# Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (Text with EEA relevance), Division 2.1.3: Qualitative and quantitative composition (active substance/agent, other components, impurities, batch to batch variation)

Extent: E+W+S+N.I.

The active substance(s)/agent(s) and all other components of the additive shall be listed, giving the proportion by weight in the final product. The qualitative and quantitative batch to batch variation of the active substance(s)/agent(s) shall be determined.
For micro-organisms: the number of viable cells or spores expressed as CFU per gram shall be determined.
For enzymes: each declared (main) activity shall be described and the number of units of each activity in the final product given. Relevant side activities shall be also mentioned. The units of activity shall be defined and preferably as μmoles of product released per minute from the substrate, also indicating the pH and the temperature.
If the active component of the additive is a mixture of active substances or agents, each of which is clearly definable (qualitatively and quantitatively), the active substance(s)/agent(s) components must be described separately and the proportions in the mixture given.
Other mixtures in which the constituents cannot be described by a single chemical formula and/or where not all can be identified shall be characterised by constituent(s) contributing to its activity and/or typical major constituent(s).
Without prejudice to any request of supplementary information made by the Food Safety Authority according to Article 8(2) of Regulation (EC) No 1831/2003, the applicant may omit the description of other components with no safety concerns other than active substances or agents for additives not within the categories of zootechnical additives, coccidiostats and histomonostats, and not in the scope of Regulation (EC) No 1829/2003. In any case, all studies reported in the dossier must be based on the actual additive requested for the authorisation and may provide information on the other possible different preparations that could be made. An in-house identifier may be allowed, embedded in third-party documents, and a statement is required to list the identifiers and to confirm that the identifier(s) refers to the formulation(s) for which the request is made.

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Source: https://www.legislation.gov.uk/eur/2008/429/annex/II/division/2/division/2.1/division/2.1.3 (the official version)
Page: https://openlegislation.uk/eu-regulation-2008-429/annex-II/division-2/division-2.1/division-2.1.3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.