Economic Community of West African States
Regulation C/REG.3/05/2008 on Harmonization of the Rules Governing Pesticides Registration in ECOWAS Region
- Published in official journal 53 on 1 May 2008
- Commenced
- [This is the version of this document at 18 May 2008.]
I: General provisions
Chapter 1
Definitions
Article 1 – Definitions
For the purpose of this Regulation:ECOWAS means the Economic Community of West African States;WAPRC means the West African Pesticides Registration Committee for pesticides evaluation and registration in West Africa;APPLICATOR means any individual or corporate entity engaged, for his/her own purposes or on behalf of a third party, in phytosanitary protection of crops, treatment of stored food items, treatment of the premises and materials used for storage of agricultural produce, sanitization of the means of transport for and storage of agricultural produce, sanitization of public places, dwelling accommodation and animal shelters, and in external disinfestation of animals;PROVISIONAL AUTHORIZATION OF SALE (PAS) means the temporary authorization to market a pesticide, pending collection of such additional data as may be required for its registration;BIOCIDE means any product used to combat harmful organisms; for example, products designed to eliminate mosquitoes, fleas and cockroaches; cowshed disinfectants, etc;BIOPESTICIDE means any pesticide derived from natural organisms such as animals, plants, bacteria and some kinds of mineral;PACKAGING means any container together with its protective wrappings used to deliver pesticides to the consumer through wholesale and retailer distribution networks;DISTRIBUTOR means any authorized individual or corporate body who imports or procures for himself, approved pesticides for commercial purposes;MANUFACTURER means any company, individual, public or private body, activities or functions of which comprise, directly or indirectly through an agent or body under its control, or with whom it has entered into an agreement for the manufacture of the active ingredients of pesticides or the preparation of formulations and products from such ingredients.FORMULATION means any combination of processes which aims at making a pesticide effectively usable for a set purpose or transforming such product in a marketable form;REGISTRATION means the process by which relevant national or regional authorities approve the sale and use of a pesticide after satisfying themselves through appraisal of ail available scientific data that the product in question effectively contributes to attainment of established objectives and does not constitute unacceptable risk to human and animal health or the environment;ACTIVE INGREDIENT means the biologically active part of a pesticide as contained in its formulation;COMMON NAME means the name given to the active ingredient of a pesticide by the International Standards Organization or a name endorsed by a national standards structure as generic term for the product or a name commonly used solely to describe the said active ingredient;COMMERCIAL NAME (TRADE NAME) means the name under which the pesticide is labeled, registered and marketed by the manufacturer and which, if protected by national or regional legislation, may be used exclusively by the manufacturer to distinguish the product from other pesticides containing similar active ingredient;STANDARDS means any set of benchmarks that could be used to assess the quality of a pesticide; Pesticide means any substance or combination of substances:a)used to repel, eliminate or control harmful organisms including human or animal disease vectors and undesirable plant or animal species that cause damage or are otherwise harmful during production, processing, storage, transportation or marketing of food items, agricultural produce, timber and timber products or animal feed;b)administered to animals to combat insects, arachnids and other endoor ectoparasites;c)used as growth regulator of plants and defoliants, desiccation agents and fruits polishing agents or to prevent premature fall off or fruits; as well as substances applied on crops, before or after harvest, to protect produce from deterioration.PROHIBITED PESTICIDE means any such pesticide, use of which has been fully or partly prohibited by specific regulation with the objective to protect human and animal health or the environment. This term is also applicable to a pesticide, first use registration of which has been rejected or which has been withdrawn by the industry either from the domestic market or from the national or regional registration process, where it is obvious that such a measure has been taken to protect human health or the environment.STRICTLY REGULATED PESTICIDE means all such pesticides, use of which has been fully or partly prohibited by a specific decision of the competent authority with the objective to protect human and animal health or the environment, but of which one or several specific uses have been authorized. The term is also applicable to any pesticide, registration of which has been fully or partly rejected or which has been withdrawn by the industry either from the domestic market or from the national or regional registration process, where it is obvious that such a measure has been taken to protect human health or the environment.PRODUCT OR PESTICIDE PRODUCT means any active ingredient and other components, in the form it is packaged and sold.PERSISTENT ORGANIC POLLUTANT (POP) means any chemical substance with toxic properties, resistant to deterioration, builds up in living organisms and is disseminated by air, water and migratory animals across international borders and deposited far away from its original location, or builds up in land and water ecosystems.RESIDUE means any specific substances left by pesticides in food, agricultural products, animal feed or the environment. The term refers to all pesticides residues, such as conversion products, metabolites and reagents, as well as impurities deemed significant from the toxicology standpoint. It (pesticides residues) includes residues from unknown source or unavoidable residues like those contained in the environment, and also those resulting from known use of chemical products;RETAILER means all such authorized individual or cooperate body that procures pesticides from distributors or manufacturers in the national territory for commercial purposes.Chapter II
Purpose and field of application
Article 2 – Purpose
A Regulation on pesticides registration common to all ECOWAS Member States (hereinafter referred to as Common Regulation), is hereby established.The purpose of this Common Regulation shall be to:Article 3 – Field of application
This Regulation shall be applicable to all activities involving experiments on, as well as authorization, marketing, use and control of, pesticides and biopesticides in the Member States.Chapter III
Guiding principles
Article 4 – Principle of harmonization
In pursuance of harmonization as intended by this Regulation, ECOWAS shall help bridge the gap between Member States’ legislations in the field of pesticides.Article 5 – Principle of free movement of pesticides
For effective organization of a regional market in furtherance of the regional agricultural policy, there shall be free movement of pesticides in the territory of ECOWAS Member States upon registration and being declared as being in conformity with the quality standards defined in the applicable texts.Article 6 – Principle of mutual recognition and equivalence
Member States shall implement the principle of mutual recognition of pesticides registrations based on the technical specifications and regional standards on pesticides as well as on the registration conditions and procedures applicable in ECOWAS, and shall recognize such conditions and procedures as equivalent.Article 7 – Principle of recognizing international standards
To ensure the free movement of pesticides within ECOWAS region and foster regional and international trade thereon, Member States shall anchor their pesticides technical regulations on:Article 8 – Principle of participation and information
Chapter IV
Organ and tools for pesticides management
Article 9 – West African Committee for Pesticides Registration
Article 10 – Pesticide management tools
II: Registration of pesticides
Chapter V
Obligation and responsibility to register
Article 11 – Obligation to register
No pesticide may be marketed and used in the territory of Member States unless it has been registered or accorded PAS in accordance with the provisions of this Common Regulation, except where the use for which it is intended has not been covered by the provisions of Articles 19 and 28 hereunder.Article 12 – Registration responsibility
Article 13 – Implementation
Pursuant to the provisions of Article 7 of this Regulation, the WACPR shall evaluate all the notifications and Decision Concept Papers (DCP) regarding the aforementioned Conventions. It shell submit its opinion thereon to the Commission which, in turn, shall transmit same to Member States for implementation.Article 14 – Inappropriate use
Chapter VI
Registration conditions
Article 15 – Registration requirements
Article 16 – Registration criteria
Article 17 – Registration processing fee
A fee is hereby instituted for processing of all pesticides registration applications. The amount of such processing fee shall be determined by ECOWAS Commission on the recommendation of WACPR. The said fee shall be borne by the applicant.Article 18 – Period of validity of registration
Pesticide registration shall be valid for five (5) years, renewable.Article 19 – Emergency situations
Chapter VII
Registration procedure
Article 20 – Evaluation of registration applications
The procedures for evaluation of registration applications shall be established and defined by the Commission.Article 21 – Registration decisions
Article 22 – Provisional registration and validity
Article 23 – Further study
A pesticide registration application shall be kept for further study where the information provided is not sufficient to meet the conditions stipulated in Article 15 of this Regulation. In that event, the Commission shall, through the WACPR, request the applicant to furnish the requisite additional information.Article 24 – Rejection of registration application
An application for registration of pesticide shall be rejected where it has failed to meet the conditions set out in Articles 15 and 16 of this Regulation.Article 25 – Review, modification or annulment of registrations and PAS
Article 26 – Confidentiality
Chapter VIII
Trials
Article 27 – Trial protocols
Detailed conditions for experimental protocols and methodologies, for the purpose of pesticide registration, shall be spelt out in the pesticides registration dossier of the Commission.Article 28 – Experimental trials with emissions of unauthorized products
Experimental trials in Member States for research or development purposes, involving emission into the environment of phytosanitary product not authorized by the Commission, shall not be conducted except with prior authorization of the appropriate authority of the Member State in which the trial or test is to be undertaken and in accordance with applicable national legislation.Article 29 – Biological efficacy tests
Chapter IX
Appeal
Article 30 – Right of appeal
III: Marketing of pesticides
Chapter X
Conditions
Article 31 – Licencing
Article 32 – Stock accounting
Article 33 – Warehouse storage conditions
For the purpose of effective conservation of pesticides, all warehouses for storage of pesticides intended for sale shall:Article 34 – Storage conditions
Article 35 – Transportation conditions
Article 36 – Installation of factories
Installation of pesticide manufacturing and/or packing company shall be subject to prior authorization of the country concerned in conformity with international standards.Article 37 – Import and export regimes
Chapter XI
Labelling
Article 38 – Obligation to label
Article 39 – Content of a label
Chapter XII
Packaging
Article 40 – Characteristics of packaging
The characteristics of packagings shall be those set by ECOWAS Commission, and shall be in conformity with international standards.IV: Quality control of pesticides
Chapter XIII
Responsibilities and procedures
Article 41 – General responsibility for quality control
Article 42 – Empowerment and powers of quality control agents
Article 43 – Toxicant monitoring
Registered pesticides or pesticides accorded the PAS featuring on the list of products under toxicant monitoring as stipulated in Article 10 of this Regulation shall be subject to special monitoring by the competent structures of Member States.Article 44 – Field of control
Article 45 – Control procedures
Article 46 – Right of appeal and experts' re-evaluation
V: Special provisions
Chapter XIV
Sanctions
Article 47 – Sanctions
VI: Final provisions
Article 48 – Implementation
In furtherance of its activities, WACPR shall be open to the sub-regional institutions operating in the pesticides sector. Specific Conventions shall define the modalities of such opening.Article 49 – Publication
This Regulation shall be published by the Commission in the Official Journal of the Community within thirty (30) days following signature by the Chairperson of the Council of Ministers. It shall also be published in Member States' Official Gazette within the same timeframe.Article 50 – Entry into force
This Regulation shall enter into force upon publication.History of this document
18 May 2008 this version
Consolidation