Complex national rules can become a relative minefield for companies marketing their botanical products across different EU member State markets, an industry consultant has said.
Patrick Coppens, Food Law Manager at Brussels consultancy EAS, said that with the rules for marketing botanical products in the European Union not yet harmonised, some Member States have specific requirements for these products, which can cause complications for companies in the marketplace.
Speaking in a five-minute podcast, Mr Coppens said: “In theory it should not be a problem because you have the principle of mutual recognition where a product lawfully manufactured in one Member State should be able to easily move into another Member State market. But there are still herbals allowed in some Member States and not others.”
“Gingko Biloba for example, is classed as medicinal in Germany and Spain, but as a food supplement in Italy and Belgium,” he added. “You have positive and negative lists of botanicals, and all that knowledge has to be brought together and translated into a product that will be acceptable in the relevant national market.”
Botanical products include herbs and plants, herbal infusions, and herbal extracts used in regular foods and in food supplements.
While harmonisation efforts has begun across the EU with the Food Supplement Directive, at this stage it only covers vitamins and minerals, leaving botanicals to be regulated under national laws.
Mr Coppens said: “It is important that companies know the applicable national legislations and adapt their products to it. It can be very problematic and costly if they launch products that are afterwards challenged by national authorities.”
EAS specialises in European and international regulation on food and nutritional products. It provides companies with regulatory and strategic advice for the marketing and approval of their products in Europe. EAS also advises governments, trade associations and companies on the impact of European and global policy.