NAFDAC — Dossier Requirements for Pesticide Registration in Nigeria

product dossier

September 27, 2014 — In Nigeria, registration of pesticide products is regulated by the National Agency for Food and Drug Administration and Control (NAFDAC).  NAFDAC ensures that new pesticide products intended for use in Nigeria are evaluated in field trials prior to their release for use by end users and that highly hazardous or banned pesticide products are not imported into Nigeria.

One of NAFDAC’s requirements, is that manufacturers, importers or distributors seeking to sell pesticide products for use in Nigeria must submit a dossier containing data in support of their application.  The registration dossier shall be prepared according to the data requirements of the Pesticide Registration Regulations of the Drugs and Related Products (Registration, etc.) Act, Guidelines for Pesticide Registration in Nigeria, and shall take into consideration the FAO guidelines for the registration of pesticides (FAO, 1985) as well as the ECOWAS regulation on the Harmonization of Rules Governing Pesticide Registration in the ECOWAS Region (ECOWAS, 2008).

In assessing pesticide products, NAFDAC considers the uses being proposed in determining the data required but generally, NAFDAC’s dossier requirements for pesticide registration seeks to obtain data and information relating to the following:

1. Data to identify the product (identity, composition, analysis) and manufacturer.

The dossier data should include general information relating to the trade name, brand name or trademark of the product; The Common name (International Organization for Standardization [ISO]), International Union of Pure and Applied Chemistry (IUPAC) name, and Chemical Abstracts Service (CAS) name and number of the active ingredient.

It should also provide information about the applicant company name, address, contact name, telephone number and e-mail address.  Information on whether the application is to import or manufacture (including repacking, formulating and manufacturing from raw materials) the pesticide product must be clearly included. If the application is for manufacturing, the applicant should give the location of the manufacturing plant Identity, composition, physical and chemical properties

2. Data to assess the efficacy of the product.

The dossier should include information on toxicology of the formulated product and ecotoxicology.  It should also include information on bioefficacy trials. For example, trial site, scientist, investigator, trial product, timing/frequency of application, trial results and residue at different levels.  It is important for there to be data that shows the determination of bioefficacy, phyto-toxicity and residue levels in treated crops.

3. Data relating to the site and number of application and function of the product.

The dossier should contain information relating to the site of application (e.g. maize, greenhouse tomatoes, houses for termite control, mosquito larvicidal applications to water) and the functions of the product.   For example, it should state whether the pesticide product is a herbicide, insecticide, fungicide and the target pest species.

The dossier should also contain application and mixing instructions.  For example, it should include instructions relating to the method of application, type of  equipment used, application techniques and rates for each use site, and type and volume of diluent per unit of area or volume.  It should also state the number, frequency, timing of applications (e.g. per year, per month, per crop cycle), duration of protection expected and the application rate per unit — treated and concentration of active ingredient in the material as applied (for example, if the product is diluted before application).

4. Data to assess risks to humans and the environment and disposal procedures.

In addition to data on how to use the product, the dossier must include information stating addition steps that can be taken to protect human health and the environment (e.g. buffer zones; personal protective equipment such as gloves, coveralls, respirator; prohibited application areas such  as aquatic areas and around homes; and prohibited tank mixes or incompatibility with other products).

The dossier must also contain disposal procedures and detailed actions to be followed in the event of an accident during transport, storage or use and decontamination procedures for use in the event of accidental  spillage or fire.

Also to be included are information on antidotes and medical treatment in the case of accidental exposure and the names of all co-formulants in the product that may influence the toxicity of the product.

5. Information relating to Labelling.  

The dossier should include information on proposed hazard classification, labelling and safety phrases and symbols.  It should also provide information relating to the proposed commercial label, packaging sizes, and materials and specimens of proposed packaging.

The dossier must include a statement about any risk arising from the recommended methods and precautions and handling procedures, in order to minimize those risks.  For example, the dossier should include precautionary statements of the Globally harmonized system of classification and labelling of chemicals.

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The above are only a few of the required information.  The dossier may also include information relating to the type of formulation (e.g. soluble concentrate, wettable powder, emulsifiable  concentrate); A statement about any risk for the development of resistance in the pest, resistance prevention methods and ‘mode of action’ codes; Procedures for cleaning application equipment, if relevant to the proposed use; Withholding periods, pre-harvest intervals, re-entry periods (e.g. after space spray for mosquito control), waiting periods (to avoid damage to or residues in succeeding crops) and other precautions to protect people, livestock and the environment, etc.

This article is intended to provide general information about the subject matter.  Professional legal advice should be sort about specific circumstances.

 

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About Ufuoma Akpotaire 228 Articles
Ufuoma is a Senior Editor and Director of Regulatory Policy at NLIPW. She assists clients in the protection of copyrights, trademarks and patents. She counsels clients regarding validity and infringement matters and has experience acting against the infringement of IP and addressing counterfeit issues. She holds a Masters degree (LL.M.) from Columbia Law School, New York and a law degree from the University of Nigeria (LL.B. Honors). She is admitted to practice law in Nigeria and in the State of New York. Ufuoma cut her teeth in the intellectual property practice groups of some of the largest law firms in Nigeria and has years of experience working with major non-profit organizations in New York. Email: uakpotaire@nlipw.com