Micro, Small & Medium Enterprises (MSME)
National Agency for Food and Drug Administration and Control (NAFDAC) identified the challenges of Micro, Small and Medium Enterprises (MSMEs) in registration of their products with NAFDAC. The Agency has instituted several activities which include further review of guidelines and streamlined registration processes to handle their peculiar difficulties. The aim is to remove critical bottlenecks and bureaucratic red tapes that hinder the smooth registration and regulatory activities of MSMEs
MSME Classification adopted from National Policy on MSMEs:
|1||Micro Enterprises||Less than 10|
Guidelines For MSME Products
The following guidelines are for MSMEs Enterprises:
- Guidelines for Inspection of Facilities for Manufacture of Food Products
- Guidelines For Establishment Of Cottage And Kitchen Scale Food Industries
- Guidelines for Inspection and Requirements for Bread Manufacturing Facility
- Guidelines for Inspection and Requirements for Packaged Water Facility in Nigeria
- Guidelines for Inspection of Micro Scale Enterprises in Nigeria
- Guidelines for Inspection of Small Scale Enterprises
- Guidelines for the Registration of Cosmetics made in Nigeria
- NAFDAC GMP Guidelines For Cosmetics Products
The tariff applicable to Micro and Small-Scale Enterprises are extract from the General Tariff. Please note that the reduced tariff will be in existence for only three (3) months effective from 15th May, 2020.
How to Register Your Product
Please visit our e-registration portal to apply online and upload all required documents
- Micro scale – Required documents
- Evidence of Registration with Cooperate Affairs Commission (CAC)
- (Business Name and/ or incorporation)
- Site use Agreement (Where applicable)
- Evidence of Trademark approval we advise that you get this document as It helps
- To protect the product brand /or business name.
- One vetting Sample and three labels
- Fumigation certiﬁcate
- Copy of Receipt of Payment for production registration
- Food handlers certiﬁcate / medical ﬁtnesscertificate for production staff, this should include the following: Sputum test, stool test, Urinary test,Widal test, Hepatitis B
- Small Scale – Required documents:
- The application letter
- SOP for production,
- SOP distribution /Recall,
- SOP Quality assurance,
- SOP Cleaning of equipment,
- SOP receiving of packaging materials,
- SOP Personal Hygiene,
- SOP Water analysis were applicable and
- SOP for cleaning of the environment,
- Food handlers certificate/ medical fitness certificate for production staff should include the following parameters: Sputum test, stool test, Urinary test, Widal test, Hepatitis B Test.
- List or raw material and their source(s)
- Certificate of analysis of raw materials (optional for micro scale)
- Certificate of analysis of finished products (optional for micro scale)
- Certificate of fumigation
- Label/Packaging material.
- Soft copy of all the documents submitted.
Frequently Asked Questions (FAQs)
NAFDAC does not encourage the use of consultants, however the use of consultant by any client is at his/her own risk
Currently, Micro scale food is N36,737.50 while Micro Scale Cosmetic is 41,000.00
A micro scale facility is a business enterprise with not more than five (5) employees. Its building can be purpose-built or adapted with minimum of a designated standard room that is not open directly to any source of contamination. However, there are products exempted under this scope. These include Meat products except dried, Milk & dairy products, Beverages, Packaged water, & vegetables.
A small scale facility is a facility with 1 to 10 employees. Its building can be purpose built or adapted. It must also have adequate space, capacity and equipment for its intended product (s) for registration.
The timeline is ninety (90) working days
Trade Mark, SOPs, Product Label, Cert. of Fumigation, CAC, Food handlers test, Batch Formulation, (Trademark is optional for Micro scale)
NAFDAC encourages Trademark registration, however it is optional for micro scale.
It is mandatory for companies to register with Corporate Affairs Commission. It shows that the business is a legal entity and is on the public register of duly registered companies.
A company can choose to change its factory location after registration by duly notifying and getting authorization from the Agency on the proposed relocation.
The validity period for listing certificate is two (2) years.
Not more than five (5) products can be registered under micro scale. It is important to note that Food Allergen Sources e.g. Stock fish cannot be processed in the same room alongside other non-allergen products.
Yes NAFDAC Registration Number for regulated products is mandatory.
The under listed products are exempted under micro scale enterprise: Meat and meat products (except dried), Milk and dairy products, Fish & fish products (except dried), Beverages.
Frequently Asked Questions (FAQs)- COSMETICS
Yes, NAFDAC Act Cap N1 LFN empowers the Agency to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale and use of cosmetics among other regulated products.
A cosmetic product is termed organic if it contains 70% agricultural ingredients.
Claims such as vitamin E in cosmetic product in micro scale may not be substantiated
A batch formulation is a list of all components/raw materials of the dosage form to be used in the manufacturing process.
The use of distilled, de-ionized or purified water is recommended for the production of cosmetic products.
No regulated product shall be advertised in Nigeria unless it has been registered in accordance with the provisions of NAFDAC ACT CAP F33 LFN 2004 however, you are advised to seek approval in advance before shooting any advert (Cosmetics and Medical Devices Advertisement Regulations)
Yes, ingredients such as Lanolin in baby lotion and Boric acid in baby powder are banned. Hydroquinone above 2%, mercury and its salts, corticosteroid in body creams are also banned. Other banned or restricted ingredients in cosmetics include bithionol, vinyl chloride, methanol, halogenated silicylanilides, zirconium complexes in aerosol cosmetics, chloroform, methylene chloride, chlorofluorocarbons propellants and hexachlorophene.
The use of stainless steel equipment is recommended in the production of cosmetics.
There are many chemical marketers in Nigeria but not all of them are listed with NAFDAC . You are therefore advised to source your chemicals from NAFDAC Listed Chemicals marketers. For further enquiries on the list of NAFDAC Listed marketers, please visit Chemical Evaluation Directorate of NAFDAC, NAFDAC Isolo Office Complex, Lagos or call 09063977319, 07-4609762.
The following cosmetics products are allowed under Micro and small scheme Petroleum Jelly, Shea Butter, Hair Cream (Oil based), Oils e.g. Coconut oil, Laundry detergents, Starch, Liquid Air Freshener, Soaps
Under micro scale production, certificate of analysis of raw material or finished products are optional.
Any claims that cannot be substantiated is not allowed in cosmetics products
Medical Certificate of fitness of personnel handling cosmetic products is required. Food Handlers Test is required in food industries.
All cosmetic products labels shall state the brand name (where applicable), the product statement of identity ,batch number, net content, manufacturing and expiry date, manufacturer’s name and country of origin, NAFDAC Registration number , storage condition, list of ingredients and any other information as may be prescribed by NAFDAC .
Frequently Asked Questions (FAQs)- FOOD
NAFDAC does not encourage the use of consultants, however the use of consultant by any client is at his/her own risk
Currently, Micro scale Food is ₦36,737 .50 while Micro scale Cosmetic is ₦41000.00
A micro scale facility is a enterprise with not more than nine (9) employees. Its building can be purpose built or adopted with a minimum designated standard room that is not open directly to the source of contamination. However there are products exampled under this scope. They include meat products except dried, milk & dairy products, beverages, package water and vegetables.
Timeline is ninety(90) working days
Trade Mark, SOPs, CAC, Certificate Fumigation, Food Handler Test, Product Label, Batch Formulation. (Trade Mark optional for Micro scale)
NAFDAC encourage trademark registration however is optional for Micro scale
Yes, NAFDAC registration Number for regulatory products is mandatory.
A company can choose to change its factory location after registration after dully notifying and getting authorization from the agency on the purpose of relocation.
The validity period for listing certificate is two(2) years
Not more than five(5) products can be registered under Micro scale. It is important to note that food allergy sources e.g. stock fish cannot be processed in the same room alongside with non-allergy products.
The under listed products are exempted under micro scale enterprise: Meat and Meat products(except dried), Milk and Dairy products, Fish and Fish product(except dried)
Frequently Asked Questions (FAQs) on the Palliative Program
Yes, factory inspections will be conducted after the ease of the lockdown exercise. However, arrangement can be made for virtual inspection, which may be done at any time
No, the palliative tariffs are only applicable to fresh applicants as from 15th MAY 2020.
The system will automatically pick the first 200 people qualified for the zero tariffs.
The complaints contact phone numbers are can be located on the right-hand bottom of the MSME Page.
Below are the definitions of MSMEs in terms of personnel:
- Micro Enterprise (1-9 Personnel)
- Small Enterprise (10-49 Personnel)
- Medium Enterprises (50-199)
However, an applicant in the micro category may only apply for registration of 1-5 different products and can qualify for the Micro palliative separately for each product. While an applicant making applications for more than 5 products qualifies for the Small scale.
NO, the palliative is applicable to only people registering food or simple cosmetic products. Complex cosmetics with multicomponent formula, pressurised sprays, etc cannot qualify for Micro/small enterprise product
No, someone making payments for re-analysis must pay for the laboratory fees from the current original 2020 tariff.
No, hand sanitizers are not under the MSME scheme. Check under the Drug & Medical devices page of the website for information on registration of hand sanitizers.
No, the renewal applications are already entitled to 50% discount from the current 2020 original tariff.
The duration of the MSME Palliative program is 6 months.
The duration for the MSME late renewal administrative waiver is 3months.
Maybe the size of your document is too large. The size of the document should not exceed 500KB.
Each pack size is evaluated separately, and registration is on individual product identity.
Because the change in formulation may alter the identity of the initial product whose food safety profile must be accessed before approval.
No, company should apply for such intended change and receive the Agency’s approval.
The Agency should be notified, and due process followed for approval.
By conducting a shelf life study to know how long the product can stay for before and still remain wholesome and safe for human consumption.
No, such information must be printed directly on the product pack.
You may need to visit the Agency’s website for clarification on food additives regulations: https://www.nafdac.gov.ng/wp-content/uploads/Files/Resources/Regulations/All_Regulations/Food-Additivies-Regulations-2019.pdf
Phone: +234 8033075895; 08086699452