Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market Text with EEA relevance

• (ii) The information provided at the most relevant highest taxonomic level, taken together with that for one or more preparations containing the micro-organism, shall be sufficient to permit an assessment of the impact on non-target species, likely to be at risk from exposure to the micro-organism. When submitting this information, the applicant shall take into account that the impact on non-target species can result from single, prolonged or repeated exposure and can be reversible or irreversible. The information provided shall be sufficient to:
• — decide whether or not the micro-organism can be approved,
• — specify appropriate conditions or restrictions to be associated with any approval,
• — permit an evaluation of short- and long-term risks for non-target species - populations, communities, and processes, as appropriate, and
• — specify any precautions deemed necessary for the protection of non-target species.

• (iii) In general, the duration of experimental studies shall be long enough to permit time for incubation, infection and manifestation of adverse effects in non-target organisms depending on the biological properties of the micro-organism. The provided studies shall take into consideration the maximum recommended application rate or the expected environmental concentration, the exposure that may arise from the intended uses and the potential of the micro-organism to proliferate in the environment or in the host. In order to distinguish between pathogenicity of the living micro-organism and toxic effects triggered by its metabolites of concern, appropriate controls shall be included in addition to the no-dosed control group, such as inactivated forms of the living micro-organisms, and/or sterile filtrate/supernatant controls.

• (iv) If pathogenicity/infectivity studies are required for any of the non-target organism groups indicated in points 8.1 to 8.6, the choice of the appropriate species of that non-target organisms group shall be based on the biological properties of the micro-organism (including the host range specificity, mode of action and ecology), the proposed use pattern(s) of the plant protection product (e.g. treated crops, frequency, timings, use patterns such as spraying or brushing) and consider relevant guidelines, where available. Additional studies may be conducted if tests referred to in points 8.1 to 8.6 have shown adverse effects in one or more non-target organisms and may include studies on additional species.

• (v) All known adverse effects on the environment shall be reported. Additional studies may be necessary to investigate the probable mechanisms involved and to assess the significance of these effects.

• (vi) It may be necessary to conduct separate studies for metabolites of concern identified under point 2.8, which constitute a relevant risk to non-target organisms. The study on non-target organisms shall be conducted in accordance with the relevant provision of Part A.

• (vii) In order to facilitate the assessment of the significance of test results obtained, the same species, recorded origin or, where possible, strain of each relevant non-target species shall be used in the various tests performed.

8.1.   Effects on terrestrial vertebrates

A summary on potential infectivity and pathogenicity of the micro-organism to terrestrial vertebrates (e.g. mammals, birds, reptiles, and amphibians) shall be provided, based on the information already provided under Sections 1, 2, 3, 5 and 7 and that information which may be retrieved from any other reliable source.

Relevant pathogenicity/infectivity studies shall be performed unless the applicant demonstrates, by following a weight of evidence approach, that pathogenicity/infectivity of the micro-organism to non-target terrestrial vertebrates can be assessed based on the summary provided.

If these studies are required:

• — gross necropsy shall be performed and

• — for micro-organisms with pathogenic mode of action or viruses (e.g. entomopathogens) that are expected to proliferate significantly in the environment following an application, the oral dose administered in the studies may be justified based on the information submitted under points 7.1.1 and 7.1.2.

8.2.   Effects on aquatic organisms

8.2.1.   Effects on fish

A summary on potential infectivity and pathogenicity of the micro-organism to fish shall be provided, based on the information already provided under Sections 1, 2, 3 and 7 and on other information which may be retrieved from any other reliable source.

Relevant pathogenicity/infectivity studies shall be performed unless the applicant demonstrates, by following a weight of evidence approach, that:

• — pathogenicity/infectivity of the micro-organism to fish can be assessed based on the summary provided; or

• — exposure of fish to the micro-organism is expected to be none based on information provided under Section 7.

Where adverse effects are observed in such studies, further relevant studies (e.g. under representative conditions in accordance with the proposed conditions of use) shall be performed.

8.2.2.   Effects on aquatic invertebrates

A summary on potential infectivity and pathogenicity of the micro-organism to aquatic invertebrates shall be provided, based on the information already provided under Sections 1, 2, 3 and 7 and on other information which may be retrieved from any other reliable source.

Relevant pathogenicity/infectivity studies shall be performed unless the applicant demonstrates, by following a weight of evidence approach, that:

• — pathogenicity/infectivity of the micro-organism to aquatic invertebrates can be assessed based on the summary provided, or

• — exposure of aquatic invertebrates to the micro-organism is expected to be none based on information provided under Section 7.

Where adverse effects are observed in such studies, further relevant studies (e.g. under representative conditions in accordance with the proposed conditions of use) shall be performed.

8.2.3.   Effects on algae

A summary on potential infectivity and pathogenicity of the micro-organism to algae shall be provided, based on the information already provided under Sections 1, 2, 3 and 7 and on other information which may be retrieved from any other reliable source.

Relevant studies on pathogenic/infective effects on algae growth and growth rate shall be performed if the micro-organism is known to have an herbicidal mode of action or to be closely related to a plant pathogen, unless the applicant demonstrates, by following a weight of evidence approach, that:

• — pathogenicity/infectivity of the micro-organism to algae can be assessed based on the summary provided, or

• — exposure of algae to the micro-organism is expected to be none based on information provided under Section 7.

Where adverse effects are observed in such studies, further relevant studies (e.g. under representative conditions in accordance with the proposed conditions of use) shall be performed.

8.2.4.   Effects on aquatic macrophytes

A summary on potential infectivity and pathogenicity of the micro-organism to aquatic macrophytes shall be provided, based on the information already provided under Sections 1, 2, 3 and 7 and on other information which may be retrieved from any other reliable source.

Relevant studies on pathogenic/infective effects on aquatic macrophytes shall be performed if the micro-organism is known to have an herbicidal mode of action, or to be closely related to a plant pathogen, unless the applicant demonstrates, by following a weight of evidence approach, that:

• — pathogenicity/infectivity of the micro-organism to aquatic macrophytes can be assessed based on the summary provided, or

• — exposure of aquatic macrophytes to the micro-organism is expected to be none based on information provided under Section 7.

Where adverse effects are observed in such studies, further relevant studies (e.g. under representative conditions in accordance with the proposed conditions of use) shall be performed.

8.3.   Effects on bees

A summary on potential infectivity and pathogenicity of the micro-organism to bees shall be provided, based on the information already provided under Sections 1, 2, 3 and 7 and on other information which may be retrieved from any other reliable source.

Relevant pathogenicity/infectivity studies, including adult and larval stages, shall be performed, unless the applicant demonstrates, by following a weight of evidence approach, that:

• — pathogenicity/infectivity of the micro-organism to bees can be assessed based on the summary provided, or

• — exposure of bees to the micro-organism is expected to be none based on information provided under Section 7.

Where adverse effects are observed in such studies, further relevant studies (e.g. field studies under representative conditions in accordance with the proposed conditions of use) shall be performed.

8.4.   Effects on non-target arthropods other than bees

A summary on potential infectivity and pathogenicity of the micro-organism to non-target arthropods other than bees shall be provided, based on the information already provided under Sections 1, 2, 3 and 7 and on other information which may be retrieved from any other reliable source.

Relevant pathogenicity/infectivity studies shall be performed unless the applicant demonstrates, by following a weight of evidence approach, that:

• — pathogenicity/infectivity of the micro-organism to non-target arthropods other than bees can be assessed based on the summary provided, or

• — exposure of non-target arthropods to the micro-organism is expected to be none based on information provided under Section 7.

If studies are required, they shall be performed on two arthropod species other than bees playing a role in biological control and comprising different taxonomic groups (orders), where possible, for which agreed testing protocols are available, and the applicant shall provide a justification for number and taxonomy of the tested species. Moreover, these tests may require conditions affecting growth or viability of the micro-organism.

Where adverse effects are observed in such studies, further relevant studies (e.g. extended laboratory tests or field studies under representative conditions in accordance with the proposed conditions of use) shall be performed.

8.5.   Effects on non-target meso- and macro-organisms in soil

A summary on potential infectivity and pathogenicity of the micro-organism to non-target soil meso- and macro-organisms shall be provided, based on the information already provided under Sections 1, 2, 3 and 7 and on other information which may be retrieved from any other reliable source.

Relevant pathogenicity/infectivity studies shall be performed unless:

• — pathogenicity/infectivity of the micro-organism to non-target soil meso- and macro-organisms can be assessed based on the summary provided, or

• — exposure of meso- and macro soil organisms to the micro-organism is expected to be none based on information provided under Section 7.

If studies are required, they shall be performed on two non-target meso- and macro-organisms species chosen based on the biological properties of the micro-organism under evaluation, where possible, for which agreed testing protocols are available.

Where adverse effects are observed in such studies, further relevant studies (e.g. under representative conditions in accordance with the proposed conditions of use) shall be performed.

8.6.   Effects on non-target terrestrial plants

A summary on potential infectivity and pathogenicity of the micro-organism to non-target terrestrial plants shall be provided, based on the information already provided under Sections 1, 2, 3 and 7 and on other information which may be retrieved from any other reliable source.

Relevant studies on pathogenic/infective effects on non-target terrestrial plants shall be performed if the micro-organism is known to have an herbicidal mode of action or to be closely related to a plant pathogen, unless the applicant demonstrates, by following a weight of evidence approach, that:

• — pathogenicity/infectivity of the micro-organism to non-target terrestrial plants can be assessed based on the summary provided, or

• — exposure of non-target plants to the micro-organism is expected to be none based on information provided under Section 7.

Where adverse effects are observed in such studies, further relevant studies (e.g. under representative conditions in accordance with the proposed conditions of use) shall be performed.

8.7.   Additional studies on the micro-organism

Further data may need to be submitted on potential pathogenicity/infectivity of the micro-organism on non-target species different from those species assessed to fulfil the requirements set out in points 8.1 to 8.6.

The data may also consist of a summary including the information already provided under Sections 2, 3, 5 and 7 and those which may be retrieved from any other source, or from additional infectivity and pathogenicity studies.

8.8.   Information and toxicity studies on metabolites

8.8.1.   Information on metabolites

Information (e.g. scientific literature, studies results) on the toxicological characterization of the metabolites and the related identified hazards relevant to non-target organisms, collected or generated with the aim to identify the metabolites of concern , or to exclude them as being of concern, shall be submitted.

For those metabolites for which a hazard to non-target organisms is identified, an estimation of exposure of the relevant non-target organisms shall be provided under point 7.2.1.

8.8.2.   Additional toxicity studies on metabolites of concern

For metabolite(s) of concern, identified based on information provided on hazard to (see point 8.8.1) and exposure of (see points 7.2.1 and 7.2.2) non-target organisms and listed under point 2.8, further information on their toxicity to the non-target organisms which are relevant (e.g. based on exposure and indication of toxicity) among those described in points 8.1 to 8.6, shall be provided. In case it is necessary to generate experimental data, relevant studies on ecotoxicology as provided for in Section 8 of Part A shall be submitted.