The European Commission has published a Roadmap on the evaluation of the EU Nutrition and Health Claims legislation. This evaluation will look mainly into whether the rules currently in place on health claims are fit for purpose to deal with health claims on botanicals and nutrient profiles.
It is the first step in the evaluation process and outlines the purpose, content and scope of the evaluation. Stakeholders will have four weeks to submit their comments on a dedicated webpage.
There are no rules yet put in place on nutrient profiles, but they are still warranted to achieve the objectives of the Regulation.
The results of the evaluation will be used as a basis to decide whether there is a need to review the current rules. Regulation (EC) No 1924/2006 on nutrition and health claims made on foods governs the use of these claims in the labelling, presentation and advertising of foods. It aims at enabling consumers to make healthier choices by protecting them from misleading information and ensuring a level playing field for food businesses to operate within the single market
Botanicals and derived preparations made from plants, algae, fungi or lichens have become widely available on the EU market in the form of food supplements. Examples include ginkgo, garlic, St. John’s Wort and ginseng. Such products are typically labeled as natural foods and a variety of claims are made regarding possible health benefits. They can be bought over the counter in pharmacies, supermarkets, specialist shops and via the Internet.
While most of these products have a long history of use in Europe, some concerns exist with regard to safety and quality. These include the risk of chemical or microbiological contamination and the need to ensure that concentrations of bioactive agents are within safe limits.
The EU legal system does not set out any kind of authorization procedure centralised at EU level for the use botanicals and derived preparations in food. Nonetheless, the use of botanicals and derived preparations in food has to comply with the general requirements set out in the Regulation laying down general principles and requirements of food law and creating the European Food Safety Authority (Regulation (EC) No 178/2002). This inter alia assigns primary legal responsibility for the safety of the products placed on the market to business operators.
Currently, while herbal substances presented as food (food supplements), under the terms of Regulation EC 1924/2006, may make claims for nutritional benefit and health benefit provided these claims have been previously evaluated and are supported following scientific evaluation by the European Food Safety Authority. Products marketed as food supplements can only be promoted for claims pertinent to those evaluated by EFSA. While they are required to be of good quality, hygiene compliant and labelled in accordance with food law, they are much less rigorously regulated than comparable traditional herbal medicinal products which must be manufactured in licensed premises under the conditions of Good Manufacturing Practice conditions.
