The role of compositional data in the safety assessment of Novel Foods by the European Food Safety Authority

1. The role of compositional data in the
safety assessment of Novel Foods
by the European Food Safety Authority
11th November 2020
Ermolaos Ververis
Scientific Officer, Nutrition Unit
34th EFFoST International Conference
Bridging high-tech, food-tech and health:
Consumer-oriented innovations

2. Outline
What is EFSA?
Novel Foods &
Food Chain
Safety
Assessment of
Novel Foods
The Role of
Compositional
Data
Conclusions

3. What is EFSA?

4. EFSA is
The reference body for risk
assessment of food and
feed in the European Union.
Its work covers the entire
food chain – from field to
fork
One of the number of
bodies that are responsible
for food safety in Europe

5. HEADQUARTERS
in the heart of Parma

6. What EFSA does
Provides independent scientific advice and support for EU
risk managers and policy makers on food and feed safety
Provides independent, timely risk communication
Promotes scientific cooperation

7. EFSA’s tools & partners
International
organisations
Research
institutes &
academia
National food
safety
organisations
Individual
experts

8. The Scientific Panels
Plant protection
GMO
Plant health
Animal health & welfare
Nutrition
Food Packaging
Animal feed
Biological hazards
Chemical contaminants
Food additives

9. Novel Foods & Food Chain

10. What is a Novel Food?
10
New
compounds
New
Sources
Traditional
Foods
from non-
EU
countries
New
Processes
Regulation (EU) 2015/2283 on Novel Foods

11. Krill oil Alfalfa Lycopene
from
B.trispora
11
Phytosterols Non- sticky
chewing gum
base
Ice-
structuring
protein
Examples of Novel Foods
UV-treated
milk
UV-treated
yeast
Synthetic
hydroxy-
tyrosol
Chia seeds Baobab fruit Noni Juice
traditionalfoods
fromnon-EU
countries
newsources
newcompounds
newprocesses

12. A Novel Food can be…
12
Chemical
substances
Polymers
Micro-
organisms,
fungi, algae
From plants or
their parts
Of mineral origin
From animals or
their parts
cell or tissue cultures
derived from
animals/
plants/fungi/ algae
Engineered
nanomaterials

13. Novel Foods in the food chain…
13
Boosting
Innovation
Environmental
sustainability
Cultural
exchange
Food Security
Increasing
consumers’
choices
…can offer possibilities for

14. Safety Assessment of Novel Foods

15. What EFSA does?
15
▪ Legislation
▪ Regulatory decisions
- Classifications
- Authorisations
- Conditions of
authorisations
- Labelling, post-monitoring
- Food inspections
- Sanctions
▪ Guidelines
▪ Safety assessment
▪ Collaboration
▪ Communication
YESNO

16. Novel Food Guidance
▪ Identity of NF
▪ Production Process
▪ Compositional data
▪ Specifications
▪ History of use
▪ Proposed uses- use levels & anticipated intake
▪ Nutritional information & ADME*
▪ Toxicological data
▪ Allergenicity
Safety Assessment of Novel Foods (1)
16
*Absorption, Distribution, Metabolism, Excretion

17. Safety Assessment of Novel Foods (2)
17
Production
Process
Identity
Compositional
Data
Specifications
History of
use
Nutritional
information
Proposed
uses/levels
& intake
ADME
Toxicological
information
Allergenicity

18. Safety Assessment of Novel Foods (2)
18
Production
Process
Identity
Compositional
Data
Specifications
History of
use
Nutritional
information
Proposed
uses/levels
& intake
ADME
Toxicological
information
Allergenicity

19. The Role of Compositional Data

20. Compositional data-requirements (1)
20
Biochemistry
Physico-
chemistry
Qualitative
&
Quantitative
data on
Composition
Microbiology
✓Officially-
recognized
methods
✓new scientifically-
documented &
validated
approaches

21. Compositional data-requirements (2)
21
The level of NF’s complexity can affect the testing requirements
Single
substances &
simple
mixtures
Whole
foods
Complex
mixtures
e.g. UV-treated
mushroom powder
- Proximate analysis
- Vitamin D analysis
- Investigation of
vitamin D forms (D2
vs D4)
e.g. 1-methylnicotinamide
chloride
- Identity tests
- physicochemical properties
- Solubility data
- Minimum purity
e.g. shrimp
peptide
concentrate
- Qualitative &
quantitative
analysis of main
constituents
- Peptide profile
analyzed by de
novo sequencing

22. Identity can trigger the need for more compositional data
e.g. Taxonomic classification (read-across)
- Primary/secondary metabolites
- bioaccumulation of contaminants
- endogenously produced compounds of possible concern
Compositional data can provide information on identity
Chemical fingerprinting of plant material (e.g. metabolomics)
Genomics data can verify the production strain (e.g. algae)
Identity vs Compositional data
22
examples

23. Production process vs Compositional data
23
examples
Cultivation/growth
conditions
presence of toxins,
bioaccumulation of
environmental
contaminants
Chemical synthesis
Formation of by-
products, impurities,
residual catalysts
Extraction
residual solvents,
extraction of hazardous
compounds
Thermal treatment
formation of processing
contaminants, effect on
the microflora
Storage conditions
microbial and chemical
stability
Fermenting agents
Production of
metabolites
Formation of
nanoparticles
Further analytical data
as per the respective
EFSA guidance
(nanoscience and
nanotechnologies)
Enzymatic treatment
identification &
deactivation of enzymes

24. Proposed uses & use levels can trigger the need for more
compositional data
e.g. levels of inclusion/meal replacement: further investigation of
micronutrients with established tolerable upper intake levels,
quality and bioavailability of macronutrients
e.g. use of the novel food as ingredient in foodstuffs produced with
heat-treatment: investigation of potential formation of process
contaminants (e.g. acrylamide)
Proposed uses & use levels vs
Compositional data
24
examples
Compositional data can affect the proposed uses & use levels
e.g. levels of undesirable substances can limit the permitted
uses/use levels

25. ▪ Investigate exceedance of tolerable upper intake
levels for micronutrients
▪ Qualitative & quantitative analysis of antinutritional
factors (e.g. oxalates, lectin, trypsin inhibitors,
phytic acid) that can inhibit absorption or modify
bioavailability of nutrients
▪ Possible interactions of the NF per se with nutrients
Nutritional information vs Compositional data
25
The NF must not be “nutritionally disadvantageous”

26. ADME & Toxicological information vs
Compositional data
26
examples
▪ Thorough characterization of the NF might reduce the
need for toxicological studies in some cases.
▪ Particle size can trigger ADME considerations
▪ Solubility aspects may affect ADME & toxicological
strategy
▪ Chemical structure/affinity of a compound may affect the
need for toxicological studies
▪ Type of extract affects toxicological profile due to e.g.
polarity
▪ Need for testing specific fractions of the NF (e.g.
genotoxicity)

27. ▪ Protein levels in the NF
▪ Profile of proteins in the NF (molecular weight, heat
stability, sensitivity to pH, digestibility by enzymes)
▪ Investigation of sequence homology of the NF protein
with known allergens
Allergenicity vs Compositional data
27
Potential or proven allergenicity is not a reason to say
that a novel food is unsafe!

28. Conclusions

29. ▪ Safety assessment of NF by EFSA contributes to the resilience,
diversity and safety of the food chain by providing risk
managers and policy makers scientific advice on such products
before potential EU market authorization.
▪ The respective EFSA guidance provides advice to food business
operators on the NF’s characterization approach to be followed,
allowing at the same time flexibility regarding data produced
using new scientifically documented approaches.
▪ Compositional data:
- define the scientific requirements in other areas of a NF dossier
- can be defined by other scientific requirements of the NF
dossier via a reciprocal relationship
- are the backbone of the NF safety assessment (preparation by
applicants, assessment by EFSA)
Conclusions
29

30. ▪ EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), Turck, D.,
Bresson, J. L., Burlingame, B., Dean, T., Fairweather-Tait, S., Heinonen, M., Hirsch-
Ernst, K. I., Mangelsdorf, I., McArdle, H., Naska, A., Neuhäuser-Berthold, M.,
Nowicka, G., Pentieva, K., Sanz, Y., Siani, A., Sjödin, A., Stern, M., Tomé, D., Vinceti,
M., Willatts, P., Engel, K.-H., Marchelli, R., Pöting, A., Poulsen, M., Salminen, S.,
Schlatter, J., Arcella, D., Gelbmann, W., de Sesmaisons-Lecarre, A., Verhagen, H., &
van Loveren, H. (2016a). Guidance on the preparation and presentation of an
application for authorization of a novel food in the context of Regulation
(EU) 2015/ 2283. EFSA Journal, 14(11), e04594.
https://doi.org/10.2903/j.efsa.2016.4594.
▪ Ververis, E., Ackerl, R., Azzollini, D., Colombo, P.A., de Sesmaisons, A., Dumas, C.,
Fernandez-Dumont, A., da Costa, L.F., Germini, A., Goumperis, T., Kouloura, E.,
Matijevic, L., Precup, G., Roldan-Torres, R. Rossi, A. ,Svejstil, R., Turla, E. ,
Gelbmann, W. 2020. Novel foods in the European Union: Scientific
requirements and challenges of the risk assessment process by the
European Food Safety Authority. Food Research International, 137, p.109515.
https://doi.org/10.1016/j.foodres.2020.109515
References
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32. The role of compositional data in the safety assessment of novel foods by the European Food
Safety Authority (EFSA)
Ververis Ermolaos1,2, Precup Gabriela1,3, Kouloura Eirini1, Matijevic Leonard1,4, Roldan-Torres
Ruth1, Goumperis Tilemachos1, Albert Océane1, Alfieri Fabio1, Dumas Céline1, Germini Andrea1
1 European Food Safety Authority (EFSA), Via Carlo Magno, 1A, 43126, Parma, Italy
2 School of Medicine, National and Kapodistrian University of Athens (NKUA), Ch. Lada 6, 10561, Athens, Greece
3 Faculty of Food Science and Technology, Institute of Life Sciences, University of Agricultural Sciences and Veterinary Medicine, Cluj-
Napoca (USAMVCN), 400372, Calea Mănăștur , 3-5, CJ, Romania
4 Faculty of Food Technology Osijek, J. J. Strossmayer University of Osijek (UNIOS), Franje Kuhača 20, 31 000, Osijek, Croatia
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Thank you
for your attention!