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Document 52013DC0592
COMMISSION WORKING DOCUMENT Guidance document. The concept of ‘lawfully marketed’ in the Mutual Recognition Regulation (EC) No 764/2008
COMMISSION WORKING DOCUMENT Guidance document. The concept of ‘lawfully marketed’ in the Mutual Recognition Regulation (EC) No 764/2008
COMMISSION WORKING DOCUMENT Guidance document. The concept of ‘lawfully marketed’ in the Mutual Recognition Regulation (EC) No 764/2008
/* COM/2013/0592 final */
COMMISSION WORKING DOCUMENT Guidance document. The concept of ‘lawfully marketed’ in the Mutual Recognition Regulation (EC) No 764/2008 /* COM/2013/0592 final */
TABLE OF CONTENTS COMMISSION WORKING DOCUMENT Guidance
document. The concept of ‘lawfully marketed’ in the Mutual Recognition
Regulation (EC) No 764/2008................................................................................... 3 1........... Introduction.................................................................................................................... 3 2........... The principle of mutual
recognition.................................................................................. 3 3........... The Mutual Recognition
Regulation (EC) No 764/2008................................................... 4 4........... The concept of lawfully marketed.................................................................................... 5 5........... Obligations under the Mutual Recognition Regulation....................................................... 6 6........... Means of evidence.......................................................................................................... 6 6.1........ Rights and obligations..................................................................................................... 7 6.2........ Failure to notify the economic
operator............................................................................ 8 7........... The role of the Product Contact
Points............................................................................ 8 8........... Conclusions.................................................................................................................... 9 COMMISSION WORKING DOCUMENT Guidance document.
The concept of ‘lawfully marketed’ in the Mutual Recognition Regulation (EC) No
764/2008[1] (Text with EEA relevance) 1. Introduction On 15 June 2012, the Commission adopted its
first report on the application of Regulation (EC) 764/2008 (‘the Mutual
Recognition Regulation’)[2]
and proposed that the Consultative Committee on Mutual Recognition should closely
monitor, among other areas, the difficulties faced by economic operators when
trying to demonstrate that a product has been lawfully marketed in
another Member State. To address this concern, this guidance
document seeks to provide user-friendly guidance on the concept of ‘lawfully
marketed’ in the Mutual Recognition Regulation. It will be updated to reflect experience
and information from the Member States, authorities and businesses. 2. The
principle of mutual recognition The free movement of goods is one of the
success stories of the European project. It has helped to build the internal
market, from which European citizens and businesses are now benefiting and
which is at the heart of EU policies. Obstacles to the free movement of goods
between Member States may be unlawfully created by the Member States’ competent
authorities applying, in the absence of harmonised legislation, technical rules
laying down requirements to be met by products lawfully marketed in other
Member States. The application of such rules to products lawfully marketed in
another Member State can be contrary to Articles 34 and 36 of the Treaty on the
Functioning of the European Union (TFEU), even if they apply without
distinction to all products. The principle of mutual recognition, which
derives from the case law of the Court of Justice of the European Union,[3] plays an important part in the
functioning of the internal market and allows the free movement of products in
the absence of any EU harmonising legislation. This guidance document makes it clear that,
under the Mutual Recognition Regulation, the Member State of destination of a
product[4]
must allow the placing on its market of a product lawfully marketed in another
Member State or in an EFTA state that is a contracting party to the Agreement on
the European Economic Area (‘the EEA Agreement’),[5] unless the procedural
requirements for denying mutual recognition established by the Regulation were met. A full discussion on the defences that
could be used by Member States to justify national measures that impede
cross-border trade (the exceptions listed in Article 36 TFEU) can be found in
the Commission's Guide to the application of Treaty provisions governing the
free movement of goods.[6] 3. The
Mutual Recognition Regulation (EC) No 764/2008 The Mutual Recognition Regulation, in force
since May 2009, aims to give effect to the principle of mutual recognition. Applying
exclusively to products or particular features of them not subject to
harmonisation measures at EU level, it defines the rights and obligations of
national competent authorities and those of enterprises wishing to sell in a
Member State products lawfully marketed in another Member State, when the
authorities intend to take restrictive measures regarding the product in
accordance with national technical rules. In particular, the Mutual Recognition
Regulation focuses on the burden of proof by setting out the procedural
requirements for denying mutual recognition. The Mutual Recognition Regulation applies
in all the Member States as well as in the EFTA states that are contracting
parties to the Agreement on the European Economic Area (EEA). Although the
principle of mutual recognition also applies to EU-Turkey relations,[7] the Mutual Recognition
Regulation as such does not.[8] The Mutual
Recognition Regulation lays down the rules and
procedures to be followed by the competent authorities of a Member State when taking or intending to take a decision, in accordance with national technical
rules, which would hinder the free movement of a product lawfully marketed in
another Member State and subject to Article 34 TFEU. 4. The
concept of lawfully marketed The Mutual Recognition
Regulation itself does not define the concept ‘lawfully marketed’ for products
falling within its scope, i.e. not subject to harmonisation. Furthermore, there
is no jurisprudence of the Court of Justice on this concept. Nevertheless, the concepts of 'making available' and
'placing on the market' are defined by Regulation (EC) No 765/2008[9]. Thus, ‘making available on the market’ means any supply of a product for
distribution, consumption or use on the Union market in the course of a
commercial activity, whether in return for payment or free of charge[10] and ‘placing on the market’
means the first making available of a product on the Union market[11]. For products which are
subject to the Mutual Recognition Regulation, the Commission consequently considers
that the concept of ‘marketing’ means any supply of a product for distribution,
consumption or use in another Member State or in an EFTA state that is a contracting
party to the EEA Agreement, in the course of a commercial activity, whether in
return for payment or free of charge. Correspondingly, the
Commission takes the view that the concept of ‘lawful marketing’ means that the
supply, as referred to in the previous paragraph, should take place in: –
another Member State, in accordance with the
applicable national legislation; or –
an EFTA state that is a contracting party to the
EEA Agreement in accordance with the applicable national legislation. –
Additionally, with regard to products intended
for (or which may be used by) consumers, products placed on the EU market are
subject to the requirements and safety criteria laid down by the Directive on
general product safety.[12] –
As regards products imported from third
countries, they must lawfully be marketed in a Member State or in an EFTA state
that is a contracting party to the EEA Agreement in order to benefit from
mutual recognition. An economic operator imports into an EU or EFTA state that is
a contracting party to the EEA agreement products from a third country. Once
released for free circulation[13],
these products are considered as Community goods. From that moment on
those products may be marketed in another EU or EFTA state that is a
contracting party to the EEA agreement under the terms of the Mutual
Recognition Regulation. 5. Obligations under the Mutual Recognition Regulation An essential principle of EU law is that a product
that is subject to the Mutual Recognition Regulation enjoys the basic right of
free movement of goods guaranteed by the TFEU, provided that the Member State
of destination has not taken a reasoned decision of refusal, based on
proportionate technical rules.[14] 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 assess the need to apply a technical
rule, as set out in the Mutual Recognition Regulation. Therefore, the Mutual Recognition
Regulation gives the opportunity to economic operators to provide information
to responsible authorities of the receiving Member State as regards the lawful
marketing of the product in another Member State or in an EFTA state that is a contracting party to the EEA Agreement. When the competent authority of the Member State of destination requires an evaluation of the conformity of a product lawfully
marketed in another Member State or in an EFTA state that is a contracting
party to the EEA Agreement with its own technical rules, this should be done
following the terms of the Mutual Recognition Regulation. The Regulation
addresses the collecting of information on the product in its Article 4. Under
this Article, the authority may request from the economic operator, with due
regard to the principle of proportionality, relevant information concerning the
characteristics of the product and/or relevant and readily available
information on the lawful marketing of the product in another Member State. 6. Means
of evidence The Mutual Recognition Regulation does not specify
the means of evidence that may be used by economic operators to demonstrate that
a product has been lawfully marketed in another Member State or in an EFTA
state that is a contracting party to the EEA Agreement. This avoids imposing
any additional administrative burden and does not limit in any way the means of
evidence that an economic operator may present as part of the information
mentioned by Article 4(b) to the authorities of the Member State of destination. It must also be noted that Member States
follow very different systems for placing products on the market and controlling
this activity through ex ante (prior authorisation procedures) or ex
post (market surveillance) mechanisms — in most cases a product can be
lawfully marketed without having to be approved first. Hence, any piece of evidence such as a product invoice, product
label, catalogue with evidence of a date, sale or tax records, registrations,
licences, notifications to/from the authorities, certifications, extracts from
public records, etc. should be deemed suitable to demonstrate the actual
marketing of the product in another Member State or in an EFTA state that is a contracting
party to the EEA Agreement. 6.1. Rights
and obligations Under Article 4(b) of the Mutual Recognition
Regulation, the competent authority of the Member State of destination may
request from the economic operator concerned relevant information on the
previous lawful marketing of the product in another Member State or in an EFTA state that is a contracting party to the EEA Agreement. More specifically: –
If the economic operator has proof of conformity
with the national legislation of the other Member State or the EFTA state that
is a contracting party to the EEA Agreement where the product is actually
marketed (such as written confirmation from the competent authority of the
Member State of origin[15]),
the Commission considers 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 if the economic operator
were to provide the references of the applicable provisions of law in another Member State or EFTA state that is a contracting party to the EEA Agreement. If this is not
possible, however, the competent authority in the Member State of destination
should consider obtaining such information directly from the authorities of these
States through the Product Contact Point (see section 7 below). The competent authority of the Member State of destination may request translation of the documents provided by the
economic operator when necessary. Nonetheless, it would be excessive for a Member State to require a translation certified or authenticated by a consular or
administrative authority,[16]
or to impose an excessively short deadline for providing the translation,
unless there are special circumstances warranting this. The Commission also
considers that the competent authority of the Member State of destination
should identify those 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. 6.2. Failure
to notify the economic operator The Commission considers that a request for
information by the competent authority of the Member State of destination
(and/or the examination of the product by the competent authority) cannot cause
the marketing of a product in the Member State of destination to be suspended
indefinitely, or for a long period of time, pending a reasoned decision on
marketing by the competent authority,[17]
except where an emergency measure is adopted following an alert under Directive
2001/95/EC[18]
or Regulation 178/2002.[19]
Therefore, as stated by Article 6(4) of the Mutual Recognition Regulation: ‘When the competent authority fails to notify
the economic operator of a decision as referred to in Article 2(1) within the
period specified in paragraph 2 of this Article, the product shall be deemed to
be lawfully marketed in that Member State insofar as the application of its
technical rule as referred to in paragraph 1 of this Article is concerned.’ 7. The
role of the Product Contact Points The main task of the Product Contact Points
(PCPs) is to provide information on technical rules for products to economic
operators and competent authorities in other Member States or in an EFTA state
that is a contracting party to the EEA Agreement and to provide the contact
details for these authorities. The Mutual Recognition Regulation thus addresses
difficulties affecting dialogue between national administrations in the non-harmonised
area. With the establishment of the PCPs, contacts between national authorities
as regards the non-harmonised field of products within the EU have been greatly
simplified. Contacts between national administrations
are often also necessary for getting more information about the product and the
technical rules in another Member State or in an EFTA state that is a contracting
party to the EEA Agreement, including whether it is lawfully marketed there. The
burden for both individual economic operators and national authorities is thus
alleviated by the information activities of the PCPs. The Mutual Recognition Regulation
establishes several tasks for PCPs relating to information provided at the
request of economic operators or competent authorities in other Member States
or in an EFTA state that is a contracting party to the EEA Agreement. In
particular, Article 10(3) of the Regulation establishes that: ‘Product Contact Points in the Member State in
which the economic operator concerned has lawfully marketed the product in
question may provide the economic operator or the competent authority as
referred to in Article 6 with any relevant information or observations.’ Thus, while not imposing any obligation on
the PCPs, the Mutual Recognition Regulation opens the door for these bodies to assist
economic operators or the authorities in another Member State or in an EFTA
state that is a contracting party to the EEA Agreement by providing them with
relevant information, if available, on the lawful marketing of a product. Case 1: Administrative
cooperation An economic operator has placed a product on the market in a Member State or in an EFTA state that is a contracting party to the EEA Agreement where no
specific obligations exist as regards its marketing and is now trying to
introduce it in another Member State as well. The authorities of the country of
destination would like to ascertain whether any legal procedures or market
surveillance activities have been undertaken in the State where the product was
actually marketed on account of its perceived lack of safety. The competent authorities of the Member State or the EFTA state that
is a contracting party to the EEA Agreement where the economic operator tries
to introduce its product should then contact the PCP of the State of origin, directly
or through their own PCP. This PCP in turn will provide them with the contact
details of the relevant authorities and/or forward to them the request. Administrative cooperation allows public
authorities to identify their colleagues in other Member States so that they
can easily obtain information from, and start a dialogue with, the competent
authorities in other Member States. Case 2: Disproportionate
requirements To recognise some types of products as ‘lawfully marketed’ in other
Member States, the authorities of Member State A accept only official
certifications produced by the administration of the Member State of origin. They do not consider at all any other kind of document, dismissing them as
‘easilyforged’. For products marketed in Member States where such certifications
exist, this requirement does not pose any problem, as those certifications
would immediately confirm that they are ‘lawfully marketed’ there. In contrast,
for products marketed in those Member States that do not produce such
certifications (for instance because they rely solely on market surveillance
mechanisms), this condition would amount to an impossible obstacle. In conclusion, such a condition is disproportionate and
amounts to a measure having an effect equivalent to quantitative restrictions,
thus in breach of Article 34 TFEU. Case 3: Prior authorisation
procedures Some economic operators believe that, once a product has already
been lawfully marketed in a Member State, it should not require authorisation
in the Member State of destination. That is not necessarily the case. Indeed, such national procedures may still apply in the Member State of destination and, even if considered a restriction on the free movement of
goods, they could be justified if they pursue a public interest objective
recognised by EU law and if they comply with the principle of proportionality. 8. Conclusions The Mutual Recognition Regulation is
designed to ensure observance of the principle of mutual recognition within the
internal market and in the EFTA state that are contracting parties to the EEA
Agreement, in particular through initiation of a dialogue process where market
access is impeded. In discussions of the concept of ‘lawfully
marketed’, most problems arise either from the difficulties economic operators
face at the beginning of this dialogue, when trying to find adequate means of
evidence, or once the dialogue has already started, from the additional
requirements asked for by the authorities after some documents have already
been provided. As regards adequate means of evidence, the issue is mostly a
question of information, as economic operators are not always aware that they
can rely on almost any document produced during their usual commercial
activities in another Member State or in an EFTA state that is a contracting
party to the EEA Agreement to demonstrate that their products have been
lawfully marketed there. As regards additional requirements, in
their examination and assessment of a product, in particular whether it is
lawfully marketed in another Member State, authorities should be aware that, under
Article 5 of the Regulation and the established case law of the Court of
Justice of the EU, the Member State or the EFTA state that is a contracting
party to the EEA Agreement shall show that the measure (or requirement) is
necessary and, where appropriate, that the marketing of the products in
question poses a risk and that the measure (or requirement) conforms to the
principle of proportionality. In conclusion, the relevant State bears the
burden of proof that the stated aim of the measure or requirement cannot be
achieved by any other means that has a less restrictive effect on trade. [1] This document is not legally binding. Neither the
European Commission nor any person acting on its behalf may be held responsible
for the use to which information contained in this publication may be put, nor
for any errors which may appear despite careful preparation and checking.
Ultimate responsibility for the interpretation of EU law lies with the EU Court
of Justice. [2] Regulation (EC) No 764/2008 of the European
Parliament and of the Council of 9 July 2008 laying down procedures relating to
the application of certain national technical rules to products lawfully
marketed in another Member State and repealing Decision No 3052/95/EC, OJ L
218, 13.8.2008, pp. 21–29. [3] This principle originates in the ‘Cassis de Dijon’
Judgment of 20 February 1979 (Rewe-Zentral AG v. Bundesmonopolverwaltung 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). [4] For the purposes of this guidance document, 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 34
TFEU, 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. [5] At the time of drafting this document, the EFTA states
that are contracting parties to the Agreement on the European Economic Area are
Iceland, Liechtenstein and Norway. Thus, the European Economic Area (EEA)
comprises the Member States of the EU, plus these three countries. The Mutual
Recognition Regulation was incorporated into the EEA agreement by Decision of
the EEA Joint Committee No 126/2012 of 13 July 2012 amending Annex II
(Technical regulations, standards, testing and certification) to the EEA
Agreement (OJ L 309, 8.11.2012, pp. 4-5). Some special adaptations apply: the
Regulation only applies to products covered by Article 8(3) of the Agreement
and does not apply to Liechtenstein in relation to products covered by Annex I,
Chapters XII and XXVII of Annex II and Protocol 47 to the Agreement, in cases
where the application of the Agreement between the European Community and the
Swiss Confederation on trade in agricultural products extends to Liechtenstein.
However, the Decision only entered into force on 1.4.2013 due to delays in the
notification of the ‘fulfilment of constitutional requirements’ by Norway and Iceland. Thus, any reference in this guidance document to ‘Member States’ should be
understood as encompassing these three countries as well. [6] Document
available online at: http://ec.europa.eu/enterprise/policies/single-market-goods/files/goods/docs/art34-36/new_guide_en.pdf.
Art. 36 TFEU is discussed from p. 26 on. [7] The obligation to apply the principle of mutual
recognition to products lawfully manufactured and/or marketed in Turkey is
based on Articles 5 to 7 of Decision 1/95 of the EC-Turkey Association Council
of 22 December 1995 on implementing the final phase of the Customs Union (OJ L
35 of 13 February 1996), which provide for the elimination of measures having
an effect equivalent to quantitative restrictions between the EU and Turkey. Under
Article 66 of Decision 1/95, Articles 5 to 7 must, for the purpose of their
implementation and application to products covered by the Customs Union, be
interpreted in conformity with the relevant judgments of the Court of Justice
of the European Union. Therefore, principles resulting from the Court of
Justice’s case law on issues that relate to Articles 34 and 36 TFEU,
particularly the ‘Cassis de Dijon’ case, apply to Turkey as well. [8] See above. Nevertheless, Turkey has adopted a
national Regulation on Mutual Recognition in the Non-Harmonised Area, in force
as of 1 January 2013. [9] Regulation (EC) No 765/2008 of the European
Parliament and of the Council, of 9 July 2008, setting out the requirements for
accreditation and market surveillance relating to the marketing of products and
repealing Regulation (EEC) No 339/93, OJ L 218, 13.8.2008, pp. 30–47. [10] Article 2(1) of Regulation (EC) No 765/2008. [11] Article 2(2) of Regulation (EC) No 765/2008. [12] Directive 2001/95/EC of the European Parliament and of
the Council of 3 December 2001 on general product safety, OJ L 11, 15.1.2002, pp.
4–17. [13] Article 79 of the Council Regulation (EEC) No 2913/92
establishing the Community Customs Code states that ‘Release for free circulation
shall confer on non-Community goods the customs status of Community goods. It
shall entail application of commercial policy measures, completion of the other
formalities laid down in respect of the importation of goods and the charging
of any duties legally due’. [14] The Directive on general product safety permits Member
States to take rapid restrictive measures with regard to products which are
dangerous or are likely to be dangerous, pursuant to Articles 8, 11 or 12 and
18 of the Directive. [15] Proof from the competent authority of the Member State where the EEA product is lawfully 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 34 TFEU. [16] 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. [17] In the exceptional situation of a prior authorisation
procedure, marketing may take place only after the authorisation has been
obtained. It must be underlined that, as explained by recital 12 of the Mutual
Recognition Regulation, ‘A requirement that the placing of a product on the
market be subject to prior authorisation should, as such, not constitute a
technical rule, so that a decision to exclude or remove a product from the
market exclusively on the grounds that it does not have valid prior
authorisation should not constitute a decision to which this Regulation applies’. [18] See footnote 13. [19] Regulation (EC) No 178/2002 of the European Parliament
and of the Council, of 28 January 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.