More effort must be made to ensure botanical supplement products marketed in one European Union Member State are accepted for sale in all, the European Botanical Forum (EBF) has said.
Speaking out following the publication of the European Commission’s report suggesting that no harmonisation of bioactive and botanical ingredients used in food and nutritional products should take place at this stage, the EBF said that now more than ever the sector should apply the principle of mutual recognition.
The European Commission’s report stated that the harmonisation of ingredients other than vitamins and minerals would not be necessary in the near future, as these are sufficiently covered in other laws already in place across the EU. In particular for botanicals, it notes that a variety of community and national legislation already exist and that any potential new issue can be addressed through the current food legislative framework.
The report highlights 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 refers to 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.
“We appreciate the challenges in a Europe of 27 Member States to harmonise 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 EBF highlighted its hopes for the newly adopted Mutual Recognition Regulation, which will come into effect in May next year, imposing clear obligations on Members States who would want to refuse entry onto their national markets of a product lawfully manufactured in another Member State.
The Regulation defines the procedures for companies to follow when facing restrictive ‘technical’ rules that ban a product or prevent its authorisation 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 Commission’s report recognises 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,” Dr Ruthsatz said. “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 grey area depending on the different Member State interpretations, so companies tend not to take it up,” he added. “Now that a Regulation has been put in place, the procedure will be much clearer, so it is important for companies to recognise and familiarise themselves with this valuable tool.”