Transcript REGISTRATION OF FEED ADDITIVES - AFMA

REGISTRATION OF FEED ADDITIVES
BY
SIYABONGA 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
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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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