ANNEX IIIREQUIREMENTS FOR THE DOSSIER TO BE SUBMITTED FOR THE AUTHORIZATION OF A PLANT PROTECTION PRODUCT
PART AChemical preparations
F14.Further information on the plant protection product
4.1.Packaging (type, materials, size etc.), compatibility of the preparation with proposed packaging materials
4.1.1.
Packaging to be used must be fully described and specified in terms of the materials used, manner of construction (e.g. extruded, welded etc.), size and capacity, size of opening, type of closure and seals. It must be designed in accordance with the criteria and guidelines specified in the FAO ‘Guidelines for the Packaging of Pesticides’.
4.1.2.
The suitability of the packaging, including closures, in terms of its strength, leakproofness and resistance to normal transport and handling, must be determined and reported according to ADR Methods 3552, 3553, 3560, 3554, 3555, 3556 3558, or appropriate ADR Methods for intermediate bulk containers, and, where for the preparation child-resistant closures are required, according to ISO standards 8317.
4.1.3.
The resistance of the packaging material to its contents must be reported according to GIFAP Monograph No 17.
4.2.Procedures for cleaning application equipment
Cleaning procedures for both application equipment and protective clothing must be described in detail. The effectiveness of the cleaning procedure, must be fully investigated and reported.
4.3.Re-entry periods, necessary waiting periods or other precautions to protect man, livestock and the environment
The information provided must follow from and be supported by the data provided for the active substance(s) and that provided under sections 7 and 8.
4.3.1.
Where relevant pre-harvest intervals, re-entry periods or withholding periods necessary to minimize the presence of residues in or on crops, plants and plant products, or in treated areas or spaces, with a view to protecting man or livestock, must be specified e.g.:
pre-harvest interval (in days) for each relevant crop,
re-entry period (in days) for livestock, to areas to be grazed,
re-entry period (in hours or days) for man to crops, buildings or spaces treated,
withholding period (in days) for animal feedingstuffs,
waiting period (in days), between application and handling treated products, or
waiting period (in days), between last application and sowing or planting succeeding crops.
4.3.2.
Where necessary, in the light of the test results, information on any specific agricultural, plant health or environmental conditions under which the preparation may or may not be used must be provided.
4.4.Recommended methods and precautions concerning: handling, storage, transport or fire
The recommended methods and precautions concerning handling procedures (detailed) for the storage, at both warehouse and user level of plant protection products, for their transport and in the event of fire must be provided. Where available information on combustion products must be provided. The risks likely to arise and the methods and procedures to minimize the hazards arising, must be specified. Procedures to preclude or minimize the generation of waste or leftovers must be provided.
Where relevant assessment has to be done according to ISO — TR 9122.
Where appropriate the nature and characteristics of protective clothing and equipment proposed must be provided. The data provided must be sufficient to evaluate the suitability and effectiveness under realistic conditions of use (e.g. field or glasshouse circumstances).
4.5.Emergency measures in the case of an accident
Whether arising during transport, storage or use, detailed procedures to be followed in the event of an emergency, must be provided; and include:
containment of spillages,
decontamination of areas, vehicles and buildings,
disposal of damaged packaging, adsorbents and other materials,
protection of emergency workers and bystanders,
first aid measures.
4.6.Procedures for destruction or decontamination of the plant protection product and its packaging
Procedures for destruction and decontamination must be developed for both small quantities (user level) and large quantities (warehouse level). The procedures must be consistent with provisions in place relating to the disposal of waste and of toxic waste. The means of disposal proposed should be without unacceptable influence on the environment and be the most cost effective and practical means of disposal feasible.
4.6.1.Possibility of neutralization
Neutralization procedures (e.g by reaction with alkali to form less toxic compounds) for use in the event of accidental spillages, must where they are feasible, be described. The products produced after neutralization should be practically or theoretically evaluated and reported.
4.6.2.Controlled incineration
In many cases the preferred or sole means to safely dispose of active substances as well as plant protection products containing it, contaminated materials, or contaminated packaging, is through controlled incineration in a lincensed incinerator.
Where the content of halogens of the active substance(s) in the preparation is greater than 60 %, the pyrolytic behaviour of the active substance under controlled conditions (including where relevant supply of oxygen and defined residence time) at 800 oC and the content of polyhalogenated dibenzo-p-dioxins and dibenzo-furans in the products of pyrolysis must be reported. The applicant must provide detailed instructions for safe disposal.
4.6.3.Others
Other methods to dispose of plant protection products, packaging and contaminated materials, where proposed, must be fully described. Data must be provided for such methods, to establish their effectiveness and safety.