Tel: (00229) 52348115 or email us: info@fdabenin.com
REGULATIONS FOR FOOD, COSMETICS, MEDICAL DEVICES, TOBACCO, DRUGS AND BOTTLED WATER IN BENIN
ISSUED BY Benin Department of General Administration of Consumable (BENIN/FDA)
A. GENERAL
1. THESE REGULATIONS ARE FOR THE INTEREST OF THE GENERAL PUPLIC AND IN PARTICULAR FOR FOOD, COSMETICS, MEDICAL DEVICES AND BOTTLED WATER MANUFACTURERS AND IMPORTERS IN BENIN.
2. IT IS NECESSARY TO EMPHASIZE THAT, NO FOOD, COSMETICS, MEDICAL DEVICES AND BOTTLED WATER (REGULATED PRODUCTS) SHALL BE MANUFACTURED, IMPORTED, EXPORTED, ADVERTIZED, SOLD OR DISTRIBUTED IN BENIN UNLESS IT HAS BEEN REGISTERED IN ACCORDANCE WITH THE PROVISIONS OF DECREE 19 OF 1993.
B. APPLICATION / MANUFACTURER
1.
(a) An application for registration of a regulated product shall be made by the manufacturer.
(b) In case of a manufacturer outside Benin such shall be represented in Benin by a duly registered company or individual with facilities to effect a recall of the product when necessary.
(c) An applicant for a manufacturer outside Benin must file an evidence of Power of Attorney from the manufacturer which authorizes him to speak for his principal on all matters relating to the latter’s specialties. The original Power of Attorney is to be notarized and submitted to BENIN/FDA.
(d) The manufacturer, in the case of imported products, must show evidence that the company is licensed to manufacture the related product for sale in the country of origin (Manufacturer’s Certificate). Such evidence must be by the competent Health Authority of the country of manufacture, and shall be authenticated by the Beninist Mission in that Country.
NOTE: The representative in Benin, whether a corporate body or an individual with the Power of Attorney, will be held responsible for ensuring that the competent authority in the country is informed of any serious hazard newly associated with a product imported under the provisions of the decree or of any criminal abuse of the
certificate in particular to the importation of falsely labeled, spurious, counterfeited or sub-standard related products.
2.
a. The applicant must submit to the office of the Director (Registration and Regulatory Affairs) BENIN/FDA, a written application, stating name of manufacturer, name (brand name, where applicable) of the product and obtain the prescribed application form which must be properly filled with all information required. This form shall be obtained on payment of the prescribed amount per product in Bank Draft (MICR) issued in favor of Benin Department of General Administration of Consumable (BENIN/FDA).
b. A separate application form shall be submitted for each regulated product.
C. PRODUCT
1. A food, cosmetic, medical device or bottled water product (Regulated Products) shall not be manufactured in Benin, unless the factory is inspected and Certification of Recognition is issued by BENIN/FDA.
2. In case of imported products:
a. There must be evidence of registration of such product by the competent Health Authority of the country of manufacturer i.e., Product License / Certificate of
Registration.
b. There must be evidence by the competent Health Authority, that the sale of the products does not constitute a contravention of the Food/Cosmetic/Medical Devices Laws of the country i.e. Free Sale Certificate.
3. In the case of imported new products there must be evidence that such product is registered in the country of origin and that the ingredients are approved raw materials.
4. An applicant shall not be allowed to register a product in more than one brand name, except in cases where the manufacturers are different having different brand names for the same formulation.
5. Evidence of trade mark approval from Fed. Ministry of Commerce in Benin.
6. Notarized Declaration to be notarized by a Notary Public.
7. Comprehensive Certificate of analysis of the batch of product to be registered.
8. Certification of Incorporation of the applicant.
D. LABELING
1. Labeling shall be informative and accurate.
2. Minimum requirements on the package label.
a. Name of product- brand name or common name (where applicable) must appear in bold letters.
b. Location address of the manufacturer.
c. Provision of BENIN/FDA Registration Number on product label.
d. Batch No., Date of Manufacture and Best before Date.
e. Net contents of essential ingredients in metric weight units in case of solids, semi solids and aerosols and metric volume in case of liquids
f. In case of food, the ingredients must be listed by their common names in order of their predominance by weight unless the food is standardized, in which case the label must include only those ingredients which the standard makes optional.
g. Food additives and colors must be declared on the label. Spices, flavor and colors may be listed as such, without naming the specific materials, but any artificial color or flavors must be identified as such.
h. Labeling of Food for Special Dietary Uses: “Special Dietary Use” may be defined as a particular use for which a food purports or is represented to be used, including, but not limited to the following
In the Benin republique, the Food and Drug Administration (FDA), which regulates cosmetics, defines cosmetics as "intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or functions". This broad definition includes any material intended for use as an ingredient of a cosmetic product. The FDA specifically excludes pure soap from this category.
Afro-textured hair is the natural hair texture of certain populations in Africa mainly in Sub-Saharan Africa, the African diaspora, Oceania and in some parts of South and Southeast Asia. Each strand of this hair type grows in a tiny, angle-like helix shape.
The amount payable for obtaining market authorization for a locally manufactured herbal medicine is available in the BENIN/FDA Approved tariffs. All fees attract 5% value added tax (VAT). This fee includes payment for a Production Inspection. What do I do if the outcome of my factory inspection is unsatisfactory? You are expected to correct all the non-conformance observations made during the inspection and then apply for a Follow-up Inspection on payment of the appropriate fees which are available in the BENIN/FDA Approved tariffs. All fees attract 5% value added tax (VAT). What is the procedure for renewal of expired market authorization? Apply to the Registration & Regulatory Affairs Directorate for renewal of the market authorization. Processing of this application would include payment of the appropriate fees which are available in the BENIN/FDA Approved tariffs and a GMP Reassessment Inspection. All fees attract 5% value added tax (VAT).
Have you ever started a fitness program and then quit? If you answered yes, you're not alone. Many people start fitness programs, but they may stop when they get bored, they don't enjoy it or results come too slowly. Here are seven tips to help you stay motivated.
Balance is a crucial element of success to any workout goal, whether looking to build muscle, lose fat, or improve athletic performance. It is a crucial aspect of every part of our lives, between balancing free time to maximize potential extra visits to the gym to balancing our caloric intake. It all plays a big role in the results we will see. A well-balanced diet provides important vitamins, minerals, and nutrients to keep the body and mind strong and healthy. Eating well can also help ward off numerous diseases and health complications, as well as help maintain a healthy body weight, provide energy, allow better sleep, and improve brain function. A diet with balance provides the body with the proper proportions of carbohydrates, fats, proteins, vitamins, minerals, and liquids. It is important to not eliminate any essential macronutrient, such as fats or carbohydrates, but be conscious of portion control.
People may be sick with the virus for 1 to 14 days before developing symptoms. The most common symptoms of coronavirus disease (COVID-19) are fever, tiredness, and dry cough. Most people (about 80%) recover from the disease without needing special treatment. More rarely, the disease can be serious and even fatal. Older people, and people with other medical conditions (such as asthma, diabetes, or heart disease), may be more vulnerable to becoming severely ill. People may experience: cough fever tiredness difficulty breathing (severe cases) Coronavirus disease (COVID-19) is an infectious disease caused by a new virus. The disease causes respiratory illness (like the flu) with symptoms such as a cough, fever, and in more severe cases, difficulty breathing. You can protect yourself by washing your hands frequently, avoiding touching your face, and avoiding close contact (1 meter or 3 feet) with people who are unwell. How it spreads Coronavirus disease spreads primarily through contact with an infected person when they cough or sneeze. It also spreads when a person touches a surface or object that has the virus on it, then touches their eyes, nose, or mouth. There’s currently no vaccine to prevent coronavirus disease (COVID-19). You can protect yourself and help prevent spreading the virus to others if you: Do Wash your hands regularly for 20 seconds, with soap and water or alcohol-based hand rub Cover your nose and mouth with a disposable tissue or flexed elbow when you cough or sneeze Avoid close contact (1 meter or 3 feet) with people who are unwell Stay home and self-isolate from others in the household if you feel unwell Don't Touch your eyes, nose, or mouth if your hands are not clean
Rapid improvements in health and nutrition in developing countries may be ascribed to specific, deliberate, health- and nutrition-related interventions and to changes in the underlying social, economic, and health environments. This chapter is concerned with the contribution of specific interventions, while recognizing that improved living standards in the long run provide the essential basis for improved health. Consideration of the environment as the context for interventions is crucial in determining their initiation and in modifying their effect, and it must be taken into account when assessing this effect.
Community-based programs under many circumstances provide this crucial contact. Their role is partly in improving access to technology and resources, but it is also important in fostering behavior change and, more generally, in supporting caring practices (Engle, Bentley, and Pelto 2000; UNICEF 1990). Such programs may also play a part in mobilizing social demand for services and in generating pressure for policy change.