Council Directive of 15 July 1991 concerning the placing of plant protection products on the market (91/414/EEC) (repealed)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 non-target organisms U.K.

Member States shall ensure that the available information is sufficient to permit a decision to be taken as to whether or not there may be unacceptable effects on non-target species (flora and fauna), due to exposure to the plant protection product containing the micro-organism following its intended use.

Member States shall pay special attention to possible effects on beneficial organisms used for biological control and organisms playing an important role in integrated control.

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

(a)

the micro-organism is pathogenic to birds and other non-target terrestrial vertebrates,

(b)

in case of toxic effects due to components in the plant protection product, such as relevant metabolites/toxins, the toxicity/exposure ratio is less than 10 on the basis of the acute LD ₅₀ value 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 effects occur — directly or indirectly — after use of the plant protection product according to the proposed conditions of use.

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

(a)

the micro-organism is pathogenic to aquatic organisms,

(b)

in case of toxic effects due to components in the plant protection product such as relevant metabolites/toxins, the toxicity/exposure ratio is less than 100 in case of acute toxicity (EC ₅₀ ) to daphnia and fish and 10 for long-term/chronic toxicity to algae (EC ₅₀ ), daphnia (NOEC) and fish (NOEC), unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact on the viability of exposed species occurs — directly or indirectly — after use of the plant protection product according to the proposed conditions of use.

2.8.3. Where there is a possibility of bees being exposed, no authorisation shall be granted: U.K.

(a)

if the micro-organism is pathogenic to bees,

(b)

in case of toxic effects due to components in the plant protection product such as relevant metabolites/toxins, 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 according to the proposed conditions of use.

2.8.4. Where there is a possibility of arthropods other than bees being exposed, no authorisation shall be granted if: U.K.

(a)

the micro-organism is pathogenic to arthropods other than bees,

(b)

in case of toxic effects due to components in the plant protection product such as relevant metabolites/toxins, 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 according to the proposed conditions of use. Any claims for selectivity and proposals for use in integrated pest management systems shall be substantiated by appropriate data.

2.8.5. Where there is a possibility of earthworms being exposed, no authorisation shall be granted if the micro-organism is pathogenic to earthworms or in the case of toxic effects due to components in the plant protection product such as relevant metabolites/toxins, the acute toxicity/exposure ratio 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 according to the proposed conditions of use. U.K.

2.8.6. 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 the microbial community after use of the plant protection product according to the proposed conditions of use, taking account of the ability of micro-organisms to multiply.] ] U.K.

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).