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Quality Control Tests on Soaps

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“IMPROVING THE QUALITY OF SHEANUT PRODUCTS FOR
GLOBAL COMPETITIVENESS”
PRESENTATION BY PAUL B. ORHII, JD, MD, Ph. D, DIRECTORGENERAL (NAFDAC), AT THE SEMINAR ON SHEANUT AT
HYDROHOTELS, MINNA, ON 4TH AUGUST, 2010.
Protocol:
I feel highly honored to be invited to present a paper with the theme:
“Shea nut industry in Nigeria: exploiting its potentials for economic growth and development “.
I commend the management of Central Bank of Nigeria (CBN) for organizing this seminar which provides a forum for the various stakeholders to engage in discussions towards exploiting the potentials of Shea nut industry for economic growth. The theme of the conference is also timely considering the efforts being made by various sectors in order to rescue Nigeria from the impact of the global financial crisis.
Your choice of topic: “Improving the quality of Shea nut products for global competitiveness” is also commendable. This forum will not only expose the hidden potentials of Shea nut crop and its produce but also addresses the operational challenges of policy implementation, compliance to regulatory requirements and promotion of exchange of ideas to mitigate such challenges, but will also foster collaborations among the different stakeholders towards improving our economy.
This address will highlight all the efforts of NAFDAC to effectively regulate the food , cosmetics and pharmaceutical industry as a means of improving the quality of Shea nut products for global
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competitiveness. We believe that effective regulation in these sectors will attract foreign investors as well as encourage export of locally produced foods, cosmetics and pharmaceutical products.
Regulation is a public policy that controls private behavior for public good. Effective regulation assures the quality and safety of our regulated products and also stimulates growth in the industry. Under regulation often results in low quality products that cannot compete favorably in the market while over regulation results in stifling of enterprises and investments. NAFDAC regulatory activities strive to strike a balance so that quality is maintained while investments are protected and promoted. Effective regulation is one of the keys to strengthening and unlocking Nigeria’s latent development potentials in the food and pharmaceutical industry as well as other sectors of the economy. It was in a bid to strengthen the local industry, position it for growth and development as well as encourage foreign investment that
NAFDAC was established with the mandate to regulate the products and activities of the industries. Through its numerous activities
NAFDAC provides a well regulated and favorable environment for genuine operators in the food and pharmaceutical industry to explore their prospects and achieve their full potentials for development. The
National Agency for Food and Drug Administration and Control
(NAFDAC) plays an important role in ensuring that regulated products produced with relevant quality and safety specifications.
THE NAFDAC MANDATE:
The National Agency for Food and Drug Administration and Control
(NAFDAC) was established by Decree 15 of 1993 as amended, now
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Act. Cap N1 Laws of the Federation of Nigeria (LFN) 2004, to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale and use of food, drugs, cosmetics, chemicals, detergents, medical devices and all drinks including packaged water.
The essence of regulation and control is to protect public health by ensuring that only regulated products that are safe, efficacious and wholesome reach the market, and ultimately, the consuming public.
This is achieved through various processes which include product registration/listing, inspection of production facilities, good manufacturing practice (GMP), Hazard Analysis and Critical Control
Points (HACCP)
The Shea tree grows naturally in the wild in the dry Savannah belt of
West Africa .They bear fruit after about 20 years and do not reach maturity for 45 years. They may continue to produce nuts for up to
200 years after reaching maturity. A tree can yield of 15 to 20 kg of fresh fruit that will produce 3 to 4 kg of dry kernels. The kernels contain 42 to 48% oil (butter). In recent years the Shea tree has gained importance as an economic crop because of the heavy demand for its butter, both locally and internationally. Unrefined Shea butter contains vitamins A, E and several phyto nutrients. Vitamin A in Shea butter is most important for improving a number of skin conditions: including blemishes, wrinkles, eczema, and dermatitis.
a. Characteristics and Availability
Shea Butter is a creamy or ivory-colored natural fat extracted from the nuts of the Shea-Karite tree. It readily melts at room temperature and it has a characteristic smell.

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b. Processing
Crushing and extraction by solvent are the two processing method.
Traditional process:
The green pulp exterior is removed, either by burying the fruit in the ground so that the pulp ferments and falls off or other means, the nuts is picked, dried cracked, shelled and winnowed, usually by hand, pounded for a few days. The kernels are dried further to reduce moisture content and then boiled in water for several hours. The Shea
Butter then begins to rise to the surface. This is then scooped and left to cool and set.(see flow chart
Sorting of the Nuts
Cracking and Roasting (Reducing the Use of Wood for Heating during the Production of Shea)
Grinding
Kneading and Clarification
Filtering and Stirring
Packaging and Labeling
Modern Process:
The introduction of equipment may improve upon traditional methods of production by reducing the effort and time involved and by increasing the yield. Instead of pounding by hand, a motorized mill is used and oil extracted using a mechanical or hydraulic press on the nuts, and placed in hot air ovens. Product is then bleached with a hexane solvent; butter scooped is stored and transported under cool conditions and in airtight containers to avoid rancidity. The oil extracted has a relatively high melting point and is used in rural areas in the making of foods, and cosmetics.
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c. Uses of Shea Tree
The fruit pulp, foliage, barks, leaves, flowers and nuts of a Shea tree have many uses. Their immense healing properties allow them large utility in drug, food and cosmetics industry. Some of the various benefits include:- moisturizer for the skin, dry scalp, relief from small skin wounds, eczema, blemishes, wrinkles and stretch marks. Also it is used as baking fat and to substitute for cocoa butter in chocolate and confectionery products.

d. Quality Standard
The oil content is the most crucial element of the Shea nut as that component is an important ingredient in the composition of the butter. A quality Shea butter must be free of foreign bodies, have high oil content, low Free Fatty Acid (FFA) and low moisture content with melting point of between 30° C - 40° C.
1. Laboratory analysis:
The benchmark for the composition of the Shea nut required for import / export is as stated below:
• Free Fatty Acids (FFA) = less than or equal to 6%
• Moisture Content = less than or equal to 7%
• Oil Content = greater than or equal to 45%
• Latex = 4-10%
Shea butter Laboratory Analysis is batch specific. Some of the tests that ascertain product quality are:
Physical and chemical assessment of Shea.
Moisture and debris content.

Heavy metal testing.
Pesticide residue testing.
Free Fatty Acid profile
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Rancidity Values
Size of The Non- saponifiable
Shelf Life Studies
Fraction Determination
Microbiological Analysis:
Mycotoxin determination
Molds and Bacteria
Triglycerides Profile
Iron and Copper levels
Sterol Profile when necessary determination Vitamin A Value
Peroxide Level Determination
During Grade Analysis above mentioned tests are performed to determine the level of bio-active ingredients and overall quality issues.
Shea Butter comes in different grade, Grade A; Grade B; Grade C;
Grade D; or Grade F. Before Shea Butter receives the distinction as
Grade A Shea Butter, the butter must demonstrate a distinguished bio-active fraction of 6% or greater by laboratory tests. Grade A Shea butter contains quality, natural, fixed, or aromatherapy essential oils, it is the highest and best quality for cosmetics and food industry. To that end, only the best preparation of unrefined Shea butter can earn the Grade A status. Grade D is the lowest grade missing most of the valuable nutrients. The highest grades are awarded to those butters with the largest Bio-active fraction (5% and above), a good safety screen, and rancidity value below 10 Grade F is reserved for Shea
Butter not fit for human use. Grade F Shea is contaminated by microorganisms (such as mold, yeast or coliform bacteria) or contaminated with heavy metals (such as lead or mercury).
2. Use of preservatives
Preservative used may affect quality of Shea butter. Some of the products used as preservative are; grapefruit seed extract, rosemary oil extract and Vitamin E. Potassium sorbate is another all natural preservative that is widely used; it can be effective in preserving
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against mold and yeast but does not prevent bacteria from growing in the product.
3. Coloring
Color of a true processed Shea varies from ivory, to light yellow.
There are several variables that lead to color variation, including the season when the butter is made, the method of crafting the butter, and variations of fatty acid ratio within the Shea nuts.
Longer storage period or Seasonal changes can have a direct impact on the color of Shea butter. For instance, Shea butter made in the fall with Shea nuts that have been freshly gathered is not as yellow as
Shea butter made with Shea nuts that have been stored for a longer period. This may have to do with the water content of the Shea nut.
The method of extracting the oil may have a greater impact on color of unrefined Shea butter. Stirring of the oil as it crystallizes so that fat crystals align smoothly and it becomes butter influences the color, since the amount of stirring; speed and duration determine how light the color will be. The longer it is stirred, the lighter the color will be.
Shea nuts not properly washed before grinding hold dust, darkening the color, making it unacceptable. This can also occur if the Shea nuts are grilled too long or if they are grilled over a wood fire and the smoke are incorporated into the butter. Good handcrafted, unrefined Shea butter will be ivory or light yellow and not any other color.
4. Scent
The naturally nutty scent of traditionally handcrafted Shea butter can also vary depending on extraction method and geographical location of the Shea trees. The main factor that affects the scent is
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the process of extracting the oil. If wood is used to roast the nuts or heat the oil, and the fire is too smoky, the smoke can infiltrate the butter and give it a smoky smell.
Shea nuts burnt during roasting to reduce moisture content may result in butter having a strong smoky scent. Handcrafted Shea butter is a natural product that has not been refined, and as a result, it has a natural peculiar scent which disappears 15 – 20 minutes after spreading on the body.
5. Product Registration:
It is mandatory for all genuine producers and exporters of Shea nut products to register their products with NAFDAC. The Agency has streamlined the registration procedure without compromising quality to encourage operators of Small and Medium Enterprises (SME) including producers of Shea nut products. The registration involves reviewing all the information provided on the product by the manufacturer and/or marketer before granting marketing authorization. The registration requirements are streamlined to minimize those requirements that do not impact on the quality of the products. For example, SMEs may be allowed to produce in suitable facilities within residential areas. In this way, overhead costs are reduced for small and medium scale producers. The production facilities are regularly inspected to ensure that the required standards are maintained. (see appendix 1).It also involves laboratory investigation and analysis based on national and international standards and established regulations before making pronouncements on the quality of the products.
Inspection of Production Outfits:
It is the responsibility of the Chief Executive Officers of Shea nut products outfits to ensure that their products are produced in
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accordance with the requirements for current Good Manufacturing
Practice (cGMP).

They are also required to be committed to

implementation of the Principles of Hazard Analysis and Critical
Control Points (HACCP). These are necessary for production of quality, wholesome and safe regulated products that can favorably compete in national and international markets.
Good Manufacturing Practice (GMP):
Good Manufacturing Practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by

the

marketing

authorization/product

license.

The

consistency of production and control is essential and can only come about by having clear descriptions of the way in which the work will be done. GMP specifically addresses risks such as cross-contamination and mix-ups that cannot be fully controlled by testing of the final product. The risks however, can best be controlled by having a properly managed system of working that takes them into account.
This means that there must be good design, sound operation, and planned maintenance of facilities.

It also means that the quality

checking system must be designed with these risks in mind and set out to find whether any errors have occurred.
Hazard Analysis and Critical Control Point (HACCP):
This is a concept that is used for controlling food safety hazards from production to consumption that is from ‘farm to fork’. HACCP was introduced as a food safety control system that identifies risk and means of eliminating them rather than trying to detect problems by testing the finished product. This system is based on assessing the
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inherent hazards or risks in a particular product or process and designing a system to control them. Specific points where the hazards can be controlled in the process are identified and addressed.
6.

Labeling information

A cosmetic, drug or food product under which Shea butter is classified must be labeled according to labeling regulations, this establishes quality of the product. For example, the drug ingredients must be listed alphabetically as "Active Ingredients," followed by cosmetic ingredients, listed in order of predominance as "Inactive Ingredients.
It is illegal to introduce a misbranded products (cosmetic, drug or food) into interstate commerce, i.e products whose labeling is false or misleading, its label fails to provide required information, or its required label information is not properly displayed.(see appendix 1)
e. Recommendations:
Improving quality of Shea butter products, the following steps should be adhered to.
1. Production of high quality Shea butter can be achieved by ensuring the application CGMP (current Good Manufacturing Process) and similar principles as HACCP (Hazard analysis critical control point).
2. Adequate laboratory analysis is carried out by regulated authority ascertains quality.
3. Ivory to light yellow color obtained after processing of Shea butter determines quality method.
4. Preservatives may be avoided in view of the fact that they act as contaminant, changing the natural color and while some may be effective in preserving against mold and yeast they do not prevent bacteria from growing in the product.
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5. Heat applied during roasting should be minimal so that smoke will not infiltrate the butter and give it a strong smoky smell, hereby altering the quality.
6. Labeling requirement shall be informative and accurate without which the product may be misbranded.
7. Registration of any product is the mark of quality, the authority in food, cosmetics quality in Nigeria is NAFDAC. The National Agency for
Food and Drug Administration and Control (NAFDAC) was established by Decree 15 of 1993 as amended, now Act. Cap N1 Laws of the
Federation of Nigeria (LFN) 2004, to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale and use of food, drugs, cosmetics, chemicals, detergents, medical devices and all drinks including packaged water.
8. Improvement of the techniques of transport and storage of Shea butter products.

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Product registration
A. GENERAL
It is necessary to emphasize that no Processed Food, drugs or cosmetics shall be manufactured, imported, exported, advertised, sold or distributed in Nigeria unless it has been registered in accordance with Provisions of ACT CAP F33 LFN
2004 (Formerly decree 19 of 1993) as amended by Food, Drugs and Related
Products (Registration) Decree No. 20 of 1999.
In the event of any violation in this regard, the consignment of the unregistered product would be cleared from the ports to a bonded warehouse at the expense of the importer. Thereafter the importer is prosecuted and the products forfeited to the Government together with any assets or property obtained or derived directly or indirectly from the commission of the offence.
B. APPLICATION
(a) An application for the registration of a cosmetic, food or drug product should be made by the manufacturer.
(b) In case of a manufacturer outside Nigeria, such should 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/ processor 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 by a Notary Public in the country of origin and submitted to NAFDAC. Or Contract Manufacturing Agreement:
a. Notarized by a notary public in the country of manufacture.
b. Should be 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. Please note that the representative in Nigeria, whether a corporate body or an individual with the
Power of Attorney, will be 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, corrosive, or sub-standard Shea butter products.
The applicant must submit to the Registration Division, NAFDAC, a written application, stating the name of the manufacturer or processor, name of the product, brand name (where applicable), and obtain the prescribed application
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form which must be properly filled, with all information required. This form shall be obtained on payment of the prescribed fee per product.
C. DOCUMENTATION
1. The manufacturer, in the case of imported product, must show evidence that the company is licensed to manufacture and that the sale of the Product does not constitute a contravention of the Laws of that country i.e Free Sale
Certificate (Certificate of Manufacturer and Free Sale). Such evidence must be issued by the competent Authority in the country of manufacture, and should 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.
2. Comprehensive Certificate of analysis
3. Certificate of Business Incorporation with the corporate affairs commission in
Nigeria
4. Certificate of Registration of Brand Name with trademark Registry (where necessary) 5. Applicants shall submit a letter of Invitation to inspect the factory abroad.
They shall 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.
6. A permit should be issued if documentation is satisfactory.
D. LABELING
1. Labeling should 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 (where applicable), must appear in bold letters. (b) The name and full location address of the manufacturer, packer, distributor, importer, exporter or vendor of a cosmetic should be stated on both the inner and outer labels (where necessary) in such a manner that is easily readable.
(c) Batch number, Date of Manufacture (where applicable) and Best Before /
Expiry Date.
(d) Net contents of essential ingredients in metric units.
(e) The ingredients must be listed by their common names in order of their predominance by weight.
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(f) The label must contain directions for safe use (where appropriate) 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).
(h) Provision shall be made for NAFDAC Registration Number.
E. TARIFF
All payments to the Agency should be in bank draft payable to National Agency for Food and Drug Administration and Control.
Please note that:
1. Mercury and its compounds and corticosteroids are not permitted in cosmetic products 2. Lanolin and Boric Acid are not permitted in baby products.
3. Failure to comply with these requirements may result in the disqualification of the application or lead to considerable delay in processing of registration.
4. A successful applicant will be issued a Certificate of Registration with a validity period of five (5) years.
5. Registration of a product does not automatically confer advertising permit.
6. A separate application and subsequent approval by the Agency shall be required if the product is to be advertised.
7. NAFDAC may withdraw the Certificate of Registration in the event that the product is advertised without express approval from the Agency.
8. NAFDAC reserves the right to revoke, suspend or vary the certificate during its validity period
9. Filling an application form or paying for an application fee does not confer registration status.
10. The time line for product registration from submission of samples up to issuance of registration number is eighty (80) working days. However, this depends on satisfactory compliance by the applicant.
For locally processed or manufactured Shea butter products (Food, cosmetics or drugs) Local Registration.
Application for registration of Shea butter products should be accompanied with a Bank Draft payable to NAFDAC covering the prescribed fees for Pre-production inspection. 14








The Pre-production inspection is carried out to assess if manufacturing facilities, personnel and location of plant are satisfactory.
Registration procedure is halted at this stage if the facilities, etc are not satisfactory. 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.
Purchase of product registration form with the prescribed fee payable in Bank
Draft.
Pre-registration inspection and sampling of product for NAFDAC Laboratory analysis. Final vetting of reports and preparation of briefs for consideration by the Food &
Drug Registration Committee are carried out by the Agency.

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The following must appear on the principal display panel: o An identity statement, indicating the nature and use of the product, by means of either the common or usual name, a descriptive name, a fanciful name understood by the public, or an illustration. o An accurate statement of the net quantity of contents, in terms of weight, measure, numerical count or a combination of numerical count and weight or measure. o Name and place of business. This may be the manufacturer, packer, or distributor. Distributor statement. If the name and address are not those of the manufacturer, the label must say "Manufactured for..." or "Distributed by..." o Material facts. Failure to reveal material facts is one form of misleading labeling and therefore makes a product misbranded. An example is directions for safe use, if a product could be unsafe if used incorrectly. o Warning and caution statements. These must be prominent and conspicuous. The NAFDAC Act and related regulations specify warning and caution statements related to specific products. In addition, cosmetics that may be hazardous to consumers must bear appropriate label warnings. An example of such hazardous products is flammable cosmetics. o Ingredients. If the product is sold on a retail basis to consumers, even if it is labeled "For professional use only" or words to that effect, the ingredients must appear on an information panel, in descending order of predominance. Remember, if the product is also a drug, its labeling must comply with the regulations for both OTC drug and cosmetic ingredient labeling. o Labeling Terms: Labeling shall be informative and accurate. o Minimum requirements on the package label: o Name of Product - Brand Name and generic name where applicable. The generic name must be in similar characters with the brand name. o Location Address of the manufacturer. o Batch No., Date of Manufacture and Best before/Expiry Date. o Dosage regimen on the package. o Leaflet insert, if prescription product and hospital packs. o Indications, frequency, route and conditions of administration. o Quantitative listing of all the active ingredients per unit dose.
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o o o

o

o

o

Adequate warnings where necessary.
Where a brand name is used, there MUST be the generic name which should be conspicuous in character, written directly under the brand name e.g. VENTOLIN, SALBUTAMOL
Any product whose name, package or label bears close resemblance to an already registered product or is likely to be mistaken for such registered product, shall not be considered for registration.
Any 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).
Information on indication carried on packages and leaflet insert of imported drug product shall not differ from that in other countries and in particular the country of origin of the product.
Failure to comply with these requirements may result in the disqualification of the application or lead to considerable delays in processing of registration.

A successful application attracts a Certificate of Registration with a validity period of Five (5) years.

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