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Regulatory Requirements for Starting Bottled Water Business in Nigeria

If you desire to start a bottled water business in Nigeria, it is essential that you follow the required procedure as spelt out by the regulatory authority (NAFDAC). Without NAFDAC approval, it does not matter how much you have invested, you will not be able to manufacture, advertise, sell or distribute bottled water in Nigeria unless it has been registered in accordance with the provisions of the law and the accompanying guidelines. Before your bottled water business can be approved, you need to meet the following requirement as spelt out by NAFDAC.

Organization and Personnel (of the bottled water company)

• There should be an adequate organizational structure in the proposed bottled water company that clearly defines
  1. Responsibility
  2. Authority
  3. Qualification of Personnel

• There should be adequate personnel to perform and supervise the production and packaging of potable bottled water.
• Production of bottled water must be under the supervision of a production manager who must possess a minimum of Ordinary National Diploma in a science based course obtained from a recognised tertiary institution.
• In house and In process Quality Control of functions can be carried out by the production manager while comprehensive/detailed product analysis should be performed by public analyst registered by the Institute of Public Analyst of Nigeria (IPAN)
• Personnel should be adequately clad in overall, hand gloves, nose/mouth masks, headgears and rubber shoes.

Building(s) (of the bottled water company)

• The entire factory premises of the bottled water company should be fenced to demarcate it from all other buildings (residential or commercial).
• The factory of the bottled water company must not be sited (located) near a cemetery, abattoir, quarry, sewage treatment plant, sawmill, oil depot (Petroleum and Vegetable) or any such establishment that could be a source of contamination for processing, production and packaging of potable water
• The building of the bottled water company should be designed to allow for free flow of personnel and materials to prevent cross contamination.
• The building of the bottled water company for the production of potable water should be purpose built or suitably adapted to comprise a minimum of five rooms designated as the cloak room, packaging material store, production room and finished product store & office.

Cloak Room:

• Floor of the bottled water company should be made of easily cleaned and disinfected non shedding durable material and should have smooth surface.
• Walls should be made of easily cleaned and disinfected non shedding durable material and should have smooth surface.
• Windows of the bottled water company should and be screened with insect-proof nets and be constructed in such a way as not to trap dust.
• Wall hangers/cupboard should be provided.
• Shoe rack/lockers should be provided.
• Ventilation & Illumination should be adequate.
• A netted door at the entrance should be provided.

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Packaging Materials Store:

• Floor of the bottled water company should be made of easily cleaned and disinfected non shedding durable material and should have smooth surface.
• Walls of the bottled water company should be made of easily cleaned and disinfected non shedding durable material and should have smooth surface.
• Windows if present should be screened with insect-proof nets and be constructed in such a way as not to trap dust.
• Pallets/shelves (not wooden) should be provided.
• Ventilation & Illumination should be adequate.
• An Ultraviolet sterilizing lamp should be provided and bulb changed when spent.

Production Room:

• Floor of the bottled water company should be covered with easy to clean durable materials.
• Drainage system should be adequate to prevent flooding.
• Walls should be made of easily cleaned and disinfected non shedding durable material and should have smooth surface.
• Windows should be screened with insect-proof nets and be constructed in such a way as not to trap dust.
• An air conditioner should be provided.
• Illumination and ventilation should be adequate.

Finished Product Store:

• Floor should be made of easily cleaned and disinfected non shedding durable material and should have smooth surface.
• Walls should be made of easily cleaned and disinfected non shedding durable material and should have smooth surface.
• Windows should be screened with insect-proof nets and be constructed in such a way as not to trap dust.
• Pallets/shelves (not wooden) should be provided.
• Illumination & ventilation should be adequate.
• A netted door should be provided at the exit.

Facilities and Equipment (of the bottled water company)

Source of Water

• The source of water of the bottled water company could either be from a borehole of minimum depths of 100ft 150ft depending on topography or
• Public mains provided by the local water cooperation.
• Use of dug out well is not allowed.
• Water source of the bottled water company should be at least 30-50m away from the nearest septic tank which may or may not be situated within the premises.

Tanks and Reservoir

All tanks of the bottled water company should be made of PVC or stainless steel. Underground reservoir (where available) should be made of concrete and fully tiled.

Pipes

All pipes of the bottled water company should be made of stainless steel or PVC. Use of galvanised iron pipes is not allowed.

Taps

Taps for manual filling should be made of stainless steel or PVC mounted on a stainless steel sink.

Form Filling and Sealing Machine for the bottled water

The form filling and sealing machine of the bottled water company (where available) should be designed to minimise man-material contact, safe to use, easy to clean and environmentally friendly. The equipment of the bottled water company may be a fully or semi automated device.

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Production Line (of the bottled water company)

Washing and Toilet Facilities of the bottled water company

• Adequate, clean washing and toilet facilities of the bottled water company should be provided for personnel
• Washing facilities should be equipped with soap or detergent, air driers or single-service towels. This should be walled and floored with easily cleaned and disinfected non shedding durable material and should have smooth surface.
• Toilets of the bottled water company should be away from the production or storage areas and should be easily accessible to production area.
• Sewage, refuse and other wastes within the premises of the bottled water company should be disposed of in a safe and sanitary manner.

Sanitation

• Any building of the bottled water company used in the manufacture, processing and packaging of potable water should be maintained in a hygienic condition.
• Standard operating procedures assigning responsibility for cleaning must be in place. The SOP should describe in sufficient details, the cleaning schedules as well as equipment and materials to be used in cleaning the buildings and facilities.
• The building of the bottled water company should be regularly fumigated with approved fumigants in accordance with the food and drug act and the pesticides registration regulation of NAFDAC.

Standard Operating Proceedures (SOPs) (for the bottled water company)

• Standard Operating Procedures should be written for all operations namely
• SOP for Production
• SOP for Quality Control
• SOP for cleaning of factory Premises and Equipments.
• SOP Recall and Distribution.
• SOP for cloaking and use of toilets etc.

Application for Inspection (of the bottled water company)

• Application for inspection of bottled water factory should be directed to:

The Director General

National Agency for Food and Drug Administration and Control

Plot 2032, Olusegun Obasanjo Way, Wuse Zone 7, Abuja.

• All application should be accompanied with:
  • Evidence of payment
  • Company s Certificate of Incorporation and
  • Product s Trademark Registration Certificate.

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Statutory Fees For Inspection payable by the bottled water company

• All payments to the Agency should be in bank draft in favour of National Agency for Food and Drugs Administration and Control
• All payments attract a 5% VAT charge.
• Laboratory analysis for the purpose of renewal shall be 50% of the original tariff.

S/N	Sachet	Pet Bottles, Jars and Cans
Production  Inspection	10,000.00	10,000.00
Renewal Inspection	5,000.00	5,000.00
GMP Re-Assessment	10,000.00	10,000.00
Follow-up Inspection	10,000.00	10,000.00
Advisory  Inspection	10,000.00	10,000.00
Laboratory  Analysis	10,000.00	20,000.00

Documentary Requirements for Production Inspection of Premises for Packaged Potable Water/Bottled Water

• Labelling
• The product label should comply with packaged water labelling regulations stating
• Name of product
• pack size
• Batch No:
• Manufacturing Date:
• Best Before Date:
• NAFDAC Registration Number.
• Factory Location Address (Not P.O. Box)
• Evidence of Payment
• Certificate of Incorporation of Company
• Evidence of Trade Mark Registration
• Organogram of the Company with Names and Qualification of the key officers (e.g. Managing Director, Production Manager, Quality Control Manager)
• Letter of Appointment and Acceptance of key officers.
• Credentials of the key officers.
• List of Production Facilities/Quality Control
• SOP for cleaning of factory Premises and Equipments.
• SOP Recall and Distribution
• SOP for Production
• SOP for Quality Control
• Retainership Agreement with a Hospital or Clinic (with names and signature of both parties)
• Food Handlers Test/Medical Fitness Tests which should include,
  • Sputum Test
  • Urine Test
  • Stool Test
  • Chest X-ray
  • Widal Test

• Analysis of Raw Materials and Finished Products.
• Agreement with Fumigation Company for regular fumigation of the factory with name and signature of both parties.
• Current fumigation Certificate of factory (This should be done quarterly) 25.0 Geological Survey of Borehole Report
• Telephone Number for easy contact.
• Any other relevant documents.

Four sets of the above documents in the order they appear should be presented during inspection (originals for sighting).

All correspondences and applicant should be:

The Director

Establishment Inspection Directorate

NAFDAC

Abuja

Above is the regulatory requirements you must meet as specified by NAFDAC before you can be granted approval to produce bottled water in Nigeria.

Foods and Healthcare

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