11

Tebogo BandaTebogo BandaDepartment of Agriculture, Forestry and FisheriesDepartment of Agriculture, Forestry and Fisheries

Act 36 of 1947 workshop 04 September 2013

FEED ADDITIVES AND FEED ADDITIVES AND PREMIXESPREMIXES

22

FEED ADDITIVES

33

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.

44

TECHNOLOGICAL ADDITIVES …1

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 physico-chemical

state of feed.

55

TECHNOLOGICAL ADDITIVES …2

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.

66

TECHNOLOGICAL ADDITIVES …3

10. Acidity regulators: substances which adjust the pH of feed.

11. Silage additives: substances, including enzymes or micro-

organisms, 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.

77

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.

88

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.

2. Compounds of trace elements.

3. Amino acids, their salts and analogues.

4. Urea and its derivatives.

99

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.

3. Substances which favourably affect the environment.

4. Other zootechnical additives.

1010

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.

1111

INFORMATION OR DATA REQUIREMENTS

1212

CHEMISTRY AND MANUFACTURE …1

IDENTITY OF ADDITIVE

Proposed propriety name

Type of additive according to its main function

Qualitative and quantitative composition

Physical state, particle size

Manufacturing process

1313

CHEMISTRY AND MANUFACTURE …2

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

1414

CHEMISTRY AND MANUFACTURE …3

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

1515

CHEMISTRY AND MANUFACTURE …3

PHYSIO-CHEMICAL, TECHNOLOGICAL AND

BIOLOGICAL PROPERTIES OF THE ADDITIVE Cont…

Physico-chemical or biological incompatibilities or

interactions

CONTROL METHODS

Description of analytical methods

1616

TOXICOLOGY …1

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

1717

TOXICOLOGY …2

PHARMACOKINETICS ASPECTS

SUBCHRONIC TOXICITY

CHRONIC TOXICITY/CARCINOGENICITY

REPRODUCTIVE TOXICITY

METABOLISM AND TOXICOKINETICS

RESIDUES

1818

EFFICACY AND SAFETY

EFFICACY OF THE ADDITIVE

SAFETY OF THE TARGET ANIMAL

QUALITY OF THE ANIMAL PRODUCE

1919

OTHER INFORMATION

STUDIES ON QUALITY OF THE ANIMAL PRODUCE

OCCUPATIONAL HEALTH AND SAFETY

ENVIRONMENTAL STUDIES

REGULATORY STATUS IN OTHER COUNTRIES

2020

ACCEPTABLE SOURCES OF DATA

Scientific trials

Commercial trials

in vivo and in vitro tests

Data association and extrapolation

2121

SUMMARY

• Identification of the additive

• Method of production

• Method of analysis

• Stability data

• Safety data

• Efficacy data

• Conditions for use

2222

PREMIXES

2323

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.

2424

INFORMATION REQUIRED

• Product specification sheet or Certificate of compliance of the premix

• Certificates of analyses of additives included

• Substantiation for claims

• Proposed label

2525

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.

2626

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) Name and address of customer

2727

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

2828

LABELLING

2929

LABELLING OF ADDITIVES AND PREMIXES …1

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)

3030

LABELLING OF ADDITIVES AND PREMIXES …2

Directions for use

Warnings or Product safety information

Batch number

Date of manufacture

Shelf life

3131

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

3232

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

3333

QUESTIONS?

3434

AMENDMENTS TO REGISTERED PRODUCTS

3535

TYPES OF AMENDMENTS

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

3636

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

• Manufacturing process

• Certificate of analysis

• Facilities accreditation or licensing

3737

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

3838

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

3939

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)

4040

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

4141

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

4242

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

4343

THANK YOU

4444

APPLICATION FORMSOld New