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

2.5. Influence on the environment U.K.

2.5.1. Fate and distribution in the environment U.K.

2.5.1.1. No authorisation shall be granted if the active substance and, where they are of significance from the toxicological, ecotoxicological or environmental point of view, metabolites and breakdown or reaction products, after use of the plant protection product under the proposed conditions of use: U.K.

• during tests in the field, persist in soil for more than 1 year (i.e. DT90 > 1 year and DT50 > 3 months), or

• during laboratory tests, form non-extractable residues in amounts exceeding 70 % of the initial dose after 100 days with a mineralisation rate of less than 5 % in 100 days,

unless it is scientifically demonstrated that under field conditions there is no accumulation in soil at such levels that unacceptable residues in succeeding crops occur and/or that unacceptable phytotoxic effects on succeeding crops occur and/or that there is an unacceptable impact on the environment, in accordance with the relevant requirements provided for in points 2.5.1.2, 2.5.1.3, 2.5.1.4 and 2.5.2.

2.5.1.2. No authorisation shall be granted if the concentration of the active substance or of relevant metabolites, degradation or reaction products in groundwater, may be expected to exceed, as a result of use of the plant protection product under the proposed conditions of use, the lower of the following limit values: U.K.

(i)

[F1 the maximum permissible concentration laid down by [F2 the EU-derived domestic legislation which transposed] Council Directive 98/83/EC(1); or]

(ii)

the maximum concentration laid down when approving the active substance 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 one tenth of the ADI laid down when the active substance was approved in accordance with Regulation (EC) No 1107/2009,

Textual Amendments

F1 Substituted by Commission Regulation (EU) 2018/676 of 3 May 2018 correcting Commission Regulation (EU) No 546/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products (Text with EEA relevance).

F2 Words in Annex Pt. 1.C point 2.5.1.2(i) inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(8)(c)(xv); 2020 c. 1, Sch. 5 para. 1(1)

unless it is scientifically demonstrated that under relevant field conditions the lower concentration is not exceeded.

2.5.1.3. No authorisation shall be granted if the concentration of the active substance or of relevant metabolites, breakdown or reaction products to be expected after use of the plant protection product under the proposed conditions of use in surface water: U.K.

• exceeds, where the surface water in or from the area of envisaged use is intended for the abstraction 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 of the European Parliament and of the Council(2) is compromised, or

• has an impact deemed unacceptable on non-target species, including animals, in accordance with the relevant requirements provided for in point 2.5.2.

Textual Amendments

F3 Words in Annex Pt. 1.C point 2.5.1.3 inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(8)(c)(xvi); 2020 c. 1, Sch. 5 para. 1(1)

The proposed instructions 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.

2.5.1.4. No authorisation shall be granted if the airborne concentration of the active substance under the proposed conditions of use is such that either the AOEL or the limit values for operators, bystanders or workers as referred to in point 2.4.1 are exceeded. U.K.

2.5.2. Impact on non-target species U.K.

2.5.2.1. Where there is a possibility of birds and other non-target terrestrial vertebrates being exposed, no authorisation shall be granted if: U.K.

• the acute and short-term toxicity/exposure ratio for birds and other non-target terrestrial vertebrates is less than 10 on the basis of LD₅₀ or the long-term toxicity/exposure ratio is less than 5, unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact occurs after use of the plant protection product in accordance with the proposed conditions of use,

• the bioconcentration factor (BCF, related to fat tissue) is greater than 1, unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable effects occur — directly or indirectly — after use of the plant protection product in accordance with the proposed conditions of use.

2.5.2.2. Where there is a possibility of aquatic organisms being exposed, no authorisation shall be granted if: U.K.

• the toxicity/exposure ratio for fish and Daphnia is less than 100 for acute exposure and less than 10 for long-term exposure, or

• the algal growth inhibition/exposure ratio is less than 10, or

• the maximum bioconcentration factor (BCF) is greater than 1 000 for plant protection products containing active substances which are readily biodegradable or greater than 100 for those which are not readily biodegradable,

unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact on the viability of exposed species (predators) occurs — directly or indirectly — after use of the plant protection product in accordance with the proposed conditions of use.

2.5.2.3. Where there is a possibility of honeybees being exposed, no authorisation shall be granted if the hazard quotients for oral or contact exposure of honeybees are greater than 50, unless it is clearly established through an appropriate risk assessment that under field conditions there are no unacceptable effects on honeybee larvae, honeybee behaviour, or colony survival and development after use of the plant protection product in accordance with the proposed conditions of use. U.K.

2.5.2.4. Where there is a possibility of beneficial arthropods other than honeybees being exposed, no authorisation shall be granted if more than 30 % of the test organisms are affected in lethal or sublethal laboratory tests conducted at the maximum proposed application rate, unless it is clearly established through an appropriate risk assessment that under field conditions there is no unacceptable impact on those organisms after use of the plant protection product in accordance with the proposed conditions of use. Any claims for selectivity and proposals for use in integrated pest management systems shall be substantiated by appropriate data. U.K.

2.5.2.5. Where there is a possibility of earthworms being exposed, no authorisation shall be granted if the acute toxicity/exposure ratio for earthworms is less than 10 or the long-term toxicity/exposure ratio is less than 5, unless it is clearly established through an appropriate risk assessment that under field conditions earthworm populations are not at risk after use of the plant protection product in accordance with the proposed conditions of use. U.K.

2.5.2.6. Where there is a possibility of non-target soil micro-organisms being exposed, no authorisation shall be granted if the nitrogen or carbon mineralisation processes in laboratory studies are affected by more than 25 % after 100 days, unless it is clearly established through an appropriate risk assessment that under field conditions there is no unacceptable impact on microbial activity after use of the plant protection product in accordance with the proposed conditions of use, taking account of the ability of micro-organisms to multiply. U.K.

(1)

[F1 Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption ( OJ L 330, 5.12.1998, p. 32 ).]

(2)

OJ L 327, 22.12.2000, p. 1.

Textual Amendments

F1 Substituted by Commission Regulation (EU) 2018/676 of 3 May 2018 correcting Commission Regulation (EU) No 546/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products (Text with EEA relevance).