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Document 32022R1440R(01)
Corrigendum to Commission Regulation (EU) 2022/1440 of 31 August 2022 amending Regulation (EU) No 284/2013 as regards the information to be submitted for plant protection products and the specific data requirements for plant protection products containing micro-organisms (Official Journal of the European Union L 227 of 1 September 2022)
Corrigendum to Commission Regulation (EU) 2022/1440 of 31 August 2022 amending Regulation (EU) No 284/2013 as regards the information to be submitted for plant protection products and the specific data requirements for plant protection products containing micro-organisms (Official Journal of the European Union L 227 of 1 September 2022)
Corrigendum to Commission Regulation (EU) 2022/1440 of 31 August 2022 amending Regulation (EU) No 284/2013 as regards the information to be submitted for plant protection products and the specific data requirements for plant protection products containing micro-organisms (Official Journal of the European Union L 227 of 1 September 2022)
OJ L 304, 24.11.2022, p. 97–99
(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/2022/1440/corrigendum/2022-11-24/oj
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24.11.2022 |
EN |
Official Journal of the European Union |
L 304/97 |
Corrigendum to Commission Regulation (EU) 2022/1440 of 31 August 2022 amending Regulation (EU) No 284/2013 as regards the information to be submitted for plant protection products and the specific data requirements for plant protection products containing micro-organisms
( Official Journal of the European Union L 227 of 1 September 2022 )
On page 46, Annex II, the following Table of contents shall be inserted after the title ‘PART B – PLANT PROTECTION PRODUCTS CONTAINING AN ACTIVE SUBSTANCE THAT IS A MICRO-ORGANISM’:
‘Table of contents
INTRODUCTION TO PART B
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1. |
Identity of the applicant, identity of the plant protection product and manufacturing information |
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1.1. |
Applicant |
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1.2. |
Producer of the preparation and the micro-organism(s) |
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1.3. |
Trade name or proposed trade name, and producer’s development code number of the preparation if appropriate |
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1.4. |
Detailed quantitative and qualitative information on the composition of the preparation |
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1.5. |
Physical state and nature of the preparation |
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1.6. |
Method of production of the preparation and quality control |
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1.7. |
Packaging and compatibility of the preparation with proposed packaging materials |
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2. |
Physical, chemical and technical properties of the plant protection product |
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2.1. |
Appearance (colour and odour) |
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2.2. |
Explosivity and oxidising properties |
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2.3. |
Flash point and other indications of flammability or spontaneous ignition |
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2.4. |
Acidity, alkalinity and if necessary pH value |
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2.5. |
Viscosity and surface tension |
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2.6. |
Storage stability and shelf life |
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2.6.1. |
Use concentration |
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2.6.2. |
Effects of temperature and packaging |
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2.6.3. |
Other factors affecting stability |
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2.7. |
Technical characteristics of the plant protection product |
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2.7.1. |
Wettability |
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2.7.2. |
Persistent foaming |
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2.7.3. |
Suspensibility, spontaneity of dispersion and dispersion stability |
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2.7.4. |
Dry sieve test and wet sieve test |
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2.7.5. |
Particle size distribution (dustable and wettable powders, granules), content of dust/fines (granules), attrition and friability (granules) |
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2.7.6. |
Emulsifiability, re-emulsifiability and emulsion stability |
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2.7.7. |
Flowability, pourability (rinsability) and dustability |
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2.8. |
Physical and chemical compatibility with other plant protection products including plant protection products with which its use is to be authorised |
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2.8.1. |
Physical compatibility |
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2.8.2. |
Chemical compatibility |
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2.9. |
Adherence and distribution to seeds |
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3. |
Data on application |
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3.1. |
Field of use envisaged |
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3.2. |
Mode of action on the target organism |
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3.3. |
Function, target organisms and plants or plants products to be protected and possible risk mitigation measures |
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3.4. |
Application rate |
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3.5. |
Content of micro-organism in material used (e.g. in the diluted spray, baits or treated seed) |
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3.6. |
Method of application |
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3.7. |
Number and timing of applications on the same crop, duration of protection and waiting period(s) |
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3.8. |
Proposed instructions for use |
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3.9. |
Safety intervals and other precautions to protect human health, animal health and the environment |
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4. |
Further information on the plant protection product |
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4.1. |
Procedures for cleaning and decontaminating of application equipment |
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4.2. |
Recommended methods and precautions concerning: handling, storage, transport, fire or use |
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4.3. |
Measures in case of accident |
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4.4. |
Procedures for destruction or decontamination of the plant protection product and its packaging |
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4.4.1. |
Controlled incineration |
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4.4.2. |
Others |
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5. |
Analytical methods |
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5.1. |
Methods for the analysis of the preparation |
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5.2. |
Methods to determine and quantify residues |
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6. |
Efficacy data |
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6.1. |
Preliminary tests |
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6.2. |
Minimum effective dose |
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6.3. |
Testing effectiveness |
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6.4. |
Information on possible development of resistance in target organisms |
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6.5. |
Adverse effects on treated crops |
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6.5.1. |
Phytotoxicity to target plants (including different cultivars), or to target plant products |
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6.5.2. |
Effects on the yield of treated plants or plant products |
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6.5.3. |
Effects on the quality of plants or plant products |
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6.5.4. |
Effects on transformation processes |
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6.5.5. |
Impact on treated plants or plant propagating material |
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6.6. |
Observations on undesirable or unintended side-effects on succeeding crops and other plants |
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6.6.1. |
Impact on succeeding crops |
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6.6.2. |
Impact on other plants, including adjacent crops |
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6.7. |
Compatibility in plant protection programmes |
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7. |
Effect on human health |
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7.1. |
Medical data |
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7.2. |
Assessment of potential toxicity of the plant protection product |
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7.3. |
Acute toxicity |
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7.3.1. |
Acute oral toxicity |
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7.3.2. |
Acute dermal toxicity |
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7.3.3. |
Acute inhalation toxicity |
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7.3.4. |
Skin irritation |
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7.3.5. |
Eye irritation |
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7.3.6. |
Skin sensitisation |
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7.4. |
Additional toxicity information |
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7.5. |
Data on exposure |
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7.6. |
Available toxicological data relating to non-active substances |
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7.7. |
Supplementary studies for combinations of plant protection products |
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8. |
Residues in or on treated products, food and feed |
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9. |
Fate and behaviour in the environment |
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10. |
Effects on non-target organisms |
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10.1. |
Effects on terrestrial vertebrates |
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10.2. |
Effects on aquatic organisms |
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10.2.1. |
Effects on fish |
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10.2.2. |
Effects on aquatic invertebrates |
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10.2.3. |
Effects on algae |
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10.2.4. |
Effects on aquatic macrophytes |
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10.3. |
Effects on bees |
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10.4. |
Effects on non-target arthropods other than bees |
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10.5. |
Effects on non-target meso- and macroorganisms in soil |
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10.6. |
Effects on non-target terrestrial plants |
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10.7. |
Additional toxicity studies’. |