Africa Reach Regulation For Various Sectors

Authorties

In Kenya, Pest Control Products Board (PCPB) is the pesticide management department, responsible for pesticide registration, controlling and managing pesticide, importing/ exporting, production, distribution, and application. The main pesticide regulation is the Pest Control Products (PCP) Act, Cap 346. Important Mandate of PCPB “Assessing the safety, efficacy, quality, merit and economic value of PCP with a view to approving them, if found suitable in local situation”. 

Current Status

All applications for consideration of approval of PCP must be accompanied by submission of risk assessment reports (2019/2021- Risk assessment workshops). 

Risk assessment report needs to be submitted:

(1) During submission of summary dossier for new products.

(2) Upon completion of efficacy trials for label extension. Following conclusion of the local experimental efficacy trials. 

Applicant will be required to provide detailed human (occupational and dietary) and environmental (Bees) risk assessment reports for all applications of new products and label extensions to ensure any PCP do not pose unacceptable risks (July 2021). 

Compliance Requirement

Applicants needs to provide the summary of risk assessment: 

• Quality of the data referenced for hazard assessment (e.g., Experimental design and quality of the critical study or studies). 

• Kenya Good agricultural practice (GAP) Table for efficacy and residue  

• Operator/Worker/Consumer exposure models and local risk assessment. 

• Bee exposure model and the local situation 

• The Input and output page of the exposure should be attached  

• Brief discussion of conclusion arising from the model’s output 

• Discussion on the proposed realistic pesticide risk management 

PCPB controls the importation of pesticides through various registrations and licensing: 

• Agency licensing- pesticides manufacturers outside Kenya (validity, 1 year) 

• Product registration- pesticide products imported to Kenya (validity 3 years) 

• Premise licensing- premises handling pesticides (validity, 1 year) 

• Import permit 

• Import standardization mark (ISM) 

• Environmental protection 

During the licence application process of importation or exportation of a pest control product for commercial purposes, applicants should specify its purpose such as “for resale”, “for manufacturing purpose” or “for importer’s own use”, etc.

Authority Fee 

• Introductory fee of KS 10,000 to obtain an experimental permit. 

• A certificate of registration will cost the applicant $347.40 (KSh30, 000) 

• While a renewal certificate of registration not exceeding two years costs $231.60 (KSh20, 000) 

How can GPC help you?

• Identification of compliance requirements under various guidelines including all data requirements. 

• Data gap analysis and pre-assessment support 

• Technical documentation support 

• Pre and post submission support and technical liaison with authorities.