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The National Agency for Food and Drug Administration and Control (NAFDAC) is the regulatory body responsible for ensuring the safety and efficacy of cosmetic products in Nigeria. This article explores labeling requirements mandated by NAFDAC for cosmetic products, providing a clear guide for manufacturers as well as importers of cosmetic products. Adhering to these regulations also help businesses meet their legal obligations, enhance consumer trust, and avoid penalties.
NAFDAC Labelling Requirements for Cosmetic Products
General Labelling Information
Every information on the label of the cosmetic product must be informative, accurate, prominent, legible, and distinct. The font size and style should ensure clarity, with enough contrast against the background without being obscured by designs or crowded.
Also, the name of the product and net content should be proportionate to the predominant features on the label. Additionally, information on the label must not be false, misleading, or deceptive, and must not create the wrong impression regarding the product’s character, quality, or origin.
Further, labels should not include unnecessary information that could interfere with the placement of required details, and must not reference or imply connections to other products falsely.
All labeling information must be provided in English, with other languages optionally included.
Product Identity
Where there is an outer and inner label, both must display the name of the cosmetic product, accurately reflecting the nature of the product. If a common name exists for the product, it must be used alongside the brand name. Otherwise, an appropriate descriptive name should be used.
Coined or fanciful names must not be misleading and should be accompanied by a descriptive term.
List of Ingredients
A complete list of ingredients must be written clearly on the outer label and inner label (where applicable), listed in order of predominance. If there is no outer packaging, the ingredient list should appear on the inner label.
Any fragrance, color, or flavor ingredients may be listed after the other ingredients and should be identified by their international names or codes. Ingredients below 1% concentration may be listed in any order after those above 1%. In the same vein, all components of multi-ingredient ingredients must be included in the list.
For products with multiple color shades (e.g., decorative cosmetics), their coloring agents should be listed and may be preceded by the phrase “may contain.”
Further, ingredients must be prominently displayed, readable, and understood under normal purchase conditions.
If a cosmetic product contains active drug ingredients, it must comply with NAFDAC’s Drug Labeling Regulations 2019. An active drug ingredient is any substance that has a pharmacological effect on the body, such as treating, preventing, or diagnosing a condition, e.g. zinc oxide, titanium oxide in sunscreens; benzoyl peroxide in acne treatments etc. Any ingredient that is known to cause hypersensitivity must be declared on the label.
Also, if there are multi-packs, the ingredients for each product can be listed separately or combined. Where labeling on the outer packaging is impractical, the list shall be given on a leaflet, label, tag, tape or card enclosed with the product and the consumer should be referred to the text either by abbreviated information or by a special symbol on the outer pack.
If the products within the multi-pack have containers which are individually labeled or printed with an ingredient list, there is no need for a separate leaflet, label, tape, tag or card. In the case of transparent packaging, where the ingredient labeling of the products is clearly visible, separate labeling is not required.
Lastly, impurities of the raw materials used; subsidiary technical materials used in the preparation of the cosmetic product but not present in the final product; and materials used in strictly necessary quantities as solvents or as carriers for perfumes and aromatic compositions can be excluded from the labelling.
Net Content
The average net content of any cosmetic product must be declared in metric units on both the inner and outer labels. Liquids must be measured by volume; solids by weight or count, and semi-solids by weight or volume.
For products in pressurized containers, the net quantity should include the propellant. Propellants are gaseous or liquid substance used in aerosol products to help expel the contents of a container in the form of a spray, foam, or mist.
Accurate quantity declarations should account for minor variations due to handling or manufacturing practices.
Details of the Manufacturer
The manufacturer’s name and full address must be clearly stated on both inner and outer labels. If the product is processed in another country, that country is considered the country of manufacture. For containers of 10 cm or less, the following must be included:
- Brand name
- Product identity
- Lot or batch number
- Net content
- Expiry date
- Manufacturer’s name and address
- NAFDAC registration number
Batch Number
The batch number should appear on both the inner and outer labels, and if space is limited, it can appear on the inner packaging only.
Date Marking and Storage Conditions
Date markings (e.g., expiry date) must be visible on both inner and outer labels, and batch numbers and date markings should not be pre-printed.
Storage conditions must also be stated on both inner and outer labels.
Brand Name/Trademarks and Registration Numbers
Brand names/trademarks should be displayed on the label without them giving a wrong impression as to the nature, quality and substance of the product.
The brand name/trademarks should also conform to appropriate trademark regulations in Nigeria.
In the same vein, the label should also contain the NAFDAC Registration Number (NAFDAC Reg No.) as issued on the Certificate of Registration for the product. Usually, since the labels are required as part of the registration documents, it is okay to only indicate a space where the NAFDAC Reg No. will be included after registration of the product has been approved.
Directions for Use, Warnings and Precautions
The directions for the use of the product, including reconstitutions where applicable should be listed, to ensure correct usage.
Further, the outer and inner label of the product should also carry clear and adequate warnings and precautions to avoid any dangers in the use of the product.
The words “Avoid spraying in eyes” may be omitted if the product is not expelled as a spray. E.g., Aerosol shave cream. Also, the word “puncture” may be replaced by the word “break” if the product is packaged in a glass container.
If the product is intended for use by children, the phrase “except under adult supervision” may be added at the end of the last sentence of the warning.
The following requirements should be complied with for specific cosmetic products:
- Hair Dyes: containing para-phenylenediamines or other coal tar dye intermediates, shall bear the following on its outer and inner labels:
“CAUTION”: This product contains ingredients that may cause skin irritation on certain individuals and preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eye lashes or eyebrows as to do so may lead to blindness”.
Directions for preliminary sensitivity test shall be indicated on the product.
- Products for Genital Use: should carry all directions and warnings as required for the safe use of the product.
- Pressurized Metal Containers: If the packaging of a pressurized metal container has only an inner label, the following items should be provided:
- the explosive symbol should appear on the display panel of the label.
- the word “CAUTION” should appear on the display panel of the label immediately below the symbol, printed in boldface type.
- the message “CONTAINER MAY EXPLODE IF HEATED” shall appear on the display panel of the label and this statement shall appear immediately below the signal word in boldface type,
The following statement should appear on any part on the Panel of the label, except the bottom of the container:
“Contents under pressure. Do not place in hot water or near radiators, stoves or other sources of heat and do not puncture or incinerate container or store at temperatures over 50 degrees Celsius”.
Specific NAFDAC Labelling Requirements for Soaps
Soaps produced in a container or wrapper should comply with the above requirements. However, soaps not produced in containers or wrappers, the following specific requirements should be complied with:
- The name and address of the manufacturer or Certificate of Registration Holder and the batch number shall be given on either the soap itself; or the packaging in which it is exposed for supply; or the container in which it was packed before being exposed for supply.
- The manufacturing and expiry dates should also be included
- A leaflet supplied with the soap should contain warning statements and precautionary information; product function (where applicable); and ingredient listing.
Foaming Detergent Bath Products
Any foaming detergent bath product should contain the following words:
“Caution – Use only as directed. Excessive use or prolonged exposure may cause irritation to skin and urinary tract. Discontinue use if rash, redness or itching occurs. Consult your physician if irritation persists. Keep out of reach of children.”
If the bubble bath product is intended for use by children, the phrase “Keep out of reach of children” may be expanded to further read “except under adult supervision.”
Conclusion
In conclusion, it is important to comply with these labeling requirements to avoid penalties and ensure consumer protection. Any misleading or deceptive information on cosmetic product labels is considered an offense, and Individuals who violate these rules may face imprisonment of up to one year or fines up to N50,000, while corporate bodies can be fined up to N100,000. Also, upon conviction, offenders may be asked to forfeit any assets obtained through the offense.
Additionally, altering or defacing labels is strictly prohibited.
We hope that this article has been useful. Kindly reach out to us with your enquiries and compliance needs.