Commission Regulation (EU) No 284/2013Show full title

10. EFFECTS ON NON-TARGET ORGANISMS U.K.

Introduction U.K.

(i) The information provided, taken together with that for the micro-organism(s), must be sufficient to permit an assessment of the impact on non-target species (flora and fauna), of the plant protection product, when used as proposed. Impact can result from single, prolonged or repeated exposure, and can be reversible, or irreversible. U.K.

(ii) The choice of the appropriate non-target organisms for testing of environmental effects shall be based on the information on the micro-organism, as required in Part B of the Annex to Regulation (EU) No 283/2013, and on the information on the co-formulants and other components, as required by Sections 1 to 9 of this Annex. From such knowledge it would be possible to choose the appropriate test organisms, such as organisms closely related to the target organism. U.K.

(iii) In particular, the information provided for the plant protection product, together with other relevant information, and that provided for the micro-organism, shall be sufficient to: U.K.

• specify the hazard symbols, the indications of danger, and relevant risk and safety phrases or the pictograms, signal words, relevant hazard and precautionary statements, for the protection of the environment, to be mentioned on packaging (containers),

• permit an evaluation of the short- and long-term risks for non-target species — populations, communities, and processes as appropriate,

• permit an evaluation whether special precautions are necessary for the protection of non-target species.

(iv) There is a need to report all potentially adverse effects found during routine investigations of environmental effects and to undertake and report such additional studies which may be necessary to investigate the mechanisms involved and assess the significance of these effects. U.K.

(v) In general, much of the data relating to impact on non-target species, required for authorisation of plant protection products, will have been submitted and evaluated for the approval of the micro-organism(s). U.K.

(vi) Where exposure data are necessary to decide whether a study has to be performed, the data obtained in accordance with Section 9 of Part B of this Annex, shall be used. U.K.

For the estimation of exposure of organisms all relevant information on the plant protection product and on the micro-organism must be taken into account. Where relevant the parameters provided for in this Section shall be used. Where it appears from available data that the plant protection product has a stronger effect than the micro-organism, the data on effects on non target organisms of the plant protection product have to be used for the calculation of relevant effect/exposure ratios.

(vii) In order to facilitate the assessment of the significance of test results obtained, the same strain of each relevant species shall where possible be used in the various specified tests for effects on non target organisms. U.K.

10.1. Effects on birds U.K.

The same information as provided in point 8.1 of Part B of the Annex to Regulation (EU) No 283/2013 has to be reported where it is not possible to predict the effects of the plant protection product on the basis of the data available for the micro-organism, unless it can be justified that exposure of birds is unlikely to occur.

10.2. Effects on aquatic organisms U.K.

The same information as provided in point 8.2 of Part B of the Annex to Regulation (EU) No 283/2013 has to be reported where it is not possible to predict the effects of the plant protection product on the basis of the data available for the micro-organism, unless it can be justified that exposure of aquatic organisms is unlikely to occur.

10.3. Effects on bees U.K.

The same information as provided in point 8.3 of Part B of the Annex to Regulation (EU) No 283/2013 has to be reported where it is not possible to predict the effects of the plant protection product on the basis of the data available for the micro-organism, unless it can be justified that exposure of bees is unlikely to occur.

10.4. Effects on arthropods other than bees U.K.

The same information as provided in point 8.4 of Part B of the Annex to Regulation (EU) No 283/2013 has to be reported where it is not possible to predict the effects of the plant protection product on the basis of the data available for the micro-organism, unless it can be justified that exposure of arthropods other than bees is unlikely to occur.

10.5. Effects on earthworms U.K.

The same information as provided in point 8.5 of Part B of the Annex to Regulation (EU) No 283/2013 has to be reported where it is not possible to predict the effects of the plant protection product on the basis of the data available for the micro-organism, unless it can be justified that exposure of earthworms is unlikely to occur.

10.6. Effects on soil micro-organisms U.K.

The same information as provided in point 8.6 Part B of the Annex to Regulation (EU) No 283/2013 has to be reported where it is not possible to predict the effects of the plant protection product on the basis of the data available for the micro-organism, unless it can be justified that exposure of non target soil micro-organisms is unlikely to occur.

10.7. Additional studies U.K.

Expert judgement is required to decide whether additional studies are necessary. Such decision will take into consideration the available information in this and other Sections, in particular data on the specificity of the micro-organism, and the expected exposure. Useful information may also be available from the observations carried out in efficacy testing.

Special attention shall be given to possible effects on naturally occurring and deliberately released organisms of importance in IPM. In particular the compatibility of the product with IPM shall be taken into consideration.

Additional studies might include further studies on additional species or higher tier studies such as studies on selected non-target organisms.

Before performing such studies, the applicant shall seek agreement of the competent authorities on the type of study to be performed.