- additive
means a component added to the active substance during its manufacturing, to preserve microbial stability and/or facilitate handling;
- antimicrobial agent
means any antibacterial, antiviral, antifungal, anthelmintic or antiprotozoal agent that is a substance of natural, semi-synthetic, or synthetic origin that at in vivo concentrations kills or inhibits the growth of micro-organisms by interacting with a specific target;
- colony-forming unit
(“CFU”) means a measurement unit used to estimate the number of bacterial or fungal cells in a sample, which have the ability to multiply under controlled growing conditions, with the consequence that one or more cells reproduce and multiply to form a single visible colony;
- effectiveness
means the capacity of the plant protection product to produce a positive effect regarding the desired plant protection activity;
- efficacy
means a measure concerning the overall effect of the application of a plant protection product on the agricultural system in which it is used (i.e. which includes positive effects of treatment in performing the desired plant protection activity and negative effects such as development of resistance, phytotoxicity or reduction of qualitative or quantitative yield);
- in situ production
means the production of a metabolite by the micro-organism after application of the plant protection product containing that micro-organism;
- infection
means the non-opportunistic introduction or entry of micro-organism into a susceptible host, where the micro-organism is able to reproduce to form new infective units and persist in the host, whether or not the micro-organism causes pathological effects or disease;
- infectivity
means the ability of a micro-organism to cause an infection;
- metabolite of concern
means a metabolite produced by the micro-organism under assessment, with known toxicity or known relevant antimicrobial activity, which is present in the MPCA as manufactured at levels that may present a risk to human health, animal health or the environment, and/or for which it cannot be adequately justified that in-situ production of the metabolite is not relevant for the risk assessment;
- Microbial Pest Control Agent as manufactured
(“MPCA as manufactured”) means the outcome of the manufacturing process of the micro-organism(s) intended to be used as active substance in plant protection products, consisting of the micro-organism(s) and any additives, metabolites (including metabolites of concern), chemical impurities (including relevant impurities), contaminating micro-organisms (including relevant contaminating micro-organisms) and the spent medium/rest fraction resulting from the manufacturing process or, in case of a continuous manufacturing processes where a strict separation between the manufacturing of the micro-organism(s) and the production process of the plant protection product is not possible, a non-isolated intermediate;
- non-opportunistic
means a condition under which a micro-organism exerts an infection or inflicts an injury or damage when the host is not weakened by a predisposing factor (e.g. immune system impaired by an unrelated cause);
- opportunistic infection
means an infection occurring in a host weakened by a predisposing factor (e.g. immune system impaired by an unrelated cause);
- pathogenicity
means the non-opportunistic ability of a micro-organism to inflict injury and damage to the host upon infection;
- purity
means the content of the micro-organism present in the MPCA as manufactured expressed in a relevant unit and the maximum content of substances of concern in case they are identified;
- relevant antimicrobial activity
means the antimicrobial activity caused by relevant antimicrobial agents;
- relevant antimicrobial agents
means all antimicrobial agents important for therapeutic use in humans or animals, as described in the latest available versions at the time of submission of the dossier:
- relevant contaminating micro-organism
means a pathogenic/infective micro-organism unintentionally present in the MPCA as manufactured;
- relevant impurity
means a chemical impurity that is of concern for human health, animal health or the environment;
- seed stock
means a microbial strain starter culture used to manufacture the MPCA as manufactured or the final plant protection product;
- spent medium/rest fraction
means the fraction of the MPCA as manufactured consisting of remaining or transformed starting materials, and excluding the micro-organism(s) that is the active substance, metabolites of concern, additives, relevant contaminating micro-organisms, and relevant impurities;
- starting material
means substances used in the manufacturing process of the MPCA as manufactured as substrate and/or buffering agent;
- storage stability
means the capacity of a plant protection product to maintain the initial properties and the specified content during the storage period under established storage conditions;
- strain
means a genetic variant of an organism in its taxonomic level (species) that is made up of the descendants of a single isolation in pure culture from the original matrix (e.g. the environment) and usually is made up of a succession of cultures ultimately derived from an initial single colony;
- toxicity
means the degree of injury or damage in an organism caused by a toxin or a toxic substance;
- toxin
means a substance that is produced within living cells or organisms and is able to injure or cause damage in a living organism.