Possible risks to birds shall be investigated if the toxicity of the plant protection product cannot be predicted on the basis of the data for the active substance, except, for example, where the plant protection product is used in enclosed spaces or for wound-healing treatments where birds will experience neither direct nor secondary exposure.
In the case of pellets, granules or treated seeds the amount of active substance in each pellet, granule or seed shall be reported as well as the size, weight and shape of pellets or granules. From that data, the number as well as the weight of pellets, granules or seeds required to achieve the LD50 (1) shall be calculated and reported as well.
In the case of baits the concentration of as in the bait (mg active substance/kg) shall be reported.
A risk assessment for birds shall be conducted in accordance with the relevant risk quotient analysis.
The acute oral toxicity of the plant protection product shall be investigated if toxicity cannot be predicted on the basis of the data for the active substance, or where results from mammalian testing give evidence of higher toxicity of the plant protection product compared to the active substance, unless the applicant shows that it is not likely that birds are exposed to the plant protection product itself.
The test shall provide, where possible, LD50 values, the lethal threshold dose, time courses of response and recovery, the No Observed Effect Level (NOEL), and shall include gross pathological findings. Study design shall be optimised for the achievement of an accurate LD50 rather than for any secondary endpoint.
The study shall be conducted on the species used in the study referred to in point 8.1.1 of Part A of the Annex to Regulation (EU) No 283/2013.
The highest dose used in tests shall not exceed 2 000 mg active substance/kg body weight, however, depending on the expected exposure levels in the field following the intended use of the compound, higher doses may be required.
Higher tier studies on birds shall be conducted where the first tiers of the risk assessment do not demonstrate that risk is acceptable.
Possible risks to vertebrate species other than birds shall be investigated except when the test substance is included in plant protection products used, for example, in enclosed spaces and wound-healing treatments where vertebrate species other than birds will experience neither direct nor secondary exposure.
Experimental testing of vertebrates shall only be carried out where the data required for risk assessment cannot be derived from the data generated in accordance with the requirements set out in Section 5 and 7 of Part A of the Annex to Regulation (EU) No 283/2013.
An acute and reproductive risk assessment for terrestrial vertebrates other than birds shall be conducted in accordance with the relevant risk quotient analysis.
If exposure to the formulation is considered possible and the toxicity cannot be predicted on the basis of the data for the active substance, data on the acute oral toxicity of the plant protection product from the mammalian toxicological assessment shall also be considered (see point 5.8 of Part A of the Annex to Regulation (EU) No 283/2013).
Higher tier studies on mammals shall be conducted where the first tiers of the risk assessment do not demonstrate that risk is acceptable.
Where it cannot be predicted from the active substance data and, if relevant, the risk to amphibians and reptiles from plant protection products shall be addressed. The type and conditions of the studies to be provided shall be discussed with the national competent authorities.
LD50, abbreviation for ‘Lethal Dose, 50 %’, that is to say the dose required to kill half the members of a tested population after a specified test duration.