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Document 32022R1439R(01)
Corrigendum to Commission Regulation (EU) 2022/1439 of 31 August 2022 amending Regulation (EU) No 283/2013 as regards the information to be submitted for active substances and the specific data requirements for micro-organisms (Official Journal of the European Union L 227 of 1 September 2022)
Corrigendum to Commission Regulation (EU) 2022/1439 of 31 August 2022 amending Regulation (EU) No 283/2013 as regards the information to be submitted for active substances and the specific data requirements for micro-organisms (Official Journal of the European Union L 227 of 1 September 2022)
Corrigendum to Commission Regulation (EU) 2022/1439 of 31 August 2022 amending Regulation (EU) No 283/2013 as regards the information to be submitted for active substances and the specific data requirements for micro-organisms (Official Journal of the European Union L 227 of 1 September 2022)
OJ L 304, 24.11.2022, p. 94-96
(BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
ELI: http://data.europa.eu/eli/reg/2022/1439/corrigendum/2022-11-24/oj
|
24.11.2022 |
EN |
Official Journal of the European Union |
L 304/94 |
Corrigendum to Commission Regulation (EU) 2022/1439 of 31 August 2022 amending Regulation (EU) No 283/2013 as regards the information to be submitted for active substances and the specific data requirements for micro-organisms
( Official Journal of the European Union L 227 of 1 September 2022 )
On page 17, Annex II, the following Table of contents shall be inserted after the title ‘PART B – ACTIVE SUBSTANCES THAT ARE MICRO-ORGANISMS ’:
‘ Table of contents
INTRODUCTION TO PART B
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1. |
Identity of the applicant, identity of the active substance and manufacturing information |
|
1.1. |
Applicant |
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1.2. |
Producer |
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1.3. |
Identity, taxonomy and phylogeny of the micro-organism |
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1.4. |
Specification of the microbial pest control agent as manufactured |
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1.4.1. |
Content of the active substance |
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1.4.2. |
Identity and quantification of additives, relevant contaminating micro-organisms and relevant impurities |
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1.4.2.1. |
Identity and quantification of additives |
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1.4.2.2. |
Identity and content of relevant contaminating micro-organisms |
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1.4.2.3. |
Identity and quantification of relevant impurities |
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1.4.3. |
Analytical profile of batches |
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1.5. |
Information on manufacturing process and control measures for the active substance |
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1.5.1. |
Production and quality control |
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1.5.2. |
Recommended methods and precautions concerning handling, storage, transport or fire |
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1.5.3. |
Procedures for destruction or decontamination |
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2. |
Biological properties of the micro-organism |
|
2.1. |
Origin, occurrence and history of use |
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2.1.1. |
Origin and isolation source |
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2.1.2. |
Occurrence |
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2.1.3. |
History of use |
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2.2. |
Ecology and life cycle of the micro-organism |
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2.3. |
Mode of action on the target organism and host range |
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2.4. |
Growth requirements |
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2.5. |
Infectivity to the target organism |
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2.6. |
Relationship to known human pathogens and to pathogens to non-target organisms |
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2.7. |
Genetic stability and factors affecting it |
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2.8. |
Information on metabolites of concern |
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2.9. |
Presence of transferable antimicrobial resistance genes |
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3. |
Further information |
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3.1. |
Function and target organism |
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3.2. |
Field of use envisaged |
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3.3. |
Crops or products protected or treated |
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3.4. |
Information on possible development of resistance in the target organism(s) |
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3.5. |
Literature data |
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4. |
Analytical methods |
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4.1. |
Methods for the analysis of the MPCA as manufactured |
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4.2. |
Methods to determine the density of the micro-organism and quantify residues |
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5. |
Effects on human health |
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5.1. |
Medical data |
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5.1.1. |
Therapeutic and first aid measures |
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5.1.2. |
Medical surveillance |
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5.1.3. |
Information on sensitisation and allergenicity |
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5.1.4. |
Direct observation |
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5.2. |
Assessment on potential infectivity and pathogenicity of the micro-organism to humans |
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5.3. |
Infectivity and pathogenicity studies on the micro-organism |
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5.3.1. |
Infectivity and pathogenicity |
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5.3.1.1. |
Oral infectivity and pathogenicity |
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5.3.1.2. |
Intratracheal/ intranasal infectivity and pathogenicity |
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5.3.1.3. |
Intravenous, intraperitoneal or subcutaneous single exposure |
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5.3.2. |
Cell culture study |
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5.4. |
Specific infectivity and pathogenicity studies on the micro-organism |
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5.5. |
Information and toxicity studies on metabolites |
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5.5.1. |
Information on metabolites |
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5.5.2. |
Additional toxicity studies on metabolites of concern |
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6. |
Residues in or on treated products, food and feed |
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6.1. |
Estimation of consumer exposure to residues |
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6.2. |
Data generation on residues |
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7. |
Environmental occurrence of the micro-organism, including fate and behaviour of metabolites of concern |
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7.1. |
Environmental occurrence of the micro-organism |
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7.1.1. |
Predicted environmental density of the micro-organism |
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7.1.1.1. |
Soil |
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7.1.1.2. |
Water |
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7.1.2. |
Exposure to micro-organisms known to be pathogenic either for plants or for other organisms |
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7.1.3. |
Qualitative exposure assessment of the micro-organism |
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7.1.4. |
Experimental exposure data of the micro-organism |
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7.2. |
Fate and behaviour of metabolite(s) of concern |
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7.2.1. |
Predicted environmental concentration |
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7.2.2. |
Qualitative exposure assessment |
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7.2.3. |
Experimental exposure data |
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8. |
Ecotoxicological studies |
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8.1. |
Effects on terrestrial vertebrates |
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8.2. |
Effects on aquatic organisms |
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8.2.1. |
Effects on fish |
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8.2.2. |
Effects on aquatic invertebrates |
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8.2.3. |
Effects on algae |
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8.2.4. |
Effects on aquatic macrophytes |
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8.3. |
Effects on bees |
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8.4. |
Effects on non-target arthropods other than bees |
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8.5. |
Effects on non-target meso- and macro-organisms in soil |
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8.6. |
Effects on non-target terrestrial plants |
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8.7. |
Additional studies on the micro-organism |
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8.8. |
Information and toxicity studies on metabolites |
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8.8.1. |
Information on metabolites |
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8.8.2. |
Additional toxicity studies on metabolites of concern’ |