Environmental fate and behaviour

Information on the origin, the properties, and the survival of the micro-organism and its residues 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. The interactions of the

micro-organism with the environment are of particular interest. It may be relevant to consider, according to the case, both micro-organisms and their spores and other resistant

structures.

The information provided, taken together with other relevant information, and that for one or more biocidal products 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 relevant metabolites/toxins, where they are of significance for human health and/or the environment.

In particular, the information provided should be sufficient to:

 decide whether, or not, the micro-organism can be included in a Union list of approved active substances;

 specify appropriate conditions or restrictions to be associated with any inclusion in the Union list of approved active substances;

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

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

Any relevant metabolites / toxins (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 / toxins are present in or produced by the micro-organism, data as outlined under Annex II, section 10 for chemical active substances of the BPR, may be required, if all of the following conditions are met:

 the relevant metabolite / toxin is stable outside the micro-organism, see endpoint 3.5 for active micro-organisms (section 4.1.1 of this guidance); and

 a toxic effect of the relevant metabolite / toxin is independent of the presence of the micro-organism; and

 the relevant metabolite / toxin is expected to occur in the environment in concentrations higher than under natural conditions.

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

Before performing studies as referred to below, the applicant must 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.

NOTE to the reader: The endpoints described below are numbered in accordance with the BPR, Annex II Information Requirements for Active Substances, Title 2 Micro-organisms, Core data set and additional data set for active substances.

Headings are shown in italic green font to distinguish them from the general section numbers of the Guidance document.

9. Environmental fate and behaviour 9.1. Persistence and multiplication

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 must be given to competitiveness under the environmental conditions prevailing at and after the intended use.

Estimated levels of the specified micro-organism in a time course after use of the product under the proposed conditions of use must be given as well as information on possible dispersal routes of the micro-organism (via air as dust particles or aerosols, with host organisms as vectors, etc.). In case information on a different strain is used an explanation should be given why data can be extrapolated.

9.1.1. Soil

Information on viability/population dynamics should be reported in cultivated and

uncultivated soils representative for soils typical of the various Community regions where use exists or is anticipated, unless it can be justified that exposure is unlikely to occur. If the test organisms is to be used in association with other media than soil, this must be included in the test range.

Information on population dynamics can also be based on information on natural population dynamics and background levels in relation to exposure levels.

Information on population dynamics in soil (and water) should be reported preferably for the strain (if available), but at least for the species.

9.1.2. Water

In case of probability of exposure of surface water, information on viability in water/sediment systems must be given. In case the organism is viable in

water/sediment or can survive, information on population dynamics and the fate in water/sediment systems is required.

Information on population dynamics in water (as for soil) should be reported preferably for the strain (if available), but at least for the species.

9.1.3. Air

Where applicable in case of relevant exposure, or in case of concern, information should be submitted on viability and concentration of the micro-organism in the air

compartment.

Information on population dynamics in air should be reported preferably for the strain (if available), but at least for the species.

9.1.4. Mobility

The possible spread of the micro-organism and relevant metabolites/toxins should be discussed for the relevant environmental compartments 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, life cycle stages, including

occurrence of vectors, persistence and the ability of the organism to colonise adjacent habitats are of particular interest.

In case of a relevant metabolite/toxin that is stable outside the micro-organism, a toxic effect of the relevant metabolite / toxin is independent of the presence of the micro-organism, and the relevant metabolite / toxin is expected to occur in the environment in concentrations higher than under natural conditions, further studies on this metabolite are relevant.

9.1.5. Summary and evaluation of fate and behaviour in the environment

A summary of all data and information provided under section 9 of the Annex II Title 2 of the BPR must be submitted, and include a detailed and critical assessment of those data in the context of relevant evaluative and decision making criteria and guidelines, with particular reference to the risks for the environment that may or do arise, and the extent, quality and reliability of the data base.

6.1.2.2 Biocidal Product

NOTE to the reader: The endpoints described below are numbered in accordance with the BPR, Annex III Information Requirements for Biocidal Products, Title 2 Micro-organisms, Core data set and additional data set for active substances.

Headings are shown in italic green font to distinguish them from the general section numbers of the Guidance document.

10. Environmental fate and behaviour

10.1. Foreseeable routes of entry into the environment on the basis of the use envisaged

Please follow guidance in Volume IV Part A of the Guidance on information requirements for biocides.

10.2. Further studies on fate and behaviour in the environment (ADS)

Annex III, Title 2, 10.2 Column 1 states: Where relevant, all the information required in section 9 of Annex II "Micro-organisms" may be required for the product. For products that are used outside, with direct emission to soil, water or surfaces, the components in the product may influence the fate and behaviour (and ecotoxicity) of the active

substance. Data are required unless it is scientifically justified that the fate of the components in the product is covered by the data provided for the active substance and other identified substances of concern.

10.3. Leaching behaviour (ADS)

In contrast to what is stated in Annex II Title 2 of the BPR the title should be changed to

’Mobility’ as leaching behaviour is not relevant for micro-organisms.

Please follow guidance under endpoint 9.1.4 (section 7.1.2.1 of this guidance) for active micro-organisms.

10.4. If the biocidal product is to be sprayed outside or if potential for large scale formation of dust is given then data on overspray behaviour may be required to assess risks to bees under field conditions (ADS)

Guidance on the BPR: Volume IV Environment, Part A Information Requirements may be used where relevant for micro-organisms. This guidance is available on the BPR

subsection of the “support” section, on the ECHA website⁴⁹.

6.2 Part B: Hazard, Exposure and risk assessment