Council Directive of 15 July 1991 concerning the placing of plant protection products on the market (91/414/EEC) (repealed)

[F1 [F2 2.7. Fate and behaviour in the environment U.K.

The biocomplexity of the ecosystems and interactions in the microbial communities concerned must be taken into account.

Information on the origin and properties (e.g. specificity) of the micro-organism/its residual metabolites/toxins and its intended use forms the basis for an assessment of environmental fate and behaviour. The mode of action of the micro-organism should be taken into consideration.

An assessment shall be made of the fate and behaviour of any known relevant metabolite that is produced by the micro-organism. The assessment shall be made for each environmental compartment, and shall be triggered on the basis of the criteria specified in section 7 (iv) of Annex IIB.

In the assessment of the environmental fate and behaviour of plant protection products, Member States shall have regard to all aspects of the environment, including biota. The potential for persistence and multiplication of micro-organisms has to be assessed in all environmental compartments unless it can be justified that particular micro-organisms will not reach a specific compartment. The mobility of micro-organisms and their residual metabolites/toxins must be considered.

2.7.1. Member States shall evaluate the possibility of contamination of ground water, surface water and drinking water under the proposed conditions of use of the plant protection product. U.K.

In the overall assessment, Member States should pay particular attention to potential adverse effects on humans through groundwater contamination, when the active substance is applied in regions with vulnerable conditions, such as drinking water abstraction areas.

2.7.2. Member States shall evaluate the risk for the aquatic compartment where the possibility of the exposure of aquatic organisms has been established. A micro-organism may give rise to risks because of its potential through multiplication to establish itself in the environment and can therefore have a long-lasting or permanent impact on microbial communities or their predators. U.K.

This evaluation will take into consideration the following information:

(a)

the biological properties of the micro-organism,

(b)

the survival of the micro-organism in the environment,

(c)

its ecological niche,

(d)

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

(e)

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

(f)

where relevant, information on potential interference with analytical systems used for the control of the quality of drinking water as provided for in Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (1) ,

(g)

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

2.7.3. Member States shall evaluate the possibility of exposure of organisms in the atmosphere to the plant protection product under the proposed conditions of use; if this possibility exists they shall evaluate the risk for the atmosphere. The transport, short-range and long-range, of the micro-organism in the atmosphere should be taken into account. U.K.

2.7.4. Member States shall evaluate the possibility of exposure of organisms in the terrestrial compartment to the plant protection product under the proposed conditions of use; if this possibility exists they shall evaluate the risks arising for the terrestrial compartment. A micro-organism may give rise to risks because of its potential through multiplication to establish itself in the environment and can therefore have a long-lasting or permanent impact on microbial communities or their predators. U.K.

This evaluation will take into consideration the following information:

(a)

the biological properties of the micro-organism,

(b)

the survival of the micro-organism in the environment,

(c)

its ecological niche,

(d)

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

(e)

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

(f)

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

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).

(1)

[F1 [F2 OJ L 330, 5.12.1998, p. 32 . Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council ( OJ L 284, 31.10.2003, p. 1 ).] ]

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).