Regulations no. 3812 of 2023 relating to Agricultural Remedies

This gazette is also available free online at www.gpwonline.co.za 26 No. 49189 GOVERNMENT GAZETTE, 25 AuGusT 2023 DEPARTMENT OF AGRICULTURE, LAND REFORM AND RURAL DEVELOPMENT NO. 3812 25 August 2023 26 No. 49189 GOVERNMENT GAZETTE, 25 AUGUST 2023 DEPARTMENT OF AGRICULTURE, LAND REFORM AND RURAL DEVELOPMENT NO. 3812 25 August 2023 FERTILIZER, FARM FEEDS, AGRICULTURAL REMEDIES AND STOCK REMEDIES ACT, 1947 (ACT No. 36 OF 1947) REGULATIONS RELATING TO AGRICULTURAL REMEDY I, Angela Thokozile Didiza, acting under section 23 of the Fertilizer, Farm Feeds, Agricultural Remediez and Stock Remedies Act, 1947 (Act No. 36 of 1947), make the regulations in the Annexure hereto. eee AT DIDI MINISTER FOR AGRICULTURE, LAND REFORM AND RURAL DEVELOPMENT This gazette is also available free online at www.gpwonline.co.za This gazette is also available free online at www.gpwonline.co.za sTAATsKOERANT, 25 AuGusTus 2023 No. 49189 27STAATSKOERANT, 25 AUGUSTUS 2023 No. 49189 27 INDEX 2! DSPACE TS ssa ear a Saee aa A acca ck nhac den uncanabarndessstonceonvbea cdot taanprinatusucnnceasan PART I - APPLICATION FOR REGISTRATION . Application for registration... i Liz stu dem ocatebekscvies sebsibGsemopeapaans tag taaniinranetcaca ceed vatvant psd avsasdans se sansumereny . Information to accompany the application, sisiestcemaven cabpeaS sable AAT aaNGSN4 NSS ahdah esse sanéaden gener Samples on request... siavenderincieysrnse® : SE RE Nn or pnctacassasesniadati savant opaneanaanmesnasentpe . Minor use registration... cry repreevoren anovanits Looaninsciannveneen kestenenaite ecievasscassbeslactebese Low-risk agricultural remedy hee aaa saakchuacaps Prioritisation of suitable alternative products Approval of registration. eee Refusal tO PeQISteP csscussscccscessscacsssoueosiecmeuesnssonsongerescoscemceeacorseenasssesessaecens tansesevavevecssbsabsavecnoinenservoveerseassenresseee4snees P O N A R S W h PART IX - PERIOD OF VALIDITY AND RENEWAL 10. Application for rEMEWAL..........:ccceccessessesssecsseseeneseanensaneerreysareysdoetenenscsiaseesonsucsusunetiueenssuedsannsstegenenntasiererecey ts 11, Request fOr 1aDEIS......crescssssensssuesessassssesrsventessscssesanenrrsrsereysensoeensanestaaenensanenes en eee nen AEE 12. Approval to renew registration a 13. Refusal of an application For reMeWAl,......rrsscssessessecussscecnisassenissneeseeaneraneersessessesenrtersesssemsenrcecssesencevaunanseaneene 14. Return of registration CErtifiCAte.........ccecseccernsecesssssesssansressusnsacsnrerseseessneerenneneseesssseetsqebeareiqseesnscsssesececeetiny PART ILI - LABELLING AND CONTAINER V5. GONE Al cicccscssscsssarserseeeeveeresscunosrspsbeseesiacanssearessvevensarsuavercerreverivessteetsequesecgaussiasaaseaesererssasevane 16. Languages ... 17. Label presentation. 18. Main display panel........... 19. Secondary display panels... a3 20. Restricted orca remedy - notice .. 21. Small Pack... ais cast rocteareecstieroummuanival a 22. Outer Packaging. 23. Units of measurements... anne aenn nn CL EE eeaneererer internet tracstarsrecerseamnetiteiteneerssentrtaneersaisaeerrreeteeeetetee ZA. COMTBIER, nc ccsersrerserecpoisnivssoscacsovacseusvissencvsvesiveoveosseravevernd(4uhestssvecsssvasectesvouaesas PART IV - IMPORTATION OF AGRICULTURAL REMEDY INTO THE REPUBLIC 25. General... 26. Application for import permit... 27. Decision on the permit application... seettereters 2B. POrt Of CNL... cecrscecrtsssseesesssanaasesssanarsnersersrornensssoneerssareentressreesaseennacnenssaueraaseeyis PART V - MANUFACTURING ESTABLISHMENTS 29. Requirements for establishments... 30. Practice to be followed at the establicanent:. ksi Sagi hasan Ciabhaacabl vane uiSslaasuon chabs an deheee sevepsmndTescbas PAR T VI - ADVERTISING OF AGRICULTURAL REMEDY 31. General... . 32. Details of advertisements... PART VII - SALE OF AGRICULTURAL REMEDY This gazette is also available free online at www.gpwonline.co.za Page number 12 13 13 13 13 14 14 14 14 15 16 16 16 16 16 17 17 18 18 18 19 This gazette is also available free online at www.gpwonline.co.za 28 No. 49189 GOVERNMENT GAZETTE, 25 AuGusT 202328 No. 49189 GOVERNMENT GAZETTE, 25 AUGUST 2023 59S SIROTA cesses sctsce ced wiicn eth du cavenvinvsedScebeseFuin os vp rob coSaNprsees ame Fervecbahais Glenqheonsiipon¥'4p t9bu se Spancensesstayeusrenastonschsnesedtaysh PART VIII - DISPOSAL OF CONTAINERS AND AGRICULTURAL REMEDY 34 GOMER oasis siceinsinizeanicsconsisy iva rtanenedecoteodé pn vnses rset vcatsues aes ssouecacazepaetngnquensSanaspasuaypuesosanpdseyriateceryrensversrrevartrisysriyottppsa8 PART IX ~ RECORDS AND RETURNS TO BE FURNISHED 35. Agricultural remedy sales InforMatiON FEPOFING.....-r.crseresneeeenesrererreeesesescieeeeee pesengsatertenansneneratsesineenen 36. Audited sale records... SE aeawadedbvadbedba eel scetvaessinicenaeed 37. Reporting on potentially harmful ¢ or unacceptable ‘effects... ecianovbardceasovecovananedhintepophijesions 38. Reporting on adverse reactions... dunner pacevassesdsdeneedaceipsd 39. Acess of information... ae anne ceeratrroaupiriscermeeesrirrerererpeesesartnsonrer mreateareemerarerreseensereesamri pec hriiee PART X - SAMPLING AND PERMISSIBLE DEVIATIONS 40. Sampling of agricultural remedy... 41. Permissible deviations in active ingredient contents... PART XI ~ APPEAL AGAINST THE DECISION OF THE REGISTRAR 42. General... isseetesisivanaeicoatbeaue tt auoweeaee 43. Address for ‘submission of appeals. PART XII - GENERAL 44. Offences and penalties.... Pyiitdaactatn tian tpaucenadpiof ey hanna acdderienebicressevGse repaske es svbisseyibunseias 45. Payment of fees... eadexe Se Re RE Ra TEER TECTURE TCL TaRETTEDERTaRETETaNeEeT 46. Address for submission of. documents... 47. Repeal of certain regulations.............. 4B. Transitional arrangeMent......susissecerseecrereccsncecesesestenebeaesueetauaeatequenerenan AQ... Short WE BAG: COMMENCEMEMNTS...reccrrrcsarsascessssssscoessssvesascarsasasssssnsessonsnaces mursseresassesonsabiyauigrddbebidals Idemecesemesstldace ANNEXURE A Criteria for low risk product, substance of concerns and restricted agricultural remedy 1. Low risk product... 2. Substance of concern . 3. Retricted agricultural remedy... Annexure B. Certificate in respect of the taking Of SAMPLES. ..........-ccccrreccnrsisestnceessesesesssesneenessessecaneneansesnceneanvarsuseerenss Annexure C, Certificate of results of analyses or test of a sample of agricultural remedy by analyst... This gazette is also available free online at www.gpwonline.co.za 20 21 21 22 22 22 22 26 26 26 27 29 This gazette is also available free online at www.gpwonline.co.za sTAATsKOERANT, 25 AuGusTus 2023 No. 49189 29STAATSKOERANT, 25 AUGUSTUS 2023 No. 49189 29 SCHEDULE 1. Definitions “active ingredient” means any part of the agricultural remedy that provides the mode of action of the agricultural remedy; “advertising” means the promotion of the sale and use of agricultural remedy by printed and electronic media, signs, displays, gifts, demonstrations or word of mouth; “APVMA” means the Australian Pesticides and Veterinary Medicine Authority; “administrative minor change” means applications that involve changes In registration holder‘s details; adding or changing emergency numbers, changes in agricultural remedy brand names, artwork changes, addition of any warning or voluntary restrictions on the label; removal of claims on the jabel; adding or changing resistance codes, adding or changing of distributor and registration details and inclusion of foreign !anquages, changes in packaging specifications not impacting the type of material and pack size “adverse reaction” means an unintended or unexpected effect on animals, people or the environment; “applicant” means a person who is a resident in South Africa in whose name an application for the registration of an agricultural remedy has been made; “approved label” means a label that meets the conditions of registration and authorised by the Registrar; “banned agricultural remedy” means an agricultural remedy of which all uses have been prohibited by final regulatory action, in order to protect human health or the environment; “bonded warehouse" means a customs and excise warehouse licensed in terms of section 19 of the Customs and Excise Act, 1964 (Act No. 91 of 1964); “CAS registry number” means Chemical Abstract Service Number; “certificate of registration” means a certificate issued by the Registrar under regulation 6(1); “co-formulant” means a non-active component of a formulated agricultural remedy; “container” means any object used to hold an agricultural remedy agricultural remedy; “date of manufacturer” means the date from which the supplier guarantees a shelf-life of at least 2 years, unless stated otherwise, under actual conditions of storage in the area where the technical grade active ingredient or formulation is to be marketed; “daughter/parallel registration” means a registration based on details of an agricultural remedy registered by another registration holder with the authorization of the principal registration holder; “declaration” means a sworn statement by an individual representing him or herself, or such person acting as designated authority of a legal person; “disposal” means any operation to recycle, neutralize, destroy or isolate agricultural remedy waste, used contalners and contaminated materials; “emergency registration” means a registration of an agricultural remedy that is granted under special circumstances for limited and controlled use, where such a registration is necessary because of urgency a danger which cannot be contained by any other reasonable use; “environment” means the surroundings within which humans exist and that are made up of— (a) water and atmosphere of the earth; This gazette is also available free online at www.gpwonline.co.za This gazette is also available free online at www.gpwonline.co.za 30 No. 49189 GOVERNMENT GAZETTE, 25 AuGusT 202330 No. 49189 GOVERNMENT GAZETTE, 25 AUGUST 2023 5 (b)} micro-organisms, plant and animal! life; (c) any part or combination of (a) and (b) and the interrelationships among and between them; and (d) the physical. chemical, aesthetic and cultural properties and conditions of the foregoing that influence human health and well-being; “expiry date” means the date up to which an agricultural remedy has been shown to retain the strength and other properties stated on the label and after which the agricultural remedy shall not be sold or used unless extended by the Registrar on presentation of evidence that the chemical and physical parameters and/or biological viability of the product remains within the registered specification; “EU means the European Union; “FAO” means the Food and Agricultural Organization of the United Nations; “formulation” means the combination of various ingredients designed to render the agricultural remedy useful and effective for the purpose claimed and for the envisaged mode of application; “FRAC” means the Fungicide Resistance Action Committee; “Good Experimental Practice (GEP)" means a practice in accordance with the provistons of European and Mediterranean Plant Protection Organisation (EPPO) Guidelines 181 and 152; “Globally Harmonized System” “or GHS" means the Globally Harmonized System of classification and labelling of chemicals, a guidance document developed by the United Nations for standardising and harmonising the classification and labelling of chemicals globally, as may be updated from time to time, commonly known as the UN Purple Book; “GHS hazard classification" means the GHS hazard classes and hazard categories assigned to agricultural remedy; “hazard” means the inherent property of a substance, agent or situation having the potential to cause undesirable consequences (e.g. properties that can cause adverse effects or damage to health, the environment or property); “hazard category” means a division of criteria within a GHS hazard class; “hazard class” means the nature of a physical, health or environmental hazard under the GHS; “hazard pictogram” means a graphical composition, including a symbol pius other graphical elements such as a border, background pattern or colour that is intended to convey specific information, that is assigned in the GHS to a hazard class or hazard category; “hazard statement” means a statement assigned in the GHS to a hazard class and hazard category describing the nature of the hazards of an agricultural remedy including, if appropriate, the degree of hazard; “hazardous waste” means any waste that contains organic or inorganic elements or compounds that may, owing to the inherent physical, chemical or toxicological characteristics of that waste, have a detrimental impact on health and the environment; “household agricultural remedy” means an agricultural remedy, which is packed or repacked primarily In a manner and quantity for use by a household consumer or for use in an office; “HRAC” means the Herbicide Resistance Action Committee; This gazette is also available free online at www.gpwonline.co.za This gazette is also available free online at www.gpwonline.co.za sTAATsKOERANT, 25 AuGusTus 2023 No. 49189 31STAATSKOERANT, 25 AUGUSTUS 2023 No. 49189 31 6 “Integrated Pest Management (XPM)means the careful consideration of ail available pest control techniques and subsequent integration of appropriate measures that discourage the development of pest populations and keeps agricultural remedy and other Interventions to levels that are economically justified and reduce or minimise risks to human and animal health and/or the environment; “Integrated Vector Management (IVM)"means the rational decision-making process for the optimal use of the sources for disease vector control. It alms to improve efficacy, cost-effectiveness, ecological soundness, sustainability for the contro! of vector-borne diseases; “IRAC” means the Insecticide Resistance Action Committee; “TUPAC” means the International Union of Pure and Applied Chemistry is an international federation of National Adhering Organizations that represents chemists; “label” means any written, printed or graphic representation attached to or included in a container of an agricultural remedy; “letter of access and supply” means original document by which the owner of data agrees to use such data under the specific terms and conditlons by the Registrar for purpose of granting a registration of agricultural remedy for the benefit of another applicant and understakes to supply the active ingredient should the registration be granted ; “low risk agricultural remedy” means substance which has been evaluated as having a low risk. Such substances meeting the criteria as set out in annexure A;. “minor use” means the use for which the demand originates with a grower or a group of growers for an agricultural remedy which is intended to be used on & particular pest in connection with a particular host organism, in al! of the following circumstances: (a) the use Is for an agricultural purpose ; (b) government supports the use; and (c) the use is supported by crop residue data and extrapolation of supporting efficacy data; “OECD” means Organization for Economic Cooperation and Development; “OECD GLP” means the OECD Principles of Good Laboratory Practice; “packaging” means the container together with the protective wrapping used to carry an agricultural remedy via wholesale or retail distribution channels to users; “person” means a natural person ar juristic person (company); “pictogram” means a graphical composition that may include a symbol plus other graphic elements, such as a border, background pattern or colour that is intended to convey specific information; “precautionary statement” means a phrase prescribed by the GHS that describes recommended measures that should be taken to minimise or prevent the— (a) adverse effects resulting from exposure to an agricultural remedy; or (b} improper storage or handling of an agricultural remedy; “product” means the formulated agricultural remedy [actlve ingredient(s) and co- formulants] in the form in which it ls packaged and sold; This gazette is also available free online at www.gpwonline.co.za This gazette is also available free online at www.gpwonline.co.za 32 No. 49189 GOVERNMENT GAZETTE, 25 AuGusT 202332 No. 49189 GOVERNMENT GAZETTE, 25 AUGUST 2023 7 “registration” means the process whereby the Registrar approves the manufacturing, packaging, sale and use of an agricultural remedy following an evaluation of scientific data aimed at demonstrating that the agricultural remedy is effective for its intended purposes and does not pose unacceptable risk to human or animai health or the environment; “registration holder” means the person whom a certificate of registration In respect of a particular agricultural remedy has been issued to; “registered name” means the name approved by the registrar under which a agricultural remedy is registered and may be sold; “restricted agricultural remedy” means an agricultural remedy which the Registrar, out of concern for its human health or environmental risks, has set out additional information to be shown on the label concerning essential conditions in respect of the display, distribution or limitations on use of, or qualifications of persons who may use the agricultural remedy, and such remedy shall comply with the criteria as set out in annexure A; “recycle” means separation of waste from a waste stream for further use and the processing of that separated material as an agricultural remedy or raw material; “SACNASP"” means South African Council for Natural Scientific Professions Act, 2003 (Act No.27 of 2003); “small pack” means a pack which js not large enough for ail the information required by Regulations 16 and 17 to be presented in legible print; “signal word” means the word "danger" or "warning" used on a GHS-aligned label to indicate to the reader a potential hazard, as well as the relative severity level of such hazard; “standards” means those specifications established by the FAO/WHO, APVMA, EU, and USEPA to determine equivalence for active ingredients; “substances” means chemical elements and their compounds, es they occur naturally or by manufacture, including any impurity Inevitably resulting from the manufecturing process; “substances of concern” means any substance which has an inherent capacity to cause an adverse effect on humans, animals or the environment and is present or is produced in an agricultural remedy in sufficlent concentration to present risks of such an effect. Such substances shall comply with the criteria as set out in annexure A.; “symbol” means graphical element intended to succinctly convey information; “the Act’? means Fertilizer, Farm Feeds, Agricultural remedy and Stock Remedies Act, 1947 (Act No. 36 of 1947) as amended; “toxicity” means a physiological or biological property which determines the capacity of a chemical to do harm or produce injury to a living organism by other than mechanical means; “trademark” means a mark to which the holder of the registration has the right either as owner or 4 registered user thereof, to distinguish his/her agricultural remedy from that of any other manufacturer but excludes the registered name of an agricultural remedy as intended in these regulations. “UN IMO International Maritime Dangerous Goods Code” means the International Maritime Organization's (IMO's) International Maritime Dangerous Goods (IMDG) Code, which was developed as an international code by the IMO, an agency of the United Nations, for the maritime transport of dangerous goods in packaged and bulk form, with particular reference to the segregation of Incompatible substances, as may be updated from time to time; This gazette is also available free online at www.gpwonline.co.za This gazette is also available free online at www.gpwonline.co.za sTAATsKOERANT, 25 AuGusTus 2023 No. 49189 33STAATSKOERANT, 25 AUGUSTUS 2023 No. 49189 33 8 “UN number” means the four-digit identification number assigned to an agricultural remedy In the UN Transport of Dangerous Goods: Model Regulations, as may be updated from time to time; “UN proper shipping name” means the proper shipping name of an agricultural remedy as specified in the UN Transport of Dangerous Goods: Model Regulations, most accurately describing the goods, as may be updated from time to time; “USEPA” means United States Environmenta! Protection Agency; “WHO” means World Health Organization; “withholding period” means minimum permissible time allowed between the last application of an agricultural remedy and harvesting of an edible commodity for human consumption or grazing by livestock. PARTI APPLICATION FOR REGISTRATION Application for registration 2. (1) An application in terms of section 3(1) of the Act to register agricultural remedy or amend the registration shall be submitted to the Registrar in duplicate form obtainable from the Registrar’s office. {2} An application may only be made by a person who is a resident in the Republic, or, in the case of a juristic person, who has a registered office in the Republic. Information to accompany the application 3. An application shall be accompanied by— (a) applicant’s name, business address, e-mail address, telephone number and signature or if the application is made by a representative on behalf of the applicant, both the representative’s and the applicant’s name and address business address, e-mall address, telephone number and the representatives’ signature; (b) the name and address of place of manufacture of the agricultural remedy; (c) where relevant, all necessary scientific information as indicated on the application form; (d) the applicable prescribed application fee; (e) letter of access and supply, where relevant; (f} GHS compliant safety data sheet and information presented in accordance sub regulation 14A(3) of the Hazardous Chemical Agents, 2021, published as in Government Notice No. R. 280 of 29 March 2021; {g) two printed copies of a typed label, in English; (h) where relevant, all scientific documentation required to demonstrate the safety, quality and efficacy of the agricultural remedy In respect of any of the following as set out in the guidelines issued by the Registrar’s Office: (i) chemical name, common chemical name and CAS registry number of the active ingredient(s), its percentage of the total weight of the agricultural remedy in which it is contained, the name of each impurity that it contains, and the This gazette is also available free online at www.gpwonline.co.za This gazette is also available free online at www.gpwonline.co.za 34 No. 49189 GOVERNMENT GAZETTE, 25 AuGusT 202334 No. 49189 (ii) (iii) (iv) (vy) (vi) (vii) (viii) (ix) (x) (xi) (xil) (xiii) (xiv) (xv) (xvi) (xvii) GOVERNMENT GAZETTE, 25 AUGUST 2023 9 percentage of total weight of each impurity; name and address of the supplier(s); in case of an agricultural remedy that contains one or more co-formulants, the name of each formulant, its CAS registry number, expressed In gram per Iltre or gram per kilogram of the total weight of the agricultural remedy, purpose of each whereco-formulants in the agricultural remedy; other physical and chemica! properties of the agricultural remedy and its active ingredient, or the species or strain and biological properties; the size, type and specifications of the container In which the agricultural remedy is to be distributed; validated methods of analysis for determining the active ingredient, metabolites and impurities; results of flve batch analysis studies generated in accordance with OECD GLP; toxicological, metabolism and exposure data of the active ingredient and agricultural remedy generated in accordance with OECD GLP; data on the effect of exposures on children; ecotoxicological data wildlife, aquatic organisms and non-target organisms of the active ingredient generated In accordance with OECD GLP; the environmental fate of the agricuitural remedy, including data relating to the degree of persistence, retention, movement, bie-accumulation and metabolic breakdown of its active ingredient in the environment generated in accordance with OECD GLP ; chemistry of the residue of the agricultural remedy and its active ingredient on the crop or feed and the methods of extraction, detection and analysis of such residue generated in accordance with OECD GLP; proposed Maximum Residue Limit(s) and withholding periods in accordance with the Foodstuffs, Cosmetics and Disinfectants Act (FCDA), 1972 (Act No. 54 of 1972) or a justification for not supplying such information; efficacy and phytotoxicity data generated under the supervision of a person registered with SACNASP; data on the effect on bees and other pollinators generated under the supervision of a person registered with SACNASP; an assessment report(s) for each study that has been signed by a person registered with SACNASP; efficacy and phytoxicity must be generated according to GEP; in case of aerial application, risk assessment report to demonstrate clear advantages in terms of reduced impacts on human health and the environment in comparison with other spraying methods; (xviii) where applicable, proof of compliance with the waste management measure in accordance with the Extended Producer Responsibility Scheme for the Pesticide Sector regulation, 2023, published as in Government Notice No. R. 3177 of 23 March 2023; This gazette is also available free online at www.gpwonline.co.za This gazette is also available free online at www.gpwonline.co.za sTAATsKOERANT, 25 AuGusTus 2023 No. 49189 35STAATSKOERANT, 25 AUGUSTUS 2023 No. 49189 10 (xix) in case where the agricultural remedy has been registered or refused approval for use in any foreign country — (aa) the name of the foreign country; (bb) proof of such registration or approval in the form of a registration certificate or approval certificate; (cc) the limitations, If any, imposed in the foreign country on the use of the agricultural remedy; (dd} if refused, reasons for such decision; and (ee) if banned, reasons for such decision, (xx) checklist demonstrating that dossier prov ded is complete; and (xxl) any other information as may be required by the Registrar. i. The applicant shall sign the declalration that the agricultural remedy does not contain active ingredient(s) and/or co-formulant(s) or biological organisms regarded as a substance of concern or no new sclentific evidence is available on the agricultural remedy’s potential health effects for vulnerable groups, especially children. j. The applicant shall sign the declaration that all the information provided is authentic, accurate and complete. Samples on request 4, On application to register an agricultural remedy or amend the registration, the applicant must, if requested by the Registrar, provide the Registrar with a sample of— (a) the agricultura! remedy; (b} the technical grade of its active ingredient; and (c) the laboratory standard of its active ingredient. Minor use registration 5. The Registrar may, within a reasonable period of time, expedite the review of any application for minor use in respect of an agricultural remedy registration Low-risk agricultural remedy 6. The Registrar may, within a reasonable period of time, expedite the review of any application of low-risk agricultural remedy registration. Prioritisation of suitable alternative products 7. The Registrar shall prioritize the review and registration for suitable alternative solutions for substances of concern. Approval registration 8. (1) The Registrar must grant the registration If satisfied with the following: {ay all the information contained and submitted with the application are complete and true in all materia! particular; This gazette is also available free online at www.gpwonline.co.za 35 This gazette is also available free online at www.gpwonline.co.za 36 No. 49189 GOVERNMENT GAZETTE, 25 AuGusT 202336 No. 49189 GOVERNMENT GAZETTE, 25 AUGUST 2023 (b) (c) (d) 1) (f) (9) 1 the agricultural remedy will perform its intended function without unreasonable adverse effects on the environment and human health, and that, when used in accordance with widespread and commonly recognized practice, the agricultural remedy will not cause unreasonable adverse effects on the environment and human health risks; active ingredient complles with the standards; does not contain substances of concern or agricultural remedy banned In the Republic of South Africa; the agricultural remedy is effective for the purpose claimed when used according to the label instructions, and Its jabeling and packaging comply with the applicable requirements of this regulation; if the proposed labeling bears directions for use on food crops, or if the intended use of the agricultural remedy results or may reasonably be expected to result, directly or indirectly, in agricultural remedy residues (including residues of any active or inert ingredient of the agricultural remedy, or of any metabolite or degradation agricultural remedy thereof) in or on food are in accordance with the Foodstuffs, Cosmetics and Disinfectants Act (FCDA), 1972 (Act No. 54 of 1972); and the agricultural remedy complies with the requirements of the Act and these regulations, the Registrar shall register the agricultural remedy and issue a certificate in term of Section 3(3) of the Act. (2) The certificate of registration shall contain the following Information relating to the agricultural remedy: (a) (b) (c) (d) (e) detalls of the registration holder; trade name active ingredients; registration number; and any conditions of registration the Registrar may have determibed. (3) The Registrar may approve a daughter/parallel application that uses data submitted in support of an existing registered agricultural remedy, with the permission of the holder of that registration, on the same conditions as those Imposed on the existing registration, assign a registration number thereto, and issue a registration certificate to the applicant. (4) If the holder of an agricultural remedy registration notifies the Registrar of an administrative minor change and provides a declaration confirming that no other changes in the registration details have been made, the Registrar shall advise the registration holder approval for such change has been granted. (5) In exceptional circumstances, where there is no other agricultural remedy for the intended use, the Registrar may grant an exceptional registration for the emergency use for period not exceeding 24 months. (6) Notwiththanding regulation 8(1(d), in exeptional circumstances, where there are no other agricultural remedy, the Registrar may grant registration of an implicated agricultural remedy when the following conditions are met: This gazette is also available free online at www.gpwonline.co.za This gazette is also available free online at www.gpwonline.co.za sTAATsKOERANT, 25 AuGusTus 2023 No. 49189 37STAATSKOERANT, 25 AUGUSTUS 2023 No. 49189 37 12 (a) the risk to humans, animals or the environment from exposure to the active substance in an agricultural remedy, under realistic worst-case conditions of use, is negligible or, (b) there is evidence that the active substance is essential to prevent or control a serious danger to human health, animal health or the environment; or (c) not approving the active substance would have a disproportionate negative impact on society when compared with the risk to human health, animal health or the environment arising from the use of the substance. (7) In this case, approval of an agricultural remedy may be granted for a specified period, and for restricted uses following publication of the risk assessment report for public comments by the applicant. Refusal to register 9. The Registrar may refuse to register an agricultural remedy, if the agricullural remedy does not meet the requirements for registration as contemplated in regulation 8. PART II PERIOD OF VALIDITY AND RENEWAL Application for renewal 10. (1) A certificate of registration Issued under section 3 of the Act shall, be valid for a period of three years from the date of issue and may thereafter be renewed in terms of section 3(4) of the Act for a additional periods of three years. (2) The registration holder sha!l apply for the renewal of registration of the agricultural remedy at least two months (60 days) before the expiry date; (3) An application referred in sub-regulation (2) shall be accompanied by— (a) prescribed renewal fee; (b) registration certificate; (c) In the case of a registration certificate that was issued in the circumstances described in regulation 8(3), where relevant, a copy of daughter/parallel contract(s) signed and dated within six months of the submission of the renewal application; (d)} information required by regulation 34(4); (e) declaration that the agricultural remedy does not contains active ingredient(s) and/or co-formulant(s) or biological organisms regarded as a substance of concern; (f} declaration that no new scientific evidence is avallable on the agricultural remedy’s potential health effects for vulnerable groups, especially children; (g) where relevant, signed and dated letter from the manufacturing source of the active ingredient(s) issued within six months of renewal submission; (h) a declaration confirming that the details furnished with such application in respect of the agricultural remedy concerned or of a label which is being used in This gazette is also available free online at www.gpwonline.co.za This gazette is also available free online at www.gpwonline.co.za 38 No. 49189 GOVERNMENT GAZETTE, 25 AuGusT 202338 No. 49189 GOVERNMENT GAZETTE, 25 AUGUST 2023 13 connection therewith, do not deviate in any manner whatsoever from the congruent details which have already been registered or approved in relation to that agricultural remedy or label; (i) where relevant, proof of compliance with the Extended Producer Responsibility Scheme for the Pesticide Sector regulation, 2023, published as in Government Notice No. R. 3177 of 23 March 2023; (j) where relevant, records of compliance with regulations 37 and 38. (4) Notwithstanding sub-regulation (2), the Registrar may upon payment of late penalty fees accept an application for the late renewal if it is submitted within 30 days after an expiry date of the registration certificate. Request for labels 41. The Registration holder shall, if requested by the Registrar, provide the Registrar with an electronic copy of the approved {abel and printed copies of the commercial iabel. Approval to renew a registration 12. (1) If the Registrar is satisfied that an application for the renewal of a registration meets the application requirements under regulation 8(3), the Registrar shall renew the registration and issue the registration certificate subject to conditions of renewal. (2) In the event that the new registration certificate cannot be issued before the expiry date, the Registrar shall, on request, provide the registration holder with a letter acknowledging receipt of a valid renewal application and confirming the extended validity of the current registration. Refusal of an application for renewal 13. The Registrar may refuse to renew an agricultural remedy, if (a) the agricultural remedy does not meet the requiremements under regulations 8(3) (b) conditions of registration Imposed on the registration certificate are not met. Return of registration certificate 14, (1) The registration certificate issued in terms of section 3(3) of the Act, shall be returned in terms of section 4A(3) of the Act by the registration holder to the Registrar— (a) within fourteen days of the date on which: (i) a person to whom the certificate of registration in question had been issued, was notified in writing of the reasons for the cancellation of such registration or; Gi) registration of the agricultural remedy concerned has lapsed, (b) at least 30 days prior to the date on which the registration of an agricultural remedy, Is to be transferred to another person or (c) on cancellation of the registration by the registration holder. (2) If the original certificate of registration is lost, an affidavit shall be submitted to the Registrar's office within fourteen days of its loss. This gazette is also available free online at www.gpwonline.co.za This gazette is also available free online at www.gpwonline.co.za sTAATsKOERANT, 25 AuGusTus 2023 No. 49189 39STAATSKOERANT, 25 AUGUSTUS 2023 No. 49189 39 14 PART III LABELLING AND CONTAINER Generat 15. {1) The classification and labelling agricultural remedy shall be in accordance with GHS and the Hazardous Chemical Agents, 2021, published in Government Notice No. R. 280 of 29 March 2021. (2) The registration holder shall be responsible to ensure the accuracy of the GHS classification of the agricultural remedy. Should there be any reason to question the GHS classification of the agricultural remedy, the Registrar may require an independent review of the classification by a qualified expert at the cost of the registration holder. In the event that such a review finds that the classification is incorrect, the Registrar shall require the correction of the label and, If deemed appropriate, the withdrawal of product with the incorrect label. (3) No agricultural remedy shall be distributed or sold without a label including the package leaftets approved by the Registrar. Languages 16. All labels and package leaflets shall be in English but may contain other languages provided that the information given Is identical to the approved label. Label presentation 17. (1) Alt Information on the label that is required to be shown on a label shall appear in a manner that is clearly legible and indelible. {2) Any written, printed or graphic matter on the label shal! not detract from or obscure the required information. (3) The label of a registered agricultural remedy shall consist of a main panel and a number of secondary panels. (4) The label layout shall be in terms of the guideline issued by the Reglstrar’s office. (5) All labels shall be accompanied by information defining what the hazard statement, GHS pictograms and signal symbols/wardson the label mean, and safety behaviours required to reduce exposure risks. These can be in the form of a removable leaflet for containers or part of QR codes (Quick Response Code). Main display pane! 18. The main pane! of agricultural remedy shall show the following information: (a) praduct name of the agricultural remedy, which may include distinctive brand or trademark and the common name of its active ingredient; (b) agricultural remedy type, which shall be descriptive of its general purpose; (c) formulation type of the agricultural remedy; (d) instruction to the user to read the label which statement shall be In capital letters in the following form—"READ THE LABEL BEFORE USE”; (e) instruction to the user on storage which shall be in capital letters—KEEP OUT OF REACH OF CHILDREN AND ANIMALS; This gazette is also available free online at www.gpwonline.co.za This gazette is also available free online at www.gpwonline.co.za 40 No. 49189 GOVERNMENT GAZETTE, 25 AuGusT 202340 No. 49189 GOVERNMENT GAZETTE, 25 AUGUST 2023 {f} (9) (h) (i) (i) (k) 15 the statement, as follows: (i) the word “ACTIVE INGREDIENT:” or ACTIVE INGREDIENTS:" as the case may be; (ii) the common chemical name of the active ingredient(s) expressed (according to ISO) or other focally used common name, or, In the absence of either, the chemical designation according to IUPAC; (iii) If the active ingredient is a microbiological organism or macrobiological organism, it must identified by genus and species (and If appropriate, also by subspecies and/or isolate/strain number); (iv) active ingredient content expressed as “contains X g a.l. per kg" for solids including mosquito coils, viscous liquids, aerosols or volatile liquids) or "contains X g a.i. per litre” (for other liquids). For vaporising mats, contents are expressed as mg/mat; (v) If the active ingredient Is a microbiological or macorbiological organism, content must be expressed as International Toxic Units (ITU) per mg product or as the number of viable units (spores, cells, colony forming units (cfu), etc.) per unit mass or volume product and macrobials insects unit per container at 20 degrees Celsius; a declaration of net quantity of the agricultural remedy in the contalner. This should be expressed in metric units (e.g. litre, gram, kilogram, which can be abbreviated to L, g and kg), or in number (e.g. for the pheromone dispensers or macro biological organisms)) in accordance with Legal Metrology Act, 2014 (Act No. 9 of 2014); registration number of the agricultural remedy concerned together with a reference to the Act expressed as “Reg. No ...Act No. 36 of 1947', which shail appear below or above the trademark or trade name; where applicable, the registration holder name; company registration registration number, physical contact details and telephone number, where applicable; information on the date of manufacture, batch number, shelf-life or expiry date, for product with a shelf-life of less than 2 years from the release date; and where applicable, the UN number in accordance with the National Road Traffic Act, 1996 (Act No. 93 of 1996). Secondary display panels 19. The secondary panels of the registered agricultural remedy shail show all the foltowing information: (a) Under SAFETY INFORMATION, the applicable GHS classification, pictogram, signal word, hazard statement(s), precautionary statement{s) and a list of the chemical identities of all co-formulants which contributed to the GHS health effect classification of the agricultural remedy. This shall be followed by the phrase “In case of poisoning, call the follawing number” with the contact details of a national or provincial poison information centre and the phrase “Emergency number” with the number of the registration holder’s own disaster management centre or its contracted disaster management service provider This gazette is also available free online at www.gpwonline.co.za This gazette is also available free online at www.gpwonline.co.za sTAATsKOERANT, 25 AuGusTus 2023 No. 49189 41STAATSKOERANT, 25 AUGUSTUS 2023 No. 49189 41 16 (b) under the heading “DIRECTIONS FOR USE”, and where applicable resistance warning statement and symbols as per the mode of actions described in IRAC, FRAC and HRAC, IPM/IVM advice,use restrictions, waiting period for follow-up crops, compatibility staternents, mixing instructions in the form of a table, the actual uses of the agricultural remedy concerned after such mixing shall be Indicated under those headings. (c) include NOTICE TO THE USER: “This agricultural remedy is to be used only in accordance with the instructions on the tabel. It is an offence under the Act to use this agricultural remedy for any purpose in a manner contrary with the directions on the label”; {d) reference to the relevant and applicable phrases of the SA National Standard for the aerlal application of pesticides SANS 10118 if the agricultural remedy is registered for aerial application; and (e) where applicable, the statement ‘READ ATTACHED PACKAGE LEAFLET BEFORE USING’. Restricted agricultural remedy— notice 20. If the agricultural remedy designation “RESTRICTED”, the notice that is required by regulation 18(c) shall appear prominently at the top of the secondary display panel, followed by the heading “RESTRICTED USES”, followed by the directions for use, the application rates, the timing and frequency of application and the {imitations on the use of the agricultural remedy to which the restriction relates. Small pack 21. Where the information required by regulation 18 and 19 cannot fit on the container, the container may be labelled to include the information referred to regulation 18 sub-paragrpahs (a), (b), (c}, (4), (F),(9), (h) and (1), and requlation 19 sub-paragraphs (a), (b), (c), and (e) while the rest shall be presented in a brochure/leaflet QR code attached to the container of the agricultural remedy agricultural remedy or a QR code may be e added for access to e-labelling. Outer packaging 22. A casing in which an agricultural remedy is packed for transport shall, in addition to any labelling or markings required in terms of the Natlonal Road Traffic Act, 1996 (Act No. 93 of 1996), be labelled with the applicable details as required by regulation 18 sub-paragrahs (a) and (k). Units of measurements 23. All units of measure shown on every label shall be expressed in accordance to the Legal Metrology Act, 2014 (Act No. 9 of 2014). Container 24. (4) Every container for an agricultural remedy shall be approved by the Registrar. {2) Container for an agricultural remedy must satisfy the relevant requirements of the UN Transport of Dangerous Goods with respect to packaging and fastenings, or, where applicable, the UN IMO International Maritime Dangerous Goods Code, including the following requirements— (a} is in good condition and legibly labelled; (b) it is sufficiently durable, be designed and manufactured to contain the agricultural remedy safely under normal conditions of storage, display and distribution; This gazette is also available free online at www.gpwonline.co.za This gazette is also available free online at www.gpwonline.co.za 42 No. 49189 GOVERNMENT GAZETTE, 25 AuGusT 202342 No. 49189 GOVERNMENT GAZETTE, 25 AUGUST 2023 17 (c) the container shall not resemble any container that commonly contains food or beverages and cannot mistakenly be identified as containing food or beverages; (d) It must be closed or sealed In the manner that permit the content of an agricultural remedy to be safe to the user; (e) the container is made of a material that is compatible with the agricultural remedy and will not be adversely affected by the agricultural remedy; (f) it is constructed to minimize the degradation or change of its contents resulting from any interactions; (9g) it is designed and manufactured to prevent spillage when pouring out the contents In case of a liquid agricultural remedy. PART IV IMPORTATION OF AN AGRICULTURAL REMEDY INTO THE REPUBLIC General 25. (1) No person shall import an agricultural remedy into South Africa unless that person is in possession of registration certificate issued under these Regulations. (2) No person shall import any agricultural remedy into South Africa unless such the agricultural remedy is registered, packed and labelled according to these regulations. (3) Notwithstanding what Is set out under sub-regulations (1) and (2), the Registrar may in writing permit the import of any consignment of agricultural remedy. Application for import permit 26. An application for the importation of an agricultural remedy shall contain at least the following: (a) applicable fees; (b) name of the agricultural remedy; (c) common chemical or other name of the active ingredient of the agricultural remedy and the amount it contains in the agricultural remedy; (d) details of the manufacturer of the active ingredient; (e) the total amount of the agricultural remedy belng imported, {f) name and address (postal and physical) of the applicant; (9) designation of the person representing the applicant; (h) contact details of the applicant (telephone and email address); (i) where relevant, registration number of agricultural remedy in the country of destination ; () batch number; (k} purpose of the importation; l.e. research; export to other countries ; This gazette is also available free online at www.gpwonline.co.za This gazette is also available free online at www.gpwonline.co.za sTAATsKOERANT, 25 AuGusTus 2023 No. 49189 43STAATSKOERANT, 25 AUGUSTUS 2023 No. 49189 43 18 (I) in case of importation for manufacturing, copy of proof of approval by the relevant authority that such agricultural remedy can be manufactured in South Africa; (m) details of the bonded warehouse, in case it Is for export; {n) copy of foreign registration or authorisation document in case for import for export; {o) copy of the research plan approved by a suitable qualified person, where applicable; and {p} where relevant, proof of compliance issued in terms of other applicable South African legislation(s) and regulations governing such agricultural remedy. Decision on the permit application 27. The Registrar may approve an import permit application made under regulation 26 if the Registrar is satisfied that— (a) the agricultural remedy does not contain active ingredient(s) and/or co formulant(s) regarded as a substance of concern or the agricultural remedy is not banned tn the Republic; unless if It 1s for export; and (b) import is for experimentation, laboratory analysis or some other purpose other than for sale. (c) Import permits meet the application requirements under regulations 26 Port of entry 28. (1) Unless the Registrar directs otherwise, no person shall import any agricultural remedy in terms of section 16 of the Act into the Republic of South Africa except through one of the fo/lowing ports of entry: (a) Cape Town International Airport or Cape Town harbour; (b) Port Elizabeth Internationat Airport or Port Elizabeth harbour or COEGA harbour; (c) King Shaka International Airport or Durban harbour; (d) Richards Bay harbour;and (e) O.R. Tambo International Airport. (2) Agricultura! remedy imported for export shall be stored in bonded warehouse while in the Republic, unless it is transmitted through the Republic, during which it shall be contained In bonded containers. PART V MANUFACTURING ESTABLISHMENTS Requirements for establishments 29. (1) An establishment where an agricultural remedy is manufactured, controlled, stored, packed or labelled shall have measures to contain fire or spillage to the environment, well-maintained sprinkler systems; run-off containment on the boundaries of the site in the event of flooding and fire management and other appropriate fire management. {2} The premises of such establishment shall be kept orderly and clean. This gazette is also available free online at www.gpwonline.co.za This gazette is also available free online at www.gpwonline.co.za 44 No. 49189 GOVERNMENT GAZETTE, 25 AuGusT 202344 No. 49189 GOVERNMENT GAZETTE, 25 AUGUST 2023 19 (3) The area at such establishment which is used for the performance of a particular function In connection with the manufacture, control, packing or labelling of an agzicultural remedy shall be adequate for the proper carrying out of that function. Practice to be followed at the establishment 30. The Registration holder shall ensure that— {a) there is compliance with Hazardous Chemical Agents, 2021, published as Government Notice No. R. 280 of 29 March 2021. {b) the agricultural remedy is manufactured in accordance with the processes and in facitities that were approved for registration; {c) each agricultural remedy batch is fully tested, including a full qualitative analysis, a quantitative analysis of active ingredient(s) and all the physical tests or controls necessary to ensure quality Is in accordance with the data filed and accepted by the Registrar in support of the application for registration of the agricultural remedy; {d) representative samples of each agricultural remedy on batch is kept under controlled storage conditions for approved shelf life period; (e) comprehensive records lists and quantities of agricultural remedy under production or storage as well as source(s) indicating the source of the active ingredient(s), details of the raw material(s) used and results of quality controls tests conducted are kept, and shall be— (i) maintained for five years from the time it is made; and (ii) made available to the Registrar at such times and in such manner as the Registrar may requlre. PART VI ADVERTISING OF AN AGRICULTURAL REMEDY General 31. (1) A registered agricultural remedy may be advertised to the public. (2) No advertisement for an agricultural remedy may contaln a statement, which deviates from, conflicts with or goes beyond the scope of the approved label or data filed In support of the application for its registration. (3) No person shall advertise any agricultural remedy that Is not registered under the Act. (4) No advertisement for an agricultural remedy may contain pictures of children, (5) An advertisement shail not contain any visual representation of potentially dangerous practices, such as mixing or application without sufficient protective clothing, use near food or use by or in the vicinity of children. (6) Advertisement shall draw attention to the appropriate warning phrases and symbols. The Warnings on Television must be at least a font size 10 and shown for 10 seconds. (7) Advertisement shall not guarantee or imply guarantees, such as “more profits with “or “guarantees high yields," unless definite evidence to substantiate such claims Is available. This gazette is also available free online at www.gpwonline.co.za This gazette is also available free online at www.gpwonline.co.za sTAATsKOERANT, 25 AuGusTus 2023 No. 49189 45STAATSKOERANT, 25 AUGUSTUS 2023 No. 49189 45 20 (8) No person shail publish or distribute any false or misleading advertisement relating to an agricultural remedy. (9) An advertisement shall be deemed false or misleading if it contains one or more of the following or any graphic representation which is likely to be deceiving or misleading: (a) a statement concerning the effectiveness of the agricultural remedy unless this can substantiated by data that has been approved by the Registrar; (b) comparison with another agricultural remedy; (c) statement likely to create misunderstanding about the effectiveness and safety of the agricultural remedy; (d) use statements such as "non-toxic", “non-harmful", "non-polluting" or "non hazardous” or simtlar statements indicating the agricultural remedy as not hazardous, or other statements that are inconsistent with the agricultural remedy's GHS classification on its label or packaging; (e) any statement directly or indirectly Implying that a specific brand of an agricultural remedy is recommended or endorsed by Government or any entity thereof. Details of advertisements 32. (1) An advertisement for an agricultural remedy referred in regulation 30 shall contain— (a) the registered name of the agricultural remedy; (b) where relevant, the restriction category; (c} the applicable GHS hazard signal word and hazard statement; {d) the name and amount(s) of the active ingredient(s) which It contains; (e) the registration number of the agricultural remedy with a reference to the Act as “Reg. No. Act 36 of 1947”; (F) the statement to encourage user to read the label; and (9) the name, contact details and address of the registration holder PART VII SALE OF AGRICULTURAL REMEDY General 33. (1) No person may distribute or sell a registered agricultural remedy with a composition, container and labelling not approved by the Registrar. (2) An agricultural remedy shall be distributed or sold in accordance with the conditions of registration. (3) Any person in control of an establishment selling, supplying or making available agricultural remedy shall comply with the requirements in terms of the Hazardous Substances Act, 1973 (Act No. 15 of 1973). This gazette is also available free online at www.gpwonline.co.za This gazette is also available free online at www.gpwonline.co.za 46 No. 49189 GOVERNMENT GAZETTE, 25 AuGusT 202346 No. 49189 GOVERNMENT GAZETTE, 25 AUGUST 2023 21 (4) A person shall not supply a restricted agricultural remedy, or permit a restricted agricultural remedy to be supplied, to a person who is not authorised to use the agricultural remedy under these regulations. (5) No person shall sell an agricultural remedy for any purpose or for any manner of application other than those stated by the fabel of such agricultural remedy. (6) Any person in control of an establishment that sells agricultural remedy, including through Internet sales, shall provide safety instructions, training and awareness to the distributors, advisors and users of pesticides on safety instructlons for human health and the environment. PART VIII DISPOSAL OF CONTAINERS AND AGRICULTURAL REMEDY General 34. (1) No person shali dispose of agricultural remedy and their empty containers or parts in such a manner as to endanger humans and their environment. (2) Where applicable, all containers must be recycled as a waste management measure as outlined in the the Extended Producer Responsibility Scheme for the Pesticide Sector regulation, 2023, published as in Government Notice.No. R. 3177 of 23 March 2023; (3) Agricultural remedy shall be disposed in terms of the the National Environmental Management Waste Act (Act 59 of 2008). (4) Comprehensive records of details of empty containers disposed and agricultural remedy as per sub-regulations (2) and (3) Including results of quality controls tests conducted shall be kept, and shail be— (a) maintained for five years from the time it is made; and (b) made available to the Registrar at such times and in such manner as the Registrar may require PART IX RECORDS AND RETURNS TO BE FURNISHED Agricultural remedy sales information reporting 35. (1) For the purpose of interpreting these Regulations, a quantity of agricultural remedy sold by the registration holder includes any quantity that the registration holder provides to a distributor for sale on the registration holder’s behalf. (2) The registration holder of an agricultural remedy shall submit sales information report annually and include alt the following information: (a) registration holder's name, postal address and telephone number; {b} date of the report; (c) calendar year covered by the report; (d) name and registration number of the agricultural remedy; and (e) quantity of agricultural remedy sold in the Republic, expressed in the unit of measurement identified in the declaration of net quantity in accordance to the Legal Metrology Act, 2014 (Act No. 9 of 2014). This gazette is also available free online at www.gpwonline.co.za This gazette is also available free online at www.gpwonline.co.za sTAATsKOERANT, 25 AuGusTus 2023 No. 49189 47STAATSKOERANT, 25 AUGUSTUS 2023 No. 49189 47 22 (3) A report referred in sub-regulation (2) Is for a period of one calendar year and shall be submitted on or before 31°* of May the year following the calendar year covered by the report in a form and manner directed by the Registrar. (4) The registration holder shall keep all original records and supporting data that relate to the sates information included in a report under sub-regulation {2) for five years after the day on which the report is submitted to the Registrar, and shall provide the records and data to the Registrar on request for verification and auditing purposes. Audited sale records 36. If the Registrar reasonably betieves, on the basis of any information avaitable to the Registrar, that the sales information submitted in respect of an agricultural remedy is inaccurate or incomplete, the Registrar shall, at the cost of the registration holder, require the registration hoider to submit the sales information for that agricultural remedy in a report prepared by an independent auditor, Reporting on potentially harmful or unacceptable effects 37. The holder of registration of an agricultural remedy shall immediately notify the Registrar in a form and manner directed by the Registrar of any new information concerning that active ingredient(s) or co-formuiant(s) contained in that agricultural remedy, which suggests that the agricultural remedy no longer complies with the criteria set out regulations 8(1) sub-paragraphs (c),(d), and (f). Reporting on adverse reactions 38. If during the registration process or at any time after the registration of an agricultural remedy, the registration holder has factual or scientific evidence of any adverse effect or risk of the agricultural remedy to human health or the environment, the registration holder shall immediately submit such evidence to the Registrar In a form and manner directed by the Registrar. Access of Information 39 The Registrar shall provide a quarterly updated list of registered agricultural remedies. PART X SAMPLING AND PERMISSIBLE DEVIATIONS Sampling of agricultural remedy 40.(1) An agricultural remedy that Is sold In containers shall be sampled in the presence of the registration holder or representative by selecting at different places from stock of the number of containers required to obtain a significant quantity for a sample, subject to the following conditions: (a) such containers shall be similarly labelled, and the agricultural remedy therein shall originate from the same batch; (b) If a sample is composed of the contents of more than one container, such sample shall be thoroughly mixed before being divided in terms of section 15 (3) {c) of the Act. (c) at least three sealed containers in which an agricultural remedy is sold, may also be taken as the sample of such agricultural remedy and the containers comprising such sample shall, without being opened, be divided in terms of section 15(3)(c) of the Act. This gazette is also available free online at www.gpwonline.co.za This gazette is also available free online at www.gpwonline.co.za 48 No. 49189 GOVERNMENT GAZETTE, 25 AuGusT 202348 No. 49189 GOVERNMENT GAZETTE, 25 AUGUST 2023 23 (2) Samples shall be stored at the correct temperature and in containers similar to containers that have been approved by the Registrar for the agricultural remedy, in accordance with registered storage conditions, until delivered to the analyst. (3) A sample shall be forwarded to an analyst together with a certificate referred in terms of section 15(4)(b) of the Act as set out in Annexure B (4) A certificate on which the result of a test, examination or analysis of a sample of an agricultural remedy shall be recorded as set out In Annexure C. (5) A copy of certificate of the designated analyst’s analytical report shall be provided to the registration holder of a sample that was taken. (6) A sample of an agricultural remedy may— (a) if a certificate referred to in regulation 40(4) indicates that such sample does not possess the chemical, physica! or other properties specified In the application for registration, or does not comply with any requirements referred to in these regulations, shall be retained until the action arising from such certificate is concluded; or (b) otherwise be disposed of according to the conditions contemplated in the National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008) and applicable regulations. Permissible deviations in active ingredient contents 41. (1) Notwithstanding anything to the contrary contained in these regulations, a formulated chemical agricultural remedy shall not be deemed to deviate in its registered active ingredient contents if a certificate referred to in regulation 40(4) in relation to the analysis of a sample of such agricultural remedy indicates that It nominally contains: Declared content in g/kg or g/L at 209C + Tolerance 2°C Up to 25 +15% of the declared content for —homogeneous formutations (EC, SC, SL, etc.), or +25% for —heterogeneous formulations (GR, WG, fetc.} Above 25 to 100 + 10% of the declared content Above 100 to 250 +6% of the declared content Above 250 to 500 +5% of the declared content Above 500 +2.5% of the declaired content Note, In each range the upper timit is included. PART XI APPEAL AGAINST THE DECISION OF THE REGISTRAR General 42. (1) An appeal in terms of section 6 of the Act shall be submitted to the Minister within 60 days from the date on which the reasons for the decision were made, and shall be furnished in terms of sectlon 5 of the Act. (2) Such appeal shall: This gazette is also available free online at www.gpwonline.co.za This gazette is also available free online at www.gpwonline.co.za sTAATsKOERANT, 25 AuGusTus 2023 No. 49189 49STAATSKOERANT, 25 AUGUSTUS 2023 No. 49189 49 24 (a) bein the form of a written affidavit; (b) state the reference number and date of the documents by means of which such applicant or person was given notice of that decision; {c) state the grounds on which the appeal is based; (d) be accompanied by the documents relating to the subject of the appeal; and (e} be accompanied by prescribed fee. (3) If such appeal is submitted by a person other than the person in respect of whom the decision concerned was furnished, the appeal concerned shali be accompanied by a statement in which the person concerned discloses his interest in that decision or action. Address for submission of appeals 43. An appeal referred to in regulation 42(1) shall: {a) when forwarded by post, be addressed to the Director-General, Department of Agriculture, Land Reform and Rural Development, Private Bag X250, Pretoria, 0001; and {b) when delivered by hand, be delivered to the Director-General, Department of Agriculture, Land Reform and Rural Development, Agriculture Building, 20 Steve Biko Road, Agriculture Place, Arcadia, Pretoria. PART XII GENERAL Offences and Penalties 44, Any person who contravenes or fails to comply with the provisions of these regulations shail be guilty of an offence and liable on conviction to a fine or imprisonment or to both a fine and imprisonment as contemplated in Section 18 of the Act. Payment of fees 45. (1) The postage and delivery costs of any application or document submitted in terms of these regulations shall be paid by the sender. (2) Fees payable in terms of these regulations shall be paid by Cash or Electronic Payment. (3) Monies paid in terms of these regulations, except in terms of Section 6 of the Act, are not refundable. Address for submission of documents 46. (1) Any application or document or anything else pertaining thereto, which Is required in terms of these regulations to be submitted to the Registrar. (2) When forwarded by post, be addressed to: The Registrar: Act No. 36 of 1947, Private Bag X 343, Pretoria, 0001; and / or (3) When delivered by hand, be addressed or delivered to: The Registrar: Act No. 36 of 1947, Agriculture Building, 20 Steve Blko Street, Pretoria. This gazette is also available free online at www.gpwonline.co.za This gazette is also available free online at www.gpwonline.co.za 50 No. 49189 GOVERNMENT GAZETTE, 25 AuGusT 202350 No. 49189 GOVERNMENT GAZETTE, 25 AUGUST 2023 25 Repeal of certain regulations 47. The following regulations are hereby repealed: (a) Regulations relating to Agricultural Remedies, 2006, published as Government Gazette Notice R.935 of 22 September 2006; and (b) Regulations relating to registration of Fertilizers, Farm Feeds, Agricultural Remedies. Stock Remedies, Sterilising Plants and Pest Control Operators Government Gazette Notice R.1449 of 1 July 1983. Transitional arrangements 48. Anything done under a provision of a regulation repealed by these Regulations and which could have been done under a provision of the Regulations, is regarded as having been done under the later provision. Short title and commencements 49. (1) This regulation shall be called the Regulations Relating to Agricultural Remedies, 2023, and shall, except the regulations listed in regulations 3,34,35,37, 38 and 39 come into effect on the date of publication. (2) Regulations 34, 35, 37 and 38 shalt came into effect 6 months after the promulgation of these regulations. (3) Regulations 8(1) sub-paragraph (d) and regulation 10(3) sub-paragraph {e) shall come into effect on 01 June 2024. {4} Regulation 3(h) sub-paragraphs (xili), (xiv), and (xv) and regulation 39 shall come into effect 12 months after the promulgation of these regulations. (5) Regulation 3(h) sub-paragraphs (vi), (xi) and (xvi) shall come into effect 24 months after the promulgation of these regulations. This gazette is also available free online at www.gpwonline.co.za This gazette is also available free online at www.gpwonline.co.za sTAATsKOERANT, 25 AuGusTus 2023 No. 49189 51STAATSKOERANT, 25 AUGUSTUS 2023 No. 49189 51 26 ANNEXURE A CRITERIA FOR LOW RISK PRODUCT, SUBSTANCE OF CONCERNS AND RESTRICTED AGRICULTURAL REMEDY 1. Low risk product Active substance or micro-organisms fulfils the low risk product criteria when such substance has one or more of the characteristic— (i) Criterion 1. Active substances without hazardous properties identified; (ii) Criterion 2. Active substances for which it Is not possible to differentiate between the exposure associated with its use as agricultural remedy with its environmental relevant exposure levels or its other uses in the food chain; (lii) Criterion 3. Active substances for which no consumer exposure linked to the mode of application is foreseen; and {iv) Creterion 4. Micro-organisms that are not of human or animal health concern. 2. Substance of Concern Agricultural remedy active ingredients and thelr formulations fulfils the substance of concern criteria when such agricultural remedy have one or more of the characteristic— (i) Criterion 1: agricultural remedy active Ingredients and their formulations that meet the criteria of carcinogenicity Categories 1A or 1B of the GHS or ; (ii) Criterion 2: agricultural remedy active ingredients and their formulations that meet the criteria of mutagenicity Categories 14 or 1B of the GHS or; (iii) Criterion 3: agricultural remedy active ingredients and their formulations that meet the criteria of reproductive toxicity Categories 1A or 1 B of the GHS or; (iv) Criterion 4: agricultural remedy active ingredients listed by the Stockholm Convention in its Annexes A arend B, and those meeting all the criteria in paragraph 1 of Annex D of the Convention except for dichloro diphenyl trichloroethane (DDT) used for malaria vector contro! by the Department of Health; and (v) Criterion 5: agricultural remedy active ingredients listed under the Montreal Protocol 3. Restricted agricultural remedy Agricultural remedy formulations fulfils the substance of concerns criteria when such agricultural remedy have one or more of the characteristic— (i) Criterion 1: agricultural remedy formulations that meet the criteria of classes la or Jb of the WHO Recommended Classification of Pesticides by Hazard or; (ii) Creteion 2: agricultural remedy formulation that meet the criteria of acute toxicity catergories 1 or 2 of the GHS; (iii) Criterion 3: Agricultural Remedy active ingredients and formulations listed by the Rotterdam Convention in its Annex IIL; and {iv) Criterion 4; agricultural remedy active ingredients and formulations that have shown a high incidence of severe or irreversible adverse effects on human health or the environment. This gazette is also available free online at www.gpwonline.co.za This gazette is also available free online at www.gpwonline.co.za 52 No. 49189 GOVERNMENT GAZETTE, 25 AuGusT 202352 No. 49189 GOVERNMENT GAZETTE, 25 AUGUST 2023 27 ANNEXURE B agriculture, land reform & rural development ’ , , eutture, Land Reform and Rural Development NEF REPUBLIC OF SOUTH AFRICA CERTIFICATE IN RESPECT OF THE TAKING OF SAMPLES IN TERMS OF SECTION 15 OF ACT No. 36 OF 1947 Fertilizer, Farm Feeds, Agricultural Remedies and Stock remedy Act, 1947 (Act No. 36 of 1947) (To be completed in duplicate) I here by certify that the accompanying sample of Agricultural Remedy identified by the above serial number, was taken by me on day of. 20 At in the presence of *(Name of owner/person in charge of stocks/witness) from the stock of (Name and address of seller) PARTICULARS OF AGRICULTURAL REMEDY FROM WHICH SAMPLE WAS TAKEN Name of Registration holder/Company = = Trade name oe — — Name of agricultural remedy a : Registration number .Act 36/1947 Manufacturer details 4. ces = Composition of Agricultural Remedy 6.1 Chemical composition A n s w e r {List chemicals which appear on the label) 6.2 Physical properties ds Conditions of container from which sample was taken 8. Estimated quantity of Agricultural Remedy from which sample was taken; 8.1 Number of containers 8.2 Capacity of containers 9, Rem arks Signature of witness Inspector This gazette is also available free online at www.gpwonline.co.za This gazette is also available free online at www.gpwonline.co.za sTAATsKOERANT, 25 AuGusTus 2023 No. 49189 53STAATSKOERANT, 25 AUGUSTUS 2023 No. 49189 53 28 Delete which ever is applicable. Shall be particulars as indicated on the affixed label to the containers from which the sample was taken or as it Is marked on such containers, or if the Agricultural Remedy which is sampled, is not sold in containers, as it appears on the involce which Is supplied together with that Stock Remedy. One copy shall accompany each of the three parts of the sample and the forth copy shall be kept by the officer who took the sample. This gazette is also available free online at www.gpwonline.co.za This gazette is also available free online at www.gpwonline.co.za 54 No. 49189 GOVERNMENT GAZETTE, 25 AuGusT 202354 No. 49189 GOVERNMENT GAZETTE, 25 AUGUST 2023 29 ANNEXURE C Analyst address CERTIFICATE OF RESULTS OF ANALYSES OR TEST OF A SAMPLE OF AGRICULTURAL REMEDY BY ANALYST Fertilizer, Farm Feeds, Agricultural remedy Stock remedy Act, 1947 (Act No. 36 of 1947 (To be completed in duplicate) I (full name} of a duly appointed analyst in terms of section 14 of the Fertilizer, Farm Feeds, Agricultural remedy and Stock remedy Act, 1947 (Act 36 of 1947) do hereby make oath and state: (a) that on I received a sample of from by (>) for analyses and/or test; (b) that the sample was labelled, sealed and marked‘) (c) that I have analysed and/or tested the said sample and as a result of the analyses and/or test I found it to be constituted as follows: Pure active ingredient g/kg (a) I (b) ! (c) I i Other ingredients {if required} (a) | (b) 1 (c) | Remarks Signature of analyst This gazette is also available free online at www.gpwonline.co.za