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How to register food with Food and Drugs Authority (FDA)

Registration of locally manufactured pre-packaged foods

The Micro Small Medium Enterprises (MSMEs) play a crucial role in the growth of global economy. In Ghana, MSMEs are undoubtedly, the backbone of the economy as they contribute over 85% of GDP and employs over 70% of the total workforce in Ghana. They, however, face several challenges that hinders their growth and sustainability. How to certify food with Food and Drugs Authority (FDA) is a major challenge.

Some other challenges include inability to access affordable finance, accessing market opportunities, product quality, business formalization, and product certification among others. Product certification is a necessary requirement to accessing market for local products. Certification provides a confirmation of product quality and standardization for local and international markets. The challenge, mostly, is how to certify products, where to register and why we register. These concerns remain a mystery for most MSMEs in the informal sector.

This paper provides a detailed outline of processes and requirements to register food products with the Food and Drugs Authority (FDA). A Part -2 of this article will provide detailed process of certifying cosmetics and household chemical products.

Food_and_Drug_Authority (FDA)
Food_and_Drug_Authority (FDA)

About Food and Drugs Authority (FDA)

Established by the Public Health ACT 851, 2012, the FDA is charged with the responsibility to ensure the safety, quality and efficacy of human and veterinary drugs, food, biological products, cosmetics, medical devices, household chemical substances and clinical trials, and the control of tobacco products through the enforcement of relevant standards to protect public health.

THE PROCESS

Registration of locally manufactured pre-packaged foods

PRE-PACKAGED FOODS refers to food and beverages that are produced in Ghana, preserved, and packaged for public consumption. Examples include canned tomatoes, packaged plantain chips, tom brown, shito and many more. Such products will require to go through the following;

  1. Purchase a registration form for Locally Manufactured Pre-packaged Foods. It’s is sold at GHS5.00 at all FDA offices. Complete all required field of the forms.
  2. Write an Application Letter and address it to the Chief Executive officer using the address below. The application is a request letter indicating your exact request. This letter will contain a short business profile, thus, what’s produced and where.

THE CHIEF EXECUTIVE OFFICER

FOOD AND DRUGS AUTHORITY

CANTONMENTS, ACCRA

  1. Attach a copy of Business Registration Certificate: This certificate is issued by the Registrar General Department (RGD).
  2. Certificate of Analysis for each product and variant where applicable. The certification analysis should be endorsed by an authorized officer. This certificate is obtained from accredited laboratories in Ghana Standards Authority (GSA) across the country, Food research, KNUST and in Mampong. Pre-packaged food without the certificate of analysis will not be accepted. This process confirms the appropriateness of the product for consumption as proposed by the manufacturer – thus the entrepreneur.
  3. All necessary documentation should be provided to substantiate any claim on health, nutrition, superlative, comparative on the label of the product. For example, if the product treats some disease, show scientific proof of the ingredients that cures the said disease.
  4. Submit samples of each product and variants where applicable as per FDA’s approved sample schedule. For mock samples, submit two (2) sample units and model label.
  5. Food Product Registration fee (Renewal after every 3 years); Its important to note, that the process is repeated for renewals. The FDA is mandated to constantly monitor the market using a sampling approach to check the status of products on the shelves. This process determines the validity of a product. For the purposes of renewals, enterprises are categorized to reflect the size and the renewal fees. Micro enterprises pay the minimum of GH¢ 150 per product. See below:
  • Cottage Industry – GH¢ 150 per product (3years)
  • Small Scale Industry – GH¢ 450 per product (3years)
  • Medium Scale Industry – GH¢ 600 per product (3years)
  • Large Scale Industry – GH¢ 900 per product (3years)

The FDA by operation advise all enterprises to neatly bound together all documents to be submitted for registration. This simplifies the compilation and filing process.

The FDA also request enterprises to ensure that applications submitted must be completed within 3months from initial application submission date. Client or applicants shall be required to reapply after the three months duration.

Company owners and/or competent company representatives with adequate knowledge of the company must be the ones completing the application form. This will allow for accurate details. If third party service provider is engaged to obtain the certification, the enterprise is required to write to FDA to introduce the service provider.

Sample or Model labels submitted solely for evaluation attract a fee of GH¢ 100.00 (per product, per variant).

Other services include the Name Search for products. This is done by enterprises to ensure uniqueness of product name in the market. The search comes with a fee as seen below;

  • Up to 5 products – GH¢50
  • 6 to 10 products – GH¢100
  • 11 to 20 products – GH¢200
  • More than 20 products – GH¢300

General requirements for labels

There is a standard requirement for Labelling food products for FDA approvals. It provides the needed information for user assessment before purchase. These are some guidelines:

According to the FDA, labelling shall be informative and accurate. The information on a label shall include, but not limited to, the following:

  • The name of the product.
  • A list of the active ingredients, where applicable, showing the amount of each present in a dosage unit.
  • The net content of the container. E.g., 500ml, 750ml
  • The batch numbers, example – NL0001
  • Date of manufacture and best before/expiry date
  • Directions for use, and any warnings or precautions that may be necessary
  • Any special storage conditions or handling precautions that may be necessary
  • Indications, frequency, route, and conditions of use where applicable
  • The names of any excipients known to be a safety concern
  • Name, postal address, and premises address of the manufacturer and Distributor
  • State the country of origin.

More details on Labelling

  • Product labels shall be printed in a clear font and legible. The print shall be indelible and not fade when exposed to sunlight.
  • The product name, package or label shall not bear close resemblance to a previously registered product.
  • If the original label is in a local or foreign language, the product information shall be in English or a translation thereof.
  • All products that are not recommended for use in or by children, the statement “not to be taken/used by children” shall be included.
  • All products not meant for children shall bear the statement “keep out of the reach of children”
  • The name of product shall not be offensive, unethical, socially, or traditionally unacceptable, superstitious, magical etc.
  • Product locally manufactured shall bear FDA registration number

By Gauge Network Ghana

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