Council Directive of 15 July 1991 concerning the placing of plant protection products on the market (91/414/EEC) (repealed)

[F1 7. FATE AND BEHAVIOUR IN THE ENVIRONMENT U.K.

Introduction U.K.

(i)

Information on the origin, the properties, and the survival of the micro-organism and its residual metabolites as well as its intended use form the basis for an assessment of environmental fate and behaviour.

Experimental data are normally required unless it can be justified that an assessment of its fate and behaviour in the environment can be performed with the information already available. This justification can be based on open literature, on practical experience and, on information submitted in sections 1 through 6. The function of the micro-organism in environmental processes (as defined in section 2, point 2.1.2) is of particular interest.

(ii)

The information provided, taken together with other relevant information, and that for one or more preparations containing the micro-organism, must be sufficient to permit an assessment of its fate and behaviour as well as that of its residual traces and toxins, where they are of significance for human health and/or the environment.

(iii)

In particular, the information provided should be sufficient to:

• decide whether, or not, the micro-organism can be included in Annex I,

• specify appropriate conditions or restrictions to be associated with any inclusion in Annex I,

• specify the hazard symbols (once introduced), the indications of danger, and relevant risk and safety phrases for the protection of the environment, which are to be included on packaging (containers),

• predict the distribution, fate, and behaviour in the environment of the micro-organism and its metabolites as well as the time courses involved,

• identify measures necessary to minimise contamination of the environment and impact on non-target species.

(iv)

Any relevant metabolites (i.e. of concern for human health and/or the environment) formed by the test organism under any relevant environmental conditions should be characterised. If relevant metabolites are present in or produced by the micro-organism, data as outlined under Annex II, Part A, point 7 may be required, if all of the following conditions are met:

• the relevant metabolite is stable outside the micro-organism, see point 2.8, and

• a toxic effect of the relevant metabolite is independent of the presence of the micro-organism, and

• the relevant metabolite is expected to occur in the environment in concentrations considerably higher than under natural conditions.

(v)

Available information on the relationship with naturally occurring wild type relatives should be taken into account.

(vi)

Before performing studies as referred to below, the applicant shall seek agreement of the competent authorities on whether studies need to be performed and, if so, the type of study to be conducted. The information from the other sections has, also, to be taken into account.

7.1. Persistence and multiplication U.K.

Where relevant, appropriate information on the persistence and multiplication of the micro-organism, in all environmental compartments has to be given, unless it can be justified that exposure of the particular environmental compartment to the micro-organism is unlikely to occur. Special attention shall be given to

• competitiveness under the environmental conditions prevailing at and after the intended use, and

• population dynamics in seasonally or regionally extreme climates (particularly hot summer, cold winter and rainfall) and to agricultural practices applied after intended use.

Estimated levels of the specified micro-organism in a time course after use of the product under the proposed conditions of use shall be given.

7.1.1. Soil U.K.

Information on viability/population dynamics should be reported in several cultivated and uncultivated soils representative of soils typical of the various Community regions where use exists or is anticipated. The provisions on choice of soil and its collection and handling, as referred to in Part A, point 7.1, Introduction, have to be followed. If the test organism is to be used in association with other media, e.g. rockwool, this must be included in the test range.

7.1.2. Water U.K.

Information should be reported on viability/population dynamics in natural sediment/water systems under both dark and illuminated conditions.

7.1.3. Air U.K.

In case of particular concerns for operator, worker or bystander exposure, information on the concentrations in air might be necessary.

7.2. Mobility U.K.

The possible spread of the micro-organism and its degradation products in relevant environmental compartments has to be evaluated, unless it can be justified that exposure of the particular environmental compartments to the micro-organism is unlikely to occur. In this context, the intended use (e.g. field or greenhouse, application to soil or to crops), life cycle stages, including occurrence of vectors, persistence and the ability of the organism to colonise adjacent habitats are of particular interest.

The spread, the persistence and probable transport ranges need special attention if toxicity, infectiveness or pathogenicity have been reported or if any other information suggests possible hazard to humans, animals or to the environment. In this case the competent authorities may require studies similar to those provided for in Part A. Before performing such studies, the applicant shall seek agreement of the competent authorities on the type of study to be performed.]

Textual Amendments

F1 Substituted by Commission Directive 2001/36/EC of 16 May 2001 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance).