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.
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.
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.
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.
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.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
