The FAO & WHO Guidelines for the Registration of Pesticides promote regional and international collaboration among pesticide regulatory authorities. The guidelines recommend that: “The responsible authority should establish and strengthen collaboration with other countries as well as regional and international institutions in registration of pesticides, including exchange of information on scientific, technical, economic, regulatory and legal issues and, where possible on toxicological, environmental and safety data.”

Regional collaboration for pesticide registration has clear advantages, which include: 

• Profit from collective regulatory intelligence: Dedicate more and broader expertise within the region to pesticide efficacy and risk assessments.
• Create efficiencies: Allow regional generation, and mutual acceptance, of registration data, e.g. for pesticide efficacy and residue testing. Facilitate work sharing, e.g. for regional risk assessments.
• Cut costs: Minimize duplication of testing and regulatory efforts, both for registration authorities and for registrants.
• Generate a larger pesticide market: Increase regulatory power for pesticide registration authorities. Facilitate registration of products for minor crops.
• Set harmonized or common registration standards: Facilitate cross-border enforcement. Create a level playing field for the private sector.

However, regional collaboration certainly also encounters challenges, such as:

• Legal: Agreements need to be adopted between countries.
• Administrative: Certain registration procedures may need to be harmonized regionally.
• Professional: Work cultures may be different.
• Risk of “race to the bottom”: The weakest standards in the region may become the common denominator.
• Decision making: Depending on the level of regional collaboration, some regulatory decisions may need to be made at the regional level. 

Pesticide regulators from different countries can work together in different ways. This spans everything from simple information sharing to complex regional pesticide registration schemes, with many variations in between. Click on each type of collaboration in the graphic below for more information and real world examples.

{Page 2}

Regional collaboration – Exchange information

Exchanging information between pesticide registration authorities is the simplest way of regional collaboration. 

Typical topics about which information is often exchanged are: 

• Registration decisions taken by other regulators - “has pesticide product X been registered for use on crop Y in your country?”
• National testing done in other countries - “are any efficacy tests available of product A on crop group B in your country?”
• Evaluations carried out by other registration authorities - “have you conducted a dietary risk assessment of active ingredient Z in your country?”
• Follow-up monitoring or enforcement - “do you have any indications that resistance is developing against active ingredient K when used for mosquito control in your country?”
• etc.

Information exchange can be done bilaterally (between two pesticide registration authorities), regionally (e.g. through email or messaging groups of several pesticide regulators), or publicly (generally by publication of information, such as registration decisions or -evaluations, on the web site of the pesticide regulator).

Much pesticide registration information and data is published by pesticide registration authorities or international organizations. This can be accessed through the Information Sources section of the Toolkit.

Information exchange among pesticide registration authorities generally does not require any legal measures. Much of the information received and treated by a pesticide registration authority can be exchanged with other regulators. An exception is confidential business information, which a pesticide registration authority generally cannot share with others. 

More information about data protection and confidentiality of pesticide registration data is provided elsewhere in the Toolkit.

 

{Page 3}

Regional collaboration – Coordinate

Coordination among countries with regard to pesticide registration is another level of regional collaboration. For coordination, pesticide registration authorities exchange information, but in addition also take into account what others in the region do.

Typical examples of coordination among regulatory authorities in a region are harmonization of registration procedures and mutual acceptance of data. 

Harmonization of registration procedures is not a goal in itself, but a means to facilitate further collaboration among registration authorities, and/or to reduce registration costs for the (bio)pesticide industry.

In several regions, the data requirements for pesticide registration have been harmonized. This benefits registrants, since the dossier to be submitted for registration is identical or similar for various countries in a region. However, regional harmonization of data requirements is also a first step for further collaboration among registration authorities.

Harmonization of study protocols (e.g. for efficacy trials, residue trials and (eco)toxicity studies) is needed if mutual acceptance of data is aimed for. In such a case, a study conducted in one country is acceptable for evaluation in another country because the study protocols used were identical or similar. Such harmonization is done both at global and regional levels.

Regional harmonization of registration procedures and mutual acceptance of data do require, as a minimum, regionally adopted guidelines or protocols. National pesticide legislation may also need to include provisions that take into account regionally adopted procedures. 

Some examples of harmonization of registration procedures and protocols are provided here. {INSERTLINK to page 3b}

 

{Page 3b}

Some examples of regional coordination for pesticide registration

Harmonization

Regional coordination through harmonization of pesticide registration procedures is often a first step towards closer collaboration among pesticide regulatory authorities. 

The East African Community (EAC) is a regional intergovernmental organisation of 8 Partner States. Since 2019, the EAC has published regional pesticide registration guidelines with the aim to strengthen collaboration among countries on pesticide registration. Current guidelines include harmonized data requirements for chemical pesticides and guidelines for registration of biopesticides.

[IMAGE]

The Comunidad Andina is a regional integration organization consisting of 4 countries in Latin America. It published the Andean standard for the registration and control of chemical pesticides for agricultural use which lays out harmonized pesticide registration procedures in the 4 member countries. A Technical Manual provides detailed guidance on data requirements, classification and labelling, efficacy evaluation and risk assessment.

 

Mutual acceptance of data

Regional or global systems for mutual acceptance of data allow that studies generated in one country can be used for pesticide registration in others. Examples are:

The Test Guidelines of the Organisation for Economic Co-operation and Development (OECD), which are recognised as international standards for environmental and health safety testing of chemicals. They are an integral part of the Mutual Acceptance of Data (MAD) system, which ensures that a test performed in one country is accepted in over 40 others. Pesticide tests conducted according to the OECD Guidelines are widely accepted for pesticide registration around the world.

[IMAGE] 

The European and Mediterranean Plant Protection Organization (EPPO) is an international organization responsible for cooperation and harmonization in plant protection among 52 member countries in the European and Mediterranean region. EPPO publishes Standards for the efficacy evaluation of plant protection products, which describe the conduct of field and glasshouse trials carried out to assess the efficacy of plant protection products. Within the European Union, EPPO efficacy evaluation standards allow the zonal evaluation of the efficacy of plant protection products.

[IMAGE] 

The East African Community (EAC) has adopted harmonized regional guidelines and protocols for efficacy testing of chemical and biological pesticides, for pesticide residue trials, and for designating efficacy trial centres, with the aim to allow mutual acceptance of data generated within the region. Trials conducted in one EAC Partner State can thus be used for registration in another.

{Page 4}

Regional collaboration – Collaborate

Closer regional collaboration occurs, for instance, when pesticide registration authorities share work among each other. One can think of joint registration reviews of pesticides, or joint assessments of the efficacy or risks of a product.

A prerequisite for work sharing is that pesticide evaluation procedures are regionally harmonized and that data submitted for registration are mutually accepted. Work sharing also requires close working relationships and common understanding among technical evaluators in the respective registration authorities.

While the results of a joint review will generally be common, the registration decisions can still be taken by individual national regulatory authorities. Due to differences in agricultural practices, consumption patterns or environmental conditions, a joint regional review may still lead to different national registration decisions.

Some examples of work sharing for pesticide registration are listed here. {INSERTLINK to page 4b}

{Page 4b}

Some examples of regional coordination for pesticide registration

Regional work sharing for pesticide registration is found in the below regions:

The North American Trilateral Technical Working Group on Pesticides operates under the Canada-United States-Mexico Agreement (CUSMA). The Technical Working Group focuses on facilitating cost-effective pesticide regulation and trade among the three countries, primarily through harmonization and work sharing. Cooperation has included collaborative scientific work and carrying out joint reviews of pesticides.

[IMAGE] 

A zonal system of authorisation of pesticide products operates in the European Union (EU). The EU is divided into 3 zones; North, Central and South. EU countries assess applications on behalf of other countries in their zone. The basic procedure for authorisation of new a Plant Protection Product (PPP) is a s follows:

 

1. An application is made to the EU country/countries where the PPP is intended to be placed on the market;
2. A zonal Rapporteur Member State (zRMS) is selected which carries out an assessment of the application;
3. Other Member States in the same zone comment on the zRMS's evaluation;
4. The zonal RMS takes a decision on whether to grant or refuse the authorisation;
5. Other Member States take a decision to grant or refuse the authorisation.

 [IMAGE] 

In the Pacific region, national capacity for pesticide registration is very limited. The objective of the recently established Pacific Regional Pesticide Registration Scheme (PRPRS) is to combine expertise from the different countries and conduct, where feasible, joint regional reviews of pesticides before their national approval. The PRPRS operates under the authority of the Pacific Community (SPC), the principal scientific and technical organisation supporting development in the Pacific region.

[IMAGE] 

{Page 5}

Regional collaboration – Joint decision-making

The closest form of regional collaboration for pesticide registration is joint decision-making. In such a case, countries do not take national registration decisions anymore, but a regional body takes such decisions for the whole region. Joint decision making is typically based on common efficacy and risk evaluations of the pesticide. In some cases, a regional pesticide registration entity conducts the evaluations, in other cases one of the countries in the region evaluates for all countries.

Joint regional decision making requires extensive national legislation as well as regional harmonization and/or legislation. Registration procedures need to be worked out in detail since part of sovereignty for decision making is transferred from the national to the regional level. In addition, joint decision making is based on trust among the regulatory authorities.

Only a few regions in the world have established a joint pesticide registration scheme; they are described here. {INSERTLINK to page 5b}

{Page 5b}

Current regional pesticide registration systems

Joint regional decision making for pesticide registration is rare. Regional pesticide registration are currently operational in only three regions in the world: West Africa, Central Africa and the European Union. 

West Africa

In 1992, the Common Regulation for the registration of pesticides in CILSS member states was adopted by the Council of Ministers of the Permanent Interstate Committee for Drought Control in the Sahel (CILSS). It was the basis for a joint pesticide registration scheme of 9 countries in the West African Sahel. The Sahelian Pesticides Committee (CSP) functioned as the regional entity responsible for pesticide evaluation and authorization. Registrants would submit their applications at the CSP Secretariat, after which they were further treated at the regional level.

More recently, the CILSS system has been expanded to cover all additional countries of the Economic Community of West African States (ECOWAS), and become a 17-country regional pesticide registration scheme. Evaluation and authorization of pesticide products is done by the West African Pesticide Registration Committee (WAPRC).

Central Africa

Mirroring the CILSS system in West Africa, in 2007 the Comité Inter-états des pesticides de l’Afrique centrale (CPAC) was created under the Économique and Monetary Community of Central Africa (CEMAC). The primary objective of CPAC is to coordinate pesticide management in the 6 member countries of CEMAC.

The Common regulation for the registration of pesticides in the CEMAC zone allows regional registration of pesticides by CPAC. As in West Africa, pesticide products are registered by a regional body: CPAC. 

European Union

In the European Union (EU), two regional pesticide registration schemes exist, one for plant protection products and one for biocides. 

Plant protection products

The registration procedure for plant protection products is laid down in: Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market. This is basically a two-step process: 

1. Active substances of plant protection products, as well as safeners and synergists, are evaluated at the level of the EU. The Rapporteur Member State conducts a first evaluation of the active ingredient, which is peer reviewed by the European Food Safety Authority (EFSA) and the other member states. The Standing Committee on Plants, Animals, Food and Feed (ScoPAFF - made up of representatives from each EU Member State) delivers its opinion on the proposal to approve or not approve an active substance, after which the European Commission adopts a Regulation with the final decision.
   
   The approval procedure is described in more detail here. 

2. Once active substances, safeners and synergists are approved, companies can submit in the Member States applications for authorisation for placing on the market and use of plant protection products containing them.
   
   A zonal system of authorisation operates in the EU to enable a harmonised and efficient system to operate. The EU is divided into three zones; North, Central and South. EU countries assess applications on behalf of other countries in their zone and sometimes on behalf of all zones.
   
   The procedure to apply for authorisation of a plant protection product is described here. 

Biocides

The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) concerns the placing on the market and use of biocidal products. Like for plant protection products, the registration of biocides is a two-step process. 

1. The approval of active substances takes place at EU level.
2. The subsequent authorisation of the biocidal products is done at Member State level. This authorisation can be extended to other Member States by mutual recognition. The regulation provides applicants with the possibility of an authorisation at Union level (Union authorisation).

The procedures for approval of the active ingredient and authorisation of biocidal products are explained here.

The regional entity coordinating the biocides registration is the European Chemicals Agency (ECHA).

 [IMAGE]