EUROPEAN

COMMISSION

Brussels, XXX
[…](2021) XXX draft

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND

THE COUNCIL

on the implementation of Directive 2001/95/EC of the European Parliament and of the

Council of 3 December 2001 on general product safety

EN EN
Table of Contents
INTRODUCTION ..................................................................................................................................... 2
Scope of the report ....................................................................................................................... 2
Overview ....................................................................................................................................... 3
Objectives and scope of the Directive .................................................................................. 3
Obligations of economic operators and Member State authorities ..................................... 3
Institutional and enforcement aspects ................................................................................. 3
Application and regulatory developments .......................................................................................... 4
Safety of consumer products ........................................................................................................ 4
Traceability .................................................................................................................................... 4
Functioning of market surveillance............................................................................................... 5
Market surveillance cooperation with other public authorities and with customs ............. 6
Joint action and coordinated activities of market surveillance authorities.......................... 6
Recalls and other corrective measures ................................................................................. 6
Injury databases .................................................................................................................... 7
New regulatory developments related to market surveillance ............................................ 7
Safety Gate/RAPEX and cross-border cooperation....................................................................... 7
Impact of COVID-19 .............................................................................................................. 8
RAPEX guidelines................................................................................................................... 8
Training ................................................................................................................................. 9
Standardisation ............................................................................................................................. 9
Decisions on safety requirements and standardisation requests......................................... 9
Decisions on references of standards .................................................................................. 9
The standardisation process under the Directive and potential improvement ................. 10
EU case law on issues related to the General Product Safety Directive ..................................... 10
Measures based on Article 13 of the Directive ................................................................... 10
CONCLUSIONS ..................................................................................................................................... 11

1
 INTRODUCTION
The General Product Safety Directive (the ‘Directive’) was adopted on 3 December 2001, it
entered into force on 15 January 2002 and the deadline for its transposition by the Member States
was 15 January 2004.
The Directive applies to all non-food consumer products to the extent that there are no specific
provisions with the same safety objective in other EU legislation, such as EU harmonisation
legislation (hereafter ‘harmonised legislation’) for specific products. The Directive also
establishes the EU Rapid Alert System (Safety Gate1/RAPEX), which enables quick exchange of
information between EU/EEA Member States and the European Commission on measures taken
on dangerous non-food products posing a risk to consumers and other users.
The current health crisis has highlighted the importance of the Directive in providing a safety net
for consumers, being one of the main pieces of legislation that help remove dangerous products
(especially products such as face coverings, hand disinfectants and protective gloves). The Safety
Gate/RAPEX system set up by the Directive also enables authorities to take swift action to
protect the health and safety of consumers in the EU.
Under Article 19 of the Directive, the European Commission must present a report on the
implementation of the Directive to the Council and Parliament every three years following
transposition. The first implementation report was published in 2009. The Commission
continued to monitor the implementation of the Directive in the Member States and presented its
findings in the impact assessment report that accompanied the Product Safety and Market
Surveillance Package in 2013. The impact assessment report, which included the results of data
collection on implementation issues, was considered equivalent to an implementation report. In
view of the process to revise the Directive, the findings of this third implementation report were
considered in the evaluation and subsequently in the impact assessment of the revised Directive.
For the purpose of this report the Commission used the findings of the Study for the preparation
of an implementation report of the General Product Safety Directive2.
Scope of the report
This report was drawn up pursuant to Article 19(2) of the Directive and includes information on:
• the safety of consumer products, in particular on improved product traceability;
• the functioning of market surveillance and RAPEX;
• standardisation;
• the measures taken on the basis of Article 13 of the Directive.
The geographical scope of this report covers all EU Member States as well as European
Economic Area (EEA) countries: Iceland, Liechtenstein and Norway. It covers the period 2013-
2018 and, where available, data from 2019 and 2020 as well.

1
Safety Gate is used to reflect the planned change of the name of the EU rapid alert system for non-food dangerous products (now RAPEX).
2
https://ec.europa.eu/info/files/study-preparation-implementation-report-gpsd_en

2
 Overview
Objectives and scope of the Directive
The Directive requires all consumer products placed on the EU market to be safe. It applies to
non-food consumer products that are not subject to specific EU legislation governing the safety
of the products concerned. It is also applicable to the safety aspects or risks of products which
are subject to specific safety requirements imposed by Union law, to the extent that the specific
EU harmonised legislation makes no specific provisions with the same safety objective. The
Directive therefore constitutes a safety net that ensures that all products and risks to consumers’
health and safety are covered by the safety requirement set by the Directive, even if they are not
covered by any specific EU legislation.
The Directive applies to all sales channels, offline and online.
Obligations of economic operators and Member State authorities
The Directive establishes a general obligation on producers to only place on the market products
that are safe, and to provide information to consumers and to Member State authorities. The
producers must set up a minimum system of traceability and must take appropriate corrective
measures in the event that dangerous products are found on the market, such as action to
withdraw or recall the product. Distributors have a duty of care obligation to ensure compliance
with the applicable safety requirements.
Member State authorities must ensure that products placed on the market are safe and monitor
compliance by producers and distributors with the obligations set by the Directive.
The Directive doesn’t set any specific direct obligations on the online marketplaces. It may be
noted that in accordance with Article 14 of Directive 2000/31, hosting service providers are not
liable for the information stored at the request of a recipient of the service, on condition that
upon obtaining actual knowledge or awareness of illegal activity or information, for instance by
means of a sufficiently precise and adequately substantiated notice, they act expeditiously to
remove or to disable access to the information.

Given the increasing role that online marketplaces play in the current supply chain, the
Commission facilitated the signature of the Product Safety Pledge (signed by 11 online
marketplaces to date), which is a set of voluntary commitments to improve the safety of products
sold on these online marketplaces by third-party sellers.

Institutional and enforcement aspects

The Directive establishes the Rapid Alert System for non-food consumer products (Safety
Gate/RAPEX). This system enables the Commission and Member State authorities to circulate
information on measures taken by Member State authorities and economic operators on products
posing a serious risk to the health and safety of consumers. Information on less than serious risks
can also be circulated under RAPEX (though this accounts for less than 1% of all notifications).
The RAPEX system can be opened to non-EU countries on the basis of a specific international
agreement signed between the EU and the applicant country. Under Article 15 of the Directive,
the Commission implements this Directive with the assistance of a committee composed of
representatives from the Member States (the ‘GPSD Committee’). In addition, Article 10 of the

3
Directive sets up a network of Member State authorities with the aim of further enhancing
administrative cooperation (the ‘Consumer Safety Network’).
Given that the Directive forms part of the EEA Agreement, the same rules and mechanisms
apply to EFTA countries that apply the EEA Agreement: Norway, Iceland and Liechtenstein.

Application and regulatory developments

Safety of consumer products
With the growing share of e-commerce and emerging new technologies (such as artificial
intelligence, the internet of things, interconnected products), the definition of safety given in the
Directive is being challenged in many ways. The Directive gives a definition of a safe product
that is formulated widely enough to give rise to uncertainties about its interpretations. It does not
explicitly cover risks related to emerging threats, such as cybersecurity risks, software
malfunction or risks inherent in products with artificial intelligence or machine learning
capabilities. Consequently, most national authorities lack interpretation and practice related to
new technology products and have called for the development of guidance at EU level.
Products containing new technologies pose specific difficulties for market surveillance
authorities, for instance, the lack of knowledge on possible risks that these products represent, or
the need to clarify the responsibilities of different authorities/economic operators.
Concerning online sales, in most countries market surveillance activities are conducted mostly
on traders located in their own country. The procedure can be either similar to that used for
products sold in physical stores, or it specifically focuses on online checks of online
marketplaces. Authorities that carry out enforcement action on traders selling dangerous products
and located in non-EU countries reported that they use the mechanism provided by the Product
Safety Pledge.
Traceability
Most Member States’ transposition legislation complies with the Directive in that they make it
mandatory to indicate the name and contact details of the producer and a product reference or,
where applicable, the batch number on products or packaging. However, application of these
requirements is not uniform: it may vary according to the characteristics of the products, it may
extend the obligation beyond the producer, or require additional data, and these differences
create uncertainties for businesses operating across Europe.
At present, the Directive’s provisions on traceability are not sufficiently explicit to ensure the
collection of complete information on product supply chains and distribution. The data available
in the Safety Gate/RAPEX demonstrates that product traceability is often insufficient. In 2019,
36% of alerts for dangerous products lacked information about the manufacturer; 20% of alerts
were for products of unknown brand or batch number/barcode; and 12% were for products with
no type or model information.

4
Figure 1, based on alerts registered in the Safety Gate/RAPEX, shows that the only improvement
in the availability of information was on the product manufacturer and on the batch
number/barcode (i.e. fewer alerts lacked this information). There is no clear trend indicating an
improvement on other aspects of traceability information.
Figure 1: Share of Safety Gate/RAPEX alerts with unknown product information (2013-2019)

50%
45%
40%
Pecent of all alerts

35%
30%
25%
20%
15%
10%
5%
0%
2013 2014 2015 2016 2017 2018 2019

No batch number/barcode No brand

No type/model No manufacturer
None of the four

Source: Study for the preparation of an implementation report of the GPSD, from Safety
Gate/RAPEX data, retrieved in January 2020 (calculation on basis of full dataset, number of
alerts concerning consumer products with serious risks 2013-2019).
The same data also reveal that missing product information is more typical for specific types of
products such as laser pointers, lighters, jewellery and decorative articles. These products all fall
within the scope of the Directive and are not subject to sector-specific harmonisation rules. It
follows that product categories under the Directive are more likely to lack relevant information
items essential to trace them.
Functioning of market surveillance
The market surveillance system under the Directive appears to be operating under considerable
resource constraints. In a 2018 evaluation of the product safety-related actions funded under the
EU Consumer Programme3, authorities indicated limited staff/financial resources for market
surveillance and enforcement as a factor most frequently undermining the level of achievement.
Also market surveillance of online markets poses issues, especially related to direct imports from
outside the EU.

3
See Civic Consulting (2018), ex-post evaluation of the Consumer Programme 2007-2013 and mid-term evaluation of the Consumer
Programme 2014-2020, Part 1 – Mid-term evaluation of the Consumer Programme 2014-2020 and European Commission.

5
 Market surveillance cooperation with other public authorities and with customs
There are different institutional models for market surveillance at the national level, often
characterised by a high degree of fragmentation of responsibilities. Cooperation between
authorities – customs and other authorities included – comprises a whole range of activities such
as information exchanges, regular meetings, informal cooperation and joint training courses. The
improved use of several systems such as the Safety Gate/RAPEX, the ICSMS4 and the Wiki
confluence platform5 is great value added to the authorities’ work.
Cooperation between market surveillance authorities (hereafter MSAs) and customs is very
intense and regular in several aspects of this work. In most countries, customs authorities
conduct checks on behalf of the MSAs without being a market surveillance authority in their
own right. Some countries6 take a different approach and designate the customs authorities as a
MSA in its own right, so customs officials can take samples, have them tested and decide how to
proceed further.
Joint actions and coordinated activities of market surveillance authorities
The aim of joint actions and coordinated activities7 is to promote and coordinate cooperation for
the purpose of applying Directive 2001/95/EC and ensuring a consistent approach to
implementing product safety legislation across the internal market. This typically covers:
coordinated sampling and testing of non-food products found on EU/EEA markets, risk
assessment, exchange of expertise and best practices and implementation of an effective
communication strategy.
A high number of market surveillance authorities participate regularly in coordinated actions that
has resulted in identifying a considerable number of dangerous products. To provide assistance
to the Consumer Safety Network, the Commission has co-funded 14 joint actions on market
surveillance by these authorities during the reporting period. Most joint actions have resulted in
the identification of a significant number of dangerous products, leading to notifications in
Safety Gate/RAPEX for 13 categories of products. The ongoing Coordinated Activities on the
Safety of Products (CASP) 2020 and CASP 2021 projects likewise follow the implementation
approach of joint sampling, testing, risk assessment and best practice exchange to carry out
market surveillance actions in the EU/EEA Member States.
Recalls and other corrective measures
Under Article 5(3) of the Directive, producers and distributors are required to immediately notify
respective authorities in case a product that they have placed on the market poses safety risks to
the consumer.

4
Information and Communication System on Market Surveillance: ICSMS represents an IT platform which purpose is to facilitate
communication between market surveillance authorities in Europe.
5
Wiki confluence is a web-based corporate collaboration software, widely used by market surveillance authorities.
6
Finland, France and Latvia.
7
Between 2008 and 2018, joint actions were funded and implemented by the European Commission’s Consumer Programme, under the category
of grant agreements. Since 2018, the implementation modality and financing of joint actions was replaced by a procurement framework
funded fully by the European Commission. Currently they are called Coordinated actions on the safety of products.

6
When products are found to be dangerous, Member States must ensure that they are recalled,
withdrawn or prohibit their placing on their market, and they must also inform the Commission
without delay via the Safety Gate/RAPEX. In the notification, Member States provide
information on the product and the measures adopted. Data from RAPEX contains 5 983 recalls
covering 2013-2019 in the EU/EEA, showing an increasing trend. Recalls and other corrective
measures are organised in practically all countries, both on a voluntary and a mandatory basis.
Injury databases
The EU-funded project “European Injury Database”8 (IDB) provided some data on product-
related injuries and accidents in the EU, but only a minority of Member States collected injury
data systematically.
The creation of online databases (comprising data related to statistics on dangerous products and
injuries, risk assessment, market surveillance history, findings and fines) could provide better
information for businesses, may have a deterrent effect on non-compliant companies and may
improve consumer warnings for dangerous products. There has also been a suggestion to create a
system to collect data on product-related injuries, preferably at the EU’s initiative.
New regulatory developments related to market surveillance
On 20 June 2019, Regulation (EU) 2019/1020 of the European Parliament and of the Council on
market surveillance and compliance of products was adopted, amending Directive 2004/42/EC
and Regulations (EC) No 765/2008 and (EU) No 305/2011. This Regulation brings in new
market surveillance provisions for products subject to EU harmonised rules, while rules for non-
harmonised products are set by the Directive. The majority of authorities and other stakeholders
confirmed that having different rules for harmonised and non-harmonised products was
problematic. It was suggested that aligning the Directive with the obligations and enforcement
powers detailed in the harmonised market surveillance legislation would facilitate better
enforcement action.
The Notice on the market surveillance of products sold online9 sets out good practices for market
surveillance of products sold online and for communication with businesses and consumers. The
Notice concerns the application of the Directive and of Regulation (EC) No 765/2008 and it
aimed to achieve a more uniform and coherent application of the rules governing products sold
online.
Safety Gate/RAPEX and cross-border cooperation
The number of alerts sent to the Rapid Alert System for non-food consumer products has
increased progressively over the years, remaining above 2 000 alerts a year since 2012. The
system circulated 2 243 alerts in 201910 and 2 253 alerts in 202011 across Europe.

8
https://ec.europa.eu/health/sites/default/files/indicators_data/docs/idb_flyer_en.pdf
9
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.C_.2017.250.01.0001.01.ENG, OJ C250, 1.8.2017, p. 1–19
10
https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/repository/content/pages/rapex/reports/docs/RAPEX.2019.report
.EN.pdf

7
The Safety Gate/RAPEX is the key channel for market surveillance authorities to communicate
and cooperate with their counterpart authorities in the EU/EEA. MSAs cooperate with authorities
in other EU/EEA countries once a month or more often using Safety Gate/RAPEX and
frequently using other tools (ICSMS, Wiki confluence). However, there are delays in
notifications, often due to complex market surveillance structures, or other factors such as the
lack of testing facilities or insufficient human or financial resources. This often causes delays,
resulting in a lag in the notification period of an average of two weeks between detection of a
dangerous product and notification in the system. Also the lack of sufficient information to trace
notified products prevents authorities from taking action.
In line with the reported inconsistencies of risk assessments, additional action can be taken to
harmonise and improve risk assessment approaches of MSAs, building on current guidelines and
tools12.
On the basis of a Memorandum of Understanding signed in 2006, selected information on
products originating from China and notified in RAPEX are shared with Chinese authorities for
their follow-up. Chinese authorities then report back to the Commission on follow-up action. The
administrative arrangement of November 2018 also enables automated exchange of selected
information on dangerous non-food consumer products between the EU’s Safety Gate/RAPEX
system and Health Canada’s RADAR system.
Impact of COVID-19
The COVID-19 crisis has created high demand for protective equipment such as face masks,
medical devices and hand sanitisers. As regards products covered by the Safety Gate/RAPEX
alert system, Member States notified national measures taken against dangerous products linked
to COVID-19, together with active market surveillance action on personal protective equipment,
and online sales, particularly of masks. So far, over 200 RAPEX notifications on products related
to the COVID-19 crisis (face coverings, hand disinfectants, gloves) have been made since March
202013.
RAPEX guidelines
In order to improve the functioning of the RAPEX system, under Annex II, point 8 of the
Directive, the Commission must regularly update guidelines concerning the joint management of
the Rapid Alert System by the Commission and the Member States. Commission Decision
2010/15/EU was the first update of the guidelines, followed and repealed by Commission
Implementing Decision (EU) 2019/41714.The impact of the revised guidelines is visible in the
following example: as from November 2018 the guidelines specified that if a chemical substance
in a product is already banned or restricted under EU legislation, the product can be considered

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https://ec.europa.eu_safety_consumers_consumers_safety_gate_statisticsAndAnualReports_2020_RAPEX_2020_report_EN.pdf
12
Study for the preparation of an Implementation Report of the General Product Safety Directive, 2020.
13
Please note that this data is subject to change.
14
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 (notified under document C(2018) 7334).

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to pose a serious risk without requiring a specific risk assessment. This guidance has facilitated
the notification procedure on measures taken against dangerous chemical products.
Training

Joint training courses are regularly organised involving multiple market surveillance authorities
and also other authorities, such as customs. At EU level, training and sharing of best practices of
market surveillance authorities include the E-enforcement Academy project, which was carried
out between December 2016 and December 2019. To safeguard, revise and update all project
materials and components, a second project is being launched in 2021. Similarly, it aims to
provide, update and maintain high-quality training and learning materials to support the work of
national consumer protection authorities and the network of authorities responsible for consumer
product safety (Consumer Safety Network) with a view to create common tools and methods to
tackle the challenges of online trade and e-enforcement.
Standardisation
Decisions on safety requirements and standardisation requests
Commission Decisions EU (2015) 547 and EU (2014) 59 adopted safety requirements for two
product types: alcohol-powered flue-less fireplaces and laser products15. Subsequently, the
standardisation request was published for both products and the standardisation work is
ongoing16.

Decisions on references of standards

Over the reporting period, the European Commission referenced 67 standards under the
Directive for the following product types:

 gymnastic equipment
 stationary training equipment
 child use and care articles
 bicycles
 internal blinds
 lighters
 children's clothing
 floating leisure articles
 cigarettes (ignition propensity)
 child protective products
 audio, video and similar (safety requirements)
 information technology equipment (safety - general requirements)

15
In addition to the standards referenced, a number of standardisation requests under the Directive are active, of which some have already been
issued before 2013.
16
Commission Implementing Decisions C(2015) 8011 final and C(2015)557 final.

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In 2019, 17 standards were withdrawn and replaced by revised standards 17. All remaining
standards were re-referenced and included in the Implementing decision, to create a complete list
of references, as specified in recital 26 of the Implementing Decision.
The standardisation process under the Directive and potential improvement

Article 4 of the Directive provides for a standardisation process consisting of four steps:
1. the Commission issues a decision to set safety requirements to be met by the standard;
2. the Commission issues a formal request to European standardisation organisation (ESOs) to
develop standard(s);
3. the ESOs develop a standard compliant with safety requirements;
4. the Commission issues a decision on the referencing of the standard in the OJ EU.

The length and complexity of the standardisation process inevitably builds delays, and is
reported as burdensome and in need of simplification. Step 3 came in for particular criticism.
The procedure of drawing up a European standard by the ESOs is subject to a number of
requirements, such as the participation of all stakeholders, and the application of the consensus
principle, which aims to reach unanimous agreement on the draft standard. Another general issue
is that the procedure does not adapt to technical and scientific progress as fast as it should, while
being based on a standardisation request (Step 2). Once this request is made, it may be overtaken
by technical innovation rather quickly and this may become a problem if it takes a long time to
develop the standard. This may lead to the standard becoming obsolete before being referenced.
Proposals from stakeholders to streamline the standardisation process suggest that the system
could be made more efficient. Possible improvement could be achieved by dropping some of the
steps, reducing the number of Commission decisions involved, or reducing the time it takes to
adopt a standardisation request (Steps 1 and 2), and to publish a standard and its referencing in
the Official Journal (Step 4). The involvement of two different Committees with Member States
representatives is considered by the different groups involved to be inefficient and burdensome.

EU case law on issues related to the General Product Safety Directive

Measures based on Article 13 of the Directive
In some exceptional circumstances, Article 13 of the Directive allows the Commission to adopt
temporary measures (valid for one year), via a decision, to eliminate a serious risk from certain
products. It can be used in situations where the Member States significantly differ on the
approach to managing the safety risk, and at the same time the risk must be managed with a high
degree of urgency and can be eliminated only by adopting appropriate measures at EU level.
The latest occasion the Commission applied the procedure under Article 13 of the Directive was
on 9 August 2011, when it adopted a decision on the compliance of standard EN 16156:2010 and
the assessment of the ignition propensity of cigarettes18.

17
Commission Implementing Decision (EU) 2019/1698 of 9 October 2019.
18
Commission Decision 2011/496/EU (OJ L 205, 10.8.2011, p.31-32).

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 CONCLUSIONS
The Directive has proven to be a powerful tool to ensure a high level of consumer protection. It
has helped trace and remove huge volumes of dangerous products from the European market.
The RAPEX system, set up by the Directive, has complemented the regulatory framework that
applies to some key consumer products, such as toys, childcare articles and electrical appliances,
with a well-functioning rapid exchange and alert system.
However, the Directive was adopted at a time when new technology products and connected
devices were rare, which is no longer the case. Such developments challenge the current
definition of product safety and bring new risks or change the way existing risks could
materialise (for example cybersecurity affecting product safety), and these risks must be
reflected and duly taken into account. Further challenges stem from the growing scale of online
sales, with new operators selling products online. The Directive should ensure the same level of
product safety, irrespective of the channel that they are sold to consumers.
The purpose of Article 5(1) of the Directive is that, in the event of a safety problem, dangerous
products present on the market can be traced and swiftly removed if necessary to avoid putting
consumers at risk. The Directive does not further specify the traceability requirement, and there
are differences in detail as to how the rules are applied in the Member States. Particularly in the
context of online sales, the lack of information on how to trace products and producers remains a
practical problem for enforcement authorities and certain economic operators. An analysis of
RAPEX data confirms that certain product categories are over-represented among dangerous
products in that they lack at least two of three key information items needed for traceability
(brand, type/number of product, batch number/barcode).
Market surveillance under the Directive has been successful, as indicated by the steady number
of over 2 000 RAPEX notifications per year. Nevertheless, in an increasingly global market with
more and more products coming to the EU from non-EU countries, there is a need for further
coordination of market surveillance activities between the Member States, including cooperation
with customs authorities. Coordination could be stepped up further by improving the exchange of
information and best practice between Member State authorities, and by taking measures to
increase institutional and financial capacity. Enhancing the overall framework and providing
appropriate tools (especially tools to aid online market surveillance) would considerably increase
effective enforcement by the authorities.
The European Commission provides for the development of European standards to make the
general safety requirement more operational. However, given the length of the standardisation
process under the Directive, there is a considerable lag between the start and the end of the
standardisation process. During this period, there is a lack of criteria to assess product safety and
a resulting uncertainty for economic operators and market surveillance authorities.

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