Pesticide Registration Requirements In Ethiopia

Сайт Plant Health Regulatory Directorate (PHRD) of Ethiopia has published the Guidelines for the Registration of Plant Protection Products (including application forms).
Below is a summary of the key requirements for pesticide registration in Ethiopia.

Definition of Plant Protection Products

Plant protection products refer to pesticides used to prevent, destroy, or control any harmful organism during the production, processing, storage, transport, or sale of food, agricultural products, timber, and wood-based goods.
The term also includes:

• Plant growth regulators
• Defoliants
• Desiccants or fruit-thinning agents
• Substances applied pre- or post-harvest to protect crops during storage and transportation.

1. Required Documents for Different Registration Scenarios

A. New Active Ingredient Registration

• Application form
• Dossier in accordance with List I and List II (including intended use table)
• Ethiopia-specific requirements

B. Pesticide registration when the active ingredient and/or formulation differs from a registered product

• Application form
• Letter from the technical-grade active ingredient (TGAI) manufacturer confirming supply
• Detailed TGAI information, including impurities
• Dossier (List I & II + intended use table)
• Ethiopia-specific requirements

C. Transfer of Registration

• Application form
• Written consent from the current registration holder
• Product label

D. Amendment to Existing Registration

• Application form
• Efficacy data, and updated label where required

Примечание: The forms mentioned above are for chemical plant protection products.

2. Key Items in the Application Form

1. Applicant Information

• Name of individual/company, address, phone, fax, and description
• The applicant must be the owner of the active ingredient or have an officially designated representative/distributor in Ethiopia
• If not the owner, an authorization letter from the owner is required

2. Product Information

• Trade name, trademark, classification, usage area, formulation type
• Existing registration number (for renewals, extensions, amendments, or transfers)
• Registration status in other countries (attach certificates; prioritize countries with similar agro-ecological conditions such as South Sudan, Uganda, Rwanda, Burundi, Tanzania, and Kenya)

3. Active Ingredient Details

• Manufacturer name, address, contact information
• Authorization letter if the TGAI source is already registered

4. Formulation Details

• Manufacturer’s name and contact details
• Complete list of active ingredients and adjuvants with percentages (chemical names)
• Physicochemical, toxicological, ecotoxicological, environmental fate, and residue data

5. Packaging Information

6. Declaration Statement

3. Dossier Lists I & II – Special Notes

Toxicology, Ecotoxicology, and Environmental Fate

• Data must follow internationally recognized test guidelines (e.g., OECD, US EPA)
• Studies should comply with Good Laboratory Practice (GLP) principles
• Tests conducted after 25 July 1993 must follow GLP

4. Ethiopia-Specific Requirements

Applicants must submit the following to the registration authority:

• Complete dossier (List I & II + intended use table), in duplicate, with signed and sealed application form
• Local efficacy trial reports from recognized research institutions or universities
• Product samples: two batches of 500 g/mL formulation and one batch of 1 g/mL TGAI
• Agency agreement between local representative and registrant
• Third-party batch analysis certificate from an accredited lab (certified by Chamber of Commerce or government)
• Manufacturing license and official letter confirming the pesticide is registered and authorized for production in the country of origin (government certified)
• Labels in English and Amharic indicating target pests and crops for each pack size
• Intended use table