Classical and augmentative biological control against ... - IOBC-WPRS

Chapter 5
(EC) No 1109/2009. Tests suggested by evaluation experts and intended to establish the genetic
stability of a strain do not reflect practical conditions, while in the case of potential microbial
contaminants no European reference list is available. The incidence of many pathogens can be
excluded by production methods or the geographic location of production sites. Tolerance limits for
contamination levels could take into consideration thresholds used in food industry, application
levels for the microbial product and naturally occurring background levels. The two issues
presented here but also other examples put forward to the Regulatory Review Team lead to the
statement that "not all the studies or tests that can be performed for microbials will necessarily
yield relevant data".
The most important experience with semiochemicals was made during the on-going reassessment
of Straight Chain Lepidopteran Pheromones (SCLPs), which were supported by an
IBMA Task Force. Regulators and evaluators were flexible in accepting a single common dossier
for all compounds notified but although an OECD guidance document recommends data waiving
for numerous SCLP requirements, the Rapporteur Member State insisted that all existing data and
study reports on all compounds be submitted on the grounds that the requirements of the directive
are superior to the guidance document recommendations. So far, the re-assessment procedure
resulted in the inclusion with postponed peer review of SCLPs as a group, but 25 substances are
also listed individually. New substances can be included in a simplified procedure provided that the
applicant has access to the existing dossier. Remaining questions include what industry input will
be required during the peer review by EFSA, the E.U. status of a revised OECD guidance document
for semiochemicals other than SCLPs, the decision if MRLs are required for sprayable SCLP
formulations, and equivalence criteria for SCLP substances. It was also noted that under the
Biocidal Product Directive, rules and fees applied to SCLPs created an economic hurdle which
resulted in the submission of a dossier for only one compound.
Extracts from plants - as long as not purified - consist of mixtures of molecules while data
requirements of directive 91/414/EEC maintained under new regulation (EC) No 1107/2009 are
basically designed for defined single substances. Thus those requirements often do not fit for
mixtures of several substances. It must be decided if the most “active” substance, the one with the
highest content in the extract or the whole extract shall be used in studies required for different
sections of a dossier i.e. for data on physical-chemical properties, metabolism, toxicology, residues,
environmental fate and behaviour, and which data shall be used in risk assessment. While the whole
extract can be recommended for use in toxicity studies, it is not convenient for residue, metabolism
or environmental studies because in practice it is generally not possible to determine the fate of all
compounds contained in an extract. Questions asked by evaluators from several Member States
after the issuing of a draft assessment report for Neem extract and its lead substance Azadirachtin A
illustrate the difficulties experienced by an applicant in the evaluation process for a botanical.
Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the
market provides for a specific status for "low risk active substances" (article 22). Many biocontrol
substances can be expected to qualify for this new category but one exclusion criterion, the half-life
in soil, may cause problems for microbial active substances unless it is clearly limited to chemicals.
A full set of data is required to gain the status of low risk active substance but products containing
them exclusively and without co-formulants of concern will benefit from reduced dossier
requirements and time lines for approval. Micro-organisms, plant extracts or other natural
substances may also meet the criteria for "Basic substances" provided for in article 23 but the
discussion in the ENDURE-Commission meeting made it clear that this category is without interest
for manufacturers who intend to market their substances for plant protection. It was noted that the
new regulation does not provide for generic waivers i.e. for justifications of non submission of data
or exemptions from requirements for groups of substances or products.
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