REGISTRATION OF PROCESSED BREAD PRODUCTS WITH NAFDAC IN NIGERIA

 

 

BY SAM ELEANYA

The manufacture, importation, exportation, advertisement, sale or distribution of any processed food – which includes bread – in Nigeria is prohibited except after its registration with the National Agency for Food and Drug Administration and Control, NAFDAC. Such a process is regulated under the Food, Drugs and Related Products (Registration, Etc.)Act Cap F33, LFN, 2004 as well as other Regulations and Guidelines made pursuant thereto – by NAFDAC. Import of samples of processed bread for laboratory tests or for the purpose of registration in Nigeria also requires a prior NAFDAC issued certificate.

 

Currently existing Regulations and Guidelines published by NAFDAC which are relevant to processed bread’s production, importation, exportation, advertisement, sale or distribution in Nigeria fall under two categories: the specific and the general. The first category include Guidelines for Registration of Bread; Guidelines for Inspection & Requirements for Bread Manufacturing; and the Pre-Packaged Food, Water and Ice (Labeling) Regulations. Other relevant NAFDAC regulations which apply generally to food or related products include Food Additives Regulation 2005, Food Fortification Regulation 2005, Food Fortification with Vitamin A Regulations 2005, Non-Nutritive Sweeteners in Food Products Regulations 2005, and the Processed Food Registration Regulations 2005.

 

BREAD REGISTRATION: THE NAFDAC PROCESS IN BRIEF

Registration of a bread product with NAFDAC involves the following steps.

A. THE APPLICATION

This covers:

1. Application to NAFDAC through “The Director, Food Safety and Applied Nutrition Directorate, NAFDAC, Lagos)

2. Submission of all relevant documents for registration in accordance with the issued guidelines;

3. Provision of relevant information and description of the bread making and other connected facilities for inspection by NAFDAC designated agents;

4. Provision of samples of the products to be registered when notified by NAFDAC for laboratory analysis.

5. Payment of prescribed tariffs and assessment.

Note that Supermarkets operating bakeries as part of their operations may apply to utilize a single NAFDAC registration number per bread variant for all their outlets Nationwide. This will also be applicable to bakeries with a chain of outlets for bread with the same variant but application for inspection and listing approval has to be done for each outlet separately.

 

B. VETTING OF APPLICATION DOCUMENTS AND PAYMENT

The main purpose of this step is to ensure adequacy of applicant’s compliance with the application process. Secondarily, it enables the proper assessment of sum payable by the applicant under the process – including the Payment Advice for inspection and laboratory analysis.

 

According to Section 13.0 of the NAFDAC Guidelines for Registration of Bread mandates that a processed bread product shall only be registered with NAFDAC “upon factory recognition” following inspection and after submission of the relevant documents. A combined reading of the Guidelines for Registration of Bread  and S.2 of the Guidelines for Inspection & Requirements for Bread Manufacturing outlines the following:

 

COMPULSORY DOCUMENTS

·  An application for production inspection on applicant company’s letter head addressed to the Director Food Safety and Applied Nutrition Directorate (FSAN) submitted through the NAFDAC Office Complex, Isolo Lagos or any state office of NAFDAC. Importantly, the letter should include company’s“exact factory location address (not P. O. Box) and functional email address and telephone number(s).

·  Bread Label/Packaging material (art work could be presented)

·  Evidence of payment of assessed fees to the Agency;

·  Evidence of business registration or incorporation [CAC Certificates of Business Name registration or Company incorporation (including a registered trustees or nonprofit organisation)]

·  Evidence of Registration of Trade Mark with the Trade Registry in the Ministry of Industry, Trade and Investment (done in the name of the owner of the Trade Mark or Brand name as the case may be)

·  Contract Manufacturing Agreement (where applicable)

·  the Standard Operating Procedures (SOP) Index for production, recall, distribution, cleaning of equipment and environment which will be reviewed during inspection of facilities),

·  List of equipment,

·  Company organogram,

·  Certificate of Food Handlers test for production staff (which should include tests for Sputum, Hepatitis B, Widal, Stool and Urinary Test),

·  Current fumigation Certificate (carried out quarterly)

·  Any other relevant document

OPTIONAL DOCUMENTS

·  Certificate of analysis of raw material

·  Certificate of analysis of finished product.

Failure to respond promptly to queries or enquiries raised by NAFDAC on the application (within 15 working days) will automatically lead to the closure of the Application.

 

MINIMUM PAYMENT OR TARIFF

Under section 17 of the NAFDAC Guidelines for Registration of Bread, the following tariffs currently apply:

·  Registration of bread- 31,500

·  Renewal Inspection – 15, 500

·  Bromate in Bread – 50,000

Laboratory analysis for the purpose of renewal of registration is pegged at 50% of the original tariff. 5% VAT is charged on all statutory fees.

 

Under the Treasury Single Account, TSA system, an applicant will need to visit www.remita.net to generate a Remita invoice and print out a copy; make the assessed payment in the invoice to any nearest commercial bank; and visit the NAFDAC Accounts Office to collect official receipt (evidence) of payment.

 

C. INSPECTION

Upon satisfactory application and vetting, an inspection is scheduled and subsequently conducted by the FSAN Directorate. During the inspection, an applicant is expected to ensure that the Master Baker (Production Manager) is present for the inspection and that two sets of documents are submitted during the inspection.

 

Where an inspection is found to be unsatisfactory, a Compliance Directive is issued and communicated to the company. Failure to respond to concerns raised by NAFDAC on the application or inspection, will automatically lead to delay in further processing of the application.

 

Once registered, a Certificate issued by NAFDAC shall be valid for the period of 5 years (unless suspended or cancelled pursuant to section xxx of the |Act) and can be renewed as provided for under S. 2(4) of the Act.

 

REQUIREMENTS FOR BREAD MANUFACTURING FACILITY

	Item	Minimum standards
1.	Organisation and Personnel	1.     Adequate number of qualified personnel to perform assigned duties. 2.     Every personnel engaged in bread manufacturing should have basic education and adequate training/Experience; 3.     Wearing of protective apparel like overall, head cover, nose & mouth masks and hand gloves to protect products from contamination by personnel. 4.     Evidence of good sanitation and hygienic habits among personnel 5.     Evidence of access to medical treatment and checks for communicable diseases at least twice a year by personnel with the records kept within the facility. 6.     Adequate training for employees in the particular operations that they perform.
2.	Building and Facilities	1.     Building(s) used in manufacturing, processing and packaging of bread should be adequately located, constructed and of suitable dimensions to facilitate cleaning and maintenance. 2.     The building should have adequate space for the orderly placement of equipment and materials to prevent cross-contamination. 3.     The building should be appropriately designed to maintain orderly flow of personnel and materials. 4.      There should be defined areas of adequate size to accommodate the different operations in a logical order of production flow corresponding to the sequence of the operations. 5.     The operational areas should include: ·        Cloakroom (Changing room) ·         Toilet facilities (which should not open directly into the production area) ·        Raw Materials Section ·        Packaging Materials Section ·        Production Section ·        Cooling section (screened to prevent contamination from insects and rodents). ·        Finished Products Section 6.     Floors, walls and ceilings should have smooth hard surfaces that can be easily cleaned and disinfected when necessary. 7.     Ceiling boards should be made of non-asbestos and non-flaking material. 8.     Windows and entrance doors should be screened with insect-proof net and the doors should be self-closing to prevent contamination. 9.     Adequate ventilation, cooling and lighting should be provided in all areas to facilitate easy identification of materials, cleaning, maintenance and proper operations. 10.        Pallets or shelves should be provided for storage of raw materials, packaging material. 11.        Shelving be provide for storage of finished product
3.	Equipment	The design, material, construction, location and maintenance of equipment should be such as to make them adequate and suitable for their intended use. Their layout and design must aim to minimize the risk of cross-contamination and permit effective cleaning and maintenance in order to avoid cross contamination, build-up of dust, dirt, food particle or any other contaminant that can affect the quality of the product. The parts of the equipment that make contact with products should be made of non-toxic/non-reactive materials such as food grade stainless steel.
4.	Water Treatment Process	Water used in the production of bread and washing of production equipment should be potable water (Drinking water).
5.	Raw/Packaging Materials	1.     Raw and packaging materials should be of good quality in order to produce quality products. 2.     All incoming materials should be stored under appropriate storage conditions.
6.	Environmental Sanitation and Personnel Hygiene	1.     Appropriate sanitation measures should be taken to avoid contamination and risks of all kinds. 2.     The entire factory should be cleaned frequently and thoroughly in accordance with the Standard Operating Procedure (SOP) for cleaning. 3.     Equipment should be thoroughly cleaned in strict compliance to the SOP. 4.     Toilet and washing facilities should be appropriately located, designed and equipped. The sanitation shall be maintained in a strict compliance to the SOP for cleaning. 5.     Eating, drinking and smoking should not be permitted in the production and storage areas. 6.     Person known to be suffering from communicable diseases or with wounds should be excluded from duty until they are certified medically fit again. 7.     Waste should be adequately disposed of in strict compliance with the SOP. 8.     Effective pest control program should be in place.

 

D. REGISTRATION TIMELINES

1.         Registration of food product not more than 90 days from acceptance of application.

2.       Variation of product registration takes not more than 60 days

Note that failure to comply with any Compliance Directive, CD issued by NAFDAC may be a basis for cancellation of the application and all delays of the client will not be counted within the 90 days for registration.

 

SUMMARY OF TIMELINES FOR SPECIFIC REGISTRATION PROCESSES

1.     Submission of Application – 0 days

2.     Document Verification – 10 days

3.     Facility Inspection/Sampling – 10 days for

4.     Laboratory Analysis – 30 days

5.     Final Vetting – 10 days

6.     Approval Meeting/Issuance of NAFDAC registration Number (Certificate of registration) – 20 days

Total number of days: 90 days for Food, 120 days for Drugs

 

[SAM ELEANYA is Principal Strategist at Tree & Trees JusticeMedia Group facilitators of LawNigeria, Tree & Trees LP; 3PLR [Policy, Practice and Publishing Law Reports, and Standards and Enterprise Development Center]