Erhvervs-, Vækst- og Eksportudvalget 2015-16
ERU Alm.del Bilag 389
Offentligt
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NOTE
September 2016
Danish response to the public consultation on the possible revision of
the Mutual Recognition Regulation (EC) No 764/2008 applying in
the field of the free movement of goods
General remarks
The Danish Government welcomes and supports the Commission’s initiati-
ve to improve the application and enforcement of the principle of mutual
recognition and the Mutual Recognition Regulation (MR-Regulation). The
Danish Government agrees with the objective to create better market condi-
tions for European Businesses on the Single Market for goods by addressing
the shortcomings in the current application of the MR-Regulation.
This calls for actions on various levels. This paper proposes some suggesti-
ons for further boosting the rules and procedures of mutual recognition.
The scope of the MR-Regulation should be clarified, better structures for
proportionality assessments should be put in place, and an informal set-up
could ensure better sharing of best practices among Member States. Also,
dissuasive means should be introduced to ensure that Member States notify
according to their obligations in the Regulation, e.g. by introducing legal
consequences for non-notification. Moreover, effective remedies must be
available to businesses in order for them to get quicker clarity on decisions
taken against their products on the Single Market, including enhanced trans-
parency to see the decisions. In addition, the PCPs should be optimised and
give businesses easy access to information about national decisions and
technical rules.
However, it is important not to view the MR-Regulation in isolation from
other mechanisms and tools that apply in the non-harmonised area of
goods. The Commission could also look into how Member State authorities
in general could better assess the effect on the Single Market of new natio-
ERU, Alm.del - 2015-16 - Bilag 389: Dansk høringssvar vedr. Kommissions høring om en mulig revision af forordningen om gensidig anerkendelse, fra erhvervs- og vækstministeren
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nal legislation in the non-harmonised area. Also, there is an overall need for
redeeming trust and strengthening cooperation among Member State autho-
rities across the Single Market. National rules and requirements are typically
upheld on specific cultural or historical grounds, because authorities do not
examine the possibility that the level set by another Member State authority
could, in fact, be safe enough.
Comments and suggestions
Clarification of the scope of the Mutual Recognition Regulation
The MR-Regulation is unclear on which products and situations are covered
by the regulation. When Member State authorities have doubts about to
which extend the rules and procedures apply, the risk of breaching their
obligations under the Regulation rise. In order to improve the application of
the MR-regulation, and in effect strengthen the principle of mutual recogni-
tion, authorities need to become much more confident in navigating among,
and applying, the rules and procedures in practice.
Suggestions
The Mutual Recognition Regulation should clearly state that its sco-
pe applies to products outside the harmonised area
as well as
non-
harmonised parts of harmonised areas.
Among others, the notions of “prior authorisation” and “lawfully
marketed” remain to be clarified.
Clearer structures for the assessment of proportionality
should be put in pla-
ce, combined with guiding tools, such as online access to selected
case law on mutual recognition.
Set-up of an informal environment for
better sharing of best practices
among Member States in connection with applying the MR-
Regulation, e.g. within the Committee on mutual recognition.
As a starting point, the MR-Regulation should make clear that the Regulati-
on applies to products outside the harmonised area
as well as
non-
harmonised parts of harmonised legislation. In practice, Member States in-
troduce national legislation in addition to harmonised legislation with no
regard to the mutual recognition principle. One of the reasons for this could
be the fact that the MR-Regulation does not clearly state that those national
rules are also subject to the principle of mutual recognition.
Further, both Member State authorities and businesses have difficulties de-
monstrating when a product has been “lawfully marketed” and grasping the
implications of “prior authorisation”, as both notions are vaguely described
in the Regulation. As a result, authorities may tend to privilege their own
national rules instead of mutually recognising other Member States’ techni-
ERU, Alm.del - 2015-16 - Bilag 389: Dansk høringssvar vedr. Kommissions høring om en mulig revision af forordningen om gensidig anerkendelse, fra erhvervs- og vækstministeren
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cal rules and test results, because they often are much better acquainted with
their own rules, testing schemes, etc.
A
“declaration of conformity”
could be a possible solution for businesses to
show that their products have already been lawfully marketed in another
Member State when entering a new market. However, before its introducti-
on, an assessment must indicate an opportunity for adding actual value to
the application and enforcement of the MR-Regulation - and if introduced,
the declaration should be voluntary and the burden of proof should lie with
the Member State authorities with a view to reduce burdens on businesses.
Moreover, such a declaration should to the greatest extend possible build on
existing data and structures within e.g. the context of market surveillance
activities.
Moreover,
clearer structures for the assessment of proportionality
should be put in
place to help authorities better decide on specific cases of conflicting natio-
nal rules and grounds of justification. In addition, guiding tools, such as
online access to selected case law on mutual recognition, could be launched
with a view to guide authorities’ assessment of proportionality in specific
cases.
Additionally, Member States could to a much greater extend benefit from
better sharing of best practices
in an informal environment for assessing and dis-
cussing difficulties and grey areas in connection with applying the MR-
Regulation, e.g. within the Committee on mutual recognition. In this way, it
could become clearer how national authorities should interpret the rules and
procedures of the Regulation, and how to decide on specific cases of con-
flicting national rules and grounds of justifications.
Dissuasive means to ensure fulfilment of national authorities’ obligations
According to Commission statistics, only 5 Member States notified their
decisions in accordance with the MR-Regulation in 2014. Therefore, a better
structure should be put in place to ensure that all Member State authorities
notify in accordance with their obligations under the Regulation.
Suggestions
The MR-Regulation should include
consequences of non-notification
of
decisions in accordance with the Regulation, e.g. non-notified deci-
sions cannot be enforced like it is the case of non-notification under
the Transparency Directive (2015/1535/EU).
The Commission should introduce a systematic follow up asses-
sment of Member State authorities’ grounds of justifications of
derogation from the principle of mutual recognition. This could be
combined with the introduction of
a mandatory proportionality test.
A structured framework already exists for the notification of new national
technical regulations for goods outside the harmonised area in accordance
ERU, Alm.del - 2015-16 - Bilag 389: Dansk høringssvar vedr. Kommissions høring om en mulig revision af forordningen om gensidig anerkendelse, fra erhvervs- og vækstministeren
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with the Transparency Directive (2015/1535/EU). The principle of mutual
recognition is very closely linked to this framework, as Member State autho-
rities take the decisions under the MR-Regulation on the basis of these
technical regulations. Thus, similar legal consequences could be introduced
to ensure that Member State authorities fulfil their obligations to notify un-
der the MR-Regulation.
Furthermore,
a systematic follow-up mechanism
should be introduced for asses-
sing the grounds of justifications of derogations from the principle of mutu-
al recognition. The absence of such a mechanism upholds a great deal of
legal uncertainty on the Single Market for goods. Currently, the Regulation
lists a selection of legitimate reasons that authorities may use to justify deci-
sions to deny market access for a product lawfully marketed in another
Member State. As a rule, these legitimate reasons are only allowed under
strict conditions, but in reality, they are applied in various situations without
any further case-by-case examination. Such a mechanism could be combined
with the introduction of
mandatory proportionality tests
for Member Stat autho-
rities to carefully explain the grounds of justifications in national decisions
taken in accordance with the Regulation.
Ensuring that effective remedies are available to economic operators
Today, when European businesses meet requirements of e.g. additional te-
sting, they can either choose to retest the product, and adhere to the natio-
nal decision, or challenge the decision taken against their market access, if
they believe that e.g. the grounds of justification are disproportional and
unnecessary.
However, when a business chooses to challenge a decision, they are current-
ly left with year-long proceedings in national courts and high costs of
awaiting these court proceedings. As a result, businesses simply adapt their
products to the national requirements in question, because challenging them
do not match the risk of losing profits and new market opportunities, espe-
cially for small businesses.
Suggestions
A set-up should be put in place for European businesses to have ac-
cess to
effectively challenge decisions
adopted against the free movement
of their products.
Businesses should have
better access to see notifications
of Member State
decisions taken in accordance with the MR-Regulation, as it is the
case of notifications in accordance with the Transparency Directive
(2015/1535/EU).
Businesses should be able to get quicker clarity to obstacles they meet when
entering new markets, and reduce the costs that may follow with national
requirements of, for instance, additional testing – which for small businesses
ERU, Alm.del - 2015-16 - Bilag 389: Dansk høringssvar vedr. Kommissions høring om en mulig revision af forordningen om gensidig anerkendelse, fra erhvervs- og vækstministeren
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can be potentially fatal. In that way, existing unlawful technical barriers
would be reported and addressed.
Additionally, the notification procedure for the decisions taken in accor-
dance with the MR-Regulation could be more transparent. Businesses
should have access to see and follow the notifications of decisions to en-
hance legal certainty and due process in cross-border trade. Such a
framework already exists for the notifications of new technical regulations
under the auspices of the Transparency Directive (2015/1535/EU). Similar-
ly, businesses should have access to see the decisions taken in accordance
with the MR-Regulation, and the grounds of justification of those decisions.
Strengthening the Product Contact Points and introducing strict deadlines
The PCPs should help businesses get easy access to information about
Member State decisions and technical regulations in relation to the principle
of mutual recognition. However, in practice businesses have to contact each
Member State individually, and because the functioning of the PCPs has
never been legally formalised, the service levels in Member States are very
varied, e.g. in terms of language and quality of replies as well as response
time. This is also manifested in the fact that some Member States have crea-
ted an easy online overview of already adopted decisions, etc., while others
do not have a website nor provide an e-mail address.
Suggestions
The handling and response, including response times, should beco-
me more streamlined and structured for businesses to be properly
informed and get the necessary help in an effective manner.
As part of the announced governance framework for the Single Di-
gital Gateway, the Commission should introduce common quality
criteria for the content, functioning and level of integration of each
portal, including the PCPs.
Final remarks
The Danish government is looking forward to the coming work on the pos-
sible revision of the Mutual Recognition Regulation. It is important to ensu-
re that the Commission and Member States are both ambitious and deter-
mined to reach an outcome that will, in fact, facilitate a better application
and enforcement of the principle of mutual recognition.
In the coming work it is, therefore, important to balance between the needs
of Member States and European businesses: the difficulties Member States
have with applying the rules and procedures of the MR-regulation in prac-
tice
as well as
the difficulties businesses face in cross-border trade with
goods, including the fact that they cannot get quick and efficient access to
challenge the technical barriers they meet on the Single Market.