GUIDELINES FOR REGISTRATION AND PRODUCTION
OF PACKAGED WATER IN NIGERIA
AS ISSUED BY:
NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION & CONTROL (NAFDAC)
ABUJA - NIGERIA
1. THESE GUIDELINES ARE FOR THE INTEREST OF THE GENERAL PUBLIC AND IN PARTICUALR PACKAGED WATER PRODUCERS FOR IMPORTERS IN NIGERIA.
2. IT IS NECESSARY TO EMPAHSIZE THAT NO PACKAGED WATER (REGULATED PRODUCT) SHALL BE PRODUCED, 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 ETC) DECREE NO. 20 OF 1999.
B. REGISTRATION PROCEDURE
1(a) An application for the registration of packaged water (bottled and sachet) 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 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 is to be notarized and submitted to NAFDAC.
Note: The representative in Nigeria weather 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 decree or of any criminal abuse of the certificate in particular to the importation of falsely labeled spurious, unwholesome or substandard packaged water.
(d) The manufacturer in the case of imported products must show evidence that the company is licensed to manufacture the regulated product for sale in the country of origin (Manufacturer’s certificate). Such evidence must be by the competent Health Authority of the country of manufacturer and shall be authenticated by the Nigerian Mission in that country.
2(a) The applicant must submit to the Registration Division. NAFDAC a written application, stating the name of the manufacturer, name (brand name where applicable) of the product, and obtain to prescribed application form which must be properly filled with all information required. This form shall be obtained on payment of the prescribed amount per product in Bank Draft (MICR) issued in favour of NAFDAC, Lagos.
(b) A separate application form shall be submitted for each packaged water (bottled or sachet).
3. PROCEDURE FOR REGISTRATION OF LOCALLY MANUFACTURED PACKAGED WATER
(a) Application for registration of the product should be accompanied with a Bank Draft payable to NAFDAC covering the prescribed fees for Pre-production inspection.
(b) The Pre-production inspection is carried out to assess if manufacturing facilities, personnel and location of plant are satisfactory.
(c) Registration procedure is halted at this stage if the facilities, etc are not satisfactory.
(d) If successful, a certificate of Recognition as a producer of the product is issued to the company. This enables the producer to go ahead and get the product registered.
(e) Purchase of product registration form with the prescribed fee paid in Bank Draft is also required.
(f) Preregistration inspection and sampling of product for NAFDAC Laboratory analysis are also undertaken.
(g) Final vetting of reports and preparation of briefs for consideration by the Food & Drug Registration Committee is carried out by the Agency as one of the most important stages leading to award of licence/certificate of registration.
1. Packaged water (regulated product) shall not be manufactured in Nigeria, unless the factory is inspected, and a certificate of recognition issued by NAFDAC.
2. In case of the imported products:
(a) There must be evidence of registration of such product by the competent Health Authority of the country of manufacture i.e. Product Licence/Certificate of Registration.
(b) There must be evidence from the competent Health Authority, that the sale of the Product does not constitute a contravention of the Good Laws of that country i.e. Free Sale Certificate.
3. In the case of imported new product, there must be evidence that such product is registered in the country of origin, and that the ingredients are approved raw materials.
4. An applicant shall not be allowed to register packaged water in more than one brand name, except in cases where the manufacturers are different having different brand names for the same formulation
1. Labelling shall be informative and accurate. In addition to the requirements of the regulations on labeling, the following minimum requirements must appear on the label.
a) Name of Product-Brand Name or Common Name (where applicable), must appear in bold letters.
b) Full location address of the manufacturer.
c) Batch No., Date of manufacturer and Best Before/Expiry Date.
d) Net contents of essential ingredients in metric weight units in case of solids, semisolid and aerosols and metric volume in case of liquids.
e) The ingredients must be listed by their common names in order of their predominance by weight unless the packaged water is standardized, in which case the label must include only those ingredient which the standard makes optional.
f) The label must contain directions for safe use where appropriate or necessary (on the information panel (IP) or on the package insert (PI).
g) Any regulated 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).
E. PRODUCTION REQUIREMENTS FOR PACKAGED WATER
1. ACCEPTABLE SOURCES OF WATER
i) Spring Water: Water from the spring must be collected into a reservoir at the shortest possible distance from the source to prevent environmental pollution. There should be no need to subject this source of water to chemical treatment.
ii) Borehole: The depth of the drilled borehole must be below the sea level and it should be equipped with a submersible pump. The borehole must be suitably positioned topographically from the septic tank and there must be a good distance (e.g. 30 meters) separating the two of them. The minimum depth of the borehole should be 150ft.
Note: WELL WATER and DEEP WATER are not acceptable. This is because in most Nigerian cities, the general mode of disposal of sewage is by the use of cesspools, septic tanks and pit latrines. Except for very few factories now, there are no sewer and modern sewage treatment plants. Consequently, ground water is polluted to a high degree by seepage from various sources (i.e. sewage ponds, refuse dumps, leaching of fertilizers, pesticides from agriculture, detergent, radioactive wastages, etc).
iii) Public Mains Water: The water must be running freely in the factory. Lifting of water with tankers from another location to the factory is not acceptable, in order to avoid cross-contamination of the water.
2. WATER TREATMENT AND PURIFICATION
This depends on the quality of the raw water, and can subjected to any or a combination of the processes described below:
(i) Chemical Coagulation, Flocculation and Setting: Chemical coagulants used mainly are aluminum slats like Aluminum Sulphate (alum). After coagulation and flocculation, it may be necessary to neutralize the carbonic acidity or other form of acidity in the water by the use of suitable base like the hydroxide of sodium or calcium. This process removes micro- pollutants of particulate nature.
(ii) Softening of Hard Water or Hardness Removal: Hardness does not affect the sanitary quality of the water but is of importance in the domestic use of water, particularly for laundry and boiling purposes. Calcium and magnesium salts, the principal mineral.
Constituents of hard water, consume soap and precipitates as insoluble compounds or soap curds. Until all the calcium and magnesium in the washing water is precipitated, no lather or washing action is obtained from soap (creating a waste or soap or money). Temporary hardness in water (i.e. Calcium and magnesium bicarbonates) can be removed by heating prior to use. Chemical treatments involving the addition of hydrated lime (calcium hydroxide) are also effective in softening such waters. Hardness caused by sulphate and chlorides of magnesium or calcium, referred to as permanent hardness is not removed by the above treatment but can be removed by ion exchange techniques.
(iii) Aeration: The water is acrated by exposure to air (oxygen) e.g. by spraying, a process which helps to eliminate odour, objectionable taste, ferrous and manganese irons. Iron and manganese always occur together in most Nigerian borehole water. The effect of the oxidation is to oxidize the soluble ferrous oxide to insoluble ferric oxide, soluble manganese oxide to the insoluble form to nitrify ammonia removal of odour), increase the oxygen content and therefore improve the taste of water.
(iv) Sand Filter: The water can be filtered by passing it through a graded sand filter bed after sedimentation (and sludge removal) in order to remove the suspended solids which are of particular size.
(v) Activated Carbon Filter: This special filter removes objectionable colour, taste, smell and excess chlorine (after chlorine disinfection). It is important to note that filters must be washed at regular intervals depending on the rate of filtration and the amount of suspended matter in the water. Poor back- washing adversely affects the production rate of the filter.
(vi) Industrial Micro Filters: These remove very fine suspended particles and large microbes or bacteria from the water, 5 micron, 2 micron, 0.5. micron filter thread sizes are recommended.
(vii) Disinfection of the Water: Disinfection of portable water which is necessary for the destruction of pathogenic micro-organisms in the water can be achieved by the following means:
(a) Chlorination: Gaseous chlorine or chlorine compounds such as chloride of lime or calcium hypochlorite are used. The active disinfectant is chlorine. The problem of effective chlorination is to ensure:
- Uniform application of chlorine to all portions of the water being treated.
- Uninterrupted application of chlorine
- Selection of the dose of chlorine to meet the current needs of the specific water being treated.
- Control of chlorination so as to produce safe portable water that is at the same time of attractive character.
(b) Ozone: Ozonation is a very attractive method of disinfecting water. It is also very effective in the removal of tastes, odour (it has a bleaching effect) from the water. The ozone has to be generated as needed by the passing thoroughly filtered and dried air through tubes or between plants where high voltage electric discharge occurs, changing part of the oxygen or of the air to ozone (02 to 03).
(c) Ultraviolet Light: The water to be sterilized must be clear and the lamps must be kept clean at all times. This treatment is made compulsory by NAFDAC and in combination with chlorination in order to achieve a high level of purity. It should be properly encased (not exposed as it is dangerous to the body and installed just before the filling point.
(d) Boiling: Boiling destroys all forms of disease organisms usually encountered in water in water i.e. bacteria, spores, cercariae, cysts and ova. The water must however be brought to a “rolling” boil to be safe. The appearance of bubbles (simmering) is sometimes confused with boiling or with the appearance of mist or steam over the water. None of these signs is sufficient indication that water but heating changes them to the less soluble carbonates which are deposited as scales in the system. These deposits are hard to remove and can harbor bacteria as well as introduce sediment in the water. For these reasons boiling for the purpose under discussion not recommended.
3. APPROVED STANDARDS FOR PORTABLE WATER
Portable water must be free from chemical substances and micro-organisms in amounts that could be hazardous to health. It must be organoleptically acceptable and aesthetically attractive. It is expected to meet the World Health organization (WHO) standards which are also the standards adopted by NAFDAC for portable drinking water (See Appendix 1 attached)
4. NAFDAC REQUIREMENTS FOR A WATER PACKAGING PLANT
(i) Factory and Location/Layout: The Water Processing Plant should be located in a non-residential area and never within the residential house or premises. The factory building should be walled off from external interference. Provisions should be made for the raw material and finished product storage, processing or water treatment room, packaging room, cloak room, toilet facilities fro workers etc. the factory must no be situated near a refuse dump, abattoir, grave yard, soak-away pit or oil dept; as these are possible sources of contamination. Space for production should be sufficient to allow for free movement of personnel and materials.
(ii) Personnel and Welfare: The key officers are the production and the quality control managers, who must have a sound knowledge in Food Science and Food Processing, Educational Qualification in relevant fields of science like Chemistry, Microbiology, Food Science, etc is compulsory. The workers must be properly kitted with overalls, head gear, hand gloves, mouth and nose guards, etc. they must also be medically certified fit to handle food meant for public consumption (Food Handlers Tests).
(iii) Equipment: Water holding tanks in the plant at different stages should be suitable materials, e.g. stainless steel or plastic (PVC). All automatic filling and sealing equipment is preferred to manual packaging in order to avoid human contamination of the processed water. Taps should be of stainless steel. Wash-hand basins should be of stainless steel.
N.B. Connecting pipes should be made polyvinyl chloride or stainless steel. Iron pipers should not be used because they tend to rust and contaminate the water.
(iv) Quality Control Procedure: There should be a well equipped in house quality control laboratory to cater for physio-chemical and microbiological analysis of the taw and processed water. In the absence of this the services of a government approved public analyst can be engaged. A copy of the letter of agreement between the two parties to this effect should be made available to reflect that regular analysis of the product would be carried out. All Laboratory reports must be well documented.
(v) Packaging Materials: Ensure that packaging materials are made from food grade materials. The printing should be made under hygienic conditions.
Production Room Outlook: Should be well lit and ventilated (preferably air-conditioned) fans are not allowed:
(a) Floor-well cemented. Preferably tiled.
(b) Drainage – adequate to allow smooth flow of water
(c) Wall-walls around the taps should be tiled from the floor to a height of about one foot from the taps. The rest of the walls should be painted with oil paint.
(d) There should be U.V. Fluorescent light for sterilization of the air.
(e) All demarcations should be done with cement blocks.
(f) Every member of water filling staff should occupy a separate compartment or is adequately separated fro the next filling staff.
(g) Personal hygiene of every filling/sealing staff should be checked to ensure that no member has:
i) Fresh open wound
ii) Cold (running nose, cough)
iii) All the production staff should wear head gear, nose mask and hand gloves.
(h) Movement to and from the production room should be restricted
(vii) Standard Operational Procedure (SOP)
(viii) S.O.P Should be prepared for:
- Quality Control
(ix) Packaging Material Stores: These should be well arranged especially empty bottles on pallets, while sachets should be stored on shelves or cabinet away from the ground. The store should be well lit and ventilated. Sterilization of packaging materials and air with ultra violet florescent tube is advised.
(x) Finished Product Store: Bags of water should be stored on pallets in a tidy well lit and well ventilated room.
(xi) Fumigation: should be available and strategically located.
(xii) Fire Extinguisher: Should be available and strategically located.
(xiii) Refuse Disposal: Waste bins should be kept covered and disposed hygienically with approved local authority.
WHO STAND FOR DRINKING WATER
A. Physical Chemical Specification
1. General Appearance Clear
2. Colour 5H2
3. Odour Odourless
4. PH 6.5-8.5
5. Total Hardness 500mg/litre
6. Total Dissolved Calcium carbonate
solid 50MG/L.dried at
7. Calcium (ca) 1800C
8. Chlorine (cl) 75mg.litres
9. Residual Chlorine 200mg/L-600mg/L
10. Magnesium (Mg) 30MG/1-150MG/L
11. Manganese (Mn) 0.05mg/L
12. Iron (Fc) 0.03mg/L
13. Sulphate (Scl) 200mg/L-400mg/L
14. Lead (Pb) 0.05mg/L
15. Fluorides (F) 0.05mg/L
16. Aresenic (As) 0.01mg/L
17. Cyanides (CN) should not be detectable by Analysis
18. Copper (Cu) 0.05mg/L
19. Zinc (Zc) 5.0mg/L
20. Mercury (Hg) 0.001mg/L
21. Pilenol Nill
22. Chromium (Chr) 0.05mg/L
23. Cadmium (Cd) 0.01mg/L
24. Selenium (Sc) 0.01mg/L
25. Radionidides 1000uuC/L
(gross beta 1.0mg/L
activity) 45mg/L (as No. 3)-
26. Barium (R) ingestion of excess
27. Nitrates may give rise to infantile
MICRO – BIOLOGICAL STANDARDS
1. Parasitic & Pathogenic Organisms Nill
2. Total Plate bacteria Count 100cfu/ml
3. Escherichia Coli (in 100ml water) Nill
4. Strepto-Coccus faecalls
(in 50ml water) Nill
i. Failure to comply with these requirements may result in the disqualification of the application or lead to considerable defy in processing of registration.
ii. In case of processed food and packaged water, only manufacturing outfits situated in industrial areas will have their Registration Certificate valid for 5 years while those located in residential areas have one year validity (yearly listing).
iii. A successful application will be issued a certificate of registration with a validity period of five (5) years.
iv. Registration of a product does not automatically confer advertising permit. A separate application and subsequent, approval by the Agency shall be required if the product is to be advertised.
v. NAFDAC may withdraw the Certificate of Registration in the event that product is advertised without express approval from the Agency.