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

2.7. Fate and behaviour in the environment U.K.

2.7.1. No authorisation shall be granted if the available information indicates that there may be unacceptable adverse environmental effects due to the fate and behaviour of the plant protection product in the environment. U.K.

2.7.2. No authorisation shall be granted if contamination of ground water, surface water or drinking water expected as a result of the use of a plant protection product under the proposed conditions of use, may cause interference with the analytical systems for the control of the quality of drinking water provided for in [F1 the EU-derived domestic legislation which transposed] Directive 98/83/EC. U.K.

Textual Amendments

F1 Words in Annex Pt. 2.C point 2.7.2 inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(9)(c)(xxi); 2020 c. 1, Sch. 5 para. 1(1)

2.7.3. No authorisation shall be granted if the contamination of groundwater expected as a result of the use of a plant protection product under the proposed conditions of use contravenes or exceeds whichever of the following is the lower: U.K.

(a)

the parameters or maximum permissible concentrations laid down by [F2 the EU-derived domestic legislation which transposed] Directive 98/83/EC; or

(b)

the parameters or maximum permissible concentrations laid down for components in the plant protection product such as relevant metabolites/toxins in accordance with [F3 the EU-derived domestic legislation which transposed] Directive 2000/60/EC; or

(c)

the parameters for the micro-organism or the maximum concentration laid down for components in the plant protection product such as relevant metabolites/toxins when approving the micro-organism in accordance with Regulation (EC) No 1107/2009, on the basis of appropriate data, in particular, toxicological data, or, where that concentration has not been laid down, the concentration corresponding to 1/10 of the acceptable daily intake (ADI) laid down when the micro-organism was approved in accordance with Regulation (EC) No 1107/2009,

Textual Amendments

F2 Words in Annex Pt. 2.C point 2.7.3(a) inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(9)(c)(xxii); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Annex Pt. 2.C points 2.7.3(b), 2.7.4 inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(9)(c)(xxiii); 2020 c. 1, Sch. 5 para. 1(1)

unless it is scientifically demonstrated that under relevant field conditions the lower of the parameters or concentrations is not contravened or exceeded.

2.7.4. No authorisation shall be granted if the contamination of surface water expected as a result of the use of a plant protection product under the proposed conditions of use: U.K.

(a)

exceeds, where the surface water in or from the area of envisaged use is intended for the extraction of drinking water, concentrations above which compliance with drinking water quality established in accordance with [F3 the EU-derived domestic legislation which transposed] Directive 2000/60/EC is compromised; or

(b)

exceeds the parameters or values for components in the plant protection product, such as relevant metabolites/toxins, established in accordance with [F3 the EU-derived domestic legislation which transposed] Directive 2000/60/EC; or

(c)

has an impact deemed unacceptable on non-target species, including animals, in accordance with [F3 the EU-derived domestic legislation which transposed] the relevant requirements provided for in point 2.8.

The proposed instruction for use of the plant protection product, including procedures for cleaning application equipment, must be such that the likelihood of accidental contamination of surface water is reduced to a minimum.

2.7.5. No authorisation shall be granted if it is known that transfer of genetic material from the micro-organism to other organisms, may lead to unacceptable effects on the environment. U.K.

2.7.6. No authorisation shall be granted unless there is sufficient information on the possible persistence/competitiveness of the micro-organism and relevant secondary metabolites/toxins in or on the crop under the environmental conditions prevailing at and following the intended use. U.K.

2.7.7. No authorisation shall be granted if it can be expected that the micro-organism and/or its possible relevant metabolites/toxins shall persist in the environment in concentrations considerably higher than the natural background levels, taking into account repeated applications over the years, unless a robust risk assessment indicates that the risks from accumulated plateau concentrations are acceptable. U.K.