ANNEX IIIU.K.REQUIREMENTS FOR THE DOSSIER TO BE SUBMITTED FOR THE AUTHORIZATION OF A PLANT PROTECTION PRODUCT

PART AU.K.Chemical preparations

[F14. Further information on the plant protection product U.K.

4.1. Packaging (type, materials, size etc.), compatibility of the preparation with proposed packaging materials U.K.

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 . U.K.
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. U.K.
4.1.3. The resistance of the packaging material to its contents must be reported according to GIFAP Monograph No 17. U.K.

4.2. Procedures for cleaning application equipment U.K.

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 U.K.

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.: U.K.
  • 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. U.K.

4.4. Recommended methods and precautions concerning: handling, storage, transport or fire U.K.

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 U.K.

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 U.K.

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.