Commission Regulation (EU) No 284/2013Dangos y teitl llawn

Introduction U.K.

1. Testing of the plant protection product shall be necessary where its toxicity cannot be predicted on the basis of data on the active substance. Where testing is necessary, the aim shall be to demonstrate whether the plant protection product, taking account of content of active substance, is more toxic than the active substance. Thus bridging studies or a limit test may be sufficient. However, where a plant protection product is more toxic than the active substance (expressed in comparable units), definitive testing shall be required. Possible effects on organisms/ecosystems shall be investigated, unless the applicant shows that exposure of the organisms or ecosystems does not occur. U.K.

Tests and studies conducted using the plant protection product as test material necessary to assess the toxicity of the active substance shall be reported in the context of the relevant data requirement concerning the active substance.

2. All potentially adverse effects found during routine ecotoxicological investigations shall be reported and such additional studies, which may be necessary to investigate the mechanisms involved and assess the significance of these effects, shall be undertaken and reported. U.K.

3. Whenever a study implies the use of different doses, the relationship between dose and adverse effect shall be reported. U.K.

4. Where exposure data are necessary to decide whether a study has to be performed, the data obtained in accordance with Section 9 shall be used. U.K.

For the estimation of exposure of organisms, all information on the plant protection product and on the active substance shall be taken into account. A tiered approach shall start with default worst-case parameters for exposure and be followed by a parameter refinement based on the identification of representative organisms. Where relevant, the parameters set out in this Section shall be used. Where it appears from available data that the plant protection product is more toxic than the active substance, the toxicity data for the plant protection product shall be used for the calculation of appropriate risk quotients (see point 8 of this introduction).

5. The requirements laid down in this Section shall include certain study types that are set out in Section 8 of Part A of the Annex to Regulation (EU) No 283/2013 (such as standard laboratory tests with birds, aquatic organisms, bees, arthropods, earthworms, soil micro-organisms, soil meso-fauna and non-target plants). While each point shall be addressed, experimental data with a plant protection product shall be generated only if its toxicity cannot be predicted on the basis of data on the active substance. It may be sufficient to test the plant protection product with that species of a group that was most sensitive with the active substance. U.K.

6. A detailed description (specification) of the material used as provided for in accordance with point 1.4 shall be provided. U.K.

7. In order to facilitate the assessment of the significance of test results obtained, the same strain of each species shall, where possible, be used in the various toxicity tests specified. U.K.

8. The ecotoxicological assessment shall be based on the risk that the proposed plant protection product poses to non-target organisms. In carrying out a risk assessment, toxicity shall be compared with exposure. The general term for the output from such a comparison is ‘risk quotient’ (RQ). RQ may be expressed in several ways, for example, toxicity:exposure ratio (TER) and as a hazard quotient (HQ). U.K.

9. For those guidelines which allow for study to be designed to determine an effective concentration (EC_x), the study shall be conducted to determine an EC₁₀ and EC₂₀ along with corresponding 95 % confidence intervals. If an EC_x approach is used, a NOEC shall still be determined. U.K.

Existing acceptable studies that have been designed to generate a NOEC shall not be repeated. An assessment of the statistical power of the NOEC derived from those studies shall be carried out.

10. For solid formulations an assessment of the risk from dust drift on to non-target arthropods and plants shall be required. Details on the likely exposure levels shall be presented in accordance with Section 9 of this Annex. For aquatic life, the risk of movement of the whole particle as well as dust particles shall be considered. Until agreed dust dissipation rate assessments are available likely exposure levels shall be used in the risk assessment. U.K.

11. Higher tier studies using a plant protection product shall be designed and data analysed using suitable statistical methods. Full details of the statistical methods shall be reported. Where appropriate, higher tier studies shall be supported by chemical analysis to verify exposure has occurred at an appropriate level. U.K.

12. Pending the validation and adoption of new studies and of a new risk assessment scheme, existing protocols shall be used to address the acute and chronic risk to bees, including those on colony survival and development, and the identification and measurement of sub-lethal effects in the risk assessment. U.K.