Commission Regulation (EU) No 546/2011Show full title

2.5.2.1. [F1 Competent authorities] shall evaluate the possibility of exposure of birds and other terrestrial vertebrates to the plant protection product under the proposed conditions of use; if this possibility exists they shall evaluate the extent of the short-term and long-term risk to be expected for these organisms, including their reproduction, after use of the plant protection product in accordance with the proposed conditions of use. U.K.

Textual Amendments

F1 Words in Annex Pt. 1.B points 2.5.2.1, 2.5.2.2, 2.5.2.3, 2.5.2.4, 2.5.2.5, 2.5.2.6, 2.6, 2.7.1, 2.7.2 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(8)(b)(xix); 2020 c. 1, Sch. 5 para. 1(1)

(a)

This evaluation shall take into consideration the following information:

(i)

the specific information relating to toxicological studies on mammals and to the effects on birds and other non-target terrestrial vertebrates, including effects on reproduction, and other relevant information concerning the active substance as provided for in the Annex to Regulation (EU) No 544/2011 and the results of the evaluation thereof;

(ii)

all relevant information on the plant protection product as provided for in the Annex to Regulation (EU) No 545/2011, including the information on effects on birds and other non-target terrestrial vertebrates;

(iii)

where relevant, other authorised uses of plant protection products in the area of envisaged use containing the same active substance or which give rise to the same residues.

(b)

This evaluation shall include:

(i)

the fate and distribution, including persistence and bioconcentration, of the active substance and of relevant metabolites, breakdown and reaction products in the various parts of the environment after application of the plant protection product;

(ii)

the estimated exposure of the species likely to be exposed at the time of application or during the period that residues are present, taking into account all relevant routes of exposure such as ingestion of the formulated product or treated food, predation on invertebrates, feeding on vertebrate prey, contact by overspraying or with treated vegetation;

(iii)

a calculation of the acute, short-term and, where necessary, long-term toxicity/exposure ratio. The toxicity/exposure ratios are defined as respectively the quotient of LD₅₀, LC₅₀ or non-observable effects of concentration (NOEC) expressed on an active substance basis and the estimated exposure expressed in mg/kg body weight.