Mutual recognition
The rules on mutual recognition were first established in Regulation (EC) No 764/2008 of the European Parliament and of the Council, which lays down procedures relating to the application of certain national technical rules to products lawfully placed on the market in another Member State. The fundamental basis of the principle of mutual recognition is the following idea: if a product is suitable for consumers in one Member State (i.e., it meets local requirements), it is also suitable for consumers in other Member States, and therefore the movement of such products must be permitted in those states. In other words: Member States recognize that even if products are manufactured in accordance with regulations, standards, or procedures other than their own, and provided they guarantee a comparable level of safety in principle, they cannot deny them access to their market. Regulation (EC) No 764/2008 of the European Parliament and of the Council was repealed on April 19, 2020, by Regulation (EU) No (EU) 2019/515 on the mutual recognition of goods lawfully placed on the market in another Member State and repealing Regulation (EC) No. 764/2008.
Regulation (EU) 2019/515 of the European Parliament and of the Council strengthens the functioning of the internal market by improving the application of the principle of mutual recognition and by removing unjustified barriers to trade. Regulation (EU) 2019/515 imposes an obligation to clearly justify any restriction or refusal of market access.
Regulation (EU) 2019/515 of the European Parliament and of the Council strengthens the functioning of the internal market by improving the application of the principle of mutual recognition and by removing unjustified barriers to trade. Regulation (EU) 2019/515 imposes an obligation to clearly justify any restriction or refusal of market access.
However, if the principle of mutual recognition does not apply, this constitutes a restriction on the free movement of a specific product, and the national authority must justify such a restriction in writing. A Member State is required to justify any trade barrier to the import of products from other Member States (safety, health, and environmental protection, technical requirements). Economic operators have the right to raise objections, which the national authority must take into account before issuing a final decision, and they are then guaranteed the right to judicial review of such a decision.
Regulation (EU) 2019/515 of the European Parliament and of the Council applies to products of any kind, including agricultural products, as well as to products for which EU harmonization legislation applies only to certain aspects. Regulation (EU) 2019/515 of the European Parliament and of the Council will now allow economic operators to draw up a voluntary “declaration for mutual recognition” demonstrating to the competent authorities of a Member State that a specific product has been lawfully placed on the market in another Member State. The mutual recognition declaration must contain all the information listed in Parts I and II of the Annex and must also follow the specified structure of this data. Part I of the Annex is intended for the manufacturer or its representative; Part II of the Annex is for importers or distributors. The declaration shall be submitted to the competent authority of the Member State in paper form or electronically, or made available online. For online availability, the following conditions must be met: easy identification of the type or series of products to which the declaration applies; easy searchability, traceability, and availability of the declaration, as well as access to it. If the product is also subject to an EU regulation requiring a declaration of conformity, the declaration for mutual recognition may be attached to the EU declaration of conformity. The declaration for mutual recognition is drawn up in one of the official languages of the EU; if this language is not the language required by the Member State of destination, economic operators shall translate it into the language required by that State.
Regulation (EU) 2019/515 of the European Parliament and of the Council helps improve the exchange of relevant information among individual Member States and ensures access, particularly for small and medium-sized enterprises, to information on the aforementioned national technical rules. To this end, so-called Product Contact Points are being established in each Member State; these points are interconnected, and businesses may contact them to request information on the technical regulations in force in individual Member States. The obligation to establish PCPs (Product Contact Points) applies to all Member States. Their primary task is to provide information to businesses and administrative authorities in other Member States. In the Czech Republic, the contact point is the Ministry of Industry and Trade. For businesses, this means the opportunity to obtain, free of charge and within 15 working days, information on technical rules for a specific product in a given territory and on any requirements for prior approval regarding the application of rules for the free movement of goods within the EU, as well as on general remedies in the event of a dispute between the competent authority and an economic operator, including information on the out-of-court dispute resolution system in cases of incorrect application of EU law.
Conformity assessment, the issuance of a declaration of conformity (declaration of performance), the affixing of the conformity marking to the product, and the retention of conformity assessment documentation need not be carried out by importers for those products for which conformity assessment has already been performed in accordance with the relevant technical regulations in the manufacturer’s Member State and which bear the CE marking. This principle of mutual recognition also applies in the non-harmonized sphere. In the Czech Republic, this is set forth in Section 13b of Act No. 22/1997 Coll., which introduces the so-called mutual recognition clause for products not covered by harmonized technical specifications. Conformity assessment is not performed for products lawfully placed on the market in a Member State of the European Union or the European Economic Area, provided that the technical regulations, technical standards, rules of good practice, or procedures applied in that EU Member State guarantee a level of protection of legitimate interests corresponding to the level of such protection in the Czech Republic.
Regulation (EU) 2019/515 of the European Parliament and of the Council applies to products of any kind, including agricultural products, as well as to products for which EU harmonization legislation applies only to certain aspects. Regulation (EU) 2019/515 of the European Parliament and of the Council will now allow economic operators to draw up a voluntary “declaration for mutual recognition” demonstrating to the competent authorities of a Member State that a specific product has been lawfully placed on the market in another Member State. The mutual recognition declaration must contain all the information listed in Parts I and II of the Annex and must also follow the specified structure of this data. Part I of the Annex is intended for the manufacturer or its representative; Part II of the Annex is for importers or distributors. The declaration shall be submitted to the competent authority of the Member State in paper form or electronically, or made available online. For online availability, the following conditions must be met: easy identification of the type or series of products to which the declaration applies; easy searchability, traceability, and availability of the declaration, as well as access to it. If the product is also subject to an EU regulation requiring a declaration of conformity, the declaration for mutual recognition may be attached to the EU declaration of conformity. The declaration for mutual recognition is drawn up in one of the official languages of the EU; if this language is not the language required by the Member State of destination, economic operators shall translate it into the language required by that State.
Regulation (EU) 2019/515 of the European Parliament and of the Council helps improve the exchange of relevant information among individual Member States and ensures access, particularly for small and medium-sized enterprises, to information on the aforementioned national technical rules. To this end, so-called Product Contact Points are being established in each Member State; these points are interconnected, and businesses may contact them to request information on the technical regulations in force in individual Member States. The obligation to establish PCPs (Product Contact Points) applies to all Member States. Their primary task is to provide information to businesses and administrative authorities in other Member States. In the Czech Republic, the contact point is the Ministry of Industry and Trade. For businesses, this means the opportunity to obtain, free of charge and within 15 working days, information on technical rules for a specific product in a given territory and on any requirements for prior approval regarding the application of rules for the free movement of goods within the EU, as well as on general remedies in the event of a dispute between the competent authority and an economic operator, including information on the out-of-court dispute resolution system in cases of incorrect application of EU law.
Conformity assessment, the issuance of a declaration of conformity (declaration of performance), the affixing of the conformity marking to the product, and the retention of conformity assessment documentation need not be carried out by importers for those products for which conformity assessment has already been performed in accordance with the relevant technical regulations in the manufacturer’s Member State and which bear the CE marking. This principle of mutual recognition also applies in the non-harmonized sphere. In the Czech Republic, this is set forth in Section 13b of Act No. 22/1997 Coll., which introduces the so-called mutual recognition clause for products not covered by harmonized technical specifications. Conformity assessment is not performed for products lawfully placed on the market in a Member State of the European Union or the European Economic Area, provided that the technical regulations, technical standards, rules of good practice, or procedures applied in that EU Member State guarantee a level of protection of legitimate interests corresponding to the level of such protection in the Czech Republic.
In addition to EU Member States, the principle of mutual recognition also applies to other Member States of the European Economic Area, i.e., in addition to EU Member States, it applies to EFTA states (Norway, Liechtenstein, and Iceland) as well as Turkey. From a legal perspective, the principle of mutual recognition derives directly from the Treaty on the Functioning of the European Union (Articles 28–30), and its application takes precedence over national law or administrative practices of government authorities that would conflict with it.
For further information, see also the EC website: Mutual Recognition or Mutual Recognition Agreements. Mutual recognition agreements support the market for products between the EU and countries such as Australia, Canada, Israel, Japan, New Zealand, Switzerland, and the United States.
