The applicant shall identify and quantify chemical and microbial impurities, substances with toxic or other undesirable properties that are not intentionally added and do not contribute to the activity of additive. In addition, for fermentation products, the applicant shall confirm the absence of production organisms in the additive. The protocol used for the routine screening of production batches for contaminants and impurities shall be described.
All the data provided have to support the proposal for a specification of the additive.
Specific requirements depending on the production process, complying with existing Community legislation, are listed below.
For additives whose authorisation is linked to a holder of authorisation, the relevant information related to the specific process used by the manufacturer, based on existing standards used for other related purposes, shall be provided. Joint FAO/WHO Expert Committee on Food Additives (JECFA) specifications or specifications from European Community food additive authorisations can be used.
For feed additives whose authorisation is not linked to a holder of authorisation, existing standards used for other related purposes, or that have specifications for food additives as authorised in the European Community or from JECFA can be used. When such standards are not available, or where relevant to the manufacturing process, at least the following particulars shall be described and their concentrations determined:
for micro-organisms: microbiological contamination, mycotoxins, heavy metals;
for fermentation products (not containing micro-organisms as active agents): they shall follow the same requirements as for micro-organism products (see above). The extent to which spent growth medium is incorporated into the final product shall also be indicated.
for plant derived substances: microbiological and botanical contamination (e.g. castor oil plant, weed seeds, rye ergot in particular), mycotoxins, pesticide contamination, maximum values for solvents and, where appropriate, substances of toxicological concern known to occur in the original plant;
for animal derived substances: microbiological contamination, heavy metals and maximum values for solvents, where appropriate;
for mineral substances: heavy metals, dioxins and PCBs;
for products produced by chemical synthesis and processes: all chemicals used in the synthetic processes and any intermediate products remaining in the final product shall be identified and their concentrations given.
The selection of mycotoxins for analysis shall be made according to the different matrices, where appropriate.