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…)
- Consultation process according to Regulation (EU) 2018/456
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- 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
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- Strengths and weaknesses of the substantiation
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Novel Food regulation: recalls and hot topics
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 ) 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.
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
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.
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.).
No, the NF regulation is not applicable to: additives, flavourings, food enzymes, extraction solvents, GMOs.
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.
If a plant is included in the list of authorised plants, this does not mean that all preparations made from it are authorised.
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.
Yes, according to the Implementing Regulation (EU) 2018/456 on the steps of the consultation procedure for the determination of novel food status.
4 months, renewable once.
No, a mixture of several plant extracts, a bacterium, for example, can be the subject of an application.
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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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.
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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