Overview of species and insect products encountered by EFSA so far - - PowerPoint PPT Presentation

Overview of species and insect products encountered by EFSA so far

Domenico Azzollini Nutrition Unit

12/05/2020

Species overview

2

8 Larvae 6 Adults 8 EFSA Risk assessment 6 EFSA Suitability check

2 Alphitobius diaperinus 4 Tenebrio molitor 3 Acheta domesticus 1 Gryllodes sigillatus 1 Hermetia illucens 1 Apis mellifera 2 Locusta migratoria + nymphs and pupae

Processing & formulations

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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

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Insect body parts Drying process Heat 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

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• 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

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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

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

Applications process: From reception to suitability check complete

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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

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• 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
• f the application before starting the risk assessment
• How do we do the SC?
• Applicable sectorial Regulation
• EFSA Scientific and Administrative Guidance Documents
• SC list

Suitability check of NF applications

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• Suitability check (SC)

Suitability check of NF applications

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Most frequent missing information during the SC phase

• The production process
• Rearing description
• Condition
• f

farming

• f

insect (Ex: specifications

• f

feed and rearing conditions)

• Processing description
• Covering all the formulations of the novel food (Ex. powder, whole insects,

frozen)

• Description
• f

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 test

was conducted; Stability data on the intended-for-use matrices

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Suitability check of NF applications

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

• f

human studies reporting

• n

relevant safety

• utcomes.

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

• References
• List of references
• Pdf file of each reference mentioned

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Suitability check of NF applications

Introduction to the Catalogue

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Catalogue of services at a glance

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3a Completeness/ suitability check phase 1 Pre-submission phase 2 Submission 3b Risk assessment phase 4&5 Adoption 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

Dedicated support to SMEs

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Administrative support Monitoring of applications Fast processing of queries Official register of SMEs

NEW TARGETED ACTIVITIES FOR SMES

Dedicated support to SMEs

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

Dedicated support to SMEs

Monitoring of applications

• Follow-up of applications submitted by SMEs
• Reminder emails
• Workflow with the current status of the application
• Clarification phone call if needed

EFSA staff APPLICANT

Monitoring of applications

Monitoring of applications

• If you wish to contact APDESK:

APDESK.applications@efsa.europa.eu

• If you are interested in dedicated support for

SMEs: SMEoffice@efsa.europa.eu

• 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

• f 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

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• 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

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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)

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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

PRODUCTION PROCESS (2)

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Harvest

• Removal of dead larvae?
• Fasting step?
• Separation of insects from substrate/faeces

Common issues

PRODUCTION PROCESS (3)

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• 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)

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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

• r non-glandular origin)

Common issues

COMPOSITIONAL DATA (2)

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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

COMPOSITIONAL DATA (3)

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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

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• 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

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• 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

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• 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

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• 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

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• 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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