NAFDAC Guidelines for registration of imported food products in Nigeria

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These Guidelines are for the interest of the General Public, and in particular, food and beverage inductries in Nigeria. It is necessary to emphasize that no Processed Food shall be manufactured, imported, exported, advertised, sold or distributed in Nigeria unless it has been registered in accordance with Provisions Of Decree 19 of 1993 as amended by Food, Drugs and Related Products (Registration) Decree No. 20 of 1999:

DIRECTORATE OF REGISTRATION AND REGULATORY AFFAIRS
GUIDELINES FOR REGISTRATION OF IMPORTED FOOD PRODUCTS IN
NIGERIA
NAFDAC/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.

1. The 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.

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(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).

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

nafdac2  NAFDAC Guidelines for registration of imported food products in Nigeria NAFDAC2

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

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


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