NAFDAC (Bio-Fertilizer Registration) Regulation, Statutory Instrument no. 53 of 2024

2. Application PART II - R EGISTRATIO N, CLASSIFICATION, SUSPENSION, EFFICACY, P ACKAGING, S TORAGE, ETC.

3. Application for registration ofbio-fert ilizer

4. Suspensio n or cancellatio n of Certificat e of Registration

5. Classification ofbio-fertilizer

6. Efficacy assessmen t of bio-fertilizer

7. Labellingo fbio-fertil izer

8. Advertisement of bio-fertilizer

9. Packaging ofbio-fertilizer I 0. Storage, distribution and display ofbio-fert ilizer

11. Submissio n of mandatory report

12. Disposal ofbio-fertilizer

13. Power to seal premises

14. Prohibition P ART III --OFFENCES AND P E ALTIES

15. Offences and penalties

16. Forfeiture after convictio n PART IV - MISCELLANEOUS

17. Enforcem ent of these Regulations

18. Interpretation

19. Citation B 1047 S. I. No. 53 of 2024 NAFDAC ACT, CAP., Nl LFN, 2004 AND FOOD, DRUGS AND RELATED PRODUCTS (REGISTRATION, ETC.) ACT, CAP. F33. LFN, 2004 BIO-FERTILIZER REGISTRATION REGULATIONS, 2024 [ 16th Day of October, 2024] Commence- ment In exercise of the powers conferred on the Governing Council of the National Agency for Food and Drug Administration and Control ("the Governing Council") by section 30 of the National Agency for Food and Drug Administration and Control Act, Cap. N 1, LFN, 2004 and section 12 of the Food, Drugs and Related Products (Registration, Etc.) Act, Cap. F33. LFN, 2004 and all other powers enabling it in that behalf, the Governing Council, with the approval of the Minister, makes the following Regulations - P ART I - OBJECTIVE AND A PPLICATION

1. The objective of these Regulations is to provide regulatory framework Objective for the regulation of registration of bio-fertilizer manufactured, imported, distributed, sold or used in Nigeria

2. These Regulations shall apply to registration of bio-fertilizer Application manufactured, imported, exported, advertised, sold, distributed or used in Nigeria. PART JI - REGISTRATION, CLASSIFICATION, S USPENSION, E FFICACY, PACKAGING, STORAGE, E TC.

3.-( I) Application for bio-fertilizer registration shall be made by Application submitting an application, accompanied with relevant documents prescribed for by the Agency, from time to time as follows - registration ofbio- (a) contain the particulars and description of the bio-fertilizer named in fertili zer the application; and • (b) be accompanied with the evidence of payment of fee as may be prescribed by the Agency. (2) The particulars and description of the bio-fertilizer referred in to in subregulation ( I )(a) of this regulation shall consist of administrative and technical information to allow the Agency make informed decision on the product. (3) Where the Agency considers the application for registration to be satisfactory, the applicant shall be issued a Certificate of Registration. (4) Where the application for registration is unsatisfactory, the Agency shall refuse the application and inform the applicant in writing, stating the reason for the refusal. B 1048 (5) Regis tratio n ofbio -ferti lizer unde r these Regu lation s shall be for a perio d of five years and may be renew ed. (6) Notwithstanding the provisions of subregulation (5) of this regulation, the Agen cy may suspe nd or cance l any Certi ficate of Regi strati on in accor dance with regulation 3 of these Regulations. (7) The Agen cy shall, from time to time, pub Iish on its offici al webs ite, the list ofbio -ferti lizer regis tered by the Agency. (8) The Agency may refuse an application for regist ration , wher e the - (a) proce dure used for manu factu ring, proce ssing and packa ging a bio- ferti Iizer is not adequate to reliably prese rve and ensur e its identity, streng th, quality, and purity; (b) labor atory repor t for the produ ct is not satisf actor y; (c) Good Manu factu ring Pract ice inspection repor t is not satisf actor y; (d) field trial repor t is not satisf actor y; (e) produ ct label Iing of the bio-ferti Iizer contr avene s the Agen cy's Bio- Ferti Iizer Labelling Regulation s; or (f) bio-fe rtilize r do not meet any other reason requi red by the Agen cy. Suspe nsion 4.-( I) The Agen cy may suspe nd, withd raw or cance or l the Certi ficate of Registratior. of a bio-f ertiliz er wher e - cancellation of Certif icate (a) the groun ds upon which the bio-f ertiliz er was regis tered is false or of incomplete; Registration (b) the circu mstan ces unde r which the bio-f ertili zer is regis tered no longe r exist; (c) any of the cond itions or under takin g under which the bio-f ertili zer is registered has been contr avene d; (d) stand ard of quali ty, safet y and effic acy as presc ribed in the docum entat ion for regis tratio n has not been comp lied with; (e) the prem ises in which the bio-f ertiliz er is manu factu red, packa ged or stored by or on beha lf of the holde r of Certi ficate of Regis tratio n is unsui table for the manu factu re, packa ge or stora ge of the bio-f erti Iizer; (f) new inform ation is avail able to the Agen cy which rende rs the bio- fertil izer unsaf e, dang erous or ineffe ctive; (g) there is adve rse effec t on no n-tar get orga nism s and the envir onme nt; or (h) the holde r of Certi ficate of Regis tration notifi es the Agen cy in writin g of the intention to suspe nd the produ ct registered for a perio d not excee ding the valid ity of the Certi ficate of Registration. (2) Where the regist ration ofbio -ferti lizer is suspe nded or cance lled, the Agen cy shall order the withd rawa l from ci rcu lation of the bio-f ertili zer and shall cause the suspen sion, cance llatio n or withd rawal to be publi shed. B 1049 (3) Pursuant to the provisions of subregulation ( I )(h) of this regulation, a holder of Certificate of Registration shall notify the Agency of the intention to resume marketing of a registered product and shal I submit relevant document and pay the prescribed renewal fee for product reg istration where the product registration certificate has expired.

5. The classification ofbio-ferti lizer shal I inc lude - Classification ofbio- (a) Nitrogen fixing bio-fertilizer; ferti lizer (b) Phosphate bio-fertilizer; (c) Micronutrients bio-fertilizer; (d) Plant growth promoting rhizobacte ria; (e) Compost bio-fertilizer; and (f) Mycorrhizal Fungi. 6.--{ I) Applicant for registration of bio-ferti Iizer shal I carry out efficacy Eflicacy assessment of such bio-fertil izer to ensure the efficacy for its intended use. assessment ofbio- (2) The efficacy assessment shall be - fertilize r (a) for a period of not less than two cropping seasons or as may be prescribed by the Agency; (b) in two different Agro-eco logical Zones or as may be prescribed by the Agency; and (c) monitored by the Age ncy at an approved research institute.

7. T he labelling ofbio-fertilizers shall be in accordance with the Agency's Labelling of Bio-fertilizer Labelling Regulations. bio-fertilim

8. The advertisement ofbio-fertilizers shall be in accordance with the Advertisement Agency's Bio-fertilizer Advertisement Regulations. ofbio- ferti lizcr 9.--{ I) Bio-fertilizer shall be packaged in the manner prescribed by the Packaging of Agency. bio-fertilizer (2) The package of bio-fertilizer shall be designed to - (a) maintain the integrity of the product under required storage conditions, display and distribution; (b) allow withdrawal of some or all of the contents in a manner that is safe to the user; (c) permit the closing of the package in a manner that prevents the sp illage of the bio-fertilizer under any required handling conditions; and (d) minimise the degradation or change of its contents under required storage conditions. B 1050 Storage, 10.- ( I) Bio-fe rtilize r shall be stored , distrib uted or displa distribu tion yed in accord ance with the condit ions indicated on the label. and display ofbio- (2) Bio-fe rtilize r shall not be stored , distributed or displa yed fertili7er alongs ide with human food, human drugs, veterinary medicines, animal feed or pet food. Submission 11 .-(I) A manuf acture r or impor ter ofbio- fertili zer shall keep of record of its distribution and submi t a manda tory report of its activit ies mandatory to the Agenc y annually, indica ting the name, addres s and quanti ty of suppli report es made to any company. (2) A manufacturer or importer engaged in the manufacture, impor tation, distrib ution, sale or storag e of bio-fe rtilize r sha ll submi t to the Agenc y, prelim inary and final reports of any advers e effect on non-ta rget organ ism and the enviro nment , and loss of efficac y associ ated with fertiliz er occurr ing in Nigeri a or elsewh ere. Disposa l of 12. A holder of Certif icate of Registration ofbio- fertili zer bio-fert ilizer shall dispos e of expire d, degraded o r obsole te bio-ferti Iizer in the manne r prescr ibed by the compe tent author ity in the presen ce of staff of the Agency. Power to 13. The Agenc y shal I have power to seal up any premi ses used seal or being used in conne ction with comm ission of any offenc e in violati premises on of these Regulations, until such time the bio-fe rtilize r is removed or such reason able time as the Minis ter may determ ine. Prohibition 14.- (1) Bio-fe rtilize rshall notb e- (a) manuf acture d, impor ted, export ed. advert ised, sold, distrib uted or used in Niger ia excep t it is registered in accord ance with the provis ions of these Regulations, and (b) sold or distrib uted in units other than the packa ge in which it has been originally presented during registration. (2) Notwithstanding the provis ion of subregulation (I) of this regulation, the Agenc y may grant permi t for the importation or produ ction of a sampl e of bio-ferti lizer for the purpos e of field trial or research. (3) A holder of a Certif icate of Reg istration shall not lend, hire, sell, transf er or otherw ise dispos e of the Certif icate of Regist ration to any other person withou t the approv al of the Agenc y. PART Ill - OFFENCES AND PENALTIES Offences and 15.-{ I) A person who contra venes any of the provis ions of these penalties Regul ations comm its an offenc e and is liable on conviction, in the case of- (a) an individual, to impris onmen t for a term not excee ding one year or to a fine not exceed ing N800,000 or both; and (b) a body corpor ate, to a fine not exceed ing NS,00 0,000. B 1051 (2) Where an offence under these Regulatio ns is committed by a body corporate, firm or any other associatio n of individual s, every - (a) director, manager, secretary or other similar officer of the body corporate; (b) partner or officer of the firm; (c) trustee of the body concerned ; (d) person concerne d in the managem ent of the affairs of the associatio n; or (e) person who purports to act in a capacity referred to in paragraph s (a) to (d) of this regulation , is liable to be proceeded against and be punished for the offence and in the same manner as if the person committed the offence, unless the person proves that the act or omission constituti ng the offence took place without his knowledg e, consent or connivanc e.

16.-( I) A person convicted of an offence under these Regulatio ns Forfeiture shal I forfeit to the Federal Governme nt - after (a) asset or property constitutin g proceeds derived from or obtained, conviction directly or indirectly, as a result of the offence; and (b) any of the person's property or instrumen t used in any manner to commit or to facilitate the commissio n of the offence. (2) In this section, "proceeds'" means any property derived or obtained, directly or indirectly, through the commissio n of the offence. P ART IV - M ISCELLANEOUS

17. The Agency shall be responsib le for the enforceme nt of these Enforcemen t Regulations. of these Regulations

18. In these Regulations - Interpretation "Agency" means the National Agency for Food and Drug Administration and Control; ·'Agro-ecological zones" means land resource, mapping unit defined in terms of climate, landform and soils, or land cover, and having specific range of potentials and constraint s for land use; "Approve d Research Institute" means a certified establishm ent in Nigeria for conductin g research. "Bio-fertilizer" means substance s which contain living microorga nisms, which when applied to the seed, plant surface, or soil, colonises the rhizosphe re or the interior of the plant and promote growth by increasing the supply or availabilit y ofnutrient s to the host plants; " Compost bio-fertil izers" means bio-fertil izers that contain microorganism that breaks down organic matter to enrich soil with nutrients; B 1052 "Disposa l" means the action or process of getting rid of any expired, degraded or obsolete bio-fertil izer; "Field trial" means a scientific evaluatio n conducte d by an approved research institution on a bio-fertil izer in accordan ce with direction specified for the use of bio-fertil izer, to ascertain and establish the claims indicated on the label: "Laber' means any tag, brand. mark, pictorial or other descripti ve matter, written, printed, stenciled , marked, embossed or impresse d on, or attached to a package or containe r of food; "labellin g" means the label and any other written, printed, or graphic matter upon an article o r any of its container or wrapper, or accompa nies such article; --Micro- nutrients bio-ferti lizer" means bio-ferti lizers that contain microorganism capable of solubi lising or degradin g micronu trients in soils; "Mycorrhi=af fungi" means fungi that lives in symb iotic associati on with roots of higher plants; ''Nitroge n fixing bio-ferti li=er'' means a bio-ferti lizer using living microorg anisms capable of converti ng atmosph eric Nitrogen into plant useable forms: ''Pho!)phate bio-fertil i=er·· means bio-ferti lizers that mobilise s and solubilis es the insoluble phospha te from organic and ino rganic phospha te sources; and ·'Plant growth promoti ng rhi=oba cteria" means bio-ferti lizer that promotes plant growth with improved nutrient avai labi Iity and productio n of plant growth substanc es. Citation 19. These Regulati ons may be c ited as Bio-ferti lizers Registra tion Regulations, 2024. MADE at Abuja this 16th day of October, 2024. M UHAMMAD Au PArE, CON Coordin ating Minister of Health and Social Welfare