<table><thead><tr><td>Sub-questions & Coverage</td><td>Types of analysis</td><td>Data to be collected and data sources</td></tr></thead><tbody><tr><td>g. What are the demands from the side of users (agriculture, forestry, plant quarantine) for new IBCAs/new uses of existing IBCAs to be developed?</td><td>7 MS<br/>Identification of current orphan uses, farmer's need as well as current experiments under implementation</td><td>Targeted interviews with representatives of farmer's, and forestry associations</td></tr><tr><td>h. What are expected benefits from the use of IBCAs for the ability to control additional plant pests as a substitute to chemical PPP and hence how will this impact the quantitative targets for the reduction of use of PPP outlined in the Farm to Fork strategy (quantify)?</td><td>All<br/>Qualitative descriptions of the expected benefits<br/>Different projections depending on potential initiatives to be taken to foster the development of new IBCAs and/to better regulate and control related risks.<br/>Model to establish the quantity of PPP that could be substitute with the development of IBCAs (based on the research trends) and the development of IBCAs to fight new pests rather than the development of new PPPs</td><td>Survey and Targeted interviews with industry associations representing the interests of manufacturers and retailers of IBCAs, farmers associations and scientific organisations<br/>Questionnaire sent to NCAs</td></tr><tr><td>What are the expected effects on biodiversity?</td><td>General description of the potential effects on biodiversity and ecosystems<br/>Identification of the different types of effects (direct / indirect, reversible / irreversible, etc.)<br/>Identification of the biological mechanisms that might impact natural biodiversity (competition,</td><td>Questionnaire sent to NCAs<br/>Interviews with representatives of civil society organisations</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>parasitism, predation, crossbreeding, etc.)<br>Analysis based on literature review as well as interviews of stakeholders</td><td></td></tr><tr><td>What are the expected effects on food safety?</td><td>All<br>Qualitative analysis of positive and negative impacts on food safety: decrease of PPP residues on products, possible increase of toxins, etc.<br>Illustrations from examples with previous experience of IBCAs</td><td>Targeted interviews with Industry associations representing the interests of manufacturers and retailers of IBCAs, farmers associations and scientific organisations</td></tr></tbody></table>

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

<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 Member States do not regulate at all the introduction, production and/or release of IBCAs and are IBCAs used in these Member States?</td><td>All<br>Identification of the Member States where introduction, production and/or release IBCAs are not covered by national regulation</td><td>Questionnaire sent to NCAs</td></tr><tr><td>b. Of the Member States that do regulate IBCAs, which authorities are involved in the regulatory process</td><td>All<br>Scope of application of the regulatory system in place in the Member States regarding the introduction, production and release of IBCAs:</td><td>Questionnaire sent to NCAs</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>and the decision making for the release of IBCAs for agricultural, forestry and phytosanitary purposes?<br>Which administrative levels (state, regions, municipalities) are involved in this process in the different Member States?<br>Is the same regime applied to IBCAs imported from outside the EU, from other Member States and produced domestically?<br>Do the same rules apply to amateur and professional users?</td><td><ul><li>Legal statuses of IBCAs: plant protection products / specific statuses / not defined</li><li>Scope of application of the framework(s) depending on products and use: classical / augmentative biocontrol, native / Non-native species, Agricultural / forestry / phytosanitary purposes, SIT, invasive plant species, etc.</li><li>Geographical scope of application (national level, importation and exportation from other EU MS or from third countries)</li><li>Scope of application regarding users: amateur and professionals' users</li></ul><p>Content of the regulatory system:</p><ul><li>Description of the regulatory process and decision making for the introduction, production and release of IBCAs</li><li>Existence of lists of products that can be used at Member States level (content of the lists)</li><li>Process for the introduction, production and release of a new product</li><li>In what consist the regulatory framework (law, directives, guidelines, etc.)</li></ul><p>Description of the authorities involved:</p><ul><li>Administrative level of implementation of the framework (state, regions, municipalities)</li><li>Role of the different authorities in the implementation of the framework</li></ul></td><td></td></tr><tr><td>c. Which Member States carry out a formal risk assessment before introduction, production and/or</td><td>All</td><td>Content of risk assessment process<ul><li>Scope of application</li><li>Responsible authority</li><li>Source of data used for the assessment (industry, other)</li></ul></td><td>► Questionnaire sent to NCAs</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>release within their territory is permitted and what are the elements within that risk assessment (e.g. risk to local biodiversity, risk to non-target plants, risk of unintended spread)?<br>Which Member States rely on third-party assessments in their decision-making (e.g. using the list from EPPO PM 6/3(4)) and to which extent?</td><td></td><td><ul><li>Stage of application of the risk assessment (before first introduction, before commercial use, etc.)</li><li>Impacts considered during the assessment (risk to local biodiversity, risk to non-target plants, risk of unintended spread, etc.)</li><li>Geographic scope of the analysis of the impacts</li><li>Use of EPPO list (PM 6/3)</li></ul><p>Description of the decision-making process</p><ul><li>Implication of third-party</li><li>How are benefits and risks assessed, and decision taken</li></ul><p>Number of assessments conducted each year and results (approbation or rejection of products)</p></td><td></td></tr><tr><td>d. Which Member States apply the same or similar regulatory approach to IBCAs compared to PPP (i.e. pre-marketing authorisation based on scientific risk assessment)?</td><td>All</td><td>Analysis of the answers to question b and c<br>Identification of Member States where IBCAs are considered as plant protection products</td><td>► Questionnaire sent to NCAs</td></tr><tr><td>e. In which Member States is the introduction, production or marketing of IBCAs subject to legal requirements (e.g. registration of producers or retailers, rules regarding quality control) and what are the legal</td><td>All</td><td>Description of other legal requirements for the introduction, production or marketing of IBCAs:<ul><li>Registration of producers and retailers</li><li>Rules regarding quality control</li><li>Other? (Transport requirements for example)</li></ul></td><td>► Questionnaire sent to NCAs</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>provisions and procedures in place?</td><td></td><td></td></tr><tr><td>f. In which Member States are users of IBCAs legally obliged to keep record of the IBCAs they purchase, store and/or use?<br/>Is the system independent from the corresponding obligations regarding PPP?<br/>Is a system in place to record negative impacts and possible harm by IBCAs (e.g. lack of efficacy, undesired longevity of the IBCA in the environment, interference with naturally occurring populations of plants or animals)?<br/>Is the information collected systematically by the competent authorities or merely kept available at farmer's level?</td><td>All<br/>Description of monitoring and recording process in place:<ul><li>Identification of Member States where the record of IBCAs, purchase, store and use in mandatory as well as during transport</li><li>Comparison and differences from the PPP system</li></ul>Description of data and information that are recorded:<ul><li>Negative impacts on biodiversity:<ul><li>Undesired longevity of the IBCAs in the environment</li><li>Interference with naturally occurring populations of plants or animals</li></ul></li><li>Efficacy of products</li></ul>Description of the process to collect data information<ul><li>Responsible of the data collection</li><li>Control in place</li><li>Consolidation at national level (or kept available at farmer's level)</li></ul></td><td>Questionnaire sent to NCAs</td></tr><tr><td>g. Which Member States impose risk mitigation measures in connection to the release of IBCAs? Which risks are addressed (e.g. risk to local biodiversity, risk of unintended spread) and which</td><td>All<br/>Description of the risk mitigation measures defined at Member States level before the release of IBCAs:<ul><li>Risks covered</li><li>Content of the risk mitigation measures</li><li>Process to ensure the enforcement of the measures (controls, authorities in charge, monitoring, etc.)</li></ul></td><td>Questionnaire sent to NCAs</td></tr></tbody></table>
<figure><img src="image_32.png" /></figure>

<table><thead><tr><td>Sub-questions & Coverage</td><td>Types of analysis</td><td>Data to be collected and data sources</td></tr></thead><tbody><tr><td>measures are in place?<br>How are these measures being enforced?</td><td></td><td></td></tr><tr><td>h. Does a "safe" or "low risk" list exist that requires no regulatory input?</td><td>7 MS<br>Existence of "safe" or "low risk" list at Member States level<br>Comparison of this list between Member States and with the list of EPPO</td><td>► Interviews with NCAs</td></tr><tr><td>i. Are there quality control procedures in place for the production of IBCAs?</td><td>7 MS<br>Description of quality control procedures in place:<br>- Types of indicators used to measure quality of the products<br>- Process for reporting and controls<br>- Authorities involved</td><td>► Interviews with NCAs<br>► Survey and Targeted interviews with industry associations representing the interests of manufacturers and retailers of IBCAs, and scientific organisations</td></tr><tr><td>j. Are there monitoring strategies in place to identify changes in natural ecosystems?</td><td>7 MS<br>State of the art of monitoring strategies to identify changes in the ecosystems structure and species<br>Critical review of existing approaches to monitor the changes (duration, frequency, targeted species and / or ecosystems components, etc.)</td><td>► Interviews with NCAs</td></tr></tbody></table>
### 5.3.3 Question 3: What are the characteristic elements of the regulatory approaches in force towards the introduction, evaluation, production, marketing and use of IBCAs in Member States?

<table><thead><tr><td>Sub-questions & Coverage</td><td>Types of analysis</td><td>Data to be collected and data sources</td></tr></thead><tbody><tr><td>a. What are the key data requested by Member States for authorising the release of IBCAs? What are the most common data deficits in applications for release?</td><td>7 MS<ul><li>Identification of the data used during authorisation process, source and indicators used</li><li>Identification of the most common data lacking in the applications and the data that are the most difficult to obtain</li><li>Identification of potential other challenges (reliability of data, capacity of analysis of data provided, etc.)</li></ul></td><td><ul><li>Interviews with NCAs</li><li>Targeted interviews and surveys with Industry associations representing the interests of manufacturers and retailers of IBCAs</li></ul></td></tr><tr><td>b. Are there measures in place to facilitate the administrative processes (e.g. specific, updated and publicly available guidance, pre-submission meetings for dossier submitters) in the different Member States? What are these measures and how do industry and public authorities rate their fitness?</td><td>All<ul><li>Identification of measures in place to facilitate administrative process</li><li>Perception of industry and public authorities regarding the relevance and effectiveness of the existing measures and identification of gaps and current difficulties encountered to meet the expectations</li></ul></td><td><ul><li>Questionnaires to NCAs</li><li>Interviews with NCAs</li><li>Targeted interviews with Industry associations representing the interests of manufacturers and retailers of IBCAs,</li></ul></td></tr></tbody></table>
<figure><img src="image_33.png" /></figure>

<table><thead><tr><td>Sub-questions & Coverage</td><td></td><td>Types of analysis</td><td>Data to be collected and data sources</td></tr></thead><tbody><tr><td>c. Are the users of IBCAs sufficiently informed and trained and which measures are considered to be useful in improving the situation from their point of view?</td><td>7 MS</td><td>Perception of the stakeholders regarding the level of knowledge and training of users (farmers, technical advisor from industry, from extension, etc.)</td><td>Interviews with NCAS<br/>Interviews with representatives of the users (farmers mainly)</td></tr><tr><td>d. Which Member States and stakeholders consider cross-border spread as a potential safety issue?<br/>In which Member States is a potential cross-border spread of IBCAs after release part of the risk assessment and where so, which mitigation measures are imposed?<br/>Are these measures considered realistic, affordable and sufficient by the different stakeholders?</td><td>All</td><td>Identification of the Member States and stakeholders considering cross-border spread as a potential safety issue<br/>Existence of specific risk management process towards cross-border spread risk<br/>Existence of specific mitigation measure</td><td>Questionnaire to NCAs<br/>Targeted interviews with, farmers associations and representatives of the environmental NGOs</td></tr><tr><td>e. Are there sufficient production capacities for IBCAs and how can it be assured that there is a sufficient supply with IBCAs over the season (taking into account that outbreaks may occur at differing points in time)? How will producers have sufficient IBCAs available for the case of an unexpected pest outbreak?</td><td>7 MS</td><td>Market organisations: number of producers, capacities of production<br/>Existence of supply break over the season<br/>Existence of stocks of IBCAs<br/>Time for production in case of pest outbreak</td><td>Interviews with NCAs<br/>Questionnaire to NCAs<br/>Targeted interviews with Industry associations</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>f. Which cases of undesirable impacts of the release of IBCAs (e.g. on non-targeted species, ecosystems and biodiversity in general) have been reported so far?<br>If yes, which and what was done to mitigate them? Which Member States provide for the systematic accompanying monitoring for the release of IBCAs into the environment and how is that monitoring structured?</td><td>All</td><td><ul><li>Identification of negative impacts on biodiversity reported within the EU members</li><li>Identification of possible records of problems or issues on biodiversity related to specific IBCAs species</li><li>Identification of the mitigation approach adopted by the EU members</li><li>Existence of a systematic monitoring of the effects of IBCAs on biodiversity after the release within the EU members</li><li>Nature and approach of such monitoring (methodology, species targeted, duration, frequency, etc.), especially regarding the IBCAs that can persist over the years</li></ul></td><td><ul><li>Interviews with NCAs</li><li>Questionnaire to NCAs</li><li>Targeted interviews with Industry associations representing the interests of manufacturers and retailers of IBCAs, farmers associations and scientific organisations and representative of environmental NGOs</li></ul></td></tr></tbody></table>
<table><thead><tr><td>Sub-questions & Coverage</td><td>Types of analysis</td><td>Data to be collected and data sources</td></tr></thead><tbody><tr><td>g. Are there negative effects expected from remnants of IBCAs in exported goods for the international trade of goods?</td><td>7 MS<br/>- Same approach as for question f.</td><td>- Interviews with NCAs<br/>- Questionnaire to NCAs<br/>- Targeted interviews with Industry associations representing the interests of manufacturers and retailers of IBCAs, farmers associations and scientific organisations and representative of environmental NGOs</td></tr><tr><td>h. What are the main shortcomings under the regulatory approaches in force in Member States current practice? What are the drivers behind?</td><td>All<br/>- Identification of the main shortcomings of the current regulatory approach in place in the Member States, the challenges resulting from differences in regulation and rules in place</td><td>- Questionnaires and Interviews with representatives of users and producers</td></tr></tbody></table>
### 5.3.4 Question 4: Which of the regulatory instruments below are used and in which Member States? How can they be used more effectively? Have additional instruments been mentioned by stakeholders and which are they?

<table><thead><tr><td>Sub-questions & Coverage</td><td></td><td>Types of analysis</td><td>Data to be collected and data sources</td></tr></thead><tbody><tr><td>a. What is the role of internationally agreed guidance documents? Which documents are used?</td><td>7 MS</td><td><ul><li>Use of positive lists of EPPO</li><li>Integration of the guidelines of EPPO in the approval and risk assessment in the regulation</li><li>Use of guidelines for the importation of IBCAs</li></ul></td><td><ul><li>Interviews with 7 MS</li><li>Questionnaires and interviews with EPPO, IPPC, IAEA-FAO, EFSA</li><li>Targeted interviews and questionnaire with intergovernmental organisations</li></ul></td></tr><tr><td>b. How do research projects and (public or private) funding of product development contribute to availability and usability of IBCAs? Which success stories exist? Where did the use of IBCAs fail and what are the reasons?</td><td>7 MS</td><td><ul><li>Distribution of public and private research and main characteristics (difference between augmentative and classical biological control)</li><li>Impacts on research and development on the availability of IBCAs (difference of needs of research depending on native or non-native species for example)</li><li>Examples of success stories of research projects</li><li>Examples of failure of research projects and causes</li></ul></td><td><ul><li>Documentary review / scientific papers</li><li>Interviews with 7 MS</li><li>Targeted interviews with industry associations representing the interests of manufacturers and retailers of IBCAs, farmers associations and representatives of environmental NGOs</li></ul></td></tr><tr><td>c. Is there a knowledge transfer academia - industry - users in the Member States? How is it organised</td><td>7 MS</td><td><ul><li>Description of the knowledge transfer organisation, the main stakeholders involved</li><li>Capacity developed by the Member States to</li></ul></td><td><ul><li>Interviews with 7 MS</li><li>Targeted interviews with industry associations representing the</li></ul></td></tr></tbody></table>
<table><thead><tr><td>Sub-questions &amp; Coverage</td><td></td><td>Types of analysis</td><td>Data to be collected and data sources</td></tr></thead><tbody><tr><td>and how does it look like?</td><td></td><td>support knowledge transfer</td><td>interests of manufacturers and retailers of IBCAs and representatives of environmental NGOs</td></tr><tr><td>d. Are there any economic or financial incentives (tax relief for industry and/or users, fast track procedure in administrative processes, financial instruments to increase uptake of IBCAs at user level) applied in the Member States? What are the effects and what are the costs?</td><td>7 MS</td><td><ul><li>Identification of the existing financial incentives in the member States</li><li>Impact of these incentives on research and development and use of IBCAs</li><li>Cost of the financial incentives</li></ul></td><td><ul><li>Interviews with 7 MS</li><li>Targeted interviews with industry associations representing the interests of manufacturers and retailers of IBCAs and representatives of environmental NGOs</li></ul></td></tr><tr><td>e. In which form are regular or sporadic training activities concerning IBCAs for national authorities and private advisers (e.g. awareness), industry (e.g. regulatory aspects) and/or users (e.g. use) organised, by whom and on which level (Member State, region, association)? Where do training strategies exist?</td><td>7 MS</td><td><ul><li>Review of the training strategies of Member States</li><li>Description of the current training activities for the different groups of stakeholders</li></ul></td><td><ul><li>Documentary review of documents transmitted by NCAs</li><li>Interviews with 7 MS</li><li>Targeted interviews with industry associations representing the interests of manufacturers and retailers of IBCAs, farmers associations and representatives of environmental NGOs</li></ul></td></tr><tr><td>f. Which Member States have mechanisms in place to collect feedback from</td><td>7 MS</td><td><ul><li>Documentary review of the collected feedbacks from extension and advisory services</li></ul></td><td><ul><li>Documentary review of documents transmitted by MS</li></ul></td></tr></tbody></table>
<table><thead><tr><td>Sub-questions & Coverage</td><td>Types of analysis</td><td>Data to be collected and data sources</td></tr></thead><tbody><tr><td>extension and advisory services (public and private)? Which are examples for improvements due to such feedback? How is efficiency of the regulatory process rated by Member States and stakeholders and how could the different approaches be improved?</td><td><ul><li>Identification of range for improvements of the use of IBCAs</li><li>Perception of stakeholders regarding the regulatory process and possible improvements</li></ul></td><td><ul><li>Interviews with 7 MS</li><li>Targeted interviews with industry associations representing the interests of manufacturers and retailers of IBCAs</li></ul></td></tr></tbody></table>
## 5.4 Annex 4 - Templates of the surveys and interview guides used during the study

Note: The data collection tools were adapted to each stakeholder consulted during the study. Thus, the next sections presented one example of questionnaire (sent to National Competent Authorities) and one example of interview guide (used with representatives of industry/business operators).

### 5.4.1 Questionnaire to National Competent Authorities

Our consortium has been mandated by the European Commission - DG SANTE to carry out a study on the Union's situation regarding invertebrate biological control agents (IBCAs) for the use in plant health and plant protection. The objective is to provide input to the Commission regarding the introduction, production, evaluation, marketing and use of invertebrate biological control agents within the territory of the Union, including an overview of the existing regulations in each MS (if any) and an analysis of the potential for further development of IBCAs.

In this framework, the following **questionnaire** has been developed to collect data and relevant information from each national competent authority within the European Union. It is structured as follows:

- **Section 1** seeks to collect information on **national regulation applying to IBCAs** in your country (scope, content, processes, authorities involved, etc.);

- **Section 2** seeks to collect information on the **market of IBCAs in your country** and the current uses;

- **Section 3** focuses on the main perspectives, on ways to fostering the development and use of IBCAs and potential options for developing initiatives and addressing existing problems at EU level;

- **Annexes** seeks to collect additional information on the current market and use of PPPs (for comparison with IBCAs market and the potential for development of IBCAs)

The questionnaire is integrating both some questions to be answered by Yes or No (tick boxes) and some open questions (please use the open cells in light yellow).

Could you please send the questionnaire completed **before the 17th June 2022**. We are aware that this timeframe is short, but this is unfortunately due to strained Commission schedules.

To facilitate the process, please note the following:

- We would like to schedule an exchange about this survey in the coming days to define how to support you in the collection of
expected information. Could you please propose several timeslots for
this meeting (45 minutes approximately)?

- Please feel free to send partial responses along the way/ step by step. You may send us each section as soon as it is completed to the best of your knowledge, and redirect other sections to other contributors at national level;

- **Priority question** questions are indicated **in bold**: you may first focus on these questions and we can discuss further how to collect any missing information;

- In addition to the completion of the questionnaire, <u>please do not</u> <u>hesitate to send us all additional documents that could be relevant</u> <u>for the study</u> (in national language if needed): regulatory framework, assessment grids, additional lists of species, national studies, etc.

In case you need additional information, or you have specific questions on
the content of the questionnaire, please do not hesitate to contact us
through the following email address: *EY email address was provided*

We thank you in advance for your answer and information provided,

Best regards,
The Study team

Preamble: Focus on the scope of the following Study questions

Please note that this study will focus only on **Invertebrate Biological Control Agents** such as insects, including male sterile insects, mite, and nematode species (IBCAs). Only uses which are linked to the intentional release of IBCAs shall be considered. Furthermore, only IBCAs shall be considered which are intended to protect plants or plant products, ("plants" and "plant products" as defined in Article 2 of Regulation 2016/203111), including those to control invasive plants. Insects purely used for pollination are outside of the scope of the study.

In addition, the definition of plant protection products (PPP) is the one of Article 2 of Regulation (EC) No 1107/2009 referring to substances (chemical elements and their compounds) including micro-organisms.

Thus, we thank you to apply this scope and definition for the completion
of the questionnaire.

→ If available data does not fit with the scope of the study, please clearly explain the scope and types of products covered by the data provided and, if possible, provide an estimation in accordance with the scope of IBCAs considered by this study.
# Section 1 - Regulation applying to IBCAs in your country

1. In your country, **is there a regulatory framework in place applying to IBCAs** (augmentation, inundation/inoculation, introduction/classical biocontrol, autocidal control/SIT)?

☐ Yes, adopted since ... (please specify)

☐ Yes, under development but not adopted yet

☐ No

Please send us documents describing the regulatory framework, or the regulation itself

2. IF NO, please answer to this question and go directly to section 2: Do you identify a lack of regulatory framework in your country? If relevant, what are the main challenges you identify regarding IBCAs (for instance, low use of IBCAs, poor research and development, introduction of species without assessment of the potential risks, etc.)?

text

**If YES: please provide additional information by answering following questions (sections 1.1, 1.2, 1.3 and 1.4)**

## Section 1.1: Scope and content of regulation (whether existing or under development)

3. Which of following aspects are covered by IBCA framework (existing or under development)? Please select all that apply and indicate the reference to the legislation, when applicable.

<table><thead><tr><th></th><th>Yes</th><th>No</th><th>In<br>development</th></tr></thead><tbody><tr><td>Regulation for the <u>introduction</u> of IBCAs</td><td>☐</td><td>☐</td><td>☐</td></tr><tr><td>If 'Yes', please specify/ add reference</td><td colspan="3">Text (please specify if the regulation relies on an authorization system or not)</td></tr><tr><td>Regulation for the <u>production</u> of IBCAs</td><td>☐</td><td>☐</td><td>☐</td></tr><tr><td>If 'Yes', please specify/ add reference</td><td colspan="3">Text (please specify if the regulation relies on an authorization system or not)</td></tr><tr><td>Regulation for the <u>release/<br>commercialisation</u> of IBCAs</td><td>☐</td><td>☐</td><td>☐</td></tr><tr><td>If 'Yes', please specify/ add reference</td><td colspan="3">Text (please specify if the regulation relies on an authorization system or not)</td></tr></tbody></table>
<table><tr><td>Registration of IBCA producers and retailers</td><td>☐</td><td>☐</td><td>☐</td></tr><tr><td>If 'Yes', please specify/ add reference</td><td colspan="3">Text</td></tr><tr><td>Quality control (at the time of production, storage, during transportation, etc.)</td><td>☐</td><td>☐</td><td>☐</td></tr><tr><td>If 'Yes', please specify/ add reference</td><td colspan="3">Text</td></tr><tr><td>Transport of IBCAs</td><td>☐</td><td>☐</td><td>☐</td></tr><tr><td>If 'Yes', please specify/ add reference</td><td colspan="3">Text</td></tr></table>

4. Regarding the scope of IBCA, does the national regulatory framework:

a. Provide a distinction between classical and augmentative biocontrol?

text

b. Provide a distinction between native and non-native species (if any), and in that case what is the scope/definition applied to native species?

text

c. Integrate sterile insects (SIT) releases?

text

5. Is authorisation granted either for a specific function or for a specific IBCA organism (species, strains, etc.) (where applicable)?

text

6. What is the role of internationally agreed documents (IPPC / EPPO standards, OECD, EFSA, IOBC, etc.) within this national legal framework? Is the regulation consistent with these frameworks? To what extent are these standards integrated in existing regulation?

text

7. Is the same regime applied to IBCAs imported from outside the EU, from other Member States and produced domestically?

☐ Yes

☐ No

Text - Add precisions if needed
8. Is the same regime applied to IBCA used for augmentation biocontrol, classical (introduction/acclimatation) biocontrol and autocidal control (Sterile Insect Technique)?

☐ Yes

☐ No

Text - Add precisions if needed

9. Do the same rules apply to amateur and professional users?

☐ Yes

☐ No

Text - Add precisions if needed

10. Is the same regime applied to IBCA used for research and for commercial purposes?

☐ Yes

☐ No

Text - Add precisions if needed

11. If necessary, could you provide any additional description of the Regulatory framework in place in your country to clarify its scope, content and specificities?

Text

## Section 1.2: Focus on risk assessment processes

12. Is a risk assessment conducted for IBCAs in your country?

☐ Yes

☐ No

13. If yes, at which stage(s) is the risk assessment conducted:

☐ Before importation

☐ Before first introduction outside confined spaces, e.g. for research purposes ☐

☐ Before commercial use

☐ Other? Please specify:

14. Does a "safe" or "low risk" list or a similar concept (e.g. qualified presumption of safety) exist that requires no regulatory input?

☐ Yes
☐ No

In that case could you provide this list or documentation describing the concept?

text

15. What are the key data requested for the assessment and authorisation of the release of IBCAs?

text

16. What are the sources of data used for the assessment?

☐ Applicants

☐ Third parties

☐ Others (e.g. open literature, please specify)

text

17. What are the possible unintended impacts that are evaluated?

☐ Risk to local biodiversity

☐ General risks to biodiversity

☐ Risk to other crops than those affected by the targeted pest (plant health)

☐ Risk of unintended spread

☐ Risk to human health

☐ Risk from diseases introduced as contamination of the IBCA

☐ Others (please specify)

text

18. What are the evaluated possible benefits?

☐ Plant protection /phytosanitary effects

☐ Environmental benefits

☐ Risk to local biodiversity

☐ Others (please specify)

text

19. What is the geographical scope considered for the analysis of the impacts (local, national, regional, European, worldwide, etc.)?

text

20. Is cross-border spread considered as a potential safety issue in the assessments?

☐ Yes

☐ No
21. Do the analyses take into account the possible negative effects of remnants of IBCAs in exported goods for the international trade of goods?

text

22. Is the assessment conducted at species or strains level (or other)?

text

23. Are mitigation measures imposed in your country?

☐ Yes

☐ No

If 'Yes', which of them relate to related to cross-border issues?

text

24. Does the process rely on third-party assessments in their decision-making (e.g. using the "Positive" list from EPPO PM 6/3(4))?

☐ Yes, EPPO PM 6/3(4)

☐ Yes, other ☐ No

25. What is the number of assessments conducted each year and results (approbation or rejection of dossiers)?

<table><thead><tr><th>Total number of assessments per year</th><th></th><th></th></tr></thead><tbody><tr><td>Approbation of dossiers per year</td><td>[average number per year]</td><td>[please indicate the period over which this data was collected]</td></tr><tr><td>Rejection of dossiers per year</td><td>[average number per year]</td><td>[please indicate the period over which this data was collected]</td></tr></tbody></table>

26. What is the number of assessments relying on third-party assessments:

<table><tr><td>Number (average per year)</td><td>[please indicate the period over which this data was collected]</td></tr></table>

27. What are the most common data deficits in application? For the analysis of the impacts?

text
**Section 1.3: Focus on record and monitoring measures**

28. Does the regulation framework of your country establish a systematic monitoring for the release of IBCAs into the environment?

☐ Yes

☐ No

29. If 'Yes', how is that monitoring structured?

Text

30. Are users of IBCAs legally obliged to keep record of the IBCAs they:

☐ purchase

☐ store

☐ use

31. Is the regulatory system applied to IBCAs independent from that applied to PPPs?

☐ Yes

☐ No

Please add some additional information, if appropriate

text

32. Is there data recorded regarding to post-release monitoring about:

☐ 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

☐ Effects on human health

☐ Others (please specify)

text

33. Are the data consolidated at the national level?

☐ Yes

☐ No

34. If yes, who are the authorities or stakeholders in charge of the collection and maintenance of these data?

text

35. Does your country impose risk mitigation measures in connection to IBCA releases?

☐ Yes
☐ No

36. If yes, what are the risks addressed by these mitigation measures?

text

37. Are there processes to ensure the enforcement of the measures?

☐ Yes

☐ No

38. If so, what are these processes (controls, authorities in charge, monitoring, etc.).

text

39. Have the authorities ever detected undesirable impacts of IBCAs in your country?

☐ Yes

☐ No

40. If Yes, please briefly describe the case, the mitigation measures taken and the result

text

## Section 1.4: Focus on organisation, processes and evaluation

41. Which administrative levels are involved in the implementation of the regulatory framework?

☐ State

☐ Other(s), please specify

text

42. Could you please list the name(s) of authority/authorities currently involved in the implementation of the regulatory framework? Please indicate which authority is responsible on the following:

<table><thead><tr><td></td><td>Name of Authority</td></tr></thead><tbody><tr><td>Authority responsible for the risk assessment process (if applicable)</td><td>[Text]</td></tr><tr><td>Authority responsible for the monitoring process (if applicable)</td><td>[Text]</td></tr><tr><td>Authority responsible for the final decision on the importation of IBCAs</td><td>[Text]</td></tr><tr><td>Authority responsible for the final decision on the production of IBCAs</td><td>[Text]</td></tr><tr><td>Authority responsible for the final decision on the release of IBCAs</td><td>[Text]</td></tr></tbody></table>
<table><tr><td>Other (if any)</td><td>[Text]</td></tr></table>

43. Are there any specific measures in place to facilitate the administrative process (specific, updated and publicly available guidance, pre-submission meetings for dossier submitters) in your country?

☐ Publicly available procedural guidance

☐ Pre-submission meetings for dossier submitters

☐ Other (please specify)

text

44. Are there any measures to assess the adequacy and effectiveness of the legal framework in place for the introduction, production, evaluation, marketing and use of IBCAs ?

text

45. Are the users sufficiently informed and trained to use IBCAs and which measures are considered to be useful in improving the situation from your point of view?

text

46. In your opinion, what are the main shortcomings of the regulatory approaches in force in your country (for instance, administrative burden, lack of data to conduct risk assessment, non-coverage of some risks, etc.)? What are the drivers behind?

Text

47. How could the regulatory instruments in your country be better implemented? Which elements are missing?

text

48. How is efficiency of the regulatory process rated by national services and stakeholders and how could the different approaches be improved?

Text

## Section 2 - Current uses and markets

49. Is there any specific data and information regarding **IBCA** market value, use and production in your country?

☐ Yes

☐ No

50. If so, what kind of information (sales only or more data) is available? What is the source of these information, how it is collected and who is in charge
**of the consolidation? Do you consider existing information and data is sufficiently reliable?**

text

Please complete this section with as much information as possible. When exact numbers are not available, you may instead provide *estimates* based on your knowledge or you may refer to documents where some information can be available.

Please send us any existing documents or data that can provide additional inputs.

**Use of IBCAs in your country**

51. **What is the number of IBCA uses in your country?** For this question we define a use as the combination of 1 crop, 1 issue and 1 solution. Please define what is considered a use if you have a different definition.

number

Are all uses available to professional and amateur users at the same time (if 'No',
please explain)?

☐ Yes

☐ No

text

52. What is the number of species/strains used as IBCAs in your country?

number

53. What percentage of these species/strains uses as IBCAs are native and non-native?

percentage of native species

54. What is the number of authorised PPP uses in your country? Could you specify the total of PPPs uses, insecticides and acaricides, fungicides, herbicides, others)?

number
55. If possible, could you please fill out the table below to depict the use of IBCAs in the main plant production systems in your country?
If not, do you have some relevant documents that could provide some of the information?

<table><thead><tr><th></th><th>Greenhouse (crops & ornamentals)</th><th>Orchards</th><th>Vegetables</th><th>Vineyards</th><th>Maize</th><th>Other arable crops</th><th>Forests (including short rotation and nurseries)</th><th>Amenity</th><th>Specialty crops</th><th>Invasive plants</th><th>Other</th></tr></thead><tbody><tr><td>Total surface in your country (approx)</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>% of surface covered by at least one IBCA use (approx.)</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>% of total surface covered by IBCA use in organic farming (approx.)</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>= Surface in organic farming covered by IBCA / total surface in your country (organic and non-organic)</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Insecticides and Acaricides</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Herbicides</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Fungicides</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Molluscicides</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Nematicides</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Description of the main scenarios of use (targeted species, name of invertebrate, use in complement with PPP, etc.)</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr></tbody></table>
56. Could you please list the classical biological control programmes that have been implemented in your country within the last 10 years (last 20 years if possible)?

<table><thead><tr><td>Approximate period (year range)</td><td>Target species and crop concerned</td><td>Biocontrol agent(s) released (name(s) of species)</td></tr></thead><tbody><tr><td></td><td></td><td></td></tr><tr><td></td><td></td><td></td></tr></tbody></table>

57. Could you please list the past and current programmes based on the Sterile Insect Technique (SIT) used in your country for plant protection purpose (not biocide) within the last 10 years (last 20 years if possible)?

<table><thead><tr><td>Approximate period (year range)</td><td>Target species and crop concerned</td><td>Type of sterilisation technique used</td></tr></thead><tbody><tr><td></td><td></td><td></td></tr><tr><td></td><td></td><td></td></tr></tbody></table>

## Market value (imports and exports)

58. What is the market value for IBCA products used in your country per year (in € - Exchange rate as per 1st January 2022)? If the exact number is not available could you please provide an estimation based on your knowledge of the sector?

number

59. Among the IBCAs used in your country, could you indicate an estimate of the IBCAs:

<table><tr><td>Produced in the country:</td><td>[% - market value estimation]</td></tr><tr><td>Produced in another country in the EU:</td><td>[% - market value estimation]</td></tr><tr><td>Produced outside the EU:</td><td>[% - market value estimation]</td></tr></table>

60. For IBCAs produced in your country, are these IBCAs commercialised:

- For a domestic use in your country: [% - market value estimation]

- In the EU: [% - market value estimation]

- Outside the EU: [% - market value estimation]

## National production of IBCAs in your country

61. Does your IBCA national industry have sufficient production capabilities to ensure the production of IBCAs all over the season?

text
62. What are the strategies of the industry to ensure that sufficient quantities of IBCAs are available for the case of an unexpected pest outbreak?

text

63. Could you provide with the list of authorised companies approved or registered for the production and sell of IBCAs in your Member States?

text

## Comparison with the use of Plant Protection Products (PPPs)

64. What is the market value for PPPs products in your country (in €)? Could you precise the total of PPPs uses, insecticides and acaricides, fungicides, herbicides, others?

text

65. Are IBCAs considered as "non-chemical alternatives" in the Comparative Assessment conducted at national level according to Art. 50 of Regulation 1107/2009?

☐ Yes

☐ No

# Section 3 - Policies fostering the development and use of IBCAs and perspectives

## Policies fostering the development of IBCAs (7 MS only)

66. What is the average duration of the process authorisation of a new IBCA?

Text

67. Could you provide with an estimation of the number of FTEs involved in the process of evaluation, authorisation and monitoring of IBCAs (public administration and other technical organisations, external companies, etc.)?

text

68. How do research projects and (public or private) funding of product development contribute to availability and usability of IBCAs in your country?

text

69. Which success stories exist regarding research and development? Where did the use of IBCAs fail and what are the reasons?

text

70. Is there a knowledge transfer academia - industry - users in your country? How is it organised and how does it look like?
text

71. Are there any economic or financial incentives (tax relief for industry and/or users, fast track procedure in administrative processes, financial instruments to increase uptake of IBCAs at user level) applied in your country?

text

72. Is there a system in place to monitor the effects of the financial incentives?

☐ Yes

☐ No

73. If yes, what are the effects and what are the costs of these economic/financial incentives?

text

74. In which form are regular or sporadic training activities concerning IBCAs for national authorities and private advisers (e.g. awareness), industry (e.g. regulatory aspects) and/or users (e.g. use) organised, by whom and on which level (national, region, association)? Where do training strategies exist?

text

75. In your country, are there mechanisms in place to collect feedback from extension and advisory services (public and private)?

☐ Yes

☐ No

76. If so, could you briefly list these mechanisms?

text

77. Which are examples for improvements due to such feedback?

text

78. Do you foresee to specifically support the development of IBCAs through the next strategic plan? Through which measures?

text

## Potential for the development of IBCAs

79. Are there public and private research and development on IBCA in your country?

☐ Yes
80. If yes, what are the main current IBCA public and private research and development projects implemented in your country and what are the current stage of development?

text

81. If relevant, can you provide a list of the IBCA developments targeting a phytosanitary need for which currently no phytosanitary solution exists ('empty use')?

- Text

- ...

- ...

82. What are the main current obstacles for the development and use of new IBCAs that you identify in your country? (Intellectual property, cost of development and marketing, legislative framework, etc.)

text

## Recommendations for potential actions at an EU level

83. Do you consider that the absence of a harmonised regulatory framework across the European Union on IBCAs is an issue? Why?

text

84. From your point of view, is there a need/ potential for developing actions at an EU level in order to increase innovation and safe use of biological control agents?

a. Potential for harmonising criteria, procedures and decision-making,

text

b. Potential for coordinating effort to foster research, innovation and knowledge dissemination,

text

c. Potential for a reinforced cooperation with international organisations and the support of investment,

text

d. Other types of actions

text
85. To what extent do you consider that a harmonised framework at European level would be of benefit? Can you explain why you consider this would be relevant or not?

text

86. In your opinion, in which ways could a more harmonised decision-making be achieved?

text

87. Do you expect benefits from a stronger involvement of EFSA on the issues related to IBCAs?

☐ Yes

☐ No

88. If yes, should EFSA become more strongly involved:

☐ Into drafting Guidance documents

☐ Developing scientific opinions on individual questions

☐ Carrying out risk assessments?

☐ Others? (please specify)

text

### Centralised assessment / decision-making for IBCAs at European level

89. Which positive impact (economic, environmental, social effects) would you expect from an EU *centralised assessment* of IBCAs before import, commercialisation and use?

Text

90. Would you expect any negative impact from an EU *centralised assessment* of IBCAs before import, commercialisation and use (increase of time needed to authorised the products, administrative burden, etc.) ?

Text

91. Which positive impacts would you expect from an EU-centralised *decision-making*?

text

92. Which negative impacts would you expect from a centralised *decision-making*?
### Voluntary scheme

93. Do you consider that a voluntary scheme (submission of national scheme to the European level to demonstrate compliance with common criteria and guidelines and ensure mutual recognition between the European countries) would be relevant?

94. What benefits would you expect from voluntary schemes?

95. What limits would you expect from voluntary schemes?

96. What measures would you recommend to ensure the efficiency of such scheme?

97. Do you identify shortcomings and problems not to be solved in such system?

### Other regulatory instruments

98. In your opinion, which regulatory instruments may foster innovation on IBCAs?

99. Do you identify some other instruments at European level that may be implemented to support the development, production and use of IBCAs?

### 5.4.2 Interview guide

Our consortium has been mandated by the European Commission - DG SANTE to carry out a study on the Union's situation regarding invertebrate biological control agents (IBCAs) for the use in plant health and plant protection. The objective is to provide input to the Commission regarding the introduction, production, evaluation, marketing and use of invertebrate biological control agents within the territory of the Union, including an overview of the existing regulations in each MS (if any) and an analysis of the potential for further development of IBCAs.
In this framework, the attached questionnaire has been developed to collect
data and relevant information from the main stakeholders at European or
international level. It would be completed by some interviews where relevant.

It is structured as follows:

- **Section 1** seeks to collect information on the **market of IBCAs** and the current uses;

- **Section 2** seeks to collect information on your perception of **national regulations applying to IBCAs**;

- **Section 3** focuses on the main perspectives and options to fostering the development and use of IBCAs.

The questionnaire integrates both questions to be answered by Yes or No (tick boxes) and open questions (please use the open cells).

Could you please send the questionnaire completed **before the 17th June 2022**. We are aware that this timeframe is short, but this is unfortunately due to strained Commission schedules.

To facilitate the process, please note the following:

- We can schedule an exchange about this survey in the coming days to define how to support you in the collection of expected information. Could you please propose several timeslots for this meeting (45 minutes approximately)?

- Please feel free to send partial responses along the way / step by step. You may send us each section as soon as it is completed to the best of your knowledge, and redirect other sections to other contributors as you see fit;

- **Priority question** questions are indicated **in bold**: you may first focus on these questions and we can discuss further how to collect any missing information;

- In addition to the completion of the questionnaire, **please do not hesitate to send us all additional documents that could be relevant for the study** (in national language if needed): regulatory framework, assessment grids, additional lists of species, national studies, etc.

In case you need additional information, or you have specific questions on the content of the questionnaire, please do not hesitate to contact us through the following email address: *EY email address was provided*

We thank you in advance for your answer and information provided,

Best regards,

The Study team
## Preamble: Focus on the scope of the following Study questions

Please note that this study will focus only on **Invertebrate Biological Control Agents** such as insects, including male sterile insects, mite, and nematode species (IBCAs). Only uses which are linked to the intentional release of IBCAs shall be considered. Furthermore, only IBCAs shall be considered which are intended to protect plants or plant products, ("plants" and "plant products" as defined in Article 2 of Regulation 2016/203111), including those to control invasive plants. Insects purely used for pollination are outside of the scope of the study.

In addition, the definition of plant protection products (PPP) is the one of Article 2 of Regulation (EC) No 1107/2009 referring to substances (chemical elements and their compounds) including micro-organisms.

Thus, we thank you to apply this scope and definition for the completion of the questionnaire.

<figure><img src="image_34.png" /></figure>

→ If available data does not fit with the scope of the study, please clearly explain the scope and types of products covered by the data provided and, if possible, provide an estimation in accordance with the scope of IBCAs considered by this study.

# Section 1 - Current uses, markets and potential for development

## Uses

1. What are the main current patterns of use of IBCAs? What are the main differences between Member States and why?

2. Where are IBCA most widely used? By whom and for which uses?

3. What are the current main obstacles to the use of existing IBCAs?

4. Do you have examples of pests where both IBCA use and authorized PPP uses co-exist? What are the main pros and cons of both existing solutions?

## Markets

5. Could you provide information you have on the market share of IBCAs, quantities of products of IBCAs in the European Union
6. How is the current market structured? Where are located the main producers / main capacity of production? More specifically:

a) Are there issues of supply break over the season?

b) Are there some risks of supply break?

c) Are some stocks available in the Member States?

d) What would be the time required for the production of IBCAs in case of a pest outbreak?

7. How many IBCAs are currently under development in the European Union? What is the number of new IBCAs entering the market each year?

8. What is the state of imports and exports of IBCA, both in the EU-market and outside the EU-market?

## Potential for development

9. What is the potential for development of IBCAs in the European Union over the coming 10 years in terms of:

a. New uses (in greenhouses or arable crops, forestry, major crops or minor uses, etc.)

b. Additional cropping and phytosanitary scenarios (in greenhouses or arable crops, internal landscaping, forestry, major crops or minor uses, organic farming or not, etc.)

c. Market value (% of growth) at EU level

10. What could be the main differences between Member States? For what reasons?

11. What are the current main obstacles for the development of IBCAs (Intellectual property, cost of development and marketing, availability of access to and benefit sharing of effective IBCAs legislative framework, etc.)

12. What are the demands from the side of the farmers for new IBCAs or new uses? How does the industry answer these demands?

13. For which uses and cropping/phytosanitary scenarios do you consider that there is little or no potential to develop an IBCA solution within a reasonable timeframe? What are the reasons?
14. From your point of view, what will be the main positive and negative impacts on biodiversity of the development of IBCAs? Could you illustrate with examples or do you have available data to quantify these impacts?

15. From your point of view, what will be the main positive impacts on food safety of the development of IBCAs? Main negative impacts? Could you illustrate with examples or do you have available data to quantify these impacts?

## Section 2 - Regulatory systems in place for the introduction, production and release of IBCAs and characteristics elements

16. Are the provisions, regulatory framework and processes clear, comprehensive and transparent in the Member States? Can you give details?

17. What are the measures in place to facilitate the administrative process in the different Member States (available guidance, pre-submission meetings for dossier submitters)? Do you identify relevant best practices implemented by some Member States that could be spread across the EU?

18. How well do these measures answer to your needs?

19. Do you have access to sufficient information regarding the existing frameworks and do you know who should be contacted to have further information or obtain information on the market?

20. Do you consider that the users of IBCAs are sufficiently informed and trained? How could it be further improved?

21. What are the main difficulties you identify regarding the implementation of the regulation for the introduction, production and release of IBCAs in the Member State?

22. What is the average time needed for the assessment and approval of products in the different Member States?

23. Which costs are associated to these procedures for businesses (compliance costs, notification costs, record keeping costs)?
24. What are the main difficulties encountered by producers for the production of data required during approval processes in the different Member States?

25. What are the main difficulties encountered by producers or retailers regarding the monitoring of storage and use of IBCAs?

26. What do you think of the mitigation measures developed by the Member States to limit the risk of cross border spread? Do you consider that these measures are realistic, affordable and sufficient?

27. How is quality control and effectiveness of the IBCAs used ensured?

# Section 3 - Other instruments and perspectives

## Other instruments

28. What is the current use of EPPO guidelines in the Member States?

29. Are the Member States using other guidance documents to regulate or assess risks of IBCAs?

30. What is the current support for research and development at European and national levels?

31. Could you provide examples of success stories of the contribution of research and development to the availability and usability of IBCAs? What are the main success factors?

32. Do you have examples of failures in research and development of IBCAs? What were the main reasons?

33. What do you think about the current knowledge transfer organisation regarding IBCAs? Do you think it is effective to ensure knowledge transfer?

34. What are the current incentives (economic and financial) for the development and use of IBCAs? Do you have examples of best practices in the European Member States?

35. What do you think about the current training activities implemented at Member States level? Do you think that support of training is sufficient to ensure that the main stakeholders have sufficient knowledge on this subject?
36. What is your perception of the extension and advisory services provided to the users?
Do you identify best practices in some Member States?

## Perspectives

37. In your opinion, how could the existing regulatory instruments in the Member States be better implemented?

38. Do you expect more engagement by EFSA on the issues related to IBCAs?

39. In your opinion, in which ways could a more harmonised decision-making system be achieved?

40. Which positive effects would you expect from an EU centralised assessment of IBCAs before import, commercialisation and use? Which negative effects would you expect from an EU centralised assessment of IBCAs before import, commercialisation and use?

41. Which positive impacts would you expect from an EU-centralised decision-making? Which negative impacts would you expect from a centralised decision-making?

42. Do you consider that a voluntary scheme would be relevant? What benefits would you expect from voluntary schemes? What limits would you expect from voluntary schemes?

43. In your opinion, which regulatory instruments may foster innovation on IBCAs?
## 5.5 Annex 5 - Overview of the data collected and available in the Member States

<table><thead><tr><td>Member States</td><td>Sales (in volume or value)</td><td>Permits holders / Producers</td><td>Number of IBCAs uses / products</td><td>Number / List of species authorised</td><td>Sources</td></tr></thead><tbody><tr><td>Austria</td><td>Authorisation holders have to report annually the sold amount of each PPP to the competent authority, including IBCAs. This info is not consolidated</td><td>Available</td><td>107 products authorised</td><td>List of authorised species available: 37</td><td>https://psmregister.baes.gv.at/psmregisterr/faces/main#</td></tr><tr><td>Belgium</td><td>-</td><td>-</td><td>-</td><td>For Flanders: 43</td><td></td></tr><tr><td>Bulgaria</td><td>-</td><td>Available at central administration level</td><td>-</td><td>NA</td><td></td></tr><tr><td>Croatia</td><td>250 000 € for the use of 1 SIT</td><td>-</td><td>-</td><td>2 species authorised</td><td></td></tr><tr><td>Czech Republic</td><td>Data from users and data on sales are collected however not aggregated</td><td>Yes: Act No 326/2004 on phytosanitary care (§. 46a and 46b)</td><td>256 uses authorised based on the local authorisation and unknown number of uses based on the</td><td>30 and unknown number under mutual recognition</td><td>https://eagri.cz/public/app/eagriapp/POR/Vyhledavani.aspx?type=0&vyhledat=A&amp;stamp=1664193703569</td></tr></tbody></table>
<table><thead><tr><td>Member States</td><td>Sales (in volume or value)</td><td>Permits holders / Producers</td><td>Number of IBCAs uses / products</td><td>Number / List of species authorised</td><td>Sources</td></tr></thead><tbody><tr><td></td><td>specifically for IBCAs</td><td></td><td>automatic mutual recognition</td><td></td><td></td></tr><tr><td>Denmark</td><td>-</td><td>No</td><td>-</td><td>7</td><td>https://www.retsinformation.dk/eli/lta/2021/1986#id46e86d4a-732a-4276-81efffebf76f2c31</td></tr><tr><td>Estonia</td><td>-</td><td>-</td><td></td><td></td><td></td></tr><tr><td>Finland</td><td>4,5 million €</td><td>No</td><td>190 uses</td><td>55</td><td>https://www.ruokavirasto.fi/en/farmers/plant-production/torjuntaeliot-japolyttajat/accepted-species/biological-control-agents/</td></tr><tr><td>France</td><td>The national IBMA branch forwards the consolidated data of their members to the State<br>23,6 million €</td><td>Non-native IBCA producers and introducers have to register, but not retailers</td><td>-</td><td>144 species, 440 strains (included 369 non-indigenous organism)</td><td>Legal documents</td></tr><tr><td>Germany</td><td>-</td><td>In development</td><td>-</td><td>Around 80 species</td><td>Julius-Kühn Institut</td></tr><tr><td>Greece</td><td>-</td><td>Registration (no list was shared)</td><td>-</td><td>53</td><td>http://www.minagric.gr/images/stories/docs/agrotis/Georgika_Farmaka/Makroorgani smoi/Ethnikos_Katalogos_MakroOrganism wn_tr_161019.pdf</td></tr></tbody></table>
<table><thead><tr><td>Member States</td><td>Sales (in volume or value)</td><td>Permits holders / Producers</td><td>Number of IBCAs uses / products</td><td>Number / List of species authorised</td><td>Sources</td></tr></thead><tbody><tr><td>Hungary</td><td>-</td><td>-</td><td>-</td><td>46</td><td>Presentation made by the NCA for EPPO</td></tr><tr><td>Ireland</td><td>-</td><td>No</td><td>-</td><td>15 species used (no authorisation system)</td><td>List of used IBCAs provided by the NCA</td></tr><tr><td>Italy</td><td>-</td><td>Registration (no list was shared)</td><td>-</td><td>-</td><td></td></tr><tr><td>Latvia</td><td>-</td><td>Registration (no list was shared)</td><td>67 products</td><td>34 species</td><td>https://www.vaad.gov.lv/lv/media/3398/download</td></tr><tr><td>Lithuania</td><td>-</td><td>-</td><td>-</td><td>-</td><td></td></tr><tr><td>Luxembourg</td><td>-</td><td>-</td><td>-</td><td>-</td><td></td></tr><tr><td>The Netherlands</td><td>-</td><td>Registration (no list was shared)</td><td>-</td><td>160 species</td><td>https://wetten.overheid.nl/BWBR0038668/2019-10-04/#Bijlage8<br>https://opendata.cbs.nl/statline/#/CBS/nl/dataset/84008NED/table?ts=1656676963062</td></tr><tr><td>Poland</td><td>-</td><td>-</td><td>About 65, insome cases we mean a crop (like apple tree, strawberry), sometimes a</td><td>24 (estimation)</td><td></td></tr></tbody></table>
<table><thead><tr><td>Member States</td><td>Sales (in volume or value)</td><td>Permits holders / Producers</td><td>Number of IBCAs uses / products</td><td>Number / List of species authorised</td><td>Sources</td></tr></thead><tbody><tr><td></td><td></td><td></td><td>group of crops (like berry bushes, ornamental plants).</td><td></td><td></td></tr><tr><td>Portugal</td><td>-</td><td>No</td><td>-</td><td>-</td><td></td></tr><tr><td>Romania</td><td>-</td><td>-</td><td>Approximately 45</td><td>Approximately 25</td><td></td></tr><tr><td>Slovakia</td><td>-</td><td>-</td><td></td><td></td><td>https://www.uksup.sk/orp-datasety</td></tr><tr><td>Slovenia</td><td>Estimated amount: 300 000€</td><td>Registration (Rules on biological plant protection, Article 10) but no list</td><td>91</td><td>35</td><td>Biotično varstvo rastlin | GOV.SI</td></tr><tr><td>Spain</td><td>-</td><td>Registration (Art 5 RD 951/2014), no list</td><td>1116 "IBCA products"</td><td>107 species</td><td>https://www.mapa.gob.es/app/omdfocb/ResBusCon.aspx?id=es</td></tr><tr><td>Sweden</td><td>Estimated amount: under 2,6 million €</td><td>No</td><td>-</td><td>33 in total<br>29 IBCAs are authorized by SEPA</td><td>https://www.naturvardsverket.se/amneso/mraden/miljofororeningar/biologiska-bekampningsmedel/</td></tr></tbody></table>
<table><thead><tr><td>Member States</td><td>Sales (in volume or value)</td><td>Permits holders / Producers</td><td>Number of IBCAs uses / products</td><td>Number / List of species authorised</td><td>Sources</td></tr></thead><tbody><tr><td></td><td></td><td></td><td></td><td>4 IBCAs are still authorized through the Swedish Chemical Agency's product authorizations but will be evaluated by SEPA before the approvals end (May 2023)</td><td></td></tr></tbody></table>
## 5.6 Annex 6 - Overview of the content of risk assessment at national level

<table><thead><tr><th></th><th>Austria</th><th>France</th><th>Hungary</th><th>Slovakia</th><th>Spain</th><th>Sweden</th></tr></thead><tbody><tr><td colspan="7"><strong>Part 1. Application information</strong></td></tr><tr><td colspan="7">(A) Information on the applicant</td></tr><tr><td></td><td></td><td>X</td><td>X</td><td>X</td><td>X</td><td>X</td></tr><tr><td>Purpose of use</td><td></td><td>X</td><td></td><td></td><td>X</td><td></td></tr><tr><td>Import / Research / (Mass) rearing / Release Trials / Commercial</td><td></td><td>X</td><td>X (function)</td><td></td><td></td><td></td></tr><tr><td>Type of biocontrol programme</td><td></td><td>X</td><td></td><td></td><td></td><td></td></tr><tr><td>Type of area where BCA will be released</td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Facilities and procedures</td><td></td><td>Rearing methods, historicity</td><td></td><td>Rearing localisations</td><td></td><td></td></tr><tr><td>Describe how the risks, in particular probability of escape and possible extent into the wild for import / rearing of non-indigenous organisms will be managed.</td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Contingency plan</td><td></td><td>X</td><td></td><td></td><td></td><td></td></tr><tr><td>Standard Operating Procedures</td><td></td><td>X</td><td></td><td></td><td></td><td></td></tr><tr><td>Quality control management</td><td></td><td>X</td><td></td><td></td><td></td><td></td></tr><tr><td>Accreditation</td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Information about the target organism(s)</td><td></td><td></td><td></td><td>X</td><td></td><td>X</td></tr><tr><td>Give a description of the biology and ecology of the target pest(s), including weeds.</td><td></td><td></td><td></td><td></td><td></td><td></td></tr></tbody></table>
<table><tr><td>Target host taxon</td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Names of target pests</td><td></td><td></td><td>X</td><td></td><td></td></tr><tr><td>Original area of distribution of the pests</td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Biology of pests</td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Target crops hosting the pest</td><td></td><td></td><td>X</td><td>X</td><td>X</td></tr></table>

## Part 2. Information on indigenous and non-indigenous BCAs

<table><tr><td></td><td>Identity</td><td>X</td><td>X</td><td>X</td><td>X</td></tr><tr><td></td><td>For what species / organism is the application made? Indicate which species is involved (a single species per application) and full scientific name and taxonomy</td><td></td><td></td><td></td><td>X</td></tr><tr><td></td><td>Class</td><td>X</td><td>X</td><td></td><td>X</td></tr><tr><td></td><td>Order</td><td>X</td><td>X</td><td></td><td>X</td></tr><tr><td></td><td>Family</td><td>X</td><td>X</td><td></td><td>X</td></tr><tr><td></td><td>Genus</td><td>X</td><td>X</td><td></td><td>X</td></tr><tr><td></td><td>Species</td><td>X</td><td>X</td><td></td><td>X</td></tr><tr><td></td><td>Sub-species</td><td>X</td><td></td><td></td><td>X</td></tr><tr><td></td><td>Common names</td><td>X</td><td>X</td><td>X</td><td>X</td></tr><tr><td></td><td>Alternative names</td><td>X</td><td></td><td></td><td></td></tr><tr><td></td><td>Associated organisms</td><td>X</td><td></td><td></td><td>X</td></tr><tr><td></td><td>Indicate means, methods of ID confirmation and reference (voucher) specimen (Authority / Methodology / Reference (voucher) specimen deposits)</td><td></td><td>X</td><td>X</td><td>X</td></tr><tr><td></td><td>Characterization of BCA</td><td></td><td></td><td></td><td></td></tr><tr><td></td><td>Specify life-stages, strains or taxonomic constraints.</td><td>X</td><td></td><td></td><td></td></tr></table>
<table><tr><td>Diagnostic descriptions</td><td>X</td><td></td><td></td><td></td></tr><tr><td>Specific characteristics</td><td>X</td><td></td><td></td><td></td></tr><tr><td>Taxonomic characteristics</td><td>X</td><td></td><td></td><td></td></tr><tr><td>Origin and distribution of BCA</td><td></td><td></td><td></td><td></td></tr><tr><td>Origin (Indigenous / Non-indigenous)</td><td>X</td><td></td><td></td><td></td></tr><tr><td>Field collected</td><td>X</td><td></td><td></td><td></td></tr><tr><td>Laboratory culture</td><td>X</td><td></td><td></td><td></td></tr><tr><td>Producer / supplier</td><td>X (localisation)</td><td></td><td></td><td></td></tr><tr><td>Original area and distribution</td><td>X</td><td></td><td>X</td><td></td></tr><tr><td>Areas where introduced before</td><td>X (data required)</td><td></td><td></td><td></td></tr><tr><td rowspan="2">(B) Product information</td><td rowspan="2"></td><td rowspan="2">description of storage and rearing structures</td><td>packaging: filling weight and volume, sizes, materials used for packaging, mode of sealing, test results certifying reliability of packaging</td><td>X</td><td>X</td></tr><tr><td></td><td></td><td></td></tr><tr><td>Product information</td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Product / trade name</td><td>X</td><td>X</td><td>X</td><td></td><td></td></tr><tr><td>Producer / supplier</td><td>X</td><td>X</td><td>X</td><td>X</td><td></td></tr></table>
<table><tr><td>Method of supply</td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Life stages</td><td></td><td></td><td>X</td><td></td><td></td></tr><tr><td>Label information</td><td></td><td>X</td><td></td><td>X</td><td>X</td></tr><tr><td>Storage</td><td></td><td>X</td><td>X</td><td>X</td><td>X</td></tr><tr><td>Method of use</td><td></td><td>classical /augmentative/ autocidal releasing areas number of organims per release and number of yearly releases</td><td>Mode of mass reproduction of the macro-organism Recommendation for use (mode of use, field of use, crop, target pest, dose, number of release, date of treatment, etc)</td><td>X (number of organims per unit treated, number and timing of applications, instructions for use)</td><td>X (doses, time of the application, etc.)</td></tr><tr><td>2.5 Product composition</td><td></td><td>X</td><td>concentration of the macro-organims, moisturize</td><td>X</td><td>X</td></tr><tr><td>Co-formulants</td><td></td><td>X</td><td>X</td><td>X</td><td></td></tr><tr><td>Contaminants</td><td></td><td>X</td><td>Role in spreading other pests</td><td></td><td></td></tr></table>
## 2.6 Particular situations

### Part 3. Information requirements for intentional release of a non-indigenous BCA with reference to:

<table><tbody><tr><td></td><td>Information regarding biology and ecology</td><td>X</td><td>X</td><td></td><td></td></tr><tr><td></td><td>Give a description of the biology and ecology of the BCA</td><td>X</td><td>X</td><td></td><td></td></tr><tr><td></td><td>Life cycle – generations / year</td><td>X</td><td>X</td><td>X</td><td></td></tr><tr><td rowspan="7">(A) Biology and ecology</td><td>Developmental biology</td><td>X</td><td>X</td><td>X</td><td></td></tr><tr><td>Mechanisms of survival</td><td>X</td><td></td><td></td><td></td></tr><tr><td>Mechanisms of dispersal</td><td>X</td><td>X</td><td>X</td><td></td></tr><tr><td>Climatic conditions</td><td>X</td><td>X</td><td>X</td><td></td></tr><tr><td>Habitat range</td><td>X</td><td>X</td><td></td><td></td></tr><tr><td>Host range</td><td>X</td><td>X</td><td>X</td><td></td></tr><tr><td>Natural enemies</td><td>X</td><td></td><td>X</td><td></td></tr><tr><td rowspan="5">(B) Assessment of risks and benefits</td><td>Safety and health effects</td><td>X</td><td>X, Fire safety, quality contrtol</td><td>X</td><td>X</td></tr><tr><td>Potential hazards of BCA, product or any co-formulants, and measures taken to limit operator exposure, with emphasis on Human health Animal health Measures of prevention</td><td></td><td>Fire safety, quality control, effects on human and animal health, risks jof affecting gene diversity</td><td>Waste disposal and decontamination of packaging materials</td><td></td></tr><tr><td>Information about environmental risk assessment</td><td>X</td><td>X</td><td>X</td><td></td></tr><tr><td>Potential for establishment</td><td>X</td><td>X</td><td>X</td><td></td></tr></tbody></table>
<table><tr><td>Physical constraints</td><td></td><td>X</td><td></td><td></td><td></td></tr><tr><td>Resource constraints</td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Survival data and methods used</td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Evidence of establishment</td><td></td><td>X</td><td></td><td></td><td></td></tr><tr><td>Host range assessment</td><td>X</td><td>X</td><td>X</td><td></td><td></td></tr><tr><td>Known hosts</td><td></td><td>X</td><td></td><td></td><td></td></tr><tr><td>Organisms tested</td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Procedures used for host range testing</td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Effects on plants used by target and non-target hosts</td><td></td><td>X</td><td></td><td></td><td></td></tr><tr><td>Dispersal</td><td>X</td><td>X</td><td>X</td><td>X</td><td></td></tr><tr><td>Ability to disperse</td><td></td><td>X (+ dispersal speed)</td><td>X</td><td>X (+ mobility)</td><td></td></tr><tr><td>Direct and/or indirect non-target effects</td><td>X</td><td>X</td><td>X</td><td>X</td><td></td></tr><tr><td>Summary of available information and conclusions on risks</td><td></td><td>Plant health</td><td></td><td>Plant health</td><td></td></tr><tr><td>Efficacy and benefits of the BCA</td><td></td><td>X</td><td>X</td><td></td><td></td></tr><tr><td>Assessment of efficacy, economic and environmental benefits</td><td></td><td>X</td><td>X</td><td></td><td></td></tr><tr><td>Method(s) to determine efficacy</td><td></td><td>X</td><td></td><td>X</td><td></td></tr><tr><td>Results of efficacy trials</td><td></td><td>X</td><td></td><td></td><td></td></tr><tr><td>Economic benefits</td><td></td><td>X</td><td></td><td></td><td></td></tr><tr><td>Environmental benefits</td><td></td><td>X</td><td></td><td></td><td></td></tr></table>
## 5.7 Annex 7 - Synopsis report on the stakeholder consultation

### 5.7.1 Introduction

This synopsis report presents the results of the consultation activities conducted to prepare the study on the Union's situation and options regarding invertebrate biological control agents for the use in plant health and plant protection. It contains a summary of the consultation activities, reflecting the diversity of the stakeholders' positions, and an analysis of the quality of the information collected - both qualitative and quantitative.

### 5.7.2 Presentation of the consultation strategy

The consultation method defined in the terms of reference for this study was a targeted consultation: stakeholders were pre-selected and only the explicitly invited stakeholder groups and individuals could participate in the consultation activity and provide insight into the challenges and possible scope of action of the European Union.

The objective of the consultation strategy was twofold: firstly, to obtain information on the Union's situation on IBCAs for the use in plant health and plant protection (market, uses, regulatory situation across Member states, main challenges), and secondly to consult stakeholders and Member States on their views on the potential for evolution of this sector in the European Union, and the opportunity and shape of a possible European intervention. It targeted mainly European stakeholders and national competent authorities in 27 Member States.

Stakeholders were consulted through **three consultation tools**. Each tool aimed to collect evidence that complement desk research by providing additional qualitative and quantitative inputs which are not available in official documentation:

- **Surveys**, by the mean of two structured questionnaires sent respectively to National Competent Authorities (NCAs) and other stakeholders. Questionnaires were developed to collect as much information as possible to answer questions of the Study and feed into the problem definition and the identification of possible options for an EU initiative.

- **Targeted interviews** that aimed to confirm the problem definition and collect additional views and data to measure the impact of the different options and identify main pros and cons of policy options. For 7 Member States with a specific focus (Austria, France, Hungary, the Netherlands, Portugal, Spain, and Sweden), interviews also allowed the collection of data regarding questions specific to these Member States.

- **A validation workshop**, that was organised to on August 30th and 31st to present the results of the study, validate the main findings, and discuss over some more challenging topics identified such as the main
drivers and opportunities for the IBCA market, and a potential EU-approach to harmonisation. The validation workshop was opened for participation to representatives of key stakeholders concerned by IBCAs at European level, e.g., the national competent authorities of each Member State, representatives of business operators (producers and users), representatives of NGOs, as well as recognised experts in IBCAs. Overall, participation was high, with 60 people (including the EC and the study team) present on the 30th and 56 people on the 31st

As a summary, these three tools aimed to consult the following stakeholders' groups (planed consultation strategy):

<table><thead><tr><th>Type of stakeholders</th><th>Surveys</th><th>Interviews</th><th>Validatio<br>n<br>worksho<br>p</th></tr></thead><tbody><tr><td>Member State "national competent authorities", e.g. contact points identified within each national authority in charge of IBCA in their respective country.</td><td>√ (27 MS)</td><td>√ (7 MS)<br>Interviews with national competent authorities in Austria, France, Hungary, the Netherlands, Portugal, Spain, and Sweden</td><td>√</td></tr><tr><td>Intergovernmental organisations:<br>- IPPC / EPPO,<br>- IAEA-FAO<br>- CABI</td><td>√</td><td>√</td><td>√</td></tr><tr><td>Industry associations representing the interests of manufacturers and retailers of IBCAs:<br>- IBMA</td><td></td><td></td><td></td></tr><tr><td>Farmers', forestry and home gardener's associations:<br>- COPA COGECA,<br>- IFOAM,<br>- EUSTAFOR</td><td></td><td></td><td></td></tr><tr><td>Environmental NGOs:</td><td></td><td></td><td></td></tr></tbody></table>
<table><thead><tr><th>Type of stakeholders</th><th>Surveys</th><th>Interviews</th><th>Validatio<br>n<br>worksho<br>p</th></tr></thead><tbody><tr><td>- PAN</td><td></td><td></td><td></td></tr><tr><td>Scientific organisations:</td><td></td><td></td><td></td></tr><tr><td>- EFSA,</td><td></td><td></td><td></td></tr><tr><td>- IOBC-WPRS</td><td></td><td></td><td></td></tr><tr><td>National competent authority from<br>third countries:</td><td>√</td><td>√</td><td></td></tr><tr><td>- New Zealand</td><td></td><td></td><td></td></tr><tr><td>- the USA</td><td></td><td></td><td></td></tr></tbody></table>

This consultation plan has been established in accordance with the Terms of Reference of the Study with a view to considering the interests of all relevant stakeholders' group, e.g. national authorities, industry, farmers, civil society, intergovernmental organisations, and scientific organisations.

### 5.7.3 Description of consultation activities

For each stakeholders' groups (NCA on the one hand and other groups on the other hand), consultation tools were implemented in a sequential manner: surveys were implemented between May and June 2022, whilst interviews were performed in July and August 2022. Starting with written and tailored questionnaires (adjusted to the type of stakeholder, their scope and the relevance of the consultation topic) (before interviews) aimed to leave sufficient time to target stakeholders to collect relevant documentation and consult with other authorities, where needed, to provide useful and as exhaustive as possible answers prior to being interviewed. Subsequent interviews allowed to go more in-depth and complement collected data with additional information and insights.

#### 5.7.3.1 Consultation at MS level (survey and interviews with NCAs)

Consultation at national level targeted NCAs only. NCAs were consulted through both a survey (for 27 MS) and interviews (for 7 MS, as well as some NCAs that required follow-up interviews).

- **The survey** process (written questionnaire) aimed to collect information and views on the situation of IBCAs in each MS, e.g. on the market of IBCAs in each country (used, production, market value, existing research and development programmes, etc.) and on the national regulatory frameworks in relation with IBCAs, as well as views
on the future development of IBCAs. The questionnaires covered three main topics: (1) the regulatory framework, (2) the market and uses, and (3) the perspectives on possible future harmonisation options.

- Several follow up tasks were undertaken to support NCAs and ensure a high response rate to the questionnaire and ensure better quality of the responses: phone calls, follow-up interviews, flexibility on the mode of response, but also reviews of documentation (either available online or transmitted by the Member States) and of scientific evidence to refine the elements transmitted by the Member States.

- In total **26 questionnaires** were received (including 3 questionnaires covering the federal and regional levels in Belgium), corresponding to 24 different Member States. 2 additional questionnaires could be completed by the study team based on interviews. As a result, the survey covers all Member States, except Malta and the region of Wallonia in Belgium, leading to a response rate of 28 responses out of the 30 solicited.

- **13 interviews** were organised with following Member States' NCAs: Belgium, Czech Republic, Cyprus, France, Germany, Greece, Luxembourg, the Netherlands, Portugal, Spain, Finland, Denmark and Sweden. In addition to these interviews, Austria and Hungary decided to replace interviews with written contributions.

<table><caption>Table 15 - Member State involvement in consultation activities</caption><thead><tr><td>Member State</td><td>Questionnaire</td><td>Interview</td><td>Workshop</td></tr></thead><tbody><tr><td>Austria*</td><td>✓</td><td>Replaced with written Q&A at the request of the NCA</td><td></td></tr><tr><td>Belgium (Federal)</td><td>✓</td><td></td><td></td></tr><tr><td>Belgium (Brussels)</td><td>✓</td><td>✓</td><td></td></tr><tr><td>Belgium (Flanders)</td><td>✓</td><td></td><td>✓</td></tr><tr><td>Belgium (Wallonia)</td><td>No</td><td></td><td></td></tr><tr><td>Bulgaria</td><td>✓</td><td></td><td></td></tr></tbody></table>
<table><thead><tr><th>Member State</th><th>Questionnaire</th><th>Interview</th><th>Workshop</th></tr></thead><tbody><tr><td>Croatia</td><td>✓</td><td></td><td></td></tr><tr><td>Cyprus</td><td>✓</td><td>✓</td><td></td></tr><tr><td>Czech Republic</td><td>✓</td><td>✓</td><td>✓</td></tr><tr><td>Denmark</td><td>✓</td><td>✓</td><td>✓</td></tr><tr><td>Estonia</td><td>✓</td><td></td><td>✓</td></tr><tr><td>Finland</td><td>✓</td><td>✓</td><td>✓</td></tr><tr><td>France*</td><td>✓</td><td>✓</td><td>✓</td></tr><tr><td>Germany</td><td>✓</td><td>✓</td><td>✓</td></tr><tr><td>Greece</td><td>✓</td><td>✓</td><td></td></tr><tr><td>Hungary*</td><td>✓</td><td>Replaced with written Q&A at the request of the NCA</td><td></td></tr><tr><td>Ireland</td><td>✓</td><td></td><td>✓</td></tr><tr><td>Italy</td><td>✓</td><td></td><td>✓</td></tr><tr><td>Latvia</td><td>✓</td><td></td><td>✓</td></tr><tr><td>Lithuania</td><td>✓</td><td></td><td>✓</td></tr><tr><td>Luxembourg</td><td>(questionnaire completed with the interview)</td><td>✓</td><td>✓</td></tr><tr><td>Malta</td><td>NO (documentary review)</td><td></td><td></td></tr><tr><td>Netherlands*</td><td>✓</td><td></td><td>✓</td></tr><tr><td>Poland</td><td>✓</td><td></td><td></td></tr><tr><td>Portugal*</td><td>(questionnaire completed with the interview)</td><td>✓</td><td>✓</td></tr><tr><td>Romania</td><td>✓</td><td></td><td></td></tr><tr><td>Slovakia</td><td>✓</td><td></td><td>✓</td></tr><tr><td>Slovenia</td><td>✓</td><td></td><td>✓</td></tr><tr><td>Spain*</td><td>✓</td><td>✓</td><td></td></tr><tr><td>Sweden*</td><td>✓</td><td>✓</td><td>✓</td></tr></tbody></table>

Note: an asterisk indicates the 7 case study Member States
Overall, the participation from the NCAs was good, with some differences linked to the specific situation in each MS:

- Most Member States with extensive experience in regulating IBCAs showed a high interest and provided detailed contributions;

- Several Member States with no IBCA-specific regulation showed a high interest and participated actively to the consultation activities with a learning objective and to feed into national reflexions on regulating IBCAs;

- Several Member States, mainly those with less important agricultural, showed less interest in the process.

### 5.7.3.2 Consultation at EU and international level (survey and interviews with other stakeholders' groups)

Other stakeholders' groups were also consulted to collect available data, and qualitative information on the IBCA market, the uses, and the challenges encountered.

- Participation to the questionnaires was rather low, with **3 questionnaires** being received out of the 13 targeted stakeholders.

- Most stakeholders opted for interviews, either to complement the questionnaires or to replace them. As such, **8 interviews** were led with the different stakeholders, out of the 13 targeted.

Additionally, the third countries selected for case studies participated through a questionnaire (New Zealand), written comments (the USA) and an interview (both third countries).

Participation across the different stakeholder groups differed according to their relative interest and knowledge of the subject:

- **Intergovernmental and scientific organisations** were most involved and provided factual inputs and views on the relevance and feasibility of potential options for an EU initiative;

- The main **industry organisation representing the interests of manufacturers and retailers of IBCAs** was highly active and interested in the subject. It provided key inputs on the market of IBCAs as well as feedbacks that have been considered during the process (main drivers and obstacles for IBCA producers and views on a future initiative).

- **Farmers' associations** had little knowledge on invertebrate biological control specifically, but contributed to reflexions on IPM. As such, some of them were responsive but did not participate in all steps of the consultation. While it was decided, in accordance with the terms of
reference specified, to focus consultation on representative organisations at European level only, this may have led to limited inputs from actual/ potential users, as they are not being consulted specifically on the subject of IBCAs.

* Finally, it was more challenging to get input from **environmental NGOs**: they rarely had a specific position on IBCAs, which they tend to view in the context of IPM strategies and advocating for a system change around agricultural practices.

<table><caption>Table 16 – Stakeholder involvement in consultation activities</caption><thead><tr><td>Type of stakeholders</td><td>Surveys</td><td>Interviews</td><td>Workshop</td></tr></thead><tbody><tr><td>Intergovernmental organisations: IPPC / EPPO, IAEA-FAO CABI</td><td>√ EPPO</td><td>√ EPPO, IAEA-FAO CABI Europe</td><td>√ EPPO, IAEA-FAO</td></tr><tr><td>Industry associations representing the interests of manufacturers and retailers of IBCAs: IBMA, Crop Life Europe</td><td>√ received (IBMA)</td><td>√ IBMA,</td><td>√ IBMA</td></tr><tr><td>Farmers', forestry and home gardener's associations: COPA COGECA, IFOAM, and EUSTAFOR</td><td>All stakeholders opted for interviews</td><td>√ COPA-COGECA, EUSTAFOR</td><td>√ COPA-COGECA</td></tr><tr><td>Environmental NGOs: EEB, IUCN and PAN</td><td></td><td>√ PAN Europe</td><td></td></tr><tr><td>Scientific organisations: EFSA, IOBC-WPRS</td><td>√ IOBC-WPRS</td><td>√ EFSA</td><td>√ EFSA, IOBC-WPRS</td></tr></tbody></table>
<table><thead><tr><td>Type of stakeholders</td><td>Surveys</td><td>Interviews</td><td>Workshop</td></tr></thead><tbody><tr><td>National competent authorities from New Zealand and the USA</td><td>✓ New Zealand, the USA (written comments)</td><td>✓ New Zealand</td><td></td></tr></tbody></table>

### 5.7.3.3 Validation workshop

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

This workshop aimed to present the results of the study, confirm the accuracy of the main findings, and discuss over some more challenging topics identified. It was opened for participation to representatives of key stakeholders concerned by IBCAs at European level, e.g., the national competent authorities of each Member State, representatives of business operators (producers and users), representatives of NGOs, as well as recognised experts in IBCAs. Overall, participation was high, with 60 people (including the EC and the study team) present on the 30th and 56 people on the 31st. As all Member States and stakeholders were invited to send multiple participants, 27 participants represented 18 different Member States and 15 participants represented 7 stakeholders.

During the workshop, Member States expressed their opinions less vocally than within the surveys regarding the options, but some views and inputs could be collected in roundtables and with the help of an online survey tool (Mentimeter). Some Member States also chose to contribute more through the chat (Sweden, Finland, Portugal...). Finally, some Member States participated rather vocally: the Netherlands, France, Ireland. On the stakeholder side, the most invested stakeholders were present and engaged in the conversations

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

### 5.7.4 Results of the consultation

The results from the consultation activities were used as the base for the Study. Contributions from the Member States were at the core of all questions, and especially the regulatory framework. Contributions from the industry and from the users' associations alimented Question 1 on the market and uses of IBCAs, and Question 2 and 3 on the perceived fitness of the different regulatory frameworks. The scientific organisations, as well as the intergovernmental organisations, gave hindsight into the uses of IBCAs and their challenges, but also on their own role to play in a future European framework.
Consultation activities allowed to collect complementary inputs that were all
used for the Study, both data/ information and views that were fully
considered in the report.

5.7.4.1 Information on the situation of IBCAs in the territory of the Union

The surveys and interviews allowed to gather input unequally according to the
different study areas:

► The **regulatory framework** regarding IBCAs was an area that gathered the most input from the Member States which have a regulation. Member States currently developing one also provided details. The consulted industry association also provided information on the different regulatory frameworks, and their appreciation of their respective fitness. This allowed to have a rather complete and comprehensive view on the current situation of IBCA regulations in the different Member States as well as on their strengths and weaknesses.

► Sections on the **use of IBCAs** were more unequally completed. Very few Member States were able to provide data regarding the current uses of IBCAs on their territory. Generally, the number of uses (as in one solution for one crop) is seldom if ever collected in the Member States (Austria and the Netherlands have databases on the uses for authorised organisms). There are no monitoring strategies in place in the Member States, leading to very few knowledge on the current situation within NCAs. When available, NCAs communicated the number of authorized IBCAs (for 15 Member States). Crop type data related to IBCA use was available only in a few cases (through previously mentioned uses databases). Chemical pesticide use and distribution among crops was also rarely provided. Users' associations and scientific organisations were able to provide additional information on the general context and conditions of IBCA uses.

Similarly, data on the **IBCA market** was difficult to obtain. No NCAs collected the information, although a few Member States have indicative information on the market from national IBMA branches. Some interviews allowed for more qualitative but less precise descriptions of the market and uses. At European level, stakeholders from the industry do not collect country specific information for the IBCA market. As such, the consulted industry association provided market trends for IBCAs.

► **Perspectives** were generally expressed in a very concise way by the Member States in the questionnaires. A few Member States left the section empty. A hypothesis for this response behaviour is that some respondents might think they were not at the right decision or political level to reply. Other Member States provided very detailed and exhaustive answers and were also visible during the workshop.

A detailed appreciation of the contents of the survey to NCAs is available in
annex 5.5.5.

5.7.4.2 Views on the future of IBCAs and the impact of potential initiatives at EU level

Despite partial diverging interests, the different stakeholder groups (especially
industry on the one side and NCAs on the other) showed a shared assessment
on the current problems and mostly converging views on the need for the EU
to act to foster the safe development of IBCAs in the European Union.
All stakeholders agree that the development and use of IBCAs has to accelerate on the territory of the Union and that some actions could be taken at an EU level to foster that development. They also all agree that some harmonisation is needed in that respect. The level and shape of this harmonisation has however let to some debated, as reflected below.

## Perspectives for development

All stakeholders and Member States consulted foresaw potential for development in the IBCA market and uses. The consultation and validation workshop highlighted several drivers that all participants agreed upon:

* Most Member States cited the **types of agricultural systems** (including the presence of greenhouses), the **public policies in place** (about pesticides, MRLs, etc.), the **expertise/knowledge of farmers and advisors**, to be the most important drivers. This analysis was also shared by the other stakeholders consulted.

* Other important drivers considered by participants included: **research and new technologies** for storage, transport, and field delivery, **public opinion** and **social demand**, as well as the availability and easiness of access of IBCAs to farmers, beyond the mere authorisation of the organisms.

* Less cited drivers included **specific regulatory incentives** (e.g., asking for a justification of the use of chemical pesticides when sustainable alternatives exist), **partnerships on R&D and knowledge transfers**, **communication on benefits of IBCAs** (awareness-raising on returns on investment and impact on sustainability), and **collective organisations and sharing** (through associations and cooperatives). Lack of effectiveness of some products, the time needed to develop a new product and the emergence of new pests which can disrupt current IPM strategies were cited as blocking factors.

These perspectives were especially integrated in the analysis of Question 1 (market and uses, and potential for development) and Question 4 (regulatory instruments). Furthermore, these insights allowed to refine the problem definition.

## Instruments to foster innovation and adoption by users

For all participants to the consultation, the European Union has a role to play in fostering the IBCA sector (R&D, tools, knowledge sharing, returns on experience...). Inputs and discussions during interviews and the workshop mainly relied on how the Commission could act and the tools which could be used. Users associations underlined that direct financing is a very potent tool when it comes to adoption of new agricultural methods. Most Member States also reported that IBCAs are rarely explicitly included in their national CAP plan.

These elements were also included in the report in sections on the potential for development, and on regulatory instruments.

## Opportunity for harmonisation

This section was the most debated. Most Member States and stakeholders agree that the current situation requires some harmonisation at European
level, either to cover cross-border possible issues, to provide a framework for smaller Member States, or to make the market more homogeneous and develop the use. Points of view differ on the form this harmonisation could take (centralisation of a risk-assessment, centralisation of the authorisation process, balance between European and national regulations), and on the risks and benefits each option would entail. Finally, most stakeholders agreed that the harmonisation and common guidelines could rely on the existing guidance (e.g. from EPPO) and should strive towards no duplication of work between the regional and European scales.

**Member States** have rising interest in this matter. In total, 19 Member States provided an analysis on the hypothesis of centralisation of the assessment of IBCAs in the questionnaire. Views on the degree of harmonisation tend to diverge: 6 expressed a clearly positive opinion towards centralised harmonisation, 5 expressed a clearly negative opinion, and 9 had an intermediate position. Similar points of view were expressed in the interviews and in the workshop.

* Member States without a regulation were most favourable to a common European framework and open to discussions on the centralisation of the risk-assessment and the authorisation process. (Ireland, Belgium, Portugal, Luxembourg). As a Member States who already have a regulation, Slovenia and Finland also expressed interest in a centralised risk-assessment system.

* Most Member States who expressed views on harmonisation and centralisation are favourable to some harmonisation. On the opportunity to centralise the risk-assessment, they however expressed concerns on the impacts on the market, on national biodiversity, and the administrative load, while also recognising that it can lead to positive effects. Often, these stakeholders are Member States who have already developed a regulation and who are favourable to some harmonisation to the extent where they would retain national authority on the subject.

* Finally, a few Member States expressed opposition to a centralised risk-assessment (Greece, the Netherlands, Poland, Romania, and one Member State without a regulation, Croatia).

Overall, interrogated NCAs 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 perspective of making EFSA in charge of risk assessment was more debated (10 positive, 5 negative). This was viewed relevant at two conditions:

* impact assessments do not interfere with existing national procedures and rather facilitate the work performed at national level thanks to preliminary advice at the level of species, creation of negative and positive lists that Member States can rely on 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 Member States.

* if the involvement of EFSA does not add a significant administrative burden and unnecessary delays in the processes already in place.
**Industry associations** have clear opinions on the topic of harmonising and regulating IBCAs, as it is their field of expertise. They are favourable to some harmonisation at European level, which could alleviate the authorisation and marketing processes (by reducing the proliferation of national regulations imposing different criteria) and help the economic viability of the IBCA industry. They are also cautious of the time and constraints that could arise from a European-wide process. Thus, they argue for a simple 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), as a way of reaching harmonisation. A possible involvement of EFSA is seen as a risk (administrative load and risk to have a process too similar to chemical pesticides, which is not considered to be fit-for-purpose).

**Scientific associations** have differing views according to the nature of their activities. EPPO is in favour of a harmonized system with clear guidelines, that could rely on their historical guideline-setting work.

* Among the stakeholders, EFSA provided factual elements (processes, human resources, etc.), allowing to further consider harmonisation scenarios within the Union. One intergovernmental organisation also pointed that many countries feel they do not have resources to risk-assess (both on the benefits and on the environmental risk), and that having an overarching convention across Europe for risk assessment would be beneficial

**Users' associations** (farmers, forestry) do not have clear positions on this specific subject, given its technicality and the lack of inside dedicated expertise
5.7.5 Annex: Quality and completeness of the surveys to Member States

<table><thead><tr><th rowspan="2">Member State</th><th rowspan="2">Answers to questionnaire received?</th><th colspan="2">Part 1: Regulatory framework</th><th colspan="2">Part 2: Market, uses and potential for development</th><th colspan="2">Part 3: Perspectives</th></tr><tr><th>Completion rate</th><th>Quality and reliability of the data</th><th>Completion rate</th><th>Quality and reliability of the data</th><th>Completion rate</th><th>Quality and reliability of the data</th></tr></thead><tbody><tr><td>Austria</td><td>YES</td><td>Complete</td><td>Detailed information with additional documents</td><td>Partial</td><td>Data provided on authorized uses<br/>No data provided on the market (although authorisation holders have to report annually the sold amount of each plant protection product to the competent authority (AGES, BAES), including IBCAs.<br/>Partial data on R&amp;D</td><td>Partial</td><td>Views are expressed on the harmonization but not on other instruments.</td></tr><tr><td>Belgium (Federal)</td><td>YES</td><td>NA</td><td>There is no regulation at federal level</td><td>Not completed</td><td>Only the number of authorized pesticide uses was estimated</td><td>Partial</td><td>Views are expressed (except for other regulatory instruments)</td></tr></tbody></table>
<table><thead><tr><th rowspan="2">Member State</th><th rowspan="2">Answers to questionnaire received?</th><th colspan="2">Part 1: Regulatory framework</th><th colspan="2">Part 2: Market, uses and potential for development</th><th colspan="2">Part 3: Perspectives</th></tr><tr><th>Completion rate</th><th>Quality and reliability of the data</th><th>Completion rate</th><th>Quality and reliability of the data</th><th>Completion rate</th><th>Quality and reliability of the data</th></tr></thead><tbody><tr><td>Belgium (Brussels)</td><td>YES (complemented with an interview)</td><td>Complete</td><td>There is no regulatory framework yet, but a legislation is being developed and some elements of the future legislation were included</td><td>Not completed</td><td>No data was provided as it does not exist at regional level</td><td>Partial</td><td>Views are expressed (except for other regulatory instruments)</td></tr><tr><td>Belgium (Flanders)</td><td>YES</td><td>Partial</td><td>Reliability is to be confirmed as there seems to be an informal procedure regarding non-native species</td><td>Not completed</td><td>Information on use was not available but no other entity was suggested to fill the gap</td><td>Partial</td><td>Only some questions are answered</td></tr><tr><td>Belgium (Wallonia)</td><td>No</td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Bulgaria</td><td>YES</td><td>Complete</td><td>Detailed information with additional legal documents</td><td>Not completed</td><td></td><td>Not completed</td><td></td></tr></tbody></table>
<table><thead><tr><th rowspan="2">Member State</th><th rowspan="2">Answers to questionnaire received?</th><th colspan="2">Part 1: Regulatory framework</th><th colspan="2">Part 2: Market, uses and potential for development</th><th colspan="2">Part 3: Perspectives</th></tr><tr><th>Completion rate</th><th>Quality and reliability of the data</th><th>Completion rate</th><th>Quality and reliability of the data</th><th>Completion rate</th><th>Quality and reliability of the data</th></tr></thead><tbody><tr><td>Croatia</td><td>YES</td><td>Complete</td><td>No regulation of IBCAs at national level, one specific exception exist for SIT control of Ceratitis capitata</td><td>Complete</td><td>Few uses of IBCAs: SIT on orchards and one use on forestry</td><td>Complete</td><td>Views are expressed and most questions answered</td></tr><tr><td>Cyprus</td><td>YES (complemented with an interview)</td><td>NA</td><td>No regulatory framework</td><td>Not completed</td><td>Only the number of authorized pesticide uses was provided</td><td>Partial</td><td>Only some questions are answered</td></tr><tr><td>Czech Republic</td><td>YES (complemented with an interview)</td><td>Complete</td><td>Detailed answers</td><td>Partial</td><td>There is some data on the authorized uses but the market data is not specific to IBCA</td><td>Complete</td><td>Views are expressed and most questions answered</td></tr><tr><td>Denmark</td><td>YES (complemented with an interview)</td><td>Complete</td><td>Detailed answers</td><td>Not completed</td><td></td><td>Not completed</td><td></td></tr><tr><td>Estonia</td><td>YES</td><td>NA</td><td>No regulatory framework</td><td>Not completed</td><td></td><td>Complete</td><td>Views are expressed and most questions answered</td></tr></tbody></table>
<table><thead><tr><th rowspan="2">Member State</th><th rowspan="2">Answers to questionnaire received?</th><th colspan="2">Part 1: Regulatory framework</th><th colspan="2">Part 2: Market, uses and potential for development</th><th colspan="2">Part 3: Perspectives</th></tr><tr><th>Completion rate</th><th>Quality and reliability of the data</th><th>Completion rate</th><th>Quality and reliability of the data</th><th>Completion rate</th><th>Quality and reliability of the data</th></tr></thead><tbody><tr><td>Finland</td><td>YES (complemented with an interview)</td><td>Complete</td><td>Detailed information with additional documents</td><td>Complete</td><td>There is some data on the uses, estimated market value</td><td>Complete</td><td>Views are expressed and most questions answered</td></tr><tr><td>France</td><td>YES (complemented with an interview)</td><td>Complete</td><td>Detailed information with additional documents</td><td>Complete</td><td>A large quantity of data was provided on the uses, market value, production costs</td><td>Complete</td><td>Views are expressed and most questions answered</td></tr><tr><td>Germany</td><td>YES (complemented with an interview)</td><td>Partial</td><td>There is no regulatory framework specific to IBCAs yet, but some elements of the future legislation were included</td><td>Partial</td><td>There is some data on the authorized uses and actual uses on the crops<br/>No data on the market<br/>Large information on R&D</td><td>Complete</td><td>Views are expressed and most questions answered</td></tr><tr><td>Greece</td><td>YES (complemented with an interview)</td><td>Complete</td><td>Detailed information with additional documents</td><td>Partial</td><td>There is some data on the authorized uses and actual uses on the crops<br/>No data on the market</td><td>Partial</td><td>Only some questions are answered</td></tr></tbody></table>
<table><thead><tr><th rowspan="2">Member State</th><th rowspan="2">Answers to questionnaire received?</th><th colspan="2">Part 1: Regulatory framework</th><th colspan="2">Part 2: Market, uses and potential for development</th><th colspan="2">Part 3: Perspectives</th></tr><tr><th>Completion rate</th><th>Quality and reliability of the data</th><th>Completion rate</th><th>Quality and reliability of the data</th><th>Completion rate</th><th>Quality and reliability of the data</th></tr></thead><tbody><tr><td>Hungary</td><td>YES (follow-up questions via email)</td><td>Complete</td><td>Detailed information with additional documents</td><td>Partial</td><td>Large information on R&D<br>There is some data on the authorized uses<br>No data on the market</td><td>Not completed</td><td>Only one question was covered</td></tr><tr><td>Ireland</td><td>YES</td><td>NA</td><td>No regulatory framework</td><td>Not completed</td><td>The number of authorized pesticide uses and pesticide market was estimated. A list of BCAs was communicated</td><td>Complete</td><td>Views are expressed and most questions answered</td></tr><tr><td>Italy</td><td>YES</td><td>Complete</td><td>Detailed information with additional documents</td><td>Partial</td><td>No data on the market<br>Some information on R&D</td><td>Partial</td><td>Only some questions are answered</td></tr><tr><td>Latvia</td><td>YES</td><td>Complete</td><td>Detailed information with additional documents</td><td>Partial</td><td>There is some data on the authorized uses</td><td>Not completed</td><td>Only yes/no questions were covered</td></tr></tbody></table>
<table><thead><tr><th rowspan="2">Member State</th><th rowspan="2">Answers to questionnaire received?</th><th colspan="2">Part 1: Regulatory framework</th><th colspan="2">Part 2: Market, uses and potential for development</th><th colspan="2">Part 3: Perspectives</th></tr><tr><th>Completion rate</th><th>Quality and reliability of the data</th><th>Completion rate</th><th>Quality and reliability of the data</th><th>Completion rate</th><th>Quality and reliability of the data</th></tr></thead><tbody><tr><td>Lithuania</td><td>YES</td><td>Partial</td><td>No regulatory framework specific to IBCA but reference to the general framework was provided. There seems to be a risk assessment</td><td></td><td>No data on the market available to NCA<br>Large information on R&D</td><td></td><td></td></tr><tr><td>Luxembourg</td><td>YES (interview only)</td><td>NA</td><td>No regulation. Interview showed that the Nature protection law regulates the introduction of non-indigenous species for agricultural production.</td><td>Not completed</td><td>There is no data available on market and uses. Limited use and market (interview)</td><td>Partial</td><td>A few elements were covered in the interview</td></tr></tbody></table>
<table><thead><tr><th rowspan="2">Member State</th><th rowspan="2">Answers to questionnaire received?</th><th colspan="2">Part 1: Regulatory framework</th><th colspan="2">Part 2: Market, uses and potential for development</th><th colspan="2">Part 3: Perspectives</th></tr><tr><th>Completion rate</th><th>Quality and reliability of the data</th><th>Completion rate</th><th>Quality and reliability of the data</th><th>Completion rate</th><th>Quality and reliability of the data</th></tr></thead><tbody><tr><td>Malta</td><td>No</td><td>NA</td><td>Desk research showed the absence of a regulatory framework</td><td></td><td>Desk research suggests that there are few uses in Malta</td><td></td><td></td></tr><tr><td>Netherlands</td><td>YES (complemented with an interview)</td><td>Complete</td><td>Detailed information with additional documents</td><td>Partial</td><td>Estimation of surface covered by IBCA in greenhouses. Number and detail of authorized pesticide uses</td><td>Complete</td><td>Views are expressed and most questions answered</td></tr><tr><td>Poland</td><td>YES</td><td>Complete</td><td>No regulatory framework</td><td>Partial</td><td>Some information regarding the current uses of IBCAs</td><td>Complete</td><td>Views are expressed and most questions answered</td></tr><tr><td>Portugal</td><td>YES (interview only)</td><td>NA</td><td>There is no regulatory framework specific to IBCAs yet, but some elements of the future legislation could be collected</td><td>Not completed</td><td>No data is available Qualitative information on the market (growing market)</td><td>Partial</td><td>Views on EU options were expressed by email</td></tr></tbody></table>
<table><thead><tr><th rowspan="2">Member State</th><th rowspan="2">Answers to questionnaire received?</th><th colspan="2">Part 1: Regulatory framework</th><th colspan="2">Part 2: Market, uses and potential for development</th><th colspan="2">Part 3: Perspectives</th></tr><tr><th>Completion rate</th><th>Quality and reliability of the data</th><th>Completion rate</th><th>Quality and reliability of the data</th><th>Completion rate</th><th>Quality and reliability of the data</th></tr></thead><tbody><tr><td>Romania</td><td>YES</td><td>NA</td><td>There is no regulatory framework</td><td>Partial</td><td>Estimated data on uses, data on pesticides<br>Qualitative information on the market (small market relying on imported IBCA)</td><td>Complete</td><td>Views are expressed and most questions answered</td></tr><tr><td>Slovakia</td><td>YES</td><td>Complete</td><td>Detailed answers</td><td>Partial</td><td>There is some data on the authorized uses<br>No data on the market</td><td>Not completed</td><td></td></tr><tr><td>Slovenia</td><td>YES</td><td>Complete</td><td>Detailed information with additional documents</td><td>Complete</td><td>A large quantity of data was provided on the uses including crop distribution, market value, production costs</td><td>Complete</td><td>Views are expressed and most questions answered</td></tr><tr><td>Spain</td><td>YES (complemented</td><td>Complete</td><td>Detailed information with</td><td>Not completed</td><td>No data was communicated but might exist</td><td>Not completed</td><td></td></tr></tbody></table>
<table><thead><tr><th rowspan="2">Member State</th><th rowspan="2">Answers to questionnaire received?</th><th colspan="2">Part 1: Regulatory framework</th><th colspan="2">Part 2: Market, uses and potential for development</th><th colspan="2">Part 3: Perspectives</th></tr><tr><th>Completion rate</th><th>Quality and reliability of the data</th><th>Completion rate</th><th>Quality and reliability of the data</th><th>Completion rate</th><th>Quality and reliability of the data</th></tr></thead><tbody><tr><td></td><td>with an interview)</td><td></td><td>additional documents</td><td></td><td></td><td></td><td></td></tr><tr><td>Sweden</td><td>YES (complemented with an interview)</td><td>Complete</td><td>Detailed information with additional documents</td><td>Complete</td><td>A large quantity of data was provided on the uses including crop distribution, market value, production costs</td><td>Complete</td><td>Views are expressed and most questions answered thoroughly</td></tr></tbody></table>
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