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

TG IUCLID PESTICIDE meeting 17-18 June 2020 Sub-group Microorganisms product Dimitra Kardassi, EFSA, PREV Unit Dorota Burchard-Sosnowska, ECHA

Outline Introduction Mapping file TOC for micro-organism product Discussion Next steps under IUCLID 2

Objective  Mapping file: an analysis of the submission type needed for a micro- organism 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 3

Discussion  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. 4

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 6

Discussion – Outstanding issues  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 other 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) 7

Discussion  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 8

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 of 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.

Timelines  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 ones 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 . 11

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