1. The aim of this Regulation is to strengthen the functioning of the internal market by improving the application of the principle of mutual recognition and by removing unjustified barriers to trade.
2. This Regulation lays down rules and procedures concerning the application by Member States of the principle of mutual recognition in individual cases in relation to goods which are subject to Article 34 TFEU and which are lawfully marketed in another Member State, having regard to Article 36 TFEU and the case-law of the Court of Justice of the European Union.
3. This Regulation also provides for the establishment and maintenance of Product Contact Points in Member States and for cooperation and exchange of information in the context of the principle of mutual recognition.
Article 2 -
Scope
1. This Regulation applies to goods of any type, including agricultural products within the meaning of the second subparagraph of Article 38(1) TFEU, and to administrative decisions that have been taken or are to be taken by a competent authority of a Member State of destination in relation to any such goods that are lawfully marketed in another Member State, where the administrative decision meets the following criteria:
(a)
the basis for the administrative decision is a national technical rule applicable in the Member State of destination; and
(b)
the direct or indirect effect of the administrative decision is to restrict or deny market access in the Member State of destination.
Administrative decision includes any administrative step that is based on a national technical rule and that has the same or substantially the same legal effect as the effect referred to in point (b).
2. For the purposes of this Regulation, a ‘national technical rule’ is any provision of a law, regulation or other administrative provision of a Member State which has the following characteristics:
(a)
it covers goods or aspects of goods that are not the subject of harmonisation at Union level;
(b)
it either prohibits the making available of goods, or goods of a given type, on the market in that Member State, or it makes compliance with the provision compulsory, de facto or de jure, whenever goods, or goods of a given type, are made available on that market; and
(c)
it does at least one of the following:
(i)
it lays down the characteristics required of goods or of goods of a given type, such as their levels of quality, performance or safety, or their dimensions, including the requirements applicable to those goods as regards the names under which they are sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures;
(ii)
for the purpose of protecting consumers or the environment, it imposes other requirements on goods or goods of a given type that affect the life-cycle of the goods after they have been made available on the market in that Member State, such as conditions of use, recycling, reuse or disposal, where such conditions can significantly influence either the composition or nature of those goods, or the making available of them on the market in that Member State.
3. Point (c)(i) of paragraph 2 of this Article also covers production methods and processes used in respect of agricultural products as referred to in the second subparagraph of Article 38(1) TFEU, and in respect of products intended for human or animal consumption, as well as production methods and processes relating to other products, where these have an effect on their characteristics.
4. A prior authorisation procedure does not itself constitute a national technical rule for the purposes of this Regulation, but a decision to refuse prior authorisation based on a national technical rule shall be considered to be an administrative decision to which this Regulation applies, if that decision fulfils the other requirements of the first subparagraph of paragraph 1.
5. This Regulation does not apply to:
(a)
decisions of a judicial nature taken by national courts or tribunals;
(b)
decisions of a judicial nature taken by law enforcement authorities in the course of the investigation or prosecution of a criminal offence as regards the terminology, symbols or any material reference to unconstitutional or criminal organisations or offences of a racist, discriminatory or xenophobic nature.
6. Articles 5 and 6 shall not affect the application of the following provisions:
(a)
points (b) to (f) of Article 8(1) and Article 8(3) of Directive 2001/95/EC;
(b)
point (a) of Article 50(3) and Article 54 of Regulation (EC) No 178/2002;
(c)
Article 90 of Regulation (EU) No 1306/2013; and
(d)
Article 138 of Regulation (EU) 2017/625.
7. This Regulation does not affect the obligation under Directive (EU) 2015/1535 to notify draft national technical regulations to the Commission and the Member States prior to their adoption.
Article 3 -
Definitions
For the purposes of this Regulation, the following definitions apply:
(1)
‘lawfully marketed in another Member State’ means that goods or goods of that type comply with the relevant rules applicable in that Member State or are not subject to any such rules in that Member State, and are made available to end users in that Member State;
(2)
‘making available on the market’ means any supply of goods for distribution, consumption or use on the market within the territory of a Member State in the course of a commercial activity, whether in return for payment or free of charge;
(3)
‘restricting market access’ means imposing conditions to be fulfilled before goods can be made available on the market in the Member State of destination, or conditions for keeping goods on that market, which in either case require the modification of one or more of the characteristics of those goods, as referred to in point (c)(i) of Article 2(2), or require the performance of additional testing;
(4)
‘denying market access’ means any of the following:
(a)
prohibiting goods from being made available on the market in the Member State of destination or from being kept on that market; or
(b)
requiring the withdrawal or recall of those goods from that market;
(5)
‘withdrawal’ means any measure aimed at preventing goods in the supply chain from being made available on the market;
(6)
‘recall’ means any measure aimed at achieving the return of goods that have already been made available to the end user;
(7)
‘prior authorisation procedure’ means an administrative procedure under the law of a Member State whereby the competent authority of that Member State is required, on the basis of an application by an economic operator, to give its formal approval before goods may be made available on the market in that Member State;
(8)
‘producer’ means:
(a)
any natural or legal person who manufactures goods or has goods designed or manufactured, or who produces goods which were not the result of a manufacturing process, including agricultural products, and markets them under that person's name or trademark,
(b)
any natural or legal person who modifies goods already lawfully marketed in a Member State in a way that might affect compliance with the relevant rules applicable in that Member State, or
(c)
any other natural or legal person who, by putting its name, trademark or other distinguishing feature on goods or on the documents that accompany those goods, presents itself as the producer of those goods;
(9)
‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a producer to act on that producer's behalf with regard to the making available of goods on the market in question;
(10)
‘importer’ means any natural or legal person established within the Union who makes goods from a third country available on the Union market for the first time;
(11)
‘distributor’ means any natural or legal person in the supply chain, other than the producer or the importer, who makes goods available on the market in a Member State;
(12)
‘economic operator’ means any of the following in relation to goods: the producer, the authorised representative, the importer or the distributor;
(13)
‘end user’ means any natural or legal person residing or established in the Union, to whom the goods have been made available or are being made available, either as a consumer outside of any trade, business, craft or profession or as a professional end user in the course of its industrial or professional activities;
(14)
‘legitimate public interest grounds’ means any of the grounds set out in Article 36 TFEU or any other overriding reasons of public interest;
(15)
‘conformity assessment body’ means a conformity assessment body as defined in point 13 of Article 2 of Regulation (EC) No 765/2008.
CHAPTER I - I
PROCEDURES CONCERNING APPLICATION OF THE PRINCIPLE OF MUTUAL RECOGNITION IN INDIVIDUAL CASES
Article 4 -
Mutual recognition declaration
1. The producer of goods, or of goods of a given type, that are being made or are to be made available on the market in the Member State of destination may draw up a voluntary declaration of lawful marketing of goods for the purposes of mutual recognition (‘mutual recognition declaration’) in order to demonstrate to the competent authorities of the Member State of destination that the goods, or the goods of that type, are lawfully marketed in another Member State.
The producer may mandate its authorised representative to draw up the mutual recognition declaration on its behalf.
The mutual recognition declaration shall follow the structure set out in Part I and Part II of the Annex and shall contain all the information specified therein.
The producer or its authorised representative, where mandated to do so, may fill in the mutual recognition declaration with only the information set out in Part I of the Annex. In such case the information set out in Part II of the Annex shall be filled in by the importer or by the distributor.
Alternatively, both parts of the mutual recognition declaration may be drawn up by the importer or by the distributor, provided that the signatory can supply the evidence referred to in point (a) of Article 5(4).
The mutual recognition declaration shall be drawn up in one of the official languages of the Union. Where that language is not the language required by the Member State of destination, the economic operator shall translate the mutual recognition declaration into a language required by the Member State of destination.
2. Economic operators who sign the mutual recognition declaration or a part of it shall be responsible for the content and accuracy of the information that they provide in the mutual recognition declaration, including the correctness of the information they translate. For the purposes of this paragraph, economic operators shall be liable in accordance with national laws.
3. Economic operators shall ensure that the mutual recognition declaration is kept up to date at all times, reflecting any changes in the information that they have provided in the mutual recognition declaration.
4. The mutual recognition declaration may be supplied to the competent authority of the Member State of destination for the purposes of an assessment to be carried out under Article 5. It may be supplied either in paper form or by electronic means or be made available online in accordance with the requirements of the Member State of destination.
5. Where economic operators make the mutual recognition declaration available online, the following conditions apply:
(a)
the type of goods or the series to which the mutual recognition declaration applies shall be easily identifiable; and
(b)
the technical means used shall ensure easy navigation and shall be monitored to ensure the availability of, and access to, the mutual recognition declaration.
6. Where the goods for which the mutual recognition declaration is being supplied are also subject to a Union act requiring an EU declaration of conformity, the mutual recognition declaration may be attached to the EU declaration of conformity.
Article 5 -
Assessment of goods
1. Where a competent authority of the Member State of destination intends to assess goods subject to this Regulation to establish whether the goods or goods of that type are lawfully marketed in another Member State, and, if so, whether the legitimate public interests covered by the applicable national technical rule of the Member State of destination are adequately protected, having regard to the characteristics of the goods in question, it shall contact the economic operator concerned without delay.
2. When entering into contact with the economic operator concerned, the competent authority of the Member State of destination shall inform the economic operator of the assessment, indicating the goods that are subject to that assessment and specifying the applicable national technical rule or prior authorisation procedure. The competent authority of the Member State of destination shall also inform the economic operator of the possibility of supplying a mutual recognition declaration in accordance with Article 4 for the purposes of that assessment.
3. The economic operator shall be allowed to make the goods available on the market in the Member State of destination while the competent authority carries out the assessment under paragraph 1 of this Article, and may continue to do so unless the economic operator receives an administrative decision restricting or denying market access for those goods. This paragraph shall not apply where the assessment is carried out in the framework of a prior authorisation procedure, or where the competent authority temporary suspends the making available on the market of the goods that are subject to that assessment in accordance with Article 6.
4. If a mutual recognition declaration is supplied to a competent authority of the Member State of destination in accordance with Article 4, then for the purposes of the assessment under paragraph 1 of this Article:
(a)
the mutual recognition declaration, together with supporting evidence necessary to verify the information contained in it that was provided in response to a request by the competent authority, shall be accepted by the competent authority as sufficient to demonstrate that the goods are lawfully marketed in another Member State; and
(b)
the competent authority shall not require any other information or documentation from any economic operator for the purpose of demonstrating that the goods are lawfully marketed in another Member State.
5. If a mutual recognition declaration is not supplied to a competent authority of the Member State of destination in accordance with Article 4, then for the purposes of the assessment under paragraph 1 of this Article, the competent authority may request the economic operators concerned to provide documentation and information that is necessary for that assessment concerning the following:
(a)
the characteristics of the goods or type of goods in question; and
(b)
lawful marketing of the goods in another Member State.
6. The economic operator concerned shall be allowed at least 15 working days following the request of the competent authority of the Member State of destination in which to submit the documents and information referred to in point (a) of paragraph 4 or in paragraph 5, or to submit any arguments or comments that the economic operator might have.
7. For the purposes of the assessment under paragraph 1 of this Article, the competent authority of the Member State of destination, in accordance with Article 10(3), may contact the competent authorities or the Product Contact Points of the Member State in which an economic operator claims to be lawfully marketing its goods, if the competent authority needs to verify any information provided by the economic operator.
8. In carrying out the assessment under paragraph 1, the competent authorities of Member States of destination shall take due account of the content of test reports or certificates issued by a conformity assessment body that have been provided by any economic operator as part of the assessment. The competent authorities of Member States of destination shall not refuse test reports or certificates that were issued by a conformity assessment body accredited for the appropriate field of conformity assessment activity in accordance with Regulation (EC) No 765/2008 on grounds related to the competence of that body.
9. Where, on completion of an assessment under paragraph 1 of this Article, the competent authority of a Member State of destination takes an administrative decision with respect to the goods that it has assessed, it shall notify that administrative decision without delay to the economic operator referred to in paragraph 1 of this Article. The competent authority shall also notify that administrative decision to the Commission and to the other Member States no later than 20 working days after it took the decision. For that purpose, it shall use the system referred to in Article 11.
10. The administrative decision referred to in paragraph 9 shall set out the reasons for the decision in a manner that is sufficiently detailed and reasoned to facilitate an assessment of its compatibility with the principle of mutual recognition and with the requirements of this Regulation.
11. In particular, the following information shall be included in the administrative decision referred to in paragraph 9:
(a)
the national technical rule on which the administrative decision is based;
(b)
the legitimate public interest grounds justifying the application of the national technical rule on which the administrative decision is based;
(c)
the technical or scientific evidence that the competent authority of the Member State of destination considered, including, where applicable, any relevant changes in the state of the art that have occurred since the national technical rule came into force;
(d)
a summary of the arguments put forward by the economic operator concerned that are relevant for the assessment under paragraph 1, if any;
(e)
the evidence demonstrating that the administrative decision is appropriate for the purpose of achieving the objective pursued and that the administrative decision does not go beyond what is necessary in order to attain that objective.
12. The administrative decision referred to in paragraph 9 of this Article shall specify the remedies available under the national law of the Member State of destination and the time limits applicable to those remedies. It shall also include a reference to the possibility for economic operators to use SOLVIT and the procedure under Article 8.
13. The administrative decision referred to in paragraph 9 shall not take effect before it has been notified to the economic operator concerned under that paragraph.
Article 6 -
Temporary suspension of market access
1. When the competent authority of a Member State is carrying out an assessment of goods pursuant to Article 5, it may temporarily suspend the making available of those goods on the market in that Member State only if:
(a)
under normal or reasonably foreseeable conditions of use, the goods pose a serious risk to safety or health of persons or to the environment, including one where the effects are not immediate, which requires rapid intervention by the competent authority; or
(b)
the making available of the goods, or of goods of that type, on the market in that Member State is generally prohibited in that Member State on grounds of public morality or public security.
2. The competent authority of the Member State shall immediately notify the economic operator concerned, the Commission and the other Member States of any temporary suspension pursuant to paragraph 1 of this Article. The notification to the Commission and the other Member States shall be made by means of the system referred to in Article 11. In cases falling within point (a) of paragraph 1 of this Article, the notification shall be accompanied by a detailed technical or scientific justification demonstrating why the case falls within the scope of that point.
Article 7 -
Notification through RAPEX or RASFF
If the administrative decision referred to in Article 5 or the temporary suspension referred to in Article 6 is also a measure which is to be notified through the Rapid Information Exchange System (RAPEX) in accordance with Directive 2001/95/EC or through the Rapid Alert System for Food and Feed (RASFF) in accordance with Regulation (EC) No 178/2002, a separate notification to the Commission and the other Member States under this Regulation shall not be required, provided that the following conditions are met:
(a)
the RAPEX or RASFF notification indicates that the notification of the measure also serves as a notification under this Regulation; and
(b)
the supporting evidence required for the administrative decision under Article 5 or for the temporary suspension under Article 6 is included with the RAPEX or RASFF notification.
Article 8 -
Problem-solving procedure
1. Where an economic operator affected by an administrative decision has submitted it to SOLVIT and where, during the SOLVIT procedure, the Home Centre or the Lead Centre requests the Commission to give an opinion in order to assist in solving the case, the Home Centre and the Lead Centre shall provide the Commission with all relevant documents relating to the administrative decision concerned.
2. After receiving the request referred to in paragraph 1, the Commission shall assess whether the administrative decision is compatible with the principle of mutual recognition and with the requirements of this Regulation.
3. For the purposes of the assessment referred to in paragraph 2 of this Article, the Commission shall consider the administrative decision notified in accordance with Article 5(9) and the documents and information provided within the SOLVIT procedure. Where additional information or documents are needed for the purposes of the assessment referred to in paragraph 2 of this Article, the Commission shall, without undue delay, request the relevant SOLVIT Centre to enter into communication with the economic operator concerned or with the competent authorities which took the administrative decision, for the purpose of obtaining such additional information or documents.
4. Within 45 working days of receipt of the request referred to in paragraph 1, the Commission shall complete its assessment and issue an opinion. Where appropriate, the Commission's opinion shall identify any concerns that should be addressed in the SOLVIT case or shall make recommendations to assist in solving the case. The 45 working day period does not include the time necessary for the Commission to receive the additional information and documents as provided for in paragraph 3.
5. Where the Commission has been informed that the case is solved during the assessment referred to in paragraph 2, the Commission shall not be required to issue an opinion.
6. The Commission's opinion shall be communicated through the relevant SOLVIT Centre to the economic operator concerned and to the relevant competent authorities. That opinion shall be notified by the Commission to all Member States by means of the system referred to in Article 11. The opinion shall be taken into account during the SOLVIT procedure referred to in paragraph 1 of this Article.
CHAPTER III - ADMINISTRATIVE COOPERATION, MONITORING AND COMMUNICATION
Article 9 -
Tasks of the Product Contact Points
1. Member States shall designate and maintain Product Contact Points on their territory and shall ensure that their Product Contact Points have sufficient powers and adequate resources for the proper performance of their tasks. They shall ensure that Product Contact Points deliver their services in accordance with Regulation (EU) 2018/1724.
2. Product Contact Points shall provide the following information online:
(a)
information on the principle of mutual recognition and the application of this Regulation in the territory of their Member State, including information on the procedure set out in Article 5;
(b)
the contact details, by means of which the competent authorities within that Member State may be contacted directly, including the particulars of the authorities responsible for supervising the implementation of the national technical rules applicable in the territory of their Member State;
(c)
the remedies and procedures available in the territory of their Member State in the event of a dispute between the competent authority and an economic operator, including the procedure set out in Article 8.
3. Where necessary to complement the information provided online under paragraph 2, Product Contact Points shall provide, at the request of an economic operator or a competent authority of another Member State, any useful information, such as electronic copies of, or online access to, the national technical rules and national administrative procedures applicable to specific goods or goods of a specific type in the territory in which the Product Contact Point is established or information on whether those goods or goods of that type are subject to prior authorisation under national law.
4. Product Contact Points shall respond within 15 working days of receiving any request under paragraph 3.
5. Product Contact Points shall not charge any fee for the provision of the information under paragraph 3.
Article 10 -
Administrative cooperation
1. The Commission shall provide for and ensure efficient cooperation among the competent authorities and the Product Contact Points of the various Member States through the following activities:
(a)
facilitating and coordinating the exchange and collection of information and best practices with regard to the application of the principle of mutual recognition;
(b)
supporting the functioning of the Product Contact Points and enhancing their cross-border cooperation;
(c)
facilitating and coordinating the exchange of officials among Member States and the organisation of common training and awareness raising programmes for authorities and businesses.
2. Member States shall ensure that their competent authorities and Product Contact Points participate in the activities referred to in paragraph 1.
3. Upon a request by a competent authority of the Member State of destination pursuant to Article 5(7), the competent authorities in the Member State in which an economic operator claims to be lawfully marketing its goods shall provide the competent authority of the Member State of destination within 15 working days with any information relevant for verifying data and documents supplied by the economic operator during the assessment under Article 5 relating to those goods. The Product Contact Points may be used to facilitate contacts between the relevant competent authorities in accordance with the time limit for providing the requested information set out in Article 9(4).
Article 11 -
Information and communication system
1. For the purposes of Articles 5, 6 and 10 of this Regulation, the information and communication system set out in Article 23 of Regulation (EC) No 765/2008 shall be used, except as provided in Article 7 of this Regulation.
2. The Commission shall adopt implementing acts specifying the details and functionalities of the system referred to in paragraph 1 of this Article for the purposes of this Regulation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 15(2).
CHAPTER IV - FINANCING
Article 12 -
Financing of activities in support of this Regulation
1. The Union may finance the following activities in support of this Regulation:
(a)
awareness-raising campaigns;
(b)
education and training;
(c)
exchange of officials and of best practices;
(d)
cooperation among Product Contact Points and competent authorities, and the technical and logistic support for this cooperation;
(e)
the collection of data related to the functioning of the principle of mutual recognition and its impact on the Single Market for goods.
2. The Union's financial assistance with respect to activities in support of this Regulation shall be implemented in accordance with Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (18), either directly or by entrusting budget implementation tasks to the entities listed in point (c) of Article 62(1) of that Regulation.
3. The appropriations allocated to activities referred to in this Regulation shall be determined each year by the budgetary authority within the limits of the financial framework in force.
Article 13 -
Protection of the financial interests of the Union
1. The Commission shall take appropriate measures to ensure that, when activities financed under this Regulation are implemented, the financial interests of the Union are protected by the application of preventive measures against fraud, corruption and any other illegal activities, by effective checks and, if irregularities are detected, by the recovery of the amounts wrongly paid and, where appropriate, by effective, proportionate and dissuasive administrative and financial penalties.
2. The Commission or its representatives and the Court of Auditors shall have the power of audit, on the basis of documents and of on-the-spot inspections, over all grant beneficiaries, contractors and subcontractors who have received Union funds under this Regulation.
3. The European Anti-Fraud Office (OLAF) may carry out investigations, including on-the-spot checks and inspections, in accordance with the provisions and procedures laid down in Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (19) and Council Regulation (Euratom, EC) No 2185/96 (20) with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union in connection with a grant agreement or grant decision or a contract funded under this Regulation.
4. Without prejudice to paragraphs 1, 2 and 3, cooperation agreements with third countries and with international organisations, contracts, grant agreements and grant decisions, resulting from the implementation of this Regulation shall contain provisions expressly empowering the Commission, the Court of Auditors and OLAF to conduct such audits and investigations, in accordance with their respective competences.
CHAPTER V - EVALUATION AND COMMITTEE PROCEDURE
Article 14 -
Evaluation
1. By 20 April 2025, and every four years thereafter, the Commission shall carry out an evaluation of this Regulation in light of the objectives that it pursues and shall submit a report thereon to the European Parliament, to the Council and to the European Economic and Social Committee.
2. For the purposes of paragraph 1 of this Article, the Commission shall use the information available in the system referred to in Article 11 and any data collected in the course of activities referred to in point (e) of Article 12(1). The Commission may also ask Member States to submit any relevant information for evaluating the free movement of goods lawfully marketed in another Member State or for evaluating the effectiveness of this Regulation, as well as an assessment of the functioning of the Product Contact Points.
Article 15 -
Committee procedure
1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
CHAPTER VI - FINAL PROVISIONS
Article 16 -
Repeal
Regulation (EC) No 764/2008 is repealed with effect from 19 April 2020.
References to the repealed Regulation shall be construed as references to this Regulation.
Article 17 -
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 19 April 2020.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
