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 (Text with EEA relevance)
Corrected by
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 contentsINTRODUCTION TO PART B1.Identity of the applicant, identity of the plant protection product and manufacturing information1.1.Applicant1.2.Producer of the preparation and the micro-organism(s)1.3.Trade name or proposed trade name, and producer’s development code number of the preparation if appropriate1.4.Detailed quantitative and qualitative information on the composition of the preparation1.5.Physical state and nature of the preparation1.6.Method of production of the preparation and quality control1.7.Packaging and compatibility of the preparation with proposed packaging materials2.Physical, chemical and technical properties of the plant protection product2.1.Appearance (colour and odour)2.2.Explosivity and oxidising properties2.3.Flash point and other indications of flammability or spontaneous ignition2.4.Acidity, alkalinity and if necessary pH value2.5.Viscosity and surface tension2.6.Storage stability and shelf life2.6.1.Use concentration2.6.2.Effects of temperature and packaging2.6.3.Other factors affecting stability2.7.Technical characteristics of the plant protection product2.7.1.Wettability2.7.2.Persistent foaming2.7.3.Suspensibility, spontaneity of dispersion and dispersion stability2.7.4.Dry sieve test and wet sieve test2.7.5.Particle size distribution (dustable and wettable powders, granules), content of dust/fines (granules), attrition and friability (granules)2.7.6.Emulsifiability, re-emulsifiability and emulsion stability2.7.7.Flowability, pourability (rinsability) and dustability2.8.Physical and chemical compatibility with other plant protection products including plant protection products with which its use is to be authorised2.8.1.Physical compatibility2.8.2.Chemical compatibility2.9.Adherence and distribution to seeds3.Data on application3.1.Field of use envisaged3.2.Mode of action on the target organism3.3.Function, target organisms and plants or plants products to be protected and possible risk mitigation measures3.4.Application rate3.5.Content of micro-organism in material used (e.g. in the diluted spray, baits or treated seed)3.6.Method of application3.7.Number and timing of applications on the same crop, duration of protection and waiting period(s)3.8.Proposed instructions for use3.9.Safety intervals and other precautions to protect human health, animal health and the environment4.Further information on the plant protection product4.1.Procedures for cleaning and decontaminating of application equipment4.2.Recommended methods and precautions concerning: handling, storage, transport, fire or use4.3.Measures in case of accident4.4.Procedures for destruction or decontamination of the plant protection product and its packaging4.4.1.Controlled incineration4.4.2.Others5.Analytical methods5.1.Methods for the analysis of the preparation5.2.Methods to determine and quantify residues6.Efficacy data6.1.Preliminary tests6.2.Minimum effective dose6.3.Testing effectiveness6.4.Information on possible development of resistance in target organisms6.5.Adverse effects on treated crops6.5.1.Phytotoxicity to target plants (including different cultivars), or to target plant products6.5.2.Effects on the yield of treated plants or plant products6.5.3.Effects on the quality of plants or plant products6.5.4.Effects on transformation processes6.5.5.Impact on treated plants or plant propagating material6.6.Observations on undesirable or unintended side-effects on succeeding crops and other plants6.6.1.Impact on succeeding crops6.6.2.Impact on other plants, including adjacent crops6.7.Compatibility in plant protection programmes7.Effect on human health7.1.Medical data7.2.Assessment of potential toxicity of the plant protection product7.3.Acute toxicity7.3.1.Acute oral toxicity7.3.2.Acute dermal toxicity7.3.3.Acute inhalation toxicity7.3.4.Skin irritation7.3.5.Eye irritation7.3.6.Skin sensitisation7.4.Additional toxicity information7.5.Data on exposure7.6.Available toxicological data relating to non-active substances7.7.Supplementary studies for combinations of plant protection products8.Residues in or on treated products, food and feed9.Fate and behaviour in the environment10.Effects on non-target organisms10.1.Effects on terrestrial vertebrates10.2.Effects on aquatic organisms10.2.1.Effects on fish10.2.2.Effects on aquatic invertebrates10.2.3.Effects on algae10.2.4.Effects on aquatic macrophytes10.3.Effects on bees10.4.Effects on non-target arthropods other than bees10.5.Effects on non-target meso- and macroorganisms in soil10.6.Effects on non-target terrestrial plants10.7.Additional toxicity studies".