1.4. Specification of the material used for manufacturing of formulated products U.K.
1.4.1. Content of the micro-organism U.K.
The minimum and maximum content of the micro-organism in the material used for manufacturing of formulated products, must be reported. The content shall be expressed in appropriate terms, such as number of active units per volume or weight or any other manner that is relevant to the micro-organism.
Where the information provided relates to a pilot plant production system, the information required must again be provided to the Commission and the Member States once industrial scale production methods and procedures have stabilised, if production changes result in a changed specification of purity.
1.4.2. Identity and content of impurities, additives, contaminating micro-organisms U.K.
It is desirable to have a plant protection product without contaminants (including contaminating micro-organisms), if possible. The level and nature of acceptable contaminants shall be judged from a risk assessment point of view, by the competent authority.
If possible and appropriate, the identity and maximum content of all contaminating micro-organisms, expressed in the appropriate unit, must be reported. The information on identity must be provided where possible as outlined in point 1.3 of Part B of this Annex.
Relevant metabolites (i.e. if expected to be of concern to human health and/or the environment) known to be formed by the micro-organism shall be identified and characterised at different states or growth stages of the micro-organism (see point (viii) of this introduction).
Where relevant detailed information on all components such as condensates, culture medium, etc. must be provided.
In the case of chemical impurities that are relevant for human health and/or the environment, the identity and maximum content, expressed in appropriate terms, must be provided.
In the case of additives, the identity and content in g/kg must be provided.
The information on identity of chemical substances such as additives must be provided as outlined in point 1.10 of Part A of this Annex.
1.4.3. Analytical profile of batches U.K.
Where relevant, the same data as outlined in point 1.11 of Part A of this Annex have to be reported, using the appropriate units.