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

12/05/2020 Overview of species and insect products encountered by EFSA so far Domenico Azzollini Nutrition Unit

Species overview 6 EFSA Suitability check 8 EFSA Risk assessment 6 Adults 8 Larvae 3 Acheta domesticus 4 Tenebrio molitor 2 Alphitobius diaperinus 2 Locusta migratoria 1 Hermetia illucens 1 Gryllodes sigillatus 1 Apis mellifera + nymphs and pupae 2

Processing & formulations Freezing Heat treatment Heat treatment Defatting Whole Drying Grinding (powder) Whole Grinding (powder) Multiple producers, processes Freezing/refrigeration ! and formulations within the same application. Whole Grinding (paste) 3

Species & processing related risks Insect body Heat treatment Drying process parts Chemical risk Ingestion risk Microbiological risk 4

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12 May 2020 Suitability check of dossiers of insects as NFs: missing information and common mistakes Patricia Romero Scientific officer APDESK unit

Outline What is APDESK function? Suitability check of Novel Food applications: Missing information and common mistakes Engagement with & support to applicants 2

APDESK Unit: role and activities  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 3

Applications workflow: Novel foods 30 working days Suitability APDESK unit (legal deadline) + check Request of missing information NUTRI unit 9 months (legal deadline) + Request of additional information 4

Applications workflow: Novel foods  E-submission tool from EC https://ec.europa.eu/food/safety/novel_food_en 5

Applications process: From reception to suitability check complete 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 6

Suitability check of NF applications • 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 • 7

Suitability check of NF applications • Suitability check (SC) 8

Suitability check of NF applications 9

Suitability check of NF applications Most frequent missing information during the SC phase  The production process Rearing description  Condition of farming of insect (Ex: specifications of feed and rearing  conditions) 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 test • was conducted; Stability data on the intended-for-use matrices 10

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 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 3a 4&5 1 2 3b Pre-submission phase Completeness/ Adoption and publication phase Submission Risk assessment phase suitability check phase EFSA guidance documents Clarification Submission of Notification email on Clarification teleconference during applications by adopted scientific output teleconference during completeness/ electronic means Info session risk assessment suitability check Pre-publication notification of Scientific workshop/ Applicants’ adopted scientific output conferences hearing Post-adoption Roundtable with industry teleconference associations Ad-hoc meeting with food and feed business representatives REPRO webinar APDESK web form & follow-up EFSA's Catalogue of support phone calls initiatives during the life-cycle of applications for regulated products 13

Dedicated support to SMEs 14

Dedicated support to SMEs NEW TARGETED ACTIVITIES FOR SME S Administrative support Monitoring of applications Fast processing of queries Official register of 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 APPLICANT staff

Monitoring of applications

Monitoring of applications

Thank you!  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

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12 May 2020 Scientific issues encountered during the risk assessment of insects and products thereof as novel foods Ermolaos Ververis Nutrition Unit

REQUESTS BY EFSA… … during the risk assessment process 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 2

GENERAL ISSUES  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 3

IDENTITY Common issues 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 4

PRODUCTION PROCESS (1) Common issues 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) 5

PRODUCTION PROCESS (2) Common issues Harvest  Removal of dead larvae?  Fasting step?  Separation of insects from substrate/faeces 6