Nouveaux aliments/Novel foods

Evaluation du statut réglementaire de l’ingrédient natif, avant transformation, dans les Etats membres le qualifiant dans l’Union Européenne (liste positive, négative, doctrine éventuelle).

Détermination de la procédure à suivre :

  • Procédure de consultation selon le Règlement d’exécution (UE) 2018/456
  • Procédure pays tiers selon le Règlement (UE) 2015/2283
  • Procédure complète Novel Foods selon le Règlement (UE) 2015/2283

Pré-diagnostic scientifique des données, conformément aux exigences réglementaires de recevabilité

  • Analyse des données de caractérisation sur le produit/ingrédient
  • Analyse des données sur l’historique de consommation sur le produit/ingrédient
  • Analyse des données de pharmacocinétique sur le produit/ingrédient
  • Analyse des données d’allergénicité sur le produit/ingrédient
  • Analyse des études de sécurité/toxicité sur le produit/ingrédient

Recommandations de nos experts

  • Forces et faiblesses de la justification
  • Eléments complémentaires à fournir dont éventuelles études toxicologiques et/ou Qualité à réaliser.

Constitution & soumission du dossier

  • Constitution de la demande d’allégation
  • Soumission à l’autorité nationale puis EFSA

Suivi & échanges avec les autorités (Etats membres, EFSA et Commission Européenne).

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Experts Docteurs en Physiologie et Toxicologie dédiés

La meilleure expertise du marché
Exemple d'approbation Novel Foods


Qu'est qu'un ingrédient Novel Food ?

Les nouveaux aliments sont définis comme des aliments qui n'ont pas été consommés de manière significative par l'homme dans l'UE avant 1997, date d'entrée en vigueur du premier règlement sur les nouveaux aliments (règlement 258/97).

Les nouveaux aliments peuvent être des aliments nouvellement mis au point et innovants ou des aliments produits à l'aide de nouvelles technologies et de nouveaux procédés de production, ainsi que des aliments consommés traditionnellement en dehors de l'UE.

Parmi les exemples d'aliments nouveaux figurent les produits agricoles de pays tiers (graines de chia), les nutriments nouvellement produits (zéaxanthine synthétique) ou les extraits d'aliments existants (protéines de colza).

La mise sur le marché d'un nouvel aliment nécessite une autorisation européenne préalable qui précise les spécifications du nouvel aliment et ses conditions d'utilisation (dose, matrice alimentaire, etc.).

Il n'y a que 3 options possibles pour un ingrédient :

OPTION 1 L'ingrédient n'est pas "nouveau" selon la Regulation (EC) No 2015/2283:
OUI: autorisation non nécessaire MAIS un justification peut être requise
(novel food list, novel food catalogue, national lists, etc...)
NON: option 2.

OPTION 2 L'ingrédient est "nouveau" selon la Regulation (EC) N0 2018/2283:
Ingrédient non-autorisé: Procédure Novel Food complète
Ingrédient consommé en dehors de l'UE: option 3

OPTION 3 L'ingrédient est consommé traditionnellement en dehors de l'UE :
OUI: procédure applicable aux denrées alimentaires traditionnelles en provenance de pays tiers
NON: option 2

EU Novel Food Catalogue

Source: http://ec.europa.eu/food/safety/novel_food/catalogue/

#Novel Food ingredientStatusSource
03, 3'-Diindolylmethane (DIM)
14-hydroxy isoleucine
2Abelmoschus esculentus
3Abies alba
4Abies balsamea
5Abies pectinata
6Acacia arabica
7Acacia nilotica
8Acacia rigidula
9Acacia senegal
10Acacia sp.
11Acacia verek
12Acanthopanax senticosus
13Acca sellowiana
14Acer saccharum
15Acetyl L-carnitine
16Achillea millefolium
17Achras zapota
18Actinidia arguta
19Actinidia chinensis
20Actinidia deliciosa
21Adhatoda vasica
22Aegopodium podagraria
23Aframomum melegueta
24Agaricus blazei (dehydrated mycelium powder)
25Agaricus blazei (mushroom)
26Agathosma betulina
27Agave salmiana
28Agave sisalana
29Agave tequilana
30Agmatine (4-aminobutyl) guanidine sulfate
31Ajuga reptans
32Alaria esculenta
33Albatrellus ovinus
34Albizia julibrissin
35Allium fistulosum
36Allium ramosum
37Allium tuberosum
38Aloe barbadensis
39Aloe ferox
40Aloysia citrodora
41Alpha-Ketoglutarate Calcium
42Alpinia galanga
43Alpinia speciosa
44Althaea officinalis
45Amaranthus caudatus
46Amaranthus cruentus
47Amaranthus edulis
48Amaranthus flavus
49Amaranthus hypocondriacus
50Amaranthus leucocarpus
51Amaranthus mantegacianus
52Amaranthus paniculatus
53Ambrosia artemisiifolia
54Amelanchier alnifolia
55Amomum compactum
56Amomum galanga
57Andrographis paniculata
58Angelica archangelica
59Angelica dahurica
60Angelica pubescens
61Angelica sinensis
62Aniba canelilla
63Annona cherimola
64Annona muricata
65Annona reticulata
66Annona squamosa
67Antennaria dioica
68Anthemis nobilis
69Aphanizomenon flosaquae var. flosaquae
70Apis mellifera
71Arabinogalactan
72Arbutus unedo
73Arctium lappa
74Areca catechu
75Aristotelia chilensis
76Artemisia annua
77Arthrospira platensis
78Artocarpus altilis
79Artocarpus communis
80Artocarpus heterophyllus
81Artocarpus incisa
82Artocarpus integrifolius
83Ascophyllum laevigata
84Ascophyllum nodosum
85Asimina triloba
86Asparagus racemosus
87Aster tripolium
88Astragalus membranaceus
89Atriplex hortensis
90Auricularia polytricha
91Backhousia citriodora
92Bacopa monnieri
93Bactris balanoidea
94Bactris major
95Bambusa sp.
96Barosma betulina
97Basella alba
98Basella rubra
99Bertholletia excelsa
100Betula alba
101Betula alleghaniensis
102Betula alnoides
103Betula pendula
104Betula pubescens
105Bignonia lactiflora
106Bignonia rigescens
107Bixa orellana
108Borojoa patinoi
109Borojoa sorbilis
110Boswellia serrata
111Bovine lactoferrin
112Brassica eruca
113Brassica juncea
114Brassica nigra
115Brewer's spent grain
116Bulbine natalensis
117Cajanus cajan
118Calluna vulgaris
119Camelina sativa
120Camellia furfuracea
121Camelus dromedarius
122Canarium ovatum
123Cannabidiol
124Cannabinoids
125Cannabis sativa L.
126Capparis rupestris
127Capparis spinosa
128Capsicum frutescens
129Carduus benedictus
130Carica papaya
131Carissa carandus
132Carnosine
133Carthamus tinctorius
134Carum carvi
135Castanea mollissima Blume
136Catimbium nutans
137Celastrus orbiculatus
138Centaurea cyanus
139Centella asiatica
140Centrophorus squamosus
141Ceratonia siliqua
142Cervus elaphus
143Cetraria islandica
144Chamaemelum nobile
145Chenopodium pallidicaule
146Chenopodium quinoa
147Chioca
148Chlamydomonas reinhardtii
149Chlorella luteoviridis
150Chlorella pyrenoidosa
151Chlorella vulgaris
152Chondrus crispus
153Chrysanthellum americanum
154Chrysanthemum morifolium
155Chrysanthemum parthenium
156Cinnamomum verum
157Cinnamomum zeylanicum
158Cistanche deserticola
159Cistus incanus
160Citrus aurantium
161Citrus junos
162Citrus mitis Blanco
163Clinoptilolite
164Cnicus benedictus
165Cnidium monnieri
166Codonopsis pilosula
167Coenzyme Q10
168Coffea sp.
169Coix lacryma-jobi
170Cola nitida
171Coleus forskohlii
172Collagen
173Colocasia antiquorum
174Colocasia esculenta
175Colostrum
176Combretum micranthum
177Commiphora subglauca
178Conjugated linoleic acid
179Consolida regalis
180Coprinus comatus
181Corchorus olitorius
182Cordyceps dongchongxiacao
183Cordyceps sinensis
184Coriolus versicolor
185Cortinarius caperatus
186Corylus avellana
187Costus zerumbet
188Crataegus laevigata
189Crataegus oxyachantha
190Crataegus pinnatifida
191Creatine Citrate
192Creatine Pyruvate
193Crepidula fornicata
194Crocodylus nilotikus
195Cyclopia sp.
196Cyperus esculentus
197Dacryodes edulis
198Daucus carota
199Daucus gingidium
200Delphinium consolida
201Dendrobium nobile
202Dendrocalamus asper
203Dendrocalamus latiflorus
204Desmodium gangeticum
205Dioscorea alata
206Dioscorea esculenta
207Dioscorea opposita
208Dioscorea rotundata
209Distictis lactiflora
210Distictis rigescens
211Dolichos lablab
212Dolichos purpureus
213Durio zibethinus
214Echinacea purpureae
215Ecklonia bicyclis
216Egg membrane
217Egg membrane hydrolysate
218Eleocharis dulcis
219Eleutherococcus senticosus
220Emblica officinalis
221Empetrum nigrum
222Enteromorpha sp.
223Epimedium brevicornum Maxim
224Epimedium grandiflorum
225Epimedium macranthum
226Epimedium sagitattum
227Equisetum arvense
228Eragrostis tef
229Eriobotrya japonica
230Eruca sativa
231Ethyl esters (concentrated from fish oils)
232Eugenia floribunda
233Eugenia michelii
234Eugenia uniflora
235Euphausia superba
236Eurycoma longifolia
237Euterpe edulis
238Euterpe oleracea
239Evodia lepta
240Feijoa sellowiana
241Ferula hermonis
242Ferulic acid
243Festuca arundinacea
244Foeniculum vulgare
245Fucus nodosus
246Fucus serratus
247Fucus spiralis
248Fucus vesiculosus
249Ganoderma lucidum (dehydrated mycelium powder)
250Ganoderma lucidum (mushroom)
251Garcinia cambogia
252Garcinia mangostana
253Gentianella alborosea
254Gigantochloa albociliata
255Gigantochloa levis
256Ginkgo biloba
257Globba nutans Redoute
258Glucosamine sulphate
259Gossypium sp.
260Gracilaria verrucosa (Hudson)
261Grifola frondosa (dehydrated mycelium powder)
262Grifola frondosa (mushroom)
263Gypsophila struthium
264Hamamelis virginiana
265Harpagophytum procumbens
266Helianthus annuus
267Helix aspersa maxima
268Hericium erinaceus (dehydrated mycelium powder)
269Hesperidin
270Hibiscus esculentus
271Hieracium pilosella
272Himanthalia elongata
273Hippophaë rhamnoides
274Hirneola polytricha
275Hizikia fusiforme
276Hoodia gordonii
277Hordeum vulgare
278Hovenia dulcis
279Humic acid
280Hydnum repandum
281Hydrocotyle asiática
282Hydroxy Citric Acid
283Hygrophorus camarophyllus
284Hylocereus megalanthus
285Hylocereus undatus
286Hypoxis hemerocallidea
287Hypoxis rooperi
288Hyssopus officinalis
289Ilex asprella
290Ilex guayusa
291Ilex kudingcha
292Ilex paraguariensis
293Inonotus obliquus
294Ipomoea aquatica
295Ipomoea batatas
296Ipomoea hederacea
297Irvingia gabonensis
298Jessenia bataua
299Juglans regia
300Juniperus communis
301L-citrulline malate
302L-fucose
303Lablab purpureus
304Lactarius deliciosus
305Lactarius deterrimus
306Lactarius rufus
307Lactarius torminosus
308Lactarius trivialis
309Lactarius utilis
310Lactulose
311Laminaria digitata
312Laminaria japonica
313Laminaria longicruris
314Laminaria saccharina
315Langermannia gigantea
316Languas speciosa
317Laurus nobilis
318Lavandula angustifolia
319Lavandula officinalis
320Leccinum aurantiacum
321Leccinum versipelle
322Leccinum vulpinum
323Lemna minor
324Lentinula edodes (dehydrated mycelium powder)
325Lentinula edodes (mushroom)
326Lentinus edodus
327Lepidium meyenii
328Lepidium peruvianum
329Leuzea carthamoide
330Linum usitatissimum
331Lippia citrodora
332Lippia triphylla
333Lithothamnium calcareum
334Lucuma obovata
335Lupinus albus
336Lupinus angustifolius
337Lupinus luteus
338Lutein
339Lycium barbarum
340Lycopene
341Macadamia intergrifolia
342Macrodiscus lactiflorus
343Malpighia glabra
344Malpighia punicifolia
345Malus communis
346Malus sylvestris
347Mangifera indica
348Manihot esculenta
349Manihot utilissima
350Manilkara achras
351Manilkara zapota
352Manilkara zapotilla
353Medicago sativa
354Mespilus germanica
355Methyl Sulphonyl-Methane
356methylliberine
357Momordica charantia
358Momordica grosvenorii
359Monarda didyma
360Monascus albidus
361Monascus anka
362Monascus araneosus
363Monascus major
364Monascus purpureus
365Monascus rubiginosus
366Monascus vini
367Monostroma nitidum
368Moringa oleifera
369Morus alba
370Morus nigra
371Musa acuminata
372Musa nana
373Myrciaria divaricata
374Myrciaria dubia
375Myrciaria floribunda
376Myrciaria protracta
377Myrothamnus flabellifolia
378Myrtus communis
379N-Methyl-D-Aspartate
380Nasturtium officinale
381Nauclea aculeata
382Nauclea tomentosa
383Nelumbo nucifera
384Nepeta tenuifolia
385Nephelium lappaceum
386Nigella sativa
387Ocimum sanctum
388Ocimum tenuiflorum
389Oenothera biennis
390Olea europaea
391Olivella spinosa
392Omega-3 fatty acid-lysine salt
393Opuntia ficus-indica
394Origanum minutiflorum
395Origanum vulgare
396Orthosiphon stamineus
397Oryza sativa
398Oxalis tuberosa
399Oxycoccus macrocarpus
400Oxycoccus quadripetala
401Oxytenanthera albociliata
402Ozohallila nodosa
403Paeonia officinalis
404Palm sugar
405Palmaria palmata
406Panax notoginseng
407Panax ginseng
408Panax pseudoginseng
409Panax quinquefolius
410Passiflora edulis
411Paullinia cupana
412Penicillium oxalicum var. armeniaca
413Perilla frutescens
414Perna canaliculus
415Persea americana
416Persea gratissima
417Persica vulgaris
418Phalaris canariensis
419Pharbitis hederecea
420Phaseolus angularis
421Phaseolus coccineus
422Phaseolus cylindricus
423Phellodendron chinensis
424Phlebodium aureum
425Phosphatidyl-serine
426Phyllantus emblica
427Phyllostachys edulis
428Phyllostachys pubescens
429Physalis peruviana
430Physocaulon nodosum
431Picea abies
432Pinitol
433Pinus balsamea
434Pinus koraiensis
435Pinus pinaster
436Pinus sibirica
437Pinus sylvestris
438Piper nigrum
439Pistacia lentiscus
440Plantago afra
441Plantago indica
442Plantago ispaghula
443Plantago ovata
444Plantago psyllium
445Pleurotus eryngii (dehydrated mycelium powder)
446Pleurotus ostreatus (beta glucan from the mushroom)
447Pleurotus ostreatus (dehydrated mycelium powder)
448Polyacetyl-glucosamine
449Polydextrose
450Polymnia edulis
451Polymnia sonchifolia
452Polypodium aureum
453Polypodium leucotomos
454Polyporus umbellatus (dehydrated mycelium powder)
455Polyporus versicolor
456Porphyra tenera
457Portulaca oleracea
458Pouteria lucuma
459Pouteria obovata
460Prunus cerasifera
461Prunus persica
462Prunus salicina
463Prunus spinosa
464Psidium guineense
465Ptychopetalum olacoides
466Pueraria lobata
467Pueraria mirifica
468Pueraria thunbergiana
469Punica granatum
470Pyrethrum parthenium
471Rauwolfia vomitoria
472Renealmia nutans
473Rhaponticum carthamoides
474Rhodiola Rosea
475Rhodymenia palmata
476Ribose
477Richeria grandis
478Rorippia nasturtium-aquatica
479Rosa canina
480Rosa moschata
481Rosa rubiginosa
482Rozites caperatus
483Rubus arcticus
484Rubus chamaemorus
485Rubus glaucus
486Rubus suavissimus
487Rumex acetosa
488Rumex crispus
489Rumex rugosus
490Ruscus aculeatus
491Russula claroflava
492Russula decolorans
493Russula paludosa
494Russula vinosa
495Rutin
496Saccharina latissima
497Salacia reticulata
498Salicornia europea
499Salvia hispanica
500Salvia miltiorrhiza
501Satureja hortensis
502Schinus terebinthifolius
503Schisandra chinensis
504Schizonepeta tenuifolia
505Sclerocarya birrea
506Selenicerus megalanthus
507Serratiopeptidase
508Sesamum indicum
509Silver
510Silybum marianum
511Sinocalamus oldhamii
512Siraitia grosvenorii
513Smallanthus sonchifolius
514Smilax officinalis
515Solanum angulatum
516Solanum hirsutissimum
517Solanum lycopersicum
518Solanum muricatum
519Solanum quitense
520Sorbus aucuparia
521Sorghum bicolor
522Sphaerotrichia divaricata
523Sphingo-lipids
524Spirulina sp.
525Splenopentin
526Spondias lutea
527Spondias mombin
528Spondias purpurea
529Stachyose
530Stachys affinis
531Stachys sieboldii
532Stemmacantha carthamoides
533Stevia rebaudiana
534Streptococcus salivarius
535Suillus luteus
536Suillus variegatus
537Synsepalum dulcificum
538Syzygium jambos
539Tamarindus indica
540Tanacetum parthenium
541Taraxacum officinale
542Taraxacum vulgare
543Terminalia arjuna
544Terminalia chebula
545Tetragonia tetragonoides
546Theobroma cacao
547Theobroma grandiflorum
548Thymopentin
549Thyrsostachys siamensis
550Thysostachys regia
551Tinospora cordifolia
552Tragopogon porrifolius
553Trametes versicolor
554Trapa natans
555Tribulus terrestris
556Tricholoma matsutake
557Trifolium pratense
558Trigonella foenum-graecum
559Triticum
560Triticum aestivum
561Turnera diffusa
562Ulva lactuca
563Uncaria surinamensi
564Uncaria tomentosa
565Undaria pinnatifida
566Urtica dioica
567Vaccinium macrocarpon
568Vaccinium myrtillus
569Vaccinium oxycoccus
570Vaccinium uliginosum
571Vaccinium vitis-idaea
572Valerianella locusta
573Vigna catjang
574Vigna sinensis
575Vigna subterranea
576Vigna unguiculata
577Viscum album
578Vitis vinifera
579Volvariella volvacea
580Withania somnifera
581Xanthoparmelia scabrosa
582Xanthosoma sagittifolium
583Xanthosoma violaceum Schott
584Young Tissue Extract from incubated hen's eggs
585Zea mays
586Zeolite
587Zerumbet speciosum
588Zizania aquatica
589Ziziphus jujuba
590Ziziphus vulgaris
591Ziziphus zizyphus

EFSA Journal

Nos succès Novel Food. Source https://efsa.onlinelibrary.wiley.com/

Safety of heat‐killed Mycobacterium setense manresensis as a novel food pursuant to Regulation (EU) 2015/2283

Abstract Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on heat‐killed Mycobacterium setense manresensis as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is an encapsulated ingredient composed of 200 mg mannitol and ≤ 105 heat‐killed, freeze‐dried M. setense manresensis. The information provided on the efficacy of the heat inactivation process demonstrates that the applied thermal process effectively kills all M. setense manresensis. The Panel considers that the NF is sufficiently described and characterised. The NF is intended by the applicant to be marketed exclusively in food supplements (gelatine capsules) for the general adult population excluding, children, pregnant and lactating women. The NF is not intended to be an alternative to standard treatment against tuberculosis. The applicant proposed an intake of one capsule (with ≤ 105 heat‐killed, freeze‐dried M. setense manresensis) for 14 consecutive days and a minimum of 6 months with no consumption of the NF, before another intake for fourteen days may follow. M. setense is not considered to be a suitable microorganism species for the qualified presumption of safety (QPS). Genetic analyses of the genome indicate the absence of the ability to produce exotoxins. The Panel considers that consumption of heat‐killed M. setense manresensis would not contribute to the pool of transmissible antimicrobial resistance genes already present in the intestinal microbiota. The Panel concludes that the NF is safe under the proposed conditions of use.

EFSA Journal, Volume 17, Issue 11, November 2019.
Safety of orthosilicic acid‐vanillin complex (OSA‐VC) as a novel food ingredient to be used in food supplements as a source of silicon and bioavailability of silicon from the source

Abstract The present scientific opinion deals with the safety of orthosilicic acid‐vanillin complex (OSA‐VC) as a novel food ingredient for use as a source of silicon (Si) in food supplements and with the bioavailability of Si from this source. OSA‐VC is stable in liquid solution at low pH values. OSA from OSA‐VC was available as revealed by the increase in plasma Si concentrations after oral ingestion in human volunteers. The toxicological data provided in support of the current application were not in accordance with the Tier 1 requirement of the ‘Guidance for submission for food additive evaluations’; however, this was considered justified by the Panel given that OSA‐VC at pH 6.8 dissociates into orthosilicic acid and vanillin. The daily consumption of OSA‐VC at the dose recommended by the applicant would provide a supplemental intake of Si of approximately 10–18 mg Si/day which would result in an estimated total intake of roughly 30–70 mg Si/day. The maximum vanillin intake resulting from the consumption of OSA‐VC would be less than 5% of the acceptable daily intake (ADI) value for vanillin of 10 mg/kg body weight (bw) per day established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 2002. The Panel concluded that there would be no safety concern with the proposed use and use level of OSA‐VC as a novel food ingredient intended to be used as a source of Si in food supplements for the adult population. The Panel concluded that OSA, measured as Si, is bioavailable following ingestion of OSA‐VC and appears similar to values reported in the literature for other established sources of OSA.

EFSA Journal, Volume 16, Issue 1, January 2018.


Témoignage
Nous recommandons fortement Nutraveris. Ils sont allés plus loin que la prestation Réglementaire prévue. Nous faisons confiance à l'équipe Nutraveris pour fournir les informations les plus récentes et les plus pertinentes. Au cours d'une application Novel foods pour l'UE très difficile à obtenir, l'équipe Nutraveris, en particulier notre consultant dédié, a été en mesure de mener une stratégie avec des résultats positifs. Et même plus, puisque notre projet a été réalisé en respectant le budget et s'est terminé plus rapidement que prévu. Nous n'hésiterons pas à engager Nutraveris sur n'importe lequel de nos futurs projets européens.
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