Farm Feed Regulations: Amendment (R. No. 552 of 2010)

4 No. 33310 No. R. 552 GOVERNMENT GAZETTE, 25 JUNE 2010 GOVERNMENT NOTICES DEPARTMENT OF AGRICULTURE, FORESTRY AND FISHERIES DEPARTEMENT VAN LANDBOU, BOSBOU EN VISSERYE 25 June 2010 FERTILIZERS, FARM FEEDS, AGRICULTURAL REMEDIES AND STOCK REMEDIES ACT, 1947 (ACT NO. 36 OF 1947) FARM FEEDS REGULATIONS: AMENDMENT The Minister for Agriculture, Forestry and Fisheries has under Section 23 of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act No. 36 of 1947), made the regulations in the Schedule. SHEDULE Definition 1. In this schedule "the regulations" means the regulations published by government notice No. R1087 of 3 November 2006 as amended by government notice NO.R70 of 12 February 2010. Addition of Regulation 1 2. The regulations are hereby amended by the addition in regulation 1 of the following definition; "SANAS' means South African National Accreditation System; Substitution of Regulation 3(1) 3. The regulations are hereby amended by the substitution of regulation 3(1) by the following regulation; 3. (1) Subject to the provisions of Sections 4 and 4A of the Act, an animal feed registration in terms of Section 3 of the Act shall be valid up to 30 May of a three year registration cycle; Addition of Regulation 11(7) 4. The regulations are hereby amended by the addition of regulation 11(7) in the regulations as follows; 11. (7) Subject to the provisions of Section 16 of the Act, no one shall import farm feed into the Republic for use in the manufacture of livestock feed or pet food, or for use as farm feed unless it is registered in terms Sections 3 of the Act; Substitution of Regulation 21(2)(b) 5. The regulations are hereby amended by the substitution of regulation 21(2)(b) by the following regulation; 21. (2) (b). The particulars required in terms of paragraph (a) shall appear on the label (as required) expressed as percentages or gram per kilogram for macronutrients, milligrams or micrograms per kilogram for micronutrients, International unit per kilogram for vitamin A, D and E, as activity unit per gram or activity unit per milliliter for enzymes and their preparations, as colony forming units per gram for micro-organisms and their preparations in the following order (i) Crude protein (minimum) STAATSKOERANT, 25 JUNIE 2010 (ii) Equivalent crude protein from non-protein nitrogen (maximum) (iii) Amino acids (minimum) (lv) Moisture (maximum) (v) Crude fat (minimum and/or maximum) (vi) Crude fiber (minimum and/or maximum) (vii) Calcium (minimum and/or maximum) (viii) Phosphorus (minimum) (ix) Other mineral guarantees (x) Vitamins (minimum) (xi) Total sugar as invert (minimum) (xii) Viable micro-organisms producing lactic acid (minimum) (xiii) Other guarantees (minimum) Substitution of Regulation 22(1)(g) NO.33310 5 6. The regulations are hereby amended by the substitution of regulation 22(1)(g) by the following regulation; 22. (1) (g). The information that is required to appear in the "Average analysis" or "analysis" shall be listed in the following order (i) Crude protein (ii) Moisture (iii) Crude fat/oil (iv) Crude fiber (v) Crude Ash (vi) Calcium (optional) (vii) Phosphorus (optional) Substitution of Regulation 22(1)(h) 7. The regulations are hereby amended by the substitution of regulation 22(1)(h) by the following regulation; 22. (1) (h). The average analysis shall be expressed in terms of percentages or gram per kilogram for macro-nutrients, milligrams or micrograms per kilogram for micro-nutrients and international units per kilogram (IU1kg) for vitamin A and D. All guarantees shall be expressed on an as fed basis. Vitamin inclusion levels shall be those in the pet food at the" best before" date; Substitution of Regulation 22(2)(a) 8. The regulations are hereby amended by the substitution of regulation 22(2)(a) by the following regulation; 22. (2) (a). A vignette, graphic, or pictoral presentation of a product on a pet food shall not misinterpret the contents of the package. When a graphic or picture of animal protein, vegetables. cereals and grains is used on the label it shall be used subject to the following rules (i) Where a label shows graphics or pictorial of vegetables, fish, milk and eggs it shall mean that there is at least a 4%. of the ingredient appearing in the picture or graphic in the final product; (ii) Where a label shows graphics or pictorial of cereals and/or grains. it shall mean that there is at least a 14%, of the ingredient appearing in the picture or graphic in the final product; and 6 NO.33310 GOVERNMENT GAZETTE, 25 JUNE 2010 (iii) Where a label shows graphics or pictorial of meat, it shall mean that there is at least a 26%, of the ingredient appearing in the picture or graphic in the final product. Substitution of Regulation 22(2)(m)(iv) 9. The regulations are hereby amended by the substitution of regulation 22(2)(m)(iv) by the following regulation; 22. (2) (m) (iv) in the case of nutrients, the minimum content, expressed as set out in regulation 22(1)(g), shall clearly be indicated as part of the average analysis and shall follow the mandatory guarantees; Substitution of Regulation 22(2)(m)(vi) 10. The regulations are hereby amended by the Substitution of regulation 22(2)(m)(vi) by the following regulation; 22. (2) (m) (vi) if particular attention is drawn to an inclusion as an optimum ratio then the inclusion ratio shall be shown in the analysis on the label; Substitution of Regulation 22(2)(q) 11. The regulations are hereby amended by the substitution of regulation 22(2)(q) by the following regulation; 22. (2) (q) Statements of energy content shall only be permitted on the label if they are substantiated. Where a statement(s) that make reference to weight control or obesity is claimed on the label it shall be accompanied by a declaration of product energy content; Substitution of Regulation 22(2)(u) 12. The regulations are hereby amended by the substitution of regulation 22(2)(u) by the following regulation; 22. (2) (u) A reference to quality, nature, form, or other attributes of an ingredient shall not be made unless such reference is accurate and unless the ingredient imparts a distinctive characteristic to the pet food because it possesses that attribute. Reference to poor, low, inferior, undesirable ingredient(s) quality or substance shall not be permitted on pet food label; Substitution of Regulation 22(7) 13. The regulations are hereby amended by the substitution of regulation 22(7) by the following regulation; 22. (7) Not withstanding the provisions of subregulation (1) and subregulation (2) the Registrar may, on written request of the applicant grant certain exemptions from the stipulations of these subregulations under certain conditions; Substitution of Regulation 24(3)(b) 14. The regulations are hereby amended by the substitution of regulation 24(3)(b) by the following regulation; STAATSKOERANT, 25 JUNIE 2010 No.33310 7 24. (3) (b) be accompanied by two copies of a typed version of the advertisement in English and, if applicable, two copies of illustrations to be used in connection with that advertisement; and Substitution of Regulation 26 15. The Regulations are hereby amended by the substitution of regulation 26 by the following regulation; 26. (1) The site where the manufacturing facility is located shall be maintained so as to prevent contamination and enable the productionof safe feed, such that (a) measures necessary to protect the site from any potential undesirable contaminants shall be in place and periodically reviewed to ensure they continue to be effective; and (b) the site boundariesshall be clearly defined. where natural drainage is inadequate, additional drainage shall be installed to avoid the risk of contamination of feedingstuffs; where external storage is necessary, items shall be protected from contamination and deterioration; wherever possible, all buildings shall be surrounded by a clear space. All immediate surrounding areas shall be kept clean, and effective pest control programmes shall be implemented; and waste collection shall take place in a well-defined area.(d) (b) (c) 26. (2) All grounds within the site shall be finished and maintained to an appropriate standard, such that (a) 26. (3) Premises and plant shall be designed, constructed and maintained to control the risk of product contamination, such that (a) the production process from reception to dispatch, shall be designed to permit adequate cleaning and/or disinfection ~n order to prevent personnel, product, facilities and equipment contamination and cross contamination; (b) premises shall allow sufficient working space and storage to enable all operations to be carried out properly under safe and hygienic conditions; (c) the systems of working shall, where appropriate, be such as to reduce any potential physical, chemical or microbiological contamination risks; (d) there shall be an appropriate segregation between unprocessed and processed materials to minimisethe risk of product cross-contamination; (e) segregation shall take into account the product flow, nature of materials, equipment, personnel, waste management, airflow, and air quality and services provision; and (f) manufacturing plants shall have adequate facilities for disposing of unused animal by-products remaining after the production of the products. Alternatively this material shall be sent to a processing plant or to an incinerationor co-incineration plant. 26 (4) The fabric of the site, buildings and facilities shall be suitable for the intended purpose. The use of glass shall be avoided where necessary. The (a) walls shall be designed, constructed, finished and maintained to prevent the accumulation of dirt, to reduce condensation and mould growth and to facilitate cleaning; (b) wall/floor junctions and corners shall be covered to facilitate cleaning and disinfection; cavities in the surface of walls shall be avoided, where necessary, to prevent debris from accumulatingand pest harbourage; (c) drainage shall not compromise product safety and shall flow away from high-risk areas; 8 No. 33310 GOVERNMENT GAZETTE, 25 JUNE 2010 (i) (f) (r) (v) (d) (e) (h) (g) (k) (0) (p) (I) (m) (n) (u) (q) (w) (s) (t) drainage facilities shall be adequate for the purpose intended and shall be designed and maintained to minimise risk of product contamination; floors shall be designed to meet the demands of the process, and withstand cleaning materials and methods; they shall be impervious and maintained in good conditions; floors shall have adequate slope to cope with the flow of any water or effluent towards suitable drainage; careful consideration to the sitting of machinery; suitable drainage shall be provided so that any discharge or overspill from processing goes directly into a drain rather than on the floor; use of false ceilings shall be accompanied by adequate access to the void in order to facilitate cleaning, maintenance of services and inspection for pest activity; ceilings and overhead fixtures, where necessary, shall be designed, constructed, finished and maintained to prevent the accumulation of dirt, to reduce condensation, minimise mould growth and to prevent the accumulation of dust that can affect the safety and quality of livestock or pet food; use of glass close to production machinery shall be avoided and wherever necessary it shall be protected against breakage; windows shall be designed to be opened for ventilation purposes, they shall, where necessary, be adequately screened to prevent the ingress of pests; doors shall be kept closed at all times, when not in use; doors shall be close-fitting and proofed against pests when closed; external doors to raw material handling, processing, packaging and storage areas when kept open, suitable precautions shall be taken to prevent the ingress of pests; facilities shall have adequate natural and/or artificial lighting; shatterproof plastic diffusers or sleeve covers shall protect all bulbs and strip lights, including those on electric fly killer units, where they constitute a risk to the product; for high temperature lights, where plastic covers are not viable, a fine mesh metal screen shall be fitted; where full protection cannot be provided, the glass management system shall take this into account; equipment used for the purpose of screening or filtering air shall be adequately maintained; dust extraction equipment for dry powder handling areas shall be installed; compressed air in contact with products shall be filtered; water supplies used for cleaning shall, where appropriate, be potable, either being drawn from mains supply or suitably treated according to its source; water used in livestock feed or Pet food manufacture shall be of suitable quality for animals; all piping etc. shall be of inert nature; quality of water, steam or ice that comes in contact with livestock feed or pet food shall be regularly monitored and shall present no risk to product safety; and water supply systems shall be properly labeled and segregated between potable and non-potable supplies. 26. (5) Equipment shall be suitably designed for the intended purpose and shall be used so as to minimise the risk of product contamination, such that (a) equipment shall be designed. so as to minimise the risk of error and to avoid contamination, cross-contamination and any adverse affect, generally on the safety and quality of the products; when appropriate, STAATSKOERANT, 25 JUNIE 2010 NO.33310 9 machinery coming into contact with feed shall be dried following any wet cleaning process; (b) equipment shall be positioned so as to allow easy access for cleaning and/or disinfection and servicing; (c) all equipment shall be properly specified prior to commissioning, and shall be adequately maintained, serviced and operated to allow for the production of safe and quality compliant feed; (d) all equipment surfaces coming into contact with the product shall be impervious and non-reactive; (e) all equipment shall be designed so that it does not in itself contaminate the product due to leaking seals, lubrication or through subsequent modification; and (f) all feed or food contact lubricants shall be of food grade quality. 26. (6) A system of planned maintenance shall be in place covering all items of equipment, which are critical to product safety and quality, such that (a) equipment shall undergo appropriate and regular maintenance, in accordance with written procedures pre-established by the equipment manufacturer; (b) the manufacturer shall ensure that the safety and quality of product is not jeopardised during and after maintenance operations; particular attention shall be drawn to the risk of foreign body contamination; (c) third party contractors and all engineers shall be aware of and adhere to the manufacturer's hygiene standards, with particular focus on both high and low risk areas; and (d) cleaning or replacing light fittings and glass shall be done in a manner as to minimise the potential of product contamination. 26. (7) Staff facilities shall be designed, and used to minimise the risk of product contamination, such that (a) where specific work-wear is required, changing facilities shall be provided for all personnel, whether staff, visitor or contractor, prior to entry to production or packing areas, and where appropriate, prior to entry to storage areas; (b) where appropriate, suitable and sufficient hand washing facilities shall be provided; (c) toilets doors shall not open directly into production, packing or storage areas; (d) smoking shall only be permitted in appropriate designated areas; (e) where catering facilities are provided, these shall be suitably controlled to prevent contamination of product; (f) where appropriate, changing facilities shall be located to allow personnel direct access to the packing or storage area , without first passing through areas external to the factory buildings; (g) suitable provisions shall be made for the storage of food brought onto the premises by staff; (h) outdoor clothing and other personal items shall be stored separately from work wear within the changing facilities; and (i) where appropriate, the use of work-wear shall be restricted to the work premises. 26. (8) Appropriate facilities and procedures shall be in place to control the risk of physical or chemical product contamination, such that (a) the manufacturer shall adopt all measures to comply with the maximum permitted levels of physicochemical residues; (b) appropriate storage facilities shall be provided for the control and storage of any hazardous chemicals; (c) written procedures for handling glass and hard clear plastic breakages in raw material handling, preparation, processing, packing and storage 10 NO.33310 GOVERNMENT GAZETTE, 25 JUNE 2010 (d) areas shall be in place to ensure the necessary precautions are taken; these procedures shall form part of a formal gla$s policy; and the use of wood within raw material handling, 'preparation, processing, packing and storage areas shall,be minimised. cleaning and disinfection programmes shall be implemented and effective in order to minimise the risk of contamination; programme shall be documented; all cleaning staff shall be trained and competent to perform the required tasks; the effectiveness of the cleaning and sanitation procedures in processing areas shall be verified; and only approved food grade cleaning agents shall be used. (b) (c) (d) 26. (9) Appropriate standards of hygiene and housekeeping shall be maintained at all times, such that (a) 26. (10) There shall be adequate systems for the collation, collection and disposal of waste material, such that ~ (a) sewage, waste and rain water shall be disposed of in a manner which ensures that the safety and quality of feed is not affected; spoilage and dust shall be controlled to prevent pest Invasion; (b) waste and materials not suitable as feed shall be Isolated and Identified; any such materials containing hazardous levels of veterinary drugs, contaminants or other hazards shall be disposed of in an appropriate way and not used as feed; (c) systems shall be in place to minimise the accumulation of waste in production areas, and shall prevent the use of unfit materials; defined waste areas shall be established; (d) waste disposal shall meet legislative requirements and, where appropriate, removed by licensed contractors; (e) external waste collection containers and compactors shall be closed or covered; and (f) all waste containers shall be clearly marked and designated for that purpose only. pest control programmes are implemented. the manufacturer either contract the services to a competent registered pest control operator, or shall have trained personnel, for the regular inspection and treatment of premises to stop and eradicate pest infestation; where the services of a pest control contractor are employed, the service contracted shall be clearly defined and reflect the activities of the site; detailed records of the pest control inspections, recommendations and necessary action undertaken shall be kept; where appropriate, permanently operational electric fly killers shall be provided and correctly positioned; drains shall be fitted with screens and traps to prevent pest entry; where appropriate, incoming raw materials shall be thoroughly checked on arrival for the absence of pests; raw materials, packaging and finished products shall be stored so as to minimise the risk of pest infestation; where stored the product may attract pests, appropriate measures shall be included in the control programme; (c) (d) (e) (f) (g) 26. (11) The Manufacturer shall be responsible for minimising the risk of pest infestation on the site, such that (a) (b) http:shall,.be STAATSKOERANT, 25 JUNIE 2010 No.33310 11 (h) documentation shall provide detailed information on the safe use and application of baits; and (i) the location of all pest control measures shall be identified on a plan/diagram of the site. 26. (12) The Manufacturer shall ensure that all employees are adequately trained, instructedand supervised, commensuratewith their activity, such that (a) all employees involved in the production of animal feed, including storage and transport, be aware (e.g. clearly informed in writing of their duties, responsibilities and powers) that they contribute to the quality and safety of the finished products; (b) all personnel, including temporary personnel and contractors, shall be in sufficient number, possess the skills and qualifications necessary for the manufacturingprocess and be appropriately trained prior to commencing work; they shall be adequately supervisedthroughout the working period; (c) the staff shall be adequately trained for quality management; the person responsible for supervising quality control shall furthermore be in a position to carry out his/her tasks independently and to take the appropriatedecisions; and (d) the manufacturershall have full training programmesand records. 26. (13) The Manufacturer's personal hygiene standards shall be documented and adopted by all personnel, including contractors and visitors to the factory. These standards shall be designed with due regard to the risk of product contamination, such that (a) jewellery and watches shall not be wom unless in exceptional circumstances when there is no risk of product contamination and with the exceptionof a plain wedding ring and sleeper earrings; (b) all cuts and grazes on exposed skin shall be covered (e.g. by a detectable blue metal strip plaster, that is Pet food manufacturer-issued); (c) smoking, eating and drinking shall only be permitted in designated areas; (d) hand cleaning shall be performed in an appropriate manner and frequency; (e) medical screening procedures shall be implemented, where appropriate, in particular for staff working in areas where product safety could be compromised; and (f) personnel known, or suspected, to be suffering from a disease likely to be transmitted to livestock feed or pet food, shall not be allowed to enter any feed handling area where there is a likelihood of contaminating the feed, posing a risk to the safety of the product, the target animal and to humans handlingthe feed. 26. (14) feed handlers, visitors, and contractors working in, or entering the feed handling areas, shall wear suitable feed manufacturer-issued protectiveclothing, such that (a) where appropriate, all hair shall be fully covered to prevent product contamination; (b) suitable safety footwear shall be worn within the factory environment; (c) all protective clothing shall be laundered effectively on a regular basis; and (d) gloves, if worn, shall be subject to adequate control to avoid product contamination. Substitution of Regulation 27 16. The Regulations are herebyamended by the substitutionof regulation 27 by the following regulation; 12 No. 33310 GOVERNMENT GAZETTE, 25 JUNE 2010 27. (,1) Clear responsibilities and procedures for the production process shall be in place, such that (a) a qualified employee shall be designated as the person responsible for the production process; (b) a qualified employee(s) shall be designated as the person responsible for feed formulations and such a person shall be registered in terms of the Natural Scientific Professions Act, 2003 (Act No. 27 of 2003) as an animal scientist; (c) the manufacturer shall ensure that the different production stages are carried out in accordance with written procedures and instructions; in order to obtain the desired quality of feed, these procedures shall define the critical points of the manufacturingprocess; and (d) measures shall be taken to avoid contamination, cross contamination and human error to maintain the hygieneand safety standards. 27. (2) Weighing and metering equipment, both for bulk and hand tipped ingredients, is essential and shall be accurately done in order for the production of a safe feed, such that (a) all scales and metering devices used in the manufacture of feed shall be appropriate for the range of weights or volumes to be measured and a regular programme of calibration and testing of weighing and metering equipment shall be implemented; guidance from equipment manufacturers shall be taken in developing written procedures for calibration and testing; and (b) a regular maintenance programme shall also be in place in order to ensure that weighing equipment is kept clean and that worn parts are replacedwhen necessary. 27. (3) A homogenousmixture is essential for nutritional balance and feed safety. The accuracy of mixing shall be assured and verified, such that (a) all mixers used in the manufacture of feed shall be appropriate for the range of weights or volumes being mixed, and shall be capable of manufacturing homogeneousmixes or homogenoussolutions; (b) the mixer shall be cleaned to ensure efficacy and feed safety; (c) written maintenanceschedules shall exist for examination of the mixer to ensure that worn equipment parts do not lead to the build up of residues when the mixer is emptied; (d) the mixers shall operate for a pre-set time, determined by pre-production trials to ensure homogenousmixes and/or solutions; (e) The efficiency of the mixing process shall be regularly checked to ensure that additives are evenly dispersed throughout the mix; (f) an unacceptable carry over of additives, veterinary medical substances or any other undesirablesubstance shall be prevented; and (g) operators shall demonstrate the effectiveness of mixers with regard to homogeneity. 27. (4) A Quality Control Plan shall be drawn up and implemented for the use of raw materials, premixtures and finished products. The Manufacturer shall undertake or sub-contract analysis, critical to product safety and quality, using appropriate procedures and facilities, such that (a) the Quality Control Plan shall identify checks on critical control points in the manufacturing process, sampling procedures as well as determine the frequency of these checks and sampling procedures; the plan shall also specify which methods of, analysis are to be used and how STAATSKOERANT, 25 JUNIE 2010 No. 33310 13 (f) (c) (b) (d) (e) frequently; the quality control plan shall mention actions to be taken in case of non-compliance with the specifications; the manufacturer shall, based on risk assessment (including HACCP), determine what level of analytical testing (microbiological, physical or chemical) needs to be performed to verify that the food safety managementsystem is under control; pet food and dog chews made from animal by-products, random samples shall be taken during production and finished products (before dispatching) to verify compliance with the following standards: Salmonella (absence in 25g, n=5, c=O, M=O); and Enterobacteriaceae (n=5, c=2, m=10, M=300 in 19); however, for canned pet food and other hermetically sealed heat treated containers that has undergone heat treatment described in the production section (temperature), sampling and testing for Salmonella and Enterobacteriaceae may not be necessary; proceduresshall be in place to ensure reliabilityof test results; personnel undertaking analyses shall be suitably qualified, and/or trained and shall be competent to carry out the analyses required; and where the feed manufacturer undertakes or sub-contracts analyses critical to product safety or legal compositional verification, the laboratory shall be independentlyaccredited by SANAS or ILAC. 27. (5) The Manufacturer shall be able to demonstrate effective control of all operations undertaken. Where temperature control of the raw materials, intermediate or finished product, process and/or environment is critical to product safety and quality, this shall be adequately controlled, monitoredand recorded, such that (a) in circumstances where temperature and/or time control is critical to product safety and quality (e.g. thermal processing, freezing or chilling), temperature and/or time recording equipment, linked to a suitable failure alarm system, shall be used to monitor at an appropriate frequency, the process status; (b) canned pet food and other hermetically sealed heat treated containers shall be subject to heat treatment to a minimum Fc value of 3; (c) processed pet food other than canned pet food or other hermetically sealed heat treated containers shall be subject to a heat treatment of at least 90°C throughout its substance; after treatment, every precaution shall be taken to ensure that the product is not exposed to contamination; the product shall be packed in new packaging; and (d) dog chews shall be subject to a heat treatment during processing sufficient to destroy pathogenic organisms (including salmonella); after treatment, every precaution shall be taken to ensure that the product is not exposed to contamination; the product shall be packed in new packaging. 27. (6) The Manufacturer shall ensure that all necessary steps are taken to identify, avoid, eliminate or minimise the risk of metal or other foreign body contamination, such that (a) the manufacturer shall use hazard analysis and determine the critical control points to avoid foreign body contamination. When necessary, metal or other foreign body detection equipment shall be installed; (b) where a metal or foreign body detector is required, the manufacturer shall establish and apply the best practice critical limits for detection, having due regard to the nature of the feed, the location of the detector and any other factors influencing the sensitivity of the detector; (c) the manufacturer shall establish and implement procedures for the operation, routine monitoring and testing of the metal and other foreign body detectors; and 14 No.33310 (d) GOVERNMENT GAZETTE, 25 JUNE 2010 the manufacturer shall establish and implement corrective action and reporting procedures, in the event of the monitoring and testing procedure identifying any failure of the metal or foreign body detector; these will include the isolation, quarantining and re-inspection of all products since the last acceptance test of the metal or other foreign body detector. 27. (7) The Manufacturer shall ensure that the product is not released before all the procedures have been followed, such that (a) The manufacturer shall ensure that the product is only released by authorised personnel in line with release procedures ensuring product safety. 27. (8) The Manufacturer shall ensure all out-of-specification raw materials and semi- or finished products are clearly identified, labelled and quarantined, such that (a) clear procedures for the control of non-conforming material, including rejection, acceptance by concession, or agreement to use for another purpose, shall be in place and understood by all authorised personnel; (b) corrective actions shall be implemented to avoid recurrence of non conformanceand adequate records of the action taken; and (c) all non-conforming products shall be handled or disposed of according to the nature of the problemand/or specific requirements. 27. (9) Checks shall be carried out to demonstrate that a package conforms with the Trade Metrology Act, 1973 (Act 77 of 1973) legal requirements and with any additional recognised industry sector codes/guides, such that (a) The frequency and methodology of quantity checking shall meet the minimum requirements of legislation pertaining to quantity verification, irrespective of the nature of the pre-packaged material (e.g. average quantity, weight or volume); and (b) all equipment used for quantity measurement shall be legally acceptable and regularlycalibrated. 27. (10) The Manufacturer shall operate procedures that verify that the process and equipment employed are capable of producing consistent safe products with the desired quality characteristics, such that (a) in the event of changes to product formulation, processing methods, equipment or packaging, the manufacturer shall, where appropriate, re establish process characteristics and validate product data, to ensure product safety and quality; and (b) in the case of equipment failure or process deviation, procedures shall be in place to establish the safety status of the product, prior to release. 27. (11) Equipment used to monitor critical control points and product compliance shall be calibrated and traceable, such that (a) where necessary, equipments shall: (i) be calibrated or verified at specified intervals or prior to use and the basis used for calibration or verification shall be recorded; (ii) be adjusted or re-adjustedas necessary; (iii) be identified to enable the calibration status to be determined; (iv) be safeguarded from adjustments that would invalidate the measurement results; and (v) be protected from damage and deterioration. (b) records of the results of calibration and verification shall be maintained. STAATSKOERANT, 25 JUNIE 2010 No.33310 15 27. (12) Where materials require special handling procedures, these shall be in place to ensure that product safety and quality are maintained, such that (a) where packaging materials (e.g. glass containers) pose a risk to the product safety, special handling procedures shall be in place to prevent product contamination or spoilage; records of failures and corrective actions taken shall be maintained; and (b) where re-processing is used, or reworking operations carried out, procedures shall be implemented to ensure the safety and quality of the finished product. 27. (13) Product packaging shall be appropriate for the intended use and stored under proper conditions to minimisethe risk of contamination and deterioration, such that (a) proper packaging materialsshall be used; (b) procedures shall be in place to confirm that product packaging conforms to specification; (c) where staples or other items likely to cause damage or contamination in packaging are used, appropriate precautions shall be taken to minimise the risk of productcontamination; (d) any packaging material surplus to a specific production run shall be protected before being returned to storage; and (e) packaging material shall be stored apart from raw materials to avoid cross-contamination, 27. (14) All vehicles or warehouses used for the transportation or storage of raw materials (including packaging), intermediates/semi-processed products and finished product, shall be suitable for the intended purpose, and be maintained in good repair and in a Hygieniccondition, such that (a) the manufacturer shall make sure that, the goods delivered match with those ordered, the feed is properly labeled in accordance with legal requirements; and that all measures have been taken to ensure the quality and safety of the feed delivered; (b) all containers used for transporting or warehouses used for storing raw materials and finished products shall be kept free of potential contaminants, whether chemical, odour, pests (e.g. microorganisms, rodents, insects, birds) and domestic animals; (c) only persons authorised by the manufacturer shall have access to the storage facilities; (d) the name and the addressof the carrier shall be registered; (e) raw materials, packaging materials and finished products shall be stored and transported in such a way as to make them easily identifiable (product name, number, date and time of manufacture) and to prevent cross-contamination and deterioration; (f) refrigerated transport or storage shall be capable of maintaining product/raw material temperature within specification, under maximum load. and whilst the product/raw material is stored on the vehicle or in the warehouse; (g) procedures shall, where appropriate, be in place in the case of equipment failure (e.g. refrigeration); these procedures shall ensure product safety and quality; (h) where the raw material, packaging materials or finished product transported is susceptible to damage by the weather, vehicles shall be weather proofed and shall be loaded and unloaded in covered bays to protect the material. (i) animal by-products and processed products shall be collected and transported in sealed new packaging or covered leak-proof containers or vehicles; 16 No. 33310 (f) (g) (h) (I) GOVERNMENT GAZETTE, 25 JUNE 2010 the HACCP system shall be specific to the application, practical to implement and effective in controlling the associated hazards of the operation; all existing and new products shall be covered by the HACCP system, which shall be reviewed on a regular basis (at least once a year) and shall be validated; Critical Control Points, identified in relation to the operation, shall be controlled and monitored within predetermined Critical Limits; records of confonnance and effective corrective action resulting from non confonnance shall be maintained; the food safety management system shall consist of both a validated and verified prerequisite programme and a HACCP system, and through these, the pet food manufacturer shall be able to demonstrate effective food safety control of all operations undertaken; and the HACCP study shall be carried out by a multi-disciplinary team. 27. (18) Traceability shall be applied and be the responsibility of each operator of the entire animal feed and pet food chain ("from fann to fork / from fann to feeding bowl"). The Manufacturer shall adequately identify all materials used in the livestock feed or pet food production (raw materials, additives, packaging, packaging materials), including the finished product, and be able to trace what occurred in all phases of production, and up to the distribution to the customer, such that (a) the manufacturer shall work with a system of documentation designed to ensure an adequate level of traceability; traceability is the capability to be able to identify any person from whom they have been supplied with feed materials, additives, packaging material or any substance intended to be, or expected to be, used for the production of feed; the manufacturer shall record and keep the following infonnation for at least two years, or five years if the product contains GMOs, in order to ensure product traceability: (i) the name and address of the suppliers (e.g. raw materials, additives/premixtures, packaging) and the sources of these raw materials/packaging, including the batch number, quantity and delivery date; (ii) the raw material registration number of the suppliers; (iii) the nature, formulation and quantity of the finished products manufactured, along with the manufacturing date and batch number; Samples and records of each batch shall be retained in accordancewith these regulations; and (iv) the name and address of the site where the batch of semi finished or finished products are delivered. (b) where rework or any reworking operation is performed, traceability shall be maintained. 27. (19) The Manufacturershall identify each individual sales unit, such that (a) the manufacturer shall establish and maintain documented procedures for identifying materials from reception through production to finished products; finished products shall be labeled to ensure traceability to batch. 27. (20) The Manufacturer shall have an effective product recall procedure for all products in the distribution network, such that (a) the manufacturer shall implement a system for the prompt recall of products in the distribution network; (b) should a product be delivered, which does not meet the food safety requirements, the manufacturer has to recall these products from the STAATSKOERANT, 25 JUNIE 2010 NO.33310 17 distribution network; the manufacturer has to take care that the products will not be put back into circulation unless they have undergone a risk assessment and, if required, treated in an appropriate way; the manufacturer, therefore, shall have a recall procedure implemented; a Rapid Alert System shall be in place, which is the obligation to inform the Registrar, in case a product recall is necessary; (c) the procedure shall be: appropriate; formalised; capable of being operated at any time within four hours; the procedure shall be regularly reviewed and revised as appropriate; and (d) the procedure shall be regularly tested In a manner that Is appropriate to ensure Its effective operation. 27. (21) A hazard analysis study (HACCP) shall be undertaken during the design/development phase of the product, packaging and process to identify and assess all potential safety hazards (Codex Alimentarius, 1997 (II», such that (a) the feed shall be designed to produce a safe feed and meet the nutritional requirements of the animal; (b) the manufacturer shall, where appropriate, undertake factory trials and carry out testing to verify if product formulation and manufacturing processes are capable of producing a nutritionally well balanced and safe product; (c) shelf life shall be established, taking into account the product formulation, production process, packaging process and packaging and subsequent storage conditions; and (d) packaging, process and the material used in the manufacture shall assure feed safety. 27. (22) Feed materials have to be mixed to produce a safe feed, such that (a) the presence of prohibited feed materials, undesirable substances, prohibited substances and pathogens in relation to animal or human health shall be monitored and appropriate control strategies to minimise the risk shall be in place; (b) this regulation establishes a list of products whose use as feed materials is prohibited; the manufacturer shall make sure that the products included on the list of prohibited products are not used; certain feed materials and additives are subject to restriction for use in certain species; the manufacturer shall make sure that they are used accordingly and that the risks of accidental contamination are controlled/eliminated; and (c) only permitted additives can be used and mixed in appropriate quantities and homogeneously with the feeding materials, in order to ensure that they are only present in non-toxicquantities. 27. (23) The Manufacturer shall operate procedures for approval and monitoring of its suppliers, including finished and semi-finished products manufactured by third parties, such that (a) a Vendor/Supplier Assurance (VA) programme shall exist to control the purchase of raw materials and packaging materials from approved suppliers; this programme shall document all standards and monitoring procedures dealing with primary production, inbound raw material and packaging and transport; (b) specifications, based on risk assessment, for raw materials, semi processed products (where supplied to other factories) and packaging materials shall be documented and implemented; the specification may include detail on analytical, nutritional requirements as well as food safety and hygiene requirements; there shall be a list of approved suppliers; 18 No.33310 (c) (d) (e) GOVERNMENT GAZETTE, 25 JUNE 2010 appropriate methods of assessmenUinspection of suppliers shall be performed with the frequency and type of audit being determined by risk assessment; assessment may take the form of monitoring performance through in-house checks, certificates of analysis or extend to supplier inspection, as appropriate; supplier assessment shall include the suppliers' ability to trace back to their supplier, evaluation of HACCP systems, product safety information and legal requirements; the methods and frequency of assessment shall be based on formal risk assessment; and the procedures shall define how materials of unknown origin are handled. 27. (24) The Manufacturer shall operate procedures for monitoring the quality and safety of raw material at delivery, such that (a) each feed material, additive and packaging material shall have a written specification which is regularly updated; in addition to the nutritional and analytical characteristics of the feed material, this written specification shall include a list of approved orIgins and sources, details of any processing that the material has undergone, types of feedstuffs In which Its use Is approved, notes on any hazards or limitations on Its use and any special characteristics of the feed material; (b) Monitoring at delivery shall ensure that the feed materials and additives are traceable, conform to quality and safety specifications, delivered by an approved or registered supplier, when the products are covered by an approval or registration procedure; (c) a record shall be kept of the origin of each feed material and additive delivered; (d) suppliers delivering animal by-products shall meet specific registration, production process and analytical requirements; and (e) a raw material/packaging acceptance procedure shall exist and each material shall be checked (against the specification) following a schedule of examination that takes into account its critical importance, as identified by risk assessment, in the final product, for example using certificates of analysis, sampling of the material on arrival. Substitution of Regulation 28 17. The Regulations are hereby amended by the substitution of regulation 28 by the following regulation; 28. (1) The Manufacturer shall have a clearly defined and documented quality policy statement and quality objectives, such that (a) the policy shall state the manufacturer's intentions to meet its obligations to produce safe products, and its responsibility to its customers; the policy shall also include the commitment of continuously improving the effectiveness of the quality management system; (b) quality objectives shall be established, implemented and reviewed; targets shall be defined and quality indicators shall be monitored in order to follow quality performance and trends; a regular evaluation of the data shall be a critical tool for continuous improvement of products and services which are delivered to the customer; (c) the manufacturer's Directors and Senior Management shall demonstrate commitment to the implementation of the manufacturer Quality Policy; and STAATSKOERANT, 25 JUNIE 2010 NO.33310 19 (d) the policy and the objectives, as well as the actual quality performanceltrends shall be communicated throughout the company, and regularly reviewed. 28. (2) The Manufacturer shall have a Quality Manual which states the manufacturer's commitment to quality and which covers the requirementsto Good Practice, such that (a) the Quality Manual shall contain an outline of working methods and practices that meet the requirements of these regulations; and (b) the requirements specified within the Quality Manual shall be fully implemented. 28. (3) The Manufacturer shall have an organisational structure, clearly defined and documented, reflecting the effectiveness of all the required tasks and detailing personal responsibility and reporting relationships of the staff involved in the production process; in particular those activities affecting product safety and quality, such that (a) the manufacturer's Directors shall be responsible for manufacturer policy and objectives, and shall provide adequate resources and investment to ensure product safety and quality; a qualified person responsible for quality and feed safety shall be designated; (b) the manufacturer's Directors shall ensure that all employees are aware of their responsibilities and mechanisms are in place either to monitor the effectivenessof their operation and/or to trigger corrective actions; (c) the manufacturer shall ensure that levels of responsibility and accountability are clearly defined for key staff involved with the production process, product safety, legality and quality systems; to this end, job descriptions and an organisation chart setting out qualifications and responsibilities of the supervisory staff shall be drawn up and made available to the Registrar for inspection; a qualified person responsible for production shall be designated; there shall be appropriate arrangements in place to cover for the absence of key staff; (d) the manufacturer shall have a system in place to ensure that it is kept informed of all relevant legislation, food safety issues as well as, legislative, scientific and technical developments; and (e) the manufacturer shall ensure that adequate resources are available for training all employees, in particular new employees. 28. (4) The Management shall review the quality management system on. a regular basis, such that (a) senior management shall review the organisation's quality management system, at planned intervals, to ensure its continuing adequacy and effectiveness; this review shall include an assessment of any opportunity for improvement, as well as an assessment of the need to change the quality management system, including the quality policy and quality objectives. 28. (5) The Manufacturer shall have, and operate in accordance with written detailed procedures, instructions, and reference documents to cover all relevant aspects of product safety and quality, such that (a) documents shall be clearly legible, unambiguous and sufficiently detailed to enable effective use by appropriate personnel, and shall be readily accessible at all times. 28. (6) The Manufacturer shall ensure that all documents, records and data critical to the management of product safety and quality, are in place and effectively controlled, such that 20 No. 33310 GOVERNMENT GAZETTE, 25 JUNE 2010 (a) (b) (c) (d) the Manufacturer shall keep in a register, relevant data compnsmg details of purchase, transport, production and sales for effective tracing from receipt to delivery; the documentation relating to the manufacturing process shall be designed to define and control the critical points in the manufacturing process and to establish and implement a quality control plan; the commercial documents and health certificates shall be kept for a period of at least 2 years for presentation to the registrar; and all documents in use shall be properly authorised and be the versions as issued by the manufacturer. 28. (7) The Manufacturer shall maintain records to demonstrate the effective control of product safety and quality. These records shall include product samples as appropriate, such that (a) the manufacturer shall have access to a laboratory with adequate staff and equipment; (b) a quality control plan shall be drawn up in writing and implemented, to include, in particular, checks on the critical points, sampling procedures and frequencies, methods of analysis and their frequency, compliance with the specifications; (c) The manufacturer shall operate procedures for collation, review, maintenance, storage and retrieval of all records appertaining to product safety and quality; and (d) the records shall be retained in good condition, for an appropriate defined period, but not less than two years. (9)28. 28. (8) The Manufacturer shall have in place a procedure to inform, as appropriate, the Registrar in case of hazards related to the product, such that (a) the manufacturer processing animal by-products shall inform the Registrar, should the laboratory examination of samples or any other information available reveal the existence of a serious animal health or public health hazard; (b) the manufacturer processing stock remedies into feed shall inform the Registrar, should the laboratory examination of samples or any other information available reveal the existence of a serious animal health or public health hazard; (c) the manufacturer processing contaminated animal feed shall inform the Registrar, should the laboratory examination of samples or any other information available reveal the existence of a serious animal health or public health hazard; and (d) the manufacturer processing animal containing undesirable substances shall inform the Registrar, should the laboratory examination of samples or any other information available reveal the existence of a serious animal health or public health hazard. The Manufacturershall ensure that appropriatespecifications exist for (a) raw materials; (b) packagingmaterials; (c) processing; (d) finished products; (e) intermediate/semi-processed products (where appropriate); (f) transport & Warehouse; 28. (10) The Manufacturer shall ensure that specifications according to regulation 27(9) shall be adequate, accurate, and shall ensure compliance with Occupational Health and Safety Act, 1993 (Act No. 85 of 1993) and Trade MetrologyAct, 1973 (Act 77 of 1973). STAATSKOERANT, 25 JUNIE 2010 NO.33310 21 28. (11) The Manufacturer shall monitor information relating to customer perception, such as whether the customer requirementshave been met or not, such that (a) a method for obtaining information on customer satisfaction and how to use the information shall be determined by the manufacturer; and (b) key performance indicators (KPI) on customer satisfaction are used as an important tool for continuous improvement of the product and service delivered; such KPls shall be developed in agreement with the customer, whenever possible. 28. (12) The Manufacturer shall audit those systems and procedures, which are critical to product safety and quality, to ensure they are in place, appropriate and complied with, such that (a) internal audits shall be carried out by competent auditors, who shall be independent of the area of operation being assessed; and (b) documentary results of the internal audit shall be brought to the attention of the personnel responsible for the activity audited; corrective actions and time-scales for their implementation shall be agreed. 28. (13) The Manufacturer shall, when necessary, put in place investigation on processes to assess the cause of significant non-conformity with standards, specifications and procedures, which are relevant to product safety (according to HACCP principles and procedures) and quality, such that (a) causes of problems, when clearly identified, shall be used to re-engineer processes and/or procedures to avoid recurrence of the non-conformity; this information shall also, whenever possible, be used to predict potential problems and to amend working practices to ensure that problems do not occur; (b) corrective actionsshall be undertaken in a timely manner to prevent a re occurrence of the non-conformity; (c) corrective actions shall be accurately documented, assigning responsibility and accountability; (d) HACCP is the recommended tool when taking preventive actions; a careful and detailed assessment of hazards from the product development stage up to consumption shall be performed for all products; and (e) changes in existing or new production lines, equipment or products, shall be based on HACCP study/review. 28. (14) The Manufacturer shall have a system in place for the registration and management of product complaints, such that (a) the manufacturer shall implement a system for registering and processing complaints and a system for the prompt recall of products in the distribution network; recalled products shall only be put back into circulation after undergoing a quality-control reassessment; (b) appropriate actions to the seriousness and frequency of the problems identified, shall be carried out promptly and effectively; (c) complaint records and data shall, where appropriate, be used to improve the product safety and quality, and seek to avoid a reoccurrence; (d) Pet Food safety complaints shall be evaluated in the light of the current HACCP plan and the defined Critical Control Points; the evaluation may lead to a review of the HACCP plan; and (e) livestock feeds complains shall be evaluated in light of good manufacturing practices. 28. (15) The Manufacturer shall continuously improve the quality management system, such that 22 No.33310 (a) GOVERNMENT GAZETTE, 25 JUNE 2010 the Manufacturer shall continuously improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, management review and maintaining up to date documentation. Substitution of Regulation 36(2) 18. The Regulations are hereby amended by the substitution of regulation 36(2) by the following regulation 36. (2) Laboratories performing such analyses shall be accredited by South African Accreditation System (SANAS) to perform such specific analyses or be accredited by an organisation that is a member of the International Laboratory Accreditation Cooperation (ILAC) to perform such specific analyses. Substitution of Regulation 39(2) 19. The Regulations are hereby amended by the substitution of regulation 39(2) by the following regulation; 39. (2) Any fee payable in terms of these regulations shall be paid by means of a cheque, postal order, money order in favour of the Director-General: Agriculture, Reference: Farm Feeds; if such payment is delivered by hand, they may be paid in cash in which case a receipt shall be issued, and if such fees are paid electronically through an Electronic Transfer Account payment shall be made as follows; Account name: NDA-ACT36 of 1947 Account number: 11203102 Reference: 11 F1 Branch code: 010845 Branch name: Arcadia Bank name: Standard Bank Amendment of Table 2 20. The regulations are here by amended by amending Table 2 as follows; Table 2 UNDESIRABLE SUBSTANCES IN ANIMAL FEEDS [REG. 11(3)] SUBSTANCE,PRODUCTS FARM FEEDS MAXIMUM CONTENT In mg/kg (ppm) relative to a farm feed with a moisture content of 12% and pet food with a moisture content of 10% 17. Dioxins [sum of Feed material of plant origin 0.75 ng WHO-PCDD/F polychlorinated dibenzo-para- with the exception of TEQ/kg~)(-) dioxins (PCDDs) and vegetable oils and their by polychlorinated dibenzofurans products (PCDFs)]*** Vegetable oils and their by- 0.75 ng WHO-PCDD/F products TEQ/kg(@)(-) I Feed material of mineral origin 1.0 no WHO-PCDD/F STAATSKOERANT. 25 JUNIE 2010 Animal fat, including milk fat and egg fat NO.33310 23 TEQ/kg~(--) 2.0 ng WHO-PCDDIF TEQ/k9~)(-) Other land animal products 0.75 ng WHO-PCDD/F including milk andmilk TEQ/kg~)(****) products and eggsand egg products Fish oil 6.0 ng WHO-PCDDIF TEQ/kg~(-) Fish. other aquaticanimals, 1.25 ng WHO-PCDDIF their products and by-products TEQ/kg~)(****) with the exception of fish 011 and fish protein hydrolysates containing morethan 20% faW Fish protein hydrolysates 2.25 ngWHO-PCDDIF· containing morethan 20% fat TeQ/kg~)(****) The additives kaolinitic clay, 0.75 ng WHO-PCDDIF· calcium sulphate dehydrate, TEQ/kg~)("***) vermiculite, natrolitephonolite, synthetic calcium alumlnates andclinoptilolite of sedimentary origin belonging to the functional groups of binders and anti-caking agents Additives belonging to the 1.0 ngWHO-PCDDIF functional groupof compounds TEQ/kg~)(-) of trace elements Premixtures 1.0 ng WHO-PCDD/F TEQ/kg~)(-) Compound feedingstuffs, with 0.75 ng WHO-PCDDIF the exception oHeed for fur TEQ/kg~)(-) animals, pet foodsandfeed for fish Feedfor fish. perfoods 2.25 ng WHO-PCDD/F TEQ/kg~)(-) 18. Sum ofdioxinsanddioxin- Feed material of plant origin 1.25 ng WHO-PCDD/F-PCB like PCBs[sum of with the exception of TEQ/kg (-) polychlorinated dibenzo-para- vegetable oils andtheir by dioxins(PCDDs), products II polychlorinated biphenyls (PCso 24 No.33310 GOVERNMENT GAZETrE, 25 JUNE 2010 Vegetable oils and their by- 1.5 ng WHO-PCDD/F-PCB products TEQ/kg (--) Feed material of mineral origin 1.5 ng WHO-PCDD/F-PCB TEQ/kg (-) Animal fat, including milk fat 3.0 ng WHO·PCDD/F·PCB and egg fat TEO/kg (*-) Other land animal products 1.25 ng WHO-PCDD/F·PCB· including milk and milk TEQ/kg (*..*) products and eggs and egg products Fish oil 24.0 ng WHO-PCDD/F-PCB TEQ/kg (. *) Fish, other aquatic animals, 4.5 ng WHO-PCDD/F-PCB their products and by-products TEQ/kg (....) with the exception of fish oil and fish protein hydrolysates containing more than 20% fa1## Fish protein hydrolysates 11.0 ng WHO-PCDD/F-PCB containing more than 20% fat TEQ/kg (....) The additives kaolinitic clay, 1.5 ng WHO-PCDD/F-PCB calcium sulphate dehydrate, TEQ/kg (-) vermiculite, natrolitephonolite, synthetic calcium aluminates and clinoptilolite of sedimentary origin belonging to the functional groups of binders and anti-caking agents Additives belonging to the 1.5 ng WHO-PCDD/F-PCB functional group of compounds TEQ/kg (*...) of trace elements Premixtures 1.5 ng WHO-PCDD/F-PCB TEQ/kg (....) Compound feedingstuffs, with 1.5 ng WHO-PCDD/F-PCB the exception of feed for fur TEQ/kg (....) animals, pet foods and feed for fish Feed for fish, per foods 7.0 ng WHO-PCDD/F-PCB TEQ/kg (...*) STAATSKOERANT, 25 JUNIE 2010 No. 33310 25 40. Total mould count and Feed ingredients and 5000 cfulg yeast complete feed for all species 41. Escherica Coli 0157:H7 Feed ingredients and 10 cfu/g complete feed for all species 42. Enterobacteriaceae TEC Feed ingredients and 1000 cfu/g complete feed for all species 43. Salmonella in 25g Feed ingredients and Absent complete feed for all species 44. Clostridium Feed ingredients and 10 cfu/g complete feed for all species (@) The separate maximum level for dioxins (PCDD/F) remains applicable for a temporary period. The products intended for animal feed mentioned in point 27a have to comply both with the maximum levels for dioxins and with the maximum levels for the sum of dioxins and dioxin-like PCBs during that temporary period. (#:ft.) Fresh fish directly delivered and used without intermediate processing for the production of feed for fur animals is not subject to the maximum levels, while maximum levels of 4,0 ng WHO-PCDD/F-TEQlkg product and 8,0 ng WHO PCDD/F-PCB-TEQ/kg product are applicable to fresh fish used for the direct feeding of pet animals, zoo and circus animals. The products, processed animal proteins produced from these animals (fur animals, pet animals, zoo and circus animals) cannot enter the food chain and cannot be fed to farmed animals which are kept, fattened or bred for the production of food. Substitution of Table 3 21. The Regulations are hereby amended by the substitution of Table 3 with the following table; TABLE 3 PROHIBITED INGREDIENTS [REG. 11(4)(d)] 1. Faeces, urine as well as separated digestive tract content resulting from the emptying of or removal of the digestive tract. 2. Processed hide and hide treated with tanning substances, including its waste. 3. Seeds and other plant propagating materials which, after harvest, have undergone specific treatment with plant protection products for their intended use (propagation), and any derived byproducts. 4. Wood, sawdust and other materials derived from wood treated with wood protection products. 5. Sludge from sewage plants treating waste waters. 6. Solid urban waste, such as household waste. 7. Untreated waste from eating places. 8. The packaging and parts of packaging orthe use of products from the agri-food industry. 9. Untreated or unsterilized poultry litter 10. Processed hair and its by-product 26 No.33310 GOVERNMENT GAZETTE, 25 JUNE 2010 Amendment of Table 5 22. The regulations are here by amended by amending Table 5 as follows; TABLE 5 NUTRIENT REQUIRMENTS FOR COMPLETE DOG FOOD PER KILOGRAM DRY MATTER (OM) (based on 65 % digestibility) (REG. 17) Nutrient Unit/kg OM (a) Adult Minimum All stages Maximum I (b) Minimum (b) Selenium mg 0.11 0.11 2