Novel foods

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.
  • National then EFSA authority submission

Authorities follow up & exchange (Member states, EFSA & European Commission

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Example of Novel foods success


EFSA Journal abstract with Nutraveris Novel Food success:
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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