This article aims to enlighten readers of the relevant provisions of the National Agency For Food and Drug Administration and Control (NAFDAC) on cosmetic products labelling in Nigeria, especially in light of the worrisome plethora of dubious skin care brands dominating the Nigerian market backed by extravagant marketing.
The NAFDAC regulations apply to all cosmetic products manufactured, imported, exported, advertised, sold, distributed or used in Nigeria.
Its relevant provisions are as follows:-
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Prohibition
– All cosmetic products manufactured, imported, exported advertised, sold, distributed or used in Nigeria shall be registered in accordance with the provisions of the NAFDAC regulations.
– A cosmetic product shall not be manufactured, imported, exported, distributed, advertised, displayed for sale, offered for sale, sold or used as a cosmetic products, unless a label has been affixed thereto with the information specified in the regulations and appearing on both the inner and outer container.
Labelling Information
– All information required to be indicated on the label of a cosmetic shall be informative, accurate, prominent, legible and distinct.
– All statements shall appear in font size and style type, which is legible for clarity and on a sufficient contrasting background without obscuring designs or vignettes.
– The letters of the name of the cosmetic product and the net content shall be of a size reasonably related to the predominant character on the label.
Validity of Approval
– A cosmetic product label shall state the following :-
- Brand name (where applicable)
- Product’s statement of identity
- Lot/batch number
- Net content
- Expiry date
- Manufacturer’s name and location address including country of origin
– Where a cosmetic is covered with a wrapper, the label shall be legible through the outer wrapper and shall not be obscured.
– Where the wrapper carries the required information, it shall be affixed in a manner that is not removable from the cosmetic container.
– Any claims on the cosmetic product shall be substantiated.
Product Identity
– The outer and inner labels of a cosmetic product shall be required to bear the name of the cosmetic product which shall indicate the accurate natureof the cosmetic product.
– Where a common name or statement of identity has been established for the cosmetic, it shall be used in conjunction with the brand name of the cosmetic product.
– Where no common name or statement of identity exists for a cosmetic product, an appropriate descriptive name shall be affixed to it.
List of Ingredients
– A complete list of ingredients used in preparing the cosmetic product shall be declared on the outer label and inner labels where appropriate in decreasing order of predominance, provided that :-
- Fragrance, colour or flavour may be listed in any order after the other ingredients as fragrance, colour or flavour, and
- An ingredient that is a fragrance, colour or flavour shall each be designated by internationally identified names or codes.
– Where there is no outer packaging, the list of ingredients shall appear on the inner label.
– Ingredients in concentrations of less than 1% may be listed in any order after those concentrations of 1% or more.
– The declaration of ingredients shall be prominent, readable and understood under normal conditions of purchase.
Net Content of Cosmetic Product
– The accurate average net content of every cosmetic product shall be declared on the inner and outer label in the metric system.
– The declaration of the average net content of the cosmetic product shall be required to be made in the case of :-
- Liquid cosmetic in volume
- Solid cosmetic by weight & number or count where appplicable.
- Semi-solid or viscous cosmetic by weight or volume.
Declaration of Name, Address & Country of Manufacture
– The name and full location address of the manufacturer and packer of a cosmetic product shall be specified on both the inner and outer label where appplicable in such a manner that is easily readable.
– Where the name of the holder of Certificate of Registration of a cosmetic product is specified on the inner and outer label, it shall be easily readable.
Batch Number
– This shall be indicated on both the inner and outer labels, where appplicable, of all cosmetic products & where it is impossible, for reasons of size, for details of the batch number to appear on both the inner and outer packaging, the details shall be given on the inner packaging.
Date Marking Instructions
– The date marking shall be stated for all cosmetic products and shall be stated on both the inner and outer labels, where applicable.
Storage Condition
– The required storage conditions shall be specified on both the inner and outer labels where appplicable.
Brand Name/Trademark
– The brand name/trademark shall be displayed on the label and shall not give a wrong impression of the nature, quality or substance of yhr cosmetic product.
Registration Number & Directions For Use
– All cosmetic products shall bear on its label its NAFDAC Registration number issued on the Certificate of Registration in such a manner as prescribed by NAFDAC.
– Directions for use, including reconstitution where appplicable, shall be included on the label to ensure correct utilization of the cosmetic product.
Warning and Citations
– The outer and inner label of every cosmetic product shall carry clear and adequate warning to prevent any danger in the use of the product.
Soaps
– Where soap is supplied in a container or wrapper, it shall comply with the labelling requirements contained in these regulations.
Displayed Information
– Any information displayed on a label, which misleads or deceives a consumer in anyway shall constitute an offence under these regulations.
Offences and Penalties
– An individual found guilty of violating these regulations can serve a 1 year jail term, pay a fine of 800 Thousand Naira, or both.
– A body corporate found guilty of violating these regulations will be liable to pay a fine of up to 5 Million Naira.
– Criminal prosecution in this regard can be carried out against directors, managers and secretaries of body corporates found guilty of violating these regulations except where it is proved that the offences were committed without their knowledge, connivance or consent.
Enforcement
– The NAFDAC is entrusted with the statutory duty of enforcing compliance with these regulations.
Cosmetics :- Provisions Of The NAFDAC Guidelines For The Inspection Of Facilities For Manufacture Of Veterinary Cosmetics in Nigeria
These Guidelines as released by the National Agency For Food and Drug Administration and Control (NAFDAC) are for the interest of the general public and manufacturers of Veterinary Cosmetics in Nigeria.
No Veterinary Cosmetics shall be manufactured, exported, imported, distributed, sold or used in Nigeria except in accordance with the provisions of NAFDAC Act CAP N1 (LFN)2004, other related legislations and the accompanying Guidelines.
Step 1- Application For Inspection
Upon request for facility inspection from Registration & Regulatory Affairs Directorate, the following are required :
– An application for inspection should be made on the company’s letter head paper to the Director-General (NAFDAC).
Step 2 – Procedure For Payment
– The application is reviewed to determine payment to be made.
– Payment Advice for inspection and laboratory analysis is issued by NAFDAC desk officer.
– Visit www.remita.net to generate Remita invoice and print out a copy of the invoice.
– Any nearest commercial bank for payment.
– NAFDAC Accounts Office to collect receipt of payment.
– Attach photocopy of the receipt of payment to the application to be submitted.
Step 3- Submission Of Application
– The reviewed application letter and two (2) sets of the under listed documents are submitted at the Liaison office of the Director (LOD), NAFDAC.
– Duly completed Registration form filled on-line at www.napams.org and printed.
– Photocopy of receipt of payment.
– Certificate of business incorporation of the applicant with Corporate Affairs Commission (CAC) in Nigeria.
– Certificate of registration of brand name/Evidence of Trade mark approval from the Federal Ministry of Commerce in Nigeria, done in the name of the owner of the trade mark.
– Copy of organogram of the company.
– List of Production and Quality Control equipment.
– Comprehensive Certificate of analysis of the raw materials.
– Comprehensive Certificate of Analysis of the batch of product to be registered.
– Certificate of analysis of the raw and treated water for production.
– Product labels.
– Evidence of expired NAFDAC Registration Certificate (for product registration renewal).
– Appointment and acceptance letters of the technical officer including all credentials (Degree, NYSC certificates, etc.). The technical officer should have scientific background with minimum of Ordinary National Diploma; OND or its equivalent.
– Medical Certificate of Fitness for technical and production staff.
– Retainership agreement with a Hospital/Clinic for periodic medical check-up of staff.
– Evidence of fumigation of premises/ factory.
Standard Operating Procedures (SOPs)
– SOP for Production
– SOP for Quality Control
– SOP for cleaning, sanitation and maintenance
– SOP for product recall and distribution
– SOP for receipt of raw materials
– SOP for line clearance
Step 4 – Scheduling Of Inspection
– Upon satisfactory vetting of the application, the date of the inspection is communicated to the company.
Step 5 – Inspection
– The Inspection is conducted as scheduled. Where the Inspection is unsatisfactory a Compliance Directive is issued and communicated to the company.
– For satisfactory inspections, registration samples are taken at the end of the inspection for laboratory analysis while the summary inspection report is forwarded to Registration and Regulatory Affairs Directorate for further processing.
Tariff
As advised by NAFDAC.
Labelling Information
– Labeling should be informative, accurate and in accordance with the Agency’s Labelling Regulations and any other relevant regulations.
– The labelling requirements include:
- The Name of cosmetics (common and brand name) and descriptive name where applicable.
- Name and full location address of the manufacturer.
- Provision for NAFDAC Registration Number on product label.
- Batch Number, Manufacturing date and Expiry date.
- Dosage form & strength on the package.
- Description of the method of usage (Mode of application).
- Quantitative listing of all ingredients in descending order of in-going weight.
- Adequate warnings where necessary.
- Net content of products
- Storage conditions
It should be noted that the clock stops once Compliance Directives are issued.