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)
Date: 2022-11-24
Institutions: European Commission
Subjects: antimicrobial resistance, disclosure of information, environmental protection, health risk, market approval, marketing standard, microorganism, plant health control, plant health product








L_2022304EN.01009401.xml










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







1.

Identity of the applicant, identity of the active substance and manufacturing information











1.1.

Applicant











1.2.

Producer











1.3.

Identity, taxonomy and phylogeny of the micro-organism











1.4.

Specification of the microbial pest control agent as manufactured











1.4.1.

Content of the active substance











1.4.2.

Identity and quantification of additives, relevant contaminating micro-organisms and relevant impurities











1.4.2.1.

Identity and quantification of additives











1.4.2.2.

Identity and content of relevant contaminating micro-organisms











1.4.2.3.

Identity and quantification of relevant impurities











1.4.3.

Analytical profile of batches











1.5.

Information on manufacturing process and control measures for the active substance











1.5.1.

Production and quality control











1.5.2.

Recommended methods and precautions concerning handling, storage, transport or fire











1.5.3.

Procedures for destruction or decontamination











2.

Biological properties of the micro-organism











2.1.

Origin, occurrence and history of use











2.1.1.

Origin and isolation source











2.1.2.

Occurrence











2.1.3.

History of use











2.2.

Ecology and life cycle of the micro-organism











2.3.

Mode of action on the target organism and host range











2.4.

Growth requirements











2.5.

Infectivity to the target organism











2.6.

Relationship to known human pathogens and to pathogens to non-target organisms











2.7.

Genetic stability and factors affecting it











2.8.

Information on metabolites of concern











2.9.

Presence of transferable antimicrobial resistance genes











3.

Further information











3.1.

Function and target organism











3.2.

Field of use envisaged











3.3.

Crops or products protected or treated











3.4.

Information on possible development of resistance in the target organism(s)











3.5.

Literature data











4.

Analytical methods











4.1.

Methods for the analysis of the MPCA as manufactured











4.2.

Methods to determine the density of the micro-organism and quantify residues











5.

Effects on human health











5.1.

Medical data











5.1.1.

Therapeutic and first aid measures











5.1.2.

Medical surveillance











5.1.3.

Information on sensitisation and allergenicity











5.1.4.

Direct observation











5.2.

Assessment on potential infectivity and pathogenicity of the micro-organism to humans











5.3.

Infectivity and pathogenicity studies on the micro-organism











5.3.1.

Infectivity and pathogenicity











5.3.1.1.

Oral infectivity and pathogenicity











5.3.1.2.

Intratracheal/ intranasal infectivity and pathogenicity











5.3.1.3.

Intravenous, intraperitoneal or subcutaneous single exposure











5.3.2.

Cell culture study











5.4.

Specific infectivity and pathogenicity studies on the micro-organism











5.5.

Information and toxicity studies on metabolites











5.5.1.

Information on metabolites











5.5.2.

Additional toxicity studies on metabolites of concern











6.

Residues in or on treated products, food and feed











6.1.

Estimation of consumer exposure to residues











6.2.

Data generation on residues











7.

Environmental occurrence of the micro-organism, including fate and behaviour of metabolites of concern











7.1.

Environmental occurrence of the micro-organism











7.1.1.

Predicted environmental density of the micro-organism











7.1.1.1.

Soil











7.1.1.2.

Water











7.1.2.

Exposure to micro-organisms known to be pathogenic either for plants or for other organisms











7.1.3.

Qualitative exposure assessment of the micro-organism











7.1.4.

Experimental exposure data of the micro-organism











7.2.

Fate and behaviour of metabolite(s) of concern











7.2.1.

Predicted environmental concentration











7.2.2.

Qualitative exposure assessment











7.2.3.

Experimental exposure data











8.

Ecotoxicological studies











8.1.

Effects on terrestrial vertebrates











8.2.

Effects on aquatic organisms











8.2.1.

Effects on fish











8.2.2.

Effects on aquatic invertebrates











8.2.3.

Effects on algae











8.2.4.

Effects on aquatic macrophytes











8.3.

Effects on bees











8.4.

Effects on non-target arthropods other than bees











8.5.

Effects on non-target meso- and macro-organisms in soil











8.6.

Effects on non-target terrestrial plants











8.7.

Additional studies on the micro-organism











8.8.

Information and toxicity studies on metabolites











8.8.1.

Information on metabolites











8.8.2.

Additional toxicity studies on metabolites of concern’