N°64 - Ingrédients /Extraits végétaux of 300 mg EGCG safe. The European Commis- mission will validate or not the request for eva- sion must now decide whether to include (or not) luation under Article 8. catechins in Annex III. •Monacoline K from red yeast rice: EFSA has 2,000 claims still pending been commissioned by the European Commis- sion to assess the safety of this substance. The Regarding the labelling of food supplements, opinion is being prepared, the conclusions and this aspect is also well framed. There are two debates regarding the opinion must be initiated types of wording that can be found on a label, the and fi nalized during the meeting of the ANS Panel mandatory information (mandatory information which is to end on 29 June. Once the opinion contained in the INCO Regulation, the informa- published, the Commission will also have to posi- tion provided by Directive 2002/46 and additional tion itself regarding this substance and its inclu- information related to the use of certain ingre- sion (or not) in Annex III of Article 8. dients such as plants or substances) as well as Other assessments of the safety of use of subs- voluntary wordings that will allow consumers to tances based on the principle of Article 8 are understand the product at the moment of pur- also envisaged, the Member States having posi- chase (nutrition and health claims). tioned themselves in favour of their evaluation: As regards generic health claims, Regulation synephrine, alpha-lipoic acid and fennel in infu- 432/2012 lists the claims for vitamins, minerals sions for infants. The Member States that have and substances along with their conditions of submitted the request for evaluation must now use. Botanical claims have been put on hold by produce a fi le containing the market and security the European Commission for 10 years now. Over data. Based on these fi les, the European Com- 2,000 claim applications for botanicals listed in the Europeanepositoyae still pending. Please note that in order to use a botanical claim, this latter must feature in the pending list and should 110 ESSENTIAL OILS: NOVELTIES IN THE NEAR not make reference to any pharmacological or therapeutic benefi t. FUTURE? Today’s conclusions regarding these claims are as follows: 261 claims have been authorized, Essential oils can be currently added as active 2,059 claims have been rejected, and 2,145 ingredients in food supplements only through mutual claims are still pending. In October 2015, the recognition with a registration under Article 16. Commission had launched a Roadmap including Either through Belgium - through mutual recognition of the fi nished product, or Italy - through mutual considerations on the pending claims for botani- recognition on the basis of the Italian decree, cals with the aim of supporting the recognition of which clearly authorizes certain essential oils. the traditional use of plants in their assessment. Synadiet’s working group on essential oils has produced The conclusions of this work as well as recom- two lists of essential oils which set the maximum mendations should have been published by the daily doses and the precautions for use associated end of June 2018. But the Commission has fallen with each of the listed oils. These lists were submitted behind. It is already clear that there will be no to the DGCCRF, which recognized the work done. progress on the subject of botanical claims by Following discussions with this latter, it has been the next European Commission elections (Sep- decided that these two lists should be published on tember 2019). In the meantime, 2,000 claims may the Synadiet’s website and that the DGCCRF should still be used. publish on its website the general precautions for use to be associated with any product based on essential Herbal supplements are therefore at the oils and make reference to the Synadiet’s lists to allow crossroads of different regulations and are for the registration of these oils under Article 15. This strictly regulated, which makes them safe for would be a big step forward for the sector as it would use. However, this regulatory framework is still allow the registration of certain oils under Article 15. evolving with the prospect of having a harmo- The two lists should be published during the month nized list of plants at European level and a list of of July. In the meantime, any product containing authorized claims. ■ essential oils must be registered under Article 16. Source: Elodie Veyret, Regulatory Affairs Manager, Synadiet (conference at the latest JAS edition) ■ / Juillet - Août - Septembre 2018 / N°64 / L’Actualité des Ingrédients Fonctionnels & Santé