Guidelines for the Registration of Direct Fed Microbial Products
Guideline Number: 9
Release date: 8 June 2001
Definition: A direct-fed microbial product means a product that contains viable micro-organisms for oral administration. These may be administered as 'mass medications' in feed or water or individually administered to single animals.
On this page:
1. Identity of the end-use product
- Trade name
- Qualitative and quantitative composition
- microbial organism(s)
- other components
- impurities, contaminants (including viruses)
- undesirable substances(s);
- Business name and address of place of production of each organism.
- Business name and address of the manufacturer and/or distributor/agent of the final end-use product.
If the end use product is a mixture of two or more micro-organisms each of the organisms must be described separately with an indication of their proportion in the mixture.
Where microbial and viral contaminants are known, or could be reasonably expected, the pathogenicity/innocuity of these organisms requires discussion.
2. Identity of the component micro-organisms
- Name and taxonomic description according to the International Code of Nomenclature(*).
- Name and place of culture collection, where each strain is registered and deposited and the number of registration and deposit.
- Potency, purity and activity of each organism
3. Justification for use of product
- The microbial functions should be described indicating the likely benefit to result from the use of the microbial preparation when fed in conjunction with specific feed substrates (where applicable). Such substrates must be relevant to Australian feeding practices. These functions must be supported by a detailed literature review.
- Where the preparation is a mixture of microbial components a justification for inclusion of each component must be provided.
- Where any other effects are known, or could be reasonably anticipated, these could he identified and discussed.
- Other known uses of the organism(s) (e.g. in human or animal foodstuffs, human or veterinary medicine, food processing industry etc.) should be stated.
4. Directions for use of the product
- Uses provided for in animal nutrition (species or categories of animal, type of feeding stuffs for animal, period of use, etc) must be specified.
- Proposed dosage in premixes and feeding stuffs (appropriate units of biological activity such as CFU per gram of product)
5. Technical information
- Stability of product
- with regard to physical and chemical agents during production and storage
- during the preparation of premixes and feeding stuffs
- in the presentation of premixes and feeding stuffs
- Manufacturing processes and quality control
- Detailed description of the manufacturing process and quality control procedures during its manufacture.
- Control procedures to ensure pure culture conditions will be expected to conform to GMP and GLP guidelines.
- Analytical methods
- For the identification and quantification of the organism(s) in premixes and feedstuffs.
6. Target Animal Safety and Occupational Health and Safety
- Recommendations concerning the product in relation to target species, the consumer and the environment
- recommendations for the prevention of risks and means of protection from occupational exposure during manufacture and handling.
- the results of one trial should be submitted whereby clinical responses including measured vital signs be recorded in response to a 10 times dose of the product; the organism(s) should be administered by the normal route recommended for the product.
7. Efficacy
All direct fed microbials, including yeasts, irrespective of any efficacy claims made, are required to be registered.
A convincing, scientifically based, rationale must be provided in support of any claim(s) made.
A "general claim" may be made for administration to:
- healthy animals or
- physiologically immature animals.
Australian efficacy data is not required to substantiate a general claim.
Acceptable wording for a general claim is:
- For the maintenance of performance of healthy animals during normal animal husbandry practices such as shipping, dehorning, castration, weaning, ration changes, vaccination, debeaking etc.
- As an aid in the establishment of gastrointestinal microflora of physiologically immature animals eg day old chicks, neonatal pigs, neonatal calves etc.
A "specific claim" may be made for administration to:
- animals with impaired physiology eg gastroenteritis, post-antibiotic therapy
- healthy animals for increased conversion efficiency or increased productivity.
Detailed Australian generated efficacy data will be required for the registration of any specific claims.
8. Other approvals required
- AQIS - for importation of biological material
- Office of the Gene Technology Regulator
Attachment A
Direct-Fed Micro-organisms - The following micro-organisms were reviewed by the US Food and Drug Administration, Centre for Veterinary Medicine and found to present no safety concerns when used in direct-fed microbial products. However, please note applicants are required to provide current evidence that a direct fed micro-organism has US Generally Regarded As Safe (GRAS) status. Evidence from the European Union and Food and Drug Administration are acceptable. Please note the website address for European Union is http://www.eudra.org and the website address for the Food and Drug Administration is http://www. fda.gov.
Aspergillus niger
Aspergillus oryzae
Bacillus coagulans
Bacillus lentus
Bacillus licheniformis
Bacillus pumilus
Bacillus subtilis
Bacteroides amylophilus
Bascteroides capillosus
Bacteroides ruminocola
Bacteroides suis
Bifidobacterium adolescentis
Bifidobacterium animalis
Bifidobacterium bifidum
Bifidobacterium infantis
Bifidobacterium longum
Bifidobacterium thermephilum
Lactobacillus acidolphilus
Lactobaccilus brevis
Lactobacillus bulgaricus
Lactobacillus casei
Lactobacilus cellobiosus
Lactobacillus curvatus
Lactobacillus delbruekii
Lactobacillus fermentum
Lactobacillus helveticus
Lactobacillus lactis
Lactobacillus plantarum
Lactobacillus euterii
Leuconostoc mesenteroides
Pediococcus acidilacticii
Pediococcus cerevisiae (damnosus)
Pediococcus pentosaceus
Propoinibacterium freudenreichii
Propoinibacterium shermanii
Saccharomyces cerevisiae
Streptococcus cremoris
Streptococcus diacetylactis
Streptococcus faecium
Streptococcus intermedius
Streptococcus lactis
Streptococcus thermophilus
(*) Such as "Bergey's Manual of Systematic Bacteriology". "The Yeasts, a taxonomic study" by Lodder and Kreger van Rij, "Ainsworth and Bisby's Dictionary of Fungi" by Hawksworth, Sutton and Ainsworth or "The genus Aspergillus" by Raper and Fennell.