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Regulatory Aspects for the Drugs and Chemicals Used in Food-Producing Animals Chapter | 7  117




  VetBooks.ir  pursue if other classes of growth-promoting additives  effect; and shall be allocated to one or more of the fol-
                                                                lowing categories:
             could be licensed. Subsequently, several microorganisms
             or probiotics and an organic acid product were authorized
             for use as growth promoters. Moreover, enzymes prepara-  Technological Additives
             tions, such as glucanases, xylanases, proteases, and phy-
             tases as well as prebiotics (fructo-oligosaccharides and  Technological additives are defined as any substance
             related compounds) were granted marketing authorization  added to feed for a technological purpose and include the
             (Anado ´n et al., 2010, 2016).                     following functional groups: (1) preservatives: substances
                The individual authorizations contain the characteris-  or, when applicable, microorganisms which protect feed
             tics of the products, the identification of the authorization  against deterioration caused by microorganisms or their
             holder, the maximum, minimum, and/or recommended   metabolites; (2) antioxidants: substances prolonging the
             dosages, the animal categories in which they can be used,  storage life of feeding stuffs and feed materials by pro-
             MRL, and withdrawal periods where necessary as well as  tecting them against deteriorationcausedbyoxidation;
             specific labeling provisions and further conditions where  (3) emulsifiers: substances that make it possible to form
             necessary.                                         or maintain a homogeneous mixture of two or more
                EFSA’s FEEDAP Panel evaluates safety to the target  immiscible phases in feed stuffs; (4) stabilizers: sub-
             animal, the consumer, the user (farmer), and the environ-  stances which make it possible to maintain the physico-
             ment in addition to the efficacy in the target species. The  chemical state of feed stuffs; (5) thickeners: substances
             FEEDAP Panel carries out its work either in response to  which increase the viscosity of feed stuffs; (6) gelling
             requests for scientific advice from risk managers or on its  agents: substances that give a feed stuff texture through
             own initiative. Most commonly, and following specific  the formation of a gel; (7) binders: substances that
             authorization procedures, the European Commission asks  increase the tendency of particles of feed stuffs to
             EFSA to provide scientific advice and evaluate the safety  adhere; (8) substances for control of radionuclide con-
             and/or efficacy of a given substance in the context of its  tamination: substances that suppress absorption of radio-
             authorization for use in the EU. The scientific assessment  nuclides or promote their excretion; (9) anticaking
             performed by the panel is based on Terms of Reference  agents: substances that reduce the tendency of individual
             provided by the European Commission or other European  particles of a feed stuff to adhere; (10) acidity regula-
             bodies or determined by self-tasking. This scientific  tors: substances that adjust the pH of feed stuffs;
             assessment guides the panel approach to each question.  (11) silage additives: substances, including enzymes or
             Therefore, the authorization of an additive should be  microorganisms, intended to be incorporated into feed to
             granted by the European Commission.                improve the production of silage; (12) denaturants: sub-
                Article 5 of Regulation (EC) No. 1831/2003 (EC,  stances that, when used for the manufacture of processed
             2003) states that a feed additive: (1) shall not have an  feeding stuffs, allow the identification of the origin of
             adverse effect on animal health, human health, or the  specific food or feed materials.
             environment, (2) shall not be presented in a manner that
             may mislead the user, and (3) shall not harm the con-  Sensory Additives
             sumer by impairing the distinctive features of animal
             products, or mislead the consumer with regard to the dis-  Sensory additives are defined as any substance that
             tinctive features of animal product.               improves or changes the organoleptic properties of the
                According to the Regulation (EC) No. 1831/2003 a  feed and/or the visual characteristics of food derived from
             feed additive is a substance, microorganisms, or prepara-  animal, and include the following functional groups:
             tions, other than feed material and premixtures that is  (1) colorants: (a) substances that add or restore color in
             intentionally added to feed or water in order to perform,  feeding stuffs; (b) substances that, when fed to animals,
             in particular, one or more specific functions that are enu-  add color to food of animal origin; and (c) substances that
             merated in Article 5(3) of the Regulation (EC) No. 1831/  favorably affect the color of ornamental fish or birds; and
             2003 (EC, 2003): (1) favorably affect the characteristics  (2) flavoring compounds: substances, the inclusion of
             of feed; (2) favorably affect the characteristics of animal  which in feed stuffs increases feed smell or palatability.
             products; (3) favorably affect the color of ornamental
             fish and birds; (4) satisfy the nutritional needs of
                                                                Nutritional Additives
             animals; (5) favorably affect the environmental conse-
             quences of animal production; (6) favorably affect animal  Nutritional additives supply a specific nutrient required
             production, performance or welfare, particularly by  by the animal for optimal growth. The following func-
             affecting the gastrointestinal flora or digestibility of feed-  tional groups are included: (1) vitamins, pro-vitamins, and
             ing stuffs; or (7) have a coccidiostatic or histomonostatic  chemically well-defined substances having similar effect;
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