COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Product Safety and Market Surveillance Package A proposal for a Regulation of the European Parliament and the Council on consumer product safety and a proposal for a Regulation of the European Parliament and of the Council on market surveillance for products
Date: 2013-02-13
Institutions: European Commission
Subjects: customs inspection, economic growth, environmental protection, exchange of information, market supervision, marketing standard, product safety, single market














EUR-Lex - 52013SC0033R(01) - EN











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52013SC0033R(01)

COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Product Safety and Market Surveillance Package A proposal for a Regulation of the European Parliament and the Council on consumer product safety and a proposal for a Regulation of the European Parliament and of the Council on market surveillance for products /* SWD/2013/033 final/2 */









Table of Contents
1........... PROCEDURE. 3
1.1........ Identification. 3
1.2........ Organisation
and timing. 3
1.3........ Public
consultation, opinions of stakeholders and external expertise. 3
1.4........ Scrutiny
by the Commission Impact Assessment Board. 5
2........... POLICY
CONTEXT, PROBLEM DEFINITION AND SUBSIDIARITY.. 6
2.1........ Policy
context 6
2.2........ Organisational
and institutional context 8
2.3........ Economic
context 9
2.4........ Problem
definition - Unsafe consumer and other non-compliant products on the single
market 11
2.5........ EU
right to act 24
3........... OBJECTIVES. 26
3.1........ General
objectives. 26
3.2........ Specific
objectives. 26
3.3........ Operational
objectives. 26
4........... POLICY OPTIONS. 27
4.1........ Policy
objective 1: Consolidation and reinforcement of EU product safety rules. 27
4.2........ Policy
objective 2: Better coordination and increased effectiveness of market
surveillance activities on the single EU market for goods. 30
5........... ANALYSIS OF
IMPACTS. 35
5.1........ Analysis
of impacts of policy options under objective 1 (Consolidation and reinforcement
of EU product safety rules) 35
5.2........ Analysis
of impacts of policy options under objective 2 (Better coordination and
increased effectiveness of market surveillance activities on the single EU
market for goods) 40
5.3........ Impacts
on the EU budget 47
5.4........ Other
impacts. 47
6........... COMPARING THE
OPTIONS. 48
6.1........ Comparison
of policy options under objective 1 (Consolidation and reinforcement of EU
product safety rules) 48
6.2........ Comparison
of policy options under objective 2 (Better coordination and increased
effectiveness of market surveillance activities on the single EU market for
goods) 50
6.3........ Overview
of preferred options in the light of the objectives. 55
6.4........ Form
of the legislative instrument 55
7........... MONITORING AND
EVALUATION.. 57
1.           PROCEDURE
1.1.        Identification
Lead DGs: DG SANCO and DG ENTR - Agenda
Planning/WP Reference: 2010/SANCO/031 + 2012/SANCO/019
1.2.        Organisation and timing
Work on the Impact Assessment started in
September 2009. An Impact Assessment Steering Group chaired by DG SANCO, in
cooperation with DG ENTR, was set up and met five times:, on 28 September 2009,
21 January 2010, 21 December 2011, 21 June 2012, and 5 July 2012. SG, SJ, DG
ECFIN, MOVE, ENV, MARKT, TAXUD were invited to the meetings, and representatives
of SG, DG TAXUD and MARKT attended and contributed to the discussions. The
minutes of the last IASG meeting were submitted to the IAB together with the
draft IA report.
Annex 1 contains a glossary of the main
specialised terms used.
1.3.        Public consultation, opinions of stakeholders and external
expertise
The impact assessment builds on a very
wide and long public consultation of stakeholders:
·              
The first round of public consultation was
organised by the Commission from September 2009 to January 2010. The aim of
this consultation was to define - on the basis of the Report on the
implementation of the General Product Safety Directive[1] - the scope of the problems on
which the revision of the Directive should focus. 
·              
Following the definition of the scope of the impact
assessment, the Commission proceeded with the second round of public
consultation which took place from May to December 2010. Within the framework
of this second round the Commission held between 18 May 2010 and 20 August 2010
(12 weeks) an internet public consultation. The invitation to participate in
this online public consultation was published on the "Your Voice in Europe" website of the Commission on 18 May 2010 and on the website of DG Health &
Consumers. In this online public consultation the Commission sought feedback
through four consultation papers and nine online questionnaires targeting
various groups of stakeholders. The public consultation was divided into four
topics, namely (i) pre-standardisation procedures under the General Product Safety
Directive, (ii) harmonisation of safety evaluations of consumer products, (iii)
market surveillance framework in the product safety area and (iv) the alignment
with the 2008 Free Movement of Goods Package. Within each of these four areas
stakeholders were consulted about the scope and magnitude of the identified
problems and about various options proposed to remedy these problems.
·              
This second round of public consultation was
concluded through a Workshop on the revision of the General Product Safety Directive
organised on 1 December 2010 within the framework of the International Product
Safety Week. The aim of this workshop was to receive feedback from the
stakeholders on the process and key conclusions of the online public
consultation. The principal message delivered by the stakeholders was a call
for a uniform market surveillance framework in the non-food product safety
area, simplification of the existing legal framework and more coherence in the
enforcement of product safety rules throughout the EU. The summary of the
online public consultation is set out in Annex 2.
·              
Simultaneous to the online public consultation,
the Commission received position papers from 16 stakeholders, including
consumer organisations, business associations, Member States, and individual
economic operators etc. The summary of opinions of these stakeholders is set
out in Annex 3.
·              
The third round of public consultation took
place from January to March 2011. It took the form of four targeted stakeholder
meetings on the issues of, (i) market surveillance coordination (28 January
2011), (ii) obligations of economic operators with respect to non-food consumer
products, in particular traceability and technical file requirements (18
February 2011), (iii) pre-standardisation procedures under the General Product
Safety Directive (17 March 2011), and (iv) legislative architecture of
general and specific legislative rules (31 March 2011) with the participation
of experts for the relevant areas. The conclusions of these targeted
stakeholder meetings are set out in Annex 4.
·              
Stakeholders' views were also discussed in several
bilateral meetings that took place continuously between May 2010 and June 2012.
·              
Furthermore, special consultations aimed at
small and medium-sized enterprises (SMEs) and at microenterprises were carried
out. The summary of these consultations is contained in Annex 5.
·              
The European Parliament prepared its own
initiative report on the revision of the General Product Safety Directive and
market surveillance (the "Schaldemose Report")[2]. This report was adopted on 8
March 2011 in the form of a Resolution on the General Product Safety Directive
revision and market surveillance[3].
The Report contained a number of recommendations, for example, to enhance the
coherence of EU product safety legislation, to provide more consistency in
coordination of market surveillance and customs authorities, to deploy adequate
resources for market surveillance activities, including joint market
surveillance actions, to put in place mechanisms allowing for the sharing of
market surveillance information between the Member States etc.
·              
The Commission has sought the views of national
market surveillance authorities of the Member States on possible improvement to
the current situation through its expert working group "Senior Official
for Standardisation and Conformity assessment - Market surveillance"
(SOGS-MSG) and the Committee established under the General Product Safety
Directive.
Regarding external expertise, a study on
the future of market surveillance[4]
was prepared for the purposes of the impact assessment, with the objective of
assessing the challenges of product safety market surveillance posed by future
development of manufacturing and distribution patterns of non-food products[5]. In addition to this study a
number of other existing studies and surveys directly concerning the area of
non-food product safety were used as reference documents. These other studies
included, for example, a report evaluating business safety measures in the toy
supply chain, a feasibility study for a post-manufacturing traceability system
between the People's Republic of China and the EU, etc. A list of all studies
is provided in Annex 6.
1.4.        Scrutiny by the Commission Impact Assessment Board
The Impact Assessment Board of the European
Commission assessed a draft version of the present impact assessment and issued
its opinion on 19 September 2012. The Impact Assessment Board approved the
Impact Assessment Report and suggested certain improvements and modifications.
The Impact Assessment report was amended
in line with these suggestions. In particular, the source of the
inconsistencies in and ineffectiveness of existing legislation on product
safety and market surveillance was explained in more detail and in a more
concrete and structured way. The final report better described the content of
measures under each identified options and clarified which problem drivers and
objectives they are supposed to address. It highlighted what was going to
change compared to the status quo and substantiated the expected impacts.
2.           POLICY
CONTEXT, PROBLEM DEFINITION AND SUBSIDIARITY
2.1.        Policy context
The free movement of safe and compliant
products is one of the cornerstones of the European Union. This principle
constitutes an important pillar of the single market and allows consumers and
enterprises to purchase or sell products in another Member State.[6]
The overall architecture of Union product
safety and compliance rules which serve as a basis for the proper functioning
of the single EU market can be summarised in the following way:
Table 1: Overall
architecture of Union product safety and compliance rules
 Products[7] || Consumer || Professional 
 Harmonised || Sector specific Directives and Regulations and the General Product Safety Directive || Sector specific Directives and Regulations 
 Non-harmonised || General Product Safety Directive || National product safety rules under the 'Mutual Recognition Regulation' Article 34-36 TFEU 
The two legal instruments, the General
Product Safety Directive 2001/95/EC (the "General Product Safety
Directive") and Regulation (EC) 765/2008 setting out the requirements for
accreditation and market surveillance relating to the marketing of products guarantee
an EU legal basis for market surveillance of all consumer products (harmonised
or not) and for all harmonised products (consumers and professional). However, fragmentation
of market surveillance rules among various pieces of Union legislation (the
Regulation, the General Product Safety Directive and many sector-specific Union
harmonisation Directives), as described in the following table, may lead to
confusion on the part of both operators and national authorities.[8]
Table 2:
Overview of the existing EU regulatory framework in the area of non-food
product safety
 Overview of the existing EU regulatory framework in the area of non-food product safety ||
 Products Areas || Non- Harmonised || Harmonised ||
 Non-consumer || Consumer || Non-consumer ||
 Obligations of economic operators || National product safety rules under Article 34 – 36 TFEU || GPSD || Sector specific Union harmonisation legislation (GPSD as a safety net) || Sector specific Union harmonisation legislation ||
 Market surveillance on the internal market* || Regulation 764/2008 || GPSD (only those dangerous to health and safety of consumers) || Sector specific Union harmonisation legislation + Regulation 765/2008 + GPSD || Sector specific Union harmonisation legislation + Regulation 765/2008 ||
   ||
 RAPEX* || Regulation 765/2008 referring to GPSD || Regulation 765/2008 referring to GPSD ||
 Controls on products imported to the EU* || Regulation 765/2008 ||
The complexity of the EU legislative
framework in the area of non-food product safety is due to a fast adoption of
Regulation (EC) No 765/2008 and Decision (No) 768/2008/EC necessitated by the
events of the "summer of recalls" in 2007.[9] The fast adoption did not allow
for proper definition of the relationship between the General Product Safety
Directive on the one hand, and Regulation (EC) No 765/2008 and sector specific
provisions of New Approach Directives (in the wording of reference provisions
of Annex 1 of Decision (No) 768/2008/EC), on the other hand. The relationship
between these instruments was defined only in very general terms, such as
"mutatis mutandis" use of certain of the provisions on RAPEX system[10] laid down in the General
Product Safety Directive for the purpose of Regulation (EC) No. 765/2008 or
"lex specialis" application[11]
of market surveillance provisions of the General Product Safety Directive in
relation to the market surveillance provisions of Regulation (EC) No. 765/2008.[12]
The Commission tried to clarify the
complex issue of which of the aforementioned pieces of EU product safety
legislation should apply in which situations by way of interpretation
Guidelines,[13]
however this was considered to be insufficient.[14]
Regulation (EC) No 765/2008 requires the
Commission to submit a report analysing the consistency of EU rules on market
surveillance contained in this Regulation, the General Product Safety Directive
and any other relevant Union instrument addressing market surveillance issues
and, if appropriate to amend and/or consolidate the instruments concerned, in
the interests of better regulation and simplification.[15]
Along with a series of other actions, the
Single Market Act II[16]
identified the Product Safety and Market Surveillance Package as priority
initiative that would contribute to boosting growth and creating jobs. The
Europe 2020 Strategy for smart, sustainable and inclusive growth should ensure
that innovative ideas can be turned into new products and services that create
growth by exploiting EU-scale networks and by reinforcing the competitive
advantages of our businesses, particularly in manufacturing and within our SMEs.[17]
Finally, this initiative is also in one
of the important actions of the European Consumer Agenda adopted by the
Commission in May 2012.[18]
2.2.        Organisational and institutional context
Market surveillance is a crucial tool to
protect both consumers and other users from unsafe and non-compliant products,
by ensuring that all economic actors stick to the rules. On the one hand, the
organisation of market surveillance is determined by Member States, on the
other hand, the General Product Safety Directive and Regulation (EC) No
765/2008 set out certain minimum requirements that the market surveillance
structures in Member States should fulfil, such as the obligation to have
powers and resources to perform enforcement activities, a minimum set of
measures that authorities shall take against dangerous products, an obligation
to have a single RAPEX contact point etc. The configuration of market
surveillance authorities in Member States differs from one Member State to another: in certain Member States market surveillance is centralised whereas in
other Member States it is performed on the regional or even on the local level
with central authorities performing coordination role only.[19] 
At the EU level, the basic market
surveillance infrastructures are composed of (i) the RAPEX system through which
Member States notify to the Commission (which disseminates them to other Member
States) measures taken against products posing serious risks and (ii) the
general information support system intended to collect other information about
market surveillance activities performed by Member States. In addition, in the
area of harmonised products, the so-called 'New Approach directives' include a
form of safeguard clause[20]
which obliges Member States to restrict or forbid the placing on the market and
the putting into service of dangerous – or, according to some directives,
otherwise non-compliant – products, or to have them withdrawn from the market.[21]
2.3.        Economic context
The internal market for products is
enormous. As far as consumer products are concerned (regardless of whether
harmonised or not) in between 2008 and 2010 the volume of intra-EU trade
amounted to almost EUR 1 trillion. The value of
harmonised sectors (including both consumer and
professional goods) in the EU-27 is estimated to be no
less than € 2 100 billion. [22] The world economy is characterised by globalisation and changing
trade patterns to which EU market surveillance and customs authorities will
need to adapt. In terms of value, international trade
returned to pre-recession levels by mid-year 2010[23], and
is expected to continue growing. Growth has also been seen in the numbers of
consignments and customs declarations since bottoming out in the first half of
2009. This trend can be expected to continue.[24] Since January 2010 customs and market surveillance authorities are
due to cooperate to stop dangerous goods at the border of the EU and important
progress has been made in this area. Nevertheless, a significant amount of work
is still needed to train customs officials and to improve cooperation between
customs and market surveillance authorities at a national and EU level.
Figure 1:
Development of the number of customs declarations
Although there are no statistics that
allow the estimation of the number or percentage of non-food dangerous products
present on the EU market, there are strong indications that there are still
unsafe consumer products being put on the single market. The first indication
is the number of notifications sent through RAPEX, the EU rapid alert system
that facilitates the rapid exchange of information between Member States and the Commission.[25]
In 2009, 1 993 notifications were sent to the Commission, including 1 699
notifications of measures taken against products presenting a serious risk. In
2010, the number of measures notified rose to 2 244, including 1 963
notifications of measures taken against products presenting a serious risk. In
2011, this number decreased to 1 803 with 1 556 serious risk notifications.[26] The relative temporary decline
in the RAPEX notifications in 2011 can be attributable to the application of
the revised RAPEX Guidelines, including revised risk assessment guidelines, and
to the effect of cuts in national budgets for market surveillance reported by a
number of Member States. According to the statistics for the first three
quarters of 2012, an increase in the number of notifications is expected again
in this year.[27]
Figure 2:
RAPEX notifications (2003-2011) – consumer products
Another source of information about the safety of non-food products
on the market are the "Enforcement Indicators" collected yearly by
the Commission. According to this data, throughout 2008 and 2009, national
authorities in the EU have taken at least 15,000 measures[28] against products presenting a risk to health and safety of consumers
or not complying with the applicable legislation.[29] Complementary
information on product safety can be drawn the European Injury Database (IDB).[30] Finally, some rough indications on the share of non-compliant
products on the market were provided by stakeholders in the course of a public
consultation in the field of harmonised products as shown in Annex 9.[31]
2.4.        Problem definition - Unsafe consumer and other
non-compliant products on the single market
The very existence of unsafe and
non-compliant products circulating on the internal market indicates a failure
in the functioning of the framework within which the internal market operates.
For an unsafe product, there is no free movement on the single market. Unsafe
and non-compliant products should never have entered this market. Free
circulation of safe products should be promoted whereas unsafe products must be
effectively tracked down and removed from the single EU market.[32] 
In reality, however, product safety
requirements determining whether a product is safe and can circulate on the
Union market are not always clear and consistent.[33] Moreover, unsafe products not
fulfilling product safety requirements penetrate, in a number of cases, the EU
market from third countries due to insufficient coordination of activities by
the market surveillance authorities in individual Member States. As a result,
compliant economic operators face increased compliance costs. They have to
accommodate diverging application of product safety requirements in different
Member States while they face an unlawful competition from rogue operators who –
due to insufficient coordination of market surveillance authorities from
different Member States – manage to market products not respecting applicable product
safety requirements, and thus, gain competitive advantage over the compliant
economic operators. 
At the same time, interests of consumers
and other users, in particular their health and safety, are put in danger. If,
due to the incorrect safety assessment of a product resulting from the
ambiguity of applicable safety requirements, economic operators put on the
Union market unsafe or non-compliant products, they not only generate an
immediate threat to the safety of consumers but they also undermine consumer
confidence.[34]
If consumers should have confidence in products available on the EU market,
these products must be safe, irrespective of where they are produced.[35] The latest Eurobarometer data indicate
a decrease in confidence of consumers in the safety of products sold in the EU (25%
in 2011 compared to 20% in 2010 think that a significant number of products are
unsafe, 12% in 2011 compared to 16% in 2010 think that essentially all products
are safe).[36]
The problem of unsafe and non-compliant products is also evidenced by the data from
joint market surveillance actions[37]
performed by the European Commission and market surveillance authorities of
Member States within PROSAFE.[38]
Similarly, the data from the study of the Consumer and Industrial Products
Committee of IFIA[39]
on electrical products for household use performed in 2012 show a significant
number of non-compliances and safety issues of products imported from the
outside of the EU which circulate on the internal EU market.[40]
2.4.1.     Problem 1: Difficult compliance with EU product safety
requirements 
Compliance with the EU product safety
requirements is often difficult for economic operators since; in general, EU
product safety requirements in the area of so-called non-harmonised products
are not consistent with those in the harmonised area. Furthermore, the EU
product safety requirements in the non-harmonised area are often ambiguous and
detailed benchmarks for safety evaluation are missing, whereas in the
harmonised area different and overlapping layers of product safety undermine legal
certainty.
2.4.1.1.  Lack
of consistency of EU product safety requirements (for harmonised and
non-harmonised products)
In the area of non-harmonised consumer products,
economic operators face difficulties in determining which product safety
requirements they should apply, in particular due to the lack of consistency between
non-harmonised consumer product safety requirements and the harmonised product
safety requirements, as shown in Annex 8 (section 8.3).[41] The problems caused by
differences in requirements between non-harmonised and harmonised consumer
products as well as the differences in the distribution of obligations on
different agents in the supply chain generate sometimes non-negligible costs
which are however difficult to be quantified even by economic operators
themselves.[42]
These problems were demonstrated in the case
C-132/08[43]
where a Member State unsuccessfully tried to impose obligations of
manufacturers under the Radio and Telecommunication Terminal Equipment
Directive[44]
and the General Product Safety Directive on a distributor thus restricting the
free movement of products on the internal market in a way that was not
compatible with the aforementioned Union legislation and the Treaty.
2.4.1.2.  Ambiguity
of product safety requirements and lack of specific benchmarks (for
non-harmonised consumer products)
Differences in the implementation of
certain consumer product safety requirements can also be perceived with respect
to the implementation of the obligation to identify the producer under the
General Product Safety Directive. This disparity of national rules regarding
the identification of the product and the producer in respect of consumer
products - although coming within the limits of the General product Safety
Directive - causes confusion both for the economic operators as well as for
consumers.[45]
Furthermore, in the non-harmonised area,
there are a number of European standards published by European Standardisation
Organisations. However, the presumption of conformity to the general safety requirement
is provided only by few of them despite the fact that a European standard is
deemed to be a useful element when it provides for the aforementioned
presumptions of conformity, i.e. when it can legally ensure the free movement
of product throughout the EU internal market. The scarcity of European
standards providing for presumption of conformity with the general safety
requirement for consumer products complying with such standards in the
non-harmonised area compared to harmonised area deprive all stakeholders of an
efficient tool for ensuring the safety of products on the market. 
Last but not least, under the current
rules, unsafe products on the market or new or emerging risks are not addressed
in an efficient and timely fashion. The average timeframe from the initial
discussions to establish the safety requirements until the publication of the
reference of the standard in the OJEU can be estimated at about six years. Of
these, on average, three years (or more) are needed to draft the standard (a process
run by the European Standardisation Organisations, independent from the
Commission) and the remainder of the time can be ascribed to the current
procedures.
2.4.1.3.  Complexity
of different layers of EU product safety rules (for harmonised consumer
products)
Unlike in the area of non-harmonised
consumer products, for harmonised consumer products the applicable safety
requirements are more clearly spelt out in the sector specific EU product
safety legislation. However, with respect to these products there may be some
confusion due to the overlap of various layers of legislation.[46] In order to understand exactly
which requirements apply to a given non-food product, in particular if it is
subject to both consumer product safety requirements as well as to harmonised
product safety requirements, a time consuming research or legal advice will
often be necessary. The complexity of applicable requirements resulting from
the overlapping legislation increases compliance costs for economic operators
willing to follow the rules, as they will often request legal advice or engage
in time consuming research. Those costs, which are proportionally higher for
SMEs, may overall discourage compliance.
Apart from posing risks to consumers and users, unsafe and
non-compliant products have important economic consequences: they lead to
unfair competition. Operators not adhering to the rules can make significant
savings on compliance costs. They can consequently offer their products at
lower prices than their competitors who respect the law. In sectors where there
is tough competition from imported low-price products, European industry is
disadvantaged.[47] The situation “punishes” the law-abiding manufacturer, as
compliance becomes a “competitive disadvantage.” 87% of economic operators
responding to an earlier public consultation on the New Legislative Framework
performed in 2006 consider that they suffer from unfair competition due to this
situation; during that public consultation, economic operators provided
estimates of the size of their losses in terms of their annual turnover,
reproduced below:
Figure 3: Perceived losses in % of annual turnover
2.4.2.     Problem 2: Fragmentation of market surveillance in the
single EU market
A major reason for the considerable number of non-compliant products
on the market is that market surveillance does not operate effectively in the
European Union.[48] The principal causes of ineffective and inefficient market
surveillance on the single EU market are (i) weak coordination between product
safety market surveillance authorities in different Member States, (ii)
sub-optimal functioning of EU procedures for exchange of information on product
risks and (iii) inconsistent enforcement of EU-wide product safety action.[49]
2.4.2.1.  Weak
coordination of product safety market surveillance authorities of different
Member States 
Despite the widespread harmonisation of
safety standards and other requirements for products (e.g. environmental)
across the Union and the fact that many products are regularly marketed in more
than one Member State, the Single Market is policed through 27 separate systems
of enforcement. Although the consistency in coordination of enforcement
activities of different national authorities at the EU level is crucial for
proper functioning of the EU single market, the coordination of national market
surveillance activities is rudimentary.[50]

The lack of coordination of market
surveillance actions of authorities of different Member States can be
demonstrated by the number of reactions to notifications received under the
RAPEX system. In theory, on a perfectly integrated internal market both in
terms of circulation of products[51]
and market surveillance,[52]
one RAPEX notification of a dangerous product sent by a Member State should
trigger reaction about the presence of the notified dangerous product on the
market in other 29 Member States. In reality, however, in 2010 a total of only
2 100 reactions was distributed through RAPEX in respect of 1 556 notification
received through the system.[53]
This shows that one RAPEX notification triggered on average only 1.35 reactions
compared to the maximum possible number of 29 reactions. Although in practice,
it would rarely happen than one RAPEX notification would trigger 29 reactions
from all 29 EEA Member States, the fact that one RAPEX notification triggers a
reaction of only one or two Member States points to a clear lack of
coordination of the market surveillance authorities of different Member States.
Another aspect of the problem of weak
coordination of market surveillance authorities is that most of the information
relevant for market surveillance remains within national borders and does not
benefit market surveillance authorities in other Member States. Results of
investigation, risk-assessment as well as results of product testing are
collected to a higher or lesser extent by all Member States. However, this
information is used only nationally. Although over the last years the flow of
cross-border information on market surveillance has improved[54] thanks to use of IT systems,
such as REIS[55]
and currently GRAS-RAPEX,[56]
and to other forms of information exchange, such as ICSMS[57]. Yet lots of information is
not systematically shared with the Commission and/or other Member States and used in the perspective of the functioning EU internal market. Consequently,
due to the lack of sharing and comparability of basic
investigation/risk-assessment information, no intelligence-led coordination of
market surveillance efforts at the EU level can be performed. This can result in
unnecessary doubling of checks of compliant products or economic operators or
the fact that testing and risk-assessment of a product determined as dangerous
in one Member States has to be re-done in all other Member States.[58] Thus, significant resources are
wasted and important synergies are lost.
To ensure that only compliant products
circulate on the market, every Member State depends on the market surveillance
of its neighbours. Consequently, weaknesses in the organisation of market
surveillance in one single Member State can seriously undermine the efforts
taken by other Member States to keep non-compliant products from the market;
this creates a weak link in the chain.[59]
However, in contrast to other areas where economic interests of consumers and
other users are principally protected, for example, by the Consumer Protection
Cooperation Regulation[60]
or Services Directive[61]
in the area of product safety where health and safety of consumers and other
users are at stake, market surveillance authorities do not benefit from the
procedures for effective cross-border enforcement.[62]
2.4.2.2.  Sub-optimal
functioning of EU procedures for exchange of information on product risks
The current EU product safety legislation foresees two procedures
for the exchange of information at EU level: the first for the exchange of
rapid alert information about risks (the RAPEX procedure) and the second for
the purposes of ensuring the proper functioning of the EU internal market (the
safeguard procedure).
Both under the General Product Safety Directive and Regulation (EC)
No 765/2008 Member States have an obligation to notify measures taken against
non-food products which pose a risk (to health and safety of consumers and
other users, environment and public security), including a serious risk, to the
Commission[63] and to follow up the notification received.[64] This
includes an obligation to notify both measures taken by the public authorities
(so-called compulsory measures)[65] as
well as measures taken by economic operators themselves (so-called voluntary
measures).[66]
The experience of the Commission as well as the results of the
public consultation show that many Member States still have difficulties
complying fully with their obligations under the RAPEX system; in particular,
they have problems with notifying the Commission of preventive and restrictive
measures and ensuring follow-up action to notifications distributed through the
RAPEX system. Only 44% of Member States indicate that they fully comply with
the aforementioned obligation under the General Product Safety Directive and
Regulation (EC) No 765/2008 to notify all measures taken which pose risk. 28%
of Member States notify between 75 to 99% of measures taken to the Commission,
5% between 50 and 75% and 14% notify less than 50% of measures taken that they
should have notified.[67] When asked about the main obstacles preventing them from fulfilling
their notification obligation under EU law a number of reasons were advanced
without any being significantly prevailing): ambiguity of the notification
criteria,[68] too complex notification procedure, absence of sufficient
information in the RAPEX notification allowing identification of the product on
its national market or lack of human or financial resources to send the
notifications to the Commission or to follow-up the RAPEX notifications of
other Member States.[69] Specifically, on the problem of ambiguity of the notification
criteria, authorities indicated an equal level of problems with all of the
existing criteria of risk assessment, existence of cross-border effect and the
categories of measures to be notified, without any reasons being prevailing.
Similarly to the
RAPEX procedure, also the practical implementation of the safeguard clause
procedure, as it currently stands, presents some shortcomings. Due to the
absence of articulation with the RAPEX procedure, the current framework obliges
Member States to send to the Commission parallel notifications with similar
information under the RAPEX procedure and safeguard clause procedure. This creates
an additional administrative burden for the authorities of Member States
without any added value. The "double notification" obligation leads
to the general ineffectiveness of both notification mechanisms since Member
States see little sense notifying one measure twice through different
notification procedures. As a result, the control of the functioning of the EU
internal market is weakened.
If, in theory,
all compulsory measures taken against products posing risk, including serious
risk, subject to Union harmonisation legislation (so-called harmonised
products) should be notified to the Commission under the safeguard clause
procedure,[70] the data regarding the number of safeguard clause notifications
circulated provide a different picture. The greatest number of safeguard clause
notification concern electric and electronic products falling within the Low
Voltage Directive.[71]
These problems with the
effectiveness and efficiency of the RAPEX procedure are attributable, inter
alia, to legal rules which shape the functioning of RAPEX, in particular the
notification criteria which are seen as too complex and the absence of an
effective follow-up obligation.[72] Similar to the
RAPEX procedure, the safeguard clause procedure – as it currently stands –
lacks in effectiveness and efficiency. The "double notification"
obligation leads to the general ineffectiveness of both notification mechanisms
since Member States see little sense notifying one measure twice through
different notification procedures. As a result, the control of the functioning
of the EU internal market is weakened which, in turn, makes it easier to erect
barriers to the free movement of safe products on the EU internal market.
2.4.2.3.  Inconsistent
enforcement of EU-wide product safety action
If the Commission becomes aware of the existence of a serious risk
caused by a product on the internal market, it may - under Article 13 of the
General Product Safety Directive - adopt a formal decision – a so-called EU
product safety measure - requiring all Member States to restrict or prevent the
marketing of such a product.[73] This
measure is valid for a maximum period of one year, unless it is renewed for
additional periods, none of which shall exceed one year.[74] 
Experience with EU product safety measures has shown that the
validity of these measures for up to one year is not enough to prepare a
permanent solution at the EU level. As a consequence, usually the EU product
safety measures have to be repeatedly renewed. For example, the Novelty and
Child Resistant Lighters Decision has already been renewed six times.[75] This creates legal uncertainty and considerable confusion for
economic operators who are faced with a question of whether or they should make
long-term investments to adapt their products to the new product safety
requirements or not. 
Both national market surveillance authorities and economic operators
experienced problems with the application of EU-wide product safety measures.[76] For national market surveillance authorities difficulties were seen
in the short time period for national implementation of an EU-wide product
safety measure.[77] Respondents considered it important that the EU-wide product safety
measures be very clearly described, including technical details, such as test
methods, in order to ensure even implementation by all authorities in all
Member States. Economic operators viewed inconsistent application of EU product
safety measures by Member States as a problem,[78]
despite the fact that related compliance costs with the diverging national
implementing measures were assessed as "non-negligible" by some of
the operators, although none of them were able to quantify these costs. [79]
Finally, the lack of traceability of
non-harmonised consumer products to the responsible manufacturer or importer[80], has an important impact on
the effectiveness and efficiency of market surveillance.[81] Market surveillance
authorities often experience difficulties in identifying the person who has
actually manufactured and/or supplied the products, in particular when the
manufacturer is located outside the EU and has not appointed an authorised
representative.[82]
This reduces the scope of market surveillance authorities' action. In addition,
if the proper traceability is not ensured, the market surveillance authorities
have to spend non-negligible time and resources for uncovering often very
complex supply chains in order to be able to impose effective corrective
measures.[83]
2.4.3.     Who is affected by the problem?
·                       
Final users of the products: consumers, workers and professional users. For them, there would
be a risk of accidents and injury from unsafe and non-compliant products, as
well as economic damage from unsafe and non-compliant products.
·                       
National market surveillance authorities: they suffer from higher administrative costs as a consequence of
cross-border inefficiencies, ineffective testing and investigation costs if the
operator cannot be found.[84] 
·                       
Economic operators: manufacturers, importers, authorised representatives, distributors
suffer from uncertainty and higher costs caused by the complexity and ambiguity
of the EU legislation as well as from an unfair competition from "rogue
operators" not observing the EU product safety rules
·                       
Member States:
they have to bear increased costs resulting from reimbursement of health
treatment of injuries caused by unsafe products
2.4.4.     Foreseen evolution of the problem
2.4.5.     Problem 1: Unsafe consumer and other non-compliant
products in the single market
The market for non-food consumer products
has changed over the last decades. One of the main characteristics of the new
environment is the dynamic presence on the EU market of products manufactured
in third countries. More developing countries are expected to join the market
as producers, while trans-national cooperation will steadily grow, offering a
great variety of products. E-commerce will further facilitate cross-border
transactions. Consequently, many products marketed in European countries will
be manufactured in third countries and then imported in EU. Customs and market
surveillance authorities will gradually develop cooperation on the basis of the
existing provisions of Regulation (EC) No. 765/2008.
2.4.6.     Problem 2: The fragmentation of market surveillance in
the single EU market
To respond to the developments of
globalisation and e-commerce, market surveillance authorities have an
increasingly challenging role to play in the field of product safety. New
production technologies demand efficient and updated testing methods.
On-the-spot checks at business premises require substantial funds and usually
yield lower returns on investment, the more so, the further down the supply
chain these checks are carried out. The current economic recession and the
consequent lack of resources for market surveillance authorities at Member State level could have a negative impact on the efficiency of market surveillance
activities carried out by national authorities.
2.4.7.     Action taken by the Commission (baseline scenario)
Under the baseline scenario the existing
differences between consumer product safety requirements and harmonised product
safety requirements would continue to exist. Maintaining the current specific
regime for non-harmonised consumer products would mean that the existing
lengthy and burdensome preliminary procedures leading to the adoption of
mandates for development of European standards would continue to exist. This
approach would also require the creation of parallel pre-standardisation
procedures for non-harmonised consumer products in relation to the general
rules on standardisation laid down in Regulation (EU) No 1025/2012.[85]
Except for certain minimum coordination
requirements introduced by Regulation (EC) No 765/2008 for the area of
harmonised products, Member States would continue to undertake pro-active and
reactive market surveillance mostly along national lines. Besides the various
legal instruments which partly regulate market surveillance for products, the
Commission would contribute to market surveillance activities through the
following activities:
·              
Various joint market surveillance actions are
financed by the 'Consumer Programme'[86],
including horizontal programmes, such as the EMARS I and II, or sector specific
programmes, such as helmets, sunbeds or toys. The list of these market
surveillance actions is in Annex 14.[87]
·              
Controls of products at external borders are
facilitated by EU financing under the 'Customs Programme'[88]. In order to facilitate the
implementation of Regulation (EC) No 765/2008 the Commission, together with the
Member States, has drafted the Guidelines for imports controls in the area of
product safety and compliance.[89]
The Guidelines are intended as an instrument to assist customs and market
surveillance authorities in improving cooperation methods and good
administrative practice. At the same time, the Guidelines focus on the
practical questions customs are faced with when performing controls related to
product safety and compliance.[90]
The responsible authorities for market surveillance dispose of GRAS and ICSMS
tools to exchange information and coordinate their activities at European level
in various contexts:
(a)          
GPSD Committee: The
committee assists the European Commission in several tasks related to the
implementation of the GPSD. In particular, when the Commission takes decisions
requiring the Member States to urgently introduce temporary measures
restricting the placing on the market of products or requiring the withdrawal
of products posing serious risks.
(b)         
Consumer Safety Network: A network foreseen under Article 10 of the General Product Safety
Directive where the Commission and Member States prepare joint market
surveillance actions, discuss new emerging product risks and other market
surveillance issues.
(c)         
Senior Official Group – Market Surveillance
Group: A group of Commission and Member States' experts that discuss market surveillance, accreditation and conformity
assessment issues.
(d)         
RAPEX Contact Points Group: Meeting forum of the Commission and persons responsible for
managing RAPEX Contact Points in Member States which discusses and solves
problems relating to notifications to RAPEX.
(e)         
PROSAFE:
non-profit association of market surveillance officers of Member States
ensuring realisation of joint actions and putting in practice cooperation among
Member States in the market surveillance area.
(f)           
Rapid Advice Forum – another communication platform for authorities run by PROSAFE
Regarding the notification procedures the baseline would maintain
the current status quo consisting in keeping the parallel obligations for
Member States to notify the Commission under the RAPEX procedure and the
safeguard procedure. With respect to the EU-wide product safety action the
current situation where EU-wide product safety measures are implemented by
Member States in a disparate manner due to their indirect applicability and
time limitation would be maintained. The scope of EU-wide product safety
measures would be limited to consumer products. Issuing guidelines or producing
explanatory documents would not be a solution since none of them could provide
for a direct applicability of the EU product safety measures or extend the
time-limits of their validity.
2.5.        EU right to act
The single market for products is a key
achievement of the European Union. Yet, the elimination of national barriers
for consumer and other products offered plenty of opportunities to less
scrupulous traders who do not apply the consumer safety rules or refuse to
implement the EU legislation on products. The EU has therefore the right to act
on the basis of Article 114 TFEU, in order to ensure the proper functioning of
the single market for consumer products and to increase the efficiency of
cross-border market surveillance. Article 168 (1) and Article 169 (1) of TFEU
complements this right to act. The first stipulates that a high level of human
health protection shall be ensured in the definition and implementation of all
Union policies and activities, the latter provides that in order to promote the
interests of consumers and to ensure a high level of consumer protection, the
Union shall, amongst others, contribute to protecting the health, safety and
economic interests of consumers.
The differences in national organisation
of market surveillance causes problems when viewed in the framework of the
European single market which no longer has internal borders and where controls
at national borders have practically disappeared. To ensure that only compliant
products circulate on the market, every Member State depends on the market
surveillance of its neighbours. Consequently, weaknesses in the organisation of
market surveillance in one single Member State can seriously undermine the
efforts taken by other Member States to keep non-compliant products from the
market; this creates a weak link in the chain. This interdependence is
reinforced by the fact that the competence of market surveillance authorities
is limited to the national territory. Where action is needed beyond the border,
authorities must rely on their colleagues in other Member States.
Despite the existence of the single EU
market, the enforcement of product safety requirements is the Member States'
competence. The way in which market surveillance is performed and organised
significantly varies from one Member State to another. The proper
implementation of the principle of subsidiarity therefore requires that the procedures
and actions against concrete products posing risks are carried out by Member
States. The proportionality of
the policy options will be subsequently assessed in this report.
3.           OBJECTIVES
3.1.        General objectives
The general objective of this initiative
is to improve the functioning of the single market and to achieve a high level
of consumer protection through the reduction of the number of unsafe or
non-compliant products on the single EU market.
3.2.        Specific objectives
The specific objectives of this initiative
are:
·              
Consolidation and reinforcement of EU product
safety requirements
·              
Better coordination and increased effectiveness of
market surveillance activities on the single EU market for goods
·              
Simplification of the EU legislative framework
3.3.        Operational objectives
The operational objectives to be
accomplished by this initiative are the following:
·              
Ensuring consistency of EU product safety
requirements
·              
Reducing ambiguity of product safety
requirements for non-harmonised consumer products
·              
Reinforcing EU cooperation mechanisms 
·              
Making EU product safety procedures more
coherent 
·              
More effective EU-wide product safety action
4.           POLICY
OPTIONS
The presented policy options were
established by the Commission in close cooperation with all groups of stakeholders.
The Commission proposed a number of policy options and asked all groups of
stakeholders to add other possible options and express their opinion on the
existing ones within the framework of the general public consultation and
targeted stakeholder meetings.[91]
On the basis of those consultations,
certain policy options were, however, discarded at an early stage, including
(i) the issue of regulation of safety of services, (ii) imposing product safety
requirements for non-harmonised professional products, i.e. those which
circulate only among professionals and are never used by consumers, such as
industrial machines, raw materials and semi-finished products, etc., (iii)
regulating the safety of products marketed via the internet, and (iv) the
abolition of the general requirement that all consumer products must be safe. A
detailed description of discarded options as well as of the reasons for their
rejection is presented in more detail in Annex 12.
The remaining policy options, which all
contribute to the general policy aim of reduction of unsafe and non-compliant
product on the EU internal market, are presented under two broad policy
objectives, each accompanied by simplification.
4.1.        Policy objective 1: Consolidation and reinforcement of
EU product safety rules
The options in the following sub-sections
present solutions to the problem of inconsistency of EU product safety
requirements.
4.1.1.     Ensuring consistency of EU product safety requirements
4.1.1.1.  Option
1.A – Baseline scenario: Keeping differences between consumer product safety
requirements and harmonised product safety requirements
See above Sections 2.4.1.1 and 2.4.4.
4.1.1.2.  Option
1.B – Aligning consumer product safety requirements with harmonised product
safety requirements
Under option 1.B consumer product safety
requirements would be aligned as much as possible with certain harmonised
product safety requirements (with the exception of conformity assessment
procedures and CE-marking) as described in the following table. Differences
between these two sets of rules described above in Section 2.4.1.1, would be
eliminated. For all consumer products, whether harmonised or non-harmonised, a
single set of general product safety requirements would apply.[92]
4.1.1.3.  Option
1.C – Consumer product safety requirements to be defined less strictly than
harmonised product safety requirements
Under option 1.C consumer product safety
requirements would provide for a lighter regime than that which is foreseen
under the harmonised product safety rules. This would mean, for example, that
the identification of the product and its producer for non-harmonised consumer
products would be prohibited.
4.1.1.4.  Option
1.D – Consumer product safety requirements to be defined more strictly than
harmonised product safety requirements
Under Option 1.D consumer product safety
requirements would be made stricter than harmonised product safety rules with
respect to certain products or group of products. This would mean that the
manufacturer or importer of a consumer product would have to comply with
additional product safety requirements than those in harmonised product safety
rules. Such additional safety requirements could, for example, consist of the obligation to (i) put on the product a unique
identification sign, such as a numeric barcode, radio frequency identifier, or (ii)
to indicate on the product, its packaging or accompanying documentation of
further information like place or date of manufacturing of the product, address
of the company in charge of collecting clients' claims etc.
4.1.2.     Reducing ambiguity of product safety requirements for
non-harmonised consumer products
4.1.2.1.  Option
2.A – Baseline scenario: Necessity of creation parallel pre-standardisation
procedures for non-harmonised consumer products
See above Sections 2.4.1.2. and 2.4.4.
4.1.2.2.  Option
2.B – Direct applicability of ad-hoc safety requirements
The ad-hoc safety requirements which set
the basis for establishment of mandates for the development of European
standards for non-harmonised consumer products by the European Standardisation
Organisations would become directly applicable. European standards adopted on
their basis and published in the Official Journal would provide for presumption
of conformity with the safety requirements set out in these directly applicable
measures.
4.1.2.3.  Option
2.C – Abolition of double adoption of the non-binding ad-hoc safety
requirements
This approach would align the regime for
developing European standards for consumer non-harmonised products with the
reformed general standardisation procedures applicable to the harmonised area
under Regulation (EU) No 1025/2012. This alignment would entail abolition of
the current double adoption of specific safety requirements for products in the
regulatory committees. Abolition of the double adoption of safety requirements
would however not mean the abolition of these requirements as such. These
safety requirements which provide the basis for the establishment of mandates
for the development of European standards by the European Standardisation
Organisations would continue to be established, but in a less formal procedure
within the framework of the preparation of mandates in an expert discussion
within the relevant committee. These mandates for developing European standards
would then be formally adopted in the same way as they are for harmonised
products. Once developed by the European Standardisation Organisations, the
fulfilment of criteria of high consumer safety would be assessed vis-à-vis
the general safety requirement.
4.1.2.4.  Option
2.D –Fast-track procedure for adopting already existing European standards
without mandates
Option 2.D builds on the previous option
by providing for a fast-track procedure for adopting already existing European
standards developed by the respective European Standardisation Organisation,
even if those European standards were not adopted on the basis of previous
mandates granted to European Standardisation Organisations by the Commission.
This procedure would allow for referencing
existing European standards under the general product safety legislation to
provide for the presumption of conformity under this Directive even if they
were adopted outside a Commission mandate. In the case of an existing European
standard which in the view of the Commission and the Member States satisfies the general safety requirement, the Commission would not have to do
complicated "re-engineering" of requests for development of standards
which already exist.
4.2.        Policy objective 2: Better coordination and increased effectiveness
of market surveillance activities on the single EU market for goods
The options in the following sub-sections
present solutions for the problem of fragmentation of market surveillance
activities on the single EU market. Due to the fact that market surveillance is
the responsibility of the Member States (subsidiary principle), the European
Commission does not have the power to decide the overall amount of national
resources for market surveillance activities. The following options therefore
focus on possible means to increase the impact of market surveillance efforts
for a given level of resources at the EU level; additional resources for
national markets surveillance authorities have to be funded from national budgets
of Member States.
4.2.1.     Reinforcing EU cooperation mechanisms
Despite the existence of an internal EU
market, the intensity of coordination of market surveillance activities of
Member States in the non-food product safety area lags significantly behind the
level of coordination achieved in other areas, such as in the area of
enforcement of economic interests of consumers or in the food safety area. The
different options set out below represent different levels of potential
coordination of market surveillance in the non-food product safety area: Option
3.B would advance the coordination of market surveillance to the level reached
in the areas covered by the Consumer Protection Cooperation Regulation; Option
3.C is a middle step where the intensity of coordination is above the levels of
the Consumer Protection Cooperation Regulation, but below the level of
coordination in the food safety area; finally Option 3.D describes the most
developed level of coordination reflecting that reached in under the EU Food
Regulations.[93]
4.2.1.1.  Option
3.A – Baseline scenario: keep status quo based mostly on voluntary market
surveillance coordination
See above Sections 2.4.2.1. and 2.4.4.
4.2.1.2.  Option
3.B – Coordination of cross-border enforcement of measures resulting from
"in the-field" market surveillance
This option would define procedures for
effective cross-border enforcement of measures resulting from "in
the-field" market surveillance. Such procedures would consist of (i) a
procedure triggered by a request for information, i.e. a process where authorities
of one Member State would be able to ask other authorities for information on
dangerous products or economic operators, and (ii) a procedure triggered by a
request for action, i.e. process under which authorities of one Member State
could call on authorities in another Member State to perform simultaneous
inspections on economic operators based in the respective Member States.
Providing national market surveillance authorities with tools for
coordination of concrete reactive action would help these authorities to cope
with the growing globalisation of product supply chains. Thus, these
authorities would be able to 'reach out' over national borders by effectively relying
on assistance of market surveillance authorities from other Member States.
4.2.1.3.  Option
3.C – Overall rationalisation of coordination of market surveillance activities
Option 3.C adds to Option 3.B the
possibility of rationalisation of the currently dispersed pre-planned market
surveillance activities. Indeed, an intelligence-led market surveillance
supporting the proper functioning of the EU internal market needs to be based
on the widest possible sharing of information relevant for the interception of
unsafe products among the market surveillance authorities of Member States.
In particular, to ensure proper execution
and continuation of joint EU market surveillance actions, their coordination
would be put on a more permanent footing. This would be achieved by two means:
by the implementation of the Multiannual Market Surveillance Plan[94] and through the establishment
of a coordination network (referred to as European Market Surveillance Forum)
ensuring cooperation of Member States’ authorities which would set EU-wide
enforcement priorities in close cooperation with the Commission, coordinate the
relationship with customs at an EU level, facilitate data exchange between the
Member States, develop best practices (e.g. on risk assessment), etc.
Similarly, the coordination activities at EU level would be streamlined: the
current plethora of coordination groups and committees would become sub-groups
of the European Single Market Surveillance Forum of market surveillance
officials so that coherence and consistency of messages about the direction of
market surveillance at a national level could be ensured.
Elements that would facilitate the
coordination of market surveillance would be the discussion of national market
surveillance plans[95]
and the introduction of common reporting requirements[96] on the market surveillance
activities performed, including self-assessment of their effectiveness.[97]
4.2.1.4.  Option
3.D – Centralisation of EU market surveillance in the area of non-food products
(EU Market surveillance agency)
Under this Option the intensity of market
surveillance and the level of coordination between national market surveillance
authorities of Member States would be brought to a similar level as in the food
area. This Option 3.D would entail substantial investments into the non-food
product safety market surveillance in order to establish the framework existing
already in the food area consisting of a general auditing system[98] and a market surveillance
agency.[99]
The general auditing system would relate
to the checking of the quality of controls, inspections, samplings, testing of products
and risk assessment performed. The auditing system would also assess the
national market surveillance framework in terms of effectiveness of
coordination between the relevant market surveillance services (i.e.
coordination of regional, national, sector-specific bodies, including the RAPEX
Contact Points), customs authorities, market surveillance authorities of other
Member States and with the European Commission.
Furthermore, the market surveillance
agency for non-food products would review the measures preventing and/or
restricting free movement of products taken by national market surveillance
authorities. It would assist national authorities in organising simultaneous
market surveillance actions in more than one Member State. It would also elaborate
harmonised inspection protocols, methods of risk assessment of products and
economic operators and develop a harmonised approach to risk assessment and
risk management.
4.2.2.     Making EU product safety procedures more coherent
4.2.2.1.  Option
4.A – Baseline scenario: Keeping the parallel notifications under RAPEX
procedure and safeguard procedure
See above Sections 2.4.2.2. and 2.4.4.
4.2.2.2.  Option
4.B – Simplification of the RAPEX procedure
The RAPEX
procedure would be simplified. The requirements conditioning the sending of
information on dangerous products to the Commission and other Member States would be made less onerous in order to enable easier and more cost-effective
identification of dangerous products in other Member States on the basis of
RAPEX notifications. The safeguard procedure, including its parallel
notification obligations, would continue to function next to the simplified
RAPEX procedure.
4.2.2.3.  Option
4.C – Simplification of the RAPEX procedure and streamlining of that procedure
with the safeguard procedure
The RAPEX procedure and the safeguard
procedure could be streamlined so that only one notification for both
procedures would be necessary. Once received and treated under the RAPEX
procedure, other Member States or the Commission would have the possibility to
raise an objection to such measure notified, in particular in the case of a
difficult risk assessment, and thus trigger the Union safeguard procedure at
the end of which the Commission will decide whether the adoption of the notified
measure was justified or not.
4.2.3.     More effective EU-wide product safety action
4.2.3.1.  Option
5.A - Baseline scenario: Keeping EU-wide product safety measure indirectly
applicable for a period of one year only
See above Sections 2.4.2.3. and 2.4.4.
4.2.3.2.  Option
5.B - Extension of the scope of EU-wide product safety measures to harmonised
non-consumer products
Extension of the application of EU-wide
product safety measures to other non-consumer products is a natural consequence
of the creation of a single market surveillance framework. If these measures
remained limited only to consumer products, they would become a source of
inconsistencies creating barriers to the single EU market.
4.2.3.3.  Option
5.C - Making EU-wide product safety measures directly applicable
To avoid significant delays in
implementation and differing dates of entry into force of EU-wide product
safety measures in Member States as well as to achieve their uniform
implementation, the Commission would make these EU product safety measures
directly applicable to economic operators as of a pre-determined date.
4.2.4.     Option 5.D – Removal of the limited validity of EU-wide
product safety measures
To eliminate the confusion caused by
repeated renewal of EU-wide product safety measures, the period of validity of
the EU-wide product safety measures would be extended: the duration would be
specified in the implementing act (either as limited or unlimited) taking into
account the gravity of the situation, its urgency and other relevant circumstances.

4.2.4.1.  Option
5.E – Combination of options 5.B, 5.C and 5.D
Last option 5.E consists of the
cumulative combination of options 5.B, 5.C and 5.D. Under this option EU-wide
product safety measures would not only be extended to harmonised non-consumer
products and made directly applicable, but also their period of validity would
be determined on a case-by-case basis. 
5.           ANALYSIS
OF IMPACTS
5.1.        Analysis of impacts of policy options under objective 1
(Consolidation and reinforcement of EU product safety rules)
The impacts of the different baseline
scenarios under options 1.A, 2.A, 3.A, 4.A and 5.A are assessed in Sections
2.4.2., 2.4.4. and 2.4.5.
5.1.1.     Ensuring consistency of EU product safety requirements
5.1.1.1.  Option
1.B – Aligning consumer product safety requirements with harmonised product
safety requirements
Decision (No) 768/2008/EC aligned the general non-risk related
product safety requirements in the various pieces of harmonised product safety
legislation. The same, however, did not happen with respect to consumer product
safety requirements. In consequence, similar products in terms of its
characteristics and safety properties, for example, toys and childcare
articles, are subject to differing sets of rules.[100]
Also, the public
consultation showed that 94% of national market surveillance authorities, 65%
of other stakeholders consulted, including consumer and business associations,
confirmed that the safety of consumers would be better ensured if the
harmonised product safety requirements were also applied to non-harmonised
products.[101] Thus, from the perspective of health and safety of consumers,
aligning of consumer product safety requirements with harmonised product safety
requirements would best achieve the objective of ensuring that only safe
product circulate on the internal market.
For economic
operators, an alignment of the consumer product safety requirements with
harmonised product safety requirements would lower
information-research costs and costs of legal advice. Economic operators would
no longer have to spend additional time or costs on determining whether either
the consumer product safety requirements or harmonised product safety
requirements apply to the product in question. A reduction of costs of
identification of applicable product safety rules could reduce the size of the
category of economic operators who are willing to observe the rules, but unable
to fully do so, and increase the number of those who are both willing and able
to fully respect all product safety requirements. In sum, making consumer
product safety requirements compatible with harmonised EU product safety
requirements would thus provide the desired clarity and legal certainty since
it would eliminate the existing overlap between inconsistent requirements under
consumer product safety requirements and harmonised
product safety requirements.
For market
surveillance authorities, the alignment of consumer product safety requirements
with harmonised product safety requirements would also have a positive effect
on the effectiveness and efficiency of market surveillance. The effectiveness
of market surveillance actions would be increased thanks to the alignment of
the requirements. In particular, the requirements concerning the identification
of the manufacturer and/or the importer authorities would enable enforcement
measures directly at the source of the risk which represents the most effective
and the least discriminatory enforcement approach. This
option would also contribute to the non-discriminatory treatment of economic
operators by market surveillance authorities of different Member States while
allowing market surveillance authorities to track down non-compliant economic
operators more quickly and at a lesser cost. Where
the manufacturer and/or the importer are not identified, the restrictive or
preventive measure against the dangerous product is usually addressed to the
distributor. This is a less effective approach both from the safety and
internal market surveillance perspective: containing the product at the point
of sale will always stop a lesser number of products from circulating on the
internal market than if stopped directly "at the source", that is at
the point where the product is manufactured or imported to the EU as well as it
being targeted to the person primarily responsible for the dissemination of the
risky product, i.e. the rogue manufacturer or importers to the detriment of
final distributors placed in the EU.
If the positive impact of the alignment
of general non-risk related consumer product safety requirement and harmonised
product safety requirements on the principal stakeholders can be estimated
without serious difficulties, the same cannot be affirmed with respect to
possible negative cost impacts. On the basis of discussion with relevant stakeholders
in the framework of the targeted stakeholder meeting within the process of
public consultation, it appears that producers do not structure their product
lines or marketing practices according to whether a product is harmonised or
not. This means that there are no separate production lines and marketing
approaches for harmonised products on the one hand, and non-harmonised products
on the other[102].
Thus, once a producer produces a harmonised product, it will extend the
application of the harmonised product safety requirements also to
non-harmonised product if he produces them simultaneously[103]. At the same time if the
product is likely to be used by consumers, thus increasing the risk of
liability for the producer, the producer will apply higher standards of care
going beyond the requirement prescribed by the legislation. Therefore, it will
not be unusual for producers of consumer products to apply certain additional
safety requirements and precautionary measures for consumer products even if
not prescribed by the legislation.
These statements seem to be confirmed by
responses to the public consultation with respect to the general application of
two elements of harmonised product safety requirements. With respect to the
first example of a harmonised product safety requirement consisting of
establishing technical documentation for products, most of the manufacturers
appear to establish such documentation even in the non-harmonised area, i.e. in
the area where they are not obliged to do so by the harmonised EU product
safety requirements. In the public consultation 25% of responding economic
operators indicated that they establish technical documentation for
non-harmonised products because of the requirements of national law, 55% of
responding operators establish technical documentation even without the existence
of any rule obliging them to do so[104].
Furthermore, 30% of responding economic operators to the public consultation
stated that they would expect a cost reduction if technical documentation would
have to be established in the same way for all the products; 15% would expect a
negligible cost increase, 10% a non-negligible cost increase while the
remaining 45% was not able to indicate whether this requirement would lead to a
cost increase or cost reduction.
Regarding the second example of a
harmonised product safety requirement consisting in the identification of the
manufacturer and of the product, according to the answers given in the public
consultation, all the economic operators were ensuring traceability of products
in one way or another: the most widely used means of ensuring traceability of
products was the indication (on the product, its packaging or in the
accompanying documents) of the identity of the manufacturer (77% of
manufacturers responding), followed by the indication of identification of the
product (46%), indication of the contact address and keeping the list of
component suppliers (both 38,5%) and finally keeping the list of distributors
(31%)[105].
On the basis of the above, it can be concluded
that this option will have a positive impact on consumers and other users,
economic operators other than manufacturers of non-harmonised product who
manufacture and sell their products within a single EU Member State, and market
surveillance authorities. Although there is a certain probability of the
occurrence of negative impacts of the alignment in terms of a very small cost
increase for a limited group of producers[106], this increase can be
expected to be extremely marginal and would represent a hardly perceptible
fraction of operating costs.
5.1.1.2.  Option
1.C – Defining consumer product safety requirements less strictly than
harmonised product safety requirements
This option will have a positive impact
on manufacturers of non-harmonised products only. Given the fact that according
to the aforementioned data from the RAPEX system there is no substantial
difference between the number of notifications of measures taken against
dangerous harmonised consumer products and dangerous non-harmonised consumer products,
from the perspective of protection of health and safety of consumers, there
seems to be no justification for defining consumer product safety requirements
less strictly than harmonised product safety requirements. A concrete example
is the electrical equipment covered by the Low Voltage Directive which is
applicable to equipment designed to operate with a voltage rating exceeding 50
volts. This option would constitute a risk for the health and safety of
consumers if a similar product, designed to operate with a voltage rating not
exceeding 50 volts, would be subjected by the EU to less stringent safety
requirements.
If consumer product safety requirements
were defined less strictly than harmonised product safety requirements, the economic
operators would face two sets of differing and product safety requirements –
consumer product safety requirements and harmonised product safety requirements[107]. The costs of information
research and/or the legal advice as to the applicable product safety
requirements cases would not be reduced, since economic operators - when
ascertaining which sets of requirements apply to their products - would still
have to deal with two differing sets of legal requirements[108].
Moreover, keeping two differing sets of
product safety requirements would not increase either the effectiveness or the
efficiency of market surveillance. As indicated above, the public consultation
showed that 94% of national market surveillance authorities, 65 % of other
stakeholders consulted, including consumer and business associations, confirmed
that the safety of consumers would be better ensured if the harmonised product
safety requirements were also applied to non-harmonised products[109].
5.1.1.3.  Option
1.D – Defining consumer product safety requirements more strictly than the
harmonised product safety requirements
From the safety perspective, there do not
seem to be any reasons to define consumer product safety requirements more
strictly than harmonised product safety requirements on a permanent basis since
the number of dangerous non-harmonised consumer products reported under the
RAPEX procedure is not higher than the number of reported dangerous harmonised
consumer products.[110]
For the electrical equipment covered by the Low Voltage Directive, for example,
it would lead to fairly absurd results: this Directive is applicable to
equipment designed to operate with a voltage rating exceeding 50 volts but,
under this option, a similar product designed to operate with a voltage rating
not exceeding 50 volts, would be subject to more stringent safety requirements.
This option will have a positive impact on consumers and other users.
For economic operators, the inclusion of
additional or stricter requirements for consumer product safety requirements in
comparison to the harmonised product safety requirements would not have any positive
impact on the problem of legal uncertainty caused by the application of two
differing sets of requirements for harmonised consumer products. If this option
were retained, economic operators whose products would be subject to harmonised
product safety requirements would have to check whether or not additional or
stricter consumer product safety requirements do not apply on top of the
harmonised product safety requirements. Clearly, this would not bring any
reduction of related information research or legal costs to any category of
economic operators.
Beyond that, if consumer product safety requirements
were to include on a permanent basis additional or stricter requirements in
comparison to the harmonised product safety requirements, it appears that this
would bring no further added value either in terms of effectiveness or
efficiency of market surveillance. For market surveillance authorities the
minimum requirements of identification of the manufacturer and/or importer and
the product appear to be sufficient for taking a speedy and effective action
against dangerous products "at source", i.e. against the producer who
put the dangerous product in question on the EU market, not against the distributor
at the end of the supply chain.
5.1.2.     Reducing ambiguity of product safety requirements for
non-harmonised consumer products
5.1.2.1.  Option
2.B – Direct applicability of ad-hoc safety requirements
One approach to the simplification of
pre-standardisation procedures under the General Product Safety Regulation
could consist in reinforcement of the ad-hoc safety requirements by making them
directly applicable. On the one hand, making ad-hoc safety requirements
directly applicable would make them stronger and more predictable, on the other
hand, it would not contribute to the coherence of preliminary EU procedures for
requesting standards. If ad-hoc safety requirements were to be reinforced, this
would very likely require a heavier procedure in terms of costs both for the
Commission and the Member States: as a result, the objective of a more
efficient procedure would not be attained which would, in turn, prevent the EU
from providing stakeholders with more European standards which ensure a uniform
application of product safety rules throughout the internal market.
5.1.2.2.  Option
2.C – Abolition of double adoption of the non-binding ad-hoc safety
requirements
If the procedure leading to the formal adoption
of non-binding ad-hoc safety requirements was simplified by the abolition of
double adoption, the length of the period of the preliminary procedure leading
to the establishment of mandates for developing EU standards would be
substantially reduced. Thus, the Commission could - with the necessary input
from the Member States – ask for inclusion of requests for developing European
standards under the General Product Safety Regulation into the general
standardisation working programme: the length of procedure leading to the
establishment of mandates for developing EU standards under the General Product
Safety Directive would become equal to the one under the New Approach
Directives. At the same time, this approach would preserve the general
character of the new Standardisation Regulation and thus contribute to the
clarity of procedures leading to the establishment of mandates for developing
European Standards.
5.1.2.3.  Option
2.D – Fast-track procedure for adopting already existing European standards
without mandates
The possibility of fast-track procedure
for granting presumption of conformity to existing European standards would
make it unnecessary to prepare and adopt mandates to the European
Standardisation Organisations asking them for development of a European
standard which already exists. In other words, where a European standard under
the General Product Safety Regulation was developed already by European
Standardisation Organisations outside of a mandate, it would not be necessary
to "re-create" such a mandate, but to simply decide that such a standard
does or does not comply with the general safety requirement. The artificial
"reverse engineering" of mandates for European standards would be
eliminated. Thus, allowing granting a presumption of safety for already
existing European standard developed by the European Standardisation
Organisation outside a mandate would further reduce the unnecessary
administrative burden hindering faster development of usable European standards
under the General Product Safety Regulation.
5.2.        Analysis of impacts of policy options under objective 2 (Better
coordination and increased effectiveness of market surveillance activities on
the single EU market for goods)
Further improvement of market
surveillance for products in the EU through an enhanced effectiveness of the efforts
by market surveillance authorities would have a deterrent effect on rogue
traders and would increase the detection of unsafe and/or non-compliant
products. Consequently, this, would lead to less unsafe and/or non-compliant
products becoming or remaining available on the market and to a general
positive impact on society (human health, environment, social protection). Yet, these effects would necessarily
be indirect so that it is impossible to estimate them precisely.[111]
5.2.1.     Reinforcing EU cooperation mechanisms
5.2.1.1.  Option
3.B – Coordination of cross-border enforcement of measures resulting from
"in the-field" market surveillance
Providing national market surveillance
authorities with tools for coordination of concrete reactive action would help
these authorities to cope with the growing globalisation of product supply
chains. Thus, these authorities would be able to 'reach out' over national
borders by effectively relying on assistance of market surveillance authorities
from other Member States. For example, being able to perform simultaneous checks on economic operators active in different Member
States would increase the effectiveness and coherence of market surveillance
action on the single EU market. This would in turn positively influence the
consistency of protection of consumers and other users within the Union. Therefore, this option will have a positive impact on
consumers and other users in the EU.
At the same time this option will improve
coherence of market surveillance practices across the Member State and provide a more level playing field for compliant economic
operators. As a matter of fact, in the public
consultation, 93% of national market surveillance authorities and 81% of
economic operators consulted agreed that more intensive information sharing and
cooperation between Member States would ensure more equal treatment of economic
operators by national market surveillance authorities throughout the EU with
respect to similar products[112].
This improvement could be considered a concrete positive impact on economic
operators, although not quantifiable[113].
This option will also have a positive
impact on compliant economic operators because an improvement of the
effectiveness of market surveillance will necessarily reduce the unfair competition
by non-compliant economic operators[114].
Conversely, the option would have a negative impact on those who, once the
marketing of their dangerous product has been stopped in one Member State, try to sell it to consumers in other Member States where at that moment it would
not yet have been prohibited. A negative impact of non-compliant economic
operators would, also, have a positive impact for consumers and other users due
to the increased level of safety as well as on compliant economic operators
thanks to the limitations of unfair competition from non-compliant economic
operators. It can be reasonably expected that the consequence of a more
coordinated market surveillance framework at EU level would reduce the size of
the category of economic operators "unwilling to respect the product
safety rules" since certain gaps in the EU market surveillance through
which these unscrupulous economic operators can currently escape would be
closed.
The costs of market surveillance
authorities might increase slightly due to the need to answer the request for
assistance (e.g. contact a specific economic operator based in the national
territory) by colleagues in other Member States, but the increase is expected
to be more than offset by the advantage of benefitting from this assistance.
5.2.1.2.  Option
3.C – Overall rationalisation of coordination of market surveillance activities
Option 3.C represents a more ambitious
development of Option 3.B: under Option 3.C not only reactive, but also
proactive market surveillance would be performed within a coordinated EU
framework. This is expected to further improve the overall performance of
market surveillance with respect to the previous option.
During the public consultation, 86% of
national market surveillance authorities and 96% of other stakeholders,
including consumer and business associations agreed that more intensive
information sharing and cooperation between Member States would further enhance
the safety of consumers throughout the EU[115].
In particular, the coordination of market surveillance activities of the
authorities of different Member States was appreciated, since it brings tangible
benefits for the enforcement activities at EU level: sharing of expertise with
other market surveillance organisations was quoted by the national market
surveillance authorities as the most visible benefit of these actions (95%),
followed by advice on interpretation issues (60%), joint press activities (49%)
and lower costs for surveillance activities, such as sharing of testing costs
(46%). The joint market surveillance actions caught the attention of 62% of
economic operators consulted, although a large majority of these operators
(91%) were not able to give opinions as to whether these actions brought
concrete benefits also to businesses[116].
The experience with
the functioning of the systematic coordination of pro-active market
surveillance activities of Member States has
shown that it cannot be effective and work
efficiently if it is performed on an ad-hoc basis lacking long-term perspective
and planning tools. Consequently, if systematic coordination is to produce
tangible added-value with impacts in concrete situations, it needs to be based on an EU defined framework, the functioning of
which would be supervised by the Commission. While this
systematic coordination has so far mainly focused on assisting the Member
States with the administrative activities for joint surveillance actions,
experience with horizontal projects[117]
has also shown that these projects are beneficial for raising the quality of
market surveillance and minimising differences between the Member States.[118] In particular, systematic
coordination of different market surveillance fora[119] could help resolve problems
of differing safety evaluation of identical products since more coherent
approaches could be reached at the EU level.
The new elements which would be introduced
to the pro-active market surveillance framework (establishment of a
coordination network, the streamlining of coordination groups and committees,
introduction of common reporting requirements, establishment of common
enforcement priorities at the EU level, including the joint market surveillance
actions) would bring benefits for a better organisation of the coordination of
the market surveillance framework at EU level compared to the baseline scenario
of the current situation.[120]
This option would have an important
positive impact on consumers and other users in the EU, as well as on compliant
economic operators for the same reasons explained under the previous Option 2.B.
However, since the intensity of coordination would be stronger than under the
previous option, the size of the impacts is also expected to be higher. Similarly,
a further reduction of the number of rogue operators could be foreseen.
Under of this option, market surveillance
authorities are not expected to bear more costs than under the previous one as
most coordination efforts will take place by using EU tools (exchange of
information tools, experts' groups meetings).
5.2.1.3.  Option
3.D - Centralisation of EU market surveillance in the area of non-food products
(creation of EU Market Surveillance Agency)
The centralisation of EU market
surveillance in the area of non-food products by the establishment of an EU
Market Surveillance Agency could be the next level of the integration of the
single EU market. This Option represents a higher degree of market surveillance
coordination integrating previous Options 2.B and 2.C so as to bring the
intensity of market surveillance and its coordination in the EU to the level
achieved in the food area.
On the one hand, the establishment of a
general auditing system regularly verifying the fulfilment of pre-established
common performance indicators and a European Market Surveillance Agency in the
non-food area would constitute a major leap forward in the establishment of a
common Union market surveillance framework for the internal market of goods.
On the other hand, the establishment of
such a highly advanced coordination framework, including the creation of an EU
Market Surveillance Agency in the area of non-food products, would entail very significant
costs due to the need for construction of coordination infrastructures and
capacity which currently do not exist at EU level. These costs would entail the
building and maintenance of the necessary infrastructure, such as (i) establishment
of a new EU Agency, (ii) hiring EU market surveillance inspectors able
to review the activities of national market surveillance authorities and
perform their peer assessment, (iii) providing the new Agency with facilities
necessary for performance of their activities etc. A precise estimate of these
costs is not possible. However, the order of magnitude can be imagined by
reference to existing agencies that carry out similar tasks, in particular the
European Food Safety Agency (EFSA) – performing pre-marketing approvals as well
as market surveillance functions - and the European Commission's Health and
Consumers Directorate-General directorate known as the Food and Veterinary
Office (FVO) performing market surveillance functions only (system inspection
activities). The annual budget of EFSA is estimated around 75 million EUR,
which is mainly allocated for carrying out risk assessment activities,
including scientific opinions and advice to provide support for policy making
at EU level, as well as to support the EU Member States in taking effective and
timely risk management decisions. The budget of FVO is estimated at around 30
million EUR annually. In this respect, it can be reasonably envisaged that the
total annual budget needed for an EU Agency responsible for risk assessment and
market surveillance of non-food products could be estimated to something
slightly less than the sum of the budget of the aforementioned too
institutions, i.e. slightly below EUR 100 million.[121]
Any EU Agency for market surveillance
could not replace the national systems who would certainly maintain a core advantage
in carrying out enforcement work in their own countries due to their specific
language and market knowledge, proximity and the fact that all individual
enforcement decisions are taken under national competences and procedures. Moreover,
from a financial point of view, national authorities already spend over 100 million
EUR[122]
on enforcement activities related to product safety. In spite of this, a
reduced capacity to tackle the overwhelming inflows of new products sold in the
EU every year is a recognised fact.
The creation of an EU Agency for market
surveillance would add a second layer of checks, potentially improving the
effectiveness of enforcement, but there are no guarantees and not even
reasonable indications that, from a financial point of view, the investment in
such a body would be justified and cost efficient in finding the unsafe
products among all the products that economic operators bring to the market
where there are no mandatory pre-marketing controls.
In the public consultation, the option of
the creation of an EU Market Surveillance Agency in the non-food product safety
area received only half-hearted support from market surveillance authorities,
consumer and business organisations. When asked about how the cooperation
between market surveillance authorities could be improved, both national market
surveillance authorities and consumer and business organisations, including
consumer and business associations, indicated in the first place the option of
the increase of financial support for joint market surveillance actions (81%
and 78% respectively), and in the second place the possibility of providing
more financial support for exchanges and training of the officials (56% and 71%
respectively). However, there was also support for the option of establishing a
coordination body ensuring cooperation at EU level between national authorities
(71%) and for the option of establishing more detailed rules for cooperation at
EU level (69%). With the national market surveillance authorities consulted,
this coordination body option ranked as third with the support of 54% of the authorities
consulted followed by the establishment of more detailed rules for cooperation
at EU level (42%).
In contrast, economic operators indicated in
the first place the establishment of a coordination body ensuring cooperation
at EU level between national authorities, although with relatively lower
support (40%) followed by obligatory participation of national market
surveillance authorities in joint actions and other possibilities (both 14%).[123]
In the public consultation 74% of
national market surveillance authorities consulted indicated that in the case
of divergent safety evaluations in different Member States in respect to
identical products, a repeat test in an additional laboratory would resolve the
problem of divergent safety evaluations. However, as far as economic operators
consulted were concerned 65% were unsure whether an additional test in such a
situation would bring the desired solution.
This option could be expected to have a
positive impact on consumers and other users in the EU, as well as on compliant
economic operators. At the same time it would significantly improve coherence
of market surveillance practices across the Member State and enhance the
possibilities of spreading know-how and best market surveillance practices.
Similarly to the previous option, it would have a negative impact on
non-compliant economic operators who, once the marketing of their dangerous
product was stopped in one Member State, try to sell it to consumers in other
Member States where at that moment it has not yet been prohibited.
The costs of market surveillance
authorities will definitely increase as working under the supervision of the EU
Agency would imply a reorganisation of current working methods and procedures.
5.2.2.     Making EU product safety procedures more coherent
In order to ensure rapid dissemination of
information on risky products throughout the EU, it has to be ensured that the
RAPEX system is used and applied in each Member State in the same way and that
it provides accurate, up-to-date and usable information for market surveillance
authorities of other Member States.
On the one hand, the costs of administration of the various
notifications provided by Member States to the Commission should be limited as
much as possible so that resources can be used for the on-the-field market surveillance
enforcement. On the other hand, the simplification of procedures and of the IT
systems could trigger an increase in their use (and potential higher costs for
Member States), but that would depend on each authority's own willingness to
make use of these facilities (beyond the unchanged legal requirements) and
their degree of involvement at that particular point in time. [124]
5.2.2.1.  Option
4.B – Simplification of the RAPEX procedure
Main stakeholders overwhelmingly see the positive role of the RAPEX
system in the product safety area and consider that it contributes to better
protecting the consumers throughout the EU.[125] The
notification criteria could be simplified and a clearer obligation to have an
effective follow-up could be put in place. According to respondents, changes
limited to the RAPEX notification criteria, or making them more precise, would
not make the notification process easier.[126]
5.2.2.2.  Option
4.C – Simplification of the RAPEX procedure and streamlining of that procedure
with the safeguard procedure
The RAPEX procedure and the safeguard
procedure could be streamlined so that only one notification for both
procedures would be necessary. Once received and treated under the RAPEX
procedure, other Member States would have the possibility to raise an objection
to such measure notified, in particular in the case of a difficult risk
assessment, and thus trigger the Union safeguard procedure at the end of which
the Commission will decide whether the adoption of the notified measure was
justified or not.
5.2.3.     More
effective EU-wide action
5.2.3.1.  Option
5.B – Extension of the scope of EU-wide product safety measures to non-consumer
products
The extension of the scope of EU-wide
product safety measures to harmonised non-consumer products is a natural
consequence of the creation of a single horizontal regulation of market
surveillance of non-food products.
5.2.3.2.  Option
5.C – Making EU-wide product safety measures directly applicable
The option of making EU-wide product safety measures directly
applicable would provide for clear benefits to all stakeholders: it would (i) provide
a clear legal basis for authorities to enforce the obligations laid down in
these measures without having to engage in the sometimes cumbersome formal transposition
of these measures into national laws, and (ii) save economic operators the cost
of searching for different national versions of the obligations resulting from
the differing implementation of these EU-wide product safety measures. Also,
this solution would prevent unscrupulous economic operators from off-loading
and marketing products not complying with the EU-wide product safety measures
in those Member States where the delays in formal implementation of
such measures on national prevent effective enforcement of such measures by
national market surveillance authorities. The speedier and more uniform
application of EU-wide product safety measures would also benefit consumers
since they would be protected in all Member States at the same moment and the
risk posed by the products subject to these measures could be eliminated
earlier and, thus, ensure more effective protection of consumers throughout the
EU.
5.2.3.3.  Option
5.D – Removal of the limitation of the period of validity of EU-wide product
safety measures
Whereas the option of extending the validity of EU-wide product
safety measures offers only a partial remedy, an additional alternative of
determining the validity of EU-wide product safety measures in those measures
on a case-by-case basis, would completely dissipate the concerns of
stakeholders with respect to the unpredictability of EU product safety measures.
5.2.3.4.  Option
5.E – Combination of options 5.B, 5.C and 5.D
Combination of options 5.B, 5.C and 5.D would provide for the most
effective and powerful solution for establishing a uniform EU product safety
requirements for the determined type of a product or groups of products.
5.3.        Impacts on the EU budget
The EU financial support for the initiatives included in the
proposal comes from a) Title 2 - Enterprise, Chapter 02 03: Internal market for goods and sectoral policies and
b) Title 17 – Health and consumer protection – Chapter 17 02: Consumer policy
of the ABM: Activity-Based Management – ABB: Activity-Based Budgeting
Structure.
The operational budget for the activities under the responsibility
of DG Enterprise is estimated at EUR 1.3 million from the internal market
budget line (Guidelines, technical expertise and assistance, cooperation with
third countries, support to market surveillance authorities (ICSMS)
The operational budget for the activities under the responsibility
of DG Health & Consumers is estimated at EUR 3 million, everything already
budgeted in the 2014-2020 Consumer Programme (Market surveillance and
enforcement actions - joint actions, exchange of officials, the functioning of
RAPEX, funding of the Market Surveillance Forum Secretariat).
5.4.        Other impacts
Finally, as to the other indirect impacts, such as health, social
and environmental impacts, the expected increased compliance resulting from
better and more coherently defined product requirements and more effective
market surveillance could also have a positive influence on health, social and
environmental impacts.
6.           COMPARING
THE OPTIONS
6.1.        Comparison of policy options under objective 1
(Consolidation and reinforcement of EU product safety rules)
6.1.1.     Ensuring consistency of EU product safety requirements
In order to provide consumers and other
users with an equally high level of protection against unsafe products throughout
the EU as well as to prevent barriers on the EU internal market, the EU product
safety rules must be clear and compatible across different product sectors.
The comparison of Option 1.B, on the one
hand, and Options 1.C and 1.D, on the other hand, consists of assessing whether
it is preferable – in terms of costs and benefits for the various stakeholders
- to align consumer product safety requirements with harmonised product safety
requirements or whether to define these two sets of requirements differently.
This assessment is performed in the light of criteria of legal clarity and
certainty, information research costs and effectiveness of market surveillance.
Aligning the consumer product safety
requirements with the harmonised products safety requirements would bring the
desired clarity and legal certainty. The compatibility of consumer product
safety requirements with the harmonised products safety requirements would
eliminate unjustified information-research costs resulting from the
difficulties in determination of the applicable product safety requirements
with respect to individual products. Clear product safety requirements applying
across the sectors would also contribute to the non-discriminatory treatment of
economic operators by the market surveillance authorities of different Member
States while allowing market surveillance authorities to track down
non-compliant economic operators more quickly and at a lesser cost. Last but
not least, it would contribute to the equal protection of consumers and other
users against dangerous products.
The introduction of consumer product
safety requirements which would be defined differently than harmonised EU
product safety requirements, irrespective of whether less strictly (Option 1.C)
or more strictly (Option 1.D) - would have a similar effect as the no action
option: it would raise the information research costs for economic operators,
contribute to the incoherent application of product safety rules, and in the
end create potential for further obstacles to the EU internal market.
Table 11: Comparison of the options against the
baseline scenario
                      Options Issues || Option 1.B || Option 1.C || Option 1.D 
 Safety of consumers || ++ || - || ++ 
 Legal clarity and certainty || ++ || + || - 
 Market surveillance effectiveness and efficiency || ++ || -- || + 
Table 12: Comparison of the change in costs for
economic operators compared to the baseline scenario
                     Options Cost types || Option 1.B || Option 1.C || Option 1.D 
 Information research costs/legal costs || Decrease || Slight decrease || 0 
 Production costs || 0* || 0 || Increase 
* slight increase except for a very small
group of producers.[127]
Preferred option: Option 1.B - Alignment of consumer product safety requirements with
harmonised product safety requirements
6.1.2.     Reducing ambiguity of product safety requirements for
non-harmonised consumer products
The policy options aimed at reduction in
the ambiguity of product safety requirements for non-harmonised consumer
products are benchmarked according to the criteria of rapidity of procedures
leading to the establishment of mandates for developing of European standards
under the general product safety rules and the coherence of these procedures
with the general standardisation regime under the Standardisation Regulation
1025/2012 and the costs to public administration, including that of Member
States and of EU institutions.
Option 2.B keeps the middle step of the preliminary procedures
leading to the establishment of mandates for developing EU standards and makes
it a cornerstone for the whole process of preparation of a request to develop a
European standard integrating additional decision on the mandate to be sent to
the European Standardisation Organisation. As a result, a separate procedure
for preparation of requests for standards independently of the regime foreseen
under the Standardisation Regulation 1025/2012 would have to be created, since
such approach would not be compatible with the procedures set out in this
regulation.
In Option 2.C the length of the period of the preliminary procedure
leading to the establishment of mandates for developing European standards
would be substantially reduced since the formal decisions on setting the ad-hoc
safety requirements, would no longer exist. Thus, the Commission could - with
the necessary input from the Member States – ask for direct inclusion of
requests for developing European standards under the general product safety
rules into the general standardisation working programme: the length of
procedure leading to the establishment of mandates for developing EU standards
under the general product safety rules would become equal to the one under the
New Approach Directives. At the same time, this approach would preserve the
general character of the new Standardisation Regulation and thus contribute to
the clarity of procedures leading to the establishment of mandates for
developing European Standards.
Option 2.D – building upon Option 2.C – would further
reduce the length and administrative burden of standardisation procedures under
the general product safety rules since, in addition to the simplification
foreseen under Option B – it would provide for a fast-track
procedure for already existing European standards: where the European standard
already exists and in the view of the Commission and the Member States it conforms
to the general product safety requirements, it would not be necessary prepare
and adopt the request to the European Standardisation Organisations for
development of such a an existing European standard. However, the approach of
Option 2.D would not be coherent with principles of general standardisation
under the Standardisation Regulation 1025/2012 which does not foresee the
possibility that a European standard could provide for the presumption of
conformity upon its publication in the Official Journal if it was not
established on the basis of a mandate issued by the European Commission.
In terms of rapidity and administrative burden reduction Options 2.C
and 2.D. can be considered to be superior both to Option 2.B. Between Options
2.C and 2.D produce the criterion of coherence of procedures for requesting
standards favours Option 2.C to Option 2.D.
Table 13: Comparison of options against the
pre-defined criteria
                   Options Criteria || Option 2.B || Option 2.C || Option 2.D 
 Rapidity || - || + || ++ 
 Coherence || - || + || - 
 Costs for authorities (including national authorities and EU) || Unchanged || Decrease || Decrease 
Preferred option: Option 2.C – Abolition of formal adoption of the non-binding
ad-hoc safety requirements
6.2.        Comparison of policy options under objective 2 (Better
coordination and increased effectiveness of market surveillance activities on
the single EU market for goods)
6.2.1.     Reinforcing EU cooperation mechanisms
The comparison of impacts of envisaged policy options is assessed
against the benchmarks of effectiveness of market surveillance, its efficiency
in terms of attaining the highest possible level of safety with the given
amount of resources and the potential of ensuring seamless market surveillance
for the single EU market.
Option 3.A maintaining the market surveillance framework in the
existing form in the future would mean that it would neither be able to ensure a
high level of protection and safety of consumers and other users throughout the
EU, nor would it safeguard the proper functioning of the single EU market. As
such, it offers sub-optimal solutions in comparison with the other three
options.
Option 3.B is an option of minimum progress with the existing
resources. This minimum progress consists of providing market surveillance with
tools for cross-border market surveillance which are already successfully used
in other areas of consumer protection, in particular the possibility to
coordinate reactive market surveillance actions, such as inspections, product
checks etc.
Unlike Option 3.B, Option 3.C represents an option of maximum
progress with existing resources. It provides for the rationalisation of
coordination of the reactive as well as the proactive market surveillance while
keeping the existing decentralised model of market surveillance under which
concrete market surveillance measures are taken by national market surveillance
authorities. The burden of ensuring the rationalisation of market surveillance
coordination would be mostly borne by the European Commission. The principal
vehicle for carrying out the rationalisation of market surveillance
coordination in the EU would be the multi-annual market surveillance plan.
In contrast to Options 3.B and 3.C intending to do more with the
same amount of resources, under Option 3.D a delivery of much higher benefits
for the single EU market and safety could be expected on the assumption that substantial
investments were committed into building a centralised EU framework for market
surveillance in the area of non-food product safety. If the EU possessed its
own market surveillance enforcement staff which could perform peer evaluation
of market surveillance systems and authorities in any Member State, it can be
reasonably expected that the safety of consumers and other users as well as the
functioning of the single EU market could be better safeguarded. However, in
view of the high amount of resources implied by this option, the concrete efficiency
of centralisation of EU market surveillance is difficult to estimate. 
However, as highlighted above, even under the Option 3.D, only
certain activities, such as system inspections, peer reviews of the quality of
functioning of market surveillance authorities in Member States, monitoring of
the coordination between enforcement authorities and national RAPEX contact
points, could be moved to the central EU level. By contrast, core market
surveillance actions, such as on-the-site inspections of manufacturers,
importers and distributors, testing of products, risk assessment, risk management
would have to stay on the national level.
On the basis of the above, Option 3.C seems to be the most
appropriate for fulfilling the objective of achieving a coherent and seamless
framework for decentralised market surveillance for the single EU market: in
terms of benefits it is superior to Option 3.B, although potentially inferior
to Option 3.D; in terms of costs it is equal to Option 3.B, but largely
superior to Option 3.D.
Table 14: Comparison of the options against
the baseline scenario
                        Options Issues || Option 3.B || Option 3.C || Option 3.D 
 Safety of consumers/users || + || ++ || ++ 
 Competitiveness of compliant economic operators || + || ++ || ++ 
 Effectiveness of market surveillance || + || ++ || +++ 
 Efficiency of market surveillance || + || ++ || + 
 Potential of harmonisation of enforcement approaches on the internal market || + || ++ || +++ 
Table 15: Comparison of the change in costs for public
authorities compared to the baseline scenario
                 Options Cost types || Option 3.B || Option 3.C || Option 3.D 
 Costs for national market surveillance authorities || Slight increase || Slight increase || Increase 
 Costs for the EU || Slight increase || Slight increase || High increase 
Preferred option: Option 2.C – Rationalisation of the overall coordination of
decentralised market surveillance on the single EU market.
6.2.2.     Making EU product safety procedures more coherent
The compared options are benchmarked against the criteria of
effectiveness in tracking dangerous products and the efficiency of
administration of the functioning of the EU notification procedures for Member States and the
Commission.
If the functioning of the RAPEX procedure
was simplified as foreseen under Option 4.B, but without a parallel
streamlining of the RAPEX procedure with the safeguard procedure, Member States
would still have to provide the Commission with separate notifications for the
purposes of the two procedures.
Under Option 4.C both streamlining
of the EU notification procedure and simplification of the RAPEX procedure
would take place. In comparison with Option 4.B the
administrative burden related to the administration of notifications for the
RAPEX and safeguard procedure would decrease. As a result, the Option 4.C would
guarantee that all the measures restricting or preventing marketing of
dangerous products are notified to the Commission and that each such
notification received appropriate treatment depending on the seriousness of the
risk and completeness of the information while reducing the administrative
costs relating to the notification process both for the Commission and the
Member States.
Given that the effectiveness in tracking unsafe products on the
internal EU market remains identical under both Options 4.C and 4.B, since
under both options simplification of RAPEX notification conditions would be
able to achieve that objective, Option 4.C appears to be superior to Option
4.B.
Table 16: Comparison of the change compared to the
baseline scenario in relation to public authorities
                  Options Benchmarks || Option 4.B || Option 4.C 
 Effectiveness in tracking down unsafe products || Increase || Increase 
 Costs for national market surveillance authorities || Slight decrease || Decrease 
 Costs for the EU || 0 || Decrease 
Preferred option: Option 2.C – Simplification of the RAPEX procedure and
streamlining of that procedure with the safeguard procedure
6.2.3.     More
effective EU wide product safety action
To fulfil the objective of safeguarding prompt
and effective action at the EU-level for safety against risks in situations
where the individual action of Member States fails to provide a coherent
response, the EU product safety measures have to be rapid, predictable and
capable of being effectively applied by national market surveillance
authorities.
The position of stakeholders towards the envisaged actions under option
5.B, 5.C and 5.D aimed at making the implementation of EU product safety
measures more predictable and uniform was positive. Responding national market
surveillance authorities expressed large support for direct applicability of EU
product safety measures and for the extension of the duration of such measures
until a future permanent solution is adopted.[128]
Respondents considered it important that the EU product safety measures be very
clearly described, including technical details, such as test methods, in order
to ensure even implementation by all authorities in all Member States.
According to responding economic operators compliance with EU product safety
measures would be easier (i) if these measures were directly applicable to
economic operators and/or (ii) if they were linked to a clearly defined
permanent solution (e.g. adoption of a standard or of primary legislation) or
if their validity could be extended to a fixed period of up to three years
(with equal subsequent prolongation periods).[129] A
large majority of respondents saw no problem if EU product safety measures were
made directly applicable to economic operators.[130]
Making EU product safety measures directly applicable combined with
the possibility of adopting these measures for a period specified on a
case-by-case basis fulfils best the criteria of rapidity, effectiveness and
predictability. The EU product safety measures would become directly applicable
so that market surveillance authorities could take enforcement measures on the
basis of these EU measures without having to wait until the moment when these
measures would be formally taken over to a national legislative measure or
regulation or having to resort to unsystematic "ad-hoc" individual
solutions generating a great deal of legal uncertainty while waiting for the
adoption of the formal national measure. 
Table 17: Comparison of options 5.B, 5.C and 5.D
against pre-defined criteria
                   Options Criteria || Option 5.B || Option 5.C || Option 5.D || Option 5.E 
 Rapidity || 0 || + || + || ++ 
 Predictability || 0 || 0 || + || ++ 
 Effective application || + || ++ || 0 || +++ 
Preferred option: Option 5.E – Combination
of options 5.B, 5.C and 5.D
6.3.        Overview of preferred options in the light of the
objectives
 GENERAL OBJECTIVES || SPECIFIC OBJECTIVES || PREFERRED OPTIONS 
 Reduction of the number of unsafe or non-compliant products on the single EU market || Consolidation and reinforcement of EU product safety requirements || Option 1.B – Aligning consumer product safety requirements with harmonised product safety requirements 
 Option 2.C – Abolition of double adoption of the non-binding ad-hoc safety requirements 
 Simplification of the EU legislative framework || Adoption of a single horizontal regulation for market surveillance 
 Abolition of Directive 87/357/EC which by appearing other than they are endanger the health and safety of consumers 
 Better coordination and increased effectiveness of market surveillance activities on the single EU market for goods || Option 3.C – Coordination of reactive market surveillance and rationalisation of coordination of pro-active market surveillance 
 Option 4.C – Simplification of the RAPEX procedure and streamlining of that procedure with the safeguard procedure 
 Option 5.E – Combination of options 5.B, 5.C and 5.D 
6.4.        Form of the legislative instrument
It is suggested that the selected options
would be reflected in two different legal instruments. Problem 1 would be
solved through an adoption of the Consumer Product Safety Regulation which
would be aligned with the respective provisions of Annex 1 of Decision (No)
768/2008/EC[131].
Problem 2 would be addressed by a new Regulation on market surveillance for
non-food products that would constitute the main instrument for product market
surveillance. Provisions on market surveillance in the EU internal market
legislation which are currently scattered over several Directives and Regulations
would be replaced by the provisions of this new Regulation. A Regulation, being
directly applicable upon Member States, would achieve a very high degree of
harmonisation of the rules on market surveillance and would empower market
surveillance authorities to act immediately in case of unsafe consumer products
or non-compliance, without the need for transposition of these rules into
different national laws. More details about the simplification of the
legislative framework can be found in Annex 15.
Whereas the
Regulation on market surveillance would continue to keep the form of a
Regulation, the General Product Safety Directive would be converted into a
Regulation. Where the Treaties do not specify the type of act to be adopted in
a certain field, the EU institutions shall select it on case by case basis and
in compliance with the principle of proportionality.[132] A regulation is directly
applicable in all Member States; there is therefore, no need for Member States
to transpose EU legislation into national law and no need to provide them with
time to do so. Possible national differences regarding the date and/or manner
of transposition would be eliminated, which would facilitate consistent
enforcement and a level playing field in the internal market. A regulation
better ensures that legal requirements are implemented at the same time
throughout the Union; it also better achieves streamlining of terminology,
important for defining the scope of the legislation, thereby reducing
administrative burdens and legal ambiguities.
Table 18:
Overview of the proposed EU regulatory framework in the area of non-food
product safety
 Overview of the proposed EU regulatory framework under the Product Safety and Market Surveillance Package ||
               Products   Areas || Non- Harmonised || Harmonised ||
 Non-consumer || Consumer || Non-consumer ||
 Obligations of economic operators ||   || Consumer Product Safety Regulation || Sector specific Union harmonisation legislation ||
 Market surveillance on the internal market* || Regulation 764/2008 ||     Regulation on market surveillance ||
   ||
 RAPEX* ||
 Market surveillance Controls on products imported to the EU* ||   ||
7.           MONITORING
AND EVALUATION
Apart from the evaluation of the
legislative instrument after 4 years of implementation, the monitoring of the
application of EU product safety rules will be performed through the collection
of relevant information from (i) the Eurobarometer surveys relating to consumer
safety (ii) GRAS-RAPEX information system, (iii) the general information
support system (ICSMS) and (iv) the Enforcement Indicators monitoring activity
which surveys certain parameters of market surveillance in Member States. The
European Injuries Database cannot be used for the evaluation of the
implementation of the Product Safety and Market Surveillance Package since the
data stored therein is of relatively small relevance for policy purposes. In
particular, the current data on accidents and injuries do not reflect whether
these accidents or injuries were caused by products or by other factors as well
as whether these accidents or injuries were caused by safety defects of
products or by their misuse by their user.[133]
Eurobarometer surveys collect perceptions
of safety of products from consumers and economic operators. This perception
may be a relevant indicator of whether the operational objectives of ensuring
consistency of EU product safety requirements and reducing ambiguity of product
safety requirements for non-harmonised consumer products have contributed to
the increased level of safety of consumer products.
The question to what extent the
fulfilment of these operational objectives has also positively influenced the
costs compliance of economic operators with the EU product safety measures
could be indirectly estimated through various ad-hoc studies performed in
particular by industry.
Regarding the objectives related to the
better coordination and increase in effectiveness and efficiency of market
surveillance on the single EU market, the fulfilment of these objectives could
be demonstrated by the collection of relevant information from the existing IT
systems and the Enforcement Indicators monitoring activity.
The GRAS-RAPEX information system
(launched in May 2012) will collect information on measures taken against
products posing risks, including serious risks, provided by Member States to
the Commission within the framework of the RAPEX procedure. This information
will be accessible through the weekly postings of the lists of measures taken
in Member States as well as through the RAPEX Report (published annually since
2004) which includes aggregated data sets on information obtained from RAPEX
Contact Points of Member States.
[1]               COM (2008) 905 final.
[2]               Report
on the revision of the General Product Safety Directive
and market surveillance (2010/2085(INI)), European Parliament, Committee on the
Internal Market and Consumer Protection, Rapporteur: Christel Schaldemose.
[3]               European
Parliament resolution of 8 March 2011 on the revision of the General Product
Safety Directive and market surveillance (2010/2085(INI)), P7_TA (2011)0076.
[4]               The
future of market surveillance in the area of non-food consumer product safety
under the General Product Safety Directive", Final Report, March 2011, BSI
Development Solutions, May 2011.
[5]               http://ec.europa.eu/consumers/safety/projects/market_surveillance_enforcement_en.htm
[6]               This
impact assessment does not relate to agricultural or food and feed products. It
concerns primarily the other industrially manufactured products for which the
EU adopted harmonisation rules for specific categories of products and the
General Product Safety Directive 2001/95/EC for consumer products. This set of
EU rules has put in place product safety requirements for a large number of
products, while the free movement provisions of the Treaty and the mutual
recognition principle govern the remaining product categories.
[7]               A
summary of the applicable EU rules and the description of main categories of
so-called harmonised products, non-harmonised products, consumer and
professional products are set out in Annex 8.
[8]               1. A complex legal framework that requires revision "With the adoption of the legislative package on the Free
Movement of Goods (also called the “Goods Package”), the EU regulatory
landscape on product safety and market surveillance has become very complex and
confusing. As part of this package, Regulation 765/2008/EC (“Regulation”) sets
forth new rules for the market surveillance of products subject to harmonized
EU legislation, and Decision 768/2008/EC provides rights and obligations on
business operators related to product safety that can be used by the legislator
in the adoption of legislation on specific products, as has been done recently
in the new Directive on Toy Safety and the new Regulation on Cosmetic Products […] The real confusion comes for
consumer products that are subject to harmonized EU rules, such as toys and
cosmetics products, which are subject to both the GPSD and the Regulation, as
well as the specific provisions included in the specific (toys, cosmetic) regulations
in place. To determine which provisions of each
of these three sets of rules apply (e.g. safety definition, notification
requirements for products presenting a risk, right and obligations of business
operators and market surveillance authorities, etc.) a case-by-case analysis is
necessary to determine which provision is “more specific” than the other. This creates a situation of legal uncertainty which is very unfortunate
given that it concerns essential legal provisions that are applicable in critical
situations, for example when companies and authorities need to decide on
product withdrawals and recalls." (MayerBrown,
The Revision of the EU General Product Safety Directive, Memorandum, January
2011).
[9]               In
the summer of recalls of 2007 various economic operators had to recall a large
number of consumer products in the United States as well as in the European
Union, in particular toys, because of presence toxic substances in these
products. 
[10]             Art.
22 (4) of Regulation (EC) No 765/2008.
[11]             Art.
15 (3) of Regulation (EC) No 765/2008.
[12]             The
definition of the relationship between the market surveillance provisions of
reference provisions of Annex 1 of Decision No. 768/2008/EC, in particular its
Article R31, and the market surveillance provisions of the General Product
Safety Directive was not defined at all.
[13]             European
Commission, Working Paper on the Relationship between the General Product
Safety Directive 2001/95/EC and the market surveillance provisions of
Regulation (EC) No 765/2008, 2 March 2010.
[14]             Another
source of complexities and difficulties with the application of the General
Product Safety Directive and Regulation (EC) No 765/2008 resulted from the
reversal of the order of application of these two instruments. This came about
in the final phases of the co-decision procedure in the Council and the
European Parliament relating to the adoption of the New Legislative Framework.
[15]             Article
40 of Regulation (EC) No 765/2008.
[16]             (COM
(2012) 573 final).
[17]             (COM
(2010) 2020 final).
[18]             (COM
(2012) 225 final).
[19]             A
detailed description of the organisation of market surveillance in Member
States is contained in Annex 2 to the Report on the implementation of
Regulation (EC) No 765/2008.
[20]             As
a general rule, this safeguard clause procedure is restricted to products which
are covered by 'New Approach directives', CE marked and ascertained by the
Member State to present a substantial risk, even if the products are correctly
constructed, installed and maintained, and used according to their intended
purpose. This procedure was originally designed to allow the Commission to
analyse the justification of national measures restricting the free movement of
CE marked products (products presumed to comply with requirements). The
Commission is responsible for administering the safeguard clause at Union
level, and for ensuring that it applies to the whole of the EU. To this end,
the Commission consults the interested parties to verify whether or not the
action that invoked the safeguard clause can be justified. 
[21]             The
safeguard clause procedures are drafted differently in the various directives.
Yet, Decision 768/2008/EC.
[22]             This
figure is given by the sum of production value for the big electrical
mechanical, mechanical engineering, automotive, chemical, and medical devices
sectors. A detailed description of the methods of determination of this value,
as well as of the total value of consumer products market on the single EU
market can be found in Annex 7.
[23]             According
to the European Commission's interim economic forecasts
published in September 2010. 
[24]             According
to a Commission Communication of 9 November 2010, by 2015, 90 % of world growth
is expected to be generated outside Europe, one third by China alone. Cf. Trade, Growth and World Affairs — Trade Policy as a Core Component of the
EU's 2020 Strategy; http://trade.ec.europa.eu/doclib/press/index.cfm?id=636&serie=382&langId=en
[25]             With
the exception of food, pharmaceutical and medical devices, which are covered by
other mechanisms) or to certain other public interests. 
[26]             Detailed
information the functioning of RAPEX can be found in Annex 9.
[27]             An
illustrative comparison of the notifications of measures taken against unsafe
products between the non-food sector and the food and feed sector can be made,
in particular in relation to the notifications provided to the European
Commission under the Rapid Alert System for Food and Feed (RASFF). However, it
has to be borne in mind that due to certain differences in the legislative
frameworks for the two areas different types of measures are notified through
the two different systems. Detailed information about measures taken against
food and feed products (RASFF) can be found in Annex 9 (section 9.7).
[28]             Not
all measures taken by national authorities are supposed to be notified to the
Commission. Also, since one measure can cover more than one product or one type
of a product, the number of products taken off the EU market is higher than the
number of measures notified to the Commission.
[29]             This information was provided by 23 EU Member
States, Norway and Iceland. More detailed information about enforcement
indicators can be found in Annex 10.
[30]             The
European Injury Database (IDB) is the only data source that contains
standardised cross-national data for developing preventive action against home and
leisure accidents in the EU (in 2009, 12 Member States
participated in the IDB database). The IDB is based on
a systematic injury surveillance system that collects accidents and injury data
from selected emergency departments of Member State hospitals, providing a
complement to and integrating existing data sources, such as common causes of
death statistics, hospital discharge registers and data sources specific to injury
areas, including road accidents and accidents at work. However European Injury
Database does not (i) give up to date information, (ii) provide a direct link
to victims, (iii) identify the full product details, (iv) allow for testing of
the actual product. The distribution of injuries according to product
categories is compiled on the basis of varying samples in the Member States
(e.g. 4 000 injuries in Belgium and 296 000 injuries in the Netherlands). This limits the comparability of data between countries. Moreover, the number
of injuries in each country is not exhaustive which makes it impossible to
estimate the number of injuries of a certain type per 1000 inhabitants in a
certain country. More detailed information on IDB can be found in Annex 9 (section
9.5).
[31]             SEC
(2007) 173. The figures contained in this document should however be
interpreted with prudence due to the difficulty of estimating non-compliance
and comparing it across sectors.
[32]             An
effective application of the free movement principle in the product safety area
requires that the determination of whether a product is safe or not - and thus,
whether it should stay on the market or be removed thereof - is performed in
the same way in all Member States. 
[33]             Differing
interpretations of product safety requirements laid down in particular in the
European harmonised standards or different national safety perceptions result
in an identical product being considered safe in one Member State, but not in the other, which represents a source of friction between market surveillance
authorities, consumer organisations and economic operators. 
[34]             Consumer
consumption represents 56% of the GDP of the European Union. Consumers'
confidence is a key element for ensuring a sustained level of consumer
consumption which, in turn, is essential for generating economic growth and the
proper functioning of the EU market. 
[35]             Data
collected through Eurobarometer questionnaires addressed to roughly 30,000
consumers and 7,000 retailers across the EU, show that the safety of products
is one of the most important considerations when consumers make purchasing
decisions (second after price, but ahead of brand or country of origin).
[36]             For
more details see Annex 9 (section 9.6).
[37]             For
more details see Annex 7 (section 7.3, Table 6) and Annex 14.
[38]             PROSAFE
(the Product Safety Enforcement Forum of Europe) is a voluntary association of
market surveillance officers of various EU Member States functioning since
1990.
[39]             IFIA
(International Federation of Inspection Agencies) is a federation of
organizations that provide testing, inspection and certification services,
internationally, established in 1982, with global membership of 40 testing and
inspection companies.
[40]             IFIA CIPC, Product Safety
in Europe, Results from the 2012 Study, November 2012. For more details se
Annex 7 (section 7.3, Table 7).
[41]             In
the public consultation,  a large majority (90%) of economic operators
responding indicated that they take into account the differences between the
consumer product safety requirements and the harmonised product safety
requirements. For 33% of these economic operators, these differences
represented additional costs for their businesses. The economic operators
responding mostly indicated that in general cost of diverging legislation and
resulting differing application is non-negligible, but impossible to quantify. 
[42]             The
reason for this is twofold: first, the costs of complying either with the
consumer product safety requirements or harmonised safety requirements or both
represents only a small fraction part of general compliance costs and in
general it is impossible to establish the percentage which the costs of product
safety requirements represent of the overall compliance costs; second, the
product safety compliance costs are composed of costs of the aforementioned
general non-risk related obligations and costs of specific risk-related
requirements, usually contained in the detailed technical standards. Since the
consumer product safety requirements as well as the harmonised product safety requirements
concern only the costs attributable to the general non-risk related
obligations, in theory these two costs components should be clearly
distinguished. In practice, however, these different costs components are
impossible to dissociate. Moreover, since the latter product specific
risk-related technical requirements will usually impose certain technical
solutions, the costs generated by these requirements would largely prevail over
the costs of the general non-risk related obligations.
[43]             Court of Justice of the European Union, judgement of 30 April 2009 (reference for a preliminary ruling
from the Fővárosi Bíróság (Republic of Hungary)) — Lidl Magyarország
Kereskedelmi bt. v Nemzeti Hírközlési Hatóság Tanácsa, OJ C 153,
4.7.2009, p. 12–13.
[44]             Directive
1999/5/EC of the European Parliament and of the Council of 9 March 1999 on
radio equipment and telecommunications terminal equipment and the mutual recognition
of their conformity OJ 1999 L 91, p. 10.
[45]             The
ambiguous formulation of the identification obligation has led to the situation
where certain Member States oblige producers to indicate information enabling
either the identification of the products and/or the product whereas in other
Member States ensuring the identification of the product and the producer
remain optional.
[46]             Sector
specific New Approach Directives and General Product Safety Directive.
[47]             For more details see Annex 7 (section 7.3).
[48]             There
is a widely shared perception amongst stakeholders that market surveillance is
not sufficiently active and rigorous. The fragmentation of market surveillance
has an important impact on its efficiency and effectiveness. It also leads to
unequal protection of European consumers and other users and to an uneven
playing field for economic operators.
[49]             The
lack of effectiveness of market surveillance in the single EU market has also
other grounds, such as the difficulty to trace economic operators in an
increasingly globalised market, the limitation of resources of surveillance
authorities , particularly in times of economic crisis, the growing number of
imports of non-food products from third countries.
[50]             Description
of the main objectives for achieving an effective coordination of market
surveillance activities in the single EU market Annex 8 (section 8.4, Table 6).
[51]             Based
on the assumption that each consumer product is sold in all 30 EEA Member States.
[52]             Based
on the assumption that market surveillance authorities of each EEA Member State are able to detect any product sold in another EEA Member State.
[53]             Only
"serious risk notifications" and reactions to them are taken into
account, since for "non-serious risk" notifications, there is no
obligation to send reactions under the current RAPEX rules.
[54]             184
notifications between 1994 and 2004 when no IT system supporting the procedure
for exchange of information existed.
[55]             https://reis.ec.europa.eu
[56]             https://webgate.ec.europa.eu/sanco
[57]             The
abbreviation of ICSMS stands for internet-supported
information and communication system for the pan-European market surveillance.
[58]             The study "The future of market
surveillance in the area of non-food consumer product safety under the General
Product Safety Directive", Final Report, March 2011, BSI Development
Solutions, May 2011, p. 13.
[59]             Certain
differences appear to exist between Member States as regards enforcement in
specific cases. For instance in the electro-technical sector, 80% of economic
operators having participated in a public consultation in 2010 considered that
the same product can be withdrawn from the market or otherwise restricted in a
Member State and circulate freely in another. Public consultation on the
alignment of nine Directives to Decision 768/2008/EC. http://europa.eu/rapid/pressReleasesAction.do?reference=IP/11/1385&format=HTML&aged=0&language=EN&guiLanguage=en
[60]             Regulation
(EC) No 2006/2004 on cooperation between national authorities responsible for
the enforcement of consumer protection laws (the Regulation on consumer
protection cooperation) OJ L 364, 9.12.2004, p. 1.
[61]             Directive
2006/123/EC on services in the internal market OJ L 376, 27.12.2006, p. 36.
[62]             The
differences in market surveillance frameworks in these areas are illustrated in
Annex 8 (section 8.4, Table 7). 
[63]             Art.
11 (1) and Art. 12 (2) of the General Product Safety Directive; Art. 22 (1) and
23 (1) Regulation (EC) No 765/2008.
[64]             Art.
12 (2) of the General Product Safety Directive.
[65]             Art.
12 (1) sub-p. 1 of the General Product Safety Directive.
[66]             Art.
12 (1) sub-p. 4.
[67]             See
Annex 2; 9% of authorities were not able to determine the percentage of
measures taken which are actually notifies to the Commission. This can be
explained by the fact that certain of the authorities consulted did not have
the information about the number of measures notified to the Commission since
they did not perform at the same time the role of national RAPEX Contact Point
which collects the notifications on the national level and sends them to the
Commission.
[68]             The
ambiguity of the notification criteria caused that national authority were
unsure whether a given measure should or should not be notified under the RAPEX
procedure. In such situations of ambiguity national authorities prefer not to
notify the measure rather than risk refusal of the notification by the
Commission.
[69]             For
more details, see Annex 2 (section 2.2.3.3).
[70]             See
the notification conditions contained in Art. R31 (2) and (4) of Annex 1 of
Decision (EC) No 768/2008.
[71]             The
figures on the number of safeguard clause notifications in the different
sectors can be found in Annex 9 (section 9.4, Figure 10).
[72]             The
absence of notification, of enforcement measures, or of appropriate follow-up
actions to RAPEX notifications in one Member State lowers the protection
of consumers against dangerous products not only in that Member State, but also in the other Member States. All these
factors diminish the credibility of the RAPEX system in the eyes of national
authorities, consumers and other users and economic operators.
[73]             Under
the General Product Safety Directive four EU product safety measures were
taken: the ban on phthalates in toys during the period
up to the adoption of the permanent ban under Directive 2005/84/EC (the original Decision 1999/815/EC was adopted under the previous
General Product Safety Directive 92/59/EEC was extended sixteen times out of
which three times under the General Product Safety Directive (Commission Decisions 2004/178/EC (OJ L 55, 24.2.2004, p. 66),
2004/624/EC (OJ L 280, 31.8.2004)), Decision of 11 May 2006 (2006/502/EC (OJ L
198, 20.7.2006, p. 41) requiring Member States to ensure that cigarette
lighters placed on the EU market are child resistant and to prohibit the
placing on the market of lighters which resemble objects that are particularly
attractive to children, the Decision of 21 April 2008 (Commission Decision
2008/329/EC (OJ L 114, 26.4.2008, p. 90) requiring Member States to ensure that
magnetic toys placed or made available on the market display a warning about
the health and safety risks they pose (expired on 21
April 2009) and a Decision of
17 March 2009 (2009/251/EC (OJ L 74, 20.3.2009, p. 32) requiring Member States
to ensure that products containing the biocide dimethyl-fumarate are not placed
or made available on the market (the validity of this Decision was extended three times (Commission
Decisions 2010/153/EU (OJ
L 63, 12.3.2010, p. 21), 2011/135/EU (OJ L 57, 2.3.2011, p. 43), 2012/48/EU (OJ L 26, 28.1.2012, p. 35); it expired on 5 June 2012
upon entry into force of the Commission Regulation (EU) No
412/2002 amending Annex XVII to Regulation (EC) No 1907/2006 concerning biocide dimethyl-fumarate (OJ L 128, 16.5.2012, p. 1)).
[74]             Member
States are obliged to implement this EU product safety measures by ensuring
that economic operators comply with the obligations set out in this measure.
Since these EU product safety measures are not directly applicable to economic
operators, the obligations and requirements set out in these measures must be
transposed into national legislation of each Member State.
[75]             By
Commission Decisions 2007/231/EC (OJ
L 99, 14.4.2007, p. 16), 2008/322/EC (OJ L 109, 19.4.2008, p. 40), 2009/298/EC
(OJ L 81, 27.3.2009, p. 23),
2010/157/EU (OJ L 67, 17.3.2010, p. 9), 2011/176/EU (OJ L 76, 22.3.201, p. 99),
2012/53/EU (OJ L 27, 31.1.2012, p. 24.
[76]             Formal
implementation of EU product safety measures is carried out via a wide variety
of means. These range from general legislative measures to a mix of individual
regulatory administrative measures, such as letters to individual business
associations. Due to these variations, it may be difficult for economic
operators active in several Member States to know precisely what their
obligations in an individual Member State are. Moreover, a number of Member
States did not manage to ensure formal implementation of certain EU product
safety measure within the deadlines foreseen. Thus, the entry into force of
national measures implementing EU product safety measures can vary by up to one
year. Such differences of implementation cause legal uncertainty, both for
consumers and other users as well as for economic operators.
[77]             The
enforcement of EU product safety measures causes problems to almost half of the
respondents to the public consultation from Member States (43%). For most of
these (60%) it is difficult to meet the time-limit for the adoption of national
implementation measures. A problem is also the time-limitation of the measures
and the repeated renewals (40%). For more details see Annex 2 (section
2.2.3.4).
[78]             26%
of the 23 responding businesses were ever affected by an EU product safety
measure of which 66% found it difficult to comply with the measure. For more
details see Annex 2 (section 2.2.3.4).
[79]             Of
those who had difficulties to comply, none could indicate the related costs,
but 75% considered the costs to be non-negligible. For more details see Annex 2
(section 2.2.3.4).
[80]             Eight
Member States impose of identification of the producer and the product as an
obligatory means of compliance with the obligation of economic operators to
identify the risks their products pose (Art. 5 (1) sub-p. 3 and 4 of GPSD),
whereas remaining nineteen Member States provide the identification of the
producer and the product as an optional requirement for complying with the
obligation of economic operators to identify the risks their products pose.
[81]             "The survey revealed that the identification of a dangerous product
did not normally lead to a successful investigation of the supply route to
determine the point of manufacture or import so that an accurate assessment of
the numbers of non-compliant products could be made and proportionate
enforcement actions instigated." (Report from the workshop of 10 January
2011 on the future of market surveillance within the framework of elaboration
of a study Future of Market Surveillance).
[82]             The
ever growing globalisation of supply chain makes it difficult to determine how
and by whom a product is manufactured or who has placed it on the market. 
[83]             Given
the tight budgetary conditions in which market surveillance authorities of
almost all Member States operate, the necessity to spend part of their
resources on tracing down the supply chains prevents them to apply these
resources to the part of market surveillance consisting in cleaning the market
from products which pose risks to public interests, in particular to health and
safety of consumers and other users.
[84]             A
non-exhaustive list of market surveillance authorities can be found at the
following address: http://ec.europa.eu/enterprise/policies/single-market-goods/regulatory-policies-common-rules-for-products/market-surveillance-authorities/index_en.htm.
[85]             (OJ
L 316, 14.11.2012, p. 12).
[86]             Decision
No 1926/2006/EC of the European Parliament and of the Council of 18 December
2006 establishing a programme of Community action in the field of consumer
policy (2007-2013) [OJ L 404 of 30.12.2006, p. 39] and, possibly, the future Regulation
of the European Parliament and of the Council on a consumer programme 2014-2020.

[87]             The
joint market surveillance actions represent only a very small remedy to the
problem of the lack of coordination between authorities from different Member
States. Given the current level of integration of the single EU market, in
particular in area of consumer products, if annually around 2 000 measures
taken against unsafe products are notified under RAPEX, i.e. measures against
dangerous products which are present in more than one EU Member States, a
similar number coordinated market surveillance actions by authorities from
different Member States should be expected each year. In comparison, between 2005
and- 2012 only 16 joint market surveillance actions coordinated by the
Commission took place. Moreover, as can be seen from Annex 14, none of these
actions involved all Member States so that their impact on the overall
coordination of actions of market surveillance authorities on the single EU
market remains very limited.
[88]             Decision
No 624/2007/EC of the European Parliament and of the Council of 23 May 2007
establishing an action programme for customs in the Community (Customs 2013),
OJ L154, 14.6.2007, p. 25.
[89]             See
http://ec.europa.eu/taxation_customs/resources/documents/common/publications/info_docs/customs/product_safety/guidelines_en.pdf
[90]             The
Guidelines consist of a Generic and a Specific Part. The Generic part is
essential to understand the overall relevant applicable EU legislation and in
particular the obligations on safety and compliance controls and the cooperation
between the relevant national authorities. The specific part of the Guidelines
consists of practical tools for customs officers, i.e. information sheets and
check lists for individual product groups intended to facilitate controls. The
Commission is coordinating Member States' efforts to disseminate and use the
Guidelines at national level. It is also engaged in an extensive programme of
country visits to provide as wide as possible guidance to national officials
and to address specific questions they may have.
[91]             For
more details regarding the public consultation see Annex 2 and Annex 4 with
respect to the targeted stakeholder meetings).
[92]             The
details of this alignment are described in Annex 8 (section 8.3, Table 5).
[93]             Regulation
(EC) No. 178/2002, OJ L 31, 1.2.2002, p. 1 (the
"Food Regulation"); Regulation (EC) No 882/2004
of the European Parliament and of the Council of 29
April 2004 on official controls performed to ensure the verification of
compliance with feed and food law, animal health and animal welfare rules (OJ
L 165, 30.4.2004, p.1 and corrigenda OJ L 191, 28.5.2004, p.1) (the "the Official Feed and Food Control Regulation").
[94]             The
Multi-annual Market Surveillance Plan is one of the elements of the Product
Safety Package.
[95]             On
the basis of Art. 18(5) of Regulation (EC) 765/2008 national market
surveillance plan are sent to the Commission. However, the Commission only
simply compiles these national plans, no coordination in their preparation
takes place in order to ensure a "seamless market surveillance framework"
at least in the area of planning of market surveillance activities.
[96]             Certain
benchmarks exists within the Enforcement Indicators initiative, however, the
credibility of these indicators is low. See Annex 10 for more details about the
collected enforcement indicators.
[97]             Currently
under Art. 9 (1) of the General Product Safety Directive Member States are
obliged to ensure that approaches employing appropriate
means and procedures are put in place, which may include in particular: (a) establishment,
periodical updating and implementation of sectoral surveillance programmes by
categories of products or risks and the monitoring of surveillance activities,
findings and results; (b) follow-up and updating of scientific and technical
knowledge concerning the safety of products; (c) periodical review and
assessment of the functioning of the control activities and their effectiveness
and, if necessary, revision of the surveillance approach and organisation put
in place. However, since there is no obligation provide
the programmes, follow-ups and results of assessments to the Commission.
Regulation (EC) No 765/2008 is more explicit since it obliges under Art. 18 (5)
Member States to shall establish, implement and
periodically update their market surveillance programmes and communicate them
to the Commission as well as to review and assess the functioning of their
surveillance activities and communicate such reports to the Commission, but
regarding the latter only at least every fourth year.
[98]             In
the food area the general auditing system is established under Art. 17 (2) of
the Food Regulation and Art. 45 of the Official Food and Feed Control
Regulation.
[99]             In
the food area the European Food Safety Authority is established under Art. 11
(2) of the Food Regulation.
[100]            The
differences between these sets of rules are outlined in Section 2.4.1.1 and
described in detail in Annex 8 (section 8.3, Table 4)
[101]            See
Annex 2 – Results of the public consultation.
[102]            See
Annex 4 – Summary of the targeted stakeholder meetings.
[103]            Of
the economic operators responding to the public consultation, 30% indicated
that they produced or imported harmonised products only, 65% stated they
produced or imported both harmonised and non-harmonised products (remaining 5%
were not able to ascertain whether their products are harmonised or
non-harmonised.
[104]            Remaining
20% of responding economic operators indicated that they do not establish any
technical documentation for non-harmonised products.
[105]            See
Annex 2 – Results of the public consultation.
[106]            This
group would involve producers of non-harmonised products only (none of these
economic operators  responded to the public consultation performed) who would
not apply the harmonised product safety requirements already. In theory, this
category would comprise, for example, producers who would be marketing their
products exclusively in Member States which do not require identification of
the producer and the product as an obligatory means of fulfilling the
obligation of economic operators to be kept informed of the risk that their
product may pose and who would not be following the stricter rules already.
[107]            Although
in theory, the option could bring some benefits to those producers who produce
non-harmonised products only, for the same reasons described under previous
Option 1.B., these benefits seems to be more hypothetical then practical: the
size of the category of producers producing non-harmonised products only seems
to extremely limited, the influence of definition of different sets of EU product
safety requirements, whether diverging or converging, seems to be non-existent
or infinitesimal etc.
[108]            Although
compared to the current situation the assessment of which sets of requirements,
i.e. whether consumer product safety requirements or harmonised product safety
requirements apply in the concrete case, since there would be two sets of
non-overlapping relatively coherent requirements, the determination which set
of requirements applies would still be difficult due to the problems in
answering the question of which products fall into the category of harmonised
products (so that harmonised product safety requirements would apply) and which
fall into the category of non-harmonised products. Although useful as a
legislative abbreviation, the application of the differentiation between
harmonised and non-harmonised products creates significant legal and practical
problems.
[109]            See
Annex 2 – Results of the public consultation.
[110]            See
Annex 9.
[111]            A
preliminary conclusion of the Task Force F on Enforcement Indicators,
established within the framework of joint action EMARS II, indicated that
effectiveness of market surveillance could be measured by the number of product
related accidents prevented by market surveillance action. The efficiency of
market surveillance action could be estimated if this indicator was then
compared with the amount of funding allocated annually by Member States for the
functioning of market surveillance. However, detailed data about the accidents
and injuries relevant for market surveillance purposes are very difficult to
obtain since these data are not collected in all Member States for the same
period of time and in the same form or are not detailed enough to determine
exactly which product was involved in the accident and whether it was the
product involved which was the direct cause of the accident or whether the
accident resulted from the misuse of the product (The existing IDB database indicates only limited information
relevant for the market surveillance purposes. To have more information general
practitioners would have to inquire, analyse and report about the causes of
accidents or injuries of patients upon medical examination of each patient
having suffered an injury or accident). The only alternative benchmark available for determining the
effectiveness and cost-efficiency of market surveillance in individual Member
States would be the amount of funds allocated to market surveillance
authorities by Member States. However, this benchmark would be very rough and,
as such, would have a very low value in terms of measuring the efficiency of
market surveillance for a number of reasons. Firstly, market surveillance is for the relevant
authorities in many cases only one task out of many others. The authorities
mostly have an overall budget and it is not always easy to determine the exact
percentage of that budget spent for market surveillance. The same problem
exists with the number of market surveillance inspectors. In most cases market
surveillance is only part of their occupation – but it is difficult to
determine the time spent exclusively for market surveillance (i.e. to determine
the man-years). Secondly, different
institutional structures of market surveillance authorities in Member States,
which may have an important effect on the "real value" of the amount
of funds allocated to market surveillance, are not taken into account. Thirdly, to avoid a “bad” ranking Member States
are reluctant to report exact figures spent on market surveillance but rather to
give overall budgets or the number of inspectors. Such overall figures are
however not too reliable in measuring effectiveness and efficiency since – for
example – the overall budget of an authority responsible for market
surveillance may be increased while the percentage spent for market surveillance
may decrease.
[112]            See
Annex 2 – Results of the public consultation.
[113]            65%
of economic operators were not able to estimate the costs of diverging safety
evaluations of market surveillance authorities of different Member States;
nevertheless, 88% of those who were able to provide estimations considered
these costs to be non-negligible, although they could not estimate the m. 62%
of economic operators consulted considered that the cooperation between EU
Member States should be improved (See Annex 2 – Results of the public
consultation.).
[114]            As
explained in section 2.4.1.3 in some sectors economic operators estimate the
loss in turnover due to unfair competition between 5 and 18%.
[115]            See
Annex 2 – Results of the public consultation.
[116]            See
Annex 2 – Results of the public consultation.
[117]            Examples
of such horizontal activities are the establishment of the Rapid Advice Forum,
the development of the best practice handbook, knowledge base and the recall
guide, the coordination of input into standardisation, the establishment of a
peer review process and training solutions, etc.
[118]            Details
regarding past joint market surveillance actions are set out in Annex 14.
[119]            As
described above in section 2.4.5.
[120]            "On
the one hand, the fundamental rules of the Internal Market such as the
principles of free movement of goods and mutual recognition are being
undermined by certain economic operators and Member States. On the other hand,
the checks carried out by market surveillance authorities are, for the
majority, performed in an entirely random manner. These controls do not
sufficiently prioritize the search for non/conforming and/or dangerous products
from third countries." (quote from the contribution of an economic
operator, Oxylane-Decathlon, to the public consultation).
[121]            Since
a part of the EFSA tasks is aimed at pre-marketing controls of certain food
products the whole equivalent of EFSA budget cannot be used for the projections
of the equivalent authority in the area of non-food products where no
pre-marketing controls exist.
[122]            As
indicated in the Enforcement Indicators Questionnaire. 
[123]            Results
of the public consultation on the revision of the General Product Safety
Directive, Annex I –replies of market surveillance authorities of Member
States, Annex 2 – Economic operators' replies; Annex 3 – Other Stakeholders'
replies.
[124]            Whether
any additional costs for national market surveillance authorities will actually
arise will depend on a number of factors which are impossible to predict.
Putting more "user-friendly" legislative and IT procedures for
cross-border cooperation at the disposal of market surveillance authorities for
the use in concrete actions does not facilitate a prediction of how much more
these procedures will be used. This will depend on the level of occurrence of
dangerous products and their geographical spread, frequency and nature of
product controls which will continue to be determined at the national level
without any intervention of the Commission, the intensity and quality of
planning coordination between Member States (if Member States plan their
control activities well, a number of actions will be realised simultaneously
without incurring any additional costs).
[125]            "RAPEX
is conveniently arranged: clear, detailed and informative with a photograph of
the hazardous product." (Brock, A., A Disadvantageous Dichotomy in
Product Safety Law, European Business Law Review, 2009, p. 187).
[126]            Majority
of Member States' respondents is of the opinion that change of the notification
criteria (42%) or their description in a greater detail (51%) would not make
the notification process easier. According to respondents, the change of the
RAPEX notification criteria should mainly concern 'risk assessment' and
'cross-border effects'. The main problem in applying the 'cross border effects'
criterion is the lack of evidence that the notified product was marketed on
territories of other Member States.
[127]            See above fn. no. 1066.
[128]            In
accordance with the above some 71% of the respondents did not see any problem
with measures that are directly applicable to economic operators. The Member
States respondents considered the enforcement of "emergency" measures
to be easier if the measures were directly applicable to economic operators
(71%), and if measures were in force until a permanent measure is in place
(60%). A simple extension of the validity of the measures, such as up to three
years with further 3-years extensions, was considered much less favourably
(23%). For more details se Annex 2 (section 2.2.3.4).
[129]            Compliance
with EU product safety measures was considered easier if they were directly
applicable (39%) or were applicable until entry into force of a permanent
solution (44%),  still
some 26% considered a simple extension of such a measure to up to three years
(with equal prolongation periods) as making compliance easier.
[130]            More
than 75% of other stakeholders responding saw no problem if EU product safety
measures were directly applicable to economic operators.
[131]            Articles
R1 – R7.
[132]            Article
296 TFEU 
[133]               In
none of the 13 Member States which currently participate in the European
Injuries Database data about the causes of accidents/injuries and the ways in
which they occurred are collected. For the collection of such data in a form
and content that would be relevant for market surveillance purposes new
infrastructures in basically all Member States would have to be established.
Such action would require very substantive investments which are beyond the
current budgetary possibilities of both the Member States and the European
Commission. In 2013, the Commission will launch a study to further examine the
feasibility and potential costs of setting up such a Consumer Product Safety Injuries
Database. 
Table of Contents
1........... Annex 1: Glosssary of
the terms used. 3
2........... Annex 2: Summary of
the public consultation. 9
3........... Annex 3: summary of
position papers received from stakeholders. 27
4........... Annex 4: Summary of
the targeted stakeholder meetings. 60
5........... Annex 5: Small and
medium enterprises, including micro-enterprises: consultations and analysis of
impacts (SME test) 70
6........... Annex 6: External
expertise – list of studies and reports. 87
7........... Annex 7: Monetary
value of markets of consumer and certain harmonised non-food products in the EU   91
8........... Annex 8: Differences
between consumer/non-consumer products and harmonised/non-harmonised products,
including differences relating to product safety and market surveillance
obligations. 102
9........... Annex 9: Market
surveillance data – RAPEX, including RAPEX-CHINA, safeguard clause
notifications and other data. 116
10......... Annex 10: Enforcement
indicators. 131
11......... Annex 11: Overview of
problems, objectives and options. 137
12......... Annex 12: Discarded
options. 140
13......... Annex 13:
Competitiveness analysis. 147
14......... Annex 14: Summary of
joint market surveillance actions. 155
15......... Annex 15: Legislative
simplification in detail 159
1.           Annex
1: Glosssary of the terms used
 Term || Definition 
 Art. 12 (1) of the General Product Safety Directive || sub-p. 1: Where a Member State adopts or decides to adopt, recommend or agree with producers and distributors, whether on a compulsory or voluntary basis, measures or actions to prevent, restrict or impose specific conditions on the possible marketing or use, within its own territory, of products by reason of a serious risk, it shall immediately notify the Commission thereof through RAPEX. It shall also inform the Commission without delay of modification or withdrawal of any such measure or action. sub-p. 2: If the notifying Member State considers that the effects of the risk do not or cannot go beyond its territory, it shall follow the procedure laid down in Article 11, taking into account the relevant criteria proposed in the guidelines referred to in point 8 of Annex II. sub-p. 3: Without prejudice to the first subparagraph, before deciding to adopt such measures or to take such action, Member States may pass on to the Commission any information in their possession regarding the existence of a serious risk. 
 Comitology procedure || Means a procedure through which the Commission carries out its implementing powers with the assistance of a committee consisting of representatives from Member States. In the areas covered by the General Product Safety Directive, detailed rules for comitology procedure are laid down its Articles 14 and 15. 
 Consumer product || Means any product – including in the context of providing a service – which is intended for consumers or likely, under reasonably foreseeable conditions to be used by consumers even if not intended for them, and is supplied or made available, whether for consideration or not, in the course of a commercial activity, an whether new, used or reconditioned. 
 Consumer Protection Cooperation Regulation || Means Regulation (EC) No 2006/2004 on cooperation between national authorities responsible for the enforcement of consumer protection laws. 
 Cross-border effect || Means a situation where effects of the risks posed by a dangerous product go or can go beyond the territory of one of the Member States (also called 'international event'). 'Cross-border effect' represents one of the RAPEX notification criteria (see RAPEX notification criteria). 
 Decision No 768/2008/EC || .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 
 Directive 98/34/EC || Means Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services. 
 Distributor || Means any professional in the supply chain whose activity does not affect the safety properties of a product, other than the manufacturer or the importer (who makes a product available on the market.) 
 DMF-Decision   || Means Commission Decision 2009/251/EC of 17 March 2009 requiring Member States to ensure that products containing the biocide dimethylfumarate (DMF) are not placed or made available on the market, (as amended by subsequent decisions). 
 Economic operators || Mean manufacturers, importers and distributors. 
 European standard (EN) || Means a standard adopted by a European Standardisation Organisation and made available to the public. 
 European standard referenced in the OJEU || Means a European standard (EN) the reference of which was published in the Official Journal of the European Union which provides for presumption of conformity to the general safety requirement under the General Product Safety Directive. 
 European Standardisation Organisation (ESO) || Means one of the three European Standards Organisations: CEN (European Committee for Standardisation), CENELEC (European Committee for Electrotechnical Standardisation) or ETSI (European Telecommunications Standards Institute). 
 General product safety legislation || Means the General Product Safety Directive, as implemented into national legislations of Member States. The list of national laws implementing the General Product Safety Directive can be consulted at: http://eur-lex.europa.eu/Notice.do?val=414664:cs&lang=en&list=414664:cs,&pos=1 
 General Product Safety Directive || Means Directive 2001/95/EC on general product safety, as amended. 
 Harmonised products || Mean products for which there is EU legislation harmonising the conditions for marketing. (see also Sector specific legislation on harmonised products). 
 IEC standard || Means a standard adopted by the International Electrotechnical Commission (IEC). IEC is the world's global standardisation organization that prepares and publishes international standards for all electrical, electronic and related technologies collectively known as "electrotechnology." 
 Importer || Means any natural or legal person established within the Union who places a product from a third country on the EU market. 
 International standard || Means a standard adopted by an international standardisation organisation and made available to the public. Examples of international standards are ISO standards and IEC standards. 
 ISO standard || Means a standard adopted by the International Organization for Standardisation (ISO). ISO is the world's largest developer and publisher of International Standards other than electrotechnical or telecommunication ones. 
 Joint market surveillance actions || Mean joint surveillance and enforcement actions in the area of non-food consumer product safety. They involve administrative and surveillance cooperation between the authorities of several Member States and EFTA/EEA countries and typically focus on product testing, risk assessment, market monitoring, and the exchange of expertise and best practices related to market surveillance. The Commission has supported a number such actions, for example, in the areas of safety of sunbeds and solarium services, cord extension sets, lighting chains, playground equipment etc. 
 Large enterprise || Means an enterprise not fulfilling the criteria on an SME. 
 Local event || Refers to measures adopted in relation to a product posing a risk that can only have local effects, i.e. the risk posed by a dangerous product do not go or cannot go beyond the territory of one of the Member States. This includes a situation where an authority of a Member State has reason to believe that a product has not been and will not be made available (by any means) to consumers in other Member States, e.g. measures taken with regard to a local product manufactured and distributed only in one Member State. These measures are not notified through RAPEX, but may be notified through the procedure under Article 11 of the General Product Safety Directive. 
 Magnetic Toys Decision || Means Commission Decision 2008/329/EC of 21 April 2008 requiring Member States to ensure that magnetic toys placed or made available on the market display a warning about the health and safety risks they pose. 
 Manufacturer || Means any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under his name or trademark. 
 Market surveillance || Means the activities carried out and measures taken by public authorities to ensure that products comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection 
 Market surveillance authority || Means an authority of a Member State responsible for carrying out market surveillance on its territory 
 National standard || Means a standard adopted by a national standardisation body and made available to the public. 
 Non-harmonised products || Mean products for which there is no EU legislation harmonizing the conditions for marketing. 
 Notification for information || Means a notification which cannot be sent through the system as a RAPEX notification due to various reasons (such as the non-availability of some of the information required to be present in the RAPEX notification, absence of the cross-border effect, impossibility to determine whether one or more RAPEX notification criteria were met, yet the notification involves information on product safety likely to be of interest for other Member States etc.), but the Contact Point has nevertheless decided to circulate such notification for information purpose. 
 Novelty and Child Resistant Lighters Decision || Means Commission Decision 2006/502/EC of 11 May 2006 requiring Member States to take measures to ensure that only lighters which are child-resistant are placed on the market and to prohibit the placing on the market of novelty lighters (as amended by Commission Decisions 2007/231/EC, 2008/322/EC, 2009/298/EC and 2010/157/EU). 
 Non-European standards || Mean standards other than European standards, including international standards and standards produce by states outside the EU. 
 Obligations of the economic operators with respect to harmonised products || Mean obligations of the economic operators to make sure that products comply with technical legislation, bear the required product identification, are accompanied with the adequate safety instructions, product keep a copy of a technical documentation as not to jeopardise safety properties of a product etc. 
 OJEU || Means the Official Journal of the European Union. 
 Presumption of conformity || Means that products which are in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union are presumed to be in conformity with the requirements covered by those standards or parts thereof, set out in the harmonisation legislation. 
 Product identification || Means the indication on the product, its packaging or in the accompanying documents, the identity of the manufacturer or, if imported, the manufacturer and the importer, i.e. an indication of their firm, trade name or a trademark, and the address where they can be contacted and a product reference or the reference to the batch of products to which the product belongs. 
 Product safety legislation || Means General product safety legislation and Sector specific legislation on harmonised products. 
 RAPEX || Means the Union Rapid Information System for non-food Consumer Products which Member States use to notify to the Commission measures taken to prevent or restrict the marketing or use of products posing a serious risk. See also RAPEX Guidelines. 
 RAPEX Guidelines || Commission Decision 2010/15/EU of 16 December 2009 laying down guidelines for the management of the Union Rapid Information System ‘RAPEX’ established under Article 12 and of the notification procedure established under Article 11 of the General Product Safety Directive (OJ, L22, 26.01.2010). 
 RAPEX notification criteria || Under Article 12 of the General Product Safety Directive, Member States have a legal obligation to notify the Commission when the following four notification criteria are met: (a) the product is a consumer product, (b) the product is subject to measures that prevent, restrict or impose specific conditions on its possible marketing or use (‘preventive and restrictive measures’), (c) the product poses a serious risk to the health and safety of consumers, (d) the serious risk has a cross-border effect. 
 RAPEX notification || Means a notification of a preventive or restrictive measure(s) against a consumer product posing a serious risk(s) to the health and safety of consumers adopted by an economic operator or a market surveillance organisation of a Member State , sent to the Commission under Article 12 of the General Product Safety Directive. 
 Regulation (EC) No 765/2008 || 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 Regulation (EEC) No 339/93 
 Risk assessment guidelines || Mean procedures for identifying and assessing levels of risks posed by consumer products as set out under point 5 of Part IV of RAPEX Guidelines 
 Schaldemose Report || Report on the revision of the General Product Safety Directive and market surveillance (2010/2085(INI)), European Parliament, Committee on the Internal Market and Consumer Protection, Rapporteur: Christel Schaldemose. 
 Sector specific legislation on harmonised products || Means the set of EU directives regulating conditions of marketing and safety aspects o f products in areas such as toys, cosmetics, construction products etc. and their implementation into national legislations of Member States. For more examples of this sector specific legislation, see http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/index_en.htm 
 Services Directive || Means Directive 2006/123/EC of 12 on services in the internal market. 
 SME || Means micro, small and medium-sized enterprise. It includes enterprises which employ fewer than 250 persons and have an annual turnover not exceeding €50 million, and/or an annual balance sheet total not exceeding €43 million. 
 "Standing or framework mandates" || Means a mandate to the relevant European Standardisation Organisation to draft the necessary standards in a specific field, according to the safety requirements established by the Commission, which does not require that the Commission issues a new request for each standard to be delivered or revised, except in cases of new emerging risks which will require a specific mandate from the Commission. It facilitates monitoring and production of deliverables and allows for a more effective organisation of work within the relevant European Standardisation Organisation. A standing or framework mandate also includes a work programme to identify which standards are needed or whether existing standards have to be revised to comply with the safety requirements. 
 Traceability || Means an obligation to ensure that the origin of the product can be determined, for example, by indicating on the product, its packaging or in the accompanying documents, the identity of the manufacturer and/or the importer, i.e. an indication of the firm, trade name or a trademark and the address where they can be contacted, product reference or the reference to the batch of products to which the product belongs, by keeping and providing for documentation necessary for tracing the origin of the product etc. 
 Technical documentation || Means documentation which makes it possible to assess the conformity of a product to the relevant requirements, includes an adequate analysis and assessment of the risk(s), specifies the applicable requirements and covers, as far as relevant for the assessment, the design, manufacture and operation of the product. 
2.           Annex
2: Summary of the public consultation
2.1.      Introduction
Following the delimitation
of the scope of the revision performed by the Commission in consultations with
relevant stakeholders, the Commission concentrated the public consultation
around four topics: (i) pre-standardisation procedures under the General
Product Safety Directive, (ii) harmonisation of safety evaluations, (iii)
market surveillance coordination and (iv) consistency of consumer product
safety requirements with harmonised product safety requirements, i.e. alignment
of the existing rules under the General product Safety Directive with certain
rules contained in the 2008 Free Movement of Goods Package.[1]
For each of these
four topics, the Health & Consumers Directorate-General of the European
Commission published consultation papers describing the scope of the problems
and the actions envisaged to solve them. In parallel, it opened for a period of
three months (from mid-May to mid-August 2010) an internet public consultation
to seek through online questionnaires views from different stakeholder groups
on the issues presented in the consultation papers. 
2.2.      Results of the internet public consultation
In response to the internet public
consultation the Commission received replies to the questionnaires from fifty five national authorities from all EU Member States except one,
as well as Norway, Iceland and Switzerland. Moreover, various other
stakeholders, including more than thirty business associations, seventeen
consumer organisations, and over fifty individual economic operators (including
several SMEs) contributed to the consultation.
In total, 305 replies were received to
the nine published online questionnaires. In addition, thirteen business and
consumer organisations provided separate position papers.[2] Also a number of presentations
and direct exchanges with stakeholders (both with business and consumer
organisations) were held during the consultation period.
The answers to the
internet public consultation questions could be summarised as follows.
2.2.1    Consistency
of product safety requirements
Harmonisation of the obligations of
economic operators in the non-harmonised area with those in the harmonised
area, including traceability requirements and the obligation to establish
technical documentation[3],
would make enforcement activities more effective. Traceability of manufacturers
and importers is a problem for market surveillance authorities. In addition,
economic operators and other stakeholders, including consumer organisations and
a number of business associations, see more benefits than disadvantages if the
obligations of economic operators with regard to harmonised products were
applied uniformly to all products. 
Several consumer organisations stressed
the need for better product traceability to aid recalls. They consider that
alignment in this area with the Decision 768/2008/EC is important and also
advocate the use of new technologies such as radio frequency identification
("RFID") provided that the advantages and disadvantages are assessed
also from a consumer perspective (e.g. as regards privacy, security and
health).
(a)        National market surveillance authorities
Harmonising the obligations of economic
operators in the non-harmonised area with those in the harmonised area,
including traceability requirements and the obligation to establish technical
documentation, would make enforcement activities more effective. In the case of
virtually all NMSAs, the enforcement of product safety rules would be easier if
the obligations of economic operators in the harmonised and non-harmonised area
were aligned.[4]
Almost all NMSAs have experienced problems identifying manufacturers and
importers within the framework of their market surveillance activities; a
non-negligible minority of NMSAs have faced such problems frequently.[5] A majority of authorities
indicated that they request technical documentation from economic even if national
rules do not specifically require economic operators to establish it, and most
of these authorities indeed manage to obtain the requested technical
documentation from economic operators.
(b)        Economic operators
An important majority of responding
economic operators market both harmonised and non-harmonised products; a
minority markets harmonised products only.[6]
Economic operators see more benefits than disadvantages if the obligations of
economic operators with respect to harmonised products, including the obligation
to establish technical documentation, were also applied in the area of
non-harmonised products.[7]

All respondents indicated that they
ensure traceability of products. The most common way in which the traceability
of products is ensured by manufacturers and importers is by indicating on the
product, its packaging or in the accompanying documents the identity of the
manufacturer/importer (name/brand, address) and the identity of the product
(batch or series number).[8]
A large majority of responding economic operators establish technical
documentation[9]
in respect of non-harmonised products; over a half of those who do so establish
the technical documentation in respect of non-harmonised products, although
they are not legally required to do so.[10]
(c)        Other stakeholders
(including consumers and business organisations)
An important majority of stakeholders are
of the opinion that the safety of consumers would be better ensured if the
obligations of economic operators in respect of harmonised products, including
the obligation to establish technical documentation, were also applied in the
area of non-harmonised products.[11]
Stakeholder views on whether economic operators ensure traceability of products
are divided. The same division can be observed with respect to the question as
to whether it is ensured in a uniform way.[12]
2.2.2    Market
surveillance coordination
A majority of Member States considered
that they undertake sufficient market surveillance. Nevertheless a lack of
resources for inspections and training are mentioned as reasons for not doing
more. Member States cooperate with each other and consider such cooperation to
be very beneficial, although they encounter problems linked mainly to
differences in enforcement practices or, again, a lack of resources. Actions to
improve cooperation in this area supported by over half of the respondents
include providing more financial support to joint surveillance actions and
exchanges of officials, and establishing a coordination forum at EU level. 
While economic operators and other
stakeholders were divided as to whether Member States undertake sufficient
market surveillance or whether the cooperation with customs authorities works
well, a majority considered that differences between Member States in enforcing
product safety legislation were causing problems for businesses. They also
believed that cooperation between NMSAs of different Member States needed to be
improved. Respondents were overwhelmingly of the opinion that more intensive
information sharing and/or cooperation between Member States would enhance the
safety of consumers throughout the EU.
Diverging test results as well as
diverging interpretation of standards and the risk assessment guidelines,[13] have occasionally caused
safety evaluations by one Member State to be contested (whether formally or
informally) by another Member State(s). To overcome these divergences, which
create barriers to the internal market, all groups of stakeholders favour
setting product safety requirements at the EU level. In addition, the creation
of a database for risk assessments and the establishment of an EU risk
assessment agency were suggested.
(a)        National Market
Surveillance Authorities
A significant majority of NMSAs consider
that they undertake sufficient market surveillance and that cooperation with
customs in this area works well.[14]
However, a lack of resources, inspections and training were mentioned as
reasons for not doing more.[15]
Almost all NMSAs cooperate with authorities in other Member States. They
perceive such cooperation to be very beneficial, although they do encounter
problems linked mainly to differences in enforcement practices.[16] Specifically with regard to
the joint surveillance actions co-financed by the Commission, a majority
considers these to be very useful despite a heavy administrative burden and
lack of own resources.[17]
Actions to improve cooperation in this
area supported by a majority of respondents include providing more financial
support to joint surveillance actions and exchanges of officials, and by
establishing a coordination body at EU level. Obliging Member States to respond
to a cooperation request from another Member State was also mentioned among the
possible ways to improve coordination among the NMSAs of different Member
States.[18]
About one third of responding NMSAs
indicated that their safety evaluations had, on at least one occasion, been
contested by authorities in other Member States. This was overwhelmingly due to
diverging test results, but also to diverging interpretations of standards.[19] Divergences in safety
evaluations were not avoided despite the existence of guidelines for risk
assessment set out in the RAPEX Guidelines.[20]
Some responding NMSAs suggested the creation of a database with risk
assessments which could be used for orientation, or even setting up an EU risk
assessment institute or agency. A clear majority of the responding NMSAs
considered that lasting divergences between Member States could be solved by
setting specific product safety requirements at the EU level. A minority of
stakeholders favoured non-binding EU-wide recommendations on the safety
assessment of the concerned product.[21]
(b)        Economic operators
While economic operators were divided as
to whether Member States undertake sufficient market surveillance[22] or whether the cooperation
with customs authorities works well,[23]
a majority considers that differences between Member States in enforcing
product safety legislation are causing problems for businesses[24] and that coordination and
cooperation needs to be improved.[25]

About one third of the responding
economic operators were at least sometimes affected by diverging safety
evaluations of their products in different EU Member States. The main reasons
for divergence were rooted in different test results, but also in diverging
risk assessments.[26]
An overwhelming majority of economic operators affected by these divergences
could not estimate the amount of costs resulting from these divergences, but
evaluated them as "non-negligible."[27]
A strong majority of economic operators considered binding measures at the EU
level to be the best solution to resolve lasting safety assessment divergences
between NMSAs of different Member States; non-binding EU-wide recommendations
were preferred only by a minority of the responding economic operators.[28] 
(c)        Other stakeholders
(including consumers and business organisations)
While other stakeholders are equally
divided as to whether Member States undertake sufficient market surveillance,
most of those believing they do not do so considered this to be due to a lack
of allocated resources and too few inspections.[29] Respondents are overwhelmingly
of the opinion that more intensive information sharing and/or cooperation
between Member States would enhance the safety of consumers throughout the EU.[30]
An important majority of stakeholders
reported at least occasional problems with diverging safety evaluations from
authorities in different Member States.[31]
The divergences overwhelmingly occurred in respect to risk assessments, but
also as regards test results or for other reasons, such as differing
interpretations of safety requirements, standards or legislation.[32] The preferred remedy to
resolve diverging safety evaluations of certain products was the adoption of
binding measures at the EU level; only a small minority preferred non-binding
EU-wide recommendations in such situations.[33]

2.2.3    Simplification
2.2.3.1 Simplification of the overall legislative framework
Stakeholders voiced a uniform call for a
single market surveillance regime by simplifying and consolidating the two
existing market surveillance systems established under the GPSD and the Free
Movement of Goods Package.[34]
2.2.3.2 Prestandardisation procedures under the GPSD
The great majority of respondents
considered that the absence of referenced European standards for many products
covered by the GPSD made conformity assessment and enforcement more costly.
There was also strong support for directly referencing existing European
standards even where they are not based on a prior Commission mandate, as long
as they provide a high level of consumer safety.
The speed of standardisation procedures
under the GPSD was not satisfactory for a majority of responding stakeholders.
The idea that the safety requirements formulated in Commission decisions should
become mandatory and directly applicable is also strongly supported as the
current method under the GPSD is perceived to leave too much margin of
manoeuvre to the European standardisation organisations.
(a)        National Market
Surveillance Authorities
A large majority of responding NMSAs
consider that the absence of referenced standards makes conformity assessment
and enforcement more costly.[35]
Quantification of these costs was, however, difficult to make.[36] Areas of particular concern
are child-care articles, chemicals in products, stationery, ladders, playground
equipment, candles, and furniture (e.g. flammability requirements).
Furthermore, a significant majority of respondents are in favour of directly
referencing existing European standards, in the absence of a Commission
mandate, as long as they provide a high level of consumer safety.[37] 
Likewise, a large majority of responding
NMSAs agreed that the speed of standardisation procedures under the GPSD was
not satisfactory.[38]
An important number of respondents agreed that safety requirements set in
Commission decisions should become mandatory and directly applicable to third
parties.[39]
A significant number of respondents were in favour of opening up the system to
direct referencing of non-European international standards, such as ISO
standards,[40]
and of introducing "standing" or "framework" mandates.[41] 
(b)        Economic operators[42]
An important majority of responding
economic operators considered that the absence of referenced standards made
conformity assessment more costly, but were in general unable make a measurable
cost-benefit assessment.[43]
In the absence of referenced standards, the most frequently used tools for
assessing conformity are global standards and other European standards.[44] Furthermore, a significant
majority of economic operators were in favour of directly referencing existing
European standards, in the absence of a Commission mandate, as long as they
provide a high level of consumer safety. [45]
A large majority of responding economic
operators agreed that safety requirements set in Commission decisions should
become mandatory and directly applicable to them.[46] Compared to the replies from
the NMSAs, the responding economic operators have shown a more accentuated
tendency to open up the system also to direct referencing of non-European
international standards as formal conformity compliance tools.[47] Economic operators would also
favour the inclusion of provisions aiming to set up "standing" or
"framework" mandates.[48]
(c)        Other stakeholders
(including consumers and business organisations)
Other stakeholders were more cautious and
more divided concerning the use of non-European standards or global standards
other than ISO.[49]
They were, however, in favour of making safety requirements laid down in
Commission decisions binding.[50]
A majority would favour simplification of mandating procedures by means of
"standing" or "framework" mandates[51] and direct referencing of
existing European standards elaborated outside a Commission mandate.[52] 
2.2.3.3 RAPEX procedure
The results of the public consultation
also show that many Member States still have difficulties complying fully with
their obligations under the RAPEX system;[53]
in particular, they have problems notifying the Commission of preventive and
restrictive measures and ensuring follow-up action to notifications distributed
through the RAPEX system. The main reasons are insufficient human and financial
resources, an overly complex notification procedure and insufficiently detailed
data provided in RAPEX notifications. Other stakeholders overwhelmingly see the
positive role of the RAPEX system in the product safety area and consider that
it contributes to better protecting the consumers throughout the EU.
(a)        National Market
Surveillance Authorities
The results of the public consultation
show that not all Member States fully comply with RAPEX obligations stemming
from the EU product safety legislation. This concerns particularly the
obligations to notify to the Commission preventive and restrictive measures[54] and to ensure follow-up action
to notifications distributed through the RAPEX system.[55] The main reasons for this seem
to be insufficient human and financial resources, a too complex notification
procedure and insufficient data provided in notifications.[56] 
According to respondents, only changes in
the RAPEX notification criteria, or making them more precise, would not make
the notification process easier.[57]
A majority of NMSAs, however, are of the opinion that some consideration should
be given to measures "decided" but not yet adopted, as their
exclusion from RAPEX could simplify the notification procedure.[58] Respondents also consider that
application of the 'risk assessment' criterion poses problems in
practice.[59]
(b)        Economic operators
(The questionnaire did not contain any
questions on the functioning of the RAPEX system for economic operators since
the problems with the functioning of RAPEX and the action envisaged to remedy
these problems would not affect the situation of economic operators.)
(c)        Other stakeholders
(including consumers and business organisations)
Respondents overwhelmingly see the
positive role of RAPEX in the product safety area.[60] They are of the opinion that
RAPEX contributes to the better protection of consumers throughout the EU.
2.2.3.4 EU
product safety measures
Compliance with EU product safety
measures adopted under Article 13 of the GPSD would be easier (i) if these
measures were directly applicable to economic operators and/or (ii) if they
were linked to a clearly defined permanent solution (e.g. adoption of a
standard or of primary legislation) or if their validity could be extended to a
fixed period of up to three years (with equal subsequent prolongation periods).
Inconsistent application of EU measures on product safety by national market
surveillance authorities ("NMSAs") was viewed as a problem by
economic operators. 
(a)        National Market
Surveillance Authorities
Responding NMSAs expressed large support
for direct applicability of EU product safety "emergency" measures
and for the extension of the duration of such measures until a future permanent
solution is adopted.[61]
Difficulties were seen in the short time period for national implementation of
an EU product safety "emergency" measure.[62] Respondents considered it
important that the EU product safety "emergency" measures be very
clearly described, including technical details, such as test methods, in order
to ensure even implementation by all authorities in all Member States.
(b)        Economic operators
According to responding economic
operators compliance with EU product safety measures would be easier (i) if
these measures were directly applicable to economic operators and/or (ii) if
they were linked to a clearly defined permanent solution (e.g. adoption of a
standard or of primary legislation) or if their validity could be extended to a
fixed period of up to three years (with equal subsequent prolongation periods).[63] Inconsistent application of EU
product safety "emergency" measures by NMSAs was viewed as a problem
by economic operators.[64]
Related compliance costs with the diverging national implementing measures were
assessed as "non negligible" by some of the operators, although none
of them were able to quantify these costs.[65]
(c)        Other stakeholders
(including consumers and business organisations)
A large majority of respondents saw no
problem if EU product safety measures were made directly applicable to economic
operators.[66]

2.2.4    Other
2.2.4.1 Safety of
products sold online
Economic operators and other stakeholders
do not think that national authorities pay as much attention to products sold
online as they do to products sold through other distribution channels. If
NMSAs perform market surveillance on products marketed online, they do so in an
incidental, fragmented and uncoordinated manner. A large majority of NMSAs
would find it easier to enforce product safety rules if harmonised rules
concerning products sold online were introduced at the EU level.
(a)        National Market
Surveillance Authorities
Only half of the national authorities
have specifically monitored products sold online at a certain point of time
during the last three years.[67]
A large majority of those NMSAs which performed some monitoring products sold
online had difficulties indicating the number of websites checked, the number
of products targeted or the number of products sampled for further tests.[68] Certain NMSAs have, however,
taken some preventive and/or restrictive measures against products sold through
online distribution channels.[69]
Regarding the idea of introducing
specific enforcement tools for products sold online, a large majority of NMSAs
pointed out that it would be easier to carry out market surveillance with
regard to the products sold online if specific harmonised rules were introduced
at EU level.[70]
(b)        Economic operators
A majority of economic operators think
that dangerous consumer products are sold on the internet in the EU by
operators based both in the EU and in third countries.[71] Only a minority thinks that
attention given by market surveillance authorities to the safety of products
sold online is equal (or higher) compared to that given to products sold
through other distribution channels.[72]
(c)        Other stakeholders
(including consumers and business organisations)     
A strong majority of respondents
confirmed that they were aware of dangerous consumer products being sold online
in the EU.[73]
An important majority of the respondents were also of the opinion that, with
respect to safety, NMSAs do not treat products sold online in the same way as
products sold in shops.[74]
2.2.4.2 Safety of
products provided within the context of a service
Finally, in the view of all stakeholder
groups the general safety requirement of the GPSD should not be dependent on
whether it is the consumer or the service provider who operates the product
provided within the context of a service.  
(a)        National Market
Surveillance Authorities
In the view of NMSAs, the general
safety requirement under the GPSD should not be dependent on whether it is the
consumer or service provider who operates the product provided within the
context of a service.[75]
(b)        Economic operators
A majority of responding economic
operators are convinced that products provided within the context of a service
should be safe, irrespective of whether the product is operated by a consumer
or a service provider. [76]
(c)        Other stakeholders
(including consumers and business organisations)
A large majority of stakeholders are
convinced that products provided within the context of a service should be safe
and submitted to the same regulatory environment irrespective of whether a
product is operated by a consumer or a service provider. It is the prevailing
opinion of responding stakeholders that exposure of consumers to risks
resulting from a product provided within the context of a service is
independent of whether the product is operated by the consumer or the service
provider.
Detailed results of the public
consultation were published on the following website:
http://ec.europa.eu/consumers/safety/prod_legis/gpsd_consultation/gpsd_results/index_en.htm
2.3.      Workshop
on the GPSD revision during the International Product Safety Week
Within the framework International
Product Safety Week, the Commission organised a one-day Workshop on the
revision of the General Product Safety Directive with participation of over 150
participants, representing all major stakeholders, including representatives
from non-EU countries. 
The aim of the Workshop was to inform
stakeholders of the results of the internet public consultation, receive
feedback from stakeholders on the process and topics of the consultations and
discuss the conclusions reached in the consultation. Following the presentation
of the results of the internet public consultation given by the Commission,
representatives of the key stakeholder groups, presented their views on the
revision of the General Product Safety Directive.
2.3.1    Views of
stakeholders on the internet public consultation and the revision of EU
consumer product safety rules
Michael CASSAR, board Member of PROSAFE
and the Head of Market Surveillance Directorate of Malta Standards Authority, speaking on behalf of PROSAFE presented the views
of PROSAFE on the revision of the General Product Safety Directive. He stated
that Consumers want safe products regardless whether they are harmonized or not
and that cooperation between Market Surveillance Authorities considered
fundamental for product safety. He expressed support for the alignment of NLF and GPSD to form a single
market surveillance framework and intensified cooperation between Member States.
On the specific issue of joint market surveillance actions he indicated that these
actions constitute today an very good informal means of cooperation, implemented
using best practice. In the view of PROSAFE this demonstrates the feasibility of a more
formal programme and provides an excellent basis for the development of such a
programme.
Mr. Paul Coebergh van den Braak presented the views of BusinessEurope on the
revision of the GPSD. The GPSD could be improved as there is currently an
overlap with the New Legislative Framework which is quite complex and which
allows room for legal uncertainty. Revision of the GPSD should therefore aim to
provide better coherence with the New Legislative Framework. Regarding
harmonised consumer products, there is a need to align the market surveillance
regime. Standards should remain voluntary. Specific safety requirements should
not be used to legislate for entire product groups. Regarding on-line sales,
according to him, this is a practical problem, not a legislative one. 
Mr. Jean-Philippe MONTFORT from
Mayer-Brown presented the views of the legal practitioner, representing
companies involved in global and pan-European recalls and helping companies
comply with product safety.  He outlined the complexity of the legal framework
and the confusion which exists particularly since the introduction of the New
Legislative Framework.  He proposed the adoption of one single product safety
legislation (taking over and updating the relevant provisions of the GPSD and
the New Legislative Framework) which applies to all products. Other points
raised by the legal sector include clarification of circumstances triggering
RAPEX notifications and the adoption of corrective measures, suitable rights
for operators before notification on RAPEX (e.g. right to be heard; right of
access to document (test reports); right for a second opinion) and the proposal
of a central role for the European Commission and/or a dedicated EU Agency to
act as arbitrator or facilitator.
Ms. Tania VANDENBERGHE, ANEC, and Ms
Sylvia MAURER, BEUC, presented a joint position paper on revision of the
GPSD.  The representative spoke of their concerns and identified certain shortcomings
of the GSPD. The GPSD almost entirely relies on standardisation bodies to
provide safety requirements. In the absence of a standard, or until it is
referenced in the Official Journal, products not meeting safety requirements
can still enter the market.  The temporary nature of EU product safety
"emergency" measures can cause confusion as these measures may not be
prolonged at end of validity period even if no solution is found.  The
representative called for a European framework to encourage more harmonised
national market surveillance activities, a transparent, EU-funded accident
statistic database and a pan-European contact point for consumers to report
unsafe products. She also raised the issue of better product traceability and
proposed that requirements regarding manufacturers' obligations be incorporated
in the GPSD. RAPEX too should provide more information and it was suggested
that the names of retailers be included in the RAPEX notifications. As regards
services, ANEC and BEUC support the creation of a European legal framework to
cover both the safety of consumer products and services.
Mr. Henk DE PAUW, NORMAPME, presented the
organisation which represents SMEs in all sectors of European standardisation
and cooperates with CEN and stakeholders in drafting standards. NORMAPME
submitted a position paper in response to the public consultation as they felt
the questionnaire did not allow for enough space to present their opinions.
NORMAPME believes that the GPSD should keep its lex generalis character
and that specific products should be legislated through specific legislation
not under the GPSD. Regarding the standardisation procedures under the GPSD,
NORMAPME agrees that the drafting procedure should be shortened and fully
endorses the system of framework mandates where industry, in cooperation with
CEN & standardisation bodies, can draft standards on their own initiative
when needed.  NORMAPME agrees that the EU product safety "emergency"
measures should be extended from 1 to 3 years.  It would welcome a Commission
initiative which resolves differences in interpretation by different Member State enforcement bodies.
Mr. Laurent PARROT, the Technical Service
Manager of Fédération Française des Industries Jouet-Puériculture (the French
federation of toy and childcare industries) outlined the commitments of the
federation in the field of children's products and their role in the
standardisation process.  He stated that the GPSD is considered as the
directive for childcare articles but agreed that the process for mandates is
too long.  He called on greater participation of Member States in the work of
the technical committees and proposed making participation mandatory to improve
the understanding of all the different parties involved. Regarding RAPEX, Mr
Parrot listed some areas for improvement and spoke of possible
"inappropriateness" in some cases, e.g. some notifications are made
through the system 2 years after the product is taken off the market.
Mr Hubert J.J. VAN BREEMEN, Confederation
of Netherlands Industries and Employers, representing BusinessEurope commented
that the GPSD gives authorities the possibility to use non-mandated ISO and CEN
standards to determine whether or not a product is safe. 
Ms Etelvina ANDREU SANCHEZ, Instituto
Nacional del Consumo, Spain, stated that it is very difficult for market
surveillance authorities to take measures in the absence of referenced
standards and addressing this problem is important. This is particularly
necessary when strong measures have to be taken, such as withdrawal from the
market. In such cases, a referenced standard gives market surveillance
authorities a stronger position in the case of legal appeals. Referenced standards also
contribute to the transparency and clarification of the legal framework.             
Erica SCHMEDT, Authority for Social
Affairs, Family, Health and Consumer Protection, Hamburg, Germany agreed that clearer benchmarks, such as standards, should be defined for market surveillance
purposes.  
Al KAUFMAN, Toys R Us supported the need
for consistency amongst national authorities when taking action against
dangerous products and agreed that clarity of requirements and standards are
very much needed.  He added that consideration would have to be given as to
whether to have a formal or informal mediation procedure (agreed by both
economic operators and enforcement authorities).  
Thomas BOURKE, National Consumer Agency, Ireland, urged the use of the precautionary principle to put consumers first. The Irish authorities
found the consultation to be useful although suggested some aspects could be
improved, such as working relationship between the various Commission DGs as
regards interpretation.
Jean-Luc LAFFINEUR, Laffineur Law firm,
mentioned that in the case of diverging test results, Member States tend to
rely on the tests made by laboratories on their own territory. In situations
where differences between the results of laboratories based in different Member
States appear, there should be an EU "arbitrator" and the decision
should be binding on national authorities.
2.3.2    Conclusion
The Workshop on the revision of
the General Product Safety Directive showed a general consensus of all
stakeholders on three fundamental aspects: the need for a clear and uniform
legislative framework in the area of product safety, faster procedures for
elaboration of European standards and a necessity for a deeper coordination of
national market surveillance authorities at the European level.
3.           Annex
3: summary of position papers received from stakeholders
3.1.      Introduction
Due to the intrinsic limitations of the
IT tools serving for the organisation of internet public consultation, the
Commission invited all stakeholders to send position papers on the intended
revision of the General Product Safety Directive. This possibility was used by
all groups of relevant stakeholders, including consumer organisations, business
associations, Member States as well as individual economic operators. Certain
stakeholders provided more than one position paper, usually in the form of an
update in the view of the development of the legislative initiative.[77] In total the Commission
received position papers from nine business associations, two consumer
associations, two EU/EEA Member States, one market surveillance associations,
one economic operator and one common paper from two European Standardisation
Organisations.[78]
3.2.      Positions
of consumer associations - ANEC and BEUC[79]
(a)        Consistency of product
safety requirements
In the opinion of ANEC-BEUC the safety of consumers would be
better ensured, if the obligations of economic operators in respect of
harmonised products were also applied to non-harmonised products and if there
was an obligation for economic operators to establish and maintain technical
documentation in respect of all consumer products, i.e. both harmonised and non-harmonised.
Unlike the more recent Decision, the General Product Safety
Directive does not provide a possibility to choose an appropriate conformity
assessment level depending on the risks a product may pose. (A common framework
for the marketing of products was approved jointly by the European Parliament
and Council in 2008 (Decision 768/2008/EC). It describes the modules for the
conformity assessment procedures that are to be used in Community legislation.
Essentially, the European modular system “provides for a menu of modules,
enabling the legislator to choose a procedure from the least to the most
stringent, in proportion to the level of risk involved and the level of safety
required). This is a major shortcoming bearing in mind that the General Product
Safety Directive applies to all consumer products not covered by specific
directives, even those that could pose significant risks. If the Supplier’s
Declaration of Conformity (module A) is considered the default level, higher
levels seem to be warranted in certain cases. Therefore, ANEC/BEUC propose the
introduction of a provision which allows the use of conformity assessment
procedures involving third parties for certain products. The selection of a
module higher than A should be linked to criteria should be established using a
committee procedure. 
(b)        Market
surveillance coordination
ANEC/BEUC
pointed out that Member States by lack of staff and funding do not ensure the
enforcement of product safety legislation. They stressed there was an urgent
need for establishing a European framework for market surveillance in order to
ensure the availability of sufficient resources and a coherent approach to
market surveillance activities across all 27 Member States. 
The revision of the General
Product Safety Directive gives an opportunity to introduce more demanding
requirements on market surveillance activities of Member States (such as the
need to check a minimum number of products of a certain kind agreed at the
European level). However, this would only be useful if the lack of resources of
market surveillance authorities was addressed. Hence, a pan-European debate on increasing the financing of market surveillance activities should be
initiated.
In the opinion of
ANEC/BEUC a better product traceability would improve market surveillance
cooperation and coordination under the General Product Safety Directive. It is
crucial for consumers that the withdrawal of unsafe products from the market,
or the recall of products that hold potential risks to health and safety, is
done as quickly as possible. 
Measures should be taken in order to allow the rapid and
easy identification of unsafe or defective products. In this context, the
requirements regarding manufacturers’ obligations from
the Decision on a common framework for the marketing of products should be incorporated, and in particular the
following:
“-
Manufacturers shall ensure that their products bear a type, batch or serial
number or other element allowing their identification, or, where the size or
nature of the product does not allow it, that the required information is
provided on the packaging or in a document accompanying the product.
-
Manufacturers shall indicate their name, registered trade name or registered
trade mark and the 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. The address must indicate a single point at which the manufacturer can
be contacted.”
ANEC/BEUC also consider that the
application of track-and-trace technologies, and product authentication
technologies, would be beneficial to consumer safety. The technology used
should ensure consumer safety, be reliable and applicable, and improve tracing
mechanisms to allow identification and safe recall, safeguard consumer privacy,
not hinder competition and the environment and have no major impact on the
final price of products.
A full assessment of the advantages and
disadvantages of each technology should be made. The adverse effects RFID
potentially holds for consumer privacy (tracking and profiling of consumers and
consumer discrimination), security (ID theft) and health (EMF emissions) should
be of concern.
(c)        Simplification
(i)         Simplification
of the overall legislative framework
ANEC/BEUC would agree
to include the provisions of the Directive on Dangerous Imitations in the General
Product Safety Directive provided that the prohibition of these products would
be maintained.
(ii)        Pre-standardisation
procedures under the General Product Safety Directive
ANEC/BEUC would oppose to apply
international standards as an additional benchmark for safety evaluation
because international standards are often more difficult to develop and rarely
contain requirements that are detailed enough to ensure products are safe. The
development of international standards is also more difficult for European
consumers to influence. Moreover, in most cases, international standards
relevant to the General Product Safety Directive will not be available. 
Likewise, ANEC/BEUC would not be in
favour of the application of non-European standards (other than international
standards) whenever a risk or a product is not covered by a European standard
referenced in the OJEU because there is very little influence over non-European
standards. However, the option could be supported in principle if a comitology
procedure is used and a proper consultation and evaluation involving
stakeholders is ensured. If such procedure is in place, it may be useful in
some cases to adopt safety standards from non-European countries, e.g. ASTM
standards, wholly or partly. For example, the current CEN high chair standard
is inferior to its US counterpart. It should also be possible to adopt the
provisions of a non-European standard in a modified form under this procedure.
Direct
referencing of European standard whereby an existing European standard developed
without a mandate from the Commission would be directly referenced in the OJEU,
provided that it ensures a high level of consumer protection, could be
supported by ANEC/BEUC if an adequate procedure was used to decide about such
referencing. That would be the case, for example, if the procedure allowed
Member States and stakeholders to object to the standard being referenced in
the OJEU (as is done now under the General Product Safety Directive), then
ANEC/BEUC could agree. A comitology procedure should be used to this end and a
proper consultation and evaluation involving stakeholders would need to be
ensured.
Regarding the
interests represented in the standards development process, the participation
of societal interests can be hampered by many factors such as lack of
resources, insufficient expertise and ineffective coordination. These factors
were detailed in the Access to Standardisation study of March 2009 for DG Enterprise.
Hence it is vital for public financial support to be continued in order to
enable the participation of societal stakeholders directly at European level.
We welcome the recommendation of the EXPRESS panel for public funding to be
continued to ANEC (ECOS, ETUI-REHS and NORMAPME) in the years to 2020 and
beyond. The revised General Product Safety Directive could not be successful
without the effective participation of consumers in the standardisation
process.
In
the view of ANEC/BEUC, the major shortcoming of the current General Product
Safety Directive is that it almost entirely relies on the European
Standardisation Organisations (ESOs) to provide detailed safety requirements
for specific products. ANEX/BEUC's main concern with regard to the procedure is
that the initial Commission Decision, determining the safety requirements which
the standard must meet, is not legally-binding. As the ESOs are not obliged to
accept a Commission mandate and the use of standards is always voluntary, there
is no guarantee that the standard will be developed and even if it is, there is
no certainty it will reflect what the mandate requires. However, it is true
that if a standard is developed but does not meet the safety
requirements of the Decision, the Commission, through comitology, can decide
not to publish (or to withdraw) its reference in the OJEU. This means that, in
any of the situations described above (i.e. in the absence of a standard or
until its reference is cited in the OJEU), products that do not meet the safety
requirements of the Decision can legally circulate or enter the market thereby
putting consumers’ health and safety at risk. This ‘status quo’ can last for
many years (up to 5 years and more) before a satisfactory safety measure
becomes operational. In case the Commission would in the future favour the
application of international standards, they should go through the same
procedure as European Standards before being referenced in the OJEU. If the Directive
allows for establishing any safety requirement on any product on a temporary or
permanent basis it may also be possible to make use of an existing European
standard wholly or partly. It should be also possible to adopt the provisions
of an existing European standard in a modified form. A comitology procedure
shall be used to this end and proper consultation and evaluation including
stakeholders must be ensured.
Political issues
should be dealt with at the political level and not delegated to the standardisation
bodies. An example is the establishment of content limit values for hazardous
chemicals in consumer products. The role of standardisation should be limited
to providing the technical means through which compliance with the
political decision is achieved or evaluated. The General Guidelines, which
constitute the common understanding between the EU/EFTA and the ESOs confirm
that “European standards provide technical solutions for presumption of
conformity with legal requirements” and moreover recognise the “distinct
responsibilities and competencies” of the EU/EFTA and ESOs in the
standardisation process.
Given the
shortcomings of some European standards, ANEC/BEUC proposed that the Commission
should consider introducing an alternative to standards as a means of
supporting the General Product Safety Directive. For instance, ANEC found that
seven of nine European standards, proposed by DG SANCO in 2005 to be cited in
the OJEU in support of the General Product Safety Directive, did not offer
sufficient levels of safety. In 2009, ANEC rejected most of the standards
proposed by DG SANCO to be cited in the OJEU. Both examples arose from the
unbalanced influence of industry in the development of standards to support
legislation or the wider public interest.
A further shortcoming
of the General Product Safety Directive, in the opinion of ANEC/BEUC was the
lack of a safeguard procedure which would allow Member States to express a
formal objection to a standard (such as Article 14 of the Toy Safety Directive
2009/48/EC). The use of a safeguard procedure should be possible even before a
standard is cited in the OJEU.
ANEC/BEUC
further submitted that the legislative “framework for the setting of ecodesign
requirements for energy-related products (ERP)” (2009/125/EC) be used as a
model in the field of product safety. This directive foresees the adoption of
“implementing measures” for specific product categories using a regulatory
committee procedure complemented by a “consultation forum” involving all
stakeholders. The implementing measures are based on research projects funded
by the Commission. The Commission also makes funding available to ensure the
effective involvement of consumers and environmental NGOs in the implementation
process. As in the ERP ecodesign process, ANEC/BEUC believe the General Product
Safety Directive should allow the establishment of product specific rules
without limitation, either in terms of content or period of applicability. It
could then be decided case-by-case which level of detail should be defined in
the implementing measure and which aspects left to the standards bodies. Such a
mechanism would make the procedure to specify product specific rules as the
basis for mandates superfluous. The adopted requirements would have a legal status
per se and so form a framework for the adoption of mandates. The
implementing measures could be adopted for a definite or indefinite time.
Emergency measures would not be needed because of the legal status of the
implementing measure, except for products covered by vertical product safety
regulations (e.g. the Toy Safety Directive) which do not provide for the use of
emergency measures. An alternative would be to allow the use of emergency
measures in all directives.
(iii)       EU procedures for exchange
of information on product risks
As
far as serious and immediate risks are concerned, ANEC/BEUC were of the
opinion that RAPEX contributed to
more even protection of consumers throughout the EU. However, in their view
RAPEX it had to be improved and enable a wider access to information about
dangerous products.
ANEC/BEUC held the
view that when a dangerous product was notified by a Member State to the Commission, the authorities and the Commission did not systematically inform
consumers or consumer groups unless an action (e.g. a recall) is taken. According
to ANEC/BEUC an exception to this was the information and statistics related to
the Low Voltage Directive safeguard clause notifications. These are regularly
sent by the Commission and the LVD-Administrative Co-operation Group to
consumer organisations. The same failure of communication has been shown to
happen when national authorities detect a dangerous product and negotiate an
agreement with the producer either to remove the product from sale or to modify
it. In the latter case, from time to time, the authorities do not notify even
other Member States of the voluntary agreement with the producer.
For ANEC/BEUC, the
success of any recall is dependent upon the communication of information to
consumers. Hence ANEC/BEUC call for the early and widest possible dissemination
of information relating to dangerous products. The results of a notification
should be made publicly available in order to protect consumers’ health and
safety and to increase consumers’ confidence in the Internal Market. 
ANEC/BEUC indicated
that RAPEX could be used as the basis for dissemination of information but
should be improved in order to provide more detailed information and be made
more consumer-friendly. For instance, the column that appears on the right-hand
side of the RAPEX overview, indicating the other Member States in which the
products have been notified and restriction measures taken, should be filled in
systematically. This column provides valuable information at a glance.
Furthermore, consumer
organisations should receive information beyond that made publicly available.
For example, ANEC would want to be informed about the standards with which
dangerous or unsafe products may comply. 
Finally, requirements related to the
content of recall notices should be defined so as to avoid recall notices being
perceived by consumers as advertisements for the products notified.
(iv)       EU product safety measures
ANEC/BEUC did not foresee any problem if
the EU product safety "emergency" measures were directly applicable
to economic operators. In their view, although the General Product Safety
Directive allowed regulators to adopt product specific requirements in the form
of implementing measures in emergency situations, the adoption process remained
extremely slow and the validity of the measures is always time limited.
Temporary “emergency” measures, based on Article 13 of the General Product
Safety Directive, may be adopted by the Commission, but this instrument has not
been used to any great extent. The temporary nature of Article 13 measures could
cause confusion and uncertainty among economic operators and consumers because
they may not be prolonged at the end of their validity period, even when no
solution to the risk has been found. In addition, (multiple) prolongations in
the past (lighters, phthalates) have led to an expenditure of resource that
could have been avoided if permanent measures had been adopted following a
comitology procedure (or safety requirements having a legal status).
(d)        Other
(i)         European accident database
ANEC/BEUC indicated that in the recent
report 'Injuries in the European Union - Statistics Summary 2005-2007' revealed
that around 7 million people were admitted to hospital each year, with 35
million more treated as hospital outpatients, as a result of an accident or a
violence-related injury. Injury data could be obtained from a wide range of
sources, however, most injury databases in the EU were fragmented, limited in
their size and scope or incomplete. This makes it almost impossible to compile
reliable statistics or reach conclusions. 
In opinion of ANEC/BEUC, even the
so-called European Injury Data Base (IDB) could be considered as a reliable and
representative database since only 13 Member States were known to collect
injury data through hospitals which, in turn, were not always collecting
information in a regular and consistent manner. In addition, it was very
difficult to gain access to the IDB or receive detailed information. 
ANEC/BEUC deemed accident and injury data
to be critical in the setting of priorities, the development of policy and the
determination of preventive actions and were also needed to evaluate the
effectiveness of preventive measures. For instance, reliable and consistent
accident and injury data would give a clear indication as to whether the number
of injuries and accidents involving a certain consumer product has decreased
following the introduction of a new/revised regulation or standard. If no
change is observed, regulators could require a review of the legislation or
standard related to the product(s) in question. 
Last but not least, the efficiency of the
legal framework of the New Approach and the General Product Safety Directive
depends, in the view of ANEC/BEUC on the ability of the Commission and Member
States to identify and recognise problems associated with unsafe consumer
products. Such problems can be identified only through a regular surveillance
of home and leisure accident data. 
ANEC/BEUC urge the creation of an
EU-funded accident statistical system, under the co-ordination of the European
Commission. Member States should be required to contribute to the establishment
of the database and its regular updating. This system could be the IDB system
providing that it was improved and adequately funded by the European Union.
Relevant stakeholders - such as consumer organisations - should have access to
the database. 
(ii)        Child-appealing products
ANEC/BEUC
have encountered diverging safety evaluations with respect to a particular product
by the national market surveillance authorities of different Member States and
especially cite child appealing products as an example. ANEC/BEUC considered
that Member States did not know how to evaluate products as there was no
harmonised definition in EU legislation of what should be considered as child
appealing. In the case of baby walkers and bath seats some Member States
evaluated these products as being unsafe and would prefer to ban them; others
disagreed. Same applied to disco soothers. These soothers, popular with
teenagers some years ago, contained a battery to make the soothers flash and
some batteries exploded. As a result, according to ANEC/BEUC soothers were
banned in some Member States, but not in others. Binding
EU-wide measures setting specific safety requirements for certain products
would best resolve these divergences. 
For ANEC/BEUC, the
safety of child-appealing products could be ensured by developing a harmonised
definition for child-appealing products. In their view, there was currently a
lack of a harmonised definition of what makes a product appealing to children.
In general, the child-appealing characteristics of products include shape,
size, texture, colour and decorative elements (eyes and feet, for instance).
Other characteristics that could also play a role are sound, smell, movement
and function (e.g. a lighting function). ANEC/BEUC regretted that there was still
no harmonised definition agreed in EU legislation. A legal definition of a
child-appealing product can so far be found only in the case of lighters.
Therefore,
ANEC/BEUC proposed to introduce a common definition of child-appealing products
in the General Product Safety Directive. The Commission Decision on
child-resistant lighters states that a “’child-appealing lighter’ shall mean a
lighter whose design resembles by any means to another object commonly
recognised as appealing to, or intended for use by children younger than 51
months of age.” In the opinion of ANEC/BEUC this definition could serve as a
basis for the definition to be introduced in the General Product Safety
Directive. In addition, ANEC/BEUC proposed the same definition to be introduced
in other relevant Directives, like the Low Voltage Directive, the R&TTE
Directive, the Cosmetics Directive, etc. If the same definition is not applied
in other EU legislation, there could be a risk of having different/no
definitions for other ranges of products not falling under the General Product
Safety Directive.
Furthermore,
ANEC/BEUC saw the need in establishing specific safety requirements for child
appealing products. A toaster shaped like a cartoon character, a shampoo bottle
resembling a doll, a scented candle that looks like a strawberry, a cigarette
lighter resembling a toy car that blinks; More and more products are shaped or
decorated in a way that makes them appealing to children. The lack of specific
safety requirements in product legislation for such child-appealing products
undoubtedly raised concern, particularly as children are among the most vulnerable
of all consumers.
In the viewpoint of
ANEX/BEUC specific legal requirements ought to be developed to ensure that
child appealing products are indeed safe for children. In particular, the General
Product Safety Directive should explicitly require that, whenever a product
features child-appealing characteristics, the product must be safe for children
under all conditions of use and foreseeable misuse. If deemed necessary for the
protection of children’s health and safety, a complete ban should be imposed on
certain types of products, determined by a committee procedure. Such a ban
should apply to dangerous chemical products (or their packaging) that are
appealing to children. With regard to the latter, upon the request of DG SANCO,
the Scientific Committee on Consumer Safety (SCCS) is currently assessing the
potential risks related to these products. To support this work, the members of
ANEC/BEUC submitted examples of products that can be found on the EU market,
along with information about related potential risks. The Commission shall take
measures against these dangerous products that reflect the SCCS opinion as soon
as it is published.
(iii)       Reference to persons with
disabilities
A
specific reference to people with disabilities under categories of consumers at
risk should be made under Article 2 (b) (iv) of the General Product Safety
Directive, to avoid any potential diverging safety evaluation of products.
(iv)       Collective redress mechanisms
ANEC/BEUC believed
that consumers suffering from damages due to the same defective/harmful product
should be able to gather their claims against the producer in a joint action
given that the mass production of consumer goods could lead to the distribution
of unsafe products on a large scale, significant number of consumers may be
affected.  ANEC/BEUC suggested that a collective redress mechanisms should be
put in place in all Member States to ensure fair compensation of victims
notably in product liability cases. In this context, ANEC/BEUC asked for the
General Product Safety Directive to require that information about the redress
mechanisms offered, such as reimbursement and/or compensation, should be
provided to the public at the same time as other information.
(v)        EU
complaints handling and reporting point
For ANEC/BEUC, the
absence of a system at the EU level which would allow consumers to register
problems they identify with the safety of products represented an important
shortcoming. In most Member States, consumers have the possibility to report
safety problems, incidents or accidents with products to the authorities.
However, this information is not gathered or coordinated at EU level, with the
exception of the notification of dangerous products that pose a serious risk,
which are reported by the national authorities under the EU RAPEX system.
According to
ANEC/BEUC, the Commission should establish a system under the General Product
Safety Directive through which national consumer complaints reported to Member State authorities are gathered at a single, pan-European report point. In addition,
consumers should have the right to notify unsafe or non-compliant products
directly to this European report point.
A complaints handling
and report point for the registration of unsafe children’s items (the ‘OKA
report point’) was set up in December 2005 in the Flanders region of Belgium,
as an initiative of the Flemish governmental agency "Kind en Gezin"
(Child and Family) in cooperation with three partners, one of whom was ANEC.
The philosophy was that parents, foster families, crèches and carers can use
the report point (accessible via the Kind en Gezin’s website) to report
products intended for children between 0 to 3 years of age which have been
found to be unsafe or have been involved in accidents or near-accidents. During
the First International Workshop on “Accident/Injury data collection for
non-food product and service risk assessment”, organised by DG Health &
Consumers in February 2006, this Flemish project was found to be very simple,
to incur very limited costs, and was envisaged as concrete outcome of the
workshop as “it constitutes a good pilot for further projects”. ANEC/BEUC would
strongly support this report point as model for a European report point.
In the view of ANEC/BEUC a supporting
European database would enable the timely identification of safety problems or
risks and permit national authorities (and economic operators) to take
corrective actions more quickly. This pan-European report point and database
would have to be complementary to the RAPEX system in order to ensure
coherence. ANEC/BEUC did not believe the complaints and data collected
necessarily have to be publicly available.
3.3.      EU and EEA member states or their regions
3.3.1    DENMARK
(a)        Consistency
of product safety requirements in the non-food area
In the opinion of Denmark diverging [product safety] requirements led to higher administrative burdens in
general for businesses and expectedly higher exposure of consumers to dangerous
products. Consequently, the Danish Government would strongly support the
alignment with the New Legislative Framework to the highest possible degree
leading to fewer legislative differences in Member States while ensuring the
independence of legislation not covered by the New Legislative Framework.
Providing a clear and uniform set of product safety obligations for economic
operators for all kinds of products and ensuring effective and clear product
traceability will also ensure better enforcement of existing product safety
rules.
(b)        Market
surveillance coordination
Denmark acknowledged that diverging safety evaluations posed a problem for
economic operators, as they thereby face inconsistent application of safety
legislation towards their products in different Member States. Denmark would therefore be in favour of considerably improving market surveillance
cooperation and coordination as well as the harmonisation of safety evaluations
of consumer products amongst Member States.
Denmark would support creation of an improved and more uniform control of
products since in its view it is important that authorities of all Member
States collaborate and share knowledge about how to plan to protection of
consumers in an optimum manner. Yet, Denmark pointed out that it was also
important that remedying measures, which are chosen, take into account national
and cultural differences and conditions of use of the products in question,
while still aiming at supporting the free movement of goods and services across
borders to the highest degree possible.
(c)        Simplification
(i)         The
overall legislative framework
Denmark holds the view that alignment with the New Legislative Framework
(NLF) should be ensured to the highest possible degree. Following the adoption
of the Free Movement of Products package, two sets of rules on general product
safety exist. Coexistence of these rules without a substantive and practical
alignment of the General Product Safety Directive with the NLF, will leave both
economic operators and national market surveillance authorities with differing
product safety obligations.
(ii)        Pre-standardisation
procedures under the General Product Safety Directive
Denmark would be in favour of optimisation of the speed of standardisation
procedures providing that the political consensus on the safety requirements
within the forum of Member States as well as a high level of consumer
protection was maintained and that the speed of these procedures  was  balanced
against transparency, consensus and quality.
(iii)       EU
procedures for exchange of information on product risks
N/A.
(iv)       EU
product safety measures
Denmark expressed
support for the direct applicability of EU product safety measures to economic
operators as well the extension of the period of validity of these measures, by
making the period of validity dependent on occurrence of a certain event in
future, such as adoption of an EU standard or a permanent EU legislative
measure with respect to an identified risk.
(d)        Other 
(i)         Safety
of product sold online
Denmark would favour strengthening and easing market control enforcement of
consumer products sold on the internet. In its view since the amount of
products sold on the internet is steadily increasing, it is important to better
protect consumer interest in this area and remove the remaining barriers to
cross border trade. Denmark would support creation a specific market
surveillance guideline containing a best practice on market surveillance on
products sold online.
(ii)        Safety
of services
Denmark was of the opinion that the safety of services, if they were to be
regulated, should be included in the scope of the Services Directive, and not
as an integral part of the General Product Safety Directive.
(iii)       Introduction
of a safety requirement that the product would not become dangerous in their
expected lifetime
Denmark suggested an introduction of a safety
requirement that the product would not become dangerous in their expected
lifetime. This requirement would need to take into account reasonable
maintenance to be carried out by the consumer. Justification for the
introduction of this requirement into the directive is that a wide range of
products are not yet covered by standards, that normally takes aging into
account. For the sake of consumer safety, in the view of Denmark, this requirement was necessary for proper enforcement.
3.3.2    GERMAN LÄNDER[80]
In the opinion of
German Länder this review should be seen in the context of the Commission‘s
efforts towards a new Single Market Act and of the European Parliament’s
resolution on the revision of the product safety directive and on market surveillance
dated 8th March 2011. An essential element of this review is the adaptation of
the directive to the New Regulatory Framework for the Marketing of Products
(New Legislative. The repeal of Directive 87/357/EEC and the integration of
these regulations for products which may be confused with food into the product
safety directive would be welcomed.
3.3.3    NORWAY
(a)        Consistency
of product safety requirements in the non-food area
Norway indicated
that the definitions of economic operators differ in the General Product Safety
Directive from those contained in Regulation (EC) No 765/2008 and Decision (EC) 768/2008, which could cause problems. In
its opinion it was not clear, in particular, how an authority in one country should
deal with dangerous products imported to the EU by an importer not located in
that country.  If the importer of a dangerous product was located in another
country and only the distributor was located in Norway, Norway could not carry out measures directly towards the importer. In its view, according
to Regulation (EC) No 765/2008 Norwegian authorities could not ask for detailed
safety documentation from distributors, only from importers and manufacturers.
(b)        Market
surveillance coordination
Norway expressed
concerns about the proposal from the Commission about obligatory participation
in at least one joint market surveillance action per year. One year the joint
action might include products not considered to be a problem in Norway. Due to cultural differences, different products and different use, products which were
considered as a problem in one country might not automatically pose a problem
in another country. Norway did not want to be committed to participate in a
joint action when it would not consider the product in question to pose a
significant risk in Norway.
(c)        Simplification
(i)         Overall
legislative framework
Norway strongly supported the alignment of the General product Safety
Directive with the new Legislative Framework and believes that it will be
easier for both authorities and economic operators because economic operators
have difficulties in understanding regulations in the non-harmonised area.
(ii)        Pre-standardisation
under the General Product Safety Directive
Norway expressed
its concern about non-mandated standard referencing, and highlighted that it had
to be ensured that this type of standards would not favour some economic
operators (e.g. the ones who developed the standard originally). There should
be some kind of assessment to ensure that the standard covers all the essential
safety regulations.
(iii)       EU
procedures for exchange of information on product risks
N/A.
(iv)       EU
product safety measures
Norway was positive in respect of a
direct application of product safety emergency measures to economic operators,
as it most likely would be an effective tool to ensure safe products for
consumers, but stressed the need to hear the views if economic operators before
the measure was adopted.
3.4.      Business associations
4.1       BUSINESSEUROPE[81]
(a)        Consistency of product
safety requirements in the non-food area
BUSINESSEUROPE
favoured a coherent legislative framework in the product safety area. According
to BUSINESSEUROPE, this should be achieved by limiting the application of
consumer product safety requirements under the General Product Safety Directive
only to products not regulated by harmonised product safety requirements. For
non-harmonised consumer products BUSINESSEUROPE is of the opinion that the
general safety requirement adequately covers the safety risks of those products.
On the specific issue
of identification of the manufacturer and/or importer responsible for putting
the product on the market, BUSINESSEUROPE considered, on the one hand, that it was an essential tool to deny
rogue economic operators an easy route to ignore the law, but, on the other
hand, it deemed existing traceability rules to be sufficient. In the view of BUSINESSEUROPE requirements of identification of the manufacturer and/or importer responsible
for putting the product on the market should be defined differently for
consumer non-harmonised products (more lightly) than for harmonised products (whether
consumer or professional ones).
(b)        Market surveillance
coordination
BUSINESSEUROPE expressed a strong preference for one market surveillance Regulation
which would bring together the instruments for swift action against products
posing risks. In its view, the
regulatory action should aim uniformity of rules on market surveillance, covering
all possible products placed on the market.
(c)        Simplification
(i)         Overall legislative
framework
BUSINESSEUROPE supported
a coherent legislative framework in the product safety area and called for
elaboration of a horizontal market surveillance Regulation. In its view, the
overlap between market surveillance provisions of the General Product Safety
Directive and Regulation 765/2008 created confusion amongst market surveillance
authorities with regard to the enforcement of relevant legislation and generated
legal uncertainty for economic operators and consumers. 
(ii)        Pre-standardisation
procedures under the General Product Safety Directive
BUSINESSEUROPE saw no
compelling reason for changes to the procedure for the adoption of
standardisation mandates and the elaboration of European standards as foreseen
under Article 4 of the General Product Safety Directive. At the same time, it
would like to have a consistency of procedures between  the harmonised and the non-harmonised domains.
(iii)       EU procedures for exchange of information on product
risks
N/A.
(iv)       EU product safety measures
N/A.
3.4.2    CONFEDERATION OF BRITISH INDUSTRY (CBI)[82]
(a)        Consistency of product
safety requirements in the non-food area
CBI considered that there was a limited
scope for alignment between the General Product Safety Directive and the New
Legislative Framework,[83]
i.e. between consumer product safety requirements and harmonised product safety
requirements. It thought that the need to ensure that overlap and duplication
are avoided between the sectoral directives and the General Product Safety
Directive was all the more important under current economic circumstances where
the focus was on achieving “more with less”. The duties and responsibilities of
the various economic parties in the supply chain should be clearly set out.
(b)        Market surveillance coordination
CBI believed that the issues which were
highlighted in the Commission documents, stemmed from lack of uniformity in the
application of the legal rules; these could be addressed through steps to bring
about a more even application and enforcement of the regulatory provisions,
ensuring greater coherence of approach by regulatory authorities across Member
States, rather than through regulatory changes. 
According to CBI the first step should be
to seek increased alignment at an administrative level, encouraging improved
co-operation and exchanging best practice among enforcement authorities. CBI
would support measures which would improve consistency of approach between
Member States including measures to enhance co-operation at EU level between national
authorities. The establishment of a stable co-ordination platform to oversee
and ensure such improved co-operation would be welcome, subject to a certain
level of scrutiny by stakeholders of its overall operation.
CBI considered that binding EU-wide measures
setting specific safety requirements for certain products would be a
disproportionate response to the problem of divergences in application of
product safety requirements by individual Member States. If Member States’
views were divergent because of different interpretations at national level,
this could be addressed through a mechanism of dialogue to include interested
stakeholders.
(c)        Simplification
(i)         Overall legislative framework
The CBI welcomed measures which would
bring about greater clarity and consistency in the general product safety
regulatory regime. The CBI expressed itself in favour of the alignment of
definitions in the General Product Safety Directive with those in Regulation No
765/2008 and Decision 768/2008/EC. 
(ii)        Pre-standardisation procedures under the General Product Safety
Directive
In the opinion of CBI there may be some
benefit in aligning the standardisation process as between the General Product
Safety Directive and the NFL, subject to the important proviso that there is
full stakeholder involvement in the process and that the development of
standards is based on robust scientific evidence.
(iii)       EU procedures for exchange
of information on product risks
N/A
(iv)       EU product safety emergency
measures
N/A.
(d)        Other
(i)         Safety of products sold
online
In the view of CBI the General Product
Safety Directive should contain no additional rules possibly conflicting with
the distance selling Directive 97/7/EC. 
(ii)        Safety of chemicals
According to CBI chemical safety issues
should be dealt with under REACH Regulation.
3.4.3.   EUROPEAN
PARTNERSHIP FOR ENERGY AND ENVIRONMENT (EPEE)[84]
(a)        Consistency of product
safety requirements in the non-food area
N/A
(b)        Market surveillance
coordination
EPEE
saw the main challenges in market surveillance on the internal market in differing resource levels among EU Member
States. Differing resource levels may lead to uneven implementation and uneven
national application of market surveillance may result in further market
fragmentation within the EU.
To
address these problems EPEE suggested that the Commission encourage the Member
States to take enforcement seriously, recognize the need for robust and
implementable market surveillance systems, and cooperate with the industry on
market surveillance in order to find efficient and cost-effective systems to
ensure compliance.
In
the view of EPEE, the absence of an effective market distorts the market and
comes at the expense of the environment, consumers, and industry. Non-compliance
is detrimental to the environment since it results in the sale of equipment
that use banned chemicals, are not energy efficient and properly disposed of. According
to EPEE non-compliance comes at the expense of consumers: they purchase
equipment that turns out more costly to operate than expected. Non-compliance
also undermines the climate change and energy efficiency goals of governments
who assume certain levels of equipment performance to achieve energy savings
and to reduce carbon emissions. It considered that the current situation was
unfair for companies who make the effort to comply: whilst free riders could
just declare compliant performance values without making any additional effort,
compliant companies have to modify design, add material and/or use more
expensive parts to meet the target performance required under EU legislation.
EPEE feared that if non-compliant products were not quickly identified and
removed from the market, compliant companies might go out of business due to
higher cost and lower price competitiveness due to their compliance with EU
legislation.
(c)        Simplification
N/A.
3.4.4    EUROCOMMERCE[85]
(a)        Consistency of product
safety requirements in the non-food area
EuroCommerce expressed
support for the revision of the General Product Safety Directive if the consistency
with other pieces of legislation such as the Free Movement of Goods Package[86] was ensured. In its view the
Free Movement of Goods Package provides clear definitions of roles in the
supply chain together with adapted regimes of responsibilities. This provides
legal certainty for all operators, in particular with respect to who is
responsible for what. As envisaged by Article R5 of Annex I of Decision
768/2008, the future alignment of product safety legislation should proceed on
the basis that the precise responsibilities of distributors were clearly
differentiated and exhaustively listed without exceeding those contained in
Article R5 of Annex I of Decision 768/2008.
EuroCommerce indicated
that while authorities in some Member States considered the name and address of
the manufacturer to be a sufficient proof of showing the compliance with the
relevant product safety requirements, authorities in other Member States were
asking for the immediate transmission of all technical documentation. This has
implications for companies and their relationship with their industrial
partners when they ask their suppliers to provide technical documentation in
order to check all the markings/warnings. Possessing this type of documentation
leads to many problems with suppliers - including issues of confidentiality and
copycatting.[87]
EuroCommerce would favours
more consistent and clearer rules on product liability, which recognise that
the responsibility of retailers should be limited to their sphere of
competence.
The Commission should
provide clarification on the retailers' obligations as it is laid down in
Article R5 of Annex 1 of Decision 768/2008 to verify markings and documents
accompanying products. In particular, in the view of EuroCommerce the obligation of the distributor to verify markings should be
limited to what can be controlled with the information the distributor has in
his/her possession. Moreover, the obligation not to make the product available
to the consumer if there is a reason to believe that it is non-compliant with
specific provisions should not be interpreted as meaning that distributors
should verify markings of all specific requirements of each Directive. This can
be very technical and it would require that the distributor is provided with
the technical documentation from the manufacturer.
In the opinion of
EuroCommerce, the Commission should ensure that requests from national authorities are reasoned to the
extent that they concern elements of the technical documentation that are
necessary for the investigation. Authorities should fix a deadline for receipt,
unless a shorter deadline is justified in the case of a serious and immediate
risk. Furthermore, the Commission should ensure that the distributor has the possibility, when having
received a reasoned request, to contact the importer, manufacturer or the
authorised representative in order to arrange that the request is sent directly
to the authority. Finally, the Commission should consider that in a truly functioning internal market, the manufacturer
or its representative in Europe should have to communicate information directly
to the authorities.
(b)        Market surveillance
coordination
EuroCommerce would be
in favour of market surveillance coordination provided that they possess the
human and financial resources necessary to carry out their activities.
EuroCommerce considered that improving cooperation between national market
authorities would prove to be beneficial to further increase the level of
protection of the public interests at stake. Nevertheless, it reminded that since
national market surveillance authorities often lack the necessary resources so
that any improvement in coordination should seek to increase their efficiency
rather than introduce bureaucratic requirements that may further impact
negatively on the limited resources of national authorities. EuroCommerce also
advocated introduction of a peer assessment system of national market
surveillance activities.
In the view EuroCommerce,
to minimise diverging safety evaluations of an identical product in different
Member States, EuroCommerce members consider it essential to dispose of
accepted European-wide test methods and interpretations of their results. The
assessment of the risk should be made on a common definition of what is a “serious
risk” and specific attention should be devoted to ensuring that only certain
kinds of risks have to be notified to avoid all systems being blocked and thus
causing a decrease in efficiency. To that end the adoption of a single set of
risk assessment guidelines for use by enforcement authorities would contribute
to the achievement of this objective. This would help to remove diverging legal
interpretations by national authorities while providing economic operators with
a clearer legal framework.
EuroCommerce would
welcome the proposal to reinforce market surveillance within the entire EU if such
proposal was accompanied by better cross-border cooperation among national
authorities along the lines of Article 9 of the Regulation on consumer
protection cooperation so that market surveillance measures could be taken
"at source" and avoid penalising distributors who did not produce the
product, but only made it ‘available on the market’. Passing on responsibility
to retailers for activities that go beyond their sphere of activity should be
strongly opposed.
Furthermore, EuroCommerce
would appreciate the encouragement of digital communication to improve the
efficiency of communication between business and national authorities:
EuroCommerce therefore suggested to establish a common database gathering test
reports on products. At the same time, national authorities should ensure a
mutual recognition of test reports. This would lead to a reduction in the cost
analysis impacting professionals and Member States, a decrease in the storage
time of goods waiting to be placed on the market.
Finally,
EuroCommerce emphasised that
the concept of "isolated cases" should be integrated in all
implementation guidelines related to product safety and other guides related to
corrective actions and a reference to
isolated cases into the new General Product Safety Directive provisions
should be integrated, correlating to Article 5(2) of the existing General
Product Safety Directive. 
(c)        Simplification
(i)         The overall legislative
framework
EuroCommerce would be
in favour of a coherent and effective legal framework for product safety and
market surveillance. 
(ii)        Pre-standardisation
procedures under the General Product Safety Directive
EuroCommerce did not
believe that the procedures should be accelerated, as transparency and
consultation of all stakeholders, and in particular SMEs, requires more time.
EuroCommerce would oppose any modification of the General Product Safety
Directive that would lead to make specific safety requirements in
standardisation mandates directly applicable.
(iii)       EU procedures for exchange
of information on product risks
In the opinion of EuroCommerce, RAPEX
notifications should take place only when other corrective measures would be
inappropriate or inefficient to guarantee the safety of users and/or consumers.
The Commission should also develop a common
definition of serious risk in relation to RAPEX and RASFF notifications in
order to reduce the number of (e.g. isolated cases) notifications. 
(iv)       EU product safety measures
For the sake of
efficiency and on the basis of the experience gained, EuroCommerce members
considered that EU product safety measures should be directly applicable to
economic operators, following a process of consultation of stakeholder organisations.
(d)        Other:
Safety of products sold online
With respect to
online sales, EuroCommerce stressed that rogue trading occurred in all kinds of
supply chains and trade distribution networks. As a result, the sales of unsafe
products should be banned, however it saw be no need to define a specific
regime for online sales that would defer from the one applicable for
traditional forms of distribution. The same rules should apply since the same
sort of interests to be protected is at stake.
3.4.5    MOUVEMENT
DES ENTREPRISES DE FRANCE (MEDEF)[88]
(a)        Consistency of product
safety requirements in the non-food area
N/A.
(b)        Market surveillance
coordination
N/A.
(c)        Simplification
(i)         The overall legislative
framework
MEDEF would appreciate if the Directive
on food imitating products were also revised. 
(ii)        Pre-standardisation
procedures under the General Product Safety Directive
N/A.
(iii)       EU procedures for exchange
of information on product risks
MEDEF saw the need to improve the
functioning of RAPEX, principally in
order to promote a similar behavior of the different
Member States when they submit notifications to RAPEX. Companies consider that
RAPEX could be more rigorous. In the opinion of MEDEF, it is problematic that the Member States are obliged to undertake a
risk assessment while they lack a definition of serious risk. Therefore, Member
States may submit a notification although the risk actually cannot be
considered to be serious. 
(d)        Other
In the opinion of MEDEF the term of the
consumer should be defined in the General Product Safety Directive and the
definition of serious risk specified.
3.4.6    ORGALIME[89]
(a)        Consistency of product
safety requirements
In the view of Orgalime the fact that
certain consumer products are not subject to sector specific new Approach or
Old Approach Directive setting out essential safety requirements for the given
product is a sufficient proof that such products do not pose a danger.
Therefore, the product safety requirements of non-harmonised products should
not be regulated at the EU level. The regulation of such products at the
national level subject to the principles of Mutual Recognition Regulation is,
in the view of Orgalime, an adequate regulatory response.  
(b)        Market surveillance
coordination
With respect to market surveillance Orgalime submitted that
the Commission should establish a single EU market surveillance regime, which should be consistent
with Regulation 765/2008/EC in order to ensure, without unnecessary
administrative burden, the safety of both consumers and professional users in
both the harmonised and the non-harmonised areas. 
Regarding monitoring of market surveillance authorities in
the opinion of Orgalime the objective should be to ensure better monitoring of
market surveillance in the EU primarily on the basis of existing tools, e.g.
annual “Enforcement Indicators.”  Orgalime would welcome any initiative
that would be conducive to Member states carrying out more efficient market
surveillance is welcome and reiterated the need for reinforcing the actual means
of market surveillance authorities at national level, without imposing on them
bureaucratic reporting requirements, which will become a drag on their often
insufficient resources.
Orgalime
called on Member States and the European Commission to allocate significant
resources to market surveillance and to increase their co-ordination efforts,
so as to ensure that the acquis communautaire of the Single European Market is
preserved and strengthened to the benefit of both consumers and responsible
manufacturers.” 
Finally, in this context Orgalime would welcome a peer
assessment system of national market surveillance activities and procedures,
with the support of an advisory board open to stakeholders (including consumer
and industry organisations) that would develop recommendations on the basis of
best practices. Orgalime indicated PROSAFE could be chosen for such a purpose,
acting as a facilitator in operating targeted market surveillance campaigns,
upstream communication with customs authorities and downstream communication
with manufacturers, trade and consumer organisations.”
(c)        Simplification
(i)         The overall legislative framework
N/A.
(ii)        Pre-standardisation
procedures under the General Product Safety Directive
In the opinion of Orgalime a faster
adoption of standardisation mandates should not hamper the necessary
consultation of all standardisation stakeholders including European trade
associations such as Orgalime. Orgalime believes that speeding up the standards
development should be balanced with the application of the principles of
WTO/TBT agreement (transparency, openness, impartiality and consensus,
effectiveness and relevance, coherence). Openness and wider consultation of all
stakeholders, including the SMEs that often need a summary in their own language,
call for more time.
Orgalime would strongly oppose to any
change in the General Product Safety Directive that would lead to making
specific safety requirements in standardisation mandates directly applicable
for the following reasons: In its view, “product specific safety requirements”
should be laid down through the co-decision procedure with the European
Parliament and Council, in directives and regulations applying to products,
especially to those that would be made “directly applicable to economic
operators”, should the General Product Safety Directive be transformed into a
Regulation.
(iii)       EU procedures for exchange
of information on product risks
Orgalime
expressed support for linking up RAPEX with ICSMS – an IT tool serving as a
general information support system – in order to create a common platform for
exchange of information in case of non-compliant products and an across-policy
tool could enhance the speed and efficiency of EU-wide market surveillance and
contribute to removing both unsafe and otherwise non-compliant products from
the market. 
(iv)       EU
product safety measures
Orgalime
suggested “emergency measures”, whether for the harmonised or the
non-harmonised area, could be decided by comitology provided that they are
proportionate to the risk arising and remain of temporary nature. For the sake
of efficiency, such decisions might be directly applicable to economic
operators, provided that the impacted stakeholder organisations are duly
consulted beforehand. Any decision that may affect, in the longer run, a
product group should not, in the view of Orgalime, be decided by the Commission
alone in comitology, but by the legislator via the co-decision procedure after
an impact assessment.
(d)        Other
(i)         Safety
of products sold online
For Orgalime, there
is no need to introduce specific measures, legal and/or administrative tools
into a revised General Product Safety Directive to tackle the issue of
dangerous consumers products sold on the Internet.
(ii)        Safety
of services
With
respect to the safety of services Orgalime argued that it would be disproportionate to establish general obligations to
apply to all situations and all particular cases of service provision.
(iii)       Risk
assessment guidelines
Furthermore, Orgalime called for a single set of Risk
Assessment Guidelines for use by enforcement authorities. (...) Such clear risk
assessment guidelines for authorities would contribute to building a common
approach to the market surveillance of non-food products and removing varying
legal interpretations by authorities and consequent legal uncertainty for
manufacturers.” Also, with respect to notifications, the qualification of
“serious risk” for rapid alert notifications should be clarified for products
in both the harmonised and the non-harmonised area. 
(iv)       European consumer agency
Orgalime
expressed itself against the creation of a European consumer safety agency.
(v)        Strengthening
criminal laws for placing dangerous products on the market
Member
States should, in our view, strengthen their criminal laws on the placing of
dangerous or non-compliant goods on to the Community market.
4.7       OXYLANE[90]
(a)        Consistency
of product safety requirements in the non-food area
N/A
(b)        Market
surveillance coordination
Oxylane
indicated that in its experience the checks carried out by market surveillance
authorities are, for the majority, carried out in entirely random manner. These
controls do not sufficiently prioritize the search for non-conforming and/or
dangerous products from third countries.
(c)        Simplification
(i)         The
overall legislative framework
N/A.
(ii)        Pre-standardisation procedures under the General Product Safety
Directive
As the Commission
points out European standards are published in the OJEU repositories for all
Member States. Their main effect is to ensure an equal minimum level of safety
for all consumers, irrespective of their Member State of residence. Oxylane is
favourable to the Commission proposal idea of publishing a standard under the
Directive on General Product Safety that would not have been developed under a
mandate from the Commission. This procedure appears to Oxylane indispensable.
Products that may be deemed contrary to the principle of General Product Safety
are placed on the market at the expense of the consumers. This also has the
effect of establishing unfair competition between economic operators. A
publication under European standards on Product Safety developed without a
Commission's mandate would improve the safety of products marketed or made
available and that are risky for users and, since the current European standard
would be considered satisfactory in terms of safety. Currently, no procedure in
force provides equivalent safety for consumers or for traders. Such a procedure
is essential for economic operators with operations in several Member States.
(iii)       EU
procedures for exchange of information on product risks
N/A.
(iv)       EU
product safety measures
N/A.
(d)        Other:
European Injuries Database
The European
standardisation system should be improved by making statistical data on
injuries available. Within standardization committees, the lack of
comprehensive and reliable statistical data is often felt in the course of
normative work. Regularly, standardization experts debate, seek consensus due
to the absence of statistical data on accidents or due to unreliable
statistical because often provided by manufacturers. Thus, the requirements
laid down in the European standards are not sufficiently grounded to meet the
needs of health and safety of consumers.
The availability of such
statistics would promote the principle of general product safety. Indeed, this
data would be useful not only to standardization experts but also to market
surveillance authorities. The different market surveillance authorities could
better identify the national products (and services) that do not comply with
the rules regarding general product safety and thus this would improve the
effectiveness of their controls. Similarly, the legislators, both national and
EU will be able to better identify failings which they can take into account
when adopting new regulations. Therefore, it will be necessary to establish a
European tool for ensuring that the data on injuries related to products (and
services) marketed or made available to consumers is complete and reliable.
Today, such a tool
does not exist. Within Member States, it is very difficult to obtain data on
accidents. The same applies to the EU.
4.8       UNION OF GROUPS OF INDEPENDENT RETAILERS OF EUROPE (UGAL)[91]
(a)        Consistency
of product safety requirements in the non-food area
The
template of responsibilities of laid down in the Annex of Decision
(No) 768/2008/EC and the sectoral product safety legislation clearly lay down
the obligations of manufacturers, importers and
distributors in the supply chain. This approach
determining the obligations of each person in the supply chain is the best way
to ensure that retailers play their
part in ensuring a safe supply chain.
In the view of UGAL this reduces
uncertainty about the way how risks should be dealt with in the supply chain.
(b)        Market
surveillance coordination
N/A.
(c)        Simplification
N/A.
(d)        Other:
Isolated cases
UGAL
raised the problem of the concept of "isolated cases" contained in
the General Product Safety Directive and
requested more detailed clarification of the concept in the revised General
Product Safety Directive.[92]
In its view, the current definition of "isolated cases" in the
General Product Safety Directive and the related Guidelines is insufficient. 
The legal text of the revised General Product Safety Directive should specify
more in detail what the distributor  should do if an "isolated case"
is present.
From
the point of view of UGAL, whether or not a particular
identified incident represents an
isolated case, will not always be
immediately obvious to a retailer; producer input is required to confirm the existence or not of an isolated
case. If a retailer is uncertain as to
whether or not an isolated case is present, two particular
consequences can arise: 1) Only very obvious public
health risks will be passed on to competent authorities
when identified, leaving considerable
potential important risk information under the radar (the
'tip of the iceberg' problem) 2) The retailer may take a highly
cautious view and may contact the competent authorities immediately, often
unnecessarily, thereby leading to notification overload of
competent authorities.
In
addition, UGAL considered that the lack of clarity about the "isolated
cases" might lead to unjustified notifications in the RAPEX system and
potential liability of retailers vis-à-vis producers for having passed
information about dangerous products to public authorities.
4.9       UNION EUROPÉENNE DE L'ARTISANAT ET DES PETITES ET MOYENNES
ENTREPRISES (UEAPME)[93]
(a)        Consistency
of product safety requirements in the non-food area
According to UEAPME the
new market surveillance rules, applying from 1 January 2010 clearly showed a
fragmentation related to the two legislative regimes, one for harmonised and
one for non-harmonised products. This fragmentation could be noticed due to the
different product safety obligations of the economic operators. For this reason
UEAPME calls for same principles for harmonised and non-harmonised products.
(b)        Market
surveillance coordination
Furthermore,
according to UEAPME the coordination at EU-level for surveillance efforts is
quite burdensome. The inappropriate coordination and the related interpretation
difficulties lead to uncertainty for SMEs. This needs to be rectified.
(c)        Simplification
(i)         The
overall legislative framework
Not addressed.
(ii)        Pre-standardisation
procedures under the General Product Safety Directive
UEAPME agreed with the
fact that the procedure for issuing mandates and publishing standards takes too
long, although from the average six years development and publications period
the actual drafting procedure only took three years. The last three years are
due to the slow administrative policy. UEAPME considers that the process has to
carefully be accelerated. Drafting standards is a time consuming activity and
its quality is more than crucial. For this reasons the most important issue is
to reduce the time related to the administrative part of the procedure.
(iii)       EU
procedures for exchange of information on product risks
UEAPME saw the need
to simplify the notifications in the RAPEX procedure, and strengthen the whole
system so that unfair trading practices can be tackled. 
(iv)       EU
product safety measures
UEAPME was convinced
that changes should be made to the ways of implementation od product safety
emergency measures. 
(d)        Other:
Safety of products sold online
Concerning market
surveillance of the safety of products sold on the internet UEAPME would not
support any special (legal) measures for this kind of distribution. The same
measures have to be valid for face-to-face and internet selling. Anything else
would lead to a distortion of competition, as different regimes would mean
either for the one or the other unfair benefits. The same rules should apply
for face-to-face and internet based market surveillance.
4.10     BRITISH RETAIL CONSORTIUM (BRC)[94]
(a)        Consistency
of product safety requirements in the non-food area
The BRC
considered that definitions e.g. of economic operators and their roles should
be developed. The revised General Product Safety Directive should contain
better definitions of economic operators and their responsibilities.
(b)        Market
surveillance coordination
BRC would support the
cooperation between the surveillance authorities on the basis of proportionate,
risk based, intelligence lead enforcement. BRC believed that there was a
potential for a lack of action or inappropriate action at Member State level to drive the Commission to take more control from the centre. The strengthened
cooperation between the Member States surveillance authorities should, in the
view of BRC, be overseen by a European wide product safety authority, with
cross border powers. BRC supported the proposals on harmonisation of risk
evaluations and called for "single European risk assessment
guidelines."
BRC suggested a creation
of European a testing ‘ombudsman’ who could review test results that disagree
or appear to have been interpreted incorrectly and provide a legally binding
interpretation. This would then be fed back to the standards body to correct
the error in the standard - without the need to go to court.
(c)        Simplification
(i)         The
overall legislative framework
N/A.
(ii)        Pre-standardisation
procedures under the General Product Safety Directive
BRC concurred that
the standards making process takes time but it was not convinced that a
speedier process would be of benefit to industry. Having standards ratified
through due process would reduce inconsistency but that process should not be
accelerated if this results in poorly designed standards.
(iii)       EU procedures for exchange of
information on product risks
BRC would be in
favour of a better designed RAPEX system that would be of help to business and
consumers as well as the enforcers. To improve the operation of the system, better definition of notification
criteria would be needed as well as a consistent method of risk assessment and
better communication. BRC suggested to take the inspiration from the CPSC model
operated in the United States where the emphasis is put on providing detailed
information to the consumer to protect their interests.  This would serve the
additional purpose of disseminating the information to the enforcement
community and the economic operators.
(iv)       EU
product safety measures
EU product safety measures
should remain to be used only in exceptional circumstances and have a sunset
clause during which time a more permanent solution should be created. An option
of longer term emergency measures would be preferable to the other option of
measures being directly applied to economic operators.
(d)        Other:
European accident database
In addition, BRC
suggested to establish a product accident database collecting information on
product-related injuries throughout the EU. 
3.5.      EUROPEAN
STANDARDISATION ORGANISATIONS - CEN[95]/CENELEC[96]
(a)        Consistency
of product safety requirements
N/A.
(b)        Market
surveillance coordination
(c)        Simplification
N/A.
(i)         The
overall legislative framework
N/A.
(ii)        Pre-standardisation procedures under the General Product Safety
Directive
CEN
and CENELEC welcomed the European Commission efforts to develop standardization
mandates in order to allow the further citation of currently available as well
as the citation of future European Standards. The European Commission’s need
for safe products coincides with the need (and work) of CEN and CENELEC
stakeholders to have European Standards providing a high level of safety. CEN and CENELEC would favour the continuation of the current
practice of establishing specific safety requirements under the General Product Safety Directive
which could be laid down, for example, in annexes to the General Product Safety
Directive leaving to standardization the development of technical solutions to
meet such requirements.
CEN and CENELEC further indicated that
they recognized the primacy, whenever possible, of international standards.[97] By
contrast, they would not support a more formal role for non-European standards,
since such action might multiply the number of standards on the internal market
impeding its cohesion, making the life of the stakeholders, especially SME's,
consumers, trade unions more difficult because of the need to
monitor/contribute to different channels.
(iii)       EU procedures for exchange of information on product risks
N/A.
(iv)       EU product safety
measures
N/A.
3.6.      PROSAFE[98]
(a)        Consistency
of product safety requirements
For PROSAFE, consumers expect the products they use and
consume are safe regardless of the legal framework that is established to deal
with different product sectors. This perspective, on its own, demands a greater
alignment between the so‐called harmonised and non‐harmonised product sectors. The emergence
of best practice through the previous revisions of the General Product Safety
Directive and now with the implementation the New Legislative Framework should
promote this objective. Addressing this issue would undoubtedly impact on the
arrangements for market surveillance and safety assessments. PROSAFE hoped that
the best practice identified in the Joint Actions carried out in recent years
in both the harmonised and non‐harmonised product sectors would
help provide a basis for a consistent and coherent approach to be adopted
across the different product sectors.
(b)        Market
surveillance coordination
The
strategy for the enhancement of market surveillance in the EU/EEA, agreed
within the framework of the first EMARS project, clearly identified the need
for the professionalization of support for closer cooperation amongst market
surveillance authorities and sustainable funding for a central resource at the
European level. The existence of such a resource was identified as essential to
the continued improvement of market surveillance in Europe.
Diverging
safety evaluations of consumer products obviously distort the internal market
and adversely affect the level of consumer protection Europe’s citizens can
enjoy. The experience of PROSAFE with the Joint Actions showed that clear
guidelines and promoting dialogue at an early stage between market surveillance
authorities can dispel some of the misunderstandings that can arise further on
in the process and improve the transparency of the decision‐making process. 
According
to PROSAFE the support to the joint market surveillance actions should be
reinforced. In the past five years, over fifteen joint actions were launched
and the response to these Actions was very favourable. The social and economic
stakeholders welcomed the transparency such coordinated Joint Actions bring to
the European marketplace and they have endorsed these activities and sought to
participate actively themselves.
(c)        Simplification
(i)         The
overall legislative framework
N/A.
(ii)        Pre-standardisation
procedures under the General Product Safety Directive
In the view of PROSAFE, there is a need to improve the
procedures under the General Product Safety Directive to help ensure that the
standards better reflect the needs of the public authorities and that the
standards system is responsive to mandates and feedback from the results of joint
market surveillance actions. The entry into force of a new or revised standard
has also prompted market surveillance authorities to target specific product
groups for joint market surveillance actions, e.g. lighters and baby walkers. 
(iii)       EU procedures for exchange of information on product risks
N/A.
(iv)       EU product safety
measures
N/A.
(d)        Other:
Safety of product sold online
PROSAFE stated that it was s aware that in other consumer
protection fields joint market surveillance actions on electronic commerce are
carried out, to great effect, on a regular basis and obviously this is
something that could be considered in the consumer product safety sector. The need
greater cooperation and coordination to deal with new channels of distribution
is, in the view of PROSAFE, clearly there.
4.           Annex
4: Summary of the targeted stakeholder meetings
4.1.      Introduction
On the basis of the results of the
internet public consultation (held between May and August 2010) and the
Workshop on the revision of the General Product Safety Directive (held on 1
December 2010 in the framework of the International Product Safety Week), the
Commission organised four targeted stakeholder meetings in order to discuss
concrete ways of how to put in practice the conclusions reached in the public
consultation.
To this end the Commission distributed
four consultation papers outlining the principal options of implementation of
the general objectives. These options were discussed in four targeted
stakeholder meetings:
·                   
Reinforcement of coordination of national market
surveillance activities (31 January 2011)
·                   
Clear and uniform legislative framework
(consistency of product safety requirements for economic operators) (16
February 2011)
·                   
Faster procedures for elaboration of European
standards (17 March 2011)
·                   
Clear and uniform legislative framework (overall
legislative framework and market surveillance rules) (31 March 2011)
A balanced and proportionate
representation of all relevant stakeholder groups, including consumer
organisations, business associations, representatives of market surveillance
authorities as well as economic operators, was ensured in these meetings. In
particular, the representatives who contributed to the public consultation were
invited in order to further clarify and detail their views and opinion.
4.2.      Conclusions
4.2.1    Reinforcement
of coordination of national market surveillance activities
4.2.1.1 Coordination
tasks
The participants agreed that a
pre-condition for the reinforcement of coordination of national market
surveillance authorities is an establishment of a knowledge centre for the
collection, storage and dissemination of knowledge about, for example,
products, procedures, standards, risk assessment, training, etc. This would not
necessarily mean for the organisation to collect and store this information
itself but to know where it can be found and provide easy access to it. In any
case, a proliferation of databases should be avoided.
Another
necessary step for achieving deeper coordination of national market
surveillance activities would consist in maintaining an inventory of national
plans, administrative assistance and coordination of joint actions, organising
joint testing, developing common definitions, etc. This would also involve
acting as an interface with business and consumer organisations. Driving
quality improvements should be focused on, for example, improving horizontal
skills, assisting weaker Member States, etc. This could be achieved by, among
others, exchanges of officials, peer reviews and (in the future) more formal
(voluntary) "audits".
A better
coordination of handling of consumer complaints was also mentioned since
consumers are not always aware to whom they should address complaints and,
consequently, information about unsafe products does not always reach the
safety authorities. In fact, the ICSMS website has a facility for consumer
complaints. Moreover, the General Product Safety Directive already provides for
national systems to be established by the Member States. 
4.2.1.2 Organisation
of coordination of national market surveillance authorities
When asked to consider the organisational
set-up ensuring the implementation of the reinforced coordination activities,
participants suggested a creation of a central EU body. Regarding the relation
with the Member States, it was widely agreed that it should be obligatory for
Member States to be involved in the functioning of this body but that it should
not be its role to 'force' Member States to cooperate. Member States should
also have some form of oversight over the organisation and the activities it
undertakes. Regarding the relation with the European Commission, it was
suggested that the envisaged body should be formally linked to the EU but not a
part of it.  The EU could give direction to the body and discuss the (multi)
annual plans which could be drawn up by the body with the Member States. Regarding
the relation with other stakeholders, it was proposed that the envisaged body
should be obliged to consult stakeholders, although care would have to be taken
to ensure the independence of the market surveillance authorities. The
'Consultation Forum' as it has been established under the Eco-design Directive
was mentioned as an example of best practice in this context.
As regards
resources the most important issue would be to ensure the permanence of the
proposed body. It was felt that the qualifications of staff depended on the
tasks to be undertaken by the body. Brussels was generally considered to be the
best location for such a body. One suggestion made was to have a dual funding
model: one for funding the operation and one for funding activities. No matter
what the tasks of the body would be, it was stressed that there should be a
clear distinction between the role and legal obligations of the Commission, the
Member States and this organisation, which should ideally focus on 'practical'
activities to support the operational effectiveness and efficiency of market
surveillance in the EU/EEA.
4.2.2    General
obligations of economic operators, in particular the issue of identification of
the responsible manufacturer or importer 
4.2.2.1 Differentiation
between "harmonised" and "non-harmonised sectors"
Participants commented that they were not
aware of any data which could specify the proportion of "harmonised"
and "non-harmonised" products in circulation. They were of the
opinion that it was practically impossible to provide any reasoned estimates of
such figures.
It was pointed out that it was sometimes
difficult to find out whether a given product is a "harmonised" or a
"non-harmonised" product,[99]
in particular when it is subject to regulations like the REACH Regulation,
which applies only to particular chemical substances in a given product.
Participants expressed the opinion that
products are not manufactured or marketed differently according to whether they
fall into the category of "harmonised" or "non-harmonised"
products. The key criteria which determine the way in which products are
manufactured and/or marketed are their "complexity" and the risks
they pose.  It was stressed that "risk" is the key issue and the
guiding principle for determining the related obligations, regardless of
the sector. The only difference lies in the fact that for
"harmonised" products, the evaluation of risk is easier than in the
"non-harmonised" area where no specific safety requirements exist and
standards are relatively rare. It was stated by one participant that whether or
not a product should contain safety instructions depends on whether the product
poses a risk, not whether the product is "harmonised" or
"non-harmonised".
In certain companies, it was said that a
safety assessment of products is performed regardless of whether according to
the legislation the product is "harmonised" or
"non-harmonised". The only difference between these two groups of
products is that, thanks to the more detailed regulation of safety properties of
"harmonised" goods, it is easier for a product safety professional to
check whether the given product respects the safety requirements laid down in
the "harmonised" legislation. One participant added that a key
determinant in the way products are manufactured and marketed may be the size
of the company, the number of products produced and the type of product
manufactured.
The Chair concluded that the difference
between harmonised and non-harmonised products did not seem to be a key
determinant structuring production and/or marketing processes. The key
determinant appeared to be the risk potential of the product to the final user.
4.2.2.2 Technical
documentation for non-harmonised consumer products
Participants agreed that manufacturers
should perform a risk assessment for the products they supply to consumers
regardless of whether these products are "harmonised" or
"non-harmonised". They also agreed that the fact of performing a risk
assessment should be documented.
Some participants mentioned that they already
produce technical documentation containing the aforementioned minimum
requirements, both in respect to harmonised and non-harmonised products, so its
extension to non-harmonised products would not entail any additional costs for
their businesses.
However it was mentioned by one
participant that it is crucial that technical documentation is required only in
respect to one type of a product, not for each piece of a product or for
different versions of a product where risk elements do not differ. For example,
in the case of T-shirts, technical documentation should be required in respect
of one type of a T-shirt, not for each different colour of the same T-shirt,
provided, that is, that the chemical risks of the different colours in which
the T-shirt is dyed do not differ.
Conclusion: - The Chair observed that the
use of technical documentation also for non-harmonised consumer products would
have an added value, provided that it contains information for market
surveillance authorities which would allow them to make a more objective and
better quality risk assessment and that the amount of information contained in
the technical documentation is proportionate to the level of risk posed by
products so that no unnecessary administrative burdens are created for businesses.
4.2.2.3 Requirements
of identification of the responsible manufacturer or importer
There was support for the need for
traceability regardless of whether the product is "harmonised" or "non-harmonised".
One participant indicated that his organisation provides the information at
three places: on the product, the packaging and on shipping cartons. 
As regards the inclusion of importer
information, this can pose a problem if stickers are used since they must be
permanent. Testing stickers for durability is under consideration. Also, the
obligation to include the importer's address can pose difficulties in cases
where a company has a centralised customer service to which they would prefer
enquiries be addressed. As packaging is usually discarded, one participant
thought it preferable to put the information on the product itself where
possible, although the challenge could be the size of the product and the
manufacturing process. It was proposed that legislation could address this
issue.
It was suggested by some participants
that large products could be marked with batch codes as these are useful in the
case of recalls. Traceability information was also considered to be in the
interest of the manufacturers as it can allow them to limit the extent of any recalls.
One participant commented that it is
important to decide whether traceability information should be placed on the
product or on the packaging and added that the cost of adding labels also needs
to be taken into account. There was concern that if the name of the importer is
also required, this might mean that the importer would have to open product
packaging in order to mark them - and in such cases who should decide where the
traceability information should be positioned.
In conclusion, the Chair noted that
participant businesses used traceability rules going beyond the minimum
established by EU legislation and that, in consequence, they have not
encountered problems resulting from differing national traceability
requirements in Member States. The Chair also observed that participants viewed
traceability of products as a useful requirement which should apply across
different product sectors regardless of whether products are
"harmonised" or "non-harmonised". Participants shared the
view that a number of businesses already use traceability practices and
consider them useful, in particular when they have to perform a recall of a
product. If clear, cross-sectoral, traceability requirements are laid down in
the general product safety rules, they should respect flexibility and
proportionality. This flexibility and proportionality could be achieved by
non-legislative means, for example, by providing guidelines specifying in more
detail the positioning of traceability requirements on the product, its packaging
and in accompanying documents.
4.2.2.4 Costs of
application of general product safety obligation
One participant stressed that the
information on costs, especially their quantification, is impossible to obtain.
Another added that the question of compliance costs was related to the risk and
that there was no "cost" distinction between harmonised or
non-harmonised products in this respect.
4.2.3.   Pre-standardisation
procedures under the General Product Safety Directive
4.2.3.1 Role of
ad-hoc Decisions on safety requirements under the General Product Safety
Directive
Participants agreed there was a need for
a sound procedure under the General Product Safety Directive for mandates on
the basis of which European standardisation bodies establish European standards
("EN standards") in the "non-harmonised" area.
The discussion confirmed the results of
the public consultation. Directly applicable safety requirements is an option
generally accepted, provided that all relevant stakeholders are consulted from
the onset of the process, and that a good balance is found between the contents
and level of specificity of these requirements and what should be left to
standardisation.
4.2.3.2 Referencing
of standards developed outside Commission mandate
The majority of participants agreed that
EN standards should be referenced in the OJEU but participants did not think it
appropriate to reference other standards as they had another legal basis and
might contain certain elements that are not relevant in the EU - this would be
the case, for example, of non-global/international standards (e.g. ASTM). It
was proposed, however, that ISO/IEC standards could be referred to as an
interim measure while awaiting a more permanent solution, but this should be
considered on a case by case basis. There was strong support for this option,
as far as existing EN (European standards) are concerned. References to ISO/IEC
(global standards) should be considered on a case by case basis and/or as an
interim solution. The proposal concerning references to
non-global/international standards (or standards from third-party organisations
other than ISO/IEC) was rejected. 
4.2.3.3 Review of
the provisions on the objections to European standards
There was wide support to align these
provisions to the New Approach area solution. 
4.2.3.4 Representation
of stakeholder groups in "standardisation" procedures under the
General Product Safety Directive
Participants agreed that such
consultation should take place prior to the adoption of the decision defining
the safety requirements for the given product, which then leads to the adoption
of a mandate to European standardisation bodies. There was a consensus among
participants that this consultation procedure should be formalised. One
participant suggested that national consultations could also take place in
parallel. However, it was stressed that any discussion groups created for this
purpose should contain sufficient expertise to interpret the EN standards.
A more formal procedure should be
established for the consultation of stakeholders and this should take place
before issuing a mandate. These consultations should also be accompanied in
parallel by consultations at national level. Stakeholders participating in
these consultations should also have the necessary expertise to make a
constructive contribution. 
Some participants were in favour of
setting up new, dedicated, group for these consultations. However the
Commission did not favour the idea of setting up new groups in addition to the
existing ones. 
4.2.4.   Legislative
architecture of consumer product safety rules and harmonised product safety
rules
4.2.4.1 Simplification
of legislative environment in the product safety area
Participants stated that the General
Product Safety Directive worked well as a structure and that overall its rules
were well implemented and “internalised” by Member State market surveillance
authorities. They appreciated the “gap-filling” role of the General Product
Safety Directive in the harmonised area and stressed that this should be maintained.
They considered the structure of the General Product Safety Directive to be
consistent, but sometimes too vague to prevent divergent application of market
surveillance rules by national authorities
Participants stressed that the most
important objective in the revision process is to achieve legal certainty and
to be able to predict how the market surveillance authorities in Member States
will act vis-à-vis economic operators, in particular in crisis situations. If
EU product safety rules are unclear, they are applied differently by different
market surveillance authorities and this leads to unjustified differences in
the treatment of economic operators in different Member States. All these
issues increase costs for economic operators and create barriers in the
internal market.
Participants did not consider that the
simple addition of certain rules of the General Product Safety Directive to the
Regulation 765 would bring clarity to the market surveillance rules as demanded
by stakeholders. In their view, merging the provisions covering the obligations
of economic operators, specific provisions on standardisation for
non-harmonised products, provisions for market surveillance, rules on
accreditation and conformity assessment bodies and CE marking into one instrument
would contribute to increase of confusion among stakeholders.
Participants proposed that the current
distinction between market surveillance rules for “harmonised” and
“non-harmonised” products be abolished because of its artificial character and
replaced by the distinction between “consumer” and “non-consumer” products.
Participants indicated that he could hardly imagine situations where the recall
of a professional product not presenting a risk to the health and safety of
humans could be justified on the basis of proportionality.
Another participant suggested that the
General Food Law, Regulation (EC) No 178/2002 be taken as a good example of
consistency and clarity for market surveillance rules and used as a template
when drafting the new joint market surveillance rules.
4.2.4.2 Exchange
of information about measures taken against products posing risks
According to participants, the parallel
application of these different notification systems appears to be causing
confusion for market surveillance authorities as well as for economic
operators.
To simplify the notification systems, it
was mentioned that it would be useful to have only one EU notification system
in a single EU legal instrument on market surveillance. This notification
system would cover both harmonised and non-harmonised products, as well as all
types of risks, including serious and non-serious risks posed to different
public interests, e.g. the health and safety of consumers, other users, the
environment, etc. There is also a need to explore whether it would be possible
to uniformly define the elements of such a notification system (such as the
obligation to notify measures taken, the notification criteria, the content of
the notification and the obligation to follow-up notifications), or whether
there is any justification for differences to exist with respect to certain
product sectors.
Participants appreciated the
specification in Regulation (EC) No 765/2008 concerning the 10-day period
whereby economic operators have the right to be heard following the adoption of
a market surveillance measure, such as a recall or withdrawal. However, they
indicated that often the period of 10 days is not respected by national market
surveillance authorities.  In addition, market surveillance authorities do not
always inform economic operators concerned about the measures taken or provide
test reports or risk assessments on the basis of which the measures were taken.
This fact can "de facto" eliminate the usefulness of the right of the
economic operator to be heard.  Furthermore, if the market surveillance
authorities of a Member State do not give the economic operator the required
time to be heard, or do not provide him with documents on the basis of which
they decided to take measures, but immediately notify the measure via RAPEX,
other Member States will already start to take action on the basis of this
RAPEX notification. However, if – after distribution of the RAPEX notification
to the Commission and to Member States - the economic operator proves that his
product is safe and that the original measure was not justified, it may be
impossible for him to reverse any action taken by the authorities of other
Member States on the basis of the original, incorrectly sent, RAPEX
notification. 
In this respect, participants suggested
that the European Commission verify that the 10-day "right to be
heard" period is respected and that economic operators are notified of any
measures taken by national market surveillance authorities and receive the "test
reports" which served as the basis for taking such measures. Participants
also asked whether it would be possible to include in the new legislation the
right for economic operators to be informed of the fact that a national market
surveillance authority is going to or has notified a product to RAPEX and,
possibly, to introduce a right for an economic operator to appeal against
making a RAPEX notification.
A Commission representative asked whether
the seriousness of the risk is not sometimes artificially upgraded due to the
existence of different notification channels for products posing serious risks
(RAPEX) or products posing less than serious risks (Art. 11 of the General
Product Safety Directive, Art. 23 of the Regulation 765, sector specific
safeguard clause mechanisms). Participants agreed that the intensity of a risk
is sometimes upgraded due to the existence of various notification systems. In
their opinion, there should be one horizontal notification system based on the
condition that products pose a risk and the Commission should verify more
thoroughly that the level of intensity of the risk is correctly established by
national market surveillance authorities.
4.2.4.3 General
product safety rules and rules for non-harmonised professional products under
Mutual Recognition Regulation (EC) No 764/2008
Participants felt that it would be
inconsistent and unworkable to have overlapping systems.  They felt that the
current delimitation of the scope of application between the rules for
non-harmonised, non-consumer products under Regulation 764 and the General
Product Safety Directive is not clearly defined and gives rise to confusion as
to which legislation should apply under which circumstances.
4.3.      List of
participants
4.3.1    Reinforcement
of coordination of national market surveillance activities (31 January 2011)
ASSER Jeff                                       UK Department for Business, BIS, UK
COLIJN Marijn                                Dutch
Food and Product Safety Authority
FARQUHAR Bruce                          Private
Expert
HUNTER Noel                                 PROSAFE
LEIMON Mitchell                             BIS,
UK
MAURER Sylvia                               BEUC
MURPHY Robert                             EFTA
Market Surveillance Authority
NIEDERMEYER
Hans-Georg          Bavarian Ministry for Labour, Social Affairs, Family &
Women
OLIE Nico                                        PROSAFE
PERZ Helmut                                    Federal
Ministry of Labour, Social Affairs and      Consumer Protection
RAHBEK Torben                             Private
Expert
RUSSELL Stephen                           ANEC
4.3.2    Clear
and uniform legislative framework (consistency of product safety requirements
for economic operators) (16 February 2011)
BROWN Jim                                    TOYS
R US
DOWNHILL Paul                            HOME
RETAIL GROUP
DRAGSDAHL Annette                     BUSINESSEUROPE
ERKENS Sabine                              UEAPME
LUIJKX Gerard                                UNILEVER
LASALLE Guy                                 NIKE
EMEA
MAURER Sylvia                               BEUC
MONTFORT
Jean-Philippe              MAYER & BROWN
RICHARDSON Jennifer                   VIEWSONIC
VOULOT Charles                            EUROCOMMERCE
ZAKRZEWSKI Michael                   CECED
4.3.3    Faster
procedures for elaboration of European standards (17 March 2011)
RUSSELL Stephen                           ANEC
MAURER Sylvia                               BEUC
MISSIROLI Cinzia                           CEN
HÜHLE Haimo                                 BUSINESSEUROPE
SCHMEDT Erika                             Authority
for Social Affairs, Family, Health and Consumer Protection 
DE PAUW Henk                              NORMAPME
JOCK Stephane                                OXYLANE-DECATHLON
ARVIUS Christen                             SOGS
STANDARDISATION
ROED Jan                                        Market
surveillance (Denmark)
CONSOLI Thomas                          Market
surveillance (Malta)
DORTLAND Rob                            Market
surveillance (the Netherlands)
PAUL Spencer                                 Market
surveillance (the Netherlands)
SVAREN Jesper                               Market
surveillance (Sweden)
4.3.4    Clear
and uniform legislative framework (overall legislative framework and market
surveillance rules) (31 March 2011)
MONTFORT
Jean-Phillipe               Mayer Brown (law firm)
FREEMAN Rod                               Hogan
Lovells International (law firm)
LAFFINEUR Jean-Luc                     Laffineur
(law firm)
SCHLIESSNER Ursula                    McKenna
Long (law firm)
JOCK Stephane                                Oxylane-Decathlon
(in-house lawyer)
5.           Annex
5: Small and medium enterprises, including micro-enterprises: consultations and
analysis of impacts (SME test)
5.1       Consultation
of small and
medium-sized enterprises
            Due to their size and scarce resources, small and medium-sized
enterprises (SMEs)[100]
can be affected by the costs of regulations more than their bigger competitors.
At the same time, the benefits of regulations tend to be more evenly
distributed over companies of different sizes. SMEs may have limited scope for benefiting
from economies of scale. SMEs in general find it more difficult to access
capital and as a result the cost of capital for them is often higher than for
larger businesses. SMEs play a key role in shaping Europe's economy, accounting
for 99 % of enterprises, of which 92 % are micro-enterprises. They provide more
than two thirds of private sector employment and play a key role in economic
growth. Generally, on average, where a big company spends one euro per employee
to comply with a regulatory duty a medium-sized enterprise might have to spend
around four Euros and a small business up to ten Euros.[101] Depending upon the relevance
of the initiative for SMEs and in particular micro-enterprises, appropriate
consultation to ensure input on the needs and interests of SMEs, in particular
micro-enterprises alongside large enterprises, should be used.[102]
5.1.2    Consultation of SMEs via the European Enterprise Network
The consultations of
SMEs were performed through the European Enterprise Network[103] in the same time framework as
the general internet public consultation (May – August 2010).[104] For the purposes of the
consultation, an invitation for SMEs to fill in a internet questionnaire and a
letter explaining the reason and goals of the initiative (in English and French
version) were sent to SMEs via the European Enterprise Network (covering 44
countries, including all EU/EEA Member States with more than 600 local
partners). SMEs were requested, in particular, to express any opinions and
views on the actions envisaged by the Commission described in the accompanying
letters and proposals of any further action which could enhance the functioning
of the EU general product safety regime.
According to the information from the
Contact Points of the European Enterprise Network responding to the request the
invitation to participate in the questionnaire and the accompanying letter were
distributed to circa 7200 SMEs and 19 business associations as described in the
following table:
Table 1:
Details of public consultation of SMEs
 EEN Contact Point || Number of SMEs reached[105] || Distribution channel || Response 
 Barcelona (ES) || 946 || - published on a website - Newsletter sent to subscribers || N/A 
 Czech Republic (general) || N/A || - published on a website - Newsletter sent to subscribers || N/A 
 Glasgow (UK) || 900 || - Direct contact by email - Published on the website || N/A 
 Grenoble (FR) || N/A || - published on a website || N/A 
 London (UK) || 1500 5 associations || - direct contact by email || 3 SMEs 
 München || Five Bavarian Chambers of Trade and Crafts || - Published on the websites of Bavarian EEN consortium and the Bavarian portal for foreign trade information - Sent to five Bavarian Chambers of Trade and Crafts || N/A 
 Ostrava (CZ) || 1560 || -Newsletter sent to subscribers - Published on the website ||   
 Stuttgart (DE) || 650 || Newsletter sent to subscribers || N/A 
 Thessaloniki (EL) || N/A || - Published on the website || N/A 
 Torino (IT) || 1652 || - Direct contact by email - Newsletter sent to subscribers - Published on the website || N/A 
 Vilnius (LT) || - General public (website) - 39 SMEs and 9 associations || - EEN website - Direct emails to companies || 2 SMEs and 1 association 
 Total 
 11 (in 10 Member States) || 7208 SMEs and 19 associations || --- || 5 SMEs and 1 association 
As can be seen from the table and
as confirmed by the EEN Contact Point Members, it has been extremely difficult
to collect any views or opinions on the issues related to the revision of the
General Product Safety Directive because of lack of interest of economic
operator. In sum, despite the efforts of the European Enterprise Network to
reach as many SMEs as possible in result only very few SMEs completed the
internet questionnaire.
5.1.3    Internet public consultation
Response of SMEs to the internet public
consultation (May – August 2010):
·                        
Pre-standardisation procedures questionnaire 15
(out of 31) – 8 selling locally only within one Member State
·                        
Harmonisation of safety evaluation
questionnaire: 9 (out of 23) – 4 selling locally only within one Member State
·                        
Market surveillance coordination questionnaire:
7 (out of 22) – 1 selling locally only within one Member State
·                        
Market surveillance coordination questionnaire:
7 (out of 20) – 3 selling locally only within one Member State
5.1.3    Position papers
Two business associations, namely UEAPME[106] and UGAL,[107] submitted separate position
papers.[108]
5.1.4    Use of the results of the SME consultation within the
framework of the impact assessment of the "omnibus alignment"
Within the framework of the impact
assessment of the "omnibus alignment", the Commission performed From
June to October 2010 a public consultation of economic operators, including
SMEs. It consisted of four targeted questionnaires for economic operators,
authorities, notified bodies and users and we received 300 replies.[109] In view of the high number of
SME active in the sectors concerned, a specific SME consultation was carried
out in addition to the general consultation. 603 SME were consulted through the
Enterprise Europe Network in May/June 2010. The Commission’s minimum
consultation standards were fully met. 
SME were specifically consulted through
the Enterprise Europe Network during the months of May and June 2010. A
significant number of SME participated in the exercise. The following table
gives details of the number of stakeholders having participated in the SME and
public consultations by category of respondents and by sector.
Table 2: Overview of stakeholders by
category of respondent and by sector
   ||   || Electrical & Electronic goods || Lifts || Pressure equip || Measuring Instr. || Civil explosive. || Pyrotechnic articles || Equp. For use in explosive atmospheres 
   ||   ||   ||   ||   ||   ||   ||   ||   
   || SME || 332 || 63 || 78 || 67 || 8 || 24 || 25 
   || EO || 44 (14 BO) || 8 (2 BO) || 6 || 35 (8 BO) || 0 || 1 || 4 
   || NB || 16 || 9 || 23 || 13 || 4 || 2 || 9 
   || AUT || 28 || 11 || 15 || 21 || 6 || 9 || 11 
   || Users || 5 || 1 (CO) || 11 || 6 || 0 || 2 || 8 
Due to the
similarity of the scope and the nature of problems submitted to the
consultation, in particular the overall simplification of the legislative
framework in the non-food area, the issue of further coordination of market
surveillance authorities of Member Stats, the results of this SMEs consultation
could be taken into account in this context.
5.2       Analysis of impacts on small and medium-sized enterprises
(SME test)
5.2.1    Impact of the existing EU product safety requirements on
SMEs
If large companies have generally no
problems in bearing the costs of lack of legal certainty about the applicable
rules, this may not necessarily be the case with SMEs. In the public
consultation the business representatives agreed that as far as the observation
of product safety requirements is concerned, three types of economic operators
can be identified:[110]
(i) those willing and able to respect the product safety rules (mostly large
companies), (ii) those willing to respect the product safety rules, but unable
to do so (mostly SMEs), and (iii) those unwilling to respect the product safety
rules (so-called rogue operators - usually very small importers of products who
can quickly disappear in the case of a problem).[111] The inconsistencies in the
product safety legislation gave an impact on those who are willing and able to
follow product safety (usually big multinationals) as well as those who are
willing to respect the product safety rules but unable to do so (usually SMEs),
but in a different way.
For both categories of potentially
compliant economic operators, i.e. both for the willing and able as well as for
the willing and unable, the inconsistencies between consumer product safety
requirements and the resulting diverging application of these rules, not only represent
an additional cost burden,[112]
but also determine the number of economic operators belonging to the first or
the second group. The higher these additional costs resulting from
inconsistencies in the applicable rules will, the bigger will be the group of
economic operators willing to observe the applicable safety requirements, but
unable to do so and at the same time the smaller will be the group of
"willing and able." Indeed, if the inconsistency of the different
pieces of legislation exceeds a certain point, certain economic operators will
no longer be able either to spend more time or pay more costly legal advice in
order to determine what the applicable rules are; when certain economic
operators reach that moment they will move from the category of "willing
and able" to the category of "willing, but unable" to respect
the existing product safety requirements. 
The aforementioned distinction between
different groups of economic operators as well as its consequences appear to be
confirmed by market surveillance authorities. Market
surveillance authorities from the Member States have reported that SMEs and microenterprises
often lack the knowledge regarding the rules of product safety. Therefore, SMEs
and microenterprises often do not comply with the
product safety legislation. According to market surveillance
authorities microenterprises import a big share of the products causing safety
problems. 
According to an
estimation based on product safety and compliance measures taken in 2011 by
French authorities, there is a correlation between the number of employees in a
company and the compliance with rules regarding product safety (see below the
diagram and table). In particular, in a company with less than 10 employees the
risk not to comply with rules regarding product safety is nearly twice as high
compared to a company with 10 and more employees. 
               Effectif salarié || 0 à 9 || 10 à 19 || 20 à 99 || 100 et + 
 Taux de non-conformités (toutes) || 23% || 18% || 13% || 9% 
 Taux de non-conformités graves || 5,9% || 4,8% || 3,0% || 2,0% 
In the experience of the Commission,
these results would likely not be different in other Member States.
5.2.2    Impact
of the options on SMEs
5.2.2.1 Impact on
SMEs
On the one hand, as described in section
2.1 the inconsistencies in the product safety requirements in the current
situation generate higher costs for all types of economic operators, but for
SMEs represent relatively heavier costs than for large economic operators. If
these inconsistencies in product safety requirements will be eliminated it can
be expected that they would produce the positive effects on all types of
economic operators, but with respect to SMEs, these effects may be more
accentuated, i.e. have relatively higher positive benefits. Clearer and more
understandable product safety requirements will become more easily accessible
to a higher number of SMEs. The costs savings resulting from the enhanced legal
clarity would make it possible for a number SMEs to become able to follow and
respect all product safety requirements.
            On the other hand, the
capacity of SMEs to fulfil the applicable product safety requirements, even if
made clearer and more understandable, will always be lower for SMEs. An SME
will have smaller resources to obtain expertise in the applicable legislation
or technical standards than a large economic operator as well as it will be
less equipped to perform tests and conduct controls and risk analysis for its
products. Likewise, an SME will usually be less able to
cope with circumstances requiring the withdrawal or recall of products. In some
cases, this lack of resources and organised procedures may make it difficult
for SMEs to conduct a removal operation or larger recall, which would expose
consumers to a risk not mastered and would cause the taxpayer to bear the cost
of these failures. Moreover, for SMEs it will not necessarily be possible to
remedy these deficiencies in internal organisation by use of services of
external providers as this may be beyond the financial capacities of such small
operators.
5.2.2.2 Differentiated
treatment of SMEs and other economic operators
Applying a differentiated treatment in
respect of the level of compliance with product safety requirements in order to
further reduce the relative imbalance which the applicable product safety
legislation has on the SMEs does not appear to produce the desired outcomes for
SMEs. The impacts of such option would be similar to the abolition of consumer
product safety requirements, i.e. legal problems, internal market difficulties,
discrimination issues, market distortions etc.[113]
Moreover, the differentiated treatment of
SMEs and other economic operators would be – as far as product safety
requirements are concerned – inapplicable in practice. Due to the absence of
effective traceability of non-food products, it is often impossible to identify
who put the product on the market: in consequence, under the current situation
it would be difficult effectively applying "a SME exemption or a lighter
regime" since it would be impossible to find out whether a concrete
product was put on the market by a SME or a non-SME. 
An effective
application of a lighter regime for SMEs in respect of the applicable safety
requirements would necessitate a control by public authorities of the size of
all the operators in the whole supply chain - from the producers of raw
materials via the component makers up to the manufacturer of the final product
– in order to make sure that only SMEs were entitled to apply lower safety
requirements are involved in the manufacturing of the product. Such control of
the supply chains by public authorities would either be technically impossible
to implement or extremely costly with adverse effects on the functioning of the
supply chains since all the operators in the supply chain would have to be
continuously reporting economic data to public authorities to justify that they
are entitled to benefit form the special "SME regime."  Beyond that
such controls would be impossible to put in place for the parts of the supply
chains outside the EU: if a manufacturer from a third country producing a
component of a  consumer product sold in the EU claimed the application of the
lighter SME regime to him, authorities of Member States would not have – in
such a hypothetical example – any means of checking whether such a third
country manufacturer fulfils the conditions of an SME in order to benefit from
the lighter SME regime in respect of product safety requirements.
Application of a
lighter regime for SMEs in respect of the applicable safety requirements to
producers, i.e. manufacturers and importers, would be unfair and discriminatory
to distributors, in particular retailers which are often SMEs. Due to this
lighter regime for producers liability and enforcement would be shifted on
distributors who have much lesser information about safety properties of the
given product than producers and are less able to remedy any potential safety
problems.
Furthermore, even if all the practical
obstacles were resolved and lighter SME regime in respect of product safety was
applied not only to manufacturers, importers and distributors, this
differentiated treatment of SMEs would result in creation of two production and
marketing chains: one for big brands in which safe products would be marketed
and one for SMEs where less safe products would be sold. This would a number of
negative results for SMEs: as consumers might at the end prefer big brands just
because only these would ensure safety of their products, the competitiveness
of SMEs would suffer in general compared to bring brands to which consumers
would most probably shift only out of fear of buying dangerous products with
SMEs. At the same time, it would negatively impact SMEs producing high quality
– high safety products, since products made and sold by SMEs in general would
get in the perception of average consumers the label of being unsafe and it
would be very difficult for SMEs producing high quality – high safety products
to convince the consumers about the opposite.
In addition, lighter product safety
regime would not exempt economic operators from criminal liability in the case
of an accident caused by a product produced according to lighter safety
standards only by SMEs and marketed by SMEs. In consequence, loosening
administrative rules would have a paradoxical effect of probable higher use of
criminal sanctions which would go to the detriment of both the SMEs and market
surveillance authorities.
Last but not least, "a SME exemption
or a lighter regime" from product safety rules would paradoxically provide
incentive for economic operators to ignore safety rules and market unsafe
products.
5.2.2.3 Mitigating
measures
As a part of contribution to the creation
of growth and jobs, the reduction of regulatory burden in particular in
relation to SMEs is being continuously considered when reviewing and preparing
new legislation. In addition, an active search for adapted solutions for SMEs
is performed in all relevant cases. 
To further alleviate the costs of
compliance with the consumer and harmonised product safety requirements, it
could be considered whether the Product Contact Points established under
Regulation (EC) No 764/2008 with the aim of could extend their scope of action
also to the area of products covered by the General Product Safety Directive
and harmonised Union legislation and could provide SMEs with education on the
applicable consumer and harmonised product safety requirements and their
relationship.
5.2.3    SME test
summary
 (1) Consultation with SME representatives || SME were specifically consulted through the Enterprise Europe Network during the months of June and August 2010. (See above sections 1.2 and 1.3) 
 (2) Preliminary assessment of businesses likely to be affected || According to the findings of the consultation, SME are among the economic operators affected by the problems identified. (See above section 2.1) 
 (3) Measurement of the impact on SME || If envisaged options are applied indistinctly to all economic operators irrespective of their size, it can be expected that they would produce the same positive effects on all types of economic operators. With respect to SMEs, these effects may be more accentuated since the costs savings resulting from the enhanced legal clarity would make it possible for certain SMEs to become able to follow and respect all product safety requirements. (See above section 2.2.2). As regards negative impacts, it did not appear in the impact assessment that the overall impact of this policy action would bring about significant costs increases both for SMEs as well as other economic operators. 
 (4) Assess alternative options and mitigating measures || There was no indication of the need of SME specific measures in order to ensure compliance with the proportionality principle, in particular due to the practical impossibility to apply differentiated treatment to SMEs and other economic operators as far as product safety requirements were concerned. An application of certain mitigating measures could however be envisaged, if necessary  (See above section 2.2.3). 
5.3       Consultation on
micro-enterprises
In order to minimise the regulatory
burden on very small companies to the absolute minimum, the Commission outlined
in November 2011 its new policy on "Minimizing regulatory burden for
SMEs - Adapting EU regulation to the needs of micro-enterprises".[114] The
implementation of this policy on microenterprises is detailed in operational
guidelines.[115]
According to this new
policy, the Commission's preparation of all future legislative proposals is
based on the premise that in particular micro-enterprises[116] should a priori be excluded from the scope of the proposed legislation
unless the necessity and proportionality of their being covered can be
demonstrated. Where micro-enterprises must be covered by legislative proposals
for public policy reasons recourse to adapted solutions and lighter regimes
will be sought concerning all forms of regulatory burden including, in
particular regarding administrative requirements. The demonstration of the
proportionality of covering micro-enterprises and the assessment of possible
adapted solutions should be included in the Impact Assessment, thus adding a
specific micro-enterprises dimension to the 'SME test'. 
Although the aforementioned
documents acknowledge that "much legislation will remain applicable to
SMEs and micros, covering fundamental public policy obligations, for example,
product safety standards that are integral to trading throughout the single
market,"[117]
since they do not contain any exemption from the obligation to assess the
consequences and impacts of the non-application of EU product safety
legislation to microenterprises, the analysis of the impact of exclusion of
microenterprises from consumer product safety obligations has to be performed.[118]
5.3.1    Consultation performed
Under the specific
operational guidelines on the question of microenterprises public and stakeholder
consultations should be used to collect information, statistics and views of
all relevant stakeholders in order to be able to estimate the potential
positive and negative impacts on the proposed regulatory action
micro-enterprises.
DG Health &
Consumers of the European Commission consulted all relevant stakeholders,
including the Member States, businesses as well as consumer associations via
the General Product Safety Directive Committee.[119] 
5.3.1.1 Questions asked
In the framework of
the consultation the following two questions were asked:
"(1) Please indicate
whether you possess any information about the
possible impact of:
(i) the current
product safety rules on micro-enterprises, and 
(ii) the
non-application of product safety rules on micro-enterprises. 
(2) Please feel free to provide any figures you may have. It would be
especially helpful if you could indicate:
(i) what part of
mandatory corrective action decisions (such as withdrawals, recalls etc.) were
addressed to micro-enterprises (over the last year), and 
(ii) what part of
the voluntary corrective actions were notified to your authorities by
micro-enterprises (over the last year). 
Also please feel
free to provide comments in quantitative ways if possible or even in
qualitative terms on what would be the effect on the market if those
enterprises were excluded from the application."
5.3.1.2 Distribution of the questions to stakeholders
This question was
sent by DG Health & Consumers of the European
Commission to the aforementioned stakeholders by email and through the CIRCA
information tool on 30 January 2012. The question as well as the answers
provided were then discussed in the GPSD Committee on 14 February 2012. Following the GPSD Committee the aforementioned questions were
resent to all Members of the GPSD Committee through CIRCA tool as a part of
"follow-up" actions. On 16  May 2012 DG
Health & Consumers of the European Commission sent a third request for
answers of the aforementioned questions to all Members of the GPSD Committee.
5.3.2    Results and data provided
5.3.2.1 Summary
of written responses
Of twenty-seven EU Member States, three
Member States of EEA, three business associations and two consumer
organisations consulted on the question of microenterprises, DG Health & Consumers of the European Commission received
answers from 18 EU Member States, 1 EEA Member State, 1 acceding country, one
business association and one consumer organisation. The answers provided are
summarised in the following table.
 Stakeholder (Member State) || Application of consumer product safety requirements to microenterprises? || Summary of reasons || Economic data on microenterprises 
 EU Member States 
 Austria || YES || Experience from market surveillance indicates that microenterprises are reluctant to take the necessary measures even though a big share of products causing safety problems is imported from third countries by microenterprises and dangerous product are always dangerous regardless the size of the company. || Most of the companies in Austria are micro-enterprises. (e.g. in the year 2010 : 308.735 companies established in Austria, among which 269.899 had 0 to 9 employees and an average turnover of EUR 406.000). 
 Czech Republic || YES || A limitation of the scope will foil the objectives of the GPSD (consumer safety, especially protection of health, life and property). || According to the register of economic operators of tle Czech Statistical Bureau (as to 31 March 2012), there are 236 438 active microenterprises in tle Czech Republic. Most of the companies in the Czech Republic are microenterprises.   
 The consumer is an inferior party also in relation to micro-enterprises; consumer safety must prevail when the burden for microenterprises is considered. 
 A different legislative regime for microenterprises would lead to legislative confusion, legal uncertainty, non-transparency and to an increase in the workload of market surveillance bodies. Competition might be distorted. 
 Denmark || --- || --- || N/A 
 Estonia || YES || Consumer product safety requirements do not constitute a burden to microenterprises. || Most of the enterprises in Estonia are small or micro-enterprises. 
 Spain || YES || Microenterprises (usually importers, not manufacturers, selling products with reduced price, most of which are run by third country nationals) often do not comply with the rules regarding product safety. Therefore, many actions of removal and prohibition of trade is directed to microenterprises. || One of our authorities from an autonomous community informed us that in 2011 it made a total of 9,585 performances on product safety - 9494 cases concerned "micro-enterprises" with fewer than 10 employees. This means that if microenterprises were exempted from product safety obligations, this would reduce the amount of inspections by 99%. Last year 89 corrective actions in the Autonomous Community, consisted in withdrawing from the market (destruction or return to base) a total of 672 units of 56 different products. All these actions in bazaars with fewer than ten employees. 
 The level of consumer safety would be decreased and unfair competition promoted. 
 Unsafe products would invade the market with no competent market surveillance body responsible for these products and no punishment of the producer, which would foreseeably lead to an increase in accidents. Contracts of labour might be terminated in order to establish microenterprises. 
 Finland || YES || Consumer safety must prevail when the burden (e.g. financially) for microenterprises is considered. || N/A 
 The workload of surveillance authorities would be increased because of the need in each individual case to clarify if the company in question is a microenterprise or not. 
 ·         There is a risk of artificial company arrangements. 
 France || YES || The aim is to achieve and ensure a high level of consumer safety and not to decrease it. || See above the market surveillance data provided in respect of SMEs 
 Economic operators and certain jurisdictions may be misled: Economic operators may consider their civil and criminal liability not to be at stake and certain jurisdictions may restrict the liability for microenterprises.  
 Competition might be distorted. 
 Germany || YES || The burden limitation of microenterprises may not put consumer safety at stake. A dangerous product is dangerous regardless the size of the company. ||   
 Producers could choose the product safety provisions applicable by finding artificial arrangements and establishing microenterprises. 
 Micro- enterprises do not always comply with the rules regarding product safety. 
 Even when exempted from the obligations of the GPSD, regardless of their size, micro-enterprises remain liable for defective products according to the Directive 85/374/EEC. 
 Market surveillance bodies would meet difficulties to distinguish products from microenterprises and such from larger companies making an obligatory marking on the product necessary. 
 A new market surveillance body would have to be created, which would examine the company's size and administrate a register for all existing microenterprises. 
 Greece || YES. || The burden limitation of microenterprises may not put consumer safety at stake. || Many microenterprises mainly do trade and are less active in the field of production. 
 Hungary || --- || --- || --- 
 Italy || YES || The non-implementation of the harmonized legislation could lead to the exclusion of products from microenterprises from the European market. || An important share of the companies established in Italy are micro-enterprises. 
 Latvia || YES || A limitation of the scope will foil the objectives of the GPSD and the Consumer Agenda. The aim to achieve a high level of consumer safety must be ensured regardless the size of the company. The size of the company is no suitable criterion of distinction from a viewpoint of a consumer and poses a threat to fair competition. || 83,9% of the companies are micro-enterprises, among which there is a  significant number of importers placing products in the EU market. Most of all non-compliances (about 50-60%) are found in micro-enterprises. 
 Malta || YES || Many products are manufactured by microenterprises and the GPSD encompasses a very vast range of products. ||   
 Netherlands || YES || Microenterprises do not always comply with the rules regarding product safety. Unsafe products would be invading the European market. || 98000 of 100000 companies are economically active and considered small companies (maximum of 5 employees). 
 Portugal || --- || --- || Micro-enterprises play a significant role in the Portuguese context. 
 Romania || YES || --- || N/A 
 Slovenia || YES || A limitation of the scope will foil the objectives of the GPSD. || N/A 
 Slovakia || YES || --- || Most of distributors covered by the GPSD are microenterprises in the Slovak Republic. 
 EEA Member States 
 Norway || YES || Consumer safety must prevail when the burden for microenterprises is considered. || In Norway a considerable part of different products are offered to consumers by small- and microenterprises. 
  The regulatory burden for microenterprises is neither extensive nor substantial. 
 Microenterprises often do not comply with the rules regarding product safety due to the insufficient knowledge about these rules for the consumer-products they are offering. 
 Acceding countries 
 Croatia || --- || Microenterprises often do not comply with the rules regarding product safety due to the insufficient knowledge about these rules for the consumer-products they are offering. || N/A 
 Business associations 
 BusinessEurope || YES, unless non-application to all economic operators || Consumer product safety requirements must apply indistinctly to all economic operators. If exemption for certain enterprises, such as microenterprises, exemption for all enterprises. || N/A 
 Consumer organisations 
 BEUC || YES || N/A || N/A 
5.3.2.2 Summary
of opinions expressed in the GPSD Committee
Most of the Member States indicated that
they are not able to provide any data on microenterprises since they do not
collect them within the framework of their market surveillance activities.
In the view of Ireland the safety of consumers shall not be compromised despite the need for better
regulation and the administrative burden to microenterprises, even if the
compliance with product safety requirements might be more costly and time
consuming for microenterprise than for large companies.
According to Austria in particular small operators do not carry out quality controls. Therefore, an
exemption would be counter-productive and would distort competition between
large and small enterprises.
Bulgaria emphasized the aim to achieve a general product safety which
should not be compromised; a directive on "partial product safety would
not be acceptable. A two-speed legislation allowing for safe and unsafe
products depending on the size of the producer or distributor would run against
consumers' interests. There is also a significant risk of abuse of such a
possible rule, as companies could start to divest themselves into smaller units
in order to circumvent any product safety rules.
Italy highlighted that while substantive administrative simplification
was fundamental, consumer safety must not be compromised. In its view the
simplification could already be achieved by the ensuring the compatibility of
different product safety requirements in the future legislation.
France stressed that SMEs do not always comply with the rules regarding
product safety. Due to the high number of SMEs in France, an exclusion of SMEs
from the scope of the General Product Safety Directive would be difficult to
accept.
Spain contested the application of the principle of an a priori
exclusion of microenterprises from the scope of EU legislation to the consumer
product safety area. Consumer safety could not be compromised due to the lack
of data on microenterprises. Spain indicated that differentiated treatment of
economic operators depending of their size would significantly raise the costs
and effectiveness of market surveillance, since market inspectors would have to
find out a lot of data about the operators inspected; such data may not be
available or their retrieval could be very time consuming.
Finland confirmed that in its experience product safety problems were
associated in particular with SMEs.
According to Sweden, 90% of Swedish
companies are micro-enterprises. In the view of Sweden, microenterprises would
not benefit from the exclusion from consumer product safety rules. Consumers
already put more confidence in bigger brands. If parts of the market are
unsafe, branding and marketing will become more important to the detriment of
the smaller companies. Micro-enterprises would then need to prove to consumers
that they are just as safe as the big players. Micro-enterprises need standards
in order to compete effectively so that they can prove the same level of
safety.
Poland stated
that it had no specific data at the moment but in general micro-enterprises
make up a significant number of businesses in Poland. In its opinion, product
safety must not be sacrificed by shifting the focus to reducing the
administrative burden.
BEUC highlighted that
exclusion of microenterprises from consumer product safety requirements would
undermine all Commissions initiatives to promote consumer confidence.
5.3.3    Impact
of the options on microenterprises
5.3.3.1 Impact of
the existing EU product safety requirements on microenterprises
Impact of the
existing EU product safety requirements on microenterprises can be expected to
be similar as to SMEs (as described above in section 5.2.1).
5.3.3.2 Impact of the options on
microenterprises
Neutralisation of the
aforementioned disadvantages by application of differentiated treatment to
microenterprises and other economic operators would cause similar difficulties
and negatives consequences as described above in sections 5.2.2.1 and 5.2.2.2.
with respect to SMEs. By contrast, application of mitigating measures in the
form of providing education and information on the applicable safety
requirements could be envisaged for microenterprises in the same way as for
SMEs (see above section 5.2.2.3). 
6.           Annex
6: External expertise – list of studies and reports
6.1       General
1. The future of market surveillance in
the area of non-food consumer product safety under the General Product Safety
Directive", Final Report, March 2011, BSI Development Solutions, May 2011
2. Best Practice Techniques in Market
Surveillance, PROSAFE, The Product Safety Enforcement Forum of Europe, 2009
3. RAPEX Annual Reports 2007 – 2011,
including RAPEX-China reports 2007 – 2011
4. Market Surveillance in the Member
States, commissioned by European Parliament - Internal Market and Consumer
Protection Committee, IP/A/IMCO/ST/2009/04,  Ramboll Management Consulting,
October 2009
5. Market
Surveillance and the revision of the General Product Safety Directive,
commissioned by European Parliament - Internal Market and Consumer Protection
Committee, Ramboll Management, Ramboll Management Consulting, IP/A/IMCO/ST/2010-03, September 2010
6. RPA (Risk & Policy Analysts),
Establishing a Comparative Inventory of Approaches and Methods Used by
Enforcement Authorities for the Assessment of Safety of Consumer Products
covered by Directive 2001/95/EC on General Products Safety and Identification
of Best Practices
7. Collaboration and Market Surveillance:
Success Factors for Collaboration, Report of the Association of Swedish
Engineering Industry and the Swedish Trade Federation, September 2009
8. Consumer Market Scoreboard (Editions 1
to 7)
Perception of
safety by consumers and retailers
Number of injuries and accidents per
categories of a product
Tracking Progress for Market Retail
Integration
9. Attitudes towards cross-border sales
and consumer protection, Analytical report, October 2009, Flash Eurobarometer
282 – The Gallup Organization
10. Consumer protection in the internal
market, Report, October 2008, Special Eurobarometer 298 – TNS Opinion &
Social, Special Eurobarometer 298 / Wave 69.1.
11. Business attitudes towards
cross-border sales and consumer protection, Analytical report, July 2008, Flash
Eurobarometer 224 – The Gallup Organization
12. Business attitudes towards
enforcement and redress in the internal market, Analytical report, November
2009, Flash Eurobarometer 278 – The Gallup Organization
13. Consumer attitudes towards
cross-border trade and consumer protection, Flash Eurobarometer Series,  #282 -
The Gallup Organization
14. Evaluating Business Safety Measures
in the Toy Supply Chain, Final Report, European Commission, May 2008 (Note:
according to the study conclusions of the study can be applied across consumer
product sectors)
15. Feasibility Study for a
Post-Manufacturing Traceability System between the People's Republic of China
and the European Union, EU-China Trade Project, prof. Dr Louis J. Balme,
November 2008
16. Freshfields Bruckhaus Deringer,
Getting It Right: Product Recall in the EU, March 2008
17. The revision of the EU General
Product Safety Directive, Mayer Brown, Memorandum, January 2011
18. Report of the Expert Panel for the
review of the European Standardization system Standardization for a competitive
and innovative Europe: a vision for 2020, February 2010
19. Guide to General
Market Surveillance Procedure, UNECE Working Party on
Regulatory Cooperation and Standardization Policies, September
2009, I. Hendrikx
20. EU Injury Database Annual Report 2009

21. Improving the product and services
dimension in the IDB, A feasibility study, Dutch Consumer Safety Institute,
December 2006
22. Concept note for the Workshop on
"Traceability: a tool for managing risks", UNECE
Working Party on Regulatory Cooperation and Standardization Policies, August
2011
23. Eurobarometer/OPTEM, The European
consumers' attitudes regarding product labelling, Qualitative study in 28 European
countries, May 2005
24. Evaluation of the feasibility of a
consumer safety mark, European Commission – DG Enterprise and Industry, GHK
Consulting Ltd., October 2008
25. The Empirical Economics of Standards,
DTI Economics Paper No. 12, June 2005
26. Economic benefits of consensus-based
standards, The ISO Methodology, Geneva (Switzerland), ISO Central Secretariat,
January 2010
27. Gesamtwirtschaftlicher Nutzen der
Normung, DIN Deutsches Institut für Normung e. V., Beuth Verlag, 2000
28. Impact assessment study on the
"Standardisation Package", Final Report, technopolis group, March
2010
29. Baltic Sea market Surveillance
Network, Report of sixth cooperation – results 2010 and final summary of
Best-Practice-Example "Cooperation with Customs in the Field of Technical
Consumer Products", December 2010
30. A More Open and Safe Single Market,
REGERINGEN, Danish Enterprise and Construction Authority, June 2010
31.  Réseau de surveillance de l'Internet
: le bilan 2007, DGCCRF, avril 2008
32. The European Online Marketplace:
Consumer Complaints 2004 – 2010, A summary and analysis of consumer complaints
reported to the European Consumer Centre Network, ECC-Net
33. En finir avec la mondialisation
déloyale, Jacob, Y., Guillon, S., Rapport – Ministère des Affaires Etrangères
et européennes - Ministère de l'Economie, des Finances et de l'Industrie,
Janvier 2012
34. Technische Überwachung Bd.47 (2006), Nr.
3 –März, p. 47 – 52
6.2.      Sector
specific
35. Child Appealing Research: Research
into Child Awareness of Risk: Use of electrical Equipment, A Report by Intertek
Research & testing Centre for the Department of
Trade & Industry, dti Technical Report, July 2004
36. Cross Border
Market Surveillance, LVD-ADCO, Luminaires 2006, voedsel en waren authoriteit,
Project IP0106LUM
37. Assessment of
Best Practices in Fairgrounds and Amusement Parks in Relation to Safety of
Consumers, Risk & Policy Analysis Ltd., March 2005 
38. Study on Safety of Trampolines, Austrian Committee for
Protection from Accidents in Child age, January 2008 
39. Study on Safety of Summer Sliding Facilities in Austria, Kuratorium for Transport Safety, July 2008
40. Study on Risk of Certain Sports and
Recreational Activities – the Role of Services, Dutch Consumer Safety
Institute, March 2009 
41. Best Practices in Prevention of
Skiing Accidents in Europe: The New Challenge, 2007
7.           Annex
7: Monetary value of markets of consumer and certain harmonised non-food
products in the EU
7.1.      The
value of non-food consumer products sold in the EU
7.1.1    Method
1
To illustrate the broad coverage of the market
surveillance legislation, the total value of non-food products sold in the EU-27
is estimated. The following table, compiled using Eurostat data[120] concerning final consumption expenditure of households provides an
overview of the size of the EU-wide consumption for non-food products in
relation to the whole EU GDP. Between 2007 and 2010, the EU GDP remained
relatively stable in nominal terms at circa 12,000 billion EUR. The total
household consumption (goods and services) was also relatively stable at 58% of
GDP or roughly 7,000 billion EUR. Over two thirds of these expenses were linked
to services, while approximately one third went into purchases of goods (both
food and non-food products). Each year, the consumption of non-food products
accounted for roughly 900 billion EUR, which represents 13% of the total
household consumption or about 7.5% of the total EU GDP.
Table 1:
Structure of household consumption in the EU (source: EUROSTAT)
 EU-27 || 2007 || 2008 || 2009 || 2010 
 Total GDP (billion EUR) || 12390.02 || 12479.02 || 11770.04 || 12268.38 
 Total household consumption expenditure (products & services, billion EUR) || 7090.53 || 7171.11 || 6865.52 || 7154.89 
 Total household consumption expenditure on products (food and non-food, billion EUR) || 2199.51 || 2227.84 || 2126.09 || N/A 
 Total household consumption expenditure on non food products (billion EUR) || 946.20 || 939.72 || 887.34 || N/A 
7.1.2    Method 2
The second way to
estimate the value of all non-food consumer products sold in the EU is to
examine the turnover of stores and companies which specialise in selling such
products[121]. The turnover of economic operators involved in specialised retail
sale of non-food products confirms our initial estimate that the value of
non-food products sold to consumers in the EU every year is approximately 1000
billion EUR. 
Table 2: Total turnover of companies selling
non-food consumer product in the EU (source: EUROSTAT)
 2006 || NA 
 2007 || EUR 989.07 Billion 
 2008 || EUR 1 092.35 Billion 
7.2.      Value
of harmonised product sectors (including consumer as well as non-consumer products)
in the EU-27
The value of harmonised sectors in
the EU-27 is estimated to be well above € 2 100 billion. This figure is derived
from the sum of production value for the big electrical mechanical, mechanical
engineering, automotive, chemical and medical devices sectors, as provided
below. The figures do not include the value of other harmonised sectors such as
gas appliances, pressure equipment, radio and telecommunications equipment,
recreational craft, and rail. Furthermore, they do not include any estimate of
harmonised construction products.
Table 3: Key data of certain
harmonised product sectors 
   || Products || Size of the industry (market output) || Trade balance (share of imports) || Industry structure, SME presence || Number of NB in the EU[122] 
 Electro-technical sector (Low Voltage Directive (LVD) and electro magnetic compatibility directive (EMC)) || Electric welding and soldering tools, electric domestic appliances, computers and other information processing equipment, electric motors, generators and transformers. electricity distribution and control apparatus, insulated wire and cable (LVD only), lighting equipment and electric lamps (LVD only), other electrical equipment, electronic valves and tubes and other electronic components (LVD only), television and radio receivers, sound or video recording or video recording or reproducing apparatus and associated goods. || € 235.59 billion (equipment covered by LVD) € 200.12 billion (equipment covered by EMC) || Negative trade balance: LVD: € 103.93 billion of imports and € 83.09 billion of exports. The internal consumption is estimated at € 256.42 billion. EMC: € 100.78 billion of imports and € 76.07 billion of exports. The internal consumption is estimated at € 224.83 billion Most imports come from China, followed at a considerable distance by the USA, Japan and South Korea. || The structure of the industry is characterised by a few large corporations producing a wide range of electrical equipment, and many small companies specialised in niche markets.   || 148 (LVD) 131 (EMC) 
 ATEX || Mechanical, electrical and telecommunication equipment, protective systems and devices, to be used in potentially explosive atmospheres (in underground mines, petrochemical plants, oil refineries, filling stations and other places where flammable gases may be present, and also premises like flour mills and agricultural warehouses where airborne dust can present an hazard): mechanical gears, brakes and seals; gas and steam turbines; electrical motors, pumps, fans; electrical tools and instrumentation; fork lift trucks; filter units and vented silo bins; switches, control and detection systems and components; torches; plugs and sockets outlets; heating cables; computers, phones and other similar equipment; vent panels; enclosures; sparks arrestors; temperature protective devices; etc. || € 2.2 billion || Positive trade balance: Imports amount to € 400 million. Internal consumption estimated at € 1.9 billion, 86% of internal production.   || The ATEX sector is characterised by a large number of SME and micro enterprises, around 90%, mainly based in France, Germany, Italy and the United Kingdom, but also with significant presences and market shares in Denmark, the Netherlands, Norway, Poland, Spain, Sweden as well as in Switzerland. || 55 
 Pressure Equipment (incl simple pressure vessels) || Pressure vessels, piping, boilers, steam generator, safety accessories and pressure accessories, etc… || No data available || Manufacturing of pressure equipment is gradually shifting to low cost countries. || A substantial number of SME is involved in production || 237[123] 95 (simple pressure vessels) 
 NAWI || Non-automatic weighing instruments, i.e. measuring instruments serving to determine the mass of a body and requiring the intervention of an operator during weighing || € 2.5 billion || Not available || Small companies (< 50 employees) clearly dominate with 60%. 35% are medium sized enterprises with 50-250 employees and 4% are large companies with more than 250 employees- || 270 
 Measuring Instruments || Water meters, gas meters, electricity meters, heat meters, meters for liquids other than water, weighing machines, taximeters, material measures to measure length, dimensional measuring instruments and exhaust gas analysers. || € 3.25 billion || Around 20-25% of measuring instruments in the EU27 are imported || There are around 900 manufacturers active in the 10 sectors covered by the MID not including the large number of SMEs operating as distributors, importers or providers of repair services. || 140 
 Mechanical Engineering[124] || Machines and other mechanical equipment: General purpose machinery , Agricultural and forestry machinery , Industrial processing machinery , Domestic appliances .   ||   € 498 billion (2007)   || Highly export-oriented industry – equipment exports worth €210 billion in 2007 represented 42% of the total value of its production ||   ||   
 Of which Lifts || Lifts permanently serving buildings and constructions intended for the transport of persons, persons and goods or goods alone if the car is accessible as well as safety components for use in such lifts || € 3.17 billion || Very positive trade balance: € 36 million of imports and € 693 million of exports. Internal consumption: € 2.51 billion || The structure of the industry is characterised by four multinational lifts companies and many small companies specialised. designing and installing new lifts and producing safety components for this lifts || 192 
 Civil Explosives || Explosive substances and articles which are not used by the armed forces or the police, but commercially. The main end-users of civil explosives are the mining industry, the quarrying industry, and the construction and civil engineering industry (primarily for demolition, land clearance and tunnelling) || € 1.35 billion. || Trade with third countries is limited. Imports play a significant role only in niche markets like explosives used for offshore drilling operations. Important trading partners are Norway, Switzerland and the USA. Importers in the EU are generally large companies with specific demands, for example in the oil drilling industry. || 20 manufacturers of explosives and approximately 500 distributors are active in the EU. At manufacturers’ level, there are no SME: Around 4 000 people are directly employed by these companies. Nearly all of the distributors, on the other hand, are SME employing around 5 000 people. Thus, a total of 9 000 people are employed by the civil explosives industry. || 13 
 Pyrotechnic articles || Fireworks, theatrical pyrotechnic articles, pyrotechnic articles for technical purposes and automotive pyrotechnic articles (automotive restraint systems, i.e. most importantly gas generators used in airbags and seatbelt tensioners). || € 1.4 billion (fireworks) € 2.8 billion (automotive) || 95% of all consumer fireworks are manufactured overseas. || Fireworks industry: mainly SME; altogether employing in total an estimated 15 000 to 20 000 people. Automotive pyrotechnic articles: big international automotive supplier companies, around 40 000 employees. || 10 
 Automotive[125] || Manufacture of motor vehicles, trailers and semi-trailers || turnover of over €780 billion || Positive trade balance (2007): Exports of cars from EU-27 countries amounted to€125 billion, with imports of €65 billion. ||   ||   
 Chemicals[126]               Of which Cosmetics[127] || fertilizers and biocides, paints and coatings, soaps and detergents, perfumes and cosmetics, explosives, plastics, rubber products and many more (over 70 000 products)     || Turnover of €537 billion (2007)           €63.5 billion (2006) ||                               EU  exported €8.6 billion worth of cosmetics products in 2005.. The EU exports nearly four times more it imports. || The EU chemicals industry consists of about 27,000 enterprises, 96% of which are SMEs The Petrochemicals sub-sector is vertically and horizontally integrated to a high degree Fine and Specialty chemicals, which is predominantly composed of specialised niche companies ||   
 Construction products and services[128]     Of which construction products || Onsite construction, Manufacturing of construction materials, Professional construction services Manufacture of builders' carpentry and joinery, bricks, tiles products in baked clay, cement, plaster, artciles of concrete, paster or cements, etc. || Turnover of € 2 389 billion (2007)         < € 700 billion  [129]. ||   || This sector is characterized by a dominance of small and medium sized enterprises, and a very large number of micro enterprises, which produced about 80% of the total turnover of this industry ||   
 Medical devices || Many products from simple bandages to the most sophisticated lifesupporting products || sales of €72.6 billion (2007) ||   || The medical device industry is highly heterogeneous and characterised by sub-markets at different stages in the product life cycle, and requiring different amounts of resources. There are about 11,000 medical technology companies in Europe. More than 80% of these are SMEs. ||   
 Toys || Toys and games || €4.7 billion (2003) || Negative balance: exports of traditional toys in 2010 were €1.05 billion.  imports of traditional toys in 2010 were €6.96 billion. China is the leading supplier which accounts for 86% of total imports. || There are over 2 000 manufacturers. Around 80% of the sector is composed of SMEs which have less than 50 employees; only 5% are large companies ||   
7.3.      Non-compliant
products in the EU
Table 4: Indications on the share of non-compliant
products
 Source || Share of non-compliant products on the market 
 SME Test panel (2006) || The majority of SMEs could not provide figures. Where figures were given, they differed considerably from sector to sector as well as between Member States. The figures ranged from 4%-51%, the average being 24%. 
 Enterprise questionnaire (2006) || Most respondents could not provide figures but indicated that the problem was important. However, below is an overview of the estimates provided: Electro-technical sector: 10-30% (up to 50 % in the luminaries' sector) Mechanical sector: 5-7 % Medical devices: 10-30% Construction products: 10-30% 
 Market surveillance authorities (2006) || Electro-technical 10-70 % Medical Devices 2-20 % Construction products 2-30 % Recreational Craft 1 % 
In addition, a
more recent consultation concerning a few harmonised products (both consumer
and professional) shows that many stakeholders (economic operators,
authorities, notified bodies, users) consider that their sector is affected by
non-compliance (see table 4). [130]
It appears that the problem is more strongly felt in large sectors like that of
electro-technical products (including electric domestic appliances, computers,
generators and transformers, lighting equipment, etc.), and less felt in
specialised sectors like ATEX or civil explosives, although a few cases of
non-compliance have been reported also for the latter. 
The
electro-technical sector is indeed the sector in which stakeholders and in
particular industry associations have been most active in pointing out the
problem[131]
The market surveillance authorities responsible for the application of the Low
Voltage Directive have undertaken three cross border actions in the last few
years, on portable household lights[132],
cord extension sets[133]
and Christmas lighting[134].
Only 5% of the household lights tested showed no shortcomings (either
administrative or technical). Whilst not causing immediate danger to consumers,
the shortcomings were considered serious enough to require remedies. Only one
in six cord extension sets fully complied with the requirements. 58% of the
cord extension sets tested were considered sufficiently unsafe by the
authorities to justify a sales ban. Similar findings were obtained in three
market surveillance campaigns carried out recently by the Administrative
Cooperation group (ADCO) for the implementation of the Electro-magnetic
Compatibility Directive. The campaigns focused on Energy Saving Lamps[135], Power Tools[136] and Consumer Entertainment
Electronic Products[137].
The results of these campaigns showed that the level of technical non-compliance
was 23% for the Energy Saving Lamps, 20% for the Power Tools and 50% for the
Consumer Entertainment Electronic Products. Further general conclusions drawn
from the campaigns were that the share of non-compliant imported products was
generally higher than the share of non-compliant products originating from EU
countries, and that for a considerable part of non-compliant products the
origin could not be determined.
Table 5: Percentage of respondents to the public
consultation considering that their sector is affected by non-compliance (both
consumer and professional goods)
   || Electro-technical || ATEX || Civil explosives || Pyrotechnic articles || Lifts || Measuring instruments || Pressure equipment || Total 
 Economic Operators || 96% || 75% || - || 0% (100% don’t know) || 88% || 94% || 83% || 92% 
 Authorities || 86% || 64% || 0% (50% don’t know or No) || 78% || 55% || 52% || 80% || 66% 
 Notified Bodies || 94% || 44% || 25% || 50% (50% don’t know) || 44% (55% No) || 31% (40% don’t know) || 65% || 60% 
 Users || 100% || 25% (75% don’t know) || - || 0% (50% don’t know or No) || 100% || 67% || 82% || 64% 
 SMEs || 53% || 44% || 12,5% || 0% (50% don’t know or No) || 35% (40% No) || 41% || 49% || 48% 
The problem of non-compliances is
also strongly felt by the industry in certain (mostly) professional sectors
like the machinery sector. At the European
Commission Conference on Market Surveillance and Machinery held in Brussels at the end of November 2011, various stakeholders emphasised the size of the
non-compliance problem. For instance from a CECE survey of members, 49% of
respondents had seen a non-compliant machine working on site, 37% had lost
business when their customer had opted to purchase a non-compliant product and
39% thought that the problem is increasing[138].
Another industry representative referred to over 50 non-compliant machines
(industrial trucks) exhibited at the 2011 CeMAT logistics exhibition[139].
Table
6: Results of PROSAFE joint market surveillance actions
 Title of the action || Date || Member States involved || Inspections/samples || Results 
 LIGHTNING CHAINS || 2007 - 2009 || Hungary, Germany, Slovakia, Slovenia || 196 samples taken: || 30,4% serious non-compliance and 40,2% less serious non-compliance 
 SUNBEDS 1 || 2008 - 2009 || Belgium, Cyprus, Czech Republic, Denmark,  Finland, Germany, Hungary, Latvia,  The Netherlands, Poland and Switzerland || Over 300 locations and 500 sunbeds checked || 20% incorrect labelling, 32% sunbed type not listed, 52% no UV warning, 70 of 84 sunbeds with too high radiation 
 HELMETS || 2009 - 2010 || Cyprus, Czech Republic, Germany, Iceland, Latvia, Lithuania, Norway, Slovenia, Spain, Sweden, The Netherlands || 367 samples inspected || 63% non-compliant 
Table 7:
Number of non-compliance and safety issues in the electrotechnical consumer
sector[140]
 Product categories || Total number of safety testing and certification projects completed in 2011 || Weighed % of products NOT meeting safety requirements for any reason || Weighed % of products NOT meeting requirements for safety-critical reasons only || Weighed % of products that never reached compliance 
 ELECTRICAL PRODUCTS FOR HOUSEHOLD USE || 74 508 || 42,2% || 15,1% || 2.8% 
Manufacturers,
importers and distributors who abide by the law (and especially SMEs). The most recent statistics[141]
show that manufacturing is the largest of the NACE sections within the EU-27’s
non-financial business economy both in terms of persons employed and value
added; it contributed 24.2% of the workforce in 2008 and 27.1% of value added.
Overall, 2.1 million manufacturing enterprises employed 33.0 million persons in
2008. The largest subsectors (at the NACE division level) were food and
beverages manufacturing (which are not concerned by this impact assessment) and
the manufacture of fabricated metal. The share of manufacturing within the
nonfinancial business economy’s value added varied in 2008 from 13.2% in Cyprus to 37.6% in Hungary. The range in employment terms was similar, from 13.5% in the Netherlands to 40.0% in Slovakia. 
In 2008, there
were about 2,123,000 enterprises active in manufacturing, employing
approximately 32,961,000 people in the EU. 80.2% of the enterprises are
micro-enterprise, 15.3% small enterprises, 3.7% medium-sized enterprises and
0.8% large enterprises. In the sector of manufacturing, the proportion of SMEs
in the field of distributive trades is much higher. For these enterprises,
unsafe and non-compliant products lead mainly to losses in turnover and market
share due to unfair competition from competitors not complying with the rules.
Importers and
distributors are mainly active in the field of distributive trade where most
activities involve the purchase and resale of goods. The turnover is typically
high: distributive trades generated 36.6% of non-financial business economy
turnover in the EU-27 in 2008, which can be contrasted with an 18.7% share of value
added. The substantial difference in these two output shares was reflected in
the 5.1% gross operating rate, which was by far the lowest among the NACE
sections in the non-financial business economy. Distributive trades is
characterised by high levels of part-time employment, and this sector’s
workforce of 32.8 million persons, equivalent to almost a quarter (24.1%) of
the EU-27 non-financial business economy workforce, was only slightly smaller
than that for manufacturing. Among the 6.1 million enterprises classified to
distributive trades and employing some 32,816,000 people. There are a small number of large national and
international groups and a very high number of SMEs often providing proximity
services: 93.4% are micro-enterprises, 5.8% are small enterprises, 0.7% are
medium-sized enterprises and only 0.1% are large enterprises.
8.           Annex
8: Differences between consumer/non-consumer products and
harmonised/non-harmonised products, including differences relating to product
safety and market surveillance obligations
8.1.      Definitions
The so-called
harmonised products are commonly understood to be products subject to Union
harmonisation legislation, that is products subject any Union legislation
harmonising the conditions for the marketing of products.[142] The indicative list of product sectors subject to these Directives
is contained in section 2 below.
The so-called non-harmonised products are
commonly understood to be products outside the scope of the Union harmonisation
legislation. The definition of product subject to Union harmonisation
legislation covers products sectors regulated by any of the New Approach or Old
Approach Directives. The harmonisation of products properties can be full or
partial. Products in the following sectors can be considered to be harmonised. In most cases these sectors include both consumer and professional
products.
The so-called consumer products are commonly understood to be any
product — including in the context of providing a service — which is intended
for consumers or likely, under reasonably foreseeable conditions, to be used by
consumers even if not intended for them, and is supplied or made available,
whether for consideration or not, in the course of a commercial activity, and
whether new, used or reconditioned.[143]  A
consumer product can be either a harmonised or a non-harmonised product:
whether a concrete product will be or not a consumer product will depend on
whether such product is "intended for consumers or can be reasonably
used by them." Such determination would have to be done on
case-by-case basis.
8.2.      Indicative
taxonomy of products depending on whether they consumer/professional and
harmonised/ not-harmonised
There is a
clear overlap between the area of consumer products and the area of harmonised
products. The following table provide a very rough indication of the
characterisation of main product categories as consumer/non-consumer or
harmonised/non-harmonised. 
This taxonomy
is purely indicative as it can happen that a consumer product is subject to
harmonised ruled for certain characteristics but not for other. Its
classification in this case depends on the specific characteristics of the
product that have raised the concern of a market surveillance authority. For
instance a textile product (e.g. clothes) containing a substance prohibited
under EU chemical legislation will be considered as harmonised; however if the
same garment presents a risk because of the length of its cords, it will be
considered as non-harmonised.
The list of
products under each section of the table is non-exhaustive.
Table 1:  Indicative taxonomy of products
 Products || Consumer || Non-consumer 
 Harmonised || Certain chemical products Communication and media equipment Cosmetics Electrical appliances and equipment Certain gas appliances and components ·                     Automotives ·                     Certain construction products ·                     Certain medical devices ·                     Certain mechanical equipment (machinery, lifts) ·                     Measuring instruments (meters, scales) Pressure equipment and simple pressure vessels (pressure cookers and fire extinguishers) Aerosols ·                     Radio and telecommunications terminal equipment (R&TTE) ·                     Toys ·                     Recreational crafts Pyrotechnical articles  (fireworks) Maritime equipment Any product indicated in the non-harmonised list if contains prohibited chemical substances/preparations   || Certain chemical products Certain gas appliances and components ·                     Automotives ·                     Certain construction products ·                     Electrical equipment ·                     Equipment intended for use in potentially Explosive Atmospheres (ATEX) ·                     Civil explosives ·                     Certain medical devices Certain mechanical equipment (machinery, lifts) Professional measuring instruments ·                     Pressure equipment and simple pressure vessels ·                     Pyrotechnical articles for professional use (e.g. in airbags) ·                     Rail Maritime equipment 
 Non-harmonised || Childcare articles and children's equipment Clothing, textiles and fashion items Decorative articles Furniture Hobby/sports equipment Jewellery Kitchen/cooking accessories Laser pointers Lighters Gadgets   || See following section 
Table 2: Description of the overall EU product safety
infrastructure for categories of products
 Products || Consumer || Non-consumer 
 Harmonised || Sector specific New and Old Approach Directives and the General Product Safety Directive || Sector specific New and Old Approach Directives 
 Non-harmonised || General Product Safety Directive || National product safety rules under a Mutual Recognition Regulation 
Table 3:
Examples of
non-harmonised products[144] 
 Product code || Label 
 27012000 || BRIQUETTES, OVOIDS AND SIMILAR SOLID FUELS MANUFACTURED FROM COAL 
 37012000 || INSTANT PRINT FILM IN THE FLAT, SENSITISED, UNEXPOSED, WHETHER OR NOT IN PACKS 
 37013000 || PHOTOGRAPHIC PLATES AND FILM IN THE FLAT, SENSITISED, UNEXPOSED, WITH ANY SIDE > 255 MM 
 37019100 || PHOTOGRAPHIC PLATES AND FILM IN THE FLAT, SENSITISED, UNEXPOSED, OF ANY MATERIAL OTHER THAN PAPER, PAPERBOARD OR TEXTILES, FOR COLOUR PHOTOGRAPHY 'POLYCHROME' (EXCL. INSTANT PRINT FILM) 
 37019900 || PHOTOGRAPHIC PLATES AND FILM IN THE FLAT FOR MONOCHROME PHOTOGRAPHY, SENSITISED, UNEXPOSED, OF ANY MATERIAL OTHER THAN PAPER, PAPERBOARD OR TEXTILES (EXCL. X-RAY FILM AND PHOTOGRAPHIC PLATES, FILM IN THE FLAT WITH ANY SIDE > 255 MM, AND INSTANT PRINT FILM) 
 37023120 || PHOTOGRAPHIC FILM 'INCL. INSTANT PRINT FILM', IN ROLLS, SENSITISED, UNEXPOSED, WITHOUT PERFORATIONS, WIDTH <= 105 MM, FOR COLOUR PHOTOGRAPHY 'POLYCHROME', LENGTH <= 30 M (EXCL. THAT OF PAPER, PAPERBOARD OR TEXTILES) 
 39261000 || OFFICE OR SCHOOL SUPPLIES, OF PLASTICS, N.E.S. 
 39263000 || FITTINGS FOR FURNITURE, COACHWORK AND THE LIKE, OF PLASTICS (EXCL. BUILDING COMPONENTS FOR PERMANENT MOUNTING ON PARTS OF BUILDINGS) 
 42022210 || HANDBAGS, WHETHER OR NOT WITH SHOULDER STRAPS, INCL. THOSE WITHOUT HANDLES, WITH OUTER SURFACE OF PLASTIC SHEETING 
 42022900 || HANDBAGS, WHETHER OR NOT WITH SHOULDER STRAP, INCL. THOSE WITHOUT HANDLE, WITH OUTER SURFACE OF VULCANISED FIBRE OR PAPERBOARD, OR WHOLLY OR MAINLY COVERED WITH SUCH MATERIALS OR WITH PAPER 
 42023210 || WALLETS, PURSES, KEY-POUCHES, CIGARETTE-CASES, TOBACCO-POUCHES AND SIMILAR ARTICLES CARRIED IN THE POCKET OR HANDBAG, WITH OUTER SURFACE OF PLASTIC SHEETING 
 42023900 || WALLETS, PURSES, KEY-CASES, CIGARETTE-CASES, TOBACCO-POUCHES AND SIMILAR ARTICLES OF A KIND NORMALLY CARRIED IN THE POCKET OR HANDBAG, WITH OUTER SURFACE OF VULCANISED FIBRE OR PAPERBOARD, OR WHOLLY OR MAINLY COVERED WITH SUCH MATERIALS OR WITH PAPER, INCL. SPECTACLE CASES OF MOULDED PLASTIC MATERIAL 
 42029211 || TRAVELLING-BAGS, TOILET BAGS, RUCKSACKS AND SPORTS BAGS, WITH OUTER SURFACE OF PLASTIC SHEETING 
 42029215 || MUSICAL INSTRUMENT CASES WITH OUTER SURFACE OF PLASTIC SHEETING 
 46012110 || MATS, MATTING AND SCREENS, FLAT-WOVEN OR BOUND TOGETHER IN PARALLEL, OF PLAITS OR SIMILAR PRODUCTS OF PLAITING MATERIALS OF BAMBOO, WORKED LENGTHWISE 
 46012190 || MATS, MATTING AND SCREENS, OF BAMBOO PLAITING MATERIALS, FLAT-WOVEN OR BOUND TOGETHER IN PARALLEL (EXCL. THOSE OF PLAITS OR SIMILAR PRODUCTS OF PLAITING MATERIALS WORKED LENGTHWISE) 
 46012210 || MATS, MATTING AND SCREENS, FLAT-WOVEN OR BOUND TOGETHER IN PARALLEL, OF PLAITS OR SIMILAR PRODUCTS OF PLAITING MATERIALS OF RATTAN, WORKED LENGTHWISE 
 46012290 || MATS, MATTING AND SCREENS, OF RATTAN PLAITING MATERIALS, FLAT-WOVEN OR BOUND TOGETHER IN PARALLEL (EXCL. THOSE OF PLAITS OR SIMILAR PRODUCTS OF PLAITING MATERIALS WORKED LENGTHWISE) 
 46012910 || MATS, MATTING AND SCREENS, OF VEGETABLE PLAITING MATERIALS, FLAT-WOVEN OR BOUND TOGETHER IN PARALLEL, OF PLAITS OR SIMILAR PRODUCTS OF PLAITING MATERIALS WORKED LENGTHWISE (EXCL. OF BAMBOO AND RATTAN) 
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 48201030 || NOTEBOOKS, LETTER PADS AND MEMORANDUM PADS, WITHOUT CALENDARS, OF PAPER OR PAPERBOARD 
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 96151100 || COMBS, HAIR-SLIDES AND THE LIKE OF HARD RUBBER OR PLASTICS 
 96159000 || HAIRPINS, CURLING PINS, CURLING GRIPS, HAIR-CURLERS AND THE LIKE, AND PARTS THEREOF, N.E.S. (EXCL. ELECTRO-THERMIC APPLIANCES OF HEADING 8516) 
 96161010 || SCENT SPRAYS AND SIMILAR TOILET SPRAYS 
 96161090 || MOUNTS AND HEADS FOR SCENT SPRAYS AND SIMILAR TOILET SPRAYS 
 96162000 || POWDER PUFFS AND PADS FOR THE APPLICATION OF COSMETICS OR TOILET PREPARATIONS 
 96180000 || TAILORS' DUMMIES AND OTHER LAY FIGURES, AUTOMATA AND OTHER ANIMATED DISPLAYS USED FOR SHOP WINDOW DRESSING (EXCL. THE ARTICLES ACTUALLY ON DISPLAY, EDUCATIONAL MODELS AND TOY DOLLS) 
 97011000 || PAINTINGS, E.G. OIL PAINTINGS, WATERCOLOURS AND PASTELS, AND DRAWINGS EXECUTED ENTIRELY BY HAND (EXCL. TECHNICAL DRAWINGS AND THE LIKE OF HEADING 4906, AND HAND-PAINTED OR HAND-DECORATED MANUFACTURED ARTICLES) 
 97019000 || COLLAGES AND SIMILAR DECORATIVE PLAQUES 
 97020000 || ORIGINAL ENGRAVINGS, PRINTS AND LITHOGRAPHS 
 97030000 || ORIGINAL SCULPTURES AND STATUARY, IN ANY MATERIAL 
 97040000 || POSTAGE OR REVENUE STAMPS, STAMP-POSTMARKS, FIRST-DAY COVERS, POSTAL STATIONERY, STAMPED PAPER AND THE LIKE, USED, OR IF UNUSED, NOT OF CURRENT OR NEW ISSUE IN WHICH THEY HAVE, OR WILL HAVE, A RECOGNISED FACE VALUE 
 97060000 || ANTIQUES OF > 100 YEARS OLD 
8.3       Differences between product safety obligations between
non-harmonised consumer products and harmonised products and their alignment
Table 4: Differences between certain consumer product
safety requirements and harmonised product safety requirements with respect to
producers (manufacturers and importers)
 Non-harmonised consumer product safety requirements[145] || Harmonised consumer product safety requirements[146] 
 GENERAL OBLIGATION TO PUT ONLY SAFE PRODUCTS ON THE MARKET 
 Obligation of producers* to put only safe products on the market (the general safety requirement)   * Producer includes manufacturer and importer (providing that with respect to the latter, there is no manufacturer's representative established within the EU if the manufacturer is not established within the EU) Manufacturer is defined as a person established within the EU and any other person presenting himself as the manufacturer by affixing to the product his name, trade mark or other distinctive mark, or the person who reconditions the product. Importer is not specifically defined in the General Product Safety Directive. || Obligation of manufacturers to put on the market only products designed and manufactured in accordance with the essential safety requirements [set out in the relevant sector-specific harmonised legislation]. Obligation of importers to place only safe products on the EU market.     Manufacturer is defined as any natural or legal person who manufactures a product or has a product designed or manufactured and markets that product under his name or trademark.   Importer is defined as any natural or legal person established in the Union who places a product from a third country on the Union market. 
 OBLIGATION TO KEEP RELEVANT TECHNICAL DOCUMENTATION 
 Not explicitly defined in the General Product Safety Directive, but the obligation of producers to keep relevant technical documentation can be implied from (i) the general obligation to put only safe products on the market, (ii) the obligation to keep oneself informed of the risks that the product may pose and (iii) the obligation to provide market surveillance authorities with all necessary information relating to the product in question. || Obligation of manufacturers to keep the relevant technical documentation and make sure that her products comply with technical documentation, including products produced in series production.   
 OBLIGATION TO EQUIP THE PRODUCT WITH SAFETY INSTRUCTIONS 
 Obligation of producers to inform consumers so that they can assess risk which their products may pose and to take appropriate precautions. || Obligation of manufacturers to accompany the product with safety information and instructions, if justified. 
 OBLIGATION TO IDENTIFY THE PRODUCT AND THE PRODUCER (THE MANUFACTURER AND/OR THE IMPORTER) 
 Obligation of producers to keep informed of risks which products may pose, for example, by: (i) identifying the producer[147] (by giving information on identity and details), (ii) identifying the product (by giving product reference or the batch of products to which it belongs).             The aforementioned information should appear on the product or its packaging, except where not to give such indication is justified. || Obligation of manufacturers to (i) indicate name, registered trade name or registered trade mark and the address on which they may be contacted (a single point of contact), and (ii) ensure that products bears a type, batch or serial number or other element allowing for the identification of the product.   Obligation of the importer to indicate name, registered trade name or registered trade mark and the address on which they may be contacted (a single point of contact), [in addition to the manufacturer]   The aforementioned information should appear on the product or, where that is not possible, its packaging or in a document accompanying the product. 
 OBLIGATIONS DURING TRANSPORT OF THE PRODUCT 
 This obligation of producers is not explicitly laid down in the General Product Safety Directive, but it can be implied from the general obligation to put only safe products on the market. || Obligation of importers to ensure that while the product is under their responsibility, storage and transport conditions do not jeopardise its compliance with the requirements [set out in the relevant sector-specific harmonised legislation]. 
Table 5:
Alignment of non-harmonised consumer product safety requirements with
harmonised product safety requirements
 Non-harmonised consumer product safety requirements[148] || Harmonised consumer product safety requirements[149] || WHAT WOULD CHANGE? 
 GENERAL OBLIGATION TO PUT ONLY SAFE PRODUCTS ON THE MARKET 
 Obligation of  producers* to put only safe products on the market (the general safety requirement)     * Producer includes manufacturer and importer (providing that with respect to the latter, there is no manufacturer's representative established within the EU if the manufacturer is not established within the EU) Manufacturer is defined as a person established within the EU and any other person presenting himself as the manufacturer by affixing to the product his name, trade mark or other distinctive mark, or the person who reconditions the product. Importer is not defined in the General Product Safety Directive. || Obligation of manufacturers to put on the market only products designed and manufactured in accordance with the general safety requirement. Obligation of importers to place only safe products on the EU market.               Manufacturer is defined as any natural or legal person who manufactures a product or has a product designed or manufactured and markets that product under his name or trademark.   Importer is defined as any natural or legal person established in the Union who places a product from a third country on the Union market. || The contents of the obligation to put only safe products on the market does not change. However, the change in the definitions of the manufacturer and the importer makes clear that also manufacturers established outside the EU, but producing products for the EU market are subject to the general safety requirement. 
 OBLIGATION TO KEEP RELEVANT TECHNICAL DOCUMENTATION || WHAT WOULD CHANGE? 
 Not explicitly defined in the General Product Safety Directive, but this obligation of producers to keep relevant technical documentation can be implied from (i) the general obligation to put only safe products on the market, (ii) the obligation to keep oneself informed of the risks that the product may pose and (iii) the obligation to provide market surveillance authorities with all necessary information relating to the product in question. || Obligation of manufacturers to keep the relevant technical documentation** and make sure that her products comply with technical documentation, including products produced in series production.     ** Technical documentation is defined as a document which shall include an adequate analysis. || The currently implied obligation becomes an explicit and clearly defined obligation to keep the technical documentation: the content of the technical documentation is spelled out for non-harmonised consumer products. 
 OBLIGATION TO EQUIP THE PRODUCT WITH SAFETY INSTRUCTIONS || WHAT WOULD CHANGE? 
 Obligation of producers to inform consumers so that they can assess risk which their products may pose and to take appropriate precautions. || Obligation of manufacturers to accompany the product with safety information and instructions, if justified. || A general obligation is replaced by a more precise and clear cut obligation for manufacturers and importers. 
 OBLIGATION TO IDENTIFY THE PRODUCT AND THE PRODUCER (THE MANUFACTURER AND/OR THE IMPORTER) || WHAT WOULD CHANGE? 
 Obligation of producers to keep informed of risks which products may pose, for example, by: (i) identifying the producer (by giving information on identity and details), (ii) identifying the product (by giving product reference or the batch of products to which it belongs).                 The aforementioned information should appear on the product or its packaging, except where not to give such indication is justified. || Obligation of manufacturers to (i) indicate name, registered trade name or registered trade mark and the address on which they may be contacted (a single point of contact), and (ii) ensure that products bears a type, batch or serial number or other element allowing for the identification of the product.   Obligation of importers to indicate name, registered trade name or registered trade mark and the address on which they may be contacted (a single point of contact), [in addition to the manufacturer]   The aforementioned information should appear on the product or, where that is not possible, its packaging or in a document accompanying the product. || The general obligation of the producer (including manufacturer and importer) to keep themselves informed of risks which their product may pose by means of various requirements, is replaced by a more detailed obligation to identify the product and the person responsible for its putting on the market, except where due to the size or the nature of the product (for example, due to the intended of reasonably foreseeable use or the value of the product). The possibility to put the required identification information "in a document accompanying the product is added." 
 OBLIGATIONS DURING TRANSPORT OF THE PRODUCT || WHAT WILL CHANGE? 
 This obligation is not explicitly laid down in the General Product Safety Directive, but it can be implied from the general obligation to put only safe products on the market. || Obligation of importers to ensure that while the product is under their responsibility, storage and transport conditions do not jeopardise its compliance with the general safety requirement. || Instead of being implied, the obligation of importers to ensure that while the product is under their responsibility, storage and transport conditions do not jeopardise its compliance with the general safety requirement, will be explicitly defined. 
8.4         Market surveillance framework for consumer and
harmonised products and harmonised products 
Table 6: Description of the main objectives for
achieving a completed coordination of market surveillance activities in the
single EU market
 Aspects || Objectives || Is the objective fulfilled? 
 General aspects || Uniform legislative market surveillance framework || NO 
 Clear institutional framework || NO 
 Single general information IT system accessible EU-wide || At the preparation stage 
 Planned coordination activities || Common key performance indicators (KPI) for measuring market surveillance effectiveness and efficiency || NO 
 Annual planning of market surveillance activities at the EU level || YES, but not coordinated 
 Annual reporting based on KPIs by all Member States (informing, in turn, the planning activities) || NO 
 Coordination of "on-the-field" activities || Common enforcement actions complementing national enforcement actions || YES, but rather an exception than a rule 
 Real-time sharing of information about measures taken against products posing risk within the enforcement actions || YES, but insufficient and often not real-time 
 Mechanisms ensuring coherence of national measures taken || YES, but inefficient and ineffective 
Table 7: Market surveillance instruments in different
domains
 Area || Product Safety || Unfair contract terms, consumer practices || Services 
 Interests protected || Health and safety of consumers and other users || Economic interests of consumers || Free movement of services 
 Request for information* || NO || YES || YES 
 Request for action** || NO || YES || YES 
 Possibility of coordinated action of authorities of different Member States || NO || YES || YES 
 Secured EU IT system communication tool || YES, partially || YES || YES 
* An action by which authorities of one Member State
would be able to ask other authorities for information on dangerous products or
economic operators, and (ii) a procedure triggered by a request for action
** An action under which authorities of one Member State call on authorities in another Member State to perform simultaneous inspections on
economic operators based in the respective Member States.
9.           Annex
9: Market surveillance data – RAPEX, including RAPEX-CHINA, safeguard clause
notifications and other data
9.1.      RAPEX
RAPEX is a European rapid alert system
for dangerous products. It ensures that information about dangerous products
withdrawn from the market and/or recalled from consumers anywhere in Europe is
quickly circulated between Member States and the European Commission, so that
appropriate action can be taken everywhere in the EU. Thirty countries
currently participate in the system. The participating countries are all the
European Union countries and the EFTA/EEA countries: Iceland, Liechtenstein and Norway.
The most common measures are ban/stop of
sales; withdrawal of a dangerous product from the market or its recall from
consumers; import rejection by the customs authorities. The scope of RAPEX
covers dangerous non-food products intended for consumers (e.g. a toy, a cosmetic,
clothing) and for professionals (e.g. a power drill, a machine, a construction
product) which pose a serious risk to various public interests, such as 'health
and safety of consumers', 'environment' (risk for trees, water, air, soil, etc.
from dangerous chemicals contained in a product), 'health and safety at the
workplace' and 'public security'.
9.2.      Statistics on RAPEX
In 2011, a total of 1 803 notifications
on dangerous products posing risks to the health and safety of consumers were
submitted through the RAPEX system by Member States. This constitutes 20% less
notifications than in 2010 (2 244 notifications). Of the 1.803 notifications, 1
556 notifications concerned products which posed a serious risk to consumers.
Other notifications refer to moderate risk or information only.
In 2011, for the first time since the
start of the operation of the current RAPEX system (in 2004), the total number
of notifications decreased by 20%. This is compared with annual increases of
81% in 2005, 24% in 2006, 53% in 2007, 16% in 2008, 7% in 2009 and 13% in 2010.
While this decrease, which occurred mainly in the first quarter of the year,
might be also in part to budget cuts and subsequent resource constraints in the
national administrations, it must be noted that the RAPEX system has now
reached a level of stability and maturity and that the more active use of the
risk assessment guidelines has led to the streamlining of notifications, with
improvements in their quality.
Figure 1: Number of notifications 2003-2011
Figure 2: Number of reactions 2008-2011
In 2011, EU Member States and the
EFTA/EEA countries sent a total of 2,100 reactions to all notifications
distributed through RAPEX. 2,059 reactions were sent in response to
notifications concerning a serious risk (98%); 19 reactions concerned
notifications of products with lower risk levels (1%); and 22 reactions were
sent in relation to notifications sent for information only (1%). The number of
reactions received per notification varied between 1 and 17. More than 45
notifications received at least 10 reactions.
9.2.1    Percentage
of notifications that received at least one reaction per year (all
notifications):
In 2011, 35% of all notifications have
received at least one reaction, a decrease compared to the previous years, when
the percentage has been above 40%. This means that in more than 60% of the
cases there was no follow-up done by recepients of Rapex notifications, mainly
because national authorities indicate the notified product was not found on
their respective national markets.
9.2.2    The
ratio between the total number of reactions and the total number of
notifications 
With 30 countries taking part in the
RAPEX system, each notification submitted by a country could trigger up to 29
reactions from the other participants, provided that the same product is sold
everywhere and it has the same potential risks. 
In practice, there are many products sold
in just a few countries. Moreover, it is rather difficult for market
surveillance authorities to detect dangerous products when these lack adequate
traceability information. This means that the number of reactions received from
the Member States is actually much lower than it could potentially be. 
The ratio between the total number of
reactions and the total number of notifications is slightly higher than 1,
which shows that measures taken by authorities in the notifying country are
followed by at least as many measures taken by the other Member States as
follow-up. 
In 2011, the 1803 measures taken by the
authorities and notified in RAPEX were followed by another 2100 measures taken
by other Member States.
Table 1:
Reactions/Notifications Ratio
   || % of Notifications with at least one Reaction || Reactions/Notifications Ratio 
 2008 || 44% || 1.07 
 2009 || 41% || 1.28 
 2010 || 43% || 0.96 
 2011 || 35% || 1.16 
Figure 3: Number of notifications by
notifying country: comparison with previous years (serious risk only)
In 2011, half of the participating
countries notified fewer dangerous products than in 2010. 
It
should be stressed that RAPEX statistics do not reflect all market surveillance
activities carried out in Member States. Legitimate reasons may exist for the
fact that some measures taken against dangerous products in Member States do
not result in notifications sent to the RAPEX system. Some products, for
instance, are not sold outside of the Member State concerned. The participation
rate of countries in RAPEX is the result of various factors, such as the
different way in which the national market surveillance networks are organised,
the different size of the countries, and the different production and market
structures that exist across the EU. The Commission has undertaken several
actions in 2010 and 2011 in order to facilitate the participation of Member
States in RAPEX, including the publication of the new RAPEX Guidelines, the
development of a new risk assessment application with an improved IT tool and
the organisation of several RAPEX seminars. 
Figure 4: The six most notified product
categories: comparison with previous years
The product categories most frequently
notified through the RAPEX system in 2011 were: 
·                        
Clothing, textiles and fashion items (423
notifications, 27%) 
·                        
Toys (324 notifications, 21%)
·                        
Motor vehicles (171 notifications, 11%)
·                        
Electrical appliances and equipment (153
notifications, 8%)
·                        
Cosmetics (104 notifications, 7%).
These categories of consumer products
accounted for 74% of all products notified in 2011. This year the product
category "Clothing, textiles and fashion items" was the most notified
(27%), followed by "Toys" (22%). Both categories account together for
almost half (48%) of all notifications distributed through the RAPEX system in
2011
Figure 5: Number of notifications in which brand and
model numbers are known/unknown: 
1 308 notifications validated in 2011
(84%) concerned products for which both the brand and the type/model number
were known, which ensures a better identification and therefore traceability of
the notified products. In 14% of the cases, either the brand or the type/model
number was known. In only 30 cases (2%) both the brand and the type/model
number were unknown. 
9.2.3    Notifications by country of origin of the notified product
In 54% of all notifications sent through
the RAPEX system in 2011 (i.e. 839 notifications), the country of origin of the
notified products was China (including Hong Kong). That this number is still
very high results from the significant market penetration of
Chinese-manufactured consumer products in European markets. Products are
checked according to the same, stringent safety requirements regardless of
their origin, usually based on typical risks associated with the product
category. The consistent intensification of contacts with the Chinese
administration and businesses is yielding significant returns in terms of
improved product identification and traceability for corrective measures and
will continue. 
293 notifications (19% of all
notifications sent through RAPEX) concerned products originating from the 27 EU
Member States and 3 EFTA/EEA countries. This is consistent with the data from
previous years (17% in 2010, 20% in 2009, 20% in 2008, 22% in 2007 and 21% in
2006).
128 notifications (8% of all
notifications sent through RAPEX) contained no information about the country of
origin of the notified product. Nevertheless, this figure should be seen as a
significant improvement in the operation of the RAPEX system as even though
this figure is slightly higher than the 7% recorded in 2009, it is lower than
the 10% recorded in 2010. In fact, it remains a very low level given that, in
2004, the number of cases with an unidentified country of origin was as high as
23%. The overall drop indicates that market surveillance authorities in Europe are increasingly aware of the importance of finding identification data that is
helpful to partner authorities in other Member States and, ultimately, in the
country of origin of the product.
Figure 6: Notifications by country of origin of the notified
product
9.2.4    Notifications
by type of risk
In
2011, the five most frequently notified risk categories were: 
·                        
Injuries (481 notifications, 26%)
·                        
Chemical (347 notifications, 19%)
·                        
Strangulation (275 notifications, 15%)
·                        
Choking (224 notifications, 12%)
·                        
Electric shock (216 notifications, 12%).
These
five risk categories account for 84% of all notified risks.
It should be noted that some RAPEX
notifications concern products presenting more than one risk. For example, a
toy can pose a choking risk due to small parts and, simultaneously, a chemical
risk due to excessive levels of a restricted substance. The total number of
notified risks is accordingly higher than the total number of notifications. On
the basis of RAPEX data, it can also be concluded that each product category is
likely to expose consumers to specific types of risk. For example, the main
risks arising when playing with unsafe toys are choking (often associated with
the presence of small parts) and reactions to chemicals (often associated with
the presence of significant amounts of chemical substances such as certain
phthalates, lead and other heavy metals), while the most common risk for
electrical products is electric shock, often combined with the risk of fire. 
Figure 7: The seven most
notified type of risk: comparison with previous years
9.2.5    Notifications
by type of measure: comparison with previous years
In 2011, 922 of the 1 556 RAPEX serious
risk notifications concerned compulsory preventive and restrictive measures
ordered by national authorities (60% of the total). In 598 notified cases
(38%), economic operators took preventive and restrictive measures on a
'voluntary' basis, i.e. they complied with their legal obligations without the
formal intervention of a national authority. In 36 cases (2%), 'voluntary'
actions were complemented by compulsory measures taken by the national
authority. In this situation, even though an economic operator has ceased
selling a product, national authorities still believe further action needs to
be taken and accordingly order, for example, the product to be withdrawn from
the market or recalled from consumers who have already bought it.
Figure 8:
Notifications by type of measure: comparison previous years
9.3.      Statistics on RAPEX-China
The RAPEX-China on-line system was
established in September 2006 and facilitates regular and rapid transmission of
data between the EU and Chinese product safety administrations. The European
Commission provides the Chinese authorities with information on consumer
products originating from China which have been notified through RAPEX.
AQSIQ has submitted 19 reports to DG
SANCO on enforcement actions carried out with regard to RAPEX notifications
exchanged via RAPEX-China between September 2006 and October 2011.
During this period, AQSIQ has
investigated and, where necessary, adopted measures in relation to 1,752 RAPEX
notifications. Analyses of the reports received show that, on average, AQSIQ
investigates 92 RAPEX cases over a three-month period. Summary analyses are
regularly made available at: http://ec.europa.eu/consumers/safety/rapex/index_en.htm
Figure 9 – Actions taken by AQSIQ (total figures)
9.4       Data on safeguard clause notifications
Figure 10: Number of
safeguard clause notifications for a subset of harmonised legislation
 Directive  (name and No.) || No. of  measures communicated under "safeguard clause" || Position taken by Commission on measures 
   || 2009 || 2010 || 2011 || Positive (1) || Negative (2) || Pending || No need for position (3) 
 Directive 2010/35/EU on transportable pressure equipment || 0 || 0 || 0 || 0 || 0 || 0 || na 
 Regulation EC No 2003/2003 of fertilisers || 0 || 0 || 0 || 0 || 0 || 0 || na 
 Lifts Directive 95/16/EC || 0 || 0 || 0 || 0 || 0 || 0 || na 
 Directive 2007/23/EC on pyrotechnic articles || 0 || 0 || 0 || 0 || 0 || 0 || na 
 Directive 93/15/EEC on civil explosives || 0 || 0 || 0 || 0 || 0 || 0 || na 
 Regulation 648/2004 on detergents || 0 || 1 || 0 || 1 || 0 || 0 || na 
 Directive 94/9/EC on equipment for use in explosive atmospheres || 0 || 1 || 0 || 1 || 0 || 0 || na 
 Directive 90/385/EC on active implantable medical devices || 0 || 0 || 0 || 0 || 0 || 0 || na 
 Directive 93/42/EC on medical devices || 0 || 0 || 0 || 0 || 0 || 0 || na 
 Directive 98/79/EC on in vitro diagnostic medical devices || 0 || 0 || 0 || 0 || 0 || 0 || na 
 Directive 2000/9/EC on cableways || 0 || 0 || 0 || 0 || 0 || 0 || na 
 REACH Regulation 1907/2006 || 0 || 0 || 0 || 0 || 0 || 0 || na 
 Ecodesign Directive 2009/125/EC || na || na || 1 || 0 || 0 || 1 || na 
 Marine Equipment 96/98/EC || 1 || 0 || 3 || 1 || 1* || 2 || na 
 Machinery Directive 2006/42/EC || 5 || 5 ||   || 2 || 0 || 8 || na 
 Directive 89/686/EEC on Personal Protective Equipment || 1 || 6 || 2 || 1 || 0 || 8 || na 
 Low Voltage Directive 2006/96/EC || 331 || 345 || 360 || 0 || 0 || 1 || 1035 
 Directive 88/378/EEC on toys (applicable until July 2011) || 41 (472 Rapex) || 20 (488 Rapex) || 37 (324 Rapex) || ** ||   ||   || na 
 Directive 2009/48/EC on toys (applicable since July 2011) || na || na || 2 ||   ||   ||   || 2 
(1) It means that
measures were found to be justified; (2) It means that measures were found to
be unjustified; (3) Because no Member State objected to the measures notified.
This option is only applicable to directives which set out the possibility of
objections by Member States (e.g. currently only the Low Voltage Directive and
the new Toys Directive)
*   The case was
withdrawn by the Member State before the publication of Commission decision
**  Due to the
high number of measures taken in this sector, the Commission and the Member States developed the practice of exchanging views on Rapex notifications and resort
to formal  safeguard clause decisions only if outstanding issues remained. 
9.5       Data
from the European Injury Database
The European
Injury Database (IDB) is the only data source that contains standardised
cross-national data for developing preventive action against home and leisure
accidents in the EU (in 2009, 12 Member States
participated in the IDB database). The IDB is based on
a systematic injury surveillance system that collects accidents and injury data
from selected emergency departments of Member State hospitals, providing a
complement to and integrating existing data sources, such as common causes of
death statistics, hospital discharge registers and data sources specific to
injury areas, including road accidents and accidents at work.  However European
Injury Database does not (i) give up to date information, (ii) provide a direct
link to victims, (iii) identify the full product details, (iv) allow for
testing of the actual product. The distribution of injuries according to
product categories is compiled on the basis of varying samples in the Member
States (e.g. 4 000 injuries in Belgium and 296 000 injuries in the Netherlands). This limits the comparability of data between countries. Moreover, the number
of injuries in each country is not exhaustive which makes it impossible to
estimate the number of injuries of a certain type per 1000 inhabitants in a
certain country.
Figure 11: Causes of home injuries
9.6       Data from the Eurobarometer
The latest
Eurobarometer data shows a decrease in confidence of consumers in the safety of
products sold in the EU (25% in 2011 compared to 20% in 2010 think that a
significant number of products are unsafe, 12% in 2011 compared to 16% in 2010
think that essentially all products are safe).
Figure 12: Safety perceptions
9.7       Market surveillance data from the food sector
Figures
13 and 14: Information about measures taken against food and feed products
(RASFF)
   || original || follow-up 
 year || alert || information || border rejection || follow-up alert || follow-up information || follow-up border rejection 
 2006 || 910 || 687 || 1274 || 2157 || 640 || 923 
 2007 || 952 || 761 || 1211 || 2440 || 796 || 978 
 2008 || 528 || 1138 || 1377 || 1789 || 1329 || 743 
 2009 || 557 || 1191 || 1456 || 1775 || 1861 || 871 
 2010 || 576 || 1168 || 1552 || 1977 || 2027 || 1014 
 2011 || 617 || 1285 || 1828 || 2185 || 1920 || 1017 
 % || 7,1 || 10,0 || 17,8 || 10,5 || -5,3 || 0,3 
   || 3730 ||   ||   || 5122 ||   ||   
10.         Annex
10: Enforcement indicators
10.1     Introduction
In 2008 the European Commission
established and improved a data collection tool dedicated to enforcement and
market surveillance in the Member States. Following a successful pilot, between
2008 and 2011 Member States have been collecting data which measure the key
activities of national authorities in charge of product safety enforcement. 
These enforcement indicators are collected
through an on-line questionnaire addressed to 27 Member States, Norway and Iceland. Figures in the table below show a selection of the most relevant information
provided by national authorities. The data were rescaled by the number of
retailers[150]
present in the country. This gives an indication of the size of the market in
each country and enables to better compare indicators within the 27 Member
States.  Since the indicators have been launched, the definitions have been
fine-tuned but the list of the indicators has not been changed.
Figure 1: Number of administrative decisions taken by
Member States (2008 and 2009)
10.2.    Explanations
So far, a list of approximately 15
indicators has been developed and is made of input and output indicators. 
10.2.1  Input
indicators (resources)
In particular, among the input
indicators, the budget and number of inspectors (columns 1 – 4) have been
identified to be the most pertinent and relevant for such exercise. Indeed, the
amount spent on enforcement activities depicts and assesses Member States'
enforcement capabilities. This has become even more crucial due to the budgetary
cuts Member States are confronted with during this serious economic crisis that
affects the EU economy as a whole. As a result, the protection and safety of
consumers may be seriously affected by inadequate funding of market
surveillance.
10.2.2  Output
indicators (actions and measures taken)
Concerning the
output enforcement indicators, three subgroups of indicators measure the
compliance of traders with laws and provide quantitative information on the key
activities Member States carry out to ensure this compliance. These indicators
reflect three consecutive stages of the enforcement and market surveillance
process:
(i)    Preventive and
investigative activities ensuring compliance (columns 5 – 8): These include the
number of inspections and the number of laboratory tests. The former refers to
any control undertaken by an inspector and aimed at verification of compliance
of a single trader with product safety laws. The later concerns the tests made
to verify compliance with applicable safety requirements, such as checking the
presence of dangerous substances or components or checking for possible
structural defects.
(ii)   Results of compliance checking (column 9): The aim is to
measure the number of detected infringements and irregularities as a result of the
preventive and investigative activities carried out by the relevant
authorities. Examples of such indicators are the number of products identified
as posing a serious risk. Authorities carry out risk assessment to determine if
products inspected are potentially harmful for consumers and take measures when
necessary.
(iii)   Corrective
measures (columns 10 – 14): This is the ultimate stage of the procedure when
authorities find a product that is not safe. This means that authorities will
launch administrative procedures to impose obligations on producers,
distributors or retailers to take corrective measures. These can be, for
example, product withdrawals from the market, product recalls from consumers;
or suspensions of products at the border.
10.3.    Accuracy
of the data provided
The data was provided by the national
authorities responsible for product safety enforcement under the General
Product Safety Directive. Often, data provided comprises information from
multiple authorities (regional or sectoral) and thus should not necessarily
be considered as a complete and accurate picture of product safety
enforcement across Europe. 
10.4.    Conclusions
As a general conclusion, the quality and
the comparability of data have improved. However, compared to 2009, in 2010
Member States have allocated fewer resources to product safety activities; this
clearly reflects the general trend of budget reductions and spending cuts.
Furthermore, in 2010 the number of inspectors decreased and fewer laboratory
tests were being carried out. In addition, fewer dangerous products have been
identified and consequently, fewer measures (withdrawals, recalls) were taken.
   ||   || Budget (€) || Budget (€) rescaled for the umber of retailers || Number of inspectors || Number of inspectors rescaled for the number of retailers || Number of Inspections || Number of inspections rescaled for the number of retailers || Number of products tested in labs || Number of products tested in labs rescaled for the number of retailers || Number of dangerous products posing a serious risk (product categories) || Number of administrative decisions (product categories) || Number of products withdrawn from the market(product categories) || Number of products recalled from consumers (product categories) || Number of decisions taken by customs authorities to suspend products at the border || Number of decisions to reject products at the border 
 AT || 2010 || 960,000 || 23 || 19 || 1 || 8,280 || 204 || 50 || 1 || 97 || 56 || 30 || 200 || 10 || 2 
 2009 || NA || NA || 30 || 1 || 18 || 424 || 1,450 || 34 || 115 || 28 || NA || NA || NA || NA 
 2008 || NA || NA || 18 || 0 || 9,071 || 214 || NA || NA || NA || NA || 300 || 200 || NA || 3 
 BE || 2010 || 2,790,030 || 36 || 34 || 0 || 11,867 || 154 || 663 || 9 || 193 || 190 || 194 || 0 || NA || 262 
 2009 || 2,350,000 || 32 || 32 || 0 || 6,85 || 93 || 300 || 4 || 30 || 370 || 200 || NA || 300 || 200 
 2008 || 1,530,000 || 21 || 24 || 0 || 5,5 || 75 || 400 || 5 || 30 || 1,45 || 260 || NA || 160 || 125 
 BG || 2010 || 461,207 || 5 || 120 || 1 || 11,645 || 127 || 125 || 1 || 193 || 190 || 194 || 0 || 1,484 || 4 
 2009 || 633,975 || 7 || 120 || 1 || 10,672 || 117 || 222 || 2 || 257 || 200 || 259 || 0 || 4 || 4 
 2008 || 550,828 || 6 || 112 || 1 || 7,902 || 86 || 6 || 0 || 153 || 348 || 334 || NA || NA || NA 
 CY || 2010 || NA || NA || 55 || 5 || 6,331 || 12,181 || 99 || 8 || 181 || NA || 281 || NA || 0 || 16 
 2009 || NA || NA || 24 || 2 || 5,919 || 513 || 272 || 24 || 103 || 32 || 159 || 0 || NA || NA 
 2008 || NA || NA || 12 || 1 || 4,917 || 426 || 21 || 2 || 44 || 15 || 154 || 0 || NA || NA 
 CZ || 2010 || 12,850,849 || 102 || 339 || 3 || 20,625 || 125,885 || 707 || 6 || 87 || 461 || 463 || 67 || 56 || 44 
 2009 || 7,622,646 || 61 || 418 || 3 || 30,705 || 246 || 715 || 6 || 79 || 387 || 65 || 6 || 23 || 0 
 2008 || 12,125,654 || 97 || 360 || 3 || 58,111 || 466 || 1,653 || 13 || 57 || 202 || 79 || NA || NA || 0 
 DE || 2010 || NA || NA || 440 || 2 || 53,216 || 197 || 28,057 || 104 || 204 || 6,444 || 1,202 || 411 || 1,612 || 1,004 
 2009 || NA || NA || 803 || 3 || 67,516 || 229 || 25,850 || 88 || 187 || 3,846 || 1,374 || 841 || 714 || 248 
 2008 || NA || NA || 962 || 3 || 76 || 258 || 20,194 || 68 || 240 || 1,529 || 490 || 231 || 634 || 292 
 DK || 2010 || 5,620,000 || 244 || 57 || 3 || 2,065 || 90 || 169 || 7 || 73 || 125 || 59 || 2 || 89 || 87 
 2009 || 4,010,000 || 164 || 45 || 2 || 1,177 || 48 || 409 || 17 || 45 || 51 || 35 || 13 || 58 || 50 
 2008 || 5,400,000 || 220 || 43 || 2 || NA || NA || NA || NA || NA || NA || NA || NA || NA || NA 
 EE || 2010 || 232,220 ||   || 15 || 4 || 2,309 || 536 || 268 || 62 || 28 || 160 || 98 || 5 || 319 || 189 
 2009 || 288,016 || 71 || 18 || 4 || 3,73 || 919 || 320 || 79 || 53 || 140 || 59 || 11 || 262 || 204 
 2008 || 296,961 || 73 || 19 || 5 || 3,961 || 976 || 342 || 84 || 86 || 194 || 111 || 16 || 194 || 135 
 EL || 2010 || 3,263,000 || NA || 88 || NA || NA || NA || 1,190 || NA || 111 || 447 || 137 || 10 || 2 || 2 
 2009 || 4,400,000 || 23 || 105 || 1 || 2,479 || 13 || 1,536 || 8 || 80 || 222 || 222 || 250 || 4 || 4 
 2008 || 4,846,000 || 25 || 127 || 1 || 2,05 || 11 || 305 || 2 || 199 || 230 || 205 || 18 || 155 || 9 
 FI || 2010 || 6,600,000 || 282 || 72 || 3 || 2,975 || 127 || 1,656 || 71 || 39 || 183 || 74 || 32 || 807 || 175 
 2009 || 7,286,000 || 313 || 90 || 4 || 3,067 || 132 || 2,717 || 167 || 35 || 208 || 100 || 5 || 646 || 146 
 2008 || 7,286,000 || 313 || 90 || 4 || 2,852 || 122 || 1,640 || 70 || 52 || 241 || 150 || 21 || 780 || 128 
 FR || 2010 || 16,700,000 || 38 || 202 || 1 || 28,61 || 64 || 3,076 || 7 || 133 || 605 || 111 || NA || 1,286 || 375 
 2009 || 39,912,282 || 87 || 191 || 0 || 26,372 || 57 || 2,717 || 6 || 75 || 692 || 166 || NA || 871 || 232 
 2008 || 40,309,121 ||   || 190 || 0 || 26,26 || 57 || 2,804 || 6 || 52 || 612 || 147 || NA || 921 || 197 
 HU || 2010 || 14,454,900 || 146 || 310 || 3 || 3,886 || 39 || 546 || 6 || 191 || 1,510 || 53 || 121 || 116 || 29 
 2009 || 11,133,214 ||   || 320 ||   || 14,097 ||   || 668 || NA || 157 || 1,775 || 32 || 134 || 59 || 37 
 2008 || 12,996,296 || 132 || 345 || 4 || 17,47 || 177 || 287 || 3 || 158 || 5,658 || 39 || 158 || 234 || 120 
 IE || 2010 || 750,000 || 35 || 8 || 0 || 564 || 27 ||   || NA || 23 || 119 || 0 || 0 || 0 || 1 
 2009 || 750 || 45 || 8 || 1 || 336 || 20 || 4 || 0 || 20 || 96 || 0 || 0 || NA || 1 
 2008 || NA || NA || NA || NA || NA || NA || NA || NA || NA || NA || NA || NA || NA || NA 
 IS || 2010 || 401,691 || NA || 18 || NA || 223 || NA || 1 || NA || 27 || 27 || 23 || 5 || NA || NA 
 2009 || 128,759 || NA || 14 || NA || 264 || NA || NA || NA || 25 || 46 || 17 || NA || 31 || 13 
 2008 || 253,331 || NA || 15 || NA || 486 || NA || 41 || NA || 13 || 118 || 18 || 0 || 31 || 31 
 LT || 2010 || NA || NA || NA || NA || NA || NA || NA || NA || NA || NA || NA || NA || NA || NA 
 2009 || 2,098,571 || 48 || 85 || 2 || 6,524 || 151 || 1,314 || 30 || 98 || 907 || 98 || 98 || 43 || 43 
 LV || 2010 || 685,886 || 51 || 139 || 10 || 4,702 || 350 || 1,466 || 109 || 30 || 276 || 238 || 6 || 46 || 41 
 2009 || 1,644,260 || 127 || 89 || 7 || 2,387 || 185 || 358 || 28 || 26 || 251 || 26 || 14 || 25 || 38 
 2008 || 1,279,444 || 99 || 33 || 3 || 4,189 || 324 || 215 || 17 || 16 || 240 || 53 || 5 || 54 || 38 
 MT || 2010 || 159,031 || NA || 4 || NA || 502 || NA || 38 || NA || 19 || 1 || 1 || 0 || NA || 156 
 2009 || NA || NA || 4 || 1 || 518 || 64 || 178 || 22 || 14 || 17 || 4 || 13 || 12 || 12 
 2008 || 43,888 || NA || 3 || 0 || 65 || 8 || 98 || 12 || 9 || 1 || 1 || 0 || NA || NA 
 NL || 2010 || 11,400,000 || 143 || 40 || 1 || 8,132 || 102 || 5,009 || 63 || 38 || 2,248 || NA || 0 || NA || NA 
 2009 || 13,481,000 || 171 || 41 || 1 || 9,087 || 115 || 4,491 || 57 || 73 || 1,961 || NA || 0 || NA || NA 
 2008 || 14,300,000 || 182 || 37 || 1 || 8,051 || 102 || 5,837 || 74 || 33 || 1,499 || NA || NA || NA || NA 
 NO || 2010 || 335,000 || 12 || 11 || 1 || 554 || 20 || NA || NA || 6 || 60 || 33 || 6 || NA || 16 
 2009 || 206,5 || 7 || 24 || 1 || 647 || 23 || 75 || 3 || 16 || 71 || 13 || 4 || NA || 52 
 2008 || 207,5 || 8 || 20 || 1 || 643 || 23 || 59 || 2 || 2 || 46 || 34 || 2 || 0 || 2 
 PL || 2010 || 5,682,188 || 15 || 587 || 2 || 23,616 || 62 || 2,572 || 7 || 82 || 1,749 || 330 || 1 || 613 || 509 
 2009 || 7,309,317 || 20 || 878 || 2 || 19,569 || 53 || 2,729 || 7 || 108 || 221 || 47 || 0 || 715 || 572 
 RO || 2010 || 3,393,087 || 25 || 355 || 3 || 3,853 || 28 || 997 || 7 || 35 || 1,768 || NA || N/A || N/A || N/A 
 2009 || 3,549,065 || 27 || 367 || 3 || 6 || 0 || NA || NA || 0 || 1,633 || 6,009 || NA || NA || NA 
 2008 || 865,868 || 6 || 350 || 3 || 5,368 || 40 || NA || NA || 4 || 123 || 123 || NA || NA || NA 
 SE || 2010 || 5,363,648 || 90 || 49 || NA || 1,16 || 26 || 489 || 8 || 213 || 222 || 124 || 199 || 35 || 32 
 2009 || 3,450,000 || 58 || 41 || 1 || 1,716 || 29 || 640 || 11 || 180 || 376 || 298 || 161 || 14 || 12 
 2008 || 4,774,000 || 81 || 87 || 2 || NA || NA || NA || NA || NA || NA || NA || NA || NA || NA 
 SI || 2010 || NA || NA || 16 || 2 || NA || NA || NA || NA || NA || NA || NA || NA || NA || NA 
 2009 || NA || NA || 16 || 2 || 8,397 || 1,178 || 487 || 68 || 8 || 493 || NA || 18 || 133 || 84 
 2008 || NA || NA || 20 || 3 || 6,499 || 912 || 96 || 13 || 23 || 600 || 49 || 37 || 109 || 55 
 SK || 2010 || 979,465 || 106 || 56 || 6 || 9,907 || 1,074,16 || 780 || 85 || 69 || 91 || 67 || 0 || 24 || 0 
 2009 || 7,533,425 || 828 || 170 || 19 || 3,113 || 342 || 818 || 90 || 66 || 58 || 58 || 0 || 15 || 0 
 2008 || 285,911 || 31 || 461 || 51 || 39,339 || 4,324,40 || 425 || 47 || 159 || 134 || 159 || 159 || 159 || 10 
 UK || 2010 || NA || NA || NA || NA ||   || NA || NA || NA || 98 || NA || NA || NA || NA || NA 
 2009 || NA || NA || NA || NA || NA || NA || NA || NA || NA || NA || NA || NA || NA || NA 
 2008 || NA || NA || NA || NA || NA || NA || NA || NA || 95 || 29 || 29 || 1 || NA || NA 
11.         Annex
11: Overview of problems, objectives and options
Table 1: Overview
of problems and consequences
 General problem || Specific problem || Causes (Drivers) || Consequences 
 Unsafe consumer products and non-compliant products on the EU market || Difficult compliance with EU product safety requirements || ─               Lack of consistency of EU product safety requirements (for harmonised and non-harmonised products) || ─             Consumers' and other users: danger for health and safety; possible economic damage due to non performing goods ─             Lack of consumer confidence in product safety – ensuring sustained level of consumer consumption is essential for generating economic growth ─               Compliant businesses lose market shares ─               Disparities of treatment of economic operators and products depending on location/uneven playing field ─               Unequal protection of consumers 
 ─               Ambiguity of product safety requirements and lack of specific benchmarks (for non-harmonised consumer products) 
 ─               Complexity of different layers of EU product safety rules (for harmonised consumer products) 
 Fragmentation of market surveillance || ─               Weak coordination of product safety market surveillance authorities on the single EU market ─               Sub-optimal functioning of EU procedures for exchange of information on product risks ─               Inconsistent enforcement of EU-wide product safety action 
Table 2: Overview of problems and objectives
 Problems || Objectives ||
 General problem || Specific problems || Drivers (causes) || General objective || Specific objectives || Operational objectives ||
 Unsafe consumer products and non-compliant products on the EU market || Difficult compliance with EU product safety requirements || Lack of consistency of EU product safety requirements (for harmonised and non-harmonised products) || Reduction of the number of unsafe or non-compliant products on the single EU market. || Consolidation and reinforcement of EU product safety requirements || Ensuring consistency of EU product safety requirements ||
 Reducing ambiguity of product safety requirements for non-harmonised consumer products ||
 Ambiguity of product safety requirements and lack of specific benchmarks (for non-harmonised consumer products) ||
 Simplification the EU legislative framework ||
 Complexity of different layers of EU product safety rules (for harmonised consumer products) ||
 Fragmentation of market surveillance || Weak coordination of product safety market surveillance authorities on the single EU market || Better coordination and increased effectiveness of market surveillance activities on the single EU market for goods ||               Reinforcing EU cooperation mechanisms ||
 Sub-optimal functioning of EU procedures for exchange of information on product risks ||               Making EU product safety procedures more coherent ||
               Inconsistent enforcement of EU product safety requirements || More effective EU-wide product safety action ||
Table 3: Overview of objectives and policy options
 Objectives || Policy options 
 General || Specific || Operational 
 Reduction of the number of unsafe or non-compliant products on the single EU market. || Consolidation and reinforcement of EU product safety requirements || Ensuring consistency of EU product safety requirements || Option 1.A – Baseline scenario: Keeping differences between consumer product safety requirements and harmonised product safety requirements 
 Option 1.B – Aligning consumer product safety requirements with harmonised product safety requirements 
 Option 1.C – Consumer product safety requirements to be defined less strictly than harmonised product safety requirements 
 Option 1.D – Consumer product safety requirements to be defined more strictly than harmonised product safety requirements 
 Reducing ambiguity of product safety requirements for non-harmonised consumer products || Option 2.A – Baseline scenario: Necessity of creation parallel pre-standardisation procedures for non-harmonised consumer products 
 Option 2.B – Direct applicability of ad-hoc safety requirements 
 Option 2.C - Abolition of double adoption of non-binding ad-hoc safety requirements 
 Option 2.D – Fast-track procedure for adopting already existing European standards without mandates 
 Simplification the EU legislative framework || Adoption of a single horizontal regulation for market surveillance 
 Abolition of Directive 87/357/EC which by appearing other than they are endanger the health and safety of consumers 
 Better coordination and increased effectiveness of market surveillance activities on the single EU market for goods || Reinforcing EU cooperation mechanisms || Option 3.A – Baseline scenario: keep status quo based mostly on voluntary market surveillance coordination 
 Option 3.B – Coordination of cross-border enforcement of measures resulting from "on the-field" market surveillance 
 Option 3.C – Overall rationalisation of coordination of market surveillance activities 
 Option 3.D – Centralisation of EU market surveillance in the area of non-food products 
 Making EU product safety procedures more coherent || Option 4.A – Baseline scenario: Keeping the parallel notifications under RAPEX procedure and safeguard procedure 
 Option 4.B – Simplification of the RAPEX procedure 
 Option 4.C – Simplification of the RAPEX procedure and streamlining of that procedure with the safeguard procedure 
 More effective EU-wide product safety action || Option 5.A – Baseline scenario: Keeping EU-wide product safety measure indirectly applicable for a period of one year 
 Option 5.B – Extension of the scope of EU-wide product safety measures to non-consumer products 
 Option 5.C – Making EU-wide product safety measures directly applicable 
 Option 5.D – Extension of the period of validity of EU-wide product safety measures 
 Option 5.E – Combination of options 5.B, 5.C and 5.D 
12.         Annex
12: Discarded options
12.1     Overview
The early phases of the
impact assessment process identified certain issues which could be subject to
an EU legislative action. However, a brief assessment of these showed that
either it is not appropriate to deal with these issues under the new General
Product Safety Product Directive or the new Market Surveillance Regulation,
although it may be worth treating these issues outside these legislative tools,
or that these issues should be discarded without further analysis.
Consequently, the following issues were excluded from further analysis within
the impact assessment process:
(1)         
safety of services,
(2)         
product safety requirements for non-harmonised
professional products,
(3)         
safety of products marketed via the internet,
and
(4)         
abolition of consumer product safety requirement
12.2.    Safety of services
At the current state of EU legislation,
no general legislative framework on safety of services exists. The General Product Safety Directive
did not cover the safety of services, but required the Commission to identify the needs, possibilities and priorities for Community
action on the safety of services and submit to the European Parliament and the
Council, before 1 January 2003, a report, accompanied by proposals on the subject as appropriate.[151]
The 2003 Report on the
safety of services for consumers (the "Report on Services Safety")[152] indicated that all Member
States adopted policies, legislation and administrative measures concerning
service safety, but the approaches varied significantly. Certain Member States
have introduced general legislation specifically on the safety of consumer services,
which supplements sector specific policies and legislation (Finland, France, Portugal, Spain Sweden, Belgium, Bulgaria, Denmark, Estonia, Latvia, Netherlands,  Slovak Republic, Cyprus, Malta). A few Member States cover the horizontal
aspects of consumer, user and public safety of services via their occupational
health and safety legislation. All Member States have sector specific
approaches, with a variety of provisions directly or indirectly relevant for
the safety of various categories of services. Codes of practice and voluntary
measures have also been established in some Member States, but on an ad-hoc
basis and just for a few specific service sectors. In addition to the specific
direct measures, regulation in other areas like safety of buildings and
occupational safety is of significant indirect importance. The Report concluded
that due to the complexity and variety of the relevant measures, it was very
difficult to make a comparative assessment of the regulatory situation in the
Member States and to identify specific gaps and weaknesses in the approaches in
place or in their practical application and enforcement.[153]
Following the
publication of the Report on Services Safety the overall situation has not
appeared to change significantly. The 2009 Report on the implementation of the
General Product Safety Directive[154]
highlighted - with respect to the safety of consumer
services - the lack of consensus among Member States regarding the appropriate
level of Community action and the lack of comparable data. The lack of
comparable data has not, however, prevented the Commission from pursuing new
initiatives, where the focus was on the data collection,[155] awareness raising, and
encouraging stakeholders to address priority areas for Community action, such
as hotel safety.
In the first phase of the impact
assessment process when the scope of problems the impact assessment should
dealt with was being established, the Commission included within this scope
also the possibility of taking a legislative action in the area of safety of
services. An alternative to this approach would be to continue to monitor the
different national approaches to the issue of safety of services, to collect
the necessary data and evidence, in particular on the accidents and injuries
occurring as a result of the provisions of services and on that basis pursue an
appropriate non-legislative action, such as elaboration of a white paper
mapping in detail the situation in different Member States regarding the safety
of services for consumers.
When considering the choice of the most
appropriate action in the area of safety of services, the Commission decided to
take the latter approach. This conclusion was reached on the basis of the fact
that on 28 December 2011 the Directive 2006/123/EC of 12 December 2006 on
services in the internal market (the “Services Directive”) partly dealing with
the issue of safety of services, although principally from the perspective of
free movement, entered into force.[156]
           Moreover, positions of stakeholders both at general level as
well as within certain stakeholders signalled an important rift. On the one
hand, consumer organisations, such as BEUC and ANEC strongly argued for a
comprehensive horizontal framework for consumer safety, covering both product
and service safety. In their view, the lack of an overarching legal framework for
service safety and quality is of fundamental concern to consumers and consumer
organisations and constitutes a loophole in the EU legislation since the
Services Directive deals with the safety of services only very partially. On
the other hand, business associations, such as BUSINESSEUROPE and Orgalime
opposed the introduction of any legislative proposal covering safety of
services in general. They believed that the scope of the General Product Safety
Directive with regard to services should not be revised since in their opinion the
establishment of a general services safety requirement would be
disproportionate.[157]
Among the Member
States the positions on the question of establishing a general framework for
safety of service showed similar division. The positions of individual Member
States on this issue more or less reflected the legislative situation in the Member State concerned. Thus, those Member State which had adopted general rules on the
safety of services at the national supported the adoption of the same approach
at the EU level whereas those which had not, opposed any EU legislative action with
respect to the safety of services. Certain other Member States, such as Denmark proposed that the question the safety of services should be covered by other pieces
of EU legislation, such as the Services Directive.[158]
In conclusion, for
the reasons indicated the Commission decided not to include the issue of safety
of services into the scope of this Product Safety Package.  
12.3     General
product safety requirements for professional products
The call of
stakeholders for a uniform product safety framework for with the broadest
possible scope raised the question whether the modernised harmonised product
safety requirements which appeared well suited to apply also to non-harmonised
consumer products should and could apply also to non-harmonised professional
products. Due to its expected complexity this question was chosen to be left
for a later exercise independent of this Product Safety and Market Surveillance
Package. The Commission will, however, pursue its work and may come up with
proposals on possible regulatory actions in this area at a later stage.
12.4.    Safety of products marketed via the Internet
Under the existing product safety rules
of the General Product Safety Directive products are subject to the same safety
requirements regardless of the distribution channel through which they are
marketed.[159]
The study Future of Market Surveillance indicated that “e-commerce is expanding rapidly and thus increasing cross-border trade.“[160] Despite this fact, national market
surveillance authorities of Member States have so far taken very limited action
regarding safety of products sold via the Internet.[161] As a consequence, the level
of protection of consumers and other users against health and safety risks
posed by unsafe products sold on-line lags behind the level of protection
provided in respect of other distribution channels. As a result, an unsafe
product that has been withdrawn and recalled from the EU market may still be
available to consumers via the Internet. 
In the internet public consultation,
economic operators and other stakeholders indicated that they did not think
that national authorities pay as much attention to products sold online as they
do to products sold through other distribution channels: A majority of economic
operators think that dangerous consumer products are sold on the internet in
the EU by operators based both in the EU and in third countries.[162] Only a minority thinks that
attention given by market surveillance authorities to the safety of products
sold online is equal (or higher) compared to that given to products sold
through other distribution channels.[163]
A strong majority of respondents confirmed that they were aware of dangerous
consumer products being sold online in the EU.[164] An important majority of the
respondents were also of the opinion that, with respect to safety, national
market surveillance authorities do not treat products sold online in the same
way as products sold in shops.[165]
The internet public consultation has
shown that if national market surveillance authorities perform market
surveillance on products marketed online, they do so in an incidental, fragmented
and uncoordinated manner: only half of the national authorities have specifically
monitored products sold online at a certain point of time during the last three
years.[166]
A large majority of those national market surveillance authorities which
performed some monitoring products sold online had difficulties indicating the
number of websites checked, the number of products targeted or the number of
products sampled for further tests.[167]
Certain national market surveillance authorities have, however, taken some
preventive and/or restrictive measures against products sold through online
distribution channels.[168]
The reasons for these shortcomings result from (i) a lack of explicit
harmonised rules on the surveillance of the safety of consumer products
sold via the Internet, (ii) a greater and more frequent presence of
cross-border elements (including those going beyond EU borders) in on-line
sales than in traditional sales, (iii) difficulties in tracking down economic
operators responsible for selling unsafe products via the Internet, and
(iv) the fact that many dangerous products are sold on the Internet by private
individuals.[169]
Although the General Product Safety Directive contains provisions which de
iure could be applied to Internet transactions, their use by Member State market surveillance authorities has been rather limited, mainly due to the
many uncertainties concerning their practical application.[170]
If no action with respect to safety of
products sold on-line is taken, the exposure of consumers to dangerous products
sold on the Internet will become higher than with respect to products sold
through other distribution channels. This would lead to loss of consumer
confidence in online consumer markets and could create barriers in the area of
free movement of products sold online.
Since all
products are already subject to the same requirements under the EU product
safety legislation regardless of how they are sold, one of the possible options
to address the issue of Internet sales would to clarify the practical
application of the relevant provisions in a separate guidance document which would
have a non-binding character. This document would build on the experience
developed by some Member States and stakeholders in this field and its main
goal would be the sharing and dissemination of best practices.
In case the adoption of guidelines for
the application of the existing enforcement rules towards dangerous products
sold on the Internet is not sufficient to effectively address the issue, a
stronger regulatory action could be considered. Under this option, new specific
provisions on market surveillance with regard to Internet sales would be
introduced. These provisions would introduce obligations for economic operators
selling products via Internet as well as specific enforcement powers for
national enforcement authorities. More specifically, these provisions would
address the categories of actions to be adopted by a responsible economic
operator selling unsafe products via the Internet, such as the notification
obligations, monitoring activities performed by national authorities, taking of
samples, product and seller identification obligations etc. 
The position of stakeholders on the
question of introducing specific measures to be taken against online
distribution channels in cases of safety deficiencies of products sold through
these channels were divided: whereas national market surveillance authorities
pointed out that it would be easier to carry out market surveillance with
regard to the products sold online if specific harmonised rules were introduced
at EU level,[171]
economic operators considered existing rules and enforcement means to
sufficient for the purpose of tackling dangerous products sold via the
Internet.[172]

The study "Future of Market
Surveillance" indicated that to "provide a more effective
and efficient means of identifying and testing products that would otherwise
slip past orthodox market surveillance inspectional activities," it
is necessary to establish a pan-European task force which should be able to (i)
"harness accurate information with rapid intervention to succeed in
identifying, intercepting and controlling the transit of dangerous
products," and (ii)  "identify the locations of large
supply depots and advise the relevant MSAs as appropriate."[173] The study therefore suggests
that the most appropriate answer to the issue of distribution of unsafe product
through the internet would consist in detection of the supply chains, in
particular existing warehouses, which ensure distribution of products bought
on-line by consumers and other users. Since the checks on products stored on
business premises are a part of "standard" market surveillance
authorities, adjustment of existing market surveillance tools, thus, seems to
provide an appropriate and sufficient response to the problem of unsafe product
marketed online.
Alternatively, special
market surveillance measures for products marketed through on-line distribution
channels helping to deal with dangerous products marketed on-line could be
envisaged. However, the regulation of e-commerce is dealt with by existing EU
legislative instrument.[174]
Also, the main problem of safety of products sold on-line lies in the
identification of the underlying distribution channels of physically existing
products, the adoption of special market surveillance rules on-line
distribution channels would not be able to provide desired tools for
effectively eliminating from the market the products sold through the internet.
Apart from the high
"cross-border" potential, the only difference between traditional and
on-line distribution chain seems to be that the ends of on-line distribution
chains cannot be found on the streets, but in the virtual internet environment.
The only change to the current market surveillance practice necessitated by
existence of these on-line distribution chains consists in finding the appropriate
means for identification of the links between the ends of distribution chains
appearing on the internet and the physically existing warehouses supplying
potentially dangerous products. Given the fact that this task would be more
effectively resolved in a non-regulatory way, for example, by the
aforementioned pan-European task force, changing existing legislative rules
does not seem to be necessary. However, the results of work of this
pan-European task force should be reflected in operational guidelines in order
to help national market surveillance authorities in identification of
distribution chains supplying products to the on-line distribution channels.
In
conclusion, it was chosen not to envisage legislative action with respect to
the issue of the safety of products marketed through the Internet into this
Product Safety Package. Instead, in line with the recommendations of the study
“Future of Market Surveillance” it was preferred to include in the proposed
Multiannual market surveillance plan actions aiming the establishment of a task force which should identify the most effective and efficient
methods how to tackle the problem of unsafe product sold via the Internet. Once sufficient data on this issue are gathered
and best methods identified, the Commission would consider the elaboration of
guidelines for the application of general product safety rules sold on-line,
inclusion of internet service providers among product safety actors.
13.         Annex
13: Competitiveness analysis
13.1.      Context
The General Product Safety Directive
established a general obligation on economic operators to place only safe consumer
products on the market. At the same time the Directive laid down requirements
on the organisation and performance of market surveillance of health and safety
aspects of consumer products. The Directive had as its goal to ensure that
barriers to trade and distortions of competition within the internal market
will be avoided. Therefore, the requirements on economic operators have the
potential to impact on business competitiveness by influencing the following
dimensions of competitiveness:
·                        
Cost competitiveness: through compliance costs and costs necessary to produce and
distribute the product, including for instance costs with labelling, packaging and
traceability requirements.
·                        
Capacity to innovate, by influencing the processes and requirements to develop and
recognize a European standard and, therefore, having an impact on the speed by
which they can place a product in the market.
·                        
International competitiveness, by influencing the level playing field and the ability of operators
(domestic and international) to place products on the EU market.
At the moment, the co-existence of
different legal instruments on European product safety, market surveillance and
consumer protection creates a number of complexities and ambiguities. 
Following the steps proposed in the
Operational guidance the following aspects will be assessed from the
qualitative point of view: (i) the impact of costs for economic operators, (ii)
adaptation of their methods in compliance with the law, (iii) the possible
implications for companies' ability to innovate and the expected impact on
international competitiveness. 
13.2.      Qualitative analysis
13.2.1  Availability
of information
Consumer consumption represents 56% of
the GDP of the European Union.  Consumers' confidence is a key element for
ensuring sustained level of consumer consumption which, in turn, is essential
for generating economic growth and the proper functioning of the EU market.
However, although there are no statistics that allow estimating the number or
percentage of non-food dangerous products present on the EU market, there are
indications – for example on the basis of the data from the RAPEX system - that
unsafe products are being put on the internal EU market. Due to the absence of
reliable statistics or even estimates about the number of unsafe and
non-harmonised consumer products and the number of non-compliant harmonised
products, the competitiveness proofing assessment is mainly qualitative.
13.2.2  Sectors
affected
The measures resulting from the revision
of the General Product Safety Directive and the measures concerning market
surveillance for products can have an impact on different economic operators
throughout the supply chain:
·                        
Manufacturers
have to comply with requirements concerning product safety and therefore have
to considerer those requirements in the product development and manufacturing,
including labelling and traceability. The ease of identification of
manufacturers is key for the speed at which authorities can ensure that
dangerous products for customers can be identified and withdrawn from the
market.
·                        
Importers act in
many cases as representatives of the manufacturers and therefore become responsible
for the introduction of the product in the market.
·                        
Distributors (including online distributors) are the first contact point with consumers and have the
responsibility to monitor the safety of products. Some retailers market own
branded products for which they bear the manufacturers’ responsibility.
In terms of product sectors affected the General
Product Safety Directive and Regulation (EC) No 765/2008 apply to a vast range
of products as illustrated in Annex 7.
13.2.3  Cost
competitiveness
13.2.3.1
Compliance costs
The current situation can be seen as
non-optimal from the competitiveness point of view, since the business
environment, in what concerns general product safety, can be characterised by:
·                        
Costly conformity assessment and enforcement: The uncertainties as to the applicable safety requirements as well
as the absence of referenced European standards for many products covered by
the General Product Safety Directive makes conformity assessment and
enforcement costly.
·                        
Loss of synergies and unnecessary costs with
doubling of checks of compliant products or economic operators or the fact that testing and risk-assessment of a product
determined as dangerous in one Member States may have to be re-done in other
Member States in order to make it possible to take action against such
dangerous product in the other Member States.
The current provisions on market
surveillance in the EU internal market legislation can be a source of
compliance costs for business, which can be optimised.
·                        
Currently provisions on market surveillance
are scattered over several directives and regulations. Besides certain market surveillance obligations set out in many
harmonisation directives and regulations, market surveillance provisions for
non-food products are contained in the General Product Safety Directive and
Regulation (EC) No 765/2008.
·                        
Inconsistent application of EU product measures
by national market surveillance authorities was viewed as a problem by economic
operators. Related compliance costs with the diverging national implementing
measures were assessed as "non-negligible" by some of the operators.
·                        
Failing traceability of manufacturers and
importers is a problem for market surveillance authorities. Harmonisation of the obligations of economic operators in the non-harmonised
area with those in the harmonised area, including traceability requirements and
the obligation to establish certain technical documentation, would make
enforcement activities more effective. In addition, economic operators and
other stakeholders, including consumer organisations and a number of business
associations, see more benefits than disadvantages if certain of these
obligations of economic operators with regard to harmonised products were applied
uniformly to all products.
·                        
More demanding requirements on market
surveillance activities of Member States (such as
the need to check a minimum number of products of a certain kind) can impose
additional costs to business.
13.2.3.2 Costs
of production and distribution 
Aligning the consumer product safety
requirements with the harmonised products safety requirements would bring the
desired clarity and legal certainty. Currently, there are differences between
consumer product safety requirements and harmonised product safety
requirements. Hence, stakeholders have to determine and then apply different
sets of general requirements for products which often pose the same level of
risk. There are also difficulties in particular for economic operators to
determine which of the two inconsistent sets of requirements apply to a given
product. Lack of coherence in the obligations of economic operators leads to
confusion as to the applicable product safety rules which generates cost
inefficiencies: 
·                        
Ambiguous legislation creates additional
costs for economic operators resulting from the
necessity of information research on applicable rules and legal advice on how
to correctly apply these rules.  
·                        
Unnecessary additional legal costs for
economic operators: Those arise from the absence of
consistency between overlapping legislative instruments creates and has a
negative impact on effectiveness of product safety rules.
·                        
The coexistence without a substantive and
practical alignment of the General Product Safety Directive with the New
Legislative framework  is likely to set up two separate legislative regimes –
one for harmonised and one for non-harmonised products – with their own
definitions and differing obligations for economic operators, and diverging
competences of market surveillance authorities.
·                        
Rules cannot be properly enforced and exert
their full effect: this is the case when economic
operators are not aware of which product safety requirements are prescribed or
have doubts about their application.
·                        
Legal uncertainty for both the economic
operators as well as market surveillance authorities: Market surveillance authorities and economic operators are
currently deprived of complete, up to date and efficient tools for determining
the compliance of products on the market. Consequently, economic operators have
to resort to alternatives which are sometimes costlier and which can be prone
to inconsistency.
The preferred option "Option 1.C –
Aligning consumer product safety requirements with harmonised product safety
requirements" addressing Problem 1 will have the following expected qualitative
impacts on cost competitiveness:
·                        
Lower information-research costs and costs of
legal advice to easily determine applicable product safety rules.
·                        
Improve desired clarity and legal certainty by eliminating the existing overlap between inconsistent requirements
under consumer product safety requirements and harmonised product safety
requirements.
·                        
Provide clear product safety requirements applying across the sectors and thereby also contribute to the
non-discriminatory treatment of economic operators by market surveillance
authorities of different Member States while allowing market surveillance
authorities to track down non-compliant economic operators more quickly at
lesser costs. Last but not least, it would contribute to the equal protection
of consumers and other users against dangerous products.
·                        
Enforcement of product safety rules would be
easier if the obligations of economic operators in the harmonised and non-harmonised
area were aligned.
The preferred option is expected
facilitate marketing and ensure a fairer playing field across the internal
market, having a positive impact for business production and distribution costs
as well as for improved business environment with increased certainty.
13.2.4  Capacity
to innovate
Unsafe consumer products constitute an
immediate threat to the safety of consumers and undermine consumer confidence.
They can become an obstacle for companies to launch new products and to
generate new revenues by creating resistance in customers to accept new
offerings. If consumers should have confidence in products available at the EU
market, consumer products must be safe, irrespective of the place where they
are produced.
Major shortcomings of the current General
Product Safety Directive which can impact on companies' product cycles are:
·                        
The unsatisfactory speed of standardisation
procedures under the General Product Safety Directive is not satisfactory, and
·                        
Confusion and uncertainty among economic
operators about applicable product safety requirements.
Measures to allow the rapid and easy
identification of unsafe products can contribute to the adoption of new
technologies. The application of track-and-trace technologies, and product
authentication technologies, would be beneficial to consumer safety.  The use
of new technologies such as Radio Frequency Identification (RFID) technology
tags and nano-printed intelligent packaging could aid traceability.
13.3.      Competition in the internal market
The majority of products are increasing
dependent on the globalisation supply chains which have become longer and more
complex.  Many products are regularly marketed in more than one Member State. Nevertheless, despite these developments market surveillance authorities
undertake enforcement mainly along national lines, resulting in a fragmented
enforcement effort and, hence, in unequal protection of European consumers and
other users and little level playing field for economic operators.
Differences in the transposition of the
General Product Safety Directive, and the limited powers of the Commission to
introduce coordinated approaches, lead to:
·                        
Unequal consumer protection.  The lack of coherence of consumer product safety rules laid down
in the General Product Safety Directive and other sector specific EU product
safety legislation contributes to the unequal protection of consumers
throughout the EU.
·                        
Uneven playing field for economic operators
across the EU with continuing existence of barriers on the internal market. Disparities in product safety legislation as well as the
differences in enforcement practices between EU Member States create an uneven
playing field for economic operators, in particular SMEs, which face distorted
competition. 
Aligning consumer product safety
requirements with harmonised product safety requirements" will have the
following expected qualitative impacts on competition in the internal market:
·                        
Reduction in information-research to certain
economic operators: Clear rules relating to the
identification of economic operators in the supply chain applying uniformly
across consumer product sectors would bring a reduction in information-research
to certain economic operators, in particular to those producing or marketing
both products subject to the EU product safety legislation and consumer safety
legislation, and selling their product in more than one Member State. 
·                        
Contribute to the non-discriminatory
treatment of economic operators by market
surveillance authorities of different Member States while allowing market
surveillance authorities to track down non-compliant economic operators more
quickly at lesser costs.
Providing tools for coordination of
reactive market surveillance would would be expected to have the following
impacts on competitiveness:
·                        
It would help authorities to cope with the
growing globalisation of product supply chains.
Thus, authorities would be able to 'reach out' over national borders by
effectively relying on assistance of market surveillance authorities from other
Member States. For example, being able to perform simultaneous checks on
economic operators active in different Member States would increase the
effectiveness and coherence of market surveillance action on the single EU
market. This would in turn positively influence the consistency of protection
of consumers and other users within the Union as well as it would provide more
level playing field for compliant economic operators.
13.4.      Competition with third countries
Imports from third countries are growing
faster than domestic production and the EU is faced with an increasing number
of non-conforming products arriving from third countries. The fact that market
surveillance for products within the single market is fragmented, together with
the globalization of value chains, can in some cases place European based
manufacturers at disadvantages with EU importers that ignore European product
safety rules:
·                        
"Rogue" operators sell products
cheaper than compliant economic operators.  A low
effectiveness of the sanction regime for breaches of product safety obligations
contributes to the unlawful competition of "rogue" operators and
generates health and safety risks for consumers and other users. The weakness
of the current sanction gives to the "rogue" operators an incentive
for costs savings on safety requirements and allows them to sell products
cheaper than compliant economic operators. This gives to these
"rogue" operators competitive advantage over the compliant operators
and at the same time endangers the health and safety of consumers.  "Rogue"
operators save money by not investing in safety and can consequently offer
their products at lower prices than their competitors who respect the law. In
sectors where there is tough competition from imported low-price products,
European industry is disadvantaged. The situation “punishes” the law-abiding
manufacturer, as compliance becomes a “competitive disadvantage”.
·                        
Unequal treatment of economic operators and
unequal protection of European consumers due to
fragmented enforcement effort of EU product safety rules. Market surveillance
authorities still undertake enforcement mainly along national lines despite the
growing number of imports of non-food products from third countries to the EU –
which also increasingly ends up in more than one Member State – and, more
generally, the growing size of intra-EU trade in consumer products.
·                        
Globalisation makes it difficult to determine
how and by whom a product is manufactured or who has placed it on the market. For market surveillance to be efficient, collaboration with
manufacturers is essential in order to rectify compliance, prevent the placing
on the market, and, as a last resort, to withdraw non-compliant products. In
practice market surveillance authorities often experience difficulties in
identifying the person who has actually manufactured and/or supplied the products,
in particular when the manufacturer is located outside the EU and has not
appointed an authorised representative. They often cannot find a contact person
who could provide them with the necessary information to evaluate the
conformity of the product and who could help them to ensure that dangerous
products are withdrawn from the market.
·                        
Insufficient controls at external borders are
exposing European producers to unfair competition:
External borders are the best place to detect non-conforming products from
third countries as they are the entry point for imported goods. However,
resources are not always sufficient and have not kept pace with the increase in
imports; therefore, external borders are not always sufficiently controlled.
The differences in effectiveness of border controls between entry points once
again create a problem for the whole Union. Experience has shown that where a
shipment of non-compliant products is detected and destroyed at one entry
point, importers will often look for another entry point into the Union which has less stringent controls for import of his product.
Examples:
Non-conforming products arriving from third countries leading to unfair
competition with EU producers.
EU
electro-technical sector 
The EU electro-technical
sector is faced with an increasing number of non-conforming products arriving
from third countries.  The share of imported products in the total of
non-compliant products detected by market surveillance authorities is between
70% and 99%.  Most data on non-compliance is available in the electro-technical
sector. It is also the sector in which stakeholders and in particular industry
associations have been most active in pointing to the problem.  The LVD market
surveillance authorities have undertaken three cross border actions, on
portable household lights, cord extension sets and Christmas lighting. Only 5%
of the household lights tested showed no shortcomings (either administrative or
technical). Whilst not causing immediate danger to consumers, the shortcomings
were considered serious enough to require remedies. Only one in six cord
extension sets fully complied with the requirements. 58% of the cord extension
sets tested were considered sufficiently unsafe by the authorities to justify a
sales ban. Similar findings were obtained in three market surveillance
campaigns carried out by the EMC Administrative Cooperation group (ADCO)
recently, which focused on Energy Saving Lamps, Power Tools and Consumer
Entertainment Electronic Products. The results of these campaigns showed that
the level of technical non-compliance was 23% for the Energy Saving Lamps, 20%
for the Power Tools and 50% for the Consumer Entertainment Electronic Products.
Further general conclusions drawn from the campaigns were that for the electro-technical
sector, the share of non-compliant imported products was generally higher than
the share of non-compliant products originating from EU countries, and that for
a considerable part of non-compliant products the origin could not be
determined. 
Imported toys
A survey on the safety
of imported toys in new Member States indicated that 55% of the imported
products sample was non-compliant, and of those 12% had no indication of
origin.
13.5.      Conclusion
The proposal is expected to have a
positive impact on the EU competitiveness since it has the potential to improve
the detection of unsafe consumer products in the single market and at the same
time reducing compliance costs for business by creating a unified framework.
This will translate into creating a more certain business environment and a
level playing field which will be more demanding for "rogue" traders
which distort the market.
14.         Annex
14: Summary of joint market surveillance actions
 NAME || DATE || PRODUCTS  COVERED || MEMBER STATES 
 JOINT MARKET SURVEILLANCE ACTION ON HELMETS || 1/12/2009 – 31/12/2010   || HELMETS || Cyprus, Czech Republic, Germany, Iceland, Latvia, Lithuania, Norway, Slovenia, Spain, Sweden, The Netherlands  (11 MS) 
 Joint action on sunbeds 2008 2009 || 1/9/2008-31/12/2009   || SUNBEDS + SUNBED SERVICES || Belgium, Cyprus, Czech Republic, Denmark,  Finland, Germany, Hungary, Latvia,  The Netherlands, Poland (10  MS) And Switzerland 
 JOINT MARKET SURVEILLANCE ACTION ON TOYS || 9/2008- 4/2010 || toys for children under 3 years old (small parts and magnets in toys; heavy metals) || Bulgaria, Czech republic, Denmark, Estonia, France, Greece, Germany, Italy, Lithuania, Latvia, Norway Slovakia, The Netherlands Other: Turkey, Canada (13  MS) 
 Joint Market Surveillance Action on Cords and Drawstrings on Children’s Clothing || 15/8/2008 – 15/2/2010   || children’s clothing  (cords and drawstrings) || Austria, Bulgaria, The Czech Republic, Denmark, Estonia, France, Greece, Ireland, Lithuania, The Netherlands and Portugal (11 MS) Also Turkey and Spain followed actively 
 "Safe play on the playground!” || 9/2007- 11/2008 || Playgrounds and playground equipment || Bulgaria, Denmark, Estonia, the Netherlands, Norway, Slovakia, Slovenia and Poland 
 Joint Market Surveillance Action on Child- Resistant Lighters and Novelty Lighters || 8/2007- 11/2009 || Child-Resistant Lighters and Novelty Lighters || Austria, Bulgaria, Denmark, Estonia, Greece, Latvia, Malta, The Netherlands, Norway, Poland, Slovenia, Slovak Republic and Sweden. (13 MS) 
 Joint action on “Electrical Safety of Cord Extension Sets” || 3/2007- 3/2008 || multiple outlet extension cords   || Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Germany, Denmark, Spain, Finland, Iceland, Lithuania, Luxembourg, the Netherlands, Norway, Malta, Poland, Sweden, Slovenia, Slovakia, and UK 
 Susy safe project (Surveillance System on Suffocation Injuries due to Foreign Bodies in European children) || 2/2005- 8/2009   || SUSYSAFE stands for Surveillance System on Suffocation Injuries due to Foreign Bodies in European children. || Italy, Austria, Germany, Cyprus, Greece, Czech Republic, France, Portugal, The Netherlands, Slovak Republic  (Germany +Finland participated in the first phase of the project)       
 ICSMS2   ||  1/1/2008- 31/12/2008  || The overall objective of the ICSMS2 project is to optimise ICSMS (a data exchange system on market surveillance) as a tool for the realisation of the network article 10 of the General Product Safety Directive (GPSD, 2001/95/EC). || Austria, Belgium, Estonia, Germany, Luxembourg 
 Enhancing Market Surveillance through Best Practice (EMARS) || 1/1/2006 -31/12/2008 || Aims to establish a common body of knowledge on market surveillance and to make this information and expertise available to the Member States and the Commission for both strategic and tactical goals   || Austria, Belgium, Denmark, Estonia, Finland, Germany, Greece, Hungary, Latvia, Lithuania, Malta, the Netherlands, Norway, Romania, Slovenia   
 Enhancing Market Surveillance through Best Practice  II (EMARS II) || 11/2008- 12/2011 || Continuation of EMARS I || Belgium,  Bulgaria, Czech Republic, Denmark, Estonia, Finland,  France, Germany, Greece, Iceland, Ireland, Latvia, Lithuania, Malta, Norway, Poland, Romania, Slovenia, Sweden, The Netherlands, United Kingdom Participants outside the Financial Framework: Austria, Spain, Switzerland 
  JOINT MARKET SURVEILLANCE ACTION LIGHTING CHAINS   || 1/9/2007-31/3/2009 || lighting chains || Hungary, Germany, Slovakia, Slovenia 
 Joint market Surveillance action on household appliances-child appealing designs || 12/2009 -12/2010 || household appliances-child appealing designs || Belgium, Cyprus, Czech Republic, Denmark, Estonia, Germany, Latvia, Lithuania, Malta, Poland, Sweden, the Netherlands, United Kingdom 
 Joint market surveillance action on Baby walkers   || 12/2009 -12/2010 || Baby walkers   || Austria, Cyprus, Czech Republic, Denmark, Germany, Greece, Latvia, Lithuania, Malta, Portugal, Sweden, the Netherlands 
 JOINT  MARKET SURVEILLANCE ACTION ON Sun beds AND SOLARIUM SERVICES PART ii   || 1/1/2010-31/12/2011 || Sun beds AND SOLARIUM SERVICES || Belgium, Cyprus, Czech Republic, Denmark, France, Germany, Hungary, Latvia, Norway, Portugal, the Netherlands, United Kingdom 
 JOINT FOLLOW UP MARKET SURVEILLANCE ACTION ON CHILD RESISTANT LIGHTERS AND NOVELTY LIGHTERS (LIGHTERS 2009) || 1/1/2010-31/12/2012 || CHILD RESISTANT LIGHTERS AND NOVELTY LIGHTERS || Austria, Cyprus, Czech Republic, Estonia, Greece, Iceland, Malta, Norway, Slovak Republic, Slovenia, Spain, Sweden, the Netherlands 
15.         Annex
15: Legislative simplification in detail
15.1.    Problems
with the existing legislative framework in the non-food product safety area
The current legislative framework can be
described as complex and confusing.[175]
Obligations of economic operators regarding consumer products are subject to
the General Product Safety Directive and/or to the Union harmonisation legislation
comprising sector specific New Approach and Old Approach Directives.[176] 
Thus, the product safety requirements for
consumer products which are not subject to any piece of the Union harmonisation
legislation are governed by the General Product Safety Directive (square 2:
so-called non-harmonised consumer products) whereas professional products[177] are subject to the respective
piece(s) of the Union harmonisation legislation (square 3: so-called harmonised
professional products). The consumer products which are at the same time
subject to any piece of the Union harmonisation legislation have to comply with
the requirements of both the General Product Safety Directive[178] and the relevant New Approach
or Old Approach Directive(s).[179]
The remaining products, i.e. professional products not subject to any piece of
the Union harmonisation legislation, are subject to national laws of Member
States subject to the rules of the Mutual Recognition Regulation[180] (square 4: so-called
non-harmonised professional products). 
Table 1:
Overview of applicable legislation
 Products || Consumer || Professional 
 Harmonised || 1. Sector specific New and Old Approach Directives and the General Product Safety Directive || 3. Sector specific New and Old Approach Directives 
 Non-harmonised || 2. General Product Safety Directive || 4. National product safety rules under the Mutual Recognition Regulation 
Similar confusion as to the
applicable rules exists at the level of market surveillance rules for consumer
products.[181]
If following an infringement of consumer product safety requirements and/or
harmonised product safety requirements, the application of market surveillance
rules comes into play, depending on the categorisation of the product in
question either the rules on market surveillance laid down in (i) the General
Product Safety Directive, or (ii) the Regulation (EC) No 765/2008, or (iii)
both these instruments apply.[182]
Adding to the complexity, many sector specific directives also have certain
provisions relating to market surveillance which are supposed to apply. [183] 
Table 2:
Overview of the EU regulatory framework in the area of non-foodproduct safety
             Overview of the EU regulatory framework in the area of non-food product safety 
                 Products Areas || Non- Harmonised || Harmonised 
 Professional || Consumer || Professional 
 Obligations of economic operators || National law under the Mutual Recognition Regulation || GPSD || Sector specific Union harmonisation legislation (GPSD as a safety net) || Sector specific Union harmonisation legislation 
 Market surveillance on the internal market* || GPSD (only those dangerous to health and safety of consumers) || Sector specific Union harmonisation legislation + Regulation 765/2008 + GPSD || Sector specific Union harmonisation legislation + Regulation 765/2008 
 RAPEX* ||   || Regulation 765/2008 referring to GPSD || Regulation 765/2008 referring to GPSD 
 Market surveillance on products imported to the EU* || Regulation 765/2008 
In addition to the described
shortcomings of the existing legislative framework in terms of clarity and
consistency, in the public consultation legal experts mentioned the lack of
visibility of the market surveillance rules of Regulation (EC) No 765/2008
which further contributed to the confusion about the applicable product safety
rules in the non-food area. They noted that it was extremely difficult for
specialised lawyers and virtually impossible for economic operators to be able
to ascertain which rules of which of the instruments apply, i.e. rules of the
General Product Safety Directive, Regulation (EC) No 765/2008 or of the
relevant piece of Union harmonisation legislation.[184]
In the view of the aforementioned
problems, it is not surprising that in the public consultation all groups of
stakeholders, including consumer organisations, business associations, national
market surveillance authorities, [185]
legal experts,[186]
as well as the European Parliament,[187]
called for the establishment of a uniform legislative market surveillance
framework in the area of non-food products. The establishment of such framework
was considered to be a necessary pre-condition for a more coherent application
of product safety rules by national market surveillance authorities of Member
States.
15.2     The
way forward: clarification of the legislative framework
            Product safety rules can be effectively internalised by economic
operators into their day-to day business if they are consistent, visible and
easy to apply. If visibility helps economic operators to avoid
information-research costs related to the existence of rules, consistency of
legislation gives clarity and legal certainty about the contents of product
safety requirements, and thus avoids additional legal costs of finding out
which rules are actually applicable. Consequently, addressees of consistent
rules should be able to determine easily which product safety requirements
apply in which situations without incurring heavy information-research costs or
running into interpretation difficulties. The simplification of the overall
legislative framework in the non-food product safety area called for by all relevant
stakeholders could entail three elements.
15.2.1  Splitting
the General Product Safety Directive
The current General Product Safety
Directive contains two parts:
·                        
a part concerning the general product safety
requirement of economic operators and related procedures for establishing
mandates for development of European standards giving technical details of how
the general product safety requirement can be applied in practice with respect
to different products  (Articles 3 – 5 of the current General Product Safety
Directive) and 
·                        
a part on market surveillance, i.e. enforcement
of non-food product safety requirements (Articles 6 – 18 of the current General
Product Safety Directive).
The former part of the General Product
Safety Directive (i.e. the part containing the general safety requirement,
procedures for mandating standards and the obligations of economic operators
for non-harmonised products) would be modernised in a self-standing instrument
in the form of a regulation (Consumer Product Safety Regulation), while the
latter part would be improved in the single horizontal market surveillance
regulation (Market Surveillance Regulation). 
15.2.2. Merging
market surveillance provisions into a single horizontal market surveillance
Regulation
The second part of
the General Product Safety Directive  (Art. 6 – 18 of the current GPSD)
concerning market surveillance and Chapter 3 of the Regulation (EC) No 765/2008
concerning market surveillance could both be improved and merged into a
self-standing legal instrument, a "Market Surveillance Regulation".
The consolidation of the market surveillance provisions of the two instruments would
be performed by "taking into account the
provisions developed more fully in the two existing legislative acts."[188]
Regulation (EC) No 765/2008, without its
market surveillance provisions, would remain an independent legal instrument
dealing with specific technical issues, including (i) accreditation and
conformity assessment bodies, (ii) CE marking, and (iii) EU financing of bodies
pursuing the general European interest.
15.2.3  Relationship
with sector-specific Union harmonisation legislation
Finally, the existing confusion which of
the provisions of which instruments apply in which situations[189] would be resolved by moving
all the provisions on market surveillance to the single market surveillance
Regulation This avoids interpretation issues and different transpositions in
different Member States.
15.3.    The new
simplified legislative framework in the non-food product safety area
The obligations of economic operators
would be simplified by aligning the consumer product safety requirements
contained in the current General Product Safety Directive with the harmonised
product safety requirements laid down in the relevant provisions of Annex 1 of
Decision No 768/2008/EC.[190]
The overlaps and inconsistencies would be eliminated as the consumer product
safety requirements would no longer (potentially) conflict nor overlap with the
harmonised product safety requirements. 
At the same time, the difficulties
relating to the determination of the applicable set of rules for different
categories of products (harmonised/non-harmonised/consumer/professional) would
disappear since the elimination of overlaps between different sets of rules
would render the ex ante determination of the applicable set of rules
superfluous. Since these requirements would be aligned, economic operators
would not have to perform any additional research or seek additional legal
advice as to whether, for their products, additional safety requirements from
the Consumer Product Safety Regulation apply or not.
Whereas the Regulation on market
surveillance would continue to keep the form of a Regulation, the General
Product Safety Directive would be converted into a Regulation (Consumer Product
Safety Regulation). Where the Treaties do not specify the type of act to be
adopted in a certain field, the EU institutions shall select it on case by case
basis and in compliance with the principle of proportionality.[191] A regulation is directly
applicable in all Member States; there is therefore, no need for Member States
to transpose EU legislation into national law and no need to provide them with
time to do so. Possible national differences regarding the date and/or manner
of transposition would be eliminated, which would facilitate consistent
enforcement and a level playing field in the internal market. A regulation
better ensures that legal requirements are implemented at the same time
throughout the Union; it also better achieves streamlining of terminology,
important for defining the scope of the legislation, thereby reducing
administrative burdens and legal ambiguities. 
Regarding market surveillance rules, both
the inconsistencies between the market surveillance provisions of the current
General Product Safety Directive as well as Regulation (EC) No 765/2008 as well
as between these instruments and sector specific Union harmonisation
legislation would be resolved since all the applicable market surveillance
rules would be contained in a single horizontal market surveillance Regulation
integrating all applicable market surveillance provisions for enforcement of
any EU product safety rules.
Table 3: Overview of the proposed EU regulatory
framework in the area of non-food product safety
             Overview of the  proposed EU regulatory framework in the area of non-food product safety 
                     Products Areas || Non- Harmonised || Harmonised 
 Non-consumer || Consumer || Non-consumer 
 Obligations of economic operators || National law under the Mutual Recognition Regulation || Consumer Product Safety Regulation || Sector specific Union harmonisation legislation || Sector specific Union harmonisation legislation 
 Market surveillance on the internal market* ||       Market Surveillance Regulation 
 RAPEX* || (Possibility of extension on the basis of a decision under Art. 11 of Mutual Recognition Regulation) 
 Market surveillance on products imported to the EU* ||   
[1]               In
particular, with the rules contained in Annex 1 of Decision (No) 768/2008/EC
and Chapter III of Regulation (EC) No 765/2008.
[2]               The
opinions provided in the position papers are summarised in Annex 3.
[3]               The technical documentation would contain the risk
evaluation and the indication of the national rule, standard or other
requirement with which the given product is supposed to comply.
[4]               On
the one hand, only 30% of authorities claim that they encounter enforcement
difficulties in applying harmonised and non-harmonised rules, on the other
hand, for 94% of authorities the enforcement would be easier if obligations of
economic operators in the harmonised and non-harmonised area were aligned.
[5]               Identification of the manufacturer or the importer
seems to be a bigger problem for market surveillance authorities than the
identification of the import: 17% of NMSAs responding indicate that they face
problems with the identification of manufacturer often in, 78% sometimes; for
importers importer: often: 15% of NMSAs claims to have often problem with their
identification, 16% sometimes. With respect to distributors, none of the NMSAs
responding indicates to have problems with their identification often, 70%
however report to have sometimes problem with their identification. 
[6]               The
public consultation suggests that an extremely small number of economic
operators, if any, market non-harmonised products only. 30% of responding
economic operators were marketing only harmonised products, 65% both harmonised
and non-harmonised products. None were marketing non-harmonised products only.
[7]               An
overwhelming majority of economic operators (90%) takes into account
obligations both in the sector specific legislation on harmonised products as
well as under the general product safety legislation. 39% of economic operators
are unable to say whether differing obligations under the sector specific and
general rules pose problems for them; for 33% these differences represent a
problem, for 28% not. For those who have a problem with differing obligations
67% consider the cost resulting from these differences as non-negligible, but
cannot quantify them. 40% of responding economic operators consider the
application of obligations with respect to harmonised products also to
non-harmonised products to be beneficial for their business. 25% (5) do not
think so, 35% does not know. If the obligations of economic operators with
respect to harmonised products applied to non-harmonised products, in the
opinion of 20% of responding economic operators this would lead to an increase
in operating costs, according to 15% of them to their reduction. For 15% of
responding economic operators this would have no or negligible impacts on
operating costs. 50% of the respondents were not able to provide any cost
estimation.
[8]               70%
of responding economic operators do not market products if the required product
identification is not performed by economic operators at higher level of the
marketing chain. 10% market the product even if certain information is missing,
5% complete the missing information by themselves, 15% take other action.
[9]               See
above footnote no. 7 for the description of the contents of the technical
documentation.
[10]             80%
of responding economic operators establish technical documentation in respect
of non-harmonised products. Of this 80%, 55% establish the technical
documentation in respect of non-harmonised products, although they are not
legally required to do so. If economic operators had to establish technical
documentation in the same way for all products, in the opinion of 15% of
responding economic operators, this would lead to an increase in operating
costs, according to 30% of them to their reduction. For 10% of responding
economic operators this would have no or negligible impacts on operating costs.
45% of the respondents were not able to provide any cost estimation.
[11]             65
% of respondents - 64% with respect to technical documentation - is of the
opinion that safety of consumers would be better ensured if obligations of
economic operators in respect of harmonised products, including the obligation
to establish the technical documentation, were also applied to non-harmonised
products. 18% consisting exclusively of business organisations disagrees with
this opinion. Yet, the same percentage of business organisations 18% agrees.
[12]             Stakeholders
views on whether economic operators ensure traceability of products are
conflicting (yes: 44%, no: 33%). The same strong division exists among those
who thinks economic operators ensure traceability of products with respect to
the question whether traceability is ensured in a uniform way (yes: 46%, no:
37%).
[13]             Risk
assessment guidelines for consumer products are published in section 5 of Part
IV of the "Guidelines for the management of the Community Rapid
Information System 'RAPEX' established under Article 12 and of the notification
procedure established under Article 11 of Directive 2001/95/EC" (Annex to
the Commission Decision 2010/15/EU).
[14]             Regarding
the cooperation with customs, 84% of respondents believe that this cooperation
functions well. For those disagreeing, the lack of any cooperation and the lack
of experience with customs authorities in checking product safety are seen as
the key problem areas.
[15]             A majority of Member States consider that they
undertake sufficient market surveillance (10% strongly agreed, 70 % agreed, 29%
disagreed, 1% strongly disagreed). On a related issue on what should be done to
improve the level of enforcement of product safety rules market surveillance
authorities indicated on the first place that more resources should be
allocated to market surveillance, second that inspectors should receive more
and better training and finally that more inspections should be undertaken and
more cross-border cooperation should take place (those two scoring equally).
[16]             While 60% of respondents consider the current GPSD
provisions sufficient for effective cooperation between Member States, 28%
believes that its provisions are not specific enough or worries about their
voluntary nature. Almost all respondents agreed that more intensive information
sharing and cooperation between Member States would ensure a more level playing
field for economic operators and would enhance the safety of consumer
throughout the EU.
[17]             A
lack of resources and too complicated and burdensome procedures were also
mentioned as reasons for not participating in such actions.
[18]             81%
of national authorities consider that their cooperation will improve with an
increase of financial support for joint cooperation actions, while over 50%
were in favour of the establishment of an EU level coordination body and of
increasing the financial support for exchanges of officials and trainings. 
[19]             35%
of the Member State respondents had their safety evaluations
"sometimes" contested by other authorities within the last 5 years.
This was overwhelmingly due to diverging test results (83%), and less to the
application of a different test method (42%). Further important divergences
however concerned the interpretation of standards (58%) and the application of
the same risk assessment method (50%).
[20]             Annex
to the Commission Decision 2010/15/EU.
[21]             A clear majority (60%) of all 35 respondents considered
lasting divergences between Member States be solved by setting specific EU wide
product safety requirements, although ¼ (26%) favoured non-binding EU wide
recommendations on the safety assessment of the concerned product.
[22]             Economic operators responding to the questionnaire are
divided as to whether Member States undertake sufficient market surveillance (10
agreeing/9 disagreeing). Of those believing that Member States do not enforce
consumer product safety legislation sufficiently, most consider this to be due
to a lack of resources. 
[23]             Respondents are also divided as to whether the
cooperation between market surveillance and customs authorities works satisfactorily
(9 agreeing/7 disagreeing), with those thinking it does not work well
considering this is mainly due to the lack of experience with customs
authorities in checking safety aspects of products. 
[24]             A majority of respondents (62%) consider that
differences between Member States in enforcing product safety legislation are
causing problems for businesses. The main problems identified are differences
in interpretation of standards, enforcement priorities and administrative
practices.
[25]             62% of respondents consider that cooperation between
Member States' market surveillance authorities need to be improved. These
respondents consider that an EU level coordination body and the obligation for
Member States to undertake joint surveillance actions would be preferable to
achieve such improvement. 81% of respondents believe that more intensive
information sharing and/or cooperation would ensure a more equal treatment of
economic operators, while 90% consider this would also benefit the safety of
consumers. Around two/thirds also believe this would lower the operating costs
for businesses.
[26]             34% of respondents) were affected by diverging safety
evaluations of authorities in different Member States, mostly sometimes
(6 respondents). Diverging test results were the main reason (50%) of
divergence, but also diverging risk assessments (38%).
[27]             An overwhelming majority (88%) of those affected could
not estimate the costs, but considered them non-negligible.
[28]             A strong majority (69%) of all 23 respondents
considered binding EU wide measures as best to resolve lasting safety
assessment divergences between Member State authorities, while 21% favoured
non-binding EU wide recommendations.
[29]             Other stakeholders responding to the questionnaire are
divided as to whether Member States undertake sufficient market surveillance
(27 agreeing/27 disagreeing). Of those believing that Member States do not
enforce consumer product safety legislation sufficiently, most consider this to
be due to a lack of allocated resources and too few inspections. Lack of
coordination among different national authorities was also mentioned several
times.
[30]             Regarding the ways in which such cooperation could be
improved, respondents supported all listed options (i.e. providing more
financial support to joint surveillance actions and exchanges of officials, by
establishing a coordination body at EU level, by providing more detailed rules
on cooperation at EU level, by obliging Member States to respond to a
cooperation request from another Member State and by providing more detailed
rules for cooperation at EU level).
[31]             67%
of respondents reported problems with diverging safety evaluations from
authorities in different Member States. Of these, 70 encountered them
"sometimes."
[32]             The
sources of the above divergences were overwhelmingly diverging risk assessments
(85%), but also diverging test results (44%) or other reasons (27% = 11
respondents). "Other reasons" were largely differing interpretations
of safety requirements, standards or legislation.
[33]             The
best remedy to resolve diverging safety evaluations was considered to be
binding EU wide measures (75% of respondents).
[34]             The
main legislative pieces of the Free Movement of Goods Package are: (i)
Regulation 765/2008/EC setting out the requirements for accreditation and
market surveillance relating to the marketing of products and repealing Regulation
(EEC) No 339/93 (OJ L 218, 13.8.2008, p. 82) and (ii) Decision 768/2008/EC of 9
July 2008 on a common framework for the marketing of products and repealing
Council Decision 93/465/EEC (OJ L 218,
13.8.2008, p. 82).
[35]             41% strongly agreed and 31% of NMSAa agreed that
conformity assessment costs more in the absence of a referenced EN standard.
Difficulties in assessing the safety of a product in the absence of referenced
En standard is found sometimes (64%), regularly (13%) and often (13%). In the
absence of EN referenced standards, 93% of the respondents rely on national
standards (transposing non-referenced EN standards), 77% on global standards
(e.g. ISO). Significant also the recourse to "soft-law" tools, such
as codes of practices (64%), state of the art and technology (53%) and
consumers' expectations about safety (61%) . For the latter, might be
interesting to know how and whether they are used in combination with risk
assessments. 
[36]             The
"costs of enforcement" in the absence of a referenced EN standard was
considered as non-negligible by 39% of the responding NSMAs. 13% of NMSAs
provided an estimate of these costs. 28% of NMSAs did not know whether they can
or cannot estimate the costs of enforcement of safety rules in the absence of
EN standards.
[37]             77% of the respondents would favour the direct
reference of an existing standard, provided that it ensures a high level of
consumer protection and as long as it is a EN standard (53%). However 36% would
favour also the use of non-European standards. 
[38]             The speed of the current standardisation process under
the GPSD was considered unsatisfactory by 79,5% of the respondents. 12% did not
know. 
[39]             23% strongly agreed and 67% agreed. 
[40]             82% of the respondents would favour the use of non-EN
standards, provided that they are global standards issued by formal
international bodies (such as ISO/IEC etc). 21% rejected the use of other
international or global standards other than ISO/IEC.
[41]             In
addition 72% of the respondents favour the setting up of "standing"
or "framework" mandates.
[42]             On
the basis of the additional comments received, it appears – that despite an
explanation - a large majority of responding economic operators, were not able
to distinguish between the standards and standardisation procedures under the
New Approach Directives and under the GPSD. Those who appeared to have
understood the differences between these two procedures seemed to have problem
with distinguishing between (i) the procedure before a mandate for issuing a
European standard is adopted (subject to this public consultation) and (ii)
after the procedure the mandate is issued (not subject to this consultation,
but subject to the revision under the draft of the Standardisation Regulation).
Thus, of the 30 responding economic operators, only a part of them could have
been deemed to be giving informed answers.
[43]             Although 45% of the respondents could not quantify the
additional costs incurred to ensure compliance in the absence of European
referenced standards, 20% strongly agreed and 42% agreed that compliance costs
are higher in the absence of a referenced European standard.
[44]             81%
of the respondents rely on ISO standards, whereas 61% on national standards
(transposing non-referenced EN standards). 42% rely on product safety codes,
29% on the state of the art and technology and 32% on consumers' expectations.
[45]             67% of the respondents would favour the direct
reference of an existing standard, provided that it ensures a high level of
consumer protection. Operators expressed a slight preference (38%) to
non-European standard, instead confining this solution only to European
standards (33%). 61% were in favour to setting up standing or framework
mandates. 
[46]             Making safety requirements mandatory and directly
applicable would facilitate marketing of product according to 25,8% of
operators who strongly agreed and to 45% who agreed. 
[47]             71% of the respondents would favour the use of non-EN
standards, e.g. global standards issued by formal standardisation bodies, such
as ISO (45%). However a significant majority of operators would also open up to
other international or global standards other than ISO/IEC (39%).
[48]             "Standing" or "framework" mandates
refer to mandates for group of products, e.g. childcare
articles, on the basis of which more than one standard could be drafted, either
at once or over a period of time.
[49]             56% of the respondents would favour the use of non-EN
standards, provided that they are global standards issued by formal international
bodies (such as ISO/IEC etc.). 78% rejected the use of other international or
global standards other than ISO/IEC.
[50]             39,3% strongly agreed and 33% agreed. 
[51]             51% of the respondents favour the setting up of
"standing" or "framework" mandates. 
[52]             54% of the respondents would favour the direct
reference of an existing standard, provided that it ensures a high level of
consumer protection. 
[53]             Rapid
Alert System for non-food Products.
[54]             Only
44% of Member States notify through RAPEX all measures taken with regard
to dangerous consumer products, providing that all the RAPEX notification
criteria are met. 14% of Member States notify less than 50% of adopted measures
mainly due to the insufficient human and financial resources and too complex
notification procedure.
[55]             Only
26% of Member States ensure follow-up action to all RAPEX notifications,
while 28% of Member States ensure follow-up action to less than 50% of
notifications.
[56]             According to Member States which take follow-up action
to more than 50% of RAPEX notifications, the insufficient product
identification (over 71%) and the insufficient information on the companies
marketing or distributing the notified product (over 77%) are the key problems
in this area. For Member States which take follow-up action to less than 50% of
RAPEX notifications, the insufficient human and financial resources (67%)
constitute the most significant obstacle in performing follow-up action.
[57]             Majority of Member States' respondents is of the
opinion that change of the notification criteria (42%) or their description in
a greater detail (51%) would not make the notification process easier.
According to respondents, the change of the RAPEX notification criteria should
mainly concern 'risk assessment' and 'cross-border effects'. The main problem
in applying the 'cross border effects' criterion is the lack of evidence that
the notified product was marketed on territories of other Member States.
[58]             The
overwhelming majority of Member States (almost 70%) does not decide on measures
without adopting them. Furthermore, over 60% of respondents agree that an
obligation to notify through RAPEX exclusively measures adopted (and thus the
exclusion of an obligation to notify measures decided but not yet adopted)
would simplify the notification procedure.
[59]             Respondents
consider 'risk assessment' (60%), 'cross-border effect' (60%) and 'categories
of measures to be notified' (80%) to be the RAPEX notification criteria which
are the most difficult to apply in practice.
[60]             The overwhelming majority of respondents (88%) sees the
positive role of RAPEX in the product safety area and is of the opinion that
RAPEX contributes to the better protection of consumers through the EU. Only 7
% of respondents hold different view.
[61]             In accordance with the above
some 71% of the respondents did not see any problem with measures that are
directly applicable to economic operators. The Member States respondents
considered the enforcement of "emergency" measures to be easier if
the measures were directly applicable to economic operators (71%), and if
measures were in force until a permanent measure is in place (60%). A simple
extension of the validity of the measures, such as up to three years with
further 3-years extensions, was considered much less favourably (23%).
[62]             The
enforcement of "emergency" measures causes problems to almost half of
the  respondents from Member States (43%). For most of these (60%) it is
difficult to meet the time-limit for the adoption of national implementation
measures. A problem is also the time-limitation of the measures and the
repeated renewals (40%).
[63]            Compliance with
"emergency" measures was considered easier if they were directly
applicable (39%) or were applicable until entry into force of a permanent
solution (44%),  still some 26% considered a simple extension of such a measure
to up to three years (with equal prolongation periods) as making compliance
easier.
[64]             26%
of the 23 responding businesses were ever affected by an EU product safety
measure of which 66% found it difficult to comply with the measure.
[65]            Of those who had difficulties
to comply, none could indicate the related costs, but ¾ considered the costs
non-negligible.
[66]             More
than 75% of other stakeholders responding saw no problem if EU product safety
measures were directly applicable to economic operators.
[67]             53%
of the responding national authorities monitored the safety of products at some
point of time during the last three years.
[68]          About
two thirds of these authorities pointed out that the number of websites checked
was significant, but it was difficult to even estimate the numbers; only four
NMSAs were able to quantify the number of potential unsafe products found on
the internet and chosen for further tests. Only one NMSA was able to indicate
the number of websites checked for the purpose of finding unsafe products; only
four NMSAs were able to quantify the number of products found on the internet
and sampled for further testing in order to assess their potential risks.
[69]          Three
NMSAs were able to estimate the number of actions taken, while fifteen others
confirmed that some measures were taken, without being able to quantify.
[70]         When carrying out market
surveillance of products sold online, market surveillance authorities were
faced with difficulties with: a) identifying the economic operators (78%), b)
enforcing restrictive measures on economic operators (70%), c) the cross-border
nature of cases investigated (60%) or d) difficulties in taking product samples
(50%). Over 90% of national authorities dealing with cross-border cases have
had difficulties when investigating cases of products coming from third
countries (outside EU/EEA). 64% of these national authorities also faced
problems investigating cases related to products being sold inside the EU/EEA
area. Three quarters of all national authorities would find it easier to carry
out market surveillance with regard to dangerous consumer products sold on the
internet if specific harmonised rules were introduced at EU level.
[71]         Over 60% of economic operators
pointed out that they are aware of dangerous consumer products are sold on the
internet in the EU by operators based both in the EU and in third countries.
[72]         Only 28% of economic operators
think that the attention given by market surveillance authorities to the safety
of consumer products sold online is equal or higher compared to products sold
through other distribution channels, while 35% pointed out that in fact the
attention is significantly lower.
[73]         74% of the respondents confirmed
being aware that dangerous consumer products are sold online in the EU.
[74]         Only 10% of the respondents think
that the attention given by market surveillance authorities to these products
sold online is equal (or higher) to the attention given to products sold via
other distribution channels. Over two thirds of the respondents consider that
national authorities do not treat products sold online the same way as products
sold in shops.
[75]         An important majority of
authorities (73%) thinks that there should not be any differences in the safety
requirements for situation where a product is operated by a consumer or a services
provider. About the same majority (69%) is convinced that application of a
general safety requirement to all products provided within the context of a
service without any distinction would lead to the decrease of consumer exposure
to risks. 60 % of authorities would favour the rule according to which all
products into which the consumer comes into contact would have to be safe.
[76]          55%
of responding economic operators is convinced that products provided within the
context of the service should be safe irrespective of whether the product is
operated by a consumer or a services provider, 25 % thinks the contrary, 20 %
do not know. 30 % of respondents think that exposure of consumers to risks
resulting from a product provided within the context of a service is
independent of whether the product by help of which the service is provided is
operated by the consumer or the service provider. 50 % of responding economic
operators thinks the contrary, 20 % do not know. If a general safety
requirement was established at the EU level with respect to all products with
which consumers come into contact within the provision of a service, irrespective
of whether the product is operated by the provider of a service or a consumer,
in the opinion of 10 % of the responding economic operators this would lead to
an increase in operating costs, according to 15 % of them to their reduction.
For 20 % of responding economic operators this would have no or negligible
impacts on operating costs. 55% of the respondents were not able to provide any
cost estimation.
[77]             As
- on the basis of the feedback from stakeholders - the scope of the initiative
was extended beyond the scope of the General Product Safety Directive, the
initiative also changed name to Product Safety Package.
[78]             Updates
to the original positions papers sent by certain organisations were not counted
as separate position papers.
[79]            ANEC, the
European consumer voice in standardisation, defends consumer interests in the
process of standardisation and certification. BEUC is a European Consumer
Organisation with membership of 42 independent national consumer organisations
from 31 European countries, including EU, EEA and applicant countries). BEUC
represents its members and defends the interests of all Europe’s consumers.
[80]             Baden-Württemberg, Bavaria,
Berlin, Brandenburg, Bremen, Hamburg, Hesse, Mecklenburg-Vorpommern, Lower
Saxony, North Rhine-Westphalia, Rhineland-Palatinate, Saarland, Saxony,
Saxony-Anhalt, Schleswig-Holstein, Thuringia.
[81]             BUSINESSEUROPE is an organisation whose members are 41
central industrial and employers’ federations from 35 countries, working
together to achieve growth and competitiveness in Europe.
[82]             The CBI is the UK’s leading business organisation,
speaking for some 240,000 businesses that together employ around a third of the
private sector workforce. With offices across the UK, as well as representation
in Brussels, Washington, Beijing and Delhi, the CBI communicates the British
business voice around the world. 
[83]             Consisting in particular of Regulation (EC) No 765/2008
and Decision 768/2008/EC.
[84]             The European Partnership for Energy and the Environment
(EPEE), represents the heat-pump, air-conditioning, and refrigeration industry
(HVACR) in Europe. Founded in 2000, our membership is composed of 40 member
companies and national associations across Europe realising a turnover of over
30 Billion Euros and employing more than 200,000 people in Europe.
[85]             Established
in 1993, EuroCommerce represents the retail, wholesale and international trade
sectors in Europe. Its membership includes commerce federations in 31
countries, European and national associations representing specific commerce
sectors and individual companies. 
[86]             See
above fn. no. 7.
[87]            The reason why suppliers are reluctant to provide the
technical documentation is understandable since it contains confidential data
and the Directive does not oblige the suppliers to provide this information to
the distributor.
[88]             MEDEF serves as lobbyist group for businesses, ensuring
that their voice is heard by decision makers in the local, regional or national
level of the government. It is the largest organization of employers in France with more than 700,000 member firms. The majority are SMEs, with less than 50
employees.
[89]             Orgalime is the European federation representing the
interests at the level of the EU institutions of the European mechanical,
electrical, electronic and metal articles industries as a whole. Orgalime's
member federations directly or indirectly represent some 130,000 companies of
an industry which employs 10.2 million people. 
[90]             Oxylane designs, manufactures and markets innovative
technical products, adapted to each sport. Oxylane employs around 50,000
people, all passionate about sport, and generates an annual turnover of 6
billion Euros. Its main brand store, Decathlon, is present in 15 countries with
560 stores.
[91]             UGAL
– the Union of Groups of Independent Retailers of Europe – is the European
association that acts as an umbrella organisation for the main groups of
independent retailers in the food and non-food sectors. UGAL represents  almost
300,000 independent retailers with a combined retail turnover of more than 623
billion euros and more than 540,000 sales outlets,  25 groups and associations
of groups in Europe employing a total of over 5 millions people and generating
wholesale turnover of more than 260 billion euros.
[92]            The issue of "isolated
cases" is dealt with in Annex 1 of the GPSD ANNEX I -  REQUIREMENTS CONCERNING INFORMATION ON PRODUCTS THAT
DO NOT COMPLY WITH THE GENERAL SAFETY REQUIREMENT TO BE PROVIDED TO THE
COMPETENT AUTHORITIES BY PRODUCERS AND DISTRIBUTORS
1. The information specified in Article
5(3), or where applicable by specific requirements of Community rules on the
product concerned, shall be passed to the competent authorities appointed for the
purpose in the Member States where the products in question are or have been
marketed or otherwise supplied to consumers.
2. The Commission, assisted by the
Committee referred to in Article 15, shall define the content and draw up the
standard form of the notifications provided for in this Annex, while ensuring
the effectiveness and proper functioning of the system. In particular, it shall
put forward, possibly in the form of a guide, simple and clear criteria for
determining the special conditions, particularly those concerning isolated
circumstances or products, for which notification is not relevant in
relation to this Annex.
Art. 5 (3) of the
GPSD: Where producers and distributors know or ought to know, on the basis of
the information in their possession and as professionals, that a product that
they have placed on the market poses risks to the consumer that are
incompatible with the general safety requirement, they shall immediately inform
the competent authorities of the Member States thereof under the conditions
laid down in Annex I, giving details, in particular, of action taken to prevent
risk to the consumer.
The Commission
shall adapt the specific requirements relating to the obligation to provide
information laid down in Annex I. Those measures, designed to amend
non-essential elements of this Directive by supplementing it, shall be adopted
in accordance with the regulatory procedure with scrutiny referred to in
Article 15(5).
[93]             UEAPME is the employer’s organisation representing the
interests of European crafts, trades and SMEs at EU level. UEAPME is a
recognised European Social Partner and acts on behalf of crafts and SMEs in the
European Social Dialogue and in discussions with the EU institutions. It is a
non-profit seeking and non-partisan organisation. As the European SME umbrella
organisation, UEAPME incorporates 83 member organisations consisting of
national cross-sectorial SME federations, European branch federations and other
associate members, which support the SME family. Across the whole of Europe, UEAPME represents over 12 million enterprises with nearly 55 million employees.
[94]            The BRC is the UK Trade
Association which represents the interests of the majority of small and large
UK retailers, including on-line, catalogue and mail order sellers and those in
the city centres and out of town retail sites. Our policies are developed and
endorsed by Committees representative of the membership as a whole.
[95]             CEN
(European Commiteee for Standardisation) is one of the three European
standardisation organisations providing European Standards and technical
specifications. Through its services it creates a platform for the development
of European Standards and other technical specifications.  CEN's 33
National Members work together to develop voluntary European Standards (ENs).
[96]             CENELEC (European Committee for Electrotechnical Standardisation) is another of the three European standardisation organisations responsible for standardisation in the electrotechnical engineering field.
CENELEC prepares voluntary standards, which help facilitate trade between
countries and support the development of a Single European Market. 
[97]             This
is ensured through the Vienna and the Dresden agreements that link the two ESOs
with their respective international counterparts ISO and IEC. It is worth
highlighting that 80% of CENELEC European standards and 30% of the total
collection of CEN standards are actually international standards (or based
thereon). On top of that, the efficiency of this system and the preservation of
European interests are guaranteed by a strong European presence and an influent
expertise at international level through the involvement of experts in
Technical Committees.
[98]             PROSAFE is a non-profit professional organisation
for market surveillance authorities and officers from throughout the EEA.
Its primary objective is to improve the safety of users of products and
services in Europe. 
[99]             A "harmonised" product is considered to be a
product subject to Community harmonisation legislation which is defined as
"any Community legislation harmonising the conditions for the marketing of
products." (Article 2 (21) of the Regulation (EC) No 765/2008.
[100]            The definition of an SME covers all enterprises with less than 250
employees and equal to or less than either €50 million turnover or €43 million
balance sheet total. Micro-enterprises are the smallest category of SME, with
less than ten employees and a turnover or balance sheet total equal to or
lessthan €2 million.
[101]           Report from the Expert Group on “Models to Reduce the
Disproportionate Regulatory burden on SMEs”, May 2007. 
[102]            Annex 8.4(1) of the Impact Assessment Guidelines contains specific
suggestions on how to consult SME representatives.
[103]            European
Enterprise Network is a network launched by the European Commission in 2008. It
is the largest network of contact points that provide information on EU
matters, in particular with respect to SMEs covering a large spectrum of
product groups.
[104]            A consultation via the European
Business Test Panel was requested in order to evaluate the economic impact of the
revision against the data possessed by the relevant economic operators.
However, the evaluation of the revision of the General Product Safety Directive
was refused by the EBTP for being "too specific." 
[105]            The figures presented in table do not take into account
possible unregistered visits of the internet websites by individual SMEs.
[106]           Union Européenne de l’Artisanat
et des Petites et Moyennes Entreprises (European Association of Craft, Small and Medium-sized Enterprises).
[107]            Union
of Groups of Independent Retailers in Europe.
[108]            The
summary of these position papers can be found in Annex 3.
[109]            A
summary of the results is available at http://ec.europa.eu/enterprise/policies/single-market-goods/regulatory-policies-common-rules-for-products/new-legislative-framework/index_en.htm
[110]            This
typology of economic operators was described by one of the representatives of
the businesses and found and is shared by the business community active in the
non-food product sector in general. 
[111]            The
rogue operators are not concerned by the impact of the described inconsistencies
between the consumer product safety requirements and the harmonised product
safety requirements since they do not respect either of these requirements.
[112]            The correct knowledge and compliance with several pieces
of legislation, even if consistent, not to speak of inconsistent pieces of
legislation, is time consuming and costly, both in terms of human ressources
and education.
[113]         Annex
15, section 1.3.
[114]            COM(2011)803.
[115]            Ref. Ares(2012)557005 - 07/05/2012
[116]           Enterprises with less than 10
employees and a turnover or balance sheet total equal to or less than €2
million.
[117]            (COM (2011) 803, p. 3 – 4).
[118]           "From January 2012 the Commission's
preparation of all future legislative proposals will be based on the premise
that in particular micro-entities should be excluded from the scope of the
proposed legislation unless the proportionality of their being covered can be
demonstrated. This demonstration is a new element to be included in the
SME test. Thus modified, the test will de facto reverse the burden of proof and
focus the preparation of EU law on the specific situation of SMEs and micro
companies. From the same date the Commission will also ensure that, in cases
where micro enterprises must be covered by its legislative proposals for wider
public policy reasons, its proposals will be substantiated via the introduction
of a micro-entities dimension in the "SME test" which forms part of
the regular Impact Assessment." (COM (2011) 803, p. 5).
[119]            In
the GPSD Committee three business associations, namely Businesseurope, Eurocommerce
and UEAPME as well as two consumer organisations, namely ANEC and BEUC, have a
status of observers.
[120]            "Final
consumption expenditure of households by consumption purpose - COICOP 2 digit -
aggregates at current prices" [nama_co2_c] and "GDP and main components"
(t_nama_gdp)   
[121]            EUROSTAT
data on Annual Detailed Enterprise Statistics on Trade (sbs_na_3b_tr) based on
the NACE Codes (rev. Rev.1.1 G) for 2006 and 2007 and Annual Detailed
Enterprise Statistics on Trade (sbs_na_dt_r2) based on the NACE Codes (rev.
Rev. 2 G) for 2008 (latest data available)
[122]            NANDO
database on 3 January 2011 http://ec.europa.eu/enterprise/newapproach/nando/
[123]            This
figure includes recognised third party organisations and user inspectorates.
[124]            29 NACE.
[125]            NACE 34.
[126]            NACE 24
(24.1, 24.2, 24.3, 24.5 24.6, 24.7) and 25.
[127]            NACE 24.5.
[128]            NACE
Rev 1.1.
[129]           Manufacturing of construction
materials poses particular problems because of the subsector’s composite nature
that cuts across the standard structure of the NACE classification scheme of
economic activities. This makes it difficult to obtain data that pertain to the
subsector. The estimate of max €700 billion  is provided by the difference
between the overall value of construction products and services minus  that of
services relating to demolition and site preparation
(NACE Group 45.1), general construction activities
(NACE Group 45.2), installation work
(NACE Group 45.3),completion work (NACE Group 45.4), renting of construction equipment
(NACE Group 45.5). It is estimated that those construction services in the
EU-27 generated in 2008 a turnover of €1,590 billion (SEC(2009) 1111 final, Brussels, 30.7.2009). The value of €700 billion is however still expected to include
professional construction services (architectural and technical consultancy
activities) and real estate services.
[130]            Commission
Staff Working Document, Impact Assessment, Accompanying document to 10
proposals to align technical harmonisation legislation to Decision 768/2008/EC–
SEC(2011) 1376, Brussels 21.11.2011. 
[131]            See
e.g. ORGALIME position paper Call for an effective pan-European market
surveillance system http://www.orgalime.org/Pdf/PP_Orgalime ANEC_on%20market%20surveillance_apr09.pdf
[132]            See
http://europa.eu/rapid/pressReleasesAction.do?reference=IP/08/615&format=HTML
aged=0&language=EN
[133]            See
http://ec.europa.eu/enterprise/sectors/electrical/files/lvd-adco/20080903_lvd_adco_-_final_report_-_extension_leads_-_2007_project_en.pdf
[134]            See
http://ec.europa.eu/enterprise/sectors/electrical/files/lv/report_luminaires_en.pdf
[135]            See
Report on campaign concerning Energy Saving Lamps available at http://ec.europa.eu/enterprise/sectors/electrical/files/emc/ms-campaign-first_en.pdf
[136]            See
Report on campaign concerning power tools http://ec.europa.eu/enterprise/sectors/electrical/files/emc/ms-campaign-second_en.pdf
[137]            Report
on campaign concerning Consumer Entertainment Products available at http://ec.europa.eu/enterprise/sectors/electrical/files/emc/ms-campaign-third_en.pdf
[138]            http://www.erarental.org/news/Rental-Benefit/CECE-launches-survey-on-equipment-compliance-127.html.
[139]            http://www.fem-eur.com/data/File/MktSurv%20-%20VDMA%20PR%20CeMAT%20IT.pdf
[140]           IFIA
CIPC, Product Safety in Europe, Results from the 2012 Study, November 2012. For
the purposes of the study product categories that have wide market
distribution, established safety standards, relevant potential of causing harm
to consumers were chosen as fair representatives of imported electrical goods.
These included (i) battery chargers/adapters, (ii) luminaires (LEDs, classic),
(iii) Hair dryers/curlers (iv) room heaters, (v) Electric Fans, (vi) Toasters,
grills and similar. Samples (only CE-Marked, no third-party marks) were
purchased from regular stores, in Denmark, Poland, Germany, UK and Italy and
were tested in an independent laboratory. A consensus was reached on the
test/analysis to be conducted on each product type. The laboratory tests took
place in the period of May – July 2012.
[141]            See
Report on campaign concerning Energy Saving Lamps available at http://ec.europa.eu/enterprise/sectors/electrical/files/emc/ms-campaign-first_en.pdf
[142]            Art. 2 (21) of Regulation (EC) No 765/2008.
[143]            Art. 2 (a) of the General Product Safety Directive.
[144]            http://ec.europa.eu/enterprise/intsub/a12/index.cfm?fuseaction=a12.menuproducts#).
[145]            Under
the General Product Safety Directive.
[146]            Under
Decision (No) 768/2008.
[147]            Either
manufacturer or importer.
[148]            Under
the General Product Safety Directive.
[149]            Under
Decision (No) 768/2008/EC.
[150]            The number of retailers is taken from Eurostat's annual
detailed enterprise statistics on trade. The category of retailers is called
"retail trade, except of motor vehicles, motorcycles, repair of personal
and households goods and the figures refer to 2008. 
[151]            Art. 20 of the General Product
Safety Directive.
[152]            COM(2003) 313 final.
[153]            Report on Services Safety, p. 2 – 3.
[154]            COM(2008) 905 final.
[155]            In 2007, the Commission adopted
a proposal for a draft framework Regulation concerning Community statistics on
public health and health and safety at work (COM(2007) 46).
[156]           OJ L 376, 27.12.2006, p. 36–68. The
Services Directive guarantees
the freedom is guaranteed to provide services within the European Union. In
absence of harmonisation and exceptionally in a case-by-case basis, a Member
State may take measures which derogate from the freedom of services on the
basis of the case law of the Court of Justice, if there is an overriding reason
relating to the public interest, for example due to the safety reason. If a
Member State becomes aware that the service could cause a serious damage to the
health or safety of persons or the environment, it shall inform the Member
State of Establishment (in case it differs from the notifying Member State),
the other Member States concerned and the Commission within the shortest possible
period of time through the IMI system (System for exchange of information on
service safety). The Services Directive also provides room for standardisation
in the area of services.
[157]            See
Annexes 2 and 3.
[158]            See Annexes 2 and 3.
[159]           Recital 7 of the General Product Safety Directive: "This Directive should apply to products
irrespective of the selling techniques, including distance and electronic
selling."
[160]            Study
("The future of market surveillance in the area of non-food consumer
product safety under the General Product Safety Directive", Final Report,
March 2011, BSI Development Solutions, May 2011, p. 13).
[161]            See
Annex 2, section 2.4.1.
[162]           Over 60% of economic operators
pointed out that they are aware of dangerous consumer products are sold on the
internet in the EU by operators based both in the EU and in third countries.
[163]           Only 28% of economic operators
think that the attention given by market surveillance authorities to the safety
of consumer products sold online is equal or higher compared to products sold
through other distribution channels, while 35% pointed out that in fact the
attention is significantly lower.
[164]           74% of the respondents confirmed
being aware that dangerous consumer products are sold online in the EU.
[165]           Only 10% of the respondents think
that the attention given by market surveillance authorities to these products
sold online is equal (or higher) to the attention given to products sold via
other distribution channels. Over two thirds of the respondents consider that
national authorities do not treat products sold online the same way as products
sold in shops.
[166]            53%
of the responding national authorities monitored the safety of products at some
point of time during the last three years.
[167]            About
two thirds of these authorities pointed out that the number of websites checked
was significant, but it was difficult to even estimate the numbers; only four
NMSAs were able to quantify the number of potential unsafe products found on
the internet and chosen for further tests. Only one NMSA was able to indicate
the number of websites checked for the purpose of finding unsafe products; only
four NMSAs were able to quantify the number of products found on the internet
and sampled for further testing in order to assess their potential risks.
[168]            Three
NMSAs were able to estimate the number of actions taken, while fifteen others
confirmed that some measures were taken, without being able to quantify.
[169]            Annex
2, section 2.4.1; The study ("The future of market surveillance in the
area of non-food consumer product safety under the General Product Safety
Directive", Final Report, March 2011, BSI Development Solutions, May 2011,
p. 15).
[170]            "MSAs
may struggle to prevent unsafe products reaching consumers when the location of
stock is concentrated offshore or out of jurisdiction and for practical
purposes “invisible to inspection”. The most common form of inspection will not
provide ready access to the products ready for distribution by e-commerce. This
trend will also place an unequal burden on those MSAs in Member States that
have territorial responsibility for large e-commerce operators or e-commerce
supply depots." ("The future of market surveillance in the area
of non-food consumer product safety under the General Product Safety
Directive", Final Report, March 2011, BSi Development Solutions, May 2011,
p. 13).
[171]           When carrying out market
surveillance of products sold online, market surveillance authorities were
faced with difficulties with: a) identifying the economic operators (78%), b)
enforcing restrictive measures on economic operators (70%), c) the cross-border
nature of cases investigated (60%) or d) difficulties in taking product samples
(50%). Over 90% of national authorities dealing with cross-border cases have
had difficulties when investigating cases of products coming from third
countries (outside EU/EEA). 64% of these national authorities also faced
problems investigating cases related to products being sold inside the EU/EEA
area. Three quarters of all national authorities would find it easier to carry
out market surveillance with regard to dangerous consumer products sold on the
internet if specific harmonised rules were introduced at EU level.
[172]            See
Annex 3.
[173]            Study
"The future of market surveillance in the area of non-food consumer
product safety under the General Product Safety Directive", Final Report,
Conclusions of the Workshop, BSI Development Solutions, May 2011, p. 26. 
[174]        Directive
2000/31/EC 8 June 2000 on certain legal aspects of information society
services, in particular electronic commerce, in the Internal Market, OJ L
178, 17.7.2000, p. 1.
[175]            "With
the adoption of the legislative package on the Free Movement of Goods (also
called the "Goods Package"), the regulatory landscape on product
safety and market surveillance has become very complex and confusing."
(Mayer Brown, The Revision of the EU General Product Safety Directive,
Memorandum, January 2011).
[176]           Union harmonisation legislation
is defined in Art. 2 (21) of regulation (EC) No 765/2008 as a any Union legislation harmonising the conditions
for the marketing of products.
Examples of of such legislations are in particular the so-called New Approach
Directives, such as Recreational Crafts Directive (94/25/EC), Low Voltage
Directive (2006/95/EC), Simple Pressure Vessels Directive (2009//105/EC),
Non-automatic Weighing Instruments Directive (2009/23/EC), Civil Explosives
Directive (93/15/EEC), ATEX Directive (94/9/EC), Lifts Directive (95/16/EC),
Pressure Equipment Directive (97/23/EC), Measuring Instruments Directive
(2004/22/EC), Pressure Equipment Directive (97/23/EC), Electromagnetic
Compatibility Directive (2004/108/EC),  Pyrotechnic Articles Directive
(2007/23/EC), Personal Protective Equipment Directive (89/686/EEC), Radio and
Telecommunications Terminal Equipment (1999/5/EC) etc.
[177]            Products
not fulfilling the definition of a (consumer) product under the General Product
Safety Directive.
[178]           The relationship between the
General Product Safety Directive and sector-specific pieces of Union
harmonisation legislation is governed by Art. 1 (2) of the General Product
Safety Directive which provides that this Directive shall apply to all the products defined in Article 2 (a).
Each of its provisions shall apply in so far as there are no specific
provisions with the same objective in rules of Community law governing the
safety of the products concerned. Where products are subject to specific safety
requirements imposed by Community legislation, this Directive shall apply only
to the aspects and risks or categories of risks not covered by those requirements.
This means that: (a) Articles 2(b) and (c), 3 and 4 shall not apply to those
products insofar as concerns the risks or categories of risks covered by the
specific legislation; (b) Articles 5 to 18 shall apply except where there are
specific provisions governing the aspects covered by the said Articles with the
same objective. Concrete application of the General Product Safety Directive
with respect to the sector-specific pieces of Union harmonisation legislation
was detailed in a Guidance Document on the
Relationship Between the General Product Safety Directive (GPSD) and Certain
Sector Directives with Provisions on Product Safety published by
Directorate-General for Health & Consumers in 2003 and 2005.
[179]            "The
real confusion comes for consumer products that are subject to harmonized EU
rules, such as toys and cosmetics products, which are subject to to both the
GPSD and the Regulation as well as the specific provisions included in the
specific (toys, cosmetic) regulations in place." (Mayer Brown, The
Revision of the EU General Product Safety Directive, Memorandum, January 2011).
[180]           Regulation (EC) No 764/2008 laying down procedures relating to the
application of certain national technical rules to products lawfully marketed
in another Member State (OJ L 218, 13.8.2008, p. 11)
[181]            "To
determine which provisions of each of these three sets of rules apply [the
General product safety Directive, Regulation (EC) No 765/2008 and
sector-specific Union harmonisation legislation] […] a case-by case analysis is
necessary to determine which provision is "more specific" than the
other. This creates a situation of legal uncertainty which is very unfortunate
given that it concerns essential legal provisions that are applicable in
critical situations, for example when companies and authorities need to decide
on product withdrawals or recalls." (Mayer Brown, The Revision of the
EU General Product Safety Directive, Memorandum, January 2011).
[182]           The relationship between the
General Product Safety Directive and Regulation (EC) No 765/2008 is governed by
Art. 15 (3) of the latter instrument which stipulates that the application of this Regulation shall not
prevent market surveillance authorities from taking more specific measures as
provided for in Directive 2001/95/EC (the General product Safety Directive).
The determination of which measures under the General Product Safety Directive
are more specific in relation to Regulation
(EC) No 765/2008 was specified by the Commission in the Working paper on the
relationship between the General Product Safety Directive 2001/95/EC and the
Regulation (EC) No 765/2008. 
[183]            Those
aligned to the reference provisions of Annex 1 of Decision (No) 768/2008/EC, in
particular to the provisions of Articles R31 – R34 of this Annex.
[184]            Fourth
targeted stakeholder meeting "Legislative architecture of general and
specific product safety rules  (summary of the meeting is contained in Annex 4,
section 2.4)
[185]            See
the relevant sections of Annexes 2 and 3 summarising responses to the internet
public consultation and the position papers of stakeholders.
[186]            "However,
the above demonstrates that it is the entire legal framework on the safety of
products that requires streamlining […] [and] that the market surveillance
provisions of the GPSD and the Regulation [(EC) No 765/2008] are consolidated
within a single regulation, which would therefore affect all types of products."
(Mayer Brown, The Revision of the EU General Product Safety Directive,
Memorandum, January 2011).
[187]            Schaldemose
Report, points 1 and 2.
[188]            Schaldemose
Report, point 12.
[189]           The relationship between
Regulation (EC) No 765/2008 and sector specific market surveillance provisions
contained in Annex 1 of the "alignment" (see for example, Articles 41
to 44 of the Toy Safety Directive which were "transposed" to this
Directive from the aforementioned Annex) is governed by Art. 15 (2) of this
Regulation which stipulates that Each
of the provisions of Articles 16 to 26 shall apply in so far as there are no
specific provisions with the same objective in Union harmonisation legislation.
[190]            Articles
R1 to R7.
[191]            Article 296 TFEU