Corrigendum to Commission Regulation (EU) 2022/1441 of 31 August 2022 amending Regulation (EU) No 546/2011 as regards specific uniform principles for evaluation and authorisation of plant protection products containing micro-organisms (Official Journal of the European Union L 227 of 1 September 2022)
Date: 2022-11-24
Institutions: European Commission
Subjects: antimicrobial resistance, environmental protection, health risk, market approval, marketing standard, microorganism, plant health control, plant health product








L_2022304EN.01010001.xml










24.11.2022   


EN


Official Journal of the European Union


L 304/100







Corrigendum to Commission Regulation (EU) 2022/1441 of 31 August 2022 amending Regulation (EU) No 546/2011 as regards specific uniform principles for evaluation and authorisation of plant protection products containing micro-organisms

(
Official Journal of the European Union L 227 of 1 September 2022
)


On page 77, Annex, the following table of contents shall be inserted after the title ‘PART A – Uniform principles for evaluation and authorisation of chemical plant protection products
               ’:

                           ‘
                           Table of contents








1.

Evaluation











1.1.

Efficacy











1.2.

Absence of unacceptable effects on plants or plant products











1.3.

Impact on vertebrates to be controlled











1.4.

Impact on human or animal health











1.4.1.

Impact on human or animal health arising from the plant protection product











1.4.2.

Impact on human and animal health arising from residues











1.5.

Influence on the environment











1.5.1.

Fate and distribution in the environment











1.5.2.

Impact on non-target species











1.6.

Analytical methods











1.7.

Physical and chemical properties











2.

Decision-making











2.1.

Efficacy











2.2.

Absence of unacceptable effects on plants or plant products











2.3.

Impact on vertebrates to be controlled











2.4.

Impact on human or animal health











2.4.1.

Impact on human or animal health arising from the plant protection product











2.4.2.

Impact on human or animal health arising from residues











2.5.

Influence on the environment











2.5.1.

Fate and distribution in the environment











2.5.2.

Impact on non-target species











2.6.

Analytical methods











2.7.

Physical and chemical properties’.




On page 95, Annex, the following table of contents shall be inserted after the title ‘PART B – Uniform principles for evaluation and authorisation of plant protection products containing an active substance that is a micro-organism
               ’:

                           ‘
                           Table of contents

Definitions







1.

Evaluation











1.1.

Identity and manufacturing information











1.1.1.

Identity of the micro-organism contained in the plant protection product











1.1.2.

Quality control of the production of the micro-organism contained in the plant protection product











1.1.3.

Identity of the plant protection product











1.1.4.

Quality control of the plant protection product











1.2.

Biological, physical, chemical and technical properties











1.2.1.

Biological properties of the micro-organism in the plant protection product











1.2.2.

Physical, chemical and technical properties of the plant protection product











1.3.

Efficacy











1.4.

Identification/detection and quantification methods











1.4.1.

Analytical methods for the plant protection product











1.4.1.1.

Analytical methods for micro-organisms











1.4.1.2.

Analytical methods for metabolites of concern, relevant impurities, additives, co-formulants, safeners and synergist











1.4.2.

Analytical methods for the determination of residues and density of the micro-organism











1.4.2.1.

Density of the micro-organism











1.4.2.2.

Residues of metabolites of concern











1.5.

Impact on human and animal health











1.5.1.

Effects on human or animal health arising from the plant protection product











1.5.2.

Effects on human or animal health arising from residues of metabolites of concern











1.6.

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











1.6.1.

Environmental occurrence of the micro-organism











1.6.2.

Environmental fate and behaviour of the metabolites of concern











1.7.

Effects on non-target organisms











1.8.

Conclusions and proposals











2.

Decision-making











2.1.

Identity











2.2.

Biological and technical properties











2.3.

Efficacy and absence of unacceptable effects on plants and plant products











2.3.1.

Efficacy











2.3.2.

Absence of unacceptable effects on plants and plant products











2.4.

Identification/detection and quantification methods











2.5.

Impact on human and animal health











2.5.1.

Effects on human and animal health arising from the plant protection product











2.5.2.

Effects on human and animal health arising from residues











2.6.

Fate and behaviour in the environment











2.7.

Effects on non-target organisms’.