Transcript Feed additive registration requirements

FEED ADDITIVES AND
PREMIXES
Tebogo Banda
Department of Agriculture, Forestry and Fisheries
Act 36 of 1947 workshop
04 September 2013
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FEED ADDITIVES
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WHAT ARE ADDITIVES?
“additive” means any intentionally added substance to
feedstuffs,
premixes,
feed
or
food,
not
normally
consumed as feed by itself when in combination with
other substances, whether or not it has a direct or
indirect nutritional value and is not classified as a
medicine or an essential nutrient, which affects the
characteristics of feedstuffs, feed, food, animal products,
animal production or animal performance and is generally
recognized or proven to be safe under the conditions of its
intended use.
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TECHNOLOGICAL ADDITIVES
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Any substance which favourably affects the characteristics of
feed.
Functional groups (13)
1.
Preservatives: substances for prolonging the shelf life of
feed and ingredients caused by micoorganisms or their
metabolites.
2.
Antioxidants: substances for prolonging shelf life of feed
and ingredients caused by oxidation.
3.
Emulsifiers: substances for maintaining a homogeneous
mixture of two or more immiscible phases in feed.
4.
Stabilizers: substances for maintaining the physicochemical state of feed.
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TECHNOLOGICAL ADDITIVES
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5.
Thickners: substances for increasing the viscosity of feed.
6.
Gelling agents: substances for the formation of a gel in the
feed.
7.
Binders: substances which increase the tendency of
particles of feed to adhere.
8.
Substances for the control of radionucleid contamination:
substances that suppress absorption of radionucleids or
promote their excretion.
9.
Anticaking agents: substances that reduce the tendency of
individual particles of a feed to adhere.
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TECHNOLOGICAL ADDITIVES
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10. Acidity regulators: substances which adjust the pH of feed.
11. Silage additives: substances, including enzymes or microorganisms, intended to be incorporated into feed to
improve the production of silage.
12. Denaturants: substances which are used for the
manufacture of processed feed in order to allow for the
identification of the origin of specific feed or ingredients.
13. Substances for reduction of the contamination of feed by
mycotoxins: substances that can supress or reduce the
absorption, promote the excretion of mycotoxins or modify
their mode of action.
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SENSORY ADDITIVES
Any substance, the addition of which to feed improves or
changes the organoleptic properties of the feed, or the visual
characteristics of the food derived from animals.
Functional groups (2)
1.
Colourants:
•
substances that add or restore colour in feedingstuffs.
•
substances which, when fed to animals, add colours to
food of animal origin.
•
substances which favourably affect the colour of
ornamental fish or birds.
2.
Flavouring compounds: substances the inclusion of which
in feedingstuffs increases feed smell or palatability.
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NUTRITIONAL ADDITIVES
Any substance added to feed to satisfy the nutritional needs
of animals.
Functional groups (4)
1.
Vitamins, pro-vitamins and chemically well-defined
substances having similar effect.
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2.
Compounds of trace elements.
3.
Amino acids, their salts and analogues.
4.
Urea and its derivatives.
ZOOTECHNICAL ADDITIVES
Any additive used to affect favourably the performance of
animals in good health or used to affect favourably the
environment.
Functional groups (4)
1.
Digestibility enhancers: substances which, when fed to
animals, increase the digestibility of the diet, through action
on target feed materials.
2.
Gut flora stabilizers: micro-organisms or other chemically
defined substances, which when fed to animals, have a
positive effect on the gut flora.
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3.
Substances which favourably affect the environment.
4.
Other zootechnical additives.
PHYTOGENIC ADDITIVES
Phytogenic feed additives are substances derived from
plants.
They are claimed to:
-
Stimulate feed intake
-
Improve gut function
-
Stimulate immune system
-
Have antibacterial, coccidiostatic or anti-viral effects
-
Have antioxidative effects
Depending on mode the of action and claims, they could fall
under sensory or zootechnical categories.
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INFORMATION OR DATA
REQUIREMENTS
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CHEMISTRY AND MANUFACTURE
 IDENTITY OF ADDITIVE
 Proposed propriety name
 Type of additive according to its main function
 Qualitative and quantitative composition
 Physical state, particle size
 Manufacturing process
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…1
CHEMISTRY AND MANUFACTURE
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 SPECIFICATIONS CONCERNING ACTIVE SUBSTANCE
 Name according to main active as described by
IUB/IUPAC, EINECS and CAS Number
 The biological origin
 Purity
 Optimal pH, purification process and media used
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CHEMISTRY AND MANUFACTURE
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 PHYSIO-CHEMICAL, TECHNOLOGICAL AND
BIOLOGICAL PROPERTIES OF THE ADDITIVE
 Stability during storage
 Stability during preparation of premix and feed
 Stability during storage of premixtures
 Stability to
- obtain homogenous mixtures in premixes and feed
- dust-forming properties
- resistance to degradation or loss of biological
activity
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CHEMISTRY AND MANUFACTURE
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 PHYSIO-CHEMICAL, TECHNOLOGICAL AND
BIOLOGICAL PROPERTIES OF THE ADDITIVE
 Physico-chemical or biological incompatibilities or
interactions
 CONTROL METHODS
 Description of analytical methods
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Cont…
TOXICOLOGY
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 STUDIES ON LABORATORY ANIMALS (Not necessary if
active substance is a non-photogenic naturally occurring
micro-organism)
 ACUTE TOXICITY
 Acute inhalation toxicity
 Skin and eye irritancy
 MUTAGENICITY
 Ames/Salmonella test
 Chromosomal aberration test
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TOXICOLOGY
 PHARMACOKINETICS ASPECTS
 SUBCHRONIC TOXICITY
 CHRONIC TOXICITY/CARCINOGENICITY
 REPRODUCTIVE TOXICITY
 METABOLISM AND TOXICOKINETICS
 RESIDUES
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EFFICACY AND SAFETY
 EFFICACY OF THE ADDITIVE
 SAFETY OF THE TARGET ANIMAL
 QUALITY OF THE ANIMAL PRODUCE
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OTHER INFORMATION
 STUDIES ON QUALITY OF THE ANIMAL PRODUCE
 OCCUPATIONAL HEALTH AND SAFETY
 ENVIRONMENTAL STUDIES
 REGULATORY STATUS IN OTHER COUNTRIES
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ACCEPTABLE SOURCES OF DATA
 Scientific trials
 Commercial trials
 in vivo and in vitro tests
 Data association and extrapolation
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SUMMARY
• Identification of the additive
• Method of production
• Method of analysis
• Stability data
• Safety data
• Efficacy data
• Conditions for use
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PREMIXES
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WHAT ARE PREMIXES?
“premix” means a mixture of additives or mixtures of one or
more additives with substances used as carriers, intended
for the manufacture of animal feeds.
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INFORMATION REQUIRED
• Product specification sheet or Certificate of compliance of
the premix
• Certificates of analyses of additives included
• Substantiation for claims
• Proposed label
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WHAT ARE CUSTOM MIXES
“custom mix” means a mixture compiled on the written
advice of a qualified person for a specific client or a
mixture of registered feedstuffs mixed at the written
request of an end user. Prescription mixture shall have a
corresponding meaning.
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REQUIREMENTS FOR CUSTOM MIX… 1
Registration is not required according to Section 1 of Act 36
of 1947. Manufacturer must keep records in terms of
Regulation 15(1).
a)
Results of quality checks on additives used
b)
Records of each sale (include customer and quantity
sold)
c)
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Name and address of customer
REQUIREMENTS FOR CUSTOM MIX… 2
d)
Composition and mixing instructions, as well as the
purpose for which it is needed
e)
The quantity mixed
f)
The signature of and date on which the person
submitted a request
Note: Manufacturer must keep a reference sample for at
least 3 months
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LABELLING
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LABELLING OF ADDITIVES AND
PREMIXES
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 Product name
 Product classification
– Category or Functional group (Additives)
– Specific name of constituent (enzymes and their
preparations)
– The word ‘premix’ (premixtures)
 Product registration number: Reg. No. V
Act 36/1947
 Product composition or Guaranteed analyses
 Packing size (product quantity in container at packaging)
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LABELLING OF ADDITIVES AND
PREMIXES
 Directions for use
 Warnings or Product safety information
 Batch number
 Date of manufacture
 Shelf life
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CLAIMS
 Claims must be
 Objective
 Verifiable by the regulator
 Understandable and not misleading to users
 Relate to registered information (Additives)
 Relate to claims authorised on additives included
(Premixes)
Note: Medicinal claims are not allowed
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LABELLING OF CUSTOM MIXES
 Name and address of the person who placed the order.
 The words “not for public sale”.
 Name of the product or for which purpose the product is
intended.
 Mass of the product.
 Name and address of the manufacturer.
 All NPN warnings as required in the regulations (if
applicable).
 Example
Note: Medicinal claims are not allowed
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QUESTIONS?
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AMENDMENTS TO REGISTERED
PRODUCTS
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TYPES OF AMENDMENTS
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1.
CHANGE OR ADDITION OF MANUFACTURER
2.
CHANGE OR ADDITIONAL PACKING
3.
CHANGE OF SHELF–LIFE
4.
CHANGE OF FORMULATION
5.
CHANGE OF FEEDING RECOMMENDATIONS
6.
LABEL EXTENSION
7.
ADDITIONAL OR CHANGE OF CLAIMS
CHANGE OR ADDITION OF MANUFACTURER
If any of the following changes:
• New manufacturer
• Change in manufacturing site
• Change in ownership of manufacturing site
Then submit the following information
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•
Manufacturing process
•
Certificate of analysis
•
Facilities accreditation or licensing
CHANGE OR ADDITION OF PACKING
If any of the following changes:
• Addition of different pack size
• Change of package design or material
Then submit the following information:
• Proposed label
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CHANGE OF SHELF-LIFE
If you request any of the following:
• Extension of shelf-life
• Once-off extension of shelf-life
Then submit the following information:
• Stability data
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CHANGE OF COMPOSITION
If any of the following changes:
• Composition of the product
• Guaranteed analysis
Then submit the following information:
• Certificate of analysis
• Proposed label
• Efficacy data (if necessary)
• Safety data (if necessary)
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CHANGE OF FEEDING RECOMMENDATIONS
If any of the following changes:
• Change of quantity fed to animal
• Change of duration of feeding
Then submit the following information:
• Efficacy data (if necessary)
• Safety data (if necessary)
• Proposed label
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LABEL EXTENSION
To extend the use of a product to include an additional
target species
Submit the following information:
• Efficacy data on target animal
• Safety data on target animal
• Proposed label
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ADDITION OR CHANGE OF CLAIMS
To change claims on efficacy of product
Submit the following information:
• Efficacy data on target animal
• Safety data on target animal
• Proposed label
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THANK YOU
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APPLICATION FORMS
Old
New
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