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*The European Union’s (EU) recently adopted Mutual Recognition Regulation appears to be a ‘user-friendly’ tool for the food industry in the fight to break down EU-wide barriers to trade, the European Federation of Associations of Health Product Manufacturers (EHPM) has said. *

The Regulation, which applies in areas of EU legislation not yet harmonised, regulates the Member State evaluation process for refusing product entry onto their national markets.

It's 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.

This principle provides that a product lawfully marketed in one Member State should be allowed entry in another Member State’s territory without the products needing to be in compliance with one another’s different national legislations.

Whereas industry and national authorities have on occasion been at loggerheads over the issue of free movement of goods, the Mutual Recognition Regulation aims to address the legal uncertainty over the scope of the principle and the absence of a continuous dialogue among the national authorities.

It also defines the procedures for companies to follow when facing restrictive ‘technical’ rules which directly or indirectly ban a product, prevent the authorisation for a product to be placed on the market, require product modification before it can be allowed on the market, and require the withdrawal of a product from the market.

“Awareness of the principle of mutual recognition is lacking across the EU, both within the industry and among the different national authorities,” said Peter van Doorn, Chairman of EHPM. “Within the various national markets, the industry is largely under the impression that national rules prevail, and how to apply the principle of mutual recognition isn't always clear. This Regulation is more user-friendly for industry, and we hope that it will help break down barriers to trade.”

Earlier this year, the European food supplement trade organisation conducted its first workshop on the issue of free movement of goods – a Free Trade Initiative to help companies better understand how the practical application of the mutual recognition principle and encourage its use.

The Mutual Recognition Regulation gives a definition of the rights and obligations of both the Member States and the industries: it clarifies the timing by which decisions on product entry to the market must be made; puts the burden of proof on the Member State, as opposed to the industry; and states that Member States must set up Product Contact Points, which will provide information on product authorisations and refusals to businesses and the various EU national authorities.

The Mutual Recognition Regulation will become applicable in May 2009.