Commission interpretative communication on facilitating the access of products to the markets of other Member States: the practical application of mutual recognition (Text with EEA relevance)
Date: 2003-11-04
Institutions: European Commission
Subjects: intra-EU trade, market access, mutual recognition principle, single market

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Commission interpretative communication on facilitating the access of products to the markets of
other Member States: the practical application of mutual recognition

(2003/C 265/02)

(Text with EEA relevance)

SUMMARY

The Commission has been aware for some time that a large
number of economic operators and national administrations
are unfamiliar with the principle of mutual recognition in
the area of intra-Community transfers of products.

the composition of the product

Indeed, since economic operators are primarily interested in
gaining rapid access to the national market, they often opt
in line with the
to adapt
national rules of the Member State of destination, even if this
makes access to this market more costly. On the other hand,
confronted with an unknown product which does not conform
to the letter with the technical rules of the Member State of
destination, the predominant attitude of the national adminis-
trations is uncertainty. This uncertainty is sometimes reflected
in excessive caution, leading authorities to refuse to allow the
product to be placed on the market or to make access to their
market more difficult.

To alleviate these problems, the Commission decided to publish
this communication, which outlines the rights and obligations
of economic operators and of national administrations in
situations where the principle of mutual recognition needs to
be applied. It is intended to be a practical guide to enable
Member States and economic operators to benefit from the
free movement of products in the many economic sectors
which have not yet been harmonised.

This communication makes it clear that the Member State of
destination of a product must allow the placing on its market
of a product lawfully manufactured and/or marketed in another
Member State or in Turkey, or lawfully manufactured in an
EFTA State that is a contracting party to the Agreement on the
European Economic Area, provided that this product provides
an equivalent
the various legitimate
interests involved.

level of protection of

Mutual recognition is not always automatically applicable:
it
can be affected by the right of the Member State of destination
to verify the equivalence of the level of protection provided by
the product under
scrutiny, compared with the level of
protection provided by its own national rules. When the
it may use
Member State of destination exercises this right,
the practical
communication to
examine the equivalence of
the level of protection. These
tools define the conditions applicable to the exercise of this
right to balance it correctly with the fundamental right of free
movement of products.

tools proposed by this

Despite the direct effect of Articles 28 and 30 of the EC Treaty,
the very existence of a national technical rule often discourages
economic operators and creates uncertainty for national admin-
istrators. For these reasons, this communication includes some
suggestions to Member States to foster the proper application
of
the
inclusion of a mutual
recognition clause in the laws of
Member States.

the principle of mutual

in particular

recognition,

1.

1.1.

INTRODUCTION

Product diversity: One of the European Union's
strengths

One of the features of the internal market is the very
wide variety of products which provide a high level of
protection for consumers and the environment. This
variety is both a source of considerable wealth for
European consumers
for
and of
Indeed, the enlargement of the
European companies.
European Union, the expansion of world trade and the
trade, combined
greater liberalisation of
with rapid progress
and
the variety and
distribution technologies, mean that
technical
complexity of products will undoubtedly
increase substantially in the years ahead.

international
in new manufacturing

competitiveness

In spite of the progress on the free movement of goods
that the Commission has seen over the last 15 years,
and notwithstanding the EC regulations on product
safety (1), variety can still be a source of uncertainty or
disquiet, on the part of both national administrations
and economic operators (2). The Commission has
already noted that
economic
operators and national administrations do not know
exactly
extent products which are not
harmonised at Community level may have access to
the market of another Member State, without being
adapted to the rules of
the Member State of desti-
nation (3).

large number of

to what

a

Thus,
confronted with a product which is not
harmonised at Community level and which does not
fulfil the technical rules of the Member State of desti-
the national administrations and economic
nation,
operators often do not know how to react. Very often
this ignorance results in a refusal to allow a product to
be placed on the market (or its withdrawal from the
to refrain
market), obliging the economic operator
from marketing the product in that Member State. The
result
is that uncertainty and anxiety can act as an
important barrier to gaining access to the market of
the Member State of destination and to benefiting fully
from the opportunity provided by the internal market.

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1.2.

The purpose of
rights and obligations

this communication: clarifying

In these circumstances,
the Commission considers it
advisable to call to mind the general principles which
should guide economic operators and national auth-
orities when looking at practical
issues which may
arise when assessing the conformity of products from
the EEA/Turkish with the technical rules of the Member
State of destination (4).

or

fitness

its
such as
required of a product,
characteristics
for
use,
(quality
level
composition
safety, dimensions, markings,
symbols,
performance,
its presentation (the name under which the
etc.),
its labelling) or testing
product is sold,
and test methods within the framework of conformity
assessment procedures, which is obligatory, in fact or in
law, to market or use the product in the Member State
of destination.

its packaging,

This communication aims to sum up the rights which
economic operators may derive from Community law,
and in particular from the principle of ‘mutual recog-
nition’ arising from Articles 28 and 30 of
the EC
Treaty (5), when they encounter difficulties in placing
EEA/Turkish products on the market of
another
Member State. Likewise,
it can serve as a guide for
national administrations when assessing the degree of
EEA/Turkish
equivalence
products can provide as compared to what is defined
in
product
legislation
their
conformity) (6).

protection

(verifying

national

that

the

of

the product

The principle of mutual recognition plays an important
part in the functioning of the internal market. Thanks to
it, the free movement of products is possible in the
absence of any Community harmonising legislation.
Under it, Member States of destination cannot forbid
the sale on their territories of EEA/Turkish products,
even if
in question was manufactured
according to different technical and quality rules than
those that must be met for their own products. The only
exception to this principle are restrictions laid down by
the Member State of destination, provided that these are
justified on the grounds described in Article 30 of the
EC Treaty, or on the basis of overriding requirements of
general public importance recognised by the Court of
Justice's case law.

In particular,

This communication reiterates the conditions that must
be satisfied to apply the principle of mutual recognition
correctly.
it examines the compatibility
with Articles 28 and 30 of the EC Treaty of national
the access of
technical
products in the non-harmonised field to the market
of another Member State.

rules which may impede

This communication concerns only certain measures
adopted by the Member State of destination which are
likely to hinder the access of certain products to the
market of another Member State. Consequently,
this
communication does not deal with:

— national fiscal rules applicable to products, which
must conform to other provisions of Community
law,

— market surveillance activities and technical

rules

imposed by Community law,

— selling arrangements

for products prescribed by
national measures in the Member State of desti-
nation,
in particular mandatory restrictions on the
hours and place of sale, sales promotions, national
pricing rules, etc. (7),

— difficulties in gaining access to the market of another
Member State, attributable entirely to private persons
or entities, and which do not arise from powers
vested in them by a public authority.

In view of the specific nature of the national rules
applicable to products,
this
communication are not necessarily applicable in
other
the free movement of
services, capital and persons.

the principles of

such as

fields,

For the purpose of this communication, a technical rule
the
means a technical

specification which defines

The Court of Justice recognises that, in the absence of
harmonised Community rules, the Member States have
the power to adopt technical rules.

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However, the Member State of destination must allow
to its market,
an EEA/Turkish product
an equivalent
provided that
level of
legitimate interests (8) at
protection of
stake. This principle will henceforth be referred to as
the principle of ‘mutual recognition’ (9).

it provides
the various

free access

— to which, being in conformity with a European
standard whose references have been published by
the Commission,
the presumption of safety laid
down by the Directive on general product safety (16)
applies, for the risks and risk categories covered by
the standards in question.

recognition is not always auto-
However, mutual
matically applicable: it can be affected by the right of
the Member State of destination to verify the equiv-
alence of the level of protection provided by the product
under scrutiny, compared with that provided by its own
national rules.

This communication relates only to the products or the
aspects of products
in respect of which intra-
Community free movement is guaranteed by Articles
the EC Treaty, which simultaneously
28 and 30 of
presupposes
the
the field in question is not
subject of a Community regulation (17).

that

The communication describes the right of economic
operators to appeal and offers some suggestions on
how to correctly combine the fundamental right of
free movement of products with the oversight of the
Member State of destination.

2.2.

Products lawfully manufactured and/or marketed in
another Member State or in Turkey, or lawfully
manufactured in an EFTA State that is a contracting
party to the Agreement on the European Economic
Area

2.

TYPES OF PRODUCTS COVERED BY THIS COMMUNI-
CATION

This communication applies only to ‘EEA/Turkish
products’,
the
conditions set out in points 2.1 and 2.2.

the products (10) which meet

i.e.

2.1.

Products that are not harmonised at Community
level (11)

This communication does not apply to products:

— which are covered by a marketing authorisation
which is valid throughout the Community (12), or

— which bear

the EC mark in accordance with
Community directives, for those aspects which are
harmonised at Community level (13), or

is

guaranteed

— which comply with, and in respect of which
placement on the market
by,
Community legislation (14). It should be noted that
Community legislation sometimes provides for a
system of national authorisations based on an
in-depth examination by the competent authorities
of a Member State. Once the marketing author-
isation is granted by these authorities, Community
legislation generally stipulates that
the competent
authorities of other Member States must recognise
this authorisation and grant their national author-
isation, save in exceptional cases (15),

it

approved

there (20),

and methods

— If a product is manufactured in another Member
State, in Turkey (18), or in an EFTA State that is a
contracting party to the Agreement on the European
Economic Area (19), according to the manufacturing
is
rules
considered as being lawfully manufactured. Thus, it
covers not only products which are manufactured
according to any technical rules laid down in the
laws of the Member State of manufacture, but also
products which do not infringe any other national
rule. It is obvious that a product is also lawfully
manufactured when there are no specific national
technical rules or other types of rules,
laid down
by the authorities, which are applicable to this
type of product. With regard to products intended
for (or which may be used by) consumers, products
which are placed on the Community market are
subject to the requirements and safety criteria laid
down by the Directive on general product safety.

— This

communication applies

also to products
lawfully marketed in another Member State (21) or
in Turkey.

For the purpose of this communication, ‘State of origin’
means:

— another Member State or Turkey, provided that the
product is legally manufactured or marketed there,
and

— an EFTA State that is a contracting party to the
Agreement on the
European Economic Area
provided that the product is legally manufactured
there.

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In any event, the Directive on general product safety
provides that responsibility for ensuring that products
placed on the market are safe lies with the economic
operator. According to the Community definition, a
product is safe when, under normal or reasonably fore-
seeable conditions of use including duration and, where
installation and main-
applicable, putting into service,
tenance, does not present
any risk or only the
minimum risks compatible with the product's use,
considered to be acceptable and consistent with a high
level of protection for
safety and health of
the
persons (22).

on
products marketed
EEA/Turkish products (28).

its

territory,

including

Some examples would be technical rules relating to:

— the composition of

the product (29),

its quality

level (30), its safety (31), its dimensions (32),

— the presentation of the product, its sales name (33),

its packaging (34), its labelling (35).

3.

THE RESTRICTIVE IMPACT OF TECHNICAL RULES ON
A PRODUCT'S ACCESS TO THE MARKET OF THE
MEMBER STATE DESTINATION

is

the most

in EEA/Turkish products

frequent barriers to intra-
In fact, one of
Community trade
the
application of technical rules, as defined in paragraph
2 of this communication, to these products, even if
these rules apply both to domestic products and to
EEA/Turkish
In
problems
the principle of mutual
regarding the application of
economic
an
arise
recognition
operator who decides to market a product
there is
faced with the problem that the Member State of desti-
nation imposes its own technical rules on the product in
question.

essentially when

products (23).

practice,

the

economic operator

Such rules may oblige the economic operator
to
withdraw EEA/Turkish products from the market of
the Member State of destination (24). They are also
likely to oblige
to adapt
EEA/Turkish products depending on the Member State
of destination. This will give rise to additional costs for
the economic operator. Even where these additional
costs are borne by consumers in the final analysis, the
mere prospect of having to advance
costs
constitutes a barrier for operators, since it is likely to
deter them from entering the market of the Member
State in question (25).

these

A technical rule imposed by a Member State of desti-
nation which implements a national standard (26) or
makes a national standard obligatory is particularly
likely to constitute a barrier to the free movement of
products if it makes no provision for alternate technical
level of
approaches which provide
protection, even where it applies to all the products
marketed on its
EEA/Turkish
products (27).

an equivalent

including

territory,

A very precise and excessively detailed technical rule is
also particularly likely to constitute a barrier to the free
movement of products, even when it applies to all

that

cannot

require

the product

However, technical rules in the Member State of desti-
the
nation of
EEA/Turkish products satisfy literally and exactly the
same provisions or technical characteristics prescribed
for products manufactured in the Member State of desti-
nation if
an
these EEA/Turkish products
equivalent level of protection, particularly with regard
to the health and life of consumers who use or consume
them (36).

ensure

It follows that, when the supervisory authorities of the
Member State of destination of the product exercise
their right to verify the conformity of an EEA/Turkish
product to their own technical rules, they must examine
to what extent this product provides an equivalent level
of protection.

4.

SUPERVISION BY THE MEMBER STATE OF DESTI-
NATION

An essential principle of Community law is that an
EEA/Turkish product enjoys the basic right of
free
movement of products, guaranteed by the EC Treaty,
provided that the Member State of destination has not
taken a
refusal, based on
reasoned decision of
proportionate technical rules (37).

The basic right of free movement of products is not an
absolute right: mutual recognition is subject to the right
of the Member State of destination to verify the equiv-
alence of the level of protection provided by the product
which it is examining compared with that provided by
its own national rules.

This supervision must be based on objective,
non-discriminatory criteria which are known in
advance,
in such a way as to circumscribe the
exercise of the national authority's discretion so
that this discretion is not used arbitrarily.

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Consequently, the criteria should be duly published or
easily available. In any event, supervision should always
be exercised in the framework of a procedure that is as
short, effective and inexpensive as possible. In principle,
there can be no systematic control in the Member State
of destination before release on the market. As a result,
as a general rule, the Member State of destination can
only examine the conformity of an EEA/Turkish product
with its own technical rules as part of an inspection
undertaken as part of its market monitoring activities,
and after release on the national market. However, an
authorisation procedure prior to release on the national
market of
the Member State of destination may be
justified under very strict conditions (38).

Thus, the principles of this communication must
in the
applied, mutatis mutandis,
also be
framework of an authorisation procedure prior
to release on the national market of
the
Member State of destination.

The Commission considers that, to comply with Articles
28 and 30 of the EC Treaty, the examination of the
conformity of an EEA/Turkish product in the light of
the legislation of the Member State of destination should
take account of
the following elements. These are
divided into stages:

4.1.

First stage: collecting the necessary data

When the competent authority of the Member State of
to an
destination submits an EEA/Turkish product
evaluation of
its conformity with its own technical
rules,
it would be logical that it should first contact
the economic operator who is in a position to supply
the necessary information within a reasonable time (39).
In response to targeted and precise questions,
the
economic operator will be able to supply the relevant
technical information and, where necessary, a sample of
the product in question. On the basis of its experience
the
in dealing with complaints and infringements,
Commission considers that a deadline of 20 working
days is reasonable.

The competent authority of the Member State of desti-
to obtain more extensive
nation also has the right
information on the conformity of
the EEA/Turkish
product to the rules of Member States of origin. More
specifically:

— If

the

economic operator has proof of

the
conformity (such as a written confirmation from
the competent authority of
the Member State of
origin (40)), the Commission is of the opinion that
it would be useful for this proof to be transmitted to
the competent authority of
the Member State of
destination.

— It would also be useful

were to provide the references of
provisions of law in the Member State of origin.

if the economic operator
the applicable

the

The Commission considers that the request for
information by the competent authority of the
Member State of destination and/or the exam-
competent
ination of
the product by
authority cannot cause the marketing of
the
EEA/Turkish product
in the Member State of
destination to be suspended pending a reasoned
decision on this marketing by the competent
authority
an
emergency measure is adopted following an
alert as provided for in Directive 2001/95/EC or
in Regulation 178/2002.

in question (41),

except where

The competent authority of the Member State of desti-
nation may request a translation of these documents
when necessary. Nonetheless, it would be excessive for
a Member State to require a translation certified or auth-
enticated by a consular or administrative authority (42),
or to impose an excessively short deadline for providing
such a translation, unless there are special circumstances
which warrant this. The Commission also considers that
the competent authority of the Member State of desti-
nation should identify the parts of the documents which
need to be translated. The authority should also avoid
asking for translations when the documents in question
are available in another language which the authority is
able to understand.

The competent authority of the Member State of desti-
nation has the right to take one or, if necessary, several
its
samples of
conformity with its rules (43). The number of samples
must be proportionate
risk the
product may pose.

to the potential

the product

to examine

in order

the competent authority of

the
In any event,
Member State of destination cannot duplicate
controls which have already been carried out in
the context of other procedures, either in the
same State, or in another Member State (44).

Indeed, Court of
following be taken into account:

Justice case law requires that

the

— the checks carried out by a competent authority in

the Member State of origin (45),

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— the technical or scientific analyses or laboratory tests
in a State of origin (46). The
already carried out
Commission is of the opinion that the only valid
reason for refusing to take account of tests carried
out and certificates granted by an inspection or
certification body legally established in the Member
State of origin would be that the body does not
provide appropriate and satisfactory guarantees of
technical ability, professionalism and independence.
The Commission considers that certification bodies
approved on the basis of criteria taken from the
EN 45000 series of standards do provide appropriate
technical ability,
and satisfactory guarantees of
professionalism and independence.
follows that
tests carried out by an approved
the results of
body on the basis of criteria derived from the
standards in the Member State of origin on the
basis of technical specifications of the same level
as those required by the Member State of destination
must be accepted by the latter. This State may not
call the results of the tests into question on the
technical or professional
grounds of a lack of
ability, or a lack of
the body.
However, other approaches which make it possible
to obtain appropriate and satisfactory verification
and proof of the abilities and independence of the
certification bodies must also be accepted.

independence of

It

The evidence of controls and/or
the technical or
scientific reports may be obtained from the economic
operator in question (47) or, as appropriate, from the
competent administration in the Member State of
origin (48).

However,
the Member State of destination will only
have the right to require additional tests when all the
following conditions have been met:

— these tests have not already been carried out or have
not been carried out by a body providing equivalent
guarantees
the national
bodies (49),

required for

to those

— this

type of

test

is also imposed on national

product's,

— these tests are necessary to provide the competent
authority with the information required to evaluate
the level of protection afforded by the product (50).

The Member State of destination may always carry out
additional tests, but at its own expense (51).

4.2.

Second stage: Verification of the equivalence of
levels of protection

4.2.1. Recognition of the conformity of the product with the rules of

a Member State of origin

the

that

EEA/Turkish

When the competent authority of the Member State of
destination learns
product
complies with the rules of one (or more) State(s) of
it may sometimes be aware, by virtue of the
origin,
administrative cooperation between Member States, of
the minimum level of protection provided by the legis-
lation of the State or States in question. If this level is
equivalent to that of the Member State of destination, a
is not
more detailed examination of
necessary. Subject
the
Member State of destination may carry out on the
market, the product will then continue to be marketed
in the Member State of destination without
further
action on the part of the economic operator regarding
assessment of conformity in the Member State of desti-
nation.

to the occasional checks that

the product

The level of protection of the legislation of a State of
origin may be helpful in assessing the conformity of the
EEA/Turkish product with the rules of the Member State
of destination, but it is certainly not the decisive element
in drawing conclusions as to the level of protection
provided by the product. Indeed, it is possible that the
manufacturer of the product has opted for a higher
quality than that required in the Member State of origin.

4.2.2. Identifying the technical rules applicable to the product

the information obtained on the
On the basis of
competent
EEA/Turkish product
the Member State of destination may
authority of
examine if and to what extent its national technical
rules must apply to the product concerned.

in question,

the

When the Member State of destination has no technical
rules for the marketing of EEA/Turkish products on its
territory,
in principle the marketing of a product will
not be restricted there. This will generally be the case
for simple or well-known products, which do not pose
any risk to health or safety, under normal conditions of
use.

However, in the absence of a specific technical rule in
the Member State of destination, that Member State may
nonetheless restrict the marketing of the product in the
event of problems linked to its safety,
in accordance
with the Directive on general product safety or under
Regulation 178/2002, provided, of course,
the
conditions for applying this legislation are met.

that

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However, when the Member State of destination lays
down technical rules for the marketing of EEA/Turkish
products on its territory, the competent authority should
examine the documentation relating to the product and,
if necessary, the product itself, in the light of these same
rules. This examination makes it possible to determine
the technical rules to which the EEA/Turkish product
does not conform, thus facilitating the exercise of the
right of supervision over the product in question.

4.2.3. The proportionality of the application of the technical rules of

the Member State of destination

The technical rules to which the EEA/Turkish product in
question does not conform will be the basis
for
examining the proportionality of
the application of
these rules in the case in question.

It should be pointed out that,
in the non-harmonised
field, and with due regard to the Treaty and thus the
principle of proportionality, the Member States remain
free to determine the level of protection that
they
consider appropriate for protecting legitimate objectives,
such as public health, consumers,
the environment,
public order, road safety, etc. (52).

A level of protection is generally fixed on the basis of a
risk assessment (53)
in
particular by technical rules.

various methods,

and by

The competent authority has the right
to apply its
technical rule to an EEA/Turkish product only when
the replies to the following two questions are in the
affirmative:

— Does the technical rule itself satisfy one of

the
interest motives recognised in Community

general
law?

— Will the application of the rule to the product be
able to guarantee the achievement of the objective
sought and does it refrain from going beyond what
is necessary to achieve this?

For the application of a technical rule to a product to be
proportionate, it must be both necessary and adequate:

technical

application of

(a) The necessity of the application of the technical rule:
the
to an
the
EEA/Turkish product must be based primarily on
features (54).
relevant
Secondly,
the
protection of one or more of
the objectives
recognised as legitimate by the Treaty or by the
Court's case law (55).

technical
the rule must be necessary for

scientific

rule

or

Example: The Member State of destination
prohibits the marketing of bread where the dry
matter salt content exceeds the maximum limit of
2 %. Where the Member State does not have
scientific justification for this requirement based
on
a
requirement cannot be applied to EEA/Turkish
products.

protection,

consumer

health

such

(b) The adequacy of the application of the technical
rule:
the application of a technical rule will be
deemed not to be adequate if the requirements it
is intended to protect can be protected equally
effectively by measures
intra-
Community trade.
it is necessary
to assess the protection provided by alternative
measures (56).

less
In this context,

restrictive of

Example: The Member State of destination lays
down technical rules according to which only
durum wheat may be used to make dried pasta.
The sale of pasta manufactured from common
from a mixture of common and
wheat or
durum wheat
is prohibited. The purpose of
these rules is to protect consumers by ensuring
trade is fair. This objective can be met in a way
that is less restrictive of intra-Community trade in
such pasta through appropriate labelling or by
providing a specific name for
type of
product.

this

Consequently, the competent authority will be obliged,
when examining an EEA/Turkish product, to eliminate,
on its own initiative, any technical rules which are not
the imperative
proportionate in the light of one of
as mandatory
reasons
the Court
by
requirements or mentioned in Article 30 of
the EC
treaty.

recognised

It should be emphasised that the decision not to apply
these disproportionate technical rules to an EEA/Turkish
product
is a decision which is mandatory under
Community law which, in any event, takes precedence
over national law.

regulations cannot
should satisfy

that
Moreover, national
EEA/Turkish products
and
exactly the same provisions or technical characteristics
laid down for products manufactured in the Member
State of destination, when these products afford the
same level of protection (57).

require
literally

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the possible application of a
The examination of
technical rule to an EEA/Turkish product may mean
that domestic products are treated differently, perhaps
even more severely, than the EEA/Turkish product in
an
question. When examining the
EEA/Turkish product, the competent authority cannot
regard such different treatment as a decisive factor.

conformity of

Lastly, it is possible that the Member State of destination
has chosen a different system of protection from that
adopted by the Member State of origin. This difference
has no impact on the evaluation of the necessity for and
proportionality of the technical rules in the Member
State of destination. These must be assessed only in
the light of the objectives pursued by the national auth-
orities of the Member State of destination and of the
level of protection which these rules are intended to
guarantee (58).

4.3.

Third stage:
communicating them to the applicant

the results of

the assessment and

When the Member State of destination has examined the
this
in question,
EEA/Turkish product
assessment — whether positive or negative — must
be communicated as
to the
economic operator concerned.

soon as possible (59)

the results of

The Commission considers that the competent authority
should provide the economic operator in question with
all the facts of the case, not just in the event of a
negative assessment, but also in the event of a positive
assessment. A positive assessment confirms that
the
EEA/Turkish product can legally be marketed in the
Member State of destination.

However, the restriction of trade which may arise from
a negative assessment is, in principle, a measure having
an effect equivalent to a quantitative import restriction,
prohibited by Article 28 of the EC Treaty.

It is up to the Member State which claims to have a
reason justifying a restriction on the free movement of
goods to demonstrate specifically the existence of a
reason relating to the public interest, the necessity for
the restriction in question and the proportionality of the
restriction in relation to the objective pursued (60).

regarding the grounds for such decisions from the
administration, before any recourse to law (61).

the opinion that

Other than the measures which may be taken under the
Directive on general product safety, the Commission is
of
the
Member State of destination that considers that an
EEA/Turkish product should be refused access to its
market, should in any event:

the competent authority of

— inform the manufacturer or distributor in writing of
those elements of its national technical rules which
in its opinion prevent the marketing of the product
in question in the Member State of destination,

— prove to the economic operator concerned, on the
basis of all the relevant scientific elements available
to the Member State of destination, that there are
overriding grounds of general interest for imposing
these elements of the technical rule must be imposed
on the product concerned and that less restrictive
measures could not have been used,

— then invite the economic operator to submit any
comments
period
a
(approximately 20 working days), before taking
any individual measure restricting the marketing of
his product,

reasonable

within

— duly take account of these comments in the grounds

of the final decision,

— once

the

individual measure

the
the product has been taken, notify
marketing of
the economic operator concerned of
this recent
decision stating the methods of appeal open to him,

restricting

— notify this decision to the Commission pursuant to
Article 7 of Directive 92/59/EEC on general product
safety (and, as from 15 January 2004, pursuant to
Article 11 or 12 of Directive 2001/95/EC on general
product safety), or pursuant to Article 50 of Regu-
lation 178/2002 laying down the general principles
and requirements of food law,

One of the general principles of Community law is that
everybody must have the right to effective legal recourse
before the national courts against national decisions
which infringe a right recognised by the Treaties or
by secondary Community legislation. This principle
implies that those concerned may obtain information

— or, when these articles do not apply,

inform the
Commission of this decision pursuant to Decision
No 3052/95/EC of the European Parliament and of
the Council of 13 December 1995 establishing a
procedure for
information on
the exchange of
national measures derogating from the principle of
the free movement of goods within the Community.

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5.

5.1.

METHODS OF APPEAL AVAILABLE TO THE ECONOMIC
OPERATOR

The direct applicability of Articles 28 and 30 of the
EC Treaty

The provisions of Articles 28 to 30 of the EC Treaty
take precedence over all contrary national measures (62).

Consequently, where provisions of national law incom-
patible with Articles 28 to 30 of the EC Treaty exist, the
national courts and administrations are obliged to
impact of Community law by
full
guarantee
removing, on their own initiative,
conflicting
provisions of national law (63).

the

the

In addition, penalties, be they criminal or otherwise,
involving national
restrictive measures which have
been recognised as being contrary to Community law
the
are as
restrictions themselves (64).

incompatible with Community law as

its

jurisdiction,

Thus, a national court which is called upon, within the
limits of
to apply provisions of
Community law, is under a duty to give full effect to
those provisions, if necessary refusing of its own motion
to apply any conflicting provision of national legislation,
even if adopted subsequently, and it is not necessary for
the court to request or await the prior setting aside of
such provision by legislative or other constitutional
means (65).

The national courts can, where necessary, ask the Court
of Justice to give a preliminary ruling on the interpre-
tation of Articles 28 and 30 of
in
accordance with Article 234 of that Treaty.

the EC Treaty,

5.2. Contesting a refusal on the part of the competent
authority of the Member State of destination

in principle,

A negative decision by the Member State of destination
regarding the access of an EEA/Turkish product to its
likely to constitute a measure
market is,
having an equivalent effect
to a quantitative import
restriction, prohibited by Article 28 of the EC Treaty.
Thus, the economic operator may always contest under
national law a negative decision taken against him.

In appeals to the national courts, the latter must apply
Articles 28 and 30 of the EC Treaty, interpreted in the
light of the Court of Justice's case law, together with,
in this
the principles
where appropriate,

set out

communication,
decision as incompatible with these articles.

and must

consider

the negative

6.

SOME ADVICE TO MEMBER STATES

Correct application of mutual
recognition makes it
possible to reconcile competing public interests: on
the one hand,
the free movement of EEA/Turkish
products, guaranteed under Articles 28 and 30 of the
EC Treaty and, on the other, the protection of health,
the environment, consumers and so on.

As Member States are required to give precedence to
Articles 28 and 30 of the EC Treaty over all national
rules contrary to these articles, they must ensure that
their
rules comply with Community law.
Several options are open to them to achieve this,
some of which may be combined.

technical

6.1. Mutual recognition clause

operators

economic

Despite the direct impact of Articles 28 and 30 of the
the existence of a national technical rule
EC Treaty,
from
sometimes
discourages
that
marketing their products on the territory of
Member State, even if
their products provide an
adequate and recognised level of protection in certain
other Member States. In addition, the competent admin-
istration of
the Member State of destination often
hesitates to apply Articles 28 to 30 of the EC Treaty
when there is no specific legal basis in its national
technical
laws on which to assess the conformity of
an EEA/Turkish product.

these

reasons,

For
the Commission wants
Member States to include, in their national laws,
a mutual recognition clause designed to apply the
principle of mutual recognition correctly (66). This
clause will be inserted in national
laws and
of products
should permit
in
lawfully manufactured
another Member State.

and/or marketed

the marketing

that

the principles of

the Member States'

legal certainty and the
In fact,
in areas covered by
protection of individuals require,
Community law,
legal rules
should be worded unequivocally so as to give the
persons concerned a clear and precise understanding
of
rights and obligations and enable national
courts to ensure that those rights and obligations are
observed. The Commission considers that the mutual
recognition clause is a valid means to implement these
principles.

their

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This clause can take one of the following forms:

— a simple clause, when other parts of national laws
guarantees

administrative

already
outlined in this communication,

include

the

— a clause which makes provision for a more detailed
in compliance with the principles

procedure,
outlined in this communication.

Example of a detailed mutual recognition
clause:

The requirements of this law do not apply to
products lawfully manufactured and/or marketed
in another Member State of the European Union
or in Turkey, or lawfully manufactured in an
is a contracting party to the
EFTA State that
EEA agreement.

If the competent authorities have proof that a
lawfully manufactured and/or
specific product
marketed in another Member State of
the
European Union or in Turkey, or lawfully manu-
factured in an EFTA state that is a contracting
party to the EEA agreement, does not provide a
level of protection equivalent to that sought by
this law, they may refuse market access to the
product or have it withdrawn from the market,
after they:

— have

the
informed the manufacturer or
distributor in writing which elements of the
national technical rules prevent the marketing
of the product in question, and

elements

— have proved, on the basis of all the relevant
the
to the
available
scientific
there are over-
that
competent authorities,
interest
for
riding
general
grounds
the technical
imposing these elements of
rule must be
imposed on the product
concerned and that less restrictive measures
could not have been used, and

of

— have invited the economic operator to express
any comments he may have within a period
of (at least four weeks or 20 working days),
before issuing an individual measure against
him restricting the marketing of this product,
and

— have taken due account of his comments in

the grounds of the final decision.

shall

authority

competent

the
The
individual
economic operator
measures
the
restricting
product, stating the means of appeal available
to him.

concerned of
the marketing of

notify

6.2. Repeal of the technical rule

Another option is the abolition of the technical rule. An
assessment of the potentially restrictive effects of the
technical rule may lead to the conclusion that it is no
longer relevant or that it should be applied only to
national products.

In any event, the fact that the requirements imposed on
domestic products are more severe than those applied to
EEA/Turkish products does not interfere with the correct
application of the principle of mutual recognition.

6.3.

Ensuring transparency

State

Some economic operators prefer absolute certainty and
wish to avoid any event which might have a negative
impact on the reputation of their product, such as the
suspension of marketing when the authorities of the
Member
the
non-conformity of an EEA/Turkish product with a
technical
the Member State of destination.
Other economic operators fear the unpredictability of
the application of mutual recognition in a Member
State of destination, even if the laws contain technical
rules which are, even at first sight, disproportionate.

destination

establish

rule of

of

The Commission considers that there are several ways to
improve the predictability of mutual recognition, based
on the greater transparency. Some examples are:

6.3.1. Improving the accessibility of technical rules

Access to the technical rules is vital for the economic
operators wishing to market their EEA/Turkish products
in another Member State.

The Commission has noted that, too often, the principle
of mutual recognition is undermined because economic
operators do not know where to turn and what
information to supply to ensure application of
the
principle.

The Commission invites the Member States to ensure
that these rules, drafted in a clear manner, are publicised
in such a way as to make them more accessible to
economic operators,
through detailed
Internet
sites and through brochures published by
product sector, e.g. giving the name of the authorities
competent to provide information.

in particular

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competent

administration which is

One of the challenges for economic operators is ident-
ifying the
for
applying mutual
recognition with regard to their
product. The Commission invites Member States to
use appropriate means to publicise the services which
are responsible for applying technical rules and mutual
recognition, so that economic operators can obtain the
information needed.

to determine whether the technical approach they have
adopted is actually equivalent.

The Member State could make it easier to apply mutual
recognition by publicising the references to technical
rules and standards from other Member States which
have already been accepted because complying with
them achieves the level of protection required for the
objective pursued.

6.3.2. Appropriate publicity for equivalent approaches

6.3.3. Specifying the purpose of the legislation

Even where the legislation of the Member State of desti-
nation includes a mutual recognition clause for products
which provide,
level of
safety, it is sometimes difficult for economic operators

for example, an equivalent

The Commission encourages Member States to specify
in their regulatory texts the objectives they are pursuing.
Doing so will make it easier for national administrations
and economic operators to assess equivalence.

(1) In the absence of a specific Community measures on the safety of products intended for consumers or which may
be used by consumers, Directive 92/59/EEC of 29 June 1992 on general product safety (and, from 15 January
2004, Directive 2001/95/EC of the European Parliament and of the Council) has set up a horizontal legislative
framework with a view to guaranteeing a high level of protection for individuals' safety and health. This directive
places an obligation on economic operators to market only safe products. Therefore, those products which are
intended for consumers or which may be used by consumers, and which have been placed on the Community
market, are subject to the requirements and safety criteria laid down in the said directive. The same applies to
foodstuffs under the provisions of Regulation 178/2002 laying down the general principles and requirements of
food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety,
which set out, in particular, general rules intended to ensure that only safe foodstuffs and animal feed are placed on
the market.

(2) An economic operator is any person who wishes to market products. They include manufacturers, their represen-

tatives, wholesalers, distributors and any other professionals in the marketing chain.

(3) Communication COM(1999) 299 final to the Council and the European Parliament of 16 June 1999 on mutual
recognition in the context of the follow-up to the action plan for the Single Market. First biennial report on the
application of the principle of mutual recognition (SEC(1999) 1106 of 13 July 1999) and second biennial report
COM(2002) 419 final of 23 July 2002. These documents may be consulted on the Internet at the following address:
http://europa.eu.int/comm/internal_market/en/goods/mutrec.htm

(4) ‘EEA/Turkish’ products are defined in point 2.

(5) In the absence of harmonised Community rules, in the trade of products between Member States, the general rule of
Article 28 of the EC Treaty prohibits quantitative restrictions on imports of products and/or measures having
equivalent effect, which thus constitute obstacles to the free movement of products. Article 30 of the EC Treaty
states that the provisions of Article 28 shall not preclude prohibitions or restrictions on imports, exports or goods
in transit justified on grounds of public morality, public policy or public security; the protection of health and life
of humans, animals and/or plants; the protection of national treasures possessing artistic, historic or archaeological
value; or the protection of industrial and commercial property. Such prohibitions or restrictions shall not, however,
constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States. However
the Court of Justice has also indicated that restrictions to access to the market of another Member State, imposed
through national measures liable to constitute measures having equivalent effect within the meaning of Article 28 of
the EC Treaty, may be justified in the light of certain overriding requirements recognised by it, on condition that
these are necessary and proportionate.

(6) The references to the case law of the Court of Justice in this communication are not exhaustive. They include only
the specific judgments which may assist the competent authorities and the economic operators to examine a
particular problem in the light of related Community case law.

(7) This concerns the selling arrangements within the meaning of the Judgment of the Court of Justice of 24 November
1993, criminal proceedings against Bernard Keck and Daniel Mithouard, European Court Reports 1993, p. I-6097
and its subsequent case law on this matter.

(8) Among the legitimate interests which are most commonly invoked are the protection of health and life of humans,

animals or plants, the protection of the environment, the protection of consumers.

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(9) This principle originates in the ‘Cassis de Dijon’ Judgment of 20 February 1979 (Rewe-Zentral AG v. Bundes-
monopolverwaltung für Branntwein), Case 120/78, European Court Reports 1979, p. 649. From 1980,
the
Commission drew up a number of guidelines regarding the application of the principle of mutual recognition
arising from Court case law, in particular in the communication from the Commission concerning the consequences
of the judgment given by the Court of Justice on 20 February 1979 in Case 120/78 (Cassis de Dijon) (OJ C 256,
3.10.1980).

(10) For the purposes of this communication, a product is defined as a moveable good which is capable, as such, of
forming the subject of commercial transactions: Judgment of the Court of 21 October 1999, Peter Jägerskiöld v.
Torolf Gustafsson, Case C-97/98, European Court Reports 1999, p. I-7319. According to Court of Justice case law,
goods taken across a frontier for the purposes of commercial transaction are subject to Article 28 of the EC Treaty,
whatever the nature of those transactions: see in particular ground 20 of the Judgment of the Court of 28 March,
1995, The Queen v. Secretary of State for Home Department, ex parte Evans Medical Ltd and Macfarlan Smith Ltd,
Case C-324/93, European Court Reports 1995, p. I-563.

(11) See in particular ground 32 of Judgment of the Court of 13 December 2001, DaimlerChrysler AG v. Land

Baden-Württemberg, Case C-324/99, European Court Reports 2001 p. I-9897.

(12) These are, for example, certain pharmaceutical products, biocides and plant protection products.

(13) The specific list of the ‘new approach’ directives, guaranteeing this free movement through conformity to the
essential requirements and the EC mark, may be consulted on the site http://europa.eu.int/comm/enterprise/newap-
proach/standardization/harmstds/reflist.html

(14) The applicable Community legislation may be consulted on http://europa.eu.int/eur-lex/en/lif/index.html. Please note
the importance of a careful reading of the Community legislation to determine to what extent mutual recognition
may apply to the product concerned. In fact, certain aspects of a product may be harmonised at Community level
whereas other aspects of the same product will not be covered by Community harmonisation. Mutual recognition
will continue to apply to these latter aspects.

(15) In particular,

to Directive
these are the national applications for market authorisation, awarded pursuant
2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code
relating to medicinal products for human use, or pursuant to Directive 98/8/EC of the European Parliament and
of the Council of 16 February 1998 concerning the placing of biocide products on the market, and to Council
Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market.

(16) Article 4(2) of Directive 92/59/EEC and, from 15 January 2004, Article 3(2) of Directive 2001/95/EC on general

product safety.

(17) Ground 25 of the Judgment of the Court of 23 March 2000, Criminal Proceedings against Berendse-Koenen M.G. in
Berendse H.D. Maatschappij, Case C-246/98, European Court Reports 2000, p. I-1777; Grounds 25 and 26 of the
Judgment of the Court of 23 May 1996, The Queen v. Ministry of Agriculture, Fisheries and Food, ex parte: Hedley
Lomas (Ireland) Ltd, Case C-5/94, European Court Reports 1996, p. I-2553. Member States are required to include
in their national legislation a reference to the Community legislation which they are transposing. This helps to
identify which parts of the national legislation in question transpose Community legislation and which parts are
governed by Articles 28 and 30 of the EC Treaty. Nonetheless, close reading of the Community legislation is crucial
in order to assess the extent to which mutual recognition may apply to the product in question. Indeed, certain
aspects of a product may be harmonised at the Community level while other aspects of the same product are not.
Mutual recognition continues to apply to these latter aspects.

(18) Articles 5 to 7 of Decision No 1/95 of the EC-Turkey Association Council of 22 December 1995 on implementing
the final phase of the Customs Union (OJ L 35, 13 February 1996, p. 1) provide for the elimination of measures
having an effect equivalent to customs duties between the European Union and Turkey. Pursuant to Article 66 of
Decision 1/95, Articles 5 to 7 must, for the purposes of their implementation and application to products covered
Justice.
by the Customs Union, be interpreted in conformity with the relevant
Consequently, principles resulting from the Court of Justice's case law on issues which are related to Articles 28
and 30 of the EC Treaty, particularly the ‘Cassis de Dijon’ case, apply to the Member States and to Turkey.

Judgments of

the Court of

(19) Articles 8(2) and 9 of the Agreement on the European Economic Area, and Protocol 4 thereof. The Articles 28 to
30 of the EC Treaty form part of the Community acquis included in full in Articles 11 and 13 of the Agreement on
the European Economic Area, which are interpreted in accordance with the relevant case law of the Court of Justice
of the EC prior to the date of the signing of the Agreement. This communication therefore applies also to products
manufactured in Iceland, Liechtenstein and Norway.

(20) However, it should be noted that, when national rules are contrary to Articles 28 and 30 of the EC Treaty, the
Court of Justice has confirmed that the application of those rules is prohibited only in respect of imported products
and not national products. See in particular ground 21 of Judgment of the Court of 5 December 2000, Criminal
Proceedings against Jean-Pierre Guimont, Case C-448/98, European Court Reports 2000, p. I-10663.

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(21) Article 24 of the EC Treaty states that ‘products coming from a third country shall be considered to be in free
circulation in a Member State if the import formalities have been complied with and any customs duties or charges
having equivalent effect which are payable have been levied in that Member State, and if they have not benefited
from a total or partial drawback of such duties or charges’. In addition, ground 37 of the Judgment of the Court of
22 January 2002, Canal Satélite Digital SL v. Adminstración General del Estado, in the presence of Distribuidora de
Televisión Digital SA (DTS), Case C-390/99, European Court Reports 2002, p. I-607, confirms this principle: ‘It is
well established in case law that a product which is lawfully marketed in one Member State must in principle be
able to be marketed in any other Member States without being subject to additional control, save in the case of
exceptions provided for or allowed by Community law’.

(22) See Directive 2001/95/EC and Directive 92/59/EEC on general product safety.

(23) Ground 26 of the Judgment of the Court of 21 June 2001, Commission of the European Communities v. Ireland,

Case C-30/99, European Court Reports 2001, p. I-4619.

(24) See in particular ground 36 of the Judgment of the Court of 24 October 2002, Criminal Proceedings against Walter

Hahn, Case C-121/00, European Court Reports 2002, p. I-9193.

(25) Grounds 17 and 18 of the Judgment of the Court of 16 November 2000, Commission v. Belgium, Case C-217/99,

European Court Reports 2000, p. I-10251.

(26) A national standard means a technical specification adopted by a national standards body for repeated or

continuous application, made available to the public and compliance with which is not compulsory.

(27) Judgment of the Court of 22 September 1988, Commission of the European Communities v. Ireland, Case 45/87,

European Court Reports 1988, p. 4929.

(28) Judgment of the Court of 14 June 2001, Commission of the European Communities v. French Republic, Case

C-84/00, European Court Reports 2001, p. I-4553.

(29) Judgment of the Court of 14 July 1988, Criminal Proceedings against Zoni, Case 90/86, European Court Reports

1988, p. 4285.

(30) Judgment of the Court of 5 April 2001, Criminal Proceedings against Christina Bellamy and English Shop Wholesale
SA, Case C-123/00, European Court Reports 2001, p. I-2795; Judgment of the Court of 14 June 2001, Commission
of the European Communities v. French Republic, Case C-84/2000, European Court Reports 2001, p. I-4553.

(31) Judgment of the Court of 24 October 2002, Criminal Proceedings against Walter Hahn, Case C-121/2000,

European Court Reports 2002, p. I-9193.

(32) Judgment of the Court of 12 October 2000, Cidrerie Ruwet SA v. Cidre Stassen SA and HP Bulmer Ltd, Case
C-3/99, European Court Reports 2000, p. I-8749; Judgment of the Court of 10 November 1982, Walter Rau
Lebensmittelwerke v. De Smedt PVBA, Case 261/81, European Court Reports 1982, p. 3961.

(33) Judgment of the Court of 5 December 2000, Criminal Proceedings against Jean-Pierre Guimont, Case C-448/98,

European Court Reports 2000, p. I-10663.

(34) Judgment of the Court of 4 December 1986, Commission of the European Communities v. Federal Republic of
Germany, Case 179/85, European Court Reports 1986, p. 3879; Judgment of the Court of 6 June 2002, Sapod
Audic v. Eco-Emballages SA, Case C-159/00, European Court Reports. 2002, p. I-5031.

(35) Judgment of the Court of 12 September 2000, Criminal Proceedings against Yannick Geffroy and Casino France
SNC, Case C-366/98, European Court Reports 2000, p. I-6579; Judgment of the Court of 16 November 2000,
Commission of the European Communities v. Kingdom of Belgium, Case C-217/99, European Court Reports. 2000,
p. I-10251.

(36) See in particular number 17 of the grounds of the Judgment of 28 January 1986, Commission of the European
for woodworking machines’), Case 188/84, European Court

Communities v. French Republic (‘Type-approval
Reports 1986, p. 419.

(37) The Directive on general product safety does however permit Member States to take rapid restrictive measures with
regard to products which are dangerous or are likely to be dangerous, pursuant to Articles 6,7 or 8 and 14 of
Directive 92/59/EC and, as from 15 January 2004, pursuant to Articles 8, 11 or 12 and 18 of Directive
2001/95/EC.

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(38) In its Judgment of 22 January 2002, (Canal Satélite Digital SL v. Adminstración General del Estado, and Distri-
buidora de Televisión Digital SA (DTS), Case C-390/99, European Court Reports 2002, p. I-607), the Court made it
clear that a prior authorisation procedure restricted the free movement of goods. However, to be justified in the
light of these fundamental freedoms, such legislation must pursue a motive of public interest recognised under
Community law and respect the principle of proportionality,
i.e. be able to guarantee the achievement of the
objective pursued and not go beyond what is necessary to attain it.

(39) Ground 15 of the Judgment of the Court of 13 December 1999, Criminal Proceedings against Jean-Claude Bellon,

Case C-42/90, European Court Reports 1990, p. I-4863.

(40) However, this proof by the competent authority of the Member State where the EEA/Turkish product is lawfully
manufactured and/or marketed is only one of several possibilities: it cannot be required by the competent authority
of the Member State of destination. See ground 63 of the Judgment of 8 May 2003 (ATRAL v. Belgian State, Case
C-14/02), where the Court specified that imposing as a condition the attestation of conformity of EEA products
with technical standards or rules which guarantee a level of protection equivalent to that required by the Member
State of destination is contrary to Article 28 of the EC Treaty.

(41) In the exceptional situation of a prior authorisation procedure, marketing may take place only after the author-

isation has been obtained.

(42) See, in this respect, the Judgment of the Court of 17 June 1987, Commission of the European Communities v.

Italian Republic, Case 154/85, European Court Reports 1987, p. 2717.

(43) However,

in the exceptional situation of a prior authorisation procedure,

it is sufficient to refuse the prior

authorisation.

(44) See in particular ground 36 of the Judgment of the Court of 22 January 2002, Canal Satélite Digital SL v.
Adminstración General del Estado, and Distribuidora de Televisión Digital SA (DTS), Case C-390/99, European
Court Reports 2002, p. I-607.

(45) Judgment of the Court of 8 June 1993, Commission of the European Communities v. Kingdom of Belgium, Case

C-373/92, European Court Reports 1993, p. I-3107.

(46) Ground 35 of the Judgment of the Court of 17 September 1998, Criminal Proceedings against Jean Harpegnies,

Case C-400/96, European Court Reports 1998, p. I-5121.

(47) Judgment of the Court of 17 December 1981, Criminal Proceedings against Frans-Nederlandse Maatschappij voor
Biologische Producten BV, Case 272/80, European Court Reports 1981, p. 3277; ground 23 of the Judgment of 14
July 1983, Criminal Proceedings against Sandoz BV, Case 174/82, European Court Reports 1983, p. 2445.

(48) Judgment of the Court of 8 June 1993, Commission of the European Communities v. Kingdom of Belgium, Case

C-373/92, European Court Reports 1993, p. I-3107.

(49) The Member State of destination should accept the reports and certificates drawn up by a body providing guar-
antees equivalent to those required for national bodies. It follows from this that these guarantees of independence
offered by the body established in the Member State of origin must not necessarily coincide with those laid down in
the national law of the Member State of destination: ground 69 of the Judgment of the Court of 21 June 2001,
Commission of the European Communities v. Ireland, Case C-30/99, European Court Reports, p. I-4619.

(50) See in particular grounds 34 to 36 of the Judgment of the Court of 5 June 1997, Ditta Angelo Celestini v.

Saar-Sektkellerei Faber GmbH and Co. KG, Case C-105/94, European Court Reports. 1997, p. I-2971.

(51) If there is a justified need for a check or inspection, the costs involved are to be covered by the person who is
having the check carried out or who is requesting type-approval. These costs must be proportionate, and therefore
cannot be greater than what is needed to cover the costs of the inspection procedure: see in particular grounds 41
and 42 of the Judgment of the Court of 22 January 2002 (Canal Satélite Digital SL v. Adminstración General del
Estado, and Distribuidora de Televisión Digital SA (DTS), Case C-390/99). However, as these checks are carried out
upstream and on the market, the Court of Justice deemed that such inspections cannot be considered as a service
rendered to the importer. Therefore, the expense occasioned by such inspections must be met by the general public
which, as a whole, benefits from the free movement of Community goods: Ground 31 of Court of Justice Judgment
of 15 December 1993, Ligur Carni Srl and Genova Carni Srl v Unità Sanitaria Locale n. XV di Genova and Ponente
SpA v Unità Sanitaria Locale n. XIX di La Spezia and CO.GE.SE.MA Coop arl, Joined Cases C-277/91, C-318/91 and
C-319/91, European Court Reports. 1993, p. I-6621.

(52) These are, more specifically, requirements recognised as measures which derogate from Article 28 EC by Article 30
EC, together with the overriding requirements recognised by the Court of Justice's case law as being likely to justify
a measure having an equivalent effect within the meaning of Article 28 EC.

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(53) The evaluation of the risk involves both determining the level of risk (i.e. the critical threshold of the probability of
adverse effects for one of the imperative reasons mentioned in Article 30 EC or recognised by the Court as an
imperative requirement liable to justify a measure having equivalent effect within the meaning of Article 28 EC)
and, secondly, carrying out a scientific assessment of the risks. The precautionary principle can play an important
role in the context of risk management: see communication COM(2000) 1 of the Commission on recourse to the
precautionary principle: http://europa.eu.int/comm/food/fs/pp/pp_index_en.html

(54) Judgment of the Court of 14 July 1994, Criminal Proceedings against J.J.J. Van der Veldt, Case C-17/93, European
Court Reports. 1994, p. I-35; Judgment of the Court of 4 June 1992, Criminal Proceedings against Michel Debus,
Joint Cases C-13/91 and C-113/91, European Court Reports 1992, p. I-3617; Judgment of the Court of 24 October
2002, Criminal Proceedings against Walter Hahn, Case C-121/2000, European Court Reports 2002, p. I-9193.

(55) Article 30 of the Treaty or case law on overriding requirements respectively. See in particular Judgment of the Court
of 28 January 1986, Commission of the European Communities v. French Republic (‘Type-approval of wood-
working machines’), Case 188/84, European Court Reports 1986, p. 419.

(56) For example, the competent authority should ask itself whether appropriate labelling, or the product notice, or

other characteristics of the product are sufficient to provide a suitable level of protection for consumers.

(57) This would be contrary to the principle of proportionality. Judgment of the Court of Justice of 28 January 1986,
Commission of the European Communities v. French Republic (‘Type-approval of woodworking machines’), Case
188/84, European Court Reports 1986, p. 419.

(58) Judgment of the Court of 21 September 1999, Markku Juhani Läärä, Cotswold Microsystems Ltd and Oy Trans-
atlantic Software Ltd v. Kihlakunnansyyttäjä (Jyväskylä) and Suomen valtio (Finnish State), Case C-124/97, European
Court Reports 1999, p. I-6067.

(59) This principle applies all the more in the context of the exceptional situation of the obligatory authorisation
procedure prior to marketing, which is necessary only if an a posteriori control must be considered too late to
guarantee real effectiveness and to permit it to obtain the objective pursued. Such a procedure must pursue a public
i.e. be able to
interest objective recognised by Community law and respect the principle of proportionality,
guarantee the achievement of the objective pursued and go no further than is necessary to achieve it. For such
a procedure to be proportionate, it must, in any event, be based on objective, non-discriminatory criteria which are
known in advance, in such a way as to circumscribe the exercise of the national authorities' discretion so that this
discretion is not used arbitrarily. In addition, such a procedure cannot provide for controls which,
in essence,
duplicate controls which have already been carried out in the context of other procedures, either in the same State
or in another Member State. Lastly, a prior authorisation procedure cannot comply with the fundamental principle
of the free movement of goods if, through its duration and the disproportionate costs to which it gives rise, is likely
to dissuade the operators concerned from continuing their action. In any event the Commission considers that a
period of 90 days is disproportionate.

(60) See in particular ground 16 of the Judgment of 13 December 1990, Criminal Proceedings against Jean-Claude

Bellon, Case C-42/90, European Court Reports 1990, p. I-4863.

(61) Judgment of the Court of 9 May 1985, Commission of the European Communities v. French Republic (postal
franking machines), Case 21/84, European Court Reports 1985, p. 1355; Judgment of the Court of 19 March 1991,
Commission of the European Communities v. Kingdom of Belgium, Case C-249/88 European Court Reports 1991,
p. I-1275.

(62) Judgment of the Court of 28 March 1995, The Queen v. Secretary of State for Home Department, ex parte Evans

Medical Ltd and Macfarlan Smith Ltd., Case C-324/93, European Court Reports 1995, p. I-5.

(63) Ground 18 of the Judgment of the Court of 13 March 1997, Tommaso Morellato v. Unità sanitaria locale (USL) No

11 di Pordenone, Case C-358/95, European Court Reports 1997, p. I-1431.

(64) Judgment of the Court of 20 June 2002, Radiosistemi Srl v. Prefetto di Genova, Combined Cases C-388/2000 and

C-429/2000, European Court Reports 2002, p. I-5845.

(65) Judgment of the Court of 4 June 1992, Criminal Proceedings against Michel Debus, Combined Cases C-13/91 and

C-113/91, European Court Reports 1992, p. I-3617.

(66) See in particular Judgment of the Court of 22 October 1998, Commission of the European Communities v. French
Republic, (‘Foie gras’ Judgment), Case C-184/96, European Court Reports 1998, p. I-6197. The Commission is
making certain that such a clause is included in all new technical regulations, thanks to the notification procedure
set out in Directive 98/34/EC. The website http://europa.eu.int/comm/enterprise/tris makes available draft technical
rules notified under Directive 98/34/EC together with the texts adopted after the procedure has been completed. It
thus provides economic operators with easy access to the applicable rules.