EU Mutual Recognition Regulation Becomes Applicable

It applies to areas of EU legislation not yet harmonised and sets up a compulsory dialogue between Member States and companies facing restriction to market access for their products because of national technical rules.

15/05/09 A new European Union (EU) Regulation setting down rules for operators and national authorities on how to apply the principle of mutual recognition became applicable yesterday (13 May 2009), European trade organisation EHPM has said.

EHPM Director of Regulatory Affairs Lorene Courrege said that the Regulation could be a vital tool for the food supplement sector in helping to break down national trade barriers in the EU.

The Regulation is based on the concept of mutual recognition of national rules, which stems from the principle of the free movement of goods guaranteed by the EU treaties. It applies to areas of EU legislation not yet harmonised and sets up a compulsory dialogue between Member States and companies facing restriction to market access for their products because of national technical rules.

Highlighting its ‘user-friendly’ quality, Ms Courrege said that it was imperative to raise awareness of the principle of mutual recognition both within the industry and among the different national authorities.

“Across the EU, both within the industry and among the different national authorities, there is not much awareness of the principle of mutual recognition,” she said. “The new Regulation gives a definition of the rights and obligations of both the Member States and the industries. Its clear description of the legal framework will be a significant help to supplement companies arguing for market access. We have great hope that it will help break down barriers to trade.”

Last week EHPM gave a 30-minute presentation on the Vitafoods International show floor on the topic of using the mutual recognition Regulation to help export food supplements to other EU markets.

In the presentation Ms Courrege highlighted a number of key aspects of the regulation, most notably that it puts the burden of proof on the Member State as opposed to the industry when refusing the entry of the product on grounds of safety for example; and that it states Member States must set up Product Contact Points, which will provide information to businesses and the various EU national authorities on the national technical rules that have to be complied with in order to market a product.

She said: “This regulation is doubly important in light of the European Commission’s recently released opinion that no further harmonisation of bioactive and botanical ingredients used in food and nutritional products is necessary at this stage. It means companies may find barriers to trade among different Member States, although ingredients lawfully marketed in one EU member state should, in principle, be accepted in all other EU markets. The new Regulation should be a useful tool to overcome these hurdles.”