Council Directive 2005/25/ECShow full title

1. General principles

1.1. Where appropriate, Member States shall impose conditions or restrictions on the authorisations they grant. The nature and severity of these conditions or restrictions must be selected on the basis of, and be appropriate to, the nature and extent of the expected advantages and the risks likely to arise.

1.2. Member States shall ensure that decisions taken to grant authorisations, take account of the agricultural, plant health or environmental (including climatic) conditions in the areas of envisaged use. Such considerations may result in specific conditions and restrictions on use, and, in authorisation being granted for some but not other areas within the Member State in question.

1.3. Member States shall ensure that the authorised amounts, in terms of rates and number of applications, are the minimum necessary to achieve the desired effect even where higher amounts would not result in unacceptable risks to human or animal health or to the environment. The authorised amounts must be differentiated according to, and be appropriate to, the agricultural, plant health or environmental (including climatic) conditions in the various areas for which an authorisation is granted. However, the rates and the number of applications may not give rise to undesirable effects such as the development of resistance.

1.4. Member States shall ensure that decisions respect the principles of integrated pest control if the plant protection product is intended for use in conditions where these principles are relied on.

1.5. Since the evaluation is to be based on data concerning a limited number of representative species, Member States shall ensure that use of plant protection products does not have any long-term repercussions for the abundance and diversity of non-target species.

1.6. Before issuing an authorisation, Member States shall ensure that the label of the plant protection product:

(a)

fulfils the requirements of Article 16 of this Directive,

(b)

also contains the information on protection of users required by Community legislation on worker protection,

(c)

specifies in particular the conditions or restrictions under which the plant protection product may or may not be used as referred to in points 1.1 to 1.5,

(d)

The authorisation shall mention the particulars indicated in Article 16(1)(g) and (h) of this Directive and Article 10(1.2), (2.4), (2.5) and (2.6) of Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations(1).

1.7. Before issuing authorisations, Member States shall:

(a)

ensure that the proposed packaging is in accordance with the provisions of Directive 1999/45/EC;

(b)

ensure that:

• the procedures for destruction of the plant protection product,

• the procedures for neutralisation of any adverse effects of the plant protection product if it is accidentally dispersed, and

• the procedures for the decontamination and destruction of the packaging,

are in accordance with the relevant regulatory provisions.

1.8. No authorisation shall be granted unless all the requirements referred to in point 2 are satisfied. However, when one or more of the specific decision-making requirements referred to in point 2.4 are not fully satisfied, authorisations shall be granted only where the advantages of the use of the plant protection product under the proposed conditions of use outweigh the possible adverse effects of its use. Any restrictions on use of the plant protection product relating to non-compliance with some of the requirements referred to in point 2.4 must be mentioned on the label. These advantages can be in terms of:

(a)

advantages for and compatibility with integrated control measures or organic farming,

(b)

facilitating strategies to minimise the risk of development of resistance,

(c)

reduced risk for operators and consumers,

(d)

reduced contamination of the environment and reduced impact on non-target species.

1.9. Where an authorisation has been granted according to the requirements provided for in this Annex, Member States may, by virtue of Article 4(6):

(a)

define, where possible, preferably in close cooperation with the applicant, measures to improve the performance of the plant protection product, and/or

(b)

define, where possible, in close cooperation with the applicant, measures to reduce further the exposure that could occur during and after use of the plant protection product.

Member States shall inform applicants of any measures identified under (a) or (b) and shall invite applicants to provide any supplementary data and information necessary to demonstrate performance or potential risks arising under the changed conditions.

1.10. Member States shall ensure, as far as is practically possible, that for all micro-organisms that are considered for an authorisation, the applicant has taken into account all available relevant knowledge and information in literature at the time of submission.

1.11. Where the micro-organism has been genetically modified, as defined in Directive 2001/18/EC, no authorisation shall be granted unless the evaluation conducted in accordance with Directive 2001/18/EC has been submitted, as required under Article 1(3) of that Directive. The relevant decision taken by the competent authorities in accordance with Directive 2001/18/EC must be provided.

1.12. In accordance with Article 1(3) of this Directive, no authorisation shall be granted for a plant protection product containing a genetically modified organism unless authorisation is granted according to the provisions in Directive 2001/18/EC, part C, under which that organism can be released into the environment.

1.13. No authorisation shall be granted if relevant metabolites/toxins (i.e. those expected to be of concern for human health and/or the environment) known to be formed by the micro-organism, and/or by microbial contaminants are present in the plant protection product, unless it can be shown that the amount present is at an acceptable level before and after its proposed use.

1.14. Member States shall ensure that adequate quality control measures are applied to ensure the identity of the micro-organism and contents of the plant protection product. Such measures must include a Hazard Analysis Critical Control Point (HACCP) system or equivalent system.

(1)

OJ L 200, 30.7.1999, p. 1. Directive as last amended by Directive 2004/66/EC (OJ L 168, 1.5.2004, p. 35).