National Biotechnology Authority (Genetically Modified Food and Feed) (Labelling) Regulations, 2018 (S.I. No. 159 of 2018)

Statutory Instrument 159 of 2018. ICAP.14:31 National Biotechnology Authority (Genetically Modif,ed Food and Feed) (Labelling) Regulations, 2018 ARRANGEMENT OF SECTIONS Section 1. Title. 2. Application. 3. Interpretation. 4. Application for authorisation to label. 5. Certificate for authorisation to label. 6. Food safety assessment before labelling. 7. l,abelling and packaging requirements. 8. Claims. 9. Verification of labels. 10. Existing products. 11. Imported products. 12. Monitoring, inspection and compliance. 13. Revocation or suspension of authorisation. 14. Offences and penalties. 15. Register of certiflcates. 16. Fees. 17. Confidential information. Fmsr Scrmurr: I-abels. SBcoNo Scunul-E: Application for authorisation for labelling. Trmn Scrmuur-e: Fees. IT is hereby notified that the Minister of Higher and Tertiary Education, Science and Technology Development has, in terms of section 59 of National BiotechnologyAuthorityAct lChapter 14 :3l), made the following regulations: ta21 ^ f National Biotechnology Authority (Genetically Modifi ed Food and Feed) (labelling) Regulations, 2018 Title 1. These regulations may be citedas the National Biotechnology Authority (Genetically Modified Food and Feed) (I-abelling) Regulations, 2018. Application 2. ( I ) These regulations shall apply to all food or feed irrespectiv e of threshold of the content of genetically modified material but shall not apply to (a) products fromanimals fedwithfeedwhichwas produced through genetic modif,cation or containing genetically modifled organisp5' (b) medical products for human and veterinary use; (c ) highly refined food, where the effect of the refining process is to remove novel DNA or novel protein. (2)These regulations are in additionto any labellingregulations made in terms of (a) Food and Food Standards Act fChapter 15:041; (b) Fertilizers, Farm Feeds and Remedies Act lChnpter 18:121. Interpretation 3. In these regulations "Act" means the National Biotechnology Authority Act lC hapter I 4 : 3 1l of 2006; "advertisement" means representation by any means for the purpose of promoting directly or indirecfly the sale or disposal of any food and feed; "Authority" means the National Biotechnology Authority established under section 4 of the Act; "certificate" means a certiflcate of authorisation issued in terms of section 5; "claim" means any statement rnade in labelling oradvertising about food and feed or its ingredients intendedto highlight ra28 ^ S.I. 159 of 2018 the presence or absence of specific characteristics of a food or feed; "conventional food or feed" means food or feed produced without the use of genetic modificationtechniques and for which there is history of safe use; "feed" means food givento animals with nutritive properties; "final consumer" means the ultimate consumer of a product; "food" means any substance intended forhuman consumption or intended for the rnanufacture of such substance; "geneGcally modified organism ( GMO)" means an organism the genes or material of which have been modified in a way that does not occur Daturally thrcugh rrating or natural recombination or both and ' genetic modification shall have a corresponding rneaning; "genetically modif,ed material" rleans genetic material including DNA and RNA that has been changed by the proc€ss of genetic modification; "ingredient" means any substance, including food additives, used in the manufacture or preparation offood or feed; "inspection" means evaluation by observation andjudgement accompanied as appropriate by measurement, testing, gauging or documentation; "inspector" means a person appointed as a inspector in terms of section 32 of the Act; "label" nrcans any tag, brand mark, pictorial, or other descriptive matter, written, printed or stencilled, embossed, impressed on or attached to a container of food and feed; "labelling'meAns any written, printed, or graphic matter that accompanies a food and feed oris displayednearthe food and feed, including that for the purpose of promoting its sale or disposal; "multi-ingredient food or feed" means an integral unit of food or feed consisting of a combination or more than one ingredient; 1829 National Biotechnology Authority (Genetically Modifi ed Food and Feed) (Labelling) Regulations, 2018 "novel DNA and novel protein" mean DNA or protein which, as a result of use of genetic modification, is different in chemical sequence or structure from DNA or protein presert in counterpart food that has not been produced using genetic modification, other than: (a) protein that is used as a processing aid or food additive; and (b) has an amino acid sequence that is found in nature I "operatot'' means a person or company that runs a buiness of manufacturing ortrading of food, feed or ingredients; "organi sp " 1r"ans any biological entity, wbether microscopic or not, capable ofreplication; "person" includes a company orassociation or body of persons corporate or unincorporated; "pre-packaged" means prepared and wrapped beforehaod and ready for sale; "processing aid" means any substance that is rrsed in the course of manufacturing of food or feed ingredient: "product of genetic modification" means fmd and fe€d containing organisms whose genetic material has been changed through genetic modification, or fmd and feed produced from genetically modified organis65; "source" means a quantity of food or feed produced un&r uniform conditions, "verification" means the process by which th correctness of a claim is established by either examination or demonstration. Applicationfor authorisation to label prodrrcts oJ genenc modification 4. (1) No p€rson shall label any foodor feed containing at least l7o of products of genetic modification as such u'ithout certfficate of authorisation from the Authority. 1830 Av S.I. 159 of 2018 (2) An application for certfficate of authorisation shall be made in form 1 of the Second Schedule and shall be accompanied by appropriate fee prescribed in the Third Schedule. (3) Before issuing a certiflcate in respect ofan application rbferred to in subsection 2, the Authority may (a) carry out a safety assessment; ^ G) test or validate methods proposed by the applicant; (c) request for further documents or information. Certificate of authorisation to label 5. ( 1) Where the Authority is satisfied that the applicant meets the required standards, theAuthority may issue the applicant a certificate of authorisation. (2) Where the Authority rejects an application, the Authority shall, within two working days of making that decision, inforrn an applicant of its decisiontogether with reasons and afford the applicant an opportunity to address those reasons. (3) A certificate of authorisation issued under this section shall be subject to such conditions as may be prescribed or as may be specified in the certiflcate and shall remain valid for five years, and may be renewed for such further period as may be prescribed or specified in such certificate. (4) An application for rBnewal in terms of subsection (2) shall be (a) made one year before expiry of the preceding certif cate ; (b) inform2 ofthe Second Schedule; (c) accompanied by the appropriate fee prescribed in the Third Schedule. (O The certificate granted shall have the Authority's logo. Food safety assessnent before labelling 6. Operators who produce or sell 1831 * National Biotechnology Authority (Genetically Modifled Food and Feed) (Labelling) Regulations, 2018 (a) food; or O) feed; or (c) ingredients; containing genetically modif,ed organisms or products derived from genetically modified organisms shall ensure that such food, feed or ingredients undergo appropriate safety assessments before being labelled and packaged. lnbelling and packaging re quireme nt s 7. (1) Operators who produce or sell food or feed containing at least t%o of products of genetic modiflcation shall ensure that the label has the words specif,ed in the appropriate part of the First Schedule. (2) Operators who produce or sell food or feed containing less thanl7a of products of genetic modification shall not be compulsorily required to label their products as such, and if they so wish, the operators shallensure thatthe labelhas the appropriate words specified inthe appnopriate part ofthe First schedule. (3) Operators must ensure that (a) labels are printed in clear, indelible, visible legible letters ; (b) printed in contrasting colour to that of background; (c) indicators about the genetic modification status of feed and food appear in a foot note close to the list of ingredients and the font size ofthe foot note is not less than six point. (4) Operaton may also add the following (a) information on properties or characteristic tlat make the food atrd feed different from its conv entional counterpart with respectto composition, nutritional value, intended use and health effects on humans oranimals; (b) information on methods used to test for the presence of GMOs inthe flnal product; (c) information on source of the genetic material. ta32 A S.L 159 of 2018 ,^\ Claims 8. (l) Genetically modif,ed organisms shall not be described or labeled in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding their character in any respect. (2) Ary claim on a label that a product does not contain or consist of genetically modified materials shall have clear printed statement indicating that the claim is true and not misleading, and shall be supported by validated testing and documentation of the handling practices and procedures (3) Validated testing shall be carried out in appropriate accredited laboratories and analyical procedures used shall be consistent with national and internationally laid down procedures and protocols. Verification o.f labels 9. (l) The Authority shall verify labels pertaining to the genetic modification through testing, validation of detecting methods, inspection and audit tracking. (2) Operators who label food or feed shall ensue that they (a) obtain the required information preferably in documentation form and shall keep it for five years; (b) have well annotated data on the origin of the food and A, feed and or ingredients; ' (c) have a practical plan for tracing of food and feed or ingredient, which shall include necessary precautions taken during but not limited to seed production, cultivation, harvest, transpofiation, processing and storage; (d) use internationally validated methods for testing for the presence of particular GMOs and sampling methods. Where these do not exist, the manufacturer and or food and feed processor and or rBtailers shall propose the most suitable method and this shall be validated by the Authority at the client's cost; 1833 {A National Biotechnology Authority (Genetically Modifled Food and Feed) (I-abelling) Regulations, 2018 (e) furnish the Authority with information on appropriate methods for sampling, identification and detection of particular GMOs in food and feed; (f) provide theAuthority with samples of the food and feed for which certificate of authorisation is sought. Existing products 10. (1) Products which have been lawfully placedon the market ,q\ by manufacturers, before the commencement of these regulations shall continue to be placed on the market provided that the retailer notifles the Authority, within 9) days after the commencement of these regulations. (2) The notification made in terms of subsection (1) shall be in a form of application as required in terms of section 4. (3) Sections 5,9, 12 and 13, of these regulations shall apply with necessary changes whentheAuthority considers the notification made in terms of this section. (4) The Authority may withdraw the product or any of its derivatives fromthe market where the retailerfails to notify or submits incorrect information or submits information late to the Authority. . Imryrted products 11. Prrcducts which were lawfully placed on the market in countries of origin and were labelled prior to their importation into Zimbabwe may be placed on the market provided that the retailers comply withnecessary labelling guidelines as advised by theAuthority. Monitoing, inspection and complianc e 12. (1) The Authority shall liaise with other relevant regulatory agencies to monitor any products consisting or containing genetically 66dified material for compliance with these regulations. (2) Where the Authority is satisfled that a product consisting of or containing genetically modif,ed ingredients has not been labeled in accordance with these regulations, the inspector shall serve the operator with a notice in writing 1834 lt S.I. 159 of 2018 (a) prohibiting the placing on the market of the product until it is correctly labeled; (b) prohibiting the removal of the product fromthe premises described in the notice other than to facilitate the correct labeling of the product; (3) A notice under subsectior (1) may (a) contain such conditions as the inspector is satisfied are reasonable; and (b) may be amended, suspended or revoked by a further notice in writing by the inspector at any time. (4) A notice under these regulations shall be complied with at cost of the operator on whom it is served. (s) rf (a) a notice in terms of these regulations; or (b) an action required by the notice to be taken; is not complied with within the period specifled in the notice, an inspector may arrange for it to be complied with all reasonable costs of taking such action shall being recoverable by the Authority as a penalty due from the operator on whom the notice was served. (6) Where the product has been placed on the market prior to the date of the notice, the inspector may require the withdrawal of the product within such period as may deem f,t. (7) The Authority shall, at the applicant's cost, inspect authorised prrrducts for compliance at least once every two years. Revocation or suspension of authorisation 1 3. The A uthority may, in writing, re voke or suspend an approval to label granted in terms of section 5 where the authorised person (a) contravenes any provision ofthese regulations; (b) fails to comply with any conditions specifled in the certificate; (c) if the Authority considers it in the public interest to do so. 1835 .T National Biotechnology Authority (Genetically Modif, ed Food and Feed) (Labelling) Regulations, 2018 Offences and pendties 14. A person who (a) contravenes sections 4(l),7(l),8(1) and 9(2Xa) and (e); (b) uses the Authority's logo without authorisation; commits an offence and is liable on convictiron, to a fine of level 11 or to imprisonment for a term oot exceeding flve years, or to both such fine and imprisonment. Re gister of c ertifrcates 15. (1) TheAuthority shall maintain a register of all certificates issued under these regulations. (2) The register shall be a public docurnent and may be inspected between 8.00 a.rn and 4.00 p.m. hours on working days by any person on the payment of a prescribed fee. (3) The Authority shall record all approved products on the register and on the Authority's website. Fees 16. (1) The fees prescribed in the Third Schedule shall be paid for the various applications under these regulations. Where a fee is fixed in terms of subsection (1) the fee shall be tendered withthe appropriate application; half the fee shall be refunded to the applicant if his or her application is unsuccessful. C o nfi denti al i nfor mati o n 17. (1) An applicant may indicate the information in the application which should be treated as confldential and shall give verifiable justif,cation for such indication. (2) The Authority shall make decision on the application made intenns of subsection (1), afterconsultationwiththe applicant and the Authority shall communicate its decision in writing to the applicant. 1836 (2) (a) (b) S.I. 159 of 2018 (3) The Authority shall not disclose to a third party any information considered to be confdential and shall respect the intellectual property rights related to the informatiou received regardless of whether the applicant has withdrawn the application or not. (Q The Authority shall not treat or consider the following information as confl dential (a) name andaddress ofapplicant; (b) unique identifierofthe product; (c) a sunrnnry of the risk assessmen! (d) any methods and plans for emergency response. Frnsr Scupoule (Section 7) LABELS PART l l-nssLs ron Pne-P.ccKEo kooucrs single ingredient food and feed: "This [name of product] is a product of genetic modification" or contiains [nameof ingredient] produced from genetically modified [nameof organism] or "contains genetically modified [name of organism]" multi-ingredient food and feed: "[nameof ingredients] areproductso[geneticmodification" orcontiains"name of ingredientsl produced from genetically modified [name of organism]" or contains genetically modified [name of organism/s]" PARI II Dtspr-ry PrNeL L.ceeI- ron Pnooucrs Ospenpo ro rus Frt.ql Coxsuven lN Bux AND THosE Pnrprneo at Porvr op Slu (a) single ingredient food and feed: "This [name of product] is a product of genetic modification" or contains [name of ingredient] produced trom genetically modified [nameof organism]" or contains genetically modified [name of organism]" 183',7 (a) (b) { National Biotechnology Authority (Genetically Modifi ed Food and Feed) (I-abelling) Regulations, 20 1 8 (b) multi-ingedient food and feed: "[name of ingredients] are produced of genetic modification" or contains [nameof ingredient] are products of genetic modifi cation" or"contains [name of ingredientl produced from genetically modifed [name of organism]" or contains genetically modified [name of organism/s]" PARTIII NoN Cor.,rpur-somr L,lssLLrNo (a) Labels for prepacked pnrducts shall be (i) for single ingredient food or feed "[name of product] is not a product of genetic modification ' or "[name of ingredientl not a product of genetic modification' or "[name of organisml is not genetically modified' (ii) for multi-ingredient food and feed: "[name of ingedient]" nota product of genetic modification" or"[name of organismisl and genetically modified" (b) Dsplay panel labels for products offered to the final consumer in bulk and those prepared at point of sale, the label shall have the following words on the display panel (i) singl,e ingredient food and feed " [name of product] not a prodtrct of genetic modi ficationi' or " [name of ingredientl notaproduce of genetic modifi cation" or [name of organism] is not genetically modified" (ii) multi-ingredient food and feed: "[name of ingredients] not a product of genetic modification" or "name of organismlsl are not genetically modified. SecoNo SoreDuLE (Section 4) Form I APPLICATION FOR AUTHORISAf, ION FOR LABELLING I hereby apply for a genetic modification status label of which particulars are given below:... 1838 , .*. S.I. 159 of 2018 Name and address of applicant: The product to be labeled and its specification: .............. The intended use of the product A detailed description of method of production: Copies of studies carried out whether indeperdent or peer reviewed to demonstrate safety:.... Comprehensive information and data comparing characteristics benveen GM product and conventional counterpart: The proposed label: Method of sampling and detection: Samples of the product and their control sample and information as to where reference material can be accessed: .................... Summary of dossier Any other information: 1839 National Biotechnology Authority (Genetically Modifi ed Food and Feed) (I-abelling) Regulations, 20 18 FOR OMCIALUSE ONLY Applicationreceivedby................... on ...,.,..........20........................ Fee pard US $ (in words) FOR Chief Executive Officer and Registrar National Biotechnology Authority. Form.2 APPLICATION FOR RENEWAL OF GENETIC MODIFICATION STATUS LABELUNG CERIIFICATE I hereby apply for a renewal of the genetic modification status label certificate of which particulars are given below: Name and address of applicanr Expired certifi cate number........-, A detailed description of method of production: ............... Copies of studie,s cariedoutwhetherindependentorpeerreviewed todemonstrate safety: ............ Comprehensive information and data comparing characteristics betrreen GM product and conventional counterpart.... ^ r&m S.i. 159 of 2018 Method of sampling and detection: : Sampling of the product and their control sample and information as to where . reference material can be accessed Summary of dossier: Any other information: Application received by.... ..... on ................20 Fee paid US $ (in words) FOR Chief Executive Officer and Registrar National Biotechnology Authority. Tsno Scssour-e (Sections 4, 5, otrd lQ Fees Application forAuthorisation to label US$1,000,00 Renewal of approval US$1,000,00 Inspection fees................ US$150,00 1&u g € St4rf,.enent to ihc Ztnbabwean Goverwtlent Gazette ilated the 24th Augwt,2018. Printd by the Goverrpncnt Priibr, Ilailrle rwz