Council Directive of 15 July 1991 concerning the placing of plant protection products on the market (91/414/EEC) (repealed)

[F1 [F2 2.8. Effects on and exposure of non-target organisms U.K.

Information on the ecology of the micro-organism and effects on the environment should be assessed as well as possible exposure levels and the effects of its relevant metabolites/toxins. An overall assessment of the environmental risks that the plant protection product may cause, taking into account the normal levels of exposure to micro-organisms both in the environment as well as in the body of organisms, is necessary.

Member States shall evaluate the possibility of exposure of non-target organisms under the proposed conditions of use and if this possibility exists they shall evaluate the risks arising for the non-target organisms concerned.

Where applicable, an assessment of infectivity and pathogenicity is necessary, unless it can be justified that non-target organisms will not be exposed.

To assess the possibility of exposure the following information should also be taken into consideration:

(a)

the survival of the micro-organism in the respective compartment,

(b)

its ecological niche,

(c)

the natural background level of the micro-organism, where it is indigenous,

(d)

information on fate and behaviour in the various parts of the environment,

(e)

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

2.8.1. Member States shall evaluate the possibility of exposure of and effects on terrestrial wildlife (non-domestic birds, mammals and other terrestrial vertebrates). U.K.

2.8.1.1. A micro-organism may give rise to risks because of its potential to infect and multiply in avian and mammalian host systems. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism: U.K.

(a)

its mode of action,

(b)

other biological properties,

(c)

studies on mammalian toxicity, pathogenicity and infectivity,

(d)

studies on avian toxicity, pathogenicity and infectivity.

2.8.1.2. A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects, the following information should be taken into consideration: U.K.

(a)

studies on mammalian toxicity,

(b)

studies on avian toxicity,

(c)

information on fate and behaviour in the various parts of the environment.

If mortality or signs of intoxication are observed in the tests the evaluation must include a calculation of toxicity/exposure ratios based on the quotient of the LD ₅₀ value and the estimated exposure expressed in mg/kg body weight.

2.8.2. Member States shall evaluate the possibility of exposure of and effects on aquatic organisms. U.K.

2.8.2.1. A micro-organism may give rise to risks because of its potential to infect and multiply in aquatic organisms. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism: U.K.

(a)

its mode of action,

(b)

other biological properties,

(c)

studies on toxicity, pathogenicity and infectivity.

2.8.2.2. A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consideration: U.K.

(a)

studies on toxicity to aquatic organisms,

(b)

information on fate and behaviour in the various parts of the environment.

If mortality or signs of intoxication are observed in the tests the evaluation must include a calculation of toxicity/exposure ratios based on the quotient of the EC ₅₀ value and/or the NOEC value and the estimated exposure.

2.8.3. Member States shall evaluate the possibility of exposure of and effects on bees. U.K.

2.8.3.1. A micro-organism may give rise to risks because of its potential to infect and multiply in bees. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism: U.K.

(a)

its mode of action,

(b)

other biological properties,

(c)

studies on toxicity, pathogenicity and infectivity.

2.8.3.2. A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consideration: U.K.

(a)

studies on toxicity to bees,

(b)

information on fate and behaviour in the various parts of the environment.

If mortality or signs of intoxication are observed in the tests the evaluation must include a calculation of the hazard quotient, based on the quotient of the dose in g/ha and the LD ₅₀ value in μg/bee.

2.8.4. Member States shall evaluate the possibility of exposure of and effects on arthropods other than bees. U.K.

2.8.4.1. A micro-organism may give rise to risks because of its potential to infect and multiply in arthropods other than bees. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism: U.K.

(a)

its mode of action,

(b)

other biological properties,

(c)

studies on toxicity, pathogenicity and infectivity to honeybees and other arthropods.

2.8.4.2. A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consideration: U.K.

(a)

studies on toxicity to arthropods,

(b)

information on fate and behaviour in the various parts of the environment,

(c)

available data from biological primary screening.

If mortality or signs of intoxication are observed in the tests the evaluation must include a calculation of toxicity/exposure ratios based on the quotient of the ER ₅₀ value (effective rate) and the estimated exposure.

2.8.5. Member States shall evaluate the possibility of exposure of and effects on earthworms. U.K.

2.8.5.1. A micro-organism may give rise to risks because of its potential to infect and multiply in earthworms. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism: U.K.

(a)

its mode of action,

(b)

other biological properties,

(c)

studies on earthworm toxicity, pathogenicity and infectivity.

2.8.5.2. A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consideration: U.K.

(a)

studies on earthworm toxicity,

(b)

information on fate and behaviour in the various parts of the environment.

If mortality or signs of intoxication are observed in the tests the evaluation must include a calculation of toxicity/exposure ratios based on the quotient of the LC ₅₀ value and the estimated exposure expressed in mg/kg dry weight soil.

2.8.6. Member States shall evaluate the possibility of exposure of and effects on soil micro-organisms. U.K.

2.8.6.1. A micro-organism may give rise to risks because of its potential to interfere with nitrogen and carbon mineralisation in the soil. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism: U.K.

(a)

its mode of action,

(b)

other biological properties.

Experimental data are not normally required, i.e. where it can be justified that a proper risk assessment can be performed with the available information.

2.8.6.2. Member States shall evaluate the impact of exotic/non-indigenous micro-organisms on non-target micro-organisms and on their predators following use of the plant protection product according to the proposed conditions of use. Experimental data are not normally required, i.e. where it can be justified that a proper risk assessment can be performed with the available information. U.K.

2.8.6.3. A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consideration: U.K.

(a)

information on fate and behaviour in the various parts of the environment,

(b)

all available information from biological primary screening.] ]

Textual Amendments

F1 Substituted by Council Directive 97/57/EC of 22 September 1997 establishing Annex VI to Directive 91/414/EEC concerning the placing of plant protection products on the market.

F2 Inserted by Council Directive 2005/25/EC of 14 March 2005 amending Annex VI to Directive 91/414/EEC as regards plant protection products containing micro-organisms (Text with EEA relevance).