01.01.09
The European Commission issued a report in December stating that no further steps would be taken to harmonize bioactive and botanical ingredients used in food and nutritional products because it believes they are sufficiently covered in other laws already in place across the EU (i.e., Nutrition and Health Claims, Fortification, Novel Food). In particular for botanicals, it notes that a variety of community and national legislation already exist and that any potential new issue could be addressed through the current food legislative framework.
In light of this development, the European Botanical Forum (EBF) said it is more important than ever to make sure that botanical and food supplement products in one EU member state be accepted for sale in all. “We appreciate the challenges in a Europe of 27 member states to harmonize all elements, and we hope that all of the laws currently in existence will be used as intended and preserve the place of botanical food supplements alongside medicinal products,” said EBF chairman Manfred Ruthsatz.
The commission’s report specifically highlighted the scientific work already accomplished by, for example, the European Food Safety Authority (EFSA) and the Council of Europe in relation to botanicals. It also touched on the borderline between medicines and food supplements, clearly laying out the current European Court of Justice (ECJ) rulings that apply in the case of classification issues.
The European Federation of Associations of Health Product Manufacturers (EHPM) highlighted the role that the new Mutual Recognition Regulation could play now that these substances will remain subject to different national rules. The trade organization said that companies manufacturing botanicals and bioactive substances should familiarize themselves with this regulation, as it could be the key to countering restrictions placed on their products in the various EU member state markets.
The regulation defines the procedures for companies to follow when facing restrictive “technical” rules that ban a product or prevent its authorization on the market; rules that require modifications of products before they can be allowed on the market; and rules that require the withdrawal of products from the market. “The annexes of the commission report highlights the most important other ingredients used, which should make it very difficult for member states to deny their existence in food supplements,” said EHPM chairman Peter van Doorn. “If companies and national regulatory authorities both have a clear understanding of the Mutual Recognition Regulation, it should go a long way toward breaking down EU barriers to trade.”
EBF’s Dr. Ruthsatz agreed. “The commission’s report recognizes the importance and variety of use of other ingredients, including botanicals, in food supplements across the EU—they are used almost as much as vitamins and minerals in some member states. It needs to be appreciated that for European companies to be competitive they need to be able to sell across their domestic market, which is the EU.”
“While national authorities and industry are aware of the principle of mutual recognition, how it is applied in practice is a gray area depending on the different member state interpretations, so companies tend not to take it up,” Dr. Ruthsatz added. “Now that a regulation has been put in place, the procedure will be much clearer, so it is important for companies to recognize and familiarize themselves with this valuable tool.”
The Mutual Recognition Regulation will go into effect in May.
In light of this development, the European Botanical Forum (EBF) said it is more important than ever to make sure that botanical and food supplement products in one EU member state be accepted for sale in all. “We appreciate the challenges in a Europe of 27 member states to harmonize all elements, and we hope that all of the laws currently in existence will be used as intended and preserve the place of botanical food supplements alongside medicinal products,” said EBF chairman Manfred Ruthsatz.
The commission’s report specifically highlighted the scientific work already accomplished by, for example, the European Food Safety Authority (EFSA) and the Council of Europe in relation to botanicals. It also touched on the borderline between medicines and food supplements, clearly laying out the current European Court of Justice (ECJ) rulings that apply in the case of classification issues.
The European Federation of Associations of Health Product Manufacturers (EHPM) highlighted the role that the new Mutual Recognition Regulation could play now that these substances will remain subject to different national rules. The trade organization said that companies manufacturing botanicals and bioactive substances should familiarize themselves with this regulation, as it could be the key to countering restrictions placed on their products in the various EU member state markets.
The regulation defines the procedures for companies to follow when facing restrictive “technical” rules that ban a product or prevent its authorization on the market; rules that require modifications of products before they can be allowed on the market; and rules that require the withdrawal of products from the market. “The annexes of the commission report highlights the most important other ingredients used, which should make it very difficult for member states to deny their existence in food supplements,” said EHPM chairman Peter van Doorn. “If companies and national regulatory authorities both have a clear understanding of the Mutual Recognition Regulation, it should go a long way toward breaking down EU barriers to trade.”
EBF’s Dr. Ruthsatz agreed. “The commission’s report recognizes the importance and variety of use of other ingredients, including botanicals, in food supplements across the EU—they are used almost as much as vitamins and minerals in some member states. It needs to be appreciated that for European companies to be competitive they need to be able to sell across their domestic market, which is the EU.”
“While national authorities and industry are aware of the principle of mutual recognition, how it is applied in practice is a gray area depending on the different member state interpretations, so companies tend not to take it up,” Dr. Ruthsatz added. “Now that a regulation has been put in place, the procedure will be much clearer, so it is important for companies to recognize and familiarize themselves with this valuable tool.”
The Mutual Recognition Regulation will go into effect in May.