Council Directive 2005/25/EC of 14 March 2005 amending Annex VI to Directive 91/414/EEC as regards plant protection products containing micro-organisms (Text with EEA relevance)

EU Directive 2005/25 · Adopted 14 March 2005 · Extends to United Kingdom

Contents

1. 1Article 1
2. 2Article 2
3. 3Article 3
4. 4Article 4
5. Signature
6. Annex Annex
7. INTRODUCTION
8. 1Division 1
9. 2In evaluating applications for granting authorisations Member States shall:
10. 3Division 3
11. 4Where the data and information provided are sufficient to permit completion of the evaluation for one of the proposed uses, applications must be evaluated and a decision made for the proposed use.
12. 5During the process of evaluation and decision-making, the Member State shall cooperate with the applicants in order to resolve any questions on the dossier quickly or to identify at an early stage any additional studies necessary for a proper evaluation of the dossier, or to amend any proposed conditions for the use of the plant protection product or to modify its nature or its composition in order to ensure full satisfaction of the requirements of this Annex or of this Directive.
13. 6Division 6
14. 7Division 7
15. 8Division 8
16. 9Division 9
17. 10Definitions and explanations of microbiological terms
18. BEVALUATION
19. General principles
20. 1.1Having regard to current scientific and technical knowledge, Member States shall evaluate the information provided in accordance with the requirements of Annex IIB and IIIB and in particular:
21. 1.2The quality/methodology of tests, where there are no standardised test methods, must be evaluated and the following characteristics, when available, of the methods described must be assessed:
22. 1.3In interpreting the results of evaluations, Member States shall take into consideration possible elements of uncertainty in the information obtained during the evaluation, in order to ensure that the chances of failing to detect adverse effects or of underestimating their importance are reduced to a minimum. The decision-making process shall be examined to identify critical decision points or items of data for which uncertainties could lead to a false classification of risk.
23. 1.4Division 1.4
24. 1.5Division 1.5
25. 1.6Division 1.6
26. 1.7Where specific principles in Section 2 provide for the use of calculation models in the evaluation of a plant protection product, those models shall:
27. 1.8Division 1.8
28. 2Specific principles
29. Identity
30. 2.1.1Identity of the micro-organism in the plant protection product
31. 2.1.2Identity of the plant protection product
32. Biological, physical, chemical, and technical properties
33. Biological properties of the micro-organism in the plant protection product
34. 2.2.1.1Division 2.2.1.1
35. 2.2.1.2The ability of micro-organisms to adapt to the environment must be evaluated. In particular, Member States must take account of the following principles:
36. 2.2.1.3The mode of action of the micro-organism should be evaluated in as much detail as appropriate. The possible role of metabolites/toxins for the mode of action should be evaluated and when identified, the minimal effective concentration for each active metabolite/toxin should be established. Information on mode of action can be a very valuable tool in identifying potential risks. Aspects to be considered in the evaluation, are:
37. 2.2.1.4In order to evaluate possible effects on non-target organisms, information on the micro-organism's host specificity must be evaluated, taking into account the characteristics and properties described in (a) and (b).
38. 2.2.1.5Division 2.2.1.5
39. Physical, chemical and technical properties of the plant protection product
40. 2.2.2.1Division 2.2.2.1
41. 2.2.2.2Division 2.2.2.2
42. 2.2.2.3Member States shall evaluate the physical and chemical properties of the plant protection product and the retention of these characteristics after storage and take into consideration:
43. 2.2.2.4Division 2.2.2.4
44. Further information
45. 2.3.1Quality control of the production of the micro-organism in the plant protection product
46. 2.3.2Quality control of the plant protection product
47. Efficacy
48. 2.4.1Division 2.4.1
49. 2.4.2Division 2.4.2
50. 2.4.3Member States shall evaluate the efficacy data provided for in Annex IIIB on the plant protection product having regard to the degree of control or the extent of the effect desired and having regard to relevant experimental conditions such as:
51. 2.4.4Member States shall evaluate the performance of the plant protection product under the range of agricultural, plant health and environmental (including climatic) conditions likely to be encountered in practice in the area of proposed use. The effect on integrated control must be included in the evaluation. In particular, consideration should be paid to:
52. 2.4.5Member States shall evaluate the degree of adverse effects on the treated crop after use of the plant protection product according to the proposed conditions of use in comparison, where relevant, with a suitable reference product or products, where they exist, and/or an untreated control.
53. 2.4.6Where the plant protection product label includes requirements for use of the plant protection product with other plant protection products and/or with adjuvants as a tank mix, Member States shall make the evaluations referred to in points 2.4.3 to 2.4.5 in relation to the information supplied for the tank mix.
54. 2.4.7Division 2.4.7
55. 2.4.8Where the proposed use of a plant protection product is intended to have an effect on vertebrates, Member States shall evaluate the mechanism by which this effect is obtained and the observed effects on the behaviour and health of the target animals. When the intended effect is to kill the target animal they shall evaluate the time necessary to obtain the death of the animal and the conditions under which death occurs.
56. 2.5Identification/detection and quantification methods
57. Analytical methods for the plant protection product
58. 2.5.1.1Non-viable components
59. 2.5.1.2Viable components
60. Analytical methods for the determination of residues
61. 2.5.2.1Non-viable residues
62. 2.5.2.2Viable residues
63. 2.6Impact on human or animal health
64. Effects on human or animal health arising from the plant protection product
65. 2.6.1.1Member States shall evaluate operator exposure to the micro-organism, and/or to toxicologically relevant compounds in the plant protection product (e.g. their metabolites/toxins, residual growth medium, contaminants and co-formulants), likely to occur under the proposed conditions of use (including in particular dose, application method and climatic conditions). Realistic data on exposure levels must be used and, if such data are not available, a suitable, validated calculation model. When available, a European harmonised generic exposure database for plant protection products should be used.
66. 2.6.1.2Member States shall examine information relating to the nature and characteristics of the packaging proposed with particular reference to the following aspects:
67. 2.6.1.3Member States shall examine the nature and characteristics of the protective clothing and equipment proposed with particular reference to the following aspects:
68. 2.6.1.4Member States shall evaluate the possibility of exposure of other humans (workers exposed after the application of the plant protection product, such as re-entering workers, or bystanders) or animals to the micro-organism and/or to other toxicologically relevant compounds in the plant protection product under the proposed conditions of use. This evaluation will take into consideration the following information:
69. 2.6.2Effects on human or animal health arising from residues
70. 2.6.2.1Non-viable residues
71. 2.6.2.2Viable residues
72. 2.7Fate and behaviour in the environment
73. 2.7.1Member States shall evaluate the possibility of contamination of ground water, surface water and drinking water under the proposed conditions of use of the plant protection product.
74. 2.7.2Member States shall evaluate the risk for the aquatic compartment where the possibility of the exposure of aquatic organisms has been established. A micro-organism may give rise to risks because of its potential through multiplication to establish itself in the environment and can therefore have a long-lasting or permanent impact on microbial communities or their predators.
75. 2.7.3Division 2.7.3
76. 2.7.4Member States shall evaluate the possibility of exposure of organisms in the terrestrial compartment to the plant protection product under the proposed conditions of use; if this possibility exists they shall evaluate the risks arising for the terrestrial compartment. A micro-organism may give rise to risks because of its potential through multiplication to establish itself in the environment and can therefore have a long-lasting or permanent impact on microbial communities or their predators.
77. 2.8Effects on and exposure of non-target organisms
78. Member States shall evaluate the possibility of exposure of and effects on terrestrial wildlife (non-domestic birds, mammals and other terrestrial vertebrates).
79. 2.8.1.1A micro-organism may give rise to risks because of its potential to infect and multiply in avian and mammalian host systems. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism:
80. 2.8.1.2A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects, the following information should be taken into consideration:
81. Member States shall evaluate the possibility of exposure of and effects on aquatic organisms.
82. 2.8.2.1A micro-organism may give rise to risks because of its potential to infect and multiply in aquatic organisms. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism:
83. 2.8.2.2A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consideration:
84. Member States shall evaluate the possibility of exposure of and effects on bees.
85. 2.8.3.1A micro-organism may give rise to risks because of its potential to infect and multiply in bees. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism:
86. 2.8.3.2A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consideration:
87. Member States shall evaluate the possibility of exposure of and effects on arthropods other than bees.
88. 2.8.4.1A micro-organism may give rise to risks because of its potential to infect and multiply in arthropods other than bees. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism:
89. 2.8.4.2A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consideration:
90. Member States shall evaluate the possibility of exposure of and effects on earthworms.
91. 2.8.5.1A micro-organism may give rise to risks because of its potential to infect and multiply in earthworms. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism:
92. 2.8.5.2A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consideration:
93. Member States shall evaluate the possibility of exposure of and effects on soil micro-organisms.
94. 2.8.6.1A micro-organism may give rise to risks because of its potential to interfere with nitrogen and carbon mineralisation in the soil. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism:
95. 2.8.6.2Division 2.8.6.2
96. 2.8.6.3A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consideration:
97. 2.9Conclusions and proposals
98. DECISION-MAKING
99. General principles
100. 1.1Division 1.1
101. 1.2Division 1.2
102. 1.3Division 1.3
103. 1.4Division 1.4
104. 1.5Division 1.5
105. 1.6Before issuing an authorisation, Member States shall ensure that the label of the plant protection product:
106. 1.7Before issuing authorisations, Member States shall:
107. 1.8No authorisation shall be granted unless all the requirements referred to in point 2 are satisfied. However, when one or more of the specific decision-making requirements referred to in point 2.4 are not fully satisfied, authorisations shall be granted only where the advantages of the use of the plant protection product under the proposed conditions of use outweigh the possible adverse effects of its use. Any restrictions on use of the plant protection product relating to non-compliance with some of the requirements referred to in point 2.4 must be mentioned on the label. These advantages can be in terms of:
108. 1.9Where an authorisation has been granted according to the requirements provided for in this Annex, Member States may, by virtue of Article 4(6):
109. 1.10Division 1.10
110. 1.11Division 1.11
111. 1.12Division 1.12
112. 1.13Division 1.13
113. 1.14Division 1.14
114. 2Specific principles
115. 2.1Identity
116. Biological and technical properties
117. 2.2.1Division 2.2.1
118. 2.2.2Division 2.2.2
119. 2.3Further information
120. Efficacy
121. Performance
122. 2.4.1.1Division 2.4.1.1
123. 2.4.1.2Division 2.4.1.2
124. 2.4.1.3Division 2.4.1.3
125. 2.4.1.4Division 2.4.1.4
126. 2.4.1.5Where proposed label claims include requirements for use of the preparation with other specified plant protection products or adjuvants as a tank mix, the mixture must achieve the desired effect and comply with the principles referred to in points 2.4.1.1 to 2.4.1.4.
127. 2.4.1.6Division 2.4.1.6
128. 2.4.1.7Division 2.4.1.7
129. Absence of unacceptable effects on plants and plant products
130. 2.4.2.1Division 2.4.2.1
131. 2.4.2.2Division 2.4.2.2
132. 2.4.2.3Division 2.4.2.3
133. 2.4.2.4Division 2.4.2.4
134. 2.4.2.5Division 2.4.2.5
135. 2.4.2.6Division 2.4.2.6
136. 2.4.2.7Division 2.4.2.7
137. 2.4.2.8Division 2.4.2.8
138. 2.5Identification/detection and quantification methods
139. 2.5.1Division 2.5.1
140. 2.5.2No authorisation shall be granted unless there are adequate methods for post-registration control and monitoring of viable and/or non-viable residues. Methods must be available for analysis of:
141. Impact on human and animal health
142. Effects on human and animal health arising from the plant protection product
143. 2.6.1.1Division 2.6.1.1
144. 2.6.1.2No authorisation shall be granted if the micro-organism and/or the plant protection product containing the micro-organism might, under the recommended conditions of use, including a realistic worst case scenario, colonise or cause adverse effects in humans or animals.
145. 2.6.1.3All micro-organisms should be regarded as potential sensitisers, unless it is established by means of relevant information that there is no risk of sensitisation, taking into account immuno-compromised and other sensitive individuals. Authorisations granted shall therefore specify that protective clothing and suitable gloves be worn and that the plant protection product containing the micro-organism should not be inhaled. Moreover, the proposed conditions of use may require use of additional items of protective clothing and equipment.
146. 2.6.1.4Division 2.6.1.4
147. 2.6.1.5Division 2.6.1.5
148. 2.6.1.6Division 2.6.1.6
149. 2.6.1.7Division 2.6.1.7
150. 2.6.1.8Division 2.6.1.8
151. 2.6.1.9Division 2.6.1.9
152. Effects on human and animal health arising from residues
153. 2.6.2.1Division 2.6.2.1
154. 2.6.2.2Division 2.6.2.2
155. Fate and behaviour in the environment
156. 2.7.1Division 2.7.1
157. 2.7.2Division 2.7.2
158. 2.7.3No authorisation shall be granted if the contamination of groundwater expected as a result of the use of a plant protection product under the proposed conditions of use contravenes or exceeds whichever of the following is the lower:
159. 2.7.4No authorisation shall be granted if the contamination of surface water expected as a result of the use of a plant protection product under the proposed conditions of use:
160. 2.7.5Division 2.7.5
161. 2.7.6Division 2.7.6
162. 2.7.7Division 2.7.7
163. 2.8Effects on non-target organisms
164. 2.8.1Where there is a possibility of birds and other non-target terrestrial vertebrates being exposed, no authorisation shall be granted if:
165. 2.8.2Where there is a possibility of aquatic organisms being exposed, no authorisation shall be granted if:
166. 2.8.3Where there is a possibility of bees being exposed, no authorisation shall be granted:
167. 2.8.4Where there is a possibility of arthropods other than bees being exposed, no authorisation shall be granted if:
168. 2.8.5Division 2.8.5
169. 2.8.6Division 2.8.6