Council Directive 2005/25/ECShow full title

A. INTRODUCTION

1. The principles developed in Part II of this Annex aim to ensure that evaluations and decisions with regard to authorisation of plant protection products, provided they are microbial plant protection products, result in the implementation of the requirements of Article 4(1)(b), (c), (d) and (e) of this Directive by all Member States at a high level of protection of human and animal health and the environment.

2. In evaluating applications for granting authorisations Member States shall:

(a)

• ensure that dossiers on microbial plant protection products supplied are in accordance with the requirements of Annex IIIB, at the latest at the time of finalisation of the evaluation for the purpose of decision-making, without prejudice, where relevant, to the provisions of Article 13(1)(a), (4) and (6) of this Directive,

• ensure that the data submitted are acceptable in terms of quantity, quality, consistency and reliability and sufficient to permit a proper evaluation of the dossier,

• evaluate, where relevant, justifications submitted by the applicant for not supplying certain data;

(b)

take into account the Annex IIB data concerning the active substance consisting of micro-organisms (including viruses) in the plant protection product, submitted for the purpose of inclusion of the micro-organism concerned in Annex I, and the results of the evaluation of those data, without prejudice, where relevant, to the provisions of Article 13(1)(b), (2), (3) and (6) of this Directive;

(c)

take into consideration other relevant technical or scientific information they can reasonably possess with regard to the performance of the plant protection product or to the potentially adverse effects of the plant protection product, its components or its metabolites/toxins.

3. Where, in the specific principles on evaluation, reference is made to Annex IIB data, this shall be understood as being the data referred to in point 2(b).

4. Where the data and information provided are sufficient to permit completion of the evaluation for one of the proposed uses, applications must be evaluated and a decision made for the proposed use.

Taking account of justifications provided and with the benefit of any subsequent clarifications, Member States shall reject applications for granting authorisations for which the data gaps are such that it is not possible to finalise the evaluation and to make a reliable decision for at least one of the proposed uses.

5. During the process of evaluation and decision-making, the Member State shall cooperate with the applicants in order to resolve any questions on the dossier quickly or to identify at an early stage any additional studies necessary for a proper evaluation of the dossier, or to amend any proposed conditions for the use of the plant protection product or to modify its nature or its composition in order to ensure full satisfaction of the requirements of this Annex or of this Directive.

Member States shall normally come to a reasoned decision within 12 months of receiving a technically complete dossier. A technically complete dossier is one that satisfies all the requirements of Annex IIIB.

6. The judgements made by the competent authorities of the Member States during the evaluation and decision-making process must be based on scientific principles, preferably recognised at international level, and be made with the benefit of expert advice.

7. A microbial plant protection product may contain viable and non-viable micro-organisms (including viruses) and formulation substances. It may also contain relevant metabolites/toxins produced during growth, residues from the growth medium, and microbial contaminants. The micro-organism, relevant metabolites/toxins and the plant protection product with residual growth medium and microbial contaminants present must all be evaluated.

8. Member States must take into account those guidance documents taken note of in the Standing Committee on the Food Chain and Animal Health (SCFCAH).

9. For genetically modified micro-organisms, Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms(1), must be taken into account. The evaluation completed in the framework of that Directive must be provided and taken into account.

10. Definitions and explanations of microbiological terms

Antibiosis: A relationship between two or more species in which one species is actively harmed (as by the production of toxins by the harming species).

Antigenic: Any substance that, as a result of coming in contact with appropriate cells, induces a state of sensitivity and/or immune responsiveness after a latent period (days to weeks) and which reacts in a demonstrable way with antibodies and/or immune cells of the sensitised subject in vivo or in vitro.

Antimicrobial: Antimicrobial agents or antimicrobial(s) refer to naturally occurring, semi-synthetic or synthetic substances that exhibit antimicrobial activity (kill or inhibit the growth of micro-organisms).

The term ‘Antimicrobial(s)’ includes:

• antibiotics, which refer to substances produced by or derived from micro-organisms, and

• anticoccidials, which refer to substances that are active against coccidia, single cell protozoan parasites.

CFU: Colony-forming unit; one or more cells that grow to form a single visible colony.

Colonisation: Proliferation and persistence of a micro-organism in an environment, such as on external (skin) or internal body surfaces (intestine, lungs). For colonisation, the micro-organism should at least persist for a longer period than expected in a specific organ. The population of micro-organisms may decline but at a slower rate than normal clearance; it may be a steady population or it may be a growing population. Colonisation can be related to harmless and functional micro-organisms as well as to pathogenic micro-organisms. The possible occurrence of effects is not indicated.

Ecological niche: Unique environmental position occupied by a particular species, perceived in terms of actual physical space occupied and function performed within the community or ecosystem.

Host: An animal (including humans) or plant that harbours or nourishes another organism (parasite).

Host specificity: The range of different host-species that can be colonised by a microbial species or strain. A host-specific micro-organism colonises or has adverse effects on one or only a small number of different host-species. A non-host-specific micro-organism might colonise or might have adverse effects on a broad range of different host-species.

Infection: The introduction or entry of a pathogenic micro-organism into a susceptible host, whether or not it causes pathological effects or disease. The organism must enter the body of the host, usually the cells, and be able to reproduce to form new infective units. Simply ingesting a pathogen does not imply infection.

Infective: Capable of transmitting an infection.

Infectivity: The characteristics of a micro-organism that allow it to infect a susceptible host.

Invasion: The entry of a micro-organism into the host body (e.g. actual penetration of the integument, gut epithelial cells, etc.). ‘Primary invasiveness’ is a property of pathogenic micro-organisms.

Multiplication: Ability of a micro-organism to reproduce and increase in numbers during an infection.

Mycotoxin: A fungal toxin.

Non-viable micro-organism: A micro-organism that is not capable of replication or of transferring genetic material.

Non-viable residue: A residue that is not capable of replication or of transferring genetic material.

Pathogenicity: The ability of a micro-organism to cause disease and/or inflict damage on the host. Many pathogens cause disease by a combination of (i) toxicity and invasiveness or (ii) toxicity and colonising ability. However, some invasive pathogens cause disease that results from an abnormal reaction of the host's defence system.

Symbiosis: A type of interaction between organisms where one organism lives in intimate association with another, which is favourable for both organisms.

Viable micro-organism: A micro-organism that is capable of replication or of transferring genetic material.

Viable residue: A residue that is capable of replication or of transferring genetic material.

Viroid: Any of a class of infectious agents consisting of a small strand of RNA not associated with any protein. The RNA does not code for proteins and is not translated; it is replicated by host cell enzymes. Viroids are known to cause several plant diseases.

Virulence: Measurement of the degree of disease producing ability of a micro-organism as indicated by the severity of the disease produced. Measure of the dosage (inoculum size) required to cause a specific degree of pathogenicity. It is measured experimentally by the median lethal dose (LD₅₀) or median infective dose (ID₅₀).

(1)

OJ L 106, 17.4.2001, p. 1. Directive as last amended by Regulation (EC) No 1830/2003 (OJ L 268, 18.10.2003, p. 24).