1 Tebogo Banda Department of Agriculture, Forestry and Fisheries Act 36 of 1947 workshop 04 September 2013 FEED ADDITIVES AND PREMIXES

2 FEED ADDITIVES

3 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.

4 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.

5 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.

6 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.

7 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.

8 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.

9 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.

10 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.

11 INFORMATION OR DATA REQUIREMENTS

12 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

13 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

14 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

15 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

16 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

17 TOXICOLOGY …2  PHARMACOKINETICS ASPECTS  SUBCHRONIC TOXICITY  CHRONIC TOXICITY/CARCINOGENICITY  REPRODUCTIVE TOXICITY  METABOLISM AND TOXICOKINETICS  RESIDUES

18 EFFICACY AND SAFETY  EFFICACY OF THE ADDITIVE  SAFETY OF THE TARGET ANIMAL  QUALITY OF THE ANIMAL PRODUCE

19 OTHER INFORMATION  STUDIES ON QUALITY OF THE ANIMAL PRODUCE  OCCUPATIONAL HEALTH AND SAFETY  ENVIRONMENTAL STUDIES  REGULATORY STATUS IN OTHER COUNTRIES

20 ACCEPTABLE SOURCES OF DATA  Scientific trials  Commercial trials  in vivo and in vitro tests  Data association and extrapolation

21 SUMMARY Identification of the additive Method of production Method of analysis Stability data Safety data Efficacy data Conditions for use

22 PREMIXES

23 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.

24 INFORMATION REQUIRED Product specification sheet or Certificate of compliance of the premix Certificates of analyses of additives included Substantiation for claims Proposed label

25 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.

26 REQUIREMENTS FOR CUSTOM MIX… 1 Registration is not required according to Section 1 of Act 36 of 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

27 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

28 LABELLING

29 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)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)

30 LABELLING OF ADDITIVES AND PREMIXES …2  Directions for use  Warnings or Product safety information  Batch number  Date of manufacture  Shelf life

31 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

32 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 Example Note: Medicinal claims are not allowed

33 QUESTIONS?

34 AMENDMENTS TO REGISTERED PRODUCTS

35 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

36 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

37 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

38 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

39 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)

40 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

41 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

42 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

43 THANK YOU

44 APPLICATION FORMS Old New Old New