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DIRECTORATE OF REGISTRATION AND REGULATORY AFFAIRSGUIDELINES FOR REGISTRATION OF IMPORTED FOOD PRODUCTS INNIGERIANAFDAC/RR/004/00
A. GENERAL
1. These guidelines are for the interest of the general public and in particular food industries in Nigeria.
2. it is necessary to emphasize that, no food product shall be manufactured, imported, exported, advertised, sold or distributed in Nigeria unless it has been registered in accordance with the provisions of ACT CAP F33 LFN 2004 (formerly decree 19 of 1993) and the accompanying guidelines.
B. APPLICATIONS
1(a) An application for registration of a food product shall be made by the manufacturer.
(b) In case of a manufacturer outside Nigeria such shall be represented in Nigeria by a duly registered company or individual with facilities to effect a recall of the product when necessary.
(c) An applicant for a manufacturer outside Nigeria must file an evidence of Power of Attorney from the manufacturer which authorizes him to speak for his principal on all matters relating to the latter’s specialties. The original Power of Attorney should be notarized by a Notary Public in the country of origin and submitted to NAFDAC.
Or Contract Manufacturing Agreement (where applicable) This Shall be notarized by a notary public in the country of manufacture and signed by both parties stating names and designations of the signatories with the names of all the products to be registered and other relevant clauses clearly explained in an unambiguous language.
NOTE:
The representative in Nigeria, whether a corporate body or an individual with the power of attorney, will be held responsible for ensuring that the competent authority in the country is informed of any serious hazard newly associated with a product imported under the provisions of the Act or of any criminal abuse of the certificate in particular to the importation of falsely labeled, spurious, counterfeited or sub-standard food products.
2a. The applicant must submit to the office of the Director (Registration and Regulatory Affairs) NAFDAC, a written application, stating name of the manufacturer, generic name (brand name, where applicable) of the products, and obtain the prescribed application form which must be properly filled with all information required.
(b) A separate application form shall be submitted for each food product.
C DOCUMENTATION
In addition to the Power of attorney, the following documents shall be submitted.
1The manufacturer, in the case of imported products, must show evidence that they are licensed to manufacture food for sale in the country of origin and that the sale of the product does not constitute a contravention of the food laws of that country. (Certificate of Manufacture and Free Sale). Such evidence must be issued by the Competent Authority of the country of manufacture, and shall be authenticated by the Nigerian Mission in that country. In countries where no Nigerian Embassy or High Commission exists, any other Embassy or High Commission of any Commonwealth or West African country can authenticate. (Certificate of Manufacture and Free Sale (could be one or two separate documents)
2 Certificate of Incorporation of the representative company issued by the Corporate Affairs commission in Nigeria.
3 Evidence of Trade mark registration from the Federal Ministry of Commerce in Nigeria.
4 Comprehensive Certificate of Analysis of the batch of product to be registered.
5 Permit to import samples shall be issued if documentation is satisfactory.
6 A letter of Invitation to inspect the factory abroad. This should be written by the applicant in Nigeria and should state the full location address of the manufacturer, Name of contact person, e-mail address, current phone no. & fax no., guide map illustrating the shortest land/air route to the factory overseas.
C. LABELLING
1. Labeling shall be informative, clear and accurate.
2. Minimum requirements on the package label shall be in accordance with the pre-packaged food labeling regulations and shall include:
(a) Name of product - brand name (where applicable)
(b) The name and address of the manufacturer, packer, distributor, importer, ` exporter, or vendor.
(c) Provision for NAFDAC Registration Number or listing Number
(d) Batch number, manufacturing date and expiry date.
(e) Net contents of essential ingredients in metric weight in case of solids, semi solids and aerosols and metric volume in case of liquids.
(f) The ingredients must be listed by their common names in order of their predominance by weight.
(g) Food additives and colours must be declared on the label. Spices, natural flavours and colours may be listed as such, without naming the specific materials, but any artificial colour and flavours must be identified as such.
(h) Labelling of Food for Special Dietary Uses: “Special Dietary Use” may be defined as a particular use for which a food purports or is represented to be used, including, but not limited to the following:
(i) Supplying a special dietary need that exists by reason of a physical, physiological, pathologically and other conditions, including the condition of disease, convalescence, pregnancy, lactation, infancy, allergic, hypersensitivity to food, under weigh for the need to control sodium intake.
(ii) Supplying a vitamin, mineral or other ingredient for use by humans to supplement the diet by increasing total dietary intake.
(iii) Supplying a special dietary need by reason of being a food for use as the sole item of the diet.
(i) When special dietary foods are labeled with claims of disease prevention, treatment, mitigation, cure or diagnosis they must comply with the guidelines for drugs and be registered as medicinal products.
(j) The label must contain directions for safe use (where necessary on the information panel (IP) or on the package insert (PI)
(k) Any food product which is labeled in a foreign language shall NOT be considered for registration unless an English translation is included on the label and package insert (where applicable).
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D TARIFF
All payments to the Agency shall be in bank draft in favour of National Agency for Food and Drug Administration and Control.
1 Food Registration Form Two hundred and fifty Naira (N250:00) 2 Per Food product N 750, 000:00 plus 5% VAT
. E NOTE:
1 Failure to comply with these requirements may result in the disqualification of the application or lead to considerable delay in the process time.
2 . The time line for registration process shall be eight (80) work days
3 A successful application attracts a Certificate of Registration with a validity period of five (5) years
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4 Registration of a product does not automatically confer Advertising permit. A separate approval by the Agency shall be required if the product is to be advertised.
5 NAFDAC may withdraw the Certificate of Registration in the event that the product is advertised without express approval from Agency.
6 NAFDAC reserves the right to revoke, suspend or vary the certificate during its validity period.
7 Filling an application form or paying for an application form does not confer registration status.
E. . All correspondences in respect of food registration should be addressed to:
The Director, Registration & Regulatory Affairs NAFDAC Central Laboratory Complex Oshodi, Lagos. NAFDAC website: www.nafdac.gov.ng E-mail address: registration@nafdac.gov.ng Telephone number: 01-4772452, 01-4772458, 01-4748627.
