This document is an excerpt from the EUR-Lex website
Document 52023XC0609(02)
Communication from the Commission concerning Part B of the Annex to Commission Regulation (EU) No 283/2013 setting out the data requirements for active substances in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance) 2023/C 202/03
Komunikazzjoni tal-Kummissjoni li tikkonċerna l-Parti B tal-Anness tar-Regolament tal-Kummissjoni (UE) Nru 283/2013 li jistipula r-rekwiżiti tad-data għas-sustanzi attivi, skont ir-Regolament (KE) Nru 1107/2009 tal-Parlament Ewropew u tal-Kunsill dwar it-tqegħid fis-suq ta’ prodotti għall-protezzjoni tal-pjanti (Test b'rilevanza għaż-ŻEE) 2023/C 202/03
Komunikazzjoni tal-Kummissjoni li tikkonċerna l-Parti B tal-Anness tar-Regolament tal-Kummissjoni (UE) Nru 283/2013 li jistipula r-rekwiżiti tad-data għas-sustanzi attivi, skont ir-Regolament (KE) Nru 1107/2009 tal-Parlament Ewropew u tal-Kunsill dwar it-tqegħid fis-suq ta’ prodotti għall-protezzjoni tal-pjanti (Test b'rilevanza għaż-ŻEE) 2023/C 202/03
C/2023/3552
ĠU C 202, 9.6.2023, p. 14–24
(BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
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9.6.2023 |
MT |
Il-Ġurnal Uffiċjali tal-Unjoni Ewropea |
C 202/14 |
Komunikazzjoni tal-Kummissjoni li tikkonċerna l-Parti B tal-Anness tar-Regolament tal-Kummissjoni (UE) Nru 283/2013 li jistipula r-rekwiżiti tad-data għas-sustanzi attivi, skont ir-Regolament (KE) Nru 1107/2009 tal-Parlament Ewropew u tal-Kunsill dwar it-tqegħid fis-suq ta’ prodotti għall-protezzjoni tal-pjanti
(Test b'rilevanza għaż-ŻEE)
(2023/C 202/03)
Din il-gwida ġiet żviluppata b’konsultazzjoni mal-Istati Membri. L-intenzjoni tagħha mhijiex li tipproduċi effetti legalment vinkolanti u, min-natura tagħha, ma tista tippreġudika ebda miżura meħuda minn Stat Membru fl-implimentazzjoni tar-Regolament (KE) Nru 1107/2009, u lanqas ġurisprudenza żviluppata fir-rigward ta’ din id-dispożizzjoni. Il-Qorti tal-Ġustizzja biss għandu s-setgħa li jinterpreta b’awtorita u li japplika d-dritt tal-Unjoni.
Din il-Komunikazzjoni tal-Kummissjoni tissodisfa l-Punt 6 tal-Introduzzjoni tal-Anness tar-Regolament (UE) 283/2013 li jipprevedi li, għal finijiet ta’ informazzjoni u ta’ armonizzazzjoni, il-lista ta’ metodi ta’ ttestjar u dokumenti ta’ gwida rilevanti għall-implimentazzjoni ta’ dan ir-Regolament trid tiġi ppubblikata f’Il-Ġurnal Uffiċjali tal-Unjoni Ewropea. Il-lista ta’ hawn taħt tirrappreżenta din il-lista għal Parti B tal-Anness tar-Regolament (UE) 283/2013, kif emendat bir-Regolament tal-Kummissjoni (UE) 2022/1439 (1) , u se tiġi aġġornata regolarment.
Fejn id-dispożizzjonijiet tal-Parti B tal-Anness tar-Regolament (UE) Nru 283/2013 jeħtieġu ġenerazzjoni ta’ data bbażata fuq ir-rekwiżiti stabbiliti fil-Parti A tal-Anness tar-Regolament (UE) Nru 283/2013, il-metodi ta’ ttestjar u l-gwida rilevanti huma elenkati fil-Komunikazzjoni tal-Kummissjoni rilevanti għall-implimentazzjoni tal-Parti A tal-Anness tar-Regolament (UE) Nru 283/2013 (jiġifieri fir-rigward ta’ sustanzi kimiċi attivi).
L-elenkar ta’ dokument għal taqsima jfisser li huwa rilevanti għas-subtaqsimiet kollha. F’każ li ma jkun hemm l-ebda dokument elenkat għal taqsima, bħalissa ma hemm l-ebda metodu ta’ ttestjar jew dokument ta’ gwida li jkun sar qbil fuqu disponibbli. F’dawn il-każijiet, l-applikanti potenzjali jenħtieġ li jiddiskutu proposti matul il-laqgħa ta’ qabel is-sottomissjoni mal-Istat Membru Relatur u mal-Awtorità Ewropea dwar is-Sigurtà fl-Ikel (EFSA), eż. abbażi ta’ abbozzi ta’ metodi ta’ ttestjar.
Metodi ta’ ttestjar
Huma elenkati biss il-metodi ta’ ttestjar li ġew ivvalidati (jiġifieri ring-tested mill-OECD jew minn organizzazzjonijiet internazzjonali ekwivalenti). Il-metodi ta’ ttestjar deskritti biss f’pubblikazzjonijiet xjentifiċi ma ġewx inklużi.
L-elenkar ta’ metodu ta’ ttestjar jenħtieġ li jinqara daqslikieku jirreferi għall-aktar verżjoni aġġornata ta’ dak il-metodu ta’ ttestjar disponibbli fi żmien il-bidu tal-istudju.
Għal sustanzi attivi li huma mikroorganiżmi, jistgħu jkunu meħtieġa protokolli tat-testijiet ad hoc biex jiġu indirizzati xi rekwiżiti tad-data. Matul il-fażi ta’ qabel is-sottomissjoni (2), l-applikanti, l-Istat Membru Relatur, u l-EFSA jistgħu jiddiskutu dan it-tip ta’ protokolli tat-testijiet ad hoc, b’mod partikolari jekk il-protokolli tat-testijiet elenkati fil-Komunikazzjoni tal-Kummissjoni rilevanti għall-implimentazzjoni tal-Parti A tal-Anness tar-Regolament (UE) Nru 283/2013 jistgħux jintużaw bħala surrogati jew jekk jistgħux jiġu adattati biex ikunu aktar xierqa għal sustanzi attivi li huma mikroorganiżmi.
Sabiex jiġi minimizzat l-ittestjar fuq l-annimali vertebrati, it-testijiet li diġà saru abbażi ta’ metodi ta’ ttestjar aktar antiki jenħtieġ li jitqiesu bħala parti mill-valutazzjoni tar-riskju, kif previst fl-Artikolu 62 tar-Regolament (KE) Nru 1107/2009. Madankollu, matul il-laqgħa ta’ qabel is-sottomissjoni, l-applikanti, l-Istat Membru Relatur u l-EFSA jistgħu jikkunsidraw jekk hemmx bżonn ta’ test ġdid skont metodi ta’ ttestjar aktar ġodda, jekk dan ikun iġġustifikat xjentifikament.
Fil-każijiet kollha, f’konformità mad-Direttiva 2010/63/UE tal-Parlament Ewropew u tal-Kunsill tat-22 ta’ Settembru 2010 dwar il-protezzjoni tal-annimali użati għal skopijiet xjentifiċi (3), ir-Regolament (KE) Nru 1107/2009 (il-Premessi 11 u 40, l-Artikoli 8.1(d), 18(b), 33.3(c) u 62.1) u r-Regolament tal-Kummissjoni (UE) Nru 283/2013 (4), irid jiġi evitat ittestjar mhux meħtieġ fuq l-annimali. B’mod aktar speċifiku, l-Artikolu 62 tar-Regolament (KE) Nru 1107/2009 jistipula li l-ittestjar fuq annimali vertebrati għall-finijiet tal-approvazzjoni ta’ sustanzi attivi għall-prodotti għall-protezzjoni tal-pjanti għandu jsir biss meta ma jkun hemm l-ebda metodu ieħor disponibbli. Metodi alternattivi jinkludu l-ittestjar in-vitro, metodi in-silico jew approċċi oħra bħal read-across, kif deskritt pereżempju fir-Rapport dwar l-Istatus tal-EURL ECVAM dwar l-Iżvilupp, il-Validazzjoni u l-Aċċettazzjoni Regolatorja ta’ Metodi u Approċċi Alternattivi u r-Rapport dwar l-Istatus tal-EURL ECVAM dwar Metodi Mhux bl-użu ta’ annimali fix-Xjenza u fir-Regolamentazzjoni (5). Barra minn hekk, id-disponibbiltà ta’ dokumenti ta’ gwida dwar l-ittestjar mhux fuq l-annimali u protokolli ta’ studju vvalidati u affidabbli in-vitro jenħtieġ li titqies bħala ġustifikazzjoni xjentifika valida meta jiġi kkunsidrat il-punt 1.5 tal-Introduzzjoni tal-Anness tar-Regolament (UE) Nru 283/2013.
Jekk ikun hemm disponibbli bosta metodi ta’ ttestjar biex jiġi ssodisfat rekwiżit tad-data, l-ordni tal-metodi ta’ ttestjar elenkati tindika preferenza f’każ li jkun meħtieġ test ġdid. L-ordni tagħti prijorità lill-metodi fejn ma jkun meħtieġ l-ebda annimal użat għal għanijiet xjentifiċi jew fejn ikun hemm bżonn ta’ inqas annimali użati għal għanijiet xjentifiċi u/jew dan il-metodu jkun assoċjat ma’ tbatija inqas severa tal-annimali użati għal għanijiet xjentifiċi. Madankollu, matul il-laqgħa ta’ qabel is-sottomissjoni, fuq parir tal-EFSA u tal-Istat Membru Relatur, l-ordni ta’ prijorità tista’ tinbidel meta dan ikun iġġustifikat xjentifikament (eż. minħabba limitazzjonijiet tad-dominju tal-applikabbiltà ta’ xi metodi) sabiex tiġi żgurata l-kwalità xjentifika tal-valutazzjoni.
Dokumenti ta’ gwida
Id-dokumenti ta’ gwida jikkwalifikaw biex jiġu elenkati meta:
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ikunu ġew approvati mill-Kumitat Permanenti dwar il-Pjanti, l-Annimali, l-Ikel u l-Għalf (SCoPAFF) qabel il-pubblikazzjoni ta’ din il-Komunikazzjoni, |
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ikunu ġew żviluppati taħt l-awspiċji ta’ korp uffiċjali (eż. l-EFSA, il-Kummissjoni, l-awtoritajiet nazzjonali) bil-għan li jiġi indirizzat ċertu qasam ta’ valutazzjoni tar-riskju jew kwistjonijiet proċedurali, u jkunu ġew kkonsultati mal-partijiet ikkonċernati rilevanti, jew |
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ikunu ġew approvati minn organizzazzjoni intergovernattiva (bħall-OECD, il-FAO, il-WHO, jew l-UPPE) fejn l-Istati Membri jieħdu sehem fil-proċess ta’ approvazzjoni. |
It-tipi ta’ dokumenti ta’ gwida li ġejjin ġew ikkunsidrati għall-elenkar:
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Dokumenti ta’ gwida teknika, inklużi dokumenti ta’ gwida li huma ta’ natura orizzontali li huma rilevanti għal diversi taqsimiet jew għat-taqsimiet kollha tar-rekwiżiti tad-data, inkluża l-implimentazzjoni tal-punt 1.5 tal-Introduzzjoni tal-Anness tar-Regolament (UE) Nru 283/2013; |
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Dokumenti ta’ gwida amministrattivi/proċedurali jekk ikunu rilevanti għall-implimentazzjoni tar-rekwiżiti tad-data; |
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Mudelli jew għodod ta’ kalkolu, jekk dawn ikunu rilevanti għar-rekwiżiti tad-data u jistgħu jkunu marbuta ma’ jew ikunu ta’ appoġġ għal dokument ta’ gwida; |
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L-Opinjonijiet Xjentifiċi tal-Bordijiet tal-EFSA u d-dokumenti ta’ gwida mill-Kumitat ta’ Tmexxija interżonali rilevanti għall-Istati Membri kollha ġew elenkati wara kunsiderazzjoni fuq bażi ta’ każ b’każ, jekk huma rilevanti għall-implimentazzjoni ta’ rekwiżiti speċifiċi tad-data. |
Dokumenti bħad-dokumenti ta’ gwida żonali, id-dikjarazzjonijiet tal-EFSA, il-pubblikazzjonijiet rieżaminati bejn il-pari, ir-rapporti tekniċi, ir-rapporti xjentifiċi u l-istrateġiji, ġeneralment ma humiex inklużi fil-lista ta’ hawn taħt, ħlief xi wħud li kienu soġġetti għal konsultazzjoni pubblika.
L-elenkar ta’ dokument ta’ gwida jenħtieġ li jinqara daqslikieku jirreferi għall-aktar verżjoni aġġornata ta’ dak id-dokument ta’ gwida disponibbli fi żmien il-bidu tal-istudju.
Fir-rigward tas-serje ta’ standards tal-UPPE dwar l-evalwazzjoni tal-effikaċja tal-prodotti għall-protezzjoni tal-pjanti, l-aktar standards rilevanti huma indikati fil-lista ta’ hawn taħt. Madankollu, il-lista trid titqies bħala mhux eżawrjenti peress li l-bażi tad-data globali tal-UPPE tiġi aġġornata regolarment u jistgħu jkunu meħtieġa standards oħra fuq approċċ ta’ każ b’każ. Konsegwentement, il-bażi tad-data globali tal-UPPE hija inkluża wkoll fit-tabella ta’ hawn taħt.
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Referenza għall-Parti B tal-Anness tar-Regolament (UE) Nru 283/2013 |
Metodi ta’ ttestjar (6) |
Dokumenti ta’ gwida (7) |
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Metodi ġenerali ta’ ttestjar u dokumenti ta’ gwida |
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EFSA Guidance on submission of scientific peer-reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009 (EFSA Journal 2011;9(2):2092) |
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Metodi ġenerali ta’ ttestjar u dokumenti ta’ gwida |
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EFSA Guidance on the use of the weight of evidence approach in scientific assessments (EFSA Journal 2017;15(8):4971) |
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Metodi ġenerali ta’ ttestjar u dokumenti ta’ gwida |
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EU Guidance document on the assessment of new isolates of baculovirus species already included in Annex I of Council Directive 91/414/EEC (SANCO/0253/2008) |
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Metodi ġenerali ta’ ttestjar u dokumenti ta’ gwida |
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EFSA Statement on the requirements for whole genome sequence analysis of microorganisms intentionally used in the food chain (EFSA Journal 2021;19(7):6506) |
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Metodi ġenerali ta’ ttestjar u dokumenti ta’ gwida |
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OECD Guidance Document on Good In Vitro Method Practices (GIVIMP) |
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Metodi ġenerali ta’ ttestjar u dokumenti ta’ gwida |
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OECD Guidance Document for the Regulatory Framework for the Microorganism Group: Bacteriophages Series on Pesticides No. 108 |
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EU Guidance Document for the assessment of the equivalence of technical grade active ingredients for identical microbial strains or isolates approved under Regulation (EC) No 1107/2009 (SANCO/12823/2012) |
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OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products No. 65 |
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EFSA Statement on the requirements for whole genome sequence analysis of microorganisms intentionally used in the food chain (EFSA Journal 2021;19(7):6506) |
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EU Guidance document on the risk assessment of metabolites produced by microorganisms used as plant protection active substances (SANCO/2020/12258) |
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EFSA Statement on the requirements for whole genome sequence analysis of microorganisms intentionally used in the food chain (EFSA Journal 2021;19(7):6506) |
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EU Guidance document on the approval and low-risk criteria linked to “antimicrobial resistance” applicable to microorganisms used for plant protection in accordance with Regulation (EC) No 1107/2009 (SANTE/2020/12260) |
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EPPO PP1/248 Harmonized classification and coding of the uses of plant protection products (8) |
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EPPO Global database (9) |
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EPPO PP1/248 Harmonized classification and coding of the uses of plant protection product (10) |
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EPPO PP1/213: Resistance risk analysis |
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EFSA Guidance on submission of scientific peer-reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009 (EFSA Journal 2011;9(2):2092 - including appendix (11)) |
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EU Guidance document: Technical Active Substance and Plant protection products: Guidance for generating and reporting methods of analysis in support of pre- and post-registration data requirements for Annex (Section 4) of Regulation (EU) No 283/2013 and Annex (Section 5) of Regulation (EU) No 284/2013 (SANCO/3030/99) |
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OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products No. 65 |
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Residues Analytical Methods for Risk Assessment and Post-approval Control and Monitoring Purposes (SANTE/2020/12830) (12) |
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US EPA OPPTS 885.3400 hypersensitivity Incidents |
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US EPA OPPTS 885.3050 Acute Oral Toxicity/ Pathogenicity |
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US EPA OPPTS 885.3150 Acute pulmonary toxicity/ pathogenicity |
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US EPA OPPTS 885.3200 Microbial pesticide test guidelines. Acute injection toxicity/pathogenicity |
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US EPA OPPTS 885.3500 Cell culture |
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US EPA OPPTS 885.3600 Subchronic Toxicity/Pathogenicity |
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US EPA OPPTS 885.3650 Reproductive/fertility effects |
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European Commission draft guidance document Guidance for the setting of an acute reference dose (ARfD) (7199/VI/99) |
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ECHA Guidance on the application of the CLP criteria. Guidance to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures |
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EFSA Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment (EFSA Journal 2019;17(6):5708) |
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OECD Series on Testing and Assessment No. 124, Guidance for the Derivation of an Acute Reference Dose. (ENV/JM/MONO(2010)15) |
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EFSA Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment (EFSA Journal 2019;17(6):5708) |
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EFSA Guidance document on clustering and ranking of emissions of active substances of plant protection products and transformation products of these active substances from protected crops (greenhouses and crops grown under cover) to relevant environmental compartments, Section 2 (EFSA Journal 2014;12(3):3615) |
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EU Working document to the Environmental Safety Evaluation of Microbial Biocontrol Agents, section 3.1.2 (SANCO/12117/2012) |
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EFSA Guidance document for predicting environmental concentrations of active substances of plant protection products and transformation products of these active substances in soil, section 2.7 “Applicability of the tiered assessment scheme for microbial actives substances” (EFSA Journal 2017;15(10):4982) |
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EU Working document to the Environmental Safety Evaluation of Microbial Biocontrol Agents, section 3.2.1 (SANCO/12117/2012) |
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Generic Guidance for Estimating Persistence and Degradation Kinetics from Environmental Fate Studies in Pesticides in EU Registration (based on –among others- Guidance Document on Estimating Persistence and Degradation Kinetics from Environmental Fate Studies on Pesticides in EU Registration - Final Report of the Work Group on Degradation Kinetics of FOCUS (Sanco/10058/2005); Guidance Document for evaluating laboratory and field dissipation studies to obtain DegT50 values of active substances of plant protection products and transformation products of these active substances in soil (SANCO/12117/2014)) |
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Generic guidance for Tier 1 FOCUS Ground water assessments (based on –among others-the European Commission (2014) Assessing Potential for Movement of Active Substances and their Metabolites to Ground Water in the EU - Final Report of the Ground Water Work Group of FOCUS (Sanco/13144/2010); FOCUS (2000) “FOCUS groundwater scenarios in the EU review of active substances” Report of the FOCUS Groundwater Scenarios Workgroup (Sanco/321/2000); Scientific Opinion of the Panel on Plant Protection Products and their Residues on a request from EFSA related to the default Q10 value used to describe the temperature effect on transformation rates of pesticides in soil.(doi: 10.2903/j.efsa.2008.622); Generic Guidance for Estimating Persistence and Degradation Kinetics from Environmental Fate Studies in Pesticides in EU Registration (including Guidance Document on Estimating Persistence and Degradation Kinetics from Environmental Fate Studies on Pesticides in EU Registration - Final Report of the Work Group on Degradation Kinetics of FOCUS (Sanco/10058/2005); Guidance Document for evaluating laboratory and field dissipation studies to obtain DegT50 values of active substances of plant protection products and transformation products of these active substances in soil (SANCO/12117/2014)); section 3.3.1 of European Food Safety Authority. Guidance Document for predicting environmental concentrations of active substances of plant protection products and transformation products of these active substances in soil (doi:10.2903/j.efsa.2017.4982); section 3.3 of Scientific report of EFSA on the “repair action” of the FOCUS surface water scenarios (doi:10.2903/j.efsa.2020.6119)) |
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Il-metodi rilevanti indikati taħt din it-Taqsima jista’ jkollhom bżonn jiġu adattati fuq bażi ta’ każ b’każ. Għaldaqstant l-applikabbiltà tal-metodi magħżula, jew adattamenti tagħhom, iridu jkunu ġġustifikati fid-dawl tal-karatteristiċi bijoloġiċi u ekoloġiċi tas-sustanza attiva li trid tiġi vvalutata u tista’ tiġi diskussa f’laqgħat ta’ qabel is-sottomissjoni. |
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EU Working document to the Environmental Safety Evaluation of Microbial Biocontrol Agents (SANCO/12117/2012) |
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US EPA 885.4000 (1996) Background for non-target organism testing of microbial pest control agents |
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Environment and Climate Change Canada (2016), guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS1/RM/44) |
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Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS1/RM/44), 14.1 Birds |
Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS1/RM/44), 14.1 Birds |
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Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 14.2 Small Mammals |
Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 14.2 Small Mammals |
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Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 11.1 Freshwater Fish |
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OECD Test No. 203 (2019) Fish, Acute Toxicity Test |
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OECD Test No. 210 (2013) Fish, Early-life Stage Toxicity Test |
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US EPA OCSPP 885.4200 freshwater fish Tier I |
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Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 11.1 Freshwater Fish |
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OECD Test No. 233 (2010) Sediment-Water Chironomid Life-Cycle Toxicity Test Using Spiked Water or Spiked Sediment |
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US EPA OCSPP 885.4240 Freshwater invertebrate Tier I |
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Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 10.1 Freshwater Invertebrates |
Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 10.1 Freshwater Invertebrates |
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OECD Test No. 201 (2011) Freshwater Alga and Cyanobacteria, Growth Inhibition Test |
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US EPA OCSPP 885.4300 Non target plant studies Tier I |
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Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 9.1 Freshwater plants |
Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 9.1 Freshwater plants |
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OECD Test No. 221 (2006): Lemna sp. Growth Inhibition Test |
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OECD Test No. 239 (2014): Water-Sediment Myriophyllum Spicatum Toxicity Test |
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OECD Test No. 238 (2014): Sediment-Free Myriophyllum Spicatum Toxicity Test |
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OECD Test Guideline 213 Honeybees, Acute Oral Toxicity Test |
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OECD Test Guideline 214 Honeybees, Acute Contact Toxicity Test. |
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OECD Test Guideline 245 Honey Bee, Chronic Oral Toxicity Test |
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OECD guidance document 239 Honey Bee Larval Toxicity Test, Repeated Exposure |
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OECD guidance document 75: Honey Bee Brood Test Under Semi-Field Conditions |
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EPPO Bulletin (2019) 49 Oomen Bee Brood Feeding Test |
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EPPO Bulletin (2010) 40 Side-Effects On Honeybees |
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OECD Test No. 247 (2017) Bumblebee, Acute Oral Toxicity Test |
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Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 13.2.1 Honey bees |
Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 13.2.1 Honey bees |
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US EPA OCSPP 885.4380 Honey bee Tier I |
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US EPA OCSPP 885.4340 Non-target Insect Tier I |
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Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 13.3.1 Tests for Plant-Dwelling Invertebrates |
Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 13.3.1 Tests for Plant-Dwelling Invertebrates |
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OECD Test No. 222 (2016): Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei) |
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OECD Test No. 232 (2016): Collembolan Reproduction Test in Soil |
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OECD Test No. 226 (2016): Predatory mite (Hypoaspis (Geolaelaps) aculeifer) reproduction test in soil |
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Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 13.2.2 Springtails |
Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 13.2.2 Springtails |
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Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 13.3.2 Earthworms |
Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 13.3.2 Earthworms |
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OECD Test No. 227 (2006): Terrestrial Plant Test: Vegetative Vigour Test |
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OECD Test No. 208 (2006): Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test |
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Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 12.2 Terrestrial plants |
Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 12.2 Terrestrial plants |
(1) Ir-Regolament tal-Kummissjoni (UE) 2022/1439 tal-31 ta’ Awwissu 2022 li jemenda r-Regolament (UE) Nru 283/2013 fir-rigward tal-informazzjoni li għandha titressaq għas-sustanzi attivi u r-rekwiżiti tad-data speċifiċi għall-mikroorganiżmi (ĠU L 227, 1.9.2022, p. 8).
(2) L-Artikolu 32a tar-Regolament (KE) tal-Parlament Ewropew u tal-Kunsill Nru 178/2002 tat-28 ta’ Jannar 2002 li jistabbilixxi l-prinċipji ġenerali u l-ħtiġijiet tal-liġi dwar l-ikel, li jistabbilixxi l-Awtorità Ewropea dwar is-Sigurtà fl-Ikel u jistabbilixxi l-proċeduri fi kwistjonijiet ta’ sigurtà fl-ikel (ĠU L 31, 1.2.2002, p. 1.).
(3) ĠU L 276, 20.10.2010, p. 33.
(5) Disponibbli fuq https://publications.jrc.ec.europa.eu/repository/
(6) Il-biċċa l-kbira tal-metodi ta’ ttestjar iċċitati huma disponibbli biss bl-Ingliż. Informazzjoni dettaljata dwar il-metodi ta’ ttestjar:
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ISO http://www.iso.org/iso/home/store/catalogue_ics.htm |
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OECD http://www.oecd.org/env/chemicalsafetyandbiosafety/testingofchemicals/ |
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UPPE http://www.eppo.int/STANDARDS/standards.htm |
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US EPA OCSPP https://www.epa.gov/ |
(7) Il-biċċa l-kbira tad-dokumenti ta’ gwida ċċitati huma disponibbli biss bl-Ingliż. Informazzjoni dettaljata dwar id-dokumenti ta’ gwida:
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Il-Kummissjoni Ewropea: https://food.ec.europa.eu/plants/pesticides/approval-active-substances/guidelines-active-substances-and-plant-protection-products_en |
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OECD http://www.oecd.org/env/chemicalsafetyandbiosafety/testingofchemicals/ |
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UPPE: http://www.eppo.int/STANDARDS/standards.htm |
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ECHA: http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation |
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EFSA: http://www.efsa.europa.eu/mt/publications.htm |
(8) Jekk jogħġbok ikkunsidra biss dawk l-użi li huma meqjusin rilevanti skont il-kamp ta’ applikazzjoni tar-Reg (KE) Nru 1107/2009, u mhux dawk fl-EPPO PP 1/248 li jirreferu għal asserzjonijiet bijostimulanti kif definiti t-tnejn skont il-kamp ta’ applikazzjoni tar-Reg (UE) Nru 2019/1009 u skont l-ispeċifikazzjonijiet tekniċi CEN/TS 17724, CEN/TS 17700-1, CEN/TS 17700-2, CEN/TS 17700-3, CEN/TS 17700-4, CEN/TS 17700-5, anki jekk dawn il-bijostimulanti jiġu identifikati bħala regolaturi tat-tkabbir tal-pjanti fl-EPPO PP 1/248.
(9) https://gd.eppo.int/
(10) Jekk jogħġbok ikkunsidra biss dawk l-użi li huma meqjusin rilevanti skont il-kamp ta’ applikazzjoni tar-Reg (KE) Nru 1107/2009, u mhux dawk fl-EPPO PP 1/248 li jirreferu għal asserzjonijiet bijostimulanti kif definiti skont il-kamp ta’ applikazzjoni tar-Reg (UE) Nru 2019/1009 u l-ispeċifikazzjonijiet tekniċi CEN/TS 17724, CEN/TS 17700-1, CEN/TS 17700-2, CEN/TS 17700-3, CEN/TS 17700-4, CEN/TS 17700-5, anki jekk dawn jiġu identifikati bħala regolaturi tat-tkabbir tal-pjanti fl-EPPO PP1/248.
(11) https://efsa.onlinelibrary.wiley.com/action/downloadSupplement?doi=10.2903/j.efsa.2011.2092&file=efs22092-sup-0001-Appendix.pdf
(12) jekk rilevanti għal residwi ta’ metaboliti ta’ tħassib.