Guidelines for Registration of Imported Household/Industrial Chemicals in Benin

 

 

1. General

     These Guidelines are for the interest of the general public and in particular, foreign manufactures / exporters and local importers of Chemicals in Benin. It is necessary to emphasize that, no Chemical products shall be manufactured, imported, exported, advertised, sold, distributed or used in Benin unless it has been registered in accordance with the provisions of ABREP -2020, and other related Legislations and the accompanying Guidelines.

 

1. Application

The Application for the registration of all imported Chemical products shall be made by either the foreign manufacturer or the authorized foreign merchant exporter through ABREP accredited legal agent.

 

Step I

1. Documentations.

The ABREP accredited legal agent will guide the applicant on the necessary documents for product registration. After successful submission, the documents will be processed accordingly.

• A separate application form shall be submitted for each product

• The application letter addressed to the Director-General (ABREP),

      Attention: Director, Agence Béninoise de Régulation et

      d'Enregistrement des Produits (ABREP)

      Cotonou – Republique du Benin

 

2.  Power of Attorney.

The accredited legal agent representing the applicant outside Benin must file an evidence of Power of Attorney (POA) from the manufacturer or the authorized merchant exporter which authorizes the legal agent to speak for his Principal; on all matters relating to the product approval / registration.

 

• The Power of Attorney shall (be):

 Issued by the manufacturer or the authorized merchant exporter of the product authorizes the legal agent to speak for his Principal; on all matters relating to the latter’s specialties.

 

• The Power of Attorney shall (be):

 Signed by the either the Managing Director, General Manager, Chairman, President or Owner of the company, stating the names of the product to be registered.

 

• The Power of Attorney shall also indicate ‘Authority to register the product with ABREP of the Ministry of Health Benin.

• The Power of Attorney must be notarized or legalized in the Tribunal de Commerce Benin.

• The Power of Attorney must be valid for at least 2 years (24 Months).

 

3. Contract Manufacturing Agreement:

An applicant filing an application and being the owner of Brand name/Trademark, shall provide a Contract Manufacturing Agreement, which shall be signed by the applicant and the manufacturer.

 

The Agreement shall be;

• Legalized at the Tribunal de Commerce Benin

• Signed by both parties stating names and designation of the signatories with the names of all the products to be registered and other relevant clauses clearly explained in an unambiguous language.

 

4. Certificate of Manufacture and Free Sale:

The manufacturer must show evidence that the company is licensed to manufacture Chemical products and that the sale of the product does not constitute a contravention of the laws of that country, i.e. Free Sale Certificate/Certificate of Manufacture and Free Sale.

 

The Free Sale Certificate should;

• Be issued by a relevant Health/Regulatory body in the country of manufacture

• Indicate the name and address of the manufacturer and product to be registered

• Copies of the above papers must be legalized in the Tribunal de Commerce Benin.

 

5.  Product Labels/Hazardous Warnings

Labelling of Chemical products should be informative, accurate and in conformity with the ABREP Chemical Products Labelling Regulations and any other relevant Regulations

Labels of the products must include but not limited to;

• Name / address of manufacturer

• Ingredients and amount of constituents present

• Direction for storage

• Hazard Warning

• Date of manufacture

• Batch number

• Date of expiry 

 

6.  Letter of Invitation for Good Manufacturing Practice (GMP) when applicable:

A letter of invitation to inspect the factory abroad (if applicable) shall be written by the manufacturer and state the following:

 

• MANUFACTURER’S INFORMATION: Name of company, full location address of factory (not administrative office address), email, and current phone number. Details (name, phone number and email) of contact person abroad.

• LOCAL IMPORTER/BUYER’S INFORMATION: Name of company, full location address, functional phone number, email address. Details (Name, phone number and email address) of contact person in Benin.

• BRAND NAME(S) OF PRODUCT(S): List of products submitted for registration should be included.

 

7.  Comprehensive Certificate of Analysis.

The certificate of analysis must be presented on a letter-headed paper of the Quality Control Laboratory where the sample was tested/evaluated and should contain all relevant technical parameters of interest in addition to the under-listed information:

 

• The brand name of the product.

• The batch number of the product

• The manufacturing and expiry dates

• The name, designation and signature of the analyst.

 

Step II

8. Import Permit

Upon successful screening of documentation and review of supporting documents, an electronic import permit shall be issued after which products are submitted for laboratory analysis.

After satisfactory Documentation review, GMP inspection of the production facility and laboratory analysis of product (where applicable), products are presented for the ABREP Approval Meetings.

 

9.  Submission of products for laboratory analysis

After successful vetting of products, laboratory samples are submitted. The following documents are included;

• Letter of submission of products for analysis

• Payment Receipt of applicable fee

• Certificate of analysis

 

Step IV

10.  Product Approval Meeting:

A three-member approval committee will review the product's analysis report for approval.

v

11.  Issuance of Certificate of Product Registration:

After the Product Approval meeting, an electronic Certificate of Product Registration is issued to the Applicant.

 

12.   Tariff :

See ABREP Tariff section  (Tariff)

 

13.   Note:

 

• Failure to comply with these requirements may result in the rejection of the application or lead to considerable delay in the processing of registration.

• A successful application will be issued a Certificate of Product Registration with a validity period of five (5) years.

• Registration of a product does not automatically confer Advertising Permit. A separate application and subsequent approval by ABREP shall be required if the product is to be advertised.

• For further information on advert approvals, see Guidelines for Regulated Products in Benin

 

All correspondences should be addressed to:-

Director-General (ABREP),

Attn: The Director

Agence Béninoise de Régulation et

d'Enregistrement des Produits (ABREP)

Ministere de la Sante,

Cotonou, Republique du Benin.

Email: info@santegouvbj.com

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