4.1 overview of species and insect products so far presentation.pdfstep 1 - reception: suitability...

Overview of species and insect products

encountered by EFSA so far

Domenico Azzollini

Nutrition Unit

12/05/2020

Species overview

2

8 Larvae6 Adults

8 EFSA Risk assessment 6 EFSA Suitability check

2 Alphitobius diaperinus

4 Tenebrio molitor3 Acheta domesticus

1 Gryllodes sigillatus

1 Hermetia illucens

1 Apis mellifera

2 Locusta migratoria

+ nymphs and pupae

Processing & formulations

3

Heat treatment

Drying

Whole

Grinding (powder)

Freezing

Freezing/refrigeration

Whole

Grinding (paste)

Heat treatment

Defatting

Grinding (powder)

Whole

Multiple producers, processes and formulations within the same application.!

Species & processing related risks

4

Insect body parts

Drying processHeat treatment

Ingestion risk Microbiological risk

Chemical risk

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Suitability check of dossiers of insects

as NFs: missing information and

common mistakes

Patricia Romero

Scientific officer

APDESK unit

12 May 2020

What is APDESK function?

Suitability check of Novel Food applications:

Missing information and common mistakes

Engagement with & support to applicants

Outline

2

Support to scientific REPRO units: Centralise all applications for

regulated products and perform the suitability/completeness check

Stakeholders support (develop new services for applicants during the life-cycle of applications for regulated products): Catalogue of services

Clarify workflows and timeline from reception to validation of applications (administrative guidance)

Applications web section

Dedicated support to SMEs

APDESK Unit: role and activities

3

Applications workflow: Novel foods

4

APDESK unit

NUTRI unit

Suitability check

30 working days(legal deadline)

+Request of

missing information

9 months(legal deadline)

+Request of additional

information

E-submission tool from EC

Applications workflow: Novel foods

5

https://ec.europa.eu/food/safety/novel_food_en

Applications process: From reception to suitability check complete

6

STEP 1 - Reception: Suitability request and processing dossier

STEP 2 - Acknowledgement of reception of application

STEP 3 - Suitability check

STEP 3.1 – Possible request of missing information

STEP 3.2 – Notification submission of missing information

STEP 4 – Suitability check complete

Suitability check of NF applications

7

• Suitability check (SC)

• What is the SC?• Revision of the content of the data in the application in accordance with specific

requirements

• Why do we do a SC?• To ensure the quality and compliance with regulations and guidance documents

of the application before starting the risk assessment

• How do we do the SC?• Applicable sectorial Regulation

• EFSA Scientific and Administrative Guidance Documents

• SC list


8

• Suitability check (SC)


9

Most frequent missing information during the SC phase

The production process Rearing description

Condition of farming of insect (Ex: specifications of feed and rearingconditions)

Processing description

Covering all the formulations of the novel food (Ex. powder, whole insects,frozen)

Description of production techniques and key parameters (Ex. heat-treatment, freezing, drying, dehydration, temperature, time)

Quality and safety assurance measures (Ex. HACCP, GMP, ISO)

Compositional data• Minimum number of batches (preferably at least 5)

• CoA of all the formulations of the novel food

• Method of analysis used, if in-house methods full description and validation

• Stability testing to cover the shelf-life of the product and details on how the testwas conducted; Stability data on the intended-for-use matrices

10


Most frequent missing information during the SC phase

Specifications• Table containing specifications for each formulation of the novel food

Proposed uses and use levels and anticipated intake• Food categories where the NF is intended to be used (Maximum amounts)

• For each formulation of the novel food/for each food category

• Anticipated intake of the novel food

History of use Literature review of human studies reporting on relevant safety outcomes.

Including information on search strategy, databases, terms and limits used

References List of references

Pdf file of each reference mentioned

11


Introduction to the Catalogue

12

Catalogue of services at a glance

13

3aCompleteness/suitability check

phase

1Pre-submission phase

2Submission

3bRisk assessment phase

4&5Adoption and publication phase

EFSA guidance documents

Info session

Scientific workshop/ conferences

APDESK web form & follow-up phone calls

Submission of applications by electronic means

Clarification teleconference during completeness/suitability check

Clarification teleconference during risk assessment

Applicants’ hearing

Notification email on adopted scientific output

Pre-publication notification of adopted scientific output

Post-adoption teleconference

Roundtable with industry associations

Ad-hoc meeting with food and feed business representatives

REPRO webinar

EFSA's Catalogue of support initiatives during the life-cycle of applications for regulated products


14

Administrative support

Monitoring of applications

Fast processing of queries

Official register of SMEs

NEW TARGETED ACTIVITIES FOR SMES


EFSA’s webinar dedicated support to SMEs: https://www.youtube.com/watch?v=CPF1QFdVLME



Follow-up of applications submitted by SMEs

Reminder emails

Workflow with the current status of the application

Clarification phone call if needed

EFSAstaff

APPLICANT

If you wish to contact APDESK: [email protected]

If you are interested in dedicated support for SMEs: [email protected]

Do you have a question on applications? Contact EFSA via the APDESK webform

Thank you!

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20

Scientific issues encountered during the risk assessment

of insects and products thereof as novel foods

Ermolaos Ververis

Nutrition Unit

12 May 2020

REQUESTS BY EFSA…

2

Request for additional/supplementary information “Clock-stop-letter”

- Clarification teleconference before replies are submitted by the applicant

- Indicative timelines for submitting the information apply

Request for clarification

Incomplete replies of the applicant to Requests for additional/supplementary information, e.g.

- Administrative issues

- Half-finished/ provisionary responses

- Missing documents, references, certificates, study reports

- Unjustified changes/updates

- Indicative deadline for submitting the clarification: 15 working-days

… during the risk assessment process

GENERAL ISSUES

3

Identification of pertinent data

- Absence/unclear research strategy

- EFSA (2010) principles not applied

- Missing information or studies without any justification (both data in favour and not in favour)

Critical appraisal of the provided evidence and explanation on how the evidence supports the safety of the NF are missing

Deviations from standard guidelines/protocols are not always duly justified using science-based arguments

Stand-alone dossier

European Food Safety Authority; Application of systematic review methodology to food and feed safety assessments to support decision making. EFSA Journal 2010; 8(6):1637. [90 pp.]. doi:10.2903/j.efsa.2010.1637. Available online: www.efsa.europa.eu

IDENTITY

4

Food consisting of, isolated from or produced from animals or their parts

Taxonomical classification

Contradicting or no information on the stage of development at the time of consumption

Lack of references regarding origin & occurrence

Unclear description of the NF forms/ formulations

Common issues

PRODUCTION PROCESS (1)

5

General considerations

No detailed description of all production steps

Discrepancies within the submitted documents

Size of production batches at each step

HACCP: limited information

Pre-harvest

Supply of the initial livestock?

Rearing conditions (e.g. containers, temperature, cross-contamination, veterinary drugs used)

Feeding substrate (e.g. nature, contaminants)

Common issues


6

Harvest

Removal of dead larvae?

Fasting step?

Separation of insects from substrate/faeces

Common issues


7

Effect of the processing on the NF is not extensively considered/investigated/discussed; thus the strategy to compile compositional information is incomplete

Processing contaminants?

Possible alterations to the composition

Missing/incomplete rationale regarding equivalence/ difference among NF formulations

Post- harvest processing (slaughtering, treatment & storage)

Common issues

COMPOSITIONAL DATA (1)

8

Strategy

Literature data not presented/consulted in a structured way; no read- across approach

No reasoning on the selection of constituents (e.g. micronutrients) selected to be analysed

No literature search and/or experimental data on inherent substances of possible concern to human health, even if information is available for the source of the NF or closely related species

(substances for defence or repellent purposes, of endocrine origin or non-glandular origin)

Common issues


9

Batch-to-batch analysis

Insufficient number of batches analysed

Issues with qualitative and quantitative characterisation of the main constituents

High variations among batches; no explanation

Incompliance of values with proposed specifications

No calculation of the amount of unidentified components (should be as low as possible)

Common issues

Analytical Methods

In-house/adapted methods are not sufficiently described, documented; validation missing

Protein content vs chitin not addressed


10

Stability

Stability of the NF: insufficient timespan, time 0 missing, not representative samples, selection of parameters to be monitored, testing conditions

Stability of the NF in the intended-for-use matrices: often there is completely no information; effect of processing temperature, pH, moisture levels and putative processing contaminants is not considered

Rationale behind the extrapolation of accelerated stability studies to normal conditions

Common issues

Specifications

Not in accordance with the compositional data

No rationale regarding the selection of parameters & levels

HISTORY OF USE

11

Information provided for insects in general and not for the insect species that is the source of the NF

Poor description/absence of:

- Extend of use(s)

- Characteristics of population group(s) of consumers

- Role in the diet

- Precautions and restrictions of use

- Non-food uses (e.g. medicine)

Common issues

PROPOSED USES & USE LEVELS

12

Form of uses are unclear

Food categories in which the NF is proposed to be added: unclear/overlapping

FoodEx2 classification system codes are not used/mismatched

Unclear whether the NF is intended to replace another food

Calculation of anticipated daily intakes: does not follow the methodology provided by EFSA

No exposure assessment to all identified substances of concern

Incompliance: Commission Implementing Regulation (EU) 2017/2469, Article 5

Common issues

NUTRITIONAL INFORMATION

13

Rationale behind selection of nutrients?

Bioavailability of nutrients? (in case of replacement of other foodstuff which are main elements of the current diet)

Content and effect of antinutritional factors (e.g. inhibiting absorption or modifying bioavailability) not investigated by means of literature search and/or experiments)

Other known and suspected interactions with nutrients?

Common issues

TOXICOLOGICAL INFORMATION

14

Scientific rationale for the absence of studies according to EFSA’s tiered toxicity testing approach: missing

Studies existing in the literature are missing without any justification (both in favour and not in favour)

Read- across approach among species to identify possible issues of toxicological concern: not implemented

No critical appraisal of the provided toxicological evidence

Substances of toxicological concern vs developmental stage?

Lack of history of use can trigger the need for toxicological studies

Common issues

ALLERGENICITY

15

Incomplete evidence regarding de novo sensitization and/or cross reactivity

Allergens from the substrate (e.g. gluten) not addressed

Insufficient use of existing literature

Thank you for your attention!

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17