REGISTRATION OF FEED ADDITIVES

BYSIYABONGA MBAMBO

TECHNOLOGICAL ADDITIVES‘(i) Preservatives: substances for prolonging the shelf life from micro-organism

(ii) Antioxidants: substances for prolonging shelf life protection from oxidation;

(iii) Emulsifiers: substances for maintaining a homogeneous mixture of two or more immiscible phases in feedingstuff;

(iv) Stabilizers: substances for maintaining the physico-chemical state of feedingstuff;

(v) Thickners: substances for increasing the viscosity of feedingstuffs;

(vi) Gelling agents: substances for the formation of a gel in the feedstuff;

(vii) Binders: substances which increase the tendency of particles of feeding stuffs to adhere;

(viii) Substances for the control of radionucleid contamination: substances that suppress absorption of radionucleids or promote their excretion;

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TECHNOLOGICAL ADDITIVES

(ix) Anticaking agents: substances that reduce the tendency of individual particles of a feedstuff to adhere;

(x) Acidity regulators: substances which adjust the pH of feedingstuffs;

(xi) Silage additives: substances, including enzymes or micro-organisms, intended to be incorporated into feed to improve the production of silage;

(xii) Denaturants: substances which are used for the manufacture of processed feedingstuffs in order to allow for the identification of the origin of specific food or feed materials;

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SENSORY ADDTITIVES

‘(i) Colourants; substances that add or restore colour in feedstuffs or substances which, when fed to animals, add colour to food of animal origin or substances which favourable affect the colour of ornamental fish or birds

(ii) flavouring compounds: substances which, when included in feedingstuffs increases feed smell or palatability

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NUTRITIONAL ADDITIVES

Vitamins, pro-vitamins and chemically well defined substances having similar effect;

(ii) Compounds of trace elements;

(iii) Amino acids, their salts and analogues;

(iv) Urea and its derivatives;

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ZOOTECHNICAL ADDITIVES

Digestibility enhancers: substances which, when fed to animals, increase the digestibility of the diet, through action on target feed materials;

(ii) Gut flora stabilizers: micro-organisms or other chemically defined substances, which when fed to animals, have a positive effect on the gut flora;

(iii) Substances which favourable affect the environment;

(iv) Other zootechnical additives.

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DATA REQUIRMENTS

PART 1: APPLICATION OVER VIEW

1.1 Product rational

1.2 Active substance/ substances

PART 2: CHEMISTRY AND MANUFACTURE

2.1 IDENTITY OF ADDITIVE

2.1.1 Proposed propriety name(s)

2.1.2 Type of additive according to its main function

2.1.3 Qualitative and quantitative composition (active substance, other components, impurities)

2.1.4 Physical state, particle size

2.1.5 Manufacturing process including any specific processing process

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TOXICOLOGY

PART 3 TOXICOLOGY

3.2 ACUTE TOXICITY

3.2.1 Acute inhalation toxicity

3.2.2 Skin and eye irritancy

3.3 MUTAGENICITY

3.3.1 Ames/Salmonella test

3.3.2 Chromosomal aberration test

3.4 PHARMACOKINETICS ASPECTS

3.5 SUBCHRONIC TOXICITY

3.6 CHRONIC TOXICITY/CARCINOGENICITY

3.7 REPRODUCTIVE TOXICITY

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DATA REQUIRMENTS

PART 4 METABOLISM AND TOXICOKINETICS

PART 5 RESIDUES

PART 6 REGULATORY STATUS IN OTHER COUNTRIES

PART 7 OCCUPATIONAL HEALTH AND SAFETY (MSDS)

PART 8 ENVIRONMENTAL STUDIES

PART 9 EFFICACY AND SAFETY

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EFFICACY STUDIES

9.1.1 Broiler trails

9.1.2 Layer hen trials

9.1.3 Turkey trails

9.1.4 Piglet trials

9.1.5 Fattening pig trials

9.1.6 Sow trails

9.1.7 Ruminant trials

9.1.8 Other relevant trials

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TRIALS

• Commercial trials• Scientific trials• Data association and extrapolation (General information)• In vivo and in vitro test • Alternative products (antibiotics, vitamins, etc)

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