Commission Regulation (EU) No 544/2011 (repealed)Show full title

Introduction

(i) Active substances are defined in Article 2(2) of Regulation (EC) No 1107/2009 and include chemical substances and micro-organisms including viruses.

This Part provides data requirements for active substances consisting of micro-organisms, including viruses.

The term ‘micro-organism’ as defined in Article 3 of Regulation (EC) No 1107/2009 applies to, but is not limited to, bacteria, fungi, protozoa, viruses and viroids.

(ii) For all micro-organisms that are subject to application all available relevant knowledge and information in literature should be provided.

The most important and informative information is obtained by the characterisation and identification of a micro-organism. Such information is found in Sections 1 to 3 (identity, biological properties and further information) which form the basis for an assessment of human health and environmental effects.

Newly generated data from conventional toxicological and/or pathological experiments on laboratory animals are normally required unless the applicant can justify, on the basis of the previous information, that the use of the micro-organism, under the proposed conditions of use, does not have any harmful effects on human and animal health or on groundwater or any unacceptable influence on the environment.

(iii) Pending the acceptance of specific guidelines at international level, the information required shall be generated using available test guidelines accepted by the competent authority (e.g. USEPA guideline(1); where appropriate, test guidelines as described in Part A of this Annex should be adapted in such a way that they are appropriate for micro-organisms. Testing shall include viable and, if appropriate, non-viable micro-organisms, and a blank control.

(iv) Where testing is done, a detailed description (specification) of the material used and its impurities, in accordance with point 1.4, must be provided. The material used shall be of that specification that will be used in the manufacture of preparations to be authorised.

Where studies are conducted using micro-organisms produced in the laboratory or in a pilot plant production system, the studies must be repeated using micro-organisms as manufactured, unless it can be demonstrated that the test material used is essentially the same for the purposes of the testing and assessment.

(v) Where the micro-organism has been genetically modified, a copy of the evaluation of the data concerning the assessment of risk to the environment, as stated in Article 48 to Regulation (EC) No 1107/2009, has to be submitted.

(vi) Where relevant, data shall be analysed using appropriate statistical methods. Full details of the statistical analysis shall be reported (e.g. all point estimates shall be given with confidence intervals, exact p-values should be given rather than stating significant/non-significant).

(vii) In the case of studies in which dosing extends over a period, dosing shall preferably be done using a single batch of the micro-organism, if stability permits.

If the studies are not performed using a single batch of the micro-organism, the similarity of the different batches has to be stated.

Whenever a study implies the use of different doses, the relationship between dose and adverse effect must be reported.

(viii) If the plant protection action is known to be due to the residual effect of a toxin/metabolite or if significant residues of toxins/metabolites are to be expected not related to the effect of the active substance, a dossier for the toxin/metabolite has to be submitted in accordance with the requirements of Part A of this Annex,.

(1)

USEPA Microbial Pesticide Test Guidelines, OPPTS Series 885, February 1996.