Claims regulation

The Novel Food Regulation ((EU) 2015/2283; NFR) went into force at the beginning of this year. The aim of this regulation is to improve the conditions of food business operators bringing new and innovative foods to the EU market while maintaining a high level of food safety for European consumers. With the creation of the Unions list of novel foods, specifications and conditions of use for these foods and food ingredients are centralized. The Union list is updated regularly. All authorization decisions can be found on the Commission website. All authorizations granted under the old regulation are no longer applicant-specific but have become generic following their inclusion in the Union list. Now, a year down the line, we have the first examples for authorizations with or without protection of proprietary data. A number of notifications based on traditional foods from non-EU countries were submitted but not yet included in the Union list. The new NFR also triggered food business operators to consult with National Authorities to determine the status of their novel foods (art. 4(2) of the NFR). A summary table of finalized evaluations under art. 4(2) can be found here. All these examples help understand how the authorization process works and is put into practice under the new conditions. For the first time a triple combination of herbal extracts (Cynanchum wilfordii Hemsley, Phlomisumbrosa Turcz. and Angelica gigas Nakai (EstroG -100™)) gained approval as a novel food. However, no health claim has as yet been approved.

There have been plenty of discussions around maximum levels of vitamins and minerals allowed in food supplements in Europe. Due to the lack of action from the EU Commission on defining these maximum levels, as was foreseen in the directive 2002/46/EC, more and more Member States are setting their own maximum levels for vitamins, minerals, and other substances. After Belgium, Norway, Denmark, Italy, and France, the Spanish Council of Ministers has approved this year a decree containing maximum levels for “other substances” allowed in food supplements. Also, The Netherlands published its final text introducing new maximum levels of vitamin B6 in food supplements. Meanwhile, Germany has not yet legally defined maximum levels for vitamins and minerals in food supplements, but the BfR has suggested recommended safe levels. Looking at the maximum levels of the different Member States, the values differ considerably, hindering the free movement of goods in the EU.

Also during this year, EFSA provided an update on two scientific guidances for health claim applications, one being on oxidants, oxidative damage and cardiovascular health and the other related to muscle function and physical performance. These updated guidances support applicants in the preparation of their applications for authorization of health claims. If you would like to read more about the updates introduced on the guidance related to muscle function and physical performance, please go to our November issue.

In terms of ingredients and claims, from the six EFSA opinions on innovative/proprietary health claims (article 13.5) published this year, two received a positive opinion. They were: a) Carbohydrate solutions and contribute to the improvement of physical performance during a high-intensity long-lasting physical exercise and b) Black tea and improvement of attention. One negative EFSA opinion for an article 14 health claim application, was also published (Symbiosal® and lowering of blood pressure and reduced risk of hypertension). In the meantime, one claim was approved by the EU Commission on a combination product referring to the reduction of disease risk (14.1 health claim). This claim was submitted by Laboratoire Lescuyer (France) on Limicol®. In 2013, EFSA had already issued a positive opinion on this health claim. Now, 5 years later, the EC Commission finally agrees.

The use of botanicals in food supplements among Member States is a complex business. To make things even more complex, Italy has recently published a new Decree which includes a new list of botanicals allowed in food supplements. With this decree, Italy becomes a stand-alone market for some food supplements containing botanicals, and there is no longer harmonization on the use of botanicals among the BELFRIT States. The Decree took effect on the 10th December 2018. Likewise, the impasse concerning “on hold” botanical claims used in foods continues. Under the Commission’s Regulatory Fitness and Performance (REFIT) program, botanicals have been under “reflection” concerning the use of health claims to establish a community list of permitted general health claims for foods. However, no news is yet available. It looks like no real solution is expected for botanical claims in the near future.