News \ Legislation - N°66 procédure susceptible d’ar- red yeast rice, both existing Auxiliaires bitrer au niveau européen for many years on the Euro- technologiques : sur le statut d’un produit, et pean market. liste positive d’harmoniser indirectement The qualifying periods are modifiée l’autorisation des subs- unsustainable for the com- tances et plantes. Mais dont panies, according to Syna- Processing aids: la vocation est d’assurer la diet (FrenchFood Supple- positive list gets sécurité du consommateur. ments Association), which modified has formulated a number of A useful reminder: the pro- proposals concerning this cedure under Article 8 of issue. For example: in the Un arrêté du 24 octobre 2018 a Regulation (EC) 1925/2006 case of mocacolin, manu- modifié la liste positive de l’ar- aims to evaluate the safety facturers had less than 10 rêté du 19 octobre 2006 fixant of use of a food substance; months to submit new toxi- les auxiliaires technologiques. Il this evaluation may result in cological data that some- inscrit notamment de nouvelles the prohibition of the said times require several years enzymes alimentaires et en étend substance or restrictions of to be collected. In this case, les leur autorisation d’emploi. use. It applies if a substance the lack of data invalidates Le décret 2011-509 du 10 mai is added to a food and if this the establishment of a fair 2011 définit au plan national latter may pose a potential and reasoned opinion. les conditions d’autorisation et risk to consumers. In addition, the absence of a d’utilisation de ces auxiliaires The European Commis- provisional timetable of eva- selon deux procédures: la pro- sion has the possibility to luations does not allow the cédure d’autorisation d’emploi request the assessment of companies to anticipate and préalable pour certains auxi- the safety of a substance exchange with EFSA (on the liaires (antimousses, enzymes, by EFSA; depending on the quality of the studies to be agents de décontamination des 039 results, the Commission may submitted). produits d’origine végétale, sol- place the substance in one The lack of harmonization - at vants d’extraction, huiles miné- of the three parts of Annex European level - of the plants rales de basse densité, subs- III to the Regulation: Subs- and substances authorized tances chimiquement réactives, tances whose use is pro- for use in food supplements oxydantes) et celle de simple hibited (Part A), restricted is also problematic. Various déclaration pour les autres. (Part B) or under Community States have different visions Scrutiny (Part C). In the latter and traditions. Some of them A decree of 24 October 2018 case, the companies are have a strong tradition with modified the positive list esta- requested to provide addi- plants, others with vitamins. blished through the Decree of tional data within 18 months The same substances may 19 October 2006, which set out to benefi t from a re-evalua- have different statuses (food the processing aids approved tion by EFSA. supplements or medicines) for use. It adds to it, in parti- Since the enactment of depending on each country. cular, new food enzymes while this procedure, EFSA has Free movement and mutual extending their allowed use. been entrusted with the recognition amplify these The Decree 2011-509 of 10 May assessment of five subs- cultural differences and the 2011 lays down in the national tances: Ephedra species, Member States have no plan the conditions of use and Yohimbe, Hydroanthracene other alternative but to rely authorization for these aids derivatives (they are found on the European Commis- according to two procedures: in Aloe Vera, rhubarb, senna, sion, which uses Article 8 the procedure for the authoriza- buckthorn...), yeast Mona- - the only procedure likely tion of use of certain aids (defoa- colin K from red yeast rice, to arbitrate the status of a mers, enzymes, decontamination Catechins from green tea. product, and indirectly har- agents for plant-origin products, Out of these ingredients, monize the authorization of extraction solvents, low-density two are closely examined: plants and substances. But mineral oils, chemically reactive/ hydroanthropene deriva- whose primary vocation is to oxidizing substances) and that of tives and monacolin K from ensure consumer safety.■ a simple declaration for others.■ News on Functional & Health Ingredients \ N°66 \ January - February - March 2019 \ ■