Mutual recognition of products

The principle of mutual recognition of products (including agricultural products) stems from EU Regulation 2019/515. It defines that EU countries cannot restrict or deny market access on their territory for products that are already lawfully marketed in another Member State, even if the product does not fully comply with the technical rules of the other country.

The principle of mutual recognition ensures market access for products that are not subject to EU harmonization (free movement of products in the non-regulated area).

According to EU Regulation 2019/515, Member States have mutually agreed that national technical rules equally protect public interests. Member States can restrict or deny market access for products that are already lawfully marketed in another Member State only in exceptional cases proving that public interests are not adequately protected and national technical rules (justified and proportionate) are necessary to ensure the protection of public interests.

The legal basis of mutual recognition in Latvia is covered by the 1996 law On Conformity Assessment (Chapter VII. Mutual Recognition). According to the legislation, the competent Latvian authorities are obliged to notify the EU Member States and the European Commission about the products that were denied or restricted market access through the information and communication system (ICSMS) no later than 20 working days after they took the decision.

Competent authorities are obliged to justify why market access has been restricted or denied. If the authority fails to do so, the economic operator can use SOLVIT, – a problem-solving mechanism that is free of charge.

Read more:

• Guidance document on the application of EU Regulation 2019/515 (source European Commission)
• Training material on mutual recognition: The application of the mutual recognition regulation to food supplements (source European Commission)

In order to determine whether a product can be placed on the market under the principle of mutual recognition, economic operators need to answer several questions:

Public interests – justified on grounds of public morality, public policy or public security; the protection of health and life of humans, animals or plants; the protection of national treasures possessing artistic, historic or archaeological value; or the protection of industrial and commercial property. Such prohibitions or restrictions shall not, however, constitute a means of arbitrary discrimination or a disguised restriction on trade

Read more:

• Guidance on Articles 34-36 of the Treaty on the Functioning of the European Union (free movement of goods) - gives an overview of the case law of the EU Court of Justice (source European Commission)

Requirements for the same product placed on the market may differ in the EU Member States and it results in unnecessary burden, delays and additional costs for economic operators.

Therefore, economic operator may draw up a voluntary mutual recognition declaration either in paper form or by electronic means. Mutual recognition declaration will demonstrate to the competent authorities of the Member State of destination that the products are lawfully marketed in another EU Member State. Mutual recognition declaration is voluntary.

Example of Mutual recognition declaration 

Economic operators are responsible for the content and accuracy of the information they provide in the mutual recognition declaration as well as ensure that the declaration is updated in case of changes.

If the economic operator provides mutual recognition declaration, it enables the national authorities, where necessary, to obtain the information to evaluate products promptly and to accelerate the application of the principle of mutual recognition.

If economic operator submits mutual recognition declaration by filling in all the necessary information following the Article 4 of EU Regulation 2019/515, there is no reason for the competent authority to request additional information, such as prior authorization or other documentation, to prove product’s compliance with national technical rules.

The use of mutual recognition declaration does not prevent national authorities from taking administrative decisions restricting or denying market access if the product does not cover public interests.

The mutual recognition declaration can be provided in a free form, under the requirements of Article 4 and Annex of EU Regulation 2019/515.

Read more:

• About declaration of mutual recognition (source European Commission)
• Declaration of mutual recognition (source European Commission)

The economic operator can make the products available on the market while the competent authority carries out the assessment and he may continue to do so unless the economic operator receives an administrative decision restricting or denying market access.

The economic operator cannot place the products on the market in case the assessment is carried out in the framework of a prior authorisation procedure, or where the competent authority temporary suspends market access.

Latvian competent authority informs the economic operator about the assessment of products and specifies the products to which it applies as well as specifies applicable national technical rules or prior authorization procedure.

If a mutual recognition declaration is supplied to a competent authority, then for the assessment:

• the mutual recognition declaration, together with supporting evidence necessary to verify the information contained in it, competent authority accept as sufficient to demonstrate that the products are lawfully marketed in another Member State
• the competent authority shall not require any other information or documentation from any economic operator to demonstrate that the products are lawfully marketed in another EU Member State

If a mutual recognition declaration is not supplied to a competent authority, then for the assessment, the competent authority may request the economic operators concerned to provide documentation and information that is necessary for the assessment of products.

The economic operator concerned is allowed at least 15 working days following the request of the Latvian authority to submit the documents and information or to submit any arguments or comments.

For the assessment, Latvian authority may contact the competent authorities or the Product Contact Points of the EU Member State in which an economic operator claims to be lawfully marketing its products.

Where, on completion of an assessment, Latvian competent authority takes an administrative decision (positive or negative) concerning the products, it notifies that administrative decision without delay to the economic operator. If the competent authority issues a negative decision or decides to temporarily suspend the marketing of products until the detailed examination is complete, administrative decision will be notified to the European Commission and the other EU Member States no later than 20 working days after it took the decision.

The following information is included in the administrative decision of competent authority:

• the national technical rule on which the administrative decision is based
• the legitimate public interest grounds justifying the application of the national technical rule on which the administrative decision is based
• 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 has occurred since the national technical rule came into force
• a summary of the arguments put forward by the economic operator concerned that are relevant for the assessment, if any
• the evidence demonstrating that the administrative decision is appropriate for achieving the objective pursued.

The administrative decision specifies the remedies available under the national law of the Member State of destination and the time limits applicable to those remedies. It also includes a reference to the possibility for economic operators to use SOLVIT mechanism.

The administrative decision is not taking effect before it has been notified to the economic operator concerned.

Latvian competent authority gives official approval before the product is made available on the Latvian market under the prior authorization procedure based on the economic operators’ application.

Although prior authorization is considered a restrictive measure for free trade, its application is justified if the purpose of the Latvian law is to ensure that the public interests covered by EU law are respected, non-discriminatory, and in line with the principle of proportionality.

The requirements provided in the national technical regulations can also be considered prior authorization, i.e., before placing products on the Latvian market, it could be necessary to receive confirmation from the relevant competent authority regarding the conformity of the product with certain requirements.

Before placing a product on the Latvian market, it is necessary to obtain prior authorization for the following products:

• gas cylinders – a permit for the registration of a trading venue is issued by the Consumer Rights Protection Centre
• precious metals – hallmarking before entry into free circulation is performed by the Assay Office of Latvia or any other authorized and independent testing authority of the EU, Switzerland, Turkey or EEA country
• electronic cigarettes and refill containers – the Health Inspectorate should be notified before the commencement of trade, indicating the address of the point of sale
• pyrotechnics – special permits (licences) for commercial activities with pyrotechnic articles and transfer within EU/EEA territory are issued by the State Police
• explosives and explosive devices for civil uses – special permits (licences) for commercial activities and transfer within EU/EEA territory issued by the State Police