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

Erhvervs-, Vækst- og Eksportudvalget 2015-16
ERU Alm.del Bilag 389
Offentligt

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.

“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

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.