## Risk regarding cross-border spread

Unintended cross-border spread has already been a cause for concern in the EU and its neighbours, particularly between Switzerland and Italy, with the release of an IBCA close to the common border of these two countries. Five countries currently consider cross-border spread as a potential safety issue in the assessment of risks: Austria, France, Italy, Slovenia, Spain. For Austria, it is considered indirectly. Countries which apply mitigation measures (Denmark, Greece, Italy, Netherlands, Sweden) don't seem to include specific measures related to cross-border issues. However, countries mention general rules related to unintended spread which can indirectly apply to cases of cross-border spread. For instance, Swedish regulation (20016:402) notes that anyone spreading IBCAs should take measures to prevent the organism from spreading outside the intended spreading area.

An ecoregion can be defined as "a physical region that is defined by its ecology, which includes meteorological factors, elevation, plant and animal speciation, landscape position and soils". The ecoregion concept can predict the spread of IBCAs: "Alien species that are suited to Europe north of the Mediterranean region can be expected to spread throughout mainland Europe with little hindrance from natural barriers". For example, the horse chestnut leafminer and the western corn rootworm have crossed the English Channel and have been reported in the UK, likely due to trade and human movement. Based on this information, one can conclude that introduced IBCAs established in one area in Europe could spread extensively within their preferred ecological limits over a few years<fnref n="89" />. Within the same book, the authors of explain, "Although dispersal distance is potentially a species-specific trait, as it is dependent upon longevity and power of flight, there is often an overriding influence of the abiotic and biotic characteristics of the surrounding landscape". These characteristics are important to note when conducting risk assessments and evaluations of IBCAs.

**Some Member States also carry out an analysis of benefits:** they cover mostly plant protection/phytosanitary effects (13 Member States), benefits to local biodiversity (Bulgaria, Denmark, France, Latvia, Slovenia), and environmental benefits (Bulgaria, France, Greece, Italy, the Netherlands, Slovenia). In Italy, the economic, social and environmental impacts, including the reduction in the use of insecticides, are also assessed. Efficacy, which is assessed by several Member States, can also be included among benefits.

Variation in the scope of the regulation leads to differences in the number of risk assessments conducted each year in the Member States. However, the number of applications received remains low and the majority of

<footnote n="89">⁸⁹ https://www.researchgate.net/profile/Barbara-Barratt/publication/233390234_Assessing_safety_of_biological_control_introductions/links/00463518d9348ed2b3000000/Assessing-safety-of-biological-control-introductions.pdf</footnote>
applications are approved. The table below summarizes the number of assessments, approvals and rejections in the last years among the Member States which carry out risk assessments.

<table><caption>Table 11 - Summary of assessments, approvals and rejections in the Member States</caption><thead><tr><th>Member States</th><th>Number of assessments</th><th>Approbations</th><th>Rejections</th><th>Period</th></tr></thead><tbody><tr><td>Austria</td><td></td><td></td><td></td><td></td></tr><tr><td>Czech Republic</td><td>0</td><td>0</td><td>0</td><td>2020-2022</td></tr><tr><td>Denmark</td><td>36</td><td>28 (2022 applications still pending)</td><td>0</td><td>2020-2022</td></tr><tr><td>Finland</td><td>0-10</td><td>9</td><td>1</td><td>Yearly average</td></tr><tr><td>France</td><td>14</td><td>17</td><td>1</td><td>2020-2021</td></tr><tr><td>Greece</td><td>22</td><td>18</td><td>0</td><td>Yearly average over 2016-2021</td></tr><tr><td>Italy</td><td>2</td><td>2</td><td>0</td><td>2020-2022</td></tr><tr><td>Latvia</td><td>5.5</td><td>5.5</td><td>0</td><td>Yearly average over 2014-2021</td></tr><tr><td>The Netherlands</td><td>10</td><td>9.5</td><td>0.5</td><td>Yearly average over the last 10 years</td></tr><tr><td>Slovakia</td><td></td><td></td><td></td><td></td></tr><tr><td>Slovenia</td><td>1</td><td></td><td></td><td>Since 2006</td></tr><tr><td>Spain</td><td>43</td><td>33</td><td>10</td><td>2012-2021</td></tr><tr><td>Sweden</td><td>8</td><td>5</td><td>0 (with a few pending applications)</td><td>Yearly average 2017-2022</td></tr></tbody></table>

Source: Responses to the questionnaire sent to NCAs, EY elaboration. Question 22.
While applications are rarely rejected, some Member States (Austria, Denmark, France, Finland, Greece, Italy, Slovenia and Sweden) impose risk mitigation measures related to IBCA releases.

- In Austria, Denmark, France and Sweden, the approval can be conditioned to specific conditions of use, for instance restricted to greenhouses or controlled conditions, to limit the risk of dissemination and contact with the national population; in Sweden, there can also be restrictions related to origin (to minimize risk of hybridization) or to specific strains (limit risk of establishment). For France, specific risk management measures may be established if needed at the stage of authorization. The risks addressed relate to unintended spread, hybridization, plant health, decreased efficacy of beneficial insects when mixed with synthetic/biologic insecticides.

- In Finland, specific support from the Ministry of Agriculture can be provided to determine how to mitigate risks in the case of adverse effects on plant health

- In Austria, an additional labelling for risk on health (wear protective gloves, may produce allergic reactions) is mandatory

### 3.2.6 Other legal requirements regarding introduction, production or marketing of IBCAs

In addition to the authorisation of IBCAs, 9 Member States are providing specific authorisation and registration of producers and/or retailers

Nine Member States register IBCA producers and retailers: for France, this only applies to producers and introducers of non-native IBCAs, and not for retailers. In Latvia, the IBCAs are considered as plant protection products and special permits are required for distribution.

**Quality control requirements are not included in national frameworks**

Very few requirements have been identified in the Member States regarding quality control of IBCA products, and they do not consist in strong quality control process:

- In France, the applicants are asked to describe measures that will be implemented to ensure the sanitary quality of the population to be introduced. It is analysed during the risk assessment.

- In Greece, some controls are performed on domestic unit manufacturing to ensure they comply with standard operating procedures.

- In addition, the Netherlands conducts specific controls on quality only in the case of export to third countries when an export permit is required.
Recording and monitoring measures vary across Member States

**Only Denmark, France, Italy and Slovenia have established a monitoring framework for the release of IBCAs into the environment.** For Denmark, this applies when a derogation is granted for the release of a non-native species; in that case, a written report must be submitted on whether the derogation has been used. In Slovenia, professionals must keep a record concerning the quantities of beneficial organisms that have been cultivated, introduced, sold or disposed to a third person.

In several countries, even in the absence of a monitoring framework consolidated at the national level, users of IBCAs are obliged to keep record of the IBCAs they use (Austria, Denmark, Finland, Greece, Italy, Latvia, Slovakia, Slovenia), and/or store (Czech Republic, Denmark, Italy, Latvia and Slovenia), with some countries making also record of purchase mandatory (Czech Republic, Latvia, Slovakia).

**Data is recorded for post-release monitoring** in several Member States. In Austria and Greece, all effects have to be reported to the authority. France, Italy, the Netherlands, and Spain mention recording the following elements:

- Negative or positive impacts on biodiversity

- The duration of the occurrence of the IBCAs in the environment

- Interactions with naturally occurring populations of plants or animals

- Efficacy in terms of pest/weed/pathogen control (which is recorded by Slovenia as well).

Only France records specifically effects on human health. In France, the applicants also have to send to the national authority all information related to post-release monitoring that are susceptible to change the initial evaluation. The data is consolidated at the national level in Finland, France and Italy. In Greece, while there is no systematic monitoring system in general, the installation of the insect *Torymus sinensis*, which was released for the first time in 2018 with a program of the Ministry of Rural Development and Food, is monitored by annual sampling.

The authorities in charge of the collection and maintenance of the monitoring system are generally the ones already involved in IBCA regulation in their respective countries.
### 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?

This question aims at providing additional information on the characteristics of the regulatory approach in the different Member States (key data requested in applications, most common data gaps). It will also focus on the implementation of the existing legal frameworks, their challenges, and consider views from the users of IBCAs and other non-institutional stakeholders.

#### 3.3.1 Key data requested in applications and most common data gaps

The risk assessments mainly rely on the data provided directly by the applicants as well as documentary review (scientific publications or available risk assessment).

The data requested and main issues encountered in the implementation of risk assessment were merely analysed in the 7 Member States identified as case studies: Austria, France, Hungary, the Netherlands, Portugal, Spain and Sweden. While a large part of the data required is similar in all 7 Member States, the format of the application is not homogenous and specific requirements differ from country to country, such as the assessment of efficacy (Austria), of expected benefits (France), suggestions to include information on other restrictions in other countries (Hungary), or taxonomic and contamination risks, e.g. confusion with similar species (Sweden). For the Netherlands, the request of key data is aligned on EPPO PM 6/2; this is also mostly the case for Spain.

A table presenting the content of the EPPO PM6/2 standards and the content of the risk assessment at national level is provided in Annex for the Member States for which the information was transmitted (section 5.5.6).

Austria requires a description of the product (including the organism species), and Good Agricultural Practice (GAP) tables. Several risk assessments are then performed which require specific data:

- An efficacy assessment. When the organism is not listed in EPPO PM 6/3, data on efficacy is required. Non-GEP trials and publications can be used in the assessment.

- An environmental risk assessment. For this assessment, data on the geographical home range is used to determine if the species is indigenous or not. If the species is not indigenous, additional data is required:

- Potential of an exotic species to establish (survival and ability for reproduction at low temperatures, potential of hibernation, ability for diapause)

- Potential of dispersal (mechanism of dispersal, life-span, habitat conditions)
- Host range/specifity and direct effects on non-target organisms

- Indirect effects of released species on non-target-organisms.

- Will the exotic macro-organism provide better pest control than native species?

- A human health risk assessment. For this assessment, data for co-formulants is required, such as transport material or storage material.

In the case of Hungary, the data requested falls within 8 categories:

1. General data on the formulation containing macro-organisms

2. Biological properties

3. Biological activity of the product containing the macro-organism

4. Toxicological data of the macro-organisms concerning pesticides and other chemicals and micro-organisms (IOBC risk scale 1-4)

5. Environmental data of the macro-organism

6. Food hygienic aspects of the use of products containing macro-organisms, occurrence of macro-organisms and their non-viable residues on the crop at harvest

7. Other information (including possible restrictions of the product in other countries)

8. Annexes

For France, the assessment process seeks to evaluate the probability of establishment and dispersal, the risk of adverse effect to human, animal, plant health, and the risk to adverse effect on other non-target organisms. This dossier is noticeably close to the EPPO standard PM 6/2. To this effect, the following data is required:

- Proof of the organism's identity (morphological and/or molecular identification)

- Origin of the claimed strain

- Data related to the biology and ecology of the species

- Data on measures implemented to ensure the sanitary quality of the population to be introduced (contaminants and others).

- Data related to the benefits of introducing organisms into the environment

Obtaining the right data is a recurrent challenge for Member States, especially for risk assessments<fnref n="90" />.

One of the main challenges identified during the study is related to the lack of available data regarding the impacts of IBCAs.

<footnote n="90">⁹⁰ Source: Responses to the questionnaire to NCAs – Question 26 for case studies</footnote>
Obtaining the necessary data to meet the application requirements can prove challenging, and a large part of the work relies on applicants. Assembling data may take about a year, but if there is not much known about the IBCA, this process could take longer. A biocontrol program from the beginning to the release can take over a decade depending on the complexity of the organism. Best practices and methodologies to perform a complete environmental risk assessment entail<fnref n="91" />:

- "Identification and evaluation of potential risk of releasing a natural enemy,"

- "A plan to minimize risk and mitigate unwanted effects of biological control agents," and,

- "A risk/benefit analysis of the proposed release of the natural enemy, together with risk/benefit analyses of current and alternative pest management methods", that may at the same time prevent serious mistakes without making biological control unfeasible<fnref n="92" />

A negative impact on an ecosystem can be defined as something that can be, "named and measured, such as direct and indirect negative effects on non-target organisms and negative effects on the environment."<fnref n="93" />

Risk assessments and pre-release tests are performed in a laboratory setting, in order to complete host specificity screening for the pest if it is a plant. There are specific and established regulations and tests required for herbivorous insects, such as the standardization for screening of biocontrol agents from the International Organization for Biological Control (IOBC), but much less regulation for predators and parasitoids<fnref n="94" />. Pre-release tests are different for herbivore, predator, and parasitoid species, and therefore, one single test cannot be applied to all three categories of invertebrates.

For each target, scientists analyse relationships through exposure tests, taxonomically, investigating relationships between predator and prey or preferred plants. One test performed is "no-choice," in which the invertebrate is given only one food source, and thus would have no choice but to consume what is given or not. Scientists can also perform "two-choice" or "multiple choice" with the same concept but with two or more food sources to determine what the insect is likely to consume. However, performing tests within greenhouses can produce inaccurate results because insects in a closed space will likely try plants within the greenhouse that they would not eat in the field because they have limited food sources. This would be the same for parasitoids and predators.

<footnote n="91">⁹¹ Environmental Impact of Invertebrates for Biological Control of Arthropods: Methods and Risk Assessment, chapter 15: "Environmental Risk Assessment: Methods for Comprehensive Evaluation and Quick Scan," (van Lenteren and Loomans 256)</footnote>

<footnote n="92">⁹² De Clercq, Patrick, Peter G. Mason, and Dirk Babendreier. "Benefits and risks of exotic biological control agents." BioControl 56.4 (2011): 681-698.7</footnote>

<footnote n="93">⁹³ Environmental Impact of Invertebrates for Biological Control of Arthropods: Methods and Risk Assessment Chapter 15 Environmental risk assessment: methods for comprehensive evaluation and quick scan (van Lenteren and Loomans)</footnote>

<footnote n="94">⁹⁴ Interview with Bernd Blossey, co-author of "Post-release Evaluation of Non-target Effects of Biological Control Agents" and professor at Cornell University</footnote>
Thus, the Member States identified several data gaps when the risk assessments are implemented:

- Data gaps concerning theoretically available information:

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

- Identity, origin, history and distribution of the organism in the national territory (Austria, France), and more specifically variations within species

- General lack of data and literature (France, Sweden)

- Data gaps concerning information that is either unavailable or difficult to obtain

- Establishment potential for non-native organisms (Austria, Sweden)

- Practical effectiveness (France)

- Unintended effects (Austria, France, Sweden), including on non-targets organisms and risks due to pathogens and endosymbiotic organisms, genetic diversity. Respondents from Austria and Sweden underlined the difficulty to evaluate the risk to the environment as some topics are not covered by existing research.

- Host range and prey preference in the case of polyphagous species

Regulators have to balance the need to perform a comprehensive assessment to mitigate risks effectively, with the cost incurred for the administration and the applicant, which may hinder the adoption of IBCAs<fnref n="95" />. The type of authorisation process used has an impact on the precision of the data required: authorisation systems which consider the specificity of the demand at the product level can be more demanding data-wise than authorisation systems which base their considerations on the type of organism. Overcoming current data challenges may require finding the right level of detail required for the authorisation process, engaging in further training applicants and sustaining research and development efforts in the field of IBCAs:

Risk anticipation is difficult, as there are almost always risks within biocontrol, but **the level of risk of biocontrol could be compared with**

<footnote n="95">⁹⁵ In this regard, IBMA questions the need to carry out several dimensions of the authorisation and risk assessment process, including local efficacy trials, requiring that the IBCA has been collected on the national territory, rather than on the broader European ecological zone, and considering distinctions between indigenous and non-native species at the country level rather than at the European level, on the ground that these dimensions of the assessment represent a significant cost compared to their value added.</footnote>
the risks of continuing with current practices, or "doing nothing.",
and be taken into account when performing the risk analysis.

In addition to the issue regarding data used for risk assessment, the post
release monitoring is also facing the same challenges leading to very little
available knowledge regarding the negative and positive impacts of IBCAs
on biodiversity.

The current post release monitoring strategies implemented in the Member
States rely on the submission of a report or alert if an unexpected effect is
identified. However, the identification of such effect requires a strong
scientific monitoring in place (which could be expensive).

There are various ways of monitoring IBCA populations, including mark-release-recapture (MRR)<fnref n="96" /> which, “has been the most widely used approach in the analysis of dispersal and has been applied to insects of all sizes” (Mills et al. 116). This strategy is predominantly used for quantifying movement and spread of IBCAs within the ecosystem. Several strategies can determine the effect that IBCAs have on natural ecosystems<fnref n="97" />, specifically taking field samples of the target pest habitat, to analyse if the IBCAs attack any non-target species and to determine the proportion of non-target species being attacked. Field samples include gut analysis (done in the field or in a laboratory) and should be performed on IBCAs to determine if non-target species are being consumed. Finally, when analysing what the IBCAs consume, one must examine the demography of not only the target pest, but also native species and potential non-target species<fnref n="98" />.

Introduction of herbivore IBCAs for the control of weeds may cause risks to existing plants (both crops and other plants), that may also be eaten by the herbivores, analysing an insect's impact on non-target species relies mostly on the examination of demography, how the population changes over time. The study of possible decline in population of native species along with other non-target species after the IBCA is released allows to determine the impact of the introduced herbivore species on the ecosystem.

Furthermore, the authors of "Post release evaluation of non-target effects of biological control agents" recommend creating a predictive model of the IBCA population's impact before they are released, and once completed, a life-table analysis post release should be done to demonstrate how the predictive models compare to the post release evaluation. A life table analysis would examine the mortality, birth, and reproductive rates of

<footnote n="96">⁹⁶ Environmental Impact of Invertebrates for Biological Control of Arthropods: Methods and Risk Assessment, chapter 7: "Methods for Monitoring the Dispersal of Natural Enemies from Point Source Releases Associated with Augmentative Biological Control"</footnote>

<footnote n="97">⁹⁷ Environmental Impact of Invertebrates for Biological Control of Arthropods: Methods and Risk Assessment, chapter 10: "Post release evaluation of non-target effects of biological control agents"</footnote>

<footnote n="98">⁹⁸ Interview with Dr. Bernd Blossey</footnote>
organisms, along with hazard and survival rates of the population over a
certain time period<fnref n="99" />.

Scientists who work with predatory IBCAs cannot always conduct very sophisticated post release tests because it is complex and measuring demography is difficult and expensive. The scale of the project further impacts the cost of monitoring: the time necessary to complete post release monitoring may take between five to twenty years, as biocontrol is usually slow.

### 3.3.2 Facilitation of the administrative process and support to the applicants

Generally, all Member States who have a regulation on IBCAs also have some level of facilitation of the administrative process and support to the applicants. Only exceptions are Germany (who is in the process of reviewing the existing regulation), Slovakia and Slovenia.

7 Member States reported having publicly available guidance: Austria, Denmark, Finland, Greece, the Netherlands, Spain and Sweden. In Austria, this is included in guidance and pre-submission meetings available to all kinds of plant protection products. Romania also has measures for plant protection products and fertilizers, but none are specific to IBCAs. In Sweden, a web-based application system with guidance is planned. More generally, the competent authorities specified that some level of guidance is included in the application forms.

5 Member States can offer pre-submission meetings to applicants, although this can take several forms: in France this is informal assistance in the pre-constitution of dossiers prior to their submission to Anses, in Latvia these meetings are available on request of the applicant. In Sweden, SEPA has ongoing contact with companies that wish to have new IBCAs approved.

Several Member States also have internal facilitation of the administrative process. Specifically in Italy, where the subject of IBCA is regional matter, the National Phytosanitary Committee sets up specific National Technical Groups on specific biocontrol problems in which scientific institutions and stakeholders also participate.

### 3.3.3 Shortcoming and challenges identified by the Member States regarding the implementation of their national regulatory framework

Several Member States are rather satisfied with the current functioning of their regulatory frameworks and mention few to no problems<fnref n="100" /> (Latvia,

<footnote n="99">⁹⁹ Hintze, Jerry L. (2007) "Life-Table Analysis." NCSS User's Guide III. https://ncss-wpengine.netdna-ssl.com/wp-content/themes/ncss/pdf/Procedures/NCSS/Life-Table_Analysis.pdf (570-1, 570-2, 570-3)</footnote>

<footnote n="100">¹⁰⁰ Source: Questionnaire to NCAs - Question 41</footnote>
Netherlands, Spain, Sweden). Some Member States would rather mention challenges or share good practices (like Sweden). Several areas of improvement and challenges have been identified by the Member States::

- Organisational and administrative issues (e.g. Slovenia, Italy, Bulgaria, Germany, France) may impact the length of authorisation procedures: different administrations and administrative perimeters may be involved in the process and generate time-consuming back-and-forth between administrations. Human resources (human capacity but also internal expertise) may also be lacking and insufficiently trained to make adequately informed decisions on IBCAs without relying on external expertise.

- Legislative issues (Finland, Sweden, Bulgaria, Greece) may arise from a scope that is too limited. For example, the lack of inclusion of environmental effects in the legislation, the absence of clear definitions for native and non-native species, the lack of inclusion of SIT, or the lack of an effective and efficient monitoring system are all issues that have been reported by Member States.

- Application processes and data gaps (Netherlands, Austria, Sweden): the national application processes may not be to applicants, which hinders the quality of applications. Lack of experience of applicants in drafting a dossier is also frequent, and producers are small and medium enterprises have difficulties in drafting applications and shouldering application costs. Finally, producing new knowledge once information gaps have been identified remains a challenge.

Several good practices have sometimes been established to overcome the identified shortcomings:

- In Sweden, the change from product to organism authorization has been positive with respect to increasing the number of available IBCAs and lowering the cost and administrative work required. Organism-based authorization systems however come with their own challenges, in that the monitoring of the products used and not registered in Sweden is more difficult, for example, if there is need to follow up possible side-effects in the field.

- In Sweden as well, to try and bridge the knowledge gaps, information gaps are acknowledged in evaluations performed on the initiative of SEPA. The Swedish Environmental Protection Agency communicates knowledge gaps continuously to universities and research centres (such as the Swedish Agricultural University), which has resulted in both master theses, analyses, and experimental studies (some with funding from SEPA).
## 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?

This question aims at identifying the main regulatory or other instruments used in the Member States to promote and foster the development of IBCAs. In addition to national strategies, the answer to this question relies on the analysis of the current use of specific instruments to support the development and the use of IBCAs, especially:

- Use and role of internationally agreed guidance documents and especially EPPO standards in the current regulatory process or other commercial activities;

- Organisation, role and support provided to research and development;

- Knowledge transfer organization and support, training activities for national authorities, private advisers, industry and users;

- Economic and financial incentives such as tax relief for industry and/or users, fast track procedures in administrative processes, financial instruments to increase uptake of IBCAs at user level, etc.).

- Perception from stakeholders of the different approaches to regulation in the Member States

### 3.4.1 Role of internationally agreed guidance documents

The main international organisation relevant to biological control of plant pests is the International Plant Protection Convention (IPPC), which has designed frameworks regarding the import and release of exotic biological control agents

Even if there is no specific framework at the European Union level, there are some international standards with specific guidelines and risk assessment of products.

**The IPPC/FAO ISPM-3 Guidelines** for the export, shipment, import and release of biological control agents and other beneficial organisms are the main international framework for IBCA regulation. They were first adopted in 1995 and later revised in 2005 and 2017. They define standards that list the related responsibilities of contracting parties to the IPPC, national plant protection organizations (NPPOs) or other responsible authorities, importers and exporters: "*The standard addresses biological control agents capable of self-replication (including parasitoids, predators, parasites, nematodes, phytophagous organisms, and pathogens such as fungi, bacteria and viruses), as well as sterile insects and other beneficial organisms (such as mycorrhizae and pollinators) and includes those packaged or formulated as commercial products.* Provisions are also
included for import for research in quarantine stations of non-indigenous biological control agents and other beneficial organisms."

Exporters and importers are encouraged to ensure the safe transportation of these products, along with proper documentation to provide to the national authorities. NPPOs and / or the relevant designated contracting authorities are encouraged to:

- carry out pest risk analysis of biological control agents and other beneficial organisms prior to import or prior to release

- ensure, when certifying exports, that the phytosanitary import requirements of importing contracting parties are complied with

- obtain, provide and assess documentation as appropriate, relevant to the export, shipment, import or release of biological control agents and other beneficial organisms

- ensure that biological control agents and other beneficial organisms are taken either directly to designated quarantine stations or mass-rearing facilities or, if appropriate, passed directly for release into the environment

- encourage monitoring of release of biological control agents or beneficial organisms in order to assess impact on target and non-target organisms.

The IPPC subsection relevant to Europe is the European and Mediterranean Plant Protection Organisation (EPPO), although its scope is broader than the European Union, with 52 members

Nine regional plant protection organizations (RPPOs) work to facilitate the implementation of the IPPC among its 180 contracting parties. The relevant RPPO at the European level is **EPPO (European and Mediterranean Plant Protection Organisation)**. All EU-Member States are adherents to EPPO, although its geographical scope is wider. EPPO established in 1996 a **Panel on biological control agents**, which operates along the lines set out by the IPPC, strongly focusing on invertebrates, and occasionally including microbials.

EPPO works conjointly with the International Organisation for Biological and Integrated Control – West Palaearctic Regional Section (IOBC-WPRS in a Panel, to consider all aspects of the assessment and regulation of the import and release of biological control agents for use in plant protection and assists the EPPO Secretariat and Working Parties in preparing guidance for use by member countries and the biological control industry. Since then, the Panel has developed four Standards, intended to be used by the relevant authorities at national level in their overseeing and, if appropriate, regulating of the introduction and use of biological agents.
The **EPPO standard series PM 6 – ‘Safe use of biological control’** provides information concerning import and release of invertebrates, as well as a decision-making scheme and a list of IBCAs which are widely used in several EPPO countries. Although these standards are not legally binding, they are useful instruments for a National Authority (i.e. National Plant Protection Organisations) to structure the facilitation, implementation and need for information requirements for risk assessment of IBCAs.

Providing general guidelines for risk assessment and reduction of biocontrol agents, the Standards make a framework intended to be "as light as practically possible" as not to hamper the growth of BCA use.

- PM 6/1(1) 'First import of exotic biological control agents for research under contained conditions';

- PM 6/2 (3) 'Import and release of non-indigenous biological control agents'. These Guidelines for the completion of an application form for import and release of BCAs in EPPO countries are available on the EPPO website. They cover four main categories:

- Part 1. Application information (information on the applicant, purpose of the application and use)

- Part 2. Information for indigenous and non-indigenous BCAs (taxonomy and origin, product information)

- Part 3. Information requirements for intentional release of a non-indigenous BCA with reference to: Biology and ecology, and assessment of risks and benefits (Establishment, Host specificity, Dispersal, Non-target effects)

- Part 4. Submission of forms and signature (Submission details, agreement: safeguards and signature)

- PM 6/3(5) 'List of biological control agents widely used in the EPPO region- 2021 version'. This list is amended on a yearly basis (except between 2002 and 2008), approved by the EPPO Working Party for Phytosanitary Regulations, and represents a register of BCAs for which EPPO recommends its member countries to use a simplified procedure for import and releases. Criterion for inclusion include

- For **augmentative BCAs** (appendix 1): they must have been marketed and officially used, and be widespread in the EPPO region or parts thereof (either indigenous or established), or have been used by at least 5 EPPO countries for at least 5 years and in any of these cases with no reported adverse effects, or with acceptable adverse effects

- For **classical BCAs** (appendix 2): successfully established BCAs 5 years after their introduction

- Appendix 3 includes BCAs which previously were on the above-mentioned lists, but removed as there were reports of adverse effects; these species need to be re-assessed before introduction
* PM 6/4(1) 'Decision-support scheme for import and release of biological control agents of plant pests. It can be used by a national competent authority to assess whether to authorize the import and release of a non-indigenous BCA.

EPPO has also developed Guidelines on Pest Risk Analysis (standard PM 5/1(1)) with a checklist of information required for risk-assessment. It is currently under revision and brought 'in line' with ISPM 11- IPPC, but yet has to be adopted for IBCAs specifically. These guidelines aim to facilitate procedures for a proper risk-assessment, but they do not yet provide working instructions for the risk-assessment itself.

Nevertheless, these standards are not sufficient to create a level playing field between Member States, as clearly stated in the recitals to Council Decision (EU) No 2021/1102, which requests the Commission to assess the potential for harmonisation within this study.

**The available guidance is often informally considered in the different regulation systems developed by European Member States**

Most MS have used the IPPC/EPPO standards when developing their regulations (with or without referencing them explicitly) or have integrated them to some extent. The other standards mentioned by NCAs in their questionnaires are the International Standards for Phytosanitary Measures (ISPM) for Italy, and the Organisation for Economic Co-operation and Development (OECD), EFSA and IOBC for other Member States.

**Regarding EPPO guidelines, some Member States rely on the use of these guidelines to authorize the use of IBCAs.**

**The most frequently used guideline is the EPPO PM 6/3 "safely used" list:** 11 Member States (Austria, Czech Republic, Finland, France, Greece, Hungary, Italy, Latvia, the Netherlands, Spain, and Sweden) declared that they take this standard into account when reviewing risk assessment in the applications. As indicated by Sweden, "The fact that an IBCA has been assessed and included on the positive-list is of course an advantage in the risk assessment". Most Member States however still carry out their own risk assessment, but in some Member States, the IBCAs listed in the EPPO positive lists are concerned only by simplified procedures (in Spain, they are considered native and subject to fast-track authorisation processes). Belgium (the regions of Brussels and Flanders), Germany and Portugal also indicated that in their future regulations, the EPPO standard PM 6/3 will also be included.

In line with this general alignment, the data requested in application processes seem mostly consistent with EPPO standards, which are often adapted into the regulations. Specifically, the Netherlands indicated strong participation within the EPPO-IOBC Panel and the development of the standards. As a consequence, the regulation in the Netherlands is aligned
quite strictly to these standards (with the standards PM 6/1 and PM6/2 being applied to non-indigenous BCAs only) and is expected to evolve taking into account the newer standards. The national whitelist in the Netherlands was set up in 2017 but is different from the safely used EPPO list. Its upcoming revision is also expected to include information from the EPPO list.

Explicit mention of international guidance documents within the regulatory texts is rarer. In Italy, the Ministerial Decree mentions the ISPM 3, and the FAO code of conduct for the import and release of exotic biological control agents.

### 3.4.2 Contribution of research projects and funding of product development to availability and usability of IBCAs

The availability of IBCAs strongly relies on research and development to develop effective solutions and ensure that they do not present risks for the environment. Inversely, even if some IBCAs 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).

At European level, around 129 projects can be identified in the EU database Cordis in the last 20 years through a search with key word "biocontrol"<fnref n="101" />. The number of projects supported by the European Union tends to increase above years, thus, from the selection of 129 projects:

<figure><img src="image_27.png" /><figcaption>**Figure 11 - Number of research projects on biocontrol supported by the European Commission**</figcaption></figure>

Source: EY based on Cordis database

From the Horizon 2020 projects, the projects mainly concerned the mobility of researchers and their training and exchange of knowledge, support

<footnote n="101">¹⁰¹ Exploring the benefits of biocontrol for sustainable agriculture (ibma-global.org)</footnote>
public-private partnerships to developing near-to-the-market prototypes of biological agents and increase technology readiness levels of the solutions and finally support collaborative research projects to support the development of specific guidelines or foster the development of products.

A national level, the organisation of research and development is strongly related to the potential for commercial development of IBCAs. Thus, research and development for classical biological control and development of SIT are mainly supported by public authorities as it requires important costs of development, longer timeframe, and limited commercial perspectives. Indeed, the aim of classical biological control is to establish the IBCAs in the environment in the long term so little to no repetitive commercial activity could be envisaged. For SIT, it seems that the process is highly technical and use effective when it concerns geographical area of a certain size, so the decision to use this technique is mostly not made at individual grower level.

For the most part, commercial perspectives rely on augmentative biocontrol, where a part of the research and development is supported by private companies, or through public-private partnerships (in Spain for instance). The industry, through supplier field agents and crop consultants, is in constant contact with growers; advising on cultivation (incl. pest management practices). During these on farm visits, IBCA producer consultants obtain first-hand 'needs-knowledge' of growers. This information is fed back to R&D and business intelligence structures at IBCA producers and Business Cases for new emerging or reoccurring pests are developed. Local growers' associations, research and academic institutions survey pest incidence and prioritize R&D needs. Much of the latter is often done in collaboration with private IBCA producer businesses in order to also consider later stage commercialization.

## Success stories

Thanks to the research and development work carried out by public and private organizations, the improvement of breeding and packaging techniques have allowed the development of diffusers that contain *Trichogramma* at different stages of development to ensure staggered releases and cover the entire egg-laying period of the borer. This is one of the main successes of the IBCAs spread in the agricultural sector

Some of the very first research projects in the Netherlands are examples of R&D success stories. In the Netherlands, the use of *Encarsia formosa* against greenhouse whiteflies in the 1980's is a good example. Collaboration between academics (Wageningen UR) and growers was essential. More recent examples of such collaborations between producers and academics include the use of predatory mites.

Industries, generic public research financing and dedicated national or regional funding programmes (e.g. aiming at promoting IPM, Agroecology or biocontrol) consistently finance research and development in Member State organisations. However, most investments are of small size (when compared to that on pesticides or other biocontrol categories).
The size of the R&D public or private community is relatively small, with teams well identified in each MS and experts involved in the main biocontrol networks or associations (IOBC). Overall, R&D activities result in 1-3 new IBCAs per year for augmentation and 1 or 2 ongoing classical biocontrol programmes (i.e. one programme starting every 4-5 years and lasting 4-7 years).

### 3.4.3 Knowledge transfer and training on the use of IBCAs usually takes place at the industry-to-grower level

*The knowledge of professional users regarding IBCAs stems mainly from general information provided by authorities as well as industry advisory services*

Having an important understanding of the correct use of IBCAs and the main stakes surrounding them is particularly important. This is due to the specific nature of IBCAs: contrary to conventional pesticides that are simply applied to control a pest, IBCAs need to be considered in a broader perspective, at the ecosystem level: an understanding of the targeted pest and IBCA life cycles, their interaction and timing in order to apply the most appropriate management strategy. This ecosystem perspective also integrates natural conservation strategies, which are a factor to invertebrate biological control success. In Spain, a tool has been designed to advise growers how to establish the right functional biodiversity surrounding the greenhouses<fnref n="102" />. One of the companies producing IBCAs is also already providing information to the growers about how to design margins and islands of vegetation inside the crops that favour the native populations of natural enemies, as well as providing commercially the mixtures of native plant species to create these ecological infrastructures.

In the countries selected for the case studies, general information is available to all users<fnref n="103" />. A formal training is not required to use IBCAs in the Member States. In Hungary, the information which is considered as necessary for the use is provided through the authorisation certificate, and no qualification or license are required for the purchase and use of the product. In Sweden, written information is also available from the Swedish Board of Agriculture and can be accessed online<fnref n="104" />. The effective knowledge of users however depends on the accessibility of the information, and therefore on the dissemination strategy, rather than on its mere existence.

For professional users, more detailed information is often provided by the IBCA industry and the users' technical staff<fnref n="105" />. In Austria, basic use information is provided by use tables and supporting label

<footnote n="102">¹⁰² https://www.arc2020.eu/wp-content/uploads/2017/06/WackersVanRijn-Gurr2012-Ch9.pdf ; www.diseñen.es</footnote>

<footnote n="103">¹⁰³ Source: Responses to the questionnaire to NCAs – Question 45 for case studies</footnote>

<footnote n="104">¹⁰⁴ www.jordbruksverket.se</footnote>

<footnote n="105">¹⁰⁵ Source: Responses to the questionnaire to NCAs – Question 45 for case studies</footnote>
warnings/advice, and specific support is usually provided by authorization holders, through instructions of use, according to the questionnaire. Similarly, in the Netherlands, according to the questionnaire, informing and training users about product application is considered as the responsibility of the producer and not that of the authority.

The degree of knowledge may therefore differ depending on the status of the users:

- **Users of IBCAs in the professional field are generally sufficiently informed**, according to IBMA. Technical support is often part of the service provided by companies, on top of products. Season-long contracts are often made for biological crop protection during the growing season. Furthermore, suppliers of IBCAs may be incentivized to inform farmers, so that their products are used correctly to increase the farmers' confidence in the products. The degree of knowledge may however differ depending on the profile of the user and on the country. Data from Sweden confirm this positive outlook on farmers' general knowledge regarding IBCAs, for the case of Sweden: according to the questionnaire, most of professional growers have a basic education regarding plant protection products, apart from a number of organic growers, and information about the legal framework, including that for the IBCAs, is included in this education. Some information about the use of specific IBCAs is also included in the education for use of pesticides in greenhouse production. It should be noted that according to Directive 2009/128, all professional users of pesticides in the EU must follow training or undergo similar measures on, amongst others, IPM strategies and techniques and on biological pest control methods. According to a 2019 report by the Swedish Plant Protection Council<fnref n="106" />, there is a good knowledge on IBCAs among users, as they often work closely with their advisor (wholesale IBCA companies). The report suggests that advisory, information and communication initiatives would be useful to increase the use of IBCAs among those who don't use them. Most States also have specific measures in place to facilitate the administrative process. Several factors may however limit the knowledge available to professional users at the European level, such as formal training on IBCAs is currently limited in curricula from agricultural schools and universities.

- **Amateur users, or more generally users who often buy products from third parties or on the internet may be considerably less knowledgeable than professional users** who receive advice and training from biological control companies.

<footnote n="106">¹⁰⁶ Jordbruks verket (2019), *Hinder för ökad användning av alternativa bekämpningsmedel*, retrieved from: Hinder för ökad användning av alternativa bekämpningsmedel (jordbruksverket.se)</footnote>
The industry estimates that there is a **wide discrepancy between Member States with regards to availability of biocontrol experts**, who not only have experience in the subjects of Entomology, Nematology or Acarology and crop production, but also **understand the integration into grower needs**. As a result, regulatory personnel in national competent authorities often lack understanding of IBCA application in IPM strategies, in particular in the field (covered crop and open field). During the consultation, IBMA suggested that an expert panel or group constituted of IBMA / EPPO / IOBC experts could deliver regular "training" to competent national authorities, especially to raise awareness in the use of IBCAs in IPM strategies.

From the side of public research experts, the opinion is that intensity and quality of knowledge transfer and training are correlated to the size of the IBCA markets and intensity of IBCA uses. For example, the professional communities (producers, advisors, groups of producers, etc.) working on greenhouse crops display high level of expertise on IBCAs and knowledge transfer is ensured via multiple canals: companies, extension services, research projects increasingly involving local stakeholders (for co-design and transfer). In areas with high usage of biocontrol (e.g. in the regions of Almeria or Valencia in Spain), a rich landscape of public to private organisations are involved on knowledge transfer and training and are supported by regional public bodies). However, in crop sectors where no or little IBCA use exists (e.g. cash crops), level of expertise is low and involvement of public and private organisations is close to inexistent.

**Concerning knowledge transfer and training towards end users,** public authorities could develop more positive communications, workshops, and more incentives for the use, sanctuarizing and focusing on IBCA as a sustainable tool, especially in IPM programs. In Austria, the national agency for health and food safety (AGES - Österreichische Agentur für Gesundheit und Ernährungssicherheit) sees the submission of an application, which includes in its data requirements detailed instructions of use as part of the submitted data, to be a form of knowledge transfer. According to IBMA, on the academia side, there is limited focus on IBCA in curricula from agricultural schools and universities. The industry estimates that universities and research institutions could be stimulated to transfer their knowledge to growers through extension programs. However, this could also be led to a lack of knowledge and diffusion of the existing materials and training to the farmers.

Finally, to counter **limited funding regarding independent advisory services and knowledge dissemination**, supporting the development of demonstration farms could contribute to disseminating knowledge, as it has been identified as an important tool for raising awareness and changing attitudes to alternative pesticides in general. Forums for exchanging experiences and disseminating information should also be encouraged, and even harmonized at European level.
## Good practices regarding knowledge transfer and training: France and Sweden

### Sweden

The Swedish Board of Agriculture provides education for advisors about IPM and the use of IBCAs. Written information that can be used by advisors and users is directly available on the web-site: Växtskyddsåtgärder i din odling - Jordbruksverket.se. There are also regular meetings organized by for example The Federation of Swedish Farmers (LRF) or The Rural Economy and Agricultural Societies, - with advisors, industry and users, at national, region and association level, in which information about IBCAs is included in the information about IPM strategies.

### France

#### Knowledge transfer

In France, the "biocontrol" consortium, launched in 2016, aims to promote the use of biocontrol and support the deployment of biocontrol in France. The about 50 private and public members of the consortium work jointly on scientific and technical programme of collective interest. The consortium's strategy is to focus its efforts on pre-competitive research and actions aimed at increasing the expertise and know-how of the Research-Development-Innovation community. It is not specifically focused on IBCAs but on all biocontrol alternatives to chemical pesticides.

At regional scale, competitiveness clusters are also working closely with industrials and institutes to bring together research and innovation and allow the transfer from academia to industries. Five clusters are oriented toward biosolutions, included IBCAs.

France regularly launches calls for projects open to biocontrol manufacturers. The selected projects generally involve public laboratories, technical institutes and private organisations.

#### Sporadic training activities

Although there is no coordination of technical trainings at national level by the French authorities, the French Ministry for agriculture and Food participates to workshops and trainings to present the French regulation of IBCAs. They are delivered to professionals, regional authorities, competitive clusters, university, institutes...

### 3.4.4 Strategic approaches in different Member States regarding the development and use of IBCAs

Member States have different approaches regarding their national strategy to support the development and use of IBCAs. Some of the Member States have also developed specific financial incentives to support the implementation of this strategy.
For instance, France adopted an action plan in 2008 regarding plant protection products and the support to an agriculture less dependent to chemical products ("Ecophyto" Plan). One of the priorities of this action plan aims to increase the research and development of alternatives to chemical products and their use by farmers. More specifically, the objectives are to:

- Reinforce research and development activities of sustainable solutions

- Support the development of biocontrol through the support of innovation in SMEs and the improvement of the current national authorization process (reduction of delays) as well by encouraging the European Commission to recognize biocontrol products in regulation 1107/2009

- Facilitate the access to natural preparations of low concern

- Support farmers in the adoption of existing alternatives and favour collective approaches

Since 2020, it has been accompanied by a strategy for the deployment of biocontrol (2020-2025) that plans specific actions related to research and development, training, communication, and public policies fostering the development and use of biocontrol solutions. In this frame, a large R&D programme specific to biocontrol, supported by public financing of about 40 M€ over 5 years, is under preparation. Specific provisions have been put in place to encourage retailers of plant protection products to promote the use of various alternative methods to chemical pesticides through a regulatory system called "certificats d'économie de produits phytopharmaceutiques (CEPP)". IBCAs are part of these alternative techniques since 2019.

However, in France and other countries where public financing supports R&D on IBCAs, the extent of support is, overall, proportional 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). Seen the small size of IBCA markets, resources available to IBCA R&D remains very modest, even in the most active MS (e.g. France, The Netherlands, Spain). For example, consolidated data from public financing of R&D projects in France (2017-2021) reveals that direct subvention to IBCA research and development is between 1 and 2 million € per year (which is consistent with the idea that R&D efforts of private actors is approximately 10% of their sales – approx. 15-20 M€ / year – and that there is a balanced effort between the public and private sector in France). This tight link between public and private investment also accounts for the relatively low support of conservation/classical biocontrol and autocidal control for which the industry currently does not allocate efforts.

IBCA are also included in some MS strategies. In Austria, the strategy process "Zukunft Pflanzenbau" ("Future Plant Production") of the Austrian Ministry of Agriculture, Regions and Tourism includes regular round table
meetings called "Dialog Zukunft Pflanzenbau" of experts and stakeholders. Amongst others, the use of beneficials as plant protection products was discussed (2017). In the Netherlands, such programmes also exist: there are different funding programmes for research where companies may be involved. These funding bodies are versatile. National programmes include NWO, Dutch Research Council, PPS, an example of a dedicated international programme is the BINGO-ITN framework of the Marie Curie Grants.

IBCAs are also included in several CAP plans: in Germany, IBCA use is subsidized in the case of *Trichogramma brassicae* against European Corn Borer. The use of IBCA in greenhouses is supported as agri-environmental measure within the second pillar of CAP-scheme. In France, IBCAs are also included in the CAP plan.

### 3.4.5 Perception from the industry of the different regulatory systems

Knowledge regarding the current regulatory systems in place in the Member States is very scarce, only the industry had a sufficient knowledge to give a comparative perception of the current frameworks.

The average time needed for the assessment and approval of products in the different Member States is very variable, with 3 to 24 months between renewal and new registration and a median of 6 to 9 months. For example, in Spain the commercialization is allowed from the moment the communication (for native species) is sent, and in Finland, IBCAs on the EPPO list are typically approved within two weeks (industry data). In the case of France, approval of commercialization can take up to 24 months (industry data).

The costs for these procedures for biological control companies are estimated and reported below (based on IBMA data):

<table><tr><td rowspan="6">Application and registration costs</td><td>Finland, Belgium, UK, France: no fees for applicants</td></tr><tr><td>Latvia: 284€</td></tr><tr><td>Sweden: 747€</td></tr><tr><td>The Netherlands: 800€</td></tr><tr><td>Austria: around 2300€</td></tr><tr><td>Spain: Communication of commercialization of native IBCAs: 223,92€, Request of authorisation of exotic IBCAs: 746,36 €</td></tr></table>

Source: IBMA, questionnaire to NCAs

For the industry, putting a new product on the market also entails internal direct and indirect costs, referred to as "Market Access expenditure". In addition to the application and registration costs presented above, it also entails documentation fees (legalization, translation, postage, consultant),
trademark maintenance, time and human resources, and were estimated at around 25 000€ per product. Additional record keeping costs linked to the frequent actualization of dossiers (related both to Market Access costs and R&D trials and confirmations) are also incurred by the development of products and their authorization and estimated at around 5 000€ per product.

**Some Member States are recognized as having clear frameworks and procedures by the industries:**

Concerning industry perception of the different regulatory systems, **Finland, France, and Spain** are seen as having very clear regulations and procedures, based on native status and environmental risk assessment. Spain was highlighted by the industry for its regulation on naturally occurring species, as only a communication sent to the Plant Health DG of the Ministry of Agriculture, Fisheries and Environment (MAPA) suffices to obtain the registration of the product. This communication, at the moment it is sent, also allows commercialization to start.

**Denmark** regulations are also well appreciated by the Danish IBCA manufacturers who were interviewed during the collection phase, especially with regards to IBCAs on the EPPO list, that can easily be imported and produced without complex, costly, or time-consuming registration processes.

**The Netherlands** has a process that is also rated as clear and simple, as native and widely used beneficials are exempt from regulation/registration requirements. Newly discovered natives or imported IBCAs can be applied for based on a risk assessment with the RVO, where the latter process is highly transparent with open interaction with the case officer.

**Hungary** was described as having a clear procedure, with case-by-case exception for pest of significant economic importance. Hungary recognizes neighbouring Member State decisions in support of an environmental risk assessment for the approval of IBCAs native to other EU countries.

On the contrary, some Member States are seen as having developed restrictive frameworks for importation and release of IBCAs. The Finnish producer of IBCAs mentioned Austria, Germany and Sweden as extremely difficult MS to export to. Larger companies may have the resources needed, but smaller companies find it is very difficult to get their biocontrol products approved and registered. This shows that complex legislations can also have an impact on the competitiveness and integration of the IBCA market.
## 3.5 Q5: Which successful alternative approaches exist in countries outside the Union and how can they be characterised?

In order to provide experience and examples from countries outside the European Union, New Zealand and the USA were chosen to provide inputs on their national frameworks. The goal was to understand the type of organisation and regulation adopted as well as ensure a global international coherence on this subject.

### 3.5.1 New Zealand

#### Uses and market

Few information is available on the uses, as neither the Environmental Protection Authority (EPA) nor the Ministry for agriculture and forestry (MAF) focus on IBCA as a separate category.

Most of the time, BCA releases are used to control weeds and invasive insects in classical biological control programs outside of the agricultural sector. In particular, biological control is mainly used for weeds that are hard to reach out (weeds far in the forest or high in the mountain). Successful examples are showcased on the EPA biological control online page<fnref n="107" />.

In parallel, New Zealand is one of the countries that uses most pesticides and herbicides in the world, and the primary sector is very important. The growers community tend to use pesticides to treat their crops more than biological control agents. The mindset is reported to be changing slowly, but there are no financial incentives to support the use of biological control agents in crops.

#### Regulatory framework

Public authorities have long-term established regulatory processes for the use of IBCAs. The regulation process for the introduction of new biological control agents in New Zealand is described in the 1996 Hazardous Substances and New Organisms Act (HSNO Act), which came into force in 1998 for new organisms, and 2001 for hazardous substances. It was formerly managed by the Environmental Risk Management Authority (ERMA). In 2011 the responsibilities of this government agency have been transferred to a new public body, the Environmental Protection Authority (EPA).

This 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 (when the HSNO came into force for new organisms), and an indicative list is available in the Ministry for Agriculture and Forestry's Biosecurity Index. "New organisms" include any species of any animal, plant, bacterium, virus and genetically modified organisms<fnref n="108" />.

<footnote n="107">¹⁰⁷ https://www.epa.govt.nz/industry-areas/new-organisms/biological-control-agents/</footnote>

<footnote n="108">¹⁰⁸ https://environment.govt.nz/assets/Publications/Files/guide-to-hsno-act-jul01.pdf</footnote>
It distinguishes between biological control agents (both macro and micro-organisms) and other organisms (such as tropical plants or pollinators). In some cases where the environmental risk is low such as the importation in contained environments like laboratories, or for SIT, rapid pathways exist (25 working days). Although the assessment is typically done at species level, the EPA can decide to approve an organism at the strain level.

Since 1998, 39 biological control agents have been approved by the EPA. They include both micro and macro-organisms, and are used to control insects (11 BCAs) and weeds (28 BCAs).

Binding deadlines require a quick decision of public authorities after the filing of an authorization request.

The fees associated with the formal application are 25 000$ for biological control agents, and 35 000$ for other organisms. In practice, many applications go through a sometimes long pre-application stage, where drafts can be submitted by the future applicant, and reviewed and commented by the EPA, free of charge. Potential rejections are usually identified before the formal receipt of the application and withdrawn, leading to on average 2 formal applications per year. Once the application is formally submitted, the EPA has 100 working days to assess it. The breakdown is as follows:

- 10 working days to make a rapid assessment of the application and publicly notify the application<fnref n="109" />. This includes making a list of stakeholders that may be interested, contacting them, and

- 30 working days to collect submissions from the open consultation (Maori consultation should typically be done before the application is formally received)

- 30 working days to organize a hearing (if requested by a stakeholder or a member of the civil society). A report should be publicly available 10 days before the hearing.

After this consideration period, the EPA meets with the committee and submits their assessment report and recommendation.

Once the EPA has released their assessment, the applicant can obtain the permit for release from the HSNO Committee. Although a feedback form at the end of each process is sent to the applicant and submitters, the EPA's role does not exceed this recommendation for approval and does not regard effects after actual release. This lack of post-release impact consideration is identified by the EPA as the main shortcoming of the regulatory approaches in force. In the future, the Authority's role might evolve to include this.

**The assessment process is based on a risk-cost-benefit (RCB) analysis**

The 1998 HSNO Act principles stipulate that if the benefits of a new introduction are higher than potential adverse impacts, it should be

<footnote n="109">¹⁰⁹ https://www.epa.govt.nz/public-consultations/</footnote>
allowed. This approach is radically different from the one focusing on the
quantum of risk, without analysing the potential benefits. In practice, the
EPA follows guidelines describing the positive and adverse effects (risks and
costs are generally regarded as being adverse (or negative) effects, and
benefits as being positive). Most information is provided by the applicant,
but the EPA also conducts a literature review and, from time to time, hires
a consultant expert in a specific domain.

Regarding risks, cost and benefits, the EPA considers both the likelihood of
occurrence (probability) and the potential magnitude of the consequences,
as well as at distribution effects (who bears the costs, benefits and risks).
The risks and benefits that are considered are the following:

- Environmental (e.g. could the organism cause any significant displacement of any native species within its natural habitat, cause any significant deterioration of natural habitats or cause significant adverse effect to New Zealand's inherent genetic diversity,

- Plant health (is the organism likely to cause disease, be parasitic, or become a vector for animal or plant disease? Risk to other crops)

- Human health and safety

- The relationship of Māori to the environment, the principles of the Treaty of Waitangi, society and the community

- The market economy

- New Zealand's international obligations.

Risk of unintended spread is not considered, as the regulation does not
differentiate between classical and augmentative biocontrol. Due to the
latitude of the island, many species have the potential to establish (for
example, the winter season is not cold enough) and are treated as such. It
is also relevant to point out that in the application, the described use is not
specific to a crop: the EPA only considers the couple targeted pest / biocontrol agent. A list is available on the EPA website.

Facilitated access to EPA advisors and clear online communication
allow for detailed applications

Due to the pre-approval period, most applicants have detailed enough
applications (although Māori consultation was identified as the most
common data deficit). The quality of applications is variable depending on
whether the applicant has experience with the process and the EPA's
information needs. Even with experience, in the pre-approval period a lot
of back-and-forth can happen.

The EPA pages on biological control also include some positive
communication<fnref n="110" /> on the benefits and relevance of biological control.

<footnote n="110">110 https://www.epa.govt.nz/industry-areas/new-organisms/biological-control-agents/</footnote>
Best practices identified in New Zealand:

- The **informal open-communication canal** between applicants and the EPA, which improves the quality of formal applications

- The short and clearly paced timeframe for processing applications

- The open consultation procedure

- The inclusion of **benefits to the market economy** in the risk assessment requirements

3.5.2 The United States of America

The situation in the USA concerning "commercial" biological control agents is similar to that of the European Union: little information is available at the level of the National Competent Authorities, and most of the information comes from the industry. However, patterns of use seem to be similar to European Union: a large percentage of commercial biological control agents are used in greenhouses. The use in crops under field conditions is also significant (e.g., strawberries and cannabis).

In the USA, federal regulatory system covers the importation, interstate transportation, transit through the United States of America, and a list of indigenous or established species that can be moved Interstate without a permit

In **the USA**, the federal context implies the construction of a harmonized regulatory system. The overarching regulations relevant to IBCAs is the Plant Protection Act (2000)<fnref n="111" />. This act, and more specifically the rule 330, which explicitly prohibits the unauthorized importation, interstate movement, transit through the US, and release of biological control organisms and pests into the environment. It also sets exceptions and requirements for packaging. It should be noted that rule 330 also covers plant pests, pathogens, and organisms under study as biostimulants until their mode of action is elucidated and ultimate jurisdiction determined (transfer to the Environmental Protection Authority if relevant).

The authorization process is led by a federal administration within the U.S. Department of Agriculture, the Animal and Plant Health Inspection Service (APHIS), department of Plant Protection and Quarantine (PPQ). There are no legal fees. APHIS issues permits specific to each scenario: importation, transportation, release... Export however is not limited in any way, except for protected and endangered species.

This regulation includes a framework for the entirety of the United States, as well as its Territories and Possessions, with one centralized authorization system that includes State-specific consultation when appropriate, and a permitting system for movement to all US States and includes an exempted

<footnote n="111">111 https://www.ecfr.gov/current/title-7/subtitle-B/chapter-III/part-330#330.200</footnote>
list for the movement of naturally occurring organisms in the continental
US<fnref n="112" />.

Importation and release of a new organism

When a lab or company wishes to introduce or use a non-native species in the USA, they must first be imported under a specific USDA-APHIS permit into an APHIS-certified quarantine containment facility for further evaluation<fnref n="113" /> (APHIS may request inspections of sites and facilities to assess the dissemination or dispersal of invertebrates, generally inspections are led every three-years by field agents who work conjointly with state Plant Health authorities). Mitigation procedures are in place in case of a containment breach. If the results are satisfactory this may lead to a request ("Petition") for release into the environment.

This petition must address the nature and impact of the pest target, the taxonomy and biology of the natural enemy, information on its effectiveness against the target, and anticipated non-target impacts and mitigations (if any). Usually, the petitions are reviewed by APHIS before they are formally submitted. The reviewing process of applications is as follows:

- Once the application is formally received, it is sent by APHIS:

* If it is a petition for the control of an invertebrate: to an ad hoc biocontrol review committee to obtain their recommendation<fnref n="114" />. The committee chair sends the petition to outside reviewers, often a dozen or so, to obtain a range of opinions. The reviewers are generally scientists and regulators working in biocontrol, pest management, invasive species and environmental management, or related areas. The reviews may recommend granting the petition or ask for revisions including more data that address their questions, or rejection. APHIS generally accepts the committee's recommendation but is not required to do so.<fnref n="115" />

* If it is a petition for the control of weeds: to the Technical Advisory Group (TAG), with the same process.

- If the dossier is satisfactory, then assessments are carried out:

* If it is a petition for the control of an invertebrate: an environmental assessment is carried out to determine if there may be an impact on the endangered arthropod and insect species in the US. This list is relatively small.

* If it is a petition for the control of weeds: a formal biological assessment needs to be prepared within APHIS. It evaluates

<footnote n="112">¹¹² USDA APHIS | APHIS Revises the Regulations for the Movement of Plant Pests and Biocontrol Agents</footnote>

<footnote n="113">¹¹³ United States, as well as its Territories and Possessions</footnote>

<footnote n="114">¹¹⁴ While the committee is not specifically NAPPO, it attempts to have representation of Canada and Mexico.</footnote>

<footnote n="115">¹¹⁵ Interview with researchers with expertise on the US system</footnote>
(with the data provided by the petitioner) the potential impact
on the over 1600+ endangered species in the US. This is then
shared with the U.S. Fish and Wildlife Service (part of the U.S.
Department of the Interior) as part of an informal consultation
with experts at their regional field offices. A Letter of
Concurrence with the proposal to release a novel biological
control agent generally necessary to continue with the process.

- Then an assessment is also carried out to determine if the species has potential to have negative impacts on other areas of value, including to crops, plants of cultural importance and also the potential to be a nuisance pest - all possible impacts on human condition.

- The petition is then shared with tribal authorities for consultation, and if the comments are positive, it is published in the Federal register and public comments are open for 30 days to anyone in the targeted area. In most cases this area encompasses the 48 continuous States, in other cases it might be only for Alaska or Hawaii. Any State can comment as part of this process. They are also often brought into the TAG. The comments are addressed and added in an appendix in the environmental impact.

- If the process is successful, then the Plant Health official will sign a "finding of no significant impact", which opens the possibility to import the organism or to remove it from containment. APHIS is the regulatory authority, but each State may review the permit application for their State.

Petitions for the release of novel biocontrol organisms in the U.S. happen on an annual basis, almost entirely for classical biocontrol agents of arthropods or weeds. Regarding petitions for specific agents as part of classical biocontrol programs, the approval rate might approach 50%, however the time over which they are evaluated can be lengthy (2 years at minimum). Generalist biocontrol agents for commercial use are rarely applied for, typically because they are not always specific to a particular pest or weed, which makes it difficult for petitioners to prove that they are "no-risk".

Permits come with requirements: usually the post-release monitoring is kept to the recording of specific releases.

## Movement of an organism through the United States

Moving a resident or native beneficial organism from one state where it occurs to another where it does not naturally occur requires a permit: native species found uniquely in one US region that do not occur in other parts of the US are in effect treated as exotic species when it comes to inter-state transportation and introduction. Commercial biocontrol producers are usually selling species approved across the contiguous U.S., however, if they would like to sell a species of unknown distribution,
obtaining details of that distribution would be required as part of the permitting process.

When determining the distribution of a potential commercial biocontrol agent for permitting, the required information will notably include a study of natural distribution across the US. Not all States are required to be positive, it's more about common sense and general distribution. For instance, if an organism is found in a sufficient number of south-eastern states, it would be approved for the entire zone. The zones are not formally fixed, but there are usually geographical distinctions across natural demarcations (such as the Rocky Mountains). In any case, States have a say in the permit for transportation. Certain biological control organisms are subject to exceptions, when they are considered to be established throughout their geographical or ecological range in the continental United States and are determined not to present any additional plant pest risk to plants or plant products. APHIS maintains this list of biological control organisms which are well-known, widely used natural enemies that are exempted from **transport permit** requirements within the U.S. due to their long and widespread use in North America and which are generally accepted as safe for use with no significant non-target impacts (on the PPQ Permits and Certifications website). Importation of these species still requires a permit, however subsequent movement within the U.S. can be done without additional permit. The initial list was approved through a national public consultation process, in which the States could raise objections. As such, if an organism is authorised in a specific State and on that list, it does not require further permits.

This list may be expanded upon request to APHIS by a petitioner with a dossier containing evidence that the organism is indigenous or established (on the taxon level) or is present in a limited area and has limited to no potential to establish (augmentative biological control), based on field study data (sampling for direct and indirect impacts), and a literary scientific review. A process is being developed by APHIS for adding organisms to the various lists (biological control agents of arthropods, of weeds, and plant pests) of organisms that can be moved without a permit. This process is completely different from approving a novel biological control agent for release in the U.S. Importation of these species still requires a permit, however subsequent movement within the U.S. can be done without additional permit. At this point, APHIS is beginning to get new requests for organisms to be included on these lists, but no organisms have yet been either approved, or rejected. As for the initial lists, the petition would then be published on the Federal register, and open for national consultation. Similarly, organisms may be removed from the list when previously unknown evidence emerges. Some individual states may have their own permit processes (California for example). A few may be stricter than APHIS national policies, others less, and some may simply accept the recommendation of APHIS.
Information is regularly shared for stakeholders on the APHIS website<fnref n="116" />.

**Common research and development projects are supported at federal level**

- The USDA-APHIS (Animal and Plant Health Inspection Service) also supports many types of biological control activities, at the APHIS Center Plant Health Science and Technology laboratories, or through cooperative agreements with Universities and other State and federal agencies. Activities are funded by APHIS under several programs and coordinated by a cross-functional working group. Some projects are funded under the Plant Protection Act 7721¹¹⁷. This covers projects linked to the investigation and evaluation of potential new agents against plant pests or noxious weeds

- Some projects are funded through more related to field operations, especially in developing techniques to enable successful establishment, implementing the release and distribution of these agents, and conducting post release monitoring and evaluation.

- APHIS also funds CABI to assist with a variety of biological control programs against weeds.

The “Biocontrol Target Pest Canvassing and Evaluation” process is conducted every 5 years and relies on the State Plant Health Directors. Input is solicited from agencies, universities, weed management districts, to identify important exotic insects and weeds that can be considered as possible targets for cooperative biological control program.

The biological control of weeds in particular is the subject of a **Technical Advisory Group (TAG)**, why was established due to the perception of greater risks for weed biological control agents in relation to potential non-target impacts on Threatened or Endangered (T&E) Species or habitats, or to plants of economic or cultural importance. This committee includes:

- USDA, APHIS, National Biological Control Institute

- USDA, Agricultural Research Service

- USDA, Cooperative State Research, Education, and Extension Service

- USDA, Forest Service

- USDA, Natural Resources Conservation Service

- USDI, Bureau of Land Management

- USDI, Bureau of Reclamation

- USDI, U.S. Fish and Wildlife Service

- USDI, National Park Service

- USDI, U.S. Geological Survey

<footnote n="116">¹¹⁶ https://www.aphis.usda.gov/aphis/newsroom/stakeholder-info</footnote>

<footnote n="117">¹¹⁷ https://www.aphis.usda.gov/aphis/ourfocus/planhealth/ppa-ppdmdpp</footnote>
- USDI, Bureau of Indian Affairs

- US Environmental Protection Agency

- DOD, US Army Corps of Engineers

- The National Plant Board

- The Weed Science Society of America

- ARS Biological Control Documentation Center

- Other Federal agencies expressing interest in participating

The goal is to review petitions from the agency's perspective, evaluate risks to agriculture, human health, the environment, and compare them to the expected benefits. Experts are consulted as part of the process, and APHIS considers TAG recommendations carefully. APHIS works with researchers in the process of collecting information for petitions and if after a petition is reviewed, additional information is required; APHIS will maintain a dialogue with the petitioner to assist them in ensuring the information collected is appropriate. Additionally, TAG may conduct training workshops.

## Best practices identified in the USA

- A **federally harmonised assessment procedure** for importation in confined environments and release, leaning on the **consultation** of States, and other relevant stakeholders

- Specialised **expert bodies** responsible for this assessment

- A system of **permits for the movement of species** across the USA that allows US States to authorise species themselves if they wish, leaning on a **list of exempted species**

- State-wide needs assessment and inventory procedures for research projects
## 3.6 Q6: Prospective question - Which instruments could complement the regulatory provisions in place and what are their expected effects?

This question aims to analyse the range of improvement of the current situation regarding IBCAs based on the answers and data collected during the interviews and through the questionnaires. It focuses especially on the potential for developing a harmonized framework at the European level and identifying the perception of the stakeholders and willingness of the Member States to adopt these new frameworks. Impacts of complementary implementation modalities such as voluntary schemes or European guidelines are also analysed and discussed. In addition, the potential evolution in the roles of actors (e.g., responsible authorities, etc.) and other stakeholders is also analysed, especially the implication of current actors like EFSA, and EPPO.

The detailed questions are listed below:

a) What is the scope for the better implementation of existing instruments, taking into account the differences between the Member States, as identified during the study?

b) What are expected benefits of more engagement by EFSA into the process and what level is most appropriate (guidance documents, scientific opinions, risk assessments)? Are there concerns raised by Member States or other stakeholders towards this approach and what are these concerns?

c) In which ways could a more harmonized decision-making be achieved?

d) What are the expected effects of a centralized assessment of IBCAs before import on the market and/or use? How do they compare to the expected effects of a centralized decision-making structure?

e) What are the benefits and limits of voluntary schemes? How can efficiency be assured? Which of the shortcomings and problems identified are not expected to be solved in such system?

f) Which regulatory instruments are expected to be the most efficient to foster innovation?

### 3.6.1 Scope for the better implementation of existing instruments and for achieving a more harmonised decision-making between Member States

The study has revealed important differences between the policies in different MS, from no specific instrument applying on IBCAs (Ireland, Estonia, etc.) to impact assessments and authorization processes that include the potential impact of biological variability among populations within a same IBCA species (such as France). In other cases, national
regulation may still apply to IBCAs but only considering them at the level
of the species, and in which detailed analyses are performed only when
such species cannot be considered native.

The study also 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 prepare guidance documents, providing positive and/or negative lists of IBCAs. Some Member States have also implemented more detailed risk-assessment procedures. This is to say that most of the raw material to implement a harmonised framework at the EU level is already available. A key exception is the absence of clearly planned post-release monitoring strategies, likely because of their (potentially high) costs when compared to the size of the market and industry.

Regarding the implementation of existing instruments, the main findings
can be seen in the answers provided by the National Competent Authorities:

- Member States that already have a regulation in place have expressed that they are very reluctant to change their processes; they consider themselves satisfied with the functioning of both public authorities and entities submitting authorization demands in this regard.

- They further insisted on the fact that Member States should retain their ability to decide how they wish to manage biodiversity on their territory, hence making the option of a completely centralised process unable to reach a possible consensus (in current regulatory situation).

However, the option for a more harmonised and centralized framework
appears possible for the MS authorities who were contacted.

Some of the Member States that do not rely on strong national framework
and/or did not develop a process for the implementation of risk
assessments are more open to the possibility of conducting risk
assessments at the EU level because they do not have the competencies to
perform these analyses at the national level.

Hence, the study indicates that there is space for a homogenization of
procedures at the EU level, provided that Member States retain a sufficient
level of freedom at the national or regional level.

A consensual approach would likely combine several levels of instruments:

- A package of guidance documents (scientific and regulatory) and species lists available to all MS with existing national regulatory processes applying to IBCAs.

- A centralized procedure available to MS with no national regulation on IBCAs,

- A few provisions and principles applying to all countries.
Some of the main potential scenarios have been identified on this basis and in consideration of the other findings of the study. They are presented in the next section.

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 the risks vary depending on the type of IBCAs used. Thus, having adapted processes according to the risk level will ensure a balanced regulatory system. In addition, the risk assessment should also weigh the benefits 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 other private sector actors. This is true especially for IBCAs where the development of new products takes several years and is performed by SMEs with limited economic capacity.

- Ensure that the applicants are well informed on the process and data required, and that they have open communication channels with the competent authority. This point was especially mentioned by the USA and New Zealand.

### 3.6.2 Expected benefits of more engagement by EFSA into the process

The main benefits of an increased engagement from EFSA identified via the questionnaires and interviews are the following:

- An increased independence of the material (guidance documents, lists, etc.), analysis work or decisions when compared to what can be provided by voluntary networks or associations like EPPO.

- More consistent data quality if verified and curated by a dedicated service of EFSA,

- An increased level of mutual recognition among countries that services or agencies could rely on data and lists published by EFSA, strengthened by its independence and its quality procedures.

On the possible role of EFSA, we observed a clear contrast between the positions of the public bodies and the industrial stakeholders represented by IBMA:

Overall, public bodies positively saw a role of EFSA. There was relative consensus on the interest of having EFSA involved in the production of guidance documents and organisation of expert panels and opinions (out of the 15 Member States that expressed an opinion on the involvement of EFSA, 13 were positive and 2 negative). The possibility of making EFSA in charge of risk assessments was more contentious (10 positive, 5 negative) and would be dependent on two conditions:
- (i) the impact assessments do not interfere with existing national procedures, but rather facilitate the work performed at national level thanks to preliminary advice at the species level, with the creation of a 'negative' and 'positive' list to which Member States may refer in their own analysis and decision, and if EFSA can compile data to define if the species are already resident or not in each of the MS.

- (ii) if the involvement of EFSA does not add a significant administrative burden and unnecessary delays to the processes already in place.

IBMA argues for the simplest possible process at the EU-level, corresponding to the strict application of the EPPO guidance documents and lists (while seeing an interest in improving these documents and lists). A possible involvement of EFSA is seen as a risk; as EFSA oversees the analysis for the pesticides, it is seen as a 'non-relevant' merging of IBCAs with pesticides by a large share of stakeholders. However, from an IBMA perspective, this risk did not seem as critical as the risk of a proliferation of national regulations imposing different criteria and involving analyses at the intraspecific levels, virtually obliging the commercialisation of different strains in different countries, which would eventually render the production and distribution of most IBCA economically unviable.

### 3.6.3 Expected effects of a centralised assessment and decision-making of IBCAs

In total, 14 Member States provided an analysis on the hypothesis of centralisation of the assessment of IBCAs. Of these, 4 MS were positive, 4 negative, and 6 held an intermediate position.

A centralised impact-assessment would bring several benefits according to the Member States:

- It would ensure a unique process throughout the EU for all entities, with maximum clarity on the process, ensuring higher attractivity of the EU market for companies.

- It would enable the homogenisation of the processes of all Member States, with minimum safety standards for all countries, including those with no current regulation. This is seen as a guarantee of better biodiversity protection by several MS (including issues related to transboundary risks).

- It would enable access to a large panel of experts at the international level.

However, some drawbacks were also identified:

- Member States expressed their concern about possible additional administrative burden and slow processes when compared to national processes. In particular, this view was expressed by the countries with an existing regulation (or setting up a regulation).
- Such a scheme may be confronted to critical difficulties due to large differences in the expectations of MS in terms of analysis depth required during the assessments and enabling to reach authorisation decisions. For example, France will request the consideration of intraspecific variations while such a level of complexity would be considered an unacceptable administrative burden for other MS. The inverse is also true: an impact assessment conducted at the level species as implemented by some MS (e.g., Spain) would appear less safe to Member States like France, who would ask to carry out their own national impact-assessment.

- A centralised impact-assessment may also be excessively complex and costly because the benefits and risks would have to be evaluated in all Member States' biological contexts (including specificities related to island systems, ultramarine systems for some Member States, or other specific ecological systems) while commercialisation may sometimes be intended in some specific areas only. One option, however, would consist of carrying out an assessment for a list of specific areas for which an authorisation is requested by the petitioning entity.

Regarding the possibility of developing a **centralised decision-making framework**, of the 15 Member States that expressed themselves on this subject, 7 were clearly negative, none were positive, and 8 had intermediate positions. A central decision-making framework would have the advantage of homogenising and simplifying the process at the EU level, and would provide an option to the MS that do not have a regulation system for IBCAs or do not wish to carry out decision-making at the national level. However, the majority of Member States were heavily critical of a centralized decision-making framework. They argued that authorities of each MS should keep their decision-making capacity to ensure that their own territorial, ecological and political context is always taken into account.

### 3.6.4 Benefits and limits of voluntary schemes

Voluntary schemes are instruments that are supported by the industry because of their simplicity. Out of the 14 Member States that expressed themselves about voluntary schemes, 7 were negative, 4 were positive, and 3 had intermediate positions.

The most cited voluntary scheme would rely on EPPO standards PM6. However, several Member States expressed concerns regarding EPPO data and procedures. This criticism is related to (i) the composition of the EPPO-IOBC Panel on Biological Control Agents with regard to the industry and (ii) the processes used by the EPPO-IOBC Panel to define their lists, which may benefit from more details and depth. For example, the use of a given species can be considered safe provided it has been introduced in a country for a few years without reported negative impact, even if there was no or no scientifically sound post-release monitoring of possible impacts.
Another concern is the lack of impact of such schemes: they are not considered to be binding enough, the level of implementation remains low, and it does not make significant changes to the current situation, with a set of countries strongly relying on EPPO lists (e.g. The Netherlands, Latvia, Greece, Finland, and Slovenia), a set of countries with a national process little influenced by EPPO documents, and countries with no regulation.

Such voluntary schemes may also be too flexible and fail to limit the emergence of a range of contrasting instruments in the Member States, which would defeat the purpose of harmonising the regulations, pose risks to the protection of the environment, and may eventually become a problem for the industry (multiplying the human resources involved in the application processes).

The questionnaires and interviews did not enable the elaboration of precise measures that would ensure the efficiency of such scheme. However, a few elements were discussed, such as a directive or common guidelines and timescales to provide key principles and basic rules. Another proposal was to create a hybrid network of experts within a perimeter set by EFSA to ensure independence and the creation of EFSA-validated material (documents, lists) using data and information shared between EPPO and EFSA.

### 3.6.5 Regulatory instruments to foster innovation

Regulatory instruments may be classified within two categories, according to their intended effect. They may indeed foster innovation via (i) innovation push or (ii) innovation pull.

No quantitative or scientifically sound impact study of various regulatory instruments on innovation were identified as part of the literature research. There was very little Member States input in the questionnaires, although two Member States mentioned possible systems of subsidies or obligations to use biocontrol strategies. Hence, the discussions below are based on qualitative evaluations, discussions, opinions of experts and NCAs, as well as scientific publications providing data on innovation trends.

Retrospective descriptions of innovation dynamics on IBCAs (see for example articles from Van Lenteren from 1988 to 2022) all converge to the same trends, whatever the continent considered. A first set of innovations and peaks of use were first observed before and soon after the second world war. This period gave birth to major biocontrol innovations (e.g., the development of *Trichogramma* products). Innovations from these periods reached a plateau in terms of market penetration during the late 1990s and early 2000s. Since then, IBCAs grew slowly, following a continuous trend punctuated by rapid and strong increase in specific systems (e.g., in greenhouses after specific scandals related to pollution by pesticides in the 2000s or after 2019 France after the "Loi Labbé" prohibited the use of chemical pesticides in public areas and gardens).
This trend of overall slow growth in terms of new products and market sizes reveals that strategies to push innovation, implemented by France for example, via the Ecophyto Plan 2008-2018 or the "Credit Impot Recherche" (a tax credit proportional to R&D investment by companies), have likely had little impact on the growth of IBCA innovation and its markets. Moreover, funding available for innovation push in the industry (support to private R&D) is recurrently underused. Sudden and fast growth of innovation activities were rather triggered by events affecting the phytosanitary markets and creating very strong innovation pull (e.g., scandals and pesticides bans). Dominant systems, in which chemical pesticides are cornerstones ensuring short-term economic benefits, locked innovation pull in most crop systems, and eventually decreased the strength (proportional to R&D investment, which is itself proportional to sales) and the effects of innovation push instruments.

The importance of the interplay between innovation on IBCAs and the evolution of the agricultural and agrifood value chains and markets is further underlined by recent research works. Most recent instruments fostering innovation in France have been redirected towards more innovation pull. For example, the CEPP instruments (certificates for economy of chemical pesticides) promote the use of alternative strategies (with approx. 30% of strategies relying on biocontrol) via a credit system applying to agricultural input distributors. An increasing number of innovation support actions also focus on co-innovation initiatives at the level of territories or value chains, to stimulate innovation pull.

In light of the brief analysis presented above, our recommendation is, without neglecting instruments fostering innovation push (e.g., supports to research & development at the national or EU level), to focus on new instruments fostering innovation pull.

Innovation pull would seek to:

- **Foster transitions to agrosystems that are more favourable to IBCAs** (e.g. relying on prevention and resistance rather than the systematic use of chemical pesticides), be it in terms of biological/technical compatibility (most IBCAs are strongly impacted by chemical pesticides or their action is seen as insufficient in agrosystems where natural regulations are absent or decreased by the effects of chemical pesticides) or economic competition (chemical pesticides are economically beneficial at short term and dominate all alternative strategies whenever their price does not include their hidden costs related to impacts on biodiversity and health. Moreover, chemical pesticides are produced at large scale and benefit from all of the agrifood infrastructure (distributors, agri-equipment) that has been designed for their use). Such measures may include **pro-active programmes of progressive exclusion or additional taxation of chemical pesticides** whenever biocontrol methods or alternative strategies are available or close to being so (leave them space for production at larger scale, decrease of costs, etc.). Such
measures may be relevant particularly if the timeframe of the programme is set to create a strong boost to R&D investment of all actors while allowing enough time for innovation to support the crop sector facing the progressive/partial loss of agrochemical tools. A future example will likely be the incoming ban of neonicotinoids in sugar beet in France, that is currently accompanied by a massive public-private innovation investment.

* Fostering co-innovation dynamics between the biocontrol industry and actors of the agrifood value chain. This would, for example, involve fostering dialogue and co-design of innovation strategies with a view to integrate product specifications, including the use of agroecological measures (including biocontrol) at the level of cooperatives, food transformation or retail. Other instruments may foster the development of an insurance system against any losses caused by pests that would be based on the adequate use of IBCAs to replace chemical pesticides. These insurances may be inserted into contracts between agrifood actors (cooperatives, food processing industry) and their providers (farmers). In all cases, instruments fostering pull by downstream actors that ultimately add value to growers engaged in sustainable practices involving the use of IBCAs should be favoured. This added value will enhance risk-taking, boost the adoption of new methods, increase market size and lead to a virtuous loop sustained by increased investments on innovation, supported by mechanisms already in place for innovation push (that will be increasingly used by IBCA R&D actors).

* Another important element to consider is **the risk of focusing excessively on IBCAs corresponding to products similar to classical inputs.** The most indispensable IBCA services to agriculture are probably not the ones provided by the introduced products, but rather the ones provided by populations well established providing free and extensive pest regulation throughout the seasons. This biocontrol activity falls into the specific categories of conservation biocontrol and classical biocontrol. However, new business models that rely increasingly on services and the intelligent use of inoculation (be it of innocuous exotic organisms associated to an invasive pest or of native organisms temporarily in insufficient density) should be fostered. **Classical biocontrol would require specific instruments for its safe use** (with specific resources and guidance to produce comprehensive data for risk assessment and post-release monitoring) and more balanced partnerships between public and private investment from agrifood actors (classical biocontrol is excessively relying on public funding in Europe). Business models specific to activities falling in between inoculation biocontrol and conservation biocontrol should also be fostered.
# 4 Synthesis of the problem definition and analysis of the main potential options for an EU intervention

## 4.1 Problem definition

The current situation regarding IBCAs in the European Union presented in the previous sections, conducts to several issues and challenges that are presented below.

<figure><img src="image_28.png" /><figcaption>Figure 12 - Problem tree</figcaption></figure>

### 4.1.1 Problems and their drivers

#### Core problems

Two main problems emerge from available data and analyses:

- The use of IBCAs is growing too slowly considering their potential contribution to reducing the use of chemical pesticides and meeting farmers' expectation of finding alternative methods.

- Divergent levels of environmental protection exist in the European Union. The use of IBCAs could also present some risks for environment and biodiversity, especially where non-native species are used and considering that IBCAs can spread beyond the borders. The frameworks developed in the Member States are based on different perceptions. The differentiated way of taking
this risk into consideration of leads to various levels of protection
of the environment: some Member States are conducting little to
no risk assessment for the use of IBCAs in their territory where
some have developed a protective framework.

Main drivers

Several related causes and drivers can be listed, which are obstacles for
the further development and use of safe, reliable, and effective IBCAs:

Market failures:

**The use of IBCAs is often considered economically not as**  
**competitive as chemical pesticides for growers.** The use of IBCAs is  
often considered in the context of a substitution for chemical pesticides.  
However, in comparison to chemical pesticides, the cost of IBCAs remains  
high for farmers (2 or 3 times higher, as stated in section 3.1.3). They can  
also be considered as less efficient than chemical products as they often  
rely more on controlling the pest than total eradication.

In addition, farmers do not have sufficient knowledge regarding IBCAs' solutions and their potential benefits. The use of IBCAs must be integrated into global biocontrol strategies at the farm level, which may be very technical to implement for farmers. For instance:

The use of IBCAs can be integrated into biological control programs that
may involve up to 15-20 different species of naturel enemies to be
effective<fnref n="118" />

The use of other (especially chemical) products can lead to the eradication
of the IBCAs.

Application methods of IBCAs are different from chemical pesticides and climatic conditions may have highest consequences on their effectiveness in outdoor crops.<fnref n="119" />

Thus, the use of IBCAs requires specific training for farmers to support them
in the reduction of the use of pesticides and ensure that the IBCAs are used
appropriately. In addition, despite the European and national strategies, the
incentives for farmers are not always sufficient to conduct to a global
change of practices at farm level.

**The development and commercialisation of IBCAs is not sufficiently**  
**economically interesting for producers.** Regarding augmentative  
biological control, the cost and time required to develop new solutions  
remain high as new species need to be captured, studied, cultured, etc<fnref n="120" />.  
to know if they may be used as IBCAs. Mos the existing solutions concerned  
high value crops in greenhouses system where the economic viability can

<footnote n="118">¹¹⁸ 841 Lenteren et al ABC Plenty of Ops BiCo 2017.pdf (boerenlandvogels.nl)</footnote>

<footnote n="119">¹¹⁹ 841 Lenteren et al ABC Plenty of Ops BiCo 2017.pdf (boerenlandvogels.nl)</footnote>

<footnote n="120">¹²⁰https://www.researchgate.net/publication/316251091_Best_practices_for_the_use_and_exchange_of_invert
ebrate_biological_control_genetic_resources_relevant_for_food_and_agriculture</footnote>
be reached. The issue of intellectual property could further erode economic interest, thus impeding the development of new solutions, because the "classic" patents cannot be applied to natural species. The industry however makes an increased use of patents concerning processes and techniques. In addition, many producers of IBCAs in Europe are small-scale SMEs with lack of professionalisation, which encounter difficulties to develop effective production techniques, transport of IBCAs, etc.

In addition, some of the IBCAs are used for classical biological control, which is not economically interesting for businesses as it is based on the establishment of a new species in the environment that does not lead to long term business model. It mainly relies on public research and support with limited capacity of funding.

**Important knowledge gaps exist** regarding both:

- The current IBCAs market and the use of IBCAs in the European Union; these gaps do not allow for any monitoring or clear identification of necessary actions to accelerate the take-off of IBCA market. Indeed, it does not give sufficient information for public authorities to make informed decisions on which kinds of needs, uses or segments of the market would most benefit from public funding.

- The long-term effects of some IBCAs, especially on biodiversity (positive and negative effects). Knowledge and data gaps have also been identified by the Member States during the implementation of risk assessment. It should also be underlined that the current regulations in place do not integrate any system for monitoring the use and potential side-effects of the use of IBCAs, which further limits the production of data to assess the impact of IBCA on biodiversity. Thus, the current data gaps in the long-term effects on biodiversity lead to some risks regarding the protection of the environment.

**Legal gap:**

The different approaches of Member States to authorising the introduction, production and/or release of IBCAs can lead to **potential adverse effects on biodiversity** as risks concerning biodiversity are managed differently across Member States. While some are implementing specific risk assessments, some other Member States do not assess the risk and do not regulate the use of IBCAs. Moreover, invertebrates are able to spread and cross borders, and an IBCA used and authorised in one Member States may be harmful in another MS due to different local conditions.

Some Member States, regardless of whether they have a legislation in place or not, have reported **lacking the necessary competences and capacity to properly conduct risk assessments and regulate IBCAs**. Member States frequently face a lack of sufficient data to provide a decision based on comprehensive scientific evidence (for instance, Sweden underlined the lack of available data regarding the potential of
establishment of exotic species or the consequences with respect to genetic diversity of native species).

The different provisions in Member States around risk assessments and the placing on the market of IBCAs also cause **competition and market-related issues due to uncertainty and additional administrative burden for IBCA producing companies**. The different regulations among European countries cause serious problems to the biocontrol industry because dossiers must respect the various national requirements and criteria in countries where regulation is in place. This makes applications more time consuming and costly and can deter a company from developing a new product if the estimated market potential is low in comparison to its development costs. In addition, some Member States rely on the EPPO positive list PM 6/3 to authorise (or not) a species on their territory. However, non-native species products need to have been on the market for several years to be included in the EPPO list, thus this is not adapted for new products and species coming in the market.

## Societal needs

The (too) limited development of IBCAs is becoming a growing issue. The slower the use of IBCAs develops, the less they can contribute to a reduction in the use of chemical plant protection methods. Citizens' expectations and political scrutiny regarding the use of pesticides is raising for various reasons. These reasons include:

- The use of chemical pesticides has very negative impacts on human health, especially children's development<fnref n="121" />;

- The use of chemical pesticides leads to declines in biodiversity, especially for pollinators;

- The estimated cost of chemical pest control in Europe (€2,3 billion) is considerably higher than its benefits (€0,9 billion), according to the firm BASIC<fnref n="122" />.

Citizen's concerns continue to be raised regarding the use of chemical pesticides. For example, two European Citizens Initiatives have been launched and were largely supported:

- European Citizens Initiative "Stop Glyphosate"<fnref n="123" /> in 2017 calls for a ban on glyphosate (an herbicide), to reform the pesticide approval procedure, and to set EU-wide mandatory reduction targets for pesticide use

- More recently, European Citizens Initiative "Save Bees and Farmers"<fnref n="124" /> calls on the Commission and European Parliament to act to gradually reduce the use of synthetic pesticides by 80% in EU agriculture by 2030 and to phase it out completely by 2035.

<footnote n="121">¹²¹ https://www.pan-europe.info/issues/health/children</footnote>

<footnote n="122">¹²² https://eeb.org/wp-content/uploads/2022/02/SUD-Joint-Statement.pdf</footnote>

<footnote n="123">¹²³ https://europa.eu/citizens-initiative/ban-glyphosate-and-protect-people-and-environment-toxic-pesticides_en</footnote>

<footnote n="124">¹²⁴ https://www.savebeesandfarmers.eu/eng</footnote>
### 4.1.2 Baseline scenario

An analysis of the evolution of the problems identified and their likely evolution is provided below. Two main consequences have been 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 contributing to the reduction of the use of chemical pesticides and achieving the objectives of the Farm to Fork strategy;

- Potential negative consequences on biodiversity, as risks on biodiversity are managed differently across Member States. While some are implementing specific risk assessments, other Member States are not assessing the risks and do not regulate the use of IBCAs. Despite the potential economic and ecological benefits of biological control as a pest control strategy, there are growing concerns about the risks associated with the use of non-native natural enemies for plant protection.

#### 4.1.2.1 Slow development and use of IBCAs

The consequences in terms of market development, which may be slower than expected, are analysed in terms of potential impact on the quantitative targets for the reduction of use of pesticides outlined in the F2F strategy.

**Estimation of the total potential of IBCAs development**

The assumption and conclusion were presented during the workshop organised in the framework of this study.

A set of a few assumptions were established to reach quantitative estimates:

- IBCAs mostly target insects and mites. Although the company Biobest claims the development of a predatory mite targeting both pests and fungi (mildew), this currently remains an exception and it is difficult to estimate the extent to which this type of IBCA can be generalized in the future. Augmentatively released IBCAs are not expected to play an important role in the control of weeds, but resident ones could contribute to their control.

- The global relative uses of fungicides, herbicides and insecticides will remain similar at 45%, 35% and 15% of total pesticide quantities respectively (data in 2020 from Eurostat).
- Reduction of pesticide use will not be reached by substituting each current PPP use by an IBCA use. On the contrary, pesticide use will be decreased by the implementation of new and more resistant agrosystems that enable the combination of levers, including the use of IBCAs. Hence, estimating the rate of substitution of pesticides by IBCA is likely not a relevant method.

- Classical biological control will likely be vital for the response to biological invasions of exotic pests. It may also have a small impact on pests currently triggering pesticide use (e.g., *Cydia pomonella*, *Drosophila suzukii*, etc.).

- Conservation biological control fostering the activity of resident IBCAs is probably the most important tool to reduce pesticide use. It may act on all crop sectors and enable the use of most other agroecological levers.

- Augmentation biological control and SIT have the potential to enable pesticide free production under greenhouse and have strong focused impacts in other systems (e.g., against Lepidoptera and Tephritid flies in compatible cropping sectors).

In the long term, assuming a concrete transition to agroecology where pesticides are used in extremely small quantities, the potential impact of IBCA is likely capped at -10% of pesticide use. Indeed, IBCAs and semiochemicals, together with other levers of agroecology (resistant varieties, agronomic practices), have the potential to enable crop production without chemical insecticides (-15% of current pesticides based on the current share of insecticides in chemical pesticides use) and to decrease the use of a few fungicides (estimation at -1%) and herbicides (-2%). With a scenario where semiochemicals and IBCA remain equally important in biocontrol against arthropods (the trend observed within the last ten years), the possible impacts of IBCAs can be estimated to (-15% / 2) - 1% - 2% = -10.5%.

This corresponds to the long-term potential total impact of IBCAs.

The analysis of the current situation shows that, as a baseline, the IBCA market will continue to develop during the next 5 to 10 years.

The possible growth rate of the IBCA market is high: a recent report specifically dealing with IBCAs (the Global Beneficial Insects Companies Market Report) estimates the global IBCA market to be US$ 633 Million in 2020 and projects it to reach more than USD $ 1.4 bn by 2028, thus an increase of 220%. Applying this growth rate to the European IBCA market, it could be estimated that IBCAs will represent around 3-4% of the European crop protection market by 2030. Thus, it can be considered that IBCAs will contribute to a reduction in chemical pesticide use of 1 to 2% in the European Union from now until 2030.
#### 4.1.2.2 Possible negative consequences on biodiversity

There have been very few reports of adverse non-target effects<fnref n="125" /> despite the over 5000 introductions of over 2000 species of arthropod biological control agents over the past 100 years. This can be explained by the limited number of scientific publications on the subject as well as by the limited establishment of the species in the environment (only 5 species of biological control agents were removed from the EPPO positive lists).

EPPO has identified the risks related to invasive alien species, including the following: crossbreeding, competition for resources with native species, predation, and parasitism, as well as apparent competition. In addition, the risks related to the propagation, reproduction and perhaps modification of the intrinsic nature of the genetic heritage of the native species of the ecosystems, close to the introduced species, seem real.

Some examples of negative impacts of some species used as IBCAs could be reported (see also section 3.1.5):

* The main known example is *Harmonia axyridis*, also known as the harlequin ladybird, or Asian ladybeetle. Originally used for both classical and augmentative uses over the world and in Europe, this 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. Formerly listed by EPPO as a successfully introduced classical biological control agent, *Harmonia axyridis* has been removed from the EPPO list PM 6/3.

* *Cales noacki* is a hymenopteran parasitoid that was used for biological control of *Aleurothrixus floccosus* (a whitefly). It was introduced in Mediterranean countries in the 70s. However, it has been removed from the EPPO list in 2008 as "commercial releases may lead to establishment in non-target habitats in certain areas. Outdoor releases have shown a wide host range that extends beyond the Hemiptera order and in some areas, out competes indigenous natural enemies."

With the expected development of the use of IBCAs, especially in arable crops, the risk for biodiversity should be carefully analysed before their release and be monitored to ensure that their use does not negatively impact ecosystems.

### 4.2 Objectives to be considered

Based on the analysis of the problem definition, two main objectives have been identified:

<footnote n="125">¹²⁵ A critical evaluation of augmentative biological control, Timothy Colliera and Robert Van Steenwyk</footnote>
- Foster market access and increase the availability of effective IBCAs in the territory of the European Union (existing and new solutions);

- Ensure the safe development and use of IBCAs across the European Union

4.3 Options and scenarios to be considered

Considering the drivers identified during the analysis of the problem definition, several options have been identified to answer to the problems described above.

These options are covering four main topics:

- **Options related to the harmonisation of the legal framework and/or risk assessment between Member States.** This is to both ensure that farmers have access to safe IBCAs in all Member States thanks to authorization and that the analysis of risks for biodiversity are homogeneously covered in the European Union.

- **Options related to the production, recording and monitoring of IBCA data** for the continued accumulation of knowledge in the European Union regarding the effects of using IBCAs (especially negative and positive effects on biodiversity).

- **Options related to fostering research and development** for the development of new and more effective solutions, without being limited by high costs for research and development.

- Options related to fostering training and knowledge transfer.

A first analysis of the pros and cons of these options is provided in the tables in each section. It aims to underline the extent of the effects they will have on:

- The evolution of the main problems identified and how these options will address the two main issues identified:

- Regarding the slow development of the use of IBCAs, the pros and cons of the options are assessed against two criteria: the availability of IBCAs and the time needed to market new products.

- Regarding the potential negative effects on biodiversity, the pros and cons of the options regarding environmental safety are provided.

- In addition, the pros and cons are analysed regarding the feasibility of the options as well as the economic sustainability of their implementation.
### 4.3.1 Options related to the harmonisation of the legal framework and/or risk assessment between Member States

Based on the analysis of the main issues identified through the findings of the study and the analysis of the problem identified, the Study identified several options regarding the possible harmonization of the legal framework between Member States:

- **Systematically integrate IBCAs as an alternative to chemical pesticides the initiatives and other documents of the European Commission** including as a candidate for substitution in a comparative assessment conducted at the national level according to Art. 50 of Regulation 1107/2009

- **Harmonized definitions of native, exotic and/or established species** can be provided at the European level

- **The establishment of whitelist(s) of safe IBCAs could be systematized.** It could be implemented by requiring the Member States to establish national lists of native and established species which can be used as IBCAs, establishing a whitelist of IBCAs that can be used safely at the European level (native and/or non-native species) or using the EPPO list PM6/3 as a common whitelist at the EU level.

- **The content of risk assessment and consequences of the analysis (especially mitigation measures) could be harmonized.** Several options have been identified to ensure that the content of the risk assessments performed takes account of the main risks, and that the same risks are analysed across the Member States. It also aims to ensure that the risk assessments are adapted to the species and types of organisms in order to limit any administrative burden. The main options are the following:

* Use of EPPO guidelines in all Member States as a minimum common basis;

* Increased homogenization of guidelines, standards, and form templates at the European level to be used by the Member States (including required data);

* Adaptation of guidelines and forms to fit all IBCA uses (classical or augmentative biological control, native or non-native species, SIT, type of organism) in a flexible way;

* Analysis of risk-benefits (and not only risks)

* Analysis at species level only or analysis at the level of subspecies/strain, i.e., taking into account intraspecific variability

* Distinction between demands for research and commercialisation: the authorisation process can be lightened
for research under certain specific conditions (confined space especially)

○ Use of process with several steps: importation, introduction, commercialization to ensure that the analysis of the risk is adapted to the specific challenges of each step

o Definition of risk mitigation measures or plans as a result of the risk assessments in the Member States and control of their implementation

- **The existence of processes to ensure that IBCAs can be authorized after proper risk assessment in all the Member States.** Several options have been identified depending on the level of centralization and the involvement of third parties:

o Requirement of Risk-Assessment performed by Member States

o Risk-Assessment performed by EFSA. It can be the only authority in charge of the risk assessments in the European Union but can also be considered as a complementary option to conduct risk assessment in addition to the process in place in the Member States. In that case, several possibilities exist regarding the scope of the geographical coverage of the risk assessment: at the European level, considering the specific oversea/island zones, for specific zones required by the applicant, etc.

o Centralized decision-making at the European level

o Decision-making by each Member State

o Mutual recognition between Member States
<table><thead><tr><th>Options</th><th>Availability of IBCAs</th><th>Environmental safety</th><th>Time to market new products</th><th>Economic sustainability of the approach</th><th>Feasibility</th></tr></thead><tbody><tr><td>Systematically integrate IBCAs as an alternative of chemical pesticides in the publication of the European Union and policy frameworks</td><td>+</td><td>-</td><td>-</td><td>-</td><td>- It should be ensured that the benefit-risk assessments are well adapted to consider IBCAs</td></tr><tr><td colspan="6">Definition and list of species</td></tr><tr><td>Harmonized definition of native, exotic and/or established species</td><td>-</td><td>-</td><td>-</td><td>-</td><td>- Would require negotiations among MS and among stakeholders</td></tr><tr><td>List of native and established species for each Member State</td><td>+</td><td>-</td><td>-</td><td>-</td><td>-</td></tr></tbody></table>
<table><thead><tr><td>Options</td><td>Availability of IBCAs</td><td>Environmental safety</td><td>Time to market new products</td><td>Economic sustainability of the approach</td><td>Feasibility</td></tr></thead><tbody><tr><td>Establishment of EU-wide harmonized whitelist of IBCAs</td><td>+ Speed up regulatory process in the Member States where the process will be lighter for the IBCAs on the whitelist<br/>+ Ensure a minimum list of authorised IBCAs in all Member States</td><td>- Review performed at the EU level will need to ensure that all the specificities of Member States are covered (crops, climate conditions, etc.)</td><td>-</td><td>- Would require review work to establish this list</td><td>- Would require negotiations among the Member States and among the stakeholders to establish the list</td></tr><tr><td>Use EPPO list as a common whitelist at EU level</td><td>+ Speed up regulatory process in the Member States where process will be light for the IBCAs on the whitelist<br/>+ Ensure a minimum list of authorised IBCAs in all Member States</td><td>- The list should be adapted to each geographical zone to ensure coverage of variety of climate conditions and ecosystem<br/>- There is no information available regarding the risk assessment or</td><td>-</td><td>-</td><td>-</td></tr></tbody></table>
<table><thead><tr><th>Options</th><th>Availability of IBCAs</th><th>Environmental safety</th><th>Time to market new products</th><th>Economic sustainability of the approach</th><th>Feasibility</th></tr></thead><tbody><tr><td></td><td></td><td>mitigation measures to be implemented</td><td></td><td></td><td></td></tr><tr><td colspan="6">Content and consequences of risk assessments</td></tr><tr><td>Use of EPPO guidelines in all Member States</td><td>Stakeholders already know the procedures.</td><td></td><td></td><td></td><td>+ No impact for the Member States with a regulation in place</td></tr><tr><td>Increased homogenization of guidelines, standards and forms templates (including required data)</td><td>-</td><td>+ Would ensure that a minimum framework in all the Member States regarding risk on biodiversity</td><td>+ Facilitates the implementation for petitioners and experts</td><td>-</td><td>- Decrease flexibility at the level of each MS</td></tr><tr><td>Adaptation of guidelines and forms to fit all IBCA uses (classical or augmentative biological control, native or non-native species, SIT, type of organism) in a flexible way</td><td>- Would enable the use of the same procedures and forms for all types of IBCA uses, based on a smart use of specific subsections if needed.</td><td>-</td><td>-</td><td>- Analyses of dossiers would require additional expertise and flexibility</td><td>- Might complicate processes for individual MS with regulation separating the different uses.</td></tr></tbody></table>
<table><thead><tr><td>Options</td><td>Availability of IBCAs</td><td>Environmental safety</td><td>Time to market new products</td><td>Economic sustainability of the approach</td><td>Feasibility</td></tr></thead><tbody><tr><td>Analysis of risk-benefits (and not only risks)</td><td>-</td><td>Enables balanced analyses that account for both the risks and benefits for MS biodiversity.</td><td>-</td><td>Increased costs of gathering sound data on efficacy and efficiency of crop protection</td><td>Better fits most current Member State regulatory frameworks.</td></tr><tr><td>Analysis at species level only</td><td>-</td><td>May overlook specificities of strains or other taxa within a so-called species (see below).</td><td>-</td><td>-</td><td>Prevents complication induced by considering subspecific aspects, and consequently easier to handle.</td></tr><tr><td>Analysis at the level of subspecies/strain, i.e. taking into account intraspecific variability</td><td>-</td><td>Different strains may carry different pathogens that should be specifically analysed during the risk assessment</td><td>Requires precise data that the petitioner may not be able to produce.<br/>Gathering the required data may be costly and would slow down R&amp;D</td><td>Accounting for intraspecific variability requires high expertise and high flexibility and adaptability when analysing the dossiers.</td><td>There may be misidentification in complexes of species, leading to irrelevant assessments.</td></tr></tbody></table>
<table><thead><tr><td>Options</td><td>Availability of IBCAs</td><td>Environmental safety</td><td>Time to market new products</td><td>Economic sustainability of the approach</td><td>Feasibility</td></tr></thead><tbody><tr><td></td><td></td><td>+ Strains may be very different at the phenotypic level (case of strains improved or modified for their use as IBCAs, or subjected to genetic drift in rearing), it will ensure that the different existing strains continue to exist.</td><td></td><td>- Different MS may develop strict or contrasting regulations preventing the industry from selling an IBCA species using the same strain throughout the EU. This would be a severe lock to most current business models based on economy of scale.</td><td></td></tr><tr><td>Distinction between demands for research and commercialisation: the authorisation process can be lightened for research under certain specific</td><td>-</td><td>-</td><td>+ Speed up research and development</td><td>-</td><td>-</td></tr></tbody></table>
<table><thead><tr><th>Options</th><th>Availability of IBCAs</th><th>Environmental safety</th><th>Time to market new products</th><th>Economic sustainability of the approach</th><th>Feasibility</th></tr></thead><tbody><tr><td>conditions (confined space especially)</td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Processes with several steps: importation, introduction, commercialisation</td><td>-</td><td>-</td><td>+</td><td>Enables parsimony in the efforts asked to petitioners at early steps of R&amp;I processes</td><td>- Increased number of interactions and dossiers between petitioners and competent risk analysis services</td></tr><tr><td>Ensure that risk mitigation measures or plans are used and implemented in the Member States</td><td>-</td><td>+</td><td>-</td><td>- Implementation of control will be necessary</td><td>-</td></tr><tr><td colspan="6">Level of centralisation and third-party involvement</td></tr><tr><td>Requirement of Risk-Assessment performed by Member States</td><td>Possible unavailability of IBCAs in Member States without adequate procedures, services or expertise.</td><td>Different MS may develop strict or contrasting regulations preventing the industry from selling an IBCA species using the same strain throughout the</td><td>-</td><td>- Redundant work in several MS<br/>- Lack of knowledge and capacity in some Member States to conduct theses risk assessment</td><td>+</td></tr></tbody></table>
<table><thead><tr><td>Options</td><td>Availability of IBCAs</td><td>Environmental safety</td><td>Time to market new products</td><td>Economic sustainability of the approach</td><td>Feasibility</td></tr></thead><tbody><tr><td></td><td></td><td>EU. This would be a severe lock to most current business models based on economy of scale. Local officials have the necessary competence on local habitats, subspecies, populations</td><td></td><td></td><td></td></tr><tr><td>Risk-Assessment performed by EFSA</td><td>- Risk of increase of the time needed for authorization of IBCAs<br/>+ Increase access to authorised IBCAs in all the Member States</td><td>+ Ensures high standards of quality and independence.<br/>- Risk assessment should consider variety of conditions between the Member States</td><td>-</td><td>- New procedures to be set up, with additional resources to EFSA and an EC portal to submit dossiers<br/>- Additional resource and investment: An EC portal used as entry point transmitting to EFSA is required.</td><td>-</td></tr></tbody></table>
<table><thead><tr><td>Options</td><td>Availability of IBCAs</td><td>Environmental safety</td><td>Time to market new products</td><td>Economic sustainability of the approach</td><td>Feasibility</td></tr></thead><tbody><tr><td></td><td></td><td></td><td></td><td>Additional resources must be planned to make sure EFSA can perform risk-assessment within short times<br/>+ Avoid reductant work between Member States</td><td></td></tr><tr><td>Centralized decision-making</td><td>+ IBCAs will be available at European level</td><td>- Does not let MS authorities to decide their own principles of biodiversity protection and risk-management</td><td>-</td><td>+ One procedure for multiple Member States</td><td>-</td></tr><tr><td>Decision-making by each MS</td><td>-</td><td>+ Let the Member States decide according to its own risk-management strategy and its own specificities (local biodiversity,</td><td>-</td><td>- Redundancy of procedures with up to 27 Member States conducting decision making</td><td>-</td></tr></tbody></table>
<table><thead><tr><td>Options</td><td>Availability of IBCAs</td><td>Environmental safety</td><td>Time to market new products</td><td>Economic sustainability of the approach</td><td>Feasibility</td></tr></thead><tbody><tr><td>Mutual recognition between Member States</td><td>+ Facilitate authorisation and availability of IBCAs</td><td>- Some regional / local specificities have to be considered regarding risk on biodiversity</td><td>-</td><td>+ Limit the redundancy between Member States</td><td>-</td></tr></tbody></table>
Four types of scenarios have been defined by combining the different options in order to provide some examples of the possible frameworks that can be developed at the European Level within a gradient from voluntary scheme to a completely centralised assessment and centralised decision-making. These scenarios have been discussed during interviews with NCAs and other main stakeholders as well as during the workshop. They are described below, and the main pros and cons identified are summarised for each of them:

## Scenario 1: Voluntary scheme based on the use of data from EPPO

The simplest voluntary scheme may rely on the production by EPPO of a set of guidance documents and positive/negative lists including the native/exotic status of species in each Member States (if known). Member States or groups of Member States could then agree to use these documents and lists as directly usable criteria to provide authorisation of importation/use of IBCAs or as a mere source of information to feed their own regulatory processes. This system may then be more or less constrained in so far is it can impose quality or reliability criteria on the data published by EPPO, with different possible extents of intended harmonization.

The pros and cons of this scenario (and that of scenario 2 below) were discussed precisely during the validation workshop on 31st of August. The outcomes of this discussion are summarized in the table below.

<table><thead><tr><td>Pros</td><td>Cons</td></tr></thead><tbody><tr><td><ul><li>Industry already knows how to work under this scenario</li><li>Little administrative burden.</li><li>Flexible in terms of use by the MS.</li></ul></td><td><ul><li>Not binding enough to ensure availability and safety throughout the EU</li><li>Not enough homogenization at EU level</li><li>No consideration of cross border issues</li><li>Requires that all MS have a regulation</li><li>Risk assessment would require a higher level of independence vs stakeholders and formal management of conflict of interest</li><li>Difficulty for small companies to handle many different national frameworks</li></ul></td></tr></tbody></table>
<table><tr><td></td><td><ul><li>Lot of work for all MS</li><li>Not suitable for MS without national regulation</li><li>Disruption of free movement of goods</li></ul></td></tr></table>

## Scenario 2: A two-levels procedure to find a balance between homogenization and freedom of action of Member States

Here, EFSA (or another EU organisation with expertise on IBCAs) would play a major role by being responsible for (i) an impact assessment for any species to be produced/used/commercialised and not previously listed in the EU, and (ii) the publication of guidance documents, negative and positive lists, and lists detailing the exotic/resident status of species in Member States (referring to the data produced by EPPO if relevant). The work at the EU level will only concern assessment and studies at the species level. The only obligation for all Member States would be to automatically prohibit the use of species on the negative list produced at the European level. Then, the Member States would be able to choose between several options: (i) Member States may use EU documents and lists as a source of information to implement their own national processes for the authorisation of products on their territory (e.g. reliable data from EFSA would be appreciated in Spain and France that already set their national regulations); (ii) Member States with no national regulation on IBCAs or no impact assessment process may use the impact assessments and existing lists to reach their conclusions regarding authorisations (or may even delegate additional specific assessment regarding strains or specific geographical area or the authorisation decision to EFSA). In addition, some voluntary mutual recognition schemes could also be integrated for groups of Member States by specific zones.

<table><thead><tr><td>Pros</td><td>Cons</td></tr></thead><tbody><tr><td><ul><li>The initial centralized risk assessment performed once for any new (exotic or previously not assessed) IBCA ensures safety for all MS.</li><li>The two-step process combines safety for all MS and flexibility/freedom for MS in terms of implementation</li><li>A competent EU risk assessment body is involved in the</li></ul></td><td><ul><li>Risk of duplication of work between centralized and national risk-assessments</li><li>Longer timelines involved by a formal EU-level procedure and involvement an EU agency.</li><li>Risk of redundancy between EFSA and EPPO</li><li>If the centralized risk-assessment is performed for the</li></ul></td></tr></tbody></table>
<table><tr><td>assessment of new (exotic or previously not assessed) IBCAs.<ul><li>Higher level of homogenization</li><li>Whitelist and negative lists help with decision making</li><li>Sharing of information and resources</li><li>Close cooperation between EFSA and EPPO</li></ul></td><td>entire EU zone, this is a challenging work<ul><li>Longer time to set up the new framework</li></ul></td></tr></table>

### Scenario 3. A centralized impact-assessment managed by EFSA (or another EU organisation with expertise on IBCAs).

Under this scenario, EFSA would handle the demands from all entities and perform impact assessments. Decision-making would be left to the government services of each Member States on the basis of the results of the European analysis (unless decision making is delegated to EFSA by the Member State authorities).).

<table><thead><tr><td>Pros</td><td>Cons</td></tr></thead><tbody><tr><td><ul><li>Simple process, one entry point</li></ul></td><td><ul><li>Limited freedom/flexibility for MS at the national level for risk-assessment</li></ul></td></tr></tbody></table>

### Scenario 4: A completely centralized process, from assessments to decision-making.

Under this scenario, EFSA (or another EU organisation with expertise on IBCAs) would handle the whole process, from assessment to decisions of authorizations of importation/production/commercialisation in Europe.

<table><thead><tr><td>Pros</td><td>Cons</td></tr></thead><tbody><tr><td><ul><li>Simplest process, one entry point and one decision-making procedure</li></ul></td><td><ul><li>Exclusion of the MS authorities from the risk-assessment and decision-making processes</li></ul></td></tr></tbody></table>

Each of the scenarios based on a high level of centralisation (3 and 4) would then have to be split into two sub-scenarios: (i) with impact-assessments at the species level only and (ii) with impact assessments taking into account intraspecific variations (e.g., as it is currently implemented in France). The rationale behind the choice to deal with intraspecific variations is that very different subspecies or differentiated populations can be found within a same so-called species and may display very different phenotypes
and contrasting risks and benefits in terms of use as biocontrol agent; these risks and benefits may also differ according to the release environment: ecological zone, island, etc.

On the relevance of accounting for intraspecific variations in IBCAs, from a scientific point of view, IBCA populations may display significant differences in terms of phenotypes affecting the risks they can pose on biodiversity and the benefits they can provide to crop protection. IBCA populations display a gradient of genetic differentiation that ranges from local variations to genetic differentiation. This can cause reproductive isolation. There is no clear boundary to set at which populations can be considered differentiated populations, subspecies, sibling species, different species, etc. In theory, accounting for intraspecific variations is relevant, because assessments may be biased by the occurrence of intraspecific differences which, in turn, may affect the risks and benefits.

In practice, however, data about genetic structure of IBCA populations are extremely scarce and data about genetic structure impacting functional diversity (i.e., impacting phenotypic traits important for biocontrol features; which by the way are not clearly set in the scientific literature) are, to our knowledge, not available. Hence, the risks of misinterpreting intraspecific data and creating a high administrative burden due to assessments based on poor quality data or inadequate interpretation of data in an evolutionary and ecological perspective are very high. Obliging petitioners to produce scientifically sound intraspecific data would also be unrealistic: most companies do not have the resources to do so (particularly with regard to running analyses at the level of functional genetic diversity) and the costs would be unreasonably high when compared to the possible accessible markets. It could be underlined that there is only one entry in the EPPO positive list that goes to strain level (only the non-diapausing strain of *Neoseiulus californicus* is accepted in the positive list of commercially available IBCAs).

On the definition (or absence of definition) of zones relevant to the risk-benefit assessment. One issue is the difficulty in agreeing to the zones that ought to be considered separately when assessing risks and benefits. Member States currently use at least political borders (which is not making sense in a scientific point of view), and they sometimes delineate zones within their borders (in islands and in ultramarine territories, for instance). Some experts and stakeholders argue that Europe can be considered as a single zone or that several zones could be delineated according to a range of criteria: (i) using the same zones (South, North, Centre) as those used in the regulation applying to pesticides, (ii) zones delineated by barriers (mountains, sea, etc.) relevant to dispersal capacities of IBCAs, (iii) zones delineated by pedoclimatic features, (iv) zones delineated by crop sector features, (v) "ecoregions"<fnref n="126" />, etc. Choices may also be influenced by the type of regulatory framework to be adopted. The more the processes are

<footnote n="126">¹²⁶ https://www.cabdirect.org/cabdirect/abstract/20063106175</footnote>
centralized, the more relevant the discussions about the delineation of zones when assessing risks and benefits will be.

### 4.3.2 Options related to the production of data, recording and monitoring of IBCAs

As identified during the study, little data is available regarding the current market of IBCAs in the EU and the use of IBCAs by the Member States (including the long-term effects of the release of IBCAs). The following options aim at improving the current situation regarding the production of data and the recording and monitoring of the use of IBCAs:

<table><thead><tr><td>Options</td><td>Availability of IBCAs</td><td>Environmental safety</td><td>Time to market new products</td><td>Economic sustainability of the approach</td><td>Feasibility</td></tr></thead><tbody><tr><td>Require the registration of European producers and volume of sales</td><td><strong>+</strong> Increase understanding of the mean of production available in Europe and the evolution of the market</td><td>-</td><td>-</td><td>-</td><td>-</td></tr><tr><td>Monitor the use of IBCAs through the definition of common indicators to be reported at EU level (i.e. number of species authorised, number of products, etc.)</td><td><strong>+</strong> Facilitate sharing of knowledge and return of experience regarding the use of IBCAs</td><td><strong>+</strong> Deepen knowledge on where and which IBCAs are used to ensure monitoring of the situation and react faster in case of detection of unintended effects</td><td>-</td><td><strong>-</strong> Additional administrative burden for Member States and European Commission</td><td>-</td></tr><tr><td>Develop the process to</td><td>-</td><td>-</td><td><strong>+</strong> Speed up the risk</td><td>-</td><td><strong>-</strong> Some issues</td></tr></tbody></table>
<table><thead><tr><td>Options</td><td>Availability of IBCAs</td><td>Environmental safety</td><td>Time to market new products</td><td>Economic sustainability of the approach</td><td>Feasibility</td></tr></thead><tbody><tr><td>increase the share of information on risk assessment between the Member States</td><td></td><td></td><td>assessment in Member States</td><td></td><td>may be encountered regarding private property</td></tr><tr><td>Set up a working group at EU level to conduct specific work on post release assessment (and especially positive and negative impacts of IBCAs)</td><td>-</td><td>+ Increase of knowledge on post-release effects of IBCAs</td><td>-</td><td>- Need of financial support to conduct large scale scientific projects on a long-term basis (effects should be monitored on several years)</td><td>-</td></tr></tbody></table>

### 4.3.3 Options related to innovation fostering

As previously mentioned; the effort to support the research and development of IBCAs could be increased. This push for innovation could be supported by several national and/or European initiatives:

- Several financial schemes exist at the European level that support public and private stakeholders (and public-private partnerships): Horizon programme, CAP (through EARDF), ERDF, etc.

- BTSF program could be mobilized to increase the expertise of both risk analysis specialists and BCA users. It is funded by the EC with specific training sessions to improve the capacity of the expert work with microorganisms. There are specific sessions for technicians which could be extended for BCAs, not only to train technicians on BCAs, but extend them to NCAs.

- EIP Agri projects
o Generally, EU-funded projects in Horizon Europe are large, but there are also smaller programs, also related to knowledge dissemination (Ex RELAX, under which some field trials are funded). They are also a very important part of the practical information transfer to farmers.

- Specific efforts should be focused on the strategies with the highest cost-benefit ratios for farmers, i.e. coupling conservation biocontrol, establishment biocontrol and inoculation augmentation biocontrol, and establishing non-academic players working on their routine implementation with stakeholders (cooperatives, farmers' groups, etc.). So far, IBMA does not include companies that proved able to create an economically viable activity from conservation biocontrol for example, because the suitable business models, that strongly depart from the classical "input producer" model, have not been put into practice.

- Specific programs focused on generating data and references about impacts (environmental, economic, social) of IBCAs, including life-cycle analyses, could be beneficial to remove constraints to development and use. Horizon Europe calls may specifically target this objective of producing data on biocontrol sustainability (including that of IBCAs) over the coming years.

- Encouraging co-innovation projects among different stakeholders (until downstream industries that create added value for food produced via more agroecological methods) could help foster innovation. This is currently encouraged in most EU calls, but not always put into practice and rarely (or never) performed specifically on co-innovation regarding biocontrol methods. This could be fostered both at the levels of Member states and Horizon Europe.

- Financial incentives could be given to farmers for the use of IBCAs to support the demand of products (it could also be integrated in CAP strategic plans, as it is the case in France)

The pros and cons of these options are summarized in the table below.

<table><thead><tr><td>Options</td><td>Availability of IBCAs</td><td>Environmental safety</td><td>Time to market new products</td><td>Economic sustainability of the approach</td><td>Feasibility</td></tr></thead><tbody><tr><td>Using financial schemes at the EU level to support public and</td><td>+</td><td>+</td><td>+</td><td>-</td><td>-</td></tr></tbody></table>
<table><thead><tr><td>Options</td><td>Availability of IBCAs</td><td>Environmental safety</td><td>Time to market new products</td><td>Economic sustainability of the approach</td><td>Feasibility</td></tr></thead><tbody><tr><td>private stakeholders: Horizon programme, CAP (through EARDF), ERDF, etc.</td><td></td><td></td><td>commercialisation of new products</td><td></td><td></td></tr><tr><td>Leveraging EU and national programs focused on assessing impacts</td><td>-</td><td>+</td><td>-</td><td>-</td><td>-</td></tr><tr><td>Encouraging co-innovation projects involving local stakeholders, growers, industry</td><td>+</td><td>This would make more solutions available on the market</td><td>+</td><td>-</td><td>-</td></tr><tr><td>Requiring national strategies regarding the development and use of IBCAs</td><td>+</td><td>This would make more solutions available on the market</td><td>+</td><td>-</td><td>-</td></tr></tbody></table>
<table><thead><tr><td>Options</td><td>Availability of IBCAs</td><td>Environmental safety</td><td>Time to market new products</td><td>Economic sustainability of the approach</td><td>Feasibility</td></tr></thead><tbody><tr><td>Setting financial incentives to support the demand of IBCA products among farmers</td><td>-</td><td>+ This could help decrease the use of insecticides among farmers</td><td>-</td><td>for the strategy<br/>- This would require additional financial expenses at the EU or national level</td><td>-</td></tr></tbody></table>

### 4.3.4 Options related to training, knowledge transfer and behavioural changes along the agrifood value chains

Knowledge of IBCAs among growers has been identified by the study as a key driver for the adoption of IBCAs. As mentioned above, knowledge transfer currently happens foremost between industry advisors and growers. Other sources of knowledge could be reinforced, such as education, public communication, industry associations, etc. Several means exist to support training and knowledge transfer:

- Developing a specific platform / working group supported by the European Union to share information between the stakeholders and Member States regarding the use of IBCAs (or more generally biocontrol solutions). In particular, it would ensure that specific contacts are identified in each Member State and in charge of the subject. At the EU scale, this could be fostered through programmes like the Circular Bio-based Europe Joint Undertaking (CBE JU)<fnref n="127" />.

- Supporting farmers' capacity development and share experience, from financial support to training on the subject.

- Supporting the monitoring and data collection regarding the use of IBCAs in the Member States and encourage the sharing of this data at European level.

- Fostering communication and success stories in which IBCAs are successfully integrated into place-based and collective agroecological initiatives. Communication among Member states should be

<footnote n="127">¹²⁷ Circular Bio-based Europe Joint Undertaking (CBE JU).</footnote>
emphasized. Several national programmes exist but they rarely engage stakeholders from other Member States.

Knowledge is not only lacking among growers, but also among NCAs, specifically on risk assessment. Several initiatives could help improve the situation:

Providing additional guidelines and tools for Member States to develop their own framework

- Providing training regarding risk assessments

The pros and cons of these options are summarized in the table below:

<table><thead><tr><th>Options</th><th>Availability of IBCAs</th><th>Environmental safety</th><th>Time to market new products</th><th>Economic sustainability of the approach</th><th>Feasibility</th></tr></thead><tbody><tr><td colspan="6"><strong>For growers</strong></td></tr><tr><td>Developing a specific platform / working group supported by the European Union in order to share information between the stakeholders</td><td>+</td><td>This would promote the adoption of IBCAs</td><td>-</td><td>-</td><td>- This working group should complement /improve existing networks and not duplicate them</td></tr><tr><td>Supporting farmers capacity development through financial support to training on this subject and sharing of experience</td><td>+</td><td>This would promote the adoption of IBCAs</td><td>-</td><td>- This would require additional financing</td><td>- Communicat on on these initiatives is important for their success, especially in Member States in which the use of IBCAs is limited</td></tr></tbody></table>
<table><thead><tr><th>Options</th><th>Availability of IBCAs</th><th>Environmental safety</th><th>Time to market new products</th><th>Economic sustainability of the approach</th><th>Feasibility</th></tr></thead><tbody><tr><td colspan="6"><strong>For growers</strong></td></tr><tr><td>Supporting the monitoring and data collection and ensuring accessibility to this data in the European Union</td><td>-</td><td>+</td><td>+</td><td>-</td><td>- This would require significant effort as data requirements and whether data is consolidated at the national level differ across Member States</td></tr><tr><td>Fostering communication and success stories in which IBCAs are successfully integrated into place-based and collective agroecological initiatives</td><td>+</td><td>This would promote the adoption of IBCAs</td><td>+</td><td>-</td><td>-</td></tr><tr><td colspan="6"><strong>For Member States</strong></td></tr><tr><td>Providing additional guidelines and tools for Member States to develop their</td><td>+</td><td>This would promote the adoption of IBCAs</td><td>+</td><td>+</td><td>- As different Member States have different approaches to</td></tr></tbody></table>
<table><thead><tr><th>Options</th><th>Availabil-<br>ty of<br>IBCAs</th><th>Environ-<br>mental<br>safety</th><th>Time to<br>market<br>new<br>products</th><th>Economic<br>sustain-<br>nability<br>of the<br>approach</th><th>Feasibi-<br>lity</th></tr></thead><tbody><tr><td colspan="6"><strong>For growers</strong></td></tr><tr><td><strong>own<br>framework</strong></td><td></td><td>safety of<br>IBCAs</td><td>would<br>speed up<br>the<br>authorisati<br>on process</td><td></td><td>regulations<br>and different<br>perceptions<br>of risk,<br>guidelines<br>should be<br>careful not to<br>suggest a<br>unique<br>model</td></tr><tr><td><strong>Providing<br>training<br>regarding risk<br>assessments</strong></td><td>+</td><td>This<br>would<br>promote<br>the<br>adoption of<br>IBCAs</td><td>+</td><td>This<br>could help<br>disseminat<br>e good<br>regulatory<br>practices<br>which<br>would<br>speed up<br>the<br>authorisati<br>on process</td><td>- As<br>different<br>Member<br>States have<br>different<br>approaches<br>to<br>regulations<br>and different<br>perceptions<br>of risk,<br>guidelines<br>should be<br>careful not to<br>suggest a<br>unique<br>model</td></tr></tbody></table>

Preliminary inputs regarding the impacts of the implementation of the option on the achievement of the objectives of reduction of the use of chemical pesticides of the Farm to Fork Strategy.

As mentioned in the analysis of the pros and cons of the different options, these options will have various impacts on the development and use of IBCAs and thus, on the achievement of the objectives of the Farm to Fork Strategy.
Within the next 10 years in the frame of the Farm-to-Fork strategy, assuming (i) strong policy measures to increase market penetration of augmentative biocontrol and SIT, and (ii) above all, concrete actions to professionalize the management of conservation biocontrol, IBCAs may contribute to a reduction of -3% to -5% of pesticide use in 2030, given that the timeframe is very limited (7 years to 2030). Thus, an additional reduction of -2% to -4% of pesticides in comparison to the baseline.

Knowing that impacts from starting research are generally reached after 15-20 years and that, as a consequence, only results of already started and identified R&D activities will be able to impact in 2030. However, from a longer-term perspective, the support to innovation may ensure that the maximum potential for the reduction of the use of chemical pesticides thanks to IBCAs is reached faster.

<figure><img src="image_29.png" /><figcaption>**Figure 13 - Schematic view of the potential of decrease of the use of chemical pesticides through the development of IBCAs**</figcaption></figure>

The impacts of the options would need to be further assessed in case of the implementation of the various options by the European Commission.
4.4 Intervention logic

<figure><img src="image_30.png" /></figure>
# 5 Annexes

## 5.1 Annex 1 - Key definitions regarding IBCAs

### BCAs

**Biological control** is a concept in plant protection and plant health defined by the OECD as a "pest management strategy making use of living natural enemies, antagonists or competitors and other self-replicating biotic entities"<fnref n="128" />. However, this definition is still controversial among researchers<fnref n="129" />.

Biological control mainly relies on the agents and substances used to control plant pests and invasive alien plants. The OECD programme on biological pesticides identifies four groups of **biological control agents (BCAs)**: (i) plant extracts/botanicals, (ii) semiochemicals, (iii) microbials, and (iv) macrobials/invertebrates. This classification is presented below:

<table><caption>Table 12: classification of biocontrol agents into 4 groups</caption><thead><tr><th>Groups of BCAs</th><th>Biocontrol agents</th><th>Examples</th></tr></thead><tbody><tr><td>Plant extracts / natural products<fnref n="130" /></td><td>Natural biocides or pesticides</td><td>Extracts of onion, garlic, eucalyptus, tobacco, ground and dried flowers, essential oils...</td></tr><tr><td>Semiochemicals<fnref n="131" /></td><td>Species-specific organic compounds used by insects to convey specific chemical messages that modify behaviour or physiology. Biocontrol management strategies include monitoring, mass trapping, mating disruption, attract-and-kill, and push-pull</td><td>Pheromones, allochemicals (allomones, kairomones, synomones, apneumones)</td></tr><tr><td>Microbials</td><td>Micro-organisms (mainly viruses, bacteria, and fungi) which can be used to control pests, pathogens, and weeds. Most micro-organisms used against pests and weeds are pathogens, while modes of action to control other micro-organisms can be via direct or indirect antagonism (parasitism, competition, etc.).</td><td>Bacteria, algae, fungi, protozoans, viruses</td></tr></tbody></table>

<footnote n="128">¹²⁸ OECD (PDF) Guidance for Information Requirements for Regulation of Invertebrates as Biological Control Agents (IBCAs) (researchgate.net)</footnote>

<footnote n="129">¹²⁹ https://doi.org/10.1023/A:1014193329979; https://doi.org/10.1017/9781139029117; https://dx.doi.org/10.1007/s10340-021-01354-7</footnote>

<footnote n="130">¹³⁰ 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="131">¹³¹ Anamika Sharma, Ramandeep Kaur Sandhi, and Gadi V. P. Reddy https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6955951/</footnote>
<figure><img src="image_31.png" /></figure>

**Macrobiai / invertebrates**

Invertebrate animals which can be used to
control pests and diseases as well as vectors
of such pests and diseases, unwanted
organisms and weeds.

Insects, mites,
nematodes

IBCAs

**Invertebrate biological control agents (IBCAs)**, also called
macrobiai, are invertebrate animals which can be used to control pests
and diseases as well as vectors of such pests and diseases, and unwanted
organisms. They can act as predators, parasitoids, parasites, competitors
for common resources, or otherwise inhibit their population growth or
spread:
<table><caption>Table 13: types of IBCAs (or macrobials) species</caption><thead><tr><td>Category</td><td>Mode of action</td><td>Examples</td></tr></thead><tbody><tr><td>Predators</td><td>Predators kill and feed other organisms<br/>Specific advantages for biological control: smaller range of prey species, shorter life cycles allow for predator population density to fluctuate in response to changes in the density of their prey</td><td>Spiders, predatory mites, lady beetles, ground beetles, lacewings, nematodes, etc.</td></tr><tr><td>Parasites</td><td>Organisms that live in or on other organisms, without killing them</td><td>Nematodes, mites ...</td></tr><tr><td>Parasitoids</td><td>Insects parasitic only in their immature stages, killing its host in the process of its development, and free living as an adult<sup>132</sup>.<br/>High host specialization<br/>Sterile insect techniques are being developed to release sterile parasitoids that still kill their hosts, but have lesser impact on non-target organisms<sup>133</sup></td><td>Hymenoptera (parasitoid wasps), Diptera (parasitoid flies)</td></tr><tr><td>Competitors</td><td>For common resources (honeydew, plant nectar or pollen)<br/>For common mates: Sterile Insect Technique (SIT) involving the mass-rearing and release of sterilised insects to disrupt fecundity</td><td>SIT</td></tr><tr><td>Phytophages</td><td>Herbivorous invertebrates used to control weeds. Classified according to what they consume (roots, stems, leaves, flowers, seeds, fruits), and by how they feed (sucking, chewing, leaf or stem mining, root boring). Some herbivores can be vertebrates (goats, fishes...) but are outside the scope of this study</td><td>Herbivorous invertebrates</td></tr></tbody></table>

Invertebrates used for biological control can be either:

<footnote n="132">¹³²□OCDE (PDF) Guidance for Information Requirements for Regulation of Invertebrates as Biological Control Agents (IBCAs) (researchgate.net)</footnote>

<footnote n="133">¹³³ Horrocks, Kiran & Avila, Gonzalo & Holwell, Gregory & Suckling, David. (2021). Irradiation-induced sterility in an egg parasitoid and possible implications for the use of biological control in insect eradication. Scientific Reports. 11. 10.1038/s41598-021-91935-4. https://www.researchgate.net/publication/352287980_Irradiation-induced_sterility_in_an_egg_parasitoid_and_posible_implications_for_the_use_of_biological_control_in_insect_eradication</footnote>
* **Native species** (also called indigenous) species, meaning that they originate from and have evolved in a local area over a long period of time. Species that are native are described in terms of their geographic origin: this could lead to specific challenges as in a same specific Member State, a species can be considered as a native one in a specific region but not in another area (this is especially the case for Member States with outermost regions). This will be further investigated through survey and interviews with NCAs to better understand the definition applied at national levels.

* **Non-native species** (also called exotic or alien species), that on the contrary refer to organisms that have evolved in a different area of the world and are now present elsewhere or may occur elsewhere. **Non-native species are called introduced** species when they were introduced either intentionally or accidentally in environments in which they were not native. **Non-native species are called "established"** when they do not need human help to reproduce and maintain themselves over time in an area where they are not native.

Member States may have their own definition of the scope of IBCAs, especially with regards to what is considered as native or non-native. Thus, some Member States may not consider SIT as being part of the scope in their legislation, or not consider native species as they only regulate non-native ones.

**Biocontrol mechanisms**

The use of BCAs (including IBCAs) in pest management relies on different strategies. Traditionally, biological control can be achieved through four different mechanisms which refer to different introduction methods of the agent, different origins, and/or different types of biological control agent(s) used in the process. The four categories of biocontrol are briefly presented below<fnref n="134" />:

<footnote n="134">¹³⁴ Eilenberg J, Hajek A, Lomer C. 2001. Suggestions for unifying the terminology in biological control.
BioControl 46:387-400 DOI:10.1023/A:1014193329979</footnote>
<table><caption>**Table 14: types of biological control mechanisms / strategies**</caption><thead><tr><th colspan="2">Types of biological control</th></tr></thead><tbody><tr><td>Natural biological control<sup>135</sup></td><td>Natural biological control refers to the natural functioning of ecosystems where pest organisms are reduced by naturally occurring beneficial organisms. This occurs in all the world's ecosystems <strong>without any human intervention</strong></td></tr><tr><td>Conservation biological control of existing natural enemies<sup>136</sup></td><td>Conservation biological control refers to the protection, promotion, and attraction of native beneficial organisms by:<br>Providing or restoring habitat and resources for natural enemies (other sources of nectar and pollen, shelter, substitute prey and hosts...)<br>Reduction of pesticide use (to preserve highly pesticide-sensitive natural enemies), selection of pesticides impacting them less, application of these pesticide in a manner more likely to affect the pest more than the beneficial organism<br>Attracting of natural enemies by semiochemicals</td></tr><tr><td>Classical biological control: introduction and establishment of a new species</td><td>The intentional introduction and permanent establishment of an exotic biological agent for long-term pest management<sup>137</sup>. The species introduced is a non-native species that present capacities 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).<br>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.</td></tr><tr><td>Augmentative biological control: periodic release</td><td>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. In case of the use of non-native species it does not aim to establish these species on the long term. Several techniques exist<sup>138</sup>:<br><strong>Inundative biocontrol</strong>: short-term release for crops with a short production cycle (e.g. nematodes, SIT, microbials)<br><strong>Seasonal inoculative biocontrol</strong>: longer term production cycle. Ex: appropriate for natural enemies who cannot survive winter, for</td></tr></tbody></table>

<footnote n="135">135 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="136">136 Alissia Rousseaux, Lorie Seychal, Jean-Pierre Sarthou. 2018. Conservation biological control : Definition. Dictionnaire d'Agroecologie, https://dicoagroecologie.fr/en/encyclopedia/conservation-biological-control/</footnote>

<footnote n="137">137 OCDE Guidance for Information Requirements for Regulation of Invertebrates as Biological Control Agents (IBCAs) (researchgate.net)</footnote>

<footnote n="138">138 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>
greenhouses where all possible natural habitat for the natural enemy
at the end of a production cycle is removed<fnref n="139" />

The study will focus on **classical and augmentative biocontrol** using invertebrates (including SIT), which target the deliberate production, release, and marketing of macrobial organisms. The **distinction between these two types of biocontrol will be key**, as they follow different logics: classical biocontrol aims at establishing a new species with a long-term perspective, whereas augmentative biocontrol focuses on shorter-term release of organisms. As such, the study questions may apply most directly to one type or the other.

**Other relevant definitions linked to IBCAs**

- **Biological diversity / Biodiversity:** The variety of life on Earth. It includes all organisms, species, and populations; the genetic variation among these; and their complex assemblages of communities and ecosystems. It also refers to the interrelatedness of genes, species, and ecosystems and in turn, their interactions with the environment<fnref n="140" />. (Definition adopted by The United Nations Environment Programme (UNEP). In the present document, biodiversity more specifically relates to the variety of organisms in specific geographical area.

- **Integrated Pest Management (IPM):** Integrated Pest Management (IPM) means the careful consideration of all available pest control techniques and subsequent integration of appropriate measures that discourage the development of pest populations and keep pesticides and other interventions to levels that are economically justified and reduce or minimize risks to human and animal health and the environment. IPM emphasizes the growth of a healthy crop with the least possible disruption to agro-ecosystems and encourages natural pest control mechanisms (Definition adopted by FAO).

- **Invasive alien species (IAS):** Species whose introduction and/or spread outside their natural past or present distribution threatens biological diversity and related ecosystem services<fnref n="141" />. (IUCN)

- **Plant pest:** "Any species, strain or biotype of plant, animal or pathogenic agent injurious to plants or plant products" (IPPC)

<footnote n="139">¹³⁹ 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="140">¹⁴⁰ https://www.unep.org/unep-and-biodiversity</footnote>

<footnote n="141">¹⁴¹ UNEP - Convention on Biological diversity. 2018. https://www.cbd.int/doc/c/0c6f/7a35/eb8815eff54c3bc4a02139fd/cop-14-inf-09-en.pdf</footnote>
* **Quarantine plant pest:** "A pest of potential economic importance to the area endangered thereby and not yet present there, or present but not widely distributed and being officially controlled" (IPPC)

**Other relevant definitions for the purpose of the Study**

For the use of this study, the following terms are used:

- Introduction of IBCAs refers to the import and entry of IBCAs in the territory of the Union;

- Production of IBCAs refers to the breeding of invertebrates to obtain sufficient number of individuals (mass-rearing);

- Release of IBCAs refers to the actual use of IBCAs (in a contained or non-contained environment);

- Marketing of IBCAs refers to the placement of a product on the market.

**5.2 Annex 2 - Documentary review**

**Guidance documents**

OECD & van Lenteren. 2004. Guidance for Information Requirements for Regulation of Invertebrates as Biological Control Agents (IBCAs) : http://www.researchgate.net/publication/40123759_Guidance_for_Information_Requirements_for Regulation_of_Invertebrates_as_Biological

OECD - Biocigal pesticides https://www.oecd.org/chemicalsafety/pesticides-biocides/biological-pesticides.htm

EFSA PLH Panel (EFSA Panel on Plant Health), 2015. Statement on the assessment of the risk posed to plant health in the EU territory by the intentional release of biological control agents of invasive alien plant species. EFSA Journal 2015;13(6):4134, 12 pp. https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2015.4134

EFSA PLH Panel (EFSA Panel on Plant Health), 2015. Risk to plant health in the EU territory of the intentional release of the bud-galling wasp Trichilogaster acaciaelongifoliae for the control of the invasive alien plant Acacia longifolia https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2015.4079

IPPC Secretariat. 2017. Guidelines for the export, shipment, import and release of biological control agents and other beneficial organisms. International Standard for Phytosanitary Measures No.3. Rome. FAO on behalf of the Secretariat of the International Plant Protection Convention https://www.fao.org/3/j5365e/J5365E.pdf

**Legislative texts**
Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02009L0128-20190726

Regulation 1107/2009 (EC) of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32009R1107&from=fr#d1e583-1-1

Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02012R0528-20220415

Council Decision (EU) 2021/1102 requesting the Commission to submit a study on the Union's situation and options regarding the introduction, evaluation, production, marketing and use of invertebrate biological control agents within the territory of the Union and a proposal, if appropriate in view of the outcomes of the study. OJ L 238, 6.7.2021, p.81 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021D1102

Regulation (EU) 2016/2031 of the European Parliament and of the Council on protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No 652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 2000/29/EC, 2006/91/EC and 2007/33/EC. OJ L 317, 23.11.2016, p.4. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R2031

Regulation (EU) 1143/2014 of the European Parliament and of the Council on the prevention and management of the introduction and spread of invasive alien species. OJ L 317, 4.11.2014, p.35. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02014R1143-20191214

Commission Directive (EU) 2019/782 of 15 May 2019 amending Directive 2009/128/EC of the European Parliament and of the Council as regards the establishment of harmonised risk indicators. OJ L 127, 16.5.2019, p.4. https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32019L0782

### Non-legislative texts published by the Commission

BIOLOGICAL CONTROL CONFERENCE, Lisbon, 28 April 2021, Presentation of BCA MS survey https://www.dgav.pt/wp-content/uploads/2021/05/DGAV_-conferencia_BCA.pdf

European Commission, Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: A Farm to Fork Strategy for a fair, healthy and environmentally-friendly food system. COM/2020/381
final. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52020DC0381

Scientific studies & Research projects

REBECA (Registration of Biological Control Agents) Final activity report
https://cordis.europa.eu/docs/results/22/22709/123869671-6_en.pdf

Anamika Sharma, Ramandeep Kaur Sandhi, and Gadi V. P. Reddy. 2019. A Review of Interactions between Insect Biological Control Agents and Semiochemicals https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6955951/

Horrocks, Kiran & Avila, Gonzalo & Holwell, Gregory & Suckling, David. (2021). Irradiation-induced sterility in an egg parasitoid and possible implications for the use of biological control in insect eradication. Scientific Reports. 11. 10.1038/s41598-021-91935-4.
https://www.researchgate.net/publication/352287980_Irradiation-inducedSterility in an egg parasitoid and possible implications for the use of biological control in insect eradication

Eilenberg J, Hajek A, Lomer C. 2001. Suggestions for unifying the terminology in biological control. BioControl 46:387-400
https://www.researchgate.net/publication/227328058_Eilenberg_J_Hajek_A_Lomer_C_Suggestions_for_unifying_the_terminology_in_biological_control_BioControl

van Lenteren, J.C. 2012. The state of commercial augmentative biological control: plenty of natural enemies, but a frustrating lack of uptake. BioControl 57:1-20.

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

R. F. Smith and H. T. Reynolds. 1966. Principles, definitions and scope of integrated pest control. Proc. FAO Symposium on Integrated Pest Control 1: 11-17.
https://www.academia.edu/19937522/Compendium_of_IPM Definitions_CID_What_is_IPM_and_how_is_it_defined_in_the_Worldwide_Literature

Venter, J. Invasive species and the Working for Water programme in South Africa https://www.fao.org/3/y5968e/y5968e13.htm

Sterile Insect Technique (Hendrichs & Robinson) IAEA-FAO

E. J. Hunt et al., Review of invertebrate biological control agent regulation in Australia, New Zealand, Canada and the USA: recommendations for a harmonized European system, 2007
https://onlinelibrary.wiley.com/doi/full/10.1111/j.1439-0418.2007.01232.x

R. Hill, D. Campbell, L. Hayes, S. Corin and S. Fowler, Why the New Zealand Regulatory System for Introducing New Biological Control Agents Works, International Symposium on Biological Control of Weeds, 2011
https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&v
ed=2ahUKEwiV8pHT86_3AhXCh_0HHYV9BzMQFnoECAQQAQ&url=https%
3A%2F%2Fwww.invasive.org%2Fproceedings%2Fpdfs%2Fhill.pdf&usg=A
OvVaw02Jewl0cwAh1ckR8QjYFcn

J. Brodeur, P.K. Abram, G.E. Heimpel and R.H. Messing Biocontrol, 63 (1)
(2018), pp. 11-26

Heimpel and Mills, 2017, Biological Control – Ecology and Applications

Crowder, D.W., Northfield, T.D., Strand, M.R., Snyder, W.E., 2010. Organic agriculture promotes evenness and natural pest control. Nature 466, 109–112

Others

Alissia Rousseaux, Lorie Seychal, Jean-Pierre Sarthou. 2018. Conservation biological control : Definition. Dictionnaire d'Agroecologie, https://dicoagroecologie.fr/en/encyclopedia/conservation-biological-control/ https://dicoagroecologie.fr/en/encyclopedia/conservation-biological-control/

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

UNEP and Biodiversity https://www.unep.org/unep-and-biodiversity

UNEP - Convention on Biological diversity. 2018. https://www.cbd.int/doc/c/0c6f/7a35/eb8815eff54c3bc4a02139fd/cop-14-inf-09-en.pdf

IBMA Black Box Market Survey 2021 https://ibma-global.org/wp-content/uploads/2021/10/IBMA-Membership-Appraisal-Black-Box-Survey-2021_summary.pdf

DIR-SIT - HISTORY OF TRANSBOUNDARY SHIPMENTS OF STERILE INSECTS (iaea.org) https://nucleus.iaea.org/sites/naipc/dirsit/SitePages/HISTORY%20OF%20TRANSBOUNDARY%20SHIPMENTS%20OF%20STERILE%20INSECTS.aspx?WikiPageMode=Edit&InitialTabId=Ribbon%2EEditingTools%2ECPEditTab&VisibilityContext=WSSWikiPage

Directory of SIT facilities (IAEA) https://nucleus.iaea.org/sites/naipc/dirsit/SitePages/All%20Facilities.aspx

"Hulot, J.F. and Hiller, N. (2021) 'Exploring the benefits of biocontrol for sustainable agriculture – A literature review on biocontrol in light of the European Green Deal', Institute for European Environmental Policy."
https://ibma-global.org/wp-content/uploads/2021/06/IEEP-Exploring-the-benefits-of-biocontrol-for-sustainable-agriculture-2021.pdf
Joint EPPO / COST-SMARTER Workshop on the Evaluation and Regulation of the use of Biological Control Agents in the EPPO Region, Budapest, 2015-11-23/24 https://www.eppo.int/MEETINGS/2015_meetings/wk_biocontrol

"IBMA - Position paper on the interpretation of 'native' in invertebrate biocontrol agent regulations" https://ibma-global.org/wp-content/uploads/2020/12/positionpaperlocalpopulationsvotedabim2015ad optiononwebsite20161213.pdf
## 5.3 Annex 3 - Study grids and sources

### 5.3.1 Question 1: What is the current market of IBCAs on the level of Member States and how can it be further developed?

<table><thead><tr><th>Sub-questions & Coverage</th><th>Types of analysis</th><th>Data to be collected and data sources</th></tr></thead><tbody><tr><td>a. Which information is available on the market value of IBCAs used in different Member States?</td><td>7 MS<br>Data to be collected: Number of IBCAs subject to commercial activities, sales of IBCAs (in euros), market destination (internal/EU/global) (in euros), native/non-native species<br>Question to IBMA (and NCAs in each of the 7 MS): do they collect data on IBCA market value? how? What factors determine the availability and quality of existing information: existence of national umbrella organisation, directly from industry members...? How reliable is that information? What are existing challenges? Is that information sufficiently detailed to be able to compare IBCAs with BCAs in general, and with PPP?<br>If no comparable data: review of existing data as provided by IBMA or NCAs, and analysis of their specific scope and how they are produced and collected by the data provider. If possible, the Study team will process collected data in order to have comparable information<br>In case no data is available to certain Member States: The Study team will rely on other sources of information as far as possible such as representatives of IBMA at national level or research publications.</td><td><ul><li>IBMA market survey 2022</li><li>Questionnaire sent to NCAs</li><li>Interviews with 7 MS</li></ul></td></tr><tr><td>What is their market share in comparison to PPP?</td><td>7 MS<br>Analysis based on:<br>- Data collected for question a)</td><td><ul><li>Questionnaire sent to NCAs</li></ul></td></tr></tbody></table>
<table><thead><tr><th>Sub-questions & Coverage</th><th>Types of analysis</th><th>Data to be collected and data sources</th></tr></thead><tbody><tr><td></td><td><ul><li>Data on PPP sales (euros) and available studies</li><li>Complementary data from NCAs on PPP market at national level</li></ul></td><td><ul><li>Survey and interviews with industry associations representing the interests of manufacturers and retailers of IBCAs</li></ul></td></tr><tr><td>b. What is the proportion of IBCA uses in relation to authorised PPP uses?</td><td>All<br>Analysis based on the lists of uses at European level and in each Member States<br>Specific analysis for pests where both alternatives are existing (examples to be identified during interviews)</td><td><ul><li>Eurostat</li><li>EPPO list of uses</li><li>Questionnaire sent to NCAs</li><li>Interviews with NCAs</li><li>Survey and interviews with industry associations representing the interests of manufacturers and retailers of IBCAs</li></ul></td></tr><tr><td>c. In which cropping or phytosanitary scenarios (e.g. greenhouse, specialty crops ('minor uses'), major crops,...) are IBCAs currently used?<br>How are these use patterns distributed</td><td>All<br>Number of IBCAs for commercial activities, Surface of application of IBCAs in the main different scenarios on the basis of a typology of uses. Typology will rely on the types of IBCAs used, the targeted crop / forest, the conditions of use (greenhouse especially), minor/major use, use in association</td><td><ul><li>Questionnaire sent to NCAs</li><li>Targeted interviews with industry associations representing the interests of manufacturers and retailers of IBCAs</li></ul></td></tr></tbody></table>
<table><thead><tr><th>Sub-questions & Coverage</th><th>Types of analysis</th><th>Data to be collected and data sources</th></tr></thead><tbody><tr><td>or replicated over the Union: are the patterns similar across all Member States or do specific national patterns exist and how do they look like?</td><td>with PPP, conventional or organic farming, etc.<br>Identification of IBCAs used for classical biocontrol agents and established in Member States, targeted crops and pests, etc.<br>Mapping of existing uses across MS<br>Comparison across MS, with an identification of some groups of MS with similar patterns<br>Identification of factors that explain these use patterns</td><td>g the interests of manufacturers and retailers of IBCAs, farmers association s and scientific organisations</td></tr><tr><td>d. What is the potential for development of IBCAs over the coming 10 years in terms of new uses, additional cropping and phytosanitary scenarios as well as of market value in the different areas considered under point (c)? How many of these uses are currently empty (i.e. no phytosanitary solution exists)? How many uses of chemical PPP are likely to be substituted and what will be the quantitative impact on the Harmonised Risk Indicators defined under Directive 128/2009/EU?<br>e. On the opposite: for which uses and cropping/</td><td>All<br>Analysis will rely on data collected in questions c), f) and g) as well as some additional data to cover all MS:<br>Development of a model considering different scenarios and assumptions:<br>- Existing gaps based on current/ future demand and available products<br>- Potential products available in the short/ middle term (depending on their development stage, time to develop new products...)<br>- Other assumptions depending on potential initiatives at EU level: stronger incentives to develop new products, marketing authorisations...<br>It will be crucial to consider the point of view of experts, researchers, producers and users.<br>Specific analysis to feed into the model assumptions:<br>- Analysis of historical trends for the development of the products and time of research</td><td><ul><li>Questionnaire sent to NCAs</li><li>Targeted interviews with industry representatives, farmers association s and scientific organisations</li></ul></td></tr></tbody></table>
<table><thead><tr><th>Sub-questions & Coverage</th><th></th><th>Types of analysis</th><th>Data to be collected and data sources</th></tr></thead><tbody><tr><td>phytosanitary scenarios is there little or no potential to develop an IBCA solution within a reasonable timeframe? What are the reasons?</td><td></td><td>required / number of products entering the market per year<br/>- Analysis of farmer's needs and current orphan uses<br/>- Analysis of existing public and private research activities (to be linked with existing instruments of incentives in question 4)<br/>Analysis of the quantitative impact on the Harmonised Risk Indicators defined under Directive 128/2009/EU:<br/>- Identification of the pesticides that could be substitute by IBCAs in the coming 10 years<br/>- Application of the methodology to calculate Harmonised Risk Indicators</td><td></td></tr><tr><td>f. In which Member States are IBCAs produced, how significant is the production (compared to the overall production in the Union and globally) and for which markets are they produced (domestic/EU/global)?<br/>How many new IBCAs are under development and how many newly enter the market per year?</td><td>7 MS</td><td>Analysis will rely on data collected in question a), in addition the following data will be collected:<br/>- Overall production of IBCAs in Europe and globally<br/>- Number of IBCAs under development (public and private)<br/>- Number of IBCAs entering the market per year (historical data)</td><td><ul><li>Data from industry associations representing the interests of manufacturers and retailers of IBCAs</li><li>Questionnaire sent to NCAs</li><li>Targeted interviews with scientific organisations</li></ul></td></tr></tbody></table>