Regulatory Requirements For The Change Of Food and Feed Formulations In Nigeria

Effective from the 30th of March,2023, the NAFDAC issued a set of guidelines for the interest of the general public and in particular, manufacturers of local and imported food and feed products.

By virtue of these guidelines, it is necessary to emphasize that, no regulated food and feed product shall be manufactured, in accordance with the provisions of the NAFDAC act, other related Legislations and the accompanying Guidelines.

A change in formulation or food reformulation is the process of altering the processing or composition of a food or beverage product;

1. to improve its nutritional profile and, 
2. to increase, reduce, remove or replace its content of ingredients or nutrients of concern while maintaining taste, flavour and characteristics of the product.

Application

-A written application for Change in Formulation of Food and Feed product(s) should be made on the company’s letter head to the Director-General (NAFDAC).

-An online application form for change in food and feed formulation shall be purchased, completed and submitted online

-A separate application form shall be submitted for each product.

Labelling Information

-Labelling should be informative, accurate and in conformance with the Agency’s Food Labelling Regulations and the International Code of Marketing of Breastmilk Substitutes Regulations (Control of Marketing of Breastmilk Substitutes) and any other relevant Regulations, as applicable.

Step I

Documentation

-The application letter stating the purpose and justification for the Change in formulation (Reformulation).

-Evidence of Business Incorporation.

-Current and proposed Batch formulations

-Evidence of product registration.

-Evidence of payment.

-Contract Manufacturing Agreement (where applicable).

– Evidence of Registration of Brand Name with Trademark Registry in the Ministry of Industry, Trade and Investment. This should be done in the name of the owner of the Trademark/Brand name, as the case may be.

 -Current and proposed Product Labels/artworks.

-Comprehensive Certificates of Analysis for current and proposed formulations.

Step II

Product Approval Meeting

-Upon satisfactory documents review, GMP inspection and laboratory analysis reports, products are presented for Approval Meetings.

-Products not approved at approval meeting are issued compliance directives.

Step III

Issuance of Notification of Approval

-For products approved at the meeting, a notification of product approval is issued to the applicant.

Notes

-Failure to comply with these requirements may result in the disqualification of the application or delay in processing of the application.

– An approval for change in formulation does not automatically confer advertisement permit. A separate application and subsequent approval by the Agency shall be required if the product is to be advertised.

– A failure to respond to compliance directives within 90 working days will automatically lead to the closure of the Application. Please note that the clock stops once compliance directives are issued.

– The time line for processing applications for change in formulation from submissions to approval is ninety (90) working days.

– A change in formulation approval does not in anyway affect the validity of the product license and elapse when the product license expires.

Important Provisions Of The NAFDAC Regulations on Soft Drinks in Nigeria

The National Agency For Food and Drug Administration and Control (NAFDAC) passed in 2021, a set of regulations which apply to all soft drinks that are manufactured, imported, exported, advertised, sold, distributed or used in Nigeria. 

The provisions of these guidelines will form the focus of this article.

Prohibition

– Nobody is allowed to manufacture, import, export, distribute, advertise, display for sale, offer for sale, sell or use soft drinks specified in the schedule to the relevant NAFDAC Regulations, unless such soft drinks have been registered appropriately with NAFDAC.

Labelling

– In addition to compliance with NAFDAC food labeling regulations and any other relevant regulations of the agency, the following shall apply :-

a). Labelling of soft drinks specified in the regulations shall not bear the word “fruit juice”, unless the fruit content is as prescribed in the agency’s fruit juice nectar regulations.

b). Labelling of soft drinks specified in these regulations shall not bear the word “fruit drink” unless the fruit juice content is 5% and above.

c). The package of the soft drink specified in these regulations shall not show any pictures, images, & likeness of fruits unless the fruit juice content is not less than 5%.

d). Every package containing fruit squash, fruit cordial or fruit crush of the standard of composition prescribed by NAFDAC shall bear a label, which shall indicate the nature of the contents and the fruits from which they have been prepared.

e). Every package containing imitation, synthetic or artificial squash, or cordial or crush with their synonymous names or of same composition shall bear a label with the words “flavored” & in close proximity to this and in the same letter & colour type shall bear the words “contain no natural fruit juice”.

Offences & Penalties

– Any individual found guilty of violating these regulations will be sentenced to a jail term of 1 year, a fine of 800 Thousand Naira,or both.

– A body corporate found guilty if violating these regulations will be penalized with a fine of 5 Million Naira and criminal prosecution can be effected against its managers, directors, secretary, trustee or partner except it is proved that the offences were committed without their connivance, consent or knowledge.

Forfeiture After Conviction

-Any person convicted of an offence under the regulations shall forfeit to the Federal Government any asset or property constituting proceeds of the offence as well as any instrumentality.

Enforcement

– The NAFDAC is entrusted with the statutory duty of enforcing compliance with these regulations.