Sub-group Microorganisms product Dimitra Kardassi, EFSA, PREV Unit - - PowerPoint PPT Presentation

Sub-group Microorganisms product

TG IUCLID PESTICIDE meeting 17-18 June 2020

Dimitra Kardassi, EFSA, PREV Unit Dorota Burchard-Sosnowska, ECHA

Outline

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Introduction Mapping file TOC for micro-organism product Discussion Next steps under IUCLID

• Mapping file: an analysis of the submission type needed for a micro-
• rganism product -> mapping between planned microorganisms

table of contents to the IUCLID TOC for chemical product

• Comments on the mapping file focused on the amendments needed of

the existing documents and also whether new documents should be created (for the product).

• Needed to be included into the IUCLID version that will be released

in October 2020

Objective

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• Comments by 29 May: EFSA, IBMA, DE, EE
• Comments on mapping file was discussed in 2 meetings held in 5 and

8 June

• Aim: To discuss the outcome of the commenting and agree on the remaining

sections/new sections expected

• Actions / conclusions / decisions taken at the meetings on 5 and 8

June on the mapping file for the micro-organisms (product) are included directly in column F of the xls file available on the DMS.

• Comments or subsections that considered not relevant after the

discussion have been strikethrough.

Discussion

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TG IUCLID on micro-organisms (product) : action points and deadlines

• Mapping file discussed in the sub-group meetings is available in DMS

https://dms.efsa.europa.eu/otcs/cs.exe?func=ll&objaction=overview&obj id=23210940

Micro-organisms (product) : potential needs for format changes & existing IUCLID backlog

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• Data on application (Section 3)
• Pending the outcome of the discussion in the GAP sub-group
• Acute Tox (Section 7)
• Comparison between USEPA reports and IUCLID documents -> pending the

comparison, experts assigned should check if needed the comparison also in the

• ther acute toxicity studies.
• OHT sent to OECD. The consultation is ongoing until end of July 2020. Potential

changes can be inserted in the commenting document - please contact Jane.

• Residues (Section 8), Fate (Section 9)
• Information provided in the a.s., the product should have the data waiver and the

justification in order those data to not reported twice.

• If template needs to be added this should be the same with a.s.
• Ecotox (Section 10)
• Short-term/long-term toxicity to fish and aquatic invertebrates (documents to be

adapted for micros)

Discussion – Outstanding issues

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• If the experts need to propose some changes in the extracted

documents from IUCLID, these should be done directly in the extracted documents stored here: https://dms.efsa.europa.eu/otcs/cs.exe?func=ll&objId=23413121&o bjAction=browse&viewType=1

Discussion

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Next steps

• A full submission type for the product specific for micro-organisms will

be prepared for the October 2020 release of IUCLID according to Part B

• f the data requirements for both product and organism.
• The first version of the micro-organisms proof of concept dossier is

available in the EFSA IUCLID instance

• https://b2dfc4c3-bc43-4531-b736-5643cfbb7551.ecs.echa.europa.eu/iuclid6-

web/dossier/9e6781f3-d0d3-4f87-8f3a- bdb3ee2ebbc0?content_uri=iuclid6%253A%252F9e6781f3-d0d3-4f87-8f3a- bdb3ee2ebbc0%252Fheader&node=0

• Feedback from this project will be used to refine the micro-organism

dataset for the October release.

• For the OHTs which have been already sent for the consultation at the

OECD level and the consultation is ongoing until end of July 2020 a note has been added - contact Jane for potential changes that can be inserted in the commenting document.

• For the OHTs which have not been modified this year, and have not been

shared with OECD for commenting, a note has been added that new consultation at the OECD level would be required, those OHTs should be reviewed by 16 of June.

• At the moment it is only relevant to

ENDPOINT_STUDY_RECORD.AdditionalPhysicoChemical.

• For the documents have been extracted for review, with no changes

foreseen so far – those should be also reviewed by 16 of June.

Timelines

• Column I, in which guidelines related to microorganisms were added.

In blue – those which have been added already. In black (in row 2) the

• nes that should be assigned to an existing document – it should be

done by 16 June as well.

• For existing IUCLID documents which are not OHTs: these should be

encoded by the end of June, so if input is required from the experts, the deadline is by 22 of June.

• Also updated picklists to be provided by 22 June
• For new documents to be designed: the document should be proposed

by the end of July.

Timelines

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Thanks for your attention!