Regulatory evaluation of the native ingredient before processing (plant, animal product, other source…) in EU Member States that specifically qualify it (positive/negative lists, potential doctrines…)

 
Procedure selection

  • Consultation process according to Regulation (EU) 2018/456
  • Traditional food from third countries process according to Regulation (EU) 2015/2283
  • Complete procedure according to Regulation (EU) 2015/2283

Scientific gap analysis of the data in accordance with Regulatory admissibility criteria

  • Characterization data on the food/ingredients
  • History of consumption on the food/ingredients
  • Pharmacokinetic data on the food/ingredients
  • Allergenicity data on the food/ingredients
  • Safety/toxicological data on the food/ingredients

Experts Recommendations

  • Strengths and weaknesses of the substantiation
  • Complementary elements to provide including additional toxicology and/or quality studies

File constitution & submission

  • Preparation of the file.
  • EC submission and EFSA assessment

Authorities follow up & exchange (EFSA & European Commission)


Novel Food regulation: recalls and hot topics

Introduction

Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, applicable since 1 January 2018, allows novel foods to be subject to simpler, clearer regulation and a more efficient and fully centralised authorisation procedure at EU level, allowing safe and innovative foods to be placed on the EU market quickly without compromising a high level of public health.

What is a novel food?

A novel food remains defined in Regulation (EU) 2015/2283 as a food for which human consumption was negligible in the European Union before 15 May 1997, when the first novel food regulation came into force with Regulation (EC) 258/97.

The sources from which novel foods are derived are plants, animals, microorganisms, cell cultures, minerals, etc. Novel foods may come from specific categories of foods (insects, vitamins, minerals, food supplements, etc.), foods resulting from production processes and advanced practices and technologies (e.g. new or intentionally modified molecular structure, nanomaterials), which were not produced or used before 1997 and can therefore be considered as novel foods.

Examples of novel foods include agricultural products from third countries (chia seeds), newly produced nutrients (synthetic zeaxanthin) or extracts of existing foods (rapeseed protein). Genetically modified foods (Regulation (EC) 1829/2003), food enzymes (Regulation (EC) 1332/2008), food additives (Regulation (EC) 1333/2008), food flavourings (Regulation (EC) 1334/2008) and extraction solvents (Directive 2009/32/EC) remain excluded from the scope of this regulation.

Novel foods may not be placed on the market or used in food for human consumption until they are included in the Union list, which stipulates the specifications of the novel food and its conditions of use (dose, food matrix, etc.), and groups the novel foods authorised to be placed on the market in the Union.

An ingredient can only be in one of the three situations illustrated in the diagram below. The ingredient is either not new and therefore useable (unless there are national restrictions), new and therefore not authorised, or new in the EU but traditional in a third country. In all cases the novel food status of an ingredient must be justifiable.

How do you justify that an ingredient is not new?

Many sources of literature are useful in defining whether or not an ingredient is new. If the ingredient is on the Union list of novel foods and/or its updates (Implementing Regulations), does it correspond to the specifications, conditions of use, etc. of the new ingredients already authorised? National positive lists and interpretations by national authorities in Member States considering the ingredient as native before processing may also be indicative. The type of preparation of a plant, its manufacturing process, solvents used, plant/extract ratio, active ingredient content, etc. make it possible to define whether a preparation is new or not. If a plant is included in the list of authorised plants, this does not mean that all preparations derived from it are authorised. For example, the French decree on plants specifies the type of preparation expected for certain plants (hydroalcoholic extract for the guava tree, cooking for the tribe…). The Novel Food Catalogue lists the knowledge shared by the Member States concerning certain ingredients. Documents proving a history of significant human consumption of food in the European Union before 15 May 1997 can thus prove the Novel Food status of an ingredient. Such documents are sales statistics, sales invoices, information on quantities sold, import documents, declarations or certificates from other EU Member States (it must be clearly stated that the novel food status has been assessed), labels with dates, catalogues, sales brochures, kitchen recipes… Note that a price list alone or photos of products are not sufficient, as this does not show that the product was marketed in the EU and/or before 1997. It is important that the proof of consumption mentions the date (before 15/05/97) and the commercial territory concerned (EU).

As stated in Article 4 of Regulation (EU) 2015/2283, food business operators must verify the novel food or non-food status of the food they place on the market. In case of doubt they must follow the consultation procedure for the determination of novel food status, according to the implementing Regulation (EU) 2018/456.

In case of doubt, the consultation procedure on the novel food status

A request for consultation to define the novel food status or not of an ingredient consists of the elements to characterise it and evidence of its significant consumption history in the EU before 15 May 1997. The characterisation of the ingredient is done on the basis of its specifications, certificates of analysis demonstrating its regulatory compliance in terms of quality and contaminants, its production process and any other supporting data such as bibliography. The consumption history comes back to what is mentioned above, i.e. documents from sales, imports, publications etc… proving that the food was consumed in the normal diet in the EU before May 1997. This procedure is very rapid and the recipient Member State reaches a conclusion on the novel food status of a food within four months from the date on which it has decided on the validity of the request for consultation. In the case of requests for additional elements, this period may be extended by a maximum of 4 months. The final opinion and the status of the ingredient shall then be publicly visible on the Commission’s website. This very recent procedure, only put in place in May 2018, shows that so far the majority of the applications submitted have resulted in recognition of the novel food status of the evaluated ingredients. In March 2020 :

  • 28 ingredients are considered “Novel when used as or in foods” (Selenium mushrooms Agaricus bisporus, Cocoa pulp juice, CBD isolate purity > 98%…);
  • only 1 is considered as “Novel when used as or in foods Not novel only in food supplements” (Maqui berries fruit of the Aristotelia chilensis plant);
  • 1 is considered “Not novel only in food supplements” (Coix lacryma-jobi L. – seeds);
  • 5 are considered “Not novel when used as or in foods” (Pine cone Pinus sylvestris syrup, Passiflora edulis f. edulis Sims., Mineral enriched fungal biomass Aspergillus oryzae).

Where there is no longer any doubt as to the novel food status of an ingredient, its marketing shall be prohibited until it is included in the European Union list, in accordance with the procedure described below.

The complete procedure for novel foods

A novel food application must demonstrate the safety of the novel food/ingredient and will be forwarded to the authorities for evaluation. The objective of such a dossier is to characterise the ingredient and prove its safety through toxicological testing. The application must provide the elements for the description of the novel food, its production process, composition, specifications, proposed uses and levels of use and intended consumption. Data concerning its history of use and/or source, absorption, distribution, metabolism, excretion, nutritional information, toxicological information and allergenicity are also expected. It is expected that the toxicity tests will show an absence of genotoxicity and a NOAEL (No Observable Adverse Effect Level) in rodents and from which the safe dose for human use will be calculated with an uncertainty factor of 200 between the dose studied/tested in animals and the dose allowed in humans. This procedure is now much quicker than under the previous regulation and EFSA must deliver its scientific opinion within nine months, which may be extended depending on requests for additional information. In addition to these deadlines, the Commission must publish the authorisation in the EU list within a maximum of seven months. Experience has shown that EFSA’s assessment of applications which result in a positive opinion and authorisation of the new ingredient is almost always positive, unless there is a clear toxicity problem.

The simplified procedure for traditional foods from third countries

It is appropriate to facilitate the placing on the market in the Union of traditional foods from third countries where it has been demonstrated that they have a history of safe use as food in a third country. Such food must have been consumed in at least one third country for at least 25 years as part of the normal diet of a significant number of people. To this end, information is requested on the description, production process, composition, specifications, history of use and proposed conditions of use of the traditional food for the EU market. The references used may be scientific publications, expert scientific opinions, monographs, information from international or national organisations, government documents, values on cultivation/harvesting, sales and marketing. Additional information can be obtained from cookbooks, recipes and other anecdotal data. This procedure is very fast, as is the consultation procedure and EFSA has to deliver its scientific opinion within four months from the date on which it decides on the validity of the application. Experience shows that EFSA’s assessment is almost always positive, unless it is impossible to conclude on the safety of use (Leaf powder of Moringa stenopetala, maqui berry), of applications that lead to a positive opinion and the authorisation of the new ingredient.

Some major topics in novel food news

The positive EFSA opinion (2017 [4777]) on Ocean Spray cranberry extract had two effects on the food supplement market. On the one hand some may have had a positive reading confirming the high chances of success of a novel food application. Indeed here a perfectly characterized ingredient, with a good decrease of consumption on the source, cranberry fruit, juice as well as various types of extracts and a good exposure calculation was recognized as safe, even without any toxicity data in the animal presented. EFSA’s position was indeed based on clinical studies conducted with other cranberry extracts and three studies on the requested extract. On the other hand, this opinion has generated a great concern among those who consider that if cranberry fruit and juice is food, a cranberry extract has been recognized as novel food. Indeed it should be noted that the type of extract authorized here by the novel food route is the one widely used in food supplements for the urinary tract. The legitimate question asked at the time was that if an extract as classic as cranberry extract is considered as novel food, what about all the plant extracts used in food supplements?

The subject cranberry extract novel food must be put back in its context which was that the initial application, for use in various food matrices such as beverages, yoghurts, had been recognized as responding to novel food for the authorities. It was then during the evaluation by EFSA that the subject deviated and was reduced for safety reasons to the positive opinion that we know. Asked about this, the Commission replied that it did not consider that all cranberry extracts should be considered as novel food, but that only those corresponding to the specifications of Ocean Spray should be considered as novel food.

Turmeric has been in the news since Italy’s alert on cases of hepatotoxicity in 2019, which led France and Norway, Denmark having already done so since 2018, to set or reduce the maximum daily dose of curcumin, authorised as a dietary supplement, to 210 mg, which corresponds to the safety dose defined by EFSA at 3 mg/kg/day for the additive curcumin E100. In addition to this aspect of curcumin dose, the type of preparation of curcuma, novel food or not arises. The Belgian and British authorities have already given their opinion. For Belgians, curcumin (extract titrated at 95% curcumin) is not considered as novel food in food supplements and the intake of curcuminoids with their natural bioavailability (original, present by nature) must be limited to 500 mg of curcuminoids per day. For the British, turmeric oleoresin extract or pure curcumin powder are novel foods. If it is obvious that the very many new turmeric preparations whose aim is to improve natural properties (increased bioavailability, improved solubility, pure or synthetic curcumin, etc.) are novel foods, what about the historical extract of turmeric root with 95% curcuminoids? Asked about this subject, the Commission’s answer shows that the situation is not so clear for historical turmeric extract, as this subject does not appear in the Novel Food Catalogue because it has never been discussed by Member States. As for cranberry, if such a classic extract as turmeric as a food supplement were considered a novel food, what would happen to most other plant extracts?

The bay of maqui is a good illustration of one of the first positive opinions in the consultation procedure, authorised as a food supplement only and novel food, thanks to Italy’s position alone. This berry, in powder and juice form, has also been the subject of a request for traditional novel food. EFSA raised objections and comments concerning safety of use. According to the Novel Food Catalogue berries are not novel food only in food supplements. On the other hand the extract appears as novel food.

Concerning cannabis and CBD, which represent a huge market given the pressure from many operators and trade unions for their use in food, the position of the national (Member States) and European (Commission) authorities expressed in the Novel Food Catalogue is very clear. The seed, its oil and seed meal are allowed while hemp extracts and derived products containing cannabinoids or CBD and CBD obtained by synthesis are clearly novel food. Thus the consultation procedure concluded that the CBD isolate (purity > 98%) is novel food as or in food. Similarly, trans-cannabidiol, synthetic trans-cannabidiol and chemically derived cannabidiol are the subject of ongoing novel food applications.

Conclusion

The various examples presented here show that it is not sufficient that one plant or part of a plant is authorised for all its preparations to be authorised. The assessment must be made on a case-by-case basis, depending on the type of preparation and whether or not it is possible to defend significant food consumption in the European Union before 1997.


Novel food news about Cannabidiol


What is a novel food?

A novel food is defined as a food for which human consumption remained negligible in the European Union before 15 May 1997, when the first regulation (Reg. 258/97) on novel foods came into force.

How do you market a novel food in the EU?

The marketing of a novel food/ingredient requires a prior European authorisation which stipulates the specifications of the novel food and its conditions of use (dose, food matrix, etc.).

Can the novel food procedure be followed for new additives, flavourings, food enzymes, extraction solvents, GMOs?

No, the NF regulation is not applicable to: additives, flavourings, food enzymes, extraction solvents, GMOs.

What are the only 3 possible options for a food ?

The ingredient is not “new” in the sense of Regulation (EU) 2015/2283, it is, or the ingredient is a traditional food in a third country.

Is any preparation whose plate is on a national list allowed?

If a plant is included in the list of authorised plants, this does not mean that all preparations made from it are authorised.

A low hydroalcoholic preparation of an authorised plant and plant part is necessarily traditional and not NF ?

No, it must be possible to prove on a case-by-case basis that this type of preparation was significantly consumed before 1997 in the EU.

In case of doubt about the NF status of an ingredient, can the authorities help me?

Yes, according to the Implementing Regulation (EU) 2018/456 on the steps of the consultation procedure for the determination of novel food status.

How long is the consultation procedure?

4 months, renewable once.

Is an NF necessarily an extract of a plant?

No, a mixture of several plant extracts, a bacterium, for example, can be the subject of an application.

Are extracts of Cannabis sativa or cannabinoids authorised because they are already on the market?

No, the Commission is very clear, extracts of Cannabis sativa L. and derived products containing cannabinoids are considered as novel foods because no history of consumption has been demonstrated.

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EU Novel Food Catalogue

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

✅ Authorize 💊 Food supplement 🚫 Forbidden ⚠️ information required
#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💊
41Alpha-Hydroxy-isocaproic Acid💊
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💊
78Armoracia rusticana
76Artemisia annua🚫
77Arthrospira platensis
78Artocarpus altilis
79Artocarpus communis
80Artocarpus heterophyllus
81Artocarpus incisa
82Artocarpus integrifolius
83Ascophyllum laevigata
84Ascophyllum nodosum
85Asimina triloba
86Asparagus acutifolius L and Asparagus aphyllus L
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💊
153Chrysanthellum indicum💊
154Chrysanthemum morifolium🚫
155Chrysanthemum parthenium💊
156Cinnamomum verum💊
157Cinnamomum zeylanicum⚠️
158Cistanche deserticola🚫
159Cistus incanus💊
160Citrus aurantium
161Citrus junos
162Citrus mitis Blanco
163Clinoptilolite🚫
163Clitoria ternatea💊
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
196D-mannose💊
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🚫
236Euryale ferox🚫
236Eurycoma longifolia🚫
237Euterpe edulis🚫
238Euterpe oleracea
239Evodia lepta🚫
240Feijoa sellowiana🚫
241Fermented wheat germ extract🚫
241Ferula hermonis⚠️
242Ferulic acid💊
243Festuca arundinacea🚫
243Ficus carica🚫
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⚠️
469Quercus rotundifolia
471Rauwolfia vomitoria🚫
471Red clay sea salts
472Renealmia nutans🚫
473Rhamnogalacturonan-rich pectin hydrolysate🚫
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
588Zizania palustris
589Ziziphus jujuba
590Ziziphus vulgaris
591Ziziphus zizyphus

Nutraveris in EFSA Journal

With our Novel Food success. 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.


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