Opinion of the European Economic and Social Committee on the Proposal for a Regulation of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products COM(2007) 37 final — 2007/0029 (COD)
Date: 2007-12-13
Institutions: European Economic and Social Committee
Subjects: EC conformity marking, consumer protection, free movement of goods, harmonisation of standards, market supervision, marketing, product safety

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III

(Preparatory Acts)

EUROPEAN ECONOMIC AND SOCIAL COMMITTEE

440th PLENARY SESSION HELD ON 12 AND 13 DECEMBER 2007

Opinion of the European Economic and Social Committee on the

— ‘Proposal for a Regulation of the European Parliament and of the Council setting out the require-

ments for accreditation and market surveillance relating to the marketing of products’

— and the ‘Proposal for a Decision of the European Parliament and of the Council on a common

framework for the marketing of products’

— and the ‘Proposal for a Regulation of the European Parliament and of the Council laying down
procedures relating to the application of certain national technical rules to products lawfully
marketed in another Member State and repealing Decision 3052/95/EC’

COM(2007) 37 final — 2007/0029 (COD)

COM(2007) 53 final — 2007/0030 (COD)

COM(2007) 36 final — 2007/0028 (COD)

(2008/C 120/01)

On 14 March 2007, the Council decided to consult the European Economic and Social Committee, under
Articles 95 and 133(3) of the Treaty establishing the European Community, on the

Proposal for a Regulation of the European Parliament and of the Council setting out the requirements for accreditation
and market surveillance relating to the marketing of products

and the Proposal for a Decision of the European Parliament and of the Council on a common framework for the
marketing of products.

On 2 April 2007, the Council decided to consult the European Economic and Social Committee, under Arti-
cles 37 and 95 of the Treaty establishing the European Community, on the

Proposal for a Regulation of the European Parliament and of the Council laying down procedures relating to the appli-
cation of certain national technical rules to products lawfully marketed in another Member State and repealing Decision
3052/95/EC.

The Section for the Single Market, Production and Consumption, which was responsible for preparing the
Committee's work on the subject, adopted its opinion on 21 November 2007. The rapporteur was
Mr Pezzini.

At its 440th plenary session, held on 12 and 13 December 2007 (meeting of 13 December), the European
Economic and Social Committee adopted the following opinion by 68 votes to two with three abstentions.

1. Conclusions and recommendations

marketed in a Member State can also be marketed without
hindrance throughout the EU.

The EESC is firmly convinced of

the importance of
1.1
ensuring full application of the principle of the free movement
of goods, which is enshrined in the Treaty and confirmed by
numerous Court of Justice judgments, so that products lawfully

1.2
The EESC believes it is a priority to guarantee certainty,
transparency and efficiency in trade, eliminating duplication of
checks and tests and ensuring high levels of protection for

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consumers, citizens and businesses, and to coordinate and step
up market surveillance activities to ensure active, uniform appli-
cation of Community product safety requirements.

smaller businesses and non-mass produced or products
produced in small quantities;

1.3
The EESC stresses that the free movement of goods is an
essential driver for competitiveness and the economic and social
development of the European single market and that reinforce-
ment and updating of the requirements for the marketing of
safe, high-quality products are key factors for consumers, busi-
nesses and European citizens.

The EESC believes that the updating and streamlining of

1.4
EU legislation on goods cannot be put off, given:

— the problems encountered in implementing and enforcing

the provisions of the Treaty;

— full

involvement of all market players and,

in particular,

consumers;

— explicit provision for out-of-court redress mechanisms, with
time frames and costs reduced to the absolute minimum.

1.6
legal
The EESC feels that high levels of transparency,
certainty and simplification must be ensured in the application
of common mutual recognition procedures, by means of:

— reversal of

the burden of proof, and the possibility of

recourse to national courts;

— the lack of a consistent approach to market surveillance in

Product Contact Points, including on line;

— the possibility of out-of-court settlement of disputes at

the Member States;

— reduced time frames for both judicial and out-of-court

— shortcomings in conformity assessment bodies and in the

proceedings;

legal protection of the CE marking;

— gaps in businesses', administrations' and citizens' awareness

of their rights and obligations.

— provision of capable, competent national technical facilities
which can produce any proof needed quickly — using emer-
gency procedures where applicable;

1.5
The EESC supports the Commission's initiative of putting
together a legislative package on the subject insofar as it fully
achieves:

— an active role for regulatory bodies in producing a telematic
guide making it possible to trace all existing legislation
throughout the EU.

— effective, uniform implementation of the mutual recognition

principle;

— more robust market surveillance;

— a European common accreditation system, providing a

public service of general interest;

— common levels of competence for accredited certification

bodies;

— more stringent selection criteria and harmonised selection

procedures for conformity assessment;

— greater systematic, ongoing cooperation between national

authorities;

— greater legal protection for the CE marking, avoiding confu-

sion caused by the existence of too many marks;

— full

identification and definition of responsibilities for all

those placing products on the market;

— a more uniform legal framework with greater consistency
between existing texts, high levels of conformity and
minimal red tape;

— a traceability guarantee for any product placed on the

market;

1.7
The EESC endorses the basic principles of the proposals,
which are derived from combining the successful elements of
in the area of
the ‘new approach’ with the ‘global approach’
conformity assessment. They should be applied across the board
in present and future Community legislation, covering all
aspects of products sold, particularly as regards safety, health
and environmental protection.

1.8
It is vital that all economic operators in the supply and
distribution chain — be they manufacturers, authorised repre-
sentatives or importers — take the necessary measures and
equal responsibility to ensure that only products which comply
with the regulations are marketed.

Product traceability, ensuring accountability of economic
1.9
operators who place goods on the market, must allow these
operators to be identified clearly so that Community rules can
be properly applied.

1.10
In the EESC's view, the problems of placing goods on
the market online need to be addressed, given that online selling
is not yet fully regulated.

1.11
improve the current ‘new approach’ framework, as regards:

The EESC feels that clearer provisions are essential to

— full application of the principle of proportionality of certifi-
cation responsibilities and procedures, particularly as regards

— obligations for economic operators which are necessary and
proportionate and do not entail heavy bureaucratic and
administrative costs;

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— more efficient market surveillance and more uniform levels
of
competence among notified conformity assessment
bodies, to ensure competence, impartiality and effectiveness
throughout the European Economic Area and a level playing
field for all producers.

national accreditation bodies must be members of the EA, to
ensure equivalence,
transparency, reliability and effectiveness;
moreover, the EA network must be supported by the Member
States.

1.12
The EESC agrees that there is a need to enhance the
status and significance of the CE marking, affording it greater
legal protection by registering it as a collective mark, which will
enable public authorities to take swift action and curb misuse.

1.18
The EESC believes that, since accreditation bodies have
to show that the confidence placed in them is well-founded,
they should have to prove that they participate successfully in
peer reviews.

The EESC stresses that technical standardisation plays a
1.13
key role throughout this area, as the new approach is based
precisely on essential legal requirements and European technical
standards — which must be supported and harnessed — being
closely linked.

In addition, the EESC believes that it is important for
1.19
stakeholders to be involved:
they should be represented on
accreditation bodies and this provision should be an integral
part of the new Regulation.

1.14
The European Accreditation System (EAS) — providing
a public service of general interest — must be based on interna-
tionally recognised standards and clear definitions, ensure accep-
tance across the board of conformity assessment results and
prevent unnecessary duplication of assessment.

1.15
The provisions of the Regulation which relate to the
EAS must apply to all accreditation bodies and the services they
provide, within the European Economic Area, irrespective of the
kind of conformity assessment services supplied to clients.

1.16

These provisions must ensure:

— a coherent set of clear,

transparent common definitions
which are in line with international standards, to be used in
‘new approach’ directives and product-specific direc-
all
tives (1),
including those on conformity assessment and
conformity assessment bodies;

— a public accreditation system which is not

subject

to

commercial competition;

— general coverage of all

relevant Community legislation,
without exceptions in the area of either safety and health or
environmental protection;

including calibration,

— application to all activities subject to accreditation across the
board,
the
purpose of the accreditation is to meet legal conformity
to comply with private
assessment
contracts;

irrespective of whether

requirements or

1.20
The EESC believes in this connection that there should
be greater awareness and acknowledgement of consumers' rights
in the internal market and that an appropriate initiative needs to
be planned to this end.

surveillance activities

1.21 Market
should also apply to
products covered by the General Product Safety Directive
(GPSD) as numerous products are sold both for professional use
and for use by an end consumer. The EESC feels that the exis-
tence of the current rapid information-exchange system, RAPEX,
which can assist market surveillance effectively, is fully justified.

It is necessary for customs authorities to cooperate in a
1.22
European network with market
to
ensure effective checks on products before they are placed on
the European internal market, where they can circulate freely.

surveillance authorities,

1.23
For this and other reasons, customs authorities must be
equipped with trained staff, sufficient funds and powers to be
able to cope effectively with the tasks assigned to them, and
instruments to deal rapidly with seasonal products or products
sold over limited periods.

Lastly, the EESC believes that the Regulation should
1.24
specify that measures taken in response to a proven lack of
conformity must comply with the proportionality principle as
well.

— that national accreditation bodies comply with competence
and impartiality standards by requiring them to take in part
in peer evaluations carried out under the supervision of all
the parties involved in the accreditation process.

1.17
The EESC believes that it is necessary to establish a
clear legal basis for European cooperation for Accreditation
(EA), whose role must be enhanced and better defined: all

(1) In EU legislation, different definitions have been used to address the
same concepts in different product legislation covering aspects such as
liability,
environmental-conscious design, product safety, product
waste disposal, energy efficiency etc. This has caused confusion for
stakeholders, especially when different directives apply to the same
product.

2. Introduction

2.1
The internal market for goods is not only the driving
force for growth within the Community: it also has a consider-
able impact on the European Union's ability to compete on the
international market. As the EESC has pointed out a number of
times, ‘a factor which has increased its importance is “Globalisa-
tion” which is both a challenge and an opportunity. The chal-
lenge can only be met if the full potential of the single market is
realised’ (2).

(2) OJ C 93 of 27.4.2007, Review of

the Single Market. Rapporteur:

Mr Cassidy.

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2.2
The central pillar of the single market is the free move-
ment of goods: under Articles 28-30 (3) of the Treaty essential
progress has been made in harmonising technical regulations at
EU level to remove technical barriers to trade, often by means
of ‘new approach’ directives (also known as ‘CE marking’ direc-
tives).

manufactured in another country. Member States should trust
each other's systems. A sound legal system, high and transparent
quality standards and consumer education initiatives provide the
best conditions for increasing trade in goods between Member
States.’

2.3
However, gaps have emerged in the application and
enforcement of the Treaty's provisions, particularly in the area
of non-harmonised products. The introduction of national tech-
nical rules has created major barriers to free trade, especially for
SMEs, because of a legislative framework which is still too frag-
mented and the lack of a consistent approach to market surveil-
lance among Member States.

2.7
The EESC also stressed that knowledge of consumer
rights in the internal market is extremely limited and that it had
on several occasions drawn attention (6) — particularly as
regards peripheral and recent accession countries — to these
failings and the way in which national and local officials often
exploit this ignorance.

2.4
The EESC has stressed that ‘Member States have a heavy
responsibility to ensure that EU measures are properly trans-
posed into their national law and enforced’ and that it is impor-
tant that ‘the resulting regulatory framework at national level is
both as balanced in terms of content and as simple as possible
for business,
society
players’ (4).

employees,

consumers

and all

civil

2.8
In addition, the EESC points out that the four main
barriers to the proper operation of the internal market identified
by the SMO in 2007 are:

— uncertainty among economic operators and national admin-
istrations regarding rights and obligations relating to the
implementation of the mutual recognition principle;

The EESC firmly supports the goals of more transparent,
2.5
effective rules and stronger, updated requirements for marketing
of safe, high-quality products, in order to provide:

— consumers with higher levels of safety and quality and
greater freedom of choice on the basis of reliable conformity
assessments of both domestic and imported products;

— producers with legal certainty and clear, consistent legisla-
tion, with a common framework for industrial products; the
agility necessary to adapt to technological developments;
genuine free trade without unnecessary technical barriers,
administrative controls or additional, burdensome tests for
access to the individual domestic markets;

— citizens with protection of health and the environment,
removing burdensome, unnecessary red tape and giving
them a practical experience of a tangible, close-at-hand,
quality-based ‘Europe that delivers’ as a key part of European
citizenship.

2.6
In its opinion on the Internal Market Strategy — Priori-
ties 2003-2006 (5), the EESC pointed out that ‘trade with third
countries has been growing faster than trade between Member
States.’ and that ‘one reason is the failure of mutual recognition
products
designed

confidence

consumers

give

to

in

(3) See also Articles 94-95 of the EU Treaty.
(4) OJ C 309 of 16.12.2006, Implementing the Community Lisbon programme:
A strategy for the simplification of the regulatory environment. Rapporteur:
Mr Cassidy.

(5) OJ C 234 of 30.9.2003. Rapporteur: Mr Cassidy.

— insufficient

trust,

transparency and cooperation between
Member States to facilitate mutual recognition and accep-
tance of certification and free movement of goods, providing
a clearer framework,
in terms of conformity assessments,
accreditation and market surveillance systems, transparency
and protection of the ‘CE marking’;

— lack of coherent measures to ensure high levels of safety and
health in the products to be placed on the market and
optimum general requirements relating thereto.

2.9
The EESC has stated: ‘It is noticeable and regrettable that
after many years of European integration EU law and policy are
not yet sufficiently integrated in a number of Member States as
a political and administrative layer in domestic policy-making in
those areas in which they have committed themselves to
common policies and to carry out the results of common deci-
sion-making’ (7).

It went on to point out:

‘An effective and transparent
2.10
approach of EU matters at national
is indispensable as
25 Member States, each with their own administrative culture
and traditions as well as process management, have to respect
the same acquis, which includes similar requirements regarding
lawmaking, transposition, implementation and enforcement of
EU law’ (8).

level

(6) OJ C 208 of 3.9.2003. Rapporteur: Mr Pezzini.
(7) OJ C 325 of 30.12.2006. Rapporteur: Mr van Iersel.
(8) Ibid.

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According to the ‘Kok Report’ (9),

2.11
‘the free movement
of goods within the EU continues to be hindered by a range of
local rules, often applied arbitrarily and in clear contradiction to
the mutual recognition principle’ (10).

— consumers, citizens, and SMEs, are still to a large extent
uninformed or unaware of their rights, while new barriers
and new red tape hampering the exercise of these rights are
gradually emerging.

2.12
In the light of the above, the EESC feels that it is an
urgent priority, with a view to securing the future of European
integration, the protection of consumers and citizens and the
development of European businesses, to:

— ensure full application of the principle of the free movement
of goods, which is enshrined in the Treaty and confirmed by
numerous Court of
Justice judgments, so that products
lawfully marketed in a Member State can also be marketed
without hindrance throughout the EU;

— guarantee certainty,

transparency and efficiency in trade,
eliminating duplication of checks and tests and ensuring
high levels of protection of consumers, citizens and busi-
nesses;

— eliminate uncertainties, layers of legislation, inconsistencies
in the law and unnecessary complexity in product confor-
mity assessments: these should be appropriate, authoritative,
independent and impartial and comply with a common
legal framework for industrial products;

— coordinate and step up market surveillance activities to
ensure active, uniform application of Community product
safety requirements;

— promote, strengthen and protect more effectively the CE
this must be a genuine ‘conformity passport’
marking;
allowing free movement throughout the EU, with due regard
for the safety and quality levels laid down by Community
legislation.

3. The Commission proposals

The Commission takes as a starting point the observa-

3.1
tion that the internal market is not yet complete:

3.2

To address these issues, the Commission proposes:

— a Regulation (COM(2007) 36 final) laying down procedures
relating to the application of certain national technical rules
to products lawfully marketed in another Member State and
repealing Decision 3052/95/EC;

— a Decision (COM(2007) 53 final) on a common framework
for the marketing of products, while in parallel with the
proposal, the Commission will register the CE marking as a
collective mark to ensure its legal protection;

— a Regulation (COM(2007) 37 final) setting out the require-
ments for accreditation and market surveillance relating to
the marketing of products.

3.3
The first regulation (COM(2007) 36 final) proposes the
repeal of the current procedure for mutual exchange of informa-
tion and addresses some aspects of the non-harmonised area:

— a new procedure for national authorities to follow when
they intend to impose a national technical rule and do not
believe they can apply mutual recognition;

— definition at EU level of

the rights and obligations of
national authorities and of enterprises wishing to sell in a
Member State one of their products which is already lawfully
marketed in another Member State;

— establishment

in each Member State of one or several
‘Product Contact Points’, with the task of providing informa-
tion on the technical rules on a product or specifying the
competent authorities/bodies to be contacted; it will also be
possible to set up a telematic network linking these Product
Contact Points, for the exchange of information, in accord-
ance with the IDABC interoperability scheme.

The decision (COM(2007) 53 final) sets out the general

3.4
framework for future sectoral legislation with:

— national technical rules still constitute important barriers to
free trade within the EU. As has been noted (11),
in one
survey, over a third of enterprises reported problems caused
by technical rules in another Member State and about half
of enterprises decided to adapt their products to these rules;

— harmonised definitions, common obligations for economic
operators, criteria for the selection of the conformity assess-
ment bodies, criteria for the national notifying authorities
and rules for the notification process;

— too many EU rules have proven to be inconsistent or too
complex: different definitions applying to the same product,
overlapping conformity assessment procedures, differing
conformity assessment bodies, a fragmented regulatory
framework, with a patchwork of different rules and proce-
dures;

(9) Report from the High Level Group chaired by Wim Kok: ‘Facing the

Challenge’, November 2004 — European Commission.

(10) SEC(2007) 113 of 14.2.2007.
(11) Second Biennial Report on the Application of the Principle of Mutual Recog-

nition in the Single Market — COM(2002) 419 final.

— rules for the selection of conformity assessment procedures
as well as the harmonised range of procedures, to avoid
burdensome overlaps;

— a single definition for the CE marking (with corresponding
responsibilities and safeguards) as a Community collective
mark, for those directives which already provide for it;

— an information and market surveillance procedure as an

extension of the GPSD system;

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— harmonised provisions for the future safeguard mechanisms

as a complement to those for market surveillance.

between the EU-27 Member States now accounts for two-thirds
of all EU trade.

The second regulation (COM(2007) 37 final) provides for
3.5
reinforcement of
the requirements for accreditation and for
market surveillance, so that non-compliant products can be
easily identified and taken off the market. The main objective of
the proposal is to ensure the free movement of goods in the
harmonised area by:

Implementing the provisions of Articles 28 and 30 (13)
4.3
of the EC Treaty, harmonising the old and new approach tech-
nical rules and applying the mutual recognition principle prop-
intraCommunity
erly are key pillars for the development of
trade.

— stepping up European cooperation, so that accreditation can
in the proper

level of control

genuinely provide the final
functioning of EU legislation;

— establishing a framework for recognition of

the existing
organisation ‘European cooperation for Accreditation’ (EA),
so as to ensure the proper functioning of a rigorous peer
evaluation (12);

— putting in place a Community framework for market
surveillance and checks on products entering the EU market,
with closer cooperation between internal authorities and
customs authorities,
information between
exchange of
national authorities and cooperation between them in the
case of products on the markets of more than one Member
State;

— applying clear, standardised rules across all sectors, ensuring
legal stability and consistency in measures, and reducing
some of the burdens in pre-marketing requirements and in
conformity assessment;

— providing Community funding for sectoral accreditation
schemes, the activities of the EA central secretariat, setting-
up and coordination of market surveillance projects, training
programmes and exchange of national officials,
including
customs authorities.

4. General comments

The EESC firmly believes that the free movement of
4.1
for competitiveness and the
goods
is an essential driver
economic and social development of
the European single
market and that reinforcement and updating of the require-
ments for the marketing of safe, high-quality products are key
factors for consumers, businesses and European citizens.

Over the past 50 years, the single market for goods has
4.2
helped to bring Europe's economies increasingly close: trade

(12) At present there are about 1700 notified bodies in the EU.

There are many reasons why the updating and adjust-
4.4
ment of EU legislation on goods cannot be put off:
the
problems encountered in implementing and enforcing the provi-
sions of the Treaty; the lack of a consistent approach to market
surveillance in the Member States; shortcomings in conformity
assessment bodies and in the legal protection of the CE marking;
the inconsistencies and complexity of European legislation,
which is often multi-layered and overlapping, with a patchwork
of different procedures; and gaps in businesses', administrations'
and citizens' awareness of their rights and obligations.

4.5
The EESC supports the Commission's initiative, as, more-
over, it has already stressed, and it repeatedly called for such an
initiative in its opinions on the single market (14); it supports the
proposals issued insofar as they reflect the comments made in
this opinion.

(13) See also Articles 94-95 of the EU Treaty.
(14) List of recent EESC opinions on Simplification, Better Lawmaking

and Priorities of the Single Market:

1) OJ C 93 of 27.4.2007, Review of the Single Market, rapporteur:

Mr Cassidy.

2) Opinion on the Communication from the Commission to the
European Parliament, the Council, the European Economic and Social
Committee and the Committee of the Regions — Implementing the
Community Lisbon programme: A strategy for the simplification of
the regulatory environment, COM(2005) 535 final, rapporteur:
Mr Cassidy, OJ C 309 of 16.12.2006.

3) Exploratory opinion at the request of the UK Presidency on
adopted on

rapporteur: Mr Retureau,

lawmaking,

Better
28.9.2005, OJ C 24, 31.1.2006.

4) Own-initiative opinion on How to improve the implementation
and enforcement of EU legislation, rapporteur: Mr van Iersel,
adopted on 28.9.2005, OJ C 24, 31.1.2006.

5) Opinion on the Communication from the Commission to the
Council, the European Parliament, the European Economic and Social
Committee and the Committee of the Regions: Updating and simpli-
fying the acquis communautaire, COM(2003) 71 final, rapporteur:
Mr Retureau, adopted on 31.3.2004, OJ C 112, 30.4.2004.
6) Own-initiative opinion on Simplification with particular reference
rapporteur:

to
Mr Simpson, adopted on 26.3.2003, OJ C 133, 6.6.2003.

European Governance:

lawmaking,

Better

7) Exploratory opinion on the Communication from the Commission
— simplifying
environment,
COM(2001) 726 final, rapporteur: Mr Walker, adopted on
21.3.2002, OJ C 125, 27.5.2002.

improving

regulatory

and

the

8) Own-initiative opinion on Simplification, rapporteur: Mr Walker,

adopted on 29.11.2001, OJ C 48, 21.2.2002.

9) Own-initiative opinion on Simplifying rules in the single market,
rapporteur: Mr Vever, adopted on 19.10.2000, OJ C 14,
16.1.2001.

10) Own-initiative opinion on the Priorities of

the Single Market
2005-2010, rapporteur: Mr Cassidy, adopted on 7.4.2005,
OJ C 255, 14.10.2005.

11) Opinion on the Communication from the Commission to the
Council, the European Parliament, the European Economic and Social
Committee and the Committee of
Internal Market
Strategy — Priorities 2003-2006,
rapporteur: Mr Cassidy,
adopted on 16.7.2003, OJ C 234, 30.9.2003.

the Regions

12) Information report on simplification.
13) Information report on the State of co-regulation and self-regulation
rapporteur: Mr Vever, adopted on

in the Single Market,
11.1.2005, CESE 1182/2004 fin.

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4.6
The EESC believes that four key criteria should be used
to assess the proposed measures, to ensure that they are incor-
porated into the existing Community framework:

— the level of

transparency, simplification, reliability,

legal
certainty and accessibility for the Community user, whether
consumers, businesses, public administrations or individuals;

— the level of consistency with EU policy and other goals;

— the level of communication and information exchange on
rights and obligations between Community stakeholders;

— the amount of unnecessary red tape and related burdens,
particularly for minor stakeholders such as consumers, small
and medium-sized enterprises and individuals.

The EESC feels that the Commission's proposals allow

4.7
major steps forward as they lay down:

— provisions for increasing market surveillance;

— a common accreditation system;

— common levels of competence for accredited certification

bodies;

— more stringent selection criteria and harmonised selection

procedures for conformity assessment;

— more

cooperation and information exchange between

national authorities;

— greater legal protection for the CE marking as a Community

collective mark.

4.8
The EESC fully agrees that there is a need to improve the
quality of the system for accrediting notified bodies and to
establish more stringent criteria for selecting, managing and
supervising these bodies, with a legal
framework providing
consistency, comparison and coordination in the decentralised
system to ensure reliability and increase mutual trust.

Particularly in view of

4.9
the
market surveillance system must provide a common legislative
framework ensuring efficient, consistent application of legisla-
tion throughout the EU.

increasing globalisation,

4.10
Non-compliant, potentially dangerous products must
not be allowed to reach the market, as stressed in the RAPEX
(Rapid Alert System for non-food consumer products) 2006
annual report on dangerous consumer products (15).

(15) European Commission RAPEX 2006 report, http://ec.europa.eu/
rapex. The report issued on 19 April 2007 notes a steadily increasing
number of notifications in recent years. The number of notifications of
non-food consumer products presenting a serious safety risk in
Europe more than doubled between 2004 and 2006, rising from 388
to 924, while in 2006 the annual increase over 2005 was 32 %,
relating mainly to the toy, electrical-appliance, motor-vehicle, lighting-
equipment and cosmetics sectors, entailing risk of injury, electric
shock, fire and burns, choking and suffocation and chemical risk.

4.11
As regards the CE marking — conceived as a confor-
mity mark rather than a quality mark — the EESC feels that it is
essential to restore faith in conformity marks. The value of the
CE marking must be restored, with greater possibilities of prose-
cution for breach thereof and legal protection ensured for some-
thing which represents the legislative linchpin for all the ‘new
approach’ directives, now covering 20 production sectors.

Regarding the current legislative framework, the EESC
4.12
believes that
the inconsistencies, duplicated rules and legal
uncertainties may well be the Achilles Heel of the entire system,
severely harming consumers, businesses, citizens and civil
society as a whole.

4.13
The existence of several layers of legislation and failure
to respect the need for consistency among initiatives linked to
EU policy and other goals have led to excessive red tape and
considerable burdens in terms of time relating to the actual
launch of differing procedures. This has had a very harmful
impact, especially on consumers, small and medium-sized enter-
prises and individuals.

reference

framework

The EESC therefore fully supports the proposal for a
4.14
common
of
products (16). This framework should include common elements,
procedures and definitions for the future reorganisation and
adjustment of individual directives so as to remove unnecessary
red tape and shortcomings from the current legislative frame-
work.

the marketing

for

4.15
The EESC feels that it is important, as a key element in
the single market, to draw up a practical telematic guide for the
marketing of products in the European single market (17), giving
a user-friendly overview of all legislation and procedures broken
down by major sectors, including rights and obligations, access
procedures, time frames and launch costs.

5. Specific comments

5.1 Proposal for a Regulation on Mutual Recognition and ‘Product

Contact Points’ (COM(2007) 36 final)

The principle of mutual

5.1.1
recognition, provided for
under Articles 28 and 30 of the Treaty, is a cornerstone of the
free movement of goods and services in the internal market.
Fifty years on, as the EU has progressively enlarged and markets
have become increasingly globalised, the EESC believes there is a
need to strengthen and safeguard its role, providing greater legal
certainty and uniform implementation, and harness its full
potential
for economic operators, European businesses and
national authorities alike.

5.1.2
this direction since it:

The Commission proposal represents a positive step in

— sets up a procedure to contest exceptions to the general

principle;

(16) The common framework should also take account of services, which

are increasingly linked to the marketing of products per se.

(17) Cf. point 5.1.11.

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— establishes a common framework of rights and obligations

for national authorities and businesses;

— the possibility of recourse to national courts, without invol-
ving any further, excessive demands in terms of costs, time
and energy;

— proposes a system for information and administrative coop-

eration with regard to national regulation.

The EESC believes, however, that there remain several
5.1.3
problem issues which the proposal needs to address more speci-
fically:

— implementation of

the principle of mutual

recognition
cannot be decoupled from mutual trust between Member
States with regard to the reliability of market surveillance
mechanisms, which play a vital role in granting a product
access to the European internal market; the effectiveness of
conformity assessment procedures; the role played by test
laboratories; and the competence of certifiers and standardi-
sation bodies;

— access to out-of-court complaint procedures, using tried and

tested EU procedures;

— freer, more efficient movement of goods and services, using
combined information and training campaigns targeting
businesses, consumers and administrations;

— shorter procedural time frames; after receiving a written
reasoned notification from the national authority, a business
has 20 days to submit its counter arguments and,
if the
issue is not resolved within a specific timeframe, it can take
it to the national courts of the country of the potential
market;

— in the draft regulation the role of the Commission is more
circumscribed compared to that provided for under Decision
3052/95/EC;

— European networking and inclusion on the EU website for
(PCP) provided for in each
to ensure sufficient communication and

the ‘Product Contact Points’
Member State,
provision of information on rights and obligations.

— administrative cooperation mechanisms would be limited to
vertical cooperation between national businesses and autho-
rities, whereas it would seem important to develop hori-
zontal cooperation between administrative authorities and
likewise between the different Product Contact Points;

— the lack of reference to dispute settlement mechanisms such
as SOLVIT (18), which would allow businesses to directly
request a rapid, tried and tested procedure;

— the reversal of

including for third
country products brought to the Community market by
European importers;

the burden of proof,

— the inclusion of a positive product list, which could be parti-
cularly tricky given that the principle of mutual recognition
applies to all products that are not covered by harmonised
legislation.

The EESC feels that it would be appropriate for the text
5.1.4
to refer explicitly to the Treaty legal bases establishing the prin-
ciple of mutual recognition, thus highlighting that safeguarding
supposed national requirements can only be the exception.

5.1.5
The EESC feels that high levels of transparency, legal
certainty and simplification must be ensured in the application
and enforcement of the mutual recognition principle:

— reversing the burden of proof on national authorities
wishing to derogate from this principle, using simple proce-
dures and definite time frames in order to make resolution
of disputed cases faster and more transparent;

(18) http://ec.europa.eu/solvit/

In the EESC's view,

5.1.6
the maximum time limits for
discussing appeals should be defined so that an issue can be
settled before the court of first instance.

5.1.7
The Member States must equip themselves with effi-
cient technical structures (including provision for an urgency
procedure) in order to rapidly produce any evidence for a dero-
gation from the principle of mutual recognition in accordance
with Article 30 of the Treaty, which ‘allows Member States to
take measures having an effect equivalent to quantitative restric-
tions when these are justified by general, non-economic consid-
erations (public morality, public policy or public security, the
protection of health and life of humans, animals or plants, the
protection of national treasures and the protection of industrial
and commercial property)’ (19).

(PCP)

The Product Contact Points

5.1.8
should employ
SOLVIT methods in an initial attempt to settle disputes and to
allow businesses whose products have been blocked at borders
to access this out-of-court procedure for administrative coopera-
tion between Member States, with answers due within
10 weeks (20).

(19) European Parliament Fact Sheets: 3.2.1 Free movement of goods.

Last updated on 22 October 2001.
http://www.europe-infor.de/facts/en/3_2_1.htm

(20) SEC(2007) 585. Commission staff working document SOLVIT 2006
Report ‘Development and Performance of the Solvit network in
2006’, 30.4.2007.
All EU Member States as well as Norway, Iceland and Liechtenstein,
have created a SOLVIT centre, in most cases within their ministry of
foreign or economic affairs.
These centres cooperate directly via an on-line database to solve
problems submitted by citizens and businesses rapidly and pragmati-
cally. The rules for cooperation within Solvit are included in a 2001
Commission recommendation that was endorsed by Council conclu-
sions. Solvit has been operational since July 2002. In addition to the
recommendation, the Solvit centres adopted a set of common quality
and performance standards in December 2004 to ensure a high quality
of service throughout the network.

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5.1.9
The EESC believes it is important for the PCPs to take
a proactive approach by making practical procedural guides
available. They could also set up national websites, linked in a
European network and to an EU website, featuring decisions on
previous resolved cases, the list of products covered by the
mutual recognition principle and a database open to potential
users linked to the telematic network for the exchange of infor-
mation between PCPs in accordance with IDABC interoper-
ability (21).

5.1.10
Preparing and operating these instruments cannot be
optional; it should be an obligation, stipulated in the proposal.
The PCPs should, together with the Commission, hold regular
joint information and training seminars for economic operators,
administrative and customs officials and for consumers,
to
ensure proper understanding and dissemination of the rights
and obligations laid down in the Treaty.

5.1.11
There is also a need to prepare a Telematic Guide,
giving a user-friendly EU overview of all the current legislation
in force, broken down horizontally and by major sector.

It does not seem worth drawing up a list of positive
5.1.12
products covered by the Regulation, just as it would be inap-
propriate to exclude the urgency procedure provided for in the
General Product Safety Directive.

5.1.13
The Commission must monitor closely the way the
notification mechanisms are operated: Member States must thus
be required to submit a copy of every notification and to draw
up an annual report on the measures adopted, under the terms
of the Regulation, to enable the Commission to submit a report
to the European Parliament, the Council and the EESC — SMO.

5.2 Proposal

for a Decision on a Common Framework for

the

Marketing of Products and CE Marking (COM(2007) 53 final)

The EESC endorses the principles of

5.2.1
the proposal,
which is underpinned by the positive experience of the New
Approach, combined with the Global Approach (22) on confor-
mity assessment. These principles should be applied across the
board to current and future Community legislation, covering all
aspects of marketed products, especially as regards safety, health
and environmental protection. The key principle of the internal
i.e. non-discrimination between economic operators,
market,
must be fully respected in law and implemented by the Member
States.

(21) OJ C 80 of 30.3.2004, rapporteur: Mr Pezzini.
(22) The global approach brought in a modular approach. This divides
conformity assessment into a number of steps or ‘modules’ which
differ according to the development phase of the product (e.g. plan-
ning, prototype, full production), the type of assessment carried out
(checking paperwork, type approval, quality guarantee), and respon-
sibility for the assessment (manufacturer or third party).
The global approach was formalised by Council Decision 90/683/EEC,
repealed and updated by Decision 93/465/EEC: both decisions set
general guidelines and detailed procedures for conformity assessment,
for use in the new approach directives.

5.2.2
The EESC would stress that ‘all economic operators
intervening in the supply and distribution chain should take the
appropriate measures to ensure that they make available on the
market only products which are in conformity with the applic-
able legislation’ (23), whether they be manufacturers, authorised
representatives or importers (24).

5.2.3
Product traceability is essential in order to identify the
liability of economic operators who place goods on the
European market, and to ensure that all the relevant Community
requirements are enforced, rather
the conformity
requirement ‘limited to certain control measures’, as proposed
by the Commission (25).

than just

5.3.3

point

5.2.4
Turning to the subject matter and scope of the Deci-
sion, the EESC feels that the exceptions contained therein must
be avoided and that the Common Framework for the Marketing
of Products must apply — in line with the proposals advanced
in
the
to
relating
Surveillance
European Accreditation System and Market
mechanisms — to all relevant Community legislation without
exception, either for health and safety or environmental protec-
tion. The new framework must apply to the whole body of
legislation in this field, without waiting to see whether each
individual directive or regulation might be subject to a general
review.

the Regulation

on

5.2.5
The common definitions contained in Chapter 1 of the
proposal are of vital importance to market operators, given that
too many directives use different definitions to cover the same
products.

5.2.6

The EESC believes the following are essential:

— clearer description of economic operators' obligations,
order to improve the existing New Approach framework;

in

— more efficient market surveillance;

— more uniform levels of competence for the notified confor-

mity assessment bodies.

5.2.7
The obligations for economic operators must be justi-
fied, proportionate and free from costly bureaucratic and admin-
istrative red tape, both with regard to sample testing of
marketed products and the register of complaints (second para-
graph of Article 7(4)), and as regards the reporting requirement,
which should be restricted to the dangerous products as defined
in the General Product Safety Directive.

5.2.7.1
the action
In the European Accreditation System,
taken by conformity assessment bodies must be proportionate;
these bodies must use suitable methods when dealing with
small and medium-sized businesses and non-mass produced
products or products produced in small quantities.

(23) Recital 14, COM(2007) 53 final.
(24) Including importers of

from third countries,
‘no-name products’
which are marketed for short periods and often under fantasy names,
according to the ‘sell and run’ principle.

(25) Recital 17, COM(2007) 53 final.

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and

effectiveness

5.2.8 With regard to the Notified Bodies, the EESC would
reiterate that they must provide a guarantee of competence,
impartiality
European
Economic Area. In order to enable all manufacturers to compete
on even terms, and in compliance with the accreditation obliga-
tion laid down in Article 3 et seq., accreditation assessment must
be carried out by the National Accreditation Body and accepted
by the notifying authority, thus avoiding pointless, expensive
duplication.

throughout

the

5.2.9 Module A for internal control should be the preferred
conformity assessment procedure, largely due to the fact that, in
any case, product liability rests entirely with the manufacturer
or with the importer, in the European Economic Area (EEA).
There is also a need to ensure choice between several different
simplified modules,
in particular for SMEs and limited series
production.

5.2.10
The very heart of the provisions is the CE marking
system, which is intended to certify the product's compliance
with the applicable rules and which the Member States are
effectively by responding to
required to safeguard more
improper use with sufficient and proportionate sanctions,
like the old ones,
including penal ones. The new provisions,
stipulate
attested by the
conformity,
CE marking, does not relieve the maker of the obligation to
make good any damage caused by a product subsequently
revealed to be faulty.

the product's

that

5.2.11
The EESC agrees unreservedly that a lack of credibility
of the CE marking amounts to a ‘lack of confidence in the
whole system: market surveillance authorities, manufacturers,
laboratories and certifiers, and ultimately the adequacy of New
Approach legislation’ (26).

5.2.12
The best way to boost the standing and importance
of the CE marking, as defined in Council Decision 93/465 (27),
is through a radical shake-up of the marking itself, which would
involve:

— making it clear that it should not be used or regarded as a
marking or labelling system for purposes of consump-
tion (28), nor a guarantee of quality or certification or
approval by independent third parties, but only as a declara-
tion of conformity with product requirements and a tech-
nical document that the manufacturer or the importer has
an obligation and full responsibility to produce for the
authorities and the consumer;

— rationalising the various procedures for assessing confor-

mity;

— strengthening legal protection of the CE marking by regis-
tering it as a collective mark, which means that the public
authorities can act swiftly to clamp down on abuses, while
keeping open the possibility of additional national markings;

— strengthening market surveillance mechanisms and border

customs checks;

(26) The role and significance of the CE marking — European Commission

Draft Certif Doc 2005 — 11 of 30.8.2005.

(27) Council Decision 93/465/EEC: modules decision:

‘The CE marking
symbolises conformity to all the obligations incumbent on manufac-
turers for the product by virtue of the Community directives providing
for its affixing.’

(28) BEUC 298/2007 of 5.6.2007 on Internal Market package for goods.

Jim Murray, EP hearing 5.6.2007.

— getting producers and consumers to look into the pros and
cons of a possible voluntary code of conduct on the efficacy
of the proliferation of European and national quality marks
and labels —voluntary or otherwise — and how they mesh
with the CE marking.

5.2.13
The market surveillance mechanisms are dealt with in
point 5.3.13 et seq., but here the EESC wishes to stress the
importance of Commission involvement, not only in the case of
all products that, though complying, also entail risks for health
and safety, but also in cases of
formal non-compliance as
covered by Article 38 of the Proposal for a Decision.

5.2.14
The EESC reiterates the crucial role played in all
aspects of this issue by the process of technical standardisation,
since the very foundation of the new approach is the close
linkage of minimum legal requirements and European technical
standards, which need to be supported and harnessed. If there is
a formal objection to harmonised standards (29), therefore, the
relevant standards authority should be informed immediately so
that it can pay due attention to this in drawing up the stan-
dards.

5.3 Proposal for a Regulation setting out the requirements for accredi-
surveillance relating to the marketing of

tation and market
products (COM(2007) 37 final)

5.3.1
The EESC supports the proposals for establishing a
European Accreditation System founded on mutual trust and
cooperation inasmuch as this puts in place binding rules for
both economic operators and public authorities to ensure that
all products put on the market meet high levels of safety and
health protection. The system should also guarantee the same
level of application and regulation to all European consumers
and to all economic operators, with simpler and more stream-
lined procedures.

ensure
The European Accreditation System must
5.3.2
universal acceptance of the outcome of conformity assessments
and avoid superfluous duplication of testing: in order to ensure
that the system is internationally acceptable, the competence of
the accreditation assessment must be based on internationally
recognised standards, and the definitions of ‘conformity assess-
ment’, ‘conformity assessment bodies’, ‘designation of the body’
and ‘notification’ must be stated explicitly in the Regulation.

5.3.3
The provisions of the Regulation must apply to all
accreditation bodies and the services they provide, within the
European Economic Area, irrespective of the kind of conformity
assessment services supplied to clients, and they must ensure:

— a coherent set of common, clear, transparent definitions
which are in line with international standards, to be used in
all ‘new approach’ directives and the product-specific direc-
tives, including those on conformity assessment and confor-
mity assessment bodies;

(29) Article 14 of Proposal for a Decision COM(2007) 53 final.

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— an accreditation system which is run by the public authority

and must not be subject to commercial competition;

— general coverage of all

relevant Community legislation,
without exceptions either in the area of safety and health or
in the area of environmental protection:
the growing
complexity of Community legislation in this area must be
recast in a single coherent framework for both EU and
non-EU producers;

including calibration,

— application to all activities subject to accreditation across the
board,
the
purpose of the accreditation is to meet legal conformity
assessment
to comply with private
contracts;

irrespective of whether

requirements or

— that national accreditation bodies comply with competence
and impartiality standards by requiring them to take part in
peer evaluations carried out under the supervision of all the
parties involved in the accreditation process;

— cost effectiveness, proportionality, reliability and reciprocal
trust in the common accreditation system for both the regu-
lated and the non-regulated area.

5.3.4
include calibration, testing, certification,
conformity assessment activities.

The definition of accreditation should be modified to
inspection and other

In addition, to ensure uniform rules embracing all the
5.3.5
conformity assessment procedures,
including those of quality
assurance, calibration and ISO 43 evaluation tests, there should
be no exemptions: all accreditation bodies and all the services
they provide in the European Economic Area should be covered
by the Regulation, irrespective of the kind of conformity assess-
ment services supplied to clients.

National accreditation bodies should operate on a
5.3.6
non-profit basis as proposed in Article 4(6). However,
the
present wording risks hampering the creation of the start-up
capital needed to secure a sound financial footing for delivering
quality services. In the EESC's view, national accreditation bodies
should operate like non-profit bodies in the sense that they
must not distribute profits, as established internationally in
ISO/IEC 17011 (30).

5.3.7
The European Accreditation System (EAS) should be
regarded as the system's highest level of accreditation, and as a
public service of general interest must be free of competition.
The EESC supports the rule which obliges Member States to
have a single national accreditation body whose competence,
objectivity and impartiality must be subject to peer review, with
some exceptions in certain circumstances (31) for smaller states
should they wish to use the national accreditation bodies of a
neighbouring Member State.

5.3.8
The EESC thinks that a clear legal basis needs to be
established for European cooperation for Accreditation (EA),

whose role must be strengthened and better defined: all the
national accreditation bodies must be members of the EA in
order to ensure equivalence, transparency, reliability and efficacy,
and the EA network must be supported by the Member States.

5.3.9
In order to further strengthen EA, the EESC thinks that
the accreditation bodies must be signatories of multilateral
recognition agreements (MLAs) operated by EA. In addition, the
financing mechanisms enshrined in the Regulation should not
only cover EA, but be extended to campaigns in support of
market surveillance activities and joint training of the various
national administrations taking part.

5.3.10
The peer review enshrined in Article 9(1), intended to
facilitate and improve the operation of the single market by
increasing its trustworthiness, must be organised within the
European Accreditation System and implemented according to
harmonised rules defined within EA. The results of the peer
review must be rendered public and communicated to all the
Member States and to the Commission.

5.3.11
Since accreditation bodies must actively demonstrate
that the trust they enjoy is well placed, the EESC thinks they
should have to prove that they participate successfully in peer
review.

5.3.12
The EESC also considers it important for stakeholders
to be involved: they should be represented on accreditation
bodies and provision to this effect should be an integral part of
the new Regulation.

5.3.13
The EESC stresses the importance of Member States
achieving equivalent, more coherent and efficient market surveil-
lance mechanisms by way of a harmonisation of Community
legislation which includes the strengthening of crossborder
cooperation: there should be a realignment of provisions on
general product safety — Product Safety Directive 2001/95/EC
— and of the other relevant directives in order to ensure the
full application of the ‘better lawmaking’ principle to the opera-
tion of the single market. Market surveillance activities should
also apply to products covered by the General Product Safety
Directive (GPSD), as numerous products are sold both for
professional use and for use by an end consumer. The EESC
therefore regards as unjustified the exclusion of the GPSD from
the provisions mentioned in Article 13(2), as this would create
more confusion and complications for economic operators
rather
than greater cohesion of single market surveillance
activities.

5.3.14
The EESC feels that the existence of the current rapid
information-exchange system, RAPEX (32), which is capable of
it
effectively assisting market surveillance,
should, however, be used in a more uniform and coordinated
way by the Member States and the customs and administrative
authorities.

is fully justified:

(30) ISO/IEC 17011 ‘The accreditation body shall have the financial
resources, demonstrated by records and/or documents, required for
the operation of its activities’.

(31) Article 6(1) of Proposal for a Regulation COM(2007) 37 final.

(32) In addition to RAPEX there are: the RASFF alert system for the food
and feed sector, the EWRS system for human diseases, and the ADNS
system for animal diseases. Compare Decision 2004/478/EC and
Regulation 2230/2004/EC.

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5.3.15
Customs authorities should cooperate with market
surveillance authorities in a European network in order to
ensure effective checks on products before these are put on the
single European market, and customs authorities must be
equipped with trained staff, financial resources and sufficient
powers to carry out the tasks entrusted to them effectively.

5.3.16 Market surveillance and customs inspection mechan-
isms must have, above all, the necessary instruments to deal
promptly with products that are seasonal or sold only for
limited periods as special promotions, often under ephemeral

made-up names. The authorities must have the powers and
means for rapid intervention against these and the importer
into the Community must bear full responsibility for ensuring
they satisfy essential EU requirements, especially as regards
safety and environmental protection.

5.3.17
Finally, the EESC thinks that the Regulation should
clearly stipulate that the measures taken in response to a proven
lack of conformity respect the principle of proportionality, irre-
spective of the guidelines proposed in Article 19(1): the EESC
thinks that Article 17 should be amended accordingly.

Brussels, 13 December 2007.

The President

of the European Economic and Social Committee

Dimitris DIMITRIADIS

APPENDIX

to the Opinion of the European Economic and Social Committee

The following amendments, which received at least one quarter of the votes cast, were rejected in the course of the
debate:

Point 5.2.12

Add on to first bullet:

‘— making it clear that it should not be used or regarded as a marking or labelling system for purposes of consumption, nor a
guarantee of quality or certification or approval by independent third parties, but only as a declaration of conformity with
product requirements and a technical document that the manufacturer or the importer has an obligation and full responsibility
to produce for the authorities and the consumer. Consequently, as the CE mark is not a guarantee of quality or certification or
approval by independent third parties, it is sufficient that the CE mark is put on the accompanying papers and not on the
product itself;’

Reason

Under the existing rules all products of the particular kind, for instance toys, must be stamped with the CE mark. This
means that there is no message to the consumer that one product is better than the other. It (only) means that the
product lives up to the safety standards to be sold at all. The consumer expects all products in the shop to be allowed to
be sold.

And if for instance the consumer is looking at sports equipment like roller skates and/or skateboards there is no CE mark
required on the products meant for children over 20 kilos. They may sit together on the shelf, and the consumer may
think that those marked with CE are better than the others.

Numerous surveys over time have shown that consumers do not understand/are misled by the CE mark. Among the
misconceptions are: that the products have a certain quality (are not only safe), have been third party tested, or that they
are produced in the EU.

And it is understandable that consumers do not understand the system. All food products are not obliged to carry a
special mark, but they have to live up to the EU regulations and directives, anyway. It is the opinion of the European
consumer organisations, BEUC and ANEC that it is sufficient for the CE mark — as the safety passport to the market —
to be on the accompanying papers for the relevant authorities to check.

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Voting

For: 24 Against: 27 Abstentions: 10

Point 5.2.12

Add a new 6th bullet:

‘— Getting the Commission, producers and consumers to look into creating a real product quality mark scheme based on third

party certification covering more aspects than the basic safety rules in the directives;’

Reason

Such a discussion could look into creating standards not only on safety, but also covering demands regarding quality,
environment and ethics to enable some producers — should they so wish — to have their products tested to more
demands than safety.

If this amendment is agreed, section 1 ‘Conclusions and recommendations’ should be adapted accordingly (for instance in
point 1.5 after the 7th bullet).

Voting

For: 25 Against: 29 Abstentions: 12