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Supplements leaders hail EU's new mutual recognition law

The European Union's new Mutual Recognition Regulation will help the dietary supplements sector break down barriers to trade, according to the Federation of Associations of Health Product Manufacturers.

The legislation, which will apply from next May in areas of EU legislation not yet harmonised, regulates the member state evaluation process for refusing the entry of a product onto their national market.

It 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.

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.

Industry and national authorities have on occasion been at loggerheads over the issue of free movement of goods, but the new regulation will address this.

"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 is not always clear. This regulation is a lot more user-friendly for industry, and we have great hope that it will help break down barriers to trade."

The Mutual Recognition Regulation defines the procedures for companies to follow when facing restrictive technical rules which directly or indirectly ban a product.

It also gives a definition of the rights and obligations of both member states and the industry and clarifies the timing by which decisions on product entry to the market must be made. In addition, it places the burden of proof on the member state, as opposed to the industry.

EHPM, which is based in Brussels, represents 2,000 specialist health product manufacturers across Europe.

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