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AUSTRALIAN PESTICIDES AND VETERINARY
MEDICINES AUTHORITY
GUIDELINES FOR THE REGISTRATION OF ENZYME BASED PRODUCTS
USED IN STOCK FEEDS
Release date: 8 June 2001
Guideline Number: 10
APVMA
PO Box E240
Kingston ACT 2604
Australia
Phone: +61 (0)2 6272 3744
Fax: +61 (0)2 6272 5249
Email: [email protected]
http://www.apvmagov.au
Guidelines for the Registration of Enzyme Based Products Used in Stock Feeds
INTRODUCTION
In an effort to achieve greater consistency in the review procedures for animal feed
enzymes, this preamble sets out some relevant issues. An outline is also given of the
information which must be presented for evaluation of enzymes used in animal feeds.
What are enzymes?
Enzymes are natural substances produced by all living cells. All living organisms
depend on enzymes to carry out energy-releasing reactions, to synthesize the building
blocks of cells and to conduct virtually all other physiological processes.
Enzymes are high-molecular weight proteins composed of amino acids. They may
also contain non-protein parts such as carbohydrates, lipids, phosphate groups and
metals.
The enzymes that are used in human and animal feeds or in the food processing
industry may be of plant, animal or microbial origin.
What do enzymes do?
Enzymes are able to accelerate the rate of specific chemical reactions but do not
themselves undergo any chemical change.
Enzymes are specific in their catalytic properties
Firstly, each enzyme acts on a restricted number of compounds (substrates). In many
cases it is active on only one compound.
Secondly, an enzyme when acting on its substrate, catalyses only one specific type of
reaction, for instance, enzymes can break down complex molecules into smaller units,
catalyse structural changes within one molecule or join the substrate molecules to
other specific molecules.
Some enzymes are not capable of acting alone but require the presence of a lowmolecular weight component called a co-factor. The most common co-factors are
metal-ions and nucleotides.
The specificity and catalytic activity of a particular enzyme is due to the molecular
structure and three-dimensional shape of the enzyme molecule. The sequence of the
different amino acids makes up the primary structure of the enzyme molecule.
The characterisation and nomenclature of enzymes are based on the specific substrate
and the type of reaction catalysed, and not on their molecular composition.
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Guidelines for the Registration of Enzyme Based Products Used in Stock Feeds
Production of microbial enzymes
For the microbial sourced enzymes pure cultures of selected strains of microorganisms are used to produce specific enzymes. During fermentation, these microorganisms are grown on natural substances such as starch and molasses. The use of
pure cultures of selected strains excludes the effects of competing micro-organisms
and ensures consistency in the performance of the process and the quality of the
product.
In the recovery process the enzymes are separated from the fermentation broth.
However the final enzyme preparation may still contain small amounts of
fermentation residues. Standardisation of the main enzymatic activity must then be
achieved by the addition of appropriate food grade materials.
Safety Considerations
The safety of animal feed enzymes can be evaluated at three different levels:
•
•
•
potential risk to the environment in which the micro-organisms and/or their
products are released,
possible health hazard for the staff working with the product,
safety of use on the target animals.
Since enzymes are readily biodegradable, their environmental release should not
cause any environmental problems. Furthermore the containment of the production
organism itself is controlled by the physical nature of the fermentation system and by
the recovery plant meeting a high standard. Biological containment is ensured by the
production organisms having been adapted to grow only under defined fermentation
conditions.
Some occupational health risks may arise from the handling of enzyme preparations.
Enzyme dusts may lead to respiratory allergies in susceptible individuals while certain
proteases may cause irritation to the skin, eyes or mucous membranes. These risks
can be avoided by protective measures and the use of specific formulations of the
enzyme preparations.
To ensure safety to target animals the microbial enzymes must be obtained from nonpathogenic and non-toxicogenic micro-organisms grown on raw materials which do
not contain components that might be hazardous to human health. Target animal
safety must also be demonstrated in animal feeding trials.
Whenever a new strain with improved enzyme production capabilities is developed or
when production conditions are altered the possible impact on safety must be
carefully considered.
Each new strain must be checked for its key taxonomic characteristics. If the
production strain contains recombinant DNA consultation with and approval by the
Office of Gene Technology Regulator (OGTR) is an additional requirement.
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Guidelines for the Registration of Enzyme Based Products Used in Stock Feeds
The characteristics and safety record of each of the strains contributing genetic
information to the production strain must be carefully assessed and appropriate safety
tests performed.
The safety of the final enzyme preparations is ensured by compliance with "Good
Manufacturing Practice" (GMP). The purity of the preparations is checked for the
level of contaminating micro-organisms and for absence of heavy metals, mycotoxins
and antibacterial activity. Refer Section 2.3 and Appendix 3.
Finally, since enzymes are always used at very low dosage levels in animal feeds and
will be digested in the animals gut, no tissue residues will result. It can therefore be
concluded that the enzymes do not in themselves present any hazard to human health.
Consequently an Acceptable Daily Intake (ADI) for enzymes is generally not
considered necessary.
SUMMARY OF REGULATORY REQUIREMENTS
The following information and documentation must be provided:
1.
IDENTITY OF END-USE PRODUCT
1.1
Trade name
1.2
Qualitative and Quantitative composition
•
•
•
•
each principal active substance(s)
other components including incidental enzyme(s)
any impurities and undesirable substance(s)
typical composition of the commercial enzyme preparation including the
content of proteins, carbohydrates, fats, ash, water and diluents identity of
stabilisers, preservatives and any other formulating agents; these substances
should be compatible with the intended use of the enzyme preparation.
1.3
Name and address of manufacturer(s) of enzyme(s).
1.4
Name and address of manufacturer of final end use product(s).
1.5
Name and address of distributor/agent of final end use product(s).
2
IDENTITY AND BIOLOGICAL SOURCE OF COMPONENT
ENZYMES
2.1
Enzyme production strain(s)
The taxonomy of the micro-organism should be precisely defined and the literature
reviewed for reports of use in human or animal food as well as any toxicogenicity and
pathogenicity associated with the species.
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The names of the micro-organisms are those recommended in Bergey's Manual of
Determinative Bacteriology (8th edition Baltimore Press, 1974), "The Genus
Aspergillus" (Raper and Fennel, Baltimore Press, 1965) and "The Yeasts: a
taxonomic study" (Lodder and Kreger van Raj, Delft, 1970).
Where new production strains are obtained by classical mutation-selection or genetic
engineering methods, a description of the origin of the strain should be included. For
recombinant DNA organisms, the donor organism, vector system, inserted gene as
well as the host organism should be described.
2.2
Classification of the enzyme
The main enzyme activity with corresponding EC, IUB and CAS numbers should be
declared. The activity of the commercial enzyme preparation should be standardised
and may be expressed in international or manufacturer's units.
The names of the enzymes are those recommended in Enzyme Nomenclature,
Recommendations of the Nomenclature Committee of the International Union of
Biochemistry (Academic Press, 1984).
2.3
Specifications of the enzyme preparation
Physical, chemical and microbial specifications including purity and potency of the
enzyme product must be presented. The requirements correspond with those given by
the FAO/WHO Joint Expert Committee for Food Additives (JECFA) and Food
Chemicals Codex (FCC), including, where appropriate, the General Considerations
and Specifications for Enzymes from Genetically Manipulated Organisms. . The
following limits for contaminants have been set:
•
•
•
•
•
•
•
•
•
Arsenic
Lead
Heavy metals
Mycotoxins (fungal enzymes
only)
Antibiotic activity
Coliforms
Escherichia coli
Salmonella
Total viable count
not more than 3 ppm
not more than 10 ppm
not more than 40 ppm
negative by test
negative by test
not more than 30 per gram
negative in 25 gram
negative in 25 gram
not more than 500 000 per gram
Analytical methods must be defined.
The activity of each enzyme with regard to appropriate types of substrates, shall be
expressed as µmole of product released per minute per gram of the chemically pure
enzyme. Optimum pH, moisture, temperature (and other appropriate properties) must
be stated.
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Guidelines for the Registration of Enzyme Based Products Used in Stock Feeds
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.
2.4
Approved Enzymes
The Australia and New Zealand Food Authority (ANZFA), JECFA and USFDA have
developed lists of microbial enzymes and source micro-organisms that are "generally
regarded as safe" (GRAS). Such lists are published from time to time. ANZFA have
published a list of approved enzymes and approved source organisms in the
Australian Food Standards Code. The list appended to this document is constructed
from lists published by ANZFA and includes those enzymes and source organisms
approved for use up to June 2001. (Refer to Appendix 1). For the most up-to-date list
of enzymes please refer to the Australian Food Standards Code on the ANZFA
website (http://www.anzfa.gov.au)
Wherever ANZFA, JECFA or USFDA have approved a food enzyme that is to be
used as an animal food additive a minimal technical review of that enzyme will be
required by the APVMA. However for any enzyme that has not previously been
evaluated a more extensive review will be required. This may involve separate
evaluations by the Therapeutic Goods Administration (TGA), National Occupational
Health and Safety Commission (NOHSC), Office of Gene Technology Regulator
(OGTR) and Environment Australia (EA).
Where enzymes or enzyme based foodstuffs are imported there will also be a
requirement that the Australian Quarantine Inspection Service (AQIS) have separately
approved the importation of biologically derived materials (Refer Section 8).
3.
JUSTIFICATION FOR USE OF PRODUCT
The main enzymatic effects should be described indicating the likely benefit to result
from the use of the enzyme preparation when fed in conjunction with specific feed
substrates. Such substrates must be relevant to Australian feeding practices.
Where the preparation is a mixture of effective components a justification for
inclusion of each component must be provided.
Where any other effects are known, or could be reasonably anticipated, these should
be identified and discussed.
Other known uses of the active substance or the preparation (in human or animal
foodstuffs, human or veterinary medicine, food processing industry etc.) should be
stated.
4.
DIRECTIONS FOR USE OF PRODUCT
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The particular uses in animal nutrition (species or classes of animal, type of feeding
stuffs, period of use, etc.) must be specified. See Section 7 for specific requirements
relating to efficacy claims.
The proposed dosage in premixes and feeding stuffs expressed in appropriate units of
biological activity such as activity units per gram.
5.
TECHNICAL CONSIDERATIONS
5.1
Stability of product
•
•
•
effects of physical and chemical agents during production
during the preparation of premixes and feeding stuffs
within the end-use product packaging during storage.
5.2
Manufacturing processes and quality control
•
description of the process of manufacture and methods used to control the
quality of the product during manufacture,
identity and purity of the raw materials. Principles in the manufacturing
procedure, including the operations applied in recovery, should also be
described,
control procedures ensuring pure culture conditions and chemical and micro
biological purity should also be described,
micro biological control procedures will be expected to conform to Good
Manufacturing Practice.
•
•
•
5.3
Assay methods for component enzymes
Analytical methods for the determination of each enzyme present in premixes and
final feed stuffs must be provided. Literature references may suffice.
6.
TARGET ANIMAL SAFETY AND OCCUPATIONAL HEALTH
•
Where the component enzyme(s) have not been approved by ANZFA and/or
JECFA and/or USFDA evidence of non-toxicogenicity of the enzyme
preparations must be provided by extensive animal feeding trials.
•
Evidence of the non-pathogenicity of the production strain should be provided
either be literature search or by actual experiments.
•
Recommendations concerning potential hazards and protection from
occupational exposure during manufacture and handling.
•
The information required for the safety evaluation of immobilised enzyme
preparations will not differ substantially from the above, except that a detailed
description of the immobilisation system will be essential. Here tests for
physical and chemical stability of the carrier, immobilisation agent and the
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Guidelines for the Registration of Enzyme Based Products Used in Stock Feeds
enzyme will be the key to the safety assessment. For systems where no
leakage of carrier, immobilisation agent or enzyme can be demonstrated in
validated assays, toxicological tests will not be necessary.
7.
EFFICACY CONSIDERATIONS
A two tiered structure of clearance/registration is envisaged.
(a)
Where non-specific or generic claims are made
Such claims shall be restricted to "to increase the digestibility of certain feeds [e.g.
barley/oats/wheat based diets] fed to specific animals [e.g. pigs/poultry including,
where relevant, specific classes of those animals]". The types of diets must be
relevant to Australian conditions and evidence provided from local and/or overseas
trials that "increased digestibility" of these diets will result from the use of that
particular enzyme(s).
In this situation the information required relates only to the identity and specifications
of the ingredient(s) and end use product as specified above i.e. identity, purity and
potency and freedom from extraneous organisms, antibiotic activity or mycotoxins
and heavy metal contaminants. No Australian efficacy data will be required here.
(b)
Where specific efficacy claims are made
Such claims might include improved Feed Conversion Efficiency (FCE) or specific
productivity gains in target animals.
Where such claims are made, detailed efficacy studies, in support of those claims,
must be provided. A significant component of Australian field trials is a requirement.
It is however recognised that overseas data might comprise the bulk of the data
submitted.
8.
APPROVAL TO IMPORT BIOLOGICALLY ACTIVE SUBSTANCES
Where the final end-use product or any component enzymes are imported it will be an
absolute requirement that the applicant holds a current Australian Quarantine
Inspection Service (AQIS) import permit. A copy of the AQIS certificate should be
provided at the time of any Application for Clearance by the APVMA.
Implicit in the issue of the AQIS certificate will be that the product conforms to the
above specifications in terms of identity, purity and potency and that the products are
free from extraneous organisms, antibiotic activity or mycotoxin contaminants. It is
considered that the evidence provided and accepted by AQIS, at the time of their
issuing an importation permit, shall be acceptable to the APVMA.
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Guidelines for the Registration of Enzyme Based Products Used in Stock Feeds
9.
INTERIM OFFICE OF GENE TECHNOLOGY (IGOT) APPROVAL
If the production strain contains recombinant DNA, a separate application to the
IOGT is a requirement. In addition, the donor organism, vector system, inserted gene
as well as the host organism should be described.
10.
OTHER APPROVALS
Whenever it is proposed that a ANZFA-, JECFA- or USFDA- approved food enzyme
is to be used as an animal feed enzyme minimal technical review by the APVMA will
be required. However for any new enzyme that has not previously been evaluated by
ANZFA and/or APVMA will require a more extensive review. This may involve
separate evaluations by the Therapeutic Goods Administration (TGA), the Office of
the Gene Technology Regulator (OGTR), Environment Australia (EA) and National
Occupational Health and Safety Commission (NOHSC).
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Guidelines for the Registration of Enzyme Based Products Used in Stock Feeds
APPENDIX 1
Enzymes approved for use by ANZFA as Food Processing Aids – for the most
up-to-date list of enzymes approved for use by ANZFA please see the Food Standards
Code available from the ANZFA website (http://www.anzfa.gov.au)
GROUP 1 - Animal Origin
Enzyme
Source
α-Amylase (EC 3.2.1.1)
Porcine pancreas
Lipase (EC 3.1.1.3)
Bovine stomach; Salivary glands or forestomach of calf, kid or
lamb; hog or bovine pancreas
Pepsin (EC 3.4.23.1)
Bovine stomach; Hog stomach
Phospholipase A2
(EC 3.1.1.4)
Porcine pancreas
Rennet (crude rennin)
(EC 3.4.23.4)
Bovine, calf, goat, kid, sheep or lamb stomach
Trypsin (EC 3.4.21.4)
Porcine or bovine pancreas
GROUP 2 - Plant Origin
Enzyme
β-Amlyase (EC 3.2.1.2)
Source
Sweet potato (Ipomoea batatas)
Bromelain (EC 3.4.22.4)
Pineapple stem (Ananas Comosus)
Malt carbohydrases
(α-Amylase & β-Amylase combined
(EC 3.2.1.1 & EC 3.2.1.2)
Malted barley and barley
Ficin (EC 3.4.22.3)
Ficus sp
Papain (EC 3.4.22.2)
Carica papaya
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Guidelines for the Registration of Enzyme Based Products Used in Stock Feeds
GROUP 3 - Microbial Origin
Enzyme
Sources
α- Acetolactate decarboxylase (EC 4.1.1.5)
Bacillus subtilis1,3
Aminopeptidase (EC 3.4.11.1)
Lactococcus lactis
α-Amylase
(EC 3.2.1.1)
Aspergillus niger2
Aspergillus oryzae
Bacillus licheniformis4
Bacillus subtilis3,4
β- Amylase (EC 3.2.1.2)
Bacillus subtilis3
Arabinase (EC 3.2.1.99)
Aspergillus niger2
Carboxyl proteinase
(EC 3.4.23.6)
Aspergillus melleus
Aspergillus niger2
Aspergillus oryzae
Bacillus lentus
Bacillus subtilis
Catalase
(EC 1.11.1.6)
Aspergillus niger2
Micrococcus lysodeikticus
Cellulase multicomponent enzyme
(EC 3.2.1.4)
Aspergillus niger2
Trichoderma reesii6
Dextranase
(EC 3.2.1.11)
Chaetomium gracile
Penicillium lilacinum
Esterase
(EC 3.1.1.1)
Rhizomucor meihei5
Fructosyl transferase Arabino-furanosidase
(EC 3.2.1.55)
Aspergillus niger2
α-Galactosidase
(EC 3.2.1.22)
Aspergillus niger2
β-Glucanase
(EC 3.2.1.6)
Bacillus subtilis3
Aspergillus niger2
Penicillium emersonii
Trichoderma harzianum
Trichoderma reesii6
Aspergillus oryzae
Disporotrichum dimorphosphorum
Humicola insolens
Glucoamylase
(EC 3.2.1.3)
Aspergillus niger2
Aspergillus oryzae
Rhizopus niveus
β-Glucosidase (EC 1.1.3.4)
Aspergillus niger2
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Guidelines for the Registration of Enzyme Based Products Used in Stock Feeds
Glucose isomerase (xylose isomerase)
(EC 5.3.1.5)
Bacillus coagulans
Actinoplanes missouriensis
Streptomyces murinus or
Streptomyces rubiginosus
Microbacterium arborecens
Glucose oxidase
(EC 1.1.3.4)
Aspergillus niger2
Hemicellulase (Multicomponent enzyme identified by
EC 3.2.1.78)
Aspergillus niger2
Bacillus subtilis3
Trichoderma reesii6
Hemicellulase endo-1,3-β-D xylanase
(EC3.2.1.32)
Humicola insolens
Hemicellulase endo-1,4-β-D xylanase
(EC 3.2.1.8)
Humicola insolens
Trichoderma reesii6
Hesperidinase
(EC 3.2.1.21/EC 3.2.1.43)
Aspergillus niger2
Invertase
(EC 3.2.1.25)
Saccharomyces cerevisiae
Saccharomyces cerevisiae var carlsbergensis
Inulinase (EC 3.2.1.7)
Aspergillus niger2
Lactase (β-Galactosidase)
(EC 3.2.1.23)
Saccharomyces fragilis7
Saccharomyces lactis8
Aspergillus niger2
Aspergillus oryzae
Lipase
(EC 3.1.1.3)
Aspergillus niger2
Aspergillus oryzae9
Candida antarctica
Rhizomucor miehei5
Rhizopus arrhizus
Maltase (α-glucosidase)
(EC 3.2.1.20)
Aspergillus oryzae
Metalloproteinase
(EC 3.4.24.4)
Aspergillus oryzae
Bacillus subtilis3
Bacillus coagulans
Naringinase
(EC 3.2.1.21/EC 3.2.1.40)
Aspergillus niger2
Pectinase (multicomponent enzyme)
(EC 3.2.1.15)
Aspergillus niger2
Aspergillus oryzae
Trichoderma reesii6
Pentosanase (multicomponent enzyme)
Humicola insolens
Phytase (EC 3.1.3.8)
Aspergillus niger2
Pullulanase
Bacillus acidopullulyticus
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Guidelines for the Registration of Enzyme Based Products Used in Stock Feeds
(EC 3.2.1.41)
Bacillus subtilis3
Klebsiella aerogenes
Renin (chymosin)
(EC 3.4.23.4)
Rhizomucor meiheih
Mucor pusillus
Endothia parasitica
Serine proteinase
(EC 3.4.21.14)
Bacillus licheniformis
1
α-Acetolactate decarboxylase is produced by a genetically manipulated strain
of Bacillus subtilis containing the gene for α- Acetolactate decarboxylase
isolated form Bacillus brevis and inserted by plasmid pUW235
2
The Apergillus niger group covers strains known under the names Aspergillus
aculeatusa, A.awamori, A. ficum, A.foetidus, A.japonicus, A. phoenicis, A.
saitor, and A. usamii.
3
Bacillus subtilis also known as Bacillus amayloliquefaciens
4
α- amylase may be produced from:
(i) a genetically manipulated strain of Bacillus licheniformis containing the
gene for α-amylase isolated from Bacillus stearothermophilus and inserted by
plasmid pPL1117,or
(ii) a genetically manipulated strain of Bacillus subtilis containing the gene for
α-amylase isolated from Bacillus stearothermophilus and inserted by plasmid
pDN1413.
5
Mucor miehi is the former name for Rhizomucor miehei
6
Trichoderma reesii is also known as Trichoderma longibrachiatum and
Trichoderma viride
7
Saccharomyces fragilis is also known as Kluyveromyces fragilis
8
Saccharomyces lactis is also known as Kluyveromyces lactis
9
Lipase may be produced from a genetically manipulated strain of Aspergillus
oryzae containing the gene for lipase isolated from Humicola lanuginosa and
inserted by plasmids pBoe1960 and p3SR2
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Guidelines for the Registration of Enzyme Based Products Used in Stock Feeds
APPENDIX 3
Good Manufacturing Practice in microbial food enzyme production
General
Good Manufacturing Practice in the microbial food enzyme industry ensures that
enzyme preparations are produced, packed and handled in a hygienic way.
All operations are designed to avoid contamination, formation of undesirable byproducts, deterioration and handling errors.
The principles of GMP include systems of quality control and quality assurance,
employee qualifications, maintenance standards for equipment, control of raw
materials and product stability.
The key issues in GMP are the microbiological control of the micro-organism selected
for enzyme production, the control and monitoring systems ensuring pure culture and
optimum enzyme productivity conditions during fermentation and control of the
hygienic conditions throughout recovery and finishing of the enzyme preparations.
Identity control and laboratory management of the production strain
When a micro-organism has been selected for enzyme production, its taxonomic
identity is checked. The master culture is kept as spores, on slants or as a dried
preparation and stored at temperatures , sufficiently low to avoid degeneration and
secure genetic stability. All vials or-slants for seed cultures are clearly labelled and in
revival of the culture, strict aseptic techniques are applied. The seed culture is also
checked for identity by morphological characterization and comparison with the
taxonomic characteristics originally identified. Its purity is checked before transfer to
the fermentation equipment by serial dilutions, plating and macroscopic and
microscopic inspection for any foreign micro-organisms.
Control of pure culture and operational parameters during fermentation
Prior to fermentation the growth medium, consisting of a mixture of food or feed
grade quality substances, is sterilized and, in the case of submerged fermentation’s, it
is checked for sterility. Contamination during fermentation is prevented by the use of
a large inoculum, carefully controlled optimum growth conditions for the production
strain, overpressure in fermentation vessel, appropriate foam control in submerged
fermentation and the use of sterile air.
The culture liquid from submerged fermentation is sampled at regular intervals
throughout processing and inspected by microscopy. To ensure sterility, incubated
plates are checked for the presence of foreign micro-organisms.
In semi-solid surface fermentation, sterility control is restricted to visual inspection.
If a significant contamination develops, the batch is rejected from further food grade
processing. Enzyme activity and operational parameters like temperature, pH and
oxygen content are monitored during fermentation and kept within predetermined.
ranges based on experience. Deviations from these ranges may indicate a
contamination before it can be detected in microbial assays
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Guidelines for the Registration of Enzyme Based Products Used in Stock Feeds
Hygienic control during enzyme recovery
GMP will ensure that contamination of the product during recovery is minimized.
Hygienic conditions are assured by careful cleaning of equipment. Samples from
down-stream processing are analyzed for the level of contamination and the finished
enzyme preparation is analyzed for total viable counts, as well as for pathogenic
micro-organisms. The final product has to meet the criteria formulated by the
WHO/FAO Joint Experts Committee on Food Additives (JECFA) and the Food
Chemicals Codex (FCC), including, where appropriate, the General Considerations
and Specifications for Enzymes from Genetically Manipulated Organisms.
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Guidelines for the Registration of Enzyme Based Products Used in Stock Feeds
ATTACHMENT
ENZYME BASED PRODUCTS USED IN ANIMAL FEEDS
CLEARANCE/REGISTRATION PROCESS
AQIS
EXISTING ENZYME
WITH PRIOR
APPROVALS
FOR USE IN FOOD
(ANZFA, JECFA, FDA)
IDENTITY
EFFICACY
SPECIFIC CLAIMS
AQIS
NEW
ENZYME/SOURCE
OGTR
WITH NO PRIOR
APPROVALS FOR
USE IN FOODS
TGA
EA
NOHSC
ANZFA
EFFICACY
SPECIFIC CLAIMS
Page 16 of 16