available to the public through 
the Safety Gate portal. Member States are therefore encouraged  to notify in the Safety EN 27  EN Gate all corrective measures on products  posing a risk to the health and safety of 
consumers . 
(53) In case the information has to be notified in the information and communication 
system according to Regulation (EU) 2019/1020, there is the possibility, for such 
notifications, to be submitted dire ctly in the Safety Gate or, to be generated from 
within the information and communication system for market surveillance provided 
for in Article 34 of Regulation (EU) 2019/1020. For this purpose, the Commission 
should maintain and further develop the inter face that has been set up for the transfer 
of information between the information and communication system and the Safety 
Gate, in order to avoid double data entry and facilitate such transfer.  
(54) The Commission should maintain and further develop the S afety Business Gateway 
web portal, enabling economic operators to comply with their obligations to inform 
market surveillance authorities and consumers of dangerous products they have placed 
or made available on the market. This tool should also enable eco nomic operators to 
inform market surveillance authorities of accidents caused by products they have 
placed or made available on the market. It should enable quick and efficient 
information exchange between economic operators and national authorities, and 
facilitate information to consumers from economic operators.  
(55) There might be cases where it is necessary to deal with a serious risk at the Union 
level where the risk cannot be contained satisfactorily by means of measures taken by 
the Member State con cerned or by any other procedure under Union legislation. This 
could notably be the case of new emerging risks or those impacting vulnerable 
consumers. For that reason the Commission can adopt measures either on its own 
initiative or upon request of the Member States. Such measures should be adapted to 
the gravity and urgency of the situation. It is furthermore necessary to provide for an 
adequate mechanism whereby the Commission could adopt immediately applicable 
interim measures.  
(56) The determination  of the risk concerning a product and its level is based on a risk 
assessment performed by the relevant actors. Member States, in performing risk 
assessment, might reach different results as far as the presence of a risk or its level is 
concerned. This cou ld jeopardise the correct functioning of the single market and the 
level playing field for both consumers and economic operators. An arbitration 
mechanism should therefore be made available to Member States, on a voluntary 
basis, which would allow the Comm ission, to provide an opinion on the issue in 
dispute.  
(57) The Consumer Safety Network enhances the cooperation on product safety 
enforcement between Member States. In particular, it facilitates the activities of 
exchange of information, the organisation  of joint market surveillance activities, the 
exchange of expertise and best practices. The Consumer Safety Network should be 
duly represented and participate in the coordination and cooperation activities of the 
Union Product Compliance Network provided f or in Regulation (EU) 2019/1020 
whenever coordination of activities falling under the scope of application of both 
Regulations is necessary to ensure their effectiveness.  
(58) Market surveillance authorities might carry out joint activities with other auth orities or 
organisations representing economic operators or end users, with a view to promoting 
safety of products and identifying dangerous products, including those that are offered 
for sale online. In doing so the market surveillance authorities and the  Commission, as 
appropriate, should ensure that the choice of products and producers as well as the EN 28  EN activities performed does not create situation which might distort competition or affect 
the objectivity, independence and impartiality of the parties.  
(59) Simultaneous coordinated control actions (‘ sweeps’) are specific enforcement actions 
that can further enhance product safety. In particular, sweeps should be conducted 
where market trends, consumer complaints or other indications suggest that certain 
product categories are often found to present a serious risk.  
(60) The public interface of the Safety Gate, the Safety Gate portal, allows the general 
public, including consumers, economic operators and online marketplaces, to be 
informed about corrective meas ures taken against dangerous products present on the 
Union market. A separate section of the Safety Gate portal enables consumers to 
inform the Commission of products presenting a risk to consumer health and safety 
found in the market. Where relevant, the Commission should provide adequate follow -
up, notably by transmitting such information to the concerned national authorities.  
(61) In making available information on product safety to the public, professional secrecy, 
as referred to in Article 339 of the Treaty, should be protected in a way which is 
compatible with the need to ensure the effectiveness of market surveillance activities 
and of protection measures.  
(62) When a product already sold to consumers turns out to be dangerous, it may need to be 
recalled to protect consumers in the Union. Consumers might not be aware that they 
own a recalled product. In order to increase recall effectiveness, it is therefore 
important to better reach consumers concerned. Direct contact is the most effective 
method to  increase consumers’ awareness of recalls and encourage action. It is also the 
preferred communication channel across all groups of consumers. In order to ensure 
the safety of the consumers, it is important that they are informed in a quick and 
reliable wa y. Economic operators should therefore use the customer data at their 
disposal to inform consumers of recalls and safety warnings linked to products they 
have purchased. Therefore, a legal obligation is needed to require economic operators 
to use any custo mer data already at their disposal to inform consumers of recalls and 
safety warnings. In this respect, economic operators will make sure to include the 
possibility to directly contact customers in the case of a recall or safety warning 
affecting them in e xisting customer loyalty programmes and product registration 
systems, through which customers are asked, after having purchased a product, to 
communicate to the manufacturer on a voluntary basis some information such as their 
name, contact information, the  product model or serial number.   
(63) A third of consumers continue using dangerous products despite seeing a recall notice, 
notably because recall notices are drafted in a complex way or minimise the risk at 
stake. The recall notice should therefore be clear, transparent and clearly describe the 
risk at stake, avoiding any terms, expressions or other elements that may decrease 
consumers' perception of risk. Consumers should also be able to get more information, 
if needed, via a toll -free telephone number  or other interactive instrument.  
(64) To encourage consumer response to recalls it is also important that the action required 
from consumers be as simple as possible and that the remedies offered be  effective, 
cost-free and timely. Directive (EU) 2019/771  of the European Parliament and of the EN 29  EN Council32 provides the consumers with the contractual remedies for a lack of 
conformity of goods that existed at the time of delivery and became apparent within 
the liability period. The economic operator responsible f or the recall should provide 
similar remedies to the consumer.  
(65) In order to facilitate the effective and consistent application of the general safety 
requirement set out in this Regulation, it is important to make use of European 
standards covering cer tain products and risks in such a way that a product which 
conforms to such a European standard, the reference of which is published in the 
Official Journal of the European Union, is presumed to be in compliance with that 
requirement.  
(66) Where the Commi ssion identifies a need for a European standard ensuring compliance 
of certain products with the general safety requirement under this Regulation, it should 
apply the relevant provisions of Regulation (EU) No 1025/2012 of the European 
Parliament and of the  Council33 to request one or several European standardisation 
organisations to either draft or identify a standard which is suitable to ensure that 
products which conform to it are presumed to be safe.  
(67) Certain provisions of Regulation (EU) 1025/2012 s hould be amended to take the 
specificities of this Regulation into account, and in particular the need to define the 
specific safety requirements under this Regulation before launching the request to the 
European standardisation organisation.  
(68) Togethe r with the adaptation of Regulation (EU) 1025/2012, a specific procedure for 
the adoption of the specific safety requirements with the assistance of the specialised 
Committee provided for by this Regulation should be introduced.  
(69) European standards, th e references of which have been published in accordance with 
Directive 2001/95/EC, should continue providing a presumption of conformity with 
the general safety requirement set out in this Regulation. Standardisation requests 
issued by the Commission in ac cordance with Directive 2001/95/EC should be 
deemed standardisation requests issued in accordance with this Regulation.  
(70) The Union should be able to cooperate and to exchange information related to product 
safety with regulatory authorities of third c ountries or international organisations 
within the framework of agreements concluded between the Commission and third 
countries or international organisations. Such cooperation and exchange of 
information should respect confidentiality and personal data pr otection rules of the 
Union . 
(71) In order to play a significant deterrent effect for economic operators and online 
marketplaces to prevent the placing of dangerous products on the market, penalties 
should be adequate to the type of infringement, to the po ssible advantage for the 
economic operator or online marketplace and to the type and gravity of the injury 
                                                 
32 Directive (EU) 2019/771 of the European Parliament and of the Council of 20 May 2019 on certain 
aspects concerning contracts for the sale of goods, amending Regulation (EU) 2017/2394 and Directive 
2009/22/EC, and repealing Directive 1999/44/EC (OJ L 136, 22. 5. 2019, p. 28).  
33 Regulation (EU) No  1025/2012 of the European Parliament and of the Council of  25 October 2012 on 
European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 
94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 
2009/105/EC of the European Parliament and of the Coun cil and repealing Council Decision 
87/95/EEC and Decision No  1673/2006/EC of the European Parliament and of the Council (OJ L 316, 
14. 11. 2012, p. 12).  EN 30  EN suffered by the consumer. Furthermore an homogenous level of penalties is important 
to ensure a level playing field, avoiding that economic operators  or online 
marketplaces concentrate their activities in territories where the level of penalties is 
lower.  
(72) When imposing penalties, due regard should be given to the nature, gravity and 
duration of the infringement in question. The imposition of pena lties should be 
proportionate and should comply with Union and national law, including with 
applicable procedural safeguards and with the principles of the Charter of fundamental 
rights.  
(73) In order to facilitate the more consistent application of penal ties, common non -
exhaustive and indicative criteria for the application of penalties should be included. 
Those criteria should include the duration or temporal effects of the infringement, as 
well as its nature and gravity, in particular the level of risk incurred by the consumer. 
Repeated infringement by the same perpetrator shows a propensity to commit such 
infringements and is therefore a significant indication of the gravity of the conduct 
and, accordingly, of the need to increase the level of the penal ty to achieve effective 
deterrence. The financial benefits gained, or losses avoided, because of the 
infringement should be taken into account, if the relevant data are available. Other 
aggravating or mitigating factors applicable to the circumstances of t he case should 
also be taken into account.  
(74) In order to ensure more consistency, a list of those types of infringements that should 
be subject to penalties should be included.  
(75) The deterrent effect of penalties should be reinforced by the possibili ty to publish the 
information related to the penalties imposed by Member States. Where these penalties 
are issued against natural persons or include personal data, they may be published in a 
manner that complies with the data protection requirements as set  out in Regulation 
(EU) 2016/679 of the European Parliament and of the Council34 and Regulation (EU) 
2018/1725 of the European Parliament and of the Council35. The annual report on the 
penalties imposed by the Member States should contribute to the level pla ying field 
and to prevent repeated infringements. For reasons of legal certainty and in accordance 
with the principle of proportionality, it should be specified in which situations a 
publication should not take place. As far as natural persons are concerne d, personal 
data should only be published in exceptional circumstances justified by the seriousness 
of the infringement, for instance when a penalty has been imposed to an economic 
operator whose name identifies a natural person and such economic operator has 
repeatedly failed to comply with the general product safety requirement.  
(76) In order to ensure uniform conditions for the implementation of this Regulation, 
implementing powers should be conferred on the Commission to adopt the specific 
safety requirements, to determine the output indicators on the basis of which Member 
States have to communicate data concerning the implementation  of this Regulation, to 
                                                 
34 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the 
protection of natural persons with regard to the processing of personal data and on the free movement of 
such data, and repealing Directive 95/46/EC (General Data Protection Regulation)  (OJ L 119, 4.5.2016, 
p. 1).  
35 Regulation (EU) 2018/1725 of the Europea n Parliament and of the Council of 23 October 2018 on the 
protection of natural persons with regard to the processing of personal data by the Union institutions, 
bodies, offices and agencies and on the free movement of such data, and repealing Regulation ( EC) No 
45/2001 and Decision No 1247/2002/EC  (OJ L 295, 21.11.2018, p. 39).  EN 31  EN adopt the modalities and procedures for the exchange of information regarding 
measures commun icated through the Safety Gate and criteria to assess the level of 
risk, to take measures as regards the products presenting a serious risk, to adopt the 
modalities for the sending of information by consumers in the Safety Gate portal, to 
set out the requirements for registration of products for recall purposes and to adopt 
the template for a recall notice . Those powers should be exercised in accordance with 
Regulation (EU) No 182/2011 of the European Parliament and of the Council36. 
(77) The Commission should adopt immediately applicable implementing acts where, in 
duly justified cases relating to the health and safety of consumers , imperative grounds 
of urgency so require.  
(78) In order to maintain a high level of health and safety of co nsumers, the power to adopt 
acts in accordance with Article 290 of the Treaty should be delegated to the 
Commission in respect of the identification and traceability of products bearing a 
potential serious risk to health and safety. It is of particular imp ortance that the 
Commission carries out appropriate consultations during its preparatory work, 
including at expert level and that those consultations be conducted in accordance with 
the principles laid down in the Interinstitutional Agreement of 13 April 2 016 on Better 
Law-Making37. In particular, to ensure equal participation in the preparation of 
delegated acts, the European Parliament and the Council receive all documents at the 
same time as Member States' experts, and their experts systematically have ac cess to 
meetings of Commission expert groups dealing with the preparation of delegated acts.  
(79) Since the objectives of this Regulation, namely to ensure a consistent, high level of 
consumer health and safety protection while preserving the unity of the Single market, 
cannot be sufficiently achieved by the Member States given the need for a high degree 
of collaboration and coherent action between Member States’ competent authorities 
and for a mechanism to quickly and efficiently exchange information on da ngerous 
products in the Union but can rather, by reason of the Union -wide character of the 
problem, be better achieved at Union level, the Union may adopt measures, in 
accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on 
European Union. In accordance with the principle of proportionality, as set out in that 
Article, this Regulation does not go beyond what is necessary in order to achieve those 
objectives.  
(80) Any processing of personal data for the purpose of this Regulati on should be in 
compliance with Regulations (EU) 2016/679 and (EU) 2018/1725. When consumers 
report a product in the Safety Gate, only those personal data will be stored that are 
necessary to report the dangerous product and for a period not exceeding five  years 
after such data have been encoded. Manufacturers and importers should hold the 
register of consumer complaints only as long as it is necessary for the purpose of this 
Regulation. Manufacturers and importers, when they are natural persons should 
disclose their names to ensure that the consumer is able to identify the product for 
purpose of traceability.  
                                                 
36 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 
laying down the rules and general principles concerning mechanisms for control by the  Member States 
of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).  
37 OJ L 123, 12.5.2016, p. 1.  EN 32  EN (81) The European Data Protection Supervisor was consulted in accordance with Article 42 
of Regulation (EU) 2018/1725 and delivered an opinion on XX X XXX.38 
HAVE ADOPTED THIS REGULATION:  
CHAPTER I  
General provisions  
Article 1  
Subject matter  
This Regulation lays down essential rules on the safety of consumer products placed or made 
available on the market.  
Article 2  
Scope  
1. This Regulation shall apply  to products defined in Article 3(1), placed or made 
available on the market in so far as there are no specific provisions with the same 
objective in rules of Union law which regulate the safety of the products concerned.  
Where products are subject to spec ific safety requirements imposed by Union 
legislation, this Regulation shall apply only to the aspects and risks or categories of 
risks not covered by those requirements.  
In particular, as regards products subject to specific requirements imposed by Union 
harmonisation legislation as defined in Article 3(25),  
(a) Chapter II shall not apply insofar as the risks or categories of risks covered by 
Union harmonisation legislation are concerned;  
(b) Chapter III, Section 1, Chapters V and VII, Chapters IX to XI sh all not apply.  
2. This Regulation shall not apply to:  
(a) medicinal products for human or veterinary use;  
(b) food;  
(c) feed;  
(d) living plants and animals, genetically modified organisms and genetically 
modified microorganisms in contained use, as well as products of plants and 
animals relating directly to their future reproduction;  
(e) animal by -products and derived products;  
(f) plant protection products;  
(g) equipment on which consumers ride or travel which is operated by a service 
provider within th e context of a service provided to consumers;  
(h) aircraft referred to in point (d) of Article 2(3) of Regulation 2018/1139;  
                                                 
38 … EN 33  EN (i) antiques.  
3. This Regulation shall apply to products placed or made available on the market 
whether new, used, repaired or reconditioned. It shall not apply to products to be 
repaired or reconditioned prior to being used where those products are made 
available on the market as such.  
4. This Regulation is without prejudice to the rules laid down by Union law on 
consumer protect ion.  
5. This Regulation shall be applied taking due account of the precautionary principle.  
Article 3  
Definitions  
For the purposes of this Regulation the following definitions apply:  
 ‘product’ means any item, interconnected or not to other items, supplie d or made 
available, whether for consideration or not, in the course of a commercial activity 
including in the context of providing a service – which is intended for consumers or 
can, under reasonably foreseeable conditions, be used by consumers even if no t 
intended for them;  
  ‘safe product’ means any product which, under normal or reasonably foreseeable 
conditions of use or misuse, including the actual duration of use, does not present any 
risk or only the minimum risks compatible with the product's use, considered 
acceptable and consistent with a high level of protection of health and safety of 
consumers;  
 ‘dangerous product’ means any product which does not conform to the definition of 
‘safe product’;  
 ‘risk’ means the combination of the probability of an  occurrence of a hazard causing 
harm and the degree of severity of that harm;  
 ‘serious risk’ means a risk for which, based on a risk assessment and taking into 
account the normal and foreseeable use of the product, the combination of the 
probability of occ urrence of a hazard causing harm and the degree of severity of the 
harm is considered to require rapid intervention by the market surveillance authorities, 
including cases where the effects of the risk are not immediate;  
 ‘making available on the market’ me ans any supply of a product for distribution, 
consumption or use on the Union market in the course of a commercial activity, 
whether in return for payment or free of charge;  
 ‘placing on the market’ means the first making available of a product on the Union  
market;  
  ‘manufacturer’ means any natural or legal person who manufactures a product or has a 
product designed or manufactured, and markets that product under its name or 
trademark;  
 ‘authorised representative’ means any natural or legal person establishe d within the 
Union who has received a written mandate from a manufacturer to act on his or her 
behalf in relation to specified tasks;  EN 34  EN  ‘importer’ means any natural or legal person established within the Union who places a 
product from a third country on the  Union market;  
 ‘distributor’ means any natural or legal person in the supply chain, other than the 
manufacturer or the importer, who makes a product available on the market;  
 ‘fulfilment service provider’ means any natural or legal person offering, in the c ourse 
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 Article 2, point 1 of Directive 97/67/EC of  the 
European Parliament and of the Council39, parcel delivery services as defined in Article 
2, point 2 of Regulation (EU) 2018/644 of the European Parliament and of the 
Council40, and any other postal services or freight transport services;  
 ‘economic opera tor’ means the manufacturer, the authorized representative, the 
importer, the distributor, the fulfilment service provider or any other natural or legal 
person who is subject to obligations in relation to the manufacture of products, making 
them available on the market in accordance with this Regulation;  
 ‘online marketplace’ means a provider of an intermediary service using software, 
including a website, part of a website or an application, operated by or on behalf of a 
trader, which allows consumers to con clude distance contracts with other traders or 
consumers for the sale of products covered by this Regulation;  
 ‘online interface’ means any software, including a website, part of a website or an 
application, that is operated by or on behalf of an economic o perator, and which serves 
to give end users access to the economic operator's products;  
 ‘end user’ means any natural or legal person residing or established in the Union, to 
whom a product has been made available either as a consumer outside of any trade, 
business, craft or profession or as a professional end user in the course of its industrial 
or professional activities;  
 ‘European standard’ means a European standard as defined in Article 2(1), point (b) of 
Regulation (EU) No 1025/2012;  
 ‘International stan dard’ means an international standard as defined in Article 2(1), 
point (a) of Regulation (EU) No 1025/2012;  
 ‘National standard’ means a national standard as defined in Article 2(1), point (d) of 
Regulation (EU) No 1025/2012;  
 ‘European standardisation orga nisation’ means a European standardisation organisation 
as listed in Annex 1 to Regulation (EU) No 1025/2012;  
 ‘market surveillance’ means the activities carried out and measures taken by market 
surveillance authorities to ensure that products comply with the requirements set out in 
this Regulation;  
                                                 
39 Directive 97/67/EC of the European Parliament and of the Council of 15 December 1997 on common 
rules for the development of t he internal market of Community postal services and the improvement of 
quality of service (OJ L 15, 21. 1. 1998, p. 14).  
40 Regulation (EU) 2018/644 of the European Parliament and of the Council of 18 April 2018 on cross -
border parcel delivery services (OJ L 112, 2. 5. 2018, p. 19).  EN 35  EN  ‘market surveillance authority’ means an authority designated by a Member State 
under Article 10 of Regulation (EU) 2019/1020 as responsible for organising and 
carrying out market surveillance in the territory o f that Member State;  
 ‘recall’ means any measure aimed at achieving the return of a product that has already 
been made available to the consumer;  
 ‘withdrawal’ means any measure aimed at preventing a product in the supply chain 
from being made available on t he market;  
 ‘Union harmonisation legislation’ means Union legislation listed in Annex I to 
Regulation (EU) 2019/1020 and any other Union legislation harmonising the 
conditions for the marketing of products to which that Regulation applies.  
Article 4  
Distanc e sales  
1. Products offered for sale online or through other means of distance sales shall be 
deemed to be made available on the market if the offer is targeted at consumers in 
the Union. An offer for sale shall be considered to be targeted at consumers in  the 
Union if the relevant economic operator directs, by any means, its activities to one or 
several Member State(s).  
2. For the purpose of determining whether an offer is targeted at consumers in the 
Union, the following non -exhaustive criteria shall be taken into account:  
(a) the use of an official language or currency of the Member States,  
(b) a domain name registered in one of the Member States,  
(c) the geographical areas to which the products can be dispatched.  
CHAPTER II  
Safety requirements  
Article 5 
General safety requirement  
Economic operators shall place or make available on the Union market only safe products.  
Article 6  
Presumption of safety  
1. For the purpose of this Regulation, a product shall be presumed to be in conformity 
with the general safety requirement laid down in Article 5 in the following cases:  
(a) if it conforms to relevant European standards or parts thereof as far as the risks 
and risk categories covered are concerned, the references of which have been 
published in the Official Journal of the European Union  in accordance with 
Article 10(7) of Regulation (EU) 1025/2012;  
(b) in the absence of European standards referred to in point (a), as regards the 
risks covered by health and safety requirements laid down in the law of the EN 36  EN Membe r State where the product is made available on the market, if it 
conforms to such national requirements.  
2. The Commission shall adopt implementing acts determining the specific safety 
requirements necessary to ensure that products which conform to the Eur opean 
standards satisfy the general safety requirement laid down in Article 5. Those 
implementing acts shall be adopted in accordance with the examination procedure 
referred to in Article 42(3).  
3. However, presumption of safety under paragraph 1 shall not  prevent market 
surveillance authorities from taking action under this Regulation where there is 
evidence that, despite such conformity, the product is dangerous.  
Article 7  
Aspects for assessing the safety of products  
1. Where the presumption of safety l aid down in Article 5 does not apply, the following 
aspects shall be taken into account in particular when assessing whether a product is 
safe:  
(a) the characteristics of the product, including its design, technical features, 
composition, packaging, instru ctions for assembly and, where applicable, for 
installation and maintenance;  
(b) the effect on other products, where it is reasonably foreseeable that it will be 
used with other products, including the interconnection of products among 
them;  
(c) the effect that other products might have on the product to be assessed, 
including the effect of non -embedded items that are meant to determine, 
change or complete the way another product falling under the scope of this 
Regulation works, which have to be taken  into consideration in assessing the 
safety of that other product;  
(d) the presentation of the product, the labelling, any warnings and instructions for 
its safe use and disposal, and any other indication or information regarding the 
product;  
(e) the categ ories of consumers at risk when using the product, in particular 
vulnerable consumers such as children, older people and persons with 
disabilities;  
(f) the appearance of the product and in particular where a product, although not 
foodstuff, resembles foods tuff and is likely to be confused with foodstuff due 
to its form, odour, colour, appearance, packaging, labelling, volume, size or 
other characteristics;  
(g) the fact that although not designed or not intended for use by children, the 
product resembles an object commonly recognized as appealing to or intended 
for use by children, because of its design, packaging and characteristics;  
(h) the appropriate cybersecurity features necessary to protect the product against 
external influences, including malicious t hird parties, when such an influence 
might have an impact on the safety of the product;  
(i) the evolving, learning and predictive functionalities of a product.  EN 37  EN 2. The feasibility of obtaining higher levels of safety or the availability of other 
products p resenting a lesser degree of risk shall not constitute grounds for 
considering a product not to be safe.  
3. For the purpose of paragraph 1, when assessing whether a product is safe, the 
following elements, when available, shall be taken into account, in pa rticular:  
(a) European standards other than those the references of which have been 
published in the Official Journal of the European Union in accordance with 
Article 10(7) of Regulation (EU) 1025/2012;  
(b) international standards;  
(c) international agreements;  
(d) voluntary certification schemes or similar third -party conformity assessment 
frameworks, in particular those conceived to support Union legislation;  
(e) Commission recommendations or guidelines on product safety assessment;  
(f) national sta ndards drawn up in the Member State in which the product is made 
available;  
(g) the state of the art and technology, including the opinion of recognized 
scientific bodies and expert committees;  
(h) product safety codes of good practice in force in the sect or concerned;  
(i) reasonable consumer expectations concerning safety;  
(j) safety requirements adopted in accordance with Article 6(2).  
CHAPTER III  
Obligations of economic operators  
Section 1  
Article 8  
Obligations of manufacturers  
1. When placing their pro ducts on the market, manufacturers shall ensure that these 
products have been designed and manufactured in accordance with the general safety 
requirement laid down in Article 5.  
2. Manufacturers shall investigate the complaints received that concern produ cts they 
made available on the market,  and which have been identified as dangerous by the 
complainant , and shall keep a register of these complaints as well as of product 
recalls.  
Manufacturers shall make publicly available to consumers, communication cha nnels 
such as telephone number, electronic address or dedicated section of their website, 
allowing the consumers to file complaints and to inform them of any accident or 
safety issue they have experienced with the product.  
Personal data stored in the register of complaints shall only be those personal data 
that are necessary for the manufacturer to investigate the complaint about an alleged EN 38  EN dangerous product. Such data shall only be kept as long as it is necessary for the 
purpose of investigation and n o longer than five years after they have been encoded.  
3. Manufacturers shall keep distributors, importers and online marketplaces in the 
concerned supply chain informed of any safety issue that they have identified.  
4. Manufacturers shall draw up technic al documentation of the product. The technical 
documentation shall contain, as appropriate:  
(a) a general description of the product and its essential properties relevant for 
assessing the product's safety;  
(b) an analysis of the possible risks related to the product and the solutions adopted 
to eliminate or mitigate such risks, including the outcome of any tests 
conducted by the manufacturer or by another party on their behalf;  
(c) the list of the European standards referred to in Article 6(1) point a, or the other 
elements referred to in Article 7(3), applied to meet the general safety 
requirement laid down in Article 5.  
Where any of the European standards, health and safety requirements or elements 
referred to in Article 7(3) have been only partly applied , the parts which have been 
applied shall be identified.  
5. Manufacturers shall keep the technical documentation, for a period of ten years after 
the product has been placed on the market and make it available to the market 
surveillance authorities, upon r equest.  
6. Manufacturers shall ensure that their products bear a type, batch or serial number or 
other element allowing the identification of the product which is easily visible and 
legible for consumers, or, where the size or nature of the product does n ot allow it, 
that the required information is provided on the packaging or in a document 
accompanying the product.  
7. Manufacturers shall indicate their name, registered trade name or registered trade 
mark and the postal and electronic address at which the y can be contacted on the 
product or, where that is not possible, on its packaging or in a document 
accompanying the product. The address shall indicate a single contact point at which 
the manufacturer can be contacted.  
8. Manufacturers shall ensure that t heir product is accompanied by instructions and 
safety information in a language which can be easily understood by consumers, as 
determined by the Member State in which the product is made available. This 
requirement shall not apply where the product can b e used safely and as intended by 
the manufacturer without such instructions and safety information.  
9. Manufacturers shall ensure that procedures are in place for series production to 
remain in conformity with the general safety requirement laid down in Ar ticle 5.  
10. Manufacturers who consider or have reason to believe, on the basis of the 
information in their possession, that a product which they have placed on the market 
is not safe, shall immediately take the corrective measures necessary to bring the 
product into c onformity, including a withdrawal or recall, as appropriate.  
11. Manufacturers shall, via the Safety Business Gateway referred to in Article 25, 
immediately alert consumers of the risk to their health and safety presented by a 
product they manufacture and  immediately inform the market surveillance authorities 
of the Member States in which the product has been made available to that effect, EN 39  EN giving details, in particular, of the risk to health and safety of consumers and of any 
corrective measure already tak en. 
Article 9  
Obligations of authorised representatives  
1. A manufacturer may, by a written mandate, appoint an authorised representative.  
2. An authorised representative shall perform the tasks specified in the mandate 
received from the manufacturer. The  mandate shall allow the authorised 
representative to perform at least the following tasks:  
(a) provide a market surveillance authority, upon its reasoned request, with all 
information and documentation necessary to demonstrate the safety of the 
product in  an official language which can be understood by that authority;  
(b) where they have a reason to believe that a product in question presents a risk, 
inform the manufacturer;  
(c) cooperate with the competent national authorities, at their request, on any 
action taken to eliminate the risks posed by products covered by their mandate.  
Article 10  
Obligations of importers  
1. Before placing a product on the market importers shall ensure that the product is 
compliant with the general safety requirement laid down i n Article 5 and that the 
manufacturer has complied with the requirements set out in Article 8 (4), (6) and (7).  
2. Where an importer considers or has reason to believe that a product is not in 
conformity with Article 5 and Article 8(4), (6) and (7), he or she shall not place the 
product on the market until it has been brought into conformity. Furthermore, where 
the product is not safe, the importer shall inform the manufacturer and ensure that the 
market surveillance authorities are informed.  
3. Importers s hall indicate their name, registered trade name or registered trade mark, 
the postal and electronic address at which they can be contacted on the product or, 
where that is not possible, on its packaging or in a document accompanying the 
product. They shall  ensure that any additional label does not obscure any information 
on the label provided by the manufacturer.  
4. Importers shall ensure that the product they imported is accompanied by instructions 
and safety information in a language which can be easily u nderstood by consumers, 
as determined by the Member State in which the product is made available, except 
where the product can be used safely and as intended by the manufacturer without 
such instructions and safety information.  
5. Importers shall ensure t hat, while a product is under their responsibility, storage or 
transport conditions do not jeopardize its conformity with the general safety 
requirement laid down in Article 5 and its conformity with Article 8 (6) and ( 7). 
6. Importers shall investigate complaints related to products they made available on the 
market and file these complaints, as well as products recalls, in the register referred 
to in Article 8(2), first subparagraph, or in their own register. Importers shall keep EN 40  EN the manufacturer and distributors informed of the investigation performed and of the 
results of the investigation.  
Importers shall ensure that the communication channels referred to in Article 8(2), second 
subparagraph, are available to consumers all owing them to present complaints and 
communicate any accident or safety issue they have experienced with the product. If 
such channels are not available the importer shall provide for them.  
Personal data stored in the register of complaints shall only be those personal data that are 
necessary for the importer to investigate the complaint about an alleged dangerous 
product. Such data shall only be kept as long as it is necessary for the purpose of 
investigation and no longer than five years after they have been encoded.   
7. Importers shall cooperate with market surveillance authorities and the manufacturer 
to ensure that a product is safe.  
8. Importers who consider or have reason to believe, on the basis of the information in 
their possession, that a product  which they have placed on the market is not safe shall 
immediately inform the manufacturer and ensure that the corrective measures 
necessary to bring the product into conformity are adopted including withdrawal or 
recall, as appropriate. In case such meas ures have not been adopted, the importer 
shall adopt them. Importers shall ensure that, through the Safety Business Gateway 
referred to in Article 25, consumers are immediately and effectively alerted of the 
risk where applicable and that market surveillan ce authorities of the Member States 
in which they made the product available to that effect be immediately informed, 
giving details, in particular, of the risk to health and safety of consumers and of any 
corrective measure already taken.  
9. Importers shal l keep the technical documentation referred to in Article 8(4) for a 
period of 10 years after they have placed the product on the market and make it 
available to the market surveillance authorities, upon request.  
Article 11  
Obligations of distributors  
1. Before making a product available on the market, distributors shall verify that the 
manufacturer and the importer have complied with the requirements set out in Article 
8(6), (7) and (8) and Article 10(3) and (4), as applicable.  
2. Distributors shall ensur e that, while a product is under their responsibility, storage or 
transport conditions do not jeopardize its conformity with the general safety 
requirement laid down in Article 5 and its conformity with Article 8( 6), (7) and (8) 
and Article 10(3) and (4), as applicable.  
3. Distributors who consider or have reason to believe, on the basis of the information 
in their possession, that a product is not in conformity with the provisions referred to 
in paragraph 2, shall not make the product available on the mark et until it has been 
brought into conformity. Furthermore, where the product is not safe, the distributor 
shall immediately inform the manufacturer or the importer, as applicable, to that 
effect and shall make sure that, through the Safety Business Gateway  referred to in 
Article 25, the market surveillance authorities are informed.  
4. Distributors who consider or have reason to believe, on the basis of the information 
in their possession, that a product which they have made available on the market is 
not s afe or is not in conformity with Article 8(6), (7) and (8) and Article 10(3) and EN 41  EN (4), as applicable, shall ensure that the corrective measures necessary to bring the 
product into conformity are adopted, including withdrawal or recall, as appropriate. 
Furth ermore, where the product is not safe, distributors shall immediately inform the 
manufacturer or the importer, as applicable, to that effect and shall make sure that, 
through the Safety Business Gateway referred to in Article 25, the market 
surveillance au thorities of the Member State in which they made the product 
available to that effect are informed giving details, in particular, of the risk to health 
and safety and of any corrective measure taken.  
Article 12  
Cases in which obligations of manufacturers  apply to other economic operators  
1. A natural or legal person, other than the manufacturer, that substantially modifies the 
product, shall be considered a manufacturer for the purposes of this Regulation and 
shall be subject to the obligations of the man ufacturer set out in Article  8 for the part 
of the product affected by the modification or for the entire product if the substantial 
modification has an impact on its safety.  
2. A modification shall be deemed to be substantial where the three following cr iteria 
are met:  
(a) the modification changes the intended functions, type or performance of the 
product in a manner which was not foreseen in the initial risk assessment of the 
product;  
(b) the nature of the hazard has changed or the level of risk has inc reased because 
of the modification;  
(c) the changes have not been made by the consumer for their own use.  
Article 13  
Internal processes for product safety  
The economic operators shall ensure that they have internal processes for product safety in 
place, al lowing them to respect the general safety requirement laid down in Article 5.  
Article 14  
Cooperation of economic operators with market surveillance authorities  
1. Economic operators shall cooperate with market surveillance authorities regarding 
actions wh ich could eliminate or mitigate risks that are presented by products made 
available on the market by those operators.  
2. On request of a market surveillance authority, the economic operator shall provide all 
necessary information, and in particular:  
(a) a full description of the risk presented by the product;  
(b)  a description of any corrective measure undertaken to address the risk.  
3. On request, the economic operators shall also identify and communicate the 
following information:  
(a) any economic opera tor who has supplied them with the product;  
(b) any economic operator to whom they have supplied the product.  EN 42  EN 4. Economic operators shall be able to present the information referred to in paragraph 
2 for a period of ten years after they have been supplied with the product and for a 
period of ten years after they have supplied the product, where relevant.  
5. Economic operators shall ensure that the corrective measure undertaken is effective 
in eliminating or mitigating the risks. Market surveillance authorit ies may request the 
economic operators to submit regular progress reports and decide whether or when 
the corrective measure can be considered completed.  
Article 15  
Responsible person for products placed on the Union market  
1. Article 4(1), (2) and (3) of Regulation (EU) 2019/1020 shall also apply to products 
covered by this Regulation. For the purposes of this Regulation, references to “Union 
harmonisation legislation” in Article 4(1), (2) and (3) of Regulation (EU) 2019/1020 
shall be read as “Regulation [ …]”.  
2. In addition to the tasks referred to in Article 4(3) of Regulation (EU) 2019/1020, the 
economic operator referred to in Article 4(1) of Regulation (EU) 2019/1020 shall 
periodically carry out sample testing of randomly chosen products made available  on 
the market. When the products made available on the market have been subject to a 
Commission decision adopted under Article 26(1) of this Regulation, the economic 
operator referred to in Article 4(1) of Regulation (EU) 2019/1020 shall carry out, at 
least once a year, for the entire duration of the decision, representative sample testing 
of products made available on the market chosen under the control of a judicial 
officer or any qualified person designated by the Member State where the economic 
operato r is situated.  
3. The name, registered trade name or registered trade mark, and contact details, 
including the postal and electronic address, of the economic operator referred to in 
Article 4(1) of Regulation (EU) 2019/1020 shall be indicated on the produc t or on its 
packaging, the parcel or an accompanying document.  
Article 16  
Information to economic operators  
Member States shall put in place procedures for providing economic operators, at their 
request and free of charge, with information with respect to the implementation of this 
Regulation.  
Article 17  
Traceability of products  
1. For certain products, categories or groups of products, which are susceptible to bear a 
serious risk to health and safety of consumers, based on accidents registered in the 
Safety Business Gateway, the Safety Gate statistics, the results of the joint activities 
on product safety and other relevant indicators or evidence, the Commission may 
require economic operators who place and make available those products on the 
market to est ablish or adhere to a system of traceability.  
2. The system of traceability shall consist in the collection and storage of data, 
including by electronic means, enabling the identification of the product, its EN 43  EN components or of the economic operators involve d in its supply chain, as well as in 
modalities to display and to access that data, including placement of a data carrier on 
the product, its packaging or accompanying documents.  
3. The Commission is empowered to adopt delegated acts in accordance with Article 41 
to supplement this Regulation by:  
(a) determining the products, categories or groups of products or components 
susceptible to bear a serious risk to health and safety of persons as referred to 
in paragraph 1. The Commission shall state in the de legated acts concerned if it 
has used the risk analysis methodology provided for in Commission Decision 
(EU) 2019/41741 or, if that methodology is not appropriate for the product 
concerned, it shall give a detailed description of the methodology used;  
(b) specifying the type of data, which economic operators shall collect and store by 
means of the traceability system referred to in paragraph 2;  
(c) the modalities to display and to access data, including placement of a data 
carrier on the product, its packagi ng or accompanying documents as referred to 
in paragraph 2.  
4. When adopting the measures referred to in paragraph 3, the Commission shall take 
into account:  
(a) the cost -effectiveness of the measures, including their impact on businesses, in 
particular s mall and medium -sized enterprises;  
(b) the compatibility with traceability systems available at Union or at 
international level.  
Section 2  
Article 18  
Obligations of economic operators in case of distance sales  
Where products are made available on the market online or through other means of 
distance sales by the relevant economic operators, the relevant offer of the product 
shall clearly and visibly indicate at least the following information:  
(a) name, registered trade name or registered trade mark of the manufacturer, as 
well as the postal or electronic address at which they can be contacted;  
(b) in case the manufacturer is not established in the Union, the name, address, 
telephone number and electronic address of the responsible person within the 
mean ing of Article 15(1);  
(c) information to identify the product, including its type and, when available, 
batch or serial number and any other product identifier;  
(d) any warning or safety information that is to be affixed on the product or to 
accompany it i n accordance with this Regulation or the applicable Union 
                                                 
41 Commission Implementing Decision (EU) 2019/417 of 8 November 2018 laying down guidelines for 
the management of the European Union Rapid Information System ‘RAPEX’ established under Article 
12 of Directive 2001/95/EC on general product safety and its notification system ( OJ L 73, 15.3.2019, 
p. 121).  EN 44  EN harmonisation legislation in a language which can be easily understood by 
consumers.  
Article 19  
Obligations of economic operators in case of accidents or safety issues related to 
products  
1. The ma nufacturer shall ensure that, through the Safety Business Gateway referred to 
in Article 25, an accident caused by a product placed or made available on the 
market is notified, within two working days from the moment it knows about the 
accident, to the com petent authorities of the Member State where the accident has 
occurred. The notification shall include the type and identification number of the 
product as well as the circumstances of the accident, if known. The manufacturer 
shall notify, upon request, to  the competent authorities any other relevant 
information.  
2. The importers and the distributors which have knowledge of an accident caused by a 
product that they placed or made available on the market shall inform the 
manufacturer, which can instruct the  importer or one of the distributors to proceed to 
the notification.  
CHAPTER IV  
Online marketplaces  
Article 20  
Specific obligations of online marketplaces related to product safety  
1. Online marketplaces shall establish a single contact point allowing for direct 
communication with Member States’ market surveillance authorities in relation to 
product safety issues, in particular for orders concerning offers of dangerous 
products.  
Online marketplaces shall register with the Safety Gate portal and indicate on the 
portal the information concerning their single contact point.  
2. As far as powers conferred by Member States in accordance to Article 14 of 
Regulation (EU) 2019/1020 are concerned, Member States shall confer on their 
market surveillance authorities the  power, for all products covered by this 
Regulation, to order an online marketplace to remove specific illegal content 
referring to a dangerous product from its online interface, to disable access to it or to 
display an explicit warning to end users when t hey access it. Such orders shall 
contain a statement of reasons and specify one or more exact uniform resource 
locators and, where necessary, additional information enabling the identification of 
the illegal content concerned. They may be transmitted by me ans of the Safety Gate 
portal.  
Online marketplaces shall take the necessary measures to receive and process the 
orders issued in accordance with this paragraph. They shall act upon receipt of the 
order issued without undue delay, and in any event within tw o working days in the 
Member State where the online marketplace operates, from receipt of the order. They 
shall inform the issuing market surveillance authority of the effect given to the order EN 45  EN by using the contacts of the market surveillance authority pub lished in the Safety 
Gate.  
3. Online marketplaces shall take into account regular information on dangerous 
products notified by the market surveillance authorities in line with Article 24, 
received via the Safety Gate portal, for the purpose of applying t heir voluntary 
measures aimed at detecting, identifying, removing or disabling access to the illegal 
content referring to dangerous products offered on their marketplace, where 
applicable. They shall inform the authority that made the notification to the S afety 
Gate of any action taken by using the contacts of the market surveillance authority 
published in the Safety Gate.  
4. Online marketplaces shall give an appropriate answer without undue delay, and in 
any event within five working days, in the Member St ate where the online 
marketplace operates, to notices related to product safety issues and dangerous 
products received in accordance with [Article 14] of Regulation (EU) […/…] on a 
Single Market for Digital Services (Digital Service Act) and amending Direc tive 
2000/31/EC.  
5. For the purpose of the requirements of Article 22(7) of Regulation (EU) […/…] on a 
Single Market for Digital Services (Digital Services Act) and amending Directive 
2000/31/EC, online marketplaces shall design and organise their online interface in a 
way that enables traders to provide the following information for each product 
offered and ensures that it is displayed or otherwise made easily accessible by 
consumers on the product listing:  
(a) name, registered trade name or registered tr ade mark of the manufacturer, as 
well as the postal or electronic address at which they can be contacted;  
(b) where the manufacturer is not established in the Union, the name, address, 
telephone number and electronic address of the responsible person withi n the 
meaning of Article 15 (1);  
(c) information to identify the product, including its type and, when available, 
batch or serial number and any other product identifier;  
(d) any warning or safety information that is to be affixed on the product or to 
accompany it in accordance with this Regulation or the applicable Union 
harmonisation legislation in a language which can be easily understood by 
consumers.  
6. Online marketplaces shall cooperate with the market surveillance authorities and 
with relevant econ omic operators to facilitate any action taken to eliminate or, if that 
is not possible, to mitigate the risks presented by a product that is or was offered for 
sale online through their services. That cooperation shall include in particular:  
(a) cooperatin g to ensure effective product recalls, including by abstaining from 
putting obstacles to product recalls;  
(b) informing the market surveillance authorities of any action taken;  
(c) cooperating with law enforcement agencies at national and Union level, 
including the European Anti -Fraud Office, through regular and structured 
exchange of information on offers that have been removed on the basis of this 
Article by online marketplaces;  EN 46  EN (d) allowing access to their interfaces for the online tools operated by market 
surveillance authorities to identify dangerous products;  
(e) upon request of the market surveillance authorities, when online marketplaces 
or online sellers have put in place technical obstacles to the extraction of data 
from their online interfaces  (data scraping), allowing to scrape such data for 
product safety purposes based on the identification parameters provided by the 
requesting market surveillance authorities.  
CHAPTER V  
Market surveillance and implementation  
Article 21  
Market Surveillance  
1. Articles 10 to 16, Articles 18 and 19 and Articles 21 to 24 of Regulation (EU) 
2019/1020 shall apply to products covered by this Regulation.  
2. For the purpose of this Regulation, Regulation (EU) 2019/1020 shall be applied as 
follows:  
(a) references to ‘ Union harmonisation legislation’ in Articles 10 to 16, Articles 18 
and 19 and Articles 21 to 24 of Regulation (EU) 2019/1020 shall be read as 
references to ‘this Regulation’;  
(b) reference to ‘that legislation and this Regulation’ in Article 11(1) point b  of 
Regulation (EU) 2019/1020 shall be read as ‘Regulation […]’;  
(c) references to ‘Network’ in Articles 10 to 16, Articles 18 and 19 and Articles 21 
to 24 of Regulation (EU) 2019/1020 shall be read as references to ‘Network 
and Consumer Safety Network ref erred to in Article 28 of this Regulation’;  
(d) references to ‘non -compliance’ in Articles 10 to 16, Articles 18 and 19 and 
Articles 21 to 24 of Regulation (EU) 2019/1020 shall be read as reference to 
‘failure to comply with this Regulation’;  
(e) the refer ence to ‘Article 41’ in Article 14(4), point (i) of Regulation (EU) 
2019/1020 shall be read as reference to ‘Article 40 of this Regulation’:  
(f) the reference to ‘Article 20’ in Article 19(1) of Regulation (EU) 2019/1020 
shall be read as reference to ‘Arti cle 24 of this Regulation’.  
3. Where a dangerous product has been identified, the manufacturer shall indicate, upon 
request by market surveillance authorities, which other products, produced with the 
same procedure, containing the same components or being part of the same 
production batch, are affected by the same risk.  
4. Market surveillance authorities may set up schemes focusing on control of internal 
processes for product safety set up by economic operators according to Article 13.  
Article 22  
Implementa tion EN 47  EN 1. Member States shall communicate to the Commission, once a year, data concerning 
the implementation of this Regulation.  
2. The Commission, by means of implementing acts, shall determine the output 
indicators on the basis of which Member States have  to communicate this data. 
Those implementing acts shall be adopted in accordance with the advisory procedure 
referred to in Article 42(3).  
CHAPTER VI  
Safety Gate rapid alert system  
Article 23  
Safety Gate  
1. The Commission shall further develop and maintai n a rapid alert system for the 
exchange of information on corrective measures concerning dangerous products (‘the 
Safety Gate’).  
2. The Commission and the Member States shall have access to the Safety Gate. For 
that purpose, each Member State shall designa te a single national contact point which 
shall perform the tasks provided for in Article 24(1) to (6) .  
Article 24  
Notification through the Safety Gate of products presenting a risk  
1. Member States shall notify in the Safety Gate corrective measures taken by their 
authorities or by economic operators :  
(a) on the basis of provisions of this Regulation in relation to products presenting a 
risk to the health and safety of consumers;  
(b) on the basis of Regulation (EU) 2019/1020  in relation to products presenting a 
serious risk , in accordance with  Article 20 of Regulation (EU) 2019/1020.  
2. Member States may notify  in the Safety Gate corrective  measures taken by their 
authorities or by ec onomic operators on the basis of provisions of Union 
harmonisation legislation and Regulation (EU) 2019/1020 in relation to products 
presenting a less than serious risk.  
The notification shall be submitted in the Safety Gate within two working days from 
the adoption of the corrective measure.  
3. On receiving a notification, the Commission shall check whether it complies with 
this Article and with the requirements related to the operation of Safety Gate defined 
by the Commission on the basis of paragraph 7,  and shall transmit it to the other 
Member States if the requirements are complied with.  
4. Member States shall notify in the Safety Gate without delay any update, modification 
or withdrawal of the corrective measures referred in paragraph 1.  
5. Where a Me mber State notifies corrective measures taken in relation to products 
presenting a serious risk, the other Member States shall notify in the Safety Gate the 
measures and actions taken subsequently in relation to the same products and any EN 48  EN other relevant inf ormation, including the results of any tests or analyses carried out, 
within two working days from the adoption of the measures or actions.  
6. If the Commission identifies products which are likely to present a serious risk and 
for which Member States hav e not submitted a notification in the Safety Gate, it shall 
inform the Member States. Member States shall undertake the appropriate 
verifications and, if they adopt measures, notify them in the Safety Gate in 
accordance with paragraph 1.  
7. The Commission shall develop an interface between the information and 
communication system referred to in Article 34 of Regulation (EU) 2019/1020 and 
the Safety Gate, in order to avoid double data entry and enable a draft Safety Gate 
notification to be triggered from tha t information and communication system.  
8. The Commission shall adopt implementing acts specifying the implementation of 
this Article, and in particular the access to the system, the operation of the system, 
the information to be entered in the system, the  requirements notifications must meet,  
and criteria to assess the level of risk. Those implementing acts shall be adopted in 
accordance with the examination procedure referred to in Article 42(3).  
Article 25  
Safety Business Gateway  
1. The Commission shall maintain a web portal enabling the economic operators to 
provide market surveillance authorities and consumers with the information referred 
to in Articles 8(11), 9(2) point c), 10(8), 11(3), 11(4) and Article 19.  
2. The Commission shall draw up  guidelines  for the practical implementation  of the 
Safety Business Gateway.  
CHAPTER VII  
Commission role and enforcement coordination  
Article 26  
Union action against products presenting a serious risk  
1. If the Commission becomes aware of a product, or a specific ca tegory or group of 
products presenting a serious risk to the health and safety of consumers, it may take 
any appropriate measures, either on its own initiative or upon request of Member 
States, by means of implementing acts, adapted to the gravity and urge ncy of the 
situation if, at one and the same time:  
(a) it emerges from prior consultations with the Member States that they differ 
significantly on the approach adopted or to be adopted to deal with the risk; 
and; 
(b) the risk cannot be dealt with, in vie w of the nature of the safety issue posed by 
the product, category or group of products, in a manner compatible with the 
degree of gravity or urgency of the case, under other procedures laid down by 
the specific Union legislation applicable to the products  concerned; and  
(c) the risk can be eliminated effectively only by adopting appropriate measures 
applicable at Union level, in order to ensure a consistent and high level of EN 49  EN protection of the health and safety of consumers and the proper functioning of 
the internal market.  
Those measures may include measures prohibiting, suspending or restricting the 
placing or making available on the market of such products or laying down special 
conditions for their marketing, in order to ensure a high level of consumer safety 
protection.  
In those implementing acts, the Commission shall lay down the appropriate control 
measures to be taken by Member States to ensure their effective implementation.  
2. The implementing acts referred to in the paragraph 1 shall be adopted in  accordance 
with the examination procedure referred to in Article 42(3). The implementing act 
shall determine the date, on which it will cease to apply.  
3. On duly justified imperative grounds of urgency relating to the health and safety of 
consumers the Commission may adopt immediately applicable implementing acts in 
accordance with the procedure referred to in Article 42(4).  
4. The export from the Union of a product that has been prohibited to be placed or 
made available on the Union market pursuant to a  measure adopted in accordance 
with paragraph 1 or 3 shall be prohibited, unless the measure expressly so permits.  
5. Any Member State may submit a substantiated request to the Commission to 
examine the need for the adoption of a measure referred to in par agraph 1 or 3.  
Article 27  
Arbitration mechanism  
1. Products that have been deemed dangerous on the basis of a decision of a market 
surveillance authority in one Member State shall be presumed dangerous by market 
surveillance authorities in other Member Sta tes.  
2. Where market surveillance authorities in other Member States reach a different 
conclusion in terms of identification or level of the risk on the basis of their own 
investigation and risk assessment, the Member States concerned may request the 
Comm ission to arbitrate. In that case, the Commission shall invite all Member States 
to express a recommendation.  
3. Taking into account the recommendations referred to in paragraph 2, the 
Commission shall adopt an opinion on the identification or on the level of the risk of 
the relevant product as appropriate  
4. The opinion shall be taken into due account by the Member States.  
5. The Commission shall draw up guidelines for the practical implementation of this 
Article.  
Article 28  
Consumer Safety Network  
1. A European network of the authorities of the Member States competent for product 
safety (‘Consumer Safety Network’) shall be established.  
2. The Commission shall promote and take part in the operation of the Consumer Safety 
Network, in particular in the f orm of administrative cooperation.  EN 50  EN 3. The objective of that Consumer Safety Network shall be, in particular, to facilitate:  
(a) the exchange of information on risk assessments, dangerous products, test 
methods and results, recent scientific developments as  well as other aspects 
relevant for control activities;  
(b) the establishment and execution of joint surveillance and testing projects;  
(c) the exchange of expertise and best practices and cooperation in training 
activities;  
(d) improved cooperation at EU level with regard to the tracing, withdrawal and 
recall of dangerous products;  
(e) enhanced cooperation on product safety enforcement between Member States, 
in particular to facilitate the activities referred to in Article 30 . 
4. The Consumer Safety Networ k shall coordinate its action with the other existing 
Union activities.  
5. The Consumer Safety Network shall be duly represented and participate in the 
activities of in the Union Product Compliance Network established under Article 29 
of Regulation (EU) 2 019/1020 and shall contribute to its activities in relation to 
product safety to ensure adequate coordination of market surveillance activities in 
both harmonised and non -harmonised areas.  
Article 29  
Joint activities on product safety  
1. In the framework of the activities referred to in Article 28(3), point (b), market 
surveillance authorities may agree with other relevant authorities or with 
organisations representing economic operators or consumers to carry out activities 
aimed at ensuring safety and pro tection of consumers health with respect to specific 
categories of products placed or made available on the market, in particular 
categories of products that are often found to present a serious risk.  
2. The market surveillance authorities and the Commissi on, where applicable, shall 
ensure that the agreement to carry out activities does not lead to unfair competition 
between economic operators and does not affect the objectivity, independence and 
impartiality of the parties to the agreement.  
3. A market su rveillance authority may use any information resulting from the activities 
carried out as part of any investigation regarding the safety of products that it 
undertakes.  
4. The market surveillance authority concerned and the Commission where applicable 
shall make the agreement on joint activities, including the names of the parties 
involved, available to the public.  
Article 30  
Sweeps  
1. Market surveillance authorities may decide to conduct simultaneous coordinated 
control actions (“sweeps”) of particular product categories to check compliance with 
or to detect infringements to this Regulation.  EN 51  EN 2. Unless otherwise agreed upon by the market surveillance authorities concerned, 
sweeps shall be coordinated by the Commission. The coordinator of the sweep may, 
where appropriate, make the aggregated results publicly available.  
3. When conducting sweeps, the market surveillance authorities involved may use the 
investigation powers set out in Chapter V and any other powers conferred upon them 
by national law.  
4. Mark et surveillance authorities may invite Commission officials, and other 
accompanying persons authorised by the Commission, to participate in sweeps.  
CHAPTER VIII  
Right to information and remedy  
Article 31  
Information between public authorities and consumers  
1. Information available to the authorities of the Member States or to the Commission 
relating to measures on products presenting risks to consumer health and safety shall 
in general be made available to the public, in accordance with the require ments of 
transparency and without prejudice to the restrictions required for monitoring and 
investigation activities. In particular, the public shall have access to information on 
product identification, the nature of the risk and the measures taken.  This information 
shall be provided in accessible formats for persons with disabilities.  
2. Member States and the Commission shall take the necessary steps to ensure that their 
officials and agents are required not to disclose information obtained for the purpos es 
of this Regulation which, by its nature, is covered by professional secrecy in duly 
justified cases, except for information relating to the safety properties of products 
which must be made public in order to protect consumers.  
3. Protection of professio nal secrecy shall not prevent the dissemination to the 
competent authorities of Member States of information relevant for ensuring the 
effectiveness of market monitoring and surveillance activities. The authorities 
receiving information covered by professi onal secrecy shall ensure its protection.  
4. Member States shall give consumers and other interested parties the opportunity to 
submit complaints to the competent authorities on product safety and on surveillance 
and control activities and these complaints  shall be followed up as appropriate.  
Article 32  
Safety Gate portal  
1. For the purpose of Article 31(1) and Article 19, the  Commission shall maintain a 
Safety Gate portal, providing the general public with free access to selected 
information notified in ac cordance with Article 24.  
2. Consumers shall have the possibility to inform the Commission of products 
presenting a risk to consumer health and safety through a separate section of the 
Safety Gate portal. The Commission shall take in due consideration the  information 
received and ensure follow up, where appropriate.  EN 52  EN 3. The Commission, by means of an implementing act, shall adopt the modalities for 
the sending of information by consumers in accordance with paragraph 2, as well as 
for the transmission of suc h information to the concerned national authorities for 
possible follow up. This implementing act shall be adopted in accordance with the 
examination procedure referred to in Article 42(3).  
Article 33  
Information from economic operators to consumers  
1. In case of a recall or where certain information has to be brought to the attention of 
consumers to ensure the safe use of a product (‘safety warning’), economic 
operators, in accordance with their respective obligations as provided for in Articles 
8, 9, 10 a nd 11, shall directly notify all affected consumers that they can identify. 
Economic operators who collect their customers’ personal data shall make use of this 
information for recalls and safety warnings.  
2. Where economic operators have product registra tion systems or customer loyalty 
programs in place for purposes other than contacting their customers with safety 
information , they shall offer the possibility to their customers to provide separate 
contact details only for safety purposes. The personal da ta collected for that purpose 
shall be limited to the necessary minimum and may only be used to contact 
consumers in case of a recall or safety warning.  
3. The Commission, by means of implementing acts, shall set out requirements for 
registration of produ cts or specific categories of products. Those implementing acts 
shall be adopted in accordance with the examination procedure referred to in Article 
42(3).  
4. If not all affected consumers can be contacted directly, economic operators, in 
accordance with t heir respective responsibilities, shall disseminate a recall notice or 
safety warning through other appropriate channels, ensuring the widest possible 
reach including, where available: the company’s website, social media channels, 
newsletters and retail ou tlets and, as appropriate, announcements in mass media and 
other communication channels. Information shall be accessible to consumers with 
disabilities.  
Article 34  
Recall notice  
1. Where information on a recall is provided to consumers in a written form, i n 
accordance with Articles 33(1) and (4), it shall take the form of a recall notice.  
2. A recall notice shall be available in the language(s) of the Member State(s) where the 
product has been put on the market and include the following elements:  
(a) headline ‘Product safety recall’;  
(b) clear description of the recalled product, including:  
(i) photograph, name and brand of the product;  
(ii) product identification numbers, such as batch or serial number, and, 
if applicable, graphical indication of wher e to find them on the 
product;  EN 53  EN (iii) information on when and where the product was sold, if available.  
(c) clear description of the hazard associated with the recalled product, avoiding 
any elements that may decrease consumers’ perception of risk, includi ng terms 
and expressions such as “voluntary”, “precautionary”, “discretionary”, “in 
rare/specific situations” as well as indicating that there have been no reported 
accidents;  
(d) clear description of the action consumers should take, including an instruc tion 
to immediately stop using the recalled product;  
(e) clear description of the remedy available to consumers if appropriate;  
(f) free phone number or interactive online service, where consumers can get more 
information in relevant official language(s) o f the Union;  
(g) an encouragement to further share information about the recall, if appropriate.  
3. The Commission, by means of implementing acts, shall set out the template for a 
recall notice, taking into account scientific and market developments. Those  
implementing acts shall be adopted in accordance with the advisory procedure 
referred to in Article 42(2).  
Article 35  
Right to remedy  
1. Without prejudice to Directive (EU) 2019/771, in the case of a recall, the economic 
operator responsible for the recal l shall offer to the consumer an effective, cost -free 
and timely remedy. That remedy shall consist of at least one of the following:  
(a) repair of the recalled product;  
(b) replacement of the recalled product with a safe one of the same type and at 
least t he same value and quality;  
(c) refund of the value of the recalled product.  
2. Repair, disposal or destruction of the product by consumers shall only be considered 
an effective remedy where it can be carried out easily and safely by the consumer. In 
such cases, the economic operator responsible for the recall shall provide consumers 
with the necessary instructions and/or, in the case of self -repair, free replacement 
parts or software updates.  
3. The remedy shall not entail significant inconvenience for the  consumer. The 
consumer shall not bear the costs of shipping or otherwise returning the product. For 
products that by their nature are not portable, the economic operator shall arrange for 
the collection of the product.  
CHAPTER IX  
International cooperation  
Article  36 
International cooperation  EN 54  EN 1. The Commission may cooperate, including through the exchange of information, 
with third countries or international organisations in the field of application of this 
Regulation, such as:  
(a) enforcement activities an d measures related to safety, including market 
surveillance;  
(b) risk assessment methods and product testing;  
(c) coordinated product recalls and other similar actions;  
(d) scientific, technical, and regulatory matters, aiming to improve product safety;  
(e) emerging issues of significant health and safety relevance;  
(f) standardisation -related activities;  
(g) exchange of officials.  
2. The Commission may provide third countries or international organisations with 
selected information from its Safety Gate system and receive relevant information on 
the safety of consumer products and on preventive, restrictive and corrective 
measures taken by those third countries or international organisations. The 
Commission shall share such information with national autho rities, where relevant.  
3. The information exchange referred to in paragraph 2 may take the form of either:  
(a) a non -systematic exchange, in duly justified and specific cases;  
(b) a systematic exchange, based on an administrative arrangement specifying the 
type of information to be exchanged and the modalities for the exchange.  
4. Full participation in the Safety Gate system may be open to applicant countries and 
third countries, provided that their legislation is aligned with the relevant Union 
legisla tion and that they participate in the European Standardisation System. Such 
participation shall entail the same obligations as for Member States according to this 
Regulation, including notification and follow -up obligations. Full participation in the 
Safet y Gate shall be based on agreements between the Union and those countries, 
according to arrangements defined in these agreements.  
5. Any information exchange under this Article, to the extent it involves personal data, 
shall be carried out in accordance w ith Union data protection rules. Personal data 
shall only be transferred to the extent that such exchange is necessary for the sole 
purpose of the protection of consumers’ health or safety.  
6. The information exchanged pursuant to this Article shall be use d for the sole purpose 
of the protection of consumers’ health or safety and respect confidentiality rules.  
CHAPTER X  
Financial provisions  
Article 37  
Financing activities  
1. The Union shall finance the following activities in relation to the application of this 
Regulation:  EN 55  EN (a) performance of the tasks of the Consumer Safety Network referred to in Article 
28; 
(b) the development and operation of the Safety Gate referred to in Article 23, 
including the development of electronic interoperability solutions for:  
– the exchange of data between the Safety Gate and the national market 
surveillance systems;  
– the exchange of data between the Safety Gate and national customs 
systems;  
– the exchange of data with other relevant restricted systems used by 
market surveillance au thorities for their enforcement purposes.  
(c) the development and maintenance of the Safety Gate portal referred to in 
Article 32 and the Safety Business Gateway, referred to in Article 25, including 
a public non -restricted software interface for data exch ange with platforms and 
third parties.  
2. The Union may finance the following activities in relation to the application of this 
Regulation:  
(a) the development of instruments of international cooperation referred to in 
Article 36;  
(b) the drawing up and up dating of contributions to guidelines on market 
surveillance and product safety;  
(c) the making available to the Commission of technical or scientific expertise for 
the purpose of assisting the Commission in its implementation of market 
surveillance admini strative cooperation;  
(d) the performance of preliminary or ancillary work in connection with the 
implementation of market surveillance activities linked to the application of 
this Regulation such as studies, programmes, evaluations, guidelines, 
comparativ e analyses, mutual joint visits and visit programmes, exchange of 
personnel, research work, the development and maintenance of databases, 
training activities, laboratory work, proficiency testing, inter -laboratory tests 
and conformity assessment work;  
(e) Union market surveillance campaigns and associated activities, including 
resources and equipment, IT tools and training;  
(f) activities carried out under programmes of technical assistance, cooperation 
with third countries and the promotion and enhancemen t of Union market 
surveillance policies and systems among interested parties at Union and 
international levels.  
3. The Union's financial assistance to the activities under this Regulation shall be 
implemented in accordance with Regulation (EU, Euratom) No 2018/1046 of the 
European Parliament and of the Council42, either directly, or indirectly by delegating 
                                                 
42 Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on 
the financial rules applicable to the general budget of the Union, amending Regul ations (EU) No 
1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) 
No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing 
Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018 , p. 1).  EN 56  EN budget implementation tasks to the entities listed in Article 62(1), point (c) of that 
Regulation.  
4. The appropriations allocated to activities referred  to in this Regulation shall be 
determined each year by the budgetary authority within the limits of the financial 
framework in force.  
5. The appropriations determined by the budgetary authority for the financing of market 
surveillance activities may also cover expenses pertaining to preparatory, monitoring, 
control, audit and evaluation activities which are required for the management of the 
activities pursuant to this Regulation and the achievement of their objectives; in 
particular, studies, meetings of experts, information and communication actions, 
including corporate communication of the political priorities of the Union as far as 
they are related to the general objectives of market surveillance activities, expenses 
linked to information technology net works focusing on information processing and 
exchange, together with all other technical and administrative assistance expenses 
incurred by the Commission for the management of the activities pursuant to this 
Regulation.  
Article 38  
Protection of the Union' s financial interests  
1. The Commission shall take appropriate measures to ensure that, when actions 
financed under this Regulation are implemented, the financial interests of the Union 
are protected by the application of preventive measures against fraud,  corruption and 
any other illegal activities, by effective checks and, if irregularities are detected, by 
the recovery of the amounts wrongly paid and, where appropriate, by effective, 
proportionate and dissuasive administrative and financial penalties.  
2. The Commission or its representatives and the Court of Auditors shall have the 
power of audit, on the basis of documents and of on -the-spot inspections, over all 
grant beneficiaries, contractors and subcontractors who have received Union funds 
under the S ingle Market Programme and its successor43. 
3. The European Anti -Fraud Office (OLAF) may carry out investigations, including on -
the-spot checks and inspections, in accordance with the provisions and procedures 
laid down in Regulation (EU, Euratom) No 883/20 13 of the European Parliament and 
of the Council44 and Council Regulation (Euratom, EC) No 2185/9645, with a view to 
establishing whether there has been fraud, corruption or any other illegal activity 
affecting the financial interests of the Union in connect ion with a grant agreement or 
grant decision or a contract funded under the programme.  
4. Without prejudice to paragraphs 1, 2 and 3, cooperation agreements with third 
countries and with international organisations, contracts, grant agreements and grant 
decisions resulting from the implementation of this Regulation shall contain 
                                                 
43 OJ L292, 14.11.1996, p.2.  
44 Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 
September 2013 concerning investigations conducted by the European Anti -Fraud Office (OLAF) and 
repealing Regulation (EC) No 107 3/1999 of the European Parliament and of the Council and Council 
Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1).  
45 Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on -the-spot checks 
and inspections carried out by t he Commission in order to protect the European Communities' financial 
interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2).  EN 57  EN provisions expressly empowering the Commission, the Court of Auditors and OLAF 
to conduct such audits and investigations, in accordance with their respective 
competences.  
CHAPTER XI  
Final provisions  
Article 39  
Liability  
1. Any decision taken pursuant to this Regulation and involving restrictions on the 
placing of a product on the market or requiring its withdrawal or its recall shall not 
affect the assessment of the liability of the party concerned, in the light of the 
national law applying in the case in question.  
2. This Regulation shall not affect Council Directive 85/374/EEC46. 
Article 40  
Penalties  
1. Member States shall lay down the rules on penalties applicable to infringements o f 
this Regulation and shall take all measures necessary to ensure that they are 
implemented. The penalties provided for shall be effective, proportionate and 
dissuasive. Member States shall, by [insert date - 3 months after to the date of entry 
into force of this Regulation], notify the Commission of those rules and of those 
measures and shall notify it, without delay, of any subsequent amendment affecting 
them.  
2. Member States shall take into account at least the following indicative criteria for the 
impo sition of penalties, where appropriate:  
(a) the duration or temporal effects of the infringement, the nature and the gravity, 
in particular the level of risk incurred by the consumer;  
(b) the number of dangerous products made available on the market or the  number 
of consumers affected or both;  
(c) the role and responsibility of the economic operator or online marketplace;  
(d) any action taken by the economic operator or online marketplace to timely 
mitigate or remedy the damage suffered by consumers;  
(e) where appropriate, the intentional or negligent character of the infringement;  
(f) any previous infringements by the economic operator or online marketplace;  
(g) the financial benefits gained or losses avoided directly or indirectly by the 
economic operator or online marketplace due to the infringement, if the 
relevant data are available;  
(h) the size of the undertaking;  
                                                 
46 Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and 
administra tive provisions of the Member States concerning liability for defective products (OJ L 210, 
7.8.1985, p. 29).  EN 58  EN (i) the degree of cooperation with the auth ority;  
(j) the manner in which the infringement became known to the authority, in 
particular whether, and if so to what extent, the economic operator or online 
marketplace timely notified the infringement;  
(k) any other aggravating or mitigating factor app licable to the circumstances of 
the case.  
3. The types of infringements by economic operators or online marketplaces, where 
applicable, subject to penalties shall be any of the following:  
(a) infringement of the general product safety requirement;  
(b) failure to inform the authority in a timely manner about a dangerous product 
they placed on the market;  
(c) failure to comply with any decision, order, interim measure, economic 
operator’s commitment or other measure adopted pursuant to this Regulation;  
(d) failure to comply with traceability and information obligations of economic 
operators referred to in Articles 8, 9, 10, 11 and 18 and 19;  
(e) providing incorrect, incomplete or misleading information in response to a 
request from market surveillance authori ties; 
(f) failure to provide requested information within the required time -limit;  
(g) refusal to submit to inspections;  
(h) failure to provide the required documents or products during inspections;  
(i) falsifying test results.  
4. In the case of fines, the  maximum amount of penalties shall be at least 4 % of the 
economic operator’s or, where applicable, online marketplace’s annual turnover in 
the Member State or Member States concerned.  
5. Member States may also impose periodic penalty payments to compel ec onomic 
operators or online marketplaces, where applicable:  
(a) to put an end to a violation of the provisions of this Regulation;  
(b) to comply with a decision ordering corrective measure;  
(c) to supply complete and correct information;  
(d) to submit to a n inspection;  
(e) to allow market surveillance authorities to perform data scraping of online 
interfaces.  
6. By 31 March of each year, Member States shall inform the Commission of the type 
and the size of the penalties imposed under this Regulation, ident ify the actual 
infringements of this Regulation, and indicate the identity of economic operators or 
online marketplaces upon which penalties have been imposed.  
7. Each year, the Commission shall elaborate and make public a report on the penalties 
imposed b y Member  States.  
8. The information referred to in paragraph 6 shall not be published in the report 
referred to in paragraph 7 in any of the following circumstances:  EN 59  EN (a) where it is necessary to preserve the confidentiality of an investigation or of 
nation al judicial proceedings;  
(b) where publication would cause disproportionate damage to the economic 
operator or online marketplace;  
(c) where a natural person is concerned, unless the publication of personal data is 
justified by exceptional circumstances, i nter alia, by the seriousness of the 
infringement.  
Article 41  
Exercise of the delegation  
1. The power to adopt delegated acts is conferred on the Commission subject to the 
conditions laid down in this Article.  
2. The power to adopt delegated acts referred  to in Article 17(3) shall be conferred on 
the Commission for an indeterminate period of time from [ insert date - the date of 
entry into force of this Regulation].  
3. The delegation of power referred to in Article 17(3) may be revoked at any time by 
the Eu ropean Parliament or by the Council. A decision of revocation shall put an end 
to the delegation of the power specified in that decision. It shall take effect the day 
following its publication in the Official Journal of the European Union or at a later 
date specified therein. It shall not affect the validity of any delegated acts already in 
force.  
4. Before adopting a delegated act, the Commission shall consult experts designated by 
each Member State in accordance with the principles laid down in the 
Interi nstitutional Agreement on Better Law -Making of 13 April 201647.  
5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to 
the European Parliament and to the Council.  
6. A delegated act adopted pursuant to Article 17(3) shall  enter into force only if no 
objection has been expressed either by the European Parliament or by the Council 
within a period of two months of notification of that act to the European Parliament 
and the Council or if, before the expiry of that period, the European Parliament and 
the Council have both informed the Commission that they will not object. That 
period may be extended by two months at the initiative of the European Parliament 
or of the Council.  
Article 42  
Committee procedure  
1. The Commission shal l be assisted by a Committee. That Committee shall be a 
committee within the meaning of Regulation (EU) No 182/2011.  
2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 
182/2011 shall apply.  
                                                 
47 OJ L 123, 12.5.2016, p. 1  EN 60  EN 3. Where reference is made to this par agraph, Article 5 of Regulation (EU) No 
182/2011 shall apply.  
4. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 
182/2011, in conjunction with Article 5 thereof, shall apply.  
Article 43  
Evaluation  
1. By [insert date five years after the date of entry into force] the Commission shall 
carry out an evaluation of this Regulation. The Commission shall present a report on 
the main findings to the European Parliament, the Council and the European 
Economic and Social Committee. The repo rt shall in particular assess if this 
Regulation achieved the objective of enhancing the protection of consumers against 
dangerous products while taking into account its impact on businesses and in 
particular on small and medium -sized enterprises.  
2. On re quest, Member States shall provide the Commission with information necessary 
for the evaluation of this Regulation.  
Article 44  
Amendments to Regulation (EU) No 1025/2012  
1. Regulation (EU) No 1025/2012 is amended as follows:  
In Article 10, the following pa ragraph 7 is added:  
‘7. Where a European standard drafted in support of Regulation (EU) …/… of the 
European Parliament and of the Council48[this Regulation (GPSR) ] satisfies the 
general safety requirement laid down in Article 5 of that Regulation and the sp ecific 
safety requirements referred to in [Article [6] of that Regulation], the Commission 
shall publish a reference of such European standard without delay in the Official 
Journal of the European Union .’ 
In Article 11, paragraphs 1, 2 and 3 are replaced b y the following:  
‘1. When a Member State or the European Parliament considers that a harmonised 
standard or European standard drafted in support of Regulation (EU) …/… [ this 
Regulation (GPSR) ] does not entirely satisfy the requirements which it aims to cov er 
and which are set out in the relevant Union harmonisation legislation or in that 
Regulation, it shall inform the Commission thereof with a detailed explanation. The 
Commission shall, after consulting the committee set up by the corresponding Union 
harmo nisation legislation, if it exists, or the committee set up by Regulation (EU) 
…/… [ this Regulation (GPSR )], or after other forms of consultation of sectoral 
experts, decide:  
(a) to publish, not to publish or to publish with restriction the references to t he 
harmonised standard or European standard drafted in support of Regulation 
(EU) …/… [ GPSR ] concerned in the  Official Journal of the European Union;  
                                                 
48 Regulation (EU) …/… of the European Parliament and of the Council on general product safety, 
amending Regulation (EU ) No 1025/2012 of the European Parliament and of the Council, and repealing 
Council Directive 87/357/EEC and Directive 2001/95/EC of the European Parliament and of the 
Council (OJ …)’  EN 61  EN (b) to maintain, to maintain with restriction or to withdraw the references to the 
harmonised standard or European standard drafted in support of Regulation 
(EU) …/… [ GPSR ] concerned in or from the  Official Journal  of the European 
Union .’ 
2. The Commission shall publish information on its website on the harmonised 
standards and European standards drafted in su pport of Regulation (EU) …/… 
[GPSR ] that have been subject to the decision referred to in paragraph 1.  
3. The Commission shall inform the European standardisation organisation concerned 
of the decision referred to in paragraph 1 and, if necessary, request the revision of the 
harmonised standards or of the European standards drafted in support of Regulation 
(EU) …/… [ GPSR ] concerned.’  
Article 45  
Repeal  
1. Directive 87/357/EEC and Directive 2001/95/EC are repealed with effect from [date 
of application].  
2. References to Directives 87/357/EEC and 2001/95/EC shall be construed as 
references to this Regulation and to Regulation (EU) No 1025/2012, and shall be 
read in accordance with the correlation table in the Annex.  
Article 46  
Transitional provisions  
Member S tates shall not impede the making available on the market of products 
covered by Directive 2001/95/EC which are in conformity with that Directive and 
which were placed on the market before [insert date – date of application  of this 
Regulation].  
Article 47  
Entry into force and application  
This Regulation shall enter into force on the twentieth day following that of its 
publication in the Official Journal of the European Union.  
It shall apply from [6 months after the entry into force of this Regulation ].  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
For the European Parliament  For the Council  
The President  The President  EN 62  EN LEGISLATIVE FINANCIAL STATEMENT  
1. FRAMEWORK  OF THE  PROPOSAL/INITIATIVE  
 1.1. Title of the proposal/initiative  
 1.2. Policy area(s) concerned  
 1.3. The proposal/initiative relates to:  
 1.4. Objective(s)  
 1.4.1.  General objective(s)  
 1.4.2.  Specific objective(s)  
 1.4.3.  Expected result(s) and impact  
 1.4.4. Indicators of performance  
 1.5. Grounds for the proposal/initiative  
 1.5.1.  Requirement(s) to be met in the short or long term including a detailed 
timeline for roll -out of the implementation of the initiative  
 1.5.2.  Added value of Union involvement (it may result from different factors, e.g. 
coordination gains, legal certainty, greater effectiveness or complementarities). For 
the purposes of this point 'added value of Union involvement' is the value resulting 
from Union intervention which is addition al to the value that would have been 
otherwise created by Member States alone.  
 1.5.3.  Lessons learned from similar experiences in the past  
 1.5.4.  Compatibility with the Multiannual Financial Framework and possible 
synergies with other appropriate instrum ents 
 1.5.5.  Assessment of the different available financing options, including scope for 
redeployment  
 1.6. Duration and financial impact of the proposal/initiative  
 1.7. Management mode(s) planned  
 2. MANAGEMENT  MEASURES  
 2.1. Monitoring and reporting ru les 
 2.2. Management and control system(s)  
 2.2.1.  Justification of the management mode(s), the funding implementation 
mechanism(s), the payment modalities and the control strategy proposed  
 2.2.2.  Information concerning the risks identified and the intern al control system(s) 
set up to mitigate them  
 2.2.3.  Estimation and justification of the cost -effectiveness of the controls (ratio of 
"control costs ÷ value of the related funds managed"), and assessment of the 
expected levels of risk of error (at payment & at closure)  
 2.3. Measures to prevent fraud and irregularities  
3. ESTIMATED  FINANCIAL  IMPACT  OF THE  PROPOSAL/INITIATIVE   EN 63  EN  3.1. Heading(s) of the multiannual financial framework and expenditure 
budget line(s) affected  
 3.2. Estimated financial impact of t he proposal on appropriations  
 3.2.1.  Summary of estimated impact on operational appropriations  
 3.2.2.  Estimated output funded with operational appropriations  
 3.2.3.  Summary of estimated impact on administrative appropriations  
 3.2.4.  Compatibility with the current multiannual financial framework  
 3.2.5.  Third -party contributions  
 3.3. Estimated impact on revenue  EN 64  EN 1. FRAMEWORK  OF THE  PROPOSAL/INITIATIVE   
1.1. Title of the proposal/initiative  
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF 
THE COUNCIL on general product safety and repealing Council Directive 
87/357/EEC and Directive 2001/95/EC  
1.2. Policy area(s) concerned   
Title: 03 – Single Market –  
Chapter: 03 02 Single Market Programme  
Item: 03 02 04 Empowering consumer and civil society and ensuring high level of 
consumer protection and product safety including the participation of end users in 
financial services policy -making  
1.3. The proposal/i nitiative relates to:  
 a new action   
 a new action following a pilot project/preparatory action49  
 the extension of an existing action   
 a merger or redirection of one or more actions towards another/a new action   
1.4. Objective(s)  
1.4.1.  General obje ctive(s)  
Consumer protection, fairer and deeper internal market; digital single market.  
To ensure that only safe products are placed on the internal market and to assure a 
high level of consumer safety and protection and a level -playing field for business es 
in the Single Market.  
The aim of the proposal is to revise Directive 2001/95/EC on general product safety 
to ensure that EU consumers are protected from dangerous products, while ensuring 
proper functioning of the Single market, in particular level pla ying field for 
businesses.  
The purpose of proposed budgeted action is to continue and further develop the 
cooperation measures related to market surveillance (including at international level), 
the financing of the electronic interfaces allowing exchange o f data and informing 
the consumers and economic operators on dangerous products and to implement the 
new proposal (via implementing and delegated acts and increased standardisation 
activities).  
1.4.2.  Specific objective(s)  
Specific objective No  
1. Reinforc ing market surveillance cooperation procedures among enforcement 
authorities, reducing fragmentation and inefficiencies;  
                                                 
49 As referred to in Article 58(2)(a) or (b) of the Financial Regulation.  EN 65  EN 2. Increasing operational capacity, improving efficiency and availability of 
resources for coordination of enforcement and implementat ion of the proposal 
(monitoring, delegated acts), increasing the use of standardisation procedure;  
3. Strengthening the enforcement toolbox, allowing market surveillance 
authorities to use more deterrent, effective and future -proof tools;  
4. Improving the exchange of information on dangerous products both inside the 
EU and with external partners (including via IT tools). Improving information to 
businesses and consumers on dangerous products via IT tools;  
5. Promoting compliance with EU product safety legis lation on non -harmonised 
consumer products.  
The objectives cover market surveillance within the EU and at the external borders 
and encompass digital as well as traditional supply chains.  
1.4.3.  Expected result(s) and impact  
Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted.  
The target population will be all European Union consumers who will benefit from 
safe products placed on the internal market. Increased market surveillance will 
benefit European producer s by preventing unfair level playing field with businesses 
that do not respect their obligations to protect consumer health and safety.  
1.4.4.  Indicators of performance  
Specify the indicators for monitoring progress and achievements.  
The monitoring of the  implementation of the proposal will be based on predefined 
core monitoring and enforcement indicators. The Commission will start monitoring 
the implementation of the revised GPSD after the entry into force of the initiative.  
The Impact Assessment identifi ed a set of monitoring indicators proposed to monitor 
the achievement of the policy objectives identified (see section 9 of the Impact 
Assessment).  
The monitoring will be done mainly by the Commission, based on regular EU -wide 
consumer surveys, data provid ed by businesses and MSAs and data from the Safety 
Gate. The monitoring and evaluation will be done on the basis of existing data 
sources where possible.  
The proposal sets out reporting obligations for Member States. This reporting will be 
done on the bas is of enforcement indicators which will be further defined by a study. 
The Commission is carrying out a study aiming to define a common set of feasible 
and relevant enforcement indicators in the product safety field, to be agreed with 
Member States.  
The C ommission has also mapped existing sources of injury information and looked 
into the possibility of establishing an EU -level injury database to help the 
implementation of the product safety legislation. It is currently assessing the costs 
and benefits of s etting up such an EU wide injury database (via coordinated actions 
with Member States).  
In addition to the regular monitoring and reporting, an evaluation of the 
effectiveness, efficiency, relevance, coherence and EU added value of this legislative 
interve ntion is proposed 5 years after implementation by Member States of this 
proposal.  EN 66  EN 1.5. Grounds for the proposal/initiative  
1.5.1.  Requirement(s) to be met in the short or long term including a detailed timeline for 
roll-out of the implementation of the i nitiative  
This proposal aims to meet the following achievements:  
The assessment of risk presented by new technology products will improve as of the 
adoption of the proposal allowing thereby a better safety net function of the 
legislative act.  
In the short term, we expect improvement of the safety of consumer products bought 
online thanks to better market surveillance rules for online sales and increased 
obligations on product safety for online marketplaces.  
The market surveillance rules for non -harmonised products will be aligned with 
those of harmonised products. Furthermore, some improvements of the market 
surveillance rules under this initiative for market surveillance of all products will 
enhance market surveillance and ensure higher product safety in t he medium term.  
The proposed improvement of the current Safety Gate/RAPEX system will make the 
exchange of information more rapid, allowing earlier corrective actions.  
Effectiveness of product recalls is expected to increase in the short term thanks to the  
enhanced recall procedure and better information to consumers.  
Increased efficiency at Commission level in the standardisation process for non -
harmonised products will facilitate setting standards for these products: we can 
expect to have an increased num ber of standards in the medium term. The increased 
use of European standards will give producers greater certainty that their products 
comply with the relevant safety requirements and will permit businesses to compete 
on a level -playing field by ensuring t hat they have equal opportunities.  
The proposal will harmonise the risk assessment of food -imitating products and 
thereby ensure their equal treatment across the Member States.  
1.5.2.  Added value of Union involvement (it may result from different factors,  e.g. 
coordination gains, legal certainty, greater effectiveness or complementarities). For 
the purposes of this point 'added value of Union involvement' is the value resulting 
from Union intervention which is additional to the value that would have been 
otherwise created by Member States alone.  
Reasons for action at European level (ex -ante)  
EU involvement in product safety for non -harmonised products has clear benefits 
demonstrated by the evaluation of the GPSD and the impact assessment of this 
proposal:  
- Common Union rules allow economy of scale in market surveillance, in 
particular due to the exponential development of online selling which intensifies 
cross -border sales and direct imports from outside the EU. Sharing costs of market 
surveillance occurs also by performing joint market surveillance actions among EU 
countries and exchange information.  
- EU action allows faster and more efficient circulation of information, in 
particular via the Safety Gate/RAPEX, thus ensuring fast actions against dangerous  
products across the EU and level playing field.  EN 67  EN - Common rules for product safety at EU level have benefits in term of costs 
savings and lower administrative burden and complexities for businesses by avoiding 
them having to comply with heterogeneous sets  of national rules. This enables also 
free circulation of goods in the EU and allows for closer cooperation between 
Member States.  
- Common Union rules enable developing EU product safety standards, which 
by giving EU -wide presumption of safety facilitate product safety compliance for 
businesses (and potentially decrease the related costs).  
- At international level, the common set of provisions established by the GPSD 
has also allowed the EU to be stronger in promoting a high level of safety with 
internatio nal actors, thus tackling the increasingly high circulation of goods from 
third countries via online selling.  
Expected generated Union added value (ex -post)  
The functioning of the internal market will be improved by EU level action since 
coherent product  safety and market surveillance rules across the EU will ensure a 
more even treatment of businesses and therefore less likely distorted competition on 
the EU Single Market. Better market surveillance and enhanced coordination 
between Member States will lea d to higher detection of unsafe products, and thus to 
higher consumer protection and trust.  
1.5.3.  Lessons learned from similar experiences in the past  
The Union adopted its first general product safety regulation in 1992. The current 
GPSD was adopted in 2001. The Evaluation of the current GPSD and the stakeholder 
views showed that the GPSD is still a very valid instrument in particular thanks to its 
“safety net” function. It appears overall to have met its objectives of ensuring a high 
level of safety of consumers, while ensuring an effectively operating internal market 
for goods; however, we observe that still too many unsafe products reach or remain 
in the hands of consumers, which provides the grounds for the current proposal.  
1.5.4.  Compatibility with  the Multiannual Financial Framework and possible synergies 
with other appropriate instruments  
The aim of the proposal is to revise Directive 2001/95/EC on general product safety 
to ensure that EU consumers are protected from dangerous products, while ensu ring 
proper functioning of the Single Market, in particular level -playing field for 
businesses. Therefore, it fits perfectly into Art.3(2)(d) of the Single Market 
Programme Regulation that is to empower consumer and civil society and ensure a 
high level of  consumer protection and product safety.  
The financial impact on operational appropriations will be entirely covered by the 
allocations foreseen in the MFF 2021 -27 under the financial envelopes of the Single 
Market Programme.  
The proposal is one of the le gal initiatives under the New Consumer Agenda.  
The proposal ensures a better alignment with the provisions of Regulation (EU) 
2019/1020 on market surveillance and compliance of products. The proposal, as a 
safety net, is compatible and complementary to ha rmonised legislation in two ways. 
First, it applies in its entirety to consumer products falling outside the scope of 
harmonised legislation (e.g. furniture, childcare articles, clothes). Secondly, it applies 
partially to consumer products covered by harmo nised legislation (e.g. toys or cars) EN 68  EN as long as aspects of product safety covered by the GPSD are not covered in the 
harmonised legislation.  
The safety of food products is regulated separately under the General Food Law 
Regulation (EC) No 178/2002. Howeve r, the Regulation (EC) No 1935/2004 on food 
contact materials can interact with the proposal when it comes to products containing 
such materials (e.g. reusable lunch boxes) and remains compatible. Unsafe products 
containing food -contact materials products might be subject to safety alerts in both 
alert systems, RASFF for food and Safety Gate/RAPEX for non -food products.  
The proposal is fully consistent and compatible with the other EU policies and recent 
proposals to strengthen enforcement in other policy a reas, such as:  
- Digital Services Act (DSA): The DSA proposal aims to establish new 
obligations for online intermediaries inter alia in relation with how they handle all 
types of illegal content hosted on their websites including unsafe products. The DSA 
establishes the general horizontal obligations for online intermediaries and leaves 
room for legislation in relation with specific types of illegal content (such as product 
safety) to be more specific. This proposal will also regulate other product safety 
aspects of online sales beyond the role of online intermediaries, such as the role of 
sellers and the powers of market surveillance authorities.  
- Artificial Intelligence (AI) horizontal framework: it aims to focus on high -risk 
applications. Consequently, a nd with respect to product safety, it will function like 
sectorial legislation, establishing specific requirements for AI applications, and this 
proposal will apply as a safety net for products and aspects not covered by other 
sectorial legislation to prov ide a legal basis for withdrawing such products to ensure 
an effective protection of consumers.  
- NIS Directive: The recent proposal lays down obligations for all Member 
States to adopt a national strategy on the security of network and information 
system s to enhance cybersecurity across the EU. However, it does not include 
minimum cybersecurity requirements for consumer products, so it does not provide 
any legal basis for authorities to take action against products presenting such risks.  
- Circular Econo my: According to the new Circular Economy Action Plan, 
products placed on the EU market should be more sustainable and therefore designed 
to last longer, to be easier to repair and upgrade, recycle and reuse. It is essential that 
repaired, upgraded, recycl ed or reused products continue to meet product safety 
requirements. According to the eco -design directive, safety and health have to be 
taken into account in the choice of a specific design solution; however safety issues 
related to the end products are no t specifically addressed. The Sustainable Product 
Policy Initiative (which will replace the eco -design directive and extend its scope) 
will notably aim at correcting the fact that many products cannot be easily and safely 
reused, repaired or recycled. In c ase some safety aspects related to products in the 
circular economy are not specifically addressed by initiatives from the Circular 
Economy Action Plan, the safety net function of this proposal comes into play.  
There is thus no overlap, but complementarit y between these initiatives. The 
advantage of integrating aspects of substantive alternative policy areas into product 
safety legislation is therefore to ensure a real safety net for consumers, making 
possible that that all non -food consumer products on th e EU market are safe.  EN 69  EN 1.5.5.  Assessment of the different available financing options, including scope for 
redeployment  
/ EN 70  EN 1.6. Duration and financial impact of the proposal/initiative  
 limited duration  
–  in effect from [DD/MM]YYYY to [DD/MM]YYYY  
–  Financial impact from YYYY to YYYY for commitment appropriations and 
from YYYY to YYYY for payment appropriations.  
 unlimited duration  
– Implementation with a start -up period from YYYY to YYYY,  
– followed by full -scale operation.  
1.7. Management mode(s) plan ned50  
 Direct management  by the Commission  
–  by its departments, including by its staff in the Union delegations;  
– by the executive agencies  
 Shared management  with the Member States  
 Indirect management  by entrusting budget implementation tasks to:  
–  third countries or the bodies they have designated;  
–  international organisations and their agencies (to be specified);  
–  the EIB and the European Investment Fund;  
–  bodies referred to in Articles 70 and 71 of the Financial Regulation;  
–  public law bodie s; 
–  bodies governed by private law with a public service mission to the extent that 
they provide adequate financial guarantees;  
–  bodies governed by the private law of a Member State that are entrusted with 
the implementation of a public -private partnersh ip and that provide adequate 
financial guarantees;  
–  persons entrusted with the implementation of specific actions in the CFSP 
pursuant to Title V of the TEU, and identified in the relevant basic act.  
– If more than one management mode is indicated, please p rovide details in the ‘Comments’ section.  
Comments  
The executive agency could manage the contractual aspects of specific projects under the 
supervision of the parental DG.  
                                                 
50 Details of management modes and references to the Financial Regulation may be found on the 
BudgWeb site: 
https://myintracomm.ec.europa.eu/budgweb/EN/man/budgmanag/Pages/budgmanag.aspx   EN 71  EN 2. MANAGEMENT  MEASURES   
2.1. Monitoring and reporting rules  
Specify frequency and conditions.  
The proposal includes an evaluation obligation.  
The IT system called “Safety Gate” that connects market surveillance authorities and 
the Commission will be strengthened by this proposal. By using the IT system the 
monitoring of operational activity could take place on an ongoing basis in an 
efficient manner.  
The monitoring through the IT system will be completed by the work of the existing 
Consumer Safety Network and the provision by Member States of more reliable and 
more comprehensive information on product safety and enforcement activity of non -
harmonised products as part of their national enforcement strategies.  
Achievement of the specific objectives will be monitored on the basis of the pre -
defined indicators.  
2.2. Management and control system(s)  
2.2.1.  Justification of the management mode(s), the funding implementation mechanism(s), 
the payment modalities and the control strategy proposed  
Direct management by the Commission will allow to maintain direct cont acts with 
the Member States authorities and the stakeholders engaged in the activities. 
Through direct management, the Commission can better adapt the actions to the 
needs of the policy to have more flexibility to re -adjust priorities in case of emerging 
needs and contribute to the common objectives of the Union.  
2.2.2.  Information concerning the risks identified and the internal control system(s) set up 
to mitigate them  
Operational risks concern the Safety Gate IT system: risk that the IT -system fail to 
effectively support the cooperation of market surveillance authorities and the 
Consumer Safety Network.  
Operational risks also concern the level of resources dedicated to the market 
surveillance authorities at the level of Member States.  
To mitigate them, effective IT -governance processes, which actively involve the 
systems’ users, are implemented.  
2.2.3.  Estimation and justification of the cost -effectiveness of the controls (ratio of "control 
costs ÷ value of the related funds managed"), and assessment of the expected levels 
of risk of error (at payment & at closure)  
The costs of controls are negligible compared to the appropriations for the 
development of the IT system itself.  
2.3. Measures to prevent fraud and irregularities  
Specify existing or envisaged prevention and protection measures, e.g. from the Anti -Fraud Strategy.  
The measures implemented by the Commission will be subject to the ex -ante and ex -
post controls in accordance with the Financial Regulation. Contracts and agreements 
financing the implementation of this Regulation will expressly entitle the EN 72  EN Commission, including OLAF and the Court of Auditors to conduct audits, on -the-
spot checks and inspections.  EN 73  EN 3. ESTIMATED  FINANCIAL  IMPACT  OF THE  PROPOSAL/INITIATIVE   
3.1. Heading(s) of the multiannual financial framework and expenditure budget 
line(s) affected  
 Existing budget lines  
In order  of multiannual financial framework headings and budget lines.  
Heading of 
multiannual 
financial 
framework  Budget line  Type of  
expenditure  Contribution  
Number  
 Diff./Non -
diff.51 from 
EFTA 
countries
52 
 from 
candidate 
countries53 
 from third 
countries  within the 
meaning of 
Article  21(2)(b) of 
the Financial 
Regulation  
1 03.020401  Diff.  YES  NO NO NO 
                                                 
51 Diff. = Differentiated appropriations / Non -diff. = Non -differentiated appropriations.  
52 EFTA: European Free Trade Association.  
53 Candidate countries and, where applicable, potential candidates from the Western Balkans.   
EN 74  EN 3.2. Estimated financial impact of the proposal on appropriations  
3.2.1.  Summary of estimated impact on operational appropriations  
–  The proposal/initiative does not require the use of operational appropriations  
–  The proposal/initiative requires the use of operational appropriations, as explained below:  
EUR million (to three decimal places)  
Heading of multiannual financial  
framework  Number 
1  
DG: JUST   Year 
202454 Year 
2025  Year 
2026  Year 
2027  Enter as many years as 
necessary to show the duration 
of the impact (see point 1.6)  TOTAL  
 Operational appropriations      Post 
2027     
Budget line55 03.020401  Commitments  (1a) 7,000  7,000  7,000  7,000     28,000  
Payments  (2a) 2,100  7,000  7,000  7,000  4,900    28,000  
Appropriations of an administrative nature financed from the 
envelope of specific programmes56  
         
Budget line 03010101   (3) 0,200  0,200  0,200  0,200     0,800  
TOTAL appropriations  
for DG J UST   Commitments  =1a+1b 
+3 7,200  7,200  7,200  7,200     28,800  
Payments  =2a+2b  
+3 2,300  7,200  7,200  7,200  4,900    28,800  
  
                                                 
54 Year N is the year in which implementation of the proposal/initiative starts. Please replace "N" by the expected first year o f implementation (for instance: 2021). The same for the 
following years.  
55 Accordi ng to the official budget nomenclature.  
56 Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions ( former ‘BA’ lines), indirect research, direct research.   
EN 75  EN Heading of multiannual financial  
framework  7 ‘Administrative expenditure’  
This section should be filled in using the 'budget data of an administrative nature' to be firstly introduced in the Annex to the Legislative 
Financial Statement  (Annex V to the internal rules), which is uploaded to DECIDE for interservice c onsultation purposes.  
EUR million (to three decimal places)  
   Year 
2024  Year 
2025  Year 
2026  Year 
2027  Enter as many years as 
necessary to show the duration 
of the impact (see point 1.6)  TOTAL  
DG: JUST 
 Human resources  3,054  3,054  3,054  3,054     12,216   
 Other administrative expenditure  0,095  0,095  0,095  0,095     0,380   
TOTAL DG J UST Appropriations  3,149  3,149  3,149  3,149     12,596  
 
TOTAL appropriations  
under HEADING  7 
of the multiannual financial framework   (Total commitments = 
Total payments)  3,149  3,149  3,149  3,149     12,596  
EUR million (to three decimal places)  
   Year 
202457 Year 
2025  Year 
2026  Year 
2027  Enter as many years as 
necessary to show the duration 
of the impact (see point 1.6)  TOTAL  
TOTAL appropriations  
under HEADINGS 1  to 7 
of the multiannual financial framework   Commitments  10,349  10,349  10,349  10,349     41,396  
Payments  5,449  10,349  10,349  10,349  4,900    41,396  
                                                 
57 Year N is the year in which imp lementation of the proposal/initiative starts. Please replace "N" by the expected first year of implementation (for instance:  2021). The same for the 
following years.   
EN 76  EN 3.2.2.  Estimated output funded with operational appropriations  
Commitment appropriations in EUR million (to three decimal places)  
Indicate 
objectives and 
outputs  
 
   Year 
2024  Year 
2025  Year 
2026  Year 
2027  Enter as many years as necessary to show the 
duration of the impact (see point 1.6)  TOTAL  
OUTPUTS  
Type58 
 Avera
ge 
cost 
No 
Cost 
No 
Cost 
No 
Cost 
No 
Cost 
No 
Cost 
No 
Cost 
No 
Cost Total 
No Total 
cost 
SPECIFIC OBJECTIVE No 159 Reinforcing market surveillance cooperation procedures among enforcement authorities, reducing fragmentation and inefficiencies  
Coordinated 
activities for the 
safety of product  activitie
s 0,300  10 3,000  10 3,000  10 3,000  10 3,000        40 12,000  
Studies, peer 
reviews, piloting 
national 
products safety 
strategies  reports  0,200  2 0,400  2 0,400  2 0,400  2 0,400        8 1,600  
Subtotal for specific objective No 1  12 3,400  12 3,400  12 3,400  12 3,400        48 13,600  
SPECIFIC OBJECTIVE No 2 ...  Increasing operational capacity, improving efficiency and availability of resources for coordination of enforcement and imple mentation of the 
proposal (monitoring, delegated acts), increasing the use of standardisation procedure  
Implementation 
of the proposal 
(delegated acts, 
monitoring, 
standardisation)                    
                                                 
58 Outputs are products and services to be supplied (e.g.: number of student exchanges fin anced, number of km of roads built, etc.).  
59 As described in point 1.4.2. ‘Specific objective(s)…’   
EN 77  EN Subtotal for specific objective No 2                  
SPECIFIC OBJECTIVE No 3  Strengthening the enforcement toolbox, allowing market surveillance authorities to use more deterrent, effective and future -proof tools  
Big data and 
other innovative 
tools in online 
market 
surveillance and 
product safety - data 
collec. 
IT tools  0,125  2 0,250  2 0,250  2 0,250  2 0,250         1,000  
Subtotal for specific objective No 3  2 0,250  2 0,250  2 0,250  2 0,250         1,000  
SPECIFIC OBJECTIVE No 4  Improving the exchange of information on dangerous products both inside the EU and with external partners (including via IT t ools). Improving 
information to businesses and consumers on dangerous products via IT tools  
Safety Gate 
galaxy  IT 
systems  0,166  9 1,500  9 1,500  9 1,500  9 1,500         6,000  
Exchange of 
data with 
international 
partners and 
other 
international 
cooperation  Linkage 
with 
other 
systems  0.35 3 1,050  3 1,050  3 1,050  3 1,050         4,200  
Subtotal for specific objective No 4  12 2,550  12 2,550  12 2,550  12 2,550         10,200  
SPECIFIC OBJECTIVE No 5  Promoting compliance with EU product safety legislation on non -harmonised consumer products.  
Promotion and 
communication 
activities  Confere
nces, 
press, 
campai
gn 0,2 4 0,800  4 0,800  4 0,800  4 0,800         3,200  
Subtotal for specific objective No 5  4 0,800  4 0,800  4 0,800  4 0,800         3,200  
TOTALS   7,000   7,000   7,000   7,000         28,000   
EN 78  EN 3.2.3.  Summary of estimated impact on administrative appropriations  
–  The proposal/initiative does not require the use of appropriations of an 
administrative nature  
–  The proposal/initiative requires the use of appropriations of an administrative 
nature, as explained below:  
EUR million (to three decimal places)  
 Year 
2024 60 Year 
2025  Year 
2026  Year 
2027  Enter as many years as necessary to show the 
duration of the impact (see point 1.6)  TOTAL  
 
The appropriations required for human resources and other expenditure of an administrative nature will be met by 
appropriations from the DG that are already assigned to management of the action and/or have been redeployed within the 
DG, together if necessary with any additional allocation which may be granted to the managing DG under the annual 
allocation procedure and in the light of budgetary constraints.  
                                                 
60 Year N is the year in which implementation of the proposal/initiative starts. Please replace "N" by the expected first 
year of implementation (for instance: 2021). The same for the following years.  HEADING 7  
of the multiannual 
financial framework          
Human resources  3,054  3,054  3,054  3,054     12,216  
Other administrative 
expenditure  0,095  0,095  0,095  0,095     0,380   
Subtotal HEADING 7  
of the multiannual 
financial framework  3,149  3,149  3,149  3,149     12,596  
TOTAL  3,149  3,149  3,149  3,149     12,596   
EN 79  EN 3.2.3.1.  Estimated requirements of human resources  
–  The proposal/initiative does not require the use of human resources.  
–  The proposal/initiative requires the use of human resources, as explained 
below:  
Estimate to be expressed in full time equivalent units  
 
Year 
2024  Year 
2025  Year 
2026  Year 
2027  Enter as many years as 
necessary to show the duration 
of the impact (see point 1.6)  
 Establishment plan posts (officials and temporary staff)  
20 01 02 01  (Headquarters and Commission’s Representation 
Offices)  18 18 18 18    
20 01 02 03 (Delegations)         
01 01 01 01  (Indirect research)         
 01 01 01 11 (Direct research)         
Other budget lines (specify)         
 External staff (in Full Time Equivalent unit: FTE)61 
 
20 02 01  (AC, END, INT from the ‘global envelope’)  5 5 5 5    
20 02 03 (AC, AL, END, INT and JPD in the delegations)         
XX 01 xx yy zz 62 
 - at Headquarters  
        
- in Delegations         
01 01 01 02  (AC, END, INT - Indirect research)         
 01 01 01 12 (AC, END, INT - Direct research)         
Other budget lines (specify)         
TOTAL  23 23 23 23    
XX is the policy area or budget title concerned.  
The human resources required will be met by staff from the DG who are already assigned to management of the 
action and/or have been redeployed within the DG, together if necessary with any additional allocation which 
may be granted to the managing DG under the annual allocation procedure and in the light of budgetary 
constraints.  
Description of  tasks to be carried out:  
Officials and temporary staff  Preparation of delegated acts (related to traceability and recalls), set -up the new 
cooperation activities (new arbitration mechanism, peer reviews, cooperation with the 
Union Product Compliance Netwo rk), pilot national product safety enforcement 
strategies, improving interlinks with other databases (ICSMS, customs), international 
cooperation and monitoring of the Regulation. Preparation of implementing acts for 
the standardisation activities.  
AD staf f for product safety and market surveillance, technical and legal analysis, joint 
actions management, specific market surveillance expertise, project management, 
Safety Gate coordination and implementation, international cooperation, the 
Secretariat of the  Consumer Safety Network, communication and promotion activities, 
IT and data -systems supervision and financial management tasks.  
AST staff for support to meeting organisation and all administrative tasks.  
                                                 
61 AC= Contract Staff; AL = Local Staff; END= Seconded National Expert; INT = agency staff; 
JPD=  Junior Professionals in Delegations.  
62 Sub-ceiling for external staff covered by operational appropriations (former ‘BA’ lines).   
EN 80  EN External staff  Routine IT maintenance and specific development projects –.  
EN 81  EN 3.2.4.  Compatibility with the current multiannual financial framework  
The proposal/initiative:  
–  can be fully financed through redeployment within the relevant heading of the 
Multiannual Financial Fr amework (MFF).  
Explain what reprogramming is required, specifying the budget lines concerned and the corresponding 
amounts.  Please provide an excel table in the case of major reprogramming.  
No reprogramming is required.  
–  requires use of the unallocated m argin under the relevant heading of the MFF 
and/or use of the special instruments as defined in the MFF Regulation.  
Explain what is required, specifying the headings and budget lines concerned, the corresponding 
amounts, and the instruments proposed to be used.  
–  requires a revision of the MFF.  
Explain what is required, specifying the headings and budget lines concerned and the corresponding 
amounts.  
3.2.5.  Third -party contributions  
The proposal/initiative:  
–  does not provide for co -financing by third parties  
–  provides for the co -financing by third parties estimated below:  
Appropriations in EUR million (to three decimal places)  
 
Year 
N63 Year 
N+1 Year 
N+2 Year 
N+3 Enter as many years as necessary 
to show the duration of the 
impact (see point 1.6)  Total  
Specify the co -financing 
body           
TOTAL appropriations 
co-financed          
                                                 
63 Year N is the year in which implementation of the proposal/initiative starts. Please replace "N" by the 
expected first year of implementation (for instance: 2021). The same for the following years.   
EN 82  EN 3.3. Estimated impact on revenue  
–  The proposal/initiative has no financial impact on revenue.  
–  The proposal/initiative has the following financial impact:  
 on own resources  
 on other revenue  
please indicate, if the revenue is assigned to expenditure lines   
   EUR million (to three decimal places)  
Budget revenue line:  Appropriations 
available for 
the current 
financial year  Impact of the proposal/initiative64 
Year 
N Year 
N+1 Year 
N+2 Year 
N+3 Enter as many years as necessary to show 
the duration of the impact (see point 1.6)  
Article ………….          
For assigned revenue, specify the budget expenditure line(s) affected.  
/ 
Other remarks (e.g. method/formula used for calculating the impact on revenue or any other 
information).  
/ 
                                                 
64 As regards traditional own resour ces (customs duties, sugar levies), the amounts indicated must be net 
amounts, i.e. gross amounts after deduction of 20  % for collection costs.