# Study on the Union's situation and options regarding invertebrate biological control agents for the use in plant health and plant protection

Christina Castella, Clémence Orsat, Marine Marcdargent, Thibaut Malausa,

Nicolas Desneux, Patrick De Clercq, Maria Pappas, Johan A. Stenberg,

Nicolas Roques

► To cite this version:

Christina Castella, Clémence Orsat, Marine Marcdargent, Thibaut Malausa, Nicolas Desneux, et al. Study on the Union's situation and options regarding invertebrate biological control agents for the use in plant health and plant protection. European Union. 2022. hal-04228764

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# Study on the Union's situation and options regarding invertebrate biological control agents for the use in plant health and plant protection

## Final report

Written by:

Christina Castella - EY

Clémence Orsat - EY

Marine Marcdargent - EY

Thibaut Malausa - INRAE

Nicolas Desneux - INRAE

Patrick De Clercq - Ghent University

Maria Pappas - Democritus University of Thrace

Johan A. Stenberg - Swedish University of Agricultural Sciences

Nicolas Roques - Biotope

<figure><img src="image_3.png" /></figure>

For the Directorate General For Health and Food Safety
12 / 2022
EUROPEAN COMMISSION

Directorate General For Health and Food Safety

Directorate G – Crisis preparedness in food, animals and plants

Unit G.1 – Plant Health

Contact: sante-g1-plant-health@ec.europa.eu

European Commission
B-1049 Brussel
# Study on the Union's situation and options regarding invertebrate biological control agents for the use in plant health and plant protection

## Final report
PROJECT TEAM

Christina Castella – EY

Clémence Orsat – EY

Marine Marcdargent – EY

Thibaut Malausa – INRAE

Nicolas Desneux – INRAE

Patrick De Clercq - Ghent University

Maria Pappas - Democritus University of Thrace

Johan A. Stenberg - Swedish University of Agricultural Sciences

Nicolas Roques - Biotope

LEGAL NOTICE

This document has been prepared for the European Commission however it reflects the views only of the authors, and the European Commission is not liable for any consequence stemming from the reuse of this publication. More information on the European Union is available on the Internet (http://www.europa.eu).

PDF

ISBN: 978-92-76-60184-5

doi: 10.2875/990274

EW-05-22-420-EN-N

Manuscript completed in 12/ 2022

Luxembourg: Publications Office of the European Union, 2022

© European Union, 2022

<figure><img src="image_4.png" /></figure>

The reuse policy of European Commission documents is implemented by the Commission Decision 2011/833/EU of 12 December 2011 on the reuse of Commission documents (OJ L 330, 14.12.2011, p. 39). Except otherwise noted, the reuse of this document is authorised under a Creative Commons Attribution 4.0 International (CC-BY 4.0) licence (https://creativecommons.org/licenses/by/4.0/). This means that reuse is allowed provided appropriate credit is given and any changes are indicated.

For any use or reproduction of elements that are not owned by the European Union, permission may need to be sought directly from the respective rightholders.

How to cite this report: European Commission, Directorate General For Health And Food Safety, Castella, C., Orsat, C., Macdargent, M., Malausa, T., Desneux, N., De Clercq, P., Pappas, M., Stenberg, J.A., Roques, N., *Study on the Union's situation and options regarding invertebrate biological control agents for the use in Plant Health and Plant Protection*, Publications Office of the European Union, 2022, https://data.europa.eu/doi/10.2875/990274
## Contents

<table><tr><td>Executive Summary</td><td>2</td></tr><tr><td>Acronyms</td><td>11</td></tr><tr><td>1 Background, objectives and scope of the Study</td><td>12</td></tr><tr><td>1.1 Objectives</td><td>12</td></tr><tr><td>1.2 Scope</td><td>12</td></tr><tr><td>1.3 Overview of Study questions</td><td>13</td></tr><tr><td>2 Methodological approach, timeline, and data collection</td><td>15</td></tr><tr><td>2.1 Overview of the approach</td><td>15</td></tr><tr><td>2.2 Summary of data collection activities</td><td>16</td></tr><tr><td>2.3 Robustness of the data and of the analysis</td><td>21</td></tr><tr><td>2.4 Difficulties and limitations of the Study and related mitigation measures</td><td>23</td></tr><tr><td>3 Findings of the study</td><td>25</td></tr><tr><td>3.1 Q1: What is the current market of IBCAs on the level of Member States and how can it be further developed?</td><td>25</td></tr><tr><td>3.2 Q2: What (regulatory) systems are in place in relation to introduction, production and/or release of IBCAs in the different Member States?</td><td>64</td></tr><tr><td>3.3 Q3: What are the characteristic elements of the regulatory approaches in force towards the introduction, evaluation, production, marketing and use of IBCAs in Member States?</td><td>83</td></tr><tr><td>3.4 Q4: Which of the regulatory instruments below are used and in which Member States? How can they be used more effectively? Have additional instruments been mentioned by stakeholders and which are they?</td><td>90</td></tr><tr><td>3.5 Q5: Which successful alternative approaches exist in countries outside the Union and how can they be characterised?</td><td>103</td></tr><tr><td>3.6 Q6: Prospective question - Which instruments could complement the regulatory provisions in place and what are their expected effects?</td><td>112</td></tr><tr><td>4 Synthesis of the problem definition and analysis of the main potential options for an EU intervention</td><td>120</td></tr><tr><td>4.1 Problem definition</td><td>120</td></tr><tr><td>4.2 Objectives to be considered</td><td>126</td></tr><tr><td>4.3 Options and scenarios to be considered</td><td>127</td></tr><tr><td>4.4 Intervention logic</td><td>152</td></tr><tr><td>5 Annexes</td><td>153</td></tr><tr><td>5.1 Annex 1 - Key definitions regarding IBCAs</td><td>153</td></tr><tr><td>5.2 Annex 2 - Documentary review</td><td>159</td></tr><tr><td>5.3 Annex 3 - Study grids and sources</td><td>164</td></tr><tr><td>5.4 Annex 4 - Templates of the surveys and interview guides used during the study</td><td>181</td></tr><tr><td>5.5 Annex 5 - Overview of the data collected and available in the Member States</td><td>205</td></tr><tr><td>5.6 Annex 6 - Overview of the content of risk assessment at national level</td><td>210</td></tr><tr><td>5.7 Annex 7 - Synopsis report on the stakeholder consultation</td><td>216</td></tr></table>
**Executive Summary**

**Introduction / overview**

The Council adopted on 22 June 2021 a Decision (EU) 2021/1102 requesting the Commission to submit by 31 December 2022 "a study on the Union's situation and options regarding the introduction, production, evaluation, marketing and use of invertebrate biocontrol agents (IBCAs) within the territory of the Union".

In this context, the Commission requested EY to undertake a study aiming to provide input in analysing the Union's current situation (extent of use of IBCAs, potential for further development, state of regulations at Member State level), to identify the main problems, and to support the preparatory work for the design of a possible initiative that addresses these shortcomings.

In line with the evaluation criteria required by the Better Regulation Guidelines, this study relied both on quantitative data and a qualitative consultation: national competent authorities from the EU Member States; key representatives from relevant European stakeholders: intergovernmental, scientific and civil society organisations; and industry and user associations.

**Key findings**

**Current IBCA market, uses, and potential for development**

**Market**

IBCAs in Europe are a growing market (estimated between 300 and 350 million euros per year), representing around 30% of the European biocontrol market (around 1bn€). Although this growth is significant (103% increase between 2016 and 2020), it remains slower than the global market for biological control.

This market is expected to be more developed in Member States with an extensive agricultural production, especially in horticultural and protected crops. According to representatives of the IBCA industry, biological control has reached significant critical mass, especially in the protected crop segment, which is seen as mature: 80% of commercially used IBCAs are used in greenhouses, and 20% in field crops (mainly for maize and some specialty crops).

Production of IBCAs relies on a few large companies and a base of SMEs, contrary to the chemical industry that mostly relies on large international companies. Several countries have few or no implanted producers and rely mostly on imported organisms from neighbouring countries.
## Uses

Uses of IBCAs firstly depend on the type of biological control considered. The European market focuses on augmentative biological control. It corresponds to the periodic release of natural enemies to control a recurring pest and is a commercially viable business model. It is generally used by growers, on a crop-to-crop basis. This market is expected to continue growing, with more limited expected growth on the open-field market (although a few success stories exist, such as *Trichogramma*, parasitoid wasps against corn borers in maize).

Classical biological control on the other hand aims at controlling pests more permanently, by introducing and establishing a permanent population of their natural enemies, which are not yet present in the field. Introduction programs rely mainly on national initiatives, coordinated and led by research. The use of Sterile Insect Technique (SIT) relies on the same logic as it requires large technical facilities for research and production. Commercial perspectives are completely different from those of augmentative biological control as there is no business model replicable from one year to another. These strategies may, however, become activities handled by other types of private actors, with risk-taking and investments shared between growers, food chain value actors and public bodies.

Classical biological control introductions used to be frequent during the last century. However, recent restrictive regulations have set directions for the evaluation of their safety with respect to biodiversity but reduced their number: less than 20 classical biological control programs were identified in the study since the 2000s. Biological control of animal pests is more advanced, whilst other biological control (especially of plants or fungi) would require some more development.

The use of IBCAs varies significantly across the Member States. Some species are widely authorised and some only used in a restricted number of Member States. More generally, the following drivers and parameters shape the use of IBCAs and the potential for development:

- **The type of agriculture or horticulture that prevails in a given Member State:** Member States with sophisticated horticulture and substantial areas of protected cropping have adopted a much larger number of uses.

- **The general public policy approach of a Member State:** Member States that focus strongly on Integrated Pest Management (IPM) through policy initiatives, dedicated R&D and industry engagements have a much better chance to increase familiarity with the newest methods and IBCA use, and finally in broader scale adoption.

- **The agricultural approach of growers:** IBCA use is frequent among organic growers and growers who follow IPM principles, as well as in some horticultural crops where pesticide use is limited (e.g. crops that depend on bumblebees for pollination).
* **The efficacy of IBCA, especially in outdoor crops:** Adoption by farmers, especially in outdoor use, is hampered by the lower immediate efficacy of IBCAs that is often behind that of plant protection products. Efficacy is however a concept linked to the *modus operandi* of chemical PPPs and is not well-adapted to biological control, which often relies on pest population regulation (rather than eradication), and whose impacts may be observed after several seasons.

* **The high costs of the IBCA solutions:** The technicity of IBCA development, shipment, and application, can lead to high costs, especially where large quantities of IBCAs are required. Transport and storage can be challenging, and the field-delivery is often manual, and thus labour intensive. These costs can limit the use of IBCAs.

* **The demand on the final consumers' side:** Concerns regarding the environment, biodiversity and the use of chemical PPPs are increasing. Communication on the benefits of IBCAs (returns on investment, higher sustainability), collective organisations and sharing (through associations and cooperatives) are success factors in IBCA uptake.

* **The lack of knowledge on IBCAs:** On the side of farmers and advisors, lack of knowledge or expertise may lead to no use or the misuse of IBCAs, which may be counterproductive in the adoption of this solution in farmers' practices. IBCAs can also have a bad reputation on the public's side.

Although the use of some IBCAs is sometimes claimed to be compatible with the use of pesticides (especially selective ones), this combination is rarely an efficient approach. The replacement of PPPs by IBCAs in systems developed for chemical pesticide use (which rely on the immediate curative effect of pesticides and very little on preventive measures and pest regulating agroecosystem services that are suppressed by pesticides) leads to biocontrol failures and a sense among growers that biocontrol is not effective or efficient. Profound system changes in cropping approaches are very likely much more efficient in speeding up the development of biocontrol.

**Regulatory frameworks**

*At European level*

IBCAs are not covered by the current European regulation for the placing into the market of PPPs<fnref n="1" />. (Regulation (EC) No 1107/2009). However, they fall under the scope of two European regulations to ensure protection of biodiversity (Regulation (EU) No 1143/2014) and plants<fnref n="2" />.

<footnote n="1">¹ Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market</footnote>

<footnote n="2">² Regulation (EU) No 1143/2014 of the European Parliament and of the Council of 22 October 2014 on the prevention and management of the introduction and spread of invasive alien species and Regulation (EU)</footnote>
(Regulation (EU) 2016/2031). At international level, there are however
several guideline-setting organisations, whose work is often informally
considered in the different regulation systems developed by European
Member States. This is mainly the work undertaken by the IPPC (global
level) and EPPO (regional level), in developing standards on importation
for research, for release into the environment, on safely used species,
and on guidelines for authorisation and risk-assessment.

At Member State level

14 Members States have established provisions specifically regulating the introduction, production and/or release of IBCAs in their national legislation, while three more Member States are currently developing such provisions. They are almost systematically different from those applied to PPPs.

- The **14 Member States with specific regulations for IBCAs** have regulatory frameworks that differ depending on whether they cover all IBCAs (11 Member States) or only non-native ones (three Member States).

- The **13 Member States without a specific national or regional regulation** often have a limited use of IBCAs. Among the Member States without specific regulations for IBCAs, five (and two regions in Belgium) have environmental regulations which prohibit the introduction of non-native species (specific derogations can be provided in some Member States). The remaining seven Member States (and one region in Belgium) do not have specific national (or regional) regulations restricting the introduction of native or non-native species.

The scope of these regulations is also heterogeneous: some Member
States treat release and introduction differently, and may regulate one
and not the other. Transport is regulated in only one Member State, and
production in five Member States.

**Authorisation processes related to IBCAs also take different shapes,** and can cover a specific IBCA (species, strain, source), a specific plant protection product (containing one or more specific IBCA organisms), and specific uses (research, commercial, indoors, outdoors). Finally, most Member States do not distinguish between augmentative and classical biocontrol. Two factors may however *de facto* implicitly distinguish between classical and augmentative biocontrol: (i) the distinction between native and non-native species, as classical biocontrol only relies on non-native species; and (ii) the risk assessment, where the impact on biodiversity and the potential of the IBCA to become invasive is considered.

**The risk-assessment processes are also heterogeneous.** Among
the Member States who carry out a formal risk-assessment (not all

<footnote>2016/2031 of the European Parliament of the Council of 26 October 2016 on protective measures against pests of plants</footnote>
countries who have a regulation), the requirements also vary according
to the status of the species: native (sometimes to the strain level), non-
native, in an EPPO list, authorised in another Member State. The contents
of these assessments also vary, and the procedures may focus most
frequently on the risks of unintended spread, risks for plant health and
biodiversity. Risks to human and animal health are less frequently
assessed. Finally, some Member States also carry out an analysis of
benefits: they cover mostly plant protection/phytosanitary effects,
benefits to local biodiversity, and environmental benefits. Most dossiers
are approved by the authorities. Obtaining the right data is however a
recurrent challenge for Member States, and it make take years for
companies to elaborate a dossier ready to be formally submitted, and its
examination by authorities may also take 6 to 9 months on average.

Several data gaps were identified by the Member States:

- Establishment potential for non-native organisms

- Unclear description of the intended use, especially in terms of territories, target organism, dose rate, stage of development, and product formulation

- Identity, origin, history and distribution of the organism in the national territory, variations within species and possible effects on genetic diversity

- Practical effectiveness and unintended effects, including on non-target organisms, host range, and contamination risks

- General lack of data and literature

The risk for the environment is particularly difficult to evaluate, as some
topics are not covered by existing research.

This legal heterogeneity also takes place at the **monitoring** level: the
registration of IBCA producers and retailers (nine Member States register
both, one Member State only registers producers), quality control (rarely
included in the regulations), and post-release monitoring. The latter is
rarely conducted: current strategies at the national level rely on the
submission of a report or alert if an unexpected effect is identified.
However, the identification of such effects requires a strong and
expensive scientific monitoring, which is rarely performed. Few Member
States mentioned undesirable impacts of IBCAs after release (the only
reported cases of undesirable impacts concerned *Harmonia axyridis*,
*Cales noacki* and *Lysiphlebus testaceipes*, which have been removed from
the EPPO safely used list), as well as *Nesidiocoris tenuis* (reported by
Finland and also the target for control in Belgium and France, although it
is used without negative consequences in some other Member States).

Concerning the administrative process and support to the
applicants, publicly available guidance is often available, although
sometimes only in the national language, and a limited number of
Member States offers regularly informal pre-submission meetings. Areas
of improvement of the procedures revolve around the facilitation of
administrative and organizational processes, the internalization of
expertise and specific training regarding IBCAs, the scope of the
legislation (e.g., lack of inclusion of environmental effects, no provisions
for SIT, etc.). Overall, representatives from the industry underlined that
their main needs are Member States with clear frameworks and simple
procedures for naturally occurring species.

Research and innovation projects and knowledge transfer

The availability of IBCAs depends heavily on research and development to develop effective solutions and ensure that they do not pose a risk to the environment. Inversely, even if some IBCA research programs have shown results and interest from farmers, there could be a lack of industrial interest due to limited commercial perspectives (for minor crops and/or minor target pests).

The knowledge of professional users regarding IBCAs stems mainly from
general information provided by authorities as well as industry advisory
services. Amateur users or users who often buy products from third
parties or on the internet may be considerably less knowledgeable.
Finally, on the administrative side, there is a **wide discrepancy**
**between Member States with regard to availability of biocontrol**
**experts**, and the specialisation of public officials on biocontrol and more
specifically IBCAs.

Strategic approaches at national level

Member States have different approaches regarding their national
strategy to support the development and use of IBCAs. Some of the
Member States may also have developed specific financial incentives. The
extent of support is, overall, proportionate to the investment from the
private sector (via programmes financing public-private projects, public
projects with likely transfers to the existing industry, tax credits for
companies carrying out R&D). Given the small size of IBCA markets,
resources available to IBCA R&D remain very modest, even in the most
active Member States. However, the study identified specific provisions
for IBCAs in only two national CAP plans.

The analysis of the framework of two third countries, New Zealand and the USA, showed different approaches. In New Zealand, few incentives are given to develop the use of IBCAs, which are principally classical biological control uses. The framework regulates the introduction, release, commercialisation, quality control and transport of all new organisms that were not present in New Zealand before 29 July 1998. Procedural costs are much higher than in Europe (25 thousand dollars), but most dossiers are approved thanks to an open informal feedback channel between the authority and the petitioners. In the USA, the
framework is federal and regulates all aspects of IBCA use with State-
specific permits. IBCAs are the subject of federal funding of research.

Instruments to bridge gaps

The study outlines that key instruments already exist in a few countries or at the level of international organisations: Member States authorities and EPPO display the capacity to provide guidance documents, providing positive and/or negative lists of IBCAs. Some Member States have also implemented more or less detailed risk analysis procedures. Hence, most of the raw material to implement a regulation framework at the EU level is already available (except for post-release monitoring strategies).

As a synthesis of the information collected, several criteria can be
identified to ensure balanced regulatory systems:

- **Develop frameworks that are proportionate to the risks.** As mentioned above, the risks vary depending on the type of IBCAs used. Thus, adapting processes depending on the level of risk ensures a balanced regulatory system. In addition, the risk assessment should also put in balance the benefits of the use of IBCAs in comparison to chemical solutions.

- Ensure stability of the framework over time. As in all authorisation processes, changes in the rules that apply may have important consequences on the applicants and private sector. It is especially true for IBCAs where the development of new products takes several years and is performed by SMEs with limited economic capacity.

Regulatory instruments to foster innovation may be classified within two
categories: (i) innovation push (e.g., supports to research & development
at the national or EU level) or (ii) innovation pull, which the study
recommends focussing on. Innovation pull would foster transitions to
agrosystems more favourable to IBCAs, greater co-innovation dynamics
between the biocontrol industry and actors of the agrifood value chain,
as well as specific instruments for classical biological control.

Main potential options for an EU intervention

Two main consequences of observing the status quo were identified
during the study:

- Insufficient development and use of IBCAs as an alternative to chemical pesticides in the control of plant pests, which will limit their role in achieving the objectives of the Farm to Fork strategy;

- Potential negative consequences on biodiversity, as risks on biodiversity are managed differently across Member States.

Several options were identified to address these problems, with the
objective to foster market access, increase the availability of effective
(existing and new) solutions and ensure the safe development and use of
IBCAs:

- **Options related to the harmonisation of the legal framework between Member States** to ensure that farmers have access to safe IBCAs in all Member States due to authorisation and that the analysis of risks for biodiversity are homogeneously covered in the European Union. **These options can be designed with different scenarios for centralisation:**

o The systematic integration of IBCAs as an alternative of chemical pesticides in the initiatives and other documents of the European Commission,

o The harmonisation of definitions of native, exotic and/or established species, the establishment of whitelist(s) of safe IBCAs,

o The harmonisation of the content of risk assessment and consequences of the analysis (especially mitigation measures)

o The existence of processes to ensure that IBCAs can be authorized after proper risk assessment in all the Member States

Scenarios have been developed which reflect different levels of centralisation: a voluntary scheme based on the use of data from EPPO; a two-level procedure to find a balance between homogenization and freedom of action of Member States; centralized risk analysis managed by an EU organisation with expertise on IBCAs, and finally a completely centralized process, from risk assessments to decision-making.

- **Options related to the production, recording and monitoring of IBCA data** to ensure that knowledge continues to be gained in the European Union regarding the effects of using IBCAs (especially negative and positive effects on biodiversity). They include the registration of European producers as well as data on their sales, the monitoring of IBCA use through indicators aggregated at EU level, processes to share information on risk-assessment between the Member States, and a working group at EU level on post-release assessment.

- **Options related to fostering research and development** for the development of new or more effective solutions (innovation push through EU-wide funding programmes, specific efforts focused on the strategies that display the highest cost-benefit ratios for farmers, generate data and references about impacts, and co-innovation projects).

- **Options related to fostering training, knowledge transfer and behavioural changes along the agrifood value chains (innovation pull).** These options include developing a specific platform / working group supported by the European Union in order to share information
between the stakeholders and Member States regarding the use of IBCAs (or more generally biocontrol solutions) in redesigned agroecosystems; strongly engaging downstream industries and retailers in initiatives promoting sustainable cropping systems and food chains; supporting farmers through financial support and training; supporting the monitoring and data collection and its availability at EU level; training public authorities; and emphasizing communication and success stories, through forums or demonstration farms for example.
## Acronyms

<table><tr><td>BCA</td><td>Biological control agents</td></tr><tr><td>CAP</td><td>Common Agricultural Policy</td></tr><tr><td>CBA</td><td>Cost-benefit analysis</td></tr><tr><td>EC</td><td>European Commission</td></tr><tr><td>EPPO</td><td>European and Mediterranean Plant Protection Organization</td></tr><tr><td>EFSA</td><td>European Food Safety Authority</td></tr><tr><td>EU</td><td>European Union</td></tr><tr><td>FAO</td><td>Food and Agriculture Organisation</td></tr><tr><td>F2F</td><td>Farm to Fork Strategy</td></tr><tr><td>IAS</td><td>Invasive alien species</td></tr><tr><td>IBCA</td><td>Invertebrate Biological Control Agents</td></tr><tr><td>IBMA</td><td>International Biocontrol Manufacturers Association</td></tr><tr><td>IFOAM</td><td>International Federation of Organic Agriculture Movements</td></tr><tr><td>IOBC-WPRS</td><td>International Organisation for Biological and Integrated Control - West Palaearctic Regional Section</td></tr><tr><td>IPM</td><td>Integrated Pest Management</td></tr><tr><td>IPPC</td><td>International Plant Protection Convention</td></tr><tr><td>MRLs</td><td>Maximum Residue Levels</td></tr><tr><td>MS</td><td>Member State</td></tr><tr><td>NCA</td><td>National Competent Authority</td></tr><tr><td>NPPO</td><td>National Plant Protection Organization</td></tr><tr><td>OECD</td><td>Organisation for Economic Co-operation and Development</td></tr><tr><td>PAN</td><td>Pesticide Action Network</td></tr><tr><td>PPP</td><td>Plant Protection Products</td></tr><tr><td>SIT</td><td>Sterile Insect Technique</td></tr><tr><td>SUD</td><td>Sustainable Use of Pesticides Directive</td></tr><tr><td>ToRs</td><td>Terms of Reference</td></tr><tr><td>USA</td><td>United States of America</td></tr></table>
# 1 Background, objectives and scope of the Study

## 1.1 Objectives

The Council adopted on 22 June 2021 Decision (EU) 2021/1102 requesting the Commission to submit by 31 December 2022 "a study on the Union's situation and options regarding the introduction, production, evaluation, marketing and use of invertebrate biocontrol agents (IBCA) within the territory of the Union".

In this context, the Commission has requested EY to undertake a study aiming to support and provide input in analysing the Union's situation and establishing options regarding the introduction, production, evaluation, marketing and use of IBCAs within the territory of the Union and support the preparatory work for the design of a possible initiative that address shortcomings of the existing system in place. Provided inputs shall be part of further considerations towards future policy options to foster the development and use of IBCAs and address existing gaps in terms of managing risks and ensuring access to safe and sustainable products and services.

More specifically, the Study aims to:

- Allow a comprehensive description of the current situations of IBCAs in the Union, including an analysis of the current extent of use of IBCAs, the potential for further development and the state of regulations at Member State level;

- Identify problems of the current system in different MS and underlying drivers;

- Identify objectives and policy options, which will involve identifying and listing instruments that may address problems, as well as possible elements for policy options;

- Assess potential positive or negative effects/impact, e.g. identify and assess (mainly from a qualitative perspective, but also where possible through a quantitative cost-benefit analysis approach) pros and cons, e.g. positive of negative consequences which may be expected from the implementation of different policy options.

## 1.2 Scope

### Content:

The study focuses on **Invertebrate Biological Control Agents** such as insects, including male sterile insects, mite, and nematode species (IBCAs). As mentioned in the ToRs, only uses which are linked to the intentional release of IBCAs shall be considered. Furthermore, only IBCAs shall be
considered which are intended to protect plants or plant products, ("plants" and "plant products" as defined in Article 2 of Regulation 2016/203111), including those to control invasive plants.

Further inputs regarding definitions and the scope of the Study are provided under Annex 1 of this final report.

**Territory:**

In terms of geographical scope, the study covers the territory of the Union. Most analyses cover all EU Member States, with some specific questions focusing on a more limited sample of 7 Member States that are representative of the composition of the Union. **Selected 7 Member States for this study are Austria, France, Hungary, the Netherlands, Portugal, Spain, and Sweden.**

In addition, the study aims to analyse the situation and alternative approaches in two third countries. In agreement with DG SANTE, the selected third countries were **New Zealand and the USA.**

**Timeline:**

The Study is both retrospective and prospective. Its retrospective component mainly focuses on analysing the current situation and current regulation, thus establishing current existing problems. The prospective component includes projections for the next 5 to 10 years.

**1.3 Overview of Study questions**

The Study aims to answer the following **questions** as defined in the ToRs:

1. What is the **current market** of IBCAs on the level of Member States and how can it be further developed?

2. What **(regulatory) systems** are in place in relation to introduction, production and/or release of IBCAs in the different Member States?

3. What are the **characteristic elements of the regulatory approaches** in force towards the introduction, evaluation, production, marketing and use of IBCAs in Member States?

4. Which of the **regulatory instruments below** are used and in which Member States? How can they be used more effectively? Have additional instruments been mentioned by stakeholders and which are they?

* Internationally agreed guidance documents

* Research projects & funding of product development

* Knowledge transfer

* Economic and financial incentives

* Training activities
* Mechanisms to collect feedback from extension and advisory services

- 5. Which successful alternative approaches exist in **countries outside the Union** and how can they be characterised?

- 6. Which complementary instruments exist that are complementary to regulatory provisions in place and what are their expected effects?

Sub-questions and their specific scope are listed in annex 3.

Considering these Study questions as guiding elements, the report is structured as follows:

- Chapter 2 provides an overview of the methodological approach followed by the Study, and highlights existing limitations in terms of data gaps and completeness of findings and conclusions; in addition to this chapter a synopsis report is provided in Annex 5;

- Chapter 3 provides detailed answers to each Study question;

- Chapter 4, which is based on the findings presented in Chapter 3, summarizes existing problems and suggests potential actions to be taken at an EU level to address them. It also integrates an analysis of the pros and cons of the identified options considering the issues identified with the current situation.
# 2 Methodological approach, timeline, and data collection

## 2.1 Overview of the approach

The methodological approach for this Study has been divided into three phases and four main tasks (study design, consultation, analysis, synthesis and reporting) as follows:

<table><caption>Table 1 - Phases, tasks and timeline of the Study</caption><thead><tr><th>PHASES</th><th>TASKS</th><th>DELIVERABLES & MEETINGS</th></tr></thead><tbody><tr><td>Phase 1: inception phase</td><td><strong>Study design</strong> (Task 1 as per ToRs):<ul><li>Exploratory interviews with identified and approved stakeholders</li><li>Desk research</li><li>Elaboration of the draft Intervention logic</li><li>Development of the draft methodological approach and consultation strategy</li></ul></td><td><p><strong>Kick off meeting:</strong> 11 March 2022</p><p><strong>Draft Inception Report:</strong> 25 April 2022 (revised version sent on 16 May 2022)</p><p><strong>Steering committee meeting:</strong> No 2: 29 April 2022</p></td></tr><tr><td>Phase 2: consultation and preliminary analysis phase</td><td><strong>Consultation activities</strong> (Task 2 as per ToRs):<ul><li>Collection of feedback and inputs from relevant stakeholders through interviews, surveys, and desk research</li></ul><strong>Analysis</strong> (Task 3 as per ToRs):<ul><li>Preliminary answers to Study questions leading to a revised/ completed problem definition</li><li>Initial identification of objectives and potential policy options and instruments that may address problems, and analysis of their potential positive or negative effects/impact</li></ul></td><td><p><strong>Progress meeting:</strong> 15 June 2022</p><p><strong>Draft Interim Report:</strong> 8 July 2022 (revised version sent on 29 August 2022)</p><p><strong>Steering committee meeting:</strong> No 3: 12 July 2022</p></td></tr></tbody></table>

<figure><img src="image_5.png" /></figure>

<figure><img src="image_6.png" /></figure>

<figure><img src="image_7.png" /></figure>

<figure><img src="image_8.png" /></figure>

<figure><img src="image_9.png" /></figure>

<figure><img src="image_10.png" /></figure>
<table><thead><tr><th>PHASES</th><th>TASKS</th><th>DELIVERABLES & MEETINGS</th></tr></thead><tbody><tr><td rowspan="5">Phase 3: final analysis, synthesis, and reporting</td><td>Continuation of consultation activities (Task 2 as per ToRs):<ul><li>Finalisation of collection of feedback and inputs from relevant stakeholders</li></ul><strong>Final analysis (Task 3 as per ToRs):</strong><ul><li>Triangulation of both quantitative and qualitative data to provide evidence-based answers to all Study questions, propose policy options and analyse their consequences (pros and cons)</li></ul><strong>Synthesis and reporting (Task 4 as per ToRs):</strong><ul><li>Completion of analyses</li><li>Validation workshop</li><li>Final conclusions</li></ul></td><td><p>Validation workshop: <strong>30-31 August 2022</strong></p><p>Draft Final report: <strong>9 September 2022</strong></p><p>Steering committee meeting No 4: <strong>23<sup>rd</sup> September 2022</strong></p><p>Final report: <strong>30 September 2022</strong></p></td></tr></tbody></table>

<figure><img src="image_11.png" /></figure>

<figure><img src="image_12.png" /></figure>

<figure><img src="image_13.png" /></figure>

<figure><img src="image_14.png" /></figure>

## 2.2 Summary of data collection activities

### 2.2.1 Inception (phase 1)

Phase 1 aimed at refining the background and scope of the Study and detailing the work programme and methodological approach of the study. It included:

- **7 scoping interviews** were conducted with:

- the Commission (DG SANTE, DG AGRI),

- EU agencies (the European Food Safety Authority (EFSA))

- organisations representing users (IFOAM), the industry (IBMA), and scientific organisations (IAEA-FAO and EPPO).

During these interviews, the study was presented to the stakeholders, as well as the main needs for data and key issues to be dealt with. An open discussion was organised to give the stakeholders the opportunity to describe their view of the topics addressed and the main pros and cons they foresee in terms of implementation of public policies at the EU level. The stakeholders were also invited to make suggestions of institutions to be contacted for the various issues to address and to gather data needed for the study. These interviews allowed the team to get a
clearer overview of their respective role and responsibilities, collect their expectations on the study, and estimate their degree of involvement and knowledge regarding IBCAs, and which data could be obtained in the later steps of the study.

- **Initial desk research and preliminary analysis.** These tasks included desk research at an EU and national level (in selected MS only) to provide initial input to the Study questions, better identify existing data gaps and define how to address these gaps through consultations and additional documentary review. The documentary review mainly focus on:

- Official documents (legal texts and websites) to complement the consultation, or to address gaps in the consultation (Malta and the region of Wallonia). These documents include for example the lists of species available for use and/or authorised in some Member States, legal provisions for data requirements and risk assessments

- A literature review to anchor the analysis in the existing scientific findings. The list of documents consulted is provided in Annex 2.

- Databases: Eurostat (pesticide sales, agricultural output in the EU-Member States, and crop production in EU standard humidity)<fnref n="3" />, 2021 and 2022 IBMA market studies, lists of approved or commercially available species in the Member States, databases on the uses of IBCAs in the Member States

- **Preparation of the consultation programme.** Based on the scoping interviews and preliminary analyses, several types of stakeholders have been identified as targets to gather data and information. For each, questionnaires or interview guidelines have been developed. A plan to contact and interview each category has been defined.

### 2.2.2 Consultation activities (phase 2)

**Stakeholders consulted**

Stakeholders were pre-identified in the Terms of Reference of the Study by the European Commission and validated with the study team. The choice was made to keep the stakeholder consultation at European level. The following categories of stakeholders have been contacted for the assignment:

- European Institutions;

- Relevant national competent authorities in all 27 Member States, e.g., authorities in charge of Plant Health, Plant Protection and Environmental protection. As requested by the ToRs, "the contractor

<footnote n="3">³ Annual pesticide sales per Member State in kilograms Statistics | Eurostat (europa.eu)
Economic accounts for agriculture - values at current prices Statistics | Eurostat (europa.eu)
Crop production in EU standard humidity Statistics | Eurostat (europa.eu)</footnote>
shall limit its contacts to the authority being in the lead for the national process for the production and release of IBCAs, respectively".

- Third countries: competent authorities in 2 non-EU countries to compare and identify alternative approaches. New Zealand was chosen for its historical approach to the regulation of IBCAs, while the United States of America were selected as a relevant case study on how the federal level can be articulated with State independence and decision-making power.

- Organisations other than public entities, which includes:

- 3 Intergovernmental organisations on biological control

- 2 International and EU Industry associations representing the interests of manufacturers and retailers of IBCAs

- 3 Farmers', forestry and home gardeners' associations at EU and international level;

- 3 Civil society organisations (environmental NGOs);

- 2 Scientific organisations.

## Consultation tools

Stakeholders and National Competent Authorities were consulted through two main data collection tools that were implemented in a sequential manner. Each tool enabled to collect evidence that complements desk research by providing additional qualitative and quantitative inputs which are not available in official documentation. These tools are the following:

- **Surveys**, by the mean of structured questionnaires sent to NCAs and other stakeholders. Questionnaires were developed during phase 1 to collect as much information as possible to answer questions of the Study and feed into the problem definition and the identification of possible options for an EU initiative. Starting with written questionnaires (before interviews) left more time to targeted stakeholders to collect relevant documentation and consult with other authorities, where needed, to provide useful and as exhaustive as possible answers. The goal was to consult all 27 Member States and the 12 other stakeholders, as well as one relevant authority from a third country. In total, 26 questionnaires were received, corresponding to 24 different Member States. One of the third countries sent a detailed questionnaire, while the other opted for selective e-mail responses. 3 questionnaires were collected from stakeholders, who generally preferred to provide input during the interviews rather than sending written answers..

- **Targeted interviews** that aim to confirm the problem definition and collect additional views and data to measure the impact of the different options and identify main pros and cons of policy options. They were led with Member States to better refine and complement
the questionnaires, and sometimes were proposed to replace the questionnaire to accommodate NCAs (this was the case for 2 Member States and one regional authority). Stakeholders were also proposed this option, to ensure maximum contribution, and this proved to be their preferred consultation tool. The goal was to lead 20 interviews with a representative sample of stakeholders, including at least 7 Member States, at least one non-EU country and 1-2 representatives of each other stakeholder category. In total, 23 interviews were organised: 13 with the Member States (in two cases to replace the questionnaire), 8 with the stakeholders, and finally 2 with both non-EU countries.

Both consultation tools were implemented in a sequential manner. The survey was launched at the end of May, and interviews were conducted from June to August 2022. This allowed to consult the following stakeholders:

<table><caption>**Table 2 - Consulted stakeholders**</caption><thead><tr><td>Type of stakeholders</td><td>Surveys</td><td>Interviews</td></tr></thead><tbody><tr><td>27 Member State “national competent authorities”, e.g. contact points identified within each national authority in charge of IBCA in their respective country.</td><td>✓<br/>Additional and complementary questions were asked in the form of interviews and emails</td><td>Interviews were led with authorities from Belgium (Brussels region), Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, the Netherlands, Portugal, Spain and Sweden</td></tr><tr><td>Intergovernmental organisations</td><td>✓ EPPO</td><td>✓ EPPO, IAEA-FAO CABI Europe</td></tr><tr><td>Industry associations representing the interests of manufacturers and retailers of IBCAs:</td><td>✓ IBMA<br/>No response from other contacted association</td><td>✓ IBMA,</td></tr><tr><td>Farmers', forestry and home gardener's associations:</td><td>All stakeholders opted for interviews</td><td>✓ COPA-COGECA, EUSTAFOR</td></tr></tbody></table>
<table><thead><tr><td>Type of stakeholders</td><td>Surveys</td><td>Interviews</td></tr></thead><tbody><tr><td>Environmental NGOs</td><td>No response from contacted organisations</td><td>√ PAN Europe</td></tr><tr><td>Scientific organisations</td><td>√ IOBC-WPRS</td><td>√ EFSA</td></tr><tr><td>National competent authorities from third countries</td><td>√ New Zealand, the USA</td><td>√ New Zealand, the USA</td></tr></tbody></table>

## Focus on the consultation with National Competent Authorities

NCAs were mainly consulted through a structured questionnaire, complemented with a series of interviews.

Several follow up tasks were undertaken to support NCAs and ensure a high response rate to the questionnaire, and ensure better quality of the responses:

- Phone calls and frequent reminders by email, to ensure that data is collected and at least get in touch with each stakeholder to ensure to receive feedbacks (including negative ones).

- Series of follow-up interviews and email exchanges with stakeholders who are not able to provide written answers as well as with stakeholders with answers not sufficiently detailed or which required clarification.

- Review of relevant national documentation, either transmitted by national competent authorities or available online, to fill the data gap.

- Documentary review for Member States who did not reply.

- Literature review of scientific evidence to support and refine the elements transmitted by the different stakeholders and Member States, when possible.

Detailed inputs could be obtained for 25 Member States (all Member States except Malta). In total 26 questionnaires were received (including 3 questionnaires covering the regional level in Belgium), corresponding to 24 different Member States. 2 more Member States (Luxembourg and Portugal) were interviewed (although no questionnaire was received, these interviews enabled to complete the questionnaire). Finally, an additional documentary review was led for Malta, which confirmed the absence of a regulatory system. As a result, the survey covers all Member States, except for Malta and the region of Wallonia in Belgium, with a response rate of 28 responses out of the 30 solicited.

A detailed overview of Member States' participation in the consultation activities is available in section 5.5.3.1.
### 2.2.3 Validation workshop (phase 3)

An online validation workshop was organized on August 30th and 31st 2022.

This workshop aimed to present the results of the study, validate the main findings, and discuss over some more challenging topics identified. It was opened for participation to representatives of key stakeholders concerned by IBCAs at European level, e.g., the national competent authorities of each Member State, representatives of business operators (producers and users), representatives of NGOs, as well as recognised experts in IBCAs. Overall, participation was high, with 60 people (including the EC and the study team) present on the 30th and 56 people on the 31st.

<table><caption>**Table 3 - Number of participations per stakeholder group and overall target**</caption><thead><tr><td>Type of stakeholders</td><td>Number of participations per stakeholder groups</td><td>Target number of participations per group</td></tr></thead><tbody><tr><td>Member States</td><td>17</td><td>27</td></tr><tr><td>Intergovernmental organisations</td><td>2</td><td>3</td></tr><tr><td>Industry associations representing the interests of manufacturers and retailers of IBCAs</td><td>1</td><td>2</td></tr><tr><td>Farmers', forestry and home gardener's associations</td><td>1</td><td>2</td></tr><tr><td>Environmental NGOs</td><td>0</td><td>3</td></tr><tr><td>Scientific organisations</td><td>2</td><td>2</td></tr></tbody></table>

Alongside the data collection, the workshop's outputs were included in the report.

### 2.3 Robustness of the data and of the analysis

The content of the report has been developed in compliance with the Better regulation guidelines which define a six-step approach to construct robust evidence base: understanding, mapping, collection, analysis, interpretation
and presentation<fnref n="4" />. Regarding the analysis step more specifically, it has mainly involved: (i) Survey data consolidation, cleansing and processing, (2) documentary review and analysis, (3) combination and cross-analysis of collected data as well as triangulation to describe the situation of IBCAs across the EU, inform on existing problems and assess potential impact of an EU action.

Although the quality of data collected, especially at Member States level, is mixed (see below), the triangulation of several sources ensures the robustness of the analysis. Main findings of the Study were presented and discussed with representatives of the Member States and key experts during a validation workshop.

The level of details and the quality of data collected at Member State level are mixed:

- Survey's sections about the regulatory framework have been thoroughly completed for Member States which have a regulation. Member States currently developing one have also provided certain details on their future regulations. The sections on the legal aspect of IBCAs are therefore robust.

- Sections on the use of IBCAs were more unequally completed. Generally, the number of uses (as in one solution for one crop) is seldom if ever collected in the Member States. When available, the number of authorized IBCAs was communicated, and the desk research allowed to form a database of the species that are either authorised or available for use, without hindsight into the actual use of these organisms. And pesticide use and distribution among crops was also rarely provided. Crop type granularity was available only in a few cases. As such, the analysis of the uses relies more on converging qualitative data obtained through interviews and questionnaires. While this analysis is quite robust, it is missing to some extent the point of view of users (farmers, foresters, gardeners, etc.), that was not thoroughly detailed and available at the level of European organisations. Indeed, the users consider IBCAs as one of the existing alternatives to chemical pesticides and were able to provide the main needs and issues encountered with biological controls. They apply to IBCAs and have been considered in the conclusions. However, they were rarely able to provide specific insights regarding IBCAs. Thus, the analysis consolidates these general concerns on the demand and use side with more specific data and challenges raised in other interviews and relevant studies.

- Similarly, data on the market was difficult to obtain, except for a few Member States which collect indicative information from

<footnote n="4">⁴ Better Regulation Toolbox, tool #4</footnote>
industry associations. Some interviews allowed for more qualitative but less precise descriptions of the market.

- Perspectives were generally expressed in a very concise way. A few Member States left the section empty. A hypothesis for this response behaviour is that some respondents might think they were not at the right decision or political level to reply. Other Member States provided very detailed and exhaustive answers. Ample room was however given to the stakeholders to express their views, through the questionnaires, interviews and the workshop: while not all expressed their view, it can be reasonably thought that not all had views to express given the technicality of the subject, and that the analysis is not limited by this factor.

## 2.4 Difficulties and limitations of the Study and related mitigation measures

Based on the data collection and assessment of the quantitative and qualitative data available, several limitations could be underlined:

- **Important lack of data regarding the market and current use of IBCAs:**

- Very few Member States were able to provide data regarding the current uses of IBCAs on their territory and none of them have data regarding the market of IBCAs at national level. There is no monitoring strategy in place in the Member States leading to very little knowledge on the current situation within NCAs.

- IBMA conducts annual surveys at European level regarding the market of BCAs. However, few data were available from the 2022 survey and important delays in the publication of the results were encountered. In particular, due to some technical issues, the information regarding the market at Member States level is not available. All available data have been integrated in the report.

- Considering the lack of available data, we have proposed in this report an assessment of the current market based on the available data and a qualitative assessment of the structuration of the market in Europe to describe the main producers and the main characteristics of the market. A typology of the types of use has also been proposed, reflecting the main drivers identified during the study and confirmed during the workshop, e.g. Member States' agricultural scenarios, and public policies in place with regards to IBCA authorisation, research, and incentivisation.

- **Difficulty to establish projections at this stage:**

The potential for development of IBCAs has proved challenging to assess by the consulted stakeholders, both in the questionnaires and in the interviews. Especially, information on the product pipeline specific to IBCAs
was not available to IBMA. An estimation of the cost breakdown of new
products was however provided by IBMA, as well as the market value of
their members' yearly sales, and the estimation of their representativity in
the overall European biocontrol market. These estimations were used for
the projection of the total IBCA market. Finally, projections related to the
impact on pesticide use relied on Eurostat data on pesticide use and on
market projections for the evolution of biocontrol. Additional information
regarding methodology used for quantitative projections are provided in
the section detailing the baseline scenario (section 4.1.2.1).

- Challenges when assessing the impact on substituting chemical pesticides and contributing to achieving the F2F targets:

Some of the study questions tend to assume that current chemical
pesticides' uses can be substituted by IBCA uses one by one, with no further
consequences. However, the differences in the type of products (chemical
substance versus living organisms) made this analysis very difficult to
perform. The findings of the study have showed that IBCAs are generally
included in a more global strategy (IPM especially) with the aim of
regulating pests by favouring natural enemies (conservation biological
control), introducing additional predators and parasitoids to the pests in
specific context to regulate the pest population (augmentative biological
control), and sometimes alongside chemical biological control. However, it
relies on more long-term strategy with potential higher effects on the crop
production in comparison to pesticides where one chemical product is used
as a specific solution to one problem. The projections regarding IBCAs were
therefore based on the estimation of the total potential of development of
non-chemical alternatives and the specific contribution of IBCAs estimates
based on the feedbacks from the stakeholders and internal expertise.

- Challenges concerning the analysis of the various regulatory instruments on innovation:

No quantitative or scientifically sound impact study of various regulatory
instruments on innovation could be surveyed in this study. Moreover, very
little input was proposed by Member States within the questionnaires,
although two Member States mentioned possible systems of subsidies or
obligations to use biocontrol strategies. To address this shortcoming,
discussions had to rely on qualitative evaluations, discussions, opinions of
experts and NCAs, and scientific publications providing data on innovation
trends.
# 3 Findings of the study

## 3.1 Q1: What is the current market of IBCAs on the level of Member States and how can it be further developed?

This question aims to develop a clear understanding of the current and potential future market of IBCAs in the 27 Member States of the European Union. It especially provides information on the following elements:

- Market value and market share, especially in comparison to that of chemical pesticides as well as to current production (location, volumes, market destination, etc.) and demand (type of users, unmet needs, gaps in terms of available products or IBCA solutions, etc.)

- Uses: current uses, scenarios of uses (types of crops, types of users, association with chemical pesticides, etc.), potential for new uses (based on unmet needs as well as on the potential for developing new IBCAs), proportion in relation to authorised chemical pesticide uses, etc. Specific focuses are placed on the factors that shape differently the patterns of uses across the Member States, as well as on the different types of invertebrate biological control (augmentative and classical).

- Potential for development of new solutions and products

- Expected benefits on the Farm to Fork objectives, as well as biodiversity and food safety (as defined in the Terms of Reference)

### 3.1.1 Availability of data on market share and uses of IBCAs

One major objective of the Study is to provide an overview of the data available at the European and national level regarding the market share and the use of IBCAs.

#### Availability of data at the national level

Data collection tasks undertaken during the Study have revealed that there is little to no data available at the Member State level regarding IBCA market value, use and production, albeit some data on the authorised species. An overview of the data collected and/or available in the NCAs is provided in Annex 4.

- Data on the market and on the industry

Little information is available at the level of the National Competent Authorities. Some NCAs were able to either transmit data collected from national industry associations, or provide an estimate of the market value. Some Member States require the sellers to communicate data, but they have not been able to communicate market value numbers specific to the IBCA market (our working hypotheses are that they are either not consolidated at the national level, or that the IBCA segmentation of the biocontrol market is not available). Finally, a proportion of the IBCAs used
in the Member States is imported (from other European MS or from third countries). As such, IBCA market data remains largely invisible to the National Competent Authorities (NCAs).

Contrary to chemical pesticides, there is no data on the volume of IBCAs produced and sold. On the other hand, there exists some available data on the IBCA sales collected by industry associations; this information is not available for chemical pesticides.

* Data on authorised species

16 Member States have provided information on the number of species that are authorised and accessible for purchase in their territory. In some Member States with an authorization system, the number of authorized species is also not known (implicit authorization, for example in the Czech Republic).

While in some cases, the number of authorized uses is available, it does not necessarily reflect the number of actual uses (including those who are not subject to authorization).

* Data on the actual uses

Only a few countries have been able to communicate precise data on the actual uses and their repartition by crop type and aim (France, the Netherlands, Slovenia and Sweden). The most developed tool among the different Member States can be found in the Netherlands: the open data website StatLine<fnref n="5" /> provides very precise data collected in agricultural censuses<fnref n="6" /> on the uses of various beneficials, combining crop types and couples of target pests and IBCAs. However, only two censuses have been made so far, for the years 2012 and 2016. Austria has also developed a website<fnref n="7" /> for the authorized plant products which includes IBCAs, and gives information on the field of use, the target pest and the type of crop, although no specific search is possible for IBCAs.

No data is collected at the national level in Member states with no regulation. The National Competent Authorities were therefore not able to communicate the number of actual uses. In many countries with a regulation, the regulation does not include any provision related to the monitoring of the uses of IBCAs, and thus no generation nor consolidation of IBCA-related data. As a result, the collected data is insufficient and heterogeneous across Europe, which does not allow for any consolidation or comparison between Member States.

Despite this lack of data, most NCAs have been able to qualitatively describe the main uses in their territory and provide some examples and best practices.

<footnote n="5">⁵ https://opendata.cbs.nl/statline/#/CBS/nl/dataset/84008NED/table?ts=1656676963062</footnote>

<footnote n="6">⁶ Use of pesticides in agriculture (cbs.nl)</footnote>

<footnote n="7">⁷ Pflanzenschutzmittel-Register (baes.gv.at)</footnote>
Availability of data at the European level

The data produced by companies is not consolidated at the European level. However, IBMA conducts a market study on their member base (which represents around 90% of the European biological control market) on an annual basis. However, due to confidentiality challenges, the data is aggregated at the European level by an external contractor and does not give any insight into the national biological control markets. In this report, the representativity of the data provided (market share of surveyed companies) is not known. Furthermore, at this stage, most of the newest data from the 2022 IBMA market survey remains unavailable. As such, data from the 2021 market study was also used to complement the most recent figures.

At EU and international levels, there are lists available on the use of species
across Member States. EPPO PM 6/3 contains a list of safely used species
(although its scope goes beyond the territory of the European Union).
Studies also look at the species used at the international level<fnref n="8" />, and
especially by van Lenteren, and their repartition by invertebrate and crop
types, and were utilised in the analysis.

**3.1.2 Current market of invertebrate biological control agents**

IBCAs are a growing market, representing around 30% of the
European biocontrol market

According to IBMA, the international biocontrol market represented around €3bn in 2020⁹, and the European biocontrol market around €1bn (30% of the global biocontrol market). IBMA estimates that **invertebrates (also named macrobials) represent around 30% of the European biocontrol market (between 300 and 350 million euros)**<fnref n="10" />.

<footnote n="8">⁸ https://link.springer.com/chapter/10.1007/978-3-030-22304-5_16</footnote>

<footnote n="9">⁹ Sources: Dunham Trimmer and HIS Markit</footnote>

<footnote n="10">¹⁰ IBMA 2022 – EY projection: detailed data rely on extrapolation based on data covering 43% of the market</footnote>
**Figure 1 – Distribution of market value of biocontrol market categories in Europe in 2020**

<figure><img src="image_15.png" /></figure>

Source: IBMA Market survey 2022

The market for IBCAs has steadily increased over the last years. According to the data received from IBMA through their annual market survey (which covers between 40 and 50% of the market), the market share of invertebrate biocontrol agents has increased by 103% between 2016 and 2020 from €89 million to €180 million while the year 2019 to 2022 saw a 22% increase.

**Figure 2 - Evolution of the market of IBCAs in Europe (in € millions)**

<figure><img src="image_16.png" /></figure>

Source: Analysis based on IBMA Market surveys 2021 and 2022

**The IBCA market is still limited in comparison with chemical pesticides**

IBCAs represent less than 3% of the current European crop protection market.
Although the growth of the IBCA market is significant, it remains slower than the global market for biological control which had increased by 188% between 2016 and 2020 (+20% between 2018 and 2019). In the same period, the market value of microbials increased by 228% while natural substances and semiochemicals increased by 182% and 110% respectively (with a stable market between 2018 and 2019). Company sales information is commercially sensitive, but IBMA estimates that price increases since 2016 are mostly linked to inflation and would represent 15 to 20% of the total increase in market value. The remaining increase, upwards of 80%, can be thought to be due to increased volumes.

**Very little data is available on the current IBCAs market in the Member States**

Very few Member States have information on the national market value of IBCAs. Only four reported estimated figures of the annual sales of IBCAs used in their territory:

<table><caption>**Table 4 - Estimated market value for IBCA per Member State based on available information**</caption><thead><tr><td>Member States</td><td>Annual sales</td><td>Indicative share of the EU IBCA market</td></tr></thead><tbody><tr><td>France</td><td>23,6 million euros</td><td>7,9%</td></tr><tr><td>Finland</td><td>4,5 million euros</td><td>1,5%</td></tr><tr><td>Sweden</td><td>&lt; 2,6 million euros</td><td>&lt; 0,9%</td></tr><tr><td>Slovenia</td><td>0,3 million euros</td><td>0,1%</td></tr><tr><td>Croatia</td><td>0,25 million euros</td><td>0,1%</td></tr></tbody></table>

Source: IBMA France and questionnaires to NCAs

This data shows that gross IBCA sales and trends are probably very different from one Member State to another, with different levels of uses across Europe.
## Box 1: Evolution of IBCAs sales in France

Consolidation of data from IBMA France (representing >90% of the national biocontrol market) since 2015 reveals a growth of IBCA sales which reached approximately 45% between 2016 and 2020 (below the EU estimated average), with a growing proportion within the national crop protection market; it amounted to 1.2% in 2020, still below the EU estimate average of 3%.

<table><caption>Table 5 - Evolution of IBCAs sales in France</caption><thead><tr><td>Year</td><td>Sales (M€)</td><td>% of crop protection market</td></tr></thead><tbody><tr><td>2016</td><td>16.5</td><td>0.8%</td></tr><tr><td>2017</td><td>19.6</td><td>0.8%</td></tr><tr><td>2018</td><td>18.7</td><td>0.9%</td></tr><tr><td>2019</td><td>21.7</td><td>1.1%</td></tr><tr><td>2020</td><td>23.6</td><td>1.2%</td></tr></tbody></table>

Given the scarcity of available information on the current market, another approach had to be used to give an overview of the current development of IBCAs in the Member States. The number of IBCAs authorized is one of the main data available in the Member States. The following assumption can be considered: the number of species authorized in the Member States is correlated with the number of actual uses and the development of IBCAs<fnref n="11" />.

The following graph presents the number of authorized species in the Member States based on data transmitted in the questionnaire.

<figure><img src="image_17.png" /><figcaption>Figure 3 - Number of authorised species in the Member States</figcaption></figure>

Source: Questionnaire to NCAs

<footnote n="11">¹¹ For the Member States who transmitted information on their national IBCA market, this assumption is consistent with the number of authorized uses</footnote>
This data shows important differences regarding the number of species authorized as IBCAs: from more than 100 in Spain, France and Netherlands to less than 20 species in Slovenia.

However, it should be noted that in Slovakia and the Czech Republic, some species can be introduced based on mutual recognition (when it is authorized in another Member States), thus the number of species can be higher than the number reported.

**The current IBCAs market is mostly concentrated in the main EU crop producers and in Member States with substantial area under protected cropping**

The market of IBCAs is more developed in Member States with an extensive agricultural production, especially horticultural and under protected cropping. Biological control has reached significant critical mass, especially in the protected crop segment, which is seen as mature by representatives of the industry. 80% of commercially used IBCAs are used in greenhouses, and 20% on field crops (arable and specialty crops shows the higher potential for expansion)<fnref n="12" />.

The European crop market is very segmented, with four countries leading production (France, Italy, Spain and Germany) with crop outputs above 25 000 million euro in 2020, distorting the European average by Member State to around 8 127 million euro in 2020. A second group (crop outputs between 5 000 and 15 000 million euros) is formed by the Netherlands, Poland, Romania, and Greece. The remaining 19 Member States have crop outputs below 5 000 million euro, around the median (3 303 million euros).

A study in 2012¹³ shows that in the European Union, between 2006 and 2010, the average utilized agricultural area (UAA), was 165 493 thousand hectares, of which 0,09% (146,7 thousand hectares) were crops under greenhouses. Utilised agricultural area (UAA) includes arable land, permanent grassland, fruit crops, crops under glass, and hardy nursery stock. The leading countries with regards to indoor crops production are similarly ranked: the largest production under protected cropping is in Spain (65 thousand hectares on average between 2006 and 2010, representing 0,26% of the UAA, then comes Italy (33,8 thousand hectares, 0,24% of Italy's UAA), the Netherlands (10,8 thousand hectares, 0,53%) and France (7,8 thousand hectares, 0,03%).

Eurostat data is available for some of the main crops under protected conditions (lettuce, peppers, tomatoes, cucumber, and strawberries)<fnref n="14" />. In 2010 they represented 86,1 thousand hectares in the European Union and

<footnote n="12">¹² van Lenteren, J.C., Bolckmans, K., Köhl, J. et al. Biological control using invertebrates and microorganisms: plenty of new opportunities. *BioControl* **63**, 39–59 (2018). https://doi.org/10.1007/s10526-017-9801-4</footnote>

<footnote n="13">¹³ Pierre Hucorne, 2012, EPPO website https://www.eppo.int/media/uploaded_images/ACTIVITIES/plant_protect_products/zonal_assessment/Hucorne_2012_crop_distribution.pdf</footnote>

<footnote n="14">¹⁴ Crop production in EU standard humidity Statistics | Eurostat (europa.eu)</footnote>
in 2021 they represent 104 thousand hectares. For these crops, the major producing Member States are also Spain, Italy, France and the Netherlands. Greece and Poland have also become leading countries in terms of protected cropping on these specific crops, with levels of production similar to respectively France and the Netherlands.

Top crop producers are also Member States with the highest pesticides sales<fnref n="15" />: Spain (22% of pesticide sales in Europe in 2020 according to Eurostat data), France (19%), Italy (16%), Germany (14%) and Poland (7%). Consistently with their agricultural crop output, these five countries are thus the highest consumers of pesticides, making up 70% of the 345 508 tonnes of pesticides sold in 2020. It should be noted that, between 2016 and 2020, the quantity of pesticides sales in Europe had decreased from 370 000 tonnes in 2016 to 333 418 tonnes in 2019 (-10%). However, even considering this decrease in sales volumes in the last years, the estimated annual growth rate of the pesticide market for 2021-2026 is an expected 4,1%.<fnref n="16" />

<figure><img src="image_18.png" /><figcaption>**Figure 4 - Crop agricultural output and authorised IBCA species across EU Member States**</figcaption></figure>

Sources: Questionnaires sent to Member States; IBMA, Eurostat

<footnote n="15">¹⁵ Annual pesticide sales per Member State in kilograms Statistics | Eurostat (europa.eu)</footnote>

<footnote n="16">¹⁶ IMPACT ASSESSMENT REPORT_ Proposal for a Regulation on the sustainable use of PPP 1 / June 2022 citing Europe
Biopesticides Market | 2021 - 26 | Industry Share, Size, Growth - Mordor Intelligence</footnote>
Production of IBCAs relies on some big companies and a strong involvement
of SMEs

The production of IBCAs relies on:

- Some large companies that have production sites in several Member States (mainly France, Belgium, Netherlands, and Spain) and sell IBCAs in the Member States that use IBCAs most;

- A large number of SMEs: in 2019, SMEs made up 61% of biocontrol (all categories included) sales value, and 87% of biocontrol products sales.17 For example, Germany relies mainly on SMEs (7 companies identified) to produce IBCAs.

Thus, IBCAs and, more generally, biocontrol industry, differs greatly from
the structure of the chemical industry, which relies mostly on international
big companies with thousands of employees. In comparison, a study in
2011 reported that in Europe, around 20 “large” commercial producers
(companies of more than 10 people) were active (two thirds of producers
worldwide), of which less than five employed more than 50 people. The
largest employed 600 people<fnref n="18" />. Worldwide, in 2017 there were around 500
commercial producers of IBCAs, employing for most of them less than 10
people. Several countries (such as Sweden, Portugal Czech Republic,
Romania), have no, or very few, implanted producers and rely mostly on
imported organisms from neighbouring countries. For example, Portugal
does not produce IBCAs, so the farmers mainly rely on importation from
Spain where the production is well developed. Similarly, Sweden, or smaller
countries like Luxembourg, have no national production and rely exclusively
on imports from other Member States.

Finally, it should be noted that some of the companies who produce IBCAs
within the European Union also have productions sites just outside the
European Union, such as Morocco and Turkey.

The graph below summarizes the number of companies with a production
site identified in the Member States based on information transmitted by
the Member States and IBMA.

<footnote n="17">17 IBMA Market survey 2021</footnote>

<footnote n="18">¹⁸ Joop C. van Lenteren 2011, The state of commercial augmentative biological control: plenty of natural enemies, but a frustrating lack of uptake, BioControl (2012) 57:1–20, DOI 10.1007/s10526-011-9395-1</footnote>
<figure><img src="image_19.png" /><figcaption>Figure 5 - Number of known companies with a production site in EU Member States</figcaption></figure>

Source: IBMA, input from Member States

Production in augmentative biological control is usually linked to recurring pests for which the solutions already exist as commercial products. Supply is very responsive to the needs: the industry works on very limited timeframes, as shelf life of the IBCAs is very short (the products are generally to be used within 2 to 3 days), but their generation times can vary. Species that take one week to be generated are much easier to scale up and to supply quickly than species who require one month.

The IBCA producing companies have developed planning systems that allow anticipation of the growers' needs. There is an element of predictability with regard to the resurgence of known pests (e.g. when white flies / aphids are supposed to appear). However, IBMA acknowledges that they are subject to climate variation. In the event of a shortage in one supplier, there were alleged cases of suppliers supplying each other. The supply chains have been refined, with air transport, and truck transport within Europe. Therefore, the industry estimates that there is limited risk of supply break in the EU. It should however be noted that "while hundreds of companies sell beneficial insects, mites and nematodes, fewer than 30 trade internationally"<fnref n="19" />, as the complexity of logistical and regulatory requirements is a deterrent for smaller producers. Indeed, the smaller size of most IBCA producers also limits their capacity to develop effective production techniques and transport processes. Thus, availability of

<footnote n="19">¹⁹ E. Vila, F. Wäckers & J. Klapwijk, Shipping augmentative biocontrol agents</footnote>
products is still a limiting factor for some growers, for instance when they
have to supply themselves in other countries.

### 3.1.3 Uses of invertebrate biological control agents in Europe

Uses of invertebrate biological control agents first depend on the type of
biological control considered. Augmentative biological control is a
commercially viable business model, as shown by the growing segment of
macro-organism biocontrol (which is centred on augmentative releases) in
the IBCA market and aims at the periodic release of natural enemies to
control a recurring pest. It is generally used by growers, on a crop-to-crop
basis. Classical biological control on the other hand aims at controlling pests
more globally, by introducing and establishing a permanent population of
natural enemies, which are not yet present on the field. Introduction
programs rely mainly on national initiatives, coordinated and led by
research.

While the Sterile Insect Technique (SIT) also relies on the periodic mass-release of invertebrates. This approach is also more publicly funded and operates on a wider geographical scale.

In addition, the use of IBCAs varies significantly across the Member States. Some species are widely authorised in the Member States, such as some native nematodes (Heterorhabditis bacteriophora) or non-native species (such as *Eretmocerus eremicus*, a whitefly parasite used for prevention and control whiteflies). On the contrary some species are authorised only in a restricted number of Member States, even if the pest occurs in a larger number of Member States (such as *Coccophagus scutellaris* that parasitizes small soft scales, which is only authorized in France, the Netherlands and Slovenia).

The next section provides an overview of the main factors that differentiate the use patterns across the Member States. A description of the current uses for augmentative and classical biological control are provided afterwards.

#### 3.1.3.1 Main factors that differentiate the use patterns across the Member States

The consultation activities as well as the documentary research allowed the identification of several drivers and blocking factors for the use of IBCAs in the European Union.

**The type of agriculture or horticulture that prevails in a given Member State.**

Countries with sophisticated horticulture and substantial areas under protected cropping have adopted a much larger number of uses. Indeed, protected cropping is more favourable to current use of IBCAs because of
reduced vulnerability to weather variations. In 2008, augmentative biological control was estimated to be used on 10% of protected cropping<fnref n="20" />. As such, representatives of the IBCA industry indicated during the consultation that "apart from several open field crops (maize, several orchards) where massive releases of IBCA are performed, the major markets where IBCAs are most widely used are protected crops (glasshouses, plastic houses, walk-in plastic tunnels and multi-span structures)". Within protected cropping, use also varies depending on the crop type: IBCAs are used much more intensively in fruit vegetables (tomato, cucumber, peppers, aubergine...) than in leafy vegetables or ornamental greenhouse crops. Finally, IBCA uses are more developed in high added-value crops.

Agriculture systems with high IPM expertise and low pesticide use increase IBCA adoption (in particular crops dependent on pollination by insects).

Inversely, there are several phytosanitary scenarios that limit IBCA use. According to the IBCA industry, scenarios which have limited potential for IBCA portfolios include crops that cannot tolerate insect vectored diseases (such as seed potatoes needing to be 100% virus free), or crops exported to countries where plant protection services reject or destroy any plant material on which a quarantine species is detected. Finally, systems where the use of conventional pesticides remain high may be incompatible with IBCA use (on the short term: chemical residues that are toxic to natural enemies can remain for months on the crops). The International Organization for Biological Control (IOBC) side-effects database includes pesticides of different toxicity classes to natural enemies. Selective pesticides identified in this database could be used together with IBCAs. However, even fungicides, which are not directly toxic to IBCAs, can have negative indirect effects, leading to lower IBCA populations in fungicide treated fields (Ioriatti et al. 1992)<fnref n="21" />. The shape of the agriculture may also limit the need to use IBCAs. Luxembourg reported limited use of IBCAs in horticulture due to insect pests are not perceived as being a critical issue in the country (unlike fungi and diseases).

**The national policy approach regarding chemical pesticides, biocontrol and IBCAs**

Member States that focus strongly on IPM through policy initiatives, dedicated R&D and industry engagements (grower bodies, etc.) have a much higher chance of increasing their familiarity with new methods and IBCA use, ultimately leading to broader scale adoption. With regard to chemical pesticides, the ban or restriction of some chemical products leads

<footnote n="20">²⁰ Bale J.S, van Lenteren J.C and Bigler F 2008 Biological control and sustainable food production Phil. Trans. R. Soc. B363761-776 http://doi.org/10.1098/rstb.2007.2182</footnote>

<footnote n="21">²¹ Ioriatti C., Pasqualini E., Toniolli A. (1992) Effects of the fungicides mancozed and dithianon on mortality and reproduction of the predatory mite Amblyseius andersoni. Experimental & Applied Acarology 15:109-116. DOI: 10.1007/BF01275521.</footnote>
to an increased use of IBCAs. One case in Spain showed that this replacement can also happen when pesticides cannot be used: between 2004 and 2007 in the Almeria region, isofenphos-methyl had to be substituted by augmentative biological control so that exports to Germany could resume<fnref n="22" />. Encouragement of non-chemical alternatives makes IBCA adoption by farmers more likely, especially when it takes the form of direct subsidies for the use of IBCA. For example, in Germany, the use of *Trichogramma brassicae* against European Corn Borer or the use of IBCA in greenhouses is supported as an agri-environmental measure within the second pillar of the CAP-scheme.

Fostering the research and development of new solutions and new technologies: technological improvements (e.g., with regard to storage, transport and field delivery)<fnref n="23" /> are also expected to make solutions more attractive and enable larger deployment (facilitating the use in greenhouse and enabling access to non-protected crops). At the European level, a main driver of biocontrol and biodiversity improvement can be EU subsidies in the Common Agricultural Policy (CAP) for greening.

On the other hand, the regulation may become an obstacle for the use of IBCAs. There are instances where an IBCA solution exists but is not approved by the Member State, or where the registration/authorisation process is lengthy and generates administrative costs on the manufacturer or retail side. When it comes to the development and authorisation of a new IBCA in response to a new emerging pest, the time needed in the regulatory processes may become a limiting factor to the efficacy before the new pest becomes invasive.

A lack of knowledge of the environmental impact and of the unintended effects of IBCAs may be another barrier or limitation, as it can lead to incomplete or unsatisfactory dossiers for risk evaluations. Still, in most Member States that have a regulation in place, the submitted request for the release of an organism is often approved. Many Member States take into account, when conducting their risk assessments, the EPPO-IOBC Panel on biological control "positive list", which relies on field evidence, and few undesirable impacts have been recorded.

Finally, the national listing of native species can also be a limiting factor (lack of recording of species in a Member State can lead to native species not being known or identified if they later expand their geographical range).

<footnote n="22">²² Product-country image and crises in the Spanish horticultural sector: Classification and impact on the market
M. Mar Serrano-Arcos, Juan Carlos Pérez-Mesa, Raquel Sánchez-Fernández
https://doi.org/10.7201/earn.2018.01.05.</footnote>

<footnote>Green Pest Management Revolution: An Opportunity That Arose from a Food Safety Alert (mdpi.com)</footnote>

<footnote n="23">²³ For example, the transportation framework can be streamlined (e.g industry paper Streamlining cross-border shipping of live invertebrates), field delivery can be improved by drone aerial spraying, etc.</footnote>
## The agricultural approach of growers

This factor is key in IBCA use, which is more frequent among organic growers and growers who follow IPM principles, as well as in some horticultural crops where growers depend on bumblebees for pollination and cannot use pesticides.

According to IBCA manufacturers, and consistently with farmers' representatives' input, there is demand on the growers' side for more alternative options against pests. One of the drivers behind demand is the need for a response to the apparition of invasive new pests, which normally enter a country through unrelated imports: IBCA species can be identified, developed and commercially produced to answer these needs. Most classical biological control programs (for example *Torynus sinensis* against *Dryocosmus kuriphilus*<fnref n="24" />) are examples of needs that arose from the emergence of new invasive pests (see 3.1.3.2). In augmentative biological control, *Trichogramma achaeeae* against *Tuta absoluta* is an example of a successfully developed commercial IBCA against a new pest (*T. absoluta* is a pest from South America that was first spotted in the European Union in 2006). A recent example of new needs that do not have clearly effective IBCA available yet is *Drosophila suzukii*, a significant pest of berries and fruits (research is underway). Pre-emptive biological control actions also may drive demand and public health programmes, to identify and answer to new emerging pests.

On the grower side, options are sought after for uses where no, chemical PPPs are available (they may either have been banned, or pests often develop resistance against conventional pesticides). Further, accreditations such as GlobalGap<fnref n="25" /> and other retailer-affiliated (private) standards put pressure on growers with regard to pesticide residues and Maximum Residue Levels (MRLs). This leads growers towards measures which have no inherent risk for pesticide residues in the crop. In Spanish horticulture, in the years 2000-2010, a significant shift from chemicals to the use of IBCAs took place after media attention in several member states on high residue levels on agricultural products (see also 3.1.3.4).

Several types of growers were identified by the industry:

- Growers of **high-value crops** represent the large majority of the European IBCA market.

The use of IPM in high value crops such as fruits, vegetables and flowers is now the norm, according to IBMA. Many growers of high value crops incorporate IBCA's into their mix of IPM tools, sometimes simultaneously with chemical products. IBCA use by growers of high-value crops is particularly widespread in protected crops. In some horticultural crops,

<footnote n="24">²⁴ https://www.inrae.fr/actualites/combattre-guepe-guepe-succes-torymus-sinensis-lutte-contre-cynips-du-chataignier</footnote>

<footnote n="25">²⁵ https://www.globalgap.org/uk_en/for-producers/index.html</footnote>
growers are dependent on IBCAs when pollination goes by bumblebees,
for example on tomatoes, cucumbers and sweet peppers.

- Non-organic growers are also users of IBCAs, without necessarily prioritizing their use in their agricultural practices

For a broad range of reasons (willingness to decrease their environmental/health impact, incentives from public policies or downstream industry, resistance of pests to chemical pesticides, pollination by bees, etc) growers commonly use IBCAs even if their production is not organic. However, some of them also revert to the use of pesticides e.g. when new chemistry becomes available or in case of a pest outbreak<fnref n="26" /> or because of the introduction of a new exotic pest for which no biocontrol solution is available yet (e.g. *Tuta absoluta*).

- Organic growers are, logically, users of IBCA, although their limited numbers make them a relatively small market for IBCAs

IBCAs are of particular importance for organic growers given their limited options (only a few low-risk chemical pesticides are accepted for organic production). IBMA members see the organic market as a place for “innovation setting” for IBCA companies, since organic growers – in contrast to IPM growers – cannot rely on chemical pesticides as a backup solution and IBCA companies are hence motivated to find new ways to “stretch” the application of IBCA’s beyond what is typically done in an IPM setting. This in turn may lead to new practices that are later adopted in IPM production.

Source: IBMA, EY analysis

The efficacy of IBCA

Efficacy of IBCAs is the subject of a conceptual shift from chemical PPPs, as it often relies on pest population regulation (rather than eradication), and impacts may be observed after several seasons. Efficient use is possible only in favourable systems, i.e. ensuring high regulation of pests (resistant varieties, management of functional biodiversity, etc.) and compatibility with the use of IBCAs. This is the case in many protected crops where systems tend to implement most IPM levers and successfully integrate IBCAs.

Adoption by farmers, especially in outdoor uses, is hampered by the lower
immediate efficacy of IBCA that is often behind that of plant protection
products. Representatives of the farmers estimate that about 3% of
farmers in arable crops in the EU manage to use biocontrol effectively,
especially due to weather conditions; an abundance of rain or high humidity
may compromise IBCA use. Nematodes are easier to apply but are only

<footnote n="26">²⁶ Of the one targeted by the IBCA or another one that would need another IBCA – that may not always be available – but that can be controlled using chemical pesticides</footnote>
used by few farmers, e.g. against codling moth (Cydia pomonella) to
complement potential resistance to viruses (biopesticides). Effective
utilization implies wide changes of agricultural systems, including the
management of crops, resistant varieties, soil fertilization, agroecological
principles to sustain and boost functional biodiversity etc. However, for the
latter, it is possible to obtain EU subsidies. The current concept of efficacy
in itself is hampering the use of IBCAs, as IBCA use does not bring
immediate efficacy, but rather longer-term and more sustainable pest
control.

For already developed and approved organisms, the timescale needed for
the solution to operate is estimated by manufacturers to be no critical issue.
Through thorough monitoring growers can predict pest outbreaks well and
take timely action. Unexpected events occur that may lead to reliance on
chemical pesticides as IBCAs may be insufficient to provide a quick 'knock
down'.

## High costs of the IBCA solutions

According to the consulted farmers’ organisations, farmers do not feel that the use of IBCAs is available and affordable. Due to the technical nature of IBCA development, shipment, and application, costs can be high and become blocking factors, especially where large quantities of IBCAs are required (outdoor uses, systems which are less favourable to the growth of IBCA populations). Transport and storage can be challenging, and the field-delivery is often manual, and thus labour intensive.

Studies on the cost of biological control estimate the direct cost of
application to range from 175€ to 350€ (although this includes micro-
organism biological control). SIT for controlling the onion fly would cost
approximately 400€ per hectare and nematode application around 600€ per
hectare<sup>27</sup>. Trichogramma use may be lower. Finding comparable information
for the direct application cost of chemical pesticides is more difficult. By
way of indication, a study carried out in France in 2008 found that typical
pesticide expenditures range between 152€ per hectare for low-pesticide
use technologies to 220€ per hectare for high-pesticide usage
technologies<sup>28</sup>. Pesticide expenditure for crop mixes including vegetables,
wheat (durum) and corn ranged from 191€ to 257€ per hectare. However,
one should take into account the longer-term benefits of biocontrol
application in crops (less pest resurgence, longer persistence of beneficials
in the crops, etc.), as well as social and environmental costs and benefits<sup>29</sup>.

<footnote n="27"><sup>27</sup> Cost of crop protection measures – Panel for the Future of Science and Technology (2021)</footnote>

<footnote n="28">²⁸ (PDF) Exploring cost dominance between high and low pesticide use in French crop farming systems by varying scale and output mix (researchgate.net)</footnote>

<footnote n="29">²⁹ https://www.ars.usda.gov/ARSUserFiles/4056/Naranjo%20et%20al.%20IPMEconomicsBookChapter.pdf</footnote>
## The demand on the final consumer's side

Concerns of citizens regarding environment, biodiversity and the use of chemical pesticides are increasing<fnref n="30" />. This drives the market and farmers towards more sustainable agricultural practices. Communication on the benefits of IBCAs (returns on investment, higher sustainability), and collective organisations and sharing (through associations and cooperatives) may further improve IBCA uptake in farmers' agricultural practices.

The development of organic farming and the effect it has on the demand for IBCA is also linked to consumer willingness to pay for quality food<fnref n="31" />. Industry associations pointed out that a Member States' sovereign wealth and consumers' spending capacities play a major role in the demand for higher quality food products. Consumer opinions on the 'goodness' of organic food are not equally aligned with actual purchase decisions, which largely depend on disposable income<fnref n="32" />. High disposable income means that consumers are more likely to afford more sustainable and high-quality food products. This in turn may push for more biological or organic production and therefore support more restrictive policies for chemical pesticides. The food market however remains volatile and the recent inflation across the EU and globally, also have an impact on consumer choice. This may factor into the augmentation of IBCA uses, even if most IBCA uses are within conventional production, often alongside chemical pesticides.

## The lack of knowledge on IBCAs

On the side of farmers and advisors, lack of knowledge or expertise may lead to no use or the misuse of IBCAs, which may be counterproductive in the adoption of this solution in farmers' practices. For example, a study in 2020 showed that cider-apple farmers in Spain underestimate the importance of biological control and have misconceptions and knowledge gaps related to the interactions between natural enemies (especially arachnids and insects, with the exception of ladybugs) and pests. Developing farmers' knowledge regarding biological control and natural enemies would promote biological control in cider-apple orchards<fnref n="33" />. As for the general public, some Member States reported that public opinion and thus demand may be negatively impacted by the image of invertebrates on crops, and by the negative publicity of *H. axydiris*.

<footnote n="30">³⁰ See for example European Citizens Initiatives "Save Bees and Farmers", "Ban glyphosate and protect people and the environment from toxic pesticides", PAN resources on the impacts of pesticides on children</footnote>

<footnote n="31">³¹ Li Shanshan, Kallas Zein, 2021, Meta-Analysis of Consumers' Willingness to Pay for Sustainable Food Products http://dx.doi.org/10.22004/ag.econ.314970</footnote>

<footnote n="32">³² Household income positively influences consumers' likelihood of buying organic food: Rimal, A.P., Moon, W. and Balasubramanian, S. (2005), "Agro-biotechnology and organic food purchase in the United Kingdom", British Food Journal, Vol. 107 No. 2, pp. 84-97. https://doi.org/10.1108/00070700510579162</footnote>

<footnote n="33">³³ Martinez-Sastre et al., 2020, Farmers' perceptions and knowledge of natural enemies as providers of biological control in cider apple orchards https://doi.org/10.1016/j.jenvman.2020.110589</footnote>
### 3.1.3.2 Focus on augmentative biological control

Augmentative biological control refers to the large-scale release or inoculation of natural enemies (parasitoids, predators or micro-organisms) that can be native or non-native species. With the use of non-native species, it does not aim to establish these species in the long run. Several techniques exist<fnref n="34" />:

- **Inundative biocontrol:** short-term release for crops with a short production cycle (e.g. nematodes, SIT).

- **Seasonal inoculative biocontrol:** for crops with a longer production cycle, establishment is made impossible by the natural climatic conditions (for instance for species that cannot survive winter), or by the removal in greenhouses of all possible natural habitat for the natural enemy at the end of a production cycle<fnref n="35" />.

**The European market focuses on augmentative biological control, which is a viable business model with companies selling mainly species native to the European Union**

The EPPO Positive list (standard PM 6/03) counts 112 species that are considered "safe" and used in the EPPO region for augmentative biocontrol across countries (87 insect species, 17 arachnid species and 8 nematode species). This list refers to commercially available or officially used IBCAs that are either:

- Indigenous and widespread in part of, or the whole of, the EPPO region; or

- Established and widespread in part of, or the whole of, the EPPO region; or

- Used for at least 5 years in at least 5 EPPO countries (exceptionally fewer, if relevant crops, target pests or plants are present in <5 countries);

- And for which no adverse effects or only acceptable adverse effects have been reported.

In 2016, almost 40% of the income of the European companies originates from invertebrate biological control agents sold for control of thrips, another 30% for control of whitefly, 12% for control of spider mites, 8% for control of aphids, and the remaining 10% for control of various other pests<fnref n="36" />.

<footnote n="34">³⁴ van Lenteren, J.C., Bolckmans, K., Köhl, J. et al. Biological control using invertebrates and microorganisms: plenty of new opportunities. BioControl 63, 39-59. 2018. https://link.springer.com/article/10.1007/s10526-017-9801-4</footnote>

<footnote n="35">³⁵ Marieke Busson, Julien Chetty, Marie-Hélène Robin, Jean-Noël Aubertot. 2019. Biocontrol : Definition. Dictionnaire d'Agroecologie, https://dicoagroecologie.fr/en/encyclopedia/biocontrol/</footnote>

<footnote n="36">³⁶ van Lenteren, J.C., Bolckmans, K., Köhl, J. et al. Biological control using invertebrates and microorganisms: plenty of new opportunities. BioControl 63, 39-59 (2018) https://link.springer.com/article/10.1007/s10526-017-9801-4</footnote>

<footnote>4# : ~ : text = Almost%2040%25%20 of%20 the%20 income, other%20 pests%20 (Bolckmans%20 K%2C%20 per person</footnote>
So far, most of the IBCA market corresponds to the use of insects and mites to control insect or mite pests in protected crops, i.e. vegetables, fruits and ornamentals grown under greenhouses. This is due to extensive environment control in greenhouses and the high incentive to use plant protection solutions which do not interfere with the use of hymenopteran pollinators. Most IBCAs used are predators (e.g. Predatory mites to control mites, whiteflies and thrips, or miridae to control thrips, whiteflies, aphids) or parasitoid wasps (van Lenteren 2000, 2012; van Lenteren et al. 2018). A few nematodes are also used in Europe, e. g. against a range of coleopteran and dipteran larvae and slugs.

A notable exception is the relatively large use of the micro-wasps of the genus *Trichogramma* to control the European corn borer *Ostrinia nubilalis* in maize (up to 25% of surfaces affected by this pest in France, i.e., 150,000 to 250,000 Ha).

Overall, IBCA use is characterized by a large number of products available but a low uptake of most of them. Only a few products have reached large market value and a use of a substantial proportion of crop surfaces. Some examples of the main IBCAs (in terms of market value) in Europe are provided in the table below:

<table><caption>**Table 6 - Widely used organisms across the EU and intended targets**</caption><thead><tr><td>Biocontrol agent</td><td>Target</td></tr></thead><tbody><tr><td>Aphidius &amp; Aphelinus hymenopteran parasitoids</td><td>Aphids</td></tr><tr><td>Predatory mites (e.g. Amblyseius, Typhlodromus, Hypoaspis, Neoseiulus, Phytoseiulus)</td><td>Mites, thrips, whiteflies, flies</td></tr><tr><td>Parasitoid wasps (e.g. Aphytis)</td><td>Scale insects</td></tr><tr><td>Predatory Neuroptera (e.g. Chrysoperla)</td><td>Aphids</td></tr><tr><td>Predatory ladybirds (e.g. Cryptolaemus, Adalia)</td><td>Scale insects, Aphids</td></tr><tr><td>Predatory mirids and anthocorids (Macrolophus, Orius)</td><td>Whiteflies, thrips, Lepidoptera</td></tr><tr><td>Encarsia &amp; Eretmocerus Hymenopteran parasitoids</td><td>Whiteflies</td></tr><tr><td>Trichogramma Hymenopteran parasitoids</td><td>Lepidoptera</td></tr><tr><td>Nematodes (Heterorhabditis, Steinernema)</td><td>Coleoptera, Diptera, slugs</td></tr></tbody></table>

All IBCAs cited in this table are used under protected conditions, except for *Trichogramma* which are used outdoors, on maize, and for a few marginal uses of *Chrysoperla* in other outdoor crops.
With regard to augmentative biological control of forest pests, augmentative releases of natural enemies to forests are very uncommon. This is more due to the low efficiency of this method in forests than prohibitive regulations. However, augmentative biological control is sometimes used to combat pests in forest nurseries.

## Specific use of SIT

The insects used in the sterile insect technique (SIT), are not considered as part of the biocontrol market by IBMA. Their status is somewhat similar to that of classical biocontrol programmes, as they cannot be considered as simple commercial products and their use rely on business models mixing service and products. Initial exchanges with IAEA-FAO suggest that the use of SIT, although responding to an augmentative biocontrol logic, stands alone in terms of use and regulations. It is highly species-specific, using indigenous species (i.e. sterile individuals of the pest to be controlled), and presents a low risk of establishment of new strains (sterilization is not 100% effective, and a limited possibility of gene introgression remains). Release objectives can include eradication, containment (by establishing barriers of SIT to prevent their spread), prevention, and as part of suppression programs.

Insects are sterilized by γ-radiation with a dose that does not significantly impair the ability of the sterile males to fly, mate, and transfer sperm to wild females. As such, and with a sufficient sterilized-to-wild ratios, the proportion of fertile mating decreases. Therefore, SIT is best used at low population density of pests, and over entire ecosystems rather than specific crops (or herds of animals). This "area-wide approach" necessitates coordination over wide geographical areas, which sets conditions rarely met in Europe. SIT is currently very little used in the EU (uses were identified in only four Member States, see below).

The Valencia region (Spain) is one of the rare agricultural areas with large-scale farming activities in Europe where SIT is efficiently used. Some uses have been recorded in Croatia, who imports *Ceratitis capitata* from Spain and Israel since 2010 in support of an eradication program<fnref n="37" />.

Production facilities in Europe are located in<fnref n="38" />:

- Spain: *Ceratitis capitata*, or Mediterranean fruit fly. Production capacity of 500 million insects per week, currently working at half-capacity

- The Netherlands: *Delia antiqua*, or onion maggot. Small production used to treat 5000 ha of onion.

- Other production facilities related to non-plant health use are located in Spain, Italy (production of Asian tiger mosquitoes, combined

<footnote n="37">³⁷ DIR-SIT - IAEA - HISTORY OF TRANSBOUNDARY SHIPMENTS OF STERILE INSECTS</footnote>

<footnote n="38">³⁸ Directory of SIT facilities (IAEA) Site Pages - Default (iaea.org)</footnote>
capacity of 1,25 million per week) and Slovakia (tsetse flies for export, capacity of 0,3 million insects per week)

- France has also started several programmes to test SIT strategies against the codling moth *Cydia pomonella* and mosquitoes and supports R&D of new SIT techniques against the invasive fruit fly *Drosophila suzukii*.

The main identified uses are reported below:

<table><caption>**Table 7 - Overview of the main recent uses of SIT for plant protection in the European Member States**</caption><thead><tr><th></th><th>Cyprus</th><th>France</th><th>The Netherlands</th><th>Spain</th></tr></thead><tbody><tr><td>Ceratitis capitata</td><td>X</td><td>X</td><td></td><td>X</td></tr><tr><td>Cydia pomonella</td><td></td><td>X</td><td></td><td></td></tr><tr><td>Bactrocera dorsalis</td><td></td><td>X</td><td></td><td></td></tr><tr><td>Delia antiqua</td><td></td><td></td><td>X</td><td></td></tr></tbody></table>

While some examples do exist, the use of SIT is still extremely low in terms of proportion of crop surfaces covered in Europe. This is due to the fact that this technique needs to be used in complementarity with other control methods, can only be used in very specific conditions, and faces specific challenges in comparison to other types of invertebrate biological control:

- Technical feasibility: as the sterile insects belong to the pest population, the selected species need to be released at a mature but not damaging stage of growth. Production and use of SIT is also very technical (definition of spatial and temporal ecological parameters of the target population, insect quality, rearing of mainly male insects, establishing genetic sexing strains, etc.).

- Economic feasibility: the technique is costly and necessitates significant investments in research and development. In Europe, this has impacted production structures, which are generally publicly owned research centres (Centro Agricoltura Ambiente "Giorgio Nicoli" in Italy, Bioplanta de Insectos Estériles in Spain). Development of SIT and commercial production will necessitate to globally harmonize quality control procedures for production, processes, and products.
### 3.1.3.3 Focus on classical biological control

Classical biological control refers to the intentional introduction and permanent establishment of an exotic biological agent for long-term pest management<fnref n="39" />. The species introduced is a non-native species with the capacity to regulate the pest targeted. It is often used when an exotic pest has been imported without its natural enemies, to introduce this natural enemy in the territory and control the pest. In case of neoclassical biological control, the introduction is based on a novel association of the pest and a natural enemy species (with no previous coevolutionary interaction).

As the aim is to establish a new species in a specific territory, this might require a long process of research, selection, risk-assessment, quarantining, release methodology, etc. This type of biological control is more generally state-funded and thought to be less commercially viable.

Classical biological control introductions used to be frequent, but restrictive regulations have reduced the number of introductions.

For classical biological control, a retrospective approach can be adopted to better understand the main successes of the establishment of new species in Europe. In the past, the introduction and establishment of classical biological control strongly relied on public research and development. No products are currently commercially available and commercial perspectives are lower than for augmentative biological control as there is no business model replicable from one year to another (once the species is established in the environment, there will be no further sale of IBCAs).

EPPO also lists 42 insect species safely used for classical biocontrol in Europe. It gathers information on IBCAs for classical biological control, which is found at least 5 years after release, to be successfully established in part of, or the whole of, the EPPO region.

In total, around 650 introductions of biocontrol agents can be identified in the EU. Italy, France, Spain and Greece account for more than 50% of these introductions. Out of these 650 introductions, around 200 resulted in the establishment of the agent, and 130 significantly impacted the targeted pests<fnref n="40" />. Although the number of introductions has drastically decreased since the 2000's, recent successes have been obtained in Europe using this strategy. For example, the Asian parasitoid *Torymus sinensis* has been used in the last 10 years against the invasive chestnut gall wasp and successfully managed its damages (see section on forestry below).

Several classical biological control programs were reported by the national competent authorities surveyed, and are listed below:

<footnote n="39">³⁹ OCDE Guidance for Information Requirements for Regulation of Invertebrates as Biological Control Agents (IBCAs) (researchgate.net)</footnote>

<footnote n="40">⁴⁰ Base de données BIOCAT, analysed dans Seehausen ML, Afonso C, Jactel H, Kenis M. 2021. Classical biological control against insect pests in Europe, North Africa, and the Middle East: What influences its success? NeoBiota 65: 169-191. doi: 10.3897/neobiota.65.66276</footnote>
<table><caption>Table 8 - Classical biological control programs reported by National Competent Authorities</caption><thead><tr><td>Year</td><td>Country</td><td>Biocontrol agent</td><td>Target species and crop</td></tr></thead><tbody><tr><td>2006-2008</td><td>France</td><td>Cibdela janthina</td><td>Rubus alceifolius (invasive weed of forest edges and open areas in La Réunion)</td></tr><tr><td>2012-2015</td><td>Greece</td><td>Neodryinus typhlocybae</td><td>Metcalfa pruinosa (various crops, mainly Actinidia chinensis)</td></tr><tr><td>2012</td><td>The Netherlands</td><td>Stenopelmus rufinasus</td><td>Azolla filiculoides (aquatic systems)</td></tr><tr><td rowspan="7">Since 2012</td><td rowspan="7">Slovenia</td><td>Aphidoletes aphidimyza, Aphidius matricariae</td><td>Aphididae, pepper</td></tr><tr><td>Neoseiulus cucumeris</td><td>Thysanoptera, pepper</td></tr><tr><td>Encarsia formosa, Macrolophus pygmaeus</td><td>Trialeurodes vaporariorum, tomato</td></tr><tr><td>Steinernema kraussei, Heterorhabditis bacteriophora, Steinernema carpocapsae</td><td>Otiorhynchus sulcatus, ornamentals</td></tr><tr><td>Steinernema carpocapsae and Steinernema feltiae</td><td>Steinernema carpocapsae and Steinernema feltiae</td></tr><tr><td>Steinernema feltiae</td><td>Sciaridae, ornamentals</td></tr><tr><td>Heterorhabditis bacteriophora</td><td>Melolontha, Amphimallon solstitiale - greens, parks, golf courses</td></tr><tr><td>2014</td><td>France</td><td>Allotropa burelli</td><td>Pseudococcus comstocki, apple orchards, ornamental trees</td></tr><tr><td>2010-2011</td><td>France</td><td>Torymus sinensis</td><td></td></tr></tbody></table>
<table><thead><tr><td>Year</td><td>Country</td><td>Biocontrol agent</td><td>Target species and crop</td></tr></thead><tbody><tr><td>2014-2017</td><td>Croatia</td><td></td><td>Chestnut wasp</td></tr><tr><td>2018-2022</td><td>Greece</td><td></td><td>Dryocosmus kuriphilus (Yasumastu)</td></tr><tr><td>before legislation change</td><td>Italy</td><td></td><td>chestnut</td></tr><tr><td>2018</td><td>Spain</td><td>Tamarixia dryi</td><td>Trioza erytreae, Citrus</td></tr><tr><td>2019</td><td>The Netherlands</td><td>Aphelara itadori</td><td>Fallopia japonica, ornamentals</td></tr><tr><td>2020-2022</td><td>Italy</td><td>Trissolcus japonicus</td><td>Halyomorpha halys, orchards</td></tr><tr><td>2021-2022</td><td>Italy</td><td>Ganaspis brasiliensis</td><td>Drosophila suzukii, berries</td></tr><tr><td>To be launched in 2022</td><td>France</td><td>Mastrus ridens</td><td>Cydia pomonella, apple</td></tr><tr><td>To be launched in 2022</td><td>France</td><td>Ganaspis brasiliensis</td><td>Drosophila suzukii, berries</td></tr></tbody></table>

Classical biological control in forestry

Forests within the EU and around the world are increasingly affected by exotic pests that sometimes become invasive. Outside of the EU, such exotic pests are often combated using classical biological control, as this type of biocontrol is especially suited for perennial systems where introduced IBCAs have better opportunities to establish and contribute to permanent pest control than in annual systems. In fact, at the global scale, the majority of all classical biocontrol initiatives have been recorded from forest systems (Reviewed by Kenis et al. 2017). In this perspective, the EU stands out with remarkably few cases of classical biological control.

The best-known European examples of classical biological control of forest pests include releases of the monospecific predatory beetle *Rhizophagus grandis* to control the great spruce bark beetle (*Dendroctonus micans*) in France (Grégoire et al. 1984) and the UK (Fielding and Evans 1997). The populations of the bark beetles normally drop below the economic injury level within 10 years after *R. grandis* releases (Fielding & Evans 1997) indicating that the biocontrol is effective.

A more recent example is the release of the Asian parasitoid *Torymus sinensis* to control the invasive chestnut gall wasp (*Dryocosmus kuriphilus*).
This parasitoid was released in Italy in 2005 (Quacchia et al. 2008), France 2011 (Borowiec et al. 2014) and Croatia, Hungary, and Slovenia 2014 (Matošević et al. 2015). The releases of the parasitoid are considered rather successful, showing that classical biological control can be a useful tool in forest systems, although negative effects on biodiversity have been recorded<fnref n="41" />.

**Classical biological control of weeds is mostly under development outside of the Union**

Many examples show that classical biological control can be used to control exotic weeds. However, almost all of these examples are from non-EU regions.

The only known example of intentional introduction of exotic IBCAs to combat weeds in the EU is from Portugal, where the gall-forming wasp *Trichilogaster acaciaelongifoliae* (endemic to Australia) was released in 2015 to control the environmental weed *Acacia longifolia* (Marchante et al. 2017). If this attempt is successful in Portugal, we are likely to see initiatives to release the same wasp in other Mediterranean Member States where *Acacia longifolia* is a problematic weed.

In addition, some exotic IBCAs have been accidentally introduced and established in the EU – for example, the azolla weevil *Stenopelmus rufinasus* (from Florida) was unintentionally introduced in the 1920s together with its weed host plant *Azolla filiculoides* to Belgium and Italy and has since spread over parts of central and southern Europe (Shaw et al. 2004). Likewise, the ragweed leaf beetle *Ophraella communa* was accidentally introduced in Italy and shows strong potential to control the common ragweed *Ambrosia artemisiifolia*.

Shaw et al. (2016) highlight a positive change in attitude towards these exotic IBCAs within the EU, arguing that the future of classical biological control of weeds within the EU is probably bright, despite current regulations. Sheppard et al. (2006) argued that the most important factors obstructing classical biological control of weeds in the EU are the legislative and regulatory framework for biocontrol as well as a lack of financial resources. The same authors further proposed 13 weed species that would be particularly suitable for classical biocontrol in the EU.

<table><caption>**Table 9 - 13 environmental weed species proposed by Sheppard et al. (2006) to be suitable for classical biological control using exotic IBCAs. Some of these IBCAs have already been reported as accidentally introduced to some parts of the EU.**</caption><thead><tr><td>Common weed name</td><td>Latin name</td><td>Exotic IBCAs</td></tr></thead><tbody><tr><td>Butterfly bush</td><td>Buddleja davidii</td><td>Cleopus japonicus</td></tr></tbody></table>

<footnote n="41">⁴¹ https://planthealthportal.defra.gov.uk/assets/uploads/Risk-Analysis-T.-sinensis.pdf</footnote>
<table><thead><tr><td>Common weed name</td><td>Latin name</td><td>Exotic IBCAs</td></tr></thead><tbody><tr><td rowspan="3">Japanese knotweed</td><td rowspan="3">Fallopia japonica</td><td>Mecyslobus erro</td></tr><tr><td>Lixus sp.</td></tr><tr><td>Aphalara sp.</td></tr><tr><td>Silver wattle</td><td>Acacia dealbata</td><td>Trichilogaster acaciaelongifoliae</td></tr><tr><td rowspan="3">Tree of heaven</td><td rowspan="3">Ailanthus altissima</td><td>Eucryptorrhynchus brandti</td></tr><tr><td>Cryptorhynchus chinensis</td></tr><tr><td>Orthopagus lunulifer</td></tr><tr><td rowspan="2">Water fern</td><td rowspan="2">Azolla filiculoides</td><td>Stenopelmus rufinasus</td></tr><tr><td>Pseudolampsis guttata</td></tr><tr><td rowspan="3">Black locust</td><td rowspan="3">Robinia pseudoacacia</td><td>Phyllonorycter robiniella</td></tr><tr><td>Obolodiplosis robiniae</td></tr><tr><td>Megacyllene robiniae</td></tr><tr><td rowspan="2">Common ragweed</td><td rowspan="2">Ambrosia artemisiifolia</td><td>Zygogramma suturalis</td></tr><tr><td>Epiblema strenuana</td></tr><tr><td rowspan="4">Silverleaf nightshade</td><td rowspan="4">Solanum elaeagnifolium</td><td>Leptinotarsa texana</td></tr><tr><td>Leptinotarsa defecta</td></tr><tr><td>Orrina phyllobia</td></tr><tr><td>Hellinsia balanotes</td></tr><tr><td rowspan="4">Groundsel-bush</td><td rowspan="4">Baccharis halimifolia</td><td>Megacyllene mellyi</td></tr><tr><td>Rhopalomyia californica</td></tr><tr><td>Trirhabda bacharidis</td></tr><tr><td>Eurosta solidaginis</td></tr><tr><td>Floating pennywort</td><td>Hydrocotyle ranunculoides</td><td>Listronotus elongatus</td></tr><tr><td>Water primrose</td><td>Ludwigia grandiflora</td><td>Lysathia ludoviciana</td></tr><tr><td rowspan="2">Parrot's feather</td><td rowspan="2">Myriophyllum aquaticum</td><td>Lysathia sp.</td></tr><tr><td>Listronotus marginicollis</td></tr><tr><td rowspan="4">Canadian goldenrod</td><td rowspan="4">Solidago canadensis</td><td>Eurosta solidaginis</td></tr><tr><td>Gnorimoschema gallaesolidaginis</td></tr><tr><td>Phaneta formosana</td></tr><tr><td>Epiblema scudderiana</td></tr></tbody></table>

### 3.1.3.4 Use of IBCAs in combination or substitution of (chemical/ non-chemical) pesticides

**Substitution may be possible in some cases**

Current pesticide uses targeting emerging exotic pests in EU (but also pre-emptive biocontrol actions) as well as low-threshold pests in crops e.g. like ornamentals, or when in need to control certain insect vectors of plant viruses, could be substituted by IBCAs. IBCAs are often already considered as substitutes to pesticides in the Member States: 13 Member States (and one regional authority in Belgium) consider IBCAs as "non-chemical alternatives" in the Comparative Assessment conducted at national level (Art. 50 of Regulation 1107/2009). Only 3 Member States do not, and 12 Member States did not have information on the question.

Evidence is accumulating that IPM strategies relying on IBCAs can ensure production under greenhouse with little or no use of chemical pesticides.
Data from Spain following isofenphos-methyl crisis<fnref n="42" /> in 2006 triggered a rapid shift to biocontrol. Surfaces using biocontrol increased from 129 ha in 2005 to 17,000 ha in 2009⁴³ and now reach approximately 26,000 ha<fnref n="44" />. Qualitative discussions with MS reveal that the common use of IBCAs under greenhouse has reached most parts of Europe. Although the relative use of IBCAs and pesticides is difficult to estimate under greenhouse throughout the EU, most if not all greenhouse surfaces use at least a few IBCAs.

The biocontrol industry views the main pros and cons of IBCAs as follows:

<table><caption>**Table 10 - Summary of the pros and cons of chemical pesticide use vs. IBCA use**</caption><thead><tr><th></th><th>Pros</th><th>Cons</th></tr></thead><tbody><tr><td>IBCA use</td><td><ul><li>Self-regulating, once the pest is controlled the IBCA populations drop back to natural levels or disappear</li><li>Populations can be built up using food supplements</li><li>Bio-control organisms are often specific in their action</li><li>Safe for users</li><li>Popular among consumers</li><li>Mostly safe for crops</li><li>Residue free</li><li>No PHI – so harvesting can be done daily within greenhouse optimising produce quality</li></ul></td><td><ul><li>Specific conditions required</li><li>Application requirements</li><li>Often preventive use, which requires to anticipate</li></ul></td></tr><tr><td>Pesticide use</td><td><ul><li>Often quick action</li><li>Ease of use</li><li>Efficacy</li></ul></td><td><ul><li>Residues</li><li>Phytotoxic effects on crop (photosynthesis reduction)</li></ul></td></tr></tbody></table>

<footnote n="42">⁴² See also 3.1.3.1 Main factors that differentiate the use patterns across the Member States, or the paper "Green Pest Management Revolution: An Opportunity That Arose from a Food Safety Alert" (mdpi.com)</footnote>

<footnote n="43">⁴³Lozano et al. 2010. Evolution of the phytosanitary control system in the intensive horticulture model of high yield in Almería (2005-2008). Journal of Food, Agriculture & Environment Vol.8: 330-338.;</footnote>

<footnote n="44">⁴⁴https://www.juntadeandalucia.es/organismos/agriculturaganaderiapescaydesarrollosostenible/servicios/actualidad/noticias/detalle/284551.html</footnote>
<table><thead><tr><td>Pros</td><td>Cons</td></tr></thead><tbody><tr><td></td><td><ul><li>Contamination of soil and water</li><li>Persistence (often for decades)</li><li>Pests may become resistant to PPPs</li><li>Side-effects to beneficial organisms such as pollinators, predators and parasitoids</li><li>Re-entry periods/ post-harvest intervals</li><li>Requirement for operator safety measures and training</li></ul></td></tr></tbody></table>

Source: IBMA Global

### Combination can also be an option...

In many agricultural scenarios, predominantly in IPM managed crops, both IBCAs and authorized pesticide uses (chemical, but also microorganisms, semiochemicals, plant products) co-exist, alongside other types of biological control (conservation biological control). The combined use of IBCAs and pesticides requires a specialized understanding of the ecological system of the crop to make the different control methods work synergistically and/or sequentially. Growers have to be trained and will often require advice from the companies producing either of both natural enemies and other pesticides. Quite often these companies offer a pack for the farmer: Representatives of scientific organisations pointed that IBCA producing companies and their advisory services have recommendations ready for combined use of IBCAs and authorized pesticides, mainly for protected crops, vineyards, orchards and field vegetables.

An example of IBCAs and pesticides combination exists in citrus plantations: the use of paraffin oils and/or pheromone traps for the control of the red scale *Aonidiella aurantii* can be made compatible with the releases of the parasitoid wasp *Aphytis melinus*. Likewise, the use of sterile males of the medfly *Ceratitis capitata*, which is combined with other control methods (pesticide applications, mass-trapping, conservation biological control in different fruit crops (including citrus). The compatibility relies on separation, either spatially or in time<fnref n="45" />.

<footnote n="45">⁴⁵ IOBC-WPRS survey</footnote>
## Compatibility is yet challenging

However, compatibility between IBCAs and chemical pesticides is very low and selective chemicals are not often available. For instance, whitefly control in glasshouse tomatoes can be reached through a combination of many IBCAs: *Macrolophus pygmaeus*, *Encarsia formosa*, *Eretmocerus eremicus*, *Amblyseius swirskii*, *Amblyseius montdorensis*. However, farmers may use chemical control to prevent other pests from inhabiting the crop (e.g. the invasive leaf miner *Tuta absoluta*), leading to adverse effects on IBCAs targeting whiteflies (e.g. sublethal effects, see Desneux et al. 2007, Annu Rev Entomol) and thus leading to failure in whitefly control by released IBCAs.

As the use of chemical products is mostly reduced when a product is banned, or when a pest develops resistance, an approach to substitution on a use-by-use basis will be limited. Still, a few empty uses have been identified, for which IBCA solutions are currently being developed, or are starting to arrive on the market:

- In Cyprus, *Cales noacki* was introduced in 1998 to control the woolly whitefly *Aleurothrixus floccosus*, for which currently no phytosanitary solution exists. However, this species has been removed from the EPPO list due to reported non-target effects. Today, *C. noacki* is not reared but every few years a survey is conducted to record its presence in citrus areas infested with whiteflies. In Germany, the Julius Kühn-Institute for Biological Control, is currently involved in the EUPHRESCO-project "Preparedness in biological control of priority biosecurity threats". Within this project, potential IBCAs of priority quarantine pests are considered (e.g. *Bactrocera* sp., *Popilia japonica*, *Agrilus planipennis*, *Anoplophora* spp. and others) and decision support schemes for risk assessments are developed.

- The *Halyomorpha halys* issue is an example of a phytosanitary problem that has not been able to be solved with treatments with insecticides or with other systems including insect nets, for which the path of biological control has become mandatory. R&D is ongoing, based on the use of egg parasitoids of the genera *Trissolcus* and *Anastatus* (among those, *Anastatus bifasciatus* is currently on the market).<fnref n="46" />

- Control of aphids is a challenge in many crops. Hoverflies and lacewings are among the naturally present IBCAs of aphids in the field. Modification of the habitats, active release of flies and manipulation of fly behaviour might increase the efficacy of hoverfly application.

- Long-legged flies are the most important natural enemies of spruce-forest damaging bark beetles. Better knowledge on the presence,

<footnote n="46">⁴⁶ https://doi.org/10.3390/insects12050464</footnote>
identity, and behaviour of the flies are key for their exploitations as IBCAs and is facilitated through the development of an attractant.

* Slugs are an increasing problem in agriculture and their chemical control is costly. Nematodes are potential IBCAs of slugs (the nematode Phasmarhabditis is on the market) but better knowledge of their establishment and new innovative ways of application might increase the efficiency of their control.

**Replacement of pesticides by integrating IBCAs in systems developed for the use of chemical pesticides is not the right approach**

Overall, and despite previous works to study compatibilities between pesticides and IBCAs (summarized and updated by IOBC), there is consensus among the experts involved in this study that research on pesticide substitution with IBCAs, in order to integrate IBCAs in cropping systems, is likely to be a good idea only at first sight: it actually implicitly encourages the integration of IBCAs in systems that have been created and developed for the use of chemical pesticides, with little mobilization of agroecological levers that enable pest prevention and regulation. It leads to situations where practitioners try to integrate IBCAs in systems that are mostly unfavourable to their wide and efficient use, and ultimately contributes to the apparent inefficacy or inefficiency of IBCAs. It seems that the best examples of IPM packages successfully including IBCAs are found in systems in which chemical pesticides could not be used (following a ban or following pesticides having become inefficient) and where new systems had to be designed (e.g. the situation observed in Almeria greenhouses in the 2000's).

In terms of trajectories used to foster the use of IBCAs, transitions aiming at decreasing the use of chemical pesticides by introducing progressively IBCAs and other agroecological levers are not the right approach. Civil society organisations also insisted that a reimmagination of cropping systems and profound system changes will likely be more efficient in speeding up the development of biocontrol.

**3.1.4 Potential for development of the IBCA market**

**Uses regarding augmentative biological control should continue to grow in high-value systems**

Representatives of the industry highlighted that companies consistently invest in the R&D of high-value systems such as greenhouses (now, the industry estimated that one to three new IBCAs enter the market in the European Union each year). To reflect the dynamism of R&D within the industries, it can be highlighted that in 2019 in Europe, 208 biological control products (not differentiating macrobials, microbials, semiochemicals and natural substances) were in the IBMA companies'
pipeline, with half having been submitted for registration (IBMA 2021 Market Survey). Aside from the development of new products, R&D also happens at the level of public and private partnerships, and the development of solutions to facilitate IBCA use (e.g., drone aerial spraying<fnref n="47" />, which is faster and less labor-intensive than manual application).

The number of uses should continue to increase within the next years, answering the demand from the market of alternatives to chemical pesticides (as mentioned before). As for the current uses, the development and R&D of IBCAs is also strongly stimulated by the ban of some active substances at European level or the arrival of new pests in Europe. Products will also continue to be accompanied by services (advice, monitoring, decision-support tools) that should take profit from technological advances in the fields of digital tools, diagnostic capacities, etc. Pre-emptive biocontrol actions may also rise (identification, selection, risk assessment and potential pre-approval for release of selected IBCAs prior to the arrival of the target pest in a given new area, or inundative biocontrol for known pests referred to as "standing army" biological control by the industry). This will strengthen the position of IBCAs in greenhouse systems, which will progressively help decrease the use of pesticides that are currently still used.

Outside of greenhouses, specific situations of high-value crops grown in open field, such as vineyards, may also host new IBCA uses, for example *Trichogramma* against *Lobesia botrana* or, a mite genus new to biocontrol which proves able to suppress mildew.

Finally, concerns regarding intellectual property seem to be minor for the industry: while species cannot be patented, the use of species in particular processes, or techniques linked to production processes can be patented. Representatives from the industry reported an increase in such intellectual property applications by IBCA-rearing and selling companies.

**Experts have limited expectations towards IBCAs in non-protected crops although a few exceptions may continue to punctually create success-stories.**

In cash crops or open-field vegetables and fruit orchards, perspective of a massive increase of uses is considered unlikely by experts. Successes are expected to remain exceptions, like *Trichogramma brassicae* on maize (or *Trichogramma* and *Cotesia* on sugarcane in Brazil), but such exceptions may prove to be stimulating success stories. The reason for this comes down to the incompatibility of IBCA mass-rearing costs when compared to the quantities of IBCA individuals that would be necessary to achieve pest control in open-field systems and the crop protection financial capacities of growers in these crop sectors. In addition, most application methods of

<footnote n="47">⁴⁷ https://www.uaviq.com/en/biocontrol/</footnote>
IBCAs are costly, which further reduces competitiveness of IBCAs over chemical pesticides (that are easily sprayed). Game changers may be next-generation diagnostic and decision-support tools that boost the efficacy and efficiency of inoculative introductions (although this may be hindered by strong dispersal capacity of IBCAs released, this implying release plans at large scales for being effective). However, to our knowledge, short- or mid-term perspectives of research advances are not expected to specifically target IBCAs, although they will have a positive impact on their uses. For instance, possible IBCA developments showing the highest potential involve the management and/or manipulation of farmland habitats (e.g. development of temporary ecological structures) that enable IBCAs to sustain their populations while pests are absent or at low densities. These could be coupled with the development of IBCA release systems to increase further biocontrol services provided by IBCAs in open field systems.

**Classical biological control and conservation biological control development perspectives are limited as business models but can develop through public-private partnerships.**

Industries and most public bodies in MS tend to restrict market analyses and perspectives to augmentation biological control. This is likely because most, if not all, industrial players in Europe generate sales by selling IBCAs as commercial products using business models that look like that of chemical pesticides (although services associated to products are often more important in the biocontrol sector) and favour organisms to be used in the closest possible way to a pesticide: in the largest possible quantity and with the fastest possible action against the target (while most IBCAs are costly to produce and display the potential to regulate pest populations over time, but more rarely at short term).

As discussed in the augmentation section, it is likely that such intended use of IBCAs will continue to grow slowly in most cropping systems because the intrinsic features of IBCAs clearly depart from those of chemical pesticides.

By contrast, it is likely that industries and policy makers will neglect the potential of conservation biocontrol (that may favour resident IBCAs but also the ones used in augmentation biocontrol) and classical biocontrol. From a scientific point of view, this presents a paradox because conservation biocontrol and classical biocontrol display a remarkable history of success in relation to their often-outstanding cost-benefit ratios (e.g., from 1:50 to > 1:3000 for classical biocontrol programs performed in New Zealand and Australia in the past few decades) (Page et al. 2006; Hardwick et al. 2016). Fear-related risks implied by the use of exotic organisms in classical biocontrol may be an explanatory factor but it is probably not the only one, as conservation biological control is not much more developed in terms of explicit implementation. A hypothesis accounting for this situation is that these strategies using IBCAs do not have established and recognized business models, especially in Europe.
Biocontrol industries see conservation and classical biocontrol as economically unviable activities that should be handled by the public sector, because these activities do not rely on inputs that can be recurrently sold to farmers in large areas. These strategies may however become activities handled by other types of private actors, with risk-taking and investments shared between growers, food chain value actors and public bodies. Success stories already exist (e.g. the Coöperatie Collectief Hoeksche Waard in the south of Rotterdam that implemented a conservation biocontrol programme allowing a consistent 90% decrease in insecticide use in potatoes and wheat). Public efforts should foster the exploration of possible business models and organizational innovations that will enable the emergence of a private sector exploiting conservation and classical biocontrol, as these would be an enormous source of IBCA uses for a wide range of crop sectors.

**Autocidal control (including SIT) is not highly prioritized, but contains perspectives for development**

Perspectives of uses of autocidal control methods, such as the Sterile Insect technique, probably fall in between the situation of augmentation and conservation/classical biocontrol. SIT is known to generate recurrent sales and rely on massive releases of IBCAs. In that sense, it attracts more interest from the industry. However, business models applicable to SIT remain very different to that of augmentation biocontrol and in many cases, SIT has been considered as an activity to be handled by public organisations. Consequently, its use across Europe is mostly limited; the use of SIT has been identified only in four Member States: Croatia, France, the Netherlands and Spain.

Recently, French research institutes, extension services and public authorities (notably within the Ecophyto Plan) have launched several programmes attempting to produce proofs of concept on new uses of SIT (Cydia pomonella, Ceratitis capitata and Bactrocera dorsalis in orchards, Drosophila suzukii in strawberry and orchards). If successful, and if sustainable business models can be implemented, SIT may also be a source of new uses outside greenhouses for IBCAs.

**Development of IBCAs within holistic IPM strategies**

IBCAs are typically developed as stand-alone elements in plant protection. However, optimal IPM strategies ideally combine multiple plant protection elements which synergistically improve each other's function (Stenberg 2017 48). Efforts to optimise biocontrol within broader IPM strategies are so far mainly developed for resident IBCAs (conservation biological control) in arable fields and forests, while the progress for added IBCAs (augmentation

<footnote n="48">48 Stenberg 2017, A conceptual framework for integrated pest management. *Trends in Plant Science* 22: 759-769</footnote>
and classical biocontrol) still is limited in this respect. Thus, there is still room for considerable development of augmentation biocontrol in this area.

Most examples of holistic IPM strategies where IBCAs constitute one element within a bouquet of many elements are based on efforts to maximise biodiversity to improve resilience. High biodiversity can be obtained at the level of forests, landscapes, or individual fields using e.g., crop rotation (Rusch et al., 2013)<fnref n="49" />, mixed forests (Klapwijk and Björkman 2018), intercropping (Brandmeier et al. 2020)<fnref n="50" />, hedge rows (Gontijo 2019)<fnref n="51" />, flower strips (Cahenzli et al. 2019)<fnref n="52" />, and cultivar mixing (Dahlin et al., 2018; Musaqaf et al., 2022). Such efforts often have direct negative effects on pests, while at the same time promoting IBCAs and pollinators.

Another rapidly growing approach involves breeding for plant resistance traits that are compatible with biocontrol (Peterson et al., 2016)<fnref n="53" />. Recent research shows that forest trees, grain crops, and horticultural crops typically have resistance traits that either promote IBCAs or are disadvantageous to IBCAs. Breeding efforts to optimise those plant traits to promote (or at least not disfavour) IBCAs are ongoing for e.g., willow trees, strawberry, and barley.

Unfortunately, the research fields underlying the development of resident and added IBCAs have developed separately from one another for many decades. Much of the advances made for resident IBCAs (conservation biological control) in these areas could be implemented for added IBCAs (mainly augmentation biocontrol). Mutual cross-fertilization of these areas holds strong potential to improve the development of IBCAs

**The Nagoya Protocol may negatively impact the R&D and the introduction of new products**

The Nagoya Protocol, a supplementary agreement to the Convention on Biological Diversity, came into force on 12 October 2014. Its goal is to provide a framework for the effective implementation of the fair and equitable sharing of benefits (ABS) arising out of the utilization of genetic resources, which includes biological control agents. Countries have sovereign rights over the genetic resources in their territory and access to these resources can be regulated by mutual agreements, covering the fair sharing of the benefits that arise from this biological material. This may negatively affect commercial uptake of IBCAs: 58f58s additional step in the research and development of new IBCAs could hinder the development of the sector in the European Union.

The IOBC considers that the main benefit that arises from the use of genetic material for invertebrate biological control is the reduced use of pesticides

<footnote n="49">⁴⁹ https://doi.org/10.1111/1365-2664.12055</footnote>

<footnote n="50">⁵⁰ https://doi.org/10.1016/j.baae.2021.02.011</footnote>

<footnote n="51">⁵¹ https://doi.org/10.1016/j.biocontrol.2018.10.014</footnote>

<footnote n="52">⁵² https://doi.org/10.1016/j.agee.2019.03.011</footnote>

<footnote n="53">⁵³ Knowledge sharing, cooperative research in source countries and transfer of production technology to</footnote>
for the benefit of farmers and consumers, especially when exotic species
are mostly used for classical biological control, sustained by governments
and universities. A guide for best practices for the use and exchange of
invertebrate biological control genetic resources was subsequently
developed by the IOBC: it includes knowledge sharing, collaborative
research with source countries and production technology transfer to
source countries <fnref n="54" />. Additionally, common efforts could be made at the European level
to harmonize access and benefit sharing agreements with third countries.

**3.1.5 Expected benefits and negative impacts on biodiversity and food safety**

NB: the potential impact on the quantitative targets for the reduction of use of pesticides outlined in the F2F strategy is analysed under section 4.2.2.1

*Benefits of biological control agents are well-established*

Between 20-40% of global crop production are lost to pests annually and each year, plant diseases cost the global economy around US$220 billion, and invasive insects cost around US$70 billion<fnref n="55" />. Controlling pest and diseases on crops is a necessity in economic terms and for food security. Chemical pesticides can reduce crop losses; however, they may cause important damage to the environment and human health.

In comparison to chemical products, pest control with IBCAs presents
various advantages:

- They are more environmentally friendly as they cause no pollution (no chemical residues) and affect only specific species, thus limiting the impacts on biodiversity especially in comparison to non-specific chemical insecticides for example (some risks for biodiversity could however still exist and are described in the next section); when biocontrol with IBCAs is successful, it may be beneficial for native species. In 2010, a review of 70 cases of classical biological control showed that biological control often has positive effects on the protection of biodiversity in 98% of the projects, and classical biological control against insects (21 projects) provided benefits to protection of biodiversity in 81% of the projects in the meta-analysis<fnref n="56" />.

- IBCAs also present a low likelihood of resistance-building amongst targeted organisms and decrease the risk to conduct to failures in pest control;

<footnote n="54">⁵⁴ Mason, P.G., Cock, M.J.W., Barratt, B.I.P. *et al*. Best practices for the use and exchange of invertebrate biological control genetic resources relevant for food and agriculture. *BioControl* **63**, 149-154 (2018).
https://doi.org/10.1007/s10526-017-9810-3</footnote>

<footnote n="55">⁵⁵ Food and Agriculture Organisation, 21: https://www.fao.org/news/story/en/item/1402920/icode/</footnote>

<footnote n="56">⁵⁶ R.G. Van Driesche et al. / Biological Control 54 (2010) S2–S33</footnote>
* They will reduce the risk of plant protection on human health in comparison to the negative impacts on the health of users (farmers and field workers) as well as of consumers following the presence of chemical residues in food products;

* IBCAs could be a solution where no other alternatives are available, especially in organic farming or to support the development of Integrated Pest management strategies;

* They may be, in certain situations and when commercial products are well established, cost-effective. In addition, for classical biological control, it is self-perpetuating or self-sustaining and therefore permanent.

Potential theoretical negative impacts on biodiversity (risk of damage to surrounding ecosystems and established organism relationships) are real, although they have so far remained limited

Directly affecting species on the same trophic level, IBCAs may increase competition between invertebrate predators, causing displacement or interferences within established food webs, which may decrease the amount of biodiversity within an environment<fnref n="57" />. Historically, the use of generalist biocontrol agent species has generated a few but famous cases of unintended impacts. The most recent case is the ladybird *Harmonia axyridis*, initially introduced for classical biocontrol in the USA, and then sold worldwide as an augmentative biocontrol product. It later became a worldwide invader, and which has been suspected to be involved in decreases in the abundance of certain native ladybirds (including in Europe). According to EPPO, the species is currently recognised as damaging for European biodiversity as it has a wide host range across many taxonomic groups with a strong capacity for natural spread, and is known to attack non-target prey, including some beneficial species. This is mainly due to the nature of the ladybug: its feeding habits, climatic adaptability, high degree of phenotypic plasticity, effective chemical and physical defence strategies and good dispersal abilities contribute to its high establishment potential (van Lenteren et al. 2008). An article in the journal BioControl titled, "Intraguild predation involving *Harmonia axyridis*: a review of current knowledge and future perspectives"<fnref n="58" />, describes the success of this insect, along with the threat that *H. axyridis* poses to biodiversity. The authors of this study describe how *H. axyridis* served as an effective biocontrol agent against aphids and other hemipteran pests, evidence suggests that the introduction of this invertebrate in 2004 caused the decline of some native coccinellid species due to their, "superior competitive ability and status as an intraguild predator". Replacement of native coccinellid species in the EPPO region could thus be expected.

<footnote n="57">⁵⁷ Barratt, B. "Assessing safety of biological control introductions." Perspectives in Agriculture, Veterinary Science, Nutrition and Natural Resources 6.042 (2011)</footnote>

<footnote n="58">⁵⁸ Pell, J.K., Baverstock, J., Roy, H.E. et al. "Intraguild predation involving Harmonia axyridis: a review of current knowledge and future perspectives." BioControl 53, 147-168 (2008). https://doi.org/10.1007/s10526-007-9125-x</footnote>
Furthermore, this article introduces the concept of guild diversity, which is the diversity within the group of species that utilizes the same kinds of resources in comparable ways. The authors state that, "Declines in guild diversity as a result of introduction of *H. axyridis* could, therefore, reduce the resilience of pest suppression in the long term.". Formerly listed as a successfully introduced classical biological control agent, *Harmonia axyridis* has been removed from the EPPO list PM 6/3. The case of *H. axyridis* is the most salient example of recorded negative consequences on biodiversity following the introduction of an IBCA on biodiversity and was mentioned by several Member States in the consultation. However, based on the scientific information available, this did not lead to the disappearance of any local species.

Some cases of negative impacts on plant health were also reported but are not as consistent across Europe. For example the predatory bug *Nesidiocoris tenuis*, although successfully used as an IBCA in several Member States (for example Spain, Greece, Belgium or Hungary), negatively affected the tomato greenhouses in the Finnish Osthrobotnia region. *N. tenuis* is an arthropod that predates pests but also feeds from the plant. Plant feeding behaviour in this species is variable. This species is generally highly beneficial, but it was shown in Finland to cause significant losses of tomato yield. It even led to the use chemical pesticides to control its populations, threatening IPM programmes<fnref n="59" />. The problem was more important in year-round tomato greenhouses because *N. tenuis* could install on the long term as its reproductive cycle was not broken in wintertime in greenhouses. This led to the establishment of a regulatory system in Finland and the use of this organism is now forbidden.

Negative side effects of the introduced parasitoid *Lysiphlebus testaceipes* were also reported<fnref n="60" />, which led to the removal of the species from the safely used list (Appendix 3 of EPPO PM6/3).

Apart from the example of *Harmonia axyridis*, the introduction of IBCAs seems to have rarely led to negative consequences for biodiversity. A study by van Lenteren et al. in 2006 reviewed over 5000 introductions over the past 120 years of 2000 exotic arthropod agents for control of arthropod pests in 196 countries or islands and showed rare negative environmental effects: Less than 1% appears to have caused population-level effects in nontargets species (0,5% for classical biological control against insects and 0,7% against weeds), and only 3% to 5% may have caused some smaller

<footnote n="59">⁵⁹ https://onlinelibrary.wiley.com/doi/abs/10.1111/jen.12789</footnote>

<footnote n="60">⁶⁰ Lumbierres B., Starý P., Pons X., 2007. Seasonal parasitism of cereal aphids in a Mediterranean arable crop system. Journal of Pest Science, 80: 125-130.
Pons X., Lumbierres B., Starý P., 2004. Expansión de Lysiphlebus testaceipes (Cresson) (Hym., Braconidae, Aphidiinae) en el Noreste dela Península Ibérica. Boletín de Sanidad Vegetal. Plagas, 30: 547-552.34
Starý P., Lumbierres B., Pons, X., 2004. Opportunistic changes in the host range of Lysiphlebus testaceipes (Cr.), an exotic aphid parasitoids expanding in the Iberian Peninsula. Journal of Pest Science, 77: 139-144</footnote>
effects. Augmentative biological control had no population effects in non-target species, but higher percentage of smaller effects<fnref n="61" />.

However, it should be underlined that:

- Theoretical risk for biodiversity remains high, knowing that only one case of uncontrolled introduction of a species is sufficient to disrupt ecosystems;

- In addition, the available data regarding post-release monitoring are limited (see section 3.2.1). More and more methods for assessing the impact of the release of species are being developed and may reveal blind spots in anterior research.

**Expected impacts on food safety are very positive**

Although the literature suggests that the introduction of non-native invertebrates can be detrimental to biodiversity, IBCAs have clear benefits in terms of food safety. In a journal article from the journal of BioControl titled, ""Biological control using invertebrates and microorganisms: plenty of new opportunities"" the authors describe the multiple facets of augmentative biological control, and its potential as an alternative to conventional farming. The authors stated that augmentative biological control is not only healthier for farm workers and for people living in farming communities, but also resulted in "a healthier product and reduced pesticide residues [well below the legal Maximum Residue Levels (MRLs)]" (van Lenteren et al.). This same article describes some accomplishments within augmentative biological control. For example, in greenhouses in Spain, augmentative biological control allowed for the "virtually complete replacement of chemical pesticides by predators (mites and hemipterans) to control thrips and whiteflies on sweet peppers" (van Lenteren et al).

This also has impacts on the internal market; the excessive use of chemical pesticides and the resulting high levels of residues in sweet peppers had caused a collapse in the export of peppers to Germany by 40% between 2004 and 2007. Widespread implementation of augmentative biocontrol in 2006/2007 allowed for a full recovery of the sector, leading to a 200% increase since 2012 (IBMA<fnref n="62" />).

Although this example may demonstrate how invertebrate biological control agents can operate within modern agriculture, closed areas may not serve as accurate representations of how IBCAs may affect open-air environments.

<footnote n="61">⁶¹ ASSESSING RISKS OF RELEASING EXOTIC BIOLOGICAL CONTROL AGENTS OF ARTHROPOD PESTS
J.C. van Lenteren, J. Bale, F. Bigler, H.M.T. Hokkanen, A.J.M. Loomans, Annual Review of Entomology 2006
51:1, 609-634 https://www.annualreviews.org/doi/10.1146/annurev.ento.51.110104.151129</footnote>

<footnote n="62">⁶² Widespread implementation of augmentative biocontrol in 2006/2007 allowed for a full recovery of the sector, leading to a 200% increase since 2012</footnote>
## Expected impacts on international trade

IBCAs can complicate international trade when they are present in consignments and are intercepted during inspections. Some countries may consider certain categories of IBCAs (e.g., non-native species with a potential environmental impact, plant-feeding IBCAs with potential a plant health impact) as a biosecurity concern and when those are intercepted, this may lead to consignments being stopped or having to be treated. For example, in Australia, the 2019 Final Pest Risk Analysis for Cut Flower and Foliage Imports notably mentions intercepting the IBCA mite *Neoseiulus californicus*, with a yearly average of between 10 and 50 events per year. While it is not a quarantine pest for Australia, two other species intercepted in this genus, *N. bicaudus* and *N. longisiphonulus*, are quarantine pests for Australia. The Dutch administration also reported that consignments of plants/plant materials are regularly refused by New Zealand biosecurity services when any live natural enemies are found.
## 3.2 Q2: What (regulatory) systems are in place in relation to introduction, production and/or release of IBCAs in the different Member States?

This question aims at providing a comprehensive overview of the regulatory systems in place in EU-27 Member States regarding the introduction of the organisms in the territory (in a contained or non-contained environment), production of IBCAs, and release of IBCAs in the environment (including the placement on the market and marketing). The analysis will especially focus on:

- The current **regulatory frameworks** in place: how IBCAs are currently covered by the national regulations (specific to BCAs, specific to IBCAs, included in pesticide regulation, etc.), the legal provisions applied to their use and production, processes for authorization (when relevant), the link made with international guidelines (EPPO guidelines especially), authorities in charge, etc.

- The processes for **risk assessment** before the introduction, production and/or release of IBCAs (elements analysed, authorities in charge or involvement of third parties, mobilisation of experts, mitigation measures for the release of IBCAs, etc.)

- The other legal requirements regarding the introduction of IBCAs

### 3.2.1 Introduction: EU legal framework for BCAs (and IBCAs)

**IBCAs are not covered by the current European regulation that regulate the placing into the market of pesticides...**

IBCAs are not specifically referred to in any EU strategy and regulation.

First there are no common EU rules on the production, use and placing on the market of IBCAs. Existing legal instruments regulate the **placing of "Plant Protection Products" (PPP) on the market**, but do not include IBCAs in their scope as IBCAs do not fall into the definition of PPPs in existing EU texts<fnref n="63" />. **Regulation (EC) No 1107/2009⁶⁴**, which aims to "ensure a high level of protection of both human and animal health and the environment and to improve the functioning of the internal market through the harmonization of the rules on the placing on the market of plant protection products", applies to substances (chemical elements and their compounds) including micro-organisms having general or specific action against harmful organisms or on plants, parts of plants or plant products, referred to as "active substances and define specific requirements for authorisation and market access". IBCAs are outside the scope of this Regulation; however, it follows the principles of integrated pest management (and based on the principle of subsidiarity) set out in the

<footnote n="63">⁶³ This EU definition differs from other existing definitions, such as OECD's definition which defines Plant Protection Products as chemical or biological products used in agriculture to protect plants; OECD definition of biological pesticides also explicitly includes invertebrates/macrobials. (https://www.oecd.org/chemicalsafety/pesticides-biocides/biological-pesticides.htm)</footnote>

<footnote n="64">⁶⁴ https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32009R1107</footnote>
Sustainable Use Directive 2009/128⁶⁵. Protecting and enhancing important beneficial organisms is one of these principles. According to this regulation, Member States should give priority in their National Action Plan wherever possible to non-chemical methods of plant protection and pest and crop management (without any explicit reference to IBCAs).

## ...but IBCAs fall under the scope of two European regulations to ensure protection of biodiversity and plants

However, IBCAs (as well as micro-organisms used for biological control, insofar as they are non-native living organisms) fall within the scope of two European regulations in place to ensure protection of biodiversity and protection of plants:

- **Regulation (EU) No 1143/2014** ⁶⁶on the prevention and management of the introduction and spread of invasive alien species provides specific requirements to prevent, minimize and mitigate the adverse impact on biodiversity of the introduction and spread within the Union, both intentional and unintentional, of invasive alien species. It relies on a list of exotic alien species regularly updated by the European Commission. As "alien species" are defined as any live specimen of a species, subspecies or lower taxon of animals, plants, fungi, or microorganisms introduced outside its natural range, non-indigenous IBCAs can be considered as 'alien species'.

- **Regulation (EU) 2016/2031** ⁶⁷on protective measures against pests of plants establishes protective measures against the introduction into the Member States from other Member States or third countries of organisms which are harmful to plants or plant products. It defines specific controls and requirements for these types of organisms considered as pests in the European Union. It relies on a list containing the plants, plant products and other objects which are prohibited from being introduced into the territory of the Union as well as a list with special requirements, or equivalent requirements for their introduction. This may be relevant to omnivorous and herbivorous IBCAs, which can cause unintended damage to crop and other plants, such as *Nesidiocoris tenuis* in some specific conditions.

In case of negative impacts on biodiversity or plant health, IBCAs could be added to the above-mentioned lists, conducting to restrictions for their introduction in Europe. It prevents the introduction of already known threads on biodiversity or plant health in Europe and the management of the current species with negative impacts. These lists are regularly revised, and Member States are engaged in the identification of new species to be added on those lists when risk assessments are performed for example.

<footnote n="65">⁶⁵ https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32009L0128</footnote>

<footnote n="66">⁶⁶ https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32014R1143</footnote>

<footnote n="67">⁶⁷ https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32016R2031</footnote>
In addition, the article 22 of the Council Directive 92/43/EEC of 21 May 1992 ⁶⁸on the conservation of natural habitats and of wild fauna and flora established that the Member States should "ensure that the deliberate introduction into the wild of any species which is not native to their territory is regulated so as not to prejudice natural habitats within their natural range or the wild native fauna and flora and, if they consider it necessary, prohibit such introduction. The results of the assessment undertaken shall be forwarded to the committee for information."

**In addition, the European Commission is engaged in the reduction of the use of chemical pesticides through the European Green Deal objectives and the support to the Integrated pest management.**

**The Farm to Fork Strategy (F2F),** a comprehensive 10-year plan adopted by the European Commission to drive the transition to a fair, healthy, and environmentally friendly food system in Europe, is at the heart of the "European Green Deal" and stands in line with the Sustainable Development Goals (SDGs) since it touches upon many sectors from agriculture to food labelling. Among its ambitious targets, it aims to "**enhance provisions on integrated pest management**" and to "**achieve a reduction by 50% of the use and risk of chemical pesticides, and the use of more hazardous pesticides by 50% by 2030**". Other objectives also include a reduction of nutrient losses by at least 50% while ensuring that there is no deterioration in soil fertility; a reduction of overall EU sales of antimicrobials for farmed animals and aquaculture of 50% by 2030; and reaching 25% of agricultural land under organic farming by 2030. These targets cannot be achieved without developing, producing, and providing alternative tools for farmers.

**The Sustainable Use Directive (Directive 2009/128/EC<fnref n="69" />)** is currently under revision. The Commission proposal for a Regulation of the European Parliament and of the Council on the sustainable use of plant protection products and amending Regulation (EU) 2021/2115 ⁷⁰has been published in June 2022. It established a specific definition of biological control (specifically mentioning IBCAs) and mentions biological control as one of the general principles for IPM in Annex. It also strengthens the trainings and information to pesticide users on Integrated Pest Management (IPM), in particular by establishing advisory services in each Member State. The proposal also refers to the current study to define what could be a future EU intervention in this area.

Finally, **the EU's new Biodiversity Strategy for 2030** 71 contains a vision of ecologically sustainable farming. Target 3 of the EU Biodiversity Strategy aims at achieving more sustainable agriculture and forestry, to preserve species and their habitats. As part of the European Green Deal, it aims to build European resilience to future threats such as the impacts of climate

<footnote n="68">⁶⁸ https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A31992L0043</footnote>

<footnote n="69">⁶⁹ https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02009L0128-20190726</footnote>

<footnote n="70">⁷⁰ https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021R2115</footnote>

<footnote n="71">⁷¹ https://environment.ec.europa.eu/strategy/biodiversity-strategy-2030_en</footnote>
change, fires, food insecurity, and disease outbreaks. It recalls the economic benefits of biodiversity, especially including restoration of carbon-rich habitats and climate-friendly agriculture, and the need to "provide space for wild animals, plants, pollinators and natural pest regulators", with the objective of bringing back at least **10% of agricultural area under high-diversity landscape features**. It states the need to reduce pollution, in particular coming from pesticides, circulating back to the Farm to Fork Strategy.

Thus, this framework establishes a favourable context and clear support of the European Commission for the development of the use of the IBCAs in alternative to chemical pesticides. However, IBCAs are not explicitly and systematically referred in these strategies.

### 3.2.2 Existence of national regulations in Member States

IBCAs are an alternative to chemical products, which has high benefits for pest management. However, they can also present risks for plant health (especially for other species than the one targeted, when the IBCAs are herbivorous) as well as for biodiversity. Thus, even if no regulatory framework has been developed at European level, some Member States have adopted legal provisions that specifically regulate the introduction, production and/or release of IBCAs on their national territories.

#### 15 Members States have established provisions specifically regulating the introduction, production and/or release of IBCAs in their national legislations, whilst three more MS are currently developing such provisions

Project REBECA<sup>72</sup>, which was conducted in 2006 and 2007, aimed at accelerating "*the market introduction of environmentally safe BCAs*", through acceleration of their registration process, cost reduction, and preservation of safety. The outputs of the project included a review of EU legislation, and of risk assessment strategies tailored to each BCA subgroup (microbials, macrobials, semiochemicals and plant extracts). It also analysed risk-benefits of existing regulation, and proposed measures to accelerate registration of BCA products. At this time, several Member States had already developed regulations and administrative procedures covering IBCAs (Austria, Czech Republic, Denmark, Hungary, Sweden), six countries were still working on the design and implementation of a regulation system (Finland, Germany, Ireland, Netherlands, Slovenia, Spain). The remainder Member States had no regulation implemented.

<footnote n="72">72 REBECA Final Activity Report v4.doc (europa.eu)</footnote>
Since then, an increasing number of Member States have adopted dedicated regulations over the years or revised their regulation. The situation at the date of this Study across 26 Member States is as follows<sup>73</sup>:

<figure><img src="image_20.png" /><figcaption>**Figure 6 - Status of adoption of regulatory frameworks for IBCAs in EU Member States**</figcaption></figure>

Source: EY, based on questionnaires, documentary research and interviews

► **15 Member States have introduced specific provisions regarding IBCAs** in their national legislation that govern a process for permitting IBCAs (involving environmental risk assessment and other review criteria for decision-making). These include 5 Member States already identified by the REBECA project (Austria, Czech Republic, Denmark, Hungary, Sweden), and 10 additional countries (Bulgaria, Finland, France, Greece, Italy, Latvia, the Netherlands, Slovakia, Slovenia, and Spain). Sweden and Austria, which were the first Member States having adopted dedicated regulations respectively in 1991 and 1997, have updated them in the recent years. In Sweden for instance, the revised 2016 national regulation aimed to reduce the cost of IBCAs' application and registration incurred by companies as costs were identified as a main obstacle

<footnote n="73"><sup>73</sup> Information is not available regarding the current situation in Bulgaria.</footnote>
for the development towards more available IBCAs. These MS have either developed specific IBCA-dedicated regulations or have integrated specific IBCAs' provisions in their national regulation on plant protection products, except Denmark. In Denmark, specific IBCAs' provisions have been introduced in the national environmental regulation.

<figure><img src="image_21.png" /><figcaption>**Figure 7 - Dates of adoption of regulatory frameworks for IBCAs in EU Member States**</figcaption></figure>

Source: Responses to the questionnaires sent to NCAs, EY elaboration

- 3 Member States are currently developing **regulatory provisions specific to IBCAs**, at national level in Germany<fnref n="74" /> and in Portugal, and at regional level in Belgium (in the region of Flanders and Brussels<fnref n="75" />). For these three cases, although there is currently no specific regulation in force that governs a process for permitting IBCAs, the release into the environment of non-native animals requires a permit considering the interests of species conservation, which is regulated by national environmental/ nature conservation regulations.

- The remaining 9 Member States do not have any **specific process governing the use of IBCAs**: Belgium - region of Wallonia, Croatia, Cyprus, Estonia, Ireland, Lithuania, Luxembourg, Poland, Malta, and Romania. Croatia does not have a regulation; however, the country has a specific procedure linked to the use of a SIT biological control program of *Ceratitis capitata*, and *Torymus*

<footnote n="74">⁷⁴ According to the German Plant Protection Act, the Ministry of Agriculture (BMEL) is legitimated to establish a regulatory framework for regulation of import, marketing and use/release of invertebrate biological control agents. A draft for such a regulation is currently under development</footnote>

<footnote n="75">⁷⁵ In Belgium the introduction of species is regulated at regional level and rules varied in the three regions.</footnote>
*sinensis* has also been used for biological control program implemented during the 2014-2017 period for forestry.

### 3.2.3 Scope of national regulations in Member States

Regulatory frameworks in Member States are defined by a corpus of several layers of regulations: European regulation, national environmental regulation, and specific processes for the authorisation of IBCAs, which can fall under the plant protection regulation or consist in derogations to the environmental regulation. This framework defines the degree of restrictiveness towards the use of IBCAs, and notably towards non-native species. The different configurations are summarized in figure 9.

Among the countries without specific regulations for IBCAs, 6 countries have environmental regulations which prohibit the introduction of unauthorised non-native species (top right of figure 9). They however differ regarding the restrictiveness of their regulation:

- Croatia, Estonia, Brussels region in Belgium and Portugal are very restrictive and do not allow derogations for IBCAs. Non-native IBCAs are not specifically targeted by the regulations but are almost always prohibited.

- The Flanders region in Belgium, Denmark, and Germany are less restrictive and can provide derogations for non-native species.

Among the countries with specific regulations for IBCAs (middle of figure 9), two main categories can be identified. Their regulatory frameworks differ depending on whether they cover all IBCAs or only non-native species:

- In Finland, France, and Slovenia, environmental regulations prohibit the introduction of exotic species, while native species are allowed. Specific regulations for IBCAs cover only non-native IBCAs, for which an authorisation process is required<fnref n="76" />.

- In 10 countries (Austria, Czech Republic, Greece, Italy, Hungary, Latvia, the Netherlands, Slovakia, Spain, Sweden), environmental regulations are stricter and native species also require an authorisation. As a result, IBCA regulations cover all species.

Two of these countries, Czech Republic and Slovakia, however, have de facto more permissive regulations, as they implement mutual recognition without risk assessment. For these two countries, IBCA regulation doesn't cover species imported and authorised in other European countries, nor species introduced for non-commercial purposes; it only applies to species which are first commercialized on their national territory.

<footnote n="76">⁷⁶ It should be underlined that Slovenia indicated that an authorisation process is in place for exotic species but it does not seem to be effective as all current uses are native IBCAs</footnote>
Finally, 8 countries or regions (the Wallonia region in Belgium, Cyprus, Ireland, Lithuania, Luxembourg, Malta, Poland, Romania; bottom of figure 9) don't have specific national (or regional) regulations restricting the introduction of native or non-native species. They however refer to the European lists for invasive species and quarantine pests. These countries often have a limited use of IBCAs, which may explain the absence of specific regulation.

<figure><img src="image_22.png" /><figcaption>**Figure 8 - Typology of the different regulatory settings for IBCAs in Member States**</figcaption></figure>

When IBCA regulation is integrated in the environmental regulation, it is **almost systematically different from that applied to pesticides**. In some countries, IBCA and pesticide regulations are similar for specific points; for instance, in Sweden the same regulation applies for supervision (but not for approvals and registration). The regulation which is currently being developed in the Brussels region could be an exception as it will cover both pesticides and IBCAs within a comprehensive framework on ecological management of green infrastructure and integrated pest management<fnref n="77" />.

**The regulation applies to the introduction stage for almost all Member States** which have specific processes for IBCAs; Hungary, Latvia and Slovakia are exceptions as they don't regulate the introduction but the

<footnote n="77">⁷⁷ Source: interview with the NCA from the Brussels region</footnote>
release/commercialisation of IBCAs. France regulates both introduction and commercialisation/release, while the Italian legislation applies to introduction, production and release. Denmark, Greece, Italy, the Netherlands and Slovenia also cover the stage of production.<fnref n="78" /> Transport is only covered in Italy. The regulation in Bulgaria also covers all fields, as their regulation prohibits import, introduction, movement and use of biological control agents unless they have been approved and published to a list of biological agents maintained by the regulating authority. Companies have to formally notify the Regional/District Food Safety Directorate.

Authorisation processes differ depending on the kind of IBCA (taxonomy, origin...)

**While some Member States regulations set out different provisions according to whether the IBCA is indigenous or not**⁷⁹⁸⁰, it should be noted that the definitions of native and non-native species are not homogeneous, which introduces additional differences between national regulations. While some countries align their considerations on EPPO's framework, others use national definitions. For Denmark, the Nature Conservation Act (Section 31) sets apart animals that do not occur naturally in the wild in Denmark, which does not only include non-native species, but also species which are native but have been absent from Denmark for a period of time. In Finland, invasive alien species definition is based on species which have been introduced after 1850.

In most Member States such as Austria, Finland, France, Greece, and Latvia, authorisation is granted for a specific IBCA (species, strain, source) or for a specific plant protection product (containing a specific IBCA organism) for specific uses. In other MS such as Bulgaria, Hungary, Latvia, the Netherlands, Sweden and Spain, the authorisation process is carried out for specific species or organisms. France gives authorisation for a combination of a specific species, origin, and applicant. In Italy, the level of analysis (species or strain) is determined by the information on the diffusion of the ICBA and its differentiation in relation to the geographic diffusion in the area of origin and the specialization on different hosts.

**Safe or low risk lists** exist in Austria, the Netherlands, and Spain, which are often aligned or coherent with the EPPO safe list (Standard PM 6/3).

For some Member States, authorisation processes also differ depending on the use of the IBCA

The process can differ depending on whether the IBCA is used for research or commercial purpose:

- For Denmark, Germany, the incoming regulation of the Brussels region, and Spain, the same process applies. For France, while the same process

<footnote n="78">⁷⁸ To be confirmed at the next stage of the study</footnote>

<footnote n="79">⁷⁹ The existence of list of native species will be further assessed during the study</footnote>

<footnote n="80">⁸⁰ Source: Responses to the questionnaire to NCAs - Question 4b</footnote>
generally applies, adaptations can be made in case of strict confinement
of IBCAs.

- For Austria, Czech Republic, Hungary, Italy, Latvia, Slovakia and Sweden, processes are different. For Austria, IBCAs used for research purpose don't need an authorisation unless trials are intended. Information on ability to survive outside is asked in the case of non-native species; the same applies for Hungary. In Czech Republic, a notification must be sent to the regulator in case of experimental use. In Italy, requests from scientific institutions follow a different process and are examined by the National Phytosanitary Committee. In Slovakia, IBCAs for research are subject to a specific authorisation. For Slovenia, some exotic organisms may be allowed only for research intentions.

Countries with specific processes for authorisation of IBCAs differ
depending on whether they authorize SIT:

- **The use of SIT is generally not authorized**, as 12 of these countries (Austria, Bulgaria, Czech Republic, Denmark, Finland, Germany, Hungary, Italy, Latvia, the Netherlands Slovakia, Slovenia), **don't cover it in specific provisions**. In Italy for instance, IBCA regulation does not allow the release of pests; the authorisation process only covers their natural antagonists.

- **SIT is authorised in a minority of countries (France, Greece, Spain and Sweden).** In France, SIT must follow the regulation established for non-indigenous species. In Greece, while SIT is included in the definition of IBCA and therefore covered by IBCA specific provisions, it has been left out of the ministerial decision that followed, and the required data required for the use of such insects lacks clarity; no specific authorisation request has been presented so far. In the Brussels region, the text currently being developed includes specific provisions for SIT as a special case of biological control.

**Most Member States do not distinguish between classical and augmentative biocontrol**<fnref n="81" />. This distinction can however emerge as a factor in risk assessments, when the impact on biodiversity and the potential of the IBCA to become invasive is considered: this is the case for Austria. The Netherlands seems to be an exception in conducting risk assessments differently when IBCAs are used for classical or augmentative biocontrol.

**The same regime generally applies regardless of where the IBCA is produced in EU countries or in other countries.** For Czech Republic and Slovakia, however, the application of the mutual recognition principle implies that IBCAs which are produced in other EU countries will be automatically authorised.<fnref n="82" />

<footnote n="81">⁸¹ Source: Responses to the questionnaire to NCAs – Question 4a</footnote>

<footnote n="82">⁸² Czech Republic applies the Regulation (EU) 2019/515 of the European Parliament and of the Council of 19 March on the mutual recognition of goods lawfully marketed in another Member State is applicable</footnote>
Regarding the profile of user of the IBCAs, the same rules generally apply.
Czech Republic is the only country which mentions different rules for
amateur users, who don't have to submit an application<fnref n="83" />.

### Example of a national regulatory framework for IBCAs: the case of Sweden

Sweden adopted its first regulation for IBCAs in 1991 and updated it in 2016. Before 2016, IBCAs were registered in the same way as microbials: the products were registered by the Swedish Chemicals Agency, and companies bore costs for the application as well as yearly costs for registration. The costs were however identified as an important obstacle for the development for IBCAs. With the aim to increase the number of available IBCAs in Sweden, a new regulation came in place in 2016⁸⁴, and the Swedish Environmental Protection Agency (SEPA) became the responsible authority for authorization of IBCAs.

The current authorization process focuses on organisms, not products. The Swedish state funds the evaluation of all species on EPPOs list of biological control agents safely used in the EPPO region<fnref n="85" />. To register other IBCAs, applicants incur a cost to register IBCAs (8000 SEK, or 746 €). Once an IBCA is approved, it can be imported and marketed in Sweden by anyone. It is also possible to apply for non-authorized IBCAs for R&D projects, for 3000 SEK, or 279 €.

To be approved, IBCAs have to undergo a risk assessment focusing on several factors: health, environment, and effects on biodiversity. Factors such as the purpose of use, or its effectiveness, are not considered. Approval may be subject to special conditions related to origin, strain, area of use, if it is motivated from a health or environmental perspective.

Once an IBCA has been approved, stakeholders who import or market IBCAs have the obligation to notify the Swedish Environmental Protection Agency if adverse effects on human health or the environment are detected. SEPA can reconsider approval decisions if necessary, on the ground of new information regarding adverse effects.

### 3.2.4 Organisation and processes

Although Member States with a regulatory framework all have a legislation which is distinct from that for pesticides<fnref n="86" />, some similarities and mutualization can be noted in terms of organisation and processes. In Sweden, for supervision, the same regulation is applied to all chemical products and biotechnical organisms. In Czech Republic, inspection

<footnote n="83">⁸³ Source: Responses to the questionnaire to NCAs – Question 9</footnote>

<footnote n="84">⁸⁴ Regulation 2016:402</footnote>

<footnote n="85">⁸⁵ EPPO Standard PM 6/3, Appendix I, the "Positive List"</footnote>

<footnote n="86">⁸⁶ Source: Responses to the questionnaire to NCAs – Question 27</footnote>
authorities are similar for IBCAs and pesticides, and the obligations in place for professional pesticides users are applied on IBCAs as well.

The implementation of the regulatory framework is performed at the State level<fnref n="87" /> and sometimes at a more decentralized level or with more specialized stakeholders. Several authorities are involved<fnref n="88" />: Ministries dedicated to Agriculture or Rural Development, authorities related to health, food and product safety, environment protection agencies, and specialized institutes. As the implementation of the regulatory framework includes several dimensions (risk assessment process, monitoring, importation, production, and release), it sometimes includes several of these stakeholders. In Greece, the Benaki Phytopathological Institute is responsible for the risk assessment and monitoring process, while the Directorate of Plant Produce Protection at the Ministry of Rural Development and Food is responsible for importation, production and release. Regional authorities are not involved, with two exceptions: Belgium, a federal state in which regulations are being developed in the regions of Brussels and Flanders, and Italy, where a National Phytosanitary Committee is responsible for importation and production, while regional phytosanitary services are responsible for monitoring.

### 3.2.5 Risk assessment

A risk assessment is a formal process where researchers or scientists examine the data, review literature, and provide the legislative body that oversees insect introductions with a document or proposition.

Almost all Member States that do regulate IBCAs carry out a formal risk assessment. Some exceptions have to be underlined:

- In Belgium - Flanders, there is no specific process for new application or risk assessment process in place. Only some specific derogations have been provided for native species or species listed in EPPO list.

- In Hungary, there is no proper risk assessment in place. However, the opinion of the nature conservation authority is required for non-native species.

- In Germany, the risk assessment is not adapted to IBCAs as it relies on the requirements of the Federal Nature Conservation Act that prohibit any risks to ecosystems, biotopes or species. However, some permits have been granted for non-native species.

**The scope of application of the risk assessment and its content vary across the Member States** depending on the type of organisms concerned (native or non-native mainly), the integration of the organisms in the EPPO list or when the IBCA is already authorised in another Member State. In Czech Republic and Slovakia, mutual recognition is in place for

<footnote n="87">⁸⁷ Source: Responses to the questionnaire to NCAs – Question 37</footnote>

<footnote n="88">⁸⁸ Source: Responses to the questionnaire to NCAs – Question 38</footnote>
IBCAs authorised in other Member States without additional risk assessment at national level.

The table below provides an overview of the scope of risk assessment in the Member States.

<table><caption>**Figure 9 - Scope of risk assessments according to national IBCAs' regulations**</caption><thead><tr><th>Member States</th><th>Native organism</th><th>Non-native organism</th><th>IBCA of the EPPO list</th><th>IBCA authorised in another Member State</th></tr></thead><tbody><tr><td>Austria</td><td>Risk assessment (no environmental risk assessment required)</td><td>Risk assessment</td><td>If listed in EPPO PM 6/3, no efficacy assessment required</td><td>Risk assessment</td></tr><tr><td>Bulgaria</td><td colspan="4">Risk assessment</td></tr><tr><td>Czech Republic</td><td>Risk assessment</td><td>Risk assessment</td><td>Risk assessment</td><td>Automatic mutual recognition without notification</td></tr><tr><td>Denmark</td><td>Use without authorisation</td><td colspan="3">Risk assessment</td></tr><tr><td>Finland</td><td>Notification</td><td>Risk assessment</td><td>Automatic approval</td><td>Risk assessment</td></tr><tr><td>France</td><td>Use without authorisation</td><td colspan="3">Risk assessment</td></tr><tr><td>Greece</td><td>Risk assessment restricted to efficacy, environment and health</td><td>Risk assessment (detailed)</td><td>Risk assessment</td><td>Risk assessment</td></tr><tr><td>Italy</td><td>Use without authorisation</td><td>Risk assessment</td><td>Risk assessment</td><td>Risk assessment</td></tr><tr><td>Latvia</td><td>Risk assessment</td><td>Risk assessment (detailed)</td><td>Risk assessment</td><td>Risk assessment</td></tr><tr><td>The Netherlands</td><td>Risk assessment</td><td colspan="3">Automatic approval</td></tr><tr><td>Slovakia</td><td>Risk assessment</td><td colspan="3">Risk assessment</td></tr><tr><td>Slovenia</td><td>Use without authorisation</td><td>Risk assessment</td><td>Risk assessment</td><td>Risk assessment</td></tr><tr><td>Spain</td><td>Use without authorisation</td><td>Risk assessment</td><td>Risk assessment</td><td>Risk assessment</td></tr><tr><td>Sweden</td><td>Risk assessment</td><td colspan="3">Risk assessment financed by the State</td></tr></tbody></table>

<figure><img src="image_23.png" /></figure>

Risk assessment

<figure><img src="image_24.png" /></figure>

Automatic approval

Lighter risk assessment

<figure><img src="image_25.png" /></figure>

Use without authorisation

Source: Responses to the questionnaire sent to NCAs and interviews with NCAs

Risk assessments are carried out for non-native IBCAs in all Member States. For native IBCAs, the situation differs depending on the restrictiveness of the environmental regulation:

- Native IBCAs can be used without authorisation in Denmark, France, Italy, Slovenia and Spain; for Finland, only a notification is required.

- A risk assessment is still required in Latvia, the Netherlands, Slovakia, and Sweden.
- The risk assessment is lighter in Austria, where no environmental risk assessment is performed, and Greece, where it is restricted to efficacy, environment and health.

IBCAs included in the EPPO list PM6/3 are automatically approved in Finland and the Netherlands. Other countries still carry out risk assessments for these IBCAs, although being on the list is considered as a significant advantage and can lead to a lighter risk assessment (Austria) or a fully financed process (Sweden).

The content and analysis conducted during risk assessment are also heterogeneous among the Member States

Risk assessments usually start with the identification of the organism concerned. The authorisation is provided at species level in all Member States apart from France where it is required at strain level. However, in some other Member States, specific issues at strain level could be analysed during the risk assessment:

- In Austria, for single predatory mites and nematodes the strain level may be considered if corresponding information is provided by the applicant;

- In Italy, the level of analysis regarding species or strain is determined by the information on the diffusion of the ICBA and its differentiation in relation to the geographic diffusion in the area of origin and the specialization on different hosts;

- In Slovenia, it is conducted at both levels.

**Risk assessment in France**

A sharper risk assessment in place is in France. It includes requested detailed identification information on the IBCA, both at morphology and molecular levels, as well as characterization at the level of the strain; such focus on identification of actual IBCA to assess is related to the potential differences in biological characteristics exhibited by various strains belonging to a same species. Voucher specimens should be sent to a dedicated ANSES lab. Details should be given on the planned uses and targets of the IBCA, its mass rearing, product composition, and planned packaging, and precaution regarding IBCA usage. In addition, detailed assessment of both **benefits** and **risks** associated with the release of the IBCA should be provided; notably, the applicants should provide an assessment of the probability IBCA establishment in the environment, of its dispersal, and its potential risks to human and/or animal health, plant health, and non-target organisms (including risk of competition or hybridization with other species).

All this information should be supported by data generated by the applicants (including field data when dealing with effectiveness of the IBCA planned to be released) as well as by data from the literature when available.
In addition, the risks considered during the assessments are different depending on the Member States. The assessments focus most frequently on the risks of unintended spread, risks for plant health and biodiversity. Risks to human health and risks from diseases are less frequently assessed.

<figure><img src="image_26.png" /><figcaption>Figure 10 - Question to Member States: What are the possible unintended impacts that are evaluated?</figcaption></figure>

Source: Responses to questionnaires sent to NCAs, EY Elaboration. The question has been answered by 13 Member States with specific processes for IBCAs and which perform risk assessments (Austria, Czech Republic, Denmark, Finland, France, Greece, Italy, Latvia, Lithuania, the Netherlands, Slovenia, Spain and Sweden). Bulgaria, Hungary and Slovakia are not included as they have not provided a detailed answer.

More specific risks include genetic diversity and risks from pathogens or endosymbiotic bacteria (Sweden), risks of hybridization (Spain), and phytotoxicity (Austria).