The aim of Regulation (EU) 515 of 2019, 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.
The principle of mutual recognition ensures market access for products that are not subject to EU harmonisation. In this regard, Member States may not prohibit the sale on their territory of goods which are lawfully marketed in another Member State, even where those goods have been produced in accordance with different technical rules, including goods that are not the result of a manufacturing process.
To benefit from the principle of mutual recognition, goods must be lawfully marketed in another Member State. It should be clarified that, for goods to be considered to be lawfully marketed in another Member State, the goods need to comply with the relevant rules applicable in that Member State, and need to be made available to end users in that Member State.
The producer (or his importer/distributor) 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 types of goods covered by this Regulation include agricultural products. The term ‘agricultural products’ includes products of fisheries, as provided for in Article 38(1) TFEU.
The Member State of destination may refuse the marketing of a product only when it can be justified and is strictly necessary for the protection of, for example, public safety, health or environment. Regulation (EU) 515 of 2019 imposes the obligation to clearly justify why market access has been restricted or denied. In that case, the Member State of destination must also demonstrate that its measures are the least trade-restrictive.
Under the Mutual Recognition Regulation, Product Contact Points are established to help economic operators obtain reliable and specific information about the law in force in a given Member State. In Malta, the Regulatory Affairs within the Technical Regulations Division of MCCAA is the Product Contact Point.
To help you to understand the Regulation you may want to look to our Principle of Mutual Recognition website, as well to the publications of the European Commission, the Guidance on the application of the Mutual recognition regulation available in all official languages, which can be found here, and the training material on mutual recognition available in all official languages which may be found on this link
If you would like to know information about additional national requirements regulated by the MCCAA, click here for more info. For information on additional national requirements on products regulated by other Maltese Authorities, click here.