Burden of proof shifts to the member state refusing entry to a product
The concept of 'mutual recognition' underpins the principle of the free movement of goods across the European Union. It means that if a product is permitted for sale in one member state, it should be permitted for sale in all member states, even where there is no harmonisation of national laws.
But it is harder to apply than it is to explain, as demonstrated recently when the EU Commission was forced to take Spain to the EU Court of Justice to force the country to accept the sale of botanicals within its borders.
Spain considers products containing herbs to be medicinal, despite the fact they are sold legally in other member states as supplements. The court agreed that Spain's actions hindered the free movement of goods.
It was a significant industry victory. But it was also the third case in recent times involving food supplements vs medicinal products, demonstrating how tricky in practice mutual recognition is.
Happily, however, life is set to become easier for suppliers of functional products. New legislation coming into force on May 13, The EU Regulation on the Mutual Recognition of Non-Harmonised Goods, will herald significant changes for mutual recognition, and covers a wide variety of products, including food and food supplements.
The regulation is good news for those involved in the supplements and functional-foods sector, according to Lorene Courrege, director of regulatory affairs at European Federation of Associations of Health Product Manufacturers, because it swings the balance of power a little in their favour.
"At the moment, there is rarely an opportunity for dialogue with the national authority refusing to allow the marketing of your product," she explained. "This means it is very difficult for a company to go against what a national member state says. But this new regulation sets up a mandatory dialogue, whereby the member state has to follow a stated procedure and timeline to inform the company about the reason why it has refused entry into the market."
There's more, Courrege explained. "The regulation also expressly states that the burden of proof when deciding a product is not safe is on the member state. In the past, it was often the case that a member state would request that a company proved its product was safe, which was very difficult and contrary to how mutual recognition was intended to be applied. Now it's clearly written in black and white that it is for the member state to justify its decision."
Elodie Lebastard, food-law adviser at Brussels-based consultancy EAS, agrees the regulation will benefit the functional-products sector. "Although mutual recognition has been the rule for decades, it has been hard to make member states apply this in certain areas," she said. "In terms of food supplements, there are many cases of national authorities denying the mutual-recognition principle."
In particular, Lebastard said, the law will be important to intra-community trade, particularly now that the EU Commission has decided not to harmonise the rules for bioactives other than vitamins and minerals. The regulation won't necessarily mean an end to legal tussles over whether functional products are allowed into individual markets. There are 27 EU member states and it is not just Spain that harbours prejudices against certain products. But it will help, she said, by giving companies a valuable tool.