New Mutual Recognition Regulation
On 19 April 2020, Regulation (EU) 2019/515 of the European Parliament and of the Council of 19 March 2019 on the mutual recognition of goods lawfully marketed in another Member State and repealing Regulation (EC) No 764/2008 (hereinafter Regulation 2019/515) entered into force. This new Mutual Recognition Regulation will now govern this mechanism.
What is mutual recognition
Mutual recognition is the rule governing European Union (EU) law under which any product lawfully marketed in one EU Member State must, in principle, be admitted to another Member State. It has been applied as a formula for be able to market food supplements in the countries of the European Union.
The free movement of goods and persons is one of the basic values and principles of the EU Treaties. Quantitative import restrictions between Member States and all measures with equivalent effects are prohibited. Member States cannot directly or indirectly impede trade in goods within the EU.
By the principle of mutual recognition Member States may not prohibit the sale on their territory of goods lawfully marketed in another Member State, even where such goods have been produced under different rules, even goods other than the result of a manufacturing process.
Mutual recognition shall apply to goods placed on the market lawfully and correctly in another Member State, complying with its rules and being available to users and end consumers of that Member State.
New application of mutual recognition
The Mutual Recognition Declaration procedure is governed by Article 4 of Regulation 2019/515. A producer of goods intending to sell its products in another Member State may draw up a voluntary declaration of legal marketing of goods for mutual recognition purposes. With that declaration, you can demonstrate to the authorities of that Member State that your products are placed on the market in another EU State.
This statement may be made by an authorized representative. It must have the structure set out in Part I and II of the Annex containing Regulation 2019/515.
The producer or his authorised representative may enter in the declaration of mutual recognition only the information set out in Part I of the Annex. In that case, however, the importer or distributor shall complete the information provided for in Part II of the Annex. Furthermore, the importer or distributor may draw up both parts of the declaration of mutual recognition provided that the signatory can provide the proof referred to in Article 5(4)(a):
“If a declaration of mutual recognition is given to a competent authority of the Member State of destination in accordance with Article 4, for the purposes of the assessment in accordance with paragraph 1 of this Article:
- (a) the competent authority shall accept the adequacy of the declaration of mutual recognition, together with any supporting evidence necessary to verify the information contained therein and which has been provided in response to a request from the competent authority, to demonstrate that the goods are legally placed on the market in another Member State.”
The declaration of mutual recognition shall be drawn up in one of the official languages of the EU. If that language is not required by the State where the product is to be marketed, it has to be translated into the one that it does accept. The official languages of the EU are those of each Member State.
The Spanish State states in article 15 of Law 39/2015, of 1 October, of the Common Administrative Procedure, that the language of the proceedings brought before the General Administration of the State will be The Castellano. The other languages of Spain can be used in the Autonomous Communities where they are co-official, both in dealing with the General Administration in its headquarters in those territories, and with the bodies of those Communities. Therefore, in Spain the declaration must be translated into Spanish or if it is addressed to a community with a co-official language, in that language.
It is very important to note that Regulation 2019/515 provides that economic operators must ensure that the declaration of mutual recognition is always up-to-date and reflects any changes in the information provided.
Obligation to faithfully perform mutual recognition
The information given in those statements must be real and true. In Spain, making false or unrealistic claims to the Public Administration can have consequences in the form of administrative and even criminal sanctions. Article 4(2) of Regulation 2019/515 states:
“Economic operators who sign a declaration of mutual recognition or part thereof shall be responsible for the content and accuracy of the information they provide in the declaration of mutual recognition, including the correction of the informationand translate. For the purposes of this paragraph, legal liability under national law shall lie with economic operators.”
The penal consequences in Spain can reach, can go from the procedural fraud, the crime of false testimony or the one of documentary falseness depending on the moment in which the falsity takes place.
Of relevance is what is contained by Article 5 of the new Mutual Recognition Regulation, since it is the one that regulates the evaluation of goods. Above all, what is stated in its third paragraph of this article. The economic operator shall be allowed to market the goods in the Member State of destination as the competent authority carries out the assessment and may continue to do so unless the economic operator receives an administrative decision restricting or denying access to the market for that good.
It should be noted, that the fourth recital in the preamble to the new Regulation, as well as Article 5 thereto, imposes the obligation to clearly justify the grounds for restriction or refusal of access to the market.
However, the content of the third subparagraph of Article 5 shall not apply if the assessment is carried out in the context of a prior authorisation procedure, or if the competent authority temporarily suspends placing the market on the market.
Market access may only be temporarily suspended when that state conducts a merchandise assessment and sees that it poses a serious risk to safety or citizen health or the environment. Even if they are not of immediate effect, or if there is a widespread prohibition on the placing on the market in that Member State of those goods for reasons of morality or public security.
Internal Market Problem Resolution Network (SOLVIT)
Any administrative decision affecting a product to be placed on the market in a Member State should refer to the remedies against that decision and to the possibility for economic operators to use the Internal Market Problem-Solving Network (SOLVIT) and the problem-solving procedure set out in this Regulation.
SOLVIT is a service provided by the national administration of each Member State in order to find solutions for individuals and undertakings where the public authorities of another Member State have infringed their rights.
SOLVIT may intervene in cases where a public administration from another EU country does not respect the rights conferred by the EU on citizens and businesses and the matter has not yet been brought to court (administrative remedies do not prevent SOLVIT from intervening).
Article 8 of Regulation 2019/515 lays down an interesting procedure for where an economic operator affected by an administrative decision has submitted it to SOLVIT. If, during the SOLVIT procedure, the centre of origin or the centre responsible requests the Commission to give an opinion to help resolve the matter, the centre of origin and the centre responsible shall provide the Commission with all relevant documents relating to the administrative decision in question.
After evaluation, the Commission must issue an opinion to be communicated through the SOLVIT centre corresponding to the economic operator concerned and to the competent authorities. The Commission’s intervention has a period of 45 working days, not including the time required for the Commission to receive any additional information and documents it deems necessary. If the case is resolved during this period, the Commission should not be required to deliver an opinion.
It therefore appears that the new European rule aims to establish a clear procedure for ensuring the free movement of goods and to ensure that the free movement of goods is affected only when The Member States have legitimate reasons in the public interest for this purpose, always taking into account that restrictions must be justified and proportionate.