11.1 Requirements for ingredients
Ingredients must conform with and comply to the definitions as set out in Annexure 1 of the Guidelines.
All ingredients must be marked and labeled accordingly.
11.2 Requirements for enzymes, micro-organisms and their preparations in farm feeds
(1) TERMS
Enzyme a protein made up of amino acids or their derivatives which catalyses a defined chemical reaction. Required cofactors should be considered as an integral part of the enzyme
Source organism the organism that actually produces the enzyme(s).
Enzyme substrate the material or substance which is acted upon catalytically by the enzyme.
Enzyme activity (unit of) The catalytic activity required to convert a given quantity assay substrate to a given quantity of product per unit time under the standard conditions set forth in the assay procedure.
(2) REGISTRATION REQUIREMENTS FOR ENZYMES, MICRO-ORGANISMS AND THEIR PREPARATIONS
(3) (a) The following information must be submitted:
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Identity of the product:
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Trade name.
(b) Qualitative and quantitative composition:
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active substance (1),
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other components,
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impurities,
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undesirable substances.
(c) Specifications concerning the active substance.
(4) For micro-organisms:
(a) name and taxonomic description according to an international code of nomenclature.
(b) the number of colony-forming units (CFU/g).
(5) For enzymes:
(a) name according to main enzymatic activities – refer to Table A.
(b) relevant activities with regard to appropriate types of chemically pure substrates (expressed in activity unites (4) per g).
NB: If the active substance is a mixture of active components, all the components must be described separately with an indication of their proportion in the mixture.
(6) Properties of the product:
Main effect:
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information concerning effectiveness,
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justification for the presence of each component if the substance is a mixture of active components.
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Other effects:
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Product safety.
11.3 Conditions for the use of product:
Uses provided for in animal nutrition (species or categories of animal, type of feeding stuffs, period of use, etc).
Proposed dosage in premixes and feeding stuffs (appropriate units of biological activity such as CFU per gram of product for micro-organisms or activity units per gram for enzyme preparations.
Other known uses of the active substance or the preparation (in foodstuffs, human or veterinary medicine, industry etc).
Recommendations concerning product safety in relation to targeted species, the consumer and the environment.
If necessary, measures for the prevention of risks and means of protection during manufacture and use.
(1) Technical information:
(a) Stability of the product:
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with regard to atmospheric agents,
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during the preparation of premixes and feeding stuffs,
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during the storage of premixes and feeding stuffs,
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description of the process of manufacture and methods used concerning the control of the quality of the product during its manufacture.
(b) Control:
Method(s) of analysis for determining the active component(s) in:
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the product itself,
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premixes,
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feedingstuffs.
11.4 Labelling requirements for enzymes, micro-organisms and their preparations
Enzymes, micro-organisms and their preparations, as well as premixtures and complete feeds in which they have been incorporated, may be marketed only if the particulars listed below, which must be clearly visible, legible and indelible are shown on the packaging, the container or on a label attached thereto:
(1) For enzymes and their preparations:
(a) the specific name of the active constituent(s) according to their enzymatic activity(ies);
(b) the activity units (activity units per g or activity units per ml);
(c) the name and the address of the registration holder;
(d) the registration number reflected as Reg No. ……. Act No. 36 of 1947;
(e) the expiry date of the guarantee or the storage life from the date of manufacture;
(f) the batch reference number and the date of manufacture;
(g) directions for use and where appropriate, a safety recommendation;
(h) the net mass and for liquid additives either the net volume or the net mass.
(2) For micro-organisms and their preparations:
(a) the identifications of the strain(s);
(b) the number of colony-forming units (CFU/g);
(c) the name and address of the registration holder;
(d) the expiry date of the guarantee or the storage life from the date of manufacture;
(e) the batch reference number and the date of manufacture;
(f) the directions for use and, where appropriate, a safety recommendation;
(g) the net mass and for liquid additives either the net volume or the net mass;
(h) where appropriate, indication of any particular significant characteristics due to the manufacturing process.
TABLE A Enzymes/Source organisms acceptable for use in farm feeds
In the case of microbial enzymes it is understood that they are produced from non-pathogenic and non-toxigenic strains
Classification/
Name
|
Source organism
|
Typical substrate 1
|
Function
|
Current supported use
|
Carbohydrases
|
alpha-amylase
|
Animal pancreatic tissue
Aspergillus niger, var.
Aspergillus oryzae, var.
Bacillus amyloliquefaciens
Bacillus lentus
Bacillus licheniformis
Bacillus licheniformis containing a Bacillus
stearothermophilus gene for alpha-amylase
Bacillus stearothermophilus
Bacillus subtilis containing a Bacillus
megaterium gene for alpha-amylase
Bacillus subtilis containing a Bacillus
stearothermophilus gene for alpha-Amylase
Bacillus subtilis, var.
Barley malt
Rhizopus niveus
Rhizopus oryzae, var.
|
corn silage, corn, corn feed meal,
corn gluten feed, soya-bean meal, wheat, wheat middlings, wheat feed meal, barley, grain sorghum, pea, oat, tapioca, millet, rice, rice feed meal
|
hydrolyses starch
|
|
Maltogenic alpha-
amylase
|
Bacillus subtilis containing a Bacillus
stearothermophilus gene for maltogenic
alpha-amylase
|
see alpha-amylase
|
hydrolyses starch with
production of maltose
|
|
beta-amylase
|
Barley malt
|
see alpha-amylase
|
hydrolyses starch with
production of maltose
|
|
Cellulase
|
Aspergillus niger, var.
Humicola insolens
Trichoderma longibrachiatum (formerly reesei)
|
corn, barley, wheat, wheat bran,
rye, grain sorghum
|
breaks down cellulose
|
|
Alpha-galactosidase
|
Aspergillus niger, var.
Morteirella vinaceae var. raffinoseutilizer
Saccharomyces sp.
|
sweet lupin, soya-bean meal
|
hydrolyses oligosaccharides
|
|
Beta-glucanase
|
Aspergillus niger, vat.
Bacillus lentus
Bacillus subtilis, var.
Humicola insolens
Penicillium funiculosum
Trichoderma longibrachiatum (formerly
reesei)
|
wheat, barley, canola meal,
wheat byproduct, oat groats, rye,
triticale, grain sorghum
|
hydrolysis of B-glucans, a
type of non-starch polysac-
charide
|
reduction of digesta
viscosity with barley-based
poultry diets, reduces
soluble non-starch
polysaccharides in digesta
|
Beta-glucosidase
|
Aspergillus niger, var.
|
plant cell wall constituents
|
hydrolyses cellulose
degradation products to
glucose
|
|
Glucoamylase
(Amyloglucosidase)
|
Aspergillus niger, var.
Aspergillus oryzae, var.
Rhyzopus niveus
Rhizopus oryzae, var.
|
see alpha-amylase
|
hydrolyses starch with
production of glucose
|
|
Hemicellulase
|
Aspergillus aculeatus
Aspergillus niger, var.
Bacillus lentus
Bacillus subtilis, var.
Humicola insolens
Trichoderma longibrachiatum (formerly
reesei)
|
corn, soya-bean meal, guar meal,
barley, rye, grain sorghum,
wheat, oats, peas, lentils
|
breaks down
hemicellulose
|
reduction in stickiness of
excreta in poultry fed
guar meal
|
Invertase
|
Aspergillus niger, var.
Saccharomyces sp.
|
sucrose containing
products and by-products
|
hydrolyses sucrose to
glucose and fructose
|
|
Lactase
|
Aspergillus niger, var.
Aspergillus oryzae, var.
Candida pseudotropicalis
Kluyveromyces marxianis var. lactis (formerly
Saccharomyces sp.)
|
lactose containing
products and
by-products
|
hydrolyses lactose to
glucose and galactose
|
|
Beta-mannanase
|
Aspergilus niger, var.
Bacillus lentus
Trichoderma longibrachiatum (formerly
reesei)
|
corn, soya-bean meal, guar meal,
copra meal
|
hydrolyses B-mannans, a
component of hemicellulose
|
reduction in stickiness of
excreta in poultry fed guar
meal
|
Pectinase
|
Aspergillus aculeatus
Aspergillus niger, var.
Rhizopus oryzae
|
corn, wheat
|
breaks down pectin
|
|
Pullulanase
|
Bacillus acidopullulyticus
Bacillus licheniformis containing a Bacillus
Deramificans gene for pullulanase
|
see alpha-amylase
|
hydrolyses starch
|
|
Xylanase
|
Aspergillus niger, var.
Bacillus lentus
Bacillus subtilis, var.
Humicola insolens
Penicillium funiculosum
Trichoderma longibrachiatum (formerly
reesei)
|
corn, barley, rye, wheat, grain
sorghum, triticale, oats
|
hydrolyses xylans, a compo-
nent of hemicellulose
|
reduction of digesta
viscosity with poultry
diets
|
Lipases
|
Lipase
|
Animal pancreatic tissue
Aspergillus niger, var.
Aspergillus oryzae, var.
Candida rugosa (formerly cylindracea)
Edible forestomach of calves, kids, and lambs Rhizopus oryzae
|
plant and animal sources
of fats and oils
|
hydrolyses triglycerides
|
|
Protcases
|
Bromelain
|
Pineapples – stem, fruit
|
plant and animal proteins
|
hydrolyses proteins
|
|
Ficin
|
Figs
|
plant and animal proteins
|
hydrolyses proteins
|
|
Papain
|
Papaya
|
plant and animal proteins
|
hydrolyses proteins
|
|
Pepsin
|
Procine or other animal stomachs
|
plant and animal proteins
|
hydrolyses proteins
|
|
Protease (general)
|
Asperigillus niger, var.
Aspergillus oryzae, var.
Bacillus amyloliquefaciens
Bacillus licheniformis
Bacillus subtilis, var.
Bacillus subtilis containing a Bacillus
amyloliquefaciens gene for protease
|
plant and animal proteins
plant proteins
|
hydrolyses proteins
|
|
Trypsin
|
Animal pancreas
|
plant and animal proteins
|
hydrolyses proteins
|
|
Oxidoreductases
|
Catalase
|
Aspergillus niger, var.
Micrococcus lysodeikticus
|
hydrogen peroxide
|
produces water and
oxygen from hydrogen
peroxide
|
|
Glucose oxidase
|
Aspergillus niger, var.
|
glucose
|
degrades glucose to
hydrogen peroxide and
gluconic acid
|
|
Phosphatases
|
Phytase
|
Aspergillus niger, var.
Aspergillus oryzae, var.
|
corn, soya-bean meal
meal, hominy, tapioca, plant
by-products
sunflower
|
hydrolyses phytate
|
increases the digestibility
of phytin-bound phospho-
rus in pig and poultry diets.
|
1This list is to provide guidance and is not all inclusive.
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