Mutual Recognition

What is this principle?

Mutual recognition is an established principle of EU law. Its aim is to ensure the smooth functioning of the internal market by making sure that intra-Community trade in goods also goes unhampered in areas where regulatory differences between Member States remain (non-harmonised areas).

In food law an example where only partial harmonisation persists to exist is the law governing food supplements. The Food Supplements Directive 2002/46/EC provides for a harmonised list of vitamins and minerals that may be used for the manufacture of food supplements. The Directive does, however, not (yet) state what the maximum daily amount of vitamins and minerals in food supplements should be or what ‘other substances’ may be authorised. It is in that instance that the principle of mutual recognition should step in to ensure that a Member State does not prohibit the sale on its territory of food supplements which are lawfully marketed in another Member State.

Legal Basis in Primary Law

Articles 34 and 36 of the Treaty on the Functioning of the European Union (TFEU).

Legal Basis in Secondary Law

Regulation (EC) No 764/2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State

Where does it apply?

The Regulation applies to regulatory mesaures of Member States that concern any product, including agricultural and fish products, lawfully marketed in another Member State, where the direct or indirect effect of the regulatory measure(s) is any of the following:

  • The prohibition of the placing on the market of that product or type of product;
  • The modification or additional testing of that product or type of product before it can be placed or kept on the market;
  • The withdrawal of that product or type of product from the market.

Why was it necessary?

Half a century of economic integration has not levelled out all differences in product regulations and has so far failed in many instances to remove obstacles to the free movement of goods between the 28 Member States. This is in particular felt in the foodstuffs market where Member States often use the public policy justification provided for in  Article 36 TFEU to impose regulatory measures that hamper intra-EU trade.

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Our Mission

EHPM represents the interests of specialist health product manufacturers and distributors in Europe. It works towards developing an appropriate regulatory framework throughout the EU for its members' products, and promotes industry best practices for product quality and safety.

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